Biostock published January 18th an article about Iconovo that can be found in its entirety below

2020 was an eventful year for Iconovo, which included the company entering into agreements with BNC Korea, Amneal and Monash University. A CE marking and several positive patent notices were also obtained. Additionally, Iconovo made significant changes in its organisation to strengthen the company’s business development, including the appointment of Johan Wäborg as CEO, with Orest Lastow becoming CTO. BioStock contacted Johan Wäborg to hear his thoughts on 2020 and the company’s plans for 2021.

Iconovo develops inhalation products consisting of both inhaler devices and associated dry powder formulations. The complete inhalation products are out licensed to customers, thus, Iconovo offers a faster way to market with lower risk and at a lower cost.

The inhalation products are primarily intended for the treatment of asthma and chronic obstructive pulmonary disease (COPD), but there is also potential in other and new types of inhaled drugs, which is exemplified by Iconovo’s latest agreement with Monash University for inhaled oxytocin (more details below).

Achieved milestones and good sales in 2020

Since its founding in 2013, Iconovo have developed a broad product portfolio that includes four inhalation platforms – ICOres, ICOcap, ICOone ICOpre. In 2020, significant progress was made in the development and commercialisation of all platforms despite the Covid pandemic. A strong sales trend could also be noted in combination with several achieved milestones.

New CEO with international experience in business development

In early 2020, Iconovo announced that Dr. Orest Lastow, the inventor behind the company’s inhaler platforms, had decided to leave his role as CEO to instead act as Iconovo’s CTO. Taking over the role as CEO was Johan Wäborg, who most recently held a position as CEO of Actelion Pharmaceuticals in the Nordic and Baltic countries, where he was involved in the process when the company was acquired by Janssen Pharmaceuticals for USD 30 billion.

Since Wäborg’s appointment as CEO in April, Lastow, as CTO, has focused in particular on the development of Iconovo’s fourth inhalation platform, ICOpre, which is the company’s largest investment to date. At the same time, this marks a shift where the company is transitioning from a company in establishment phase, to a growth company with sustainable profitability.

Amneal – new development partner for ICOres

In May, Amneal Ireland Ltd was welcomed as the new partner for the development of Iconovo’s ICOres budesonide/formoterol product, a generic version of AstraZeneca’s Symbicort. The global market value of a combination product with budesonide/formoterol is estimated at approximately USD 2.5 billion per year according to Iconovo.

Amneal has extensive experience in bringing generic products to market, but also the necessary financial muscle to guarantee continued progress in development. Iconovo wants to reach the market as quickly as possible in order to offer a good product alternative to asthma and COPD patients, but also to obtain royalties on future sales

CE marking for ICOcap and DMF submitted to FDA

 At the end of May, Iconovo received a Class I certification for the capsule inhaler ICOcap, which means that the requirements for a Class I medical device are met. With this quality stamp on its back, ICOcap could start being sold to customers for use in clinical trials. This was an important step towards the ultimate goal – to launch ICOcap globally and start commercial sales.

ICOcap is sold through Stevanato, Iconovo’s manufacturing and distribution partner, which announced in December that a Type III Drug Master File (DMF) had been submitted to FDA. According to Wäborg, this was a big step forward in the American market, the world’s largest pharmaceutical market and a crucial market for success with ICOcap.

Extended patent portfolio

 In March 2020, the European Patent Organization (EPO) announced that they intend to grant two of Iconovo’s patents – one for ICOres and one for ICOone.

Iconovo already had two approved Swedish patents for ICOone and now they had also received a European patent for ICOone, which is a single-dose inhaler. The European patent for ICOone describes the technology used in Iconovo’s oxytocin project with Monash University, among other projects.

Agreement with Monash University for inhaled oxytocin in ICOone

Just before the turn of the year 2020/2021, Iconovo signed an agreement with Monash University for the development of inhaled oxytocin in ICOone. The agreement gives Monash University the exclusive right to use ICOone to administer oxytocin to the lungs to prevent postpartum haemorrhage (PPH), which is the most common cause of maternal mortality worldwide.

Today, oxytocin is only administered as an injection to prevent bleeding in the mother after childbirth. If Monash University and Iconovo succeed in developing an inhaled preparation of oxytocin in ICOone, it would mean great benefits such as cheaper and smoother transport and greater user-friendliness than a syringe. According to Iconovo, the main strength of the product will be its thermal stability allowing it to be distributed and stored without refrigeration temperature requirements.

Patent protection for ICOres in China and the USA

In April 2020, the EPO announced the intention to grant a third patent regarding ICOres, which is important as Europe is the largest market for the multi-dose inhaler.

During the summer, two more positive patent notices were received for ICOres in the USA and China. Iconovo previously had approved patents for ICOres in Sweden, Europe and Japan. The US patent in particular will be an important asset in Iconovo’s patent portfolio, according to CEO Johan Wäborg:

»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.«

The Chinese market is also of high value given the increasing prevalence of respiratory diseases in China. Additionally, a patent granted in China is crucial for business development in the country.

Agreement with BNC Korea

 In July, Iconovo signed its fourth licensing agreement – a 20-year agreement with BNC Korea Co Ltd for ICOcap formulations – covering the development of generic versions of Novartis’s Ultibro Breezhaler and Seebri Breezhaler, both approved for the treatment of COPD. Iconovo’s CEO had this to say about the agreement:

»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. With BNC Korea we are confident that the products can be advanced to market in a fast and effective way.« 

The deal has a milestone value of EUR 550,000. In addition, future royalty payments from BNC Korea will be received based on the sales of the generic products once they have been launched.

According to Novartis’s financial report 2019, Ultibro and Seebri together generated 548 MUSD in sales during the financial year. Iconovo estimates that about 15 per cent of global sales derive from the territory where BNC Korea has exclusive rights.

Two new recruitments for increased customer focus

With the company’s growing project portfolio and with many projects in an active final phase, Iconovo chose in October to make two key recruitments for an increased focus on customer needs and project delivery. Nina Bladh, Ph.D, was appointed to Director Project Management and Måns Österberg Widerstrand was appointed to Director of Alliance Management.

Nina most recently held a position as Director CMC Regulatory Affairs for Camurus, while Måns previous position was Senior Scientific Advisor Allergy for Thermo Fischer.


The CEO comments on 2020 and Iconovo’s future plans

Johan Wäborg, CEO

BioStock contacted Iconovo’s CEO, Johan Wäborg, to hear his thoughts on the past year and the plans for 2021.

Johan Wäborg, 2020 was a successful year for Iconovo and it was also the year that you took over as CEO of Iconovo. How would you describe 2020 and your first months as CEO of the company?

– My first 9 months at Iconovo have been really good! Full speed ahead. When I came in as the new CEO in the middle of the Covid-19 pandemic’s first wave, I did not know at all how we would be affected. It was just a matter of rolling up my sleeves and getting into the business with high energy.

– Helpful and knowledgeable employees made my introductory period smooth. I feel confident and I have a management team that works very well together – it’s incredibly fun.

Iconovo has certainly achieved a great deal in 2020, despite the pandemic. What do you think is Iconovo’s biggest achievement in 2020? 

– I am proud of our employees who worked with good energy throughout 2020. It has led to progress in all functional areas, for example new customer agreements, new patents, progress in ICOpre development, deliveries in projects and more.

– I think our greatest achievement is that we managed to end the year according to our tough plan. It shows that this team can deliver even in tough times.

Iconovo has just signed an agreement with Monash University for the development of inhaled oxytocin in ICOone. How do you assess the potential in this project?

– Inhaled oxytocin is an exciting project as it is our first commercial project for ICOone and our first innovative inhalation project as our previous projects are generic projects.

– The deal has a milestone value of 900 000 Euro and will provide some royalty income, even if the low prices in resource-poor countries will affect the royalty income. However, it opens up a door to more innovative inhalation projects such as vaccines, migraines or emergency treatment of various conditions.

»We will also continue our commercial approach and aim to enter into new agreements during the year.«

Now that 2020 has passed, it is time to look ahead – what plans does Iconovo have for 2021?

 – This year we will be able to accelerate further and work with increased capacity, especially since we hired several new employees during 2020. We will soon make a Technology transfer to Amneal so that they can carry out a pilot PK study during the year. A clinical study will also be conducted for the project with Monash.

– The other projects have some remaining time left until studies can be initiated. However, the projects with Intas and BNC also have important deliveries during the year that are in the late phase of development. We will also continue our commercial approach and aim to enter into new agreements during the year.

 

Read the article at the Biostock webpage

Biostock published December 23th an article about Iconovo that can be found in its entirety below

In a final push before the Christmas break this week, the inhalation device company Iconovo announced the signing of a deal with Monash University to develop an inhaled oxytocin treatment against postpartum haemorrhage using Iconovo’s ICOone platform. The project is supported by a research agreement with Johnson & Johnson aimed at speeding up clinical development. BioStock takes a closer look at the ramifications of this new partnership.

Most maternal deaths occur during the first 24 hours after delivery, and one of the main causes is postpartum haemorrhage (excessive bleeding) (PPH) due to the lack of uterus contractions right after childbirth. The hormone oxytocin, often referred to as the love hormone thanks to its role played in establishing romantic relationships, is also a key player during childbirth as it causes the uterus to contract during labour.

Therefore, through the years, oxytocin became a treatment for PPH, and is, in fact, recommended by the WHO that women receive an injected dose of oxytocin during the third stage of labour to prevent PPH. While the treatment is considered effective, there is a strong demand for alternative forms of drug delivery, as the injections require skill levels and equipment that may not always be available. This is especially problematic in developing countries.

New PPH treatment platform in the pipeline

Researchers at Monash University’s Institute of Pharmaceutical Sciences (MIPS) in Melbourne, Australia, have been working on an alternative oxytocin formulation that does not require an injection. To speed things along, the MIPS recently entered into an R&D agreement with Janssen Pharmaceutica, part of Johnson & Johnson, to further advance the clinical development of inhaled oxytocin for the prevention of PPH in developing countries.

Iconovo contributes with ICOone system

This week, news broke that the project received a big boost as Monash University signed a development deal with Swedish inhalation device company Iconovo to use Iconovo’s proprietary ICOone platform to deliver an inhalable dry powder version of oxytocin through the lungs. The dry powder formulation would not require refrigeration and would enable ease of use by frontline health workers, birth attendants and mothers themselves.

Iconovo’s CEO Johan Wäborg displayed his excitement regarding the news in the latest press release:

»We are excited to be contributing with ICOone and our inhalation know-how to such an important medical innovation. There is a huge need to ease administration of oxytocin so that these unnecessary and tragic deaths can be reduced all over the globe. In this project, we all come together to make great things happen. For Iconovo, this project will broaden our experience to include innovative development and we look forward to many more such projects where we can use our inhalation experience. It sends a clear signal that these innovation-focused partners see ICOone as a promising inhaler for innovative applications«

A clinical phase I trial for the project is planned for 2021, and the agreement has a staged technology access fee of 900 000 EUR that will be triggered by milestones in the clinical trial stage. The first out of three milestones will be paid as an exercise fee to license the device subject to a positive outcome during phase I. In addition, Monash will pay Iconovo for commissioned development work through milestones that are yet to be defined. Royalties from sales over a 20-year period from launch will range from 5 – 10 per cent.

ICOone has versatility and strong IP protection

The ICOone platform, which consists of a single-dose disposable user-friendly dry powder inhaler, can be used with a wide range of formulations and can deliver treatments more quickly and safely to patients. The technology for the device has good IP protection. In fact, during the spring of this year, it had received an intention to grant from the EPO for ICOone.

Photo: Iconovo

Thanks to its versatility, PPH is not the only indication where the ICOone platform could make a difference; in fact, this is not the first collaboration for Iconovo regarding ICOone. In 2018, the company  signed an agreement with McMaster University in Canada for the joint development of a vaccine against tuberculosis (TB). The agreement relates to the development of a dry powder preparation of inhalable vaccine to be administered through Iconovo’s ICOone inhaler. The project was highlighted by BioStock earlier this year in recognition of World TB day.

Contributing to significant market potential

Overall, the Iconovo-Monash University agreement has the potential to address a critical unmet medical need among women. Iconovo estimates that roughly 15 – 20 per cent of the expected 115 million annual live births occurring in less developed parts of the world, like the rural parts of Africa or Asia, could benefit from an inhaled formulation. It could provide important advantages such as ease of use, cheaper transport and management of hazardous waste material like used syringes.

In the future, such potential could expand to other markets like USA and Europe where the need for a safer, non- invasive alternative to injections is not to be overlooked.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

 

Read the article at the Biostock webpage

Lund, December 21, 2020. Iconovo AB (publ) today announced that the company has signed a development agreement with Monash University for the development of inhaled oxytocin in ICOone®. The agreement verifies the suitability of ICOone for use with innovative pharmaceuticals. Monash University’s Institute of Pharmaceutical Sciences (MIPS) is leading the development project supported by a research agreement with Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and ongoing support from long term partner GSK.

The agreement gives Monash an exclusive global right to use ICOone with oxytocin to prevent postpartum haemorrhage in women giving birth. The agreement has a staged technology access fee of €900,000 that will be triggered by milestones in the clinical trial stage of the project where the first out of three milestones will be paid as an exercise fee to license the device subject to a positive Phase 1 trial that is planned for 2021. In addition, Monash will pay Iconovo for commissioned development work through milestones that are yet to be defined. Royalties from sales over a 20-year period from launch will be in the 5 – 10 % range, as previously communicated for similar agreements.

“We are excited to be contributing with ICOone and our inhalation know-how to such an important medical innovation. There is a huge need to ease administration of oxytocin so that these unnecessary and tragic deaths can be reduced all over the globe. In this project, we all come together to make great things happen,”

said Johan Wäborg, CEO of Iconovo.

“For Iconovo, this project will broaden our experience to include innovative development and we look forward to many more such projects where we can use our inhalation experience. It sends a clear signal that these innovation-focused partners see ICOone as a promising inhaler for innovative applications. We are very pleased that we now have commercial royalty bearing agreements for all Iconovo’s three platforms,” continued Johan Wäborg.

Currently, injectable oxytocin is used to prevent postpartum hemorrhage (PPH) after childbirth. It is recommended by the WHO that women should receive an injected dose of oxytocin during the third stage of labor to prevent PPH. An inhaled formulation can provide important advantages such as ease of use, cheaper transport and storage without cold chain and no handling of used needles and syringes. It is particularly important in parts of the world where infrastructure is less developed, like in rural parts of Africa or Asia. To remove the need for a cold-chain and the management of hazardous waste will be a great cost reduction and potentially help eliminate disease spreading by infected needles. Iconovo estimates that there are 115 million live births in the region of interest, whereof 65 million are in rural areas with the greatest need. Iconovo believes that the product will be used in 15 – 20 % of live births in rural areas. In the future there is a possibility that also other markets like USA and Europe will open for inhaled oxytocin as a safer, non-invasivealternative to injections.

“This is an exciting opportunity to expand this collaboration between industry and academia to develop an important healthcare innovation that aims to address a critical unmet medical need,” said Monash University’s Professor Michelle McIntosh, who has pioneered the inhaled delivery of oxytocin. “There is a massive ripple effect when a mother dies – it’s a very significant burden for these families and communities, and we are committed to bringing gold-standard care to all mothers.”

ICOone is a single-dose inhaler designed for ultra-low manufacturing cost and easy operation. In these areas, ICOone is particularly suitable since it can deliver one dose at a low price-point and with a mode of operation that requires a minimum of training. Therefore, ICOone supports the potential of delivering an inhaled oxytocin product at an affordable price point comparable to other uterotonic options available in low- and middle-income countries.

About PPH

PPH, a condition of excessive blood loss after birth, is the leading cause of maternal mortality globally, resulting in an estimated 60,000 deaths per year, overwhelmingly in resource-limited countries. Most deaths resulting from PPH could be avoided if access to suitable medical innovation were available. It is effectively managed in developed countries using the gold standard therapy, oxytocin, a manufactured form of a natural hormone. Accessibility to quality oxytocin in resource-poor countries is, however, limited as current products are only available in an injectable form requiring supply and storage under refrigerated conditions and trained personnel to administer the product safely.

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.

About Monash University’s Institute of Pharmaceutical Sciences (MIPS)
MIPS has formed an alliance with a number of industry partners, including Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and GSK, as well as philanthropic organisations such as the McCall MacBain Foundation, to develop a novel, temperature-stable formulation of oxytocin. The 2020 QS World University Rankings by Subject ranked Monash University number two in the world for Pharmacy and Pharmacology. The University has also retained a long-held position as Australia’s and the Asia-Pacific’s number one University for Pharmacy and Pharmacology, and since the subject rankings were introduced in 2011 has consistently ranked in the most elite group of Pharmacy and Pharmacology programs worldwide with an average top ten ranking.

For further information, please visit https://www.monash.edu/pharm/research

Contacts

Johan Wäborg, CEO
+46 707 78 51 71
johan.waborg@iconovo.se

About Iconovo

Iconovo was founded in 2013 by people with long experience in inhalation development. The company develops inhalers and associated drug preparations that are used to treat asthma and COPD. However, Iconovo also has the competence to develop products for new types of inhaled drugs such as vaccines.

By working with Iconovo, pharmaceutical companies and generic companies can access a complete pharmaceutical product, thereby eliminating the complex and costly early stages of the development phase. Iconovo licenses its patented products to customers and offers a faster way to the inhalation market with lower risk and at a lower cost.

More information about the company can be found at www.iconovo.se.

Iconovo is based in Lund and its share (ticker ICO) is listed on Nasdaq First North Growth Market, Stockholm since April 6, 2018. The Company’s Certified Adviser is Erik Penser Bank AB, Box 7405, SE-103 91 Stockholm, phone +46 8 463 80 00, email: certifiedadviser@penser.se.

This information is information that Iconovo is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2020-12-21 07:30 CET.

Attachments, PDF iconovo-signs-agreement-for-development-of-inhaled-oxytocin-in-icoone-for-maternal-health

Biostock published December 9th an article about Iconovo that can be found in its entirety below

Since entering a collaboration with the Italian healthcare technology company Stevanato Group, Iconovo has taken significant steps towards commercialisation with its ICOcap inhaler platform. After receiving CE-marking for use in clinical trials earlier this year, most recently the device has been submitted to the FDA by Stevanato as Type III Drug Master File, a certification that would guarantee the device a stronger standing globally, especially on the US market.

Iconovo is a Swedish medical device company that develops not only generic inhalers but also dry powder formulations to be used with their inhalers for the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) through its four proprietary inhalation platforms – ICOresICOoneICOcap, and ICOpre. The company’s business strategy partly involves partnering with global healthcare distributors and receive royalty payments through their sales. This gives Iconovo the opportunity to insert itself into a growing global market, and the company has taken several steps to reach that goal.

A great partner in Stevanato

One of Iconovo’s first licensing deals came in 2018, when the company made an agreement with Italian healthcare technology company Stevanato Group for the manufacturing, international sales, and distribution of their ICOcap platform. ICOcap is a capsule-based dry powder inhaler designed to be robust but also easy to use and with the potential to handle different capsule sizes. The device itself has the same function and performance as Boehringer Ingelheim’s capsule-based dry powder inhaler HandiHaler and Novartis’s dry powder inhaler Breezhaler, both of which have been licensed by Stevanato. However, currently, the Breezhaler version is the only one available from Stevanato.

Since beginning the partnership with Stevanato, ICOcap has received a Class I Medical Device certification in conformity with the requirements of Directive 93/42/EEC. This CE marking means that European customers who produce dry powder formulations for treating asthma and/or COPD can now purchase ICOcap from Stevanato and use the device in clinical trials.

Large investments and more visibility in US market

Following the CE-marking announcement, Stevanato stated their intention to invest heavily in the ICOcap platform – part of an almost 400 million EUR investment in manufacturing and R&D programs for drug delivery systems. In the meantime, Stevanato also 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 customisations and formulation services. See the site here.

More good news came out of the Iconovo-Stevanato partnership recently when Stevanato announced that it had submitted a Type III Drug Master File (DMF) application to the FDA for ICOcap. This means that new ICOcap customers can now reference this DMF submission when developing their drug-device product for the US market, thus giving ICOcap even more market visibility on a global level.

Iconovo’s CEO, Johan Wäborg, was very pleased with the announcement and overall collaboration with Stevanato:

”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.”

One of two royalty agreements regarding ICOcap

The partnership with Stevanato is one of several that Iconovo has entered in the last two years and one of two agreements regarding ICOcap. The other partnership involving ICOcap was announced this summer when Iconovo signed a licensing agreement with BNC Korea – a deal that gives Iconovo access to a vast territory in Asia representing about 15 per cent of today’s global market for generic formulations of Novartis’ Seebri Breezhaler and Ultibro Breezehaler.  Read more about this agreement here.

However, the deal with Stevanato is expected to generate royalty payments to Iconovo starting in 2022 according to analysts. This would make it the first partnership to show that Iconovo has a business model that can generate more sustainable business opportunities as it moves from 100 per cent milestone income to longer-term royalty income.

Overall, considering the progress made through the ongoing relationship between the two companies and assessing the future potential, Stevanato will remain an important partner for Iconovo, and vice versa.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

Read the article at the Biostock webpage

Iconovo announce that the capsule-based dry powder inhaler ICOcap® has been submitted to U.S. Food and Drug Administration (FDA) by partner Stevanato Group 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.

Biostock published November 4th an article about Iconovo that can be found in its entirety below

During Q2 and Q3, Iconovo took several steps to put more focus on business development, and the latest quarterly report shared by the Swedish inhalation company indicates that the moves have been paying off so far. Thanks to a strong sales performance along with several milestones achieved during Q3, analysts predict a significant upside in Iconovo’s share price.

Since the spring of this year, Iconovo has quickly transitioned from a company in establishment phase to a company more focused on growth, setting its sights on more sustainable profitability with a secure profit margin through growing royalty revenues.

A big step in that transition came during Q2, when Iconovo hired Johan Wäborg as new CEO. This move secured international strategic business development experience at the very top levels of management, which is essential for Iconovo’s future growth. Read more.

Best quarter for Iconovo in three years

Wäborg gave a presentation to investors at Erik Penser Bank’s Company Day, on September 24, giving a detailed overview of the company’s four inhalation platforms and overall business model. Thanks to Iconovo’s in-house inhalation expertise, which pertains to both inhalation devices and dry-powder formulations to match those devices, generic pharma companies could potentially save three to four years in product development time by partnering with Iconovo, who, in turn, would receive revenue in the form of milestone payments and royalties from the market sales.

Thanks to a strong sales performance equal to SEK 5.8 million in Q3 (a 66 per cent increase compared to the same period last year) Iconovo recently posted its best quarterly results in the last three years. Overall, the company’s Q3 report highlights the progress made so far this year and is a testament to its business model.

Business model pays off

During that period, Iconovo received milestone payments from its partnership with Amneal. The pharma company is developing a generic version of AstraZeneca’s Symbicort Turbuhaler (budesonide/formoterol) for treating asthma and chronic obstructive pulmonary disease (COPD) using Iconovo’s ICOres platform.

Furthermore, in July, Iconovo was able to announce a new licensing deal with BNC Korea. This is the fourth royalty agreement for the company, and this one relates to generic formulations of Novartis’ Seebri Breezhaler and Ultibro Breezehaler for Iconovo’s ICOcap platform. Read more details about the deal and why it is important for Iconovo here. In connection with signing, a technology access fee of EUR 150 000 was paid to Iconovo.

Good cash position

In Q3, Iconovo also invested significantly in expanding its team with highly qualified workers, including a formulation specialist, a mechanical design engineer, a personal responsible for commercial partnerships and customer relationships, and a senior project manager. Furthermore, Iconovo made investments in the adaptation of the quality system to meet the requirements of the US Food and Drug Administration (FDA), as well as lab upgrades. And the company is continuing to make investments in the development of their new ICOpre platform.

However, the company’s cash position, SEK 72 million in cash and cash equivalents at the end of September, shows a good balance between investments and invoicing. In fact, Iconovo estimates its cash balance to last just over three years given its current burn rate. By then, Iconovo is expecting to receive royalties, which will translate to positive cash flow and good profitability for the company.

Analysts forecast jump in share price

The good Q3 report was picked up by analysts from Danske Bank and Erik Penser Bank, both of which ran positive valuations for Iconovo and a significant upside in the company’s share price.

Both analyses expect Amneal’s ICOres-based product to commercially launch in Europe during the first part of 2023, which will result in Iconovo collecting its first royalty payments from this deal. Meanwhile, Penser expects royalty payments from the BNC Korea deal to come in 2025.

It is also worth noting that the Danske Bank analysis forecasts first royalty payments from Stevanato Group to come in 2022. The Italian healthcare service provider sells Iconovo’s ICOcap platform, which has been CE-marked for use in clinical trials.

Overall, analysts see a medium risk in Iconovo’s stock, and with Iconovo expecting the same high pace in delivery of milestones for the rest of the year, high invoices are expected for Q4 as well.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

Read the article at the Biostock webpage

Good progress in customer projects

Key figures in TSEK unless otherwise indicated  Jul-Sep 2020 Jul-Sep 2019 Jan-Sep 2020 Jan-Jun 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 60,123 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

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


Contacts


Johan Wäborg, CEO
+46 707 78 51 71
johan.waborg@iconovo.se


About Iconovo


Iconovo was founded in 2013 by people with long experience in inhalation development. The company develops inhalers and associated drug preparations that are used to treat asthma and COPD. However, Iconovo also has the competence to develop products for new types of inhaled drugs such as vaccines.

By working with Iconovo, pharmaceutical companies and generic companies can access a complete pharmaceutical product, thereby eliminating the complex and costly early stages of the development phase. Iconovo licenses its patented products to customers and offers a faster way to the inhalation market with lower risk and at a lower cost.

More information about the company can be found at www.iconovo.se.

Iconovo is based in Lund and its share (ticker ICO) is listed on Nasdaq First North Growth Market, Stockholm since April 6, 2018. The Company’s Certified Adviser is Erik Penser Bank AB, Box 7405, SE-103 91 Stockholm, phone +46 8 463 80 00, email: certifiedadviser@penser.se.

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.

Biostock published October 9th an article about Iconovo that can be found in its entirety below

Swedish inhalation company Iconovo offer a faster way to the inhalation market by developing ready-to-use inhalation products, consisting of both the device itself and the dry-powder formulation(s) to go with it. The company’s four inhalation platforms address a huge market worth 14 billion USD in product sales annually. Now, with the recent regulatory approvals of GSK’s Trelegy Ellipta in asthma from the FDA and Novartis’s Enerzair Breezhaler in asthma from the European Commission, Iconovo’s market potential has expanded even further.

Iconovo targets two indications spanning huge markets: asthma and chronic obstructive pulmonary disease (COPD). In fact, according to WHO, more than 339 million people suffered from asthma globally in 2016, and the prevalence for COPD was estimated at 251 million cases during the same year. The Lund-based med tech company use their inhalation expertise to develop generic versions of both inhalation devices and dry-powder formulations resembling those developed by large pharmaceutical companies.

CEO presents Iconovo’s business strategy

Johan Wäborg, CEO at Iconovo, recently held a presentation at Erik Penser Bank’s Company Day, explaining the company’s inhalation platforms and business model.

He emphasized that the development process for innovative products typically is very time-consuming and often involves high-risk projects and swollen development costs. However, development timelines for generic (inhalation) products are significantly shorter. Iconovo has optimized this concept as they develop the inhalation products in advance, while the generic pharma companies run the pharmacokinetic trials and market registration once outlicensed to them by Iconovo. This working methodology reduces the risk and costs and minimizes the time to market. An earlier entry onto the market means higher market share and larger revenue streams.

So far, Iconovo has signed four royalty agreements within the company’s proprietary inhalation platforms – ICOcap, ICOres, ICOone and ICOpre – which, together, address a total market worth 14 billion USD in product sales annually. Two of these platforms, ICOpre and ICOcap, recently expanded their market potential thanks to two new regulatory approvals for products targeted by these platforms.

ICOpre is the biggest investment to date

ICOpre is the company’s latest inhalation platform and the biggest and most important strategic investment so far for the company. It is a pre-metered dry-powder inhaler that is designed to be able to combine products, and it contains two times 30 individually-sealed doses for a month’s supply and has a dose counter that checks the number of remaining doses.

This platform is being developed to target the global market, with a specific aim set on the valuable US market. The inhalation device is similar to the Ellipta inhaler from GSK, but with an improved design that avoids Iconovo from infringing any Ellipta patents. Like Trelegy, ICOpre has multiple compartments which makes it suitable for mono, duo or triple drugs and thereby also multiple combination therapies.

The Ellipta portfolio is highly valued as analysts forecast 4.5 billion USD in sales in 2023. However, the patent for the Ellipta portfolio expires in 2025, which means that there will be an opening for generic versions. Iconovo’s aim is to find a collaboration partner that Iconovo can help get to the market as the first or one of the first generic versions of Ellipta in 2025.

FDA approval of Ellipta product for new indication

Last month, the FDA approved GSK’s Trelegy Ellipta as a maintenance therapy for asthma, making it the first once-daily, triple-drug inhaler approved for this indication. The approval means that Trelegy Ellipta can now be used for the treatment of both asthma and chronic obstructive pulmonary disease (COPD) in the US.

This is good news for Iconovo and especially its inhalation platform ICOpre because the approval increases the platform’s market potential and opens up opportunities in the longer term for Iconovo.

In fact, according to GSK’s financial report for the second quarter of 2020, Trelegy Ellipta generated 254 million USD in sales for the company – a 58 per cent increase from the same time period last year.

Increased market potential for ICOcap

In July, Iconovo announced that they had signed their fourth royalty agreement – a 20-year royalty agreement with BNC Korea which covers the development of two generic formulations of Novartis’s Ultibro Breezhaler and Seebri Breezhalerto be used in Iconovo’s ICOcap – a recently CE-marked capsule-based dry powder inhaler that is designed to be both robust and easy to use. BNC Korea has the exclusive right to market, sell and distribute the formulations in an Asian territory with over 2.7 billion inhabitants.

According to Novartis’s financial report 2019, Ultibro and Seebri together generated 548 MUSD in sales during the financial year. During the summer, Novartis received an approval from the European Commission for Enerzair Breezhaler as a maintenance treatment for asthma not adequately controlled with a maintenance combination of a long‑acting beta2‑agonist (LABA) and inhaled corticosteroid (ICS). Just like with the FDA’s approval for GSK’s Trelegy Ellipta in Asthma, this approval expands Iconovo’s market potential in the long term even further.

Award-winning company

Overall, Iconovo’s business model, while it does not come without risks, according to analysts, is a strong model as it can rely on a large market potential covered by the company’s vast product portfolio, and it can expect rising profit margins in the long term.

Experts in the medtech community are taking notice of Iconovo’s potential; in fact, in August, the company was recognized by the magazine Medtech Outlook with Top Drug Delivery Device company 2020 award for being one of 10 companies that are at the forefront of providing drug delivery device solutions. It will be exciting to follow Iconovo in its journey as it continues its development.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

Read the article at the Biostock webpage

Pareto Securities´11th Annual Healthcare Conference

Ett av bolagen som tog chansen att presentera sig vid denna konferens var CEO Johan Wäborg, Iconovo som utvecklar inhalatorer med tillhörande läkemedelsberedning.  

Se videointervjun med Johan Wäborg