The abbreviated Interim Report for January to March 2022 is now avaialble in English.

Read it here

Iconovo has entered into a strategic collaboration with Galenica AB – a company specializing in the development and manufacture of pharmaceuticals for clinical studies. The main purpose of the collaboration is to facilitate the manufacturing of clinical trial material for companies developing new drugs for Iconovo’s innovative single dose inhaler ICOone.

Innovative inhalers are necessary to bring out the full potential from future medicines for respiratory and lung diseases. Other types of medicines and vaccines can also be administered via inhalers, not least biological drugs that otherwise have to be given as an injection, which comes with requirements for sterility and often also cold storage. The development of complete inhalation products requires both a technology platform and formulation expertise, something that most research-based pharmaceutical companies lack, but which Iconovo can offer. Another challenge for pharmaceutical companies is the manufacturing of the material needed to start the first clinical studies. Iconovo is now investing in a solution, where equipment is placed at Galenica, to standardize the processes for the manufacture of clinical trial material in a GMP environment. Standardized processes and established forms of cooperation will shorten the time for the manufacture of clinical trial material and facilitate technology transfer to the customer’s production facility.

Both companies are located in the Malmö-Lund region which is a great advantage as the technology transfer can be significantly streamlined through close cooperation. The focus of the collaboration will be on customers who develop novel pharmaceuticals and want to use Iconovo’s innovative disposable inhaler ICOone.

“The collaboration with Galenica is part of our efforts to broaden the use of ICOone among international pharmaceutical companies developing novel medicines. We will have an even more attractive and complete customer offering by being able to provide our customers with a product ready to go into early clinical trials,” says Johan Wäborg, CEO of Iconovo.

The process for Iconovo’s customers becomes more seamless and slot times for manufacturing can be scheduled with short lead times due to the close collaboration between Iconovo and Galenica. Galenica will be responsible for the efficient preparation of each individual customer project, for example by ensuring prior qualification of equipment and approved raw material suppliers.

“I’m happy that we can offer more customers our expertise in inhalation by collaborating with Iconovo. Through this close cooperation with Iconovo, the customer can quickly and seamlessly access world-class development in inhalation, which benefits the development of novel treatments that can help patients sooner,” says Ronnie Wallin, CEO of Galenica.

The plan is for the manufacturing equipment to be implemented and put into operation in August 2022.

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 Galenica AB
Galenica AB was founded in 1999 and is located at Medeon Science Park in Malmö. The business offers development and manufacturing of new pharmaceuticals both in-house and on behalf of customers. Extensive work is carried out in three different branches of activity – CRO, CMO and Pharma. Within CRO, analytical and pharmaceutical development takes place in pre-clinical and clinical phases, as well as manufacturing and quality control of investigational drugs. Small-scale commercial drug manufacturing takes place within CMO. The third branch of operations, Pharma, comprise of the company’s patented Ovixan®, a prescription cream for psoriasis and eczema. Ovixan® is the market leader in the Nordic region and is also sold in several non-Nordic markets. Oviderm® was launched in 2018, a moisturizing cream used to treat dry skin in adults, youth, and children. Galenica has also been conducting license sales of the drug Ameluz since 2021 which treats actinic keratosis in the Nordic region.

The Quarterly Report for Q1 2022 was released today and is available here, in Swedish.

The Iconovo team will be open to meetings in Orlando from May 2nd-4th.
For meetings at RDD, contact Roger Lassing; roger.lassing@iconovo.se 

Significant progress in Iconovo’s three strategic business areas

Significant events 1 October – 31 December

  • Iconovo signed an agreement with TOA Pharmaceutical Co, Ltd for the evaluation of an Iconovo inhaler for generic product development. The agreement has a value of SEK 2 million, with potential further development.
  • Iconovo registered its subsidiary Iconovo Pharma AB with the Swedish Companies Registration Office. This is part of the communicated strategy to establish a proprietary pharmaceutical sales infrastructure in the Nordic market. Iconovo’s target is to reach sales revenues totalling
    SEK 200 million by 2026, of which approximately one-third is expected to be generated from Iconovo Pharma.
  • The China National Intellectual Property Administration intends to approve (Notice of Allowance) a patent for the ICOone inhalation platform. Iconovo already has approved patents for ICOone in Sweden, Europe (EPO), the USA and India. The patent describes the single-dose inhaler used in Iconovo’s two innovative customers products with Oxytocin and a COVID-19 vaccine.

Significant events 1 January – 30 September

  • In July, Iconovo carried out a directed share issue and raised SEK 75 million before issue expenses. The issue was subscribed by a number of Swedish and international institutional investors, including Alcur Fonder, FE Fonder and Humle Fonder, as well as a number of existing shareholders, including Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fonder. The proceeds of the issue will primarily be used for acceleration and value creation activities and investments linked to the Company’s long-term strategy.
  • The agreement with Amneal for a generic equivalent of Symbicort has been expanded during the year to include the key US and Chinese markets and the Nordic sales rights, more than doubling the potential for future annual royalty income.
  • In May, Iconovo communicated its 5-year business targets at its first Capital Market Day. By 2026, the Company expects to achieve sales of SEK 200 million, with an operating margin of 50%. The Company also announced its long-term strategy, with three strategic areas with the original core operation of generic inhalation product development now supplemented with the new areas of innovative inhalation product development and pharmaceutical sales in the Nordics.
  • In March, Iconovo signed an agreement with ISR (Immune System Regulation AB) for the development of an inhaled COVID-19 vaccine.
  • In July, Iconovo entered into an agreement with ISR for additional work on the ongoing inhaled COVID-19 vaccine project for the development of a nasal version of Iconovo’s ICOone inhaler. The additional work could provide up to SEK 4.9 million on top of the previous agreement. In addition, there is the possibility of future royalties.
  • In May, Iconovo entered into an agreement with Respiratorius for the development of an inhalation product for the treatment of COPD. The agreement includes a tiered fee for project work, with a total value of up to SEK 3 million.
  • The Board was strengthened at the AGM with the election of Ann Gidner. Gunnar Gårdemyr took over the chairmanship from Mats Johansson, who continues to serve on the Board as a member.
  • The quality system has been upgraded to meet the requirements for medical devices in the USA under the Quality System Regulation. The upgrade is a critical step in gaining access to the US market for Iconovo’s products together with pharmaceuticals.
  • During the year, the Company received notification that the United States Patent and Trademark Office intends to approve (Notice of Allowance) a patent for the ICOres inhalation platform. The Japan Patent Office also intends to approve (Intention to Grant) a patent for the platform. Iconovo already has approved patents for ICOres in Japan, Sweden, Europe (EPO) and the USA. The patent describes the technology used in Iconovo’s many customer projects, including generic Symbicort. The Company also received notification that the United States Patent and Trademark Office intends to approve (Notice of Allowance) a patent for the ICOone inhalation platform. Iconovo already has approved patents for ICOone in Sweden, Europe (EPO) and India.

Significant events after the end of the fourth quarter

  • Subsequent to the end of the quarter, Iconovo announced the completion of a pilot clinical pharmacokinetic study conducted by Amneal Pharmaceuticals. The study has provided valuable information that supports the continued development of ICOres budesonide/formoterol as a potential replacement product for Symbicort.
Key figures in TSEK unless otherwise indicated  Oct-Dec 2021 Oct-Dec 2020 Jan-Dec 2021 Jan-Dec 2020
Net turnover 3,600 7,681 15,409 17,792
Operating profit/loss -8,706 -3,610 -26,513 -16,717
Cash flow for the period -12,060 -10,398 33,248 -27,467
Earnings per share (SEK) before and after full dilution -0.98 -0.58 -3.15 -2.20
Cash and cash equivalents 94,937 61,689 94,937 61,689
Equity 137,034 92,729 137,034 92,729
Number of shares at period-end 8,847,500 7,776,000 8,847,500 7,776,000
Number of royalty agreements** 6 5 6 5

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

A WORD FROM THE CEO

Our long-term strategy is already yielding good results

Last May, we launched a new long-term strategy for Iconovo based on three business areas – generic inhalation products, innovative inhalation products and Nordic pharmaceutical sales. This strategy is already starting to bear fruit, which is extremely gratifying. Among other things, we have achieved our goals for the development of the ICOpre® inhalation platform, which is based on entirely proprietary technology that does not infringe on the patent protection of GSK’s bestseller Ellipta®, but at the same time provides a user experience that is very similar to Ellipta®. By using ICOpre®, generic companies can start manufacturing, marketing and selling Ellipta-based drugs as soon as patent protection is lost for several of the compounds in best-selling Ellipta-based asthma and COPD products. ICOpre is now ready for the market and we will focus on increasing customer acquisition in this large segment going forward.

Four partner agreements last year
Another key element of our strategy is the goal of signing two to three partner agreements each year. During the year, we were able to sign four. In May, we signed an additional agreement with the generics company Amneal Pharmaceuticals, giving them the right to sell our ICOres-based generic version of Symbicort® also in the US and China, more than doubling the potential for our future annual royalty income to between SEK 110 and 220 million.

In the same month, we signed an agreement with biotech company Respiratorius to develop a dry powder formulation and an inhalation product based on Iconovo’s ICOone® inhaler for use in Phase I clinical trials for Respiratorius’ drug candidate RES030-085. The agreement also involves jointly investigating which of Iconovo’s inhalation platforms is best suited for the commercialisation of Respiratorius’ drug substance. The first part of the agreement is worth approximately SEK 3 million.

Together with the immunotherapy company Immune System Regulation (ISR), we contracted for the development of an inhaled COVID-19 vaccine in Iconovo’s ICOone inhaler and also a nasal version of ICOone. The agreement has a value of SEK 14 million, excluding royalties.

The fourth agreement was signed in November with TOA Pharmaceuticals of Japan for the development of an inhaler for a generic version of a drug with significant sales in the Japanese market.

Proof that our business model works
This is strong proof that our business model and strategy are working, and that our three different areas of activity complement and support each other in a logical and positive way. Based on our proprietary inhalation platforms, we are able to develop inhalation products with international pharmaceutical companies for both generic and innovative drugs that are then sold globally by our partners, but for which we have the option of retaining the rights for the Nordic market. The collaboration with Amneal Pharmaceuticals is an excellent example of this. As we have the rights to sell generic Symbicort in our ICOres® inhaler in the Nordic region, we have the opportunity to work a market with the potential to generate between SEK 80 to 100 million in annual turnover. Additional proof is that during the year we completed a successful share issue that raised SEK 75 million before issue costs, which at the end of the year gave us a strong cash position with SEK 95 million in cash and cash equivalents, compared to SEK 62 million at the end of 2020.

Now we are growing in numbers and strengthening our skills
There is a lot happening in the Company as we continue to deliver on our strategy and attract more and more customers. That is why we are strengthening our skills by recruiting new employees and establishing collaborations with external expertise for e.g. our commercial department, which brings together marketing, communication, business development and the development of established partnerships – all to take on more projects and become a more sales-oriented organisation.

I am also pleased to announce that we will be moving to new premises this spring. For some time now, we have been in a cramped space and even in different buildings. The move, about 500 metres to Ideon Science Park, will take place in March. It will be an incredible boost for us to gather the Company under one roof in facilities and labs that meet the standard we need for the development of inhalation products according to our long-term strategy.

All of this means that we can feel both proud and satisfied with the year that has passed, and approach 2022 with great confidence.

Johan Wäborg, CEO

 

Last week, Iconovo’s partner ISR received the reviewed and approved toxicology report that examined the company’s vaccine for intranasal application against SARS-CoV-2. The report shows no evidence of toxicological reactions after the 3-dose intranasal vaccine.

”With this very important step in the company’s vaccine program completed, we now move on to already planned clinical trials”, says Ola Winqvist, CEO of ISR.

ISR and Iconovo signed a partnership in 2021, regarding development of a covid-19 vaccine for nasal inhalation. Iconovo has developed the powder-based vaccine formulation and the ICOone Nasal single-use inhaler that will be distributed to pharmacies and patients. Additionally, Iconovo has guided ISR in setting up the commercial production facilities.

Both companies see a great market potential for a nasal vaccine, especially in regions with poorly developed infrastructure, since there is no need for cold chain distribution like for traditional vaccines. Further on, the vaccine can be inhaled by patients themselves and there is no need for medical staff to administer the vaccine. The nasal vaccine will give millions of people access to vaccine in regions with currently low vaccination coverage.

More information about ISR can be found at: https://israb.se/media-room/inga-tecken-pa-toxikologiska-reaktioner-for-isrs-vaccinkandidat-mot-sars-cov-2-ett-viktigt-steg-for-den-vidare-utvecklingen

As part of Iconovos global commercialization plan, we are now strengthening our international IP portfolio by trademarking ICOpre in Japan. ICOpre is a pre-metered dry powder inhaler similar to the well-known Ellipta from GSK, used for consistent, once-daily treatment.