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.

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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.

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.

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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).

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Iconovo announce that the company has signed a know-how license agreement granting BNC Korea Co Ltd the exclusive rights to use the know-how to manufacture the formulations and to market, sell and distribute the formulations together with ICOcap® in the territory. BNC Koreas has exclusive rights in a territory consisting of Korea, Japan, China, Taiwan, Russia, the CIS Countries and the Southeast Asian Countries (including Turkey). The license agreement covers two generic formulations, a generic Ultibro® Breezhaler® (indacaterol, glycopyrronium) product and a generic Seebri® Breezhaler® (glycopyrronium) product. The deal has a value of EUR 550,000 whereof EUR 150,000 is to be paid as an access fee. Royalties from future sales will be a mid-single digit percentage of sales depending on market.

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. Iconovo estimates that approx. 25 % of global sales comes from the territory that is licensed to BNC Korea (territorial sales of approx. Euro 140 million for both products). The remaining territory is still available for licensing where Europe is the largest opportunity.

”Iconovo is looking forward to work with BNC Korea to bring these two products to market in a very important territory with over 2.7 billion inhabitants. BNC Korea is a regional dynamic company with fast decision-making and established distribution networks. With BNC Korea we are confident that the products can be advanced to market in a fast and effective way. We will work closely with BNC Korea using our combined knowledge to form a strong alliance. This agreement is a validation of our technology and will make an important first block in our continuing licensing efforts for the remaining territory.” says Johan Wäborg, CEO of Iconovo.

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.

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/

Today, Iconovo released a briefing document on its homepage covering the market opportunity, patent situation, ICOpre® product features and partnering strategy

The objective is to be transparent to customers and investors regarding Iconovo’s perception of this product opportunity.

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The Chinese Patent Agency has announced the intention to grant a patent regarding Iconovo’s inhalation device, ICOres

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

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Projektet Porösa läkemedelsbärare för inhalerbara terapier har nyligen startat upp

Det är finansierat av KK-stiftelsen och är ett samarbete mellan Biofilms – Research Center for Biointerfaces på Malmö Universitet, Iconovo AB och Nanologica AB. Nästa steg är att rekrytera en post doc. Iconovo kommer att bidra med sina egenutvecklade torrpuverinhalatorer (DPIs), inhalationsdevice, karakteriseringar av inhalationsberedningar liksom sin generella expertis inom inhalerade läkemedel.

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Iconovo announce that the capsule-based dry powder inhaler ICOcap™ is CE-marked for use in clinical trials

ICOcap™ is now available for customers to use in clinical trials that develop capsule-based formulations and can be bought from Stevanato, the manufacturing and distribution partner of Iconovo. The CE mark is applied in conformity with the requirements of Directive 93/42/EEC as a Class 1 Medical Device in collaboration with our partners Stevanato Group and their affiliate Balda Medical GmbH.

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