Iconovo develops complete inhalation products based on five proprietary inhaler platforms. The overall goal for the products is to enter into licensing agreements that enable access to revenue streams through royalties or profit-sharing agreements.
Two extensive development projects now complete
Iconovo develops dry powder inhalation products internally or in collaboration with pharmaceutical companies. The company has developed two comprehensive and technologically advanced products entirely in-house: a generic version of Symbicort in the ICOres inhaler, and generic versions of the Ellipta portfolio in the ICOpre inhaler.
The development processes have been resource- and time-consuming and have included both inhalers and powder formulations. Now these major development projects have been successfully completed, meaning the company is entering a new phase where fewer resources are required.
Reorganization brings cost savings
To streamline operations, the company has therefore decided to implement an organizational change that is estimated to reduce costs by approximately SEK 14–16 million on an annual basis, with full effect from the third quarter of 2025.
– Unfortunately, the transition means a reduction in staff, but given that the inhalation platforms are largely fully developed, we are convinced that a commercially oriented project organization is the right step to take for the company's future development, says CEO Johan Waborg in the company's Q1 report.
Going forward, the company will increase its focus on commercialization and leverage its five inhaler platforms for revenue-generating projects. The ambition of the reorganization is to create a more customer-focused organization while reducing fixed costs.
Capital raising
The company has also decided to strengthen its cash position through a rights issue of approximately SEK 36,6 million before deduction of issue costs. The subscription period runs from May 16, 2025 to June 2, 2025 and the subscription price per share is SEK 1,15. The rights issue is covered 100 percent by subscription intentions, subscription commitments and guarantee commitments.
The proceeds from the issue will be used to support out-licensing activities for ICOpre with the aim of achieving separate or combined license agreements, support partner Amneal in the development of a budesonide/formoterol product in ICOres and for further development of projects for intranasal semaglutide up to preclinical proof-of-concept.
In parallel with the company's ongoing projects, Iconovo is holding discussions with potential partners with the aim of establishing collaborations for the development of both new drugs and generics in the company's inhalers.
Regionalized out-licensing process for ICOpre
Iconovo has accelerated the work of entering into a license agreement for a generic portfolio of Ellipta products in ICOpre by initiating a structured process for Europe and Asia in parallel with the US.
Opening up regional licensing agreements creates the opportunity for both faster agreement processes and earlier market access, as patent validity periods and market size vary between regions. In the US, patents for several of the largest products remain in place for a few more years, while they expire earlier in Europe.
The company originally aimed to enter into a global licensing agreement, but in practice this has led to negotiations with a primary focus on the U.S. To enable licensing in other parts of the world, the company has chosen to initiate parallel discussions with players in several regions.
Development project for generic Symbicort progresses
According to Iconovo's latest quarterly report, the development of ICOre's budesonide/formoterol continues in collaboration with Amneal Pharmaceuticals according to plan.
The product is a generic version of the best-selling asthma treatment Symbicort. Symbicort's global sales are expected to increase from USD 2,4 billion in 2023 to approximately USD 3 billion in 2024, underscoring continued strong market growth and good opportunities for generic alternatives.
The next step in the development work is to initiate a pivotal study for a registration application. This requires preparations in the form of, among other things, scale-up and detailed planning.
Intranasal semaglutide for obesity
In parallel, the development of an inhalable version of the GLP-1 treatment semaglutide for the treatment of obesity is progressing. Iconovo and the contract manufacturer Lonza has entered into a collaboration to develop spray-dried formulations of semaglutide for Iconovo's proprietary intranasal inhaler ICOone Nasal. Read more hereThe collaboration aims to identify optimal particle size, stability and compatibility with the inhaler while preserving biological activity. According to the company, the collaboration is progressing according to plan.
This is the first project in Iconovo's strategic focus on reformulating known drugs and replacing injections and oral treatments with inhalation. An intranasal treatment would be a significantly more user-friendly alternative to injection treatment.
CEO comments on organizational changes
BioStock contacted Iconovo's CEO Johan Wäborg to learn more about the company's ongoing projects, as well as the reorganization and capital raising.
You are now conducting a fully secured rights issue of SEK 36,6 million. How far do you expect this capital to last, and what strategic milestones do you aim to achieve with the financing?
– With the organizational change, we ensure that the capital will last 12 months. We have calculated that it will be enough even in the event that revenue is not generated – but the goal is absolutely that we will achieve revenue. We now want to feel secure in having capital so that we can focus on customers and business. The milestones we are working towards achieving in the coming 12-month period are to out-license ICOpre Ellipta generics in one or more of the global regions, for Amneal to begin the pivotal study needed to be able to register the product in the EU, and to achieve preclinical proof-of-concept for intranasal semaglutide in ICOone.
You are also choosing to restructure the organization with an increased focus on commercial activities. How does this affect the composition and skill profile of the team?
– The company will be organized with the focus on the projects. At the same time, project work at Iconovo will become more customer-oriented now that the goal is commercialization for our large, fully developed products. We will have project teams with great expertise and experience and work more with outsourcing for specific tasks as we take on new revenue-generating assignments. It will be a flat and efficient organization with the great expertise needed to carry out customer projects and attract new customers.
What concrete benefits do you see with a more customer-oriented organization?
– More focus from everyone on the customer's needs will mean that we can reach a commercially ready product faster and easier. With increased customer contacts, we can also control and influence more.
How do you ensure that the transition does not have a negative impact on your development projects or existing partnerships?
– The contact area customers have with us will be strengthened in the new organization, which will lead to a positive impact on how the customer perceives us and our offering.
Could you provide an overall timeline for your Symbicort development project with Amneal and how it can strengthen the company's revenue streams going forward?
– This year, the goal for Amneal is to scale up the process to a commercial scale for the product. They will also prepare for the start of the pivotal study. We are there all the time to support Amneal and they themselves have a very well-qualified team working on the product. Next year, the pivotal study can then be carried out.
– It is a relatively short study that takes a few months with about 80-100 healthy volunteers. If the study shows that the product is bioequivalent to the original product, a registration will be submitted. We expect that a central registration process in the EU will take about 12 months and a decentralized process could be somewhat faster. When the product can be sold in the EU, Iconovo will receive a 5-10 percent royalty on sales and in the Nordics we have the opportunity to earn even more by selling the product ourselves.
In conclusion – how do you view the company's position and how it may change in the coming years?
– It is unique to have five fully developed inhalers combined with the strong expertise we possess. Our reputation as experts in dry powder inhalation is established and will continue to grow as existing projects are commercialized. In recent years, we have seen increasing interest from large companies and this should lead to business. Now that we are focusing more on commercialization and at the same time reorganizing and cutting costs, we hope to get more return on future revenues. We are working to continuously improve our EBITDA and towards becoming profitable.
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This material has been prepared for marketing purposes and is not and shall not be considered to constitute a prospectus under applicable laws and regulations. The full terms and conditions of the rights issue and further information about the company have been set out in a prospectus which has been published and published on the said company's website.
