>340
CGMP batches released
>50
Audits completed
>30
Process development projects
>70
Qualified assays and methods
About Oxford Biomedica
We believe in pushing the boundaries of scientific possibility and know it takes exceptional knowledge and innovative processes to make that happen.
- 1st worldwide to administer lentiviral vector gene therapy in vivo
- 1st commercial supplier of lentiviral vectors for a CAR-T therapy
AAV platform
Bring confidence to clinical trials with our proven AAV viral vector development and production process, capable of producing consistently high quality and high titre products.
We have:
- Demonstrated >E15 vg/L titers
- Achieved >90% fully intact vector
- Analytical toolbox with over 45 methods
- Process scales from 2L to 2000L
- Six successful IND/CTA filings
Tech transferred-in
Alongside our own LentiVector® and AAV platform technologies, we have the facilities and expertise to fulfil almost any development need. You define the methods and processes, and we leverage our class-leading capabilities as appropriate.
Latest news
Discover our latest updates.
Business Update
Current contracted value signed in 2023 of £124 million, an increase of 47% compared to £85 million in the year ending 31 December 2022 (excluding COVID-19 vaccine manufacturing) On track to achieve 2023 guidance provided at the Interim Results and reiteration of medium term guidance; growth supported by new orders recently signed across lentivirus, adeno-associated virus (AAV) and adenoviral vectors Progress towards multi-vector multi-site model with transfer of lentiviral vector capabilities to Bedford, Massachusetts site and acquisition of ABL Europe Recruitment of UK and US Site Heads with extensive CDMO experience to support move to site-based structure and strategic shift to a pure-play CDMO Significant progress in streamlining of operations to become a pure-play CDMO resulting in annualised cost-savings of c.£30 million Oxford, UK – 7 December 2023: Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica” or “the Company”), a quality and innovation-led cell and gene therapy CDMO, today announces a business update for the year ending 31 December 2023. Becoming a pure-play CDMO in cell and gene therapy Oxford Biomedica has made significant progress in its streamlining of operations to become a pure-play quality and innovation-led global cell and gene therapy CDMO. The Company has concluded the reorganisation of its workforce, which, among other measures to increase efficiencies, includes a more streamlined structure across the UK and US. This organisational restructuring is tailored to boost efficiency and client-centricity, aligning roles and operations with the specific requirements of a pure-play CDMO. These strategic changes will result in a reduction of the ongoing cost base from 1 January 2024 by c.£30 million on an annualised basis compared to 2023. Positive momentum in commercial activity The Company continues to demonstrate robust business development activity, a testament to its strong position in the viral vector space. This year, Oxford Biomedica has more than doubled the number of contracts and client orders signed compared to the previous year, reflecting a growing demand for its services from a diverse array of pharmaceutical and biotech clients. Current contracted value of client orders signed in 2023 is £124 million, an increase of 47% compared to £85 million in the year ending 31 December 2022 (excluding COVID-19 vaccine manufacturing). Furthermore, the pipeline of opportunities continues to progress as anticipated, not only in lentivirus, AAV, and adenoviral vectors but also in other vector types. Work with these additional vector types now account for more than 10% of the weighted pipeline. Current trading and medium term guidance In line with guidance provided at the Interim Results in September, the Company is on track to deliver revenues for the year ending 31 December 2023 of approximately £90 million. Also in line with guidance provided at the Interim Results, Operating EBITDA loss for the second half of 2023 is on track to be approximately £10 million better than the first half. The Company also remains on track to deliver broadly breakeven Operating EBITDA in 2024, bolstered by positive momentum in business development activities and new orders recently secured across lentivirus, adenoviral vectors and AAV, with both new and existing clients. This momentum will further support the Company’s medium term guidance of a three-year revenue CAGR in excess of 30%, and at least a doubling of revenues by the end of 2026. The above guidance excludes the financial impact of the acquisition of ABL Europe SAS (“ABL Europe”). The Company will provide further financial guidance after the completion of this transaction, currently expected in the first quarter of 2024. Multi viral vector CDMO capabilities across multiple sites Oxford Biomedica has achieved significant progress in transferring its lentiviral vector capabilities to its Bedford, Massachusetts site. The transfer of its 5L process is already underway. This will be followed shortly by the introduction of 7L scale and 50L pilot scale capabilities. The material produced from these pilot scale batches will be instrumental in supporting assay qualification for pre-clinical activities as well as for IND (Investigational New Drug) and IMPD (Investigational Medicinal Product Dossier) enabling studies. In October 2023, Oxford Biomedica welcomed Thierry Cournez, formerly of Merck Life Science, as Chief Operating Officer & Site Head of UK Operations, to lead the integration of Oxford Biomedica’s sites and take direct responsibility for the Company’s UK operations in Oxford. This appointment follows the earlier recruitment of Mark Caswell who brings extensive CDMO experience from his previous roles at Rentschler Biopharma and Lonza. In July 2023, he took on the role of Site Head of US Operations. The shift to a site-based structure allows the Company to maximise efficiencies as well as be better adapted to serve client’s needs. On 4 December 2023, Oxford Biomedica announced it had entered into a sale and purchase agreement with Institut Mérieux for the acquisition of ABL Europe for a consideration of €15 million. This will support the future growth of all viral vector segments and allow the Company to expand its international footprint into the European Union with sites in Lyon and Strasbourg, France. Completion of the transaction is currently expected to take place in the first quarter of 2024 subject to the satisfaction and/or waiver of outstanding conditions, including obtaining the necessary regulatory approvals. Dr. Frank Mathias, Chief Executive Officer of Oxford Biomedica, commented: “Oxford Biomedica is successfully delivering on its strategic vision to become a pure-play CDMO. The streamlining of our operations has involved a strategic shift towards a CDMO mindset and we are now focused on being entirely client-centric. We remain encouraged by our increase in client orders, which have doubled since 2022 and we are now well-positioned to drive robust revenue growth while targeting broadly breakeven Operating EBITDA by the end of 2024.” Attendance at the Annual J.P. Morgan Healthcare Conference Oxford Biomedica is attending the Annual J.P. Morgan Healthcare Conference. Frank Mathias, Chief Executive Officer, will give a presentation, which will be available on the Oxford Biomedica website after the conference at www.oxb.com/investors/results-reports-presentations-webcasts . -Ends- Enquiries: Oxford Biomedica plc: Sophia Bolhassan, VP, Corporate Affairs and IR – T: +44 (0) 7394 562 425 / E: ir@oxb.com ICR Consilium: T: +44 (0)20 3709 5700 / E: oxfordbiomedica@consilium-comms.com Mary-Jane Elliott / Matthew Neal / Davide Salvi About Oxford Biomedica Oxford Biomedica (LSE: OXB) is a quality and innovation-led cell and gene therapy CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, the Company has more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies. The Company collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.com, and follow us on LinkedIn and YouTube.
Read moreOxford Biomedica signs agreement to acquire ABL Europe from Institut Mérieux, consolidating position as a global pure-play CDMO
– Oxford Biomedica announces the signing of a sale and purchase agreement with Institut Mérieux for the acquisition of ABL Europe – The transaction: Provides Oxford Biomedica with multi viral vector CDMO capabilities – to be made available across the Company’s six manufacturing sites in EU, US and UK Expands Oxford Biomedica’s capacity in process and analytical development and early-stage manufacturing to better address client needs Provides new facilities in France to enhance service for clients adding process development and manufacturing capacity in the EU Reinforces Oxford Biomedica’s position as a world leading cell and gene therapy CDMO Institut Mérieux intends to increase current ownership in Oxford Biomedica from 3.3 percent to approximately 10.0 per cent of the enlarged issued share capital by the end of Q3 2024. Oxford, UK – 4 December 2023: Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica” or “the Company”), a quality and innovation-led cell and gene therapy CDMO, today announces that it has entered into a sale and purchase agreement (the “Agreement”) with TSGH SAS, a subsidiary of Institut Mérieux SA (“Institut Mérieux”), for the acquisition of ABL Europe SAS (“ABL Europe”) (the “Transaction”). This follows the announcement on 20 September 2023, of exclusive negotiations in relation to the proposed acquisition by Oxford Biomedica of ABL Europe, a pure-play European CDMO with specialised expertise in the development and manufacturing of solutions for biotechs and biopharma including viruses for gene therapy, oncolytic viruses and vaccine candidates, in exchange for Oxford Biomedica ordinary shares. The acquisition of ABL Europe will consolidate Oxford Biomedica’s operations into a global pure-play CDMO in the cell and gene therapy space. It will broaden the Company’s international presence by establishing a footprint within the European Union through facilities located in Lyon and Strasbourg, France. In addition, the acquisition will increase Oxford Biomedica’s capacity in process and analytical development and early-stage manufacturing and address increased client demand for process development. ABL Europe currently works on more than 10 cell and gene therapy programmes spanning disease areas including more than six different vector types. Forecasted revenues for ABL Europe for the year ending 31 December 2023 are c.€15 million. Institut Mérieux has acquired a 3.3 percent stake in Oxford Biomedica, through purchases in the open market, which it intends to increase to approximately 10.0 per cent in aggregate by the end of Q3 2024. Completion of the Transaction (“Completion”) is currently expected to take place in the first quarter of 2024 subject to the satisfaction and/or waiver of outstanding conditions, including obtaining the necessary regulatory approvals. Further Information Upon Completion, the Transaction is expected to be immediately revenue accretive to Oxford Biomedica. Further financial guidance will be provided after Completion. As at 31 December 2022, ABL Europe had earnings before interest tax and depreciation (EBITDA) of c.€(1.7)m and gross assets of c.€23.6m. The Transaction constitutes a Class 2 transaction for the Company for the purposes of the UK Financial Conduct Authority’s Listing Rules. Dr. Frank Mathias, Chief Executive Officer of Oxford Biomedica, commented: “The acquisition of ABL Europe strengthens Oxford Biomedica’s operations into a global pure-play CDMO in the cell and gene therapy space. We will now be establishing a significant presence in the EU, while also freeing up Oxford Biomedica’s capacity to better serve our growing client demand worldwide. We look forward to realising the operational and commercial synergies of this acquisition in 2024 and beyond.” Transaction Terms As previously disclosed, key details of the Transaction follow below: • Acquisition of ABL Europe by Oxford Biomedica for a consideration of €15 million (including the value of €10 million of pre-completion cash funding from Institut Mérieux in ABL Europe for, amongst other things, development capex), to be satisfied by the issue of new ordinary shares in the Company (the “Consideration Shares”). The Consideration Shares will be issued at a price being the higher of (i) 407.4 pence per share equating to the 6-month volume weighted average price (“VWAP”). to market close on 19 September 2023 (being the last business day before the announcement of Oxford Biomedica and Institut Mérieux entering into exclusive negotiations with regards to the Transaction); and (ii) the VWAP between 19 September 2023 and the second trading day before the date of Completion. Applications will be made for the Consideration Shares to be admitted to the premium listing segment of the Official List of the Financial Conduct Authority and to be admitted to trading on the main market for listed securities of the London Stock Exchange plc. • Commitment from Institut Mérieux to provide the Company with €20 million of additional funding, to cover capital expenditure and potential operational losses in relation to the acquisition of ABL Europe, by means of an equity subscription in the Company (“Deferred Subscription Shares”), with timing at Oxford Biomedica’s discretion prior to 27 September 2024. Pursuant to the Deferred Equity Subscription, Institut Mérieux will provide the additional funding by the end of Q3 2024, or such earlier date requested by Oxford Biomedica subject to 10 business days prior notice to Institut Mérieux (the “Deferred Subscription Date”), in exchange for Oxford Biomedica ordinary shares (the “Deferred Subscription Shares”). The Deferred Subscription Shares will be issued at a price being the 30-day VWAP to closing on the second business day before the Deferred Subscription Date. -Ends- Enquiries: Oxford Biomedica plc: Sophia Bolhassan, VP, Corporate Affairs and IR – T: +44 (0) 7394 562 425 / E: ir@oxb.com ICR Consilium: T: +44 (0)20 3709 5700 / E: oxfordbiomedica@consilium-comms.com Mary-Jane Elliott / Matthew Neal / Davide Salvi About Oxford Biomedica Oxford Biomedica (LSE: OXB) is a quality and innovation-led cell and gene therapy CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, the Company has more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies. The Company collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.com, and follow us on LinkedIn and YouTube. About Institut Mérieux As an independent family-owned company, Institut Mérieux is dedicated to the fight against infectious diseases and cancers, with a global and long-term vision. Thanks to five companies – bioMérieux, Transgene, ABL, Mérieux NutriSciences and Mérieux Equity Partners – Institut Mérieux develops complementary approaches to meet today’s public health challenges: from prevention of health risks to innovative disease treatment, including the key step of diagnosis. Present in 45 countries, Institut Mérieux employs 22,000 people around the world and achieves a turnover of 4,3 billion euros. www.institut-merieux.com
Read moreOxford Biomedica PLC interim results for the six months ended 30 June 2023
Newly appointed Chief Executive Officer, Dr. Frank Mathias, is leading a transformation to position Oxford Biomedica as a pure-play CDMO; strategic and operational streamlining ongoing Transformation into a pure-play CDMO by 1 January 2024, with £30 million of annualised costs savings Strong execution and delivery of commercial strategy evidenced by client base expanding by 50% since the end of 2022, with a robust growing business pipeline across all key vector types and clinical stages On track for revenue growth in 2024 from existing and new client programmes, targeting broadly breakeven Operating EBITDA by year-end 2024 Medium term guidance provided; 3-year revenue CAGR in excess of 30% and Operating EBITDA margins in excess of 20% by the end of 2026 Entered into exclusive negotiations with respect to a proposed acquisition of ABL Europe from Institut Mérieux, as part of pure-play CDMO transformation. The proposed transaction would include: Addition of ABL Europe’s facilities in Lyon and Strasbourg allowing Oxford Biomedica to gain a footprint in the EU and expand Oxford Biomedica’s capacity to address increased client demand Consideration of £12.9 million (€15 million), including the value of £8.6 million (€10million) of pre-completion cash funding in ABL Europe from Institut Mérieux Institut Mérieux providing an additional £17.2 million (€20 million) of committed future funding in exchange for Oxford Biomedica shares, with timing at Oxford Biomedica’s discretion Institut Mérieux to become a major shareholder in Oxford Biomedica by building its ownership of Oxford Biomedica shares through purchases in the open market with the intention of reaching, in aggregate, approximately 10 per cent of the Company’s enlarged issued share capital Oxford, UK – 20 September 2023: Oxford Biomedica plc (“Oxford Biomedica” or “the Group”) (LSE: OXB), a quality and innovation-led cell and gene therapy CDMO today announces interim results for the six months ended 30 June 2023. Dr. Frank Mathias, Oxford Biomedica’s Chief Executive Officer, said: “Oxford Biomedica is a market leader in the fast-growing gene and cell therapy market. Our expertise and unmatched track record sets us apart, and our focus on being a pure-play cell and gene therapy CDMO gives us a unique position in the market. Six months into the role, I am fully focused on sustainable growth and our path to profitability – accelerating us to being a pure-play CDMO. With the cell and gene therapy industry at an inflection point, I believe that we are in the right market at the right time, and well-equipped to succeed with our highly skilled workforce and leading-edge technology. “This has required a transformation and a change of mindset. We are adapting our structure and processes to better serve our clients and work more efficiently. We will now work together as one company with aligned operations from our headquarters here in Oxford, UK, a footprint in the US, and will offer multiple vector types from our multiple sites. I value our staff tremendously and thank everyone for their hard work and contribution to Oxford Biomedica both now and into the future. “’I’m especially excited to announce the potential acquisition of ABL Europe today, from Institut Mérieux, as part of our transformation strategy. This would bring us the opportunity to gain a footprint in the EU and greatly enhance our capacity to address the increase in client demand we are seeing. It would also enable us to become an end-to-end CDMO capable of serving customers across both sides of the Atlantic and across vector modalities, leveraging cutting edge science and innovation. “We are already seeing the success of our new commercial strategy and increased market recognition. Not only did we grow our client base by 50% since the start of the year, but at the end of July we had signed more client orders than we had in the whole of 2022 (excluding COVID-19 vaccine manufacturing). We aim to be the partner of choice for pharma and biotech companies developing life changing cell and gene therapies, enabling them to get their products to market faster and reach more patients. Having already made significant progress, the Board and I are extremely excited about the future of Oxford Biomedica.” FINANCIAL HIGHLIGHTS (including post-period events) Total revenue decreased by 33% to £43.1 million (H1 2022: £64.0 million) and bioprocessing and commercial development revenues decreased by 29% to £40.6 million (H1 2022: £57.3 million), with the non-recurrence of COVID-19 vaccine revenue partly offset by double-digit growth in lentiviral vector revenues and a full six months of revenues from Oxford Biomedica Solutions. License, milestones & royalties were £2.5 million (H1 2022: £6.7 million), a decrease of 63% due to a generally lower level of milestone payments from existing clients and relatively lower license fees from new clients in the period. Operating EBITDA1 loss and operating loss of £33.7 million and £50.7 million respectively (H1 2022: Operating EBITDA loss and operating loss of £5.8 million and £19.2 million respectively), the higher losses compared to prior year driven by the non-recurrence of COVID-19 vaccine revenue as well the full six-monthly impact of operating expenditure from the acquisition of Oxford Biomedica Solutions in March 2022. Cash at 30 June 2023 was 9% higher at £129.4 million compared to £118.5 million at 30 June 2022. The net cash position was 16% higher at £90.1 million as of 30 June 2023 (30 June 2022: £78.7 million). Cash and net cash at 31 August 2023 were £121.4 million and £83.0 million respectively. 1 Operating EBITDA (Earnings Before Net Finance Costs, Tax, Depreciation, Amortisation, fair value adjustments of assets at fair value through profit and loss, and Share Based Payments) is a non-GAAP measure often used as a surrogate for operational cash flow as it excludes from operating profit or loss all non-cash items, including the charge for share options. A reconciliation to GAAP measures is provided on page 14. OUTLOOK AND FINANCIAL GUIDANCE Significant revenue growth anticipated in 2024 vs. 2023 as existing client programmes progress through development, supplemented by new client wins reflecting a significant step up in business development activities. Accelerating towards broadly breakeven Operating EBITDA1 by the end of 2024; the Group’s revenue backlog1 at 30 June 2023 stood at £95 million; this is the amount of future revenue available to earn from current orders. The Group expects to grow this backlog significantly going forward based on high levels of business development activity driving new client acquisition as well as orders from existing clients. Aiming to achieve three-year revenue CAGR in excess of 30% resulting in at least a doubling of revenues by the end of 2026 compared to c.£90 million in 2023. With increased operational efficiencies, targeted cost management and targeted investment, the Group aims to achieve Operating EBITDA1 margins in excess of 20% by the end of 2026. As a result of the business transformation towards a quality and innovation-led pure-play CDMO, cost reductions will be completed by the end of December 2023. The ongoing cost base from 1 January 2024 is anticipated to be reduced by c.£30 million on an annualised basis compared to 2023. A one-off restructuring cost of c.£10 million is expected to be incurred in the current financial year. Group revenues for 2023 are expected to be approximately £90 million; below current market expectations due to lower milestone and license payments than previously expected and reduced or delayed bioprocessing orders from clients. More than 90% of forecasted revenues for the second half of the year are covered by existing binding purchase orders and rolling client forecasts. Financial impact from the proposed transaction to acquire ABL Europe announced today is excluded from mid-term guidance pending completion of the transaction. Revenue backlog represents ordered CDMO revenues available to earn. The value of customer orders included in revenue backlog only includes the value of work for which the customer has signed a financial commitment for OXB to undertake, whereby any changes to agreed values will be subject to either change orders or cancellation fees. ANALYST BRIEFING Oxford Biomedica’s management team, led by new CEO, Dr. Frank Mathias, Stuart Paynter, CFO, and Dr. Sebastien Ribault, CCO, will be hosting a briefing and Q&A session for analysts at 13:00 BST / 8:00 EST today, 20 September, at One Moorgate Place Chartered Accountants Hall, 1 Moorgate Pl, London EC2R 6EA, United Kingdom. A live webcast of the presentation will be available via this link. The presentation will be available on Oxford Biomedica’s website at www.oxb.com If you would like to dial in to the call and ask a question during the live Q&A, please email Oxfordbiomedica@consilium-comms.com ______________ Read the Oxford Biomedica PLC interim results for the six months ended 30 June 2023 in full: Download PDF here London Stock Exchange website RNS NOTES Unless otherwise defined, terms used in this announcement shall have the same meaning as those used in the 2022 Annual report and accounts. ENQUIRIES Oxford Biomedica plc: Sophia Bolhassan, VP, Corporate Affairs and IR T: +44 (0)1865 783 000 / E: ir@oxb.com ICR Consilium Strategic Communications Mary-Jane Elliott / Matthew Neal / Davide Salvi, T: +44 (0)20 3709 5700 Peel Hunt (Joint Corporate Brokers): James Steel /Dr. Christopher Golden, T: +44 (0)20 7418 8900 JP Morgan (Joint Corporate Brokers): James Mitford / Manita Shinh, T: +44 (0)207 1347329 ABOUT OXFORD BIOMEDICA Oxford Biomedica (LSE: OXB) is a quality and innovation-led cell and gene therapy CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, the Company has more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies. The Company collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.com, www.oxbsolutions.com, and follow us on LinkedIn and YouTube.
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Learn about our 4th generation lentiviral vector delivery system and how this latest lentiviral vector technology developed at Oxford Biomedica can significantly enhance the development and manufacture of safer and more effective lentiviral vector based.
You can also download brochures for our other unique technologies including our TRiP System™ and LentiStable™ cell lines here.
