Iconovo meddelar att en typ III Drug Master File (DMF) för ICOcap® har skickats in till amerikanska läkemedelsmyndigheten FDA av bolagets partner Stevanato. ICOcap® har utvecklats av Iconovo. Nya ICOcap® kunder kan referera till denna DMF ansökan när de skickar in registreringsansökan av en drug-device produkt för USA-marknaden. Denna FDA ansökan följer på en tidigare CE-märkning för kliniska prövningar i EU för ICOcap®.

”Stevanato gör ett fantastiskt arbete i förberedelserna för att få ICOcap® lanserad globalt av läkemedelsföretag som vill använda ICOcap® i sina inhalationsprodukter. De har nu tagit rejäla kliv framåt på två av de viktigaste marknaderna i världen. USA, som är världens största läkemedelsmarknad, är en avgörande marknad för framgång med ICOcap®”, säger Johan Wäborg, VD på Iconovo.

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.

Iconovo announce that the capsule-based dry powder inhaler ICOcap® has been submitted to U.S. Food and Drug Administration (FDA) by partner Stevanato as Type III Drug Master File. New customers to ICOcap® can now reference this DMF submission when developing their drug-device product for the US market. This FDA submission follows a receival of CE-mark in European Union for clinical trials with ICOcap®.

”Stevanato is doing a great job in getting the ICOcap® inhaler globally ready for pharmaceutical companies to develop their products with ICOcap®. Now they have managed to take major steps in two of the largest markets in the world. US, the largest pharma market in the world, is a crucial market to be in with ICOcap®”, says Johan Wäborg, CEO for Iconovo.

About ICOcap

ICOcap is a patented capsule-based dry powder inhaler with a one-piece-design and improved handling features making it easy-to-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 for quick product launch and competitively priced off-the-shelf supply.

Vid årsstämman den 8 maj 2020 beslutades att Iconovo ska ha en valberedning som ska bestå av fyra ledamöter representerande de fyra största aktieägarna per den siste september 2020.

 Valberedningen inför årsstämman 2021 består av:

Mats Johansson;

Hans Karlsson Höiden, utsedd av Orest Lastow;

Stefan Berger, utsedd av Eiffel Investment Group;

Johan Lundgren, ordförande i valberedningen

Valberedningens övergripande ansvar inför årsstämman 2021 är att presentera lämpliga kandidater för ordförande respektive styrelseledamöter och revisor (er) i Bolaget, samt att föreslå deras arvodering.

 Valberedningen ska arbeta fram förslag i nedanstående frågor att föreläggas årsstämman för beslut:

förslag till ordförande vid stämman,

förslag till antalet bolagsstämmovalda styrelseledamöter samt, i förekommande fall, antalet revisorer,

förslag till arvode till icke anställda ledamöter i styrelsen samt till icke anställda ledamöter i styrelsens olika utskott,

förslag till arvode för revisorerna,

förslag till val av styrelsens ordförande och övriga styrelseledamöter samt, i förekommande fall, val av revisorer,

förslag till riktlinjer för att utse ledamöter i valberedningen och för valberedningens uppdrag,

förslag till arvode till valberedningens ledamöter.

 

Aktieägare som önskar lämna förslag till valberedningen kan vända sig till valberedningen per e-post på adress: Johan.Lundgren@zenitdesign.se.

För att valberedningen skall kunna behandla inkomna förslag med tillräcklig omsorg bör dessa vara valberedningen tillhanda senast den 1 mars 2021.

LUND 17 NOVEMBER 2020

STYRELSEN

At the Annual General Meeting of 8 May 2020, it was resolved that Iconovo shall have a Nomination Committee consisting of four members representing the four largest shareholders as of 30 September 2020.

 The Nomination Committee for the 2021 Annual General Meetings consists of:

Mats Johansson;

Hans Karlsson Höiden, appointed by Orest Lastow;

Stefan Berger, appointed by Eiffel Investment Group;

Johan Lundgren, Chair of the Nomination Committee

The Nomination Committee’s overarching responsibility for the 2021 Annual General Meeting is to present suitable candidates for the positions of Board Chair, Board members and auditor (s) of the Company, and to propose their remuneration.

 The Nomination Committee shall prepare proposals in the following matters to be submitted to the Annual General Meeting for decision:

proposal for Chair of the AGM,

proposal for the number of AGM-elected Board members and, where applicable, number of auditors,

proposal for remuneration to non-employed members of the Board and to non-employed members of the various committees of the Board,

proposal for remuneration to the auditors,

proposals for election of Board Chair, other members of the Board and, where applicable, auditors,

proposals for guidelines for appointing members to the Nomination Committee and for the Nomination Committee’s assignments,

proposal for remuneration to the members of the Nomination Committee.

 

Shareholders who wish to submit proposals to the Nomination Committee can contact the Nomination Committee by email at Johan.Lundgren@zenitdesign.se.

In order for the Nomination Committee to process received proposals with sufficient care, these should be received by the Nomination Committee by 1 March 2021.

LUND, 17 NOVEMBER 2020

BOARD OF DIRECTORS

Good progress in customer projects

Key figures in TSEK unless otherwise indicated  Jul-Sep 2020 Jul-Sep 2019 Jan-Sep 2020 Jan-Sep 2019 Jan-Dec 2019
Net turnover 5,754 3,474 10,111 11,737 11,737
Operating profit/loss -2,304 -2,036 -13,104 -4,567 -11,774
Cash flow for the period -3,640 -4,908 -17,069 -12,299 36,106
Earnings per share (SEK) before full dilution -0.25 -0.26 -1.62 -0.57 -1.68
Cash and cash equivalents 72,087 40,751 72,087 40,751 89,156
Equity 97,245 60,125 97,245 60,125 108,794
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** 4 3 4 3 3

**Number of agreements at the end of the period.

Significant events 1 July – 30 September

  • 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.
  • The United States Patent and Trademark Office issued an intention to approve (Notice of Allowance) a patent for the ICOres inhalation platform.

Significant events 1 January – 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.
  • 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 potential impact would be 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.
  • Orest Lastow took the role of company Chief Technology Officer (CTO), and Johan Wäborg was hired as the new CEO of Iconovo in April. Orest Lastow, one of the co-founders, is one of the largest shareholders together with the company’s Chairman of the Board. Orest 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 Chinese Patent Office issued an Intention to Grant notification regarding a patent for the ICOres inhalation platform. 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, two European patents, and one Japanese patent). The patents describe the technology used in Iconovo’s many customer projects, including generic Symbicort.
  • 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 third quarter

  • Iconovo recruited a Director Project Management and a Director Alliance Management. These roles will focus on customer needs and enable the delivery of high-quality customer projects in a planned, efficient manner.

A word from the CEO

Strongest quarter in three years
During the third quarter, significant progress was made in the projects, and several milestones were achieved and could be invoiced to Amneal and Intas. Sales for the quarter amount to SEK 5.8 million, making it the strongest quarter in three years.

Generic Symbicort
The Amneal project with a generic version of Symbicort in ICOres is now in its final phase and work with the final milestones will take place in the next quarter. The final technical delivery will then take place at the beginning of next year and the customer will begin pharmacokinetic studies. The purpose of the studies is to verify that our product gives the patient the same uptake of drug as the original product.

With the technical delivery completed at the beginning of next year and an assumption that the studies will be positive, we can assume that launch in European countries should be possible from early to mid-2023. This timepoint will also mark the start of royalty income for Iconovo from this product.

Important new agreement
In early July, we were able to announce a new customer agreement with BNC Korea. In connection with signing, a technology access fee of EUR 150 000 was paid. The agreement relates to the development of generic formulations of Seebri and Ultibro, which will be used in our ICOcap inhaler.

It is an important agreement for several reasons. Having active customers and business in Asia will help us establish more projects in this part of the world. The contracted territory currently has about 2.7 billion inhabitants, and they are increasing sharply in both number and purchasing power. In the near future, this part of the world may drastically increase its need and consumption of inhalation drugs. The territory currently accounts for approximately 15% of global Seebri and Ultibro sales, which means that the remaining 85% is left as an opportunity for a new contract.

The agreement also serves as verification that a model with early in-house development of certain interesting formulations makes our projects even more commercially viable. Since this leads to a more finished product, it will also be easier for the customer to enter into an agreement.

Other progress during Q3
Our ICOres project with Intas also made good progress in Q3, with subsequent invoicing of milestones. The Intas project will enter a new phase at the beginning of next year, when a period of technical delivery begins. We expect the entire project to be fully delivered by the end of 2022.

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

Investments for increased capacity and customer focus
We have recently made many investments that will help us expand our capacity, put further focus on project implementation, and make us even better in attracting new customers.

During the period July-October, we appointed four new highly qualified people: a formulation specialist, a mechanical design engineer, a personal responsible for commercial partnerships and customer relationships, and a senior project manager.

We are also building efficiency and capacity through several investments, including adaptation of the quality system to meet the requirements of the US Food and Drug Administration (FDA), acquisition of modern HPLC equipment, and setup of two new formulation labs. The new labs will lead to higher capacity and efficiency. At the same time, several patents, design protection and trademarks have also been registered. Last, but not least, we are making investments in the development of the new ICOpre platform according to plan.

I consider the investments we are now making, absolutely necessary in order to help the company grow, keep up our pace, and increase our commercial success.

Our investments affect our cash flow, but at the same time are balanced by good invoicing. We are currently well capitalised and had SEK 72 million in cash and cash equivalents at the end of September. At our current burn rate, our capital is estimated to last just over 3 years. This takes us into a period when we are expected to receive royalties, which will provide good profitability in the company.

Optimistic about next quarter
We are now keeping the same high pace in our delivery of current milestones for the rest of the year. We therefore expect to be able to invoice to the same extent in Q4 as we were in Q3.

Johan Wäborg, CEO

Iconovo meddelar att man genomfört två nyrekryteringar för att fokusera på kundernas behov och för att kunna leverera kundprojekt på ett planenligt effektivt sätt och med hög kvalitet. Med en ökande projektportfölj och många projekt i en mycket aktiv slutfas har Iconovo tillsatt två nya positioner som kommer bidra till ökad kapacitet i arbetet med såväl nya som existerande projekt.

Nina Bladh, Ph.D., har utsetts till Director Project Management. Nina har 25 års erfarenhet av utveckling av farmaceutiska produkter och kommer senast från en roll som Director CMC Regulatory Affairs på Camurus med stor erfarenhet av att ta farmaceutiska kombinationsprodukter hela vägen till marknad. Nina var dessförinnan på AstraZeneca i 16 år med bl.a. projektledande roller och arbete med inhalationsprodukter. Hon doktorerade 1995 i fysikalisk-organisk kemi vid Lunds Universitet. Nina kommer att ansvara för projektledningen av kundprojekt såväl som interna utvecklingsprojekt.

Måns Österberg Widerstrand har utsetts till Director Alliance Management. Måns har en bred erfarenhet från läkemedelsbranschen. Han började sin karriär som läkemedelsforskare, ledde senare produktion och R&D avdelningar men har de senaste 11 åren haft rådgivande och kundvårdande roller gentemot ledande läkare och B2B kunder, bl.a. som Key Account Manager på Thermo Fisher och Head of Global Generics Sales på Polypeptide. Senast kommer Måns från en roll som Senior Scientific Advisor Allergy på Thermo Fischer. Måns kommer att ansvara för kundvården gentemot befintliga kunder, följa projekten till marknad samt utveckla affären gentemot befintliga kunder. Han kommer ge en generell förstärkning av den kommersiella förmågan hos Iconovo.

”Vi kan idag meddela att vi tillsatt två viktiga nya positioner. Nina och Måns kommer med stor erfarenhet som är både direkt tillämplig och även komplementär till den kompetens som finns inom Iconovo i dag. Stärkta satsar vi nu framåt för att ta de existerande projekten till slutleverans. Vi kommer med de nya positionerna kunna intensifiera vår kommersiella ansats och arbeta vidare målmedvetet med att säkra fler kundkontrakt”, säger Johan Wäborg, VD för Iconovo.  

Iconovo announces two new recruitments to increase focus on customers’ needs and to deliver their projects in an effective and high-quality manner. With a growing project portfolio and many projects in a very active late phase, Iconovo has made appointments to two new positions that will contribute to an increased capacity for delivering new as well as existing projects.

Iconovo has accordingly appointed the following two new Directors.

Nina Bladh, PhD; has been appointed to Director Project Management. Nina has 25 years of experience in the development of pharmaceutical products. Her previous position was Director CMC Regulatory Affairs at Camurus, Lund, where she has gained considerable experience in taking pharmaceutical combination products to registration and launch. Prior to Camurus, Nina worked 16 years at AstraZenca including project management positions and work with inhalation products. She obtained her PhD in Physical Organic Chemistry at the University of Lund in 1995. Nina will primarily be responsible for leading customer and internal development projects.

Måns Österberg Widerstrand has been appointed to Director Alliance Management. Måns has a broad experience from the pharmaceutical industry. He started his career as a pharmaceutical scientist, later to lead manufacturing and R&D departments while the latest 11 years has been spent in advisory and customer relation roles with KOLs and B2B customers, such as Key Account Manager at Thermo Fisher and Head of Global Generics Sales at Polypeptide. Most recently, Måns held a position as Senior Scientific Advisor Allergy at Thermo Fischer. Måns will be responsible for the alliance management of current customers, follow our projects to market, while developing the business relationship with the customer. He brings a general strengthening of the commercial abilities of Iconovo.

”With joy I can today announce that we have appointed two persons in two newly created key positions. Nina and Måns brings a lot of experience that is directly applicable and complementary to the competence we have in Iconovo today. This is an important investment at a time when we move our existing projects towards final delivery. With these new positions we can intensify our commercial efforts and goal-oriented continue to secure new contracts with customers”, says Johan Wäborg, CEO at Iconovo.

Johan Wäborg, CEO at Iconovo, presented Iconovo at Erik Penser Bank’s Company Day 24 September where he gave the story of Iconovo covering the business model, products and how Iconovo will generate royalty income as the projects mature and gets launched into the market.

Johan Wäborg, VD på Iconovo, presenterade Iconovo på Erik Penser Banks Bolagsdag 24 september 2020 där Johan berättade historien om Iconovo och dess affärsmodell, produkter och hur Iconovo kommer att generera royaltyintäkter när projekten utvecklats och når marknaden.

Se presentationen (engelska): https://www.youtube.com/watch?v=QZDwBNsXY9Y

Sitdown intervju (svenska): https://www.youtube.com/watch?v=kAUROwEXtio

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.