Abbreviated interim report 1 January – 31 March 2022

Significant successes for ICOres and ICOone

Significant events 1 January – 31 March

  • Iconovo is expanding its collaboration with the immunotherapy company Immune System Regulation AB (ISR), which is now accelerating the development of an inhalable COVID-19 vaccine. The expansion increases the contract value of the collaboration by nearly SEK 13.6 million. Iconovo is also entitled to low single-digit royalties on sales of the finished product.
  • Iconovo has announced that a pilot clinical pharmacokinetic study, conducted by Amneal Pharmaceuticals, has been completed. The study has provided valuable information that supports the continued development of ICOres budesonide/formoterol as a potential replacement product for Symbicort.

Significant events after the end of the first quarter

  • No significant events have occurred since the end of the quarter.
Key figures for the Group, in TSEK unless otherwise indicated  Jan-Mar 2022 Jan-Mar 2021* Jan-Dec 2021*
Net turnover 2,766 2,145 15,409
Operating profit/loss -9,462 -7,325 -26,513
Cash flow for the period -15,540 -8,521 33,348
Earnings per share (SEK) before and after full dilution -1.05 -0.91 -3.15
Cash and cash equivalents 79,497 53,168 95,037
Equity 127,882 85,651 137,034
Number of shares at period-end 8,847,500 7,776,000 8,847,500
No. of licensing agreements (royalty)** 6 6 6
No. of feasibility agreements** 2 0 2

*Refers to the figures of the parent company, as there were none for the Group at this time point.
**Number of agreements at the end of the period.


Strong interest in working with Iconovo

The first quarter of the year saw progress in both the originator drugs area and in generics development, while work was continued to establish the Iconovo Pharma subsidiary ahead of the potential launch of our first own-label product in the Nordic region. This quarterly report is the first to be prepared in accordance with the International Financial Reporting Standards (IFRS), a natural transition in light of the company's increasing maturity.

Expanded collaboration with ISR on the development of ICOone

At the end of March, we expanded our collaboration with the immunotherapy company Immune System Regulation (ISR), which is now accelerating the development of an inhalable COVID-19 vaccine using two different variants of our unique ICOone inhaler – one for administration to the lungs and one for inhalation via the nose. The supplementary agreement increases the contract value of the collaboration by nearly SEK 13.6 million. Iconovo is also entitled to low single-digit royalties on sales of the finished product.

During the COVID-19 pandemic, it has become clear that vaccines need to be administered in more ways than by injection, and the benefits of delivering treatment via the nose and airways are obvious. The practical handling of vaccines in dry powder form is very simple; no refrigerated transport is required and the vaccine can be administered without injection. ICOone and ICOone Nasal open up completely new possibilities for simplified mass vaccination, especially in countries with limited access to qualified healthcare personnel and well-functioning logistics chains. Nasal inhalation has the advantage that the immune system is triggered by the first contact of the vaccine with the nasal mucosa and the lungs.

Completed pilot study of ICOres budesonide/formoterol

ICOres budesonide/formoterol is being developed under a licensing agreement with Amneal Pharmaceuticals as a generic version of Symbicort Turbuhaler, a well-established treatment for asthma and COPD with sales of approximately USD 2.7 billion. Amneal holds the global rights to ICOres budesonide/formoterol, but Iconovo has the option to market the product in the Nordic region following regulatory approval.

A previous clinical pharmacokinetic study showed that ICOres worked as intended when used in clinical practice. The aim of the second pilot study, which was completed in the first quarter of 2022, was to further compare the pharmacokinetic properties between ICOres budesonide/formoterol and Symbicort Turbuhaler. Two batches of ICOres budesonide/formoterol and one batch of Symbicort Turbuhaler were investigated in 30 healthy subjects.

The relative bioavailability results support further development of ICOres budesonide/formoterol, and provide valuable information to optimise the product for the next study. The development programme is progressing according to plan, with the aim of submitting an application for marketing authorisation in the EU in 2023. This would allow for a product launch in 2024.

In place in new premises

In March, we inaugurated our new premises in Ideon Science Park in Lund. The move meant not only that we now have all our functions under one roof, but also that we have access to even more purpose-built laboratories. We are now able to house the new employees we plan to recruit in the coming years, as the company continues its journey of growth.

A stable position for our continued value creation

Iconovo’s cash position at the end of the quarter was approximately SEK 80 million, providing a stable base for continued investment in product development, the establishment of new commercial cooperation agreements, and the building of our own marketing organisation in the Nordic region. We have already established eight commercial cooperation agreements, and the goal is to sign two to three new agreements per year. The basis for value creation is our proprietary and patent-protected inhalers, and I can say that there is great interest in collaborating with Iconovo from both originator and generic drug companies around the world. We are now moving forward to continue to support our existing partners and establish more revenue-generating collaborations.

Johan Wäborg