AI assistant
Arctic Bioscience — Investor Presentation 2024
Mar 1, 2024
3536_rns_2024-03-01_b3fbf9bc-ef83-43e3-a39b-c44db6027816.pdf
Investor Presentation
Open in viewerOpens in your device viewer

Arctic Bioscience
Presentation of financial results; Q4 2023 update / prelim. FY 2023 results
March 1st 2024
Christer L. Valderhaug (CEO) Jone R. Slinning (CFO) Runhild Gammelsæter (Global Medical Director) Matters discussed in this Presentation may constitute or include forward-looking statements. Forward-looking statements are statements that are not historical facts and may include, without limitation, any statements preceded by, followed by or including words such as "aims", "anticipates", "believes", "can have", "continues", "could", "estimates", "expects", "intends", "likely", "may", "plans", "forecasts", "projects", "should", "target" "will", "would" and words or expressions of similar meaning or the negative thereof. These forward-looking statements reflect the Company's beliefs, intentions and current expectations concerning, among other things, the Company's results of operations, financial condition, liquidity, prospects, growth and strategies. Forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. The forward-looking statements in this Presentation are based upon various assumptions, many of which are based, in turn, upon further assumptions that may not be
accurate or technically correct, and their methodology may be forward-looking and speculative.
An investment in the Company's shares should be considered as a high-risk investment. Several factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievement that may be expressed or implied by statements and information in this Presentation.
A multitude of factors can cause actual results to differ significantly from any anticipated development expressed or implied in this Presentation, including among others, economic and market conditions in the geographic areas and industries that are or will be major markets for Company's businesses, changes in governmental regulations, interest rates, fluctuations in currency exchange rates and such other factors.
The information obtained from third parties has been accurately reproduced and, as far as the
Company is aware and able to ascertain from the information published by that third party, no facts have been omitted that would render the reproduced information to be inaccurate or misleading.
The contents of this Presentation are not to be construed as financial, legal, business, investment, tax or other professional advice. By receiving this Presentation, the Recipient acknowledges that it will be solely responsible for its own assessment of the Company, the market and the market position of the Company and that it will conduct its own analysis and is solely responsible for forming its own opinion of the potential future performance of the Company's business. In making an investment decision, the Recipient must rely on its own examination of the Company, including the merits and risk involved. This Presentation is not an advertisement for the purposes of applicable measures implementing the EU Prospectus Regulation.
This Presentation is not a prospectus and does not contain the same level of information as a prospectus.
Disclaimer


Developing and commercializing pharmaceutical and nutraceutical products based on unique bioactive marine compounds, utilizing proprietary technology and methodology
Intro and 2023 operational highlights 2023 operational review Business outlook Q&A
- 2023 consolidated Group financial review (prelim.)
Agenda
5

Intro and 2023 operational highlights
Liquidity position according to development plans
NOK 109,6 million as of end 2023
Cellular studies project on Mode of Action of HRO350 completed
Key objectives of this project were to gain a deeper understanding of the cellular mechanisms and structural characteristics of HRO350. Plan to publish results H1 2024
Financial results in line with earlier guiding
Gross margin 29% / adj. EBITDA MNOK -38,6
Kotler strategic partnership continues to develop well
End-customer sales doubled in 2023, which is expected to impact revenues in 2024 for Arctic Bioscience
22% y/y B2C revenue growth
Implemented measures have had postivie effects on B2C development in 2023
Acquisition of Arctic Algae AS in Q1 2023
Foundation for future expansion of our product portfolio into marine algal oils
2023 highlights
Phase IIb clinical trial for HRO350, the HeROPA-study, fully recruited 6-months primary end-point read-out expected in H2 2024


Operational review Nutra
Global nutra business with distribution via B2C, B2B and partner channels

Based on extracts from the caviar of wild-caught North Atlantic herring Phospholipid omega-3 products - especially rich in DHA

Nutra B2C/B2B Norway
- Arctic Bioscience sells ROMEGA® to consumers in Norway. In 2023 B2C sales revenues increased by 22% y/y
- The primary growth in B2C revenues is driven by sales coming from the new "ROMEGA ® Hjerne" product
- The ROMEGA® products are available through e-commerce subscription at romega.no
- In addition, the ROMEGA® product is sold at Farmasiet, Sunkost, Life, Arnika and Kinsarvik. The B2B revenue in Norway increased by 20% y/y
Nutra Americas & Europe
- Nutra B2B in general had a revenue growth through 2023 of 12% y/y
- o Revenue in Europe grew by 46%
- o Revenues from Americas dropped by 27%.
- o Affected by changes in customer's delivery plans
- Several new US brands signed in 2023 and are expected to launch through 2024
- More than 40 nutra brands globally contains ROMEGA ®












Nutra APAC
- The sale of ROMEGA ® -products in China was strong and doubled y/y in 2023. However, being reflected in the 2024-revenues for Arctic Bioscience due to stock changes and manufacturing delays end of year
- Arctic Bioscience sales revenue from China in 2023 dropped by 29% y/y
- Key products in China are ROMEGA®Prenatal, ROMEGA®Eye and ROMEGA®Brain
- APAC ex China grew by 30% y/y
- The interest and demand from other large Asian markets are positive and may become key growth drivers going forward



Operational review Pharma

*Split between mild and moderate patients varies in the literature.
Sources: HRO350 Commercial Opportunity Assessment in Psoriasis, IQVIA; WHO Global Report on Psoriasis; Rendon. Int J Mol Sci. 2019 Mar; 20(6): 1475; UpToDate; American Academy of Dermatology Association; Papp. Dermatol Ther. 11:1053; 2021; National Psoriasis Foundation; Evaluate Pharma 2022 Psoriasis Market Size, November 2022 Analysis. ABG-SC Arctic Bioscience Initiation Reponrt (17th March 2021)
In the EU5,

Novel oral product meets an unmet medical need for patients with non-severe psoriasis
HRO350 market potential in mild-to-moderate psoriasis
Large market potential in mild-to-moderate psoriasis
- ~22.5M total psoriasis patients across severity types (~10.7 U.S. and ~11.8 EU5)
- ~80% of U.S. patients and ~90% of EU5 patients have mild-to-moderate psoriasis
- HRO350 is targeting a total addressable market of ~18.7M mild-to-moderate psoriasis patients
HRO350 has the potential to become a blockbuster drug
• Analysts predict potential for peak annual revenue above 1 billion USD
- Drug development program for children <18 years of age with psoriasis
- Component of the regulatory drug development journey for HRO350
- Prerequisite for filing for marketing authorization (MA) for new medicines in Europe
Limited approved products in standads of care High unmet medical need
Paediatric Investigation Plan (PIP) agreed with the Paedatric Committee* of the EMA
• Plan for expanded indication for HRO350
• Limited treatment options – potential first line treatment for mild-to-moderate psoriasis
- 1% of children under age 18 suffer from psoriasis
- in children
- A future paediatric indication would have benefit of HRO350

increase patient population who could
Paediatric indication for HRO350: added potential
*The Paediatric Committee of the EMA provides opinions on the quality, safety and efficacy of a medicine for use in the paediatric population
References: Augustin M, Glaeske G, Radtke MA, Christophers E, Reich K, Schäfer I. Epidemiology and comorbidity of psoriasis in children. Br J Dermatol. 2010 Mar;162(3):633-6. doi: 10.1111/j.1365-2133.2009.09593.x. Epub 2009 Nov 18. PMID: 19922529; Haulrig MB, Zachariae C, Skov L. Off-Label Treatments for Pediatric Psoriasis: Lessons for the Clinic. Psoriasis (Auckl). 2021 Feb 11;11:1-20. doi: 10.2147/PTT.S268462. PMID: 33604269; PMCID: PMC7886293.; Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients [published correction appears in J Am Acad Dermatol. 2020 Mar;82(3):574]. J Am Acad Dermatol. 2020;82(1):161-201.
Potential first-line treatment for children with mild-to-moderate psoriasis
To investigate efficacy, safety, and dose of HRO350 versus placebo in mild-to-moderate psoriasis
HeROPA phase IIb study progress and status per February 2024
submission and approval

Recruitment complete: 519 patients
All patients will be treated for 6 months - primary endpoint Data read-out estimated H2 2024 Base for planning phase 3 clinical program
Secondary endpoints after 52 weeks of placebo-controlled treatment
8 weeks follow-up to investigate rebound and safety
All study data to be published 2025

MAA: Marketing Authorization Application; MoA: Mode of Action; IMPD: Investigational Medicinal Product Dossier; CTA: Clinical Trial Application * PIP agreed with the EMA Pediatric Committee*in Q1 2022. The Paediatric Committee of the EMA provides opinions on the quality, safety and efficacy of a medicine for use in the paediatric population Sources: EMA PDCO meeting report of opinions on paediatric investigations plans and other activities, 21 January 2022, available online

HRO350 clinical program progress and timeline update
MAA in adults
Cellular data on HRO350 Mechanism-of-Action in psoriasis "Properties of phospholipids from Herring Roe in Psoriasis" supported by grant from the Research Council of Norway
Most existing treatments for psoriasis work by reducing inflammation, commonly by inhibiting specific signaling substances from immune cells which affect skin cells. This includes the cytokines IL17 and IL23. A key symptom of psoriatic skin is overproliferation of keratinocytes, leading to psoriatic plaques with scaling.
Specialized pro-resolving mediators (SPMs) are a type of bioactive lipids that actively terminate inflammation and drive the restauration of tissue homeostasis through activating signs of resolution1. Lipid mediators are elevated in lesional psoriatic skin3. SPMs effects have been demonstrated in-vitro, e.g. Maresin-1 (MaR1) has been shown to suppress IL-17A production in a murine psoriasis model.
Project has investigated:
- Effects of HRO350 in skin cell cultures, advanced skin cell models and human immune cells
- Effects of HRO350 on response genes and psoriasis markers in skin cells
- Uptake of HRO350 to skin cells and immune cells
- Analysis of Specialized Pro-Resolving Mediators (SPMs)
Data under review for patenting opportunities
Posters will be presented at congresses and multiple peer-reviewed publications estimated Q3-4 These data will be important in the future Marketing Authorization Application for HRO350
Figures: Histopathology of psoriasiform epidermal hyperplasia: licensed under the Creative Commons Attribution 4.0 International. References: 1) Basil MC, Levy BD. Specialized pro-resolving mediators: endogenous regulators of infection and inflammation. Nat Rev Immunol. 2016;16(1):51-67; 2) Chiurchiù V, Leuti A, Maccarrone M. Bioactive Lipids and Chronic Inflammation: Managing the Fire Within. Front Immunol. 2018;9:38. Published 2018 Jan 29; 3) O' Serhan CN, Levy BD. Resolvins in inflammation: emergence of the pro-resolving superfamily of mediators. J Clin Invest. 2018;128(7):2657-2669; 3) Sorokin AV, Norris PC, English JT, et al. Identification of proresolving and inflammatory lipid mediators in human psoriasis. J Clin Lipidol. 2018;12(4):1047-1060;
Arctic Orphan (ABS302): Novel orphan designation drug candidate for brain development in extremely premature infants

~15 million premature births annually worldwide1
~5% are extremely premature (< 28 weeks)2
Extremely premature infants are bereaved three months of the normal in utero development time, do not have fully developed brains, and a high risk of disability and complications
Lipid drug candidate ABS302 is intended for the support for brain development and prevention of neurodevelopment complications in extremely premature infants
Project plan ABS302
Quality/CMC/regulatory preparations Process and formulation development GLP manufacture for pre-clinical program Preclinical program GMP manufacture of clinical materials Clinical development with Smerud of ABS302


2023 consolidated group financial review (prelim.)
Key financial figures
SALES REVENUES



GROSS MARGIN AVAILABLE LIQUIDITY
Sales revenues down 1,5% y/y, mainly driven by postponement in delivery plans into 2024 from some of our largest customers
-
• Positive development in B2C-segment in line with expectations, with a y/y revenue growth of 22,4%
• Strong growth in y/y revenues also on the European B2B-segment, in total a growth of 46% y/y
• End-customer sales in China doubled in 2023, effects from this trend expected to be affected in the revenues for 2024
Positive development in gross margin the last couple of years
-
• Increased in total 5 p.p. compared to 2021
• Gross margin in 2023 influenced by mix of sold products compared to 2022, together with a larger part of deliveries of finished goods has been moved into 2024
Arctic Algae AS fully incorporated in the consolidated figures from
Q2-2023
FY adjusted EBITDA in line with expectations and earlier guiding
TNOK 2023 2022 Income statement
| Sales revenue | 33 750 | 34 272 |
|---|---|---|
| Other revenues | 6 | 197 |
| Cost of goods sold | 23 976 | 22 626 |
| Gross profit | 9 774 | 11 646 |
| Gross margin % | 29,0 % | 34,0 % |
| Employee benefits expenses | 23 513 | 24 355 |
| Depreciation and amortisation expenses | 5 382 | 3 730 |
| Other expenses | 29 470 | 21 147 |
| Operating profit (loss) | -48 586 | -37 389 |
| Net financial items | 3 072 | 3 364 |
| Net profit (loss) for the period | -45 514 | -34 025 |
| EBITDA | -43 204 | -33 659 |
| Adj. EBITDA | -38 597 | -30 996 |
Breakdown of Nutra revenue
REVENUE BY BUSINESS LINE REVENUE BY REGION

Available liquidity end of period of MNOK 109,6
Cash flow from investments MNOK -43,1
- Of this net MNOK 34,1 are related to the HRO350 phase IIb study
- Investment activities also affected by the Arctic Algaetransaction in late Q1-2023
Cash flow from financing activities MNOK 18,8
- New net long-term liabilities of MNOK 2,0 as part of the Arctic Algae-transaction
- Proceeds from equity includes exercise of share options, and debt conversion into shares related to the Arctic Algaetransaction
By end of 2023 Arctic Bioscience also has an unused credit facility of MNOK 30, established in August 2023
| TNOK | 2023 | 2022 | Cash flow statement | ||
|---|---|---|---|---|---|
| Profit/loss before tax | -45 515 | -34 024 | Available liquidity end of period of MNOK 109,6 | ||
| Ordinary depreciation | 5 382 | 3 731 | |||
| Change in inventory | 2 668 | -6 936 | |||
| Change in accounts receivable | 3 905 | -5 771 | Cash flow from operations MNOK -40,3 mainly driven by negative | ||
| Change in accounts payable | 123 | 9 893 | operating result | ||
| Change in other accrual items | -6 850 | 7 712 | |||
| Net cash flow from operating activities | -40 287 | -25 395 | Cash flow from investments MNOK -43,1 | ||
| Of this net MNOK 34,1 are related to the HRO350 phase IIb study • |
|||||
| Investments in tangible and intangible assets | -45 334 | -58 565 | |||
| Payment from sale of tangible assets | 2 230 | 0 | Investment activities also affected by the Arctic Algae • transaction in late Q1-2023 |
||
| Net cash flow from investment activities | -43 104 | -58 565 | |||
| Net new long-term liabilities | 2 049 | 0 | Cash flow from financing activities MNOK 18,8 | ||
| Proceeds from equity | 16 792 | 750 | |||
| Net cash flow from financing activities | 18 841 | 750 | New net long-term liabilities of MNOK 2,0 as part of the Arctic • Algae-transaction |
||
| Proceeds from equity includes exercise of share options, and • |
|||||
| Net change in cash | -64 550 | -83 210 | debt conversion into shares related to the Arctic Algae | ||
| Cash at the start of the period | 144 152 | 227 362 | transaction | ||
| Cash at the end of the period | 79 602 | 144 152 | |||
| Unused credit facility | 30 000 | 0 | By end of 2023 Arctic Bioscience also has an unused credit facility of | ||
| Avaliable liquidity at the end of the period | 109 602 | 144 152 | MNOK 30, established in August 2023 |
Solid financial position at end of period
Total assets MNOK 300,3
• Fixed assets of MNOK 167,1 mainly comprised of intangible assets related to pharma development
• Current assets of MNOK 133,1 mainly comprised of MNOK 79,6 in cash and MNOK 32,8 in inventory
• Additional MNOK 30 in available liquidity due to unused credit facility as of end 2023
Total equity MNOK 258,6, corresponding to an equity ratio of 86%
Long term liabilities relates to financial leasing agreements
Financial position
-
| TNOK | 31.12.2023 | 31.12.2022 | |
|---|---|---|---|
| ASSETS | |||
| Non-current assets: | |||
| Intangible assets | 140 658 | 107 043 | |
| Property, plant and equipment | 26 438 | 22 332 | |
| Total non-current assets | 167 096 | 129 375 | |
| Current assets: | |||
| Inventories | 32 794 | 35 462 | |
| Accounts receivable | 9 571 | 13 476 | |
| Other current assets | 11 188 | 5 237 | |
| Cash | 79 602 | 144 152 | |
| Total current assets | 133 155 | 198 327 | |
| TOTAL ASSETS | 300 251 | 327 702 | |
| EQUITY & LIABILITIES | |||
| Equity: | |||
| Share capital | 2 537 | 2 438 | |
| Share premium reserve | 256 020 | 284 842 | |
| Total equity | 258 557 | 287 280 | |
| Liabilities | |||
| Liabilities to financial institutions | 2 049 | - | |
| Total liabilities | 2 049 | - | |
| Current liabilities | |||
| Accounts payable | 18 376 | 18 253 | |
| Public duty payables | 2 253 | 1 741 | |
| Other current liabilities | 19 016 | 20 428 | |
| Total current liabilities | 39 645 | 40 422 | |
| TOTAL EQUITY & LIABILITIES | 300 251 | 327 702 |


Business outlook
New inhouse manufacturing line in Ørsta
- Earlier plans to build a full-scale manufacturing facility were set on hold at the beginning of 2022
- Since then, Arctic Bioscience has worked with alternative inhouse manufacturing solutions which are better adapted to future operations and demands
- A concept development project has decided to go forward with a GMP manufacturing line established in Ørsta
- The decided solution will secure production volumes in the years to come, both for our pharmaceutical and nutraceutical operations
External debt funding secured:
- In February 2024, an agreement with the company's primary bank and with Innovation Norway was reached
- Debt funding of MNOK 65 + MNOK 3 in additional soft funding
Next phase in the project is estimated to commence in Q4 2024 depending on timing of other key processes and projects

-
Business outlook
HeROPA clinical trial will be the main focus in 2024
- With all needed patients now recruited the 6-months primary end-point read-out is expected in H2 2024
- We continue pursuing potential commercial partnership for HRO350 will have strong focus in the forthcoming periods
Positive prospects for our nutraceutical business
- We will continue to build our customer base
- New products will be introduced into the market in 2024
- We are aiming for solid sales growth in the coming years
- Given the prospects and market outlook we see today, we forecast a break-even contribution from the nutraceutical business by end of 2025
Arctic Algae development
- Initial project of producing oil from selected algae species successful. Support of NOK 500 000 from Regionalt Forskningsfond (RFF) granted in project involving NORCE and NIVA as collaborating partners
- The phase 2 of the project continues in 2024 and recently received funding of NOK 2 mill from Regionalt Forskningsfond (RFF 50%) to upscale algae case from benchtop to pilot production
Financing outlook
Financing of future activities
- When Arctic Bioscience was listed on Euronext Growth in 2021, it was stated that one of the main reasons for both the capital increase and the listing was to fund the HRO350 phase IIb study. This study is now well underway
- At the end of 2023 the financial position is satisfying
- Arctic Bioscience has constant focus on ensuring a satisfactory capitalization to secure progress in the ongoing projects. In 2024 the company will work with various financing alternatives to secure the future funding of the company's activities post the 6 months data readout, including commercial partner search for HRO350
29




Contact
CEO - Christer L. Valderhaug: [email protected]
CFO - Jone R. Slinning [email protected]
Medical Director - Runhild Gammelsæter: [email protected]
Subscribe to news
www.arctic-bioscience.com/investors/home
