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

 

 

United States Patent and Trademark 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) 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 is a confirmation that ICOone is a very unique and innovative inhaler. With granted patents in USA, EU and India we now have a very strong protection on markets in great need of 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.

Iconovo AB (publ), a company developing complete inhalation products for a global market, today announced that it has signed an agreement with the immunotherapy company Immune System Regulation AB (ISR), an affiliate to ISR Immune System Regulation Holding AB (publ), for the development of an inhaled covid-19 vaccine in Iconovo’s inhaler ICOone®. The agreement is Iconovo’s second agreement within its newest strategic area innovative inhalation projects and confirms the suitability of ICOone to be used also for vaccines.

The agreement gives ISR exclusive rights to use ICOone for the treatment of covid-19 and its variants with a technology based on so-called spike proteins with an adjuvant. Iconovo will contractually develop an inhalation product with the aim to test the product in a human clinical trial targeted to start during the second half of 2021. In the agreement ISR receives an option to also use its vaccination technology in ICOone for influenza, RS-virus, and new strands of covid-virus vaccines based on the same technology.

The agreement includes stepwise payments of a 9 MSEK technology access fee, set up as five increasing milestone payments over the development to market authorization. The first milestone of 0.2 MSEK was paid at the agreement signature. ISR will also pay Iconovo for the contract development of the inhalation product which in a first binding feasibility trial amounts to 3.6 MSEK, followed by the production of clinical trial material at a preliminary value of 5.5 MSEK. Additionally, the agreement will give Iconovo low single-digit percentage royalties over a period of 14 years from market launch.

Today there are 3.9 billion people in lower-middle-income and low-income countries who will have a late access to covid-19 vaccines, according to the World Bank. With a price corresponding to the vaccines from AstraZeneca or J&J (8 – 10 USD per vaccination) this represents a full market potential of totally 31 – 39 billion USD. The size of the sales potential for an inhaled covid vaccine will depend on the rate of vaccination in these countries. There is also a scenario where the virus will mutate and, in the future, create the need for annual vaccinations similar to how influenza is managed today. As a comparison, the market for annual influenza vaccinations amount to at least 5.5 billion USD per year.

”With this project Iconovo widens its experience within the new strategic area innovative inhalation projects, and we look forward to more similar projects where we can contribute with our inhalation experience. It sends a strong signal to the market that more companies see ICOone as a suitable inhaler for innovative applications,” says Johan Wäborg, CEO of Iconovo.

ISR has previously shown in animal models that its vaccine gives good protection against covid and this is the next step in the development of a spray-dried inhaled vaccine formulation for use in Iconovo’s single-use inhaler ICOone. An inhaled formulation gives important benefits such as ease of use, cheaper transportation, storage without the need for refrigeration and no handling of needles and syringes. To remove 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 affected area in the pulmonary tissue that will give the needed type of immune response for protection.

“This is a very important step towards taking our inhaled covid-19 vaccine to the market quickly with a suitable single-use inhaler. We believe that the product will be of greatest use in developing countries with restricted access to refrigeration and where the vaccination programs have not advanced yet. We also hope that an inhaled vaccine will give a more adequate immune reaction in the lung which is patrolled by another type of anti-body,” said Ola Winqvist, CEO of ISR.

“The potential for an innovation like this will be huge if it reaches the market. We believe that ICOone has the potential to replace injections of vaccines and other important molecules, thereby offering a smarter way to administer these pharmaceuticals. Iconovo is a global leader and wants to act as a driving force in this development,” said Johan Wäborg.

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.

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.

50 percent growth in 2020 and ambitious goals for the future

Key figures in TSEK unless otherwise indicated  Oct-Dec 2020 Oct-Dec 2019 Jan-Dec 2020 Jan-Dec 2019
Net turnover 7,681 17,792 11,737
Operating profit/loss -3,610 -7,207 -16,717 -11,774
Cash flow for the period -10,398 48,405 -27,467 36,106
Earnings per share (SEK) -0.58 -1.10 -2.20 -1.68
Cash and cash equivalents 61,689 89,156 61,689 89,156
Equity 92,729 108,794 92,729 108,794
Number of shares at period-end 7,776,000 7,776,000 7,776,000 7,776,000
Number of royalty agreements** 5 3 5 3

**Number of agreements at the end of the period

Significant events 1 October – 31 December
· In December, Iconovo signed an agreement with Monash University for the development of inhaled Oxytocin in ICOone. The agreement confirms the suitability of using ICOone for innovative drug projects. Australian Monash University is leading the development project in collaboration with Janssen Pharmaceuticals. Through the agreement, Iconovo will receive a technology access fee totalling EUR 900,000, where the first milestone will be paid as a licence fee for the project after a positive phase 1 study, planned for 2021. The agreement provides royalties ranging from 5 to 10% over a 20-year period from the date of launch.
· Iconovo recruited a Director Project Management and a Director Alliance Management. This is to increase focus on customer needs and enable the delivery of customer projects at an even higher quality and in a more efficient manner.

Significant events 1 January – 30 September
· In July, Iconovo signed a regional know-how licensing agreement with BNC Korea Co Ltd. The agreement gives exclusive rights to manufacture, market, sell and distribute two capsule formulations together with ICOcap in the territory. The deal has a value of EUR 550,000 and future royalties of a medium single-digit percentage of sales.
· In May, Amneal joined as a new partner in the development of Iconovo’s project with generic Symbicortâ. Amneal is taking over all obligations under the current agreement from CBC. The project will proceed according to plan.
· The ICOcap capsule inhaler has become CE-marked for use in clinical trials and can be purchased directly from Stevanato, which is the manufacturing and distribution partner.
· In April, Orest Lastow took over the role of company Chief Technology Officer (CTO), and Johan Wäborg was hired as the new CEO. Orest Lastow, one of the co-founders and one of the largest shareholders together with the company’s Board Chair, is the inventor behind Iconovo’s three inhaler platforms and is now focusing on development of the new ICOpre platform.
· The COVID-19 pandemic currently has a limited impact, and this is expected to be the case in the future as well. The company has the required goods in stock, and sales are not physical. The greatest impact that could occur is some delay in development in the event that company employees fall ill.
· On 11 March 2020, an Extraordinary General Meeting was held which decided on an incentive programme and the issue of 200,000 warrants to the future CEO. Subsequently, there was subscription
of 200,000 warrants for a total of SEK 1,224,000.

Significant events after the end of the quarter
· 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.

A word from the CEO

50% increase in turnover
Q4 ended the year with a good pace in project deliveries, and we reached MSEK 7.7 in turnover, which is the highest quarterly turnover in three years. 2020 thus lands on a 50% increase in turnover compared to the previous year.

I am proud of the project teams, who were able to reach several important milestones during the quarter. It is worth mentioning that some of the last milestones in the Amneal project were delivered, and that several milestones were delivered in the Intas project.

In the internal development project with ICOpre as well, the teams were able to reach our goal of developing a functional inhaler with several injection-moulded components.

Agreement with Monash University
At the end of December, we announced that we have entered into a new agreement with Monash University, backed by Janssen Pharmaceuticals, which is part of J&J. The agreement gives Monash a licence to commercialise ICOone with inhalable Oxytocin.

Inhalable Oxytocin has the potential to save thousands of lives. Each year, upwards of 75,000 mothers die from postpartum haemorrhage, mainly in rural areas in economically weak regions. This is prevented in economically stronger countries through use of Oxytocin injections in connection with childbirth. In many countries, it is difficult to transport and store drugs in an unbroken chain of refrigeration. Inhalable Oxytocin in ICOone can solve this problem, while at the same time eliminating the risks of spreading infection and hazardous waste.

We are extremely proud to be selected to contribute our know-how and ICOone to this important project with a strong connection to sustainability. This serves as confirmation that our platforms are of global interest, including for innovative drugs.

Ambitious operational goals for 2021
In January 2021, we communicated our operational goals for the year, which will see final delivery of the development work for Amneal, Intas and BNC Korea. The customers can then begin bioequivalence studies. Amneal is expected to start its study in Q2, with study results in Q3. Monash University will also begin its Phase 1 study of inhalable Oxytocin in ICOone.

We will also take our strategically important ICOpre project to a phase where we can launch a structured sales process. The goal for this year is to produce a fully ready-to-use inhaler with formulations for all five products in GSK’s ElliptaÒ portfolio, whose sales are forecasted at USD 4.5 billion by 2023. The first out is RelvarÒ  in the USA, where the patent expires in 2025.

As a result of our increased commercial focus, we are also doubling the target number of new deals, with a view to achieving two new agreements in 2021.

New year, new strategic area
As a result of the agreement with Monash, we see a large increased interest in projects with substances that are suitable for administration with a single-use inhaler. We are therefore creating a new strategic area: Innovative inhalation drugs, which, together with our current strategic area generic inhalation drugs, will be extremely important for our future growth. The potential is enormous.

Impact through sustainability goals
Iconovo works globally all over the world, and we currently have customers in the USA, Korea, Australia, India and Europe. We thus have a great opportunity to use our influence to steer the world around us towards achieving sustainable local and global solutions.

In 2021, we will link both company goals and individual goals to the UN’s sustainability goals, referred to as the 2030 Agenda. In recent months, we identified and prioritised three of the 17 global goals that not only best match our operations and the phase we are in today, but are also important to our employees, customers and owners. We are focusing on Good Health and Well-being, Decent Work and Economic Growth, and Climate Action.

COVID-19
COVID-19 is having minimal impact on Iconovo, and work on our projects is progressing according to plan. In business development, it is possible to maintain a high level of activity through virtual meetings. However, we look forward to and are planning to reconnect with our customers via physical meetings as soon as possible.

The organisation is growing at pace with increasing business
We recently made many investments to increase our capacity, put further focus on project implementation, and become better at customer acquisition.

In recent months, we hired several new key employees. We are now a force of 27 people – a very competent organisation in which new employees quickly become part of our family and contribute to us having increased capacity to both handle current projects and take on more projects.

Keeping an eye on the bottom line
At the end of 2020, we had MSEK 61.7 in cash and cash equivalents. After a very active Q4 with a high level of invoicing, we are entering the new year with MSEK 8.9 in accounts receivable. As a result, we are well funded for the future. I look forward to letting you knowabout our upcoming activities. We have a very exciting year ahead of us.

Johan Wäborg, CEO

 

Contacts


Johan Wäborg, CEO
+46 707 78 51 71
johan.waborg@iconovo.se


About Iconovo


Iconovo was founded in 2013 by people with long experience in inhalation development. The company develops inhalers and associated drug preparations that are used to treat asthma and COPD. However, Iconovo also has the competence to develop products for new types of inhaled drugs such as vaccines.

By working with Iconovo, pharmaceutical companies and generic companies can access a complete pharmaceutical product, thereby eliminating the complex and costly early stages of the development phase. Iconovo licenses its patented products to customers and offers a faster way to the inhalation market with lower risk and at a lower cost.

More information about the company can be found at www.iconovo.se.

Iconovo is based in Lund and its share (ticker ICO) is listed on Nasdaq First North Growth Market, Stockholm since April 6, 2018. The Company’s Certified Adviser is Erik Penser Bank AB, Box 7405, SE-103 91 Stockholm, phone +46 8 463 80 00, email: certifiedadviser@penser.se.