The demand for biologics and advanced therapies continues to accelerate, and manufacturers must be ready to meet that challenge with the right capacity, expertise and technology. By expanding our sterile manufacturing capabilities, we are investing in the infrastructure needed to support the next wave of pharmaceutical innovation. This investment enables us to support more programmes from development through commercial supply, while strengthening our ability to help customers scale efficiently and accelerate timelines. The US remains a critical market for our customers, and these investments position Recipharm as a partner of choice for companies bringing the next generation of therapies to patients.

Oncolytic viruses represent one of the most promising areas in cancer immunotherapy today. We are pleased to collaborate with Fusix Biotech to help advance this innovative platform toward the clinic. This partnership reflects Recipharm’s growing expertise in complex biologics and viral-based therapies, and our ability to support customers from process development through GMP manufacturing as they advance the next generation of oncology treatments.

Customers need sterile manufacturing partners that can combine technical expertise, operational scale and reliable delivery. This investment expands Recipharm’s BFS capacity, strengthens our technical offering and positions Recipharm to meet growing customer demand with the speed, scale and quality required for today’s complex product programmes.

Our work with CEPI will evaluate how NMR technology can be integrated directly into the manufacturing workflow to enable real-time, simultaneous monitoring of multiple CQAs. By shifting from traditional off-line testing to in-line analytical measurement, our new method has the potential to significantly accelerate quality assessment and batch release timelines, enabling faster manufacturing process.

Sustainability is a defining part of who we are at Recipharm. In 2025, our commitment translated into tangible progress and clear leadership, demonstrating that responsible pharmaceutical development and manufacturing can go hand in hand with strong operational performance. We are proud of the measurable results we have achieved and remain focused on accelerating progress across our global operations and value chain.

Showcasing modern analytics ultimately supports better, more reliable access to critical therapies. We view this seminar series as an opportunity to contribute to open, technical dialogue around emerging analytical and digital approaches that can strengthen process robustness and product quality across the industry.

High potency oral solid dose manufacturing remains one of the most capacity-constrained and technically demanding areas in our industry. By adding dedicated high potency development and pilot capabilities at Leganés, we are strengthening our ability to partner with customers earlier and support them across late-stage development through clinic to commercialisation. Just as importantly, our experienced high potency experts work closely with customers to understand their specific requirements and to jointly identify the right technical and operational solutions for what can often be highly complex programmes.

Regulatory change should not become a barrier to innovation or patient access. Our role as a CDMO is to adapt to our customers’ need and how the market is regulated. We evolve our manufacturing capabilities so our partners can focus on what matters the most to them: researching and developing new drugs.

Partnering with Infant Bacterial Therapeutics on this breakthrough therapy underscores our shared commitment to addressing critical unmet needs in vulnerable patient populations. By combining IBT’s innovative approach with Recipharm Advanced Bio’s microbial expertise and accelerated path to manufacturing, we are ensuring PPQ and commercial readiness are delivered on a fast and reliable timeline, bringing this lifesaving treatment for premature infants fast to market. In addition, we are well positioned to support IBT’s future growth with scalable capacity across both Europe and the USA.

IBP-9414 will be the first LBP (Live Biotherapeutic Product) globally, and after careful consideration, we now proceed to Process validation for Drug substance with Recipharm Advanced Bio in Cuxhaven. With the possibility of Recipharm Advanced Bio being a future drug substance supplier, we are strengthening our commercial supply chain possibilities. We feel that we are in good hands for this work, given Recipharm Advanced Bio’s deep expertise and understanding of pharmaceutical quality requirements for scalable commercial manufacturing.

The progress made by Telomir and MIRA reflects the strength of their science, vision, and commitment to addressing important medical needs. At Recipharm, we are proud to have built a true partnership with Erez Aminov and his teams, providing the expertise and consistent quality that help advance these innovative programs. Partnerships like these are at the heart of our mission to enable breakthroughs that can make a real difference for patients.

The work underway with Telomir-1 and Ketamir-2 is deeply important, reflecting our commitment to advancing new scientific approaches in areas where current options are limited. Recipharm’s technical rigor and dependability have been essential in progressing both programs. We are proud of the partnership and look forward to continuing this important work together.

This grant from The Gates Foundation enables Recipharm Advanced Bio to demonstrate how AI, coupled with PAT, can help close the global access gap. Smarter, faster and more cost-effective manufacturing can make life-affirming medicines available to more people around the world. At Recipharm, we are leading with innovation to build next-generation manufacturing platforms that ultimately benefit patients by delivering advanced therapies more efficiently and affordably.

We are committed to enabling the development of innovative, accessible vaccines that can address urgent global health challenges. Supporting iiCON and ImmBio to bring PnuBioVax® into Phase 2 cGMP clinical supply is a testament to the strength of collaborative science and manufacturing excellence. We are proud to contribute to a project that has the potential to save lives and reduce the global burden of antimicrobial resistance.

By adding key analytical services in Cuxhaven, we are reducing our reliance on external third-party labs, and providing our customers with faster, more cost-effective access to the highest quality analytical testing. Our expanded capabilities position us to better support the growing demands of advanced modality development and manufacturing.

We are proud to contribute to the development of a therapy with the potential to make a meaningful difference for people living with ALS. Developing PrimeC required overcoming significant formulation challenges, and I am proud of our team’s ability to create a robust, scalable solution. This collaboration reflects Recipharm’s strength in tackling complex therapies and advancing innovative treatments for patients with rare and devastating diseases like ALS.

These partnerships highlight Recipharm’s position as a trusted partner from early clinical development through to commercialisation. Recipharm’s BFS clinical platform is designed for speed, adaptability and efficient API use, enabling the delivery of high quality clinical trial material across Phases 1, 2 and 3. Combined with our specialist expertise, we are empowering clients to bring innovative products to market faster and with greater confidence.

We are entering the second half of 2025 well positioned for success. Every milestone this year is a testament to the passion and purpose of our global team, and to our unwavering focus on making advanced biologics more accessible and impactful than ever before.

We designed the PAT platform to fundamentally shift how manufacturers approach analytical testing. It’s about putting insights directly into the hands of those running the process, optimising quality in real time, and enabling scalable, sustainable biomanufacturing. 

This collaboration with ReciBioPharm has been instrumental in accelerating the development of our malaria vaccine portfolio. With numerous malaria vaccine candidates now developed or in active development, this partnership plays a critical role in advancing innovative solutions aimed at reducing the global burden of malaria, and supports our shared mission to eradicate malaria altogether.

We’re proud to deepen our collaboration with the University of Oxford on such a critical global health challenge. Our ability to deliver drug substance and drug product for larger scales under GMP conditions makes us a strong partner for accelerating vaccine candidates from lab to clinic. Together, we’re advancing science with the potential to save millions of lives.

This partnership brings together Recipharm’s development and manufacturing expertise, with PLG’s 2,000 regulatory experts, operating across 150 countries. By integrating scientific, regulatory, operational and commercial strategy from the outset we help our customers move faster, avoid costly delays and build confidence that their product submissions will meet and exceed, agency requirements, for critical medicines worldwide.

As regulatory complexity grows, our clients need integrated solutions that connect strategy and execution. With Recipharm’s 700 product development experts and over 400 projects delivered annually, this partnership allows us to embed regulatory thinking directly into product development and operational planning. Together, we help our clients ensure compliance and build stronger submissions from the start.

I am proud of the collective progress we have made in advancing our sustainability agenda. This year’s achievements reflect a significant cultural transformation, where sustainability is a shared responsibility embedded across all sites and teams, and fully integrated in our operations, innovation and growth strategy. Together, we are contributing to a more sustainable future for the pharmaceutical industry.

2024 was a year of exceptional transformation and achievement for Recipharm. Our record-breaking revenue and strategic advancements reaffirm our commitment to being a trusted partner to the pharmaceutical and biotech industries. By focusing on customer collaboration, innovation and operational excellence, we have strengthened our position for even greater success in 2025. Recent investments and partnerships have significantly expanded our capacity in key areas such as pre-filled syringes (PFS) and lyophilisation, ensuring we can meet the evolving needs of our customers with agility and expertise.

With the addition of these new product development and pilot scale capabilities, alongside our ReciPredict Platform, we can now offer an even faster, cost-efficient and fully integrated solution for oral solids from clinical development to commercialisation.

With this unit, we offer our clients a flexible, high-quality and GMP-compliant solution for their development and clinical production needs. This installation reflects our commitment to investing in innovative technologies that enable faster and more efficient pharmaceutical development.

We are excited to join forces with Recipharm to expand the reach of our pipeline and bring our innovative CNS focused products to new partners and patients across global markets.

This partnership exemplifies our ability to combine cutting-edge development platforms like Flexitab™ with Recipharm’s strong manufacturing expertise and regulatory history. Recipharm’s proven track record in executing FDA and EU-approved manufacturing transfers, coupled with our reliable supply chain, makes us the ideal partner to bring these novel CNS therapies to market. By joining forces with Spektus Pharma, we aim to deliver treatments that make a real difference to patients and meet growing global demand for innovative, safe, solutions in CNS care.

This grant represents a significant milestone in our commitment to advancing RNA manufacturing technologies that meet FDA standards. We are proud to lead this transformative effort, expanding access to RNA-based solutions for underserved regions.

Our previously-announced collaboration with MIT has underscored the potential of continuous manufacturing for RNA therapeutics. This grant will help to strengthen our role as a pioneer in innovation and support our mission to make lifesaving technologies more accessible. 

We are dedicated to delivering innovative, end-to-end solutions that help our customers bring high-quality drug products to market efficiently. Our advanced capabilities in oral dose formulations, coupled with our state-of-the-art API development services, allow us to support every stage of the product lifecycle. With the current investments in our oral product development capabilities in Germany and India and the addition of our ReciPredict platform, we are able to accelerate timelines, improve cost efficiency and enhance process reliability during product development, Tech Transfers and life cycle management. This comprehensive approach ensures that we can manage even the most complex projects, helping our customers achieve the best outcomes for their patients. Our existing high potency manufacturing suite enables Recipharm to collaborate with pharmaceutical companies on manufacturing advanced treatments, including oncology drugs and other highly potent medicines, while adhering to the highest safety and compliance standards.

We are excited about this strategic alliance with Exela, which significantly enhances our manufacturing footprint in the US. This partnership aligns with our commitment to provide high-quality manufacturing solutions and expand our capabilities in the production of sterile products, such as GLP1, peptides, biologics, ADCs and other critical pharmaceuticals.

Recipharm is a highly respected CDMO with world-wide reach. We are honoured and excited to be Recipharm’s exclusive US partner. This collaboration offers a unique and efficient CDMO platform for biopharma customers that seek to participate in both US and EU markets and are looking for scale, speed and versatility with experience in delivering complex projects.

With these advancements, we can now offer late-stage product development, clinical supply and commercial manufacturing from a single site. This integration makes it more efficient and cost-effective for our customers, providing them with access to top experts, while ensuring efficiencies in material consumption, including APIs. With our investment in ReciPredict as well as the GMP pilot scale for dry granulation and now the pilot scale for dry technologies, we have the tools and equipment at hand to support our customers with a faster clinic-to-market timeline for new drugs and de-risking manufacturing, ensuring greater certainty in meeting customer needs.

ReciPredict accelerates the journey of new drugs to the clinical stage by 3-6 months, substantially expediting the drug development process. It also offers significant cost savings by reducing API consumption by 30% to 70%. Another crucial advantage is that applying ReciPredict de-risks tech transfers by identifying the right parameters for best process robustness, consequently achieving consistent and high-quality results. This is a win-win for our customers and for patients, as it helps bring new drugs to market faster.

Today's announcement marks a significant step forward in our sustainability journey. We take pride in the validation of our GHG emission reduction targets by the SBTi and the evident improvement in our CDP ratings. These accomplishments underscore our unwavering dedication to reducing our environmental impact and actively contributing to a more sustainable future. Furthermore, they attest to our transparency regarding our environmental progress, as we willingly open ourselves to scrutiny by internationally-recognised third parties.

We are delighted to be working with GeneVentiv, an ambitious and innovative biotech who wanted to leverage not just our equipment and space, but our extensive knowledge and expertise too.

Gene therapies pose unique development and manufacturing challenges, so it was essential we chose the right partner to collaborate with, to minimise manufacturing risks and ensure we meet our key development milestones. ReciBioPharm quickly demonstrated that their team is the perfect development and manufacturing partner for our asset, enabling us to access their extensive experience and impressive capabilities. Our collaboration with them provides us with GLP and GMP product to meet both our IND and Phase I/II milestones.

Extending this agreement involves combining our cutting-edge nasal technology with Resyca’s product development capabilities. This collaboration with Resyca will enable us to bring innovative solutions to the market that will redefine the landscape of nasal drug delivery.

We are thrilled to enter into this extended strategic partnership with Medspray. This move aligns perfectly with our mission to pioneer advancements in aerosol drug delivery systems. The exclusive licence from Medspray will significantly strengthen our position in the market, allowing us to bring innovative and effective soft mist nasal delivery devices to patients worldwide together with our pharma customers.

We are proud to be associated with Medspray and Resyca in this landmark licensing agreement. As a CDMO committed to driving innovation, we look forward to supporting both companies in bringing their pioneering soft mist nasal delivery devices to the market to improve patient experience and expand what is possible via the nasal delivery route.

Harmonizing quality processes and GxP documentation across Recipharm sites will make our quality operations more efficient and scalable. With Veeva Vault Quality, Recipharm is setting a new global standard for quality management, site collaboration, and compliance. The system will enable us to provide our customers with a standard approach to quality. It forms a key part of our focus on continuous improvement, to unleash excellence in quality across our services.

Unifying quality processes, content, and training on Veeva Vault Quality will help Recipharm keep contract development and manufacturing on track as it continues to scale. We’re excited to partner with Recipharm in evolving its quality operations.

This collaboration has enabled a number of Acuitas partners to rapidly progress from concept to clinic thanks to Acuitas’ deep process and analytical experience and our flexible development capability and strong CGMP execution. We look forward to continuing our work together and, with Acuitas’ licensed customer base, to bringing new mRNA-based therapeutics to patients.

At Acuitas, we have a commitment to excellence and a high standard for quality control for our proprietary delivery technology and the ReciBioPharm team has the same dedication to the manufacturing and transfer of our LNP. We are proud to call them our partners and look forward to the continuation of this positive business relationship.

Oz-UK has an excellent reputation for innovation in methods and processes for accelerating the early stages of product formulation. This relationship will enable us to bring greener pMDIs to the patients who rely on them to treat chronic illnesses such as asthma and COPD more quickly than ever before. With the manufacturing expertise and development capabilities to support a choice of propellant, and a team of experts on hand at both Recipharm and Oz-UK to support our customers, we are well placed to become the partner of choice for companies developing sustainable pMDIs for respiratory care.

Recipharm’s agility in adapting to the challenges of the new greener propellants is impressive, and a big part of what attracted us to work with them. We’ve requested specific valve builds and have been able to put them on products and test them in our lab within a week. This is the speed that is needed for success in the transition to low-GWP propellants, and we are excited to see our clients’ programmes accelerate as a result of this collaboration.

Autoimmune diseases affect approximately one in ten individuals, meaning 0.8 billion patients globally will be able to benefit from the drugs derived from our platform. Recipharm is dedicated to helping organisations like ours that work to develop treatments for rare diseases. This agreement represents a key milestone and the beginning of an exciting journey. Recipharm is the pharmaceutical industry’s best-in-class provider of contract development and manufacturing solutions, and we are looking forward to working closely with the team on this project.

There are more than 7,000 rare diseases that need a cure. We are proud to be partnering with Ahead Therapeutics and look forward to providing a GLP environment to scale up production for a vital treatment to tackle what is currently an unmet patient need. Together with our partner, we are determined to help them turn hope into reality for people living with myasthenia gravis. We have the expertise to help Ahead Therapeutics bring drugs to market faster, so they can continue to deliver on their promise to change patients’ lives.