Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 1
CONSOLIDATED ANNUAL REPORT
BIOTON S.A. GROUP
for the period 1 January 2025 to 31 December 2025
Warsaw, 29 April 2026
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 2
Table of Contents
I. SELECTED FINANCIAL DATA ............................................................................................................................................................................. 5
II. CONSOLIDATED AND SEPARATE FINANCIAL STATEMENTS OF THE BIOTON S.A. GROUP................................................................. 8
III. THE AUDITOR’S REPORT ON THE AUDIT OF THE CONSOLIDATED AND SEPARATE FINANCIAL STATEMENTS OF THE BIOTON
S.A. GROUP AND THE COMPANY ................................................................................................................................................................................. 8
IV. BASIC INFORMATION ABOUT THE ISSUER AND ITS ACTIVITIES ............................................................................................................... 8
1. Composition of the Management Board and Supervisory Board of Bioton S.A. ................................................................................ 8
2. Audit Committee of the Supervisory Board of Bioton S.A. ...................................................................................................................... 9
3. Description of the organisation of the Company and the Group, indicating the entities subject to consolidation, and a
description of changes in the Group’s organisation, together with the reasons for such changes ......................................................... 9
4. Principles adopted in the preparation of the financial statements ...................................................................................................... 9
5. Events having a material impact on the entity’s operations that occurred during the financial year, as well as after its end,
up to the date of approval of the financial statements ..................................................................................................................................... 11
6. Discussion of key economic and financial figures disclosed in the annual separate and consolidated financial statements,
including a description of the structure of assets and liabilities from the perspective of the Company’s and the Group’s liquidity
13
7. A description of significant off-balance-sheet items by entity, nature and value ........................................................................ 21
8. A description of significant risk factors and threats, specifying the extent to which the Company and the Group are
exposed to them .......................................................................................................................................................................................................... 21
9. Indication of proceedings pending before a court, an arbitration body or a public administration body ............................... 23
10. Information on core products, goods or services, including their value and volume, and the share of individual products,
goods and services (if material) or their groups in the Company’s and the Group’s total sales, as well as changes in this respect
during the financial year ............................................................................................................................................................................................. 23
11. Information on sales markets, broken down into domestic and foreign markets, and information on sources of supply for
production materials, goods and services, specifying dependence on one or more customers and suppliers, and where the
share of a single customer or supplier reaches at least 10% of total sales revenue - the name (business name) of the supplier or
customer, their share of sales or supplies, and their formal links with the Group...................................................................................... 25
12. Information on agreements concluded that are significant to the operations of the Company and the Group, including
agreements known to the Company and the Group concluded between shareholders, and cooperation or collaboration
agreements .................................................................................................................................................................................................................... 27
12.1. Cooperation agreement between Yifan Pharmaceutical Co., Limited and Bioton S.A. ......................................................................... 27
12.2. Novation Agreement ......................................................................................................................................................................................... 28
12.3. Licence and supply agreement for recombinant human insulin for the Malaysian market ................................................................. 28
12.4. Agreements for the distribution of Liraglutide in Poland ........................................................................................................................... 28
12.5. Contract manufacturing agreement for Glargine at Bioton’s facilities for the European Union markets .......................................... 28
12.6. Research and development agreement with Biotts S.A. – update ........................................................................................................... 29
12.7. Cooperation regarding the use of Bioton’s API in a pharmaceutical product by EnteroTarges ApS – update ............................... 29
13. Information on organisational or capital links between Bioton S.A. and the Group and other entities, and a description of
its main domestic and foreign investments (securities, financial instruments, intangible assets and property), including capital
investments made outside its group of related entities, and a description of the methods used to finance them ......................... 30
13.1. Investments in fixed assets and intangible assets ...................................................................................................................................... 30
13.2. Expenditure on research and development ................................................................................................................................................. 30
14. Information on significant transactions entered into by Bioton or its subsidiary with related parties on terms other than
market terms, together with their amounts and information specifying the nature of such transactions ......................................... 31
15. Information on loan and credit agreements entered into and terminated during the financial year, specifying at least their
amount, type, interest rate, currency and maturity date ................................................................................................................................. 31
16. Information on loans granted during the financial year, with particular regard to loans granted to entities related to Bioton
S.A., specifying at least their amount, type, interest rate, currency and maturity date .......................................................................... 32
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 3
17. Information on sureties and guarantees granted and received during the financial year, with particular emphasis on
sureties and guarantees granted to entities related to Bioton S.A................................................................................................................. 32
18. In the event of a securities issue during the reporting period – a description of how the Company and the Group have
utilised the proceeds from the issue up to the date of this report ................................................................................................................ 32
19. Explanation of the differences between the financial results disclosed in the annual report and the previously published
forecasts for the year.................................................................................................................................................................................................. 32
20. An assessment, together with its justification, of the management of financial resources, with particular emphasis on the
ability to meet obligations, and an identification of any risks and measures that the Company and the Group have taken or
intend to take to counteract such risks ................................................................................................................................................................. 32
20.1. Key financial performance indicators of the Group .................................................................................................................................... 32
20.2. Key financial performance indicators of the Company .............................................................................................................................. 36
21. An assessment of the feasibility of implementing investment plans, including capital investments, in relation to the
amount of funds available, taking into account possible changes in the financing structure of such activities............................... 38
22. An assessment of factors and unusual events affecting the results of the Company’s and the Group’s operations for the
financial year, specifying the extent of the impact of these factors or unusual events on the results achieved ............................. 39
23. A description of external and internal factors significant to the development of Bioton S.A. and the Group, and an outline
of the prospects for the development of the Company’s and the Group’s operations at least until the2026 .................................. 40
24. Changes in the fundamental principles of management of Bioton S.A. and the Group................................................................. 43
25. Any agreements concluded between Bioton S.A. and its management personnel providing for compensation in the event
of their resignation or dismissal from their position without valid cause, or where their dismissal or removal from office is due to
a merger of the Company through a takeover ..................................................................................................................................................... 43
26. The value of remuneration, awards or benefits, including those arising from incentive or bonus schemes based on Bioton
S.A. equity, including schemes based on senior bonds, convertible bonds and subscription warrants (in cash, in kind or in any
other form), paid, due or potentially due, separately for each of the Company’s management and supervisory personnel at
Bioton S.A., regardless of whether they were recognised as expenses or resulted from profit distribution, and information on the
value of remuneration and awards received for performing functions in the governing bodies of subsidiaries ............................... 44
27. Specification of the total number and nominal value of all Bioton S.A. shares and shares in the Company’s related entities
held by management and supervisory personnel (separately for each person) ........................................................................................ 44
28. Information on agreements known to Bioton S.A. (including those concluded after the balance sheet date) which may
result in future changes to the proportions of shares held by existing shareholders and bondholders .............................................. 44
29. Information on the control system for employee share schemes ...................................................................................................... 44
30. Information on the auditor ............................................................................................................................................................................. 44
31. Information on the impact of armed conflicts worldwide on the Company’s operations ............................................................ 44
31.1. The economic and political situation in Ukraine .......................................................................................................................................... 45
31.2. Economic and political situation in the Middle East ................................................................................................................................... 45
V. STATEMENT BY THE MANAGEMENT BOARD OF BIOTON S.A. ON COMPLIANCE ............................................................................... 46
VI. STATEMENT BY THE MANAGEMENT BOARD OF BIOTON S.A. ON THE APPOINTMENT OF THE AUDITOR .................................... 46
VII. STATEMENT BY THE MANAGEMENT BOARD OF BIOTON S.A. ON THE APPLICATION OF CORPORATE GOVERNANCE
PRINCIPLES ..................................................................................................................................................................................................................... 47
1. Indication of the set of corporate governance principles to which Bioton S.A. is subject and the place where the text of
the set of principles is publicly available ............................................................................................................................................................... 47
2. Indication of the provisions of the corporate governance code from which Bioton S.A. has departed, an explanation of the
circumstances and reasons for such deviation, and a description of how the company intends to address any consequences of
non-compliance with the relevant provision or what steps it intends to take to reduce the risk of non-compliance with the
relevant provision in the future ................................................................................................................................................................................ 47
3. A description of the main features of the internal control and risk management systems applied within the Company in
relation to the process of preparing separate and consolidated financial statements ........................................................................... 48
4. A list of shareholders holding, directly or indirectly, significant blocks of shares in Bioton S.A., together with an indication
of the number of shares held by these entities, their percentage share in the share capital, the number of votes arising
therefrom and their percentage share in the total number of votes at the general meeting ................................................................. 49
5. Identification of holders of any securities conferring special control rights in relation to Bioton S.A., together with a
description of those rights ........................................................................................................................................................................................ 49
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 4
6. An indication of any restrictions on the exercise of voting rights, such as restrictions on the exercise of voting rights by
holders of a specified portion or number of votes, time-based restrictions on the exercise of voting rights, or provisions under
which, with the Company’s cooperation, the capital rights attached to the securities are separated from the holding of the
securities ........................................................................................................................................................................................................................ 49
7. Indication of any restrictions on the transfer of ownership of Bioton S.A. securities .................................................................... 50
8. A description of the rules governing the appointment and removal of management personnel and their powers, in
particular the right to decide on the issue or redemption of shares ............................................................................................................. 50
9. Description of the rules governing amendments to the Articles of Association of Bioton S.A. ................................................... 50
10. The procedure for the General Meeting and its principal powers, as well as a description of shareholders’ rights and the
manner in which they are exercised, in particular the rules set out in the General Meeting’s rules of procedure, if such rules have
been adopted, provided that this information is not already explicitly provided for by law .................................................................. 50
11. The composition of the board and any changes thereto during the last financial year, and a description of the operations
of the management and supervisory bodies of Bioton S.A. and their committees .................................................................................... 57
VIII. STATEMENT ON NON-FINANCIAL INFORMATION OF THE COMPANY AND THE BIOTON S.A. GROUP .......................................... 61
1. Legal requirements .......................................................................................................................................................................................... 61
2. Description of the entity’s business model .............................................................................................................................................. 61
3. Risk management ............................................................................................................................................................................................. 64
4. Ethics management ......................................................................................................................................................................................... 65
5. Policies and procedures relating to social responsibility, their outcomes and key non-financial performance indicators66
5.1. Policies and indicators relating to labour issues .......................................................................................................................................... 66
5.2. Policies and indicators relating to human rights .......................................................................................................................................... 73
5.3. Policies and indicators relating to anti-corruption issues ......................................................................................................................... 74
5.4. Policies and indicators relating to social issues ........................................................................................................................................... 74
5.5. Policies and indicators relating to environmental issues ........................................................................................................................... 79
5.6. List of indicators................................................................................................................................................................................................. 82
IX. Statement by the Management Board ....................................................................................................................................................... 84
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 5
Pursuant to §66 of the Regulation of the Minister of Finance of 6 June 2025 on current and periodic information disclosed by
issuers of securities and the conditions for recognising as equivalent information required by the laws of a non-member state
(Journal of Laws of 2025, item 755) BIOTON S.A. (“the Company”) hereby provides the following information:
I. SELECTED FINANCIAL DATA
The measurement currency and reporting currency of these financial statements is the Polish zloty; figures are presented in
thousands of zlotys. The following conversion rules from PLN to EUR have been applied for the presentation of selected
financial data in EUR:
• balance sheet data has been converted using the average exchange rate of the National Bank of Poland (NBP)
announced on:
− 31 December 2025 at an exchange rate of EUR/PLN 4.2267,
− 30 September 2025 at an exchange rate of EUR/PLN 4.2692,
− 31 December 2024 at an exchange rate of EUR/PLN 4.273,
− 30 September 2024 at an exchange rate of EUR/PLN 4.2791.
• data from the profit and loss account and the cash flow statement have been converted using the exchange rate
representing the arithmetic mean of the average exchange rates for that period as follows:
− for the fourth quarter of 2025 at an exchange rate of EUR/PLN 4.2383,
− for the fourth quarter of 2024 at an exchange rate of EUR/PLN 4.3074,
− for the period from 1 January 2025 to 31 December 2025 at an exchange rate of EUR/PLN 4.2402,
− for the period from 1 January 2024 to 31 December 2024 at an exchange rate of EUR/PLN 4.3065.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 6
Selected financial data for the Bioton S.A. group
in PLN thousand
in thousands of EUR
BREAKDOWN
1 January 2025
– 31 December
2025
1 January 2024
– 31 December
2024
1 January 2025
– 31 December
2025
1 January 2024
– 31 December
2024
Net sales revenue
282,521
207,763
66,629
48,244
Gross profit (loss) from operating activities
13,325
(5,709)
3,143
(1,326)
Gross profit (loss) before tax
7,831
(11,880)
1,847
(2,759)
Net profit (loss)
3,393
(15,658)
800
(3,636)
Net cash flow from operating activities
22,620
36,326
5,335
8,435
Net cash flow from investing activities
(13,003)
(11,184)
(3,068)
(2,597)
Net cash flows from financing activities
(8,297)
(22,063)
(1,955)
(5,123)
Total net cash flows
1,320
3,080
311
715
Weighted average number of shares
85,864,200
85,864,200
85,864,200
85,864,200
Earnings (loss) per ordinary share (in PLN / EUR)
0.0395
(0.1824)
0.0093
(0.0423
Diluted earnings (loss) per ordinary share (in PLN/EUR)
0.0395
(0.1824)
0.0093
(0.0423)
31 December
2025
31 December
2024
31 December
2025
31 December
2024
Total assets
764,562
794,138
180,889
185,850
Liabilities and provisions for liabilities
170,592
203,590
40,361
47,646
Long-term liabilities
67,679
60,472
16,012
14,152
Current liabilities
102,913
143,118
24,348
33,493
Equity
593,970
590,548
140,528
138,204
Share capital
1,717,284
1,717,284
406,294
401,892
Weighted average number of shares
85,864,200
85,864,200
85,864,200
85,864,200
Book value per share (in PLN / EUR)
6.9176
6.8777
1.6335
1.6096
Diluted book value per share (in PLN / EUR)
6.9176
6.8777
1.6335
1.6096
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 7
Selected standalone financial data for Bioton S.A.
in PLN thousand
in thousands of EUR
BREAKDOWN
1 January
2025 – 31
December
2025
1 January
2024 – 31
December
2024
1 January
2025 – 31
December
2025
1 January
2024 – 31
December
2024
Net sales revenue
287,389
214,052
67,777
49,704
Gross profit (loss) from operating activities
11,185
(8,160)
2,638
(1,895)
Gross profit (loss) before tax
5,329
(14,448)
1,257
(3,355)
Net profit (loss)
1,452
(18,479)
342
(4,291)
Net cash flow from operating activities
21,084
32,822
4,972
7,622
Net cash flow from investing activities
(11,852)
(8,075)
(2,797)
(1,875)
Net cash flows from financing activities
(7,776)
(21,769)
(1,832)
(5,055)
Total net cash flows
1,457
2,979
344
692
Weighted average number of shares
85,864,200
85,864,200
85,864,200
85,864,200
Earnings (loss) per ordinary share (in PLN / EUR)
0.0169
(0.2152)
0.0040
(0.0500)
Diluted earnings (loss) per ordinary share (in PLN / EUR)
0.0169
(0.2152)
0.0040
(0.0500)
31
December
2025
31
December
2024
31
December
2025
31
December
2024
Total assets
777,090
807,414
183,853
188,957
Liabilities and provisions for liabilities
172,126
204,027
40,723
47,748
Long-term liabilities
67,329
60,983
15,929
14,272
Current liabilities
104,797
143,044
24,794
33,476
Equity
604,964
603,387
143,129
141,209
Share capital
1,717,284
1,717,284
406,294
401,892
Weighted average number of shares
85,864,200
85,864,200
85,864,200
85,864,200
Book value per share (in PLN / EUR)
7.0456
7.0272
1.6638
1.6446
Diluted book value per share (in PLN / EUR)
7.0456
7.0272
1.6638
1.6446
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 8
II.
Consolidated Financial Statements of the Bioton S.A and the Separate Financial Statements of Bioton S.A. as at 31 December
2025 and for the period ended 31 December 2025, prepared in accordance with International Financial Reporting Standards
as adopted by the European Union, are attached to this report.
III. STATEMENT OF THE AUDITOR ON THE AUDIT OF THE CONSOLIDATED AND SEPARATE
FINANCIAL STATEMENTS OF THE BIOTON S.A. GROUP AND BIOTON S.A.
The auditor’s reports on the audit of the consolidated financial statements of the Bioton S.A. Group and the separate financial
statements of Bioton S.A. are attached to this report.
IV. BASIC INFORMATION ABOUT THE ISSUER AND ITS ACTIVITIES
1. Composition of the Management Board and Supervisory Board of Bioton S.A.
Composition of the Management Board of Bioton S.A. as at 31 December 2025:
• Mr Jeremy Launders (Chairman of the Management Board),
• Mr Romuald Harwas (Member of the Management Board).
On 29 July 2025, Mr Adam Polonek tendered his resignation from the position of Member of the Management Board of Bioton
S.A. with effect from 31 July 2025. The resignation was due to personal reasons. On the same day, the Company’s Supervisory
Board adopted a resolution appointing Mr Romuald Harwas as a Member of the Management Board of Bioton S.A. with effect
from 1 August 2025.
Composition of the Supervisory Board of Bioton S.A. as at 31 December 2025:
• Mr Jia Li (Chairman of the Supervisory Board),
• Mr Ramesh Rejentheran (Vice-Chairman of the Supervisory Board),
• Mr Dariusz Trzeciak (Vice-Chairman of the Supervisory Board),
• Mr Nicola Cadei (Member of the Supervisory Board),
• Mr Jubo Liu (Member of the Supervisory Board),
• Mr Vaidyanathan Viswanath (Member of the Supervisory Board),
• Mr Tomasz Siembida (Member of the Supervisory Board)
• Mr Kaiguo Xia (Member of the Supervisory Board).
On 22 May 2025, Ms Valery Yeo (Yeo Jien Fong) resigned from her membership of the Company’s Supervisory Board and
Audit Committee. The resignation was due to personal reasons.
The Annual General Meeting of Bioton S.A., held on 23 June 2025, appointed Mr Kaiguo Xia to the position of Member of the
Supervisory Board of Bioton S.A.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 9
2. The Audit Committee of the Supervisory Board of Bioton S.A.
The Audit Committee consists of three members of the Supervisory Board. The detailed procedures governing the functioning
of the Audit Committee are set out in the Rules of Procedure of the Audit Committee of the Supervisory Board of Bioton S.A.
The following persons have been appointed to the Audit Committee:
• Mr Dariusz Trzeciak – Chairman of the Audit Committee, who meets the independence criteria referred to in § 18(1)(2)
– (4) of the Articles of Association of Bioton S.A.;
• Mr Ramesh Rajentheran – Vice-Chairman of the Audit Committee, who meets the independence criteria referred to
in § 18(1)(2) to (4) of the Articles of Association of Bioton S.A.;
• Mr Nicola Cadei – Member of the Audit Committee.
3. Description of the organisation of the Company and the Group, indicating the entities
subject to consolidation, and a description of changes in the Group’s organisation, together
with the reasons for such changes
As at 31 December 2025, the subsidiaries of Bioton S.A. were:
• BIOTON MARKETING AGENCY Sp. z o.o. with its registered office in Macierzysz, in which Bioton S.A. holds 100% of the
shares;
• BIOLEK Sp. z o.o. with its registered office in Macierzysz, in which Bioton S.A. holds 100% of the shares;
• BIOTON (International) GmbH, with its registered office in Baar (Switzerland), in which Bioton S.A. holds 100% of the
shares;
• BioPartners GmbH, based in Reutlingen (Germany), has been entered in the commercial register as “in liquidation”;
however, the company cannot be struck off the commercial register due to a pension liability towards an employee.
The company remains entered in the commercial register but is no longer conducting business.
As at 31 December 2025, the subsidiaries of Bioton S.A. included in the consolidation were:
• BIOTON MARKETING AGENCY Sp. z o.o. with its registered office in Macierzysz, in which Bioton S.A. held 100% of the
shares;
• BIOLEK Sp. z o.o. with its registered office in Macierzysz, in which Bioton S.A. held 100% of the shares;
• BIOTON (International) GmbH, with its registered office in Baar (Switzerland), in which Bioton S.A. held 100% of the
shares;
4. Accounting policies applied in the preparation of the financial statements
Since 1 January 2005, the Bioton S.A. Group (“the Group”) has maintained its accounts in accordance with International
Financial Reporting Standards (“IFRS”), as adopted by the European Union, and, in matters not covered by those standards, in
accordance with the requirements of the Accounting Act (Journal of Laws of 2019, item 351) and the implementing regulations
issued thereunder, as well as in accordance with the requirements set out in the Regulation of the Minister of Finance of 6
June 2025 on current and periodic information disclosed by issuers of securities and the conditions for recognising as
equivalent information required by the laws of a non-member state (Journal of Laws of 2025, item 755, as amended).
The financial data contained in this report covers the accounting period from 1 January 2025 to 31 December 2025 and as at
31 December 2025, and comparative data for the period from 1 January 2024 to 31 December 2024 and as at 31 December
2024. The financial data presented for the financial period from 1 January 2025 to 31 December 2025 had, as at the date of
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 10
publication of this report, been audited by an independent auditor. The comparative figures for the period from 1 January
2024 to 31 December 2024 and the financial figures as at 31 December 2024 were subject to audit by an independent auditor.
The Group’s financial statements are prepared on a historical cost basis, with the exception of financial instruments measured
at fair value through profit or loss.
In the opinion of the Management Board and the Supervisory Board of the Parent Company, it is appropriate to prepare both
the separate and consolidated financial statements on a going concern basis for the foreseeable future.
As at the balance sheet date, the Issuer’s Management Board analysed and assessed the entity’s ability to continue as a going
concern, taking into account various events or circumstances which, individually or collectively, could potentially indicate
significant uncertainty regarding the entity’s ability to continue as a going concern.
The Issuer’s Management Board assumes that the company will continue its operations for at least 12 months after the balance
sheet date to an unchanged, material extent, with no intention of liquidation or bankruptcy. The Management Board bases its
assumption on the following premises.
Based on the Management Board’s current estimates, revenue from contracts already signed, together with contracts
potentially secured this year with new and existing customers, and available bank financing, are sufficient to maintain the
Group’s current liquidity. As at 20 April 2026, completed and/or placed orders amounted to 60.3% of the Group’s budget for
2026, i.e. approximately 67.13% of the volume required to provide the Company with sufficient funds to cover operating
expenses and debt servicing throughout 2026. There are no negative cash flows from operating activities reported in the
forecast financial statements. The Company’s budget does not anticipate an operating loss or a significant reduction in the
value of cash-generating assets.
As at the balance sheet date, the current liabilities of both the Company and the Group do not exceed current assets.
The loans are due in November and December 2026, and the refinancing process completed in December 2025 allows the
Management Board to take a realistic view of their extension, as there are no indications as at the date of this report that the
terms of the loan agreements cannot be met. As at the date of publication, the financial covenants as at the balance sheet
date specified in the terms of the loan agreements entered into by Bioton S.A. were met. The loans taken out finance working
capital and there is no reliance on short-term loans to finance long-term assets. As at the balance sheet date, the Company
has no significant overdue liabilities.
In the past period, there were also no operational events or circumstances which, individually or collectively, could potentially
indicate uncertainty regarding the entity’s ability to continue as a going concern, and in particular: there was no loss of key
management personnel without replacement, the emergence of a highly effective competitor, shortages of important raw
materials, staff shortages, interruptions in production or the provision of services due to labour disputes, significant
dependence on the success of a specific project or new product, or the loss of a core market, key customers, licences or a
main supplier.
In its analysis of the ability to continue as a going concern, the Issuer’s Management Board also took into account other
factors, such as: changes in laws, regulations and government policy which may have a negative impact on the entity, and the
absence of any pending legal or administrative proceedings against the entity which, if decided against the entity, could give
rise to claims that it is unlikely to be able to satisfy.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 11
5. Events having a material impact on the entity’s operations that occurred during the financial
year, as well as after its end, up to the date of approval of the financial statements
Execution of a contract for Malaysia
On 18 October 2024, the Company entered into an agreement with a global pharmaceutical company concerning the
production of recombinant human insulin to ensure the treatment of patients in Malaysia, with deliveries having commenced
as early as December 2024. In April 2025, the Company extended the agreement, which significantly boosted revenue from
this source to PLN 103.2 million in the reporting period, having a significant impact on the financial results of the Company
and the Group in 2025. The agreement was concluded for a period of five years. The volume for 2025 under the contract has
been fully delivered. With regard to further orders for Malaysia, the Company is awaiting the allocation decision in the tender
issued by the Malaysian Ministry of Health. The Company sees a strong opportunity for future orders, given its presence in
the bids of many distributors participating in the Malaysian Ministry of Health’s tender.
Preparations for the contract manufacturing of Glargin for European Union markets
On 7 February 2025, the Company signed an Agreement for the contract manufacturing of Glargine. Under this agreement,
Bioton S.A. has obtained a non-exclusive licence to the product technology for the manufacture of Finished Products by
Bioton S.A. The agreement was concluded for a period of five years, with the option to extend for further periods by mutual
agreement between the parties. The project has successfully passed the first stage (site suitability assessment) and is
currently in the technology transfer phase. The agreement will result in the establishment of Bioton’s production facility in
Macierzysz as a validated manufacturing site for Glargine, registered in the regulatory documentation of the CMO’s client. The
company has already placed orders for new machinery and equipment related to the fulfilment of this contract. The
equipment is scheduled for delivery in 2027. The value of the European market for Glargine is four times greater than that of
the RHI insulin market.
Conclusion of licence agreements for new molecules
In 2025, the Company entered into a number of licence and supply agreements in connection with the development of its
portfolio for the manufacture of the following substances:
• Famotidine (on 7 February 2025) – the Company made two milestone payments in respect of licence fees, and the
registration dossier has been submitted; the registration process is ongoing, and the Company is also reassessing
the role of this drug in its portfolio
• Liraglutide (on 4 November 2025) – conclusion of an agreement between Bioton and a major international
pharmaceutical company for the in-licensing of GLP-1 Liraglutide for the Polish market. At the time of publication,
the registration process is ongoing and the Company maintains its intention to launch the product in 2026.
• Rivaroxaban (on 4 November 2025) – the registration process is ongoing, and the Company plans to launch the
product in early 2027.
• Apixaban (on 4 November 2025) – the registration process is ongoing, and the Company plans to launch the product
in early 2027. This will enable the Company to expand its portfolio with further molecules and formulations in the
diabetes and obesity market (via a GLP-1 analogue).
RHI’s portfolio of insulin-complementary medicines – in oral and injectable forms – has seen significant growth in revenue
and volumes. This justifies Bioton’s continued interest in this area of activity.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 12
Optimisation of working capital financing
In 2025, Bioton S.A. renegotiated and restructured its debt financing, establishing a strategic partnership with UniCredit, which
was returning to the Polish corporate market. The new agreement replaced the existing working capital facilities at ING Bank
Śląski. The change in co-financing institution allowed the credit terms to be adjusted to the Company’s current operational
needs and debt servicing costs to be optimised, supporting the Group’s liquidity stability in subsequent periods. The
Company provided detailed information on this subject in Note 7.23 to the Separate Financial Statements, “Liabilities arising
from loans and borrowings and other debt instruments”.
Aligning the capital structure with strategic objectives and opening up to new sources of financing
After the balance sheet date of 14 April 2026, the Extraordinary General Meeting of Shareholders of Bioton S.A. adopted a key
resolution regarding the reduction of the Company’s share capital by decreasing the nominal value of the shares. The main
objective of this operation is to optimise the balance sheet structure and eliminate historical losses from previous years,
which is an essential step in the Company’s financial restructuring process. This will enable more effective raising of external
financing for operational and investment purposes, including opening up to grant funding (non-dilutive): It will also allow for
the streamlining of the capital structure, which is often a prerequisite for applying for advanced dedicated funds and research
and development (R&D) grants. As non-repayable and non-dilutive to the shareholder base, this funding is a key element of
the strategy to build the Company’s value without the need to issue new shares. Aligning the level of capital with the Group’s
actual needs and scale of operations allows for more flexible management of liquidity and working capital.
Intensification of activities in the area of securing grant funding – applications to the Medical Research Agency (ABM)
In pursuit of its strategy to build the Company’s value based on innovation and an optimal capital structure, on 21 April 2026
Bioton S.A. submitted three applications to the Medical Research Agency for funding for research and development projects.
The total value of the proposed projects amounts to PLN 79 million, with a requested grant amount of PLN 42 million.
The submitted applications focus on key areas of development within the Company’s biotechnology portfolio, and their
potential implementation will bring the Group a number of tangible benefits:
• Non-dilutive financing: Securing funds from ABM will enable the implementation of capital-intensive R&D projects
without the need to commit own funds or issue new shares. This allows for the development of innovative
technologies whilst maintaining the existing shareholding structure.
• Acceleration of work on new medicines: Public support significantly reduces the financial risk of technologically
advanced projects, enabling the Company to bring modern therapeutic solutions to market more quickly.
• Strengthening competitive advantage: Carrying out projects in collaboration with a renowned state agency enhances
the Company’s prestige within the scientific and business communities, confirming the high quality of its research
processes.
• Leverage effect on working capital: By refinancing part of the operating costs through grants, free cash (including
credit facilities with UniCredit) can be redirected towards the ongoing commercialisation of products and market
expansion.
The Company’s Management Board notes that the mere submission of grant applications is an initial stage and does not
guarantee the award of funding. The projects are currently subject to a multi-stage, formalised procedure of substantive and
formal assessment by ABM experts. This is a complex and risky process; consequently, there is no guarantee that it will result
in a positive decision to award funding for all or any of the submitted applications.
The submission of the above applications is directly linked to the commencement of the process of restructuring the balance
sheet, which will enable the Company to meet the stringent formal criteria required when applying for large-scale public
funding
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 13
6. Discussion of key economic and financial figures disclosed in the annual separate and
consolidated financial statements, including a description of the structure of assets and
liabilities from the perspective of the Company’s and the Group’s liquidity
A factor affecting the comparability of data for 2025 was the change in the PLN exchange rate against the main currencies
used by the Company compared to 2024. In 2025, the average daily exchange rate:
• USD/PLN fell by 5.58%,
• EUR/PLN fell by 1.53%;
The growth rates of individual items in the consolidated balance sheet were calculated by comparing their values as at 31
December 2025 with those as at 31 December 2024.
Key items of the Group’s consolidated annual financial statements
Consolidated analytical balance sheet – assets
31 December 2025
31 December 2024
changes
Total
structure
total
structure
(in PLN
thousand)
as a %
(in PLN
thousand)
(as a
percentage
)
(in PLN
thousand)
(as a
percentage)
ASSETS
764,562
100.0
794,138
100.0
(29,576)
(3.7)
A: Fixed assets
619,456
81.0
640 141
80.6
(20,685)
(3.2)
Property, plant and equipment
273,739
35.8
283,117
35.7
(9,378)
(3.3)
Other intangible assets
327,060
42.8
337,731
42.5
(10,671)
(3.2)
Assets arising from rights of use
18,568
2.4
19,205
2.4
(638)
(3.3)
Long-term accruals
90
-
88
0.0
2
1.7
B: Current assets
145 105
19.0
153,997
19.4
(8,892)
(5.8)
Inventories
95,007
12.4
107,287
13.5
(12,279)
(11.4)
Income tax receivables
-
-
26
0.0
(26)
(100.0)
Trade and other receivables
37,770
4.9
34,687
4.4
3,083
8.9
Cash
8,283
1.1
6,963
0.9
1,320
19.0
Current accruals
4,045
0.5
5,033
0.6
(988)
(19.6)
In 2025, the Group’s balance sheet total fell by 3.7% (PLN 29.57 million).
Non-current assets fell by 3.2% (a change of PLN 20.6 million), primarily due to the depreciation of property, plant and
equipment and amortisation of intangible assets.
The Group’s current assets fell by 5.8% (PLN 8.9 million). The change in current assets was significantly influenced by:
• a reduction in inventories by 11.4% (PLN 12.2 million) to PLN 95 million, driven, among other things, by increased sales
in 2025 and the optimisation of working capital;
• an increase in trade and other receivables by 8.9% (PLN 3.08 million), linked, amongst other things, to increased sales
and, consequently, foreign receivables from the contractor Biocon.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 14
The ratio of non-current assets to current assets was 81.0% to 19.0%.
Consolidated analytical balance sheet – liabilities
31 December 2025
31 December 2024
changes
Total
structure
total
structure
(in PLN
thousand)
as a %
(in PLN
thousand)
(as a
percentage
)
(in PLN
thousand)
(as a
percentage)
LIABILITIES
764,562
100.0
794,138
100.0
(29,576)
(3.7)
A: Equity
593,970
77.7
590,548
74.4
3,422
0.6
Share capital
1,717,284
224.6
1,717,284
216.2
-
0.0
Share premium
57,131
7.5
57,131
7.2
-
0.0
Reserve capital
260,776
34.1
260,776
32.8
-
0.0
Reserve capital
(266,607)
(34.9)
(266,734)
(33.6)
127
0.0
Reserve capital from transactions between
shareholders
(80,844)
(10.6)
(80,844)
(10.2)
-
0.0
Foreign exchange differences on translation of
subsidiaries
21
0.00
119
0.00
(98)
(82.4)
Retained earnings
(1,093,791)
(143.1)
(1,097,184)
(138.2)
3,393
(0.3)
B: Long-term liabilities
67,679
8.9
60,472
7.6
7,207
11.9
In respect of loans, borrowings and debt
instruments
7,273
1.0
-
-
7,273
-
From leasing
13,644
1.8
13,698
1.7
(54)
(0.4)
Employee benefits
2,661
0.3
2,534
0.3
128
5.0
Deferred income
30,943
4.0
33,877
4.3
(2,934)
(8.7)
Deferred income tax
11,787
1.5
7,839
1.0
3,948
50.4
Other liabilities
1,372
0.2
2,525
0.3
(1,153)
(45.7)
C: Current liabilities
102,913
13.5
143,118
18.0
(40,205)
(28.1)
In respect of loans, borrowings and debt
instruments
32,154
4.2
36,958
4.7
(4,804)
(13.0)
From leasing
4,092
0.5
5,912
0.7
(1,820)
(30.8)
Employee benefits
2,894
0.4
2,300
0.3
594
25.8
Trade and other receivables
32,367
4.2
53,044
6.7
(20,677)
(39.0)
Income tax
322
0.0
30
0.0
292
973.3
Other accruals
31,084
4.1
44,874
5.7
(13,790)
(30.7)
D: Liabilities related to assets held for sale
-
0.0
-
0.0
-
0.0
The Group’s equity increased by 0.6% to PLN 593.9 million.
Long-term liabilities increased by 11.9% (PLN 7.2 million) to PLN 67.6 million, mainly as a result of:
• an increase in liabilities arising from loans, borrowings and debt instruments due to the raising of a loan being repaid
in accordance with the schedule specified in the agreement;
• an increase in the deferred tax provision (as a result of the realisation of a tax loss asset due to the profit generated
and differences in balance sheet and tax depreciation rates).
Current liabilities amounted to PLN 102.9 million, a decrease of 28.1% (PLN 40.2 million) compared with the previous year,
mainly due to the settlement of trade payables.
The share of current liabilities in total liabilities stood at 13.5% and was lower than in the previous year (a change of 28.1%).
Growth rates for individual items of the consolidated profit and loss account were calculated by comparing their values in
2025 with those for 2024.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 15
Consolidated analytical profit and loss account
01.01–31.12.2025
01.01–31.12.2024
changes
Total
structure
(in %)
total
structure
(in %)
(PLN
thousand
)
(as a
percentage
)
(in PLN
thousand)
(in PLN
thousand)
1. Revenue from sales
282,521
100.0
207,763
100.0
74,758
36.0%
2. Cost of sales
(185,788)
65.8
(140,993)
67.9
(44,795)
31.8%
3. Costs of downtime and unused capacity
(4,936)
1.7
(1,929)
0.9
(3,007)
155.9%
4. Gross profit on sales
91,797
32.5
64,841
31.2
26,956
41.6%
5. Cost of sales
(37,098)
13.1
(36,118)
17.4
(980)
2.7%
6. General and administrative expenses
(36,301)
12.8
(31,081)
15.0
(5,220)
16.8%
7. Research and development costs
(3,975)
1.4
(4,043)
1.9
68
(1.7%)
8. Total operating costs (2+3+5+6+7)
(268,099)
94.9
(214,165)
103.1
(53,934)
25.2%
9. Profit on sales
14,422
5.1
(6,402)
3.1
20,824
325.3%
10. Other operating income
2,944
1.0
2,645
1.3
299
11.3%
11. Other operating costs
(4,041)
1.4
(1,952)
0.9
(2,089)
107.0%
12. Gross profit on operating activities
13,325
4.7
(5,709)
2.7
19,034
333.4%
13. Financial income
352
0.1
1,988
1.0
(1,635)
(82.3%)
14. Finance costs
(5,847)
2.1
(8,159)
3.9
2,312
(28.3%)
16. Profit before tax
7,831
2.8
(11,881)
5.7
19,711
165.9%
17. Income tax
(4,438)
1.6
(3,778)
1.8
(660)
17.5%
18. Net profit from continuing operations
3,393
1.2
(15,658)
7.5
19,051
121.7%
In 2025, the Group achieved revenue of PLN 282,521 thousand, representing a year-on-year increase of 36.0%. Insulin sales
accounted for 82.2% of total revenue, an increase of 25.7 percentage points compared to 2024. In value terms, the increase
in insulin sales amounted to PLN 72,490,000, or 45.3%, and was driven primarily by the Malaysian market, where sales rose by
PLN 85,640,000 year-on-year. Additional growth was also recorded in Uruguay, Pakistan, Thailand and Bangladesh, confirming
the growing importance of emerging markets in the Group’s sales structure.
Cost of sales (excluding downtime costs and unused capacity) for the whole of 2025 amounted to PLN 185,788,000,
representing a 31.8% year-on-year increase. This growth is mainly attributable to: higher sales year-on-year, changes in the
geographical sales structure, including a greater share of foreign markets with higher unit costs, and changes in the product
mix, in particular a greater share of products with higher production costs.
The gross margin on sales in 2025 at the consolidated level stood at 32.5% and was 1.3 percentage points higher than in the
comparative period. In value terms, it stood at PLN 91,797 thousand compared to PLN 64,861 thousand. The main driver of the
41.6% increase in gross margin in value terms was higher year-on-year sales.
In the coming periods, the Company expects a further improvement in the sales mix, which should translate into a higher
share of medium- and high-margin products. Additionally, planned measures to optimise production processes , reduce
component costs and increase the efficiency of production capacity utilisation should have a positive impact on the total
cost of sales for all types of insulin in the coming quarters.
In 2025, the Group’s operating costs (excluding cost of sales and costs of downtime and unused capacity) amounted to PLN
77,375,000, representing an increase of PLN 6,132,000 (+8.6%) compared to 2024. The increase in operating costs was
primarily driven by higher general and administrative expenses and selling expenses, alongside a slight decrease in research
and development costs.
Selling costs amounted to PLN 37,098 thousand, representing an increase of 2.7% year-on-year. The rise in costs was primarily
due to the intensification of commercial activities and increased market activity, particularly in foreign markets. The rise in
costs was accompanied by an increase in sales volume, which translated into higher cost efficiency relative to revenue.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 16
General and administrative expenses rose by PLN 5,220,000 (+16.8% y/y) and were the main driver of the increase in operating
costs in 2025. The rise in costs was due, amongst other things, to:
• the development of organisational structures supporting the scaling of operations,
• an increase in personnel and administrative costs,
• the implementation of operational and process projects,
• further investments in areas supporting production and sales activities.
In 2025, R&D costs amounted to PLN 3,975,000, representing a stable level compared with 2024 (a decrease of 1.7%). The
maintenance of a comparable cost level is due to the continuation of key development projects, whilst optimising expenditure
within individual initiatives.
Other operating income amounted to PLN 2,944,000, whilst other operating costs amounted to PLN 4,041,000. As a result,
the balance of other operating income and expenses was negative at PLN -1,097 thousand, whereas in 2024 a positive result
of PLN 693 thousand was recorded. The year-on-year change in the balance was mainly due to:
• higher incidental or non-cash operating costs, e.g. compensation, provision for annual leave,
• a lower proportion of one-off revenue-generating events compared to the previous year.
In 2025, the Group’s gross operating profit amounted to PLN 13,325,000, whereas in 2024 a loss of PLN 5,709,000 was
recorded. This represents an improvement in the operating result of PLN 19,034,000 year-on-year.
The key factor contributing to the improvement in the result was an increase in gross profit on sales of PLN 26,956 thousand,
resulting from higher sales year-on-year, a proportional reduction in cost of sales and an improvement in the gross margin,
stemming from changes in the geographical and product mix. For the whole of 2025, the Group’s gross margin stood at
34.24%, compared to 32.14% in 2024. The improvement in profitability was a consequence of an increase in the share of
domestic sales, characterised by higher margins, and a change in the structure of finished goods, including a greater share of
products with a higher profitability profile.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 17
Key items of the Company’s separate annual financial statements
Analytical balance sheet – assets
31 December 2025
31 December 2024
Changes
ASSETS
total
structure
total
structure
(in PLN
thousand)
(as a
percentage)
(in PLN
thousand)
(as a
percentage)
(in PLN
thousand)
(as a
percentage)
A: Fixed assets
632,822
81.4
654,980
81.1
(22,157)
(3.4)
Property, plant and equipment
273,739
35.2
283,117
35.1
(9,378)
(3.3)
Intangible assets
326,504
42.0
337,172
41.8
(10,668)
(3.2)
Assets arising from right of use
17,202
2.2
19,131
2.4
(1,929)
(10.1)
Long-term financial assets
11,334
1.5
11,518
1.4
(184)
(1.6)
Investments in subsidiaries and associates
3,965
0.5
3,965
0.5
-
-
Long-term accruals
78
<0.1%
75
<0.1%
3
3.4
B: Current assets
144,268
18.6
152,434
18.9
(8,166)
(5.4)
Inventories
93,393
12.0
105,124
13.0
(11,731)
(11.2)
Current financial assets
1,648
0.2
1,606
0.2
42
2.6
Trade and other receivables
36,994
4.8
33,983
4.2
3,011
8.9
Tax receivables
<0.1%
<0.1%
0
-
Cash
8,194
1.1
6,738
0.8
1,456
21.6
Cash in a restricted account
<0.1%
<0.1%
0
-
Accruals and deferrals
4,038
1
4,983
1
(945)
(19)
Available-for-sale assets
0
<0.1%
0
<0.1%
0
-
TOTAL ASSETS
777,090
100.0
807,414
100.0
(30,324)
(3.8)
In 2025, the Company’s balance sheet total fell by 3.8% compared to 2024. Total non-current assets fell by 3.4%, or PLN 22.1
million, with the largest impact coming from depreciation of property, plant and equipment and amortisation of intangible
assets.
The Company’s current assets fell by 5.4% (PLN 8.16 million). The change in current assets was significantly influenced by:
• a 11.2% decrease in inventories (PLN 11.7 million) to PLN 93.3 million, linked, amongst other things, to increased sales in
2025 and the optimisation of working capital, an increase in trade and other receivables by 8.9% to PLN 36.9 million,
linked, amongst other things, to increased sales and, consequently, foreign receivables from the customer Biocon;
• an increase in cash by 21% (PLN 1.4 million) to PLN 8.1 million.
The share of fixed and current assets in the 2024 balance sheet amounted to 81.4% and 18.6% of the balance sheet total,
respectively.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 18
Analytical balance sheet – liabilities
31 December 2025
31 December 2024
Changes
LIABILITIES
total
structure
total
structure
(in PLN
thousand)
(as a
percentage
)
(in PLN
thousand)
(as a
percentage
)
(in PLN
thousand)
(as a
percentage
)
Equity
604,964
77.8
603,387
74.7
1,577
0.3
Share capital
1,717,284
221.0
1,717,284
212.7
-
0.0
Share premium
57,131
7.4
57,131
7.1
-
0.0
Reserve capital
260,776
33.6
260,776
32.3
-
0.0
Reserve capital
(268,623)
<0.1
(268,748)
<0.1
125
(0.0)
Retained earnings/losses
(1,161,603)
<0.1
(1,163,056)
<0.1
1,453
(0.1)
Long-term liabilities
67,329
8.7
60,983
7.6
6,346
10.4
In respect of loans, borrowings and other debt
instruments
7,273
0.9
-
<0.1
7,273
-
From leasing
12,867
1.7
13,698
1.7
(832)
(6.1)
Deferred income tax
12,481
1.6
8,575
1.1
3,906
45.6
Employee benefits
2,394
0.3
2,308
0.3
86
3.7
Deferred income
30,943
4.0
33,877
4.2
(2,934)
(8.7)
Other liabilities
1,372
0.2
2,525
0.3
(1,153)
(45.7)
Current liabilities
104,797
13.5
143,044
17.7
(38,247)
(26.7)
In respect of loans, borrowings and other debt
instruments
32,073
4.1
36,633
4.5
(4,560)
(12.4)
From leasing
3,528
0.5
5,791
0.7
(2,263)
(39.1)
Employee benefits
2,520
0.3
2,044
0.3
477
23.3
Trade and other receivables
36,306
4.7
54,303
6.7
(17,997)
(33.1)
Other accruals
30,370
3.9
44,274
5.5
(13,904)
(31.4)
TOTAL LIABILITIES
777,090
100
807,415
100.0
(30,324)
(3.8)
The Company’s equity increased by 0.3% to PLN 604.9 million, primarily driven by the profit recognised in the income
statement for the current year.
The share of equity in the structure of liabilities increased to 77.8%.
On the liabilities side, the following were also recorded:
• an increase in long-term and short-term liabilities arising from loans, borrowings and other debt instruments by a
total of PLN 2.7 million, caused by an increase in debt to financial institutions arising from a loan taken out and repaid
in accordance with the schedule specified in the agreement;
• a decrease in trade and other payables by PLN 17.9 million, mainly related to the settlement of trade payables due in
2024;
• an increase in deferred tax liabilities of PLN 3.9 million, caused mainly by the realisation of a tax loss asset due to the
profit generated and differences in tax and balance sheet depreciation rates;
The growth rates of individual items in the profit and loss account were calculated by comparing their values in 2025 with
those for 2024.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 19
Analytical profit and loss account
01/01/2025 – 31/12/2025
01/01/2024 – 31/12/2024
changes
(in PLN
thousand)
share of
sales
(in PLN
thousand)
share of
sales
(in PLN
thousand)
(%)
1. Sales revenue
287,389
100.0%
214,052
100.0%
73,337
34.3%
2. Cost of sales
(193,528)
67%
(150,253)
70.2%
(43,275)
28.8%
3. Cost of downtime and unused capacity
(4,936)
2%
(1,929)
0.9%
(3,007)
155.9%
4. Gross profit on sales
88,926
31%
61,870
28.9%
27,056
43.7%
5. Cost of sales
(38,418)
13%
(37,458)
17.5%
(960)
2.6%
6. General and administrative expenses
(34,643)
12%
(29,505)
13.8%
(5,138)
17.4%
7. Research and development costs
(3,890)
1%
(3,990)
1.9%
100
(2.5%)
8. Total operating costs (2+3+5+6+7)
(275,415)
95.8
(223,136)
104.2
(52,278)
23.4%
9. Profit on sales
11,975
4.2
(9,084)
4.2
21,059
231.8%
10. Other operating income
2,944
1%
2,518
1.2%
426
16.9%
11. Other operating costs
(3,735)
1
(1,594)
0.7%
(2,141)
134.3%
12. Gross profit on operating activities
11,185
3.9%
(8,160)
3.8%
19,345
237.1%
13. Financial income
1,027
0%
2,833
1.3%
(1,806)
(63.8%)
14. Finance costs
(6,882)
2
(9,121)
4.3%
2,239
(24.6%)
15. Profit before tax
5,329
1.9%
(14,448)
6.7
19,777
136.9%
16. Income tax
(3,877)
1%
(4,031)
1.9%
154
(3.8%)
17. Net profit
1,452
0.5%
(18,479)
8.6%
19,931
107.9%
In 2025, the Company generated sales revenue of PLN 287,389 thousand, with sales of insulin formulations accounting for the
largest share of the sales mix. In the comparable period of 2024, sales revenue amounted to PLN 214,052 thousand, meaning
that in 2025 it was 34.3% higher year-on-year.
Cost of sales rose to PLN 193,528 thousand, i.e. by 28.8% year-on-year, but its share of revenue fell from 70.2% to 67.0%,
indicating improved manufacturing efficiency and a favourable shift in the sales mix.
At the same time, costs related to downtime and unused production capacity rose significantly, amounting to PLN 4,936,000,
compared with PLN 1,929,000 in the previous year (an increase of 155.9% year-on-year). The increase in these costs had a
negative impact on the gross margin, but did not offset the positive effect resulting from significantly higher revenue.
The gross margin on sales, calculated taking into account the costs of downtime and unused production capacity, reached
30.9% at Bioton, representing an increase of 2.0 percentage points compared to the same period in 2024.
The gross margin was significantly influenced by the sales mix of Insulin between the domestic and international markets, as
well as a change in the product mix, involving an increase in sales of cartridges at the expense of vials. The margin on insulin
sold on the Polish market is higher than on international markets, which is primarily due to strong competitive pressure abroad
and the fact that part of sales is conducted through tender procedures, mainly involving vials.
Additionally, the improvement in gross margin was positively influenced by a shift in the sales mix towards higher-margin
products, in particular APIs (active pharmaceutical ingredients) and cartridges, alongside a decline in the share of vial sales.
Sales of APIs and cartridges are characterised by a higher gross margin compared to vials, which is due, among other things,
to:
• better utilisation of production capacity,
• a more favourable cost structure,
• the higher value added of these products.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 20
The reduction in the share of vial sales, which are characterised by relatively lower profitability, had a positive impact on the
Company’s overall gross margin.
Selling costs remained at a similar level to the previous year and amounted to PLN 38,418,000 (a decrease of 2.6% y/y).
Maintaining costs at a level similar to the previous year, whilst revenue increased, resulted in a significant reduction in their
share of sales, from 17.5% to 13.0%, and was made possible by:
• optimisation of marketing expenditure,
• a reduction in logistics costs per unit of product,
• a higher proportion of sales based on long-term contracts.
General and administrative expenses rose by 17.4% year-on-year to PLN 34,643,000, although their share of revenue fell from
13.8% to 12.0%, confirming that cost discipline has been maintained despite the expansion of operations. The increase in
general and administrative expenses was primarily due to:
• the development of organisational structures supporting the scaling of operations,
• an increase in staff and administrative costs,
• the implementation of operational and process projects,
• further investments in areas supporting production and sales activities.
Research and development expenditure decreased slightly to PLN 3,890,000, compared with PLN 3,990,000 in 2024.
In total, operating costs rose to PLN 275,415,000, i.e. by 23.4% year-on-year, although the rate of increase was significantly
lower than the growth in revenue, which had a positive impact on improving the profitability of operations.
Consequently, in 2025 the Company achieved a profit on sales of PLN 11,975,000, whereas in the previous year a loss of PLN
9,084,000 was recorded, representing an improvement of PLN 21,059,000 year-on-year.
Other operating income in 2025 amounted to PLN 2,944,000 and was PLN 426,000 higher than in 2024. This increase was
mainly due to:
• compensation and indemnities received,
• the settlement of grants and other one-off income,
• positive differences arising from incidental operational settlements.
Other operating costs in 2025 amounted to PLN 3,735,000 and were PLN 2,141,000 higher than in 2024. They included, in
particular:
• inventory write-downs and the reversal of write-downs, as well as the disposal of goods and materials,
• provisions for unused holiday entitlement,
• written-off and cancelled receivables,
• the creation of a provision for employee severance pay.
After taking into account other operating income and expenses, the operating profit amounted to PLN 11,185,000, compared
to a loss of PLN 8,160,000 in 2024, confirming a significant improvement in the profitability of the Company’s core business.
The net financial result improved, despite lower financial income, mainly due to a significant 24.6% year-on-year decrease in
financial costs. In 2025, financial costs were lower than in 2024, primarily due to:
• the Company’s lower debt levels year-on-year,
• more favourable financing terms,
• changes in interest rates on loans and borrowings denominated in PLN and USD.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 21
As a result, profit before tax amounted to PLN 5,329,000, compared with a loss of PLN 14,448,000 in the previous year.
After taking into account income tax of PLN 3,877 thousand, the Company achieved a net profit of PLN 1,452 thousand,
whereas in 2024 a net loss of PLN 18,479 thousand was recorded.
7. Description of significant off-balance sheet items by entity, nature and value
In 2025, the Company and the Group had no significant off-balance sheet items other than those disclosed in the financial
statements of the Company and the Group.
8. Description of significant risk factors and threats, specifying the extent to which the Company
and the Group are exposed to them e
Risk associated with refusal or delays in the marketing authorisation of the Company’s and the Group’s products
New products of the Company and the Group may only be authorised for marketing in a given market after obtaining the
relevant authorisation in accordance with applicable law. Preparing the documentation necessary to obtain authorisation for
a given product, particularly in certain markets, requires a significant amount of work and time. The procedure for obtaining
such authorisation may also prove to be extremely time-consuming. This applies in particular to the centralised registration
procedure for biotechnology products, which may be further prolonged by frequent regulatory changes and the associated
interpretative uncertainties. These factors may cause significant delays in the Company and the Group bringing new products
to market. A refusal or delay in the marketing authorisation of the Company’s and the Group’s products could have a material
adverse effect on the Company’s and the Group’s business, financial position or operating results. Risk – high.
Risk associated with the occurrence of side effects, interactions with other medicines or quality defects in specific products
of the Company and the Group
It cannot be ruled out that, following the marketing authorisation of a medicinal product, previously unforeseen side effects
or interactions with other medicines may occur. Such situations may also arise with medicines that have been available on
the market for a long time and may lead to specific measures being taken by the relevant authorities. For example, in Poland,
if an unexpected, serious, adverse reaction to a medicinal product is identified that poses a threat to human life or health, or
if there is a lack of the declared therapeutic efficacy, or if the risk of use is deemed disproportionate to the therapeutic effect,
the Minister of Health revokes the marketing authorisation for the product. Furthermore, in the event of a reasonable suspicion
that a medicinal product does not meet the requirements established for it, the Chief Pharmaceutical Inspector issues a
decision to suspend the marketing of specific batches of the medicinal product within his jurisdiction. The occurrence of any
of the above factors may have a material adverse effect on the operations, financial position or operating results of the
Company and the Group. Risk – medium.
Risk of failing to achieve the intended results of development work in the biotechnology medicines segment
A significant portion of the expenditure and costs incurred by the Company and the Group is allocated to funding
development work, including in the field of biotechnology products. Expanding operations in the biotechnology products
market requires significant costs, and the risk of failing to achieve the intended results of research and development work in
the field of biotechnology products is greater than in the case of generic medicines. The failure of development work funded
by the Company and the Group could result in the inability to recoup the expenditure and costs incurred through the sale of
biotechnology products developed as a result of the funded development work, which may have a material adverse effect on
the business, financial position or operating results of the Company and the Group. Risk – high.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 22
Risk associated with the strategy for commercialising the Company’s and the Group’s products in key markets
The Company’s and the Group’s strategy for commercialising the Group’s products in key markets is based on cooperation
with international pharmaceutical companies under long-term distribution agreements. In 2018, the Company signed a global
distribution agreement for conventional human insulin with Yifan International Pharmaceutical Co., Ltd, which was amended
in January 2020 under a Novation Agreement. There is no certainty that the sales targets set by the distribution partner for
individual markets will be met, and consequently whether the Group’s production and sales volumes will be realised at the
anticipated levels. The levels of expenditure on marketing and sales of the Group’s products incurred by distribution partners,
the resources they hold in selected foreign markets, and their knowledge and experience in the promotion and sale of
pharmaceutical products in a given market may prove insufficient to achieve the targeted sales volumes. In view of the above,
there is no certainty that the Company’s and the Group’s operations in selected foreign markets will yield the expected
results. It cannot be ruled out that distribution partners will be unable to achieve their intended objectives and that their
marketing strategy in certain export markets will prove ineffective. The occurrence of any of the above factors could have a
material adverse effect on the operations, financial position or operating results of the Company and the Group. Risk –
medium.
Risk associated with changes to drug reimbursement rules
In most of the countries in which the Company and the Group operate, the market for medicines, including reimbursed
medicines, is strictly regulated by relevant legislation. These regulations determine the list of reimbursed medicines, the scope
of reimbursement, including prices, limits and the reimbursement rate. Adverse changes to the laws regulating the medicines
market, such as the removal of the Company’s and the Group’s medicinal products from the list of reimbursed medicines, the
introduction of a separate, higher price limit for the reimbursement of competing products, a change in the price limit or a
reduction in the reimbursement rate for a given medicine, may adversely affect the competitiveness of the Company’s and
the Group’s products, which may have a material adverse effect on the Company’s and the Group’s business, financial position
or operating results. Risk – medium.
Foreign exchange risk
Part of the Company’s and the Group’s revenue derives from the export of medicines, whilst some of the components required
for the production of medicines by the Company and the Group, as well as the supply of contract products, are imported.
Consequently, part of the Company’s and the Group’s revenue and part of their costs are generated or incurred in foreign
currencies. Furthermore, the majority of the Company’s and the Group’s export revenue is denominated in US dollars, whilst
imports are settled mainly in USD and EUR. In the event of an imbalance between costs and revenue, as well as in the event
of an imbalance between revenue and costs in the same foreign currency, fluctuations in exchange rates may have a material
adverse effect on the business, financial position or operating results of the Company and the Group. Risk – high.
Risk associated with changes in tax legislation in Poland
The Company and the Group are exposed to the risk of changes in the legal and tax environment in Poland. The evolving legal
and tax environment has been and will continue to be subject to frequent changes; furthermore, the law is not applied
uniformly by the courts and tax authorities. Risk – medium.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 23
Risk associated with changes in tax legislation
Both the Company and the Group are exposed to the risk of changes in regulations concerning value added tax, corporation
tax and social security contributions, which are subject to frequent changes. These frequent changes result in a lack of
appropriate points of reference, inconsistent interpretations and few established precedents that could be applied. The
applicable regulations also contain ambiguities that lead to differences of opinion regarding the legal interpretation of tax
provisions. Tax settlements and other areas of activity may be subject to audits by authorities authorised to impose
substantial penalties and fines, and any additional tax liabilities arising from such audits must be paid with interest.
Consequently, the amounts presented and disclosed in the financial statements may change in the future as a result of a final
decision by the tax inspection authority. Risk – medium.
9. Indication of proceedings pending before a court, an arbitration body or a public
administration body
The information provided regarding proceedings pending before a court, an arbitration body or a public administration body
is set out in note 7.48 of the Company’s annual separate financial statements and in note 7.59 of the Group’s annual
consolidated financial statements for the period from 1 January 2025 to 31 December 2025
10. Information on the Company’s and the Group’s principal products, goods or services,
including their value and volume, and the share of individual products, goods and services (if
material) or their groups in the Company’s and the Group’s total sales, as well as changes in
this respect during the financial year
The main products and goods of the Company and the Group are:
• recombinant human insulin in the form of a pharmaceutical substance and injectable preparations,
• oral antidiabetic medicines,
• other goods (blood glucose test strips, OTC preparations for diabetics, products from the gastroenterology range),
• devices (injectors, test strips, needles) .
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 24
Key items for the Group
The Group’s sales structure by product range (by value)
in PLN thousand
01/01/2025–31/12/2025
01.01.2024–31.12.2024
(in PLN thousand)
structure (in %)
(in PLN thousand)
structure (in %)
Insulin
232,369
82.25%
159,878
76.95%
Finished Goods
232,369
82.25%
159,878
76.95%
Oral antidiabetic medicines
22,479
7.96%
21,291
10.25%
Other goods PL
17,657
6.25%
12,784
6.15%
Syringes
4,534
1.60%
4,141
1.99%
Goods and materials
44,670
15.81%
38,217
18.39%
Services
5,482
1.94%
9,668
4.65%
Total sales revenue
282,521
100.00%
207,763
100.00%
In 2025, the Group achieved revenue of PLN 282,521 thousand, representing a year-on-year increase of 36.0%. Insulin sales
accounted for 82.2% of total revenue, an increase of 25.7 percentage points compared to 2024. In value terms, the increase
in insulin sales amounted to PLN 72,490,000, or 45.3%, and was driven primarily by the Malaysian market, where sales rose by
PLN 84,192,000 year-on-year. Additional growth was also recorded in Uruguay, Pakistan, Thailand and Bangladesh, confirming
the growing importance of emerging markets within the Group’s sales structure.
On the Polish market, total sales rose in 2025 by PLN 5,750,000, or 6.3% year-on-year, mainly due to very strong sales of
finished products such as Avamina, Intesta, Combodiab and Nanosilver. At the same time, sales of the key product – insulin
– fell by 3.0%, from PLN 63,352,000 in 2024 to PLN 61,419,000 in 2025, despite an increase in market share from 40.4% to
43.3%. This confirms that the decline is structural in nature and stems from the shrinking market for human insulins, rather
than a reduction in the product’s competitiveness.
Key figures for the Company
Sales on the domestic market are conducted directly by the Company. Sales outside Poland are conducted mainly under a
cooperation agreement with SciGen and other sales agreements concluded directly with foreign partners. In the case of
foreign trading partners, cooperation mainly involves direct exports. In the case of domestic trading partners involved in
exports, the products are delivered by the Company to locations specified by the trading partners responsible for delivering
the products abroad.
The Company’s sales structure by product range (by value)
Breakdown
01/01/2025–31/12/2025
01.01.2024–31.12.2024
Value
Structure (in %)
Value
Composition (in %)
Insulin
232,369
80.85%
159,878
74.69%
Finished products
232,369
80.85%
159,878
74.69%
Oral antidiabetic medicines
22,479
7.82%
21,291
9.95%
Other goods PL
17,657
6.14%
12,784
5.97%
Syringes
7,894
2.75%
8,922
4.17%
Goods and materials
48,030
16.71%
42,997
20.09%
Services
6,991
2.43%
11,177
5.22%
Total sales revenue
287,389
100.00%
214,052
100.00
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 25
In 2025, the Company generated sales revenue of PLN 287,389 thousand. In the comparable period of 2024, revenue
amounted to PLN 214,052 thousand, representing an increase of 34.3%. The largest share of revenue came from insulin sales
– PLN 232,369,000 – which were 45.34% higher than in 2024. The increase in insulin sales in 2025 compared to 2024 was
driven by higher sales in international markets, mainly to Malaysia (PLN 84,192,000). Additional growth was also recorded in
Uruguay, Pakistan, Thailand and Bangladesh, confirming the growing importance of emerging markets in the sales structure.
However, it should be noted that insulin sales on the Polish market fell by 3.0%, from PLN 63,352,000 in 2024 to PLN 61,419,000
in 2025, despite an increase in market share from 40.4% to 43.3%. This confirms that the decline is structural in nature and
stems from the shrinking market for human insulins, rather than a reduction in the product’s competitiveness.
Other categories of OADs or gastroenterology medicines grew in line with or above the market in Poland and abroad.
11. Information on sales markets, including a breakdown into domestic and foreign markets, and
information on sources of supply for production materials, goods and services, specifying
dependence on one or more customers and suppliers, and where the share of a single
customer or supplier reaches at least 10% of total sales revenue - the name (company name)
of the supplier or customer, their share of sales or supply, and their formal links with the Group
The Group’s sales structure in individual foreign markets
The Group’s sales structure by geographical market
01/01/2025–31/12/2025
01/01/2024–31/12/2024
(in PLN
thousand)
structure
(in PLN
thousand)
structure
(in %)
(in %)
Malaysia
105,896
57.19%
Malaysia
21,704
18.69%
Tunisia
12,439
6.72%
Tunisia
11,500
9.90%
Thailand
8,478
4.58%
Thailand
6,507
5.60%
China
8,062
4.35%
China
11,352
9.77%
Bangladesh
6,470
3.49%
Bangladesh
4,668
4.02%
Vietnam
5,870
3.17%
Vietnam
21,283
18.32%
Uruguay
5,419
2.93%
Uruguay
1,516
1.31%
Philippines
4,730
2.55%
Philippines
4,652
4.01%
Ukraine
3,316
1.79%
Ukraine
3,292
2.83%
Pakistan
2,900
1.57%
Pakistan
154
0.13%
Other*
21,585
11.66%
Other*
29,529
25.42%
Total sales revenue
185,165
100.00%
Total sales revenue
116,157
100.00%
’s supply sources
The geographical breakdown of purchases of individual production materials in 2024, in value terms, comprised:
• active ingredients – the source of supply for active ingredients was Bioton S.A.’s own production;
• excipients – approx. 50% were purchased from domestic companies, most of which were distributors of imported
raw materials; the remainder came from Europe and non-European countries;
• packaging – the largest suppliers of direct packaging (i.e. vials, caps, stoppers, cartons, leaflets and labels) were from
EU countries (approx. 60%), whilst domestic supplies accounted for approx. 40%.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 26
No single supplier accounted for 10% of the Company’s and the Group’s sales revenue. Mutual relations are governed by
relevant commercial agreements or commercial offers.
Structure of the Company’s sales on the domestic and foreign markets
In 2025, the Company generated domestic sales revenue of PLN 102.2 million, representing a 4.4% increase compared to
2024.
Revenue from insulin sales on the Polish market, in terms of sales to pharmaceutical wholesalers, amounted to PLN 61.4 million.
The Company achieved a 43.3% share of the classic insulin market in value terms at the end of 2025.
BIOTON S.A.’s sales structure on the domestic market
Sales revenue – product mix
PL
01.01.2025–31.12.2025
01.01.2024–31.12.2024
(in PLN thousand)
structure
(in PLN thousand)
structure
(in %)
(in %)
Insulin
61,419
60.08%
63,352
64.71%
Finished products
61,419
60.08%
63,352
64.71%
Oral antidiabetic medicines
22,479
21.99%
21,291
21.75%
Other goods PL
11,593
11.34%
5,520
5.64%
Syringes
4,208
4.12%
5,436
5.55%
Goods and materials
38,281
37.45%
32,247
32.94%
Services
2,525
2.47%
2,297
2.35%
Total sales revenue
102,225
100.00%
97,896
100.00
In 2025, the largest percentage share of the Company’s sales was recorded by three pharmaceutical wholesalers operating
on the domestic market: Neuca S.A., Farmacol S.A. and Polsk Grupa Farmaceutyczna S.A.
BIOTON S.A.’s sales structure in foreign markets
Sales revenue – product range
structure
EXP
01/01/2025–31/12/2025
01.01.2024–31.12.2024
(in PLN thousand)
structure
(in PLN thousand)
structure
(in %)
(as a percentage)
Insulin
170,949
92.32%
96,526
83.10%
Finished products
170,949
92.32%
96,526
83.10%
Oral antidiabetic medicines
0
0.00%
0
0.00%
Other goods
6,064
3.27%
7,264
6.25%
Syringes
3,686
1.99%
3,486
3.00%
Goods and materials
9,750
5.27%
10,751
9.26%
Services
4,466
2.41%
8,880
7.64%
Total sales revenue
185,165
100.00%
116,157
100.00%
In 2025, the Company generated export sales revenue of PLN 185,165 million, representing a year-on-year increase of 59.4%
compared with 2024.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 27
The growth in export sales was primarily due to significantly higher sales of Insulin, which rose by 77.1% year-on-year and was
the main driver of the improved results.
The largest increase in sales was recorded in the following markets:
• Malaysia – sales amounted to PLN 19.4 million, representing an increase of PLN 8,626,000 year-on-year,
• Tunisia and Uruguay – total sales of PLN 11.5 million, an increase of PLN 3,902,000 year-on-year,
• Vietnam and Pakistan – sales of PLN 10.3 million, an increase of PLN 2,746,000 year-on-year.
In the Other Goods segment, comprising primarily sales of the Intesta product, a year-on-year decrease in revenue of PLN
1,218,000 was recorded. The main market where Intesta sales were lower in 2025 was the Malaysian market.
The decline in revenue from services was due to the following factors:
• lower re-invoicing of marketing service costs and transport costs settled with the main distributor,
• lower revenue from warehousing services,
• the absence of revenue from distribution rights, which was incidental in 2024.
12. Information on agreements concluded that are significant to the operations of the Company
and the Group, including agreements known to the Company and the Group concluded
between shareholders, and cooperation or collaboration agreements
12.1. Cooperation agreement between Yifan Pharmaceutical Co., Limited and Bioton S.A.
On 16 July 2019, the Management Board entered into an agreement with Yifan Pharmaceutical Co., Limited (“Yifan”) concerning
mutual cooperation between the parties in the field of active substances for insulin analogues and the final medicinal product
(in finished form), from their production to commercialisation (“Agreement”). The Agreement provides for the financing of the
entire project, as all costs associated with the purchase and installation of equipment necessary to carry out each stage of
the Agreement, and the purchase of raw materials and excipients necessary to manufacture the products within the scope
of the relevant orders, will be covered by Yifan. If the results of the work demonstrate that the commercial production line is
suitable for the manufacture of the medicinal product in finished form (Drug Product – Finished Form), BIOTON S.A. will be
granted the right to use Yifan’s intellectual property as well as a 25-year exclusive right to manufacture, distribute, market,
offer and sell the product within Poland, and BIOTON S.A. will be granted the right of first refusal to obtain the right to use the
product in European countries under its own brand. BIOTON S.A. will also act as the manufacturer of the products worldwide.
On 11 March 2024, the Company received correspondence indicating that Yifan is proposing a change to the business model
of cooperation with the Company on projects concerning insulin Glargine and Lispro analogues. According to this
correspondence, Yifan is considering changing the current cooperation model under the Agreement, which may lead to the
transfer of API and finished drug technology to the Company, or Yifan supplying the API and the Company manufacturing the
finished drug using Yifan’s technology. In both cases, the Company may become the main supplier of finished medicinal
products in Europe, provided the terms of the agreement are maintained. For the purposes described by Yifan, the parties
should enter into a licence agreement. Furthermore, Yifan confirms in this correspondence that the Company has the right to
continue research and development of the analogue project using the external strain already acquired. In response to the
correspondence received, the Company sent an enquiry to Yifan seeking clarification regarding the parties’ continued
cooperation under the Agreement, as, according to legal analyses, the correspondence received does not result in the
termination of the Agreement or the suspension of the Lispro or Glargine project. As at the date of publication of this current
report, the Company had not received a response from Yifan.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 28
On 29 July 2024, BIOTON S.A. and Yifan entered into an agreement confirming matters relating to the intellectual property
rights of both Parties in connection with the performance of the MSA, which clearly defines the intellectual property rights
developed by both Yifan and BIOTON S.A. both under the MSA and previously held by each Party. The Company has agreed
with Yifan that it may develop its own analogues under a licensed strain from another supplier. As at the date of publication
of this report, Yifan has not taken a decision on further steps regarding insulin analogues (Lispro and Glargine) under the MSA.
The Management Board is currently awaiting instructions from Yifan and has no new information as at the date of publication.
12.2. Novation Agreement
On 16 January 2020, Bioton entered into a Novation Agreement, effective from 1 January 2020, in respect of the Global
Exclusive License Framework Agreement dated 27 March 2018, as subsequently amended, between the Company, YIFAN
INTERNATIONAL PHARMACEUTICAL CO., LTD., based in Hong Kong (“Assignor”), and SCIGEN PTE. LTD., based in Singapore
(“Assignee”), under which Bioton granted the Assignor the exclusive right to import and distribute Bioton’s products within
the Territory (all countries except Poland). Detailed information on the terms of the agreement, together with its annexes, has
previously been published by the Company in its interim reports. The Company has estimated that revenue arising from the
Agreement over the next three years, i.e. 2026–2028, will amount to approximately PLN 290 million. Revenue realised in the
years 2020–2025 amounted to PLN 389.0 million. The effects of this agreement are recognised in the financial results for the
2025 financial year.
12.3. Licence and supply agreement for recombinant human insulin for the Malaysian market
On 18 October 2024, Bioton entered into an agreement with a global pharmaceutical company concerning the manufacture
of recombinant human insulin to ensure the treatment of patients in Malaysia, with deliveries having already commenced in
December 2024. Further deliveries under this agreement will continue in the coming quarters, with sales in the first half of
2025 amounting to PLN 65.8 million. In April 2025, the Company extended the contract, which resulted in revenue of PLN
103.2 million in 2025, having a positive impact on the financial results of the Company and the Group in 2025. The contract
was concluded for a period of five years. The volume for 2025 under the agreement has been fully met. Bioton is awaiting the
outcome of the Malaysian Ministry of Health’s allocation decision for 2026.
12.4. Agreements for the distribution of Liraglutide in Poland
On 11 March 2025, by mutual agreement of the parties, the Term Sheets entered into by Bioton S.A. with Fresenius Kabi iPSUM
S.r.l. (“FKIP”), namely: (i) the CMO FINISHED DOSAGE FORM Term Sheet dated 27 April 2023; and (ii) the PEPTIDE Technology
and API Purchase Term Sheet, also dated 27 April 2023, relating to the Project concerning the production by Bioton S.A. of a
pen containing Liraglutide based on proprietary documentation and API supplied by FKIP.
On 17 March 2025, Bioton entered into a Term Sheet with a global pharmaceutical company, under which it will receive a
licence for the product dossier for Liraglutide 6mg/ml - 3ml injections (generic equivalents of Victoza and Saxenda), Synthetic,
in the form of a pen (“Product”) for the distribution of the Products in Poland. The licence and supply agreement was
concluded on 4 November 2025. The current plan envisages a market launch in the second half of 2026.
12.5. Contract manufacturing agreement for Glargine at Bioton’s facilities for European Union markets
On 7 February 2025, the Company signed an Agreement for the contract manufacturing of Glargine. Under this agreement,
Bioton S.A. has obtained a non-exclusive licence to the product technology for the manufacture of Finished Products by
Bioton S.A. The agreement was concluded for a period of five years, with the option to extend it for further periods by mutual
agreement between the parties. The other party is entitled to terminate the Agreement on the terms specified therein. Each
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 29
Party is entitled to terminate the Agreement in the event that the other Party breaches any of the terms of the Agreement
and fails to remedy or rectify the effects of the breach within 60 days of receiving a written notice, as well as in the event
that the other Party is placed into liquidation, enters into an arrangement or settlement with its creditors, enforcement
proceedings or other legal proceedings are initiated, or a receiver or other court-appointed official is appointed in respect of
its assets or property. The Agreement is governed by Polish law. In the event that the Parties fail to reach an agreement, the
dispute shall be settled by an arbitration tribunal in accordance with the Rules of the Polish Chamber of Commerce in Warsaw.
The project is currently at an advanced stage of technology transfer.
12.6. Research and development agreement with Biotts S.A. – update
On 16 November 2023, the Company signed a cooperation agreement with Biotts S.A. regarding non-invasive transdermal
insulin delivery. Under this agreement, Bioton S.A. supplied the active pharmaceutical ingredient (API) to develop a formulation
for the transdermal delivery of insulin using Biotts’ transdermal system, the MTC-Y transdermal carrier, and to carry out a
Proof of Concept (PoC) for this solution. The results of the Proof of Concept (PoC) study are promising and provide a solid
basis for further cooperation between the two companies towards the implementation of an innovative solution enabling
non-invasive insulin delivery, which will help people with diabetes treated with insulin. According to the results of preclinical
animal studies, this technology allows for more stable and sustained blood insulin levels compared to traditional
subcutaneous injections. The agreement has been concluded; both companies are currently in the business case analysis
phase, the aim of which is to assess the market and operational potential of the solution and to decide on the future model
of cooperation.
12.7. Cooperation regarding the use of Bioton’s API in a pharmaceutical product by EnteroTarget ApS –
update
On 22 August 2023, Bioton S.A. and EnteroTarget ApS signed a Term Sheet regarding cooperation between the companies on
the use of the active substance recombinant human insulin (API), produced by Bioton S.A., in EnteroTarget ApS’s
pharmaceutical product – EnterocalmTM.
EnterocalmTM is a product with enormous potential to help patients who have very few treatment options for various
intestinal diseases – offering them a better form of treatment and a significant reduction in symptoms. The EnteroTarget ApS
product – EnterocalmTM – is in the first phase of clinical trials.
Under the aforementioned agreement, Bioton S.A. holds the exclusive right to supply EnteroTarget ApS with the active
pharmaceutical ingredient (API). The agreement may be terminated by either party with 12 months’ notice.
Under the agreement, EnteroTarget ApS has the right to grant licences for the marketing and sale of EnterocalmTM; however,
if it decides to grant a licence for the sale of EnterocalmTM in Poland to entities other than Bioton S.A., the licence fees (or
gross margin for the distributor) will be split equally (50/50) between EnteroTarget ApS and Bioton S.A. Otherwise, Bioton S.A.
will have the exclusive right to wholesale EnterocalmTM in Poland.
Using BIOTON S.A.’s regular insulin, EnteroTarget ApS has developed oral capsules (patent application) and suppositories in
tablet form. Progress has been made in clinical trials, and by September 2025, Phase 1b safety trials in Poland (in Rzeszów and
Tychy) were completed without any adverse events related to the API. EnteroTarget currently plans to commence Phase 2
trials with EnteroCalm products in 2026.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 30
13. Information on organisational or capital links between Bioton S.A. and the Group and other
entities, and a description of its main domestic and foreign investments (securities, financial
instruments, intangible assets and property), including capital investments made outside its
group of related entities, and a description of the methods of financing them
BioPartners GmbH, with its registered office in Reutlingen (Germany )
BioPartners GmbH, based in Reutlingen (Germany), has been entered in the commercial register as ‘in liquidation’; however,
the company cannot be struck off the commercial register due to a pension liability towards an employee. The company
remains entered in the commercial register but is no longer conducting business.
Biolek Sp. z o.o., based in Macierzysz
The company holds a total of 100% of the shares in the share capital and of the votes at the Shareholders’ Meeting.
Bioton Marketing Agency Sp. z o.o. with its registered office in Macierzysz
The company holds a total of 100% of the shares in the share capital and of the voting rights at the Shareholders’ Meeting.
Bioton International GmbH, based in Switzerland
The company holds a total of 100% of the shares in the share capital and of the votes at the Shareholders’ Meeting.
13.1. Investments in fixed assets and intangible assets
At the end of the reporting period, expenditure on fixed assets under construction at Bioton S.A., and thus within the Group,
totalled PLN 10,270,000 and related to projects undertaken by the Group, including expenditure classified as machinery and
equipment amounting to PLN 5,257,000, buildings and structures amounting to PLN 2,761 thousand (as at 31 December 2024:
PLN 6,127 thousand, and for the aforementioned categories: PLN 4,258 thousand and PLN 169 thousand respectively).
13.2. Research and development expenditure
At the end of the reporting period, expenditure on development work and intangible assets in progress at Bioton S.A. totalled
PLN 30,966,000 and related, amongst other things, to expenditure on product registrations, including registration procedures
for conventional insulin and its registration in other territories, as well as expenditure on the implementation of analogue
technologies (as at 31 December 2024, these totalled PLN 28,552 thousand).
The Group’s capitalised expenditure on in-progress development work amounted to PLN 28,552 thousand at the end of 2025,
of which:
• The Company – PLN 30,623,000, relating to, amongst other things, expenditure on product registrations, including
registration procedures for conventional insulin and its registration in other territories, as well as expenditure on the
implementation of analogue technologies,
• BIOLEK Sp. z o.o. – PLN 343,000, relating mainly to expenditure on product registrations.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 31
14. Information on significant transactions entered into by Bioton or its subsidiary with related
parties on terms other than market terms, together with their amounts and information
specifying the nature of these transactions
In 2025, the Company and its subsidiaries did not enter into any transactions with related parties on terms other than market
terms.
15. Information on loan and credit agreements entered into and terminated during the financial
year, specifying at least their amount, type and interest rate, currency and maturity date
Detailed information regarding loans and borrowings taken out by the Company is presented in note 7.23 of the Company’s
annual financial statements and in note 7.29 of the Group’s annual consolidated financial statements for the period from 1
January 2025 to 31 December 2025.
Analysis of maturity categories as at 31 December 2025 by loan agreement term and repayment schedule:
Principal and interest on loans –
payment forecast from 31
December 2025 – in PLN thousand
up to 1 year
1 to 2 years
3 to 5 years
over 5 years
Total
BNP Paribas Bank Polska S.A.
overdraft facility
14,483
-
-
-
14,483
UniCredit S.A. overdraft facility
14,848
-
-
-
14,848
Socio-Economic Investment
Society – loan
2,727
2,727
4,546
-
10,000
Total
32,058
2,727
4,546
0
39,331
Exchange rates
The expected result on exchange rate differences on the valuation of loans received, denominated in foreign currencies,
granted to the Company by Uniapek S.A. will be reflected in finance costs/income in the Group’s consolidated financial
statements and in the separate financial statements of Bioton S.A.
In the coming months, the Company’s primary objective in its foreign exchange policy will be to hedge the exchange rate of
its commercial foreign currency receipts (in USD). The Company plans to hedge its commercial receipts in USD by entering
into forward hedging transactions. As at 31 December 2025, Bioton S.A. had no open foreign exchange hedging transactions.
Bioton S.A. is exposed to foreign exchange risk primarily in relation to its outstanding loan and the sale of finished goods,
services and purchases of raw materials, which are conducted in foreign currencies.
The alignment of the instruments used with the currency position is intended solely to hedge the foreign exchange risk arising
from Bioton S.A.’s trading activities.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 32
16. Information on loans granted during the financial year, with particular regard to loans granted
to entities related to Bioton S.A., specifying at least their amount, type and interest rate,
currency and maturity date
During the financial year covered by this report and up to the date of publication, the Company has not granted any loans to
either related parties or other entities.
17. Information on sureties and guarantees granted and received during the financial year in
question, with particular regard to sureties and guarantees granted to entities related to
Bioton S.A.
In 2025, Bioton S.A. and its subsidiaries did not grant any loan/credit sureties or guarantees.
18. In the event of a securities issue during the reporting period – a description of how the
Company and the Group have utilised the proceeds from the issue up to the date of this report
In 2025, neither the Company nor the Group carried out any transactions in securities.
19. Explanation of differences between the financial results disclosed in the annual report and
previously published forecasts for the year in question
Neither the Company nor the Group published any forecasts for 2025.
20. An assessment, together with its justification, of the management of financial resources, with
particular emphasis on the ability to meet obligations, and an identification of any risks and
measures that the Company and the Group have taken or intend to take to counteract these
risks
20.1. Key financial performance indicators of the Group
Profitability ratios:
2025
in PLN
thousand
2024
in PLN
thousand
1.
Net profit margin (ROS = Net profit / Net sales revenue)
1.2%
(7.5%)
2.
Return on assets (ROA = Net profit / Assets)
0.4%
(2.0%)
3.
Return on equity (ROE = Net profit / Equity)
0.6%
(2.7%)
4.
Financial leverage (Return on equity – Adjusted return on assets)
0.1%
(1.0%)
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 33
In 2025, the Group recorded a significant improvement in all key profitability ratios compared to 2024, which was a
consequence of improved financial results and increased operational efficiency.
The net sales profitability ratio reached 1.2%, whereas in 2024 it stood at -7.5%. This change marks a return to positive sales
profitability and was driven, among other factors, by an improvement in the gross margin, including a favourable shift in the
sales mix, and better control of operating costs.
The return on assets (ROA) rose to 0.4%, compared with -2.0% in the previous year, indicating an improvement in the
efficiency of using assets to generate net profit.
Similarly, the return on equity (ROE) stood at 0.6% in 2025, compared with -2.7% in 2024. This signifies an improvement in
the efficiency of equity utilisation and the achievement of a positive rate of return for the Company’s owners.
The financial leverage ratio in 2025 stood at 0.1%, compared to -1.0% in the previous year. The low, positive level of the ratio
reflects the Company’s conservative financing structure and limited use of external financing, alongside an improvement in
operating profitability.
The year 2025 brought a marked improvement in the Company’s profitability and a restoration of its ability to generate a
positive financial result, which represents a significant step towards the sustainable stabilisation of financial results.
Liquidity and turnover ratios:
2025
in PLN thousand
2024
in PLN thousand
1.
Current ratio (Current assets / Current liabilities)
141.0%
107.6%
2.
Quick ratio (Current assets – Inventories – Prepaid expenses) / Current liabilities)
44.7%
29.1%
3.
Average trade receivables
36,229
35,885
3a.
Trade receivables turnover ratio (Net sales revenue / Average trade receivables)
7.80
5.79
3b.
Trade receivables collection cycle in days (360 / Receivables turnover ratio)
46
62
4.
Average inventory
101,147
110,943
4a.
Inventory turnover ratio (Net sales revenue / Average inventory)
2.79
1.87
4b.
Inventory days (360 / Inventory turnover ratio)
129
192
5.
Average trade payables
42,706
49,078
5a.
Trade payables turnover ratio (Net sales revenue / Average trade payables)
6.62
4.23
5b.
Trade payables settlement period in days (360 / Trade payables turnover ratio)
54
85
In 2025, there was a marked improvement in the Group’s financial liquidity compared to 2024, as confirmed by increases in
key liquidity ratios. The current ratio rose to 141.0% from 107.6%, indicating a significant strengthening of the Company’s ability
to settle short-term liabilities on time. At the same time, the quick ratio increased from 29.1% to 44.7%, indicating an
improvement in liquidity after excluding less liquid current assets.
The efficiency of trade receivables management also improved. The trade receivables turnover ratio rose from 5.79 to 7.80,
which resulted in a reduction in the receivables collection cycle from 62 days in 2024 to 46 days in 2025. This change reflects
a more effective credit policy and improved debt collection, despite a slight increase in the average level of trade receivables
from PLN 35,885,000 to PLN 36,229,000.
A significant improvement was also recorded in inventory management. The inventory turnover ratio rose from 1.87 to 2.79,
and the average inventory holding period fell from 192 days to 129 days. At the same time, average inventory levels fell from
PLN 110,943,000 to PLN 101,147,000, indicating more effective production planning and the alignment of inventory levels with
current sales needs.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 34
In 2025, the pace of settling trade payables also improved. The trade payables turnover ratio rose from 4.23 to 6.62, and the
average settlement period shortened from 85 days to 54 days. The reduction in the average level of trade payables from PLN
49,078,000 to PLN 42,706,000 further confirms the improvement in financial liquidity and the Company’s ability to make
timely payments to suppliers.
Liquidity and turnover ratios in 2025 indicate a significant improvement in working capital management, increased financial
security and enhanced operational efficiency of the Company.
Debt ratios:
2025
in PLN thousand
2024
in PLN thousand
1.
Equity-to-assets ratio (Equity / Liabilities)
77.69%
74.4%
2.
Debt-to-equity ratio [multiple] (Long-term liabilities + Short-term liabilities) /
Equity)
28.7%
34.5
In 2025, the Group’s financing structure remained stable, whilst debt levels were reduced compared to 2024, which had a
positive impact on the Company’s financial security.
The equity-to-assets ratio stood at 22.3%, compared to 25.6% in 2024. The decline in the ratio resulted from an increase in
liabilities within the balance sheet, yet its level still indicates a significant contribution of equity to the financing of the
Company’s assets.
At the same time, the debt-to-equity ratio fell from 34.5% in 2024 to 28.7% in 2025. The reduction in this ratio signifies a
decrease in the relative level of debt in relation to equity and an improvement in the balance between debt and equity
financing.
Taken together, the analysed ratios confirm the maintenance of the Company’s conservative financing structure, low financial
leverage and a good capacity to absorb any risks associated with servicing liabilities.
Asset financing structure:
2025
in PLN thousand
2024
in PLN thousand
1.
Equity
593,970
590,548
2.
Long-term liabilities
67,679
60,472
3.
Total fixed capital (1+2)
661,649
651,020
4.
Fixed assets
619,456
640,142
5.
Current assets
145,105
153,996
6.
Fixed capital for financing current assets
42,193
10,878
7.
Current assets
145,105
153,996
8.
Current liabilities covering current assets
102,913
143,118
9.
Percentage of current assets covered:
9a.
• fixed capital
29.1%
7.1%
9b.
• current liabilities
70.9%
92.9%
9c.
• provisions
0.0%
0.0%
10.
Equity-to-fixed-assets ratio (Equity / Fixed assets)
0.96
0.92
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 35
Asset financing structure:
2025
in PLN thousand
2024
in PLN thousand
11.
Ratio of current assets covered by debt (Long-term liabilities + Current liabilities
covering current assets) / Current assets)
1.18
1.32
12.
Capital structure ratio (Equity / Debt)
3.48
2.90
13.
Asset structure ratio (Fixed assets / Current assets)
4.27
4.16
As at 31 December 2025, the Group’s asset financing structure had improved compared to the previous year, which translated
into increased financial security and a better alignment of funding sources with the asset structure.
Equity at the end of 2025 amounted to PLN 593,970 thousand, compared to PLN 590,548 thousand at the end of 2024,
representing a moderate increase. At the same time, long-term liabilities increased to PLN 67,679 thousand from PLN 60,472
thousand a year earlier. As a result, the value of fixed capital rose to PLN 661,649,000 (2024: PLN 651,020,000).
The value of fixed assets decreased from PLN 640,142,000 at the end of 2024 to PLN 619,456,000 at the end of 2025. This
means that fixed capital fully covered fixed assets, and the surplus of fixed capital allocated to financing current assets
increased significantly – from PLN 10,878 thousand in 2024 to PLN 42,193 thousand in 2025.
Current assets at the end of 2025 amounted to PLN 145,105,000, compared with PLN 153,996,000 a year earlier. At the same
time, the level of current liabilities financing current assets fell significantly – from PLN 143,118,000 at the end of 2024 to PLN
102,913,000 at the end of 2025.
As a result, the share of fixed capital in the financing of current assets rose from 7.1% to 29.1%, whilst the share of current
liabilities fell from 92.9% to 70.9%. This change indicates a marked improvement in the structure of working capital financing
and a reduction in the pressure of short-term financing of current operations.
Structural ratios also confirm the improvement in financial stability. The ratio of equity to fixed assets rose from 0.92 to 0.96,
which means that fixed assets are almost entirely financed by equity. The ratio of current assets to borrowed capital fell from
1.32 to 1.18, indicating a reduced reliance on liabilities to finance current assets.
At the same time, the capital structure ratio (equity to debt) rose from 2.90 to 3.48, confirming the strengthening of the
Group’s capital position. The asset structure ratio (fixed assets to current assets) stood at 4.27, slightly above the 2024 level
(4.16), confirming the maintenance of a capital-intensive asset structure.
At the end of 2025, the Group had a stable and secure financing structure, with a marked increase in the share of long-term
capital in the financing of current assets, which has a positive impact on long-term financial stability and resilience to liquidity
risks.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 36
20.2. Key financial performance indicators of the Company
Key financial performance indicators
Profitability ratios:
2025
in PLN thousand
2024
in PLN thousand
1.
Net profit margin (ROS = Net profit / Net sales revenue)
0.5%
(8.6%)
2.
Return on assets (ROA = Net profit / Assets)
0.2%
(2.3%)
In 2025, the Company recorded an improvement in its key profitability ratios compared to 2024.
The return on net sales (ROS) stood at 0.5%, whereas in 2024 it was -8.6%. The increase in the ratio was the result of an
improvement in net profit, driven, among other things, by an increase in gross margin resulting from a change in the sales
structure, as well as better control of operating costs.
The return on assets (ROA) reached 0.2% in 2025, compared to -2.3% in the previous year. This indicates an improvement in
the efficiency of the Company’s use of assets to generate financial results, which was a consequence of achieving a positive
net profit with a relatively stable balance sheet total.
The improvement in both ratios indicates a gradual recovery in the Company’s profitability and an improvement in the
efficiency of its operating activities in 2025.
Liquidity and turnover ratios:
2025
in PLN thousand
2024
in PLN thousand
1.
Current ratio (Current assets / Current liabilities)
137.7%
106.6%
2.
Quick ratio ((Current assets – Inventories – Prepaid expenses) / Current liabilities)
44.7%
29.6%
3.
Average trade receivables
35,489
38,270
3a.
Trade receivables turnover ratio (Net sales revenue / Average trade receivables)
8.10
5.59
3b.
Trade receivables collection cycle in days (360 / Receivables turnover ratio)
44.5
64
4.
Average inventory
99,259
111,215
4a.
Inventory turnover ratio (Net sales revenue / Average inventory)
2.9
1.9
4b.
Inventory days (360 / Inventory turnover ratio)
124
187
5.
Average trade payables
45,304
55,668
5a.
Trade payables turnover ratio (Net sales revenue / Average trade payables)
6.3
3.8
5b.
Trade payables settlement period in days (360 / Trade payables turnover ratio)
57
94
In 2025, the Company’s liquidity position improved significantly compared to 2024, as reflected in the levels of key liquidity
ratios.
The current ratio rose to 137.7% from 106.6% in the previous year, indicating a strengthening of the Company’s ability to settle
short-term liabilities on time. At the same time, the quick ratio increased from 29.6% to 44.7%, indicating an improvement in
liquidity after excluding inventories and prepaid expenses.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 37
The efficiency of working capital management also improved. The trade receivables turnover ratio rose to 8.10 from 5.59,
which resulted in a reduction in the receivables collection cycle from 64 days in 2024 to 44.5 days in 2025. This change
reflects a more effective credit policy and improved debt collection.
The company also recorded a significant improvement in inventory management. The inventory turnover ratio rose from 1.9
to 2.9, and the average inventory holding period fell from 187 days to 124 days, indicating more effective production and sales
planning.
At the same time, the trade payables cycle was shortened – from 94 days in 2024 to 57 days in 2025, with the trade payables
turnover ratio increasing from 3.8 to 6.3. This change reflects an improvement in the Company’s financial liquidity and its
ability to meet its obligations to suppliers on time.
Overall, the improvement in liquidity and turnover ratios confirms the strengthening of the Company’s financial stability and
the increased efficiency of working capital management in 2025.
Debt ratios:
2025
in PLN thousand
2024
in PLN thousand
1.
Debt-to-assets ratio ((Long-term liabilities + Short-term liabilities) / Liabilities)
22.2%
25.3%
2.
Equity-to-assets ratio (Equity / Liabilities)
77.8%
74.7%
3.
Debt-to-equity ratio [multiple] (Long-term liabilities + Short-term liabilities) / Equity)
0.28
0.34
In 2025, the Company maintained a safe level of debt, and an analysis of debt ratios indicates a further strengthening of the
financing structure compared to 2024.
The debt-to-assets ratio stood at 22.2%, compared to 25.3% in the previous year. The decline in the ratio signifies a reduction
in the share of external financing within the liability structure and a reduction in overall financial risk.
At the same time, the equity-to-assets ratio rose to 77.8% from 74.7% in 2024, confirming the Company’s strong capital
position and the high proportion of equity in the financing of its operations.
The debt-to-equity ratio fell from 0.34 to 0.28, indicating a further improvement in the debt-to-equity ratio. This level
indicates low financial leverage and the Company’s strong ability to absorb potential economic fluctuations.
Overall, the debt ratios indicate a conservative and stable financing structure for the Company in 2025, ensuring financial
security and the potential for further business development.
Asset financing structure
2025
in PLN thousand
2024
in PLN thousand
1.
Equity
604,964
603,387
2.
Long-term liabilities
67,329
60,983
3.
Total fixed capital (1+2)
672,293
664,371
4.
Fixed assets
632,822
654,980
5.
Permanent capital for financing current assets
39,471
9,391
6.
Current assets
144,268
152,434
7.
Current liabilities covering current assets
104,797
143,044
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 38
Asset financing structure
2025
in PLN thousand
2024
in PLN thousand
8.
Percentage of current assets covered:
8a.
• fixed capital
27.4%
6.2%
8b.
• current liabilities
72.6%
93.8%
8c.
• provisions
0.0%
0.0%
9.
Equity-to-fixed-assets ratio (Equity / Fixed assets)
0.96
0.92
10.
Ratio of current assets covered by debt (Long-term liabilities + Current liabilities
covering current assets) / Current assets)
1.19
1.34
11.
Capital structure ratio (Equity / Borrowed capital)
3.51
2.96
12.
Asset structure ratio (Fixed assets / Current assets)
4.39
4.30
In 2025, the Company’s asset financing structure improved compared to 2024, confirming enhanced financial stability and a
sound alignment of funding sources with the asset structure.
Equity at the end of 2025 stood at PLN 604,964,000 and remained stable compared with the previous year (PLN
603,387,000). At the same time, long-term liabilities increased to PLN 67,329 thousand from PLN 60,983 thousand, which
resulted in an increase in the total value of fixed capital to PLN 672,293 thousand (2024: PLN 664,371 thousand).
The value of fixed assets in 2025 amounted to PLN 632,822 thousand, representing a decrease compared to 2024 (PLN
654,980 thousand). Consequently, fixed capital not only fully covered fixed assets but also increasingly financed current
assets. The surplus of fixed capital allocated to the financing of current assets rose from PLN 9,391,000 in 2024 to PLN
39,471,000 in 2025.
Current assets stood at PLN 144,268,000, compared with PLN 152,434,000 a year earlier. At the same time, the financing of
current assets through current liabilities decreased significantly – from PLN 143,043,000 in 2024 to PLN 104,797,000 in 2025.
This change led to a marked improvement in the structure of working capital financing.
The share of fixed capital in the financing of current assets rose from 6.2% to 27.4%, whilst the share of current liabilities fell
from 93.8% to 72.6%. Provisions did not contribute to the financing of current assets in either of the two years analysed.
The improvement in financial security is also confirmed by structural ratios. The equity-to-fixed-assets ratio rose from 0.92
to 0.96, indicating that fixed assets were almost entirely financed by equity. The ratio of current assets to borrowed capital
fell from 1.34 to 1.19, indicating that current operations are less dependent on external financing.
The capital structure ratio (equity to debt) rose to 3.51 from 2.96, reflecting the strengthening of the Company’s capital
position. At the same time, the asset structure ratio (fixed assets to current assets) rose slightly from 4.30 to 4.39, maintaining
the capital-intensive nature of the asset structure.
In summary, the asset financing structure in 2025 was stable and conservative, with a marked increase in the share of fixed
capital in the financing of current assets, which has a positive impact on the Company’s financial security and resilience to
liquidity risks.
21.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 39
The Company plans to implement investment plans covering, in particular, the continuation of ongoing research and
development work, development projects in the area of new molecules, and capital investments related to the Company’s
core business.
As at the date of preparation of the financial statements, the Company holds sufficient funds to cover its day-to-day
operations and to implement planned activities in the short and medium term, in accordance with current budgetary
assumptions. The scope and pace of implementation of investment plans depend on the level of available funds and current
cash flows generated from operating activities.
The Management Board notes that the full implementation of planned investments, in particular those of a long-term or
capital-intensive nature, may require the securing of additional sources of financing. Potential sources of financing include, in
particular, own funds, external financing, funds from subsidy or grant schemes, as well as other available forms of financing
appropriate to the scale and nature of the planned projects.
The Management Board emphasises that there is no certainty that additional financing will be secured on the terms and within
the timeframes envisaged by the Company, and the availability of funds may depend on market conditions, the results of
ongoing projects, decisions by financing institutions, and other factors beyond the Company’s direct control.
Should it prove impossible to secure additional sources of financing, the Company will adjust the scope or schedule of its
investment plans.
22.
The Group continued to pursue its established business strategy, which involves, among other things, optimising and
developing the Group’s product portfolio, launching new products on the Polish market by signing licence agreements with
suppliers, and strengthening its position on the global pharmaceutical market, as well as further increasing sales of insulin
manufactured by the Company, both in markets where this product is already commercialised and in new foreign markets.
The Company continued the measures implemented in previous years relating to the sales strategy for the Company’s and
the Group’s products in the coming years, as well as maintaining operating costs at a sustainable level.
These activities focused on the following key areas:
• consolidation of the product portfolio aimed at accelerating the commercialisation of the Company’s key product –
recombinant human insulin – and focusing development activities on diabetes products with the highest market
potential,
• reducing operating costs and adapting the existing infrastructure to the new requirements for implementing the strategy
in selected markets,
• focusing the Group’s strategic activities on specific core competencies, namely:
o the manufacture of high-quality biotechnology products,
o research and development of new biotechnology products,
o activities relating to the registration of biotechnology products in key global markets with a view to their
subsequent commercialisation in collaboration with leading pharmaceutical companies operating on the global
market,
• debt management and enhancing the stability of the Group’s financing structure,
• the development of the product portfolio in the areas of diabetology, gastroenterology, medical devices and cardiology.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 40
A one-off event that had an indirect and limited impact on the financial results for 2025 was the correspondence from Yifan
dated 11 March 2024 and the agreement concluded on 29 July 2024, which the company described in detail in its financial
reports for 2024. Furthermore, during the period under review, there were no one-off or unusual events that affected the
financial results achieved.
23. Characteristics of external and internal factors significant for the development of Bioton S.A.
and the Group, and a description of the prospects for the development of the Company’s and
the Group’s operations at least until the end of 2026, taking into account elements of the
market strategy developed by them
Below is a detailed description of the factors influencing the development of Bioton S.A. and the company’s prospects up to
the end of 2026, based on the Group’s current market strategy.
Key external factors (Operating environment)
• Global rise in diabetes cases: According to data from the IDF (International Diabetes Federation), the number of
people with diabetes is steadily increasing, particularly in emerging markets (Asia, Africa), which guarantees long-
term growth in demand for insulin.
• Barriers to entry and competition: The human insulin market has been dominated by the ‘big three’ (Novo Nordisk,
Sanofi, Eli Lilly). Bioton competes on price and through local partnerships. In selected countries where, due to the
withdrawal of other market players, the company sees opportunities to grow its international sales of human insulin,
Bioton also faces competition from manufacturers in China and India
• Pressure on drug prices: Healthcare systems are seeking to reduce reimbursement costs, forcing the company to
optimise production costs in order to maintain profitability amid falling selling prices.
• Regulations and certification: Compliance with stringent quality requirements (e.g. EU GMP) is a prerequisite for
expansion into high-margin markets.
Key internal factors (Strengths and weaknesses)
• Supply chain resilience through vertical integration of production: Bioton possesses its own technologies for
manufacturing active pharmaceutical ingredients (APIs) and finished dosage forms, which provides control over the
value chain.
• Product portfolio: Focus on human insulin (RHI) in international markets, which is cheaper than analogues but
remains the cornerstone of treatment in emerging markets. In the Polish market, Bioton is continuing to expand its
portfolio by adding insulin analogues as well as GLP-1.
• Financial position and debt: A key internal factor is debt servicing and the ability to finance capital-intensive
research into new products.
• R&D investments: Work on new drug delivery forms (e.g. single-use insulin pens) to enhance competitiveness
through new products in the portfolio. Bioton is also developing an insulin glargine analogue in both API and DP
forms. Additionally, the Company utilises its know-how for technology transfers based on agreements signed with
external partners.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 41
Market strategy and development outlook until the end of 2026
Bioton’s strategy is based on the following pillars:
• Geographical expansion: Moving beyond the Polish market (which is saturated) towards countries in South-East
Asia, Latin America and the Middle East, where the growth rate of human insulin sales is highest.
• Development of insulin analogues: A key objective is the commercialisation or advancement of work on insulin
analogues (e.g. Insulin Glargine). Analogues are newer-generation products with higher margins, enabling
competition in developed markets.
• Strategic partnerships: The business model involves collaboration with local distributors and pharmaceutical
companies, enabling faster drug registration and access to sales channels without having to build our own
structures from scratch. The company also offers CDMO and laboratory services to external partners under signed
agreements.
• Optimisation of production capacity: The company plans to modernise its production lines, which is expected to
reduce unit costs (economies of scale) through new investments in machinery.
• Financial stabilisation: Until the end of 2026, the priority will be to improve EBITDA ratios and optimise operating
costs to increase attractiveness to investors.
• Digitalisation and medical devices: Further development and sales of pens (injectors) and CGMS, which is part of
building a patient care ecosystem, rather than merely selling the substance itself. The company plans to expand its
digital offering by adding diagnostic devices for diabetology.
• Timing risk: The outlook depends on the pace of new product registration processes in foreign markets – any delay
in certification could significantly impact projected revenues in 2026.
Market strategy and growth prospects until the end of 2026
Development of biosimilars
The Company’s strategy is to continue developing insulin analogues based on its own technology, Yifan’s technology or other
approaches, such as licensing agreements and sourcing APIs, to accelerate the development of finished drug formulations.
Due to the lack of a decision from Yifan regarding the next steps under the MSA, the Company has developed its own strategy.
Currently, the most promising analogues for development are Glargine 100 IU and 300 IU (due to the expiry of the patent for
300 IU in 2028), as well as entry into the GLP-1 market through in-house development, licensing agreements or CMO
opportunities.
With regard to the GLP-1 project, the Company has identified an API supplier and is in discussions regarding a potential form
of future collaboration. Contract negotiations are ongoing. The Company is also continuing development work on its own
Glargine API, which will enable the development of Glargine 100 IU and 300 IU. The Company intends to develop a finished
dosage form and register the product in the EU under the biosimilarity procedure. At the time of writing this report, the
Company has successfully produced Glargine API on a laboratory scale and plans to scale up to production capacity in the
future. We believe that this strengthens the Company’s technical expertise and know-how and will lead to increased
competitiveness for the Company.
In all cases, the Company retains the option to pursue the fastest route to market. The strategy may be implemented through
licensing agreements and a re-prioritisation of R&D projects. The product development prioritisation matrix will be
continuously updated based on market data.
As part of this strategy, on 8 November 2024, the Company signed a commercial Licence and Supply Agreement with a global
pharmaceutical company for the distribution in Poland of a biosimilar analogue of the long-acting insulin Glargine. The drug
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 42
has received centralised authorisation from the European Medicines Agency. Market entry in Poland is currently expected
following the reimbursement decision in the third quarter of 2026. At the time of writing, the Company has already received
its first delivery and is awaiting the outcome of the reimbursement application.
On 7 February 2025, a CMO agreement was signed for the manufacture of Glargine. The project has successfully passed the
first stage (site suitability assessment) and is currently in the technology transfer phase. The agreement will result in the
establishment of Bioton’s production facility in Macierzysz as a validated site for the manufacture of Glargine, registered in
the regulatory documentation of the CMO client. In addition to the transfer of the Glargine technology itself, Bioton is investing
in and further developing its production capacity. The Company has placed an order for equipment for the assembly and
packaging of disposable pens in order to fulfil this CMO agreement and to strengthen its CMO offering. At the time of reporting,
the Company plans to take delivery of the new equipment in 2027.
In 2025, the Company entered into a number of licensing and supply agreements in connection with the development of its
portfolio for the manufacture of the following substances:
• Famotidine (on 7 February 2025) – the Company has made two milestone payments in respect of licence fees, and
the registration dossier has been submitted; the registration process is ongoing. The Company is also re-evaluating
the role of this medicine within its portfolio
• Liraglutide (on 4 November 2025) – the conclusion of the agreement marks the next stage of cooperation following
the signing of the Term Sheet; the Company is currently operating under a definitive licence agreement (LSA), which
has replaced the previous preliminary arrangements;
• Rivaroxaban (on 4 November 2025) – the product’s registration process is ongoing; the Company plans to launch
the product in 2027
• Apixaban (on 4 November 2025) – the product’s registration process is ongoing; the Company plans to launch the
product in 2027
Product development in international markets
The Company is analysing a number of strategic initiatives aimed at expanding its international product portfolio and
increasing sales volume. One of the key projects is the update of the documentation for recombinant human insulin (RHI) to
ensure it complies with EMA guidelines. The Company has completed a review with an external consultant, obtained an
analysis of gaps in the documentation and a recommended registration pathway.
The project is ongoing, but its further implementation depends on access to investment and external financing, as well as
regulatory approvals. The company is actively seeking sources of such financing.
Global shortages of recombinant human insulin persist, affecting markets such as Brazil, South Africa, India and Malaysia.
Bioton’s production capacity enables the Company to supply these markets using various regulatory pathways. In light of
current shortages and EMA guidelines, the Company continues to see opportunities for growth in both EU and non-EU
markets.
On 18 October 2024, the Company signed a contract for the supply of recombinant human insulin to Malaysia, with delivery
commencing in December 2024 and revenue in 2025 exceeding PLN 103.2 million. The contract has been fully executed.
However, the Company has received additional orders for the first and second quarters of 2026. With regard to further orders
for Malaysia, the Company is awaiting the allocation decision in the tender issued by the Malaysian Ministry of Health. The
Company sees a strong opportunity for future orders, as it has been included in the bids of many distributors participating in
the Malaysian Ministry of Health’s tender
Growth through the launch of new products on the Polish market
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 43
As part of its strategy to launch new products on the Polish market, on 3 October 2024 the Company entered into an Annex
with Galenicum Health, S.L.U. to the Licence and Supply Agreement, extending the cooperation to include five new molecules
from the therapeutic class of DPP-4 and SLGT2 inhibitors, which will be successively launched on the Polish market between
2026 and 2030. The Company is also considering oral GLP-1 agents with the same partner. These actions are in line with the
Company’s strategy aimed at strengthening its product portfolio in Poland through the introduction of medicines in the areas
of Diabetes Management and Cardiovascular Health. Furthermore, the Company is awaiting the expiry of the exclusivity period
in order to be able to launch these products on the Polish market.
It is worth noting, however, that in addition to the aforementioned five molecules, the Company is currently planning to launch
five other new molecules from separate sources – these include Glargine and Liraglutide, whilst the others are intended for
therapeutic areas other than diabetes. Of this group, the Company plans to launch Glargine and Liraglutide as early as 2026,
two further ones in the first quarter of 2027 due to delays in the registration process, and as for the launch date of the last
one, although it is ready for launch in 2026, a decision has not yet been made.
Growth through the utilisation of existing production capacity at manufacturing sites
This strategy encompasses activities aimed at utilising the Company’s existing production capacity at Bioton’s state-of-the-
art pharmaceutical manufacturing facility, which meets the stringent standards and criteria of European Union law for
biological medicines, whether in the form of active pharmaceutical ingredients (APIs) or finished dosage forms. As previously
reported, this includes licensing agreements, the procurement of APIs, and the development of medicinal products. The
Management Board is also seeking partners who could fully utilise the plant’s capabilities within the framework of the CDMO
and CMO strategies. The Company has finalised the design specifications and is considering the introduction of an additional
filling line to meet the growing demand for human insulin and to fulfil the requirements of the EU Glargine CMO contract.
24. Changes to the core corporate governance principles of Bioton S.A. and the Group
In 2025, there were no changes to the corporate governance principles of Bioton S.A. and the Group.
25. All agreements concluded between Bioton S.A. and members of management providing for
compensation in the event of their resignation or dismissal from their position without valid
cause, or where their dismissal or termination occurs due to the merger of the Company
through the acquisition of
On 29 July 2025, an Agreement on the termination of the employment contract was concluded with Mr Adam Polonek. It was
concluded in connection with the employee’s intention to resign from his position as a member of the management board
and from his roles in subsidiaries. The contract was terminated with effect from 31 January 2026. Under the agreement, the
employee is entitled, amongst other things, to a severance payment (compensation) in connection with the termination of
the employment contract in the amount of PLN 485,100, payable in agreed instalments, from which statutory social security
contributions will be deducted. In addition, provision has been made for the possibility of receiving a bonus for 2025 of up to
25% of annual gross remuneration, subject to the achievement of targets. Furthermore, the parties have agreed to waive the
existing non-competition clause, meaning that following the termination of the employment relationship, the employee is no
longer bound by it.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 44
26. The value of remuneration, awards or benefits, including those arising from incentive or bonus
schemes based on Bioton S.A. equity, including schemes based on senior bonds, convertible
bonds and subscription warrants (in cash, in kind or in any other form), paid, due or potentially
due, separately for each of the Company’s management and supervisory personnel at Bioton
S.A., regardless of whether they were recognised as expenses or resulted from profit
distribution, and information on the value of remuneration and awards received for performing
functions on the governing bodies of subsidiaries
Detailed information regarding the remuneration, bonuses and benefits of the management and supervisory personnel of
Bioton S.A. is presented in note 7.44 of the Company’s annual financial statements and in note 7.55 of the Group’s annual
consolidated financial statements for the period from 1 January 2025 to 31 December 2025
Members of the management and supervisory bodies of the parent company do not receive remuneration or other benefits
in respect of their roles on the governing bodies of subsidiaries.
27. Specification of the total number and nominal value of all shares in Bioton S.A. and shares and
equity interests in the Company’s related entities held by members of the management and
supervisory bodies (separately for each person)
According to information held by Bioton S.A., as at the date of this report:
• the supervisory board members of Bioton S.A. do not hold any shares in the Company,
• the members of the Management Board of Bioton S.A. do not hold any shares in the Company,
• the management and supervisory personnel of Bioton S.A. did not hold shares or equity interests in the Company’s
related entities.
28. Information on agreements known to Bioton S.A. (including those concluded after the balance
sheet date) which may result in future changes to the proportions of shares held by existing
shareholders and bondholders of
No such agreements were in place in 2025 or after the balance sheet date.
29. Information on the control system for employee share schemes
As at the date of publication of this report, the Company had not issued any shares under an incentive scheme.
30. Information on the auditor
Information regarding the auditor is provided in note 7.45 of the Company’s annual financial statements and in note 7.56 of
the Group’s annual consolidated financial statements for the period from 1 January 2025 to 31 December 2025.
31. Information on the impact of armed conflicts worldwide on the Company’s operations
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 45
31.1. The economic and political situation in Ukraine
Bioton S.A. monitors on an ongoing basis the development of the geopolitical situation related to military operations on the
territory of Ukraine; the Group does not conduct direct sales of products and goods on the territory of Belarus or Ukraine.
However, the Group sells insulin (ready-to-use forms) and syringes through distributors operating in the Belarusian and
Ukrainian markets. According to sales data, in 2025 sales to the Ukrainian market amounted to PLN 3.3 million (1.2% of the
Group’s consolidated revenue) and, due to successful tenders for the Belarusian market, PLN 1.1 million (0.4% of the Group’s
consolidated revenue), which, in the opinion of the Group’s Management Board, does not constitute a significant share of
revenue. At the same time, the Group fulfils all orders received from the distributor on the Ukrainian market. The Group’s long-
term intention is to continue operating in the Ukrainian market, primarily due to the nature of its operations and the supply of
life-saving medicines, whilst seeking to mitigate the associated risks (including financial risk). The Management Board
monitors the situation regarding the risks indicated above on an ongoing basis and takes decisions aimed at ensuring the
continuity of the Company’s and the Group’s operations.
31.2. Economic and political situation in the Middle East
During the period under review, the economic and political situation in the Middle East was characterised by a heightened
level of instability, resulting, among other things, from geopolitical tensions, armed conflicts and periodic disruptions to
international trade and financial systems. Despite the presence of these factors, BIOTON S.A. and the Group continued their
operational activities in the markets affected by the region, delivering products and maintaining commercial relations with
local partners.
As at the date of this report, no material events have been identified that would have a lasting or direct negative impact on
the Group’s ability to conduct its operations in the Middle East region. The difficulties encountered were mainly of an
operational and logistical nature, including longer delivery or settlement times; however, these remained manageable at the
operational level and did not necessitate a significant adjustment to the Group’s market strategy.
The economic and political situation in the Middle East remains a significant risk factor for the operations of BIOTON S.A. and
the Group, particularly in the medium term. Potential negative impacts may arise primarily from:
• further escalation of armed conflicts or international sanctions,
• restrictions in the international payment system or currency transfers,
• increased exchange rate volatility and rising financing costs,
• increased prices of energy and materials,
• disruptions in supply chains, including international transport.
These factors may affect the timely execution of commercial contracts, the financial liquidity of counterparties and operating
costs, and in extreme cases may result in a temporary reduction in the Group’s presence in selected markets.
The Company’s Management Board notes that, according to assessments by international institutions, including the
International Monetary Fund and independent analytical centres, the Middle East region remains an area of heightened
macroeconomic uncertainty, vulnerable to further geopolitical shocks, including in terms of energy availability, inflation and
financial stability
At the same time, the Management Board of BIOTON S.A. recognises that the geopolitical situation in the region may also
generate potential development opportunities. The withdrawal of some international pharmaceutical companies from
selected markets or their reduction of product offerings may favour an increased role for suppliers capable of ensuring the
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 46
continuity of supply of essential medicines. In this context, BIOTON S.A.’s expertise in the production of human insulin and the
Group’s experience in serving high-risk markets may constitute a competitive advantage.
In summary, the economic and political situation in the Middle East constitutes a significant but manageable risk factor for
the operations of BIOTON S.A. and the Group. During the period under review, its impact was limited and did not materially
affect the Group’s ability to continue as a going concern. At the same time, the continuing volatility of the situation in the
region requires ongoing monitoring and consideration in the Company’s operational and strategic planning.
V. STATEMENT BY THE MANAGEMENT BOARD OF BIOTON S.A. ON COMPLIANCE
The Management Board of Bioton S.A. declares that, to the best of its knowledge:
• the annual separate financial statements of Bioton S.A. as at 31 December 2025 and the annual consolidated financial
statements of the Bioton S.A. Capital Group as at 31 December 2025 have been prepared in accordance with
International Financial Reporting Standards, which apply to annual financial statements and which have been
endorsed by the European Union, hereinafter referred to as “EU IFRS”, and, to the extent not covered by the
aforementioned standards, in accordance with the requirements of the Accounting Act of 29 September 1994 and
the implementing regulations issued pursuant thereto;
• EU IFRS comprise all International Accounting Standards, International Financial Reporting Standards and related
Interpretations, except for the Standards and Interpretations listed below, which are awaiting approval by the
European Union, and Standards and Interpretations which have been approved by the European Union but have not
yet come into force;
• The Company and the Bioton S.A. Group have not exercised the option to early adopt the new Standards and
Interpretations that have already been published and approved by the European Union, and which will come into
force after the balance sheet date. Furthermore, as at the balance sheet date, the Bioton S.A. Group is in the process
of identifying the aforementioned amendments, but does not anticipate any material impact on the Group’s financial
statements for the period in which they will be applied for the first time;
• the report referred to above presents a true, fair and clear view of the financial position of the Company and the
Group, as well as their financial performance;
• the report of the Management Board of Bioton S.A. on the activities of the Company and the Bioton S.A. Group
contained in the Annual Report for the period from 1 January 2025 to 31 December 2025 presents a true and fair view
of the development, achievements and position of the Company and the Group, including a description of the
principal threats and risks.
VI. STATEMENT BY THE MANAGEMENT BOARD OF BIOTON S.A. ON THE APPOINTMENT OF THE
AUDITOR
The Management Board of Bioton S.A. hereby declares that, in accordance with Article 66(4) of the Accounting Act of 29
September 1994 and pursuant to § 21(1)(1) of the Articles of Association of Bioton S.A., the Company’s Supervisory Board, by
Resolution No. 3 of 20 March 2025, appointed UHY ECA Audyt Spółka z ograniczoną odpowiedzialnością, with its registered
office in Warsaw (“UHY”), as the entity to audit the financial statements as at 31 December 2025, 31 December 2026 and 31
December 2027, and to review the financial statements as at 30 June 2025, 30 June 2026 and 30 June 2027 (separate and
consolidated). The Supervisory Board has approved the Company entering into agreements with UHY in this regard.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 47
The Management Board of BIOTON S.A. hereby informs that this entity and the auditors conducting the review meet the
conditions for issuing impartial and independent review reports, in accordance with the provisions of the International
Standards on Auditing issued by the International Federation of Accountants, Chapter 7 of the Accounting Act of 29
September 1994, and the national financial audit standards issued by the National Council of Certified Auditors in Poland. UHY
ECA Audyt Spółka z ograniczoną odpowiedzialnością is an entity entered in the register of audit firms maintained by the Polish
Audit Oversight Agency under No. 3886.
VII. STATEMENT BY THE MANAGEMENT BOARD OF BIOTON S.A. ON THE APPLICATION OF
CORPORATE GOVERNANCE PRINCIPLES
1. Indication of the set of corporate governance principles to which Bioton S.A. is subject and the
place where the text of the set of principles is publicly available
From 1 July 2021, Bioton S.A. is subject to the Good Practices of Companies Listed on the Warsaw Stock Exchange 2021
(DPSN2021). The text of the “Good Practices of Companies Listed on the Warsaw Stock Exchange” is available, inter alia, on
the website of the Warsaw Stock Exchange S.A. dedicated to corporate governance issues: www.gpw.pl/dobre-praktyki2021
2. An indication of the provisions of the corporate governance code from which Bioton S.A. has
departed, an explanation of the circumstances and reasons for such deviation, and a
description of how the company intends to address any consequences of non-compliance
with a given provision or what steps it intends to take to reduce the risk of non-compliance
with a given provision in the future
The Management Board of Bioton S.A. hereby informs that, whilst sharing the ideas and principles underlying the individual
rules of the “Good Practices of Companies Listed on the Warsaw Stock Exchange” - in view of the Company’s established
practice or provisions of the Articles of Association requiring a departure from the management and supervision model
provided for by certain corporate governance rules – it is unable to apply the principles on a permanent basis and in their
entirety. Information on the Company’s compliance with the principles contained in the Code of Best Practice for Companies
Listed on the Warsaw Stock Exchange 2021 is up to date and can be found at the following link: https://bioton.com/wp-
content/uploads/2021/08/2021.07.22_GPW_dobre_praktyki_2021_PL.pdf
The Company’s Management Board wishes to emphasise that the non-application of certain principles or the expression of
certain reservations regarding specific principles does not adversely affect the transparency of Bioton S.A.’s governance and
management rules, nor does it affect the implementation of best practices; consequently, it does not lead to a breach of the
principles underpinning corporate governance. The Management Board of Bioton S.A. will continuously assess the
management and supervisory principles introduced within the Company and will also examine investors’ expectations
regarding the Company’s position on the unadopted principles of good practice, and where changes are deemed necessary,
a decision will be taken to adopt specific principles in the wording proposed by the Warsaw Stock Exchange ( ). In the event
that the application of such principles requires a decision by another body of the Company, the Management Board will
submit a request to that body to take the appropriate decision.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 48
3. Description of the main features of the internal control and risk management systems applied
within the Company in relation to the process of preparing separate and consolidated financial
statements
The internal control and risk management system in the process of preparing financial statements at Bioton S.A. is based on:
• internal regulations setting out the duties, powers and responsibilities of individual organisational units, including those
involved in the process of preparing financial statements,
• internal procedures defining the circulation of financial and accounting documents (including document control rules),
• the maintenance of accounting records in the IT system,
• the activities of the Audit Committee appointed by the Company’s Supervisory Board, including, amongst other things,
the preliminary assessment of the Management Board’s reports on the activities of the Company and the Group, as well
as the annual financial statements of the Company and the Group, and the review of the fundamental principles of the
Company’s existing internal control and risk management system, and the submission to the Supervisory Board of
proposals and recommendations regarding the appropriateness of changes thereto, as well as informing the Supervisory
Board of any material irregularities in such a system known to the Committee, or risks associated with its organisation
and operation,
• the audit and review of financial statements by an independent auditor appointed by the Company’s Supervisory Board
on the basis of the Audit Committee’s recommendation.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 49
4. Identification of shareholders holding, directly or indirectly, significant blocks of shares in
Bioton S.A., together with an indication of the number of shares held by such entities, their
percentage share in the share capital, the number of votes arising therefrom and their
percentage share in the total number of votes at the General Meeting
According to the information held by Bioton S.A. based on notifications from shareholders, the ownership structure of the
share capital of Bioton S.A., as at the date of this report, is presented in the table below:
Shareholder
Number of shares/votes
(units)
% of share capital
1.
Dongren Singapore PTE LTD.
1)
16,989,289
19.79
2.
Perfect Trend Ventures Ltd.
2)
10,186,419
11.86
3.
Basolma Holding Ltd.
3)
6,151,852
7.16
4.
AIS Investment 2 Sp. z o. o.
5,151,852
6.00
5.
Mirosław Czarnik (together with its subsidiary – ABM Family Foundation)
5)
4,322,000
5.03
6.
Uniapek Ningbo Dongren Commerce and Trade Co., Ltd. and partners
limited partnership
4)
4,293,210
5.00
7.
Other shareholders
38,769,578
45.16
Total
85,864,200
100.00
1) Yifan Pharmaceutical Co., Ltd. holds, indirectly through Dongren Singapore PTE LTD, 16,989,289 dematerialised shares in the Company, representing 19.79% of
the Company’s share capital. Yifan Pharmaceutical Co., Ltd. is the parent company of Dongren Singapore PTE LTD.
2) Yifan Pharmaceutical Co., Ltd. holds, indirectly through Perfect Trend Ventures Limited, 10,186,419 dematerialised shares in the Company, representing 11.86%
of the Company’s share capital. Yifan Pharmaceutical Co., Ltd. is the parent company of Perfect Trend Ventures Limited.
1) and 2) Yifan Pharmaceutical Co., Ltd. indirectly holds 27,175,708 shares in the Company, representing 31.65% of the Company’s share capital and entitling the
holder to 27,175,708 votes at the Company’s General Meeting of Shareholders, which constitutes 31.65% of the total number of votes at the Company’s General
Meeting of Shareholders
3) Basolma Holding Ltd is the parent company of AIS Investment 2 Sp. z o.o.
4) Uniapek spółka akcyjna, with its registered office in Warsaw (KRS: 0000621840), was converted pursuant to Article 551 § 1 of the Commercial Companies Code
into a partnership under the name Uniapek Ningbo Dongren Commerce and Trade Co., Ltd. and Partners Limited Partnership with its registered office in Warsaw
(KRS: 0001191238).
5) Mr Mirosław Czarnik holds, directly, 3,772,000 dematerialised shares in the Company, representing 4.39% of the Company’s share capital, and holds, indirectly
through ABM Family Foundation, 550,,000 dematerialised shares of the Company, representing 0.64% of the share capital, which together amounts to 4,322,000
dematerialised shares of the Company, representing 5.03% of the Company’s share capital.
Shareholder structure based on the list of shareholders dated 11 March 2025 and the notification published on 25 July 2025.
5. Identification of holders of any securities conferring special control rights in relation to Bioton
S.A., together with a description of those rights
As at the date of publication of this report, pursuant to the Company’s Articles of Association, no shareholder is entitled to
special control rights.
6. Indication of any restrictions on the exercise of voting rights, such as restrictions on the
exercise of voting rights by holders of a specific portion or number of votes, time-based
restrictions on the exercise of voting rights, or provisions under which, with the Company’s
cooperation, the capital rights attached to securities are separated from the holding of
securities
Pursuant to Article 411(1) of the Commercial Companies Code, one share confers the right to one vote at the General Meeting.
Shareholders are entitled to vote from the date on which the shares are fully paid up.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 50
As at the date of publication of this report, the Company’s Articles of Association do not provide for any restrictions on the
exercise of voting rights.
7. Indication of any restrictions on the transfer of ownership of Bioton S.A. securities
Pursuant to Article 337(1) of the Commercial Companies Code, shareholders have the right to dispose of shares without
restriction.
8. Description of the rules governing the appointment and dismissal of management personnel
and their powers, in particular the right to decide on the issue or redemption of shares in
The Company’s Management Board consists of no more than four persons, including the President, Vice-President and other
members of the Management Board. The number of Management Board members is determined by the Supervisory Board.
Currently, members of the Management Board are appointed and dismissed by the Supervisory Board. Members of the
Management Board are appointed for a three-year term; if the Management Board consists of more than one person, the
Company is represented by two members of the Management Board acting jointly, or by a member of the Management Board
acting jointly with a proxy.
The Management Board’s powers include matters provided for in the Commercial Companies Code and the Articles of
Association. The Management Board manages the Company’s affairs and represents the Company externally.
Subject to any contrary provisions of the Commercial Companies Code or the Articles of Association, the Management Board
makes decisions on all matters relating to increases in the share capital within the authorised capital. The Chairman of the
Supervisory Board approves the issue price and the issue of shares in exchange for non-cash contributions. Furthermore, with
the consent of the Supervisory Board, the Management Board may, in whole or in part, exclude or restrict shareholders’ pre-
emptive rights in respect of shares or subscription warrants issued within the authorised capital
9. Description of the rules for amending the Articles of Association of Bioton S.A.
An amendment to the Company’s Articles of Association requires a resolution of the General Meeting and entry in the register.
A resolution on amending the Articles of Association requires a three-quarters majority of votes. Furthermore, pursuant to
Article 415 § 3 of the Commercial Companies Code, a resolution concerning an amendment to the Articles of Association
which increases the obligations of shareholders or curtails the rights granted personally to shareholders requires the consent
of all shareholders concerned.
10. The manner of operation of the General Meeting and its fundamental powers, as well as a
description of shareholders’ rights and the manner of exercising them , in particular the rules
arising from the rules of procedure of the General Meeting, if such rules have been adopted,
provided that information in this regard does not follow directly from the provisions of law
Convening General Meetings
In accordance with the Act of 15 September 2000 – Commercial Companies Code (“Commercial Companies Code” or “CCC”),
general meetings may be ordinary (Ordinary General Meetings) or extraordinary (Extraordinary General Meetings).
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 51
Entities authorised to convene a General Meeting
The General Meeting is convened by the Management Board. The Supervisory Board may convene an Ordinary General
Meeting if the Management Board fails to do so within six months of the end of the Company’s financial year, and an
Extraordinary General Meeting if it deems it appropriate to do so. The right to convene an Extraordinary General Meeting is
also vested in the Company’s shareholders representing at least half of the Company’s share capital or at least half of the
total votes in the Company. In such a case, the Company’s shareholders shall appoint the chairman of that General Meeting.
In addition, a shareholder or shareholders of the Company representing at least one-twentieth of the Company’s share capital
may request that an Extraordinary General Meeting be convened and that specific items be included on the agenda of that
General Meeting. A request to convene an Extraordinary General Meeting must be submitted to the Management Board in
writing or in electronic form. If, within two weeks of the date on which the request is submitted to the Management Board, an
Extraordinary General Meeting has not been convened, the registry court may authorise the Company’s shareholders making
such a request to convene an Extraordinary General Meeting. The court shall appoint the chairperson of that General Meeting.
Method of convening the General Meeting
A General Meeting shall be convened by means of an announcement published on the Company’s website and in the manner
specified for the disclosure of current information in accordance with the Act of 29 July 2005 on Public Offerings and the
Conditions for Introducing Financial Instruments to Organised Trading and on Public Companies (“Public Offerings Act”) and
the Regulation of the Minister of Finance of 6 June 2025 on current and periodic information disclosed by issuers of securities
and the conditions for recognising as equivalent information required by the laws of a non-member state (“Regulation on
Current and Periodic Information”), as well as the Commercial Companies Code, in particular Articles 402(1) and 402(2). The
notice should be published at least twenty-six days prior to the date of the General Meeting. The notice of the General
Meeting should include, in particular: (i) the date, time and venue of the General Meeting and a detailed agenda, (ii) a precise
description of the procedures for attending the General Meeting and exercising voting rights, (iii) the record date for
attendance at the General Meeting, (iv) a statement that only persons who are shareholders of the Company on the date of
registration for participation in the General Meeting are entitled to participate in the General Meeting, (v) an indication of
where and how a person entitled to participate in the General Meeting may obtain the full text of the documentation to be
presented to the General Meeting and draft resolutions or, if no resolutions are to be adopted, comments from the
Management Board or the Supervisory Board regarding matters included on the agenda of the General Meeting or matters to
be included on the agenda prior to the date of the General Meeting; and (vi) an indication of the website address where
information regarding the General Meeting will be made available.
In accordance with the Regulation on Current and Periodic Information, the Company is required to disclose, in the form of a
current report, inter alia, the date, time and venue of the General Meeting, together with its detailed agenda. Furthermore, in
the event of an intended amendment to the Articles of Association, the provisions currently in force, the content of the
proposed amendments and, where the Company decides to draw up a new consolidated text due to the significant scope of
the intended amendments, the content of the new consolidated text of the Articles of Association together with a list of its
new provisions must be announced in the form of a current report. The content of draft resolutions and annexes to the drafts,
which are to be the subject of the General Meeting’s deliberations and are relevant to the resolutions to be adopted, must
also be announced in the form of a current report.
The right to include specific matters on the agenda of the General Meeting
A shareholder or shareholders of the Company representing at least one-twentieth of the Company’s share capital may
request that specific matters be included on the agenda of the next General Meeting. Such a request must be submitted to
the Management Board no later than twenty-one days before the scheduled date of the General Meeting. The request may
be submitted in electronic form. The Management Board is obliged to announce, without delay but no later than eighteen
days before the scheduled date of the General Meeting, any changes to the agenda introduced at the request of the
Company’s shareholders. The announcement shall be made in the manner appropriate for convening the General Meeting.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 52
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 53
Right to submit draft resolutions to the Company
A shareholder or shareholders of the Company representing at least one-twentieth of the share capital may, prior to the date
of the General Meeting, submit to the Company, in writing or by electronic means, draft resolutions concerning matters
included on the agenda of the General Meeting or matters to be included on the agenda. The Company shall immediately
publish the draft resolutions on its website.
Right to request a list of shareholders and copies of motions
A shareholder of the Company may request that a list of shareholders entitled to attend the General Meeting be sent to them
free of charge by email, specifying the email address to which the list should be sent. Furthermore, every shareholder of the
Company has the right to request copies of motions concerning matters on the agenda of the forthcoming General Meeting.
Such a request must be submitted to the Management Board. Copies of the motions should be provided no later than one
week before the General Meeting.
Participation in the General Meeting
Method of participation in the General Meeting and method of exercising voting rights
A shareholder of the Company may attend the General Meeting and exercise their voting rights in person or through a proxy.
A shareholder of the Company intending to attend the General Meeting through a proxy must grant the proxy a power of
attorney in writing or in electronic form. The Company includes a model power of attorney in the notice convening the General
Meeting. The Company takes appropriate measures to identify the Company’s shareholder and the proxy in order to verify
the validity of a power of attorney granted in electronic form. A detailed description of the method for verifying the validity
of a power of attorney granted in electronic form is included in the notice convening the General Meeting.
A shareholder of the Company holding shares registered in more than one securities account may appoint separate proxies
to exercise the rights attached to the shares registered in each of the accounts.
If the proxy of a Company shareholder at the General Meeting is a member of the Management Board, a member of the
Supervisory Board, a liquidator, an employee of the Company, or a member of the governing bodies or an employee of a
subsidiary company or cooperative of the Company, the power of attorney may authorise representation at only one General
Meeting. The proxy holder is obliged to disclose to the Company’s shareholder any circumstances indicating the existence or
possibility of a conflict of interest. In such a case, the granting of a further power of attorney is not permitted. The proxy
referred to above shall vote in accordance with the instructions given by the Company’s shareholder. A proxy may represent
more than one shareholder of the Company and vote differently in respect of the shares of each shareholder of the Company.
A shareholder of the Company may not, either in person or through a proxy, vote on resolutions concerning their liability to
the Company on any grounds, including the granting of discharge, release from liability to the Company, and a dispute
between them and the Company. The above restriction does not apply to a shareholder of the Company voting as a proxy
for another shareholder when adopting resolutions concerning that shareholder, as referred to above.
Persons entitled to attend the General Meeting and exercise voting rights
Only persons who are shareholders of the Company sixteen days prior to the date of the General Meeting (the record date
for participation in the General Meeting) are entitled to participate in the General Meeting.
In order to attend the General Meeting, holders of the Company’s dematerialised bearer shares should request the entity
maintaining their securities account to issue a personalised certificate confirming their right to attend the General Meeting.
This request must be submitted no earlier than after the announcement of the convening of the General Meeting and no later
than on the first working day following the record date for participation in the General Meeting.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 54
Holders of registered shares and provisional certificates, as well as pledgees and usufructuaries entitled to vote, shall be
entitled to participate in the General Meeting if they are entered in the share register on the date of registration of
participation in the General Meeting.
The Company shall draw up the list of persons entitled to participate in the General Meeting on the basis of a list prepared
by the entity maintaining the securities depository in accordance with the Act of 29 July 2005 on Trading in Financial
Instruments (“Act on Trading in Financial Instruments”) and the status disclosed in the Company’s share register on the date
of registration for participation in the General Meeting. The above list is displayed at the Management Board’s offices for three
working days preceding the date of the General Meeting.
A shareholder of the Company may transfer shares during the period between the date of registration of attendance at the
General Meeting and the date of the conclusion of the General Meeting.
Powers of General Meetings
In accordance with the provisions of the Commercial Companies Code, all types of resolutions may be adopted by
shareholders at an Extraordinary General Meeting, with the exception of certain resolutions which must be adopted at an
Ordinary General Meeting.
In accordance with the provisions of the Commercial Companies Code, the agenda of the Annual General Meeting shall
include: (i) the consideration and approval of the financial statements for the previous financial year and the Management
Board’s report on the Company’s activities, (ii) the adoption of a resolution on the distribution of profit or the coverage of
losses, and (iii) the adoption of a resolution on the discharge of members of the Management Board and the Supervisory
Board from liability for the performance of their duties.
Resolutions of the General Meeting are generally adopted by an absolute majority of votes cast, subject to the provisions of
the Articles of Association and the mandatory provisions of the Commercial Companies Code requiring a qualified majority.
Pursuant to the provisions of the Commercial Companies Code, the following matters, amongst others, require resolutions of
the General Meeting:
• amendments to the Articles of Association, redemption of shares, increase in the share capital, reduction of the
Company’s share capital, issue of convertible bonds and bonds with pre-emptive rights, disposal of the business and
liquidation of the Company (requires a three-quarters majority of votes),
• the appointment, dismissal and suspension of members of the Supervisory Board,
• amending the Articles of Association to authorise the Management Board to increase the Company’s share capital within
the authorised capital (requires a three-quarters majority of votes cast by those present at the meeting, provided that
shareholders representing at least one-third of the share capital are present); if a General Meeting convened to adopt
resolutions on the above matter does not take place due to a lack of quorum, a subsequent General Meeting may adopt
such resolutions regardless of the number of shareholders present at that General Meeting,
• making a material change to the Company’s scope of business (requires a two-thirds majority of votes, regardless of the
number of shareholders present at such General Meeting),
• a merger with other companies, which requires a two-thirds majority of votes cast, unless the Articles of Association
provide for stricter requirements,
• the division of the Company and the adjournment of the General Meeting (requires a two-thirds majority of votes),
• the issue of subscription warrants (requires a four-fifths majority),
• depriving shareholders of their pre-emptive rights in whole or in part (requires a four-fifths majority of votes at the
General Meeting),
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 55
• an amendment to the Articles of Association increasing shareholders’ benefits or reducing the rights granted personally
to individual shareholders (pursuant to Article 415 § 3 of the Commercial Companies Code, the consent of all shareholders
affected by the amendment is required),
• the conclusion by the Company of a credit agreement, loan agreement, guarantee or other similar agreement with a
member of the Management Board, the Supervisory Board, a proxy or a liquidator, or for the benefit of any of these
persons, requires the consent of the General Meeting.
Pursuant to the provisions of the Articles of Association, the following resolutions of the General Meeting require a three-
quarters majority of the votes cast:
• resolutions on the redemption of shares in the case referred to in Article 415 § 4 of the Commercial Companies Code,
• resolutions concerning the acquisition of shares (treasury shares) to be offered for purchase to employees or persons
who have been employed by the Company or its subsidiaries for at least three years,
• a resolution authorising the acquisition of own shares in the case referred to in Article 362(1)(8) of the Commercial
Companies Code,
• resolutions concerning mergers with other public companies.
• In accordance with the provisions of the Articles of Association, a resolution of the General Meeting dismissing or
suspending some or all members of the Management Board requires a majority of four-fifths of the votes cast.
Voting rights
One share entitles the holder to one vote at the General Meeting. Shareholders are entitled to vote from the date on which
the shares are fully paid up. A shareholder may vote differently in respect of each share held.
Right to dispose of shares
Pursuant to Article 337(1) of the Commercial Companies Code, shareholders have the right to dispose of their shares without
restriction. Furthermore, shareholders have the right to encumber their shares with a pledge or a right of usufruct.
Other shareholder rights
In addition, shareholders are entitled to the following rights:
• the right to subscribe for shares in a new issue in proportion to the number of shares held (pre-emptive right). Pursuant
to Article 433 of the Commercial Companies Code, shareholders have a pre-emptive right to subscribe for new shares in
proportion to the number of shares held, and this pre-emptive right also applies in the case of the issue of securities
convertible into shares or incorporating a subscription right to shares,
• the right to request the election of the Supervisory Board in separate groups. Pursuant to Article 385(3) of the Commercial
Companies Code, upon a motion by shareholders representing at least one-fifth of the share capital, the election of the
Supervisory Board shall be conducted by the next General Meeting by voting in separate groups, even if the Company’s
Articles of Association provide for a different method of appointing the Supervisory Board,
• the right to request information concerning the Company. Pursuant to Article 428 of the Commercial Companies Code,
during the General Meeting, the Management Board is obliged to provide a shareholder, at their request, with information
concerning the Company, if this is justified for the assessment of a matter on the agenda of the General Meeting. The
Management Board shall refuse to provide information if this could cause harm to the Company, an affiliated company,
or a subsidiary company or cooperative of the Company, in particular through the disclosure of the Company’s technical,
commercial or organisational secrets. A member of the Management Board may refuse to provide information if doing so
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 56
could give rise to criminal, civil or administrative liability on their part. In justified cases, the Management Board may also
provide information to a shareholder in writing, no later than two weeks after the conclusion of the General Meeting. The
Management Board may also provide a shareholder with information concerning the Company outside the General
Meeting; however, such information must subsequently be disclosed by the Management Board in writing in the materials
submitted to the next General Meeting. A shareholder who has been refused disclosure of the requested information
during the General Meeting and who has recorded an objection in the minutes may, within one week of the conclusion of
the General Meeting , submit an application to the Registry Court to compel the Management Board to provide such
information. A shareholder may also submit an application to the Registry Court requesting that the Company be ordered
to disclose information provided to another shareholder outside the General Meeting. Pursuant to § 38(1)(12) and (13) of
the Regulation on Current and Periodic Information, information provided to a shareholder outside the General Meeting
pursuant to Article 428(5) or (6) of the Commercial Companies Code and pursuant to Article 429(1) of the Commercial
Companies Code, arising from the Registration Court’s order requiring the Management Board to provide information to
a shareholder who has entered an objection in the minutes regarding the refusal to disclose information requested at the
General Meeting, as well as information which the Issuer was required to disclose, pursuant to Article 429 § 2 of the
Commercial Companies Code, by the Registry Court, and which has been provided to another shareholder outside the
General Meeting, shall be disclosed to the public in the form of a current report,
• the right to bring an action to set aside or declare null and void a resolution of the General Meeting. Pursuant to Article
422 of the Commercial Companies Code, a resolution of the General Meeting that is contrary to the Articles of Association
or good practice, and which is detrimental to the Company’s interests or intended to prejudice a shareholder, may be
challenged by bringing an action against the Company to set aside the resolution. An action to set aside a resolution must
be brought within one month of receiving notice of the resolution, but no later than three months from the date the
resolution was adopted. Pursuant to Article 425 of the Commercial Companies Code, a resolution of the General Meeting
may also be challenged by bringing an action against the Company to declare a resolution of the General Meeting that is
contrary to the Act null and void, provided that the action must be brought within thirty days of the date of its
announcement, but no later than one year from the date the resolution was adopted. The expiry of these time limits does
not preclude the possibility of raising an objection to the validity of a resolution that is contrary to the Act. The following
persons are entitled to bring an action for the annulment or declaration of invalidity of a resolution of the General Meeting:
(i) a shareholder who voted against the resolution and, after it was adopted, requested that their objection be recorded
in the minutes, (ii) a shareholder who was unjustifiably denied admission to the General Meeting, and (iii) a shareholder
who was not present at the General Meeting, but only in the event that the General Meeting was convened improperly or
a resolution was adopted on a matter not included in the agenda. The Commercial Companies Code provides for certain
modifications to the general rules regarding challenges to resolutions on the merger, division and transformation of
companies, as set out in Articles 509, 544 and 567 of the Commercial Companies Code respectively,
• the right to a share in the profit shown in the financial statements audited by a statutory auditor, which has been allocated
by the General Meeting for distribution to shareholders. Pursuant to Article 347(2) of the Commercial Companies Code,
profits are distributed in proportion to the number of shares held, and if the shares are not fully paid up, profits are
distributed in proportion to the payments made on the shares,
• the right to request, in accordance with Article 6 of the Commercial Companies Code, that a commercial company which
is a shareholder of the Company provide information as to whether it is in a controlling or subordinate relationship with a
specific commercial company that is a shareholder of the Company. The entitled party may also request disclosure of
the number of shares or votes held by such a commercial company in the capital company referred to above, including
as a pledgee, usufructuary or on the basis of agreements with other persons. Answers to the questions set out above
must be provided to the entitled person and the relevant capital company within ten days of receipt of the request. If
the request for a response reached the addressee less than two weeks before the date on which the general meeting
was convened, the period for providing the response shall commence on the day following the date on which the
shareholders’ meeting or general meeting ended. From the date on which the period for providing a response begins until
the date on which the response is provided, the commercial company concerned may not exercise rights attached to
shares in the capital company referred to above,
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 57
• the right, pursuant to Article 410 of the Commercial Companies Code, vested in shareholders holding one-tenth of the
share capital represented at a given General Meeting, to have the attendance list at the General Meeting verified by a
committee appointed for this purpose, comprising at least three persons,
• the right to bring an action for compensation for damage caused to the Company, in accordance with Article 486 of the
Commercial Companies Code, if the Company does not bring an action for compensation for the damage caused to it
within one year of the date of disclosure of the act causing the damage,
• the right to a share in the assets in the event of the Company’s liquidation. Pursuant to Article 474 of the Commercial
Companies Code, the assets remaining after the Company’s creditors have been satisfied or secured shall be divided
amongst the shareholders in proportion to the contributions made by each of them to the share capital.
11. Composition and changes that have occurred during the last financial year, and a description
of the activities of the management and supervisory bodies of Bioton S.A. and their committees
Management Board:
Composition of the Management Board as at the date of publication of this report:
• Mr Jeremy Launders (Chairman of the Management Board),
• Mr Romuald Harwas (Member of the Management Board).
On 29 July 2025, Mr Adam Polonek tendered his resignation from the position of Member of the Management Board of Bioton
S.A. with effect from 31 July 2025. The resignation was due to personal reasons. On the same day, the Company’s Supervisory
Board adopted a resolution appointing Mr Romuald Harwas to the position of Member of the Management Board of Bioton
S.A. with effect from 1 August 2025.
Description of the Management Board’s activities:
The following persons are authorised to make statements and sign on behalf of the Company: the President of the
Management Board jointly with another Member of the Management Board or a proxy, or the Vice-President of the
Management Board jointly with another Member of the Management Board or a proxy.
The Management Board’s powers include matters provided for in the Commercial Companies Code and the Articles of
Association. The Management Board manages the Company’s affairs and represents the Company externally.
The work of the Management Board is governed in detail by the Rules of Procedure of the Management Board, adopted by
the Supervisory Board. In accordance with the Rules of Procedure, meetings of the Management Board are convened and
chaired by the President of the Management Board, and in his absence, by the Vice-President of the Management Board.
Persons from outside the Management Board may attend meetings of the Management Board, subject to prior agreement
with the person convening the meeting. Meetings of the Management Board are held as and when necessary on a date set by
the Chairman of the Management Board or, in his absence, by the Deputy Chairman of the Management Board, but at least
twice a month. In accordance with the Management Board’s Rules of Procedure, the Management Board determines the
Company’s development strategy and operational objectives, as well as their implementation, which are approved by the
Supervisory Board. In accordance with the Rules of Procedure, the Management Board is required to submit reports to the
Supervisory Board at least quarterly, concerning significant events in the Company’s operations. This report also includes a
statement of the Company’s revenue, costs, financial result, liabilities and key balance sheet figures. The Management Board
will also inform the Supervisory Board of any changes to the Company’s strategy and operational objectives.
Supervisory Board:
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 58
Current composition of the Supervisory Board of Bioton S.A.:
• Mr Jia Li (Chairman of the Supervisory Board),
• Mr Ramesh Rejentheran (Vice-Chairman of the Supervisory Board),
• Mr Dariusz Trzeciak (Vice-Chairman of the Supervisory Board),
• Mr Nicola Cadei (Member of the Supervisory Board),
• Mr Jubo Liu (Member of the Supervisory Board),
• Mr Vaidyanathan Viswanath (Member of the Supervisory Board),
• Mr Tomasz Siembida (Member of the Supervisory Board)
• Mr Kaiguo Xia (Member of the Supervisory Board).
On 22 May 2025, Ms Valery Yeo (Yeo Jien Fong) resigned from her membership of the Company’s Supervisory Board and
Audit Committee. The resignation was due to personal reasons.
The Annual General Meeting of Bioton S.A., held on 23 June 2025, appointed Mr Kaiguo Xia to the position of Member of the
Supervisory Board of Bioton S.A.
Description of the Supervisory Board’s activities:
The Supervisory Board consists of between 5 and 13 members, including the Chairman and two Vice-Chairmen. Members of
the Supervisory Board are appointed and dismissed by the General Meeting. Pursuant to §18 of the Articles of Association,
one of the members of the Supervisory Board appointed by the General Meeting must meet all of the following conditions: (i)
have been elected in accordance with the procedure set out in §18 of the Articles of Association; (ii) must not be a related
party (as defined in the Articles of Association) of the Company or of a subsidiary of the Company; (iii) must not be a related
party of the Company’s parent company or of another subsidiary of the Company’s parent company (as defined in the Articles
of Association); or (iv) must not be a person who has any connection with the Company or with any of the entities listed in
points (ii) and (iii) above which could materially affect that person’s ability, as a member of the Supervisory Board, to make
impartial decisions. The number of members of the Supervisory Board is determined by the General Meeting. In the event of
voting in separate groups, the number of members of the Supervisory Board shall be 13. The Supervisory Board, which, as a
result of the expiry of the terms of office of certain members of the Supervisory Board (for reasons other than dismissal),
comprises fewer than the number specified by the General Meeting, but at least 5 members, is capable of adopting valid
resolutions until its composition is replenished. Members of the Supervisory Board are appointed for a joint three-year term
of office.
For resolutions of the Supervisory Board to be valid, all members must be invited and at least half of them, including the
Chairman or Vice-Chairman, must be present at the meeting. Resolutions of the Supervisory Board are adopted by an absolute
majority of votes. Resolutions of the Supervisory Board concerning the suspension of members of the Management Board are
adopted by a four-fifths majority of votes cast. In the event of a tie, the Chairman shall have the casting vote. If necessary,
resolutions of the Supervisory Board may be adopted in writing or using means of remote communication. In such cases, they
become binding upon being signed by at least half of the members of the Supervisory Board, including the Chairman. Members
of the Company’s Management Board, as well as other invited persons, may attend meetings of the Supervisory Board, as
required. The Supervisory Board acts collectively, which does not preclude the possibility of permanently or temporarily
delegating individual members of the Supervisory Board to perform specific supervisory tasks independently.
The Supervisory Board’s powers include the matters provided for in the Commercial Companies Code. The Supervisory Board
exercises ongoing supervision over all areas of the Company’s operations and, in particular, assesses the Management Board’s
report on the Company’s activities, the financial statements for the previous financial year and the Management Board’s
proposals regarding the distribution of profits or coverage of losses, and submits annual written reports to the General
Meeting on the results of each of the above assessments. The Supervisory Board may also suspend, for good cause, individual
or all members of the Management Board from their duties. The powers of the Supervisory Board may be extended pursuant
to the Articles of Association.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 59
Furthermore, in accordance with the Articles of Association, the Supervisory Board (i) appoints the entity to audit or review
the Company’s consolidated and separate financial statements and approves the conclusion of agreements with such an
entity, and (ii) approves the conclusion by entities related to the Company of agreements or the performance of other
activities on behalf of entities related to the Company where the value of such agreements or activities exceeds, over the
course of the following 12 months, the amount of EUR 500,000 or the equivalent of this amount in other currencies, with the
exception of typical and routine activities carried out on market terms between related entities, the nature and terms of which
arise from the current operational activities conducted by the Company or its subsidiary. Resolutions on matters specified in
point (i) require, to be valid, a vote in favour of their adoption by a member of the Supervisory Board elected by the General
Meeting, in accordance with the procedure set out in the Articles of Association, who has no connection with the Company
that could materially affect that person’s ability as a member of the Supervisory Board to make impartial decisions, and in
particular is not a related party of the Company. The Supervisory Board determines the remuneration of the members of the
Management Board.
In accordance with the Rules of Procedure of the Supervisory Board, members of the Supervisory Board should attend the
Company’s General Meeting in a composition that enables them to provide substantive answers to questions asked during
the General Meeting. In accordance with the Rules of Procedure, members of the Supervisory Board should take appropriate
steps to receive regular and comprehensive information from the Management Board on all material matters concerning the
Company’s operations, as well as on the risks associated with its activities and the methods of managing such risks. The
Chairman and Vice-Chairman of the Supervisory Board are, in particular, responsible for maintaining contact with the
Management Board and for representing the Supervisory Board in dealings with third parties.
The Audit Committee comprised the following members during the period from 1 January 2025 until the date of publication
of this report:
• Mr Dariusz Trzeciak – as Chairman of the Audit Committee of the Company’s Supervisory Board,
• Mr Ramesh Rejentheran – as Vice-Chairman of the Audit Committee of the Company’s Supervisory Board,
• Ms Valery Yeo – as a Member of the Audit Committee of the Company’s Supervisory Board – until 22 May 2025
• Mr Nicola Cadei – as a Member of the Audit Committee of the Company’s Supervisory Board – from 4 July 2025
The number of Committee members is determined by the Supervisory Board. Committee members, including its Chair and
Vice-Chair, are appointed by the Supervisory Board from among its members. The composition of the Audit Committee must
meet the conditions set out in Article 129 of the Act on Statutory Auditors, Audit Firms and Public Oversight (“the Statutory
Auditors Act”).
Within the Audit Committee, Mr Dariusz Trzeciak and Mr Ramesh Rajentheran meet the independence criteria within the
meaning of Article 129(3) of the Act on Statutory Auditors.
On the Audit Committee, Mr Dariusz Trzeciak meets the requirements of the Act on Statutory Auditors regarding knowledge
and skills in the sector in which the Company operates. He has over 10 years’ experience, having served on the Company’s
Supervisory Board since 2013. Mr Dariusz Trzeciak completed a four-year doctoral programme at the Faculty of Law and
Administration of the University of Warsaw, postgraduate studies in International Business Management at the Warsaw School
of Economics, and studied at the Faculty of Law and Administration and the Faculty of History of the University of Warsaw. In
the past, he held managerial and supervisory positions in numerous companies, including the role of Chairman of the
Management Board at Towarzystwo Ubezpieczeń na Życie Polisa Życie S.A., Sferia S.A. and IT Polpager S.A. He currently serves
as: a Member of the Management Board of Premium Mobile Sp. z o.o., Member of the Management Board of Sferia S.A., Vice-
Chairman of the Supervisory Board of Muzo FM Sp. z o.o. (formerly: Radio PIN) and Member of the Supervisory Board of AltaLog
Sp. z o.o. He is a member of elected bodies in industry organisations and chambers of commerce.
On the Audit Committee, Mr Ramesh Rejentheran meets the requirements of the Act on Statutory Auditors regarding
knowledge and skills in accounting or the auditing of financial statements. Mr Ramesh Rejentheran holds an MBA in Finance
from London Business School and a degree from Newcastle Medical School in Newcastle, UK. He is the founder of AlleleHealth
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 60
Pte Ltd, Singapore. From 2015 to August 2018, he served as Chief Financial Officer at the Singapore-based Fullerton Health
(FHC). From 2017 to 2018, he served as Chief Operating Officer at the FHC Group, and from April 2018 to August 2018, he
worked there as Chief Investment Officer. From 2011 to 2015, he was employed as Managing Director of Asian Healthcare
Investment Banking within the Investment Banking Division for the Singapore/Hong Kong region at Barclays. Between 2010 and
2011, he was Director of Markets and Equities, as well as Senior Advisor to the Chairman of the Board at Hong Leong Group,
Kuala Lumpur, Malaysia. From 2009 to 2010, he worked at Barclays Capital, London, UK, as Director of Global Healthcare
Specialists. From 2006 to 2009, he was Executive Director of Global Healthcare Specialists Sales at Morgan Stanley, London,
UK.
Mr Nicola Cadei has over 25 years’ managerial experience in the pharmaceutical industry, covering finance, sales and
marketing, manufacturing, negotiations, and corporate strategy and restructuring. He specialises in operational management
and business development, including mergers and acquisitions, as well as in building relationships with customers and market
partners. Since 2016, he has served as Chief Executive Officer and a Member of the Management Board of Pharmatex Italia
S.r.l. Between 2010 and 2015, he was Chief Operating Officer (COO) at Mipharm, and prior to that he worked as a Senior
Consultant at Resources Global Professionals. Between 1993 and 2008, he was with AstraZeneca S.p.A., where he held a
number of management positions, including in finance, sales, business development and commercial operations. He is a
graduate of the Bocconi University’s School of Management ( ) in Milan (degree in Economics and Business, specialising in
Marketing). He has also completed numerous management programmes, including at SDA Bocconi and INSEAD.
The Audit Committee’s operating procedures are set out in the Audit Committee Rules of Procedure. The Audit Committee’s
tasks include, in particular: (i) monitoring the financial reporting process, (ii) monitoring the effectiveness of internal control
systems, risk management systems and internal audit, including in relation to financial reporting, (iii) monitoring the
performance of financial audit activities, in particular the audit conducted by the audit firm, taking into account any
conclusions and findings of the Audit Oversight Commission arising from an inspection carried out at the audit firm, (iv)
reviewing and monitoring the independence of the statutory auditor and the audit firm, in particular where the audit firm
provides services to the Company other than the audit, (v) informing the Company’s supervisory board of the audit results
and explaining how the audit contributed to the reliability of the Company’s financial reporting, as well as the role of the audit
committee in the audit process, (vi) assessing the independence of the statutory auditor and giving consent for the provision
by the auditor of permitted non-audit services to the Company, (vii) developing a policy for the selection of an audit firm to
carry out the audit, (viii) developing a policy regarding the provision of permitted non-audit services by the audit firm
conducting the audit, by entities affiliated with that audit firm, and by a member of the audit firm’s network, (ix) determining
the procedure for the Company’s selection of an audit firm, (x) submitting recommendations to the supervisory board
regarding the appointment of statutory auditors or audit firms, in accordance with the policies developed by the audit
committee (policy on the selection of an audit firm, policy on the provision of permitted non-audit services), (xi) submitting
recommendations aimed at ensuring the reliability of the financial reporting process within the Company.
The Company has in place a procedure for the selection of an audit firm, a policy for the selection of an audit firm to carry
out the audit, and a policy on the provision of permitted non-audit services by the audit firm carrying out the audit, by entities
affiliated with that audit firm, and by a member of the audit firm’s network. The main principles of the policy on the selection
of an audit firm to conduct the statutory audit and the policy on the provision of non-audit services by the audit firm
conducting the audit are compliance with the rules relating to: (i) maintaining the independence of the auditor, (ii) avoiding
conflicts of interest, (iii) the proper preparation of documentation in the tender process, (iv) a non-discriminatory process
for selecting an audit firm during the tender procedure, (v) a fair assessment of the experience of the audit firm, the audit
team and the key auditor, (vi) determining appropriate remuneration for the audit firm for the services provided, (vii) ensuring
proper rotation of audit firms.
In 2023, the audit firm auditing the Company’s financial statements provided the Company with permitted non-audit services,
which are described in Note 7.47 to the Separate Financial Statements.
1.
The Audit Committee performed the duties of an audit committee as provided for in the applicable regulations. In 2025,
four meetings of the Audit Committee were held: 18 February 2025, 28 March 2025, 15 September 2025, 30 October
2025, and two electronic votes on 21 February 2025 and 27 March 2025.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 61
The main objective of the Audit Committee was to discuss the financial results of the Company and its Group. Members of
the Audit Committee remained in regular contact with the Management Board regarding the matters discussed.
VIII. STATEMENT ON NON-FINANCIAL INFORMATION OF BIOTON S.A. AND ITS GROUP
1. Legal requirements
This statement contains information on the following issues: labour, respect for human rights, anti-corruption, social matters
and the environment. The legal basis for this statement is the Accounting Act, the requirements of which regarding the
statement are set out primarily in Article 55.
This statement contains selected indicators prepared on the basis of the Global Reporting Initiative (GRI Standards) guidelines
for sustainability reporting. The list of indicators used is provided in section 6.
The statement presents non-financial information for the key companies of the Bioton S.A. Group: Bioton S.A., Biolek Sp. z o.o.
and Bioton Marketing Agency Sp. z o.o.
2. Description of the entity’s business model
Bioton S.A. is Poland’s first and one of the world’s eight manufacturers of a biotechnologically produced active human insulin
substance, as well as a manufacturer of ready-to-use medicinal insulin products intended for patients. It also conducts
research and development activities. In recent years, a Technology Transfer procedure has been implemented and a Scale
Down Model for the production of the active substance has been established. These activities enable the verification of
production technologies based on a biotechnological process, utilising various microorganisms, within a relatively short
timeframe. Furthermore, following the verification of the technology, the process is scaled up to the production line and
implemented, based on the principles of Quality by Design.
The aim of the Bioton S.A. Group is to become the preferred supplier of comprehensive diabetes care solutions for patients,
doctors and the diabetes community. To this end, our qualified specialists are constantly developing and refining production
technologies, thereby responding to the current needs of patients and the market. The combination of strong expertise and
laboratory facilities equipped with state-of-the-art research equipment enables the complete transfer of developed
technology for commercial purposes.
The foundations of Bioton S.A. and the Capital Group:
Every day, we build our global success by strengthening our expertise in diabetes and biotechnology. Every day, we enhance
our operational excellence through open-mindedness, a goal-oriented approach and teamwork.
In pursuing its objectives and upholding the foundations of its operations, the Bioton S.A. Group cares for the health and
quality of life of patients by manufacturing pharmaceutical substances of the highest quality, safe and effective medicinal
products, medical devices, as well as dietary supplements and foods for special medical purposes.
As at 31 December 2025, the Group comprised the following active companies:
• Bioton S.A.;
• Bioton Marketing Agency Sp. z o.o.;
• Biolek Sp. z o.o.;
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 62
• Bioton (International) GmbH.
The key companies within the Group are the Polish companies. The parent company of the Group is Bioton S.A. – the company
responsible for the production of recombinant human insulin (active substance), as well as ready-to-use medicinal insulin
products, the sale of finished products, goods and services both through its own pharmaceutical warehouse and other
pharmaceutical wholesalers and pharmacies on the Polish market, and international distribution, based on cooperation and
sales agreements concluded with foreign and domestic partners. Bioton S.A. possesses modern research facilities enabling
scientific work and continuous product development. Bioton Marketing Agency Sp. z o.o. (BMA) is responsible for the Group’s
marketing activities on the Polish market. Meanwhile, Biolek Sp. z o.o., utilising the Group’s research facilities, specialises in
foods for special medical purposes for patients with digestive system disorders.
In recent years, the business model of the Bioton S.A. Capital Group has been simplified, focusing on the development of an
integrated diabetes care system and concentrating on key projects related to the market launch of an insulin analogue of and
other medicines or medical devices, primarily in the fields of diabetology, cardiology and oncology. The year 2025 did not
bring about any significant changes to the Group’s business model or supply chain; however, certain disruptions and risks
arose due to the geopolitical situation linked to the ongoing armed conflict in Ukraine.
History
Bioton S.A. commenced operations in June 1993 with the purchase of raw materials for the production of injectable
cephalosporins and the sale of their pharmaceutical forms. Since then, the Bioton S.A. Group has developed very dynamically,
introducing innovative products and entering new markets. The most important ‘milestones’ in the Group’s development
include:
• June 1999 – Production Plant No. 1 obtained the Good Manufacturing Practice (GMP) certificate.
• December 1999 – completion of the registration process in Poland for 17 products from the Gensulin range.
• January 2001 – acquisition of IBATECH Sp. z o.o. in Macierzysz and its transformation into the Biotechnology Plant
(production of active substance), with the Biotechnology Plant obtaining Good Manufacturing Practice (GMP)
certification.
• May 2001 – Bioton Sp. z o.o. begins selling human insulin in Poland.
• August 2004 – Bioton Sp. z o.o. was transformed into the joint-stock company Bioton S.A.; Bioton S.A. shares were
first listed on the Warsaw Stock Exchange on 31 March 2005 – Bioton S.A. became the first biotechnology company
listed on the Polish stock exchange.
• 2004–2011 – expansion into international markets through acquisitions and the signing of distribution agreements,
including in China.
• 2011 – increased sales of its own insulin on the Polish market and the launch of new products for diabetes treatment.
• 2011–2014 – further development of the portfolio of generic medicines and medical devices related to diabetes care
(agreements with MSD).
• 2015–2016 – obtaining an EC Certificate in accordance with Directive 93/42/EEC for the GensuPen Improve
automatic insulin pen and a Quality Management System Certificate in accordance with EN ISO 13485:2012, as well
as expanding operations in the manufacture of automatic insulin pens to include the GensuPen2.
• 2018 – launch of the GensuCare blood glucose meter – one of the world’s most advanced blood glucose meters,
enabling, among other things, integration with the user’s smartphone and the ability for carers to monitor readings.
• March 2018 – signing of a 15-year agreement with Yifan International Pharmaceutical Co., Ltd. for the global
distribution, sales and marketing of Bioton products.
• May 2018 – sale of shares in SciGen Ltd. as part of an investment agreement with Yifan International Pharmaceutical
Co., Ltd.
• 2018 – obtained a Quality Management System Certificate compliant with the EN ISO 13485:2016 standard.
• 2019 – establishment of cooperation with Yifan International Pharmaceutical Co., Ltd. regarding the development and
commercialisation of insulin analogues, as well as their global distribution. The agreement provides funding for the
entire project, i.e. covering the costs associated with the purchase and installation of equipment required to carry
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 63
out each stage of the agreement, as well as the purchase of raw materials and excipients necessary for the
manufacture of the products.
• October 2020 – amendment of the cooperation agreement concluded with Copernicus Sp. z o.o. following the
completion by Financiere N Nemera of the acquisition of shares in Copernicus Sp. z o.o.
• 2020–2023 – development of products from the gastroenterology range on the Polish and international markets
through Biolek Sp. z o.o. (development of the INTESTA, INTESTA MAX, ENERGAST, INTESTA BIOM and INTESTA TEMPO
brands) and further products launched in 2024.
• 2022–2023 – launch of a new diabetes treatment on the Polish market – Sitagliptin – and the launch of another
medicine, Combodiab.
• 2024 – launch of two gastroenterology products under the INTESTA brand: INTESTA PYLOSTAT and LAXIBIOM. The
most significant event of the past year was the launch of a medical device – the continuous glucose monitoring
system (CGMs) – I-Sense and CareSense Air.
• 2025 – the most significant event of the past year was the continued implementation of the medical device – the
continuous glucose monitoring system (CGMs) – I-Sense, CareSense Air, and a focus on maximising the effectiveness
of promoting the current product portfolio.
• 2026– subsequent years – The Company plans to launch further medicines in the field of diabetology and to expand
its portfolio of new medicines in accordance with the strategy described in point IV.23 above. Additionally, the
Company plans to consider development and launches in the field of gastroenterology.
Innovation
What sets Bioton S.A. and the Bioton S.A. Capital Group apart from the competition is undoubtedly their focus on innovation
and development. Consequently, considerable effort has been directed towards identifying opportunities in a variety of
scientific and research projects. Our experience to date, the expertise of our specialists and the consistent implementation
of a long-term investment strategy have created an environment open to new areas of activity, all of which share the common
goal of improving the health and quality of life of patients suffering from lifestyle-related diseases.
Bioton S.A. and the Capital Group possess modern, technologically advanced research and development facilities, staffed by
highly qualified and experienced specialists conducting research into biotechnological products and the development of new
forms of medicines, and implementing a research programme in the following fields:
• Biotechnology: the aim of researching the processes of producing, isolating and modifying biologically active proteins
is to optimise the selection of methods for processing recombinant protein substances and their production.
• Finished product manufacturing: The aim is to increase production scale to reduce manufacturing costs and expand
the company’s production capacity, as well as to develop a manufacturing process for finished analogue forms of
insulin.
As indicated, a Technology Transfer procedure has been implemented and a Scale Down Model for the production of the
active substance has been established. These activities enable the verification of production technologies based on a
biotechnological process, utilising various microorganisms, within a relatively short timeframe. Furthermore, following
technology verification, the process is scaled up to the production line and implemented, based on the principles of Quality
by Design. The company also focuses its activities on offering a range of services in the field of contract manufacturing (CMO)
and the development of other products related to diabetes therapy at our facilities (CDMO).
In order to remain competitive, the Group’s management is constantly undertaking activities aimed at expanding the current
product range. Projects currently underway to create a modern production line, based on unique and innovative solutions,
designed for the manufacture of active substances from the group of insulin analogues, are the result of this strategy. The
outcome of this initiative will be the establishment of the first facility for the production of insulin analogues in Poland, the
launch of insulin analogues on the market whilst maintaining the highest global therapeutic standards for the product, and
improved access for patients to the most advanced anti-diabetic therapies.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 64
Scale of the organisation’s operations
The Group has two production plants: Production Plant No. 1, which manufactures finished products, and the Biotechnology
Plant, which produces the active substance. Both plants are located on the parent company’s premises in Macierzysz. In 2025,
Bioton S.A. supplied over 11.0 million product packages (including 11 million Gensulin units and over 200,000 pens and glucose
meters), resulting in the Company’s net sales revenue (including revenue from Services) reaching PLN 287.4 million. Excluding
intercompany revenue, the Bioton S.A. Group achieved net sales revenue of PLN 282.5 million. The largest markets for the
Group’s products in 2025 were: , Malaysia (37.3% of revenue), Poland (34.5%) and Tunisia (4.4% of revenue), and at the end of
2025, the Bioton S.A. Group employed 389 people.
The adopted business model enables the achievement of satisfactory financial and non-financial results, as well as the
effective implementation of strategic objectives arising from the Group’s mission.
The State Treasury holds shares in the ownership structure of Bioton S.A.: PKO BP SA – 1.18%.
3. Risk management
Risk management at Bioton S.A. and the Bioton S.A. Capital Group is an integral part of effective organisational management.
Risk analysis covers all areas of activity, including economic, social and environmental aspects.
The established practice in the area of risk management comprises the following elements:
• risk identification;
• risk analysis;
• risk assessment;
• risk treatment;
• risk monitoring and review.
The organisation has identified key risks, which are subject to analysis and assessment. For each of these, risk mitigation
measures have been defined in the event that they materialise. A set of measures has also been developed to safeguard the
Group in the event of an emergency (crisis management).
In accordance with the adopted methodology, each risk includes:
• a description of the identified threats having both an indirect and direct impact on the risk in question;
• a description of the safeguards designed to mitigate the identified risk;
• assignment of the risk owner role – the person responsible, among other things, for monitoring and periodic review
of the risk.
This approach enables the determination of an acceptable level of risk that the companies belonging to the Bioton S.A. Capital
Group are able to assume in order to effectively perform key business tasks. As the risk management process is an ongoing
one, every effort is made to ensure that both the risks and the control mechanisms designed to prevent their occurrence are
subject to regular review.
• The Company has implemented a Security and Compliance Policy, the primary objective of which is to ensure
security and compliance in their entirety, including in particular: ensuring the process of identifying and mitigating
adverse phenomena/events in the sphere of human safety and business processes, and reducing the Company’s
operating costs, including reputational costs,
• defining the responsibilities of management and staff coordinating activities to improve safety standards and ensure
compliance,
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 65
• defining the basic principles for identifying, mitigating and monitoring non-compliance in the areas of safety and
compliance.
The Company’s Management Board considers the following to be the main factors influencing the level of safety:
• safety of working conditions and supervision of their provision,
• ensuring compliance with legal, ethical and internal operating standards,
• information security,
• emergencies: breakdowns, disasters and natural disasters,
• outsourced processes.
For Bioton S.A. – the parent company and, due to its size and nature, the entity most exposed to risk among the Group’s
companies – a Catalogue of typical potential risks in specific categories has been drawn up, which outlines factors that could
have an adverse impact on the Company’s operations.
A description of the significant risk factors and threats (relating directly to the financial position) to which the Group is
exposed is provided in the preceding sections of the Bioton S.A. Management Board’s Report on the Activities of the Bioton
S.A. Capital Group.
Key risks and threats associated with the Group’s operations and which simultaneously affect sustainability issues include,
amongst others, the following risks:
• employment conditions risk;
• the risk of breaches of employee rights;
• business continuity risk;
• the risk of non-compliance with legal requirements, best practices and internal regulations;
• the risk of fraud;
• risk of side effects, interactions with other medicines or quality defects;
• risk of industrial accidents: explosion, chemical leak;
• risk of prolonged drought, loss of access to water;
• the risk of tighter environmental regulations, including those relating to waste generation and the discharge of treated
effluent;
• the risk of severe weather events.
The basic principles and standards of conduct regarding the aforementioned risks, including workplace safety and oversight
of its implementation, compliance with legal, ethical and internal operational standards, information security, response to
emergencies (accidents, disasters, natural disasters) and outsourced processes have been described and implemented
within the Security and Compliance Policy, as well as in other policies and procedures such as the Policy on Preventing
Corruption Risks and Conflicts of Interest, the Compliance Policy, the Code of Ethics, the Procedure for Reporting Legal
Violations and Irregularities and the Protection of Whistleblowers within the Bioton S.A. Group, and Bioton’s Good Marketing
Practices Policy, as described in the following sections of this Statement.
4. Ethics Management
In the interests of transparency in the Company’s operations and to emphasise that ethical conduct is of fundamental
importance to the activities of Bioton S.A. and the Bioton S.A. Group, a Code of Ethics has been introduced. It constitutes a
formal summary of the standards of conduct expected of all Company employees and sets out its core values.
The Bioton S.A. Code of Ethics describes:
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 66
• the organisation’s purpose and foundations;
• commitments to customers and business partners;
• obligations towards employees;
• commitments to the Company;
• commitments to the environment;
• social engagement;
• product and consumer safety;
• privacy protection and data security.
Every new employee of Bioton S.A. and the Capital Group is required to familiarise themselves with the contents of the Code.
The document is also available to employees in both electronic and traditional formats.
Respect for business ethics is also reflected in the principles set out in Bioton’s Good Marketing Practices Policy, which
primarily relate to the activities of Bioton Marketing Agency Sp. z o.o. (BMA) – a subsidiary responsible for marketing activities.
This document describes in great detail the legal requirements and ethical principles governing advertising, promotional,
educational and image-building activities relating to medicinal products, medical devices, food supplements, foods for special
medical purposes and cosmetics. All BMA employees and all other persons involved in marketing activities are required to
comply with the provisions of the Policy.
In 2025, there were no instances of product recalls or comments from the Chief Pharmaceutical Inspectorate (GIF) or the
Chief Sanitary Inspectorate (GIS) regarding marketing information on Bioton S.A. products in Poland.
5. Social responsibility policies and procedures, their outcomes and key non-financial
performance indicators
5.1. Policies and indicators relating to employee matters
Recruitment processes are conducted on the basis of the approved recruitment plan for the given year. New employees are
initially sought within the organisation. If no candidate with the required competencies and skills is found, a decision is made
to initiate external recruitment.
Every effort is made to ensure that the working environment we create is a place where differences among employees – such
as gender, age, culture and lifestyle – are valued, in line with current industry standards on diversity and inclusion. The unique
skills and experience possessed by employees result in greater creativity and innovation, which in turn translates into a better
understanding of market needs and improved business performance. Matters relating to diversity policy within the Bioton S.A.
Group are formally reflected in the Code of Ethics and the Compliance Policy in force within the Group.
The Group makes every effort to ensure that the Company’s governing bodies and its key managers are diverse in terms of
gender, educational background, age and professional experience. The selection process for management and executive
positions takes into account factors such as relevant education, professional experience and competencies. Candidates are
not disqualified on the basis of gender or age.
At the end of 2025, the Group employed 389 people.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 67
The data below presents employment figures for Bioton S.A., Bioton Marketing Agency Sp. z o.o. (BMA), Biolek Sp. z o.o. and
the Capital Group, broken down by gender, age, type of employment contract and type of employment.
Gender
BIOTON S.A.
BMA Sp. z o.o.
Biolek Sp. z o.o.
BIOTON Capital
Group
2025
2024
2025
2024
2025
2024
2025
2024
Change 2025
vs 2024
Number of
employees (on
permanent
contracts) at the
end of 2024/2025
Women
169
166
31
32
1
0
201
198
3
Men
170
152
18
14
0
0
188
166
22
Total
339
318
49
46
1
0
389
364
25
The data broken down by type of employment contract and type of employment for the years 2024–2025 are as follows:
Total number of employees by type of employment contract and by gender (BIOTON Group)
Number of
employees (on
employment
contracts) by:
Gender
BIOTON S.A.
BMA Sp. z o.o.
Biolek Sp. z o.o.
BIOTON Group
2025
2024
2025
2024
2025
2024
2025
2024
Change 2025
vs 2024
indefinite
Women
153
150
28
28
0
0
181
178
3
Men
147
131
15
13
0
0
162
144
18
Total
300
281
43
41
0
0
343
322
21
fixed-term
Women
13
13
2
3
1
0
16
16
0
Men
23
21
3
1
0
0
26
22
4
Total
36
34
5
4
1
0
42
38
4
fixed-term
contract for a
replacement
Women
3
3
1
1
0
0
4
4
0
Men
0
0
0
0
0
0
0
0
0
Total
3
3
1
1
0
0
4
4
0
TOTAL
Women
169
166
31
32
1
0
201
198
3
Men
170
152
18
14
0
0
188
166
22
Total
339
318
49
46
1
0
389
364
25
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 68
Total number of employees by type of employment and by gender (BIOTON Group)
Number of
employees (on
employment
contracts) by:
Gender
BIOTON S.A.
BMA Sp. z o.o.
Biolek Sp. z o.o.
BIOTON Group
2025
2024
2025
2024
2025
2024
2025
2024
Change 2025
vs 2024
Full-time
Women
168
164
31
32
1
0
200
196
4
Men
168
151
17
14
0
0
185
165
20
Total
336
315
48
46
1
0
385
361
24
Part-time
Women
1
2
0
0
0
0
1
2
-1
Men
2
1
1
0
0
0
3
1
2
Total
3
3
1
0
0
0
4
3
1
TOTAL
Women
169
166
31
32
1
0
201
198
3
Men
170
152
18
14
0
0
188
166
22
Total
339
318
49
46
1
0
389
364
25
The data below shows the recruitment of new employees and staff turnover broken down by age group and gender:
Total numbers and rates of new hires and staff turnover broken down
by age group and gender (BIOTON Group)
Number of
employee
departures
Staff turnover
rate*
Number of new
hires
Employment rate**
2025
Women
under 30
4
29%
7
50%
from 30 to 50
25
20%
21
17%
over 51
4
6%
4
6%
Men
under 30
9
50%
15
83%
from 30 to 50
10
9%
25
22%
over 51
6
11%
7
13%
2024
Women
under 30
5
36%
8
57%
from 30 to 50
23
17%
16
12%
over 51
8
16%
2
4%
Men
under 30
4
24%
10
59%
from 30 to 50
12
11%
18
17%
over 51
1
2%
3
7%
*Number of departures of employees in a given category by gender / total number of employees in a given category by gender as at 31
December 2025
**Number of employees in a given category by gender / total number of employees in a given category by gender as at 31 December 2025
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 69
Including for the parent company Bioton S.A.:
Total number and ratios of new hires and staff turnover broken down
by age group and gender (BIOTON S.A.)
Number of
employee
departures
Staff turnover rate*
Number of new
employees
Employment rate*
2025
Women
under 30
4
29%
7
50%
from 30 to 50
21
21%
18
18%
over 51
4
7%
2
4%
Men
under 30
9
50%
15
83%
from 30 to 50
10
10%
21
21%
over 51
6
12%
6
12%
2024
Women
under 30
5
36%
8
57%
from 30 to 50
18
18%
11
11%
over 51
7
15%
2
4%
Men
under 30
4
24%
10
59%
from 30 to 50
11
12%
17
18%
over 51
0
0%
3
7%
*Number of departures of employees in a given category by gender / total number of employees in a given category by gender as at 31
December 2025
**Number of employees in a given category by gender / total number of employees in a given category by gender as at 31 December 2025
Before starting work, every employee familiarises themselves with the Work Regulations, which set out the employer’s
obligations and the employees’ rights and obligations. Newly recruited employees are required to undergo a series of training
courses designed to familiarise them with the safety rules applicable at their workstation, as well as policies and procedures,
including those relating to human rights and trade secrets. Detailed on-the-job training is also provided, the aim of which is,
amongst other things, to inform the employee about hazardous, harmful and nuisance factors present at the workplace and
in its immediate surroundings.
As responsible employers, the companies comprising the Bioton S.A. Group offer employment under an employment contract.
Furthermore, employees are provided with a range of additional benefits tailored to local standards, such as supplementary
life insurance, a medical package, or a sports card. The scope of changes introduced in 2025, involving the adjustment of
salaries for selected positions across the Bioton S.A. Group, demonstrates the ongoing improvement of the remuneration
structure within the Group. As a company for which caring for people’s health is a priority, we offer an attractive medical
package. Bioton S.A. and the Bioton Capital Group offer their employees the opportunity to join the Global Doctors
international healthcare programme, which covers the costs of treating chronic illnesses up to EUR 2 million worldwide. In
response to the needs of its employees, the Bioton Group has also launched the “Senior Package”, a medical package which
is also available to employees’ relatives up to the age of 85. Employees can also make use of the Benefits Cafeteria, where
they have the opportunity to use funds allocated from the Company Social Benefits Fund (ZFŚŚ) and their own funds on offers
from partners. With the health and fitness of employees in mind, the Cafeteria also offers sports cards. Since 2019, employees
have been able to join the Employee Pension Plans, an additional form of retirement savings organised by the Group.
Bioton’s management believes that the key to business success lies in dialogue with employees; therefore, this dialogue is
ongoing and takes place at all levels of the company community. Employees are regularly updated on the company’s strategy
and performance during company-wide live meetings, during which the management team also answers employees’
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 70
questions . The CEO, HR and Communications Director, and HR Business Partner meet regularly with Employee
Representatives to discuss current employee issues and to work together to find the best solutions.
The organisation strives to provide its employees with the best possible conditions for career development, which is why it
offers employees the opportunity to undertake general development training, certification and specialist courses, e.g. in the
field of biotechnology, or funding for doctoral studies. Employees can also submit their ideas for interesting professional
projects.
The decisions taken sometimes require decisive action, necessary to achieve the set objectives. Recognising the difficult
situation faced by those made redundant by the employer through no fault of their own, the employer provides for the
possibility of receiving additional remuneration, the amount of which depends on length of service and position held, thereby
offering the employee extra time to adjust to the change. For those approaching retirement age, a protection period applies,
and the transition to retirement itself is accompanied by the award of additional remuneration. As a gesture of appreciation
for employees, additional benefits beyond the statutory requirements are provided, governed by the Group’s internal
procedures.
Health and Safety
Maintaining high standards of working conditions and ensuring the safety and health of employees is a priority in the
organisation’s day-to-day operations.
This is particularly important in manufacturing companies, where employees are exposed to increased risks due to the nature
of their work. Consequently, this area is regulated in great detail in the Health and Safety Policy, and systematic measures are
taken to improve health and safety standards, including:
• Health and safety training aimed at raising employees’ awareness and improving their skills (educational activities);
• Striving for continuous improvement of working conditions and safety measures – the effective implementation of
corrective and preventive actions;
• Ongoing identification of and compliance with legal requirements regarding health and safety;
• Preventive information and consultation campaigns regarding potential hazards and associated risks among company
employees and external staff.
The organisation’s main objective in this area is to achieve a zero accident rate and zero incidence of occupational diseases.
This is made possible by regular monitoring and identification of hazards that may affect the health and safety of employees,
as well as measures taken to improve safety, including in relation to external contractors carrying out work on the premises.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 71
Number of workplace accidents, including fatal accidents, occupational diseases and days of incapacity for work
among employees of the BIOTON S.A. Group
BIOTON S.A.
BMA Sp. z o.o.
BIOTON Group
2024
2025
2024
2025
2024
2025
Number of fatal accidents
0
0
0
0
0
0
Women
0
0
0
0
0
0
Men
0
0
0
0
0
0
Total number of workplace accidents
2
6
2
1
4
7
Women
1
1
0
1
1
2
Men
1
5
2
0
3
5
Accident frequency rate*
6.3
18
43
20
11
18
Women
3.14
2.95
0
20
2.7
5.2
Men
3.14
14.8
43
0
8.2
12.9
Total number of days of incapacity for work due to
an accident at work
174
352
18
0
192
352
Women
0
82
0
0
0
82
Men
174
270
18
0
192
270
Accident severity index**
87
59
9
0
48
50
Women
0
82
0
0
0
41
Men
174
54
9
0
64
54
Number of confirmed occupational diseases
0
0
0
0
0
0
Women
0
0
0
0
0
0
Men
0
0
0
0
0
0
* Total number of accidents / workforce * 1000.
** Number of days of incapacity for work due to accidents / number of accidents.
In 2025, only minor individual accidents were recorded, mainly involving bruises. No serious, fatal or collective accidents were
recorded. In 2025, no occupational diseases were recorded among employees. No accidents at work were recorded among
subcontractors working on the premises of the Bioton Group.
The main hazards identified as potentially causing serious accidents among employees or subcontractors working on the
premises include chemical burns, thermal burns from hot water or steam, and electric shock.
Due to the nature of the operations of Bioton S.A. and the Group, the Health and Safety Policy is adapted to changes in the
working environment. All accidents occurring during the performance of work duties are reported by supervisors to the Chief
Health and Safety Specialist, who prepares accident documentation following an analysis of the circumstances and causes
of the accident by the Accident Investigation Team. The Accident Investigation Team comprises: the Chief Health and Safety
Specialist and a Staff Representative. Following each accident, an analysis is carried out to assess the implementation of
additional safeguards that would prevent similar incidents in the future.
Information on health and safety at work, together with the relevant policy governing this area, is provided to employees
during induction training – every employee must undergo such training before commencing work in a given role. Furthermore,
in the event of the implementation or updating of a safety procedure, training must be organised for employees to whom
these rules will apply. In addition, training sessions for management are organised at least once a year to discuss and promote
safe working conditions, as well as to raise awareness of the consequences of tolerating improper behaviour and working
methods by employees. When using the services of external companies, their employees are informed, prior to commencing
work, of, amongst other things , the general safety rules (as set out in the Health and Safety Policy), guidelines regarding
environmental protection (contained in the Environmental Policy) and potential hazards and emergency situations.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 72
Information Security
The basis of the internal control system for the IT environment is the Security and Compliance Policy and the dedicated
procedure ‘IT Infrastructure Access Management’, which sets out standards, rules and requirements concerning the security
of the IT environment, including, amongst other things:
• security principles;
• IT resource security;
• physical and environmental security;
• legal and regulatory security.
The creation and development of information security principles are based on the relevant standards from the ISO 27000
series, industry standards and experience gained from proven practical solutions.
Personal data protection
The personal data protection principles followed by Bioton S.A. and the Bioton Capital Group are set out in:
1) the Personal Data Protection Policy, which describes the principles of personal data protection, the procedure for
exercising the rights of data subjects, and the principles of IT resource management;
2) The Privacy Policy available on the Company’s website;
3) The Privacy by Design and by Default Policy concerning the obligations to incorporate data protection at the design
stage (privacy by design) and default data protection (privacy by default), as referred to in Article 25 of the GDPR;
4) The procedure for reporting personal data breaches regarding the conduct of persons processing personal data on
behalf of the controller (end users) in the event of a suspected personal data breach.
5) The personal data breach incident management policy, which constitutes:
a) the fulfilment of the obligation to report a personal data breach (Article 33(1) and (2) of the GDPR),
b) fulfilment of the obligation to notify the data subject of a personal data breach
(Article 34(1) of the GDPR),
c) the implementation of measures planned to remedy the breach.
6) A procedure for the transfer of personal data to a third country or an international organisation and for the
processing of data by an entity outside the EEA, which aims to ensure that the transfer of personal data to third
countries and international organisations takes place on the basis of and within the limits of the GDPR.
The above internal policies comply with applicable legal provisions imposing an obligation to protect certain types of
information, including trade secrets and personal data.
It is worth noting that all employees are required to complete dedicated online training on personal data protection.
Furthermore, employees sign a declaration confirming that they have been made aware of the regulations concerning the
protection of personal data, including in particular the provisions of the GDPR, the organisation’s applicable personal data
protection documentation, and the rules for the processing of personal data by the end user.
During the reporting period, no personal data breaches were disclosed that would require notification to the President of the
Personal Data Protection Office in accordance with the requirements of the GDPR.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 73
5.2. Policies and indicators relating to respect for human rights
Bioton S.A. and the Group exercise due diligence to ensure equal treatment in all areas of their operations, guided by the
principle that their own interests must not conflict with good corporate social responsibility practices. Therefore, all business
activities and objectives are pursued in accordance with the following values:
• providing high-quality products and services;
• customer trust and satisfaction;
• respect and kindness towards all customers;
• responsibility towards stakeholders and the business environment;
• employment conditions;
• employee development;
• respect for employees;
• promotion of teamwork.
Prevention of discrimination and bullying
The Bioton S.A. Group is committed to creating an appropriate work environment with a strong culture of conflict resolution.
To this end, the employer has established appropriate procedures to prevent bullying and discrimination. The prevention and
combating of bullying and discrimination at Bioton S.A. is implemented in the following three areas:
• the Company’s internal regulations;
• management practice;
• workplace ethics and culture.
The issue of combating discrimination and bullying at Bioton S.A. is regulated by the Anti-Bullying and Anti-Discrimination
Policy, which sets out the procedure for reporting cases of discrimination or bullying, as well as information on the measures
that may be taken if a complaint is deemed valid (e.g. transferring the employee to another position, imposing a disciplinary
penalty, issuing a reprimand, or terminating the employment relationship without notice).
This is a common policy for the Group’s key companies, i.e. the Polish companies. Due to the different nature of their
operations, as well as a different legal environment, the other subsidiaries are not covered by this policy.
These regulations were presented to all new employees during an induction training session conducted online. Each employee
was required to confirm electronically that they had completed the training. Furthermore, each new employee was required
to familiarise themselves with the Anti-Bullying and Anti-Discrimination Policy, contained in the Staff Regulations, and to
confirm their familiarity with the aforementioned Policy by signing a declaration.
During 2025, periodic refresher training was also conducted to update employees’ knowledge in this area and to communicate
changes that had taken place regarding workplace bullying, discrimination and equal treatment. The online training was aimed
at all employees, and each employee was required to confirm electronically that they had completed the training.
In 2025, no formal reports of discrimination, as required under the Anti-Bullying and Anti-Discrimination Policy, were recorded,
nor were there any formal complaints regarding the impact on respect for human rights within the formal mechanisms allowing
for the submission of complaints.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 74
5.3. Policies and indicators relating to anti-corruption issues
Anti-Corruption Policy
Bioton S.A., as a company listed on the Warsaw Stock Exchange (WSE), applies a ‘zero tolerance for misconduct’ policy at all
levels of management in order to effectively protect its reputation and assets, whilst valuing integrity and transparency. Bioton
S.A. has a Policy on Preventing Corruption Risks and Conflicts of Interest, which formalises the practices previously applied
in the area of preventing corruption risks and conflicts of interest.
This is a common policy for the Group’s key companies, i.e. the Polish companies. Due to the different nature of their
operations, as well as a different legal environment, the other subsidiaries are not covered by this policy.
It is worth noting that in 2025, no cases of corruption, breaches of free competition rules or monopolistic practices were
recorded, nor were any penalties or sanctions imposed for non-compliance with laws and regulations. Furthermore, during
the reporting period, no formal complaints regarding social impact were recorded.
Procedure for Reporting Legal Violations and Irregularities and for the Protection of Whistleblowers within the Bioton S.A.
Group
In 2021, the Management Board of Bioton S.A. adopted the Procedure for the Anonymous Reporting of Violations and
Irregularities and the Protection of Whistleblowers in the Bioton Capital Group, which was subsequently amended in 2025
was amended and adopted by the Management Board of Bioton S.A. as the Procedure for Reporting Legal Violations and
Irregularities and the Protection of Whistleblowers in the Bioton S.A. Capital Group
This procedure was introduced to establish internal regulations serving as a tool to enhance the effectiveness of monitoring,
reporting, detecting and resolving situations involving misconduct or breaches of the law, procedures and ethical standards
in force within the Bioton Capital Group, as well as to foster an internal culture of reporting irregularities and misconduct as a
matter of concern for the welfare of the Bioton Capital Group and its employees, and to define methods for the protection of
whistleblowers.
This Procedure applies to breaches of the law committed by employees or other persons linked to Bioton S.A. by a contractual
relationship of a similar nature, within the scope of the activities of Bioton S.A. and the entities of the Bioton S.A. Capital Group.
In 2025, two reports were received under the above Procedure, in connection with which appropriate investigations were
conducted; these found no breaches of any laws, internal rules, regulations or requirements applicable within the companies
of the Bioton S.A. Capital Group, nor of the principles of social coexistence.
5.4. Policies and indicators relating to social issues
Bioton S.A. and the Group strive to maintain effective communication with the public, including local communities. The priority
in social activities is, above all, education and raising awareness regarding diabetes and a healthy lifestyle. As this is an ongoing
process, Bioton S.A. makes every effort to ensure that the quality of its activities is systematically improved, thereby
guaranteeing their relevance and appropriateness in relation to the external environment.
Our primary aim is to ensure the safety of people with diabetes. Regardless of the difficulties, we are fully fulfilling our
responsibility by ensuring a secure supply of diabetes medicines – particularly insulin – to the Polish market. Furthermore,
out of concern for the health of people with diabetes, in a situation where access to education in outpatient clinics was
restricted – a situation that was clearly evident during the pandemic – we are continuing to offer the ‘Ask a Specialist’
platform, through which every patient could benefit from education provided by a diabetes nurse and safely obtain
professional support. Patients had access to educational advice from a nurse via telephone or email. In 2025, we supported
doctors and nurses in continuously enhancing their knowledge on diabetes-related topics by organising scientific meetings
and email-based education, as well as by supporting scientific societies, such as the Polish Diabetes Association, in their
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 75
statutory activities, e.g. organising conferences, including online events. For 19 years, Bioton S.A. has supported the activities
of the Polish Federation for Diabetes Education. In 2024, we supported the organisation of the 18th National Conference of
the PFED. The conference was held under the slogan “Strength and Weakness in Diabetes – STOP Complications”.
In addition, in 2025, we donated human insulin medicinal products to hospitals and provided free of charge the syringes
necessary for insulin administration, along with educational materials for patients with diabetes.
As part of its local community development programme, Bioton S.A. addresses the needs and expectations of patients. In
areas where patients have limited access to specialists, we organised Diabetes Consultation Points in 2025, where patients
had the opportunity to receive free specialist consultations conducted by diabetes specialists. As part of the celebrations
for World Diabetes Day in 2025, under the slogan “Learn more and do more for diabetes in the workplace”, and recognising
the importance of preventive measures and health education, we undertook initiatives to enhance the knowledge of Bioton
Capital Group employees. As part of our educational activities, we emphasised the importance of understanding metabolic
control and the impact of lifestyle and diet on blood glucose levels. Participants had the opportunity to see for themselves
the crucial role played by physical activity, stress, sleep, and the quantity and quality of meals in maintaining good health. In
addition, educational lectures and activities promoting healthy behaviours among employees were organised throughout the
year. Bioton S.A. also actively supports initiatives aimed at promoting physical activity among people with diabetes and those
at risk of the disease, as exemplified by our participation in the 7th Polish MTB Championships for Cyclists with Diabetes.
Diabetes poses a challenge to the entire healthcare system. In half of patients, diabetes remains undiagnosed. The other half,
with newly diagnosed diabetes, show signs of late complications. Together with the Polish Federation for Diabetes Education,
we continued to make the FINDRISC (Finnish Diabetes Risk Score) questionnaire available to the public in 2025, which allows
people to assess their risk of developing type 2 diabetes.
The standards and principles governing the development of commercial relationships with clients and the conduct of
promotional and educational activities, for which BMA is responsible, have been set out in a series of documents, in particular
in Bioton’s Good Marketing Practices Policy. In 2019, the process of digitising the Policy within the PDPM Electronic Document
Circulation (EOD) system was initiated. These activities continued in 2025 as well. Electronic document circulation leads to
even greater efficiency for BMA in the context of meetings and promotional and educational activities with representatives
of healthcare entities, those trading in medicinal products, medical devices, foods for special medical purposes and dietary
supplements in accordance with medical and pharmaceutical law, as well as health education aimed at patients.
Quality management and product responsibility
The cornerstone and, at the same time, the key value of the operations of Bioton S.A. and the Capital Group is the utmost care
for patient safety through the manufacture of medicinal products of the highest quality. As a Group, we feel a sense of
responsibility and attach great importance to ensuring that the medicinal products manufactured by Bioton S.A. are safe,
effective and durable.
Within the organisational structure of Bioton S.A. (the company responsible for production), there is a Quality and Registration
Department comprising approximately 70 qualified and trained staff, responsible for the operation of the implemented quality
system (in accordance with legal requirements) and for conducting tests and quality assessments of the finished products.
Each of the manufactured medicinal products meets the stringent requirements set out in the quality specification and the
marketing authorisation. The manufacture of medicinal products and active substances takes place in accordance with the
requirements of the marketing authorisation and in compliance with Good Manufacturing Practice standards. Compliance
with these requirements is confirmed by continuously maintained Good Manufacturing Practice (GMP) certificates, issued by
the Chief Pharmaceutical Inspector (GIF) on the basis of inspections carried out. The certification covers the implemented
Quality Management System, the production facilities manufacturing the active substance (recombinant human insulin) and
medicinal products, as well as quality control and the warehouses where they are stored. Compliance with Good
Manufacturing Practice requirements has also been confirmed by agencies in other countries.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 76
For medical devices, Bioton S.A. has an implemented and certified quality management system compliant with ISO 13485:2016.
The medical devices bear the CE marking issued by the notified body TÜV Rheinland. In accordance with the applicable
transitional provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, the
validity of the CE certificate has been confirmed by the notified body through the issuance of a relevant confirmation letter.
The certification is subject to annual surveillance audits.
For medicinal products and active substances, the quality management process is implemented through a formally
established set of policies and procedures, supply chain management, and supervision of individual manufacturing stages
and products. This also applies to the analysis of deviations from defined procedures and specifications. The effectiveness
and efficiency of the quality management system are regularly assessed (once a month). To this end, key quality indicators
have been developed which, through continuous assessment and ongoing supervision of the implementation of quality sub-
processes (including the evaluation of progress towards set objectives), or the introduction of improvements, result in a
steady increase in the effectiveness of the implemented quality system.
With a view to ensuring the quality and safety of the medicinal products and medical devices manufactured, the Site Master
File (SMF) and the Quality Manual have been drawn up; their purpose is to present the current state of the organisation and
its operations, and to demonstrate its ability to meet customer needs and legal requirements. The Quality Manual
comprehensively covers the quality management system for the entire medical device manufacturing process (the so-called
core processes), i.e. from the design stage, through product manufacture, to the storage stage. The Main Site Documentation
describes the implemented Quality Management System within the scope of activities covered by the manufacturing
authorisation, including manufacturing processes from the procurement of materials, through production, control activities,
product certification and storage. Each of these stages is regulated by additional detailed procedures and instructions.
Internal audits are conducted to assess the ongoing compliance of processes with requirements and the effectiveness of the
quality management system. Internal audits are planned on an annual basis, based on a risk analysis carried out in accordance
with established internal regulations. In 2025, 16 such audits were carried out. They focused primarily on areas such as:
• Production Plants;
• Quality and Registration Department;
• Technical Department;
• Supply Chain Operations and Warehousing Department; and Warehousing.
As a result, all non-conformities are identified on an ongoing basis and subject to corrective action.
Quality control in the supply chain and environmental sustainability
BIOTON S.A. and the Group also ensure that suppliers and business partners operate in accordance with best practices in
social responsibility. The supply chain built in this way takes social issues into account whilst minimising negative
environmental impact. Even at the supplier selection stage, a detailed verification is carried out using questionnaires
(depending on the type of cooperation or service), which contain a detailed list of issues subject to assessment. The aspects
checked include, amongst others:
• training for employees, including training on hygiene and protective clothing;
• approach to quality management (including quality control);
• product origin;
• the supplier qualification procedure.
Analysis of a dedicated questionnaire, together with verification of certificates attesting to the implementation of a quality
management system (e.g. ISO 9001, ISO 15378, HACCP, ISO 22000, ISO 13485, GMP), forms the framework for the initial
assessment process of a potential new supplier.
Verification of the quality management system implemented by suppliers is carried out not only during the initial assessment
of a new supplier, but also as part of periodic assessments and during audits. These audits are planned on an annual basis,
based on a risk analysis conducted in accordance with established internal regulations. The main criterion for selecting areas
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 77
to be audited is the assessment of potential risks. Audits are conducted by qualified internal auditors, and any findings are
presented in an audit report.
Audits cover suppliers of raw materials and packaging, service providers, as well as contract manufacturers with whom Bioton
S.A. has entered into agreements for the manufacture of medicinal products and medical devices. In 2025, 7 audits were
carried out at suppliers of materials and services and 2 audits at contract manufacturers. Non-conformities identified during
the audits were addressed in a corrective action plan.
In line with the strategy of sustainable development in the supply chain, a significant proportion of expenditure on services
and products is incurred with local suppliers. The Group’s liabilities to domestic suppliers account for 70% of all liabilities to
suppliers.
Percentage of expenditure on local suppliers in the main locations where the BIOTON Group operates
BIOTON S.A.
BMA Sp. z o.o.
BIOTON Group
Location of operations:
2025
2024
2025
2024
2025
2024
Poland
72.90%
67.70%
100.00%
100.00%
73.90%
70.00%
Bioton S.A. and the Group understand that working with local suppliers is a key factor in supporting the local economy and
maintaining good relations with the local community.
Concern for the quality and safety of the products offered is of key importance to the organisation; therefore, the Group has
a range of documents setting out the principles and standards regarding the safety and labelling of manufactured medicinal
products. A safety feature has been introduced for medicinal products to enable verification of the product’s authenticity.
This brings the organisation into line with the requirements of Directive 2011/62/EU of the European Parliament and of the
Council on the prevention of the entry of falsified medicinal products into the legal supply chain. Through the implemented
quality management system, the organisation ensures that products are safe and perform their intended function to a
satisfactory degree. During the manufacturing process, all relevant product categories are assessed for their impact on
patient health and safety. Products are labelled accurately and contain information relating to sustainability issues.
In 2024, as in previous years, no cases of non-compliance with regulations concerning the impact of products on health and
safety were recorded at Bioton S.A. and the Group. Nor were any cases of non-compliance with regulations concerning
product information and labelling recorded.
The required procedures and applicable legal regulations ensure that products are labelled correctly.
The type of information on products and services required under the procedures and the percentage of significant
product and service categories subject to such requirements
YES
NO
Origin of product or service components
ü*
Composition, particularly in the case of substances that may have an impact on the
environment or society
ü
Safety of use of the product or service
ü
Method of product disposal and impact on the environment / society
ü
Percentage of significant product and service categories subject to such requirements
100%
*In the case of contract suppliers, the origin of components is assessed during product registration and at the time of post-registration
changes. In such cases, the product packaging includes information on who the supplier is.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 78
A constant feature of the activities of the companies forming part of the Bioton S.A. Group in this area is the regular conduct
of customer satisfaction surveys, which provide feedback on the products. The results of these surveys are of key importance
for the organisation’s long-term success. In 2024, such a survey was conducted for the GensuPen 2 medical device.
Number of questionnaires submitted by representatives: 254.
The assessment of the injector’s individual features showed that: in 48 cases (19% of respondents), the product met the
customer’s requirements 100%. In 176 cases (69% of respondents), the requirements were met to between 90% and 100%. In
216 cases (85% of respondents), the requirements were met to between 80% and 100%. In 26 cases (10% of respondents),
the requirements were met to between 70% and 80%. Only 12 respondents (5%) assessed that the product met their
expectations to less than 70%.
26% of respondents indicated that they had noticed features distinguishing the product from others on the market, 44% of
respondents replied that they had not noticed any distinguishing features, whilst the remaining respondents (30% of
respondents) did not express an opinion – they answered “I don’t know/I have no opinion”.
In an open-ended question, respondents highlighted the following distinguishing features of the GensuPen 2 medical device:
automation, insulin delivery via a slider on the side of the injector, a green dot indicating that the full dose of insulin has been
administered, and ease of use.
The majority of respondents (242 people, 95% of respondents) replied that the GensuPen 2 is easy and convenient to use,
with 72% of respondents stating that the GensuPen 2 is very easy to use, followed by 23% who said it is moderately easy to
use. Only ten people (4%) said that GensuPen2 is not easy and convenient to use.
The Bioton Group is undertaking a range of measures aimed at reducing energy consumption, including:
• upgrading building management systems (BMS) – a phased process aimed at optimising the operation of the
integrated heating, ventilation and air conditioning system, ensuring thermal comfort, adequate air quality and
energy efficiency in buildings, with a particular focus on optimising air humidification and dehumidification
processes
• replacement of indoor lighting with LED sources to save energy – the next stage
• reducing water consumption for the production of clean media through changes in production technology
• closing cooling and heating circuits to recover energy and energy carriers
• improving the control of continuously operating energy-consuming equipment so that it operates only when
necessary
• thermal modernisation of installations – a phased project aimed at improving energy efficiency by minimising heat
loss
• investments in equipment and installations to improve energy efficiency, including the use of a more efficient
control algorithm for chilled water generators
• projects carried out jointly with suppliers and service providers, aimed at reducing the carbon footprint.
The Bioton Group promotes cooperation with suppliers of raw materials, packaging and service providers who are actively
involved in environmental protection and have appropriate procedures and sustainable development strategies in place.
In 2025, numerous initiatives supporting the concept of sustainable development were implemented, such as planting trees
and shrubs in the green areas of the production facilities in Macierzysz, reducing the quantity and weight of packaging, using
recycled materials, and optimising logistics operations to reduce the carbon footprint.
Projects have also been planned for the coming years, enabling the Bioton Group to contribute to the reduction of energy
consumption and greenhouse gas emissions, as well as other measures to combat climate change.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 79
5.5. Policies and indicators relating to environmental issues
Bioton S.A., as the main production company, has the greatest potential to impact the environment. However, as all Polish
companies use shared facilities and premises, the data presented below regarding energy, water, materials and raw materials
consumption, waste generated, wastewater and emissions relate to the Group’s operations at the Macierzysz site.
Bioton S.A. manufactures, among other things, modern insulin preparations from recombinant human insulin and insulin
analogues, whilst ensuring the highest level of environmental protection, which is a priority for the Company’s operations.
Through continuous investment in production technologies, improving the quality of management systems and raising
employees’ environmental awareness, the Company is able to reduce its negative environmental impact. The technologies
being developed for new medicines incorporate the necessary elements to improve environmental performance. The
implementation of human insulin analogue production eliminates the use of raw materials whose process residues previously
required disposal.
Bioton S.A. and the Capital Group operate an Environmental Policy which defines the framework of the environmental
management system and sets out objectives and key tasks in the area of environmental protection. These objectives include,
amongst others:
• managing the rational use of water and electricity through regular measurements and the introduction of innovative
solutions in the production process;
• reducing the amount of waste generated by preventing its creation, sorting it and handing it over to companies with
the appropriate authorisations;
• raising employee awareness through the provision of information on environmental protection and regular training;
• promoting pro-environmental behaviour among subcontractors.
This is a policy common to the Group’s key companies, i.e. the Polish companies. Due to the different nature of their
operations, as well as a different legal environment, the other subsidiaries are not covered by this policy.
The environmental policy is communicated to all employees during induction training and during any initiatives aimed at
motivating employees to adopt environmentally friendly behaviour.
Environmental Protection Specialists are responsible for monitoring environmental protection tasks. In consultation with the
Management Board of Bioton S.A., these specialists identify and comply with all legal requirements relating to environmental
protection on an ongoing basis. The effectiveness of our environmental protection measures is confirmed by the results of
an energy audit conducted by the Riktning Group in the second half of 2025. The next energy audit is scheduled for 2030.
In 2025, Bioton S.A. implemented several innovative ideas bringing tangible environmental benefits and financial gains for the
Company itself:
• The process of updating the building management systems (BMS) has begun – the process will be carried out in
stages and is intended to optimise the operation of the integrated heating, ventilation and air-conditioning system,
which ensures thermal comfort, adequate air quality and energy efficiency in the buildings,
• Two chillers have been replaced with energy-efficient models containing a refrigerant with a low GWP, making them
more environmentally friendly,
• 60 m² of shrubs were planted on the plant premises.
Over half of the paper packaging used by the Company and placed on the market in 2025 was produced from renewable raw
materials. At the same time, 97% of waste was sent for recycling during the same period.
Changes in the volume of energy consumed, shifting from non-renewable to renewable sources, demonstrate the efforts
undertaken by Bioton S.A. and the Group to minimise its environmental impact.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 80
Energy consumption within the organisation (in kWh)
2024
2025
Change
%
Energy consumption from non-renewable sources (hard coal, lignite, natural
gas)
9,787,897
9,303,173
0.05
Consumption of energy from renewable sources (biomass, hydroelectric
power, wind power, solar energy)
3,997,873
5,535,127*
1.38
Total energy consumption
13,785,770
14,838,300
1.07
* - photovoltaic installation owned by Bioton S.A. 1,735,240 kWh
Total water consumption by source is as follows:
Water consumption by source (in m
³
)
2024
2025
Surface water, including water from wetlands, rivers, lakes and oceans
Groundwater
106,843
110,427
Rainwater collected and stored directly by the organisation
Wastewater from another organisation
Municipal water supplies and supplies from other water companies
Total water abstraction (in m
³
)
106,843
110,427
The organisation does not generate greenhouse gases during production processes; carbon dioxide emissions result from
heat generation.
Greenhouse gas emission intensity
2024
2025
Metric tonnes of CO2 produced
17,875
18,830
Metric tonnes of CO2 produced per unit of sales revenue
0.00006
0.00006
*Net sales revenue from continuing operations of Bioton S.A. (as the main production unit).
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 81
Only volatile organic compounds (VOCs) are emitted as part of operations.
Emissions of nitrogen oxides, sulphur oxides and other significant emissions to air (in kg)*
2024
2025
Nitrogen oxides
Sulphur oxides
Persistent organic pollutants (POPs)
Volatile organic compounds (VOCs)
2705
3538
Hazardous air pollutants (HAP)
Particulate matter (PM)
Other standard categories of air emissions identified in the applicable regulations
Total emissions (in kg)
2705
3538
*The data was compiled on the basis of our own estimates, carried out as part of the ‘VOC Inventory’.
The increase in emissions of volatile organic compounds into the air is directly linked to higher production in the year under
review.
The discharge water is directed to a treated wastewater receiving point located in the Ożarowski Canal.
Total volume of wastewater (in m
³
)
2024
2025
Volume of treated wastewater discharged into the Ożarowski Canal (in m³)
109,928
109,591
The organisation makes every effort to ensure that waste generated by production has as little impact on the environment
as possible. Consequently, waste collection is carried out by authorised companies, and the methods used are the least
invasive:
Total weight of waste by type of waste and waste management method (in Mg)
2024
2025
hazardous
non-hazardous
hazardous
non-
hazardous
Reuse
Recycling
Composting
Recovery, including energy recovery
1856
124
2521
116
Incineration (mass incineration)
Injection into deep wells
Disposal at landfill sites
On-site storage
Disposal
33
14
33
7
Total weight of waste (in Mg)
1889
138
2553
123
Total weight of waste (in Mg)
2,027
2,676
The increase in the volume of waste generated is linked to higher production.
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 82
It is also worth noting that in 2025, no spills of chemicals, diesel, petrol or liquid waste were recorded. During this period, no
formal complaints regarding environmental impact were recorded. The authorities responsible for environmental monitoring
did not impose any administrative penalties in 2025.
Total expenditure on environmental protection and investments:
Costs of waste treatment and disposal, emission control and remedial measures (in PLN thousand)
2024
2025
Disposal Services
734
865
Emissions control
-
-
Expenditure on the purchase and use of emission allowances
-
-
Environmental liability insurance
Yes
Yes
Total costs (in PLN thousand)
734
865
Bioton S.A. and the Capital Group also incurred costs in 2025 related to damage prevention and environmental management,
the total value of which amounted to approximately PLN 50,000. The most significant components include: research and
development (PLN 30,000), additional expenditure on environmental protection-related purchases (PLN 15,000), external
services related to environmental protection management (PLN 24,000) and other environmental protection management
costs (PLN 5,000). The Group makes use of free environmental training courses organised by central and local government.
5.6. List of indicators
This statement contains performance indicators relating to the following areas: labour, respect for human rights, anti-
corruption, social issues and the environment. The selected indicators have been prepared using the Global Reporting
Initiative (GRI Standards) guidelines for sustainability reporting. The list of indicators, together with references to the relevant
Standard, is provided below.
Indicator name
Indicator
number
according to
GRI Standards
Name of GRI Standard
Chapter 2. Description of the entity’s business model
Scale of the organisation
2–6
GRI 2: General Disclosures 2021
Financial assistance received from the state
201-4
GRI 201: Economic Performance
2016
Economic value generated
201-1
GRI 201: Economic Performance
2016
Section 5.1. Policies and indicators relating to labour issues
Number of employees by type of employment contract and by gender, and by type
of employment and by gender
2-7 (a, b)
GRI 2: General Disclosures 2021
Total number and rates of new hires and employee turnover by age group and
gender
401-1
GRI 401: Employment 2016
Benefits provided to full-time employees that are not available to temporary or
part-time employees
401-2
GRI 401: Employment 2016
Number of workplace accidents, including fatalities, occupational illnesses and days
lost due to illness among employees
403-9
GRI 403: Occupational Health and
Safety 2018
Number of workplace accidents, including fatal accidents, occupational illnesses
and days lost due to incapacity for work among subcontractor employees working
on the premises
403-9
GRI 403: Occupational Health and
Safety 2018
Number of substantiated complaints regarding breaches of customer privacy and
loss of customer data (none)
418-1
GRI 418: Customer Privacy 2016
Section 5.2. Policies and indicators relating to respect for human rights
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 83
Indicator name
Indicator
number
according to
GRI Standards
Name of GRI Standard
Total number of hours of employee training on human rights policies or procedures
that address human rights aspects relevant to the organisation’s operations,
including the percentage of employees trained.
N/A
N/A
Total number of cases of discrimination (discriminatory incidents) and corrective
actions taken (none)
406-1
GRI 406: Non-discrimination 2016
Section 5.3. Policies and indicators relating to anti-corruption issues
Confirmed cases of corruption and actions taken (none)
205-3
GRI 205: Anti-corruption 2016
Total number of legal actions taken against the organisation regarding violations of
fair competition rules and monopolistic practices, and their outcomes (none)
206-1
GRI 206: Anti-competitive
Behaviour 2016
Amount of significant fines and total number of non-financial sanctions for non-
compliance with laws and regulations (none)
2-27
GRI 2: General Disclosures 2021
Section 5.4. Policies and indicators relating to social issues.
Percentage of significant product and service categories for which health and
safety impacts are assessed
416-1
GRI 416: Customer Health and
Safety 2016
Total number of incidents of non-compliance with regulations and voluntary codes
concerning the impact of products and services on health and safety (none)
416-2
GRI 416: Customer Health and
Safety 2016
Type of product and service information required by the organisation’s procedures
and the percentage of significant product and service categories subject to such
requirements
417-1
GRI 417: Marketing and Labelling
2016
Total number of incidents of non-compliance with regulations and voluntary codes
concerning product and service information and labelling, by type of outcome
417-2
GRI 417: Marketing and Labelling
2016
Percentage of expenditure on local suppliers at major locations of operation.
204-1
GRI 204: Procurement Practices
2016
Section 5.5. Policies and indicators relating to environmental issues.
Total energy consumption from non-renewable and renewable sources
302-1 (a, b)
GRI 302: Energy 2016
Total water withdrawal by source
303-3
GRI 303: Water and Effluents 2018
Greenhouse gas emissions intensity
305-4 (a, b)
GRI 305: Emissions 2016
Emissions of nitrogen oxides, sulphur oxides and other significant emissions to air.
305-7 (a)
GRI 305: Emissions 2016
Total volume of wastewater by quality and final destination.
303-4
GRI 303: Water and Effluents 2018
Total weight of waste by waste type and disposal method
306-3 (a, b)
GRI 306: Waste 2020
Total number and volume of significant spills (none)
N/A
N/A
Costs of waste treatment and disposal, emission abatement and remediation
N/A
N/A
Consolidated Annual Report of the BIOTON S.A. Group
for the period 1 January 2025 to 31 December 2025
Page | 84
IX. Statement by the Management Board of
The Management Board of Bioton S.A. hereby declares that, between the balance sheet date and the date of publication of
this consolidated “extended” annual report, no events other than those mentioned above have occurred that would have a
material impact on the consolidated financial statements.
Signatures of all Members of the Management Board
First name and surname
Position
Signature
Jeremy Launders
Chairman of the
Management Board
Romuald Harwas
Member of the Management
Board
Warsaw, 29 April 2026