Mats Johansson, styrelseordförande och den störste enskilde ägaren i Iconovo AB (publ), har förvärvat 5 000 aktier i bolaget för snittkurs 62,5 SEK per aktie. Efter förvärvet uppgår Mats Johanssons innehav till 925 000 aktier som ägs både privat och via bolag. Innehavet motsvarar 11,9% av aktierna i bolaget. 

Utöver Penser Bank följer även Danske Bank Iconovo. För att ta del av analysen använd denna länk, https://iconovo.se/investors/aktien/analys/

Breakthrough in Asia with a fourth royalty agreement

Key figures in TSEK unless otherwise indicated  Apr-Jun 2020 Apr-Jun 2019 Jan-Jun 2020 Jan-Jun 2019 Jan-Dec 2019
Net turnover 2,425 3,028 4,357 8,263 11,737
Operating profit/loss -5,819 -2,800 -10,800 -2,532 -11,774
Cash flow for the period -9,697 -4,584 -13,429 -7,391 36,106
Earnings per share (SEK) before full dilution -0.82 -0.38 -1.37 -0.31 -1.68
Cash and cash equivalents 75,727 45,659 75,727 45,659 89,156
Equity 99,220 61,893 99,220 61,893 108,794
Number of shares at period-end 7,776,000 6,776,000 7,776,000 6,776,000 7,776,000
Number of royalty agreements** 3 3 3 3 3

**Number of agreements at the end of the period. One further royalty agreement was signed after the end of the period.

Significant events 1 April – 30 June

  • Amneal joined as a new partner in the development of Iconovo’s project with generic Symbicort. 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.
  • The Chinese Patent Office issued an Intention to Grant notification regarding a patent for the inhalation platform ICOres. The European Patent Office, EPO, issued an Intention to Grant notification for the third European patent for the ICOres inhalation platform (which is already covered by three approved Swedish patents and two European patents). The patents describe the technology used in Iconovo’s many customer projects, including generic Symbicort.
  • Iconovo only anticipates a limited impact from COVID-19 currently and in the future. The company has the required goods in stock, and sales are not physical. The greatest impact expected to occur is some delay in development in the event that company employees fall ill.
  • Gunnar Gårdemyr was elected to the Board at the Annual General Meeting. Gunnar has a degree in economics from Lund University and over 35 years of experience in the pharmaceutical and biotech industry. Previous positions include CEO of Targovax AS, SVP Commercial development/M&A at Nycomed, Global marketing director at Ferring.

Significant events 1 January – 31 March

  • Orest Lastow took the role of company Chief Technology Officer (CTO), and Johan Wäborg was hired as the new CEO of Iconovo. Orest Lastow, who is one of the co-founders and one of the largest shareholders together with the company’s Board Chair, previously combined the position of CEO and CTO. He will now devote all of his time to the role of company CTO. Orest is the inventor behind Iconovo’s three inhaler platforms and will now focus on the development of the new ICOpre platform.
  • 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.
  • The European Patent Office, EPO, issued an Intention to Grant notification for the second European patent for the ICOres inhalation platform (which is already covered by three approved Swedish patents and one European patent). The patent describes the technology used in Iconovo’s many customer projects.
  • The European Patent Office, EPO, issued an Intention to Grant notification for the first European patent for the ICOone inhalation platform (which is already covered by two approved Swedish patents). The patent describes the technology used in Iconovo’s vaccine project.

Significant events after the end of the second quarter

  • Iconovo has 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 milestone value of TEUR 550 and additional future royalties of a medium single-digit percentage of sales.

A word from the CEO

Our fourth royalty agreement
On 8 July, we had the pleasure of announcing that we have now entered into our fourth royalty agreement with the company BNC Korea based in Seoul, South Korea. With this agreement, we make an important entry into the Asian markets with a partner who knows these markets. An important component is also that it relates to two different formulations, Seebri and Ultibro generics. Some of the development work was already carried out previously. We can therefore expect a faster development phase and that the product will thus be ready for launch when the patent expires. The deal entered into corresponds to 15% of today’s global market, which means that the remaining 85% of the global market is open for licensing.

High activity through COVID-19 times
I took over the CEO position in April, in the middle of a period when COVID-19 took off everywhere and forced us all to begin living very different lives. At Iconovo, we quickly realised the severity of the situation and implemented all recommended efforts and restrictions. Our employees are our most important resource, and we care about keeping each other healthy. We have not had any impact from the illness thus far, and we will continue following the recommendations of the Public Health Agency of Sweden and the Swedish Ministry for Foreign Affairs this autumn.

Since we are not dependent on any deliveries from other parts of the world that have been in lock-down, our technical and laboratory work can continue unhindered. Our projects are on time.

However, we are indirectly affected by the fact that we, as a globally-oriented company, have many existing and potential customers in countries with a lock-down, making some processes and administration work slower.

An unexpected upside for us is that it has been possible to hold many active discussions regarding business development, and it has been much easier to convene meetings. Compared to a normal quarter, you could say that Q2 has been extremely active. It is clear that new customer acquisition is usually more effective when you can meet face-to-face. While we are maintaining our momentum with a lot of virtual meetings, we look forward to being able to hold physical meetings as soon as possible.

We are growing
During Q2 and the summer months, we completed two recruitments of great importance for the upscaling of our operations. One Sr. Mechanical Engineer and one Formulation Scientist will start this autumn. We also initiated recruitment of two positions intended to help make the commercial aspect of our operations strong. We need one project manager to coordinate new projects, and one person with commercial drive to secure important collaborations. Our ambition is to become very good at being close to the customer, proactively initiating dialogue, following up, capturing opportunities for additional sales, and seeking new customers to secure contracts that fit well with our strategy. We expect to complete these recruitments in Q3 and for the individuals to step into their roles around the turn of the year.

Other progress during Q2
In Q2 2020, we were able to invoice two milestones under the Amneal project. Having Amneal back in the Symbicort generic project feels really great, and we can tell from their commitment level that this project is of great strategic importance for them as well. In addition to this milestone, some ongoing development work for other customers was also taken up as income.

ICOpre development work intensified during Q2. Over the summer months, we were able to select one of the three successful concepts as the best alternative. Going forward, development work will now focus entirely on this concept. ICOpre is equivalent to GlaxoSmithKline’s Ellipta inhaler, which is currently used for five different products. The development of ICOpre is a major strategic step towards developing a quality product that can capture some of this market, which is expected to reach over USD 5 billion annually by 2024. Patent protection for the first product disappears in 2025, and the market will then open up to generic versions. At that time, we will be ready with an inhaler that is based on proprietary technology and can thereby be used to launch generic products.

The ICOpre venture was identified at last year’s strategy days and now constitutes an important strategic venture going forward. Development of this new platform is now in full swing. This year, we will look at how Iconovo can grow and develop long-term to maximise value and utilise our unique expertise.

This autumn, we will continue to work with the implementation of our existing customer projects, and we will continue to work hard with business development to strike new deals.

Everyone is now back from holiday with their batteries fully charged, and we can look forward to an active and eventful autumn.

Johan Wäborg

Iconovo has been recognized as a leading solution provider of drug delivery devices by Medtech Outlook when the magazine listed 10 companies that are at the forefront of providing drug delivery device solutions and impacting the industry. Iconovo is profiled in the MedTech Outlook special edition of Drug Delivery Devices.

www.drug-delivery-device.medicaltechoutlook.com/vendor/iconovo-an-experienced-partner-for-the-development-of-inhalation-products-cid-866-mid-96.html

Orest Lastow, CTO and Founder of Iconovo was interviewed by the magazine to describe why Iconovo is a leading provider of inhalation products to the pharmaceutical industry.

“Iconovo represents inhalation experience that is only matched by a handful of companies in the world. I’m really happy that the Iconovo team gets global recognition for these efforts.” says Johan Wäborg, CEO of Iconovo.

Iconovo har blivit erkänd som en ledande leverantör av drug delivery devices av Medtech Outlook när tidningen listade 10 företag som ligger i frontlinjen med sitt erbjudande av drug delivery devices till läkemedelsindustrin. Iconovo har profilerats i den senaste specialutgåvan av MedTech Outlook där de fokuserar på Drug Delivery Devices.

www.drug-delivery-device.medicaltechoutlook.com/vendor/iconovo-an-experienced-partner-for-the-development-of-inhalation-products-cid-866-mid-96.html

Orest Lastow, CTO och grundare av Iconovo, intervjuades av tidningen och gav sin syn på varför Iconovo är en ledande leverantör av inhalationsprodukter till läkemedelsindustrin.

“Iconovo besitter ett inhalationskunnande som endast kan matchas av ett fåtal företag i världen. Det gläder mig att Iconovo erkänns på en global nivå för vårt kunnande och ansträngningar.” säger Johan Wäborg, VD för Iconovo.

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

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

“USA is the biggest market in the world. With a granted patent in USA we can now intensify our global business development. This patent means that ICOres has broad international patent protection, which increases the value of our product portfolio”, says Johan Wäborg, CEO.

United States Patent and Trademark Office har meddelat att de avser att godkänna (Notice of Allowance) ett patent avseende Iconovos inhalatorplattform, ICOres. Iconovo har sedan tidigare godkända patent på ICOres i Sverige, Europa (EPO), Japan samt Kina. Patentet beskriver den teknologi som används i Iconovos många kundprojekt bland annat generisk Symbicort©.

”USA är världens största marknad. Ett godkänt patent i USA gör att vi nu kan intensifiera vår globala affärsutveckling. Detta patent innebär att ICOres har ett brett internationellt patentskydd vilket ökar värdet av vår produktportfölj”, säger Johan Wäborg, VD.

Iconovo announced July 8th that a regional licensing agreement had been signed with BNC Korea regarding the development of two inhalation capsule formulations for generic Ultibro® and Seebri® for ICOcap®. The agreement gives BNC Korea exclusive rights in a territory consisting of Korea, Japan, China, Taiwan, Russia, the CIS Countries and the Southeast Asian Countries (including Turkey). The deal has a milestones value of EUR 550.000 whereof EUR 150.000 is to be paid as an access fee. Iconovo estimates that most of the value will be in future royalty payments and not milestones payments.

Ultibro® and Seebri® are approved for the treatment of COPD. Ultibro® Breezhaler® generated sales of USD 427 million and Seebri® Breezhaler® generated sales of USD 121 million according to the 2019 annual report of Novartis. In the announcement from July 8th the share of global sales 2019 was estimated to 25%. Iconovo’s new changed estimate is that approx. 15 % of global sales 2019 comes from the territory that is licensed to BNC Korea (territorial sales 2019 of approx. USD 82 million for both products instead of earlier communicated EUR 140 million).

Taking a dynamic view on the business opportunity Iconovo estimates that Asia and the BNC territory gradually and substantially will increase the value of the business over the 20-year royalty term. High population growth in Asia is a strong driver as it is corresponding to approx. 40-50% of the total global population increase for the next 10 years (UN, World Population Prospects 2019). Additionally, this part of the world is seeing strong economic growth with increased health expenditure per capita enabling more people to prioritize healthcare.

The remaining territory, still available for licensing, represents approx. 85% of the Ultibro® and Seebri® world market. In 2019 this market corresponded to a value of approx. USD 466 million, whereof Europe is the largest opportunity.

Iconovo is in an advanced stage of the development of the capsule formulations, thus believes that its future partners can launch in the first wave of generic products, later to be followed by late comers to the market. Iconovo believes that a feasible market share for its licensed capsule products is 13 – 20% based on normal order-of-entry models in the pharmaceutical industry considering the higher replaceability between generically approved products[1]. The market uptake speed is slower for generic inhalation products than for generic tablets. Iconovo expects that 80 % of the peak market share can be reached after 2 years on a country-by-country level[2], although the launches may happen over a number of years thereby lowering the consolidated regional uptake speed.

Iconovo is entitled to royalties on net sales of BNC Korea and their net sales will be affected by the number and sub-licensing terms agreed with their distributors. Royalties from future sales will be a mid-single digit percentage of sales, depending on country and distribution setup.

In addition, Iconovo will be entitled to royalties from Stevanato based on the separate sales of the ICOcap capsule inhalers, but it will be a lower value as the cost of the each ICOcap inhaler is a small share of the overall market price.

About ICOcap®
ICOcap is a robust capsule-based dry powder inhaler with a unique grip-friendly one-piece hinge design that ensures ease of use. It is currently designed with a low flow resistance but can be customized to a flow resistance of choice. ICOcap™ is available from Stevanato.

About COPD
COPD is a combination of inflammation in the airways and destruction of the lung tissue. The disease progresses slowly over many years and the main cause is tobacco smoking. Patients with COPD have difficulty breathing, and experience fatigue and a lack of energy. There is no cure for COPD, and the treatment goal is to try to stop further deterioration and destruction
of the pulmonary alveoli. According to WHO, COPD was the third most common cause of death in the world with 3 million deaths. The number of people living with COPD worldwide was estimated to be 251 million.

About BNC Korea
BNC Korea Co., Ltd was founded in 2007 and is enlisted on KOSDAQ market in Korea. The company has been developing biologicals and pharmaceuticals which have differentiating characteristics meeting unmet medical needs in the disease treatment market. Also, the company has been operating business in the field of medical device like HA Filler, tissue restoration material and wound healing agents and biopharmaceuticals like botulinum toxin strain type A for aesthetic purpose. Currently, the company has been establishing manufacturing facility for pharmaceutical of oral dosage form and injectables.

More information about the company can be found at https://www.bnckorea.co.kr

BNC Korea Co.,Ltd is based in Daegu and Seoul in Korea. Manufacturing site is located at Daegu and Sejong city of Korea.

[1] Kalyanaram 2008, InPharmation, IQVIA, Kremer 2008
[2] InPharmation

Iconovo meddelade den 8 juli att företaget hade tecknat ett licensavtal avseende know-how som ger BNC Korea Co Ltd exklusiva rättigheter att använda denna know-how för att tillverka, marknadsföra, sälja och distribuera kapselformuleringarna tillsammans med ICOcap® i territoriet. Licensavtalet avser två generiska formuleringar, en generisk Ultibro® Breezhaler® (indakaterol, glykopyrronium) produkt och en generisk Seebri® Breezhaler® (glykopyrronium) produkt. BNC Koreas har exklusiva rättigheter i Korea, Japan, Kina, Taiwan, Ryssland, CIS-länderna och i sydöstra Asien (inklusive Turkiet). Affären har ett milestone-värde på 550.000 EUR varav en access-fee på 150.000 EUR. Iconovo förväntar att största delen av värdet kommer från framtida royalty-betalningar och inte från milestone-betalningar.

Ultibro® och Seebri® är godkända för behandling av KOL. Ultibro® Breezhaler® hade en försäljning på USD 427 miljoner och Seebri® Breezhaler® hade en försäljning på USD 121 miljoner enligt den senaste årsredovisningen för 2019 från Novartis. I pressmeddelandet från den 8 juli estimerades att 25 % av värdet kom från territoriet. Iconovos’s nya förändrade estimat är att 15 % av den globala försäljningen 2019 kommer från BNC Koreas territorium (försäljning av cirka USD 82 miljoner för båda produkterna istället för EUR 140 miljoner som tidigare kommunicerats).

Med en dynamisk syn på affärsmöjligheten förväntar Iconovo att Asien och därmed BNC Korea’s territorium kommer att öka gradvis och substantiellt i värde över den 20-åriga royalty perioden. En hög befolkningstillväxt i Asien kommer driva utvecklingen då regionen svarar för 40 – 50 % av den globala befolkningstillväxten under den kommande 10-årsperioden (UN, World Population Prospects 2019). Dessutom upplever denna del av världen en stark ekonomisk tillväxt med ökande konsumtion av hälsovård per kapita då hälsovård prioriteras.

Resterande territorium är fortfarande tillgänglig för en licensaffär och motsvarar de återstående 85 % av världsmarknaden för Ultibro® och Seebri®. Under 2019 motsvarade denna marknad ett värde på cirka USD 466 miljoner, där Europa är den största möjligheten.

Iconovo är långt framskriden i utvecklingen av kapselformuleringarna och förväntar därför att våra framtida partners kan lansera i den första vågen av generiska produkter, för att senare följas av ytterligare eftersläntrande generiska produkter. Iconovo förväntar att detta ger en möjlighet till en marknadsandel på 13 – 20 % för kapselprodukterna baserat på normala “order-of-entry” modeller i läkemedelsindustrin och i beaktande av den högre grad av utbytbarhet mellan generiska produkter[1]. Marknadsupptaget är långsammare för generiska inhalationsprodukter än för generiska tabletter. Iconovo förväntar att 80 % av den maximala marknadsandelen kan nås efter 2 år på den enskilda landsmarknaden[2], även om lanseringarna kommer att ske över ett antal år och därmed sänker den konsoliderade regionala upptagshastigheten.

Iconovo kommer erhålla royalty-betalningar på BNC Koreas nettoförsäljning vilken i sin tur kommer påverkas av antalet och villkoren för sub-licensaffären med deras distributörer. Framtida royalties ligger på medelhöga ensiffriga procenttal av försäljningen beroende på marknad och distributionsavtal.

Iconovo kommer även erhålla royalties från Stevanato baserat på den separata försäljningen av ICOcap inhalatorer till BNC Korea, men det motsvarar ett lägre värde då kostnaden för ICOcap inhalatorn motsvarar en liten andel av marknadspriset.

Om ICOcap®
ICOcap® är en robust kapselinhalator med en unik greppvänlig design, ett patenterat
integrerat lock som gör den lätt att använda. ICOcap® är designad med ett lågt inhalationsmotstånd men kan anpassas till önskat inhalationsmotstånd. ICOcap® är direkt tillgänglig från Stevanato för snabb produktlansering och konkurrenskraftigt pris.

Om KOL
Kroniskt obstruktiv lungsjukdom, är en kombination av inflammation i luftvägarna och förstörd lungvävnad (lungemfysem). Sjukdomen utvecklas långsamt under flera år och orsakas framför allt av tobaksrökning. Vid KOL får patienten svårare att andas, blir trött och orkar mindre. KOL går inte att bota varför behandlingen går ut på att försöka hejda en fortsatt försämring och förstörelse av lungblåsorna. Enligt WHO, är KOL den tredje vanligaste dödsorsaken i världen med 3 miljoner dödsfall. Antalet personer som lever med KOL globalt uppskattas till 251 miljoner.

Om BNC Korea
BNC Korea Co., Ltd grundades 2007 och är noterat på KOSDAQ i Sydkorea. Företaget utvecklar biologiska och andra läkemedel med differentierade egenskaper för att lösa medicinska behov på behandlingsmarknaden. Företaget säljer produkter inom området medicinteknik såsom hyaluronsyrafyllare, vävnadsersättare och sårläkning och biologiska läkemedel såsom botulinum toxin typ A för estetisk användning. Företaget bygger för närvarande en ny tillverkningsanläggning för tillverkning av orala beredningar och injektionsläkemedel.

Mer information om företaget kan du finna på: https://www.bnckorea.co.kr

BNC Korea Co., Ltd är baserat i Daegu och Seoul i Sydkorea. Tillverkningen är baserad i Daegu och Sejong city i Sydkorea.

[1] Kalyanaram 2008, InPharmation, IQVIA, Kremer 2008
[2] InPharmation

Stevanato announced in their industrial plan for 2020 – 2023 that they intend to invest almost Euro 400 million in manufacturing and R&D programs for drug delivery systems. A share of this investment will be allocated to the manufacturing of ICOcap®. This update follows the announcement May 27 that ICOcap® received a CE-mark.

Stevanato also recently launched a new product site to increase the visibility of ICOcap® underlining its position as an important product for the future, where Iconovo is featured as a service provider for customizations and formulation services.  

To find the press release for Stevanato’s industrial plan: https://www.stevanatogroup.com/news-events/press-releases/stevanato-group-planned-investments-under-the-2020-2023-industrial-plan-about-400-million-euros-to-finance-the-company-development/

To find Stevanato’s new ICOcap® site: https://www.stevanatogroup.com/drug-delivery-devices/icocap/

To read more about the CE-mark of ICOcap®: https://iconovo.se/capsule-inhaler-icocap-from-iconovo-ce-marked-for-clinical-trials/