Iconovo AB (publ) hereby invites analysts, investors and media to its virtual Capital Markets Day (CMD) on Wednesday May 26, at 13:00–15:30 CET.

The CMD will focus on Iconovo's transformation into a commercial pharmaceutical company and highlight its potential in the three recently communicated strategic areas of generic inhalation products, innovative inhalation products and its own sales of inhalation generics through Iconovo Pharma.

During the day, both speakers from the company management and external guest speakers will give presentations. There will also be a moderator-led Q&A session where participants will be able to ask questions to the lecturers.

The event, which will be held in English, will be broadcast live and available on our website https://iconovo.se/capital-markets-day/. The agenda for the event is attached to this PM.

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

Iconovos nya förfyllda tvåkavitetsinhalator kommer visas publikt för första gången på RDD 2021 (4 – 7 maj). Designen, funktionen och utvecklingsprocessen av ICOpre® kommer att presenteras på en workshop på mötet. Iconovo visar hur en integrerad utvecklingsprocess kan accelerera utvecklingstiden för en komplett inhalationsprodukt som är ekvivalent med Ellipta® med avseende på både inhalator och pulverformulering. Iconovo använder en parallell utvecklingsprocess av samtliga generiska Ellipta produkter i ICOpre och planerar för en utlicensiering av samtliga produkter i portföljen till en partner.

ICOpre har utvecklats i Iconovos laboratorier av egna specialister inom inhalatorkonstruktion, pulverformulering och produktkaraktärisering. Företagets expertis reflekteras i resultaten för ICOpre utvecklingen med utmärkt in-vitroekvivalens med originalet nådd efter mindre än 12 månaders utveckling.

Ellipta portföljen representerar en signifikant kommersiell möjlighet med en prognosticerad försäljning på USD 4,9 miljarder 2025. Ellipta inhalatorn är skyddad av ett antal patent till 2030 och kommer att skydda flertalet av produkterna längre än baspatentet för läkemedelssubstanserna. Iconovo beslöt därför att utveckla en egen patentskyddad intern mekanism med en unik formsprutad disk och kavitetsöppning för att inte riskera patentintrång. Den unika lösningen undviker inte bara risken för patentintrång utan ger också ett eget patentskydd som varar i nästan 20 år. Iconovo gick ett steg längre och gav också ICOpre en ren attraktiv yttre skandinavisk design. Mer information om ICOpre möjligheten finns på iconovo.se

Dr. Orest Lastow, CTO på Iconovo, grundare och uppfinnare av inhalatorerna från Iconovo kommer presentera ICOpre på RDD som en on-demand video som kan ses av deltagarna på RDD.

Iconovo´s new prefilled dual cavity dry powder inhaler will be publicly presented for the first time at RDD 2021 (May 4 – 7th). The design, different features and the development process of ICOpre® will be displayed at a workshop at the meeting. Iconovo explains how an integrated process can accelerate the product development to arrive at a complete inhalation product bioequivalent to Ellipta® including both the inhaler and a powder formulation. Iconovo applies a parallel development process for all generic Ellipta products and plans to out-license the whole portfolio of generic Ellipta products in ICOpre.

ICOpre has been developed in Iconovo’s laboratory by its own specialists in inhaler engineering, powder formulation and analytical characterization. The expertise is reflected in excellent in-vitro equivalence for ICOpre achieved already after less than 12 months of development.

The Ellipta portfolio represents a major commercial opportunity with forecasted sales of USD 4.9 billion in 2025. However, the Ellipta inhaler is protected by several patents lasting until 2030, protecting many portfolio products longer than the drug substance patents. Iconovo decided to develop a proprietary internal design with a unique injection molded disk and cavity opening to go free from these patents. Not only will any company launching ICOpre avoid the infringement risk but also earn a patent protection for almost 20 years. But Iconovo did not stop here and has given it a clean attractive Scandinavian exterior design. More information about the ICOpre opportunity can be found at iconovo.se

The presentation at RDD is by CTO Dr. Orest Lastow, the founder and inventor of the inhalers from Iconovo and can be viewed as an on-demand video by participants at RDD.

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

Iconovo AB (publ) meddelar att United States Patent and Trademark Office har informerat att de avser att godkänna (Notice of Allowance) ett patent avseende Iconovos inhalatorplattform ICOone. Iconovo har sedan tidigare godkända patent på ICOone i Sverige, Europa (EPO) samt Indien. Patentet beskriver den endos-inhalator som används i Iconovos två innovativa kundprojekt med Oxytocin och Covid-19 vaccin.

ICOone är Iconovos plattform för administrering av vacciner och bio-molekyler på ett mycket enkelt och kostnadseffektivt sätt. Eftersom ICOone innehåller läkemedlet som ett torrt pulver, krävs ingen dyr och komplicerad kylförvaring. Med ICOone inhaleras läkemedlet och man undviker på detta sätt hantering av engångssprutor och begagnade kanyler som kan sprida blodsmitta.

”Det nya patentet är en bekräftelse på att ICOone är en mycket unik och innovativ inhalator. Med godkända patent i USA, EU och Indien har vi nu ett mycket starkt skydd på marknader med stort behov av enkel och kostnadseffektiv vaccinering”, säger Dr. Orest Lastow, CTO på Iconovo.

Om ICOone® 
ICOone är en unik och patenterad torrpulverinhalator avsedd för engångsbruk. Den smarta konstruktionen ger en ultralåg tillverkningskostnad kombinerad med en enkel och diskret användning. Den är speciellt lämplig för korttidsbehandlingar och sällandoserings-behandlingar då den ger en oöverträffat låg behandlingskostnad och prispunkt för behandlingar med få doser. Den enkla konstruktionen gör också att patienter och behandlare kan lära sig hantera inhalatorn med minimal träning. ICOone kan leverera stora inhalationsdoser som är väl fuktskyddade, vilket är viktigt för många biomolekyler. 
 
https://iconovo.se/products/icoone/ 
 

Iconovo AB (publ) meddelar att man har erhållit ett godkänt patent i Indien på sin inhalationsplattform ICOone®. Iconovo har sedan tidigare godkända patent på ICOone i Europa (EPO) och ansökningar under behandling i Kina, USA och Japan.

ICOone är Iconovos plattform för administrering av vacciner och bio-molekyler på ett mycket enkelt och kostnadseffektivt sätt. Eftersom ICOone innehåller läkemedlet som ett torrt pulver, krävs ingen dyr och komplicerad kylförvaring. Med ICOone inhaleras läkemedlet och man undviker på detta sätt hantering av engångssprutor och begagnade kanyler som kan sprida blodsmitta.

Ett bra exempel på användning av ICOone, är Iconovos samarbetsprojekt med Monash University. I detta projekt används ICOone för att ge Oxytocin till kvinnor under förlossning för att förhindra svåra blödningar, så kallad Postpartum Hemorrhage (PPH). Oxytocin ges idag normalt som injektion och kräver därför kylförvaring, vilket kan vara svårt att upprätthålla i regioner med begränsad infrastruktur. PPH är globalt den vanligaste orsaken till mödradödlighet med cirka 60 000 dödsfall årligen. Indien står för en signifikant andel av alla svåra fall av PPH.

”Ett patent i Indien är oerhört viktigt för oss eftersom det är en stor potentiell marknad som ICOone är speciellt lämpad för. Ett billigt, enkelt och säkert sätt nå ut med vaccin till en stor befolkning är av stort intresse för många potentiella kunder, inte minst i Indien”, säger Dr. Orest Lastow, CTO och grundare på Iconovo.

Om ICOone®
ICOone är en unik och patenterad torrpulverinhalator avsedd för engångsbruk. Den smarta konstruktionen ger en ultralåg tillverkningskostnad kombinerad med en enkel och diskret användning. Den är speciellt lämplig för korttidsbehandlingar och sällandoserings-behandlingar då den ger en oöverträffat låg behandlingskostnad och prispunkt för behandlingar med få doser. Den enkla konstruktionen gör också att patienter och behandlare kan lära sig hantera inhalatorn med minimal träning. ICOone kan leverera stora inhalationsdoser som är väl fuktskyddade, vilket är viktigt för många biomolekyler.

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

Iconovo AB (publ) has been granted its first patent in India on the inhalation platform ICOone®. Iconovo has previously granted ICOone® patents in Europe (EPO) and have several patents pending in USA, India, China and Japan.

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.

A good example of ICOone® use is the cooperation with Monash University. In this project Oxytocin is administered to women during birth to prevent heavy bleeding, Postpartum Hemorrhage (PPH). Oxytocin is today typically delivered as an injection and requires cold storage, which can be very challenging in regions with less developed infrastructure. PPH is globally the most common cause of maternal mortality with over 60 000 fatalities annually. India represents a significant part of all PPH cases.

”A patent in India is extremely important for us since it is a large potential market for which ICOone® is particularly well suited. A cheap, simple and safe way to supply vaccines to a large population is of great interest to many of our potential customers, not the least in India”, says Dr. Orest Lastow, CTO and founder at Iconovo.

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

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

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

Johan Wäborg, VD i Iconovo AB (publ), har förvärvat 20 000 aktier i bolaget till kursen 55 SEK, totalt 1 100 000 SEK. Förvärvet gjordes från Orest Lastow som är medgrundare och CTO i Iconovo. Orest Lastow kommer även att efter försäljningen till Johan att vara bolagets andra största aktieägare med 826 400 aktier motsvarande ca 10,6% av bolagets aktier. Efter förvärvet uppgår Johan Wäborgs innehav till 27 200 aktier samt 200 000 teckningsoptioner.