Evotec SE Case
Financing state of the art R&D and biologics manufacturing
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and the European Investment Bank (“EIB”) announced on 10th February 2023 that the EIB has granted Evotec an unsecured loan facility of € 150 m to support the Company’s R&D activities, equity investments and the building of the new J.POD® biologics manufacturing facility on Evotec’s Campus Curie in Toulouse, France.
Through this new financing of € 150 m, the EIB reiterates its supports to Evotec, a company that it already supported in 2017 with a financing of € 75 m. This new agreement is to be signed in Toulouse during a visit of the site on which the new biologics manufacturing facility will be built.
As a life science company focused on research, development, and manufacturing of novel precision medicines, Evotec aims to create global access to first- and best-in-class therapeutics. The Company works in partnerships with all Top 20 Pharma and more than 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders to achieve a better disease understanding and deliver novel and more targeted therapeutic approaches regardless of therapeutic modality.
The EIB funding specifically supports Evotec’s business strategy through a unique, innovative and flexible financing structure including a low fixed interest rate plus a reward-sharing component for the EIB. The loan with a total volume of up to € 150 m will be invested over a period of three years and each tranche will mature seven years after draw down. Evotec will use the financing to fund its internal R&D activities, equity investments, as well as the new biologics manufacturing facility, J.POD® Toulouse, France (EU).
By providing funds for proprietary research in a broad range of currently underserved therapeutic areas, the EIB financing will enable Evotec to initiate additional innovative R&D activities as well as create new partnering opportunities, leveraging its precision medicine platforms. Since 2016, Evotec has also been driving medical innovation as an operational investor in early-stage biotechnology companies – spin-offs, joint ventures as well as independent start-ups. The EIB financing will enable Evotec to further broaden its portfolio, which currently spans more than 90 active projects across more than 30 companies worldwide.
On the manufacturing side, the EIB financing will support the construction of a highly innovative facility for continuous biologics manufacturing at Evotec’s Campus Curie. J.POD® Toulouse, France (EU) is the second facility of its kind and the first one on European ground. It will bring advanced biomanufacturing to the EU and will deliver much-needed clinical and commercial manufacturing capacity for biologics. The construction of J.POD® Toulouse, France (EU) is also supported by the French government, the Occitanie Region, Bpifrance, the Haute-Garonne prefecture as well as Toulouse Métropole with up to € 50 m.
The transaction was signed by Evotec CEO Dr Werner Lanthaler, Evotec CFO Enno Spillner, Alessandro Izzo, EIB Director Equity, Growth Capital and Project Finance, and EIB Vice-President Ambroise Fayolle at a ceremony held on Evotec’s Campus Curie in Toulouse on February 10, 2023.
Enno Spillner, Chief Financial Officer of Evotec, commented: “We are excited to enter into this second financing agreement with the European Investment Bank. By funding transformational projects in key areas of public interest, EIB is an important driver of innovation in the EU. We are honoured and excited to be able to create new R&D partnering opportunities and establish Europe’s first J.POD® biologics manufacturing plant through the innovative financing model from the EIB at highly attractive terms. This new agreement with EIB builds on the excellent relationship we have developed as part of the first financing agreement entered in 2017. The EIB’s support will help us deliver on our mission ‘Together for Medicines that Matter’.”
EIB Vice President Ambroise Fayolle said: “We are very pleased to support Evotec's investments in research, development and innovation with this second financing agreement signed with the European Investment Bank. It demonstrates our commitment to supporting European biotech companies at the cutting edge of innovation in a sector marked by very strong global competition. This EIB investment will also have a significant impact on activity in the Toulouse region, as it will help to finance a 12,000 square metre plant that will create more than 200 highly skilled jobs.”
The transaction is going to be signed by Members of Evotec’s Management Board and the Vice President of the European Investment Bank, Ambroise Fayolle, during a ceremony on Evotec’s Campus Curie in Toulouse today. This financing agreement, as well as a previous loan of € 75 m by the EIB in 2017, has been developed in cooperation with kENUP Foundation, an NGO supporting innovation in Europe.
The European Investment Bank's Press Release on the matter can be found here.
Cape Biologix Case
plant-based manufacturing of affordable proteins for use in diagnostics, diagnostics and therapeutics
African manufacturing of proteins needed for the vaccines, rapid testing kits and treatments of COVID-19 and other endemic diseases will be transformed by the extension of Cape Biologix Technologies existing factory in Cape Town, followed by the construction of a new facility in Mauritius.
The large-scale cGMP manufacturing facility aims to ensure the supply of crucial reagents for the production of 100 million vaccines a month for distribution across Africa, the Caribbean and Pacific. The support will enable Cape Biologix to substantially enlarge manufacturing capacity, expand laboratory processing and build climate controlled hydroponic grow rooms to provide plant-made proteins for prevention, testing and treatment of COVID-19 and other endemic diseases.
Initiated by kENUP Foundation, new financing from the European Investment Bank (EIB) and FIND (the Foundation for Innovative New Diagnostics) for the EUR 47.5 million project was formally agreed earlier today. The EIB will provide EUR 33.3 million for the specialist manufacturing plant in Mauritius. This has been complemented by EUR 3.2m provided by FIND that is being used to fund the rapid scale-up of the pilot phase production in Cape Town, South Africa.
“Scaling up medical innovation and specialist manufacturing is crucial to control COVID-19 and combat other diseases that can be treated, but for which treatments are not accessible to many in African countries. The European Investment Bank, as part of Team Europe, is pleased to provide EUR 33 million to support Cape Biologix to expand pharmaceutical production, create jobs and increase access to affordable disease testing and treatment across Africa and around the world by increasing the affordability of key proteins. This new investment, backed by the EIB and FIND, is bringing world class research from laboratories in Cape Town to improve the lives of millions of people.” said Ambroise Fayolle, European Investment Bank Vice President.
“Local innovation and manufacturing are critical to ensuring that quality tests can reach all who need them. We are very happy to build on our longstanding relationships in South Africa to work together on this transformative project with Cape Bio, in partnership with the EIB, translating exciting research into tangible products that will benefit everyone in the region. Building local capacity is not only needed today for COVID-19, but will also improve South Africa’s preparedness to respond to future threats.” said Dr Catharina Boehme, CEO of FIND.
“Effective and affordable testing and vaccinations are crucial to tackle COVID-19, HIV and other diseases causing immense health, social and economic harms to human health across Africa and around the world. Cape Bio Pharms, the holding Company of Cape Biologix, has successfully shown how plant protein can quickly and economically produce proteins essential for disease testing and therapy. Support from the European Investment Bank and FIND will unlock large scale production of COVID-19 tests and vaccines here in Africa and unlock large scale specialist production to combat HIV and a range of diseases impacting millions of people around the world.
Today is a milestone for medical research in Africa and global public health. To get a start-up off the ground takes enormous effort and I am extremely grateful for the early investment by Dr Wolfus Otto and Richard Radtke, but more so for the strategic Business Development and scale up expertise that Dr Otto has provided to get us to the this fantastic milestone” said Belinda Shaw, Cape Bio Pharms CEO.
Belinda Shaw, CEO of Cape Biologix Technologies Ltd; Hon. Prof. Mamokgethi Phakeng, Vice-Chancellor of the University of Cape Town; Dr. Wolfram Otto, Investor
“Team Europe is committed to strengthening healthcare resilience and innovation in Africa. Supported by the European Investment Bank and global partners, this new investment will create skilled jobs in Mauritius and use world-class African research to improve public health around the world and it reconfirms the high attractiveness of Mauritius as a place to do business, located at the crossroad between Africa and Asia.” said Vincent Degert, European Union Ambassador to Mauritius.
Cape Bio Pharms is a spin-off from the University of Cape Town. The young company has successfully developed a wide range of antibodies, fusion proteins, peptides and enzymes. These contribute to critical research by life scientists around the world and accelerate the search for new diagnosis and treatments to the onslaught of human diseases.
“The western world is not in the habit of turning to Africa for solutions to global problems – even though we Africans have the innovative mindset as well as hands-on experience of the challenges the world faces. The European Investment Bank is demonstrating its commitment not only to the poor around the world who will benefit from Cape Bio Pharms innovation, but also to the ability of African-based research and technology to address a critical health need we all share.” said Mamokgethi Phakeng, Vice-Chancellor of the University of Cape Town.
The new EIB financing for Cape Bio is provided under the dedicated Impact Financing Facility that supports high-impact innovative and development focused investment across Africa, the Caribbean and Pacific.It was announced at a virtual signing ceremony attended by the CEO of Cape Bio Pharms, Vice President of the European Investment Bank, Vice Chancellor of the University of Cape Town, Board Member of FIND, and EU Ambassador to the Republic of South Africa.
API for Africa Case
Strengthening regional demand and supply chains while reducing Africa's dependency on drug imports
On 17 December 2020, the European Investment Bank launched the first ever scheme to strengthen local production of Active Pharmaceutical Ingredients (API) in Africa and scale up drug manufacturing essential to improve public health. This new initiative is aligned with World Health Organisation goals and the recently announced cooperation between the EIB and WHO to combat COVID-19 and strengthen health system resilience to better face future pandemics.
Initiated by kENUP Foundation, the EIB’s new EUR 50 million pharmaceutical investment initiative will contribute to reducing dependency on drug imports and address medical supply chain weaknesses linked to COVID-19. The programme will improve availability of specialist drugs and tackle supply chain challenges that currently damage public health across Africa.
In recent months, the global COVID-19 pandemic has strained fragile supply chains and led to acute local shortages of medical and pharmaceutical supplies, including drugs to treat HIV. Increasing local production will reduce dependency on imports and exposure to counterfeit drugs. Scaling up pharmaceutical investment in Africa will help to protect millions of people from disease and disability and strengthen resilience to ongoing and future pandemics.
“Accelerating high-impact pharmaceutical investment across Africa is crucial to improve public health, address medical supply chain weaknesses and unlock long-term economic development. The European Investment Bank is pleased to launch the first-ever financing initiative to scale up local production of API in Africa. This scheme has been designed with African and global experts and builds on the EIB’s unique global technical experience and financing expertise supporting health and innovation investment.” said Thomas Östros, European Investment Bank Vice President.
“COVID-19 has highlighted how public health in Africa is vulnerable to global supply chains and dependent on international production. Increasing local specialist manufacturing of Active Pharmaceutical Ingredients will help to improve the public health of millions of Africans. This new initiative demonstrates how specialist pharmaceutical and financing expertise can create jobs and a better future for Africa.” said Dr Mariângela Batista Galvão Simão, World Health Organisation Assistant Director-General responsible for Access to Medicines and Health Products.
“Team Europe’s new support of Africa to scale up manufacturing of API in Africa and build on the strengths of existing manufacturing expertise in Kenya and elsewhere in Africa will help to protect millions of people from disease and disability. In Africa the demand for pharmaceuticals is expected to double by the end of the next decade, this provides huge business opportunities for African pharmaceutical companies.” said Simon Mordue, European Union Ambassador to Kenya.
The API financing initiative was formally launched earlier today with participation of representatives from the European Investment Bank, World Health Organisation, EDCTP, Global Access in Action at Harvard Law School and kENUP Foundation. Kenyan-based non-profit APIFA (API for Africa) contributed their expertise throughout the process of establishing this financing facility and will act as a non-exclusive promotor to the facility.
“This is a timely facility that will transform the pharmaceutical manufacturing industry on the continent and thus enhance access to essential medicines for vulnerable populations. We call on all relevant stakeholders to now work together to support manufacturers in this transformation journey and ensure the long-term viability of this initiative”, says Gerald Macharia, a Founding Director of APIFA, an NGO promoting this initiative in the region
“In the spirit of leaving no region behind in the pursuit of Sustainable Development Goals, we warmly welcome the launch of the API for Africa initiative. This will add value to future Research & Development with more active involvement of the African region”, added Michael Makanga, Executive Director of EDCTP.
Long-term financing will be available in USD, EUR and local currency and can cover up to 90% of the total cost of eligible investment, as part of the EIB’s exceptional response to COVID-19. EIB financing can co-finance projects alongside philanthropic, equity, development financing or support from commercial banks.
The scheme will enable Africa to benefit from predicted doubling in local pharmaceutical sales over the next decade, improve access to healthcare and create specialist jobs on the continent. Demand for pharmaceutical products in Africa is expected to double to EUR 60 billion by 2020. The EIB initiative will provide long-term financing for pharmaceutical production across sub-Saharan Africa and specifically target manufacturing of API that constitute 45% of final drug costs.
Serum Institute
of India - TB Vaccine Case
of India -
EIB impact financing to develop novel vaccine against tuberculosis
Every year, nearly 1,5 million people die from tuberculosis, a disease which according to the WHO is ‘treatable and preventable’, and which is the leading cause of death from a single infectious agent worldwide.
The European Investment Bank (EIB) on August 27, 2020 agreed a €30 million loan with Vakzine Projekt Management GmbH, the German subsidiary of Serum Institute of India Pvt. Ltd., the world’s largest vaccine manufacturer. The agreement, initiated by kENUP Foundation, will support research and development of a new vaccine to prevent tuberculosis in infants in particular in high-risk HIV+ populations. The EIB loan is supported by the dedicated Impact Financing Envelope. The financing structure consists of a contingent loan where the repayment is due only if market authorization is achieved. If the trials do not reach the primary endpoint, the loan is written off.
“We are very pleased to get European Investment Bank funding for such an important trial for tuberculosis and upcoming HIV trials. With this support, I am confident that we will be able to help eliminate these dreadful diseases. Going forward such support from Institutions like the EIB will play a key role in tackling major diseases which have killed millions of people in developed and developing world.” said Dr. Cyrus Poonawalla, Chairman & Managing Director, Serum Institute of India Pvt. Ltd.
The World Health Organization declared tuberculosis a global emergency even surpassing HIV as the leading cause of infection-related death. “The BCG vaccine is the only tuberculosis vaccine currently available and is the standard of care for primary tuberculosis prevention for infants. Our goal is to replace BCG with VPM1002, which is safer, better tolerated and hopefully more effective, as prime vaccine in newborn infants. An achievement like this could be the long-desired turning point in global TB containment for almost 100 years.” Dr. Leander Grode, CEO of Vakzine Projekt Management GmbH.
“Tuberculosis is one of the top ten causes of death worldwide, causing millions of victims in recent years.” said Ambroise Fayolle, European Investment Bank Vice President. “Although the world is currently mostly preoccupied with Covid-19, TB and HIV have not gone away, yet they are treatable or even preventable. I’m proud that the European Investment Bank can support late-stage research into an improved TB vaccine that can save lives, especially children, as well as develop novel treatment for HIV. This research could have an enormous impact on health worldwide, and especially across Africa."
Vaccine research and development for the project will be carried out by Vakzine Projekt Management in Germany and clinical trials scaled up in several high-burden sub-Saharan countries. The vaccine will be also tested in high-risk, HIV-exposed groups to enable more effective treatment in Africa.
The €30 million EIB loan signed today will finance the late stage (phase III) clinical trial of a new and improved vaccine protecting against Tuberculosis in infants, which is also partly financed by the European & Developing Countries Clinical Trials Partnership (EDCTP).
With 26% of new cases on the African continent, and two countries in the top six of most impacted countries, these developments could have a major health impact on the local population. Next to this, the parties expect to sign a further €15m loan in the near future in support of R&D investment into a portfolio of new drugs for the prevention and treatment of HIV, the virus that causes AIDS.Tuberculosis is the most common illness among people living with HIV, including among those taking antiretroviral treatment, and it is the major cause of HIV-related deaths. Sub-Saharan Africa bears the brunt of the dual epidemic, accounting for 84% of all deaths from HIV-associated tuberculosis in 2018.
In particular, research backed by the EIB help to ensure a higher level of protection, improve safety and accelerate large scale production of a novel TB vaccine for immunisation of infants than BCG. Affordability and availability of the vaccine is the primary goal of the initiative. Additionally, VPM1002 may potentially have positive effects on COVID-19 infections. A study is currently testing whether it can protect from COVID-19, following research on mice, which showed it can protect against other viral lung infections.
This investment is executed in alignment with the cooperation agreement signed by EIB and the WHO that aims at enhancing cooperation to support in particular low- and middle-income countries in addressing the health impact of COVID-19 and building resilient health systems to face future pandemics. The first phase of this agreement will address urgent needs and strengthen primary health care in African countries. The EIB is committed to significant investments for the purpose of improving global public health, to support the SDGs and to ensure that no one is left behind. This initiative is especially relevant for LMICs and promotes universal health coverage by ensuring that all individuals and communities receive the health services they need without suffering financial hardship.
The signature of the finance contract was celebrated with an online signing ceremony, organized by kENUP Foundation. The WHO Chief Scientist Dr Soumya Swaminathan, Dr. Stefan Kaufmann, Founding Director of Max Planck Institute for Infection Biology and founding father of the improved TB vaccines, Ambroise Fayolle, Vice President of EIB, Dr Cyrus Poonawalla, Chairman and Managing Director SIIPL, Leander Grode, Managing Director VPM, and Björn Thümler, Minister of Science and Culture of Lower Saxony joined the ceremony and participated as speakers.
The recorded live event can be found here.
Malaria Fund Case
Fighting Malaria with an innovative financing mechanism
Today, still more than 750 children worldwide and under the age of five die every single day from a preventable disease: Malaria. For centuries, this mosquito-borne infectious disease has put a high societal and economic burden on many countries, especially on countries of the Global South. Unfortunately, progress in global Malaria efforts has stalled in recent years.
A market failure around the development of interventions against Malaria is the reason for the lack of innovation and progress: high risk in product development is associated with little potential profit. Once a project leaves academia, big pharmaceutical companies are usually not investing.
For almost three years, kENUP Foundation has worked diligently to establish the EU Malaria Fund, aimed at tackling the cause of malaria throughout the various disease stages by furthering all modes of impact, including vaccines, diagnostics, and therapeutics. Finally, on 3 June 2020, the fund has been officially established with a first closing of €70 million. It aims to raise up to €280 million within the next two years. The EU Malaria Fund is a public-private partnership between the European Union, International Organizations, corporations, and organized civil society, providing a novel funding instrument to address the market failures in infectious diseases with significant relevance to public health globally.
The major contributor to the Fund is the InnovFin EU programme funded by EU Horizon 2020 and jointly managed by the European Commission and the European Investment Bank (EIB). Part of the project is supported by the European Fund of Strategic Investments, the financial pillar of the Investment Plan for Europe. These contributions are complemented by investment from Investitionsbank Berlin, the Bill & Melinda Gates Foundation, Fondazione Monte Dei Paschi Di Siena, Jacques und Gloria Gossweiler Stiftung, Invethos AG, FINDdx, and Novartis AG.
Overall, three distinct tranches are available for investors: A non-repayable grant layer, made up of various individual donations in combination with a public benefit investment of up to 50% of the total EUMF size amounts to the first-loss piece (junior capital), carrying a 3% fixed annual interest. Additionally, a senior capital tranche, carrying a 3% fixed annual interest, makes up the third part of the EUMF.
The EU Malaria Fund works with a portfolio of promising projects. Compared to other diseases, only few companies are active in the Malaria domain. Those originate from technology transfer out of many of Europe’s leading research organisations and are not yet invested in by a large pharmaceutical company. The fund prefers to fund platform projects, allowing for secondary exploitations of their anti-malaria assets, for example into COVID-19 and other important under-served infectious diseases.
The fund provides venture loans to its portfolio companies, with disbursements based on verifiable output-driven milestones. These usually amount to the successful completion of a specified stage in the phases of the drug development, testing and approval process. The loans carry a fixed-interest rate compounded on an annual basis and must be repaid in a single instalment on the maturity date of the loan.
In cooperation with the National Academy of Medicine, the EIB, and the fund’s high-profile Scientific Advisory Council, kENUP and Investitionsbank Berlin have built a now well-established vetting and investment process that ensures the fund is only investing in high-potential projects.
On 18 June 2020, the EU Malaria Fund presented its first investment into the Italian company AchilleS Vaccines Srl. AchilleS Vaccines is a Siena-based biotech company specialising in research on malaria, antimicrobial resistance and, lately, COVID-19. The company follows an innovative approach to malaria vaccine development while also offering reverse vaccinology-based therapeutic and preventive interventions against COVID-19. The fund also offered support to Themis, a company that has developed a platform to rapidly advance immune modulation therapies for a range of infectious diseases and cancer.
kENUP Foundation is proud to have contributed to this important initiative. If successful, this initiative would be proof, that minimally invasive and highly innovative blended financing instruments can help to tackle the world’s most pressing public health issues with underlying market failures.
More information on the fund, the detailed handbook of investment guidelines, and its latest developments can be found here.
Bio-Convergence Case
Connecting the innovation systems of the European Union and the State of Israel
On April 30, 2020, the European Investment Bank (EIB) and the Israel Innovation Authority (IIA) have concluded a cooperation agreement to jointly pursue investments in the globally emerging domain of bio-convergence. The collaboration's aim is to advance the technological and investment alliances particularly at the intersection of biopharma, information technology and engineering. These three industries are pillars of both European and Israeli R&I systems, and they are indispensable components towards achieving both partner's global public health goals.
At the invitation of kENUP Foundation, EIB and IIA convened a series of meetings between October 2018 and January 2020 to discuss how to strengthen innovation in Israel and the EU, deepening the links between the two regions, closing investment gaps, jointly assuming leadership in the area of bio-convergence, and ultimately adding value for the benefit of Israeli and European citizens.
Under the envisaged scheme, both, EIB and IIA, would invest into a portfolio of innovative Israeli and European companies using each institution’s respective rules, procedures and mandates. At the same time, mutual support with appraisals and due diligence ensures a thorough and swift investment process.
The EIB has a variety of mandates and programmes at its disposal to support this scheme. Depending on the projects at hand, EIB will select the appropriate mandate. Generally, the EIB provides venture debt of up to 50% of project costs for companies active in markets with underlying market failures.
The IIA uses its dedicated R&D Fund, designed for industrial R&D support for the development of innovative competitive products and technologies. The support is offered to all Israeli High Tech companies in all sectors, at all stages of R&D. Under this mandate, the IIA shares up to 50% of the project’s R&D costs. Companies operating in favorable development regions are eligible for additional support of 10%-25%.
Pluristem Therapeutics Inc. (see below) was the first company to receive financing under the co-investment scheme between Israel and the EU. kENUP is currently scouting relevant companies that could potentially benefit from such a scheme. If successful, such a scheme could be the blueprint for efficient and highly relevant international innovation promotion and cooperation of the European Union.
The high-level online signature event was attended by EIB Vice-President Ambroise Fayolle, Dr Ami Appelbaum, Chairman, Israel Innovation Authority and Chief Scientist at the Ministry of Economy and Industry the EU Ambassador to Israel Emanuele Giaufret, the Israeli Ambassador to the EU Aharon Leshno-Yaar, Pluristem CEO and President Yaky Yanay, and kENUPs own Holm Keller, Executive Chairman. The video of the online signature event can be found here.
More information on the co-investment scheme can be found here. If you represent a company who might benefit from such a scheme, kindly get in touch with us at bioconvergence@kenup.eu.
Pluristem Case
Funding regenerative cell therapy platform, initial application in COVID-19
Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PSTI) and the European Investment Bank (“EIB”) have - in a
public online ceremony
held on April 30, 2020 - signed a Finance Contract governing an unsecured €50 million non-dilutive financing for the Company.
This Approved Financing will support Pluristem’s research and development in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19. The Approved Financing will be deployed in three tranches, subject to the achievement of certain clinical, regulatory and scaling up milestones, with the first tranche consisting of €20 million.
Pluristem recently formed a wholly-owned subsidiary in Berlin, Germany, underscoring the Company’s commitment to having a physical presence in Europe to advance research and development, and to prepare for commercialization, for its product candidates.
The Approved Financing is backed by a guarantee from the European Fund for Strategic Investments (EFSI), the financial pillar of the Investment Plan for Europe, under which the EIB and the European Commission are working together as strategic partners to boost Europe’s economic competitiveness. The transaction has been initiated by kENUP Foundation.
The Approved Financing, once granted, will not be secured and will be payable to the EIB in a single payment following five years from the disbursement of the first and second tranches and in two annual payments starting on the fourth year from disbursement of the third tranche, with each tranche having an interest rate of between 3% to 4%. The Approved Financing will support up to 50% of Pluristem’s R&D project cost. In addition, the EIB would be entitled to receive royalties from future revenues for a period of seven years starting 2024, at a rate of 0.2% to 2.3%, pro-rated to the amounts that the Company received from the Approved Financing.
“We are extremely honored to have been selected by the EIB for this prestigious financing. We believe that this financing will allow us to significantly advance the clinical development of our lead product candidates, which if successful we expect will improve the quality of life for millions of patients around the world."
"Having established research partnerships with leading European institutions such as Charité University of Medicine Berlin, BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT), as well as formed a subsidiary in Berlin, we understand the importance of having a physical presence in key markets,” stated Pluristem CEO and President, Yaky Yanay.
“As we move forward into a multinational clinical trial for PLX cells to treat patients suffering from complications associated with COVID-19, we expect this EIB financing will accelerate our path to approval and to making a potentially effective COVID19 treatment available worldwide.”
Evotec Case
Financing a strategic drug-development pipeline
Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) and the European Investment Bank (“EIB”) have announced on September 8, 2017 that the EIB has granted Evotec an unsecured loan facility of up to € 75 m to support Evotec’s Innovation strategy.
The loan agreement is operated under the European Fund of Strategic Investments (“EFSI”). EFSI is an essential pillar of the Investment Plan for Europe (IPE), under which the EIB and the European Commission are working as strategic partners to boost the competitiveness of the European economy.
The transaction is the first large equity-type investment under EFSI in any industry anywhere in Europe. Furthermore, it represents EFSI’s first contingent investment, whereupon the bank shares the risk of its client’s research & development (R&D) success.
Cures are still needed for more than 3,000 serious diseases. As a consequence, indirect healthcare costs for treating patients are enormous, especially considering the impact of ageing populations in many countries of the developed world. Hence, the demand for new therapies continues to see steady growth and this requires innovation in drug discovery in a capital-efficient manner as well as through innovative financing models.
The core of Evotec’s business is research and development to support Pharma and biotech companies, venture capital groups, academic institutions as well as foundations and not-for-profit organizations. Evotec is building a sustainable pipeline of partnered diseases-modifying product opportunities. Its R&D activities are based on cutting-edge science, highest quality drug discovery platforms (e.g. Evotec’s integrated patient-derived induced pluripotent stem cells (“iPSC”) platform) and innovative collaboration models such as the BRIDGE initiatives from Academia to Pharma. Since 2010, Evotec has built a pipeline of over 80 partnered product opportunities through such partnerships, spin-offs or equity investments. These partnerships hold significant upside value for Evotec in terms of development, clinical and commercial milestones, royalties or alternatively equity participations.
The EIB funding specifically supports Evotec’s Innovation strategy through a unique, innovative and flexible financing structure including a moderate reward-sharing component for the EIB. The € 75 m total loan financing will be invested into R&D over a period of four years and will mature seven years after draw down. The long-term character of this financing reduces the cost of capital for innovation substantially. At the same time, it allows Evotec to pursue innovative drug discovery and development paths even more intensively (e.g. orphan drug programmes; invest in certain technologies and platforms), always focusing on disease-modifying treatments for diseases with an urgent unmet medical need. Evotec expects the first investments with this new funding tool already in 2017.
EIB Vice President Ambroise Fayolle, responsible for Germany and EFSI, said: “We are proud to be able to support Evotec in this innovative and competitive strategy. Boosting research and development and standing by European companies is a priority for the EIB. Innovation is a key element for Europe in a global competition, to help secure competitiveness and jobs in the future and achieve sustainable growth.”
European Commission Vice-President Jyrki Katainen, responsible for Jobs, Growth, Investment and Competitiveness, added: "The development of innovative treatments is a process which requires sustained investment. This is where the Investment Plan can play a role. I am glad that, with today's agreement, the Plan is supporting research which aims to tackle serious illnesses and diseases."
Dr. Werner Lanthaler, Chief Executive Officer of Evotec, commented: “We are honored to be part of the European Investment Plan fund and are pleased with their trust in our innovation strategy. We will remain very focused on our investments and continue to build world-leading R&D efforts. The support of the EIB with the flexibility and innovative financing model will bring down our cost of capital significantly. Adding this new financing tool to the biotech industry is a truly important milestone and will have a real impact for the global Innovation Ecosystem in drug discovery.”
BiondVax Case
Developing a Universal Flu Vaccine
BiondVax’s M-001 vaccine candidate, consisting of nine widely conserved flu epitopes, is designed to protect against current and future, seasonal and pandemic flu strains. Clinical and pre-clinical trials have shown that M-001 is safe and immunogenic and that it has the capacity to enhance and broaden coverage of current flu vaccines. M-001 has also shown potential to improve upon current seasonal flu vaccines, and potential to serve as an immediate effective response to new flu pandemic strains. The vaccine candidate has been tested in a Phase IIb clinical trial in collaboration with UNISEC, which is funded by the EU under the 7th Framework Programme for Research and Technological Development.
EIB support for the development of BiondVax’s Universal Flu Vaccine Candidate should be seen in the context of the Horizon 2020, the EU's Research Programme, in particular the EU Finance for Innovators finance facility "InnovFin Infectious Diseases", which offers bespoke products for financing high-risk projects in the field of infectious diseases.
The EIB-BiondVax non-dilutive financing agreement will be structured as a zero-percent fixed interest loan, available for up to 36 months with a variable remuneration based on royalties of net sales of M-001 following commercialization. Funds will be advanced in three tranches. The tranches are available up to 12, 24, and 36 months following the date of the agreement, and are dependent on achievement of certain specified milestones, with the ultimate milestone including authorization to launch a Phase 3 trial. The tranches are repayable five years after each drawdown. BiondVax retains the option to repay the loan and repurchase the royalties at any time.
Valneva Case
Valneva Case
Innovation in vaccine developement
Innovation in vaccine developement
