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.

The Board of Directors of Iconovo AB (publ) (”Iconovo” or the ”Company”) has, pursuant to the authorisation granted by the Annual General Meeting of the Company that was held on 19 May 2021, resolved on a directed share issue of 1,071,500 new shares, corresponding to approximately 13.8 per cent of the total number of shares outstanding, at a subscription price of SEK 70 per share (the “Issue”). This means that the Company receives SEK 75,005,000 before transaction costs. The subscription price in the Issue has been determined through an accelerated bookbuilding procedure (the ”Bookbuilding”). The Issue was subscribed for by several new Swedish and international institutional investors, such as Alcur Fonder, FE Fonder and Humle Fonder, as well as several existing owners, such as Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fondförvaltning AB.

The Company intends to use the proceeds from the Issue for accelerating and value-creational development and initiatives connected to the Company’s new long term strategy. Approximately 40 per cent of the proceeds intends to be used to build a value-creating portfolio of projects within the strategic area Innovative inhalation products. Another approximately 40 per cent of the proceeds intends to be used for building and scaling up the Company’s Nordic sales of pharmaceuticals through licencing of products to Iconovo Pharma. Remaining share of the proceeds intends to be used for increasing the Company’s project capacity, which would reduce the risk in the portfolio and increase the likelihood of launch of additional products to market, and increased commercialisation connected to Iconovo’s three strategic focus areas (i) own sales of generic inhalation products in the Nordics, (ii) development of innovative inhalation products, and (iii) development of generic inhalation products.

The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate transaction structure in order to raise capital in a time- and cost-effective manner, whilst also further diversifying the Company’s shareholder base.

The Issue results in that the total number of shares outstanding in Iconovo increases by 1,071,500, from 7,776,000 to 8,847,500, and the share capital increases by 107,150, from SEK 777,600 to SEK 884,750, which implies a dilution effect of approximately 12.1 per cent of the share capital in relation to the number of shares in Iconovo after the Issue.

In connection with the Issue, the Company has agreed to a lock-up undertaking on future share issuance for a period of 180 days, subject to customary exceptions. In addition, the Company’s CEO, CFO and Board of Directors who hold shares in the Company at the time of the transaction, have undertaken not to sell any shares in Iconovo during the same period, subject to customary exceptions.

Advisers
In connection with the Issue, the Company has retained Danske Bank as sole bookrunner and Bird & Bird Advokat as legal adviser.

Iconovo AB (publ), which develops complete inhalation products for a global market, today announces its five-year goals for the business. By 2026, the company expects to achieve sales of SEK 200 million. The target for operating profit is SEK 100 million, corresponding to an operating margin of 50%.

The expectations reflect current publicly announced projects in Iconovo’s project portfolio and the company’s goal to bring in up to 3 new projects per year. For future projects that currently are undefined only expected milestone payments are included.

Iconovo expects to have about 50 employees in five years with ten projects in development and five launched inhalation projects that generate royalties.

There are two potential business upsides: royalty revenue from the area of innovative inhalation projects of up to SEK 100 million and royalty revenue from generic Symbicort® in the US of up to SEK 70 million.

“Iconovo is a company with high ambitions. Now that we have increased the number of innovative projects in our pipeline in a short period of time and are getting closer and closer to launch, we think it is important to communicate financial goals”, says Iconovo’s CEO Johan Wäborg.

Turnover and operating profit
Iconovo expects to achieve a turnover of SEK 200 million by 2026. The revenues consist of ongoing revenues from the development work as well as royalty revenues from five launched products – Symbicort, Ultibro, Seebri, Relvar and the undisclosed product developed in collaboration with Intas. Approximately 1/3 of the turnover is estimated to come from Iconovo’s pharmaceutical sales in the Nordics through Iconovo Pharma.

The potential royalty revenue from innovative inhalation products and royalty revenue from Amneal’s potential sales in the US is not included in the sales target but is described as potential upsides.

The target for the operating margin in 2026 is to achieve 50% and thereby an operating profit of SEK 100 million. The high margin can be achieved through royalty streams as well as a good margin from Nordic pharmaceutical sales.

Development of the business
Iconovo sets a goal to generate up to three new customer agreements per year. The focus will be on finding a good mix of agreements within Iconovo’s three strategic areas that lead to diversification of both opportunities and risk in the portfolio.

In 2026, Iconovo will be an established organization with approximately 50 employees. The target for new projects going forward and today’s project portfolio is estimated to result in ten projects being in development and five generic inhalation products being launched. Of the products launched, the intention is that the majority will be sold in the Nordic region by Iconovo Pharma.

Three strategic areas
Revenue in 2026 come from three strategic areas within Iconovo: development of generic inhalation products, development of innovative inhalation products and own sales of generic inhalation products in the Nordic region.

Iconovo Pharma – sales of generic inhalation products in the Nordics
On May 17, Iconovo announced that the agreement with Amneal would be expanded to include more territories including the United States and China. As part of the agreement, Iconovo also acquired the rights to sell generic ICOres Symbicort in the Nordic countries. In 2020, the Nordic market for Symbicort was valued to SEK 800 million. The price erosion in the region is low and stable and in recent years around 4% per year. Iconovo estimates that the company can reach a market share of 15-20% and can then realize revenue of between SEK 80 and 100 million annually when full market potential is reached.

In 2026, Iconovo Pharma is expected to account for approximately 1/3 of the turnover.

Innovative inhalation products
Projects in the space of innovative inhalation products have a lower probability of success to reach the market and takes longer to develop. Therefore, royalty income from this strategic area has been defined as an upside for 2026. One innovative inhalation project that may reach launch within the five-year period is the development of inhaled COVID-19 vaccine in ICOone together with ISR. A Phase I study is scheduled to begin in the second half of 2021. If the project is successful and maintains an accelerated timeline, it can help making Iconovo a profitable company earlier. The potential upside for a successful project with ISR is estimated to have a revenue of up to SEK 100 million by 2026.

Generic inhalation products
Iconovo estimates that royalty revenues from generic inhalation products will account for 2/3 of sales in 2026. Royalty revenues will come from five launched products that Iconovo develops today. The majority of the royalty revenue in five years time will come from our generic Symbicort in ICOres sold by Amneal.

Amneal has expanded its contract for generic Symbicort in ICOres to include approximately 90% of the global market where approximately 1/3 consists of sales in the USA. Since the decision by Amneal to launch in the US will be based on a number of future events both in the US market and in Europe, Iconovo chooses to see the US as an upside that could reach a revenue of SEK 70 million in 2026.

Risks over the five-year period
Iconovo views the largest risks of not meeting the 2026 target linked to project failure, delays, a more challenging competitive situation or that the products are launched in a smaller territory than expected. Although the risk of generic products failing is less, it happens, and uncertain price developments in different markets can cause our generic products to be launched in fewer countries than expected. Iconovo considers the market size to be relatively stable and therefore the largest uncertainty is linked to how widely the products are launched.

Iconovo AB (publ), which develops complete inhalation products for a global market, and Respiratorius AB (publ), which develops drug candidates for the treatment of COPD, and other common diseases, announced today that they have signed an agreement for the development of an inhalation formulation as well as an inhalation product for phase I studies for Respiratorius drug candidate RES030-085 within the RESP9000 project for the treatment of COPD and severe asthma.

COPD is considered one of the most common and fastest growing diseases that lack satisfactory treatment. The formulation work represents an important step for Respiratorius’ development of drug candidate, RES030-085. This is Iconovo’s third agreement in a short period of time within the company’s new strategic area for innovative inhalation projects.

“The collaboration with Respiratorius further strengthens our position in the strategic area of innovative inhalation projects. We look forward to working together to reach the market in as short a time as possible”, says Johan Wäborg, CEO, Iconovo.

The agreement requires Iconovo to develop a dry powder formulation and an inhalation product based on Iconovo’s inhaler ICOone, for use in phase I clinical studies. The intention is also to investigate which of Iconovo’s inhalation platforms is best suited for the commercialization of Respiratorius substance and, after successful development work, discuss a license agreement between the companies.

“Starting a Phase I study is an important goal for Respiratorius. We are pleased to partner with Iconovo’s inhalation experts to develop an appropriate formulation and inhaler for our substance”, says Johan Drott, CEO, Respiratorius.

The agreement includes step-by-step fee-for-service development work with the total value of up to SEK 3 million of which SEK 0.2 million is paid upon signing the agreement. The work is projected to be performed within the next 9 months.

About RES030-085
RESP9000 is a series of drug candidates with bronchial and anti-inflammatory properties that are developed to enable the treatment of both COPD and asthma patients. The main candidate RES030-085 is in preclinical phase with good results in the conducted preparatory safety studies. In 2018, a patent application for the substance series was filed within the RESP9000 project and is now in the national phase, for approval in individual countries.

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 Respiratorius
Respiratorius AB (publ) develops drug candidates, with the ambition to be able to launch medicines for diseases such as cancer, chronic obstructive pulmonary disease (COPD) and severe asthma. In addition, the project portfolio includes a project to improve the diagnosis of certain cardiovascular diseases.

For more information about the business, see www.respiratorius.com

Iconovo AB (publ), which develops complete inhalation products for a global market, today announced that its collaboration with the U.S. pharmaceutical company Amneal is expanding to include additional territories that lead to the announced potential for future annual royalty income more than doubling to USD 13.2 – 26.4 million. Iconovo has also acquired the license to sell Amneal’s generic versions of Symbicort® in the Nordic region with the potential to generate revenues between USD 9.5 – 11.9 million.

Iconovo and Amneal develop a generic Symbicort in the inhaler ICOres®. The project is now entering the final phase, and Amneal has begun the set-up of commercial manufacturing for a global market. The original agreement mainly covered sales in Europe, but also Canada, Australia, Russia and some smaller emerging markets. The new, expanded agreement gives Amneal the right to sell in the U.S. and China as well. Hereby the agreement now covers approximately 90% of the total global Symbicort market.

“We are very pleased to have been able to expand our agreement with Amneal. It is a very strong and positive signal that Symbicort in the ICOres inhaler is a product with great international potential. Financially, this is an important event for Iconovo,” said Johan Wäborg, CEO of Iconovo.

“Symbicort is a perfect example of the complex generic products that we’re aiming to bring to market over the coming years,” said Gregory Sgammato, Head of Global Corporate Development at Amneal. “It is a high-value, drug-device combination in the respiratory space, which ensures it will remain an attractive global opportunity for the foreseeable future. Iconovo has been a fantastic partner and we look forward to working with them as we launch and commercialize this product.”

Iconovo has previously announced that the European market can generate annual royalty revenues of between USD 5.2 and USD 10.3 million. This assessment is now updated to between USD 13.2 and USD 26.4 million, which now also includes both new territories and those in the original contract.

Iconovo takes over marketing and sales rights of Symbicort in the Nordic region
The new agreement with Amneal also covers the right to market and sell generic ICOres Symbicort in the Nordic market.

In 2020, the Nordic market for Symbicort amounted to SEK 800 million. Price erosion in the region is stable and was in recent years about 4 percent per year. Iconovo estimates that the company can reach a market share of 15-20 percent and can then realize revenues of between SEK 80 and SEK 100 million (USD 9.5 – 11.9 million) annually when the full market potential is reached.

Marketing and sales of ICOres Symbicort in the Nordic market will be carried out by Iconovo Pharma, which will become a new pharmaceutical division within Iconovo AB. The investment is in line with Iconovo’s long-term strategy to move higher up the value chain. Iconovo possesses unique knowledge about the development of dry powder inhalation medicines and is uniquely positioned to market these products in the Nordic countries.

“Since Iconovo is a Swedish company with long experience in the Nordic market, it is a big opportunity to also become a pharmaceutical company. For us, this is a completely natural step up the value chain, allowing us to create great value for our investors,” said Johan Wäborg.

We believe ICOres can be a success in the Nordic market as it is handled in a similar way as the reference product. That means a smaller threshold to switch from Turbuhaler® to ICOres compared to today’s generic products that have a different handling compared to the original. In addition, ICOres has a number of features that Turbuhaler lacks. The product is also the result of Swedish innovation, which can be perceived as a vote of confidence for customers,” continued Johan Wäborg.

 

 Strategic innovation generates new agreements
Key figures in TSEK unless otherwise indicated  Jan-Mar 2021 Jan-Mar 2020 Jan-Dec 2020
Net turnover 2,145 1,932 17,792
Operating profit/loss -7,325 -4,981 -16,717
Cash flow for the period -8,521 -3,732 -27,467
Earnings per share (SEK) before full dilution -0.91 -0.55 -2.20
Cash and cash equivalents 53,168 85,424 61,689
Equity 85,651 105,620 92,729
Number of shares at period-end 7,776,000 7,776,000 7,776,000
Number of royalty agreements** 6 3 5

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

Significant events 1 January – 31 March

  • In January, Iconovo communicated its operational goals for 2021.
  • In February, Iconovo received its first order for development work for Monash University. This compensation is in addition to the technology access fee previously contracted with the customer.
  • In February, the company announced that the United States Patent and Trademark Office issued an intention to approve (Notice of Allowance) a patent for the ICOres inhalation platform. This is the second patent approval for ICOres in the United States.
  • In February, the first two patent applications for the new ICOpre inhalation platform were submitted.
  • In March, Iconovo signed an agreement with ISR for the development of an inhaled COVID-19 vaccine.

Significant events after the end of the first quarter

  • 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.

A word from the CEO

Increase in revenue compared to last year
The total revenue increased to SEK 5.2 million in Q1, compared to SEK 3.2 million in the same period last year. Turnover amounted to SEK 2.1 million, an increase from SEK 1.8 million in Q1 2020. The turnover consisted of milestone revenue mainly from the Monash and Intas projects and the technology access fee paid by Immune System Regulation AB (ISR).

The turnover varies from one quarter to another, as invoicing in the projects is not evenly spread over the year.

Agreement with ISR on COVID-19 drug
At the end of March, we were proud to announce a new agreement with ISR, granting them a licence to commercialise ICOone with an inhalable COVID-19 vaccine. The agreement covers the type of vaccine that consist of spike proteins from the surface of the coronavirus and an adjuvant that enhances the effect. The agreement combines the technology platforms of Iconovo and ISR, with Iconovo taking responsibility for the drug formulation and optimising ICOone. ISR has patents on adjuvants and extensive expertise in immunomodulation.

The contract has a potential value of SEK 18.1 million for milestones and technology access fees, spread over the development period up until market authorisation. The low single-digit royalty level is slightly lower than for generic contracts, which is explained by the fact that our share of the investment is significantly smaller than for ISR, which is responsible for conducting clinical trials.

There is also an opportunity within the agreement for ISR to proceed with the development of vaccines for RS and influenza viruses. Iconovo strongly believes in the strategy of creating an immune response that generates Ig-A antibodies in the body’s first line of defence against airborne viruses in the lungs. If ISR is able to demonstrate efficacy with this type of drug, we will capture a significant share of an enormous market. Iconovo’s focus now is on developing the best possible inhalation product for the purpose.

Innovative inhalation projects
The recently announced complementary strategic focus on innovative drugs has given us focus and resulted in us securing another agreement at the end of Q1. We are seeing a clear increase in interest in inhalation for both new molecules and reformulations of, for example, injected drugs. Here, Iconovo can now showcase two ongoing projects, and our business model allows us to offer for example the ICOone platform to more customers with the desire to launch drugs as dry powder inhalation.

ICOone can replace injections
Inhalation of drugs is one of the major opportunities for improvement in drug administration, and Iconovo intends to be a driving force in this development.
One of the major advantages of dry powder inhalers is that it eliminates the need for cold storage. Hazardous waste such as infectious needles can be eliminated, and simplified administration leads to a reduced need for healthcare staff.

We work proactively in business development to alert companies to smart and sustainable options for formulating drugs for inhalation use.

Progress in line with business objectives
Work on projects is progressing in line with the objectives communicated earlier in the year. Iconovo has now delivered what is needed for Amneal to initiate a pilot PK study. Work on clinical trial material is being conducted during the second quarter, the study start is in the summer, and results are expected a few months later. The final part of the technology transfer to Amneal will be the knowledge transfer needed for the manufacturer to best produce the finished drug product.

Other plans are set: Monash University plans to start its phase 1 study of inhalable oxytocin in ICOone in the latter part of the year. For the Intas and BNC Korea projects, remaining work will be carried out during the year to allow studies to be completed.

ICOpre work intensifies
A major factor in the Q1 revenue item is capitalised own work of SEK 2.9 million. This work is mainly carried out within the ICOpre project and exemplifies the increased focus that is now in place. Commercially, we are preparing smart cultivation of customers using modern targeting, for example through targeted digital marketing and customised customer cultivation in social media. It all starts in May with the introduction of the ICOpre inhaler at the RDD congress. The development goal for the year is to take the ICOpre project to a phase where we can launch a structured sales process. An exciting year is now underway.

Johan Wäborg, CEO