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.

After an unprecedented year in the covid-19 pandemic, the challenges with vaccines requiring cold storage, from refrigeration to ultra-cold storage has become public knowledge. Dr Orest Lastow, founder and CTO of Iconovo AB (publ) that develops complete inhalation products, shares his thinking about a better vaccine solution in MEDTECH Outlook – to inhale a stable dry powder formulation using a single-use inhaler like ICOone from Iconovo.

To read more:
https://www.medicaltechoutlook.com/vp/iconovo/2021_-_search_for_vaccinations_without_cold_storage__/

ICOone has already been selected by Monash University for its suitability as a single-use inhaler of oxytocin replacing injectable oxytocin in resource-constrained countries.

Efter ett år utan motstycke i spåren av covid-19 pandemin har utmaningarna med att kylförvara vacciner blivit allmän kunskap. Dagens vacciner kräver allt från kylskåpsförvaring till ultralåg frysförvaring. Dr Orest Lastow, CTO och grundare av Iconovo AB som utvecklar kompletta inhalationsprodukter delar sina tankar om en bättre vaccinlösning i MEDTECH Outlook – att inhalera en stabil torrpulverformulering med en engångsinhalator som ICOone från Iconovo.

För mer information, besök:
https://www.medicaltechoutlook.com/vp/iconovo/2021_-_search_for_vaccinations_without_cold_storage__/

ICOone har redan valts av Monash University för sin lämplighet som en engångsinhalator för oxytocin för att ersätta oxytocin via injektion i resursbegränsade länder.

United States Patent and Trademark Office has announced the intention to grant a patent (Notice of Allowance) regarding Iconovo’s inhalation device, ICOres.

Iconovo has previously granted ICOres patents in USA, Sweden, Europe (EPO), Japan and China. The new patent covers the technology used in many of Iconovo’s projects like generic Symbicort©.

“This new patent demonstrates how unique and innovative ICOres is. With two granted patents in the USA, we now have a very strong position on the American market. Our broad international patent protection allows us to intensify our global business development effort”, says CTO Dr. Orest Lastow.

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, ICOres.

Iconovo har sedan tidigare godkända patent på ICOres i USA, Sverige, Europa (EPO), Japan samt Kina. Patentet beskriver den teknologi som används i Iconovos många kundprojekt bland annat generisk Symbicort©.

”Detta nya patent visar hur unik och innovativ ICOres är. Med två godkända patent i USA har vi nu en mycket stark position på den amerikanska marknaden. Vårt breda internationella patentskydd gör att vi kan intensifiera vår globala affärsutveckling”, säger Dr. Orest Lastow, CTO på Iconovo.

Iconovo AB (publ) meddelade idag att bolaget har tecknat sitt första avtal med Monash University för att utföra beställt utvecklingsarbete av inhalerad oxytocin i ICOone®. Denna första arbetsorder har ett värde på 99 000 euro och betalas i tre omgångar varav den första förväntas inom 3 månader. Denna ersättning är en betalning utöver tekniktillgångsersättningen på 900 000 euro.

“Samarbetet med Monash University fortskrider och är nu mer formaliserat genom att vi har kommit överens om vad som ska levereras, vilket ger den första ordern för utvecklingsarbete,” säger Iconovos VD Johan Wäborg. “Vi ser fram emot att se detta projekt gå in i den kliniska fas 1-studien, som är planerad till i år.”

I december 2020 undertecknade Iconovo ett utvecklingsavtal med Monash University i Australien för utveckling av inhalerat oxytocin i ICOone, som verifierar lämpligheten av ICOone för användning med innovativa läkemedel. Avtalet ger Monash en exklusiv global rätt att använda ICOone med oxytocin för att förhindra blödning efter förlossningen hos havande kvinnor.

Avtalet har en stegvis ersättning för tekniktillgång på 900 000 euro som kommer att utlösas av milstolpar i projektets kliniska studiefas, där den första av tre milstolpar kommer att betalas som en inledande avgift för att licensiera produkten som omfattas av en positiv fas 1-studie som planeras till 2021. Dessutom kommer Monash göra milstolpsbetalningar till Iconovo för uppdragsutvecklingsarbete. Royaltyersättning från försäljning under en 20-årsperiod från lanseringen ligger inom intervallet 5–10%, som tidigare kommunicerats för liknande avtal.

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.

Iconovo AB (publ) meddelar att dr Kyrre Thalberg blir en ny Senior Advisor inom formuleringsutveckling.

Dr Thalberg är en internationellt känd expert inom utveckling av torrpulverformuleringar för inhalation. Han har under nästan 30 år arbetat i ledande roller med formuleringsutveckling på AstraZeneca. Han har över 50 akademiska publikationer, innehar flera patent och har handlett 5 doktorander. Han kommer att ta en aktiv roll i utvecklingen av formuleringar till Iconovos nya inhalator ICOpre®. Det kommer främst att vara en generisk version av Relvar© Ellipta©.

”Vi är mycket glada att ha kunnat knyta till oss en internationell auktoritet inom formuleringsutveckling. Detta kommer att ytterligare lyfta den vetenskapliga nivån på vårt arbete och hjälpa oss att accelerera utvecklingen av vår generiska Relvar ICOpre”, säger Johan Wäborg, VD på Iconovo.

Om ICOpre®

ICOpre är en flergångsinhalator med förfyllda doser för enkel daglig behandling. Den fungerar väl med alla typer av inhalationspulver. Den har en enkel trestegshantering liknande den välkända inhalatorn Ellipta® från GSK. Med sina 30 aluminiumförseglade doser ger den en månads behandling. Varje dos kommer från två olika kammare som inhaleras samtidigt vilket gör ICOpre lämplig för både mono-, duo- och trippel-produkter. ICOpre har dessutom en exakt dosräknare som visar antalet kvarvarande doser. ICOpre har utvecklats av Iconovo med en unik princip som kommer att skyddas av ett antal patent.

https://iconovo.se/products/icopre/

Iconovo AB (publ) has appointed dr. Kyrre Thalberg to be Senior Advisor in formulation development.

Dr. Thalberg is an internationally renowned expert in development of dry powder formulations for inhalation. Over close to 30 years, he held many leading roles in formulation development at AstraZeneca. He has more than 50 academic publications, several patents and has supervised 5 Ph.D. students. He will take an active role in the development of formulations for Iconovo’s new inhalation device ICOpre®. It will mainly be a generic version of Relvar© Ellipta©.

“We are very pleased to be able to attract such international authority on formulation development. This will further strengthen the high scientific level of our work and help us to accelerate the development of our generic Relvar ICOpre”, says Johan Wäborg, CEO of Iconovo.

About ICOpre®

ICOpre® is a pre-metered multi-dose inhaler for simple once-daily treatment. It works well with all types of inhalation powders. It has an easy three-step operation; open-inhale-close, like the well-known Ellipta® inhaler from GSK. With 30 aluminum-sealed doses, it provides one month of treatment. Each dose comes from two different cavities that are inhaled simultaneously, making ICOpre suitable for mono, duo and triple products. ICOpre has a precise dose-counter that shows the number of doses remaining. ICOpre is being developed based on a unique principle that will be protected by a number of patents.

https://iconovo.se/products/icopre/

Iconovo AB (publ) has filed two ICOpre® patent applications.

ICOpre® is Iconovo’s new inhalation platform and builds on novel proprietary technology and unique technical solutions. For an innovative company like Iconovo it is paramount to protect its inventions and intellectual property. These two patents are the first step in building a strong patent portfolio around ICOpre. Iconovo has already 84 granted patents and 25 applications covering the other inhalation platforms.

”I am very pleased that ICOpre has reached this very important milestone. A strong protection of our intellectual property has always been Iconovo’s strategy and an absolute requirement from our customers. This is a major step forward in the development of our generic Relvar® ICOpre®”, says CTO Dr. Orest Lastow.

About ICOpre®

ICOpre® is a pre-metered multi-dose inhaler for simple once-daily treatment. It works well with all types of inhalation powders. It has an easy three-step operation; open-inhale-close, like the well-known Ellipta® inhaler from GSK. With 30 aluminum-sealed doses, it provides one month of treatment. Each dose comes from two different cavities that are inhaled simultaneously, making ICOpre suitable for mono, duo and triple products. ICOpre has a precise dose-counter that shows the number of doses remaining. ICOpre is being developed based on a unique principle that will be protected by a number of patents.
https://iconovo.se/products/icopre/