Disclaimer: This translation is prepared and provided for readers' convenience only. This summary does not constitute any guarantee, and the Company will not compensate any losses and/or damage stemming from actions taken based on these statements. In the case that there is any discrepancy between the Japanese and English versions, the Japanese version is assumed to be correct.
February 14, 2022
Summary of Consolidated Financial Results
for the Fiscal Year Ended December 31, 2021 (JGAAP)
Listed company's name: | RaQualia Pharma Inc. | |
Listed on: | Tokyo Stock Exchange (TSE) | |
Stock code: | 4579 | |
URL: | https://www.raqualia.com/ | |
Representative: | Hirobumi Takeuchi, President and CEO | |
Contact: | Hidefumi Sugiyama, General Manager, Finance & Accounting Dept. | (TEL) +81-52-446-6100 |
Scheduled date of general meeting of shareholders: | March 25, 2022 |
Scheduled date of dividend payment: | ― |
Scheduled date of filing of securities report: | March 28, 2022 |
Supplementary documents for financial results: | Yes |
Financial results briefing: | Yes |
(Amounts are rounded down to the nearest million yen.)
1. Consolidated financial results for the fiscal year ended December 31, 2021 (January 1, 2021 to December 31, 2021)
(1) Consolidated operating results
(Percentage figures represent changes from the previous fiscal year.)
Net sales | Operating profit | Ordinary profit | Profit attributable to | |||||||||
owners of parent | ||||||||||||
Fiscal year ended | million yen | % | million yen | % | million yen | % | million yen | % | ||||
December 31, 2021 | 2,776 | 150.7 | 707 | - | 863 | - | 755 | - | ||||
December 31, 2020 | 1,107 | (35.0) | (486) | - | (527) | - | (606) | - |
Note: Comprehensive income | Fiscal year ended December 31, 2021: | 774 million yen | [-%] | |||||||
Fiscal year ended December 31, 2020: | (610) million yen | [-%] | ||||||||
Earnings per share | Earnings per share | Profit/equity | Ordinary profit/ total | Operating profit/ net | ||||||
(Basic) | (Diluted) | assets | sales | |||||||
Fiscal year ended | yen | yen | % | % | % | |||||
December 31, 2021 | 36.07 | 36.04 | 17.2 | 18.2 | 25.5 | |||||
December 31, 2020 | (28.97) | - | (14.1) | (11.6) | (43.9) | |||||
Reference: Share of (profit) loss of entities accounted for using equity method: | ||||||||||
Fiscal year ended December 31, 2021: | - million yen | |||||||||
Fiscal year ended December 31, 2020: | - million yen |
(2) Consolidated financial position
Total assets | Net assets | Equity ratio | Net assets per share | ||
As of | million yen | million yen | % | yen | |
December 31, 2021 | 5,234 | 4,788 | 91.3 | 227.97 | |
December 31, 2020 | 4,251 | 4,011 | 94.1 | 190.88 | |
Reference: Equity As of December 31, 2021: 4,777 million yen As of December 31, 2020: 3,999 million yen | |||||
(3) Consolidated cash flows | |||||
Cash flows from | Cash flows from | Cash flows from | Cash and cash equivalents | ||
operating activities | investing activities | financing activities | at end of period | ||
Fiscal year ended | million yen | million yen | million yen | million yen | |
December 31, 2021 | 366 | (279) | (16) | 2,240 | |
December 31, 2020 | (289) | 225 | (6) | 2,061 |
2. Dividends
Annual dividends per share | Total cash | Dividend | Ratio of | |||||
dividends to | ||||||||
First | Second | Third | Fiscal year- | dividends | payout ratio | |||
Total | net assets | |||||||
quarter-end | quarter-end | quarter-end | end | (Total) | (Consolidated) | |||
(Consolidated) | ||||||||
Fiscal year ended | yen | yen | yen | yen | yen | million yen | % | % |
- | 0.00 | - | 0.00 | 0.00 | - | - | - | |
December 31, 2020 | ||||||||
Fiscal year ended | - | 0.00 | - | 0.00 | 0.00 | - | - | - |
December 31, 2021 | ||||||||
Fiscal year ending | - | 0.00 | - | 0.00 | 0.00 | |||
December 31, 2022 | - | |||||||
(forecast) |
3. Forecasts of consolidated financial results for the fiscal year ending December 31, 2022 (January 1, 2022 to December 31, 2022)
(Percentage figures represent changes from the previous fiscal year.)
Net sales | Operating profit | Ordinary profit | Profit attributable to | Earnings per | ||||||
owners of parent | share (Basic) | |||||||||
Fiscal year ending | million yen | % | million yen | % | million yen | % | million yen | % | yen | |
2,605 | (6.2) | 420 | (40.6) | 420 | (51.3) | 342 | (54.7) | 16.34 | ||
December 31, 2022 | ||||||||||
Note: As the Company conducts performance management on an annualized basis, forecasts of results over a six-month period are not presented.
- Notes
- Changes in significant subsidiaries during the fiscal year ended December 31, 2021 (changes in specified subsidiaries resulting in the change in scope of consolidation): None
- Changes in accounting policies, changes in accounting estimates, and restatements of prior financial statements
- Changes in accounting policies due to the revisions to accounting standards and other regulations: None
- Changes in accounting policies due to other reasons: None
- Changes in accounting estimates: None
- Restatements of prior financial statements: None
- Number of issued shares (common shares)
- Total number of issued shares at the end of the period (including treasury shares)
As of December 31, 2021 | 20,955,142 | shares | |
As of December 31, 2020 | 20,951,642 | shares | |
b. Total number of treasury shares at the end of the period | |||
As of December 31, 2021 | 50 | shares | |
As of December 31, 2020 | 50 | shares | |
c. Average number of outstanding shares during the period | |||
For the fiscal year ended December 31, 2021 | 20,953,020 | shares | |
For the fiscal year ended December 31, 2020 | 20,950,654 | shares | |
(Reference) Overview of non-consolidated financial results
Non-consolidated financial results for the fiscal year ended December 31, 2021 (January 1, 2021 to December 31, 2021)
(1) Non-consolidated operating results
(Percentage figures represent changes from the previous fiscal year.)
Net sales | Operating profit | Ordinary profit | Profit | |||||||||||
Fiscal year ended | million yen | % | million yen | % | million yen | % | million yen | % | ||||||
December 31, 2021 | 2,361 | 134.0 | 505 | - | 656 | - | 614 | - | ||||||
December 31, 2020 | 1,099 | (40.2) | (512) | - | (550) | - | (654) | - | ||||||
Earnings per share | Earnings per share | |||||||||||||
(Basic) | (Diluted) | |||||||||||||
Fiscal year ended | yen | yen | ||||||||||||
December 31, 2021 | 29.34 | 29.31 | ||||||||||||
December 31, 2020 | (31.26) | - |
(2) Non-consolidated financial position
Total assets | Net assets | Equity ratio | Net assets per share | |
As of | million yen | million yen | % | yen |
December 31, 2021 | 5,210 | 4,777 | 91.5 | 227.47 |
December 31, 2020 | 4,367 | 4,141 | 94.6 | 197.12 |
Reference: Equity As of December 31, 2021: 4,766 million yen As of December 31, 2020: 4,129 million yen
- Financial results reports are exempt from audit conducted by certified public accountants or an audit corporation.
- Appropriate use of financial forecasts and other special remarks
(Caution concerning forward-looking statements)
Forward-looking statements provided in this document, including financial forecasts, are based on the information currently available to the Company and certain assumptions considered reasonable. Such statements are included without any guarantee as to their future achievement. Actual results, etc. may differ materially from the forecasts depending on various factors.
(Method of accessing supplementary documents for financial results and details of financial results briefing)
The Company plans to hold financial results briefings for institutional investors and securities analysts on Tuesday, February 15, 2022 and for general investors on Wednesday, February 16, 2022.
The Company plans to post the documents used at the briefings on its website promptly after the briefings are held.
Contents of attachment | ||
1. Overview of consolidated operating results and others................................................................................................ | 2 | |
(1) | Overview of consolidated operating results for the fiscal year under review........................................................... | 2 |
(2) | Overview of consolidated financial position for the fiscal year under review.......................................................... | 6 |
(3) | Overview of cash flows for the fiscal year under review ......................................................................................... | 6 |
(4) | Outlook for the fiscal year ending December 31, 2022 ............................................................................................ | 7 |
2. Basic rationale for selecting the accounting standard .................................................................................................. | 7 | |
3. Consolidated financial statements and significant notes thereto .................................................................................. | 8 | |
(1) | Consolidated balance sheet....................................................................................................................................... | 8 |
(2) | Consolidated statement of income and consolidated statement of comprehensive income.................................... | 10 |
Consolidated statement of income.......................................................................................................................... | 10 | |
Consolidated statement of comprehensive income................................................................................................. | 11 | |
(3) | Consolidated statement of changes in equity.......................................................................................................... | 12 |
(4) | Consolidated statement of cash flows..................................................................................................................... | 14 |
(5) | Notes to consolidated financial statements ............................................................................................................. | 16 |
Notes on premise of going concern ........................................................................................................................ | 16 | |
Segment information, etc........................................................................................................................................ | 16 | |
Per share information.............................................................................................................................................. | 17 | |
Significant subsequent event .................................................................................................................................. | 18 |
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1. Overview of consolidated operating results and others
- Overview of consolidated operating results for the fiscal year under review
Overall trend
During the fiscal year ended December 31, 2021, although some positive effects of monetary easing were seen in the form of an active financial market, the global spread of the novel coronavirus (COVID-19) continued, and the outlook for the Japanese economy remains challenging due to the global slowdown in economic activities with renewed spread caused by the emergence of variants.
In the pharmaceutical industry, in addition to the impact on sales activities from suppression of medical examinations for patients and refraining from visiting customers, among others, the impact on research and development and business development activities caused by voluntarily avoiding domestic business trips, the effective prohibition of overseas travel, and the shutdown of clinical trial facilities in line with movement restrictions, remained. While some companies are experiencing challenging financial results, initiatives to develop new drugs and vaccines targeting COVID-19 are active, and competition over the development of new vaccines and therapeutic agents is accelerating.
Such industry trends as these had no small impact on the business development activities of drug discovery startups, like the Group, that operate a drug discovery business.
Under such conditions, the Group pursued activities to create development candidate compounds for pharmaceuticals based on internal, independent research or collaborative research with partner companies or academies and to expand its research and development portfolio, while also promoting licensing activities for development candidate compounds it owns and research and development to enhance value.
Accordingly, business activities for the fiscal year under review were as follows.
Regarding human drug products, sales of K-CAB® (generic name: tegoprazan)-a drug for gastro-esophageal reflux disease marketed by HK inno.N Corporation (South Korea, "HK inno.N (South Korea)")-in South Korea performed well overall from last year through this year.
The first quarter of the fiscal year under review was impacted by inventory adjustments, but the Company saw expanded growth from the second quarter onward, and sales royalty income of the Company experienced a large increase.
Regarding the global development of tegoprazan, in China, HK inno.N (South Korea)'s Chinese licensee Shandong Luoxin Pharmaceutical Group Co., Ltd. (China, "Luoxin Pharma (China)") is in the process of approval review by the Chinese authority based on a New Drug Application ("NDA") filed in 2020. HK inno.N (South Korea) expects that target period to receive approval in China for tegoprazan is the first half of 2022.
In the U.S. and Canada, HK inno.N (South Korea) began Phase I clinical trials in the U.S. and concluded a sublicense agreement with Braintree Laboratories, Inc. (U.S., "Braintree (U.S.)") in December 2021.
In Asian countries, in addition to receiving approval in Mongolia, preparations to file NDA in the Philippines, Thailand, Vietnam, Singapore, and Indonesia are underway at sublicensee companies.
Furthermore, in Central and South American countries, tegoprazan has passed the screening of the Comité de Moléculas Nuevas, one organization involved in pharmaceutical approval and screening in Mexico, and preparations aimed at receiving approval in fiscal year 2023 are currently underway at sublicensee companies.
Additionally, based on its goal of expanding into 100 global countries by 2028, HK inno.N (South Korea) is moving forward with its search for sublicensee in other regions.
Meanwhile, in Japan, the Company is examining several possibilities to implement clinical development aiming for an early market launch, including the way to build a cooperative relationship between the Company and HK inno.N (South Korea).
With regard to pet drugs, sales were strong overall.
Solid sales were seen in GALLIPRANT® (generic name: grapiprant), which is a drug for osteoarthritis in dogs, and capromorelin
(Ghrelin receptor agonist/brand name: ENTYCE®), which has an indication for anorexia management for dogs, both of which were licensed to Elanco Animal Health Inc. (U.S., "Elanco (U.S.)"). Furthermore, regarding capromorelin, Elanco (U.S.) launched sales in the U.S. under the brand name ELURA® as a drug for the management of weight loss in cats with chronic kidney disease (CKD).
Regarding ion channel drug discovery, in which the Group aims to develop strengths, the following four programs have been making steady progress: a P2X7 receptor antagonist (RQ-00466479/AK1780) discovered through collaborative research with Asahi Kasei Pharma Corporation ("Asahi Kasei Pharma"), a compound discovered through collaborative research with EA Pharma Co., Ltd. ("EA Pharma"), a selective sodium channel blocker licensed to Maruho Co., Ltd. ("Maruho"), and a collaborative research project with ASKA Pharmaceutical Co., Ltd. ("ASKA Pharmaceutical").
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RaQualia Pharma Inc. published this content on 15 February 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 February 2022 08:46:08 UTC.