On February 2, 2023 Nippon Kayaku reported its Third Quarter of the Fiscal Year Ending March 31, 2023 (Press release, Nippon Kayaku, FEB 2, 2023, View Source [SID1234626794]).

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Filing date of quarterly securities report: February 8, 2023
Scheduled date for start of dividend payments: –
Preparation of supplementary materials for quarterly financial results: Yes
Quarterly results presentation meeting: Yes (for securities analysts and institutional investors)

1. Consolidated Business Results for the First Three Quarters of the Fiscal Year Ending March 31, 2023 (April 1, 2022–December 31, 2022)
(Figures shown are rounded down to the nearest million yen.)
(1) Consolidated Operating Results
(Percentages indicate amount of change from the same period of the previous fiscal year.)
Net sales Operating income Ordinary income Profit attributable to owners of parent Million yen % Million yen % Million yen % Million yen % First three quarters of fiscal year ending March 31, 2023 153,627 11.2 19,062 9.9 20,994 11.8 15,241 8.4 First three quarters of fiscal year ended March 31, 2022 138,095 9.9 17,339 47.1 18,781 54.6 14,058 56.7 Note: Comprehensive income
First three quarters of fiscal year ending March 31, 2023: 17,699 million yen ((0.2)%) First three quarters of fiscal year ended March 31, 2022: 17,743 million yen (24.3%)

Profit attributable to owners of parent per share-primary Profit attributable to owners of parent per share-diluted Yen Yen First three quarters of fiscal year ending
March 31, 2023 90.62 90.60 First three quarters of fiscal year ended March 31, 2022 83.10 83.09
( 2) Consolidated Financial Position
Total assets Net assets Equity ratio Million yen Million yen % As of December 31, 2022 331,405 255,714 76.9 As of March 31, 2022 315,459 246,425 77.8
Reference: Equity As of December 31, 2022: 254,741 million yen
As of March 31, 2022 245,479 million yen

2. Status of Dividends
Dividend amount per share End of first quarter End of second quarter End of third quarter End of year Year Yen Fiscal year ended
March 31, 2022
Fiscal year ending
March 31, 2023 –
– 15.00
20.00 –
– 25.00 40.00 Fiscal year ending
March 31, 2023
(forecast) 20.00 40.00
Note: Changes to the most recent dividend forecast: None

3. Consolidated Business Results Forecasts for the Fiscal Year Ending March 31, 2023 (April 1, 2022–March 31,
2023)
(Percentages indicate amount of change from the same period of the previous fiscal year.)
Net sales Operating income Ordinary income Profit attributable to owners of parent Profit attributable to owners of parent per share Million yen % Million yen % Million yen % Million yen % Yen Full year 210,000 13.6 23,800 13.1 26,600 14.9 19,400 12.9 115.31
Note: Changes to the most recent forecast for consolidated business results: None

Notes
(1) Significant changes in subsidiaries during the first three quarters (changes in designated subsidiaries that result in changes in scope of consolidation): None

(2) Adoption of special accounting methods for presenting the quarterly consolidated financial statements: None

(3) Changes to accounting policies and estimates and restatements
[1] Changes to accounting policies associated with revision of accounting standards or similar items: None
[2] Changes other than [1]: None
[3] Changes to accounting estimates: None
[4] Restatements: None

(4) Number of shares issued (common stock)
[1] Number of shares issued at end of the fiscal period (including treasury stock)
As of December 31, 2022: 170,503,570 shares
As of March 31, 2022: 170,503,570 shares
[2] Number of treasury stock at end of the fiscal period
As of December 31, 2022: 2,960,258 shares
As of March 31, 2022: 2,257,985 shares
[3] Average number of shares during the fiscal period (cumulative)
First three quarters of fiscal year ending March 31, 2023: 168,186,975 shares First three quarters of fiscal year ended March 31, 2022: 169,174,386 shares

*Quarterly summary financial statements are not subject to audit by a certified public accountant or audit firm.

*Analysis related to appropriate use of the business results forecasts, and other notes
(Disclaimer concerning forward-looking statements)
The information in this report constitutes forward-looking statements regarding future events and performance. This information is based on the beliefs and assumptions of management in light of information currently available to it at the time of announcement and subject to a number of uncertainties that may affect future results. Actual business results may differ substantially from the forecasts herein due to various factors. For matters pertaining to business forecasts, please refer to "(3) Analysis of Forward-looking Statements, Including Consolidated Business Forecasts" on page 3 of the Supplementary Information.
.
(How to obtain the materials for the briefing on quarterly financial results)
We have scheduled a teleconference for securities analysts and institutional investors on Tuesday, January 31, 2023.
The materials for the briefing will be posted on the corporate website.
This document is an English translation of the Japanese-language original.
All financial information has been prepared in accordance with generally accepted accounting principles in Japan.

Supplementary Information

Contents

1. Qualitative Information Concerning Results for the First Three Quarters 2
(1) Analysis of Operating Results 2
(2) Analysis of Financial Position 3
(3) Analysis of Forward-looking Statements, including Consolidated Business Results Forecasts 3
2. Quarterly Consolidated Financial Statements and Notes to Quarterly Consolidated Financial Statements 4
(1) Consolidated Balance Sheets 4
(2) Consolidated Statements of Income & Consolidated Statements of Comprehensive Income 6
(3) Notes to Quarterly Consolidated Financial Statements 8
(Notes Regarding Assumptions for the Going Concern) 8
(Notes in Case of Significant Change in Shareholders’ Equity) 8
(Segment Information and Other Items) 8

1. Qualitative Information Concerning Results for the First Three Quarters
(1) Analysis of Operating Results
During the first three quaters of this consolidated fiscal year (April 1 to December, 2022), the global economy saw a return to normalcy from the COVID-19 pandemic. However, the sense of uncertainty increased even more as a result of the Russian invasion of Ukraine, increasing global inflation caused by high fuel and raw material prices, and the zero COVID policy in China.
The Nippon Kayaku Group launched KAYAKU Vision 2025, the new mid-term business plan beginning this fiscal year, amid such conditions, we are working to implement the roadmap to the vision specified for each business while advancing initiatives to address key company-wide issues aimed at achieving the vision.

As a result, net sales for the first three quarters of this consolidated fiscal year totaled 153,627 million yen, an increase of 15,532 million yen (11.2%) year-on-year. Sales in the pharmaceuticals business underperformed while the functional chemicals, safety systems, and other businesses outperformed the first three quarters of the previous fiscal year.
Operating income totaled 19,062 million yen, an increase of 1,722 million yen (9.9%) year-on-year. Ordinary income totaled to 20,994 million yen, an increase of 2,212 million yen (11.8%) year-on-year. Profit attributable to owners of parent was 15,241 million yen, an increase of 1,182 million yen (8.4%) year-on-year. Performance by business segment is as described below.

[Functional Chemicals Business]
Net sales reached 65,433 million yen, an increase of 6,888 million yen (11.8%) year-on-year.
The functional materials business as a whole outperformed the first three quarters of the previous fiscal year. The outperformance resulted from strong sales of MEMS and other resin composites, despite the decline in demand for epoxy resins used as semiconductor materials in consumer applications.
The color materials business as a whole outperformed the first three quarters of the previous fiscal year. This outperformance resulted from a rebound in market demand for colorants and ink for inkjet printers in industrial applications, despite the slowdown in colorants for inkjet printers for consumer uses and dyes for textiles.
The catalyst business outperformed the first three quarters of the previous fiscal year, due to strong orders, both in Japan and for exports overseas.
In the Polatechno business, demand for dye-type polarizing film was sluggish. However, demand was firm for components for X-ray analysis systems and the exchange rate on sales in foreign currencies was advantageous. This resulted in outperformance of the Polatechno business as a whole, compared with the first three quarters of the previous fiscal year.
Segment profit totaled 10,067 million yen, an increase of 527 million yen (5.5%) year-on-year. This increase resulted from growth in sales in the functional materials and catalyst businesses.

[Pharmaceuticals Business]
Sales totaled 39,293 million yen, a decrease of 453 million yen (1.1%) year-on-year.
Pharmaceuticals in Japan underperformed the first three quarters of the previous fiscal year. The underperformance resulted from the impact of drug price revisions, despite the launch of DARVIASⓇ Injection, a new drug for blood cancer, in August 2022 and growth in sales of the new generic anti-cancer drug PEMETREXED for I.V. Infusion and ALAGLIOⓇ granule packets, a photodynamic diagnostic agent.
Sales of active pharmaceutical ingredients for the Japanese domestic market and exports outperformed while sales of contract production and diagnostic drugs underperformed the first three quarters of the previous fiscal year. Segment profit totaled 6,944 million yen, an increase of 46 million yen (0.7%) year-on-year.

[Safety Systems Business]
Sales reached 40,951 million yen, an increase of 7,679 million yen (23.1%) year-on-year.
The domestic business as a whole underperformed the first three quarters of the previous fiscal year. This underperformance resulted from a year-on-year decline in sales of airbag inflators owing to low demand from automobile production cuts caused by the shortage of semiconductors and other factors, despite growth in sales of micro gas generators for seatbelt pretensioners.
The overseas business outperformed the first three quarters of the previous fiscal year in sales of airbag inflators, micro gas generators for seatbelt pretensioners, and squibs, as demand rebounded from the slump caused by policies to combat the COVID-19 pandemic implemented in different countries and despite increasing global inflation and the impact from the shortage of semiconductors.
Segment profit reached 6,165 million yen, an increase of 1,447 million yen (30.7%) year-on-year, owing to the rebound in demand and growth in sales boosted by the weakening yen.

[Other]
Sales were 7,949 million yen, an increase of 1,417 million yen (21.7%) year-on-year. The agrochemicals business overall saw a year-on-year increase in domestic sales and exports. Sales in the real estate business were flat year-onyear.
Segment profit totaled 1,536 million yen, an increase of 121 million yen (8.6%) year-on-year.

(2) Analysis of Financial Position
Total assets were 331,405 million yen, an increase of 15,945 million yen from the end of the previous consolidated fiscal year. The main increases were in raw materials and stores, an increase of 8,110 million yen; merchandise and finished goods, an increase of 7,362 million yen; notes and accounts receivable-trade, an increase of 3,631 million yen; and cash and deposits, an increase of 3,055 million yen. The main decrease was in securities, a decrease of 8,965 million yen.
Liabilities were 75,691 million yen, an increase of 6,657 million yen compared to the end of the previous consolidated fiscal year. The main increases were in short-term loans payable, an increase of 7,428 million yen; and notes and accounts payable-trade, an increase of 5,304 million yen. The main decrease was in current portion of bonds payable, a decrease of 4,000 million yen.
Net assets were 255,714 million yen, an increase of 9,288 million yen compared to the end of the previous consolidated fiscal year. The main increases were in retained earnings, an increase of 7,667 million yen; and translation adjustments, an increase of 3,310 million yen.

(3) Analysis of Forward-looking Statements, including Consolidated Business Results Forecasts
We expect the future business environment surrounding the Nippon Kayaku Group to bring a greater return to normalcy from the COVID-19 pandemic. However, the Russian invasion of Ukraine and increasing global inflation from high fuel and raw material prices pose the risk of an economic downswing.
Under these conditions, the Nippon Kayaku Group aims to respond flexibly to changes in the business environment and pursue optimal use of operating capital to increase the shareholder value, expand existing businesses in global growth markets, accelerate the development of new businesses and new products, and enhance profits.
There has been no change in the consolidated business results forecasts for fiscal year ending March 31, 2023 announced on July 29, 2022.

2. Quarterly Consolidated Financial Statements and Notes to Quarterly Consolidated Financial Statements
(1) Consolidated Balance Sheets

As of March 31, 2022 As of December 31, 2022
Million yen Assets
Current assets
Cash and deposits

38,459 41,514 Notes and accounts receivable-trade 60,719 64,350 Electronically recorded monetary claims-operating 1,868 2,469 Securities 15,186 6,220 Merchandise and finished goods 36,784 44,146 Work in process 1,149 950 Raw materials and stores 17,901 26,012 Other 3,832 4,946 Allowance for doubtful accounts
Total current assets
Non-current assets
Property, plant and equipment
Buildings and structures, net (57) (54) 175,843 190,556

43,469

43,716 Machinery, equipment and vehicles, net 26,923 26,221 Other, net
Total property, plant and equipment
Intangible assets Goodwill 18,667 19,804 89,060 89,742
3,016
2,624 Other
Total intangible assets
Investments and other assets Investment securities 4,569 4,166 7,586 6,790
33,511
34,767 Net defined benefit asset 4,572 4,716 Other 4,949 4,894 Allowance for doubtful accounts
Total investments and other assets
Total non-current assets Total assets (63) (62) 42,970 44,316 139,616 140,849 315,459 331,405

As of March 31, 2022 As of December 31, 2022
Million yen Liabilities
Current liabilities
Notes and accounts payable-trade

18,011 23,316 Short-term loans payable 3,176 10,605 Current portion of bonds payable 4,000 – Accounts payable-other 9,617 9,745 Income taxes payable 2,997 1,995 Other
Total current liabilities
Non-current liabilities Bonds payable 7,956 6,910 45,760 52,573
8,000
8,000 Long-term loans payable 1,474 800 Net defined benefit liability 380 439 Other
Total non-current liabilities Total liabilities
Net assets
Shareholders’ equity Common stock 13,419 13,877 23,273 23,117 69,034 75,691

14,932

14,932 Additional paid-in capital 15,759 15,794 Retained earnings 195,566 203,233 Treasury stock
Total shareholders’ equity
Accumulated other comprehensive income
Unrealized holding gains on other securities (2,624) (3,463) 223,633 230,498
9,818
9,164 Translation adjustments 10,630 13,940 Remeasurements of defined benefit plans
Total accumulated other comprehensive income
Non-controlling interests
Total net assets
Total liabilities and net assets 1,396 1,138 21,846 24,243 945 973 246,425 255,714 315,459 331,405
(2) Consolidated Statements of Income & Consolidated Statements of Comprehensive Income
Consolidated Statements of Income

First three quarters of fiscal First three quarters of fiscal year ended March 31, 2022 year ending March 31, 2023
Million yen Net sales 138,095 153,627 Cost of sales
Gross profit on sales
Selling, general and administrative expenses
Operating income
Non-operating income Interest income 89,883 100,640 48,211 52,986 30,871 33,924 17,339 19,062
123
381 Dividend income 777 852 Equity in earnings of affiliates 271 – Foreign exchange gains
Other
Total non-operating income
Non-operating expenses Interest expense 54 517 534 611 1,761 2,362
77
95 Equity in losses of affiliates – 47 Other losses
Total non-operating expenses
Ordinary income
Extraordinary income
Gain on sales of non-current assets 241 287 319 430 18,781 20,994
1,392
479 Gain on sales of investment securities Gain on change in equity
Total extraordinary income
Extraordinary loss
Loss on disposal of non-current assets 183 413 – 123 1,575 1,015
445
385 Loss on valuation of investment securities
Total extraordinary loss
Profit before income taxes
Income taxes-current 57 3 503 388 19,854 21,621 4,208 5,209 Income taxes-deferred
Total income taxes
Profit
Profit attributable to non-controlling interests
Profit attributable to owners of parent 1,531 1,116 5,740 6,325 14,114 15,296 55 54 14,058 15,241

Consolidated Statements of Comprehensive Income

First three quarters of fiscal First three quarters of fiscal year ended March 31, 2022 year ending March 31, 2023
Million yen Profit 14,114 15,296 Other comprehensive income
Unrealized holding gains on other securities
(23)
(654) Translation adjustments 3,687 3,316 Remeasurements of defined benefit plans (31) (259) Share of other comprehensive income of companies accounted for by the equity-method Total other comprehensive income Comprehensive income (3) 1 3,629 2,403 17,743 17,699 Comprehensive income attributable to: Owners of parent
Non-controlling interests

17,634 109
17,638
61
. (3) Notes to Quarterly Consolidated Financial Statements
(Notes Regarding Assumptions for the Going Concern)
No items to report

(Notes in Case of Significant Change in Shareholders’ Equity)
No items to report

(Segment Information and Other Items)
I. First three quarters of the fiscal year ended March 31, 2022 (April 1, 2021– December 31, 2021) 1. Information on sales and profit (loss) by reportable segment
Reportable segments Other (Note 1) Total Adjustments
(Note 2) Consolidated
(Note 3)
Functional chemicals business Pharma-
ceuticals business Safety systems business Total Million yen Sales
Sales to third parties 58,545 39,746 33,272 131,563 6,531 138,095 – 138,095 Intersegment sales and transfers 106 0 – 106 78 184 (184) – Total 58,651 39,746 33,272 131,670 6,610 138,280 (184) 138,095 Segment profit 9,539 6,898 4,718 21,156 1,414 22,571 (5,231) 17,339 Note 1: "Other" indicates a business segment that is not included in the reportable segments, including the agrochemicals business and real estate business.
Note 2: The 5,231 million yen downward adjustment to segment profit reflects a negative 5,237 million yen in corporate expense not allocable to the reportable segments and 5 million yen in eliminations for intersegment transactions. The corporate expense is mainly a general and administrative expense that is not attributed to the reportable segments.
Note 3: Segment profit has been adjusted to correspond with the total operating income as shown in the consolidated statements of income.

II. First three quarters of the fiscal year ending March 31, 2023 (April 1, 2022– December 31, 2022) 1. Information on sales and profit (loss) by reportable segment
Reportable segments Other (Note 1) Total Adjustments
(Note 2) Consolidated
(Note 3)
Functional chemicals business Pharma-
ceuticals business Safety systems business Total Million yen Sales
Sales to third parties 65,433 39,293 40,951 145,678 7,949 153,627 – 153,627 Intersegment sales and transfers 122 0 – 122 82 204 (204) – Total 65,555 39,293 40,951 145,800 8,032 153,832 (204) 153,627 Segment profit 10,067 6,944 6,165 23,177 1,536 24,714 (5,652) 19,062 Note 1: "Other" indicates a business segment that is not included in the reportable segments, including the agrochemicals business and real estate business.
Note 2: The 5,652 million yen downward adjustment to segment profit reflects a negative 5,673 million yen in corporate expense not allocable to the reportable segments and 21 million yen in eliminations for intersegment transactions. The corporate expense is mainly a general and administrative expense that is not attributed to the reportable segments.
Note 3: Segment profit has been adjusted to correspond with the total operating income as shown in the consolidated statements of income.

On February 2, 2023 Servier, an independent international pharmaceutical group, reported its financial results for the 2021/22 financial year and presents the main stages of its resolutely committed transformation (Press release, Servier, FEB 2, 2023, View Source [SID1234626809]).

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Extract from consolidated and audited results
(under IFRS [1] , ended September 30, 2022)

(in €m) 2021/22 2020/21 Variation Variation
at TCC [i]
Group turnover 4,876 4,441 +9.8% +6.6%
Turnover from the Princeps activity 3,694 3,282 +12.5% +8.9%
Revenue from the Generics business 1,182 1,159 +2.0% +0.0%
EBITDA 859 638 +34.6% –
EBITDA/turnover ratio 17.6% 14.4% +3.2pts –
Current operating income 442 251 +76% –
Net profit 192 (95) +287 –

"In a complex and unstable geopolitical and economic context, all of the Servier group’s business segments have progressed, confirming the trajectory of our transformation. I am proud of the work accomplished by our teams, which highlights our daily commitment to patients. Servier is now an international health player built around three balanced pillars: cardio-metabolism and venous diseases, oncology and generics. Our innovation capabilities have been strengthened and we now have a balanced and promising pipeline, in line with our ambition in oncology as well as in neurosciences and immuno-inflammation. The achievement of our 2025 objectives is on track and we are implementing our Servier 2030 strategic plan with determination and confidence."

Olivier Laureau, Chairman of Servier, declares
The Servier group’s consolidated revenue for the 2021/22 financial year increased by 9.8% compared to the 2020/21 financial year and reached 4.876 billion euros. This performance is notably driven by the growth in sales volume worldwide of 7.6% and a favorable exchange rate of 3.2% (+€140 million in fiscal year 2021/22 compared to a negative impact of
-€156 million the previous year). The complex context of pressure on prices had a negative effect on turnover growth of 1%, an impact of 45 million euros.

Sales of brand-name medicines amounted to €3.694 billion for the 2021/22 financial year, up 12.5% ​​compared to the 2020/21 financial year. Sales of generic drugs are up 2.0% compared to the previous financial year to reach 1.182 billion euros in 2021/22.

Top 3 of the strongest growth of the Group’s originator drugs in 2021/22

Medication 2021/22 revenue
(in €m) Progress
vs. 2020/21
(in €m at constant exchange rates i )
Tibsovo _ 256 +180
Daflon _ 552 +68
Triplixam _ 211 +37
EBITDA for the 2021/22 financial year amounted to 859 million euros, up 34.6%, and represents 17.6% of Group revenue compared to a ratio of 14.4% for the ‘Previous exercice. Current operating income for the 2021/22 financial year amounts to 442 million euros and corresponds to 9.1% of Group revenue. This performance is explained by the increase in international turnover, a favorable effect of exchange rates, coupled with very good control of expenses and the prioritization choices that were made during the financial year. . Net income, up, amounted to 192 million euros, or 3.9% of Group sales, compared to a loss of 95 million euros for the previous financial year.

"The results for the 2021/22 financial year confirm the Servier group’s trajectory and its ability to achieve its objectives of 6 billion euros in revenue and 1.3 billion euros in EBITDA in 2025. strong growth in sales in oncology as well as the major investments made in recent years confirm our strategy of becoming a focused and innovative player in oncology, projecting to achieve a turnover of 3 billion in this field in 2030. To enable the Group to invest in the long term, particularly in neurosciences and immuno-inflammation which constitute our growth drivers by 2030, our ambition is to increase the ratio of EBITDA to our turnover
to 30%. »

Pascal Lemaire, Executive Vice-President Finance of Servier
Strong growth in international sales
The share of turnover generated outside the European Union represents more than half of Group turnover, ie 56%, up 16% compared to the previous financial year. This strong growth can be explained in particular by the Group’s performance in the United States, which thus becomes the Group’s leading subsidiary, ahead of China, with revenue of 437 million euros compared to 255 million euros in 2020. /21. This 55% i growth is the result of the performance of the drug Tibsovo marketed by Servier in the United States since the second half of the 2020/21 financial year. In Japan, 2ndworld market in oncology, the subsidiary Nihon Servier achieved a turnover of 97 million euros in 2021/22 thanks to the sales of Onivyde , the marketing of which was initiated in June 2020.

The originator sales in France represent 2.7% of the Group’s sales, when this territory concentrates 51% of the Group’s investments, in particular industrial and R&D, for this financial year; a figure that testifies to Servier’s continued desire to create value in France for all of its stakeholders.

Confirmed 2025 objectives and a new ambition for 2030
The 2021/22 annual results confirm the Group’s trajectory for 2025 and its ability to achieve its objectives: revenue of 6 billion euros, including 1 billion euros in oncology, and EBITDA of 1.3 billion euros. euros, i.e. approximately 20% of turnover in 2025.

Achieving the 2025 objectives is a key step for the Group in order to tackle the second stage of its transformation plan for 2030, which is based on three pillars:

Be a focused and innovative mid-size player in oncology, as well as in neurosciences and immuno-inflammation
Maintain the Group’s leadership in cardio-metabolism and in venous diseases
Pursue the profitable growth of the generics business
The Group wishes to accelerate its transformation dynamic in order to guarantee, over the long term, its independence and its creation of value, and to generate a significant societal impact to contribute to a sustainable world. Thus, Servier plans to achieve a turnover of 8 billion euros in 2030 with an EBITDA ratio above 30%.

Cardio-metabolism and venous diseases, consolidated leadership
Sales of originator drugs in cardio-metabolism and venous diseases (CMVD) amounted to 2.693 billion euros and now represent 55.2% of the Group’s consolidated sales.

The growth of 2.9% i compared to the 2020/21 financial year is notably attributable to the performance of Daflon . Marketed in more than 100 countries, Daflon is the Group’s leading drug with sales of 552 million euros. Servier has invested since 2021, more than 100 million euros on its Oril Industrie site in Normandy (France) in order to adapt the production of the active ingredient of Daflon and to meet growing international demand.

Servier also intends to assert its leadership in the field of cardio-metabolism – the Group is the world’s 3rd largest pharmaceutical player in cardiology and the 2nd in hypertension [ 2] – by relying on its expertise in incremental innovation (Single Pill Combinations) and digital services to improve diagnosis, knowledge of chronic diseases and treatment compliance. Triplixam thus reached a turnover of 211 million euros in 2021/22.

Servier involves patients and patient associations in all projects in order to optimize the effectiveness of the solutions proposed to improve therapeutic adherence. In this regard and in the field of hypertension, Servier works in particular with Global Heart Hub and Senior International Health Association. This collaboration resulted in initial study results, presented at the European Society of Hypertension (ESH) 2022 Congress . The Group thus aims to improve adherence to treatment for patients suffering from this chronic disease and thus their life expectancy by avoiding comorbidities.

Oncology, the realization of an ambitious strategy in 2021/22
The share of oncology in consolidated sales rose sharply compared to the previous year to reach 848 million euros (up 35.4% i ), representing 17.4% of sales. consolidated business, compared to 13.6% in 2020/21. This performance is notably driven by sales of Tibsovo for 256 million euros in 2021/22. Tibsovo joined Servier’s portfolio in mid-2020/21, following the acquisition of the oncology division of Agios Pharmaceuticals. In 2022, Servier submitted a marketing authorization application to the European Medicines Agency (EMA) for Tibsovo .

Sales of other oncology drugs also contributed to this performance, including Oncaspar , with sales of 290 million euros, up 2.8% i , and Onivyde which achieved sales of 145 million euros in 2021/22, up 13.7% i compared to the previous financial year.

All of these indicators support the Group’s growth strategy in oncology. With nearly 6 billion in investments made over the past five years, Servier now has a portfolio of 7 drugs available to patients targeting pathologies with a strong unmet medical need.

The Group devotes more than 50% of its R&D budget to oncology, with the ambition of being recognized as a focused and innovative player in the development of treatments targeting hard-to-treat cancers. Servier directs its R&D programs in oncology around two approaches: immuno-oncology and targeted therapies. In addition, this major investment by the Group is now reflected in a promising pipeline of 38 R&D projects in oncology (as of January 2023).

A balanced and innovative pipeline, reflecting the successful transformation of R&D
With 43 projects in clinical development and 32 research projects [3] , the result of significant and continuous investment in R&D (more than 20% of originator sales), Servier focuses its research and development efforts on all of its therapeutic areas where the needs are major. To date, 50% of the Group’s Research projects have the potential to become "first in class" (drug with a new and unique mechanism of action) and the quality of its projects should lead the Group to launch two to three first in human studies per year.

With 21 projects in neurosciences and immuno-inflammation, Servier has built a quality pipeline capable of constituting its next source of growth.

"The quality of our pipeline concretely attests to the transformation of our R&D in our three therapeutic areas. This year, we demonstrated our ability to accelerate the process of discovering and making innovative therapies available to patients, through strategic partnerships and increased use of digital technologies. »

Claude Bertrand, Executive Vice-President Research & Development of Servier
Thus, during the 2021/22 financial year, Servier entered into new partnerships and reached important milestones regarding studies carried out in collaboration with partners. The Group notably entered into a collaborative research agreement with Oncodesign Precision Medicine (OPM) for the identification of new targets in pancreatic cancer. Also with this partner, an exclusive worldwide license option was exercised for a drug candidate in the treatment of Parkinson’s disease. Finally, in Sjögren’s Syndrome, this year marked the end of the inclusion of patients in a phase 2a clinical study conducted by Servier in partnership with OSE Immunotherapeutics, the results of which are expected in 2023.

In order to accelerate the development and marketing of new drugs and services, the Group has also entered into a strategic collaboration with Google Cloud, centered on the use of data. Servier has also entered into a partnership with GNS in the digital twin aimed at accelerating the discovery and clinical development of new treatments through AI and biosimulation.

The opening of the Servier Research and Development Institute in Paris-Saclay, during the
1 sthalf of 2023, constitutes a major step in the transformation of R&D. The result of an investment of nearly 400 million euros, it illustrates Servier’s ambition to build open, dynamic, productive and innovative research for the benefit of patients. It will be the heart of the Group’s global R&D organization and will work cross-functionally with the other R&D centers located in Budapest in Hungary, Ballerup in Denmark and Boston in the United States, as well as with the 3 hubs ( Europe, Asia-Pacific, America) for clinical research. Servier has also joined forces with BioLabs, a leading American player in the management and management of start-up incubators, for the management of its "Spartners" incubator in Paris-Saclay. The latter will host young shoots in the field of health and life sciences.

During the summer of 2022, Servier inaugurated its first Research center in Boston. Located at the heart of the world’s largest health ecosystem, the center brings together nearly 200 employees who work every day to develop innovative cancer treatments.

Generics, a strategy of local champions confirmed
Over the 2021/22 financial year, revenue from the Servier group’s generics activity remained stable compared to the previous financial year at constant exchange rates and amounted to 1.182 billion euros (24.2% of consolidated turnover of the Group). The favorable impact of sales volume growth on sales was neutralized by very strong pressure on net prices, particularly at Biogaran, and a very significant increase in the safeguard clause in France.

Today, the Group has an offer of more than 1,500 generic drugs covering the majority of pathologies and which are distributed throughout the world by four subsidiaries: EGIS in Eastern Europe, Pharlab in Brazil, Swipha in Nigeria and Biogaran, leader in the generics market in France.

Biogaran has thus consolidated its leadership around its range of reimbursed drugs, reaching 32% market share for generic drugs and has begun to diversify its activity with the ambition of becoming the reference player in the daily health of French people in the pharmacy. Biogaran, for example, launched a new range of technical dressings for wound care, developed its OTC offer, and the company also marketed GSK’s flu vaccine. It also intends to capitalize on the opening of the right to substitute biosimilar drugs in pharmacies to develop its presence in this fast-growing market.

Patient and CSR commitments at the heart of the Group’s strategy
Servier is committed to therapeutic progress for the benefit of patients. The Group thus works with patients at each stage of the drug’s life cycle. This reality was rewarded in June 2022 by a notable progression in the rankings resulting from the survey carried out by the organization PatientView in 2021 among patient associations around the world. Servier is notably ranked 7th out of 30 oncology laboratories.

During the year, Servier also acted to reduce its environmental footprint and contribute to the fight against climate change. The Group’s efforts have focused on all aspects of its business and have included in particular the eco-design of drugs, the decarbonization of its supply chain and the preservation of biodiversity. Beyond the Group’s desire to reduce its CO 2 emissions by 25% by 2030 (vs. 2015/16), more than 30,000 tonnes of CO 2 equivalent have been offset by Servier in 2022 thanks to projects capturing or limiting emissions.

A milestone in terms of diversity and inclusion, the Group launched "She is Servier", a female leadership program aimed at supporting and accompanying the women of the Group in their professional development. By 2024, Servier intends to reach a target of at least 40% women in top management.

Finally, and as part of its 2030 ambition, Servier plans to commit to a flagship CSR project every three years, in line with the Group’s vocation.

On February 2, 2023 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that members of its senior management team will participate at two investor conferences in February and March. Details for the fireside chats are as follows (Press release, Repare Therapeutics, FEB 2, 2023, View Source [SID1234626808]).

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Guggenheim Oncology Conference
Date: Thursday, February 9, 2023
Time: 3:20 p.m. Eastern Time
Location: New York, NY

Cowen 43rd Annual Health Care Conference
Date: Wednesday, March 8, 2023
Time: 9:50 a.m. Eastern Time
Location: Boston, MA

A live webcast of the fireside chats can be accessed in the Investor section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for at least 30 days.

On February 2, 2023 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for the third quarter of fiscal year 2022 (period ended December 31, 2022) (Press release, Takeda, FEB 2, 2023, View Source [SID1234626807]).

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Takeda chief financial officer, Costa Saroukos, commented:
"Our third-quarter performance demonstrates sustained momentum as our Growth and Launch Products and solid commercial execution again drove strong revenue and core profit growth. We continue to advance our organic pipeline, including notable approvals in the EU and China, and in December announced a significant acquisition that will add a potentially best-in-class TYK2 inhibitor to our late-stage pipeline and enhance our long-term growth strategy. Our robust cash flow and strong financial position enabled us to make substantive progress in deleveraging even as we continued to invest for growth."

FINANCIAL HIGHLIGHTS

Results for FY2022 Q3 Ended December 31, 2022

(Billion yen,
except
percentages and
per share
amounts)

REPORTED

CORE(c)

(Non-IFRS)(a)

FY2022 Q3 YTD

vs. PRIOR YEAR

(Actual % change)

FY2022 Q3 YTD

vs. PRIOR YEAR

(Actual % change)

vs. PRIOR YEAR

(CER % change(d))

Revenue

3,071.3

+13.9%

3,071.3

+19.8%

+4.5%

Operating Profit

401.9

-13.1%

954.7

+26.0%

+9.7%

Margin

13.1%

-4.1pp

31.1%

+1.5pp

Net Profit

285.9

+18.4%

707.2

+35.6%

+15.9%

EPS (yen)

184

+19.6%

456

+37.0%

+17.1%

Operating Cash Flow

683.5

-8.6%

Free Cash Flow

(Non-IFRS)(a)(b)

585.2

-12.8%

(a) Further information regarding certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source

(b) We define Free Cash Flow as cash flows from operating activities, subtracting acquisition of property, plant and equipment ("PP&E"), intangible assets and investments as well as removing any other cash that is not available to Takeda’s immediate or general business use, and adding proceeds from sales of PP&E, as well as from sales of investments and businesses, net of cash and cash equivalents divested.

(c) Core results adjust our reported results calculated and presented pursuant to IFRS to exclude the effect of items unrelated to Takeda’s core operations, such as, to the extent applicable for each line item, non-recurring items, purchase accounting effects and transaction related costs, as well as amortization and impairment of intangible assets and other operating income and expenses.

(d) CER (Constant Exchange Rate) change eliminates the effect of foreign exchange rates from year-over-year comparisons by translating Reported or Core results for the current period using corresponding exchange rates in the same period of the previous fiscal year.

COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS
Growth in our key business areas in FY2022 Q3 YTD was driven largely by Growth & Launch Products1, which delivered reported revenue of 1,199.6 billion yen, marking a +20% increase on a CER basis.

Gastroenterology (GI), with 857.5 billion yen in reported revenue, grew +11% on a CER basis, driven by ENTYVIO (for ulcerative colitis and Crohn’s disease; +17% on a CER basis) and by TAKECAB/VOCINTI (for acid-related diseases), whose strong uptake in China was also a key contributor to growth.
Rare Diseases, with 553.6 billion yen in reported revenue, grew +5% on a CER basis. Sales of TAKHZYRO (for hereditary angioedema) grew +25% on a CER basis due to expansion of the prophylactic market, continued geographic expansion and strong patient uptake. LIVTENCITY (for post-transplant cytomegalovirus) continues to generate high interest and strong uptake since its launch in the U.S. in December 2021, with 87% of U.S. transplant centers having initiated therapy with at least one patient.
Plasma-Derived Therapies (PDT) Immunology, with 502.4 billion yen in reported revenue, delivered outstanding growth of +18% on a CER basis. Growth was driven by higher sales of immunoglobulin products (for primary immunodeficiency and multifocal motor neuropathy), with +19% growth on a CER basis, particularly in the U.S. amid easing of pandemic pressures coupled with increasing supply. Robust growth for albumin products (primarily used for hypovolemia and hypoalbuminemia), at +20% on a CER basis, was driven by strong demand in the U.S. and in China. We added 5 donation centers as planned in the U.S. in FY2022 Q3, bringing us to 21 new centers YTD, and our global donation network to 225 centers.
Oncology, with 345.0 billion yen in reported revenue, declined -13% on a CER basis as a result of the expected entry of VELCADE generics (for multiple myeloma) that began in the U.S. in May 2022. Besides VELCADE, all other revenue totaled 320.2 billion yen, a year-over-year increase of +7% on a CER basis, driven by strong demand for ALUNBRIG (for non-small cell lung cancer; +39% growth on a CER basis) in Europe and Growth & Emerging Markets, and China. ADCETRIS (for malignant lymphomas) grew +18% on a CER basis, driven by increased access and uptake in frontline indications, while increased awareness of positive OPTIC trial results and label update contributed to +13% growth of ICLUSIG (for Leukemia) on a CER basis. Sales of EXKIVITY (for non-small cell lung cancer), which was first launched in the U.S. in September 2021 followed by several other countries, also contributed.
Neuroscience, with 477.1 billion yen in reported revenue, grew +10% on a CER basis, driven by an expanding ADHD adult market in the U.S., Europe and Canada for VYVANSE/ELVANSE. Sales of TRINTELLIX were 79.7 billion yen (+5% growth on a CER basis), due to continued recovery of the Major Depressive Disorder market in the U.S. and strong market share gains in Japan.
PIPELINE UPDATE
Takeda has continued to deliver on its ability to bring new therapies to patients and capitalize on momentum within its innovative pipeline. Updates since the FY2022 H1 announcement include:

Takeda announced that it has entered into an exclusive licensing agreement with HUTCHMED for the further development and commercialization of fruquintinib worldwide (ex-China, Hong Kong, and Macau). Fruquintinib is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, 2 and 3. It is orally administered and offers a potential new treatment option for patients with refractory metastatic colorectal cancer, regardless of biomarker status.
Additional information related to this announcement is available here.
Takeda announced that it will acquire NDI-034858, an oral selective allosteric TYK2 inhibitor being evaluated for the potential treatment of multiple autoimmune diseases, from Nimbus Therapeutics. With Phase 3 studies in psoriasis expected to begin this year, NDI-034858 has the potential to demonstrate best-in-class efficacy and safety and convenience in psoriasis as well as other immune-mediated diseases including psoriatic arthritis, inflammatory bowel disease and systemic lupus erythematosus. The acquisition is expected to strengthen Takeda’s growing late-stage pipeline in alignment with the company’s therapeutic area strategy and expertise in immune-mediated diseases. Takeda will pay Nimbus USD 4 billion upfront in addition to two milestone payments of USD 1 billion each upon achieving annual net sales of USD 4 billion and USD 5 billion for products developed from the NDI-034858 program. The upfront payment will be primarily funded by cash on hand. The transaction is expected to be finalized before the end of FY2022.
Additional information related to this announcement is available here.
QDENGA, Takeda’s dengue vaccine, was approved by the European Commission (EC) in December 2022 for use in individuals four years of age and older. With the EC approval, QDENGA becomes the only dengue vaccine approved in the EU for use in individuals regardless of previous dengue exposure. In November, the U.S. FDA granted priority review of the Biologics License Application.
Additional information related to the EC and U.S. FDA announcements is available here and here.
China’s National Medical Products Administration (NMPA) approved EXKIVITY (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY is now the first and only treatment available for this patient population in China and was reviewed as part of the NMPA’s Breakthrough Therapy program.
Additional information related to this announcement is available here.
LIVTENCITY (maribavir) was approved by the European Commission (EC) for the treatment of adults with post-transplant cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies. This approval makes LIVTENCITY the first and only treatment approved for this indication by the EC. CMV is one of the most common and serious post-transplant infections and can lead to loss of transplanted organ and failure of graft.
Additional information related to this announcement is available here.
Takeda announced favorable safety and efficacy results of TAK-755 from the first and only Phase 3 trial in congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare disease with limited treatment options. Based on this data, Takeda aims to seek marketing authorization for TAK-755 as the first recombinant ADAMTS13 replacement therapy for cTTP, a disorder with considerable unmet patient need.
Additional information related to this announcement is available here.
Takeda and Arrowhead Pharmaceuticals Inc. announced topline results from the SEQUOIA Phase 2 study of investigational fazirsiran (TAK-999/ARO-AAT) in patients with liver disease associated with alpha-1 antitrypsin deficiency (AATD-LD). Takeda has initiated a Phase 3 study to evaluate the safety and efficacy of fazirsiran in the treatment of patients with AATD-LD with METAVIR stage F2 to F4 fibrosis.
Additional information related to this announcement is available here.
Results from Takeda’s Phase 3 AURORA trial provided evidence of maribavir’s clinically meaningful and durable effect in cytomegalovirus infection in hematopoietic stem cell transplant patients despite missing the primary endpoint. Full data results will be submitted for publication in a peer-reviewed journal and are being shared with relevant regulatory agencies.
Additional information related to this announcement is available here.
Takeda’s Phase 3 PhALLCON trial met its primary endpoint, demonstrating that adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) treated with ICLUSIG (ponatinib) plus reduced-intensity chemotherapy achieved higher rates of minimal residual disease-negative complete remission compared to imatinib. There are currently no targeted treatments approved for Ph+ ALL in the U.S.
Additional information related to this announcement is available here.
TAK-861, Takeda’s oral orexin agonist for narcolepsy, met pre-specified criteria set to advance the program into two Phase 2b studies in narcolepsy type 1 and narcolepsy type 2. Both Phase 2b trials are currently enrolling patients.
Additional information related to this update is available here.
FY2022 Outlook

On track towards full-year FY2022 Management Guidance

(Billion yen)

FY2022
FORECAST
(Upgraded
October 2022)

FY2022
MANAGEMENT GUIDANCE
Core Growth at CER
(Non-IFRS)
(Unchanged from May 2022)

Revenue

3,930.0

Core Revenue

3,930.0

Low-single-digit growth

Reported Operating Profit

530.0

Core Operating Profit

1,180.0

High-single-digit growth

Reported Net Profit

307.0

Reported EPS (Yen)

198

Core EPS (Yen)

525

High-single-digit growth

Free Cash Flow

650.0 – 750.0

Annual Dividend per Share (Yen)

180

Free Cash Flow forecast does not include the impact of the upfront cash payment for the acquisition of NDI-034858 from Nimbus Therapeutics, LLC for USD 4 billion, as the exact timing of cash payment is dependent upon deal close.

For more details on Takeda’s FY2022 Q3 results and other financial information including key assumptions in FY2022 forecast and management guidance, please visit: View Source

On February 2, 2023 ADC Therapeutics SA ("ADCT" or the "Company") (NYSE: ADCT), a commercial-stage biotechnology company helping to improve the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates, reported the pricing of an underwritten offering of 12,000,000 common shares of the Company currently owned by A.T. Holdings II Sàrl (the "Selling Shareholder"), an affiliate of Auven Therapeutics Holdings L.P., at a price of $5.00 per share (before underwriting discounts and commissions) (Press release, ADC Therapeutics, FEB 2, 2023, View Source [SID1234626806]). ADCT is not selling any common shares and will not receive any proceeds from the sale of the common shares in the offering. The offering is expected to close on February 6, 2023, subject to customary closing conditions.

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The offering included participation from Redmile Group, Perceptive Advisors, Frazier Life Sciences and Surveyor Capital (a Citadel company) along with other institutional investors.

Jefferies is acting as sole book-running manager for the offering.

The offering is being made pursuant to an effective registration statement (including a prospectus) on Form F-3 previously filed with the Securities and Exchange Commission ("SEC"). A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to this offering, when available, may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, telephone: (877) 821-7388, email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification of these securities under the securities laws of any such state or other jurisdiction.