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Arctic Bioscience — Investor Presentation 2022
Aug 25, 2022
3536_rns_2022-08-25_6d01c6a7-00ac-4aeb-b5c6-d0107c1af815.pdf
Investor Presentation
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Arctic Bioscience
Presentation of financial results First half year 2022
25 August 2022
Christer L. Valderhaug (CEO) Jone R. Slinning (CFO) Runhild Gammelsæter (Global Medical Director)
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Developing and commercializing pharmaceutical and nutraceutical products based on unique bioactive marine compounds, utilizing proprietary technology and methodology

Intro and H1-2022 operational highlights
- H1-2022 operational review
- H1-2022 consolidated Group financial review
Business outlook Q&A
Agenda


Intro and H1-2022 operational highlights
Arctic Bioscience in brief

HRO 350 – a novel oral drug candidate for mild-tomoderate psoriasis. Strong scientific rationale and promising clinical effects demonstrated in pilot trial 01 02 03

Significant unmet medical
Cash generating and
in China
Robust ESG footprint Strong management team
growing global nutraceutical
strong partnership established
with broad experience within
the pharmaceutical and
nutraceutical industries
business with an especially
options in mild-to-moderate
need for new treatment
psoriasis. Large market
opportunity: USD 20bn+
market for moderate
psoriasis alone

Proprietary technology platform with control over value chain underpins both businesses 04 05 06

20 % y/y revenue growth
Positive sales prospects for H2-2022, including increased order intake from the Chinese market
Received positive opinion from EMA on Paediatric Investigational Plan
Outlines the Group's intention to investigate HRO350 for children with psoriasis
New and extended strategic partnership agreement with Kotler
Opens access to a larger part of the Chinese market, and includes potential collaboration within Pharma space in China

Financial results in line with expectations
Gross margin 27,6 % / EBITDA MNOK -14,4
H1-2022 highlights
Phase IIb clinical study on HRO350 in mild-to-moderate psoriasis largely on track 1st patient enrolled to clinical trial expected Q4-2022 (6 month inclusion period). 6-months data read out H2-2023


H1-2022 operational review



Operational review Nutra
- Continued growth with existing customers and gaining new customers in key markets
- 24 % y/y growth in B2B sales
- Increasing sales of finished products vs. bulk oil
- Participated in several trade conferences in Europe and USA during H1, which helped increase the pipeline for 2022
- COVID continued to impact ability to meet with customers, but the situation is improving
- The Romega brain product is developing well in the market – high Romega DHA content supports brain health
- B2C subscriber base is stable
- B2C-team strengthened with a new SVP for Sales & Marketing

Nutra performance on schedule for 2022
B2B B2C
- Academic seminars
- Professional salons
- KOL marketing
- Trade shows
- ROMEGA Prenatal, Eye Health and Brain Health deployed via e-commerce platforms, five supporting channels and three business partners
- Kotler has increased its headcount for the Arctic Bioscience partnership to more than 50, indicating substantial resources are invested in the long-term growth strategy

| Deployed products into various e-commerce platforms | ||||||||
|---|---|---|---|---|---|---|---|---|
| Product portfolio development and market positioning | 8 6 6 7 9 | - mhe care 北京美和眼科 | ||||||
| ROMEGA Prenatal Nutrient for healthy brain development | > | > | > | V | V | |||
| ROMES S.A. 10 |
ROMEGA Eye health Nutrient for eye Health | > | V | > | V | |||
| ROMEGA Brain Health Nutrient for brain Health | V | V | > |
Positive Nutra progress in China through the Kotler partnership
• 7 nutraceutical observational studies in prenatal, brain and eye health with data gathered here also expected to contribute to long-term growth in ROMEGA sales
• Most important study will recruit 200 pregnant women to observe the benefit of ROMEGA prenatal for pregnant women as well as the brain development of baby and is sponsored by Guangdong Women and Children's Hospital
E-COMMERCE CHANNELS OFFLINE MARKETING CHANNELS

• Due to global uncertainties, increased prices on materials and equipment, combined with extended delivery times, the Board of Directors of Arctic Bioscience in April decided to postpone the investment decision for the construction of a full-scale manufacturing facility
GMP manufacturing facility
- The Group has evaluated alternative solutions to secure capacity to manufacture materials for the planned phase III clinical trial. A final decision on next steps is expected during the second half of 2022
- Financial implication is that overall, 2022 capex for Arctic Bioscience will be significantly lower than anticipated


Operational review Pharma
Properties of investigational medicinal product HRO350
Proprietary extract of phospholipid esters from herring roe
HRO350 is a complex mixture of biologically important phospholipids
Herring roe is unusually rich in specific phospholipid esters, which are extracted and encapsulated for per-oral delivery
Composition of several lipid classes and their metabolites with immunoresolving properties
GMP production, oral soft capsules
Conducting cellular studies with Norwegian R&D institutions to further investigate mode-of-action in psoriasis
Core structure of phospholipid esters from herring roe

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

CONFIDENTIAL
21 million mild-to-moderate psoriasis patients in EU and US alone
Source: HRO350 Commercial Opportunity Assessment in Psoriasis, IQVIA report Notes: 1) Severity split based on figures from the UK, Germany, France, Italy and Spain
Developing HRO350 - a novel oral drug for mild-to-moderate psoriasis with significant market potential
There is a large proportion of patients who cannot be put on biologics and it is lot trickier and not so straight forward to put them on existing treatments. They need effective new topicals or orals."
– Clinical lecturer, Dermatology, UK
"We need cheaper options for moderate patients. We have majority of patients with PASI 5-10 but we do not want to give biologics to all and phototherapy is not feasible for everyone"
- Senior Physician, Department of Dermatology, Germany

Primary endpoint met in pilot clinical trial Improvement in Quality of Life

PASI: Psoriasis Area and Severity Index (0–72-point scale where < 10 is mild-moderate disease)
Primary endpoint: change in PASI vs placebo at week 26 Open Label Extension to week 65 showed effect is sustained and increases further over time
DLQI 6-10: Moderate effect on patient´s life
References: Tveit KS, Brokstad KA, Berge RK, Sæbø PC, Hallaråker H, Brekke S, Meland N, Bjørndal B. A Randomized, Double-blind, Placebo-controlled Clinical Study to Investigate the efficacy of Herring Roe Oil for treatment of Psoriasis. Acta Derm Venereol. 2020 May 28;100(10):adv00154. doi: 10.2340/00015555-3507. PMID: 32378724; Tveit KS et al. Long Term Efficacy and Safety of Herring Roe Oil in the Treatment of Psoriasis, a 39-week Open-label Extension Study. International Journal of Clinical and Experimental Medical Sciences. (Accepted, in press). Data on file (PASI>5.5 week 26-15 months). Pictures courtey of Dr. Tveit.
Milestone overview HRO350 drug development
HRO350 is an investigational medicinal product
| 2021 | 2022 | 2023 | 2024 | |
|---|---|---|---|---|
| GMP study drug production | Development of formulation for children | |||
| Phase IIb clinical trial | ||||
| Site feasibility | IMPD and CTA | Enrollment | Data read-outs | Publications |
| Pharmacokinetic study | ||||
| Phase III clinical program | ||||
MAA: Marketing Authorization Application; IMPD: Investigational Medicinal Product Dossier; CTA: Clinical Trial Application; GMP: Good Manufacturing Practice

Plan as presented at listing and tasks on track, certain tasks took longer than expected
Key pharma focus: Keeping on track with phase IIb clinical trial
First half 2022
- Production of HRO350 Investigational Medicinal Product for the clinical trial
- Compiling documentation and writing Investigational Medicinal Product Dossier
- Preparing submission of Clinical Trial Application
- Preparing international GMP shipments to sites
- Agreed with EMA on Paediatric Investigation Plan for HRO350



Pharma Pipeline
Paediatric Investigation Plan (PIP) for HRO350 agreed with EMA
*The Paediatric Committee of the EMA provides opinions on the quality, safety and efficacy of a medicine for use in the paediatric population Reference: 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.

Component of the regulatory drug development journey for HRO350
Prerequisite for filing for marketing authorization (MA) for new medicines in Europe
Requirement before starting the phase IIb study in adults
High unmet medical need PIP agreed with the Paedatric Committee* of the EMA Q1 2022
1% of children under age 18 suffer from psoriasis
Limited treatment options
A future paediatric indication could increase patient population who could have benefit of HRO350

~15 million premature births annually worldwide1
~5% are extremely premature (< 28 weeks)2
Babies born this early do not have fully developed brains, and therefore a high risk of disability and complications
Novel drug candidate for brain development in extremely premature infants
Smerud cover cost of clinical program
Arctic Bioscience to cover cost of formulation development
Orphan designation to be sought
In parallel with HRO350 clinical program for psoriasis

High unmet medical need Collaboration with Smerud Medical Research International
Platform technology with potential beyond psoriasis
Properties of HRO350 may have relevance in inflammatory diseases


Phospholipid esters and metabolites Potential relevance in diseases associated with inflammatory pathologies
HRO350 contains active substances with the potential to affect inflammatory processes









H1-2022 consolidated group financial review
Key financial figures



Revenue up 20% y/y to 14,4 MNOK, with also positive sales prospects for H2-2022, including increased order intake from Chinese market
• Stable revenue development in B2C-segment in line with
• B2B revenue ex. China up 7,3 %
- expectations
- share going forward
• Revenue from the Chinese market has had a very positive development, and is expected to have an increasing relative
Increased gross margin of 27,6 % vs. 26,0 % first six months
• Experienced cost increases from our suppliers, especially related to sub-production costs and freight
Operating loss of -16.2 MNOK in line with expectations
- -
• Listing costs related to IPO included in H1-2021 figures
• Total OPEX in H1-2022 below budget, increased cost focus implemented during first half of 2022
TNOK H1-2022 H1-2021 Income statement
| Total revenues | 14 402 | 11 968 |
|---|---|---|
| Cost of goods sold | 10 431 | 8 862 |
| Gross profit | 3 971 | 3 106 |
| Gross margin % | 27,6 % | 26,0 % |
| Employee benefits expenses | 7 472 | 9 653 |
| Depreciation and amortisation expenses | 1 802 | 826 |
| Other expenses | 10 915 | 13 392 |
| Operating profit (loss) | -16 218 | -20 765 |
| Finance income | 1 593 | 1 |
| Finance expenses | 320 | 464 |
| Net financial items | 1 273 | -463 |
| Net profit (loss) for the period | -14 945 | -21 228 |
Breakdown of Nutra revenue
REVENUE BY BUSINESS LINE REVENUE BY REGION

Strong cash position at end of period of 177,8 MNOK
Cash flow from operations -18,9 MNOK mainly driven by negative operating result and increases in current assets
Cash flow from investments -31,4 MNOK
- 24,5 MNOK for HRO350 phase IIb study
- 5,9 MNOK for GMP new factory facility (prelim. project)
Limited changes due to financing activities
• Share capital and share premium increased with a total of 0,75 MNOK due to exercise of share options first half of
2022
Cash flow statement
| TNOK | H1-2022 | H1-2021 |
|---|---|---|
| Profit/loss before tax | -14 945 | -21 228 |
| Ordinary depreciation | 1 802 | 826 |
| Change in inventory | -4 274 | -3 637 |
| Change in AR | -2 827 | 3 938 |
| Change in AP | -349 | -5 378 |
| Change in other accrual items | 1 649 | -2 649 |
| Net cash flow from operating activities | -18 944 | -28 129 |
| Investments in tangible and intangible assets | -31 400 | -22 589 |
| Net cash flow from investment activities | -31 400 | -22 589 |
| Repayment of long-term liabilities | 0 | -541 |
| Net change in bank overdraft | 0 | -4 618 |
| Proceeds from equity | 750 | 302 012 |
| Net cash flow from financing activities | 750 | 296 853 |
| Net change in cash | -49 594 | 246 135 |
| Cash at the start of the period (1.1) | 227 362 | 12 600 |
| Cash at the end of the period (30.6) | 177 768 | 258 735 |

-
Solid financial position at end of period
Total assets 327,9 MNOK
• Fixed assets of 104,1 MNOK mainly comprised of intangible assets related to pharma R&D
• Current assets of 233,8 MNOK mainly comprised of 177,8 MNOK in cash and 32,8 MNOK in inventory
Total equity 306,4 MNOK, corresponding to a equity ratio
of 93,4 %
The Group has no long-term debt, and the level of total liabilities, 21,6 MNOK, has been stable during the first half of 2022
Financial position
| TNOK | 30.06.2022 | 31.12.2021 | |
|---|---|---|---|
| ASSETS | |||
| Non-current assets: | |||
| Intangible assets | 81 697 | 58 548 | |
| Property, plant and equipment | 22 441 | 15 993 | |
| Total non-current assets | 104 138 | 74 541 | |
| Current assets: | |||
| Inventories | 32 800 | 28 526 | |
| Accounts receivable | 10 532 | 7 705 | |
| Other current assets | 2 681 | 3 341 | |
| Cash | 177 768 | 227 362 | |
| Total current assets | 223 781 | 266 934 | |
| TOTAL ASSETS | 327 919 | 341 475 | |
| EQUITY & LIABILITIES | |||
| Equity: Share capital |
2 438 | 2 430 | |
| Share premium reserve | 303 921 | 318 124 | |
| Total equity | 306 359 | 320 554 | |
| Short-term liabilities: | |||
| Liabilities to financial institutions | 0 | 4 | |
| Accounts payable | 8 011 | 8 360 | |
| Public duty payables | 1 619 | 2 422 | |
| Other current liabilities | 11 930 | 10 135 | |
| Total short-term liabilities | 21 560 | 20 921 | |
| TOTAL EQUITY & LIABILITIES | 327 919 | 341 475 |
-


Business outlook
- Submit Clinical Trial Application (CTA) in Q3-2022
- First patients to be enrolled in phase IIb clinical study on HRO350 in Q4-2022 with a 6 month inclusion period
- Continue research collaboration with Smerud on new drug candidate for brain development in extremely premature children
-
Process regarding commercial partner will start and run concurrently with the clinical trial of HRO350
-
Materialize on positive sales prospects and received order intake for H2-2022
- Enter new geographies for B2B, including South America and further access to APAC regions
- Intensify participation at customer/clients events, post Covid
- Continue to benefit from the relationship with Kotler on sales & marketing activities and regulatory approvals in China
- Continue to establish GMP manufacturing of materials for the planned phase III clinical trial according to timeline in previously disclosed plans
- Decision and action to be taken regarding a down-scaled production facility solution
- Continue with product development for Nutra
H2-2022 objectives
PHARMA NUTRA TECHNOLOGY / R&D
H2-2022 financial guidance
Overall budget for phase IIb study in line with earlier guiding. Major value creating milestone expected with the 6 month data read out H2- 2023
HRO350 phase IIb study fully funded
ABS continues to invest in operations. Year-end cash position will be dependent on decisions on alternative investments regarding production facilities, and the progress in the Pharma projects
Cash position year-end will be strong
Positive sales prospects and received order intake for H2-2022 indicates a y/y revenue growth for 2022 in the range of 60 – 70 %
y/y revenue growth higher than earlier guiding
Increased COGS will partly be balanced by cost focus on other opex. New hires will increase personnel expenses compared to H1-2022
FY EBITDA around -35 to -30 MNOK




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