About this Report
Since 2009 Biogen has conducted materiality assessments every two to three years to identify and prioritize the corporate responsibility topics and issues most important to the company and its stakeholders. These assessments have been informed by the Global Reporting Initiative (GRI) Principles for Defining Report Content. We are in the midst of conducting a new materiality assessment for the 2019 Corporate Social Responsibility (CSR) Report to align with a review of our global CSR strategy.
The 2018 CSR Report contains data from calendar year 2018. In some instances, we include information on initiatives or activities that may have begun in 2018 but have continued into 2019. This report was prepared in accordance with the GRI Standards “core” option. Please refer to the GRI Content Index below to see which material aspects and relevant indicators are reported and how we track our efforts in alignment with the United Nations’ Sustainable Development Goals (SDGs). The SDGs comprise 17 goals and 169 associated targets that incorporate the economic, social and environmental dimensions of sustainable development. At Biogen we support all 17 goals and encourage all businesses to consider how they may also contribute. We continue to refine our CSR strategy to align with the SDGs that are most relevant to our business.
Data in this report covers our worldwide operations, including consolidated subsidiaries but excluding joint ventures. Our operations in 2018 encompassed our major facilities in North Carolina, Denmark, Switzerland and Massachusetts. The boundaries also include our global offices and our commercial fleet operations. With regard to environmental data presented in this report, the scope includes operations over which we have operational control.
ERM Certification and Verification Services, Inc. (ERM CVS) assured the 2018 data for a number of indicators, including Scope 1 and Scope 2 GHG emissions, Biogen’s carbon neutrality methodology and select environmental and social indicators. See the ERM CVS Assurance Statement below for full details of the assurance scope, assurance standards used, work undertaken and conclusions, and see the GRI Data table below for data that was assured (when a 2018 data point is printed in bold, that means that data point was assured).
Independent Assurance Statement to Biogen Inc.
GRI Materiality Approach & Process
We are currently in the midst of conducting a new materiality assessment for next year's CSR Report in alignment with a review of our global CSR strategy. Therefore, we are using the 2016 GRI materiality assessment for this report, the most recent assessment available. In this 2016 assessment, we identified 18 potentially material issues for further attention.
After reviewing the entire list, a set of tier one priorities was agreed upon for immediate attention, including: access to treatments, investments in R&D to ensure a robust pipeline and improving patient outcomes. Throughout this 2018 CSR Report, we explain how Biogen is addressing these issues and measuring performance.
The process to develop the 2016 GRI materiality assessment involved external stakeholder interviews, desk research to establish the broader sustainability context, an internal visioning workshop to prioritize and validate the issues and external stakeholder meetings to review the findings and gather feedback.
GRI Materiality Assessment Process
Our Guiding Principles
Our commitment is grounded in our Code of Business Conduct (Values in Action), our Sustainability Policy and our other related policies and position statements. These principles and policies outline our focus on ethical business conduct, compliance, accountability and transparency, among other topics. To review the full list of our commitments, visit Our Guiding Principles.
Forward Looking Statement
This report contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to Biogen’s business activities; Biogen’s strategy and plans; potential of Biogen’s commercial business and pipeline programs; capital allocation and investment strategy; clinical trials and data readouts and presentations; regulatory filings and the timing thereof; risks and uncertainties associated with drug development and commercialization; the potential benefits, safety and efficacy of our products and investigational therapies; the clinical development program for our investigational therapies; and the anticipated benefits and potential of investments, collaborations and business development activities. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “except,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including Biogen’s dependence on sales from its products; difficulties in obtaining and maintaining adequate coverage, pricing and reimbursement for Biogen’s products; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and the risks and uncertainties relating to intellectual property claims and challenges; uncertainty of long-term success in developing, licensing or acquiring other product candidates or additional indications for existing products; failure to compete effectively due to significant product competition in the markets for Biogen’s products; failure to successfully execute or realize the anticipated benefits of Biogen’s growth and strategic initiatives; risks relating to technology failures or breaches; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including Biogen’s ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of Biogen’s drug candidates; the occurrence of adverse safety events, restrictions on use with Biogen’s products, or product liability claims; Biogen’s dependence on collaborators and other third parties for the development, regulatory approval and commercialization of products and other aspects of Biogen’s business, which are outside of Biogen’s control; risks associated with current and potential future healthcare reforms; failure to comply with legal and regulatory requirements; the risks of doing business internationally, including currency exchange rate fluctuations; risks relating to management and key personnel changes, including attracting and retaining key personnel; risks relating to investment in Biogen’s manufacturing capacity; problems with Biogen’s manufacturing processes; risks related to commercialization of biosimilars; fluctuations in Biogen’s effective tax rate; risks related to investment in properties; the market, interest and credit risks associated with Biogen’s portfolio of marketable securities; risks relating to share repurchase programs; risks relating to access to capital and credit markets; risks related to indebtedness; environmental risks; risks relating to the sale and distribution by third parties of counterfeit or unfit versions of Biogen’s products; risks relating to the use of social media for Biogen’s business; change in control provisions in certain of Biogen’s collaboration agreements; risks relating to the spin-off of Biogen’s hemophilia business, including exposure to claims and liabilities; and the other risks and uncertainties that are described in the Risk Factors section of Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the Securities and Exchange Commission.
These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this report. Biogen does not undertake any obligation to publicly update any forward-looking statements.