COSMO PHARMACEUTICALS
Environmental, Social and Governance Report 2023
1. The Cosmo Group 2. ESG Strategy and Governance 3. The Environment 4. Human Resources 5. Corporate Governance 6. Our Clinical Trials 7. Product Quality and Safety 8. Business Ethics 9. Our Community
We are committed to making a positive impact on society through our products and minimising the impact of our operations on the environment. We recognise the responsibilities we have to our employees, partners, other stakeholders and the communities in which we operate
Mission statement:
To improve peoples lives by developing products that address unmet medical needs in the fields of gastroenterology, dermatology and healthtech
Cosmo Pharmaceuticals ESG Report 1
1. The Cosmo Group 2. ESG Strategy and Governance 3. The Environment 4. Human Resources 5. Corporate Governance 6. Our Clinical Trials 7. Product Quality and Safety 8. Business Ethics 9. Our Community
Our strategy
In gastroenterology our focus is to improve the safety profile and efficacy of molecules that are already on the market
In dermatology we aim to develop novel therapies which have minimal side-effects
In healthtech we are developing cutting- edge intelligent medical devices to assist with clinical decision-making; our first device aids endoscopists in the detection of colonic mucosal lesions
We have a risk-averse financial approach and adequate cash reserves to execute our strategy.
Our overriding objective is to achieve superior long-term returns for shareholders while minimising risks.
Cosmo Pharmaceuticals ESG Report 2
1. The Cosmo Group 2. ESG Strategy and Governance 3. The Environment 4. Human Resources 5. Corporate Governance 6. Our Clinical Trials 7. Product Quality and Safety 8. Business Ethics 9. Our Community
Contents
1. | The Cosmo Group | 4 | 4. | Human Resources | 15 | 7. | Product Quality and Safety | 29 |
1.1 | About us | 5 | 4.1 | Our people strategy | 16 | 7.1 | Product safety | 28 |
1.2 | Our stakeholders | 6 | 4.2 | Our people | 17 | 7.2 | Product safety training | 28 |
1.3 | How we manage risk | 7 | 4.3 | Career management and remuneration | 19 | 7.3 | Public reporting and monitoring of product safety | 29 |
4.4 | Our work environment | 19 | 7.4 | Incident investigation and corrective action | 30 | |||
2. ESG Strategy and Governance | 8 | 4.5 | Employee training | 20 | 7.5 | Emergency response procedures | 29 | |
2.1 | Cosmo's ESG commitment | 9 | 4.6 | Restructuring responsibly | 20 | 7.6 | Product safety objectives and targets | 31 |
2.2 | Board oversight of ESG and corporate sustainability | 9 | 7.7 | Product safety audits | 30 | |||
5. | Corporate Governance | 21 | ||||||
3. | The Environment | 10 | 5.1 | Board of Directors | 22 | 8. | Business Ethics | 32 |
3.1 | Environmental strategy | 11 | 5.2 | Audit and internal controls | 23 | 8.1 | Code of Conduct | 33 |
3.2 | Pollution prevention and control | 11 | 5.3 | Executive remuneration | 24 | 8.2 | Bribery and corruption | 33 |
3.3 | Water and wastewater | 12 | 5.4 | Protecting Company assets | 24 | 8.3 | Protecting fair competition | 34 |
3.4 | Energy | 12 | 8.4 | Responsible lobbying | 34 | |||
3.5 | Atmospheric emissions | 12 | 6. | Our Clinical Trials | 25 | 8.5 | Fair treatment of suppliers | 34 |
3.6 | Use, disposal and transportation of products | 13 | 6.1 | Designing our clinical trial projects | 26 | |||
3.7 | Animal testing | 13 | 6.2 | Protecting our clinical trial research patients | 26 | 9. | Our Community | 35 |
3.8 | United Nations Sustainable Development Goals | 14 | 6.3 | Safety monitoring | 27 | 9.1 | Our community | 36 |
6.4 | Outsourcing monitoring activities | 27 |
Some of the statements in this publication may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.
Cosmo Pharmaceuticals ESG Report 3
1. The Cosmo Group 2. ESG Strategy and Governance 3. The Environment 4. Human Resources 5. Corporate Governance 6. Our Clinical Trials 7. Product Quality and Safety 8. Business Ethics 9. Our Community
The Cosmo Group
1. | The Cosmo Group | 4 |
1.1 | About us | 5 |
1.2 | Our stakeholders | 6 |
1.3 | How we manage risk | 7 |
Cosmo Pharmaceuticals ESG Report 4
1. The Cosmo Group 2. ESG Strategy and Governance 3. The Environment 4. Human Resources 5. Corporate Governance 6. Our Clinical Trials 7. Product Quality and Safety 8. Business Ethics 9. Our Community
1.1 About us
Our business model at a glance
Our business model is based on three pillars: the development and manufacturing of our own products, the distribution
of our products through selective partnerships, and drug development and manufacturing on behalf of third parties.
We are a business-to-business company; we do not directly commercialise and distribute our products and we do not have an internal sales force. Instead, once we develop a new product, we will typically licence it to commercial partners either immediately after receiving the relevant marketing authorisation ('MA') or before the start of phase III clinical trials. We retain the manufacturing and supply of our products and our commercial partners are responsible for the distribution of our products into the market place.
This model enables us to maintain a lean and simple cost base, focus on multiple research and development ('R&D') opportunities and increase profitability as new products generate revenues.
Our revenue streams typically include upfront payments, royalties and milestones, revenue from the supply of our products, and revenue from contract manufacturing.
Manufacturing
At our plant located in Lainate (Milan), Italy (the 'Plant'), we manufacture our own products and also operate as a contract development and manufacturing company, manufacturing products for third parties. We manufacture high quality products for both clinical and commercialisation purposes in compliance with good manufacturing practices ('GMP') standards. Active pharmaceutical ingredients ('API'), excipients and packaging materials are delivered by our suppliers directly to our Plant, and finished products are collected at our Plant by our partners. As a consequence, we do not manage the transportation of materials or finished products either to or from our Plant, thereby minimising our environmental impact.
Business relationships
We enter into business relationships mainly with two categories of partners, namely our selected suppliers and licensees. Operating in the highly regulated pharmaceutical industry, we rigorously select our suppliers of API, excipients and packaging materials. We generally transfer the MA of our products to our licensees, who then become responsible for pharmacovigilance and the management of product end-of-life.
Development and | Distributed through | Drug development and | |||||||||||||
manufacturing of | our selective | manufacturing on behalf of | |||||||||||||
own products | strong partnerships | third parties | |||||||||||||
This enables Cosmo to
Bear no cost for | Have a | Increase profitability | ||||
Focus on multiple | and EBITDA as new | |||||
a commercial | lean and simple | |||||
R&D opportunities | products generate | |||||
infrastructure | cost base | |||||
revenues | ||||||
Cosmo Pharmaceuticals ESG Report 5
1. The Cosmo Group 2. ESG Strategy and Governance 3. The Environment 4. Human Resources 5. Corporate Governance 6. Our Clinical Trials 7. Product Quality and Safety 8. Business Ethics 9. Our Community
1.2 Our stakeholders
We understand that focusing on our stakeholders helps us to create long-term value.
We recognise that we have responsibilities to multiple stakeholders including employees, patients, business partners, regulatory bodies, healthcare professionals and communities. We are committed to growing and creating value in a responsible and sustainable manner, protecting the environment, providing a safe working environment for our employees and respecting the laws and regulations in the countries in which we operate, while developing products which improve the quality of peoples' lives.
We have identified our key stakeholders and we are committed to building solid and long-lasting relationships with them.
Our stakeholder engagement takes different forms, such as internal meetings with employees, meetings with financial analysts and shareholders, and meetings with regulatory bodies in relation to clinical trial design and the product approval process.
International and local organisations
Business | Local |
partners | communities |
Healthcare | Authorities |
professionals |
Patients | Media |
EmployeesInvestors
Cosmo Pharmaceuticals ESG Report 6
1. The Cosmo Group 2. ESG Strategy and Governance 3. The Environment 4. Human Resources 5. Corporate Governance 6. Our Clinical Trials 7. Product Quality and Safety 8. Business Ethics 9. Our Community
1.3 How we manage risk
The Board of Directors of Cosmo (the 'Board') is responsible
for determining Cosmo's risk tolerance and for ensuring that risk management systems and internal controls are in place.
To this end, the Board has implemented a comprehensive risk management framework in order to ensure that internal controls are adequate, that financial reporting is reliable, that all laws and regulations are complied with, and that the assets of the Company are protected.
The Group's risk management framework is designed to identify, evaluate and mitigate risks, including ESG-related risks. Risks identified through our risk management framework are categorised, prioritised and assigned to a separate person who is required to continually monitor, evaluate and report on the risk(s) for which they are responsible.
Risks are classified into risks that can be managed by appropriate in-house action or risks that cannot be managed by internal action. All risks that cannot be met by internal action are then split into risks that can be insured and those that cannot be reasonably insured and must be borne as business risks.
Risk management structure
Board
Responsible for overseeing the Group risk management system, assessing the most significant risks and how these are managed.
Audit Committee
Assists the Board in executing
its duties in relation to risk management and oversight. Responsible for monitoring internal controls, overseeing financial controls and accounting policies.
Executive
Management
Updates the Board in relation to the main risks facing the Group and the mitigants in place to deal with such risks. Responsible for updating the risk register where impact and likelihood of risks are assessed.
Cosmo Pharmaceuticals ESG Report 7
1. The Cosmo Group 2. ESG Strategy and Governance 3. The Environment 4. Human Resources 5. Corporate Governance 6. Our Clinical Trials 7. Product Quality and Safety 8. Business Ethics 9. Our Community
ESG Strategy and Governance
2. ESG Strategy and Governance | 8 | |
2.1 | Cosmo's ESG commitment | 9 |
2.2 | Board oversight of ESG and corporate sustainability | 9 |
Cosmo Pharmaceuticals ESG Report 8
1. The Cosmo Group 2. ESG Strategy and Governance 3. The Environment 4. Human Resources 5. Corporate Governance 6. Our Clinical Trials 7. Product Quality and Safety 8. Business Ethics 9. Our Community
2.1 Cosmo's ESG commitment
At Cosmo we are committed to sustainability and the implementation of sustainable business practices across our operations.
Cosmo acts responsibly in its relationships with its employees, partners and communities.
We are committed to the highest ethical standards when conducting business, to acting in an environmentally responsible manner, to integrating climate change related risks into our business strategy, and to respecting the dignity of our employees, suppliers and partners. We maintain a safe and healthy work environment, and we have a Code of Conduct and an Anti-Bribery and Corruption Policy, both of which have been approved by the Board.
2.2 Board oversight of ESG and corporate sustainability
The Board has formed an Environmental, Social & Governance Committee (the 'ESG Committee'). The purpose of the ESG Committee is to further assist the Board in fulfilling its oversight responsibilities with regard to ESG matters. The ESG Committee must consist of at least three Directors; ESG Committee members must be appointed by the Board and may be removed by the Board. The ESG Committee has oversight over Company ESG matters.
ESG Committee members
David Maris (Chairman), Dieter A. Enkelmann, Kevin Donovan.
All the ESG Committee members have relevant ESG experience.
Primary responsibilities of the ESG Committee:
- Recommend to the Board an overall ESG strategy for the Company;
- Oversee the Company's ESG policies and procedures and performance;
- Oversee the Company's ESG reporting; and
- Report to the Board in relation to the activities of the ESG Committee.
A review of our ESG strategy and performance is carried out by the Board at least once per annum.
Our main focus areas
Communities
Environment
Patients
Acting
responsibly
People
Cosmo Pharmaceuticals ESG Report 9
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Disclaimer
Cosmo Pharmaceuticals NV published this content on 20 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 March 2024 08:19:01 UTC.