Scope of the Declaration

The Declaration gives a broad overview of a various aspects of the activity of Sopharma Group as a corporate citizen. It focuses on the activities of the Group for the period 01.01.2021 — 31.12.2021. The declaration contains quantitative data used as impact indicators in the main areas described below.

Vision, strategy and corporate governance

Mission, values, goals and strategy

The mission of Sopharma Group is to play an active role in raising people’s living standards by providing constant and easy access to the most important health-related products.

To ensure the fulfillment of its mission, Sopharma Group constantly invests in production — new technologies, research and studies; in increasing the efficiency of distribution; in maintaining an active and effective dialogue with all participants in the healthcare system; in participation in significant projects and programs related to the development of society and in environmental protection.

The vertically integrated model of companies operating mainly in the field of healthcare supports the application of global and European standards and practices. Consolidation in the Group leads to profitable synergies, better organization, centralization of major marketing and sales activities, cost optimization and better performance in all markets.

The parent company, as a leading pharmaceutical manufacturer, follows the best practices in the field of corporate citizenship. The values that logically determine life in the company and the interaction with the stakeholders are related to the care of people’s health not only in the physical aspect, ​but also in emotional and mental terms.

The Sopharma Group’s development strategy turns the companies into an attractive investment thanks to the following long-term goals:

  • Portfolio diversification, expansion of foreign markets, successful acquisition operations;
  • Sustainable development and strong performance in key markets;
  • Transparent and efficient management model.

The results of the Group’s work are always in favor of all stakeholders, making it a preferred "partner" in health and investment.

The Group is represented in over 45 countries with key markets in Bulgaria, Russia, Ukraine, Kazakhstan and Poland and a strategic plan focused on further market expansion in the region.

Corporate citizenship policies

The corporate citizenship of the Group operates and develops in accordance with the constitutions, laws and regulations of the countries in which the Group is active. In all its actions, the companies comply with the regulations of the state, local government and regulatory authorities and monitors the updating and strict implementation of the legislation concerning its activities. The Group follows the 10 basic principles of the UN Global compact and works towards the achievement of the Global sustainable development goals SDG 2015 through the active involvement of their companies in related projects.

Management systems

Corporate governance systems

Each of the companies operates following its basic internal rules, such as the regulations, and complies with its management systems in accordance with the imposed legislative and regulatory requirements. More specific management systems, related to pharmaceutical production and distribution are:

Corporate governance systems Description Adoption date Last update
Prospect The prospectus contains detailed information about the issuer of a financial instrument and about the issue itself. 2021 2021
Articles of Association The Articles of Association determine the basic rules according to which significant decisions are made concerning the existence of the Company. 2003 2021
Decisions taken at the General Meeting of Shareholders The decisions of the shareholders are fundamental for the activity of the Company. at least once a year 2021
Rules of operation of the Board of Directors Instructions and explanations for the duties and responsibilities of the members of the Board of Directors. 2007
Good corporate governance program A system of rules protecting the rights of shareholders and other stakeholders. 2009 2021
Good Manufacturing practice/GMP A system of principles and rules that ensure the proper course of each stage of the production process, providing a quality final product. 2003 2021
Good distribution practices/GDP The good distribution practices is a system of rules and procedures which serves to guarantee the high quality of the medicinal products at every stage of their distribution. The quality of medicinal products may be affected by a lack of adequate controls. 2003 2021
ICH "Q8 Pharmaceutical Development" Principles, governing the establishment of pharmaceutical products. 2004 2021
ICH "Q9 Quality Risk Management Principles and examples of tools of quality risk management. 2006 2021
ISO 17025 General requirements for the competence of testing and calibration laboratories. 2014 2021
AXAPTA ЕRP program, which is an integrated information system for the overall business management of production planning processes, supply chain management, sales management and planning, financial management and control, customer relationship management, business analysis and more. 2013 2021
Rules for persons, holding inside information Instructions and clarification on the obligations and responsibilities in connection with The law against financial abuse of market instruments. 2007 2021
ISO 9001: 2015 Quality Management System 2008 2018
ISO 13485: 2003 Quality management systems for medical devices 2003 2018
СЕ BRAND Conformity of Medical Device Directive 93/42 / EEC 2003 2016
Directive93/42/ЕЕС Concentration Directive for hemodialysis 2003 2016
BDSINISI/
IEC 17025
Standard for laboratory tests of foods of different origins; water and beverages; feed; control of technological surfaces and carcasses; diagnosis of diseases in all species of domestic and wild animals; bees and a beehive 2006 2017
ISO 14001:2015 Environmental management systems 2015 2019
ISO 27001:2013 Information security management systems 2013 2017
OHSAS 18001:2007 Occupational health and safety management systems 2007 2017
WHO Good dissemination practices WHO Technical statements Series, № 937, 2006. 2006

Detailed description of the corporate governance systems:

  • The program for good corporate governance

    A system of rules protecting the rights of shareholders and other stakeholders concerning the timely and accurately disclose information on all material issues related to the Company and to support its strategic management. The program also provides control over the activities of the Board of Directors/Management and Supervisory Board and its accountability to the company and shareholders.

    The program is in accordance with current legislation, to the internationally recognized standards for good corporate governance and the Bulgarian National Code of Corporate Governance.

  • GMP

    Good manufacturing practice is a system of rules and procedures which guarantee the high quality of medicinal products at every stage of their manufacturing. Its major purpose is to protect the patient’s health.

    The GMP deal with both the production process and the working conditions, the qualifications of the production personnel, the sales system in use and the method of product withdrawal from the respective market.

  • GDP

    GDP include an array of tools used in the activities of wholesale distribution, including preventing counterfelt medicinal products from entering the supply chain. Their implementation ensures control an efficient contor of the distribution chain and the maintenance of the high quality and integrity of the manufactured medicinal products.

    The GDP is applicable to any and all activities including the supply, storage, delivery or export of medicinal products, excluding the sale to the end users.

    This system also includes competency of the employees, working conditions and product retention, control at any point in time to the final delivery.

  • ICH Q8 Pharmaceutical Development

    The standard applies to the overall process of creating new products, from development to registration. It also includes risk assessment and quality assurance systems as part of product design. It concerns all components of the medicinal product, substances, excipients, active substances, development of the formulation and process of creation, knowledge accumulated during this process, physicochemical and biological properties, development of the manufacturing process and all information that may affect the final result.

  • ICH Q9 Quality Risk Management

    Principles and tools for risk management that can be applied to all aspects of pharmaceutical products — creation, production, distribution and verification of life-cycle processes of substances and medicinal, biological and biotechnological products, including raw and supplementary ingredients and materials used for packaging and labeling.

    ICH Q9 together with ICH Q8, serves to promote the development of science-based and risk-based approaches to quality. ICH Q9 Quality Risk Management refers to quality control, creation-related activities, construction facilities, equipment and power capacities, material control and management, the manufacturing processes, laboratory control and testing, packaging, labeling and various other activities.

  • ISO 17025

    This International harmonized standard contains the general competence requirements related to the competence of the testing and/or calibration laboratories, including sampling. The standard is intended to be used by laboratories that set up their quality control systems for both the administrative and technical activities. The results (protocols, certificates) issued by the accredited laboratories are used by regulators,the conformity assessment bodies for product certification as well as by the product manufacturers and others.

    The possession of this certificate is a part of the risk control process and guarantees the reliability of the results obtained from the laboratory tests and assessments and — accordingly — the safety and the quality of the manufactured medicinal products.

  • ISO 9001:2015

    The implementation of the Quality Management System to the requirements of ISO 9001: 2015 ensures the company’s ability to continuously provide services that meet the customer’s and applicable legal and regulatory requirements. Effective implementation of the system leads to increased customer satisfaction.

  • ISO 14001:2015

    Through the implementation of the standard, the company is committed to the rational use of natural resources to ensure constant control over the identified aspects of the environment that it affects. Measures are implemented to manage the environmental aspects, those that can be controlled and those that are expected to have an impact on the part of the company.

  • OHSAS 18001:2013

    Through the implementation of the standard, the company demonstrates its commitment to the health of its employees by providing a safe working environment, managing and minimizing the risks to the health of the personnel as well as to the staff of the stakeholders who work at the company’s premises.

  • ISO 27001:2013

    By applying the requirements of the standard, the company provides adequate and coherent security mechanisms, whose purpose is to protect the information assets of the company and to ensure the confidence of each interested party with special attention to the clients.

  • ISO 13485:2016

    The standard specifies the requirements for a quality management system when an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements.

  • БДС INISI / IEC 17025

    Laboratory Block BSE, DZG is an accredited laboratory according to BIS INISI / IEC 17025 by the Bulgarian Accreditation Service (BSA) and has the right to carry out tests which are recognized by all national and European food control authorities. The scope of accreditation includes tests of foods of different origins; water and beverages; feed; control of technological surfaces and carcasses; Diagnosis of diseases in all species of domestic and wild animals; bees and a beehive.

    Since 2014, the Lab Unit has been housed in new laboratory premises including Biosafety Level 3 for disease diagnosis as required by the OIE.

  • СЕ BRAND

    Conformity of Medical Device Directive 93/42 / EEC.

  • АXAPTA

    Integrated information system for business process management in the corporate activity of the high class company.

    It improves efficiency, helps to make more precise decisions, and improves interconnections with the supply chain.

    It supports sales management and planning, production to material planning and production capacity, supply chain management resoursec — stocks, warehouses and links between them, quality management.

    The program enhances the project management process: accounting and invoicing, expenditure control, splitting to sub-projects, financial and human resource management.

  • World Health Organization Good Distribution practices (WHO Technical Statement Series, No 937, 2006)

    By applying the requirements of the European Commission described in Directive 2001/83 / EC, the Management Manual of Good Practice of Distributing Practice of 5 November 2013 and the World Health Organization, the companies engaged in distribution declare their expertise and constant control over quality assurance, ensuring that products consistently stored, transported and handled under appropriate conditions as required by the marketing authorization or product specification.

Imprint of the company`s activity

Economic impact

We create added value for our stakeholders
Economic and Financial data 2021 2020 % change Stakeholders
Decision for issuance, under the conditions of initial public offering, of warrants 44 925 943 number of registered, dematerialized warrants - - Shareholders
Decision for payment of dividends by the General Meeting in the amount of BGN per 1 share - BGN 0.04 for the first half N/A Shareholders
Taxes paid in thousand BGN Incl:
Taxes paid (other) in thousand BGN
Corporate tax paid in thousand BGN
82 391 82 398 -0.01 State and local authorities
74 454 74 451 0
7 937 7 947 -0.13
Payments to suppliers in thousand BGN 1 504 805 1 341 304 12.18 Suppliers /including hired services/
Payments for wages and social insurance in thousand BGN 146 239 129 085 13.29 Employees
The economic impact is most clearly tracked through dividend decisions that show the relationship with stakeholders as shareholders; paid taxes, incl. paid corporate tax, which is a contribution to state and local authority; payments to suppliers showing relationships with companies in the supply chain; the cost of labor that shows employee relations as an interested party.
Social impact
Economic and financial data /expenses thousand BGN/ 2021 2020 Stakeholders
Plants / Number of employees 8/ 1 768 9/ 1 991 Work places — employees
Training courses /expenses BGN ‘000/ 247 215 Employees
Social benefits and payments /expenses BGN ‘000/ 4 192 3 639 Employees
Medical services/expenses BGN ‘000/ 761 853 Employees
Donations /expenses BGN ‘000/ 365 962 Local communities
Social activities and events 214 219 Local communities

Projects related to promoting health culture and investing in civil society.

The companies of the Group works to increase the economic and social development of society, to promote a healthy lifestyle and to improve the health culture.

Sopharma Group adheres to traditions that nurture fundamental values, such as health care in harmony with nature, strengthening the community and nurturing the competitive spirit.

  • We traditionally support initiatives related to sport and healthy lifestyles by supporting sports events and competitions;
  • We have a leading role in initiatives under the UN Global Compact Network — "Games of Goodness" — supporting sport with a cause: collective, individual or virtual games;
  • In 2021, efforts were made to provide a safe environment for employees and partners in a COVID-19 pandemic situation;
  • In the face of pandemic and difficult deliveries, measures were introduced to prevent the lack of vital medicines, medicines with increased consumption and directly related to the treatment of COVID-19;
  • For the benefit of patients, a system was established to perform electronic prescriptions in each of SoPharmacy’s 63 sites located in 11 cities across the country. Since the launch of the service, dozens of customers have benefited from the service;
  • A digital platform was created for training and upskilling of the staff, incl. pharmacists;
  • Investing in new digital communication channels to help society tackle smoking;
  • Donations to hospitals, Bulgarian Red Cross, nursing homes.
Ecologic impact
Indicators 2021 2020 %
Cost of materials and energy(electricity, headenergy, fuels, water; without main materials and impairment)/expenses BGN ‘000/ 29 030 26 829 8.20
Costs for transport services 4 324 4 803 -9.97
Separate waste collection 442 t. 1 700 t. -74
Exhaust emissions into the atmosphere 0The plants of Sopharma AD are certified according to Good Manufacturing Practices (GMP), which also controls the degree of environmental pollution. Emissions of waste gases are less than 50 tons per year, which according to the standards tends to 0. 0The plants of Sopharma AD are certified according to Good Manufacturing Practices (GMP), which also controls the degree of environmental pollution. Emissions of waste gases are less than 50 tons per year, which according to the standards tends to 0. 0
Emissions to wastewater Waste water is treated in WWTPFor years in the production in the factories of the company no organic substances are used for filming the tablets, which guarantees zero pollution of the wastewater.
Employees trainings and inclusion in environmental protection activities Instruction of employees;
Instructions for recovery and separate collection of waste;
Instructions on how to deal with waste substances in the units;

The main part of the turnover, operating and capital costs of the Company are related to economic activities that qualify as environmentally sustainable, with the exception of some transport activities by third parties and domestic transport activities, which decrease by BGN 479 thousand in 2021 or by 9.97% of BGN 4,803 thousand in 2020.

Projects related to responsible use of resources and environmental protection

  • Separate waste collection, minimization, utilization and recycling of production and municipal waste;
  • Caps for the Future — Charity collection of plastic caps at all production sites;
  • Providing regular training of personnel on environmental issues and pollution prevention;
  • Responsible implementation of the mandatory requirements of Decree of the Council of Ministers 137 and the Ordinance on packaging and waste;
  • Switching from plastic to paper sticks in the production of ear sticks;
  • Separate collection of household waste (paper, plastic, batteries) at the workplace. Containers provided at all production sites;
  • Reduction of printed advertising materials by 50% per year by 2025, by switching to digital content;
  • Annual measurement of waste gas emissions into the atmosphere;
  • Investments in the creation of "smart" buildings, facilities for renewable energy sources;
  • Zero pollution of wastewater and the atmosphere, through the use of water film, instead of organic substances for filming the tablets in the production in the company’s plants;
  • Measurement of the annual emissions of waste gases in the atmospheric air from the Phytochemical Plant and the Factory for Dosage Forms.
  • Emissions of waste gases are less than 50 tons per year, which according to the standards tends to 0.

Employees

The companies in Sopharma Group provide equal opportunities for work by gender, age and education.

  • Zero tolerance for any kind of discrimination in the workplace;
  • Ensuring healthy and safe working conditions;
  • Ensuring opportunities for development based on equality;
  • Ensuring the right of association and labor protection of employees.

As at 31 December 2021, the average number of employees of Sopharma Group is 5 507 (compared to 5 796 in 2020). The average number of employees of "Sopharma" AD as at 31 December 2021 is 1 860 (at 1 991 in 2020) and of "Sopharma Trading" AD is 826 (compared to 779 in 2020).

Organizational structure

Sopharma Group (the Group) is a leading Bulgarian manufacturer, exporter and distributor of pharmaceutical products with a strong presence in Eastern and Southeastern Europe. The group includes a parent company and its seventy-eight (31 December 2020: ninety four) subsidiaries. In addition, the Group has investments in two associate and one joint venture (31 December 2020: in one associate).

"Sopharma" AD, the parent company, is a commercial enterprise, registered in Bulgaria under the Provisions of the Commercial Law, with its registered office in Sofia, 16, Iliensko shose str., established in 1933. Today "Sopharma" AD is a public company and is among the most successful Bulgarian companies after privatization, with ten consecutive years being among the top 10 in revenues in pharmacy sector in Bulgaria.

Products and services

The Group operates in the following areas:

  • Production of pharmaceutical products including medicines, primarily generics, herbal-based substances (phytochemical production); food supplements; infusion solutions; hemodialysis concentrates.
  • Production of medicinal products and medicinal cosmetics, as plasters, bandages and sanitary-hygene products focused on the production site in Sandanski city;
  • Distribution of pharmaceuticals, medical supplies, sanitary materials, vitamins, food supplements and cosmetics;
  • Production and distribution of non-pharmaceutical products, primarily medical supplies such as syringes and other disposables used in medicineand other complementary activities to the production of pharmaceutical products and distribution of pharmaceutical products.

Production activity

"Sopharma" AD and its manufacturing subsidiaries has nine manufacturing plants, conforming with EU Good Manufacturing Practices (GMP), which are located in Bulgaria, complied with EU Good Manufacturing Practices (GMP), a factory in the Ukraine, certified by local authorities and recognized in all CIS countries.

The production activities of the Group are carried out and developed in the following areas:

  • production of pharmaceutical products;
  • substances and preparations based on plant raw materials (phytochemical production);
  • veterinary vaccines;
  • infusion solutions;
  • concentrates for hemodialysis;
  • medical disposable products for human and veterinary medicine;
  • injection molded products for the industry, agriculture and households.

"Sopharma" АD

The Company has more than 200 products in its portfolio: incl. nearly 190 medicinal products and 11 groups of medical devices. Medicinal products mainly include generics and 15 traditional products, 12 of which are plant-based. The traditional products of the Group (and in particular Tabex, Carsil and Tempalgin) have a major share to its export market income, while the company’s generic products are of major importance for domestic sales, Analgin being the leader among these products. The product portfolio of "Sopharma" AD focuses on the following therapeutic areas: cardiology, gastroenterology, pain management, cough and cold, immunology and dermatology, respiratory tract and asthma, neurology and psychiatry, urology and gynecology, nephrology, surgery, orthopedics and traumatology.

"Biopharm Engineering" AD

"Biopharm Engineering" AD has modern production facilities and is continuously expanding and modernizing its production capacities. The strategy of "Biopharm Engineering" AD is built upon the market and technological advantages of the company. The company’s production facilities are GMP (Good Manufacturing Practices) certified. It is successfully developing in the following areas:

  • Manufacturing of infusion solutions;
  • Manufacturing of injection solutions;
  • Manufacturing of veterinary medical products and immunological preparations;

The produced infusion solutions are marketed through "Sopharma" AD on both the Bulgarian and the international markets. Veterinary medical products are offered in Bulgaria and other European countries.

PAO "Vitamini", Ukraine

PAO "Vitamini" manufactures and sells medicines, tablets, powders, oil solutions, syrups and tinctures. Production of medicines by PAO "Vitamini" is highly effective, with excellent quality, affordable prices and is sold successfully not only in the Ukraine, but also in other CIS countries.The production takes place in the following production facilities:

  • for liquid dosage forms;
  • two production areas for solid dosage forms;
  • production site for extraction;
  • tincture production;
  • production of solutions;
  • production of powdered products.

Distribution

"Sopharma Trading" AD is the exclusive distributor on the Bulgarian market of particular pharmaceutical products of several leading international pharmaceutical and other companies in the field of healthcare such as Amgen, Astra Zeneca, GE Healthcare, Johnson and Johnson, Abbot Diagnostics, Hartmann, Novartis and Novo Nordisk.

The company is a leading distributor of pharmaceutical products and cosmetics in Bulgaria with a market share in the pharmaceutical products segment of 22.15% (according to IQVIA).

The Group has more than 15 000 products (particularly pharmaceutical products, medical equipment and devices, accessories, cosmetics, vitamins and food supplements) in its portfolio, including the brands of "Sopharma" AD, and holds exclusive rights for Bulgaria over brands of strategic partners such as "Aboca", "Colief", "Jamieson", "Planter’s", "Premax", "Skincode", "SVR" Laboratories, "US Pharmacia" and "Wyeth", specialized services (such as software solutions for pharmacies and advice and consulting services) and national logistics services. "Sopharma Trading" AD cooperates with more than 400 partners and over 3 000 clients.

SIA "BRIZ", Latvia

The company is developing, successfully and possesses the necessary certificates and licenses, such as DTI, import licenses for medicines manufactured in third countries in the EU, as well as a license to work with psychotropic substances. The mission of the company is to meet the needs of customers in natural, effective and modern medicines and cosmetics, nutritional supplements that improve health and quality of life. The main objective of the company is to increase the sales of the portfolio of products of Sopharma AD in the markets of Latvia, Lithuania, Estonia and Belarus. In addition to representative, commercial and marketing services, the company successfully provides medicinal safety services to its customers.

SIA "BRIZ" develops its activity in the following main directions:

  • Distribution of medicines and food supplements in the wholesale and retail segment;
  • Distribution of cosmetics and perfumery in the wholesale and retail segment;
  • Registration of medicines in Latvia, Lithuania, Estonia, Belarus, Bulgaria;
  • Presentation of medicines manufactured in third countries in the European Union;
  • Marketing support for products on the mentioned markets;