Significant progress in Iconovo’s three strategic business areas

Significant events 1 October – 31 December

  • Iconovo signed an agreement with TOA Pharmaceutical Co, Ltd for the evaluation of an Iconovo inhaler for generic product development. The agreement has a value of SEK 2 million, with potential further development.
  • Iconovo registered its subsidiary Iconovo Pharma AB with the Swedish Companies Registration Office. This is part of the communicated strategy to establish a proprietary pharmaceutical sales infrastructure in the Nordic market. Iconovo’s target is to reach sales revenues totalling
    SEK 200 million by 2026, of which approximately one-third is expected to be generated from Iconovo Pharma.
  • The China National Intellectual Property Administration intends to approve (Notice of Allowance) a patent for the ICOone inhalation platform. Iconovo already has approved patents for ICOone in Sweden, Europe (EPO), the USA and India. The patent describes the single-dose inhaler used in Iconovo’s two innovative customers products with Oxytocin and a COVID-19 vaccine.

Significant events 1 January – 30 September

  • In July, Iconovo carried out a directed share issue and raised SEK 75 million before issue expenses. The issue was subscribed by a number of Swedish and international institutional investors, including Alcur Fonder, FE Fonder and Humle Fonder, as well as a number of existing shareholders, including Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fonder. The proceeds of the issue will primarily be used for acceleration and value creation activities and investments linked to the Company’s long-term strategy.
  • The agreement with Amneal for a generic equivalent of Symbicort has been expanded during the year to include the key US and Chinese markets and the Nordic sales rights, more than doubling the potential for future annual royalty income.
  • In May, Iconovo communicated its 5-year business targets at its first Capital Market Day. By 2026, the Company expects to achieve sales of SEK 200 million, with an operating margin of 50%. The Company also announced its long-term strategy, with three strategic areas with the original core operation of generic inhalation product development now supplemented with the new areas of innovative inhalation product development and pharmaceutical sales in the Nordics.
  • In March, Iconovo signed an agreement with ISR (Immune System Regulation AB) for the development of an inhaled COVID-19 vaccine.
  • In July, Iconovo entered into an agreement with ISR for additional work on the ongoing inhaled COVID-19 vaccine project for the development of a nasal version of Iconovo’s ICOone inhaler. The additional work could provide up to SEK 4.9 million on top of the previous agreement. In addition, there is the possibility of future royalties.
  • In May, Iconovo entered into an agreement with Respiratorius for the development of an inhalation product for the treatment of COPD. The agreement includes a tiered fee for project work, with a total value of up to SEK 3 million.
  • The Board was strengthened at the AGM with the election of Ann Gidner. Gunnar Gårdemyr took over the chairmanship from Mats Johansson, who continues to serve on the Board as a member.
  • The quality system has been upgraded to meet the requirements for medical devices in the USA under the Quality System Regulation. The upgrade is a critical step in gaining access to the US market for Iconovo’s products together with pharmaceuticals.
  • During the year, the Company received notification that the United States Patent and Trademark Office intends to approve (Notice of Allowance) a patent for the ICOres inhalation platform. The Japan Patent Office also intends to approve (Intention to Grant) a patent for the platform. Iconovo already has approved patents for ICOres in Japan, Sweden, Europe (EPO) and the USA. The patent describes the technology used in Iconovo’s many customer projects, including generic Symbicort. The Company also received notification that the United States Patent and Trademark Office intends to approve (Notice of Allowance) a patent for the ICOone inhalation platform. Iconovo already has approved patents for ICOone in Sweden, Europe (EPO) and India.

Significant events after the end of the fourth quarter

  • Subsequent to the end of the quarter, Iconovo announced the completion of a pilot clinical pharmacokinetic study conducted by Amneal Pharmaceuticals. The study has provided valuable information that supports the continued development of ICOres budesonide/formoterol as a potential replacement product for Symbicort.
Key figures in TSEK unless otherwise indicated  Oct-Dec 2021 Oct-Dec 2020 Jan-Dec 2021 Jan-Dec 2020
Net turnover 3,600 7,681 15,409 17,792
Operating profit/loss -8,706 -3,610 -26,513 -16,717
Cash flow for the period -12,060 -10,398 33,248 -27,467
Earnings per share (SEK) before and after full dilution -0.98 -0.58 -3.15 -2.20
Cash and cash equivalents 94,937 61,689 94,937 61,689
Equity 137,034 92,729 137,034 92,729
Number of shares at period-end 8,847,500 7,776,000 8,847,500 7,776,000
Number of royalty agreements** 6 5 6 5

**Number of agreements at the end of the period.

A WORD FROM THE CEO

Our long-term strategy is already yielding good results

Last May, we launched a new long-term strategy for Iconovo based on three business areas – generic inhalation products, innovative inhalation products and Nordic pharmaceutical sales. This strategy is already starting to bear fruit, which is extremely gratifying. Among other things, we have achieved our goals for the development of the ICOpre® inhalation platform, which is based on entirely proprietary technology that does not infringe on the patent protection of GSK’s bestseller Ellipta®, but at the same time provides a user experience that is very similar to Ellipta®. By using ICOpre®, generic companies can start manufacturing, marketing and selling Ellipta-based drugs as soon as patent protection is lost for several of the compounds in best-selling Ellipta-based asthma and COPD products. ICOpre is now ready for the market and we will focus on increasing customer acquisition in this large segment going forward.

Four partner agreements last year
Another key element of our strategy is the goal of signing two to three partner agreements each year. During the year, we were able to sign four. In May, we signed an additional agreement with the generics company Amneal Pharmaceuticals, giving them the right to sell our ICOres-based generic version of Symbicort® also in the US and China, more than doubling the potential for our future annual royalty income to between SEK 110 and 220 million.

In the same month, we signed an agreement with biotech company Respiratorius to develop a dry powder formulation and an inhalation product based on Iconovo’s ICOone® inhaler for use in Phase I clinical trials for Respiratorius’ drug candidate RES030-085. The agreement also involves jointly investigating which of Iconovo’s inhalation platforms is best suited for the commercialisation of Respiratorius’ drug substance. The first part of the agreement is worth approximately SEK 3 million.

Together with the immunotherapy company Immune System Regulation (ISR), we contracted for the development of an inhaled COVID-19 vaccine in Iconovo’s ICOone inhaler and also a nasal version of ICOone. The agreement has a value of SEK 14 million, excluding royalties.

The fourth agreement was signed in November with TOA Pharmaceuticals of Japan for the development of an inhaler for a generic version of a drug with significant sales in the Japanese market.

Proof that our business model works
This is strong proof that our business model and strategy are working, and that our three different areas of activity complement and support each other in a logical and positive way. Based on our proprietary inhalation platforms, we are able to develop inhalation products with international pharmaceutical companies for both generic and innovative drugs that are then sold globally by our partners, but for which we have the option of retaining the rights for the Nordic market. The collaboration with Amneal Pharmaceuticals is an excellent example of this. As we have the rights to sell generic Symbicort in our ICOres® inhaler in the Nordic region, we have the opportunity to work a market with the potential to generate between SEK 80 to 100 million in annual turnover. Additional proof is that during the year we completed a successful share issue that raised SEK 75 million before issue costs, which at the end of the year gave us a strong cash position with SEK 95 million in cash and cash equivalents, compared to SEK 62 million at the end of 2020.

Now we are growing in numbers and strengthening our skills
There is a lot happening in the Company as we continue to deliver on our strategy and attract more and more customers. That is why we are strengthening our skills by recruiting new employees and establishing collaborations with external expertise for e.g. our commercial department, which brings together marketing, communication, business development and the development of established partnerships – all to take on more projects and become a more sales-oriented organisation.

I am also pleased to announce that we will be moving to new premises this spring. For some time now, we have been in a cramped space and even in different buildings. The move, about 500 metres to Ideon Science Park, will take place in March. It will be an incredible boost for us to gather the Company under one roof in facilities and labs that meet the standard we need for the development of inhalation products according to our long-term strategy.

All of this means that we can feel both proud and satisfied with the year that has passed, and approach 2022 with great confidence.

Johan Wäborg, CEO

 

Iconovo AB (publ), that develops complete inhalation products for a global market, has registered the subsidiary Iconovo Pharma AB with the Swedish Companies Registration Office. This is part of the previously communicated strategy to establish an infrastructure for in-house pharmaceutical sales in the Nordic market. Iconovo’s goal is to reach sales revenues of SEK 200 million by 2026, of which approximately one third is estimated to come from Iconovo Pharma.

The sales of pharmaceuticals in the Nordic region will be conducted in the subsidiary Iconovo Pharma AB as the business differs from the development of inhalation products for the global market. A separate and dedicated structure ensures the necessary focus needed in an efficient and dynamic sales organization. The recruitment of an experienced leader for Iconovo Pharma will begin in 2022, and the company plans to gradually hire the handful of specialized employees needed to promote effectively in the Nordic market.

Iconovo Pharma’s product portfolio is expected to consist largely of products that are currently being developed together with Iconovo AB’s current global partners. Iconovo’s current global partner network will open up opportunities for effective in-licensing of additional value-creating products.

Iconovo has already secured the Nordic rights for a generic version of the asthma and COPD drug Symbicort® through an agreement with its global partner Amneal. The product is developed in Iconovo’s inhaler ICOres with unique feedback features that brings significant benefits to the patient. The Nordic market for generic Symbicort is estimated to approximately SEK 900 million.

“Our ambition is to establish a Nordic pharmaceutical company with a product portfolio consisting of selected inhalation products developed by Iconovo, where we have already secured the rights to generic Symbicort in our unique proprietary inhaler ICOres. In addition, we open up for licensing of other medicines with high commercial potential,” says Johan Wäborg, CEO of Iconovo.

About Iconovo Pharma AB
Iconovo Pharma AB will sell pharmaceutical products in the Nordic region based on products that Iconovo AB develops for global pharmaceutical companies as well as other medicines with high commercial potential. The rights to sell the proprietary generic version of Symbicort® in ICOres in the Nordic markets have been licensed from Iconovo’s partner Amneal. This is the first building block in a portfolio of inhalation products to be sold in the Nordic region.

 

Iconovo is recruiting two new team members to increase the company’s commercialization and is now aiming for one to three new signed contracts per year. The aim is to reach small- and mid-sized innovation companies with Iconovo’s unique inhalers. Innovative customers have global ambitions, and therefore the inhalers must meet the regulatory requirements of the larger markets.

 

Communication and Marketing Manager

Eva Norell has been appointed Communication and Marketing Manager. Eva has broad experience in the pharmaceutical industry, and earlier in her career worked with sales in Sweden for both Pfizer and Sanofi. Most recently, she comes from a role as Marketing Manager at Gedea Biotech, where she was responsible for communication and marketing activities. Eva has broad experience of digital channels for both sales, marketing, and training initiatives from several different industries. At Iconovo, Eva will be responsible for all communication and marketing activities, including Inbound Marketing, a new focus area meant to highlight Iconovo’s expertise and offer, and generate new customer prospects.

 

Design Assurance Manager

Annika Antius has been appointed Design Assurance Manager. Annika has extensive experience in product development and quality assurance from the life science industry for both pharmaceuticals and medical devices. Most recently, she acted as QA R&D Project Manager at Baxter, where she was responsible for quality assurance of new and revised products. Annika started her career as an analytical chemist at AstraZeneca R&D Lund and has since worked as a project manager for business improvement projects at various life science companies. In recent years, she has specialized in quality assurance of medical device products and has, among other things, held the role of Quality Manager at Altran. Annika will be responsible for ensuring that the documentation of Iconovo’s inhalers and drug-device combinations meets regulatory requirements.

 

Important key competencies

“Today we have recruited two new important team members. Eva and Annika both have essential talents that Iconovo needs to raise the bar further and get one step closer to our goal of bringing products to market. The first drug registrations are not far away, and in the long term, our ambition is to ensure a steady stream of new product launches based on inhalers from Iconovo. With the new positions, we will be able to intensify our commercial approach and decisively work further to secure more customer contracts”, says Johan Wäborg, CEO of Iconovo.

Iconovo AB (publ), that develops complete inhalation products for a global market, and TOA Pharmaceutical Co., Ltd, which develops generic products for the Japanese market announced today that they have signed a feasibility agreement to use an inhaler from Iconovo for a generic product development. The feasibility agreement has a value of EUR 202.000 to be paid over the coming 12 months.

“We are very happy to continue the collaboration between TOA and Iconovo that was started in 2017. The end goal is to enter a license agreement to develop an inhaled generic product to a pharmaceutical product with significant sales in the Japanese market based on an inhaler from Iconovo,” said Johan Wäborg, CEO of Iconovo.

About TOA Pharmaceuticals

TOA Pharmaceuticals Co., Ltd. based in Japan manufactures and markets pharmaceuticals, chemicals, sanitary ware and medical devices. The company has invested in a production facility specializing in the manufacture and filling of inhalable drugs as well as manufacture of substances used in inhalers. Read more about TOA Pharmaceuticals Co., Ltd here

 

The Chinese Patent Office has announced the intention to grant a patent (Notice of Allowance) regarding Iconovo’s inhalation device ICOone.

Iconovo has previously granted ICOone patents in Sweden, Europe (EPO), USA and India. The new patent covers a unit dose inhaler used in Iconovo’s two innovative customer projects with Oxytocin and Covid-19 vaccine.

ICOone® is Iconovo’s platform for simple and cost-efficient delivery of vaccines and biomolecules to the lung. Since ICOone® delivers a dry powder, there is no need for expensive and complicated cold storage. Inhaling the drug eliminates the use of disposable syringes and no hazardous waste with blood contaminated syringes is generated.

”This patent strengthens our international patent protection of ICOone. China is a very important market for simple and cost-effective vaccination”, says CTO Dr. Orest Lastow.

About ICOone®

ICOone® is a unique, patented dry powder inhaler for single use. The smart design generates an ultra-low manufacturing cost combined with simple and discreet use. It is particularly suitable for short-term treatment and as-needed use as it provides an unsurpassed low treatment cost and price point for treatments with a low number of doses. The simple design also enables patients and caregivers to learn how to handle the inhalers with minimal training. ICOone® can deliver large inhalation doses that are well protected against moisture, an important factor for many biomolecules.

https://www.iconovo.se/products/icoone/ 

New nasal inhaler has great potential in treatment of COVID-19

Key figures in TSEK unless otherwise indicated  Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Net turnover 6,169 5,754 11,809 10,111 17,792
Operating profit/loss -3,895 -2,304 -17,807 -13,104 -16,717
Cash flow for the period 60,741 -3,640 45,308 -17,069 -27,467
Earnings per share (SEK) before and after full dilution -0.43 -0.25 -2.15 -1.62 -2.20
Cash and cash equivalents 106,997 72,087 106,997 72,087 61,689
Equity 145,667 97,245 145,667 97,245 92,729
Number of shares at period-end 8,847,500 7,776,000 8,847,500 7,776,000 7,776,000
Number of royalty agreements** 6 4 6 4 5

Significant events 1 July – 30 September

  • In July, Iconovo carried out a directed share issue and raised SEK 75 million before issue expenses. The issue has been subscribed by a number of Swedish and international institutional investors, including Alcur Fonder, FE Fonder and Humle Fonder, as well as a number of existing shareholders, including Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fonder. The proceeds of the issue will primarily be used for acceleration and value creation activities and investments linked to the Company’s long-term strategy.
  • In July, Iconovo entered into an agreement with ISR (Immune System Regulation AB) for additional work on the ongoing inhaled COVID-19 vaccine project for the development of a nasal version of Iconovo’s ICOone inhaler. The additional work could provide up to SEK 4.9 million on top of the previous agreement. In addition, there is the possibility of future royalties.
  • The Japan Patent Office issued an Intention to Grant notification regarding a patent for the ICOres inhalation platform. Iconovo already has approved patents for ICOres in Japan, Sweden, Europe (EPO) and the USA. The patent describes the technology used in Iconovo’s many customer projects, including generic Symbicort.
  • Iconovo’s Quality Management System (QMS) has been upgraded to comply with the US Quality System Regulation for medical devices. The upgrade is a critical step in gaining access to the US market for Iconovo’s pharmaceutical products.

Significant events after the end of the third quarter
No significant events have occurred since the end of the quarter.

A word from the CEO – More innovative deals through increased focus on business development

New nasal development for ICOone
Iconovo’s inhalation expertise and vast experience in the development of inhalation products for the lungs has been used to develop a new version of ICOone for nasal use. With this product, the Company entered into a further agreement with ISR in July on the use of a new version of ICOone adapted for nasal delivery of powder. Starting with this agreement, a parallel track will be opened up in the development of a powder vaccine against COVID-19. Nasal delivery enables faster progression through the study programme, which is one of the key components of the project. There will be an enormous need for vaccination for a long time to come, especially in developing countries, where liquid-based vaccines requiring cold storage are not a sustainable solution. It is very gratifying to see our partner ISR moving forward and making the plans concrete. In recent months, they have inter alia released a press release to announce that they have entered into an agreement with Northway Biotech for large-scale production of the spike protein to be used. An agreement has also been entered into with a clinical investigator in Bangladesh to start a phase 1 study.

The ISR agreement for ICOone Nasal has enabled us to kick-start our nasal version of ICOone. ICOone Nasal will be a unique inhaler based on the same innovative concept as ICOone. We can now offer the world’s first inhalation-driven, single-use inhaler for nasal powder with high performance, with a production cost that is very difficult to beat. ICOone Nasal is developed according to the same technical principles as its sibling ICOone. The technical solution is patent protected.
There is a very high demand for nasal powder delivery among several companies, all of which are looking for a smart, cost-effective solution.

In Q4, we will initiate a major marketing initiative to find suitable innovative customer projects for ICOone Nasal.

ICOpre progressing as planned
The goal for 2021 is to be able to present an ICOpre inhaler with all parts in injection-moulded plastic. Proprietary generic formulations of Relvar®, Anoro®, Trelegy®, Incruse® and Arnuity® will be tested. Once the goal is reached, we will intensify dialogues with potential customers.

Increasing our commercial efforts
A strong cash position enables additional efforts and drive behind each of our three strategies. The capital raising of SEK 75 million completed in July now enables us, among other things, to invest more heavily in business development. We aim to build a strong and well differentiated portfolio of both Generic and Innovative inhalation drugs, and have the ambition to enter into one to three new deals per year.

We are building for success by now starting recruitment and strengthening the organisation with two additional key positions, a Director Business Development and a Communications & Marketing Manager.

We recently launched a major continuous marketing effort that will target our identified customer groups using modern technology in various campaigns.

It will be an exciting and intense end to the year, with continued focus on delivering success for existing projects and securing new agreements.

Johan Wäborg, CEO

 

 

Iconovo AB (publ), that develops complete inhalation products for a global market today annonces that the company´s Quality Management System (QMS) has been upgraded to meet the US Quality System Regulation (QSR 21 CFR 820) for medical devices. The company´s development and documentation process must comply with this FDA regulation to enable registration and marketing of medical device products in the US.

This achievement is a crucial step to obtain future US market access for all Iconovo drug device combination products including ICOres, ICOpre, ICOone and ICOcap.

In 2020, Iconovo’s QMS became compliant with the international ISO 13485:2016 standard for medical devices. Thus, the QMS also complies with the EU Medical Device Regulation. This has enabled Iconovo to develop drug device combination products that will be ready for registration on the European market.

“Iconovo have global ambitions for our inhalation platforms and US is the biggest pharma market in the world. Compliance with the US regulations is a key component to advance existing projects and will unlock even more opportunity in our partnering and business development process,” said Johan Wäborg, CEO for Iconovo.

Japan Patent Office has announced the intention to grant a patent (Notice of Allowance) regarding Iconovo’s inhalation device, ICOres. Iconovo has previously granted ICOres patents in Japan, USA, Sweden, Europe (EPO) and China. The new patent covers the technology used in many of Iconovo’s projects like generic Symbicort©.

Japan Patent Office has announced the intention to grant a patent (Notice of Allowance) regarding Iconovo’s inhalation device, ICOres. Iconovo has previously granted ICOres patents in Japan, USA, Sweden, Europe (EPO) and China. The new patent covers the technology used in many of Iconovo’s projects like generic Symbicort©.

“This new patent strengthens our patent protection on the very large and important Japanese market. This provides an opportunity to our partners to launch ICOres products in Japan”, says CTO Dr. Orest Lastow.

Expanded agreement doubles royalty potential

Key figures in TSEK unless otherwise indicated  Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Net turnover 3,496 2,425 5,641 4,357 17,792
Operating profit/loss -6,586 -5,819 -13,912 -10,800 -16,717
Cash flow for the period -6,911 -9,697 -15,433 -13,429 -27,467
Earnings per share (SEK) before full dilution -0.86 -0.82 -1.77 -1.37 -2.20
Cash and cash equivalents 46,256 75,727 46,256 75,727 61,689
Equity 79,001 99,220 79,001 99,220 92,729
Number of shares at period-end 7,776,000 7,776,000 7,776,000 7,776,000 7,776,000
Number of royalty agreements** 6 3 6 3 5

**Number of agreements at the end of the period.

Significant events 1 April – 30 June

  • In May, Iconovo announced the expansion of its agreement with Amneal regarding generic Symbicort to include the key US and Chinese markets and the Nordic sales rights, more than doubling the potential for future annual royalty income.
  • In May, Iconovo communicated its 5-year business targets at its first Capital Market Day. By 2026, the Company expects to achieve sales of SEK 200 million, with an operating margin of 50%. The Company also announced its long-term strategy, with three strategic areas made up of the original core operation of generic inhalation product development plus the new areas of innovative inhalation product development and pharmaceutical sales in the Nordics.
  • In May, Iconovo entered into an agreement with Respiratorius for the development of an inhalation product for the treatment of COPD. The agreement includes a tiered fee for project work, with a total value of up to SEK 3 million.
  • In April, the Company announced that the United States Patent and Trademark Office issued an intention to approve (Notice of Allowance) a patent for the ICOone inhalation platform. Iconovo already has approved patents for ICOone in Sweden, Europe (EPO) and India.
  • The Board has been further strengthened. Ann Gidner was elected to the Board at the AGM, and Gunnar Gårdemyr has taken over the role of Board Chair.

Significant events after the end of the second quarter

  • In July, Iconovo carried out a directed share issue and raised SEK 75 million before issue expenses. The issue has been subscribed by a number of Swedish and international institutional investors, including Alcur Fonder, FE Fonder and Humle Fonder, as well as a number of existing shareholders, including Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fonder. The proceeds of the issue will primarily be used for acceleration and value creation activities and investments linked to the Company’s new long-term strategy.
  • In July, Iconovo entered into an agreement with ISR (Immune System Regulation AB) for additional work on the ongoing inhaled COVID-19 vaccine project for the development of a nasal version of Iconovo’s ICOone inhaler. The additional work could provide up to SEK 4.9 million on top of the previous agreement. In addition, there is the possibility of future royalties.

A word from the CEO – Energised for growth

Long-term strategy with three areas In May, Iconovo held its first ever Capital Market Day, during which we launched our new long-term strategy. As a company, we are uniquely positioned to develop additional areas around inhalation, and we see great opportunities for growth by broadening our offering. Our future is now being shaped in three areas – Generic Inhalation Products, Innovative Inhalation Products and Pharmaceutical Sales in the Nordics.

An important area is the development of new, innovative inhalation drugs. These may be entirely new drugs, or new formulations of substances that were previously available only as injections, for example. We call this strategic area Innovative Inhalation Products. In the last six months, Iconovo has entered into three agreements in this innovative area, clearly demonstrating that our business model can be used in a very attractive way. Our offering allows our partners to invest in an inhalable drug in a high-quality, innovative inhaler – something that very few companies in the world can match.

In June, we further demonstrated the potential of our innovative projects when we entered into a supplemental agreement with ISR for the development of a nasal COVID-19 vaccine in a new Iconovo platform called “ICOone Nasal”. The order could provide Iconovo with an additional SEK 4.9 million on top of previously agreed amounts.

Development of generic asthma and COPD drugs is an area in which Iconovo is already well established, and it remains an important part of our operations. We anticipate significant future revenue from this area, primarily through royalties. We possess globally recognised expertise and can attract generics business on the global stage. The strategic area Generic Inhalation Products will be pursued with a continued focus on winning new business and continued deliveries towards the first market launches, expected in 2023.

When entering into development agreements with generic companies around the world, it is seen as very positive if you have a lot to gain from developing a fantastic product yourself. We therefore have a dual reason to sell generic products in the Nordic market ourselves.

This not only makes as a more attractive business partner, but becoming a Nordic pharmaceutical company helps us to build our own profitable drug portfolio. The strategic area Nordic Pharmaceutical Sales is being kicked off with establishment of Iconovo Pharma in 2021–2022. The first drug product launched is expected to be generic Symbicort in 2023, with a current market value of SEK 900 million in the Nordics.

Successful capital raising In early July, a directed share issue worth SEK 75 million was carried out. Several of our existing major shareholders took part in the issue, including Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fonder. We also specifically targeted Alcur, FE Fonder and Humle Fonder, which are known for investing in quality small companies with high potential and growth.

Five-year targets A strong cash position enables additional efforts and drive behind each of our three strategies. The strategies form the basis and plan for the work that will lead us to our set targets for 2026. We will reach a turnover of SEK 200 million from our generic projects and from Nordic pharmaceutical sales. In addition to this, the innovative projects with ISR have a potential upside worth SEK 100 million in 2026. Our business model is expected to lead to 50% operating margin from operations. The above targets are based on the projects we have right now, but we have also set an additional target of entering into 1–3 new customer agreements per year during the period up to 2026. Through new agreements, we can exceed the targets, and that is precisely why we want to invest now. To this end, we chose to raise capital via a directed issue.

Now that the strategy is in place, our focus is fully on implementation. We are now energised, well-funded and ready to focus heavily on our three strategic areas to maximise the value of our operations.

Johan Wäborg, CEO

 Iconovo AB (publ), a company developing complete inhalation products for a global market, today announced that it has received an order from the immunotherapy company ISR Immune System Regulation AB (ISR), a subsidiary of ISR Immune System Regulation Holding AB (publ), for additional work for the ongoing project with inhaled COVID-19 vaccine with a development of a nasal version of Iconovo’s inhaler ICOone. The additional order may give Iconovo up to 4.9 MSEK in addition to previously announced agreement.

The order covers the development of a nasally administered COVID-19 vaccine that will become a new fast track to the market due to a faster development process. The project for a nasal administration of a COVID-19 vaccine will use ICOone Nasal, which is a new nasal platform based on ICOone. It is a unique and proprietary nasal powder delivery device.

ISR and Iconovo pushes the project for an inhaled COVID-19 vaccine forward with high speed. Therefore, ISR has decided to accelerate development by adding a nasally administered vaccine that provides a faster path through the clinical studies. This COVID-19 vaccine, with administration to the nasal cavity, is meant to be a fast track that can either lead to a separate registration or it could pave the way for an orally inhaled vaccine for administration to the lung. The new nasal vaccine will be developed by Iconovo in the new platform ICOone Nasal.

The new agreement gives ISR an exclusive global right to use ICOone Nasal under the current agreement as a line extension to ICOone, for the treatment of COVID-19 and its variants with a technology based on so-called spike proteins with an adjuvant. Under the current agreement, ISR also has a future option to use its vaccination technology in ICOone in influenza, RS-virus and new strands of covid-virus vaccines based on the same technology.

The total value of the order is 10.4 MSEK, which is 4.9 MSEK in addition to previously communicated contractual sums. Iconovo will contractually develop a nasal vaccine and manufacture clinical trial material to a phase 1 study that takes priority into phase 1 over the inhaled lung product. Payments are expected to be divided into 9.1 MSEK over the coming six months and the remaining amount over the next 24 months. Upon signing of the order, an initial payment of 1.3 MSEK will be paid.

“This order provides a great opportunity to evaluate the new platform ICOone Nasal in a clinical study for COVID-19. We give the project the highest priority to support ISR in their efforts to advance the project according to the aggressive timelines required during a pandemic. This project could be the start of a paradigm shift that opens the door to inhaled vaccines instead of injectable vaccines. A shift where Iconovo is well positioned to take the lead”, says Johan Wäborg, CEO of Iconovo.

An inhaled formulation for nasal or lung administration gives important benefits such as ease of use, cheaper transportation, storage without the need for refrigeration and no handling of needles and syringes. Removing the need for refrigeration and the handling of contagious material represent a large savings potential and can potentially eliminate the risk of spreading disease through infected needles. Another important benefit is that the vaccine directly reaches the airways and provides both a local protection in the airways and an activation of the systemic immune defense.

”The platform of ICOone with its flexibility enables a rapid, affordable and effective development of a SARS-CoV-2 vaccine for the respiratory tract. The platform can make ISR’s vaccine available on the global market shortly after conducting clinical studies. The collaboration is now deepening and broadened to include both nasal and lung administration, which we see as a great advantage, as different respiratory pathogens may have different entry ports in the airways. We see the collaboration with Iconovo as a long-term partnership with the aim of establishing a series of different vaccines”, says Ola Winqvist, CEO of ISR.

About ISR

ISR is an innovation-driven development company of pharmaceuticals within immunotherapy. The business idea is to convert preclinical immunological research to clinical development stimulating the the immune system to fight chronic infections like HIV, HBV and cancer by developing the company’s pipeline of immunostimulants Immunolider and Immunorheliner and utilize the immune system to develop designer vaccines. The company has its headquarter in Stockholm. Mangold Fondkommision AB is the certified advisor and can be reached at telephone +46 8 503 01 550.

About ICOone®

ICOone is a unique, patented dry powder inhaler for single use. The smart design generates an ultra-low manufacturing cost combined with simple and discreet use. It is particularly suitable for short-term treatment and as-needed use as it provides an unsurpassed low treatment cost and price point for treatments with a low number of doses. The simple design also enables patients and caregivers to learn how to handle the inhalers with minimal training. ICOone can deliver large inhalation doses that are well protected against moisture, an important factor for many biomolecules.

About ICOone® Nasal

ICOone Nasal is a unique and patented nasal powder delivery device driven by the inhalation of the user for single use. The smart design generates an ultra-low manufacturing cost combined with simple and discreet use. It is particularly suitable for short-term treatment and as-needed use as it provides an unsurpassed low treatment cost and price point for treatments with a low number of doses. The simple design also enables patients and caregivers to learn how to handle the nasal delivery device with minimal training. ICOone Nasal is driven by the inhalation of the user that gives an even and natural distribution of the powder on the nasal mucosa. The patented design gives a stable product avoiding the need for refrigerator-cold transport and minimize the need for preservatives.