2023 was our best year ever, and the most successful year since our inception in 2018. During the year, we took significant steps towards a leading position in rare diseases in Europe and MENA.
We are now more than 100 competent, enthusiastic and ambitious colleagues who are all working together to forge a new pharma company with a mission to make orphan products available to patients with rare diseases. Our capabilities today are very different from just a few years ago. We also developed several new capabilities, and reached new milestones, during the year that were not previously possible for Immedica.
In 2023, we completed the authorization procedure for Loargys in Europe, and the European Commission granted the product marketing authorization at the end of the year. The Medicines & Healthcare products Regulatory Agency in the UK also approved Loargys just before Christmas. We also secured global rights to Loargys during the year, which means the product is now under our own control to develop and make available globally. This is truly remarkable news for all ARG1-D patients across both Europe and other territories, such as MENA, Asia and North America, since Loargys is the first disease-modifying treatment available for people living with ARG1-D.
So, would all of these achievements be possible without hard work and temporary offsets? Of course not. With exceptional entrepreneurship, solid functional skill sets and capabilities fostered by a strong ‘can-do’ attitude, the teams have time after time proven that we can overcome any obstacle together and achieve great things.
Other very important news for many patients with refractory and relapsed AML is the data from the pivotal phase 3 study of Iomab-B that was presented at the US TANDEM meeting in February. Today, bone marrow transplantation (BMT) is the only treatment option that can offer long-term survival to treat refractory and relapsed AML. The Iomab-B data presented indicate that the large number of patients who do not respond to current therapies and are therefore ineligible for BMT will now have a new and effective treatment modality that will make them eligable for a potentially successful BMT. As a consequence of managing our business in an excellent way, our financial performance was also exeptional, reaching sales of
SEK 905M by year-end with an adjusted EBITDA proforma of SEK 382M.
Our commitment to sustainability
During the year, we also took significant strides toward structuring and integrating ESG criteria and sustainability into our business processes. Our ESG practices are related to the good we can do for society by providing innovative medicines to patients and thereby creating a better and more sustainable society. To ensure this work remains high on our agenda, ESG criteria are incorporated into both individual and business strategies.
At the end of the year, we conducted a ‘Great Place to Work’ employee survey. 95% of our employees say that Immedica is a great place to work, and this also made us one of the top 25 great places to work in Sweden, which is a fantastic result and something to be proud of.
What will be critical in 2024?
Other priorities for 2024 will be to ensure that as many ARG1- D patients as possible are identified and provided with adequate treatment for their progressive disease. Every patient who is missing this now available treatment is a patient progressing towards worse motor functions and increased disability and, as a company, we need to support the health care profession in their quest to help these patients.
We also need to work diligently with the approval of Loargys in the US, and our plan is to submit a Biologics License Application to the FDA during 2024. Another important project is to complete the regulatory dossier for Iomab-B in Europe, and to file for regulatory approval.
An integral part of Immedica’s success has been our Business Development activities, leading to a steady flow of new deals for both commercialized and pipeline products serving unmet medical needs. These activities will continue in 2024, and we hope to bring in at least one more exciting, rare disease product for subsequent registration in our territories.
In summary
To summarize 2023 and set the tone for 2024, I would like to quote our senior partner at Impilo, our main owner: “Immedica has made a truly remarkable accomplishment in 2023! And 2024 looks even more exciting.” I could not agree more. In fact, I would like to repeat what I have been privileged to say every year since Immedica’s inception in 2018: “We have never been in a better and stronger place for providing and delivering new medicines to rare disease patients in our territories (and beyond).”
I would also like to thank all of my colleagues for your efforts during the year. You are so appreciated, and you really make a difference.
All of this is great, but it also comes with great responsibility. In fact, we receive queries from people every week about how and when our products will be available for their children, relatives, or friends. Let us therefore make sure that 2024 will be the year that we can bring them the gift of medicines for their loved ones, so that by the end of 2024 many more families that are managing rare diseases across the globe will have another reason to celebrate 2024, together with Immedica, as the best year ever!
Anders Edvell
Chief Executive Officer
