November 1, 2023
Kyowa Kirin Co., Ltd.
Appendix to the Consolidated Financial Summary (IFRS)
Fiscal 2023 Third Quarter
(January 1, 2023 - September 30, 2023)
- These materials were made as a supplement to the Kessan Tanshin (Consolidated Financial Summary, IFRS), disclosed at the Tokyo Stock Exchange on November 1, 2023 for the first nine months of Fiscal 2023, from January 1, 2023 to September 30, 2023.
- This document is an English translation of the Japanese-language original.
- The statements, including earnings forecasts, contained in these materials are based on the information currently available to the Company and on certain assumptions deemed to be reasonable by management. As such, they do not constitute guarantees by the Company of future performance. Actual results may differ materially from these projections for a wide variety of reasons.
- Figures presented in these materials have been rounded to the nearest tenth
- Figures inside parenthesis presented in these materials indicate negative values.
- Change amount in these materials presents change amount compared to the same period of the previous fiscal year.
Index | Page |
- Consolidated Financial Results
1. | Trends in consolidated profit | 1 |
2. | Revenue by regional control function | 2 |
3. | Revenue by location of customer | 2 |
4. | Capital expenditures and intangible assets investment, | 2 |
depreciation and amortization | ||
5. | Number of employees by regional control function | 2 |
II. Consolidated Statement of Cash Flows | 2 | |
Ⅲ. Revenue from Main Products | 3 | |
Ⅳ. R&D Pipeline | 6 |
The average exchange rates for each period were as follows:
Unit: Yen | |||||||||
FY 2022 results | FY 2023 results | FY 2023 | |||||||
forecasts | |||||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | ||
USD | 114 | 120 | 126 | 130 | 132 | 134 | 137 | 130 | |
GBP | 154 | 158 | 160 | 161 | 161 | 164 | 170 | 160 | |
EUR | 129 | 133 | 135 | 137 | 141 | 144 | 148 | 135 |
Contact
Kyowa Kirin Co., Ltd.
Corporate Communications Department
Tel +81 3 5205 7206
Ⅰ . Consolidated Financial Results
1. Trends in consolidated profit
The "★" symbol indicates financial KPIs (numerical guidance) that were set as targets in the FY2021-2025 Medium Term Business Plan. | Unit: Billions of yen | FY2021-2025 | |||||||||||
FY 2022 results | FY 2023 results | FY 2023 forecasts | |||||||||||
Change | Rate of | Medium Term | |||||||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Progress | Business Plan | ||||
amount | change | Financial KPIs | |||||||||||
Revenue | 87.8 | 185.3 | 283.8 | 398.4 | 93.5 | 199.2 | 306.1 | 22.3 | 8% | 426.0 | 72% | ||
★ CAGR (compared to FY 2020) | - | - | - | 11.9% | - | - | - | - | - | 10.2% | - | 10% or higher | |
Cost of sales | (22.2) | (43.4) | (64.1) | (86.9) | (18.9) | (47.0) | (77.0) | (12.8) | 20% | (100.0) | 77% | ||
Gross profit | 65.6 | 141.9 | 219.6 | 311.5 | 74.6 | 152.2 | 229.1 | 9.4 | 4% | 326.0 | 70% | ||
Gross profit to revenue ratio | 74.7% | 76.6% | 77.4% | 78.2% | 79.7% | 76.4% | 74.8% | - | - | 76.5% | - | ||
Selling, general and administrative | (36.1) | (76.4) | (117.3) | (166.2) | (41.8) | (82.4) | (119.3) | (2.0) | 2% | (162.0) | 74% | ||
expenses | |||||||||||||
Research and development expenses | (13.6) | (27.9) | (44.1) | (62.9) | (16.6) | (33.7) | (51.2) | (7.0) | 16% | (79.0) | 65% | ||
★ R&D expense ratio | 15.5% | 15.1% | 15.6% | 15.8% | 17.8% | 16.9% | 16.7% | - | - | 18.5% | - | Target of 18-20% | |
Share of profit (loss) of investments | 1.4 | 2.4 | 2.6 | 4.3 | 0.8 | 1.4 | 2.3 | (0.4) | (14)% | 3.0 | 76% | ||
accounted for using equity method | |||||||||||||
Core operating profit | 17.3 | 39.9 | 60.9 | 86.7 | 17.0 | 37.5 | 60.9 | 0.0 | 0% | 88.0 | 69% | ||
★ Core operating profit ratio | 19.8% | 21.5% | 21.4% | 21.8% | 18.2% | 18.8% | 19.9% | - | - | 20.7% | - | 25% or higher | |
Other income | 0.4 | 0.6 | 1.0 | 1.7 | 0.2 | 0.5 | 16.6 | 15.6 | - | ||||
Other expenses | (0.2) | (1.2) | (5.1) | (23.1) | (2.6) | (14.2) | (16.6) | (11.6) | 228% | ||||
Finance income (costs) | 1.2 | 4.2 | 3.6 | 2.2 | 1.0 | 2.2 | 3.5 | (0.0) | (2)% | ||||
Profit before tax | 18.7 | 43.5 | 60.4 | 67.6 | 15.6 | 26.0 | 64.3 | 3.9 | 7% | 86.0 | 75% | ||
Income tax expense | (2.7) | (8.5) | (11.2) | (14.0) | (2.8) | (4.4) | (10.8) | 0.4 | (4)% | (16.0) | 67% | ||
Ratio of income tax burden | 14.3% | 19.5% | 18.5% | 20.7% | 18.1% | 16.9% | 16.8% | - | - | 18.6% | - | ||
Profit | 16.0 | 35.0 | 49.2 | 53.6 | 12.8 | 21.6 | 53.6 | 4.3 | 9% | 70.0 | 77% | ||
Profit to revenue ratio | 18.3% | 18.9% | 17.3% | 13.4% | 13.6% | 10.9% | 17.5% | - | - | 16.4% | - | ||
EPS (¥/share) | 29.85 | 65.16 | 91.57 | 99.68 | 23.74 | 40.27 | 99.62 | 8.05 | - | 130.23 | - | ||
Core EPS (¥/share)*1 | 29.52 | 66.14 | 97.70 | 131.19 | 27.33 | 61.40 | 99.69 | 1.99 | - | 136.37 | - | ||
Annual dividend (¥/share) | 51.00 | 54.00 | - | ||||||||||
★ Dividend payout ratio (%)*2 | 38.9 | 39.6 | - | Target of 40% | |||||||||
★ROE (%) | 7.1 | 8.9 | - | 10% or higher |
*1 Core EPS is calculated as an indicator showing recurring profitability by dividing core profit (determined by subtracting "other income," "other expenses" and the related "income tax expense" from "profit") by the average number of shares during the period.
*2 Dividend payout ratio is shown based on core EPS.
Unit: Billions of yen | |||||||||
FY 2022 results | FY 2023 results | ||||||||
Jan - Mar | Apr - Jun | Jul - Sep | Oct - Dec | Jan - Mar | Apr - Jun | Jul - Sep | Change | Rate of | |
amount | change | ||||||||
Revenue | 87.8 | 97.5 | 98.5 | 114.6 | 93.5 | 105.7 | 106.8 | 8.3 | 8% |
Cost of sales | (22.2) | (21.2) | (20.8) | (22.8) | (18.9) | (28.1) | (29.9) | (9.2) | 44% |
Gross profit | 65.6 | 76.3 | 77.7 | 91.8 | 74.6 | 77.6 | 76.9 | (0.8) | (1)% |
Gross profit to revenue ratio | 74.7% | 78.2% | 78.9% | 80.1% | 79.7% | 73.4% | 72.0% | - | - |
Selling, general and administrative | (36.1) | (40.4) | (40.8) | (48.9) | (41.8) | (40.6) | (36.9) | 3.9 | (10)% |
expenses | |||||||||
Research and development expenses | (13.6) | (14.3) | (16.2) | (18.8) | (16.6) | (17.0) | (17.5) | (1.3) | 8% |
★ R&D expense ratio | 15.5% | 14.7% | 16.5% | 16.4% | 17.8% | 16.1% | 16.4% | - | - |
Share of profit (loss) of investments | 1.4 | 0.9 | 0.3 | 1.7 | 0.8 | 0.6 | 0.9 | 0.6 | 233% |
accounted for using equity method | |||||||||
Core operating profit | 17.3 | 22.6 | 21.0 | 25.8 | 17.0 | 20.5 | 23.4 | 2.5 | 12% |
★ Core operating profit ratio | 19.8% | 23.1% | 21.3% | 22.5% | 18.2% | 19.4% | 21.9% | - | - |
Other income | 0.4 | 0.2 | 0.5 | 0.7 | 0.2 | 0.3 | 16.1 | 15.6 | - |
Other expenses | (0.2) | (1.0) | (3.9) | (18.0) | (2.6) | (11.6) | (2.5) | 1.4 | (36)% |
Finance income (costs) | 1.2 | 3.1 | (0.6) | (1.4) | 1.0 | 1.3 | 1.3 | 1.9 | - |
Profit before tax | 18.7 | 24.8 | 16.9 | 7.2 | 15.6 | 10.5 | 38.3 | 21.4 | 126% |
Income tax expense | (2.7) | (5.8) | (2.7) | (2.8) | (2.8) | (1.6) | (6.4) | (3.7) | 134% |
Profit | 16.0 | 19.0 | 14.2 | 4.4 | 12.8 | 8.9 | 31.9 | 17.7 | 125% |
Profit to revenue ratio | 18.3% | 19.5% | 14.4% | 3.8% | 13.6% | 8.4% | 29.9% | - | - |
- 1 -
2. Revenue by regional control function | Unit: Billions of yen | ||||||||||
FY 2022 results | FY 2023 results | FY 2023 forecasts | |||||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | Jan - Jun | Jan - Sep | Change | Jan - Dec | Progress | ||
amount | |||||||||||
Japan | 35.4 | 72.8 | 109.2 | 148.7 | 34.0 | 70.9 | 107.0 | (2.3) | 145.6 | 73% | |
North America | 20.7 | 47.5 | 75.9 | 112.6 | 25.7 | 60.3 | 92.9 | 17.0 | 132.5 | 70% | |
EMEA | 14.5 | 30.9 | 48.0 | 66.9 | 15.4 | 30.8 | 45.7 | (2.3) | 66.1 | 69% | |
APAC | 7.2 | 14.8 | 22.5 | 30.1 | 7.4 | 16.0 | 26.0 | 3.5 | 34.5 | 75% | |
Others | 9.8 | 19.3 | 28.1 | 40.1 | 11.0 | 21.2 | 34.5 | 6.3 | 47.4 | 73% | |
Total consolidated revenue | 87.8 | 185.3 | 283.8 | 398.4 | 93.5 | 199.2 | 306.1 | 22.3 | 426.0 | 72% |
- Revenue by regional control function is classified based on consolidated revenue from products of regional control functions in the One Kyowa Kirin (OKK) matrix global management structure, which combines a regional organization based on four regions of Japan, North America, EMEA and APAC, a functional organization, and a product organization (product franchises).
- EMEA consists of Europe, the Middle East, Africa, etc.
- Others consists of revenue from technology out-licensing, original equipment manufacturing, etc.
3. Revenue by location of customer | Unit: Billions of yen | ||||||||||||
FY 2022 results | FY 2023 results | FY 2023 forecasts | |||||||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Percentage of | Jan - Mar | Jan - Jun | Jan - Sep | Percentage of | Jan - Dec | Percentage of | |||
consolidated | consolidated | consolidated | |||||||||||
revenue | revenue | revenue | |||||||||||
Japan | 36.9 | 75.8 | 111.3 | 154.6 | 39% | 35.0 | 73.7 | 111.1 | 36% | 153.3 | 36% | ||
International | 50.9 | 109.5 | 172.5 | 243.7 | 61% | 58.5 | 125.6 | 194.9 | 64% | 272.7 | 64% | ||
Americas | 28.2 | 62.2 | 99.8 | 143.9 | 36% | 34.2 | 76.9 | 121.5 | 40% | 169.2 | 40% | ||
Of which, the U.S. | 27.3 | 60.3 | 97.1 | 139.9 | 35% | 32.8 | 74.4 | 117.7 | 38% | 162.6 | 38% | ||
Europe | 13.5 | 28.8 | 44.9 | 62.3 | 16% | 14.4 | 28.5 | 40.9 | 13% | 61.9 | 15% | ||
Asia | 9.1 | 18.4 | 27.6 | 37.4 | 9% | 9.7 | 19.8 | 31.9 | 10% | 40.9 | 10% | ||
Others | 0.0 | 0.1 | 0.2 | 0.2 | 0% | 0.2 | 0.4 | 0.7 | 0% | 0.7 | 0% | ||
Total consolidated revenue | 87.8 | 185.3 | 283.8 | 398.4 | 100% | 93.5 | 199.2 | 306.1 | 100% | 426.0 | 100% | ||
* Revenue by location of customer is classified by region or country based on location of customer.
4. Capital expenditures and intangible assets investment, depreciation and amortization | Unit: Billions of yen | |||||||
FY 2022 results | FY 2023 results | FY 2023 | ||||||
forecasts | ||||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | |
Capital expenditures (property, plant and equipment)* | 1.8 | 5.0 | 10.3 | 17.7 | 3.7 | 7.0 | 10.5 | 24.0 |
Intangible assets investment | 1.0 | 3.1 | 4.9 | 13.3 | 2.3 | 4.7 | 13.6 | 15.0 |
Total | 2.8 | 8.2 | 15.2 | 31.0 | 6.0 | 11.7 | 24.1 | 39.0 |
Depreciation (property, plant and equipment) | 2.9 | 6.0 | 9.0 | 11.4 | 3.1 | 6.3 | 9.7 | 13.0 |
Amortization (intangible assets) | 1.7 | 3.5 | 5.3 | 7.0 | 1.8 | 3.6 | 5.8 | 7.0 |
Total | 4.6 | 9.5 | 14.3 | 18.5 | 4.8 | 9.9 | 15.5 | 20.0 |
- Acquisitions of right-of-use assets are not included.
5. Number of employees by regional control function
FY 2022 results | FY 2023 results | |||||||
As of March 31 | As of June 30 | As of September | As of December | As of March 31 | As of June 30 | As of September | Change | |
30 | 31 | 30 | amount | |||||
Japan | 4,035 | 4,114 | 4,146 | 4,135 | 4,154 | 4,236 | 4,207 | 61 |
North America | 446 | 490 | 532 | 560 | 574 | 608 | 630 | 98 |
EMEA | 781 | 768 | 747 | 729 | 743 | 714 | 587 | (160) |
APAC | 536 | 540 | 555 | 558 | 571 | 578 | 568 | 13 |
Total | 5,798 | 5,912 | 5,980 | 5,982 | 6,042 | 6,136 | 5,991 | 11 |
Ⅱ. Consolidated Statement of Cash Flows
Unit: Billions of yen
FY 2022 results | FY 2023 results | |||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | Jan - Jun | Jan - Sep | Change | |
amount | ||||||||
Cash flows from operating activities | 8.8 | 22.5 | 35.5 | 48.7 | 29.4 | 60.3 | 84.3 | 48.7 |
Cash flows from investing activities | (4.6) | (6.8) | (13.4) | (17.2) | (9.1) | (14.0) | (12.5) | 0.9 |
Cash flows from financing activities | (13.2) | (14.1) | (27.9) | (29.0) | (15.2) | (16.1) | (31.4) | (3.5) |
Effect of exchange rate changes on cash and cash equivalents | 0.4 | 3.3 | 3.5 | 1.7 | 0.5 | 2.6 | 2.7 | (0.8) |
Net increase (decrease) in cash and cash equivalents | (8.6) | 4.8 | (2.3) | 4.1 | 5.7 | 32.9 | 43.1 | 45.4 |
Cash and cash equivalents at beginning of period | 335.1 | 335.1 | 335.1 | 335.1 | 339.2 | 339.2 | 339.2 | 4.1 |
Cash and cash equivalents at end of period | 326.5 | 339.9 | 332.8 | 339.2 | 344.8 | 372.1 | 382.3 | 49.5 |
- 2 -
Ⅲ. Revenue from Main Products
Unit: Billions of yen | |||||||||||
FY 2022 results | FY 2023 results | FY 2023 | |||||||||
forecasts | |||||||||||
Product name | |||||||||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | Jan - Jun | Jan - Sep | Change | Jan - Dec | Progress | ||
amount | |||||||||||
Nesp | 0.8 | 1.6 | 2.5 | 3.4 | 0.8 | 1.5 | 2.3 | (0.2) | 2.8 | 82% | |
Darbepoetin Alfa Injection Syringe [KKF] | 4.4 | 8.8 | 13.2 | 17.6 | 3.5 | 6.9 | 10.3 | (2.9) | 13.8 | 75% | |
Duvroq | 1.1 | 2.7 | 4.4 | 6.6 | 1.8 | 4.2 | 6.9 | 2.4 | 7.8 | 88% | |
Regpara | 0.5 | 1.1 | 1.7 | 2.2 | 0.4 | 0.8 | 1.2 | (0.4) | 2.1 | 60% | |
Orkedia | 2.2 | 4.9 | 7.5 | 10.3 | 2.2 | 5.0 | 7.6 | 0.1 | 11.2 | 68% | |
Rocaltrol | 0.7 | 1.5 | 2.3 | 3.1 | 0.7 | 1.4 | 2.1 | (0.2) | 2.4 | 86% | |
Onglyza | 1.2 | 2.6 | 3.8 | 5.2 | 1.1 | 2.2 | 3.2 | (0.6) | 4.3 | 74% | |
Coniel | 0.6 | 1.1 | 1.6 | 2.0 | 0.4 | 0.7 | 1.1 | (0.5) | 1.4 | 76% | |
G-Lasta | 7.1 | 14.8 | 22.7 | 31.1 | 7.0 | 15.0 | 23.2 | 0.5 | 33.5 | 69% | |
Japan | Fentos | 0.8 | 1.8 | 2.7 | 3.7 | 0.7 | 1.6 | 2.5 | (0.2) | 3.3 | 76% |
Poteligeo | 0.5 | 1.0 | 1.5 | 2.0 | 0.4 | 0.9 | 1.4 | (0.0) | 2.0 | 73% | |
Rituximab BS [KHK] | 2.5 | 5.0 | 7.6 | 10.3 | 2.2 | 4.4 | 6.7 | (0.9) | 8.7 | 77% | |
Romiplate | 2.2 | 4.8 | 7.5 | 10.4 | 2.7 | 5.7 | 8.7 | 1.2 | 11.2 | 77% | |
Allelock | 2.4 | 3.8 | 4.8 | 6.0 | 1.9 | 3.1 | 4.1 | (0.6) | 4.7 | 88% | |
Patanol | 1.8 | 2.2 | 2.4 | 2.8 | 1.4 | 1.5 | 1.7 | (0.7) | 1.9 | 90% | |
Dovobet | 1.7 | 3.8 | 5.6 | 7.8 | 1.8 | 3.9 | 5.7 | 0.1 | 7.6 | 75% | |
Lumicef | 0.7 | 1.5 | 2.2 | 3.0 | 0.6 | 1.3 | 2.1 | (0.1) | 3.5 | 59% | |
Nouriast | 1.8 | 3.9 | 5.9 | 8.0 | 1.7 | 3.7 | 5.5 | (0.3) | 7.5 | 73% | |
HARUROPI | 0.8 | 1.8 | 2.8 | 4.0 | 0.9 | 2.1 | 3.2 | 0.4 | 4.7 | 68% | |
Depakene | 0.8 | 1.7 | 2.5 | 3.3 | 0.6 | 1.4 | 2.1 | (0.4) | 3.0 | 69% | |
Crysvita | 2.0 | 4.1 | 6.4 | 8.9 | 2.3 | 4.8 | 7.4 | 1.0 | 11.1 | 67% | |
Crysvita | 22.2 | 49.4 | 78.7 | 118.2 | 27.1 | 61.9 | 95.7 | 17.0 | 138.0 | 69% | |
Poteligeo | 4.2 | 10.3 | 16.1 | 22.3 | 5.8 | 12.5 | 19.9 | 3.8 | 27.5 | 72% | |
Nourianz | 1.1 | 2.6 | 4.5 | 6.5 | 1.7 | 3.5 | 5.5 | 1.0 | 7.5 | 73% | |
International | Abstral | 1.4 | 3.6 | 5.4 | 6.9 | 1.1 | 2.6 | 2.9 | (2.4) | 2.0 | 149% |
Pecfent | 1.0 | 1.7 | 3.0 | 3.7 | 0.9 | 1.7 | 2.1 | (0.9) | 1.2 | 169% | |
Moventig | 0.7 | 1.5 | 2.2 | 3.1 | 0.8 | 1.6 | 1.9 | (0.4) | 1.2 | 155% | |
Adcal-D3 | 0.7 | 1.5 | 2.2 | 3.0 | 0.7 | 1.5 | 1.7 | (0.5) | 1.2 | 134% | |
Nesp | 1.9 | 3.9 | 5.9 | 7.6 | 2.2 | 4.4 | 7.0 | 1.2 | 8.0 | 89% | |
Regpara | 1.0 | 2.0 | 2.9 | 3.9 | 0.9 | 1.9 | 3.1 | 0.1 | 3.9 | 79% | |
Neulasta/Peglasta | 1.7 | 3.0 | 4.4 | 5.6 | 1.3 | 2.8 | 4.5 | 0.1 | 5.7 | 79% | |
Gran | 2.1 | 3.8 | 6.4 | 8.2 | 1.4 | 3.2 | 5.2 | (1.2) | 8.2 | 63% | |
Technology out-licensing | 7.8 | 15.7 | 23.8 | 33.8 | 9.2 | 18.4 | 30.1 | 6.3 | 40.2 | 75% | |
Of which, Benralizumab royalty | 4.7 | 9.3 | 15.4 | 21.6 | 5.7 | 11.6 | 19.1 | 3.8 |
- Revenue from products is classified into Japan or international (other than Japan) based on consolidated revenue of regional control functions.
- Revenue listed as "Technology out-licensing" represents the upfront income, milestone revenue and running royalty income that are obtained based on licensing agreements recognizing the granting to third parties the rights for development, manufacturing and sales of the Group's pipeline compounds or the use of technology, etc.
- The revenue for Abstral, Pecfent, Moventig and Adcal-D3 does not include the royalties revenue from the joint venture with Grünenthal in August 2023 and thereafter.
- Benralizumab royalty only refers to the royalty on sales of Fasenra by AstraZeneca (including the Company's own estimates).
- 3 -
Ⅲ. Revenue from Main Products
Product name
Nesp | |
Darbepoetin Alfa Injection Syringe [KKF] | |
Duvroq | |
Regpara | |
Orkedia | |
Rocaltrol | |
Onglyza | |
Coniel | |
G-Lasta | |
Japan | Fentos |
Poteligeo | |
Rituximab BS [KHK] | |
Romiplate | |
Allelock | |
Patanol | |
Dovobet | |
Lumicef | |
Nouriast | |
HARUROPI | |
Depakene | |
Crysvita | |
Unit: Billions of yen
FY 2022 results | FY 2023 results | ||||||
Jan - Mar | Apr - Jun | Jul - Sep | Oct - Dec | Jan - Mar | Apr - Jun | Jul - Sep | Change |
amount | |||||||
0.8 | 0.8 | 0.9 | 0.9 | 0.8 | 0.8 | 0.8 | (0.1) |
4.4 | 4.4 | 4.4 | 4.4 | 3.5 | 3.4 | 3.5 | (0.9) |
1.1 | 1.6 | 1.8 | 2.1 | 1.8 | 2.4 | 2.6 | 0.9 |
0.5 | 0.6 | 0.5 | 0.5 | 0.4 | 0.5 | 0.4 | (0.1) |
2.2 | 2.7 | 2.6 | 2.8 | 2.2 | 2.7 | 2.6 | (0.0) |
0.7 | 0.8 | 0.8 | 0.8 | 0.7 | 0.7 | 0.7 | (0.1) |
1.2 | 1.3 | 1.3 | 1.3 | 1.1 | 1.1 | 1.0 | (0.2) |
0.6 | 0.5 | 0.4 | 0.4 | 0.4 | 0.4 | 0.4 | (0.1) |
7.1 | 7.7 | 7.9 | 8.4 | 7.0 | 7.9 | 8.2 | 0.4 |
0.8 | 1.0 | 0.9 | 1.0 | 0.7 | 0.9 | 0.9 | (0.1) |
0.5 | 0.5 | 0.5 | 0.5 | 0.4 | 0.5 | 0.5 | 0.0 |
2.5 | 2.5 | 2.5 | 2.7 | 2.2 | 2.3 | 2.2 | (0.3) |
2.2 | 2.6 | 2.7 | 2.9 | 2.7 | 3.0 | 3.0 | 0.2 |
2.4 | 1.4 | 0.9 | 1.2 | 1.9 | 1.2 | 1.0 | 0.1 |
1.8 | 0.3 | 0.3 | 0.4 | 1.4 | 0.2 | 0.2 | (0.1) |
1.7 | 2.1 | 1.8 | 2.1 | 1.8 | 2.1 | 1.8 | (0.0) |
0.7 | 0.8 | 0.7 | 0.8 | 0.6 | 0.7 | 0.7 | (0.0) |
1.8 | 2.1 | 2.0 | 2.1 | 1.7 | 2.0 | 1.9 | (0.1) |
0.8 | 1.0 | 1.0 | 1.2 | 0.9 | 1.1 | 1.1 | 0.1 |
0.8 | 0.8 | 0.8 | 0.8 | 0.6 | 0.7 | 0.7 | (0.1) |
2.0 | 2.2 | 2.3 | 2.5 | 2.3 | 2.5 | 2.6 | 0.3 |
Crysvita | 22.2 | 27.2 | 29.3 | 39.5 | 27.1 | 34.8 | 33.8 | 4.5 | |
Poteligeo | 4.2 | 6.1 | 5.8 | 6.2 | 5.8 | 6.6 | 7.5 | 1.7 | |
Nourianz | 1.1 | 1.4 | 1.9 | 2.0 | 1.7 | 1.9 | 2.0 | 0.1 | |
International | Abstral | 1.4 | 2.2 | 1.8 | 1.5 | 1.1 | 1.4 | 0.4 | (1.4) |
Pecfent | 1.0 | 0.7 | 1.3 | 0.7 | 0.9 | 0.9 | 0.4 | (1.0) | |
Moventig | 0.7 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.3 | (0.5) | |
Adcal-D3 | 0.7 | 0.8 | 0.7 | 0.8 | 0.7 | 0.8 | 0.2 | (0.5) | |
Nesp | 1.9 | 2.0 | 2.0 | 1.7 | 2.2 | 2.2 | 2.6 | 0.7 | |
Regpara | 1.0 | 1.0 | 0.9 | 1.0 | 0.9 | 1.0 | 1.2 | 0.2 | |
Neulasta/Peglasta | 1.7 | 1.3 | 1.4 | 1.3 | 1.3 | 1.5 | 1.7 | 0.3 | |
Gran | 2.1 | 1.8 | 2.5 | 1.8 | 1.4 | 1.8 | 2.0 | (0.6) | |
Technology out-licensing | 7.8 | 7.9 | 8.1 | 10.0 | 9.2 | 9.2 | 11.8 | 3.6 | |
Of which, Benralizumab royalty | 4.7 | 4.6 | 6.1 | 6.2 | 5.7 | 5.9 | 7.5 | 1.4 |
- Revenue from products is classified into Japan or international (other than Japan) based on consolidated revenue of regional control functions.
- Revenue listed as "Technology out-licensing" represents the upfront income, milestone revenue and running royalty income that are obtained based on licensing agreements recognizing the granting to third parties the rights for development, manufacturing and sales of the Group's pipeline compounds or the use of technology, etc.
- The revenue for Abstral, Pecfent, Moventig and Adcal-D3 does not include the royalties revenue from the joint venture with Grünenthal in August 2023 and thereafter.
- Benralizumab royalty only refers to the royalty on sales of Fasenra by AstraZeneca (including the Company's own estimates).
- 4 -
Ⅲ. Revenue from Main Products
Revenue of three global strategic products
Unit: Billions of yen | ||||
FY 2022 results | FY 2023 results | FY 2023 forecasts | ||
Product name | ||||
Jan - Mar Jan - Jun Jan - Sep Jan - Dec | Jan - Mar Jan - Jun Jan - Sep | Change | Jan - Dec Progress | |
amount | ||||
Crysvita | 24.2 | 53.5 | 85.1 | 127.1 | 29.4 | 66.7 | 103.1 | 18.0 | 149.1 | 69% | ||
Japan | 2.0 | 4.1 | 6.4 | 8.9 | 2.3 | 4.8 | 7.4 | 1.0 | 11.1 | 67% | ||
North America | 15.8 | 35.9 | 57.4 | 87.0 | 18.8 | 46.0 | 70.2 | 12.8 | ||||
[Millions of USD] | 139 | 298 | 456 | 662 | 143 | 344 | 530 | 74 | ||||
EMEA | 6.3 | 13.5 | 21.2 | 31.0 | 8.0 | 15.3 | 24.5 | 3.2 | 138.0 | 69% | ||
[Millions of GBP] | 41 | 85 | 133 | 192 | 50 | 93 | 151 | 18 | ||||
APAC | 0.0 | 0.1 | 0.1 | 0.3 | 0.3 | 0.6 | 1.1 | 0.9 | ||||
Poteligeo | 4.7 | 11.3 | 17.5 | 24.2 | 6.3 | 13.4 | 21.3 | 3.8 | 29.5 | 72% | ||
Japan | 0.5 | 1.0 | 1.5 | 2.0 | 0.4 | 0.9 | 1.4 | (0.0) | 2.0 | 73% | ||
North America | 3.3 | 8.1 | 12.6 | 17.2 | 4.3 | 9.4 | 15.1 | 2.5 | 19.4 | 78% | ||
[Millions of USD] | 29 | 67 | 100 | 132 | 33 | 70 | 114 | 14 | 149 | |||
EMEA | 0.9 | 2.1 | 3.5 | 5.1 | 1.5 | 3.1 | 4.8 | 1.3 | 8.0 | 61% | ||
[Millions of GBP] | 6 | 14 | 22 | 32 | 9 | 19 | 30 | 8 | 50 | |||
APAC | - | - | - | - | - | - | 0.0 | 0.0 | - | - | ||
Nouriast/Nourianz | 2.9 | 6.5 | 10.3 | 14.5 | 3.3 | 7.2 | 11.0 | 0.7 | 15.1 | 73% | ||
Japan | 1.8 | 3.9 | 5.9 | 8.0 | 1.7 | 3.7 | 5.5 | (0.3) | 7.5 | 73% | ||
North America | 1.1 | 2.6 | 4.5 | 6.5 | 1.7 | 3.5 | 5.5 | 1.0 | 7.5 | 73% | ||
Total of three global | 31.8 | 71.3 | 113.0 | 165.8 | 39.0 | 87.3 | 135.5 | 22.5 | 193.6 | 70% | ||
strategic products | ||||||||||||
Unit: Billions of yen | ||||||||||||
Product name | FY 2022 results | FY 2023 results | ||||||||||
Jan - Mar | Apr - Jun | Jul - Sep | Oct - Dec | Jan - Mar | Apr - Jun | Jul - Sep | Change | |||||
amount | ||||||||||||
Crysvita | 24.2 | 29.4 | 31.6 | 42.0 | 29.4 | 37.3 | 36.4 | 4.8 | ||||
Japan | 2.0 | 2.2 | 2.3 | 2.5 | 2.3 | 2.5 | 2.6 | 0.3 | ||||
North America | 15.8 | 20.0 | 21.5 | 29.6 | 18.8 | 27.2 | 24.1 | 2.6 | ||||
[Millions of USD] | 139 | 159 | 158 | 206 | 143 | 202 | 186 | 28 | ||||
EMEA | 6.3 | 7.1 | 7.8 | 9.7 | 8.0 | 7.3 | 9.2 | 1.4 | ||||
[Millions of GBP] | 41 | 44 | 47 | 59 | 50 | 43 | 57 | 10 | ||||
APAC | 0.0 | 0.0 | 0.1 | 0.2 | 0.3 | 0.3 | 0.5 | 0.4 | ||||
Poteligeo | 4.7 | 6.6 | 6.3 | 6.7 | 6.3 | 7.1 | 8.0 | 1.7 | ||||
Japan | 0.5 | 0.5 | 0.5 | 0.5 | 0.4 | 0.5 | 0.5 | 0.0 | ||||
North America | 3.3 | 4.8 | 4.4 | 4.6 | 4.3 | 5.1 | 5.7 | 1.3 | ||||
[Millions of USD] | 29 | 38 | 33 | 32 | 33 | 37 | 44 | 11 | ||||
EMEA | 0.9 | 1.2 | 1.4 | 1.6 | 1.5 | 1.6 | 1.8 | 0.4 | ||||
[Millions of GBP] | 6 | 8 | 8 | 10 | 9 | 9 | 11 | 3 | ||||
APAC | - | - | - | - | - | - | 0.0 | 0.0 | ||||
Nouriast/Nourianz | 2.9 | 3.6 | 3.9 | 4.1 | 3.3 | 3.9 | 3.8 | (0.0) | ||||
Japan | 1.8 | 2.1 | 2.0 | 2.1 | 1.7 | 2.0 | 1.9 | (0.1) | ||||
North America | 1.1 | 1.4 | 1.9 | 2.0 | 1.7 | 1.9 | 2.0 | 0.1 | ||||
Total of three global | 31.8 | 39.5 | 41.7 | 52.8 | 39.0 | 48.3 | 48.2 | 6.5 | ||||
strategic products | ||||||||||||
- Revenue is classified based on consolidated revenue from regional control functions.
- The revenue, generated in various currencies inside each corporate region, is converted and aggregated in USD for North America and in GBP for EMEA.
- 5 -
Ⅳ.R&D Pipeline
antibody
Nephrology
protein | small molecule | ◎ New Molecular Entity | Updated since Dec. 31, 2022 | Updated since Jun. 30, 2023 |
As of Sep 30, 2023
Code Name
Generic Name
Formulation
KHK7580
Evocalcet
Oral
KW-3357
Antithrombin Gamma
Injection
KHK7791
Tenapanor Hydrochloride
Oral
KRN1493
Cinacalcet Hydrochloride
Oral
Oncology
Code Name
Generic Name
Formulation
KW-0761
Mogamulizumab
Injection
KRN125
Pegfilgrastim
Injection
Stage | ||||||
Mechanism of Action | Indication | Area | Approve | |||
PhⅠ | PhⅡ | PhⅢ | Filed | |||
d | ||||||
CN | ||||||
Calcimimetic | Secondary Hyperparathyroidism | KR | ||||
TW | ||||||
Recombinant Human | Preeclampsia | JP | ||||
Antithrombin | ||||||
NHE3 Inhibitor | Hyperphosphatemia in Patients | JP | ||||
on Dialysis | ||||||
Calcimimetic | Primary Hyperparathyroidism | HK |
Stage | ||||||
Mechanism of Action | Indication | Area | Approve | |||
PhⅠ | PhⅡ | PhⅢ | Filed | |||
d | ||||||
KW | ||||||
IL | ||||||
Anti-CCR4 Humanized | Mycosis Fungoides and | |||||
Antibody | Sézary Syndrome | |||||
ME | ||||||
RS | ||||||
Long-Acting | Mobilization of Hematopoietic | |||||
Stem Cells into Peripheral Blood | ||||||
Granulocyte Colony- | JP | |||||
Stimulating Factor | for Autologous Blood Stem Cell | |||||
Transplantation | ||||||
[In-House or Licensed]
Remarks
[Mitsubishi Tanabe Pharma] product name in Japan: Orkedia
[In-House]
product name in Japan: Acoalan
[Ardelyx]
[NPS Pharmaceuticals]
product name in Japan: Regpara
[In-House or Licensed]
Remarks
[In-House]
POTELLIGENT
product name in Japan, US and Europe: Poteligeo
[Amgen K-A]
product name in Japan: G-Lasta
-6-
Ⅳ.R&D Pipeline
antibody | protein | small molecule | ◎ New Molecular Entity | Updated since Dec. 31, 2022 |
Immunology/Allergy
Updated since Jun. 30, 2023
Code Name | Stage | ||||||
Generic Name | Mechanism of Action | Indication | Area | Approve | |||
Formulation | PhⅠ | PhⅡ | PhⅢ | Filed | |||
d | |||||||
Ankylosing Spondylitis | TH | ||||||
KHK4827 | Anti-IL-17 Receptor A | Non-radiographic Axial | TH | ||||
Brodalumab | Spondyloarthritis | ||||||
Fully Human Antibody | |||||||
Injection | |||||||
Palmoplantar Pustulosis | JP | ||||||
Systemic Sclerosis | JP | ||||||
JP | |||||||
NA | |||||||
◎KHK4083/AMG 451 | Europe | ||||||
Anti-OX40 Fully Human | Middle East | ||||||
Rocatinlimab | Atopic Dermatitis | ||||||
Antibody | CN | ||||||
Injection | |||||||
Asia | |||||||
Oceania | |||||||
others | |||||||
◎KK4277 | Autoimmune Disease | JP | |||||
Injection | Asia | ||||||
[In-House or Licensed]
Remarks
[Amgen K-A]
product name in Japan and Asia: Lumicef
[In-House]
POTELLIGENT
Fully human antibody production technology
Collaboration agreement with Amgen for the development of KHK4083/AMG 451 in all the countries except for Japan.
[SBI Biotech]
Other
Code Name | Stage | [In-House or Licensed] | ||||||
Generic Name | Mechanism of Action | Indication | Area | |||||
Approve | Remarks | |||||||
Formulation | PhⅠ | PhⅡ | PhⅢ | Filed | ||||
d | ||||||||
OM | ||||||||
QA | ||||||||
UAE |
Tumor Induced Osteomalacia | KW | ||
BH | |||
(TIO) | |||
RS | |||
KRN23 | Anti-FGF23 Fully | ME | |
Burosumab | |||
Human Antibody | |||
Injection | MK | ||
MO | |||
X-linked Hypophosphatemia | MK | ||
(XLH) | |||
RS | |||
ME |
[In-House]
Fully human antibody production technology
Jointly Developed with Ultragenyx in US and Europe product name in Japan, US and Europe: Crysvita
AMG531 | Thrombopoietin Receptor | Aplastic Anemia Previously | JP | [Amgen K-A] | |
Romiplostim | Agonist | Untreated with | PhⅡ/ | product name in Japan: | |
Injection | Immunosuppressive Therapy | Asia | Romiplate | ||
PhⅢ | |||||
KW-3357 | Recombinant Human | Disseminated Intravascular | [In-House] | ||
Antithrombin Gamma | Coagulation, Congenital | Europe | |||
Antithrombin | product name in Japan: Acoalan | ||||
Injection | Antithrombin Deficiency | ||||
KHK4951 | VEGF Receptor Tyrosine | Neovascular (wet) Age-Related | |||
Tivozanib | JP | [In-House] | |||
Kinase Inhibitor | Macular Degeneration | ||||
Ophthalmic | |||||
Note: Our main progress from September 30, 2023 is as follows.
We decided to discontinue the development of KW-3357 (product name in Japan: Acoalan) for treatment for preeclampsia in the nephrology field.
-7-
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Kyowa Hakko Kirin Co. Ltd. published this content on 01 November 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 November 2023 06:49:52 UTC.