Iconovo

“We have made a flying start into 2024.”

Johan Wäborg, CEO

SIGNIFICANT EVENTS DURING 1 JANUARY - 31 MARCH 2024

Iconovo received an order from a company ranked among the top ten largest pharmaceutical companies globally to evaluate a multi-dose inhaler from Iconovo. The study is a so-called in-vitro study to assess the suitability of the inhaler for the development of an original medicine. The order value is USD 21,500 and was booked during the first quarter.

The company entered into an agreement to continue formulation development with Kiox Pharma in the field of rare lung diseases. This is a continuation of the collaboration between the companies announced last year. The new agreement entails revenues of MSEK 2.7 for Iconovo during 2024, in addition to the MSEK 1.6 the company received in 2023. The project is based on reformulating an FDA-approved drug substance into one of Iconovo's patented inhalers; ICOcap. The goal is to develop a new inhalable treatment for interstitial lung disease (ILD). The market value for ILD treatment was over USD 4 billion in 2022.

In February 2024, Iconovo carried out a directed new share issue with gross proceeds of MSEK 33.3. Existing shareholders such as Gerald Engström, Fourth Swedish National Pension Fund, Second Swedish National Pension Fund, and Cicero Funds participated in the share issue. Furthermore, the company's shareholder base expanded with participation from Landia, Bolite, and Akonit.

In March, the company received a grant of SEK 680,000 from Innowwide. The grant is intended to conduct a market study to introduce the company's services and products to the South Korean market. The project will be carried out from April to September 2024 and is part of the Iconovo Accelerator program previously communicated by the company.

In February, Iconovo launched improved versions of the nasal ICOone® powder inhaler. The inhalers are designed to offer high technical performance and minimize the risk of user errors. The further development of ICOone® Nasal has been conducted within the framework of a successful development collaboration with the Bill & Melinda Gates Foundation.

In March, Iconovo and Affilogic presented positive results from a feasibility study with a Nanofitin®-based biological drug against respiratory viruses in ICOone®. The results confirmed that Nanofitins® can be formulated as a spray-dried powder for inhalation, maintaining activity and a fine particle fraction suitable for lung delivery, and administered using ICOone®. The study results will be presented in full at the Respiratory Drug Delivery 2024 congress in Tucson, Arizona, on 5-9 May 2024.

KEY FIGURES FOR THE GROUP

CEO’s MESSAGE

RAMPING UP IN 2024
The first quarter of this year has been largely characterized by business development activities, including several congresses and meetings both in Europe and the USA. The trend we observed towards the end of last year, with increasing interest in our products and services, continues, and we have initiated several discussions with potential customers, forging a number of new and important contacts on both continents. Additionally, we have closed the first two customer agreements of the year and begun building a portfolio of promising candidates for reformulation into inhalation drugs.

ICONOVO EXPANDS BUSINESS IN REFORMULATED SUBSTANCES
Over the past few months, we have embarked on an intensive effort to identify promising substances suitable for reformulation into inhalation drugs, aiming to build a portfolio of substances with significant market potential for dry powder inhalation. Our ambition is to leverage our existing inhalation platforms and our solid formulation expertise to advance these substances to in-vitro proof-of-concept at a low cost, then partner with medium-sized pharmaceutical companies for further development and commercialization. Our new team member, Gary Pitcairn, who joined the company as Senior Scientific Advisor at the end of last year, will play a key role in developing reformulated drugs. Gary has a vast network and is a globally recognized expert in the development of drug formulations for inhalation.

SUCCESSFUL EXPANSION OF CDMO ACTIVITIES CONTINUES
We continue to grow in contract development of original drugs using our proprietary inhalation platforms and plan to sustain the successful expansion of our CDMO activities. Contract development yields a handsome profit margin on our work performed, and we expect it to account for a significant portion of revenues in the coming years. Through contract development, we can help customers reach the market faster, with the goal of entering into licensing agreements with royalty revenues from sales. Already, we have five active customer agreements in this business area, and our ambition is to sign between three and five new agreements per year.

With two new customer agreements in the first quarter, we are already well on track towards our 2024 goal. As part of the first agreement, we conduct an in-vitro study on behalf of one of the world's top ten pharmaceutical companies to assess whether one of our multi-dose inhalers is suitable for the development of an investigational drug. The second agreement concerns the reformulation of an already FDA-approved medicine for rare lung diseases in ICOcap® for the Danish company Kiox Pharma. The project is a continuation of the feasibility study and preclinical pharmacokinetic study we conducted last year and represents an additional revenue of MSEK 2.7 in 2024.

ICONOVO FORGES NEW CONNECTIONS IN MULTIPLE MARKETS
Recently, we have participated in several meetings and congresses in both the USA and Europe, including DCAT Week in New York, BIO Europe in Barcelona, and most recently, the World Vaccine Congress in Washington DC, where we had several productive meetings and discussions about how ICOone® could revolutionize vaccine administration and improve global health.

In parallel, we have been awarded a grant of SEK 680,000 from the EU-funded innovation program Innowwide to conduct a market study in South Korea. The goal is to gather knowledge that will serve as the basis for introducing Iconovo's services and products in the country. The project is part of Iconovo's Accelerator program and will be carried out from April to September this year. One of the first initiatives in the program is that I will represent Iconovo in May as part of a delegation from Business Sweden visiting BIO Korea. There, we will have several meetings with leaders of major South Korean pharmaceutical companies to establish new, important contacts in the country. Establishing a presence in the South Korean market would not only mean growth opportunities for Iconovo in the country but also open doors to other Asian markets.

PROGRESS IN ICOPRE® OUT-LICENSING PROCESS ON TRACK
The out-licensing process for ICOpre® is progressing as planned, and we are working intensively to reach a favorable agreement with the most suitable partner as soon as possible. This would provide excellent opportunities for the inhaler to become the first generic challenger to Ellipta in both the EU and the USA. The first launch opportunity in the ICOpre® portfolio is expected to be a generic version of the asthma medication Relvar in the EU by 2027.

After a 2023 filled with challenges in the external environment, we have now made a flying start into 2024, and already in the first quarter, we have taken several steps towards profitability. We look forward to seizing the opportunities identified during the first quarter of this year and taking the next important step towards our goal of becoming a profitable company from the full year 2026 onwards.

Johan Wäborg
CEO

This is ICONOVO
Iconovo is actively engaged in the development of new inhalation drugs through partnerships with international pharmaceutical companies, tapping into an expanding market. Inhalation medications offer substantial benefits over traditional forms of treatment like tablets or injections. However, their development demands specialized expertise across various domains, making it a complex yet rewarding endeavor.

Novel Pharmaceuticals
Iconovo has successfully formed three strategic partnerships with research-driven pharmaceutical companies to pioneer the development of cutting-edge treatments, harnessing the potential of the company's patented inhalers to deliver enhanced value. The annual sales of medications and vaccines against diseases where inhalers offer significant benefits reaches nearly USD 100bn.

Generic Pharmaceuticals
The market for inhaled medications targeting asthma and COPD is valued at around USD 28bn. As major inhaled drugs face patent expirations, substantial commercial opportunities arise for generic pharmaceutical companies. Iconovo's products show promising potential to replace medications currently delivered through inhalers such as Turbuhaler® and Ellipta®. Notably, in 2022 Symbicort Turbuhaler® achieved sales of USD 2.4bn, and Ellipta®-inhaled medications recorded impressive sales of USD 5.0bn.

Iconovo's model offers high commercial potential with low development risk
The revenue streams from our customer collaborations comprise three key components: initial payments for access to our technology, milestone-based compensations throughout the development process, and royalties. For Novel Pharmaceutials, our royalty rates are usually set at low single-digit percentages of sales. As for Generic Pharmaceuticals, the royalty rates fall within the range of five to ten percent.

Inhalation platforms

Iconovo has four platforms that collectively address the market's various needs for effective and user-friendly inhalers, offering significant commercial opportunities both in the development of entirely new medicines and during patent expirations of branded drugs.

FINANCIAL COMMENTS 1 JANUARY - 31 MARCH 2024

Turnover and result
Net sales in January-March 2024 were 1,700 (309) TSEK with contribution from two projects.

Other operating income for January-March 2024 was lower compared to the previous year at 857 (2,728) TSEK; the main difference is lower grant income during the first quarter of 2024 compared to the first quarter of 2023 when a larger grant income from the Bill & Melinda Gates Foundation was recorded.

Capitalized development expenses amounted to 4,614 (6,036) TSEK in January-March 2024, and were made up by the development of the ICOpre and ICOcap platforms as well as related formulations.

Expenses for raw materials and supplies fell to 772 (3,064) TSEK in January-March 2024, due to high costs in the Bill & Melinda Gates Foundation project during the first quarter of 2023.

Other external expenses amounted to 3,894 (7,108) TSEK in January-March 2024. The first quarter of 2023 included a provision for bad debts of 2,700 TSEK. Excluding this provision, other external expenses mainly decreased due to lower expenses for consultants, marketing and software.

Personnel expenses increased a tad to 9,444 (9,259) TSEK in January-March 2024 mainly reflecting higher pension costs.

The average number of full-time employees (FTE) in January-March 2024 was 28.7 of whom 13.1 women, 14.8 men and 0.8 non-binary (31.1 of whom 16.7 women, 13.4 men and 1.0 non-binary).

Net financials were 23 (-144) TSEK in January-March 2024. The interest income increased considerably compared with the first quarter of 2023.

The result for the period January-March 2024 was -9,550 (-13,039) TSEK.

Investments and depreciations
Investments in tangible assets during January-March 2024 decreased to 0 (129) TSEK. Investments in intangible assets during January-March 2024 amounted to 4,787 (6,300) TSEK. The investment in these assets is primarily attributable to investments in the ICOpre and ICOcap platforms as well as related formulations.

The total cost of depreciation of tangible and intangible assets during January-March 2024 amounted to 2,599 (2,486) TSEK.

Cash, cash flow and net debt
At the end of the period, the group's cash and cash equivalents amounted to 39,084 (44,729) TSEK. There are no interest-bearing liabilities in the company.

The cash flow from operating activities during January-March 2024 amounted to -6,647 (-13,098) TSEK. The cash flow from investment activities amounted to -4,787 (-6,429) TSEK in January-March 2024. The cash flow from financing activities during January-March 2024 amounted to 32,039 (50,810) TSEK. In February 2024, the company secured gross proceeds from a directed issue of new shares of 33.3 MSEK. It is the assessment of the Board and management, taking into account liquidity needs and the presented budget, that there is nothing indicating that the Group's liquid assets would not be able to finance the company's plans for the next 12 months. The out-licensing ICOpre is a significant part of the budget and cash flow for the fiscal year 2024. However, even if this were to be excluded for any reason, the Board and management assess that the company's alternative plans are sufficient for continued operations and development for the next 12 months, albeit with a slightly shorter perspective before the need for additional financing may arise compared to the original plan.

Thus, the total cash flow for January-March 2024 amounted to 20,605 (31,283) TSEK.

Shareholders’ equity
As per 31 March 2024, shareholders’ equity totaled 134,480 (127,702) TSEK. Total assets amounted to 153,614 (152,068) TSEK at the end of the first quarter 2024.

PARENT COMPANY

Turnover and result
Net sales in January-March 2024 were 1,700 (309) TSEK with contribution from two projects. The result for the period January-March 2024 was -9,461 (-12,115) TSEK.

Shareholders’ equity
As per 31 March 2024, shareholders’ equity amounted to 139,791 (132,065) TSEK.

Contact information and calendar

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

Gunnar Gårdemyr, Chairman of the Board of Directors
gunnar.gardemyr@gmail.com

Iconovo AB (publ)
Ideon Science Park, Ideongatan 3B, SE-223 70 LUND
Tel +46 46 275 6777, info@iconovo.se, www.iconovo.se
Registration number Iconovo AB: 556938 - 0156

Certified Adviser
Carnegie Investment Bank AB (publ), Regeringsgatan 56, SE-103 38 Stockholm,
telephone: +46 73 856 42 65, email: certifiedadviser@carnergie.se

Financial Calendar
Q1 report (Jan. – March 2024) 25 April 2024
Annual report 2023 25 April 2024
Annual general meeting 21 May 2024
Q2 report (Jan. – June 2024) 12 July 2024
Q3 report (Jan. – Sep. 2024) 24 Oct. 2024

The annual report 2023 (in Swedish only) is available on the company’s homepage.
Iconovo’s shares are listed on Nasdaq First North Growth Market, Ticker: ICO, ISIN code: SE0010868943.

Key ratio definitions
EBITDA (Earnings before interest, taxes, depreciation and amortization). Operating result before depreciation and amortization.
Adjusted EBITDA. EBITDA adjusted for the provision for bad debts.

Board of Directors’ affirmation
The Board of Directors and the CEO hereby affirm that the Quarterly Report constitutes a faithful representation of the company’s operations, financial position and profit/loss and that it describes the significant risks and uncertainty factors facing the company.

This report has not been subject to the auditor’s review.

Lund, 25 April 2024,
Board of Directors, Iconovo AB


Consolidated statement of income and comprehensive income, summary

Consolidated balance sheet statement, summary

Consolidated cash flow statement, summary

Consolidated statement of changes in equity, summary

Parent company income statement, summary

Parent company balance sheet statement, summary

Notes
Accounting principles Iconovo prepares its consolidated accounts in accordance with IFRS, International Financial Reporting Standards, as endorsed by the EU. Furthermore, the Group also applies the Annual Accounts Act and the Swedish Financial Reporting Board's recommendation RFR 1 (Supplementary accounting rules for groups). The Group uses historical cost for the valuation of balance sheet items unless otherwise stated. The interim report has been prepared in accordance with IAS 34. IFRS is constantly evolving, with new standards and interpretations being published continuously. No new standards that are assessed to affect the period's results and financial position have come into force. The complete accounting principles applied by the Group can be found in the 2023 annual report on pages 63-70.

Key figures for the group

In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail.