Other information to the quarterly report of Mabion S.A. for Q3 2024
Other information
to the quarterly report of Mabion S.A.
for Q3 2024
Date of preparation: 28 October 2024
Publication date: 29 October 2024
Konstantynów Łódzki
Other information to the quarterly report of Mabion S.A. for Q3 2024
Contents
1 | SELECTED FINANCIAL DATA | 1 |
2 | INFORMATION ON MABION S.A. | 2 |
2.1 | Introduction | 2 |
2.2 | Bodies of the Company | 2 |
2.2.1 | Management Board | 2 |
2.2.2 | Supervisory Board | 3 |
2.3 | Share capital structure | 3 |
2.4 | Shareholding structure | 4 |
2.5 | Number of shares held by managing and supervising persons | 4 |
2.6 | Information on the capital group | 4 |
3 | MABION S.A.'S OPERATIONS IN Q3 2024 | 5 |
3.1 | Object of activity | 5 |
3.2 | Description of significant achievements and failures of the Company in Q3 2024 | 5 |
3.3 Description of factors and events, including of unusual nature, having a significant impact
on the condensed financial statements | 7 | |
3.4 | Transactions with related parties | 7 |
3.5 | Sureties and guarantees granted | 7 |
3.6 Proceedings pending before a court, an authority competent to conduct arbitration proceedings,
or a public administration body | 7 | |
3.7 | Opinion of the Management Board on the feasibility of previously published performance forecasts | 7 |
3.8 | Events after the balance-sheet date | 7 |
3.9 | Factors to affect the results to be achieved within at least the next quarter | 7 |
4 | OTHER INFORMATION RELEVANT TO THE ASSESSMENT OF THE COMPANY'S CONDITION | 9 |
5 | CONTACT DETAILS | 10 |
Other information to the quarterly report of Mabion S.A. for Q3 2024
1 | SELECTED FINANCIAL DATA | ||||
in PLN thousand | in EUR thousand | ||||
SELECTED FINANCIAL DATA | |||||
from 01.01.2024 | from 01.01.2023 | from 01.01.2024 | from 01.01.2023 | ||
to 30.09.2024 | to 30.09.2023 | to 30.09.2024 | to 30.09.2023 | ||
Net income from sales of products, commodities, and materials | 64,269 | 105,153 | 14,939 | 22,973 | |
Operating profit (loss) | 9,024 | 46,367 | 2,098 | 10,130 | |
Net profit (loss) | 11,539 | 42,569 | 2,682 | 9,300 | |
Net profit (loss) | 11,539 | 42,569 | 2,682 | 9,300 | |
Net cash flows from operating activities | 48,114 | (873) | 11,184 | (191) | |
Net cash flows from investing activities | (12,276) | (18,942) | (2,853) | (4,138) | |
Net cash flows from financing activities | (36,609) | 49,695 | (8,509) | 10,857 | |
Total net cash flows | (770) | 29,880 | (179) | 6,528 | |
30.09.2024 | 31.12.2023 | 30.09.2024 | 31.12.2023 | ||
Total assets | 179,343 | 230,440 | 41,911 | 49,711 | |
Liabilities and provisions for liabilities | 50,027 | 111,364 | 11,691 | 24,024 | |
Long-term liabilities | 9,154 | 34,961 | 2,139 | 7,542 | |
Current liabilities | 40,873 | 76,403 | 9,552 | 16,482 | |
Equity | 129,316 | 119,076 | 30,220 | 25,687 | |
Share capital | 1,616 | 1,616 | 378 | 349 | |
Number of shares (in pcs) | 16,162,326 | 16,162,326 | 16,162,326 | 16,162,326 | |
Profit (loss) per ordinary share (in PLN/EUR) | 11.10 | 14.26 | 2.59 | 3.08 | |
Selected balance-sheet items presented in EUR have been translated according to the average EUR exchange rate announced by the National Bank of Poland on 30 September 2024 (4.2791 PLN/EUR) and 31 December 2023 (4.3480 PLN/EUR). Selected items of the income statement and cash flow statement have been converted into EUR at the exchange rate announced
by the National Bank of Poland and being the arithmetic average of the average exchange rates for the euro effective as at the last day of each ended month in the period of nine months ended 30 September 2024 and the period of nine months ended
30 September 2023 (respectively: 4.3022 PLN/EUR and
4.5773 PLN/EUR).
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Other information to the quarterly report of Mabion S.A. for Q3 2024
2 INFORMATION ON MABION S.A.
2.1 Introduction
Mabion S.A. (hereinafter: "Mabion" or "Company") was established on 30 May 2007 as a limited liability company with its registered office in Kutno. The legal form of the Company changed on 29 October 2009 as a result of the transformation into a joint-stock company. Currently, Mabion S.A. is entered on the Register of Entrepreneurs of the National Court Register kept by the District Court for Łódź Śródmieście in Łódź, 20th Commercial Department of the National Court Register under KRS number 0000340462. The Company was assigned tax identification number NIP 7752561383 and statistical identification number REGON 100343056.
The Company's registered office is located at ul. gen. Mariana Langiewicza 60 in Konstantynów Łódzki.
Mabion is a Polish biopharmaceutical company that provides contract services for the development, analysis, and manufacture of biological medicines (Contract Development and Manufacturing Organization, CDMO).
On 18 April 2023, the Management Board of Mabion S.A adopted the Company's Strategy for 2023-2027("2023-2027 Strategy"). In line with its strategy, the Company's Management Board intends to continue the Company's development towards a fully CDMO with a biological profile. As a target, the Company will provide the full range of services typical of an integrated CDMO to clients who need support at various stages of their product development and commercialisation (from early-stage projects to commercial-scale manufacturing).
Since 2010, shares of the Company have been listed on the Warsaw Stock Exchange.
2.2 Bodies of the Company
On 3 October 2024, Mr. Sławomir Jaros tendered his resignation from the Management Board of the Company, effective as of that date. The Company informed about the event in Current Report no. 15/2024 of 3 October 2024. As at the date of submitting this report, the composition of the Company's Management Board is as follows:
- Mr. Krzysztof Kaczmarczyk - President of the Management Board,
- Ms. Julita Balcerek - Member of the Management Board,
- Mr. Grzegorz Grabowicz - Member of the Management Board,
- Mr. Adam Pietruszkiewicz - Member of the Management Board.
Due to a change in the composition of the Management Board, the scope of responsibilities and tasks entrusted to the different Members of the Company's Management Board also changed.
The current distribution of key areas, tasks and responsibilities within the Company at the Management Board level is as follows:
- Krzysztof Kaczmarczyk - President of the Management Board, Chief Executive, CEO. Directs the work of the Management Board. The main duties of the President of the Management Board include the implementation of the Company's business strategy and investment policy and the acquisition of strategic partners. The President of the Management Board is also responsible for the regulatory area, quality management, HR, legal, administration, investor relations and ESG area, and for overseeing the proper performance of the Company's business, operating, and financial activities,
2.2.1 Management Board
As at 30 September 2024, the composition of the Company's Management Board was as follows:
- Mr. Krzysztof Kaczmarczyk - President of the Management Board,
- Ms. Julita Balcerek - Member of the Management Board,
- Mr. Grzegorz Grabowicz - Member of the Management Board,
- Mr. Sławomir Jaros - Member of the Management Board,
- Mr. Adam Pietruszkiewicz - Member of the Management Board.
- Julita Balcerek - Member of the Management Board, Chief Operating Officer. Responsible for managing, overseeing and integrating the Company's operational areas in the scope of development, manufacturing, quality control, investment, and operation maintenance and qualification activities. She is responsible for developing and implementing new process technologies and analytics to characterise biological products and processes. She also oversees the warehousing and transport procurement processes and the activities of the area responsible for project management,
- Grzegorz Grabowicz - Member of the Management Board, CFO. Responsible for managing the Company's financial policy. He is responsible for acquiring funds, management reporting - including developing the Company's financial plans, and for accounting and financial reporting. In addition, he is responsible for the IT area, including the development and implementation of new technologies and IT solutions to support the Company's development,
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Other information to the quarterly report of Mabion S.A. for Q3 2024
- Adam Pietruszkiewicz - Member of the Management Board, Head of Business Development, CCO. Responsible for the Company's business development, for acquiring new clients, building new industrial relations and Mabion's brand on the CDMO market, and leading selected strategic projects related to the Company's international expansion.
2.2.2 Supervisory Board
As at 30 September 2024 and as the date of submitting this report, the composition of the Company's Supervisory Board is as follows:
- Robert Koński - Chairman of the Supervisory Board, Independent Member,
- Józef Banach - Deputy Chairman of the Supervisory Board, (Independent Member),
- Mateusz Rosa-Gawałkiewicz - Independent Member of the Supervisory Board,
- Mr. Przemysław Mencel - Independent Member of the Supervisory Board,
- Wojciech Wośko - Member of the Supervisory Board.
In Q3 2024 and until the date of this report, there were no changes in the composition of the Company's Supervisory Board.
2.3 Share capital structure
As at 30 September 2024 and as of the date of submitting this report, the Company's share capital amounts to PLN 1,616,232.60 and is divided into 16,162,326 shares with a nominal value of PLN 0.10 each, including:
Table 1. | Share capital structure | ||||
Number of shares | Type of shares | Kinds of shares | Series | ||
450,000 | registered | preference | A | ||
450,000 | registered | preference | B | ||
450,000 | registered | preference | C | ||
450,000 | ordinary | ordinary | D | ||
100,000 | registered | preference | E | ||
100,000 | registered | preference | F | ||
20,000 | registered | preference | G | ||
2,980,000 | ordinary | ordinary | H | ||
1,900,000 | ordinary | ordinary | I | ||
2,600,000 | ordinary | ordinary | J | ||
790,000 | ordinary | ordinary | K | ||
510,000 | ordinary | ordinary | L | ||
360,000 | ordinary | ordinary | M | ||
340,000 | ordinary | ordinary | N | ||
300,000 | ordinary | ordinary | O | ||
1,920,772 | ordinary | ordinary | P | ||
11,000 | ordinary | ordinary | S | ||
2,430,554 | ordinary | ordinary | U | ||
Registered shares of A, B, C, E, F and G series are privileged in such a way that each of them entitles to two votes at the General Meeting.
The total number of votes resulting from all issued shares of the Company is 17,732,326 votes.
In Q3 2024 and until the date of submitting this report, there were no changes to the Company's share capital.
On 15 July 2024, the Company's Ordinary General Meeting adopted a resolution on issuing, for the purpose of the Incentive Scheme, from 1 to 1,010,145 C series registered subscription
warrants with the exclusion of the pre-emptive right of the existing shareholders, entitling to take up V series shares, and on the conditional increase of the Company's share capital by an amount not exceeding PLN 101,014.50 by way of an issue of up to 1,010,145 V series ordinary bearer shares with a nominal value of PLN 0.10 each, with the exclusion of the pre-emptive right of the existing shareholders, as well as on the related amendment to the Company's Articles of Association. The right to take up subscription warrants will be vested in the Management Board Members and certain other persons, as designated by the Company's Supervisory Board, upon fulfilment of the allotment criteria and on the terms and conditions set out in the Incentive Scheme Rules. Detailed information on the Incentive Scheme for
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Other information to the quarterly report of Mabion S.A. for Q3 2024
2025-2029 can be found in section 4 of this report. Pursuant to the resolution, subscription warrants are issued free of charge and each subscription warrant will entitle the holder to take up 1 share at an issue price equal to the nominal value of the share. The rights attached to the subscription warrants may be exercised until 15 July 2034. As at the date of this report, the resolution of the Company's General Meeting providing for a
conditional increase in the Company's share capital had not been registered with the National Court Register.
2.4 Shareholding structure
To the best knowledge of the Company's Management Board, as at the date of submission of this report, i.e. 29 October 2024, the following shareholders hold at least 5% voting rights in the total number of votes at the General Meeting of the Company:
Table 2. | Shareholding structure | |||||
No. | Shareholder | Number | Number | Participation in | Share in the total | |
of shares | of votes | the share capital | number of votes | |||
1. | Twiti Investments Limited | 2,674,617 | 3,268,917 | 16.55% | 18.43% | |
2. | Maciej Wieczorek through*: | 1,717,485 | 2,210,335 | 10.63% | 12.47% | |
Glatton Sp. z o.o. | 1,097,135 | 1,097,135 | 6.79% | 6.19% | ||
Celon Pharma S.A. | 620,350 | 1,113,200 | 3.84% | 6.28% | ||
3. | Polfarmex S.A. | 1,474,346 | 1,957,196 | 9.12% | 11.04% | |
4. | Other | 10,295,878 | 10,295,878 | 63.70% | 58.06% | |
Total | 16,162,326 | 17,732,326 | 100% | 100% | ||
- Mr Maciej Wieczorek holds 100% of the share capital of Glatton Sp. z o.o. and indirectly, through Glatton Sp. z o.o., 58.81% of the share capital of Celon Pharma S.A. and 68.17% of the total number of votes in Celon Pharma S.A. (based on information on the website: https://celonpharma.com/struktura-akcjonariatu/).
In the period from the date of submitting the previous interim report, i.e. the report for H1 2024 published on 10 September 2024, to the date of this report, there were no changes in the ownership structure of significant blocks of shares of the Issuer.
2.5 Number of shares held by managing and supervising persons
As at the date of submission of this report, i.e. 29 October 2024, Members of the Management Board of Mabion S.A hold the following quantities of the Company's shares:
Table 3. Number of shares held by managing and supervising persons
Krzysztof Kaczmarczyk
Management Board
holds directly 7,140 shares of the Company with a nominal value of PLN 0.10 each, constituting 0.04% of the Company's
Julita Balcerek
share capital and entitling to 0.04% of votes at the General Meeting.
holds directly 3.423 shares of the Company with a nominal value of PLN 0.10 each, constituting 0.02% of the Company's share capital and entitling to 0.02% of votes at the General Meeting.
Grzegorz Grabowicz
holds directly 700 shares of the Company with a nominal value of PLN 0.10 each, constituting 0.004% of the Company's share capital and entitling to 0.004% of votes at the General Meeting.
Adam Pietruszkiewicz
holds directly 10.000 shares of the Company with a nominal value of PLN 0.10 each, constituting 0.06% of the Company's share capital and entitling to 0.06% of votes at the General Meeting.
As at the date of submission of this report, i.e. 29 October 2024, Members of the Supervisory Board of Mabion. S.A. do not hold any shares in the Company.
Members of the Management Board and Supervisory Board of Mabion S.A. do not have any rights to Company's shares.
In the period from the date of the previous interim report, i.e. the interim report for H1 2024 published on 10 September 2024, to
the date of this report, there were no changes in the management and supervisory staff's holdings of shares and entitlements to shares in the Company.
2.6 Information on the capital group
Mabion S.A. has no subsidiaries and does not form a capital group.
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Other information to the quarterly report of Mabion S.A. for Q3 2024
- MABION S.A.'S OPERATIONS IN Q3 2024
3.1 Object of activity
Mabion is an integrated service-oriented biopharmaceutical company. Mabion has expertise in the development and manufacturing stages of protein-based therapeutic products, including process development, analytics, technology transfer, validation, manufacturing process scale-up, production of active substances for drugs and finished medicinal products. Mabion has long term experience in the area of mammalian cell cultures and, in particular, in the manufacture and characterisation of recombinant protein biopharmaceuticals, including monoclonal antibodies (mAbs), and vaccine antigens.
The Company's income from sales in Q3 2024 was mainly earned from a CDMO service project involving collaboration with Novavax, Inc. (hereinafter: Novavax). The Agreement with Novavax and the additional orders entered into thereunder were of critical importance to the Company in Q3 2024, both on the operational and financial level.
The cooperation with Novavax is based on the Manufacturing Agreement entered into in October 2021 for the contract manufacturing of an active substance, i.e. a vaccine antigen for COVID-19 branded as Nuvaxovid® (product), and on additional orders, including Statement of Work #1. In April 2023, the parties entered into an annex to Statement of Work No. 1, to extend the scope of the cooperation by including the manufacture of antigens being the active substance for the Omicron variant vaccines. The Manufacturing Agreement is in force until the end of 2026.
Until the end of May 2024, there was a so-called period of unconditional contractual obligation of the counterparty to recognise the performance, for which the parties agreed on the remuneration for the Company for the provision of services or, in the absence of a manufacturing order, remuneration for guaranteeing and making available the manufacturing capacity. Upon the end of this period, the Company continues to provide services to Novavax, receiving remuneration for the work its carries out, with the value of services provided in Q3 2024 being significantly lower compared to the value of remuneration received from Novavax until May 2024.
In Q3 2024, the Company provided analytical and logistics services to Novavax in accordance with Statement of Work ('SOWs') in place. In September 2024, Novavax expanded the scope of analytical work carried out by Mabion. As part of the additional scope of work, Mabion will carry out the transfer/validation/verification of the selected analytical methods using the current variants of the SARS-CoV2 rS protein and perform stability trials covering the storage and analytical tests at the appropriate time points of the trial. The order also includes regular analytics of the DS (drug substance) and DP (drug product) trials of Novavax under the GMP-compliant (Good Manufacturing Practice), as well as reference standard
qualification studies and routine MVS (Master Virus Seed) tests. The transfer work is scheduled for Q4 2024. The work related to routine analytics and stability studies is ongoing and is expected to commence in Q1 2025.
In addition, in September 2024, the Company commenced work for a pharmaceutical company from the UK developing immunotherapeutic products based on orders covering the transfer of the process, manufacturing (DS and DP), and release of the product for clinical purposes, and the transfer/development and validation of analytical methods together with the stability study (DS and DP), and also the packaging, labelling and storing the DP. In accordance with the agreed schedule, the work is expected to be completed in Q2 2025. For further information on the orders received by Mabion, please refer to section 3.2 below.
3.2 Description of significant achievements and failures of the Company in Q3 2024
Acquisition of orders from a new client from the UK
On 16 August 2024, the Company signed three orders with a pharmaceutical company based in the UK and developing immunotherapeutic products, for the Company to carry out specific work ("SOW"). The scope of work commissioned by the Client under the SOW includes:
- process transfer, DS manufacturing, and release of the product for clinical use,
- transfer/development/validation of analytical methods together with the stability study (DS and DP),
- manufacturing, packaging, labelling and storage of DPs.
The Company commenced work for the client in September 2024, with completion expected in Q2 2025. The value of the work commissioned under the SOWs is approximately PLN 5.5 million (USD-denominated payments). The payments will be made on a monthly interval over a period of 10 consecutive months. The value of the contracted work does not include the cost of raw materials and supplies, which are settled separately.
Subsequently, on 21 October 2024 (an event after the balance- sheet date), the Company signed with the client a master agreement for the provision of services ("Master Service Agreement") related to the development of the process and analytical methods, their transfer to the GMP environment, as well as manufacturing and quality control in the GMP environment, and other activities related to the development of the client's products. The subject matter of the Master Agreement is to define the general terms and conditions of cooperation between the parties and the rules of performance of
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Other information to the quarterly report of Mabion S.A. for Q3 2024
services by the Company for the client on the basis of orders submitted each time by the client ("Statements of Work", "SOWs"). The Company will execute individual orders in accordance with the scope, schedule, and cost of the work each time agreed by the parties in the SOW. The value of the contracted work will not include the cost of raw materials and supplies, which are to be settled separately. The Master Agreement does not stipulate a minimum value of orders that the client is obliged to place. The term of the Master Agreement is 5 years as of the date thereof, and if a SOW is executed with a term beyond this period, the Master Agreement will be extended until the completion of the SOW. The Master Agreement provides for standard provisions regarding the possibility of termination by the parties in the event of, for example, significant delays in the execution of orders or in the event of breaches of material terms and conditions of the Master Agreement.
In the Company's opinion, the first major orders received within the core panel of services offered by the Company as part of Mabion's new business as a CDMO represents a significant event in the Company's ongoing transformation process. The event is significant both because of the potential for the Company to also provide other services to the client in the future, as well as for building experience and a portfolio of customers on the biopharmaceutical market, which should have a positive impact on the Company's ability to secure further contracts.
The Company reported on the acquisition of orders from a new client in Current Report no. 13/2024 of 16 August 2024, and on the execution of the master agreement for the provision of services in Current Report no. 16/2024 of 21 October 2024.
Activities undertaken to enter into a project agreement as part of the FENG call - SMART Path.
On 24 September 2024, the Management Board of Mabion S.A. decided to start activities leading to the conclusion of a co- financing agreement for the project entitled "Development of an innovative technology for generating stable cell lines producing bispecific antibodies and other therapeutic proteins" ("Project"), as part of the call by the Polish Agency for Enterprise Development ("PARP"), Path SMART FENG.01.01-IP.02-002/23, Priority 1 "Support for Entrepreneurs", European Funds for Modern Economy ("Co-financing Agreement").
The aim of the Project is to develop an innovative technology to derive cell lines for the production of therapeutic bispecific antibodies in accordance with the GMP standard. The results of the Project work would be implemented in the form of services added to the Company's offer, which, in the Company's opinion, will be innovative on the Polish market and should result in income, and boost the Company's competitiveness in the CDMO (Contract Development and Manufacturing Organisation) services market.
The total cost of the Project was estimated by the Company in its application for funding at PLN 13.1 million. The amount of funding awarded is equal to that applied for and amounts to PLN 6.4 million. The completion date for the Project was assumed at the application stage to be December 2028.
As the application was submitted in June 2023, it will be reviewed for consistency with the Company's current offer and planned future activities over the indicated time horizon as part of the planned activities. The Company will report on further significant developments related to the co-financing in future reports.
The Company informed about the commencement of the activities leading to the conclusion of the co-financing agreement for the project in Current Report no. 14/2024 of 24 September 2024.
No other significant events in the Company's operations occurred in Q3 2024. The Company implemented the agreement for Novavax, Inc. in accordance with the adopted assumptions, and carried out activities to implement Mabion's Strategy for 2023-2027. The detailed objectives of the Strategy are set out in the annual report of the Company for 2023, published on 16 April 2024.
In Q3 2024, the Company carried out the following activities:
- commercial orders for partners in the field of contract manufacturing, analytics, and development, including:
- orders from Novavax,
- analytical work to confirm the safety and absence of endotoxins in the finished product, carried out for a EU company operating in the pharmaceutical industry,
- development of a technology park within the manufacturing zone:
- continuing the qualification and validation work of the sterile filling line in accordance with the assumptions, and extending its functionality by ordering an additional filling format to enable the work commissioned by the client from the UK, as well as increasing the Company's flexibility as a CDMO,
- developing platform solutions for recombinant protein generation and qualitative analysis processes to expand opportunities for and increase competitiveness of the Company's CDMO services,
- offering and commercial and technology-related discussions to build a portfolio of CDMO orders for the Company, including participation in three international trade fairs: the European Biomanufacturing Summit in Berlin, as an exhibitor (10-11 September 2024), BioProcess International in Boston (23-26 September 2024), and Contract Pharma in New Brunswick, NJ, as an exhibitor (26-27 September 2024),
- intensification of sales activities to acquire new contracts and continuation of the activities to position the Company as a fully integrated actor on the CDMO market, by expanding the Company's portfolio of competences and services,
- intensification of marketing activities to increase the brand recognition and knowledge of Mabion's portfolio of services, including webinars available on industry portals, LinkedIn promotion campaigns, and updating of the Company's website,
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Other information to the quarterly report of Mabion S.A. for Q3 2024
- implementation of computerised systems such as: eQMS Quality Management System) - an extension of the scope of application covering the supervision of quality processes such as deviation, change control, training, OOS (out-of- specification results) and CAPA (corrective and preventive actions) and the LIMS (Laboratory Information Management System) - streamlines the quality control processes, ensures compliance with the latest standards in terms of documentation collection, archiving, data integrity, and allows for an increased scope of preventive actions, which is appreciated by clients of CDMO companies,
- efforts to acquire a partner interested in concluding a licensing agreement for MabionCD201.
3.3 Description of factors and events, including of unusual nature, having a significant impact on the condensed financial statements
In Q3 2024, there were no factors or events, including those of an unusual nature, other than those indicated in the other sections of the report, which would have a significant impact on the Company's condensed financial statements.
3.9 Factors to affect the results to be achieved within at least the next quarter
The main factors to affect the Company's performance in the coming quarters are:
- possibilities to acquire new customers in the CDMO area, for manufacturing, development, and analytical work, and to expand cooperation with the existing customers other than Novavax to continue analytical work, and to expand the cooperation by including further services in the Mabion's portfolio,
- the lapse of the period of guaranteed benefits under the manufacturing agreement for Novavax and, no plans to renew them in the current year as at the date of publication of the report,
- execution of orders for a new client from the UK and the possibility of extending this cooperation with new orders,
- possibilities to raise finance to continue operations in the absence of services provided under new agreements with the current or new customers,
3.4 Transactions with related parties
In Q3 2024, the Company did not enter into transactions with related parties on terms other than arm's length.
- implementation of agreement concerning the analytics commissioned by Novavax, as well as execution of additional orders placed under the agreement, and payments from the contractor,
3.5 Sureties and guarantees granted
In Q3 2024, the Company did not provide any loan or borrowing sureties or guarantees in aggregate to any one entity or its subsidiary where the total value of the existing sureties or guarantees would be significant for the Company.
3.6 Proceedings pending before a court, an authority competent to conduct arbitration proceedings, or a public administration body
In Q3 2024, no material proceedings concerning the Company's liabilities or receivables were pending before any court, arbitration authority, or public administration authority.
3.7 Opinion of the Management Board on the feasibility of previously published performance forecasts
The Company has not published financial result forecasts for 2024.
3.8 Events after the balance-sheet date
No significant events after the balance-sheet date have occurred other than those described in sections 2.2.1 and 3.2 of this report.
- future possible changes in the terms and conditions of the agreement with Novavax,
- possibilities of obtaining additional funding to build another facility (Mabion II),
- a possibility of acquiring a licensee for MabionCD20 and an ability to produce this antibody for a business partner that will choose to launch MabionCD20 on the market under a licence acquired from Mabion, enabling thereby the Company to meet the result indicator under the NCBR grant,
- changes in remuneration costs and general administration costs of the Company,
- conceptual and preparatory work for the launch of construction of another production facility on the property owned by Mabion S.A., located in Konstantynów Łódzki,
- exchange differences resulting from changes in foreign currency exchange rates,
- inflation and interest rates affecting the level of generated costs.
- MabionCD20 monoclonal antibody - developed by the Company as a proposed biosimilar to the reference medicines MabThera/Rituxan® (Roche), whose efficacy and safety have been clinically demonstrated.
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Other information to the quarterly report of Mabion S.A. for Q3 2024
Factors associated with the situation in Ukraine
On 24 February 2022, Russia invaded Ukraine. At the time of submission of this report, the armed conflict in Ukraine, a country neighbouring Poland, is still continuing. The international community has imposed heavy sanctions on Russia, targeting specific entities and economic sectors. As at the date of this report, the sanctions and the armed conflict have not had a direct impact on the Company's business and therefore, having analysed the impact of the Russian invasion to date and its current and future possible effects for the Company, the Management Board is of the opinion that the invasion and its effects do not affect the measurement and classification of assets and liabilities in the financial statements as at 30 September 2024.
However, volatile exchange rates, interest rates, the potential for economic growth, the impact of higher immigration and the possibility of the proliferation of conflict, have increased the uncertainty of the environment in which the Company operates. The current economic situation in the East has caused the Company to closely monitor the regulations introduced by the Polish Government, the governments of other EU countries, and the United States. A protracted conflict may result in a further increase in prices of, for example, energy, restrictions on free trade, or other business restrictions, including disruptions in the supply chain for goods and services. All the above mentioned phenomena may have a direct impact on the financial situation of the Company in the future.
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