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.
I am delighted that both Richard and Jeremy have chosen to join Recipharm at this exciting time as we build our capabilities and capacity to serve our customers in their transition to low-GWP propellant pMDIs. Combined with our collaboration with Honeywell, and our expertise in valves and actuators under our Bespak® brand, we aim to be the partner of choice for companies developing their pMDI portfolios to embrace more sustainable respiratory care.
Honeywell is making great strides to offer patients who rely on pMDIs a lower greenhouse gas solution to meet their medical needs, Through our collaboration with Recipharm, the increased use of near-zero GWP propellant used in pMDIs will help reduce the environmental impact of the life-saving medical treatments patients need, without sacrificing performance.
As the first CDMO to partner with Honeywell for use of Solstice Air, this collaboration significantly accelerates and simplifies our customers’ pathway to develop the next generation of low greenhouse gas pMDIs, Our collaboration is supported by Recipharm’s investment in manufacturing with HFO-1234ze(E) cGMP at our Holmes Chapel, United Kingdom site, and the further development of the Bespak® valve range to ensure the required product performance.
Arranta Bio is pleased with the settlement and has known from the outset that it was on firm legal ground. We will continue with our delivery of plasmid products for our customers and, ultimately, the patients that we serve. With the litigation resolved, Arranta Bio is well positioned and excited about our growth prospects and the future.
FDA’s approval is a major development in the biologics market. It will help shift the perception of microbiome medicines and open the door for new opportunities for patients around the world. I would like to thank colleagues, past and present, who have been involved in the VOWST project. Their hard work and perseverance over almost ten years have enabled this major milestone which has the potential to improve patients’ health and save lives. I can’t think of a better example to illustrate our mission, to be the bridge between innovators and patients.
We are proud to be working with MIT on this ground-breaking FDA initiative to be forward thinkers and push the boundaries of biologics manufacturing. Our work can enable new vaccines and therapies to be deployed quickly and be economically viable for patients in need. This project is yet another step towards our vision to be the CDMO of choice, for the benefit of patients.
This project leverages advances made at MIT in the continuous pharmaceutical manufacturing made over the last 10+ years, as well as more recent advances in the modular manufacturing of vaccines and other biotherapeutics. MIT is pleased to collaborate with Arranta Bio and researchers at Rensselaer Polytechnic Institute and Pennsylvania State University to advance technologies for continuous mRNA manufacturing.
I am delighted to welcome Joaquim to the Recipharm team as we continue to drive our business forward. Joaquim’s impressive credentials and expertise will be a real asset to the senior leadership team and to the business.
Recipharm’s reputation and service offering in the industry is second to none. I am thrilled to be working for a leading top five CDMO on the quest for continuous growth.
By leveraging Stevanato Group's integrated capabilities, from plastic injection molding and assembly capabilities to comprehensive scientific and analytical support services, we will be able to offer a turnkey solution, and accelerate and de-risk our pharmaceutical customers’ development programs. This is particularly true for novel inhaled biological products.
Biopharma companies are advancing patient care with new, innovative treatments, particularly in biologics and mRNA therapies. These products require specialized, high-performance drug containment systems, like our Alba® syringe platform, together with patient-centric drug delivery devices like the PFSI™. Thanks to our integrated end-to-end capabilities we are able to support our customers at scale with a comprehensive system solution.
Creating a network of strategic collaboration partners is an important element of our long-term strategy to match customers’ needs and address self-administration trends in patient care with user-friendly drug delivery devices that provide variable and accurate dosing. This agreement marks another key step in broadening our high-value solutions and integrated capabilities as we continue to diversify and enhance our presence in the drug delivery market of pen injectors, auto-injectors, inhalers, and wearable pods.
The opening of our additional development laboratory space for RNA technologies at Watertown means we are well positioned to help our clients quickly and effectively scale up processes for successful GMP manufacturing. Arranta’s ability to support best-in-class process development prior to GMP is critically important in achieving the objective of reducing the amount of time to get into the clinic and successfully advancing life-changing medicine to patients.
We’ve been working closely with RedHill since 2015 to develop and manufacture Talicia, so extending our collaboration until 2026 marks an important moment in our partnership and is testament to the hard work of both teams. Not only this, but the Recipharm and RedHill teams have also proven their expertise in delivering breakthrough solutions to the patients through formulation and commercial manufacturing expertise.
Talicia® has been growing strongly since its launch, and now occupies a leading position amongst branded therapies for its indicated use. This is a position set to further solidify with a growing prescriber base and increased payor coverage, with physicians recognizing the therapeutic value it brings.
Our customers and therefore patients can benefit from Recipharm’s superior product, and we are proud to be creating a benchmark for ‘real world nasal drug delivery performance’. Our ability to offer drug formulation specific tailoring provides a competitive advantage.
By investing in new BFS technologies like Lab+, we are able to fully support our customers through both Phase I and II clinical projects. This new machinery means we can make small batches and removes the need to dedicate a whole filling line to one project. We can offer a system that is new, and rare on the market, allowing our customers to design and test their products, to see how they will look and react in a BFS system. The new Lab+ technology supports proof-of-concept, feasibility batches (cGMP & non-cGMP) and clinical I and II batches. Recipharm is proud to make such an investment and become one of the first CDMOs in the world to use this type of technology. We look forward to supporting our customers with their packaging compatibility requirements and expanding our BFS offering.
The investment at our Wasserburg facility demonstrates Recipharm’s commitment to meet ongoing customer demand for sterile filling capabilities. The demand for pre-filled syringes is rapidly growing, with the projected market value by 2030 expecting to reach USD 6.5 billion. We are proud to be able to offer such a comprehensive service to our customers spanning device design, development and manufacturing to drug product fill & finish, and look forward to continuing to simplify the journey to market for our customers and of course helping patients access vital medicines.
We are continuing our relentless pursuit of improving access to important, life-saving inhaled therapies, while methodically building capabilities for new inhaled therapies which will help address areas of significant unmet medical need. With TRB-3 and TRB-4 we are demonstrating our ability to rapidly progress our pipeline in an effort to meet patient needs as quickly as possible. We are very excited to again be working with Recipharm to advance these important medicines.
TRB-3 and TRB-4 are exciting developments for the treatment of two increasingly common chronic respiratory conditions. Recipharm is delighted to collaborate with Transpire Bio again and we will continue to share our extensive experience and expertise in developing and commercializing inhalation products to help bring these new inhaled medicines to market.
Our mission is to improve access to important, life-saving inhaled therapies, and to introduce new inhaled therapies to help address areas of significant unmet medical need. TRB-1 and TRB-2 are our first offerings in development which will help improve access for potentially millions of patients. We are very excited to be working with Recipharm to advance these important medicines.
Recipharm is very pleased to be leveraging its broad experience and expertise in developing and commercializing inhalation technologies and products in support of the development and advancement of Transpire Bio’s TRB-1 and TRB-2 respiratory products. We look forward to the collaboration.
We are committed to decarbonisation and helping our customers meet their sustainability objectives by transitioning their pMDI products to the new propellants and helping reduce the Green House Gas (GHG) emissions from their products. Recipharm is working hard to help customers identify and reduce GHG emissions related to both product manufacturing and usage with the common aim of meeting the requirements of the Paris Agreement of limiting global warming to 1.5 degrees Celsius.
Not only that, but as other industries are also asked by regulators to phase-out propellants with higher GWP, it’s likely that the existing propellants will become less available and more costly. It is therefore important that we prepare to work with new propellants to safeguard the supply of pMDIs to patients. 2022 is an exciting year for Recipharm and our investment in these new manufacturing lines will support us in introducing more sustainable propellants to our pMDI production.
We are excited about the next phase of working with Recipharm. We’re really looking forward to addressing the challenges of reformulation for low-GWP inhalation products with the Recipharm team.
This acquisition is an important step in growing our Biologics business and developing our US presence. We will be building on the pioneering excellence which lies at the heart of these companies and providing drug developers in the Biologics market with scientifically differentiated CDMO services and expertise for ATMPs.
These deals, together with our recent acquisition of GenIbet, a specialist in the manufacture of biological clinical material, mean that we will be well placed to develop new capabilities in innovative technologies across gene therapy, viral vectors, mRNA/ plasmids, oncolytic virus and microbiome.
I would also like to take this opportunity to congratulate Mark on his achievements in building the Arranta Bio operation so successfully. I am looking forward to working with both David as he takes over the leadership at Arranta Bio and with Tom Hochuli at Vibalogics as we move into the next exciting phase of our combined growth.
We are thrilled to be closing both acquisitions and look forward to welcoming the Arranta Bio and Vibalogics teams into the Recipharm organisation.
Given the unprovoked invasion of Ukraine and the tragic humanitarian crisis which is now unfolding, we believe it is important to offer our help wherever it can be most effective. We at Recipharm are working with NGO partners to provide urgent aid and other humanitarian assistance to refugees. Our employees are keen to engage with this issue and to lend their support where they can, so we are setting up a matched funding arrangement to facilitate the donation process, working in conjunction with UNICEF, our chosen partner.
The Monts facility demonstrates our commitment as a business to meet not just present customer demand for aseptic filling, but future customer requirements, and we are investing significant sums in updating the facility and expanding its capacity. While we are bolstering our biologics capabilities, we also continue to offer strong small molecule expertise, providing a single partner to the industry for all their commercial scale aseptic filling needs. The current experience with the Monts project suggest opportunities for further breakthroughs in productivity and line flexibility.
We are excited by the opportunities that are already apparent from working with true pioneers in the area of virotherapy manufacturing. We are delighted to welcome our new colleagues from Vibalogics to Recipharm and are committed to support and even accelerate growth in the years to come and to continue to partner with customers in virus manufacturing solutions. This acquisition strengthens Recipharm’s presence in ATMPs and enables us to get closer to our US customers. We look forward to working with the Vibalogics team, building links across the wider Recipharm organisation to make this business a huge success.
Since 2006 Vibalogics has developed a specialized CDMO business and a leading virotherapy manufacturing platform that has contributed to advancing our customers’ products through development and into global clinical trials, all made possible by our dedicated employees and investors. We are excited to be joining the Recipharm organization and having the opportunity to leverage the breadth and depth of its world leading infrastructure and experience. This furthers our commitment to supporting our customers and the patients who benefit from the exciting developments we are witnessing in the virotherapy field.
We welcome Arranta and its team of experts who boast a strong reputation in the CDMO industry. Arranta is a leading player in its field that we are proud of bringing under the Recipharm umbrella and continue to build in line with our vision of supporting biotechs by providing process development, manufacturing expertise and bold solutions to take their programs from lab to patient. This acquisition is another important step for us in growing our biologics business and developing a strong presence into the US. We look forward to working closely with the Arranta team, building links across the wider Recipharm organisation to make this business a huge success.
I am convinced that Recipharm will be a great home for Arranta and our talented team and that together we can fulfil our joint vision of building the leading ATMP CDMO. We share Recipharm’s vision of focusing on ATMP customers with novel manufacturing solutions and we see a clear opportunity to accelerate to global scale in this new context.
We’re delighted to welcome GenIbet and its talented team of experts. GenIbet is a leading player in its field so we’re proud to bring it under the Recipharm umbrella and tap into its broad offering in novel modalities and incredible scientific expertise.
This acquisition is an important step for us in growing our biologics business. We look forward to working closely with the GenIbet team, building links across the wider Recipharm organisation to make this business a huge success.
We’ve enjoyed a great deal of success at GenIbet, and now is a fantastic time to be joining with Recipharm to share our expertise and broad service offer.
I’m thrilled that GenIbet will play an important role in Recipharm’s Biologics-focused future. Combining our experience and expertise with Recipharm’s capabilities and market reach, will make a significant difference for customers on an international scale.
We are proud to be involved as the CDMO of choice in this fantastic step forward for Morocco and Africa. Breaking ground on a facility of this magnitude is a significant milestone and reflects the depth of our joint commitment to meeting Morocco’s long term healthcare needs.
The past two years have shown the importance of reliable vaccine supply, and we are honoured to have been asked to use our expertise and experience in fill finish manufacturing to produce vaccines and other biotherapeutics in Morocco. Together with all parties involved, we will work to ensure that countries across Africa have greater access to the healthcare they need.
We are very proud to be supporting a big pharma partner in the delivery of a vital vaccine to the market. This deal is indicative of Recipharm’s successful and ongoing product portfolio diversification. We’ve invested heavily into new capabilities that have built on our BFS expertise and as a result, strengthened our biotech offering. We are now in a position to welcome new biopharma projects to the Kaysersberg site.
We are delighted to have the Cramlington Site join the Pharmaron Group. This acquisition complements and further enhances Pharmaron’s CMC capabilities in the United Kingdom and China. We are committed to expanding the Cramlington Site to meet growing demand. Together with our API manufacturing facility expansion in China, this transaction is another important step in realizing our vision of becoming a leading global provider of integrated small molecule drug R&D and manufacturing services.
This divestment helps us to streamline our operations in line with our strategic goals and better align with our customers’ evolving needs. I am pleased that the Cramlington Site will get a committed owner with the capacity and capability to develop it to its full potential. As a top five global CDMO, we will continue to develop and invest in our highly successful contract manufacturing business.
This divestment will help strengthen our financial position and we see it as a positive step in streamlining our operations and consolidating our position as a top five global Contract Development and Manufacturing Organisation. I am pleased that this business will get a committed owner with the capacity and capability to develop it to its full potential. We will continue to develop and invest in our highly successful contract manufacturing business.
We are happy to have made, as our first investment, the acquisition of a site with a great reputation for quality and service, the cornerstones of our values. We are confident that, with the excellent team in place, Astrea-Fontaine will be able to grow rapidly while satisfying our customers and bringing peace of mind to all. Our plans are to make this site a state-of-the-art facility and we will invest in people and equipment to reach our goal.
The SMI platform has been designed specially to deliver a true turn-key device solution to the customer that requires minimal customisation and simplifies the formulation process. As a result, we can minimise device and drug development timeframes in collaboration with Recipharm, allowing our customers to focus on clinical research.
It’s great to be able to announce the inauguration of our new analytical laboratory under Recipharm Analytical Solutions™. Despite all the challenges the pandemic has presented, our team has worked diligently to complete the project and ensure the laboratory is operational, on time. We’re confident the new laboratory will bolster our ability to support our customers and meet their method development, validation and stability studies requirements while maintaining the quality services they’re accustomed to from Recipharm.
We are delighted to present the 2020 award to Dr. Amy Pruden. Her work, which has given deeper understanding of the microbial ecology of water systems, is widely recognised and highlighted. Her work concerning antibiotic resistance is particularly interesting since this is a known challenge for the pharmaceutical industry, healthcare and agriculture sectors. Dr. Pruden’s research in this area is invaluable and will no doubt go a long way to identifying exactly how antibiotic use impacts risks in relation to antimicrobial resistance.
I am very honoured to receive this award and thank Recipharm for this recognition. Our success has really been a team effort, as tackling environmental and public health challenges requires expertise from many disciplines and perspectives. I especially would like to thank my many students for all of their hard work and dedication and I hope that this award offers some inspiration for the future.
Vaccine manufacturing capacity and the associated testing is more crucial than ever, so we’re delighted to be able to further support our customers in the area. The Recipharm team has extensive experience in handling products with aseptic requirements and this accreditation is just the latest step in ultimately bolstering our biologics offering for customers. This will allow us to not only to cater for requirements for the current pandemic, but also future requirements as we continue to see more biologics enter the drug pipeline.
We are seeing some excellent traction in this field and have already signed an agreement with several more in the pipeline. The fit with Recipharm’s broader inhalation activities is making our work with Medspray very closely aligned with our strategy as we work to become the world leading integrated device development and manufacturing provider.
Our partnership with Recipharm cements the exciting opportunities we see for the softmist spray nozzle technology in pharmaceutical applications. The potential advantages to both patient and environment make a highly compelling case for its adoption.
Roar BidCo places great value on Recipharm's management and employees. Roar BidCo's plans for the future business and general strategy do not currently include any material changes with regard to Recipharm's operational sites, its management and employees, including their terms of employment. Furthermore, there are no employees in Roar BidCo, implying that the Offer will not entail any changes for the management and employees in Roar BidCo.
Our efforts during past years to build a resilient top 5 CDMO with global reach will continue to bring benefits to customers and patients. Our short-term priorities are to continue with measures to keep our employees and customers safe and to stay focused on executing our initiatives while capturing several of the interesting growth opportunities that now lie ahead of us. This requires increased capital expenditures over the next couple of years. For 2021 we plan for capex of approximately 9 per cent of sales, to be consider in relation to our current leverage situation. Leverage will also restrict possibilities to participate in industry consolidation in the near term, even though we have the management capacity for further acquisitions. Meanwhile we have a sense of purpose and pride being part of the global fight against the COVID-19 pandemic and we will do our utmost to respond to the uncertainties and challenges we may encounter.