Environmental & Social Information • Jun 10, 2020
Environmental & Social Information
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Photocure ESG report
2019
Photocure ESG report 2019
Locations
CEO letter About this report About Photocure Key figures 2019 Corporate governance Photocure's values Photocure's approach to sustainability Photocure's stakeholders Photocure's materiality assessment Reporting on material topics Product quality and safety Supply chain responsibility Working environment Business ethics and transparency Data protection and IT security Appendix: GRI Content Index
At Photocure, we focus all our efforts and resources on delivering transformative solutions to improve the lives of bladder cancer patients. We are proud of our unique technology, making bladder cancer cells glow bright pink, which to date has helped treat over 500 000 patients worldwide and the real growth is ahead of us.
Our highly regulated business has an economic, social and environmental impact on our surroundings and stakeholders. The most important impact is the positive contribution to the patients' lives, the economies and the societies in which we operate. However, we also need to assess and address potentially negative aspects and consequences of our operations and business relations such as potential environmental impacts and human rights risks in our supply chain, potential quality and safety issues and the risk of corruption.
This impact comes with a responsibility and requires that we comply with the strict laws, norms and regulations, that we listen to our stakeholders and constantly strive to deliver quality products through responsible business operations. In the past couple of years, we have also experienced an increased attention to responsible business and high ESG (Environmental, Social and Governance) standards from our shareholders. For Photocure, sustainability is about both the products we make and the way we run our operations. We strive to give bladder cancer patients access to care in a sustainable way, while ensuring value creation for our shareholders.
Guided by the Euronext ESG guidelines and GRI Standards, we have implemented a process based on stakeholder inclusiveness and materiality to ensure that Photocure reports on the most material topics for our company and our industry. We also reference our attention to industry standards and regulations, which helps us implement our responsibilities across our value chain in a systematic manner.
This year, we deliver Photocure's first sustainability report according to the GRI Standards core option. During the spring of 2020 we have completed Photocure's first materiality assessment and undertaken systematic stakeholder dialogue, though somewhat simplified due to the effect of Covid-19 on our stakeholders. The materiality assessment will ensure that our reporting is aligned with our business objectives, supports our strategy and minimizes risks.
These material topics are focused around key topics for our company and our industry, taking into account the interests of stakeholders and the wider society. They include the quality and safety of our products, how they are produced and purchased, as well as the working environment of our employees. As for our business and risk minimization, the material topics include ethical conduct in our business relationships, in research and development and when working with personal data.
As a pharmaceutical company, I believe responsibility, transparency and sustainability must be integrated in Photocure's business model and strategy. For us, efficient, high-quality products produced, sold and used in a responsible manner is what makes us a successful company, in addition to our people and culture. Photocure's values constitute key premises for the company, both internally and externally. Our values – Care, Courage and Passion – guide our behaviour and form the basis for Photocure's ethical guidelines.
For the first time, we report on the targets and progress for each material topic, and we have set goals for how to improve our work in the future. Going forward, we will work systematically on implementing sustainability targets in our purchasing and supply chain activities. We will also strengthen the focus on a good working environment and ensure the appropriate channels for reporting concerns are put in place.
Photocure's mission is to deliver transformative solutions to improve the lives of bladder cancer patients. We seek to do so in a responsible way and we will continue to do our part to build a better future based on the foundation of diversity, equality, respect and inclusion. I hope this report will provide new insights for our stakeholders and provide the information you need about our response to the sustainability challenges and opportunities for our business and society.
Daniel Schneider President and CEO of Photocure
Photocure was founded by the Norwegian Radium Hospital to develop and commercialize a promising photodynamic nonmelanoma skin cancer product with a vision to become a global leader in photodynamic technology.
Photocure has transformed from a technology-based focus and being a global leader in photodynamic therapy to a valued player in the bladder cancer area. Based on its experience, solid foundation and the growth of its breakthrough bladder cancer product, the company has a stepwise approach to further developing its products and services for the benefit of patients, urology care providers and the health care community.
Photocure has a strong track record of developing and commercializing pharmaceutical products based on photodynamic technology. The company has brought two first-in-class products to the market, one for non-melanoma skin cancer and one for better detection and management of bladder cancer (Hexvix ®/Cysview ®). Photocure also developed a photodynamic drug-device combination product for non-surgical treatment of high-grade cervical dysplasia which was out licensed in 2019. Additionally, Photocure distributes Combat BRS and Combat BRS kits for the HivecTM procedure in the Nordics, an innovative recirculation system for the delivery of hyperthermic intra-vesical chemotherapy in the treatment of non muscle invasive bladder cancer (NMIBC).
Photocure has transformed itself from a technology-based company to a therapeutic area-focused commercial stage pharmaceutical company with a focus on bladder cancer. Today, the company's vision is driving change in bladder cancer management and its mission is to deliver transformative solutions to improve the lives of bladder cancer patients.
Photocure is located in Oslo, Norway (headquarter) and in Princeton, New Jersey, U.S.
Photocure ASA is listed on the Oslo Stock Exchange (ticker: PHO).
At the end of 2019 Photocure ASA had 67 employees including part-time employees, with 64 being full-time employees.
Photocure Group and Nordic had 26 employees at the end of 2019, 11 men and 15 women. Photocure U.S. had 41 employees at the end of 2019, 21 men and 20 women.
Photocure has made a strong commitment to ensure trust in the company and to enhance shareholder value through effective decision-making and improved communication between the management, the Board of Directors and the shareholders. The company's framework for corporate governance is intended to decrease business risk, maximize value and utilize the company's resources in an efficient, sustainable manner, to the benefit of shareholders, employees and society at large. Photocure seeks to comply with the Norwegian Code of Practice for Corporate Governance to an appropriate extent considered reasonable due to the company size and stage of development.
The Board of Directors is responsible for the overall management of the company and shall supervise the company's day-to-day management and the company's activities in general.
The Annual General Meeting (AGM) is Photocure's supreme governing body at which shareholders can influence how sustainability is practiced. Photocure's Board of Directors bears the ultimate responsibility for the company's sustainability approach and the sustainability report is discussed and approved by the board.
For more information about corporate governance, please see the Photocure corporate governance policy in the 2019 annual report on page 20.
Photocure's values constitute key premises for the company, both internally and externally. The company's values care, courage and passion guide the behavior of employees and form the basis for Photocure's ethical guidelines:
For information about this report and its content, please contact Photocure ASA and CFO Erik Dahl or Corporate Communica tions Director Maja Bergmann. This is Photocure's first sustain ability report. The report will be conducted annually.
This report is prepared for Photocure ASA in accordance with GRI Standards Core option. The report complies with Euronext guidelines for ESG reporting. For GRI index, please visit Photo cure's webpage or the GRI Database.
This Photocure sustainability report has been reviewed and approved by the Board of Directors. The claims and data in this report have not been audited by a third party.
This report covers sustainability topics that are of importance to Photocure and the company's stakeholders. Photocure's approach to sustainability reporting is based on the stakeholder dialogue and materiality assessment undertaken in April 2020 and covers the period between 1 January 2019 and 31 December 2019.
The prioritization of Photocure's stakeholders as well as the stakeholder dialogue and materiality assessment, were undertaken by an interdisciplinary working group consisting of Photocure employees representing medical affairs, finance, operations, HR, communications, IT and quality management. The work was undertaken as a series of phone interviews and digital workshops, while the stakeholder dialogue was undertaken through semi-structured interviews with key stakeholders.
Corporate Communications has facilitated the stakeholder dialogue on behalf of Photocure, speaking to representatives from key stakeholder groups. Internal and external stakeholder representatives were invited to share their thoughts and perceptions on Photocure's sustainability performance through semi-structured interviews. The stakeholder dialogue process also included document review and industry level ESG topic overviews, as well as reviewing the ESG reports of Photocure's peers.
Due to the Covid-19 pandemic, impacting business priorities in all sectors, only a limited number of external stakeholders were interviewed as part of this process. As to avoid further strain on healthcare providers during the pandemic, Photocure representatives were interviewed about the interests of their specific external stakeholder groups such as customers, government and suppliers. Photocure will resume active stakeholder dialogue with these stakeholder groups as soon as the situation improves and will update the stakeholder dialogue and materiality assessment in future ESG reports.
All stakeholders consulted pointed out the social aspects of Photocure's product and access to healthcare being an integral part of the company's business model. Another topic frequently mentioned was the importance of a good working environment and diversity and gender equality in the workplace. Financial stakeholders also emphasized the importance of business ethics, as well as openness and transparency regarding products, production and research.
Photocure's employees are directly affected by the company's internal policies and activities, and directly affect the company through their performance and actions.
Photocure's customers consist of urologists, hospitals, clinics and the bladder cancer patients they treat. Customers are directly affected by the quality and safety of Photocure products. Customers directly affect the company economically and customer expectations also impact Photocure's sustainability priorities.
Photocure's suppliers are economically affected by the company and their responsibility is indirectly affected by Photocure's focus on responsible practices and the expectations placed on them by the company. Suppliers directly affect the company through the quality and pricing of their products and services.
Photocure's investors and owners are primary stakeholders and directly affect the company's priorities and strategic direction. Photocure's economic and business performance may affect the priorities of investors and shareholders.
Government and regulatory authorities affect the company's operating conditions directly and indirectly.
Civil society affect the company's operating conditions directly and indirectly. Local communities are indirectly socially, environmentally and economically affected by Photocure's activities in terms of job creation, contribution to local value creation and environmental impact.
Based on stakeholder input and priorities, as well as an assessment of the company's business impact, the materiality of each suggested sustainability topic was considered.
The results are presented in the materiality matrix below, with topics considered material for Photocure in the upper right section.
These topics are summarized into the following over-arching material themes:
suppliers, which includes quality and ability to supply. Photocure has not terminated or discontinued contracts with any suppliers due to sustainability breaches in the reporting period.
The ability to attract and retain a skilled workforce as well as maintaining a safe and healthy working environment are key interests of both the company and its stakeholders. Photocure can directly impact the working environment through its policies and agreements, and by keeping an active dialogue with employees. Working in an office environment or remotely with sales without any inhouse production, the company and its employees are mainly exposed to risk related to the working environment, such as the psychological well-being of employees and physical risks related to the working environment, e.g. ergonomics and sedentary work and risk associated with business travel.
Photocure's high quality products and processes are a prerequisite for the company's contribution to value creation for both owners and society and for future growth.
The quality policy and the quality and compliance manual are the overarching documents describing the company's quality goals and quality system. Photocure has a quality management system (QMS) which is compliant with Norwegian, European and U.S. Health Authorities rules and regulations for drug manufacturing and safety surveillance. The QMS also covers Norwegian and European rules and regulations for distribution of medical devices. The QMS consists of a set of policies, standard operation procedures, forms and work instructions. Photocure follows the GMP standard for manufacturing, the GDP standard for distribution and the GVP standard for safety surveillance for Photocure's products. Photocure follows the EU directive for medical devices with respect to distribution of medical devices.
An annual review of the quality system, product quality and safety are done with the management team. All reports of adverse events and/or product complaints are promptly investigated and assessed. Adverse events are reported to applicable health authorities according to procedures. All complaints are investigated to identify if the root cause is linked to the manufacturing process and if there is a potential quality issue/defect with the product. This is done for all of Photocure's products. For the period 2019 there were no quality and/or safety incidents that led to any market actions or need for reporting to health authorities e.g. product recall or healthcare information letter.
• Maintain Photocure's track record of no quality and/or safety incidents that led to any market actions e.g. product recall or healthcare information letter.
Photocure relies on third-party suppliers for manufacturing and is thereby directly and indirectly exposed to risks and opportunities in its business relations and supply chain. Delays or interruptions and quality issues at the production facilities as well as improper transport, handling and delivery may impair supply of Hexvix®/Cysview® to the market and hence revenues. Additionally, other parts of the company's supply chain have direct and indirect effect on delivery, product and process risk.
As a business with outsourced production, the main effects from Photocure's operations occur outside the organization's boundaries. This means that Photocure has an impact on the indirect environmental and climate emissions, human rights and anti-corruption though its procurement practices and the follow-up of suppliers. Photocure follows several standard operating procedures for the interaction with suppliers, including qualification and follow-up, quality risk assessment, auditing and supplier re-qualification.
As part of the initial and ongoing evaluation of suppliers, the policies on Corporate Social Responsibility (CSR) and Environmental Health and Safety (EHS) are evaluated and any policies or certifications (e.g. ISO) are requested for this evaluation. Photocure does not follow any specific standard for responsible procurement practices, however, the company has detailed SOPs describing GxP operational procurement. With regards to anti-corruption, climate and the environment, human rights and/or worker's rights, these are partly covered by the SOP describing the qualification and follow-up of suppliers. The company conducts desktop audits of supplier documentation, as well as physical audits and visits to the supplier's production facilities but these audits do not directly address responsible business practices.
Annually, the company measures and analyzes potential risks in its supply chain and performs risk assessment of its GxP
Being part of a global value chain, Photocure is directly and indirectly exposed to ethical risks through its business operations. This includes good corporate governance, local and industry specific business ethics norms, such as good pharmacovigilance practices, ethical research and development activities, as well as anti-corruption and adherence to Photocure's core values and respect for human rights.
Photocure's framework for corporate governance is intended to decrease business risk, maximize value and utilize the company's resources in an efficient, sustainable manner, to the benefit of shareholders, employees and society at large. The company seeks
to comply with the Norwegian Code of Practice for corporate governance (NUES), and the quality and compliance manual describes the scope and structure of the company's quality and compliance management system.
Photocure's overarching goal is to comply with industry code of conduct in all markets. In Europe, the company follows the European Federation of Pharmaceutical Industries and Association's (EFPIA) code of practice, while for the U.S. market, Photocure follows the Pharma Code. The company's CEO and management team are responsible for following up business ethics and anti-corruption work at Photocure, and in 2020 Photocure will appoint a compliance officer.
Photocure strives to ensure a good working environment for all employees and aims to be a workplace with equal opportunities in all areas. The company's policy is to ensure and provide equal employment rights and opportunities for all persons employed by, or seeking employment with Photocure without regard to race, age, color, religion, sexual orientation, citizenship, gender, marital status, pregnancy, national origin, disability or other non-work-related criteria as may be protected by local or country law. This extends to the employment relationship and all other areas of personnel activity, such as recruiting, selection, job assignment, supervision, training, promotions, performance evaluations, transfers, terminations, compensation, benefits, educational opportunities, recreational activities and work facilities. Photocure recognizes its obligation to actively promote such opportunities for all qualified persons and will take reasonable and necessary action to ensure that these objectives are met.
The company has implemented separate processes for talent acquisition, compensation, training and development, performance management and communications that are compliant with the Norwegian Working Environment Act, U.S. employment law and standards, as well as following industry best practices. The company does not have employee representatives on the board. The number of employees covered by collective bargaining agreements in 2019 was 0%.
At the end of 2019, the organization comprised of 67 employees of which 64 were full-time employees. In addition, Photocure has a strong network of consultants to support the operations and development, and the company's practice is to outsource
non-core operations and highly specialized services. Traditionally, Photocure has recruited from environments where the number of women and men is relatively equally represented. In terms of gender equality, 40% of Photocure's board members are women, as is 50% of the senior management team at the end of 2019. Globally, Photocure employs 48% men and 52% women. Working time arrangements at the company, independent of gender, strive to enhance the individual work-life balance.
The working environment within the company is considered to be good, measured through regular employee surveys. The annual performance appraisal for Photocure employees and management includes an assessment of the performance in relation to the company's values. Photocure U.S. runs an employee survey annually, with an average employee engagement score achieved in the reporting period of 4.4 out of 5 possible points. With the pending European expansion, Photocure plans to broaden the scope of the employee survey to include the global employee base on an annual basis starting in 2021.
No accidents or injuries resulting in absence were registered in 2019. Absence due to illness in the company was 1.6% of total hours in 2019, compared 3.6% in 2018. Photocure has not been in any legal proceedings regarding working environment in 2019.
| Photocure's workforce (31.12.19) | Men | Women | Total |
|---|---|---|---|
| Total workforce (part-time and full-time employees) | 33 | 35 | 67 |
| Total workforce full-time employees | 31 | 33 | 64 |
| Total workforce part-time employees | 1 | 2 | 3 |
| Number of non-permanent employees | 0 | 0 | 0 |
Photocure develops and manufactures innovative products and markets and sells these products through its own commercial teams and in partnerships with other companies. These activities entail exposure to various risks relating to manufacturing, product quality, regulatory requirements and the like. Each year, the Board of Directors conducts a thorough assessment of the significant parts of the company's business and outlook in order to identify risks and potential risks and remedy any incident that may have occurred. The company risk assessment conducted today does not include risks relating to corruption and business ethics, which will be included at the next update. A detailed risk assessment for compliance is in planning. No significant business ethics risks were identified in the reporting period.
As part of its quality management system, Photocure has established a range of standard operating procedures for all research and development related areas. The procedures ensure activities are conducted in compliance with applicable laws and regulations, and are subject to regular review and internal audits. In contracts with business partners, Photocure has included statements that both parties are obliged to follow all applicable laws, rules and regulations, and this general statement also includes anti-corruption laws. There have not been any cases of terminations or contracts not being renewed due to suspected business ethics breaches or corruption in the reporting period, nor has Photocure been involved in any legal proceedings regarding business ethics or corruption.
Employees can report suspected cases of business ethics breaches or corruption to their line manager or the management team. The company does not have an anonymous whistleblowing channel as of today, nor is it part of any external initiatives or collaborations on corruption prevention. There have not been any reported incidents of corruption in the reporting period.
Board members receive a general introduction training from management and the legal counsel. The training includes an introduction to business ethics and insider rules, as well as a review of the company's corporate governance and CSR strategy. A transparent disclosure regarding payments and transfers of value between the medical community and the pharmaceutical industry is important to keep a trustworthy and healthy relationship with patients, health care professionals, government officials and the public, and it also strengthens the company's commitment to keeping a high ethical business standard.
Therefore, Photocure has published annual disclosure reports describing these payments and transfers on its website. Photocure is equally disclosing its support for research. No clinical studies were ongoing in the reporting period. One pre-clinical exploratory trial was performed in the reporting period. The study was approved by the Ethical Committee for Animal Experiments. One non-interventional Photocure sponsored study (Blue Light Cystoscopy with Cysview® registry) was ongoing in the reporting period. Photocure has also supported three investigator-initiated trials. During 2019, several studies were published highlighting and confirming key benefits of Blue Light Cystoscopy with Hexvix®/Cysview®. Main publications and presentations can be found in the Annual Report 2019 on page 8.
Goals and targets for 2020
As a company in the pharmaceutical sector working with research and development and cooperating with physicians and patient advocacy groups, Photocure and/or its research partners may need to gather and store personal data as part of its research and development practices or business operations. Also, as a listed company on the Oslo Stock Exchange, information security and data protection are also an important part of the company's obligations to its shareholders and the marketplace.
Data and information security is a priority for Photocure and described in the company's quality manual. IT activities and security is evaluated during management review, and if necessary new risk analyses are performed. Management is informed about the result of the evaluations and approves corrective and preventive actions.
Photocure has invested in an extensive security and information security platform based on international standards ISAE3402 and ISAE3000. The procedures and processes that Photocure has established for personal data protection are based on the Norwegian Personal Data Act and the EU Directive 95/46/EC. A personal data protection group has been established and a procedure is in place to describe the responsibility and process for data protection issues. Photocure has a dedicated personal data contact person with delegated responsibility from the board and management.
Photocure's quality manual describes the overall responsibility for both data protection and IT security. To ensure appropriate management and documentation of electronic files critical for Photocure's activities in a GxP environment, Photocure has a number of standard operating procedures. For instance, Photocure has established processing of personal data, that is governed by applicable laws and regulations, and in particular the Personal Data Act "Personopplysningsloven" and The General Data Protection Regulation (GDPR) where applicable. In addition, there are several Photocure procedures that describe the personal data process for a specific task. These procedures include work instructions for relevant roles such as employees, contractors, candidates and board members.
The security platform is supported by an industrialized information security and compliance service that simplifies work to ensure compliance with internal and external audits. This security and compliance service also acts as a compliance hub when leveraging public cloud services. Photocure's security platform is audited annually according to ISEA3402 and ISAE3000 by PWC. The ISAE reports are also mapped up to the Cloud Control Matrix framework to fit industry standards defined by the Cloud Security Alliance. Photocure keeps a live dashboard on all security incidents.
An external GDPR consultant reviewed the GDPR status in Photocure in 2019 and the overall work was considered high quality. Tasks recommended by the GDPR consultant for improvement and work on updating procedures, work instructions and employee training are ongoing.
Goals and targets for 2020
| Security tickets and breaches | 2019 |
|---|---|
| Number of moderate security tickets registered | 13 |
| Number of critical security tickets registered | 0 |
| Number of personal data breaches | 0 |
| GRI STANDARD | DISCLOSURE | PAGE NUMBER(S) AND/OR URL(S) |
||
|---|---|---|---|---|
| GRI 101: FOUNDATION 2016 | ||||
| GENERAL DISCLOSURES | ||||
| GRI 102: GENERAL DISCLOSURES 2016 |
ORGANIZATIONAL PROFILE 102-1 Name of the organization 102-2 Activities, brands, products, and services 102-3 Location of headquarters 102-4 Location of operations 102-5 Ownership and legal form 102-6 Markets served 102-7 Scale of the organization 102-8 Information on employees and other workers 102-9 Supply chain 102-10 Significant changes to the organization and its supply chain 102-11 Precautionary Principle or approach 102-12 External initiatives 102-13 Membership of associations STRATEGY 102-14 Statement from senior decision-maker ETHICS AND INTEGRITY 102-16 Values, principles, standards, and norms of behavior GOVERNANCE 102-18 Governance structure STAKEHOLDER ENGAGEMENT 102-40 List of stakeholder groups 102-41 Collective bargaining agreements 102-42 Identifying and selecting stakeholders 102-43 Approach to stakeholder engagement 102-44 Key topics and concerns raised REPORTING PRACTICE 102-45 Entities included in the consolidated financial statements 102-46 Defining report content and topic Boundaries 102-47 List of material topics 102-48 Restatements of information 102-49 Changes in reporting 102-50 Reporting period 102-51 Date of most recent report 102-52 Reporting cycle 102-53 Contact point for questions regarding the report 102-54 Claims of reporting in accordance with the GRI Standards 102-55 GRI content index 102-56 External assurance |
6 7 7 7 7 7 7 7 10 10 8 7, 14 8 5 7 7 8, 9 12 8, 9 8, 9 9 7 8 9 6 6 6 6 6 6 6 17 6 |
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| GRI STANDARD | DISCLOSURE | PAGE NUMBER(S) AND/OR URL(S) |
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| MATERIAL TOPICS | ||||
| 200 SERIES (ECONOMIC TOPICS) | ||||
| GRI 103: MANAGEMENT APPROACH 2016 GRI 205: ANTI-CORRUPTION 2016 |
ANTI-CORRUPTION 103-1 Explanation of the material topic and its Boundary 103-2 The management approach and its components 103-3 Evaluation of the management approach 205-1 Operations assessed for risk related to corruption 205-2 Communication and training about anti-corruption policies and procedures 13, 14 |
13 13 13 13 |
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| 205-3 Confirmed incidents of corruption and actions taken |
14 |
| Hoffsveien 4 | 0275 Oslo, Norway | +47 22 06 22 10 | [email protected] Photocure INC | 104 Carnegie Center, suite 303 | Princeton, NJ 08540 USA | +1609 7596500 | [email protected] www.photocure.com
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