Krävs varken vårdpersonal eller svårhanterad kylkedja

Det Stockholmsbaserade bolaget ISR har utvecklat ett covidvaccin i pulverform och Lundabolaget Iconovo en engångsinhalator som gör att pulvret dras ner och finfördelas i lungorna.

Det är bråttom eftersom pandemin pågår för fullt – och man är inte ensamma om att forska på covid-19-vaccin i pulverform.

Kliniska studier på människor kommer inledas inom några månader och om vaccinet fungerar som det är tänkt finns en enorm marknad, allra främst i u-länder, eftersom det varken krävs vårdpersonal eller kylkedjor.

Se hur pulvervaccin skulle kunna användas.

On May 26th Iconovo held a Capital Markets Day for investors and other stakeholders to Iconovo. If you missed the presentations, you can still see them following the link below.

Video presentation Iconovo Capital Markets Day

Biostock published May 25th an article about Iconovo that can be found in its entirety below

Last week, Iconovo announced its financial targets for 2026. In five years, the company expects to have ten projects in development and five launched inhalation products that generate royalties. In addition, the goal is to enter into 1 – 3 new customer agreements per year on the way there. All in all, this is expected to generate sales of 200 million SEK and an operating profit of 100 million SEK in 2026. Iconovo also sees two potential upsides: royalty revenue from innovative inhalation products as well as from royalty revenue from generic Symbicort in the US.

Iconovo develops complete inhalation products (both inhalers and respective dry powder formulations) that are licensed to other pharmaceutical and generic companies.  In exchange, Iconovo receives milestone payments for development work and royalty revenues once the products have been launched.

The company has now presented its five-year goals for the business based on customers projects in Iconovo’s project portfolio, as well as the company’s goal of bringing in up to three new projects per year.

Five market launches ahead

Iconovo, together with its customers, expects to be able to launch five products in the next five years. First up is a generic version of Symbicort, developed together with Amneal and expected to launch in Europe in 2023. Next, Iconovo expects to launch a generic Ultibro and Seebri with BNC Korea, a generic version of Relvar in the US, and an undisclosed product developed in collaboration with Intas.

Sales of 200 million SEK and operating margin of 50 per cent

One of Iconovo’s financial targets is to achieve a turnover of 200 million SEK in 2026, which is significantly more than the turnover in 2020 (17.8 million SEK). In 2026, total revenues are expected to consist of ongoing revenues for development work in the company’s various projects as well as royalty revenues from the five launched generic products Symbicort, Ultibro, Seebri, Relvar and the product developed together with Intas.

Furthermore, Iconovo sets a goal of achieving an operating profit of 100 million SEK and thus an operating margin of 50 per cent.

Potential upsides

A potential upside in the sales target is royalty revenue from the area of innovative inhalation products. According to Iconovo, these products are less likely to reach the market than generic products and they also take longer to develop. However, an innovative project that Iconovo believes may reach launch within five years is the development of an inhaled Covid-19 vaccine together with ISR. If the project is successful, it could increase revenue by up to 100 million SEK in 2026.

Furthermore, a potential upside is royalty revenue from sales through Amneal in the US. Amneal’s decision tolaunch a generic Symbicort in the US will be based on a number of future events in the US and Europe. As aresult, Iconovo chooses to see it as a potential upside of 70 million SEK in 2026.

1/3 of the turnover from Iconovo Pharma

Last week, Iconovo announced that they are starting a new pharmaceutical division called Iconovo Pharma for the Nordic market. This was decided when Iconovo acquired the rights from Amneal to sell a generic Symbicort in the Nordic region.

The majority of the launched products will be sold in the Nordic region by Iconovo Pharma. According to the recently communicated business targets, sales through Iconovo Pharma are expected to account for one third of sales in 2026. The company estimates that the remaining two thirds will come from royalty revenues for generic inhalation products.

Virtual Capital Markets Day Wednesday, May 26

The financial targets for the next five years will most likely be mentioned at Iconovo’s Virtual Capital Markets Day on May 26 at 13:00-15:30. During the day, the audience will hear presentations from members of the management team as well as external guest speakers, such as the company’s customers ISR and Monash University regarding the projects for inhaled Covid-19 vaccine and inhaled oxytocin.

The digital event will focus on Iconovo’s transformation into a commercial pharmaceutical company as well as the potential in the company’s three strategic areas – generic inhalation products, innovative inhalation products and its own sales of generic inhalation products through Iconovo Pharma. According to the business goals, Iconovo will try to find a good mix of customer agreements in all three strategic areas in order to achieve a diversified product portfolio with both opportunities and risks.

High expectations for the next five years

Iconovo seems to have high expectations for the company’s growth over the next five years, given the recently communicated ambitious business goals. In five years, Iconovo is expected to have 50 employees, a doubling compared to today. According to Johan Wäborg, CEO, Iconovo is a company with high ambitions that is getting closer and closer to launch:

»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« – Johan Wäborg, CEO Iconovo 

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

Biostock published May 21th an article about Iconovo that can be found in its entirety below

The two Lund-based development companies Respiratorius and Iconovo have signed an agreement to develop an inhalation formulation and an inhalation product of Respiratorius drug candidate RES030-085 for the treatment of COPD and severe asthma. A first inhalation product based on Iconovo’s ICOone is intended to be used in a phase I clinical trial with the candidate. BioStock has spoken to the respective CEOs of the two companies to find out more about what this means.

Iconovo develops complete inhalation products consisting of both inhalers and dry powder formulations, while Respiratorius develops drugs for the treatment of chronic obstructive pulmonary disease (COPD), asthma and cancer. The companies will now work together to develop an inhalation product for the treatment of COPD and asthma based on Respiratorius’s candidate RES030-085 and Iconovo’s inhaler ICOone. The agreement between the two companies has a total value of SEK 3 million, of which SEK 200,000 will be paid to Iconovo upon signing the agreement.

COPD – a rapidly growing disease

COPD is a collective name for lung diseases that chronically reduce air flow in the respiratory tract associated with inflammation of the lungs, which leads to breathing problems. It is one of the fastest growing diseases and is the third leading cause of death in the world today. The respiratory treatment market accounts for almost 10 per cent of all drug sales worldwide, representing a market of approximately USD 90 billion in 2020, of which medicines for COPD accounted for more than half of this amount.

RES030-085 has anti-inflammatory and bronchodilating properties

Within the project RESP9000, Respiratorius is developing the drug candidate RES030-085, which, in preclinical studies, has been shown to provide complete relaxation of small airways isolated from human lung tissue regardless of how these have been contracted. This, combined with anti-inflammatory properties, distinguishes the candidate from other medicines available today.

The project is currently in preclinical phase, where the toxicological programme has recently been initiated. Another important piece of the puzzle to lay before taking the candidate into the clinical phase is the formulation of the substance. And here an important step is now being taken with the agreement with Iconovo.

Dry powder formulation and inhaler for phase I trial

According to the agreement, Iconovo will develop a dry powder formulation of RES030-085, as well as developing an inhalation product based on ICOone, which is intended to be used in a phase I trial – a work that is estimated to take about nine months to complete. ICOone is a dry powder inhaler with a low manufacturing cost and a simple design that makes it easy to use.

Iconovo has developed a total of four inhalation platforms – ICOone, ICOres, ICOcap and ICOpre. Within the collaboration between Iconovo and Respiratorius, the companies will also investigate which of Iconovo’s inhalation platforms would be best suited for a possible market launch of the product. If the project succeeds in reaching the important milestone, licensing agreements between the two companies will be discussed. 

 

Respiratorius and Iconovo comment on the agreement

For Respiratorius, an important piece is added to the preclinical puzzle, while for Iconovo it means that a third agreement has now been signed in the new strategic area for innovative inhalation projects.

Johan Wäborg, CEO Iconovo

BioStock has spoken to Johan Wäborg, CEO of Iconovo, and Johan Drott, CEO of Respiratorius, to learn more about the agreement. First up is Johan Wäborg:

First of all, what are your expectations for the collaboration with Respiratorius?

– Our expectations are that we will be able to quickly implement this first phase with good results and then be able to deepen our cooperation. RES-030-085 has shown very promising and unique results and we feel that the product could help many patients who currently need improved treatment.

 Why is the ICOone inhaler suitable for the phase I trial with Respiratorius drug candidate?

– ICOone is a simple disposable inhaler with very good performance. Almost no matter what substance we deliver with ICOone, we get a high lung dose. If a company wants to quickly enter clinical phase I trial with low risk and cost, ICOone is an excellent choice.

With the agreement with Respiratorius, you have already reached one of your business goals to enter into two new customer agreements in 2021. Is it time to reassess this goal?

– Two new customer agreements per year is a long-term goal that we set for the first time in 2021. We have now achieved this year’s goal, but we are not slowing down and are aiming for more agreements this year. We will see a variation over the years of between 1-3 deals. 2021 has started well in this regard.

Johan Drott, CEO Respiratorius

Johan Drott also takes a very positive view of the agreement that has now been concluded.

We start by asking you the same question – what expectations do you have for the collaboration with Iconovo?

– Iconovo possesses the experience and expertise that Respratorius needs to ensure an optimal product for clinical studies. We also see that it is important that the development work takes place with access to the type of inhaler that Iconovo can offer. 

When do you plan to start the phase I clinical trial with the drug candidate RES030-085, and what do you hope to show in the study?

– Phase I studies are primarily so-called safety studies; however, we also hope to be able to obtain some kind of preliminary data on the efficacy. The work on designing the study is not yet complete, but our thoughts are moving in that direction. We have a high pace in our work to be able to have approval as soon as possible to be able to start the study.

Why did you choose Iconovo as a development partner for the phase I clinical trial? 

– Iconovo’s knowledge is exactly what we are looking for, and we know that they have products that are well suited.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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

Biostock published May 17th an article about Iconovo that can be found in its entirety below

Last week, Iconovo announced that the US and China have been added to the agreement with Amneal regarding sales of a generic version of Symbicort in the ICOres inhaler. The extended agreement covers 90 percent of the global Symbicort market, doubling the expected annual royalty revenue from Amneal. Iconovo also takes over the sales rights in the Nordic region for the generic product and therefore starts a new pharmaceutical division called Iconovo Pharma. BioStock reached out to the company’s CEO Johan Wäborg for a comment.

Iconovo develops complete inhalation products, i.e. both inhalers and associated dry powder preparations. One of the company’s inhalation products is ICOres, a multi-dose inhaler with two separate reservoirs. In addition, the inhaler provides visual feedback on the number of remaining doses and that the dose has been inhaled correctly.

Development project together with Amneal

Together with the US pharmaceutical company Amneal, Iconovo is developing a generic Symbicort in ICOres. The development project is now entering the final phase and Amneal has begun the set-up of commercial manufacturing.

Last week Iconovo announced that the agreement with Amneal has been extended to include the USA and China, two very valuable markets. The original agreement already covered sales in Europe, Canada, Australia, Russia and some smaller emerging markets.

Extended agreement doubles royalty opportunities

Under the expanded agreement, Amneal will have the rights to sell and market a generic ICOres Symbicort in markets covering about 90 percent of the total Symbicort market. The extended agreement leads to a doubling of the potential future annual royalty revenues to SEK 110 –220 million (USD 13.2 million – USD 26.4 million). Financially, the extended agreement with Amneal is an important event for Iconovo, according to CEO Johan Wäborg:

»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« – Johan Wäborg, CEO of Iconovo 

Pharmaceutical division in the Nordics

With the new agreement with Amneal, Iconovo acquires the license to sell generic versions of Symbicort in the Nordic region. According to the company, the Nordic market for Symbicort amounted to SEK 800 million in 2020, which means that there is great market potential for Iconovo/Amneal’s generic version of Symbicort in ICOres. Iconovo estimates that they can reach a market share of 15-20 percent, which could generate revenues of between SEK 80 and 100 million per year, according to the company.

In connection with this, Iconovo starts the pharmaceutical division Iconovo Pharma, which will carry out marketing and sales of the generic product in the Nordic countries.

Iconovo’s CEO comments

Johan Wäborg, CEO of Iconovo

BioStock reached out to Iconovo’s CEO Johan Wäborg to learn more about the extended agreement withAmneal, as well as the newly started pharmaceutical company Iconovo Pharma.

First of all, how significant is the agreement with Amneal regarding ICOres?

– It is a very significant agreement in many ways. It is the one of our projects that is closest to launch, which is scheduled to take place in 2023 in Europe. In addition, Symbicort is a major product globally with approximately USD 3 billion in sales, so to get maximised global coverage is of great importance and increases the potential of our future royalty revenue.

You have also taken over the rights from Amneal to market and sell ICOres Symbicort in the Nordic market. What lead to this decision and what does it mean for Iconovo’s long-term strategy in the Nordic region?

– We have a unique position in the global inhalation market and extensive knowledge in the field of dry powder inhalation. Based on this position, we believe that establishing our own sales is a winning concept. Selling pharmaceuticals in selected markets is a way to maximize our share of the value chain and thus get even more value from our innovation.

– I have been involved in sales of pharmaceuticals and have also led Nordic pharmaceutical companies for most of my working life, it is my home ground, so expanding our strategy in this way feels obvious to me.

What is on the agenda for the rest of 2021? 

– We will continue to deliver towards our communicated goals, which among other things, means developing ICOpre with five preparations. We will also continue to deliver in our projects and support the projects that enter into clinical studies this year.

– We also have a goal of signing two new agreements this year. Already in March, we entered an agreement with ISR regarding an inhaled Covid-19 vaccine in ICOone. The extended agreement with Amneal is, of course, extremely important and partly new, but we will continue our quest for even more agreements this year.

Read the article at the Biostock webpage

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

 

 

Biostock published April 28th an article about Iconovo that can be found in its entirety below

Iconovo has invested heavily in developing a new pre-metered dual cavity inhaler under the name ICOpre. The company is now presenting the inhaler to the outside world for the first time at the international Respiratory Drug Delivery 2021 conference. Details of the design, function and development process of ICOpre will be presented at a workshop at the RDD conference.

Iconovo develops complete inhalation products, i.e., inhalers and associated dry powder formulations, which are licensed to pharmaceutical and generic companies. This means that customers do not have to carry out complex and costly stages in the development process, leading to a faster way to the inhalation market together with lower risk and lower cost.

The fourth and latest addition to Iconovo’s family with inhalation platforms is the pre-filled dual cavity inhaler ICOpre. Yesterday, the company announced that ICOpre will be shown publicly for the first time at a workshop at the Respiratory Drug Delivery 2021 (RDD) virtual conference, which will take place 4-7 May. During the workshop, ICOpre will be used as an example of how Iconovo’s concept can help overcome challenges when developing generic inhalation products.

ICOpre is a significant investment

Iconovo made the decision to develop this new inhalation platform in 2019. Even then, the company had announced that the new platform would be a generic version of GlaxoSmithKline’s Ellipta, both in terms of inhaler and powder formulations, and that the platform would be intended for a global market including the US.

»This is the biggest and most important investment in Iconovo’s five-year history. With the ICOpre-platform we will be able to reach, not only the European market, but also the very valuable US market.« – Orest Lastow, CTO Iconovo 

Since then, Iconovo has made significant progress in the development of ICOpre. The development started in the first quarter of 2020, and, after less than 12 months of development, excellent in vitro equivalence with the original Ellipta was achieved. According to Iconovo, ICOpre has been developed in Iconovo’s own laboratories by experts in inhaler engineering, powder formulations and analytical characterisation.

Workshop at RDD 2021

The newly developed inhaler will now be presented to the outside world for the first time at the RDD conference. This is a large international conference for researchers, regulators, business professionals and suppliers active in pulmonary and nasal drug administration.

At the conference, Iconovo will arrange a workshop with the theme ”Development of a Generic Dry Powder Inhaler Platform for a Global Market.” During the workshop Iconovo will present the design, different features and development process of ICOpre.

The idea of the workshop is to use ICOpre as an example to show how an integrated development process can accelerate the development time of a complete inhalation product. Dr Orest Lastow, CTO of Iconovo, founder and inventor of Iconovo’s inhalers, will show an on-demand video on ICOpre that can be seen by participants at RDD.

The ICOpre design

Iconovo’s newly developed ICOpre

ICOpre is a pre-metered dual cavity dry powder inhaler with 30 doses individually sealed and protected by aluminum foil. A dose counter shows the number of remaining doses and the exterior of the inhaler has a Scandinavian design according to the company. The inhaler is operated in three steps: open-inhale-close. Each dose comes from two compartments that are inhaled simultaneously, which makes ICOpre suitable for mono, duo or triple products.

ICOpre is designed to be operated in the same way as GSK’s Ellipta, however, ICOpre is based on aproprietary mechanism with an injection-molded disk and cavity opening. Thanks to its unique technical solutions, ICOpre is not limited by Ellipta’s patent protection, which lasts until 2030. This minimises the risk of patent infringement and enables Iconovo to obtain patent protection for ICOpre for 20 years. The first twopatent applications for ICOpre were filed in February 2021.

Great market potential for generic products of Ellipta

The idea is that ICOpre will become an AB-rated (therapeutic equivalent) substitute for GSK’s Ellipta portfolio,which currently consists of five inhalation products: Relvar/Breo, Anoro, Incruse, Trelegy and Arnuity. Total sales of these products are expected to increase to 4.9 BUSD by 2025.

GSK has patent protection for both the inhaler and the drug substances in the inhalation products. When the patents and market exclusivity for the drug substances expire, a major market opportunity is opened up for generic products.

Ready for five launches

Iconovo is carrying out the parallel development of generics for all Ellipta products and plans to out-license these products to a potential partner, which is expected to take place in H1 2022. Iconovo aims to be ready for launch at the time of patent expiry for each of the products in the Ellipta portfolio.

The first patent that expires concerns Breo/Relvar in 2025 in the US. Iconovo plans to launch a generic Breo/Relvar product in the valuable US market soon after that patent expiration. According to Iconovo, such a product has a sales potential of at least 100-150 million USD. However, the main launch is expected for 2030 with the launch of a generic Trelegy, the best-selling inhalation product in the Ellipta portfolio.

The presentation of ICOpre at RDD is a stepping stone towards finding suitable partners and eventuallylaunching up to five generic products that are expected to create great value for Iconovo.

Read the article at the Biostock webpage