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Arctic Bioscience — Investor Presentation 2024
Aug 29, 2024
3536_rns_2024-08-29_61d05f46-15dd-45b2-b78a-720ec8cf5174.pdf
Investor Presentation
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Arctic Bioscience
Presentation of financial results; First half year 2024
August 29th 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 H1-2024 operational highlights
- - H1-2024 consolidated Group financial review
H1-2024 operational review Business outlook Q&A
Agenda


Intro and H1-2024 operational highlights
Cellular studies project on Mode of Action of HRO350 published
Research shows positive data of antiinflammatory effects of phospholipid esters from herring roe in immune cells
ROMEGA® sales directly to consumers in Norway increased by 20% y/y
Kotler strategic partnership continues to develop well
The Chinese consumer market is challenging, but still strong sales growth of ROMEGA® products
Liquidity position according to development plans
NOK 49,8 million as of end H1-2024
More than 100% of 2023-sales already secured via sales and received purchase orders
Gross margin > 30%
Positive Micro algae development
Findings of a new microalgae species that may open up for new and exciting future commercial opportunities
H1-2024 highlights
Phase IIb clinical trial for HRO350, the HeROPA-study, fully recruited in January 2024 Development has proceeded as planned; 6-months primary end-point read-out expected ultimo September/early October 2024


Operational review Nutra
Nutra sales status
- More than 100% of 2023-sales of Nutra-products are already secured via sales and received purchase orders
- The total sales revenues from the nutraceutical business are slightly lower in 2024 compared to the same period in 2023, mainly driven by customers' delivery plans and slower than expected sales in some areas, such as the US market
- Arctic Bioscience sells ROMEGA® directly to consumers in Norway. In H1 2024 B2C sales revenues increased by 20% y/y
- The eCommerce sales in the Chinese market remains strong, despite weak consumer spending among Chinese consumers


Operational review Pharma

PASI: Psoriasis Area and Severity Index (0–72-point scale where < 10 is mild-moderate disease); RCT: Randomized Controlled Trial b.d. = twice daily; iii = three capsules; DDD = defined daily dose
HeROPA study is progressing according to plan Phase IIb study with HRO350 in mild-to-moderate psoriasis fully recruited and approaching read-out
- Study currently ongoing in the UK, Germany, Poland, Finland and Norway
- Study endpoints include PASI score and multiple secondary endpoints
- Final patients are currently in process of completing their week 26 visit
- Primary-endpoint readout expected ultimo September/early October 2024

HRO350 is a unique lipid matrix with biologically active phospholipids
API: PEHeRo (Phospholipid Esters from Herring Roe) IRIS Substance ID: 300000046327 EV Medicinal Product Code: PRD9919073
HRO350 is manufactured according to GMP and is planned marketed as a per oral prescription medicine
Herring roe lipids has a high phospholipid content rich in polyunsaturated fatty acids
Phospholipids esters have metabolites with immunomodulatory properties, and can function as both carriers and active molecules1
Mode-of-action data in psoriasis from cell studies2
Core structure of phospholipid esters from herring roe

Example phospholipid: PC(22:6n3/16:0)

API: Active Pharmaceutical Ingredient; GMP: Good Manufacturing Practice
References: 1) Cook CM, Hallaråker H, Sæbø PC, et al. Bioavailability of long chain omega-3 polyunsaturated fatty acids from phospholipid-rich herring roe oil in men and women with mildly elevated triacylglycerols. Prostaglandins Leukot Essent Fatty Acids. 2016;111:17-24. doi:10.1016/j.plefa.2016.01.007; 2) Forskningsradet (Research Council of Norway), Properties of phospholipids d Herring Roe in Psoriasis, available online

Properties of drug candidate HRO350
HRO350 is a first in class asset with marine phospholipid esters as the active substance (API)
Specialized pro-resolving mediators (SPMs) in psoriasis
- Lipid mediators are elevated in lesional psoriatic skin3,4
- SPMs' effects have been demonstrated in vitro5,6 e.g. Maresin-1 has been shown to suppress IL-17A production in a murine psoriasis model7
Cellular research on SPMs supports the anti-inflammatory mechanism of HRO3508 • HRO350 activates the production of SPMs that promote a shift towards a protective and possibly reparative phenotype of monocyte derived macrophages
- Data supports the anti-inflammatory actions of API PEHeRo specifically, activating SPM pathways reported to be involved in tissue regeneration9
References: 1) Chiang N and Serhan CN. Specialized Pro-Resolving Mediator Network: An Update on Production and Actions. Essays Biochem. 2020;64(3):443-462; 2) Basil MC, Levy BD. Specialized pro-resolving mediators: endogenous regulators of infection and inflammation. Nat Rev Immunol. 2016;16(1):51-67; 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; 4) Coras R, Kavanaugh A, Kluzniak A, et al. Differences in oxylipin profile in psoriasis vs psoriatic arthritis. 2021;23:200; 5) Xu J, Duan X, Hu F, et al. Resolvin D1 attenuates imiquimod-induced mice psoriasiform dermatitis through MAPKs and NF-κB pathways. J. Dermatol. Sci. 2018;89:127-135; 6) Sato M, Aoki-Saito H, Fukuda H, et al. Resolvin E3 attenuates allergic airway inflammation via the interleukin-23–interleukin-17A pathway FASEB J. 2019 33(11):12750-12759. 7) Saito-Sasaki N, Sawada Y, Mashima E, et al. Maresin-1 suppresses imiquimod-induced skin inflammation by regulating IL-23 receptor expression. Sci. Rep. 2018;8:5522; and figure) Ringheim-Bakka T, Mildenberger J, Dalli J, Saliani A, Petrucelli F, Busygina M, Mancinelli D, Gammelsæter R. Phospholipid Esters from Herring Roe promotes SPM biosynthesis in human monocyte-derived macrophages with implications for the treatment of psoriasis. Poster (37) at the 9th European Workshop on Lipid Mediators, June 26-28th, 2024. 9) Serhan C and Chiang N. Resolvins and Cysteinylcontaining Pro-Resolving Mediators Activate Resolution of Infectious Inflammation and Tissue Regeneration Prostaglandins Other Lipid Mediat. 2023 166:106718.
Resolution of inflammation through bioactive SPMs
Metabolic products of phospholipid esters from herring roe are proposed to play a role in inflammatory diseases, including psoriasis

Specialized pro-resolving mediators (SPMs) Endogenous bioactive lipid mediators that have been proven to promote resolution of inflammation1,2
Inflamed primary immune cells treated with HRO350 produced SPMs involved in resolution of inflammation and tissue regeneration in vitro8
Data support a promising treatment modality in inflammatory conditions including psoriasis
Specialized pro-resolving mediators (SPMs) are endogenous molecules that have been proven to promote resolution of inflammation
- Most existing drugs are designed to reduce inflammation by inhibiting pro-inflammatory cytokines
- Immunoresolution strategies seeks to correct lipid mediator and SPM imbalances to allow for self-limitation of inflammation and complete resolution
- Push rather than pull: "push" the inflammation towards resolution rather than "pull" away downstream effects through inhibition of pro-inflammatory cytokines
HRO350 (API: PEHeRo) promotes SPM biosynthesis in immune cells
Immunoresolution: a therapeutic frontier
Fullerton, J., Gilroy, D. Resolution of inflammation: a new therapeutic frontier. Nat Rev Drug Discov 15, 551–567 (2016).https://doi.org/10.1038/nrd.2016.39 Park J, Langmead CJ, Riddy DM. New Advances in Targeting the Resolution of Inflammation: Implications for Specialized Pro-Resolving Mediator GPCR Drug Discovery ACS Pharmacol. Transl. Sci. 2020, 3, 1, 88–106; Serhan CN, Chiang N, Dalli J. The resolution code of acute inflammation: Novel pro-resolving lipid mediators in resolution. Seminars in Immunology. 2015 May;27(3):200-215. DOI: 10.1016/j.smim.2015.03.004. PMID: 25857211; PMCID: PMC4515371. Ringheim-Bakka T, Mildenberger J, Dalli J, Saliani A, Petrucelli F, Busygina M, Mancinelli D, Gammelsæter R. Phospholipid Esters from Herring Roe promotes SPM biosynthesis in human monocyte-derived macrophages with implications for the treatment of psoriasis. Poster (37) at the 9th European Workshop on Lipid Mediators, June 26-28th, 2024.

Most existing treatments for psoriasis work by reducing inflammation, commonly by inhibiting specific signaling substances from immune cells which affect skin cells (i.e., IL17, IL23).
A key symptom of psoriatic skin is over-proliferation of keratinocytes, leading to psoriatic plaques with scaling.
Data will be presented at upcoming scientific conferences; multiple peer-reviewed publications estimated Q3-4
These data will be important in the future Marketing Authorization Application for HRO350
Project information: Forskningsradet (Research Council of Norway), Properties of phospholipids d Herring Roe in Psoriasis, available online 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;


Upcoming data on HRO350 Mechanism-of-Action in psoriasis
"Properties of phospholipids from Herring Roe in Psoriasis" supported by the Research Council of Norway
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



H1-2024 consolidated group financial review
Key financial figures




GROSS MARGIN AVAILABLE LIQUIDITY
Sales revenues down MNOK 2,4 y/y, mainly affected by lower YTD sales than expected in some regions
• But; more than 100 % of total 2023-reveneus already secured via sales and received purchase orders
• Continued positive development in B2C-segment in line with expectations, with a y/y revenue growth above 20 %
• Expected strong development in sales to the Chinese market in
-
- H2-2024
Stable gross margin development
• H1-2024 gross margin 1,6 percentage points above 2023 gross
Arctic Algae AS fully incorporated in the consolidated figures from
| TNOK | H1-2024 | H1-2023 | Income statement | |
|---|---|---|---|---|
| Sales revenue Other income |
16 746 458 |
19 081 - |
Sales revenues down MNOK 2,4 y/y, mainly affected by lower YTD sales than expected in some regions |
|
| Cost of goods sold | 11 616 | 13 350 | But; more than 100 % of total 2023-reveneus already secured via • |
|
| Gross profit | 5 130 | 5 730 | sales and received purchase orders | |
| Gross margin % | 30,6 % | 30,0 % | ||
| Employee benefits expenses | 12 944 | 11 011 | Continued positive development in B2C-segment in line with • expectations, with a y/y revenue growth above 20 % |
|
| Depreciation and amortisation expenses | 2 578 | 2 552 | • Expected strong development in sales to the Chinese market in |
|
| Other expenses | 14 251 | 14 752 | H2-2024 | |
| Operating profit (loss) | -24 184 | -22 585 | Stable gross margin development | |
| Finance income | 1 955 | 2 373 | • H1-2024 gross margin 1,6 percentage points above 2023 gross margin in total |
|
| Finance expenses | 1 287 | 452 | ||
| Net financial items | 668 | 1 921 | Operating costs in line with total budget for period | |
| Net profit (loss) for the period | -23 516 | -20 664 | ||
| EBITDA | -21 606 | -20 033 | Arctic Algae AS fully incorporated in the consolidated figures from Q2-2023 |
|
| Adj. EBITDA | -20 922 | -18 293 |
Breakdown of Nutra revenue
REVENUE BY BUSINESS LINE REVENUE BY REGION
B2C B2B


| TNOK | H1-2024 | H1-2023 | |||
|---|---|---|---|---|---|
| Cash flow statement | |||||
| Profit/loss before tax | -23 516 | -20 664 | |||
| Ordinary depreciation | 2 578 | 2 552 | Available liquidity end of period of MNOK 49,8 | ||
| Change in inventory | 2 168 | 89 | |||
| Change in accounts receivable | -1 802 | -3 104 | |||
| Change in accounts payable | 890 | -4 298 | Cash flow from operations MNOK -25,6 mainly driven by negative | ||
| Change in other accrual items | -5 919 | -2 294 | operating result | ||
| Net cash flow from operating activities | -25 602 | -27 719 | |||
| Investments in tangible and intangible assets | -33 940 | -23 611 | Cash flow from investments MNOK -33,9, mainly all related to the HRO350 phase IIb study |
||
| Net cash flow from investment activities | -33 940 | -23 611 | |||
| Net new long-term liabilities | -282 | 4 193 | |||
| Proceeds from equity | 53 | 16 792 | Cash flow from financing activities MNOK -0,2, where this relates | ||
| Net cash flow from financing activities | -229 | 20 985 | mainly to payment of financial leasing liabilities | ||
| Net change in cash | -59 771 | -30 345 | |||
| Cash at the start of the period (1.1) | 79 602 | 144 152 | |||
| Cash at the end of the period (30.6) | 19 831 | 113 807 | |||
| By end of H1-2024 Arctic Bioscience has an unused credit facility of | |||||
| Unused credit facility | 30 000 | 0 | MNOK 30 | ||
| Available liquidity at the end of the period (30.6) | 49 831 | 113 807 |
Strong financial position at end of period
Total assets MNOK 273,2
• Fixed assets of MNOK 198,4 mainly comprised of intangible assets related to pharma development
• Current assets of MNOK 74,8 mainly comprised of MNOK 30,6 in inventory and MNOK 19,8 in cash
• Additional MNOK 30 in available liquidity due to unused credit facility as of end H1-2024
Total equity MNOK 235,1, corresponding to an equity ratio
of 86%
Long term liabilities relates to financial leasing agreements
Financial position
-
| TNOK | 30.06.2024 | 31.12.2023 | |
|---|---|---|---|
| ASSETS | |||
| Non-current assets: | |||
| Intangible assets | 172 847 | 140 659 | |
| Property, plant and equipment | 25 612 | 26 438 | |
| Total non-current assets | 198 459 | 167 097 | |
| Current assets: | |||
| Inventories | 30 626 | 32 794 | |
| Accounts receivable | 11 373 | 9 571 | |
| Other current assets | 12 921 | 11 188 | |
| Cash | 19 831 | 79 602 | |
| Total current assets | 74 751 | 133 155 | |
| TOTAL ASSETS | 273 210 | 300 252 | |
| EQUITY & LIABILITIES | |||
| Equity: | |||
| Share capital | 2 537 | 2 537 | |
| Share premium reserve | 232 557 | 256 020 | |
| Total equity | 235 094 | 258 557 | |
| Liabilities | |||
| Liabilities to financial institutions | 1 766 | 2 049 | |
| Total liabilities | 1 766 | 2 049 | |
| Current liabilities | |||
| Accounts payable | 19 266 | 18 376 | |
| Public duty payables | 2 840 | 2 253 | |
| Other current liabilities | 14 244 | 19 017 | |
| Total current liabilities | 36 350 | 39 646 | |
| TOTAL EQUITY & LIABILITIES | 273 210 | 300 252 |


Business outlook
Outlook H2-2024
Focus on finalizing and securing the HeROPA study for HRO350
6-months primary endpoint read-out expected ultimo September/early October 2024
HeROPA study main strategic focus
Various financing alternatives will be considered to secure funding post 6 months data read-out
Process of pursuing commercial partnership for HRO350 will continue
Liquidity situation closely monitored
Positive sales prospects and received order intake for H2-2024 indicates a y/y revenue growth for 2024 in the range of 20 – 30 %
Continuing y/y revenue growth
24




Contact
CEO - Christer L. Valderhaug: [email protected]
CFO - Jone R. Slinning [email protected]
Medical Director - Runhild Gammelsæter: [email protected]
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