Climate Change Data

Onxeo

Climate Impact & Sustainability Data (2013, 2014, 2016)

Reporting Period: 2013

Environmental Metrics

Social Achievements

  • BioAlliance and Topotarget have pursued their development in strict compliance with a number of corporate social responsibility rules and environmental sustainability.
  • BioAlliance Pharma actively contributes to the local, regional and European scientific and industrial community through its senior managers being active members of the Paris bioclusters, of France Biotech, the French association to support the development of the Biotech sector in France, and the European Technology Platform on Nanomedicine (ETPN).
  • BioAlliance Pharma has also a large number of collaboration and agreements in place with the academic research centers of excellence.
  • Topotarget has several academic collaborations: it is party to a clinical trial agreement with the National Cancer Institute (NCI) in the USA under which the NCI sponsors a number of clinical studies evaluating the activity of Belinostat (Beleodaq®) alone or in combination with other anticancer therapies.

Climate Goals & Targets

Long-term Goals:
  • The combined entity will develop breakthrough products and technologies, both in terms of nanoparticle formulation, delivery mucosa or targeted therapies that allow acting precisely on a therapeutic target and reducing resistance and / or intolerance.
Medium-term Goals:
  • Maximizing the existing collaborations and licensing agreements in place to have a recurrent source of revenue
  • Seeking new collaborations and licensing agreements for its late stage and registered products in European territories for which rights are available
  • Leveraging the potential of its main technologies: Lauriad® (muco-adhesive tablet) and nanoparticules internally or through collaborations
  • Leveraging the potential of its drugs by launching development programs in new promising indications with partners
  • Developing its drugs in-house up to their inflection points, therefore allowing strong value creation
  • Generating revenues from direct commercialization of its strategic products in major European countries
  • Actively pursuing new strategic development opportunities likely to create long-term value
  • Finding cost synergies between the two merged entities by consolidating or divesting activities
Short-term Goals:
  • Preliminary results of the phase II clinical trial with Validive® assessing the efficacy of Validive® in prevention of severe oral mucositis in patients treated by chemo/radiation-therapy for a head-and-neck cancer
  • 5th meeting of the Data Safety Monitoring Board (DSMB) relating to the phase III trial with Livatag® in primary liver cancer

Environmental Challenges

  • Risks of insufficient funds and financial resources; the combined entity could be facing residual shortfall of its net working capital over the next 12 months
  • Continued research is dependent on obtaining continuous financial resource
  • Risks associated with development of Belinostat (risk of non-performance of agreement by Spectrum Pharmaceuticals, Inc., risk of non-payment of the USD 25 million milestone, risk of delay in commercialization, etc.)
  • Risks related to drug research and development
  • Risk of a serious adverse event or of negative results in a clinical trial could affect the growth of BioAlliance Pharma
  • Risk of significant delays in the conduct of its clinical trials could affect the growth of BioAlliance Pharma
  • Risks related to outsourcing BioAlliance Pharma's R&D and production capabilities
  • Risks related to drug pricing and reimbursement policies
  • Risk associated with a delay in obtaining pricing and reimbursement rates or lower-than-expected rates
  • Risk that a marketed product will cease to be reimbursed
  • Risks related to commercial partnership agreements
  • Risks related to the safety of marketed products
  • Challenges and constraints related to the regulatory environment
  • Limitations on protection provided by patents and other intellectual property rights
  • Risks associated with exploited patents falling into the public domain, with the expiration of marketing licenses, or with the eventual emergence of generic drugs for marketed products
  • Variation of stock market price
  • Topotarget may become subject to appraisal proceedings in relation to the procedures of Cash Compensation and Redemption of shares
  • Risks attached to the registration of the Merger both in Denmark and France
  • The Merger is subject to conditions precedent
  • Risks relating to provisions on a change in control or the transfer of certain agreements concluded by Topotarget and/or BioAlliance Pharma
  • Risks relating to the integration of the activities of the two companies, costs relating to this integration and achieving synergies
  • Risks relating to the need to retain management and key personnel following the Merger
  • The value of BioAlliance Pharma and Topotarget and then of the combined entity shares are likely to fluctuate
Mitigation Strategies
  • Including this receipt, the combined entity has sufficient working capital for its present requirements, including the maximum requirements relating to the completion of the Merger, i.e. to cover the cash needs of the combined entity over the full 12-months period following the registration of the present Document E.
  • If necessary, the financing of this cash shortfall could, if need be and notably if market conditions allow it, be funded through drawdown from the existing equity line (PACEO) currently in place, and active research of complementary financings.

Supply Chain Management

Climate-Related Risks & Opportunities

Reporting Standards

Frameworks Used: IFRS

Reporting Period: 2014

Environmental Metrics

ESG Focus Areas

  • Social
  • Environmental
  • Societal

Social Achievements

  • Hired a collaborator with disabilities on a fixed-term basis.
  • Implemented a disability action plan.
  • Maintained a concerted permanent dialogue with social partners.
  • Allocated 138,700 stock options to 55 non-executive employees.
  • Allocated 72,000 Free Shares to 46 non-executive French employees.

Governance Achievements

  • Established a Code of Ethics in line with AMF recommendation no. 2010-07.
  • Implemented procedures for managing conflicts of interest.
  • Established three committees: Strategy Committee, Operations Committee, and Risk Management Committee.

Climate Goals & Targets

Long-term Goals:
  • Preparation of the extension of the indication in the treatment of peripheral T-cell lymphoma in first-line treatment for Beleodaq® (early 2016).
Medium-term Goals:
  • Extension phase III efforts for Livatag® by opening 10 to 15 additional centers (2015).
  • Finalisation of the analysis of the complete phase II trial results and preparation for phase III for Validive® (2015).
Short-term Goals:
  • Commencement of a phase III study for Validive® (2015).

Environmental Challenges

  • Risks related to drug research and development (serious side effects, negative results).
  • Risks related to outsourcing R&D and production.
  • Risks related to drug pricing and reimbursement policies.
  • Risk that a marketed product will cease to be reimbursed.
  • Risks related to commercial partnership agreements.
  • Risks related to the safety of marketed products.
  • Challenges and constraints related to the regulatory environment.
  • Limits on patent protection and other industrial property rights.
  • Risks associated with exploited patents falling into the public domain.
  • Risks of insufficient financial resources.
  • Foreign exchange risk.
Mitigation Strategies
  • Built product portfolio on innovative medicines with well-established profiles.
  • Conducts trials with maximum precautions, using associated experts.
  • Balances risk by organizing products in two key portfolios.
  • Audits subcontractors and rigorously monitors clinical trials.
  • Works with specialized consultants and medico-economic experts.
  • Took out specific product liability insurance.
  • Has a pharmacovigilance system complying with international regulations.
  • Acquired strong expertise in clinical and regulatory fields.
  • Maintains active relations with regulatory agencies.
  • Has a proactive Industrial Property strategy.
  • Intends to hedge US dollar flows as soon as payment assumptions are confirmed.

Supply Chain Management

Climate-Related Risks & Opportunities

Reporting Period: 2016

Environmental Metrics

ESG Focus Areas

  • Social
  • Environmental
  • Governance

Social Achievements

  • Maintained a concerted permanent dialogue with social partners.
  • Implemented an Occupational Health & Safety audit and action plan.
  • Committed €71,819.50 to continuous vocational training.

Governance Achievements

  • Strengthened the Board of Directors with the arrival of Dr. Jean-Pierre Kinet and Dr. Jean-Pierre Bizzari.
  • Created a US subsidiary, Onxeo US Inc.
  • Completed a capital increase raising €12.5 million.

Climate Goals & Targets

Short-term Goals:
  • Preliminary efficacy results in the Phase III study of ReLive by mid-2017.

Environmental Challenges

  • Risks related to drug research and development (side effects, negative results, delays).
  • Risks related to market acceptance of products.
  • Risks related to outsourcing of clinical studies and manufacturing.
  • Risks related to drug pricing and reimbursement policies.
  • Risks related to commercial development and partnerships.
  • Risks related to product safety and liability.
  • Risks related to the loss of key employees.
  • Challenges and constraints related to the regulatory environment.
  • Limits on patent protection.
  • Funding risk.
  • Risks related to the research tax credit.
  • Foreign exchange risk.
  • Dilution risk.
Mitigation Strategies
  • Diversified product portfolio with independent lines based on different technologies.
  • Maximum precautions in clinical trial protocols, expert use, and competitor product study.
  • Rigorous monitoring of clinical trials and subcontractors.
  • Audits of subcontractors' processes.
  • Clauses guaranteeing interests in licensing contracts.
  • Retention of in-house expertise to coordinate partners.
  • Specific product liability insurance.
  • Pharmacovigilance system complying with international regulations.
  • Proactive Industrial Property strategy.
  • Regularly files new patent applications.
  • Cash reserves and potential additional funding.
  • Close coordination with pharmaceutical and clinical subcontractors.
  • Active relations with regulatory agencies.

Supply Chain Management

Responsible Procurement
  • Supplier selection and audit process is carried out in line with pharmaceutical industry regulations.

Climate-Related Risks & Opportunities