Climate Change Data

XBRANE BIOPHARMA AB

Climate Impact & Sustainability Data (2022, 2023)

Reporting Period: 2022

Environmental Metrics

Total Carbon Emissions:10 tCO2e/year (Scope 2)
Scope 1 Emissions:0 tCO2e/year
Scope 2 Emissions:10 tCO2e/year

ESG Focus Areas

  • Contribute to health equality
  • Be seen as a credible player
  • Be a responsible player in society
  • Be an attractive employer

Environmental Achievements

  • Baseline for greenhouse gas emissions set (Scope 2 emissions were 10 tonnes of eCO2)

Social Achievements

  • Marketing authorization for Ximluci® in the EU
  • Great Place to Work® certified for the second year in a row
  • Ranked 11th on Albright’s Green List on Equality

Governance Achievements

  • 11 contract manufacturer audits completed
  • eQMS ready for implementation as an internal quality system
  • 100% of employees trained in the Code of Conduct

Climate Goals & Targets

Medium-term Goals:
  • Generate EUR 100m in revenue from Ximluci®
  • Start one new development program per year
  • Achieve positive cash flow in 2024
Short-term Goals:
  • Support STADA in establishing Ximluci® as a leading biosimilar to Lucentis® in Europe
  • Obtain a BLA for Ximluci® in the US and support the launch with Bausch+Lomb
  • Obtain market authorization for Ximluci® in Saudi Arabia and other Middle Eastern countries and support the launch with STADA
  • Scale up the production process and prepare clinical studies for BIIB801 with Biogen
  • Establish a commercial partner for the oncology portfolio

Environmental Challenges

  • Unclear demand for Ximluci®
  • Dependence on distribution partners
  • Supply chain risks
  • Risks associated with US market approval
  • Difficulty in finding third-party distributors
  • Upscaling of BIIB801
  • Production process with high analytical similarity for the oncology portfolio
  • Agreements with commercialization partners
  • Product launch delays
  • Access to expertise
  • Divestment of Primm Pharma
  • Financing risk
  • Exchange rate risk
  • The conflict in Ukraine
Mitigation Strategies
  • Competitive pricing and health economics improvements
  • Market monitoring
  • Close cooperation and active dialogue with contract manufacturers and regular quality audits
  • Close and continuous dialogue with the FDA and prominent regulatory consultants
  • Active work with STADA, mainly in Latin America
  • Active work with contract manufacturer AGC Biologics and Biogen
  • Established analytical lab with the best analytical instruments and high-quality personnel
  • Active work to find a commercialization partner for its oncology biosimilars
  • Being an attractive employer
  • Ongoing negotiations and good conditions for a sale
  • Evaluating several different options for new financing
  • Continuous reconciliations

Supply Chain Management

Supplier Audits: 11/year

Climate-Related Risks & Opportunities

UN Sustainable Development Goals

  • Goal 3
  • Goal 6
  • Goal 8
  • Goal 12
  • Goal 16

Awards & Recognition

  • Great Place to Work®

Reporting Period: 2023

Environmental Metrics

Total Carbon Emissions:9 tonnes of eCO2 (Scope 2)
Scope 1 Emissions:None
Scope 2 Emissions:9 tonnes of eCO2

ESG Focus Areas

  • Health equality
  • Credibility
  • Responsible acting in society
  • Attractive employer

Environmental Achievements

  • Reduced non-recyclable waste in the office by 20%

Social Achievements

  • Launched Ximluci® in 12 EU countries, contributing to an estimated 4,000 patients treated and EUR 9 million saved for society
  • Great Place to Work certified for the third year in a row
  • Ranked 23rd on Allbright’s Green List of equal companies

Governance Achievements

  • Joined the UN Global Compact
  • Implemented a sustainability policy and Supplier Code of Conduct
  • Conducted eight quality audits of suppliers
  • Implemented an electronic Quality Management System (eQMS)

Climate Goals & Targets

Medium-term Goals:
  • Scale up BIIB801 manufacturing and sell clinical material to Biogen Inc.
  • Out-license Xdivane™ to a global commercialization partner
  • Achieve positive cash flow in Q1 2025
Short-term Goals:
  • Support STADA in growing sales of Ximluci® in Europe
  • FDA approval and launch of Ximluci® in the US
  • Launch pre-filled syringe for Ximluci® in Europe in Q1 2025

Environmental Challenges

  • Slower than anticipated sales uptake of Ximluci® in Europe
  • Uncertainty about US market approval for Ximluci®
  • Dependence on distribution partners
  • Financing of clinical studies for pre-clinical products
  • Potential delays in the production process of product candidates
  • Need to secure agreements with commercialization partners
  • Managing growth as a relatively small company
  • Financing risk
Mitigation Strategies
  • Increased market activities and optimized manufacturing plan for Ximluci®
  • Maintaining close dialogue with the FDA and using regulatory consultants for Ximluci®
  • Working with contract manufacturers to prepare for inspections
  • Intensive efforts to conclude agreements with partners for Xdivane™ and Xdarzane™
  • Active collaboration with contract manufacturers AGC Biologics and Biogen Inc. for BIIB801 and Xdivane™
  • Active dialogue with potential licensees for oncology portfolio
  • Cost reduction program to reduce the number of employees
  • Rights issue of shares and warrants to secure funding

Supply Chain Management

Supplier Audits: 8

Responsible Procurement
  • Supplier evaluation process implemented
  • Code of Conduct for Suppliers

Climate-Related Risks & Opportunities

Reporting Standards

Frameworks Used: UN Global Compact

Certifications: Great Place to Work

UN Sustainable Development Goals

  • Goal 3: Good health and well-being
  • Goal 10: Reduced inequalities

Xbrane's vision and business concept are directly linked to global sustainability by striving to improve access to effective and high-quality drugs at a lower cost to society.

Sustainable Products & Innovation

  • Ximluci®

Awards & Recognition

  • Great Place to Work
  • Allbright’s Green List