On October 30, 2020 Kyowa Hakko Kirin reported that (Press release, Kyowa Hakko Kirin, OCT 30, 2020, View Source [SID1234569509])
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1. Consolidated Financial Results for the Nine Months Ended September 30, 2020
(2) Consolidated financial position
2. Dividends
3. Consolidated Earnings Forecasts for the Fiscal Year Ending December 31, 2020 (from January 1, 2020 to December 31, 2020)
(1) Changes to significant subsidiaries during the period (Changes of specified subsidiaries resulting in changes in the scope of consolidation during the period under review):
No (2) Changes in accounting policies, and accounting estimates: a. Changes in accounting policies required by IFRS: No b. Changes in accounting policies other than a. above: No c. Changes in accounting estimates:
No (3) Number of shares issued (ordinary shares) Quarterly financial results reports are exempt from quarterly review conducted by certified public accountants or an audit corporation.
* Notice regarding the appropriate use of the earnings forecasts and other special comments The forward-looking 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.
1. Operating Results and Financial Statements
(1) Summary of Consolidated Business Performance
1) Overview of results Since applying IFRS, the Group adopts "core operating profit" as a level of profit that shows the recurring profitability from operating activities. Core operating profit is calculated by deducting "selling, general and administrative expenses" and "research and development expenses" from "gross profit," and adding "share of profit (loss) of investments accounted for using equity method" to the amountFor the nine months ended September 30, 2020 (January 1, 2020 to September 30, 2020), revenue was ¥234.0 billion (up 3.8% compared to the same period of the previous fiscal year), and core operating profit was ¥50.7 billion (up 10.8%). Profit attributable to owners of parent was ¥37.5 billion (down 33.4%).
The increase in revenue was the result of steady growth of global strategic products in North America and EMEA and strong sales in Asia, mainly in China, despite the impact of lower revenue in Japan from the reduction in drug price standards and the switching to Darbepoetin Alfa Injection Syringe [KKF], an authorized generic of NESP, a renal anemia treatment drug, among others. The increase in core operating profit was the result of an increase in gross profit due to an increase in overseas revenue, despite an increase in selling, general and administrative expenses.
Profit attributable to owners of parent decreased as a result of the absence of the profit from discontinued operations recorded in the same period of the previous fiscal year, despite lower business restructuring expenses and impairment losses in addition to an increase in core operating profit. 2) Revenue by regional control function
Revenue in Japan decreased year on year because of the significant impact of switching to Darbepoetin Alfa Injection Syringe [KKF], an authorized generic of NESP, a renal anemia treatment drug whose patent has expired, in addition to the impact of the reductions in drug price standards implemented in October 2019 and April 2020, despite the growth in sales of new product groups.
Darbepoetin Alfa Injection Syringe [KKF] achieved rapid progress in switching from NESP, a renal anemia treatment drug.
Duvroq, an oral treatment for renal anemia, was launched in August, and it has started penetrating the market favorably.
Revenue from Patanol, anti-allergy eye drops, and ALLELOCK, an anti-allergy agent, decreased as a result of smaller pollen counts and the impact of the suppression of examinations, etc. due to the novel coronavirus disease (COVID-19). Revenue from ORKEDIA, a treatment for secondary hyperparathyroidism, increased. Meanwhile, revenue from REGPARA, a treatment for secondary hyperparathyroidism, decreased due to factors such as switching to ORKEDIA and the impact of rival products.
Revenue from ROMIPLATE, a treatment for chronic idiopathic thrombocytopenic purpura, increased as a result of receiving approval of its indication for treatment of patients with aplastic anemia who have had an inadequate response to conventional therapy, in June 2019.
Firm growth in revenue was realized for G-Lasta, an agent for decreasing the incidence of febrile neutropenia, and Rituximab BS [KHK], an anticancer agent.
In December 2019, Crysvita, a treatment for FGF23-related diseases, and HARUROPI, a Parkinson’s disease treatment patch, were launched and they have been penetrating the market favorably.
Revenue in North America increased year on year due to the steady growth of global strategic products.
Revenue from Crysvita, a treatment for X-linked hypophosphatemia, have been growing steadily since its launch in 2018.
Revenue from POTELIGEO, an anticancer agent, stayed at the same level as in the same period of the previous fiscal year due to the impact of the COVID-19 pandemic.
NOURIANZ (product name in Japan: NOURIAST), an antiparkinsonian agent which was launched in October 2019, has been penetrating the market favorably.
Revenue in EMEA increased year on year due to the steady growth of global strategic products.
Revenue from Crysvita, a treatment for X-linked hypophosphatemia, have been growing steadily as the number of countries where it has been released has been increasing since its launch in 2018.
In Germany, POTELIGEO, an anticancer agent, was launched in June, and has started penetrating the market favorably.
Revenue in Asia/Oceania increased year on year, reflecting strong sales particularly in China.
Revenue from REGPARA, a treatment for secondary hyperparathyroidism, increased compared to the same period of the previous fiscal year due to market expansion in China.
Revenue from Others decreased year on year.
Revenue decreased from the same period of the previous fiscal year due mainly to a decline in milestone revenue despite an increase in royalties revenue from AstraZeneca in relation to benralizumab. Core operating profit increased compared to the same period of the previous fiscal year due to an increase in overseas revenue mainly from global strategic products, despite a decrease in revenue in Japan and an increase in selling, general and administrative expenses associated with sales of global strategic products.
(2) Summary of Consolidated Financial PositionAssets as of September 30, 2020, were ¥781.2 billion, a decrease of ¥3.3 billion compared to the end of the previous fiscal year.
Non-current assets increased by ¥17.7 billion to ¥353.5 billion, due mainly to increases in intangible assets associated with in-licensing of development products and deferred tax assets.
Current assets decreased by ¥21.0 billion to ¥427.7 billion, due mainly to a decrease in cash reserves (total of cash and cash equivalents and loans receivable from parent) due to the purchase of intangible assets, income taxes and dividends paid, despite large increases in cash and cash equivalents due to the impact of an increase of ¥248.0 billion within loans receivable from parent with loan periods of three months or less included in the scope of cash and cash equivalents.
Liabilities as of September 30, 2020, were ¥96.0 billion, a decrease of ¥10.2 billion compared to the end of the previous fiscal year, due mainly to decreases in income taxes payable and trade and other payables. 45.8 50.7 +7.0 +0.8 +1.4-4.3 0.0 20.0 40.0 60.0 Jan.-Sep. 2019 Gross profit Selling, general and administrative expenses Research and development expenses Share of profit (loss) of investments accounted for using equity method Jan.-Sep. 2020 +4.9 8 Kyowa Kirin Co., Ltd. (4151)
Equity as of September 30, 2020, was ¥685.2 billion, an increase of ¥6.9 billion compared to the end of the previous fiscal year, due mainly to an increase due to the recording of profit attributable to owners of parent, despite a decrease due to the payment of dividends as well as a decrease in exchange differences on translation of foreign operations resulting from the impact of exchange rates, etc. As a result, the ratio of equity attributable to owners of parent to total assets as of the end of the third quarter was 87.7%, an increase of 1.3 percentage points compared to the end of the previous fiscal year.
(3) Summary of Consolidated Cash Flows Cash and cash equivalents as of September 30, 2020, were ¥285.0 billion, an increase of ¥264.2 billion compared with the balance of ¥20.8 billion as of December 31, 2019, mainly as a result of the impact of an increase of ¥248.0 billion within loans receivable from parent with loan periods of three months or less included in the scope of cash and cash equivalents. The main contributing factors affecting cash flow during the nine months ended September 30, 2020 were as follows:
Net cash provided by operating activities was ¥31.9 billion, a 17.5% decrease compared to the same period of the previous fiscal year. Major inflows included profit before tax of ¥44.2 billion and depreciation and amortization of ¥13.8 billion. Major outflows included income taxes paid of ¥26.6 billion.
Net cash provided by investing activities was ¥258.7 billion, a 6,162.4% increase compared to the same period of the previous fiscal year. Major inflows included a net decrease of ¥285.7 billion in loans receivable from parent. Major outflows included ¥19.7 billion for purchase of intangible assets, and ¥7.8 billion for purchase of property, plant and equipment.
Net cash used in financing activities was ¥25.9 billion, a 44.4% decrease compared to the same period of the previous fiscal year. Major outflows included dividends paid of ¥23.6 billion.
(4) Research and Development Activities Using cutting-edge biotechnology centered on antibody technology, we have made nephrology, oncology, immunology/allergy and central nervous system (CNS) the focus of research and development (R&D), and by investing resources efficiently, we aim to further speed up the creation of new medical value and drug creation. For the nine months ended September 30, 2020, the Group’s research and development expenses totaled ¥37.0 billion, and the progress of our main late-stage development products is as follows. ("◆" indicates the progress made during the third quarter of fiscal 2020.) Nephrology KRN321 (product name in Japan: NESP)
In June, we obtained approval of its indication for treatment of renal anemia in patients receiving hemodialysis in China.Oncology KRN125 (product name in Japan: G-Lasta)
In February, we started a phase I clinical study in Japan related to the development of an automated injection device for decreasing the incidence of febrile neutropenia in patients receiving cancer chemotherapy. ME-401 (generic name: Zandelisib)
In the U.S., Europe, South Korea, Australia, etc., we are currently conducting a phase II clinical trial for treatment of follicular lymphoma. (In April, we concluded an agreement with MEI Pharma on global license, development, and commercialization.) KW-0761 (product name in Japan, U.S. and Europe: POTELIGEO)
In the U.S., Europe, etc., we conducted a phase II clinical trial for treatment of adult T-cell leukemia/lymphoma, but we have discontinued all subsequent development from the perspective of portfolio management. Immunology and allergy KHK4827 (product name in Japan: LUMICEF)
In June, we obtained approval of its indication for treatment of plaque psoriasis in China. Central nervous system (CNS) KW-6002 (product name in Japan: NOURIAST; product name in U.S.: NOURIANZ)
In January, an application for approval of its indication for combination therapy with levodopa-based regimens for adult patients with Parkinson’s disease experiencing "off" episodes was accepted in Europe (application filed in November 2019). Other KRN23 (product name in Japan, U.S. and Europe: Crysvita)
In February in the U.S., we obtained approval for partial changes to our biologics license application for approval of its indication for treatment of tumor induced osteomalacia that cannot be curatively resected or localized, and in June, we obtained approval of its indication for treatment of tumor induced osteomalacia that cannot be curatively resected or localized for adult patients and pediatric patients who are two years of age or older.
In September, we obtained approval of its indication for treatment of X-linked hypophosphatemia in adolescent and adult patients in Europe.
In September, we obtained approval of its indication for treatment of FGF23-related hypophosphatemic rickets and osteomalacia in South Korea.
(5) Summary of Consolidated Earnings Forecasts and Other Forward-looking Statements No revisions have been made to the consolidated earnings forecasts announced on July 30, 2020.
2. Condensed Quarterly Consolidated Financial Statements and Significant
Notes Thereto
(1) Condensed Quarterly Consolidated Statement of Financial Position
(1) Condensed Quarterly Consolidated Statement of Financial Position (continued)
(2) Condensed Quarterly Consolidated Statement of Profit or Loss and Condensed Quarterly Consolidated Statement of Comprehensive Income
(3) Condensed Quarterly Consolidated Statement of Changes in Equity
(3) Condensed Quarterly Consolidated Statement of Changes in Equity (continued)
(4) Condensed Quarterly Consolidated Statement of Cash Flows
(5) Notes to Condensed Quarterly Consolidated Financial Statements Notes on going concern assumption No applicable items. Segment information As the Bio-Chemicals business was categorized as a discontinued operation effective from the previous fiscal year, the Group omitted information by reportable segment as the Group consists of only the one reportable segment, which is the Pharmaceuticals business.