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Arctic Bioscience — Investor Presentation 2021
Dec 16, 2021
3536_rns_2021-12-16_71daf7d1-071d-430f-b087-c14097e2d2ad.pdf
Investor Presentation
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Arctic Bioscience AS
Company Presentation 16 December 2021
Ole Arne Eiksund (CEO) Danielle Glenn (CFO) Runhild Gammelsæter (Global Medical Director)
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Developing pharmaceutical and nutraceutical products based on the unique properties of herring roe, utilizing proprietary technology and methodology
Arctic Bioscience
Who we are and what we do
Drug candidate for mild to moderate psoriasis with demonstrated promising
Orphan drug candidate in pipeline for brain development in extremely premature
TECHNOLOGY / R&D Proprietary technology platform and specialized know-how of bioactive marine compound
Two unique businesses based on unique properties of herring roe Utilizing proprietary technology, methodology and IP
Pharma Significant potential in drug candidate for mild-to-moderate psoriasis
PASI: Psoriasis Area and Severity Index (0-72 point scale where >10 is moderate-to-severe and severe disease) Source: HRO350 Commercial Opportunity Assessment in Psoriasis, IQVIA report Notes: 1) Severity split based on figures from the UK, Germany, France, Italy and Spain
Mean change in PASI score at week 26 estimated to -2.4 with a 95% confidence interval <-4.3, - 0.5>, p = 0.0157 (n=31 with PASI>5.5). Week 26 – 60 was an open label extension with no placebo-control (n=28 with PASI>5.5)
Randomized, placebo-controlled clinical trial
- Primary end-point: Change in PASI at week 26
- Overall reduction of 38%
- Greatest reduction in subjects with moderate psoriasis (>5.5 - <10)
- nor placebo
Well tolerated, no serious events related to active treatment
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). 1) Data on file (PASI>5.5 week 26-15 months)
Pharma
Pilot study shows significant improvement in PASI (HRO vs placebo)
| All patients had PSGA scores ≥2 and ≤4 at inclusion 40% of patients achieved clear-or-almost clear skin after 65 weeks After 65 weeks no patient had a PSGA score higher than 3 In total, 46.6% of patients had a reduction in their PSGA score |
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Reference: 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. Vol. 7, No. 1, 2021, pp. 13-20. doi: 10.11648/j.ijcems.20210701.13.
Pharma Efficacy is sustained and increases over time Supported by secondary variable (PSGA) at week 65 (n=58)
Large-scale Phase IIb study to drive pharma forward
To investigate efficacy, safety and dose of drug candidate HRO350 versus placebo
Large randomized Phase IIb study to start mid 2022 and conclude
- end 2023
- Fully funded
- Smerud Medical Research as CRO
- On track with site feasibility ongoing
Given successful Phase IIb study, phase III study to be initiated in 2024
Milestones overview for Phase IIb clinical trial
High unmet medical need
- ~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
Collaboration with Smerud Medical Research
- Smerud to cover cost of clinical program
- Arctic Bioscience to cover cost of formulation development and clinical material
- Orphan designation to be sought
- Run in parallel with HRO350 clinical program for psoriasis
- Fully funded
Pharma
New drug candidate for normal brain development in extremely premature infants
Overview
- Cash generating business
- Revenue through 30 Sep 16.8m, up 24% y/y
- International go-to-market strategy
- Channels: B2C, B2B and distribution partners
- Launching Romega Brain
China
- Product portfolio expanded and deployed into multiple e-commerce channels
- 62% q/q growth rate in Q4
- Nutritional supplement study initiated: "Effects of phospholipid DHA (herring caviar oil) supplementation on maternal and fetal DHA status in Gestational Diabetes Mellitus (GDM): A clinical study" (Kotler sponsored study)
Nutra Romega – Premium Omega-3 products
e-commerce platform exposure
Product
ROMEGA Prenatal
ROMEGA Eye Health
ROMEGA Brain Health
GMP manufacturing facility, enabling retainment of proprietary product knowhow, IP and value chain control
Technology / R&D underpins both pharma and nutra Competitive advantage in proprietary technology platform
- Planned capacity of 150 metric tons at a total cost of ~200 million, funded 65% with debt and grants
- Support development and manufacturing of nutra and pharma products
- Design phase completed; construction started November 2021
- Expected completion in H2 2023
- Protect IP and safeguard ongoing and future drug development programs
- Substantially increased margins
Building state-of-the-art manufacturing facility For both pharma and nutra businesses
Strong management team with broad experience within the pharmaceutical and nutraceutical industries
Management team with top expertise and experience
Runhild Gammelsæter, PhD
Global Medical Director
+15 years experience Former positions include medical leadership roles in GSK, Abbvie and Abbott, as well as experience from start-up biotech
Lauren Jensen, MBA SVP Sales and Marketing +15 years experience Former positions within global marketing, branding and communications for mid-
size and large enterprises
Daniele Mancinelli, MSc CTO
+20 years experience R&D specialist in omega - 3 fatty acids and responsible for concept testing, verification and up-scaling
Yuming Feng, PhD EVP Global Business Dev
+30 years experience Former positions include Procurement Manager at Campbell's, EVP at Zoneco and CEO at Holley Int.
Ole Arne Eiksund, MSc, MBA
CEO
+30 years experience Former positions include Commercial Director in GSK and VP Global Sales in Hofseth Biocare and EVP Rimfrost.
Hogne Hallaråker, MSc CSO
+15 years experience Founder of Arctic Bioscience and more than 15 years of experience from nutra industries
Per Christian Sæbø, MSc COO
+20 years experience
Former positions include Lipid Development Director in Natural ASA and Site Manager at EPAX, Hovdebygda
Danielle Glenn, BA CFO
+20 years experience
Harvard educated, former hedge fund manager at Goldman Sachs and Caxton, CEO, CFO and CSO of companies in US, UK & Norway
Advisors with long experience in pharmaceutical development
Åge Nærdal Cand. Pharm. Former positions include CEO GlaxoSmithKline AS, 30 years experience from pharmaceutical industry. Advises on pharmaceutical business development
Kari Grønås, Cand. Pharm. Broad experience from the pharmaceutical/biotech industry and securing regulatory approvals. Advises on regulatory processes and CMC development of GMP product
Knut Smerud, MSc, biochemistry. Owner of the CRO Smerud Medical Research. Advises on clinical development program, clinical trial design and regulatory processes
Kåre Steinar Tveit, MD. Dermatologist at the Haukeland University Hospital, Norway. Advises on clinical treatment of psoriasis
Solid ESG footprint
Creates health-promoting products for pharmaceutical and nutraceutical applications. Developing treatments improving quality of life for this patient groups significantly.
Gender balance among employees and management. Women in leading positions and 45% of employees are female.
Contributing to local industry and infrastructure. Dedicated R&D department developing novel products
Utilizing a residual raw material. The by-product is repurposed for the production of our products. Sustainable value chain with finalization of new production facility.
Optimizing location of production facilities minimizing transportation of raw material.
Conserving and using sustainably harvested marine resources.
2021 highlights and strategy going forward
- NOK 300 million IPO
- Phase IIb for HRO350 for mild-to-moderate psoriasis feasibility on track
- Potential new drug candidate for extremely premature infants
- China growth foundation laid for nutra business
- Launch of Romega Brain product for B2C
- Maria Holstad and Hu Cao added to Board
- Initiated construction of new manufacturing facility
- NOK 16.8 million revenue through 30 Sep
- NOK -18.6 million adjusted EBITDA through 30 Sep
- NOK 246.5 million available cash at 30 Sep
2021 Highlights
Key financials through Q3 2021 and year-end estimates
- Complete site feasibility in Q4 2021 as planned
- First patient into study mid 2022
- Deliver clinical study material intermediate to CMO for production of the HRO350 capsules that will be used in clinical phase IIb study
-
Initiate research collaboration to develop new drug candidate for extremely premature infants
-
Accelerate Romega Brain product sales, simultaneously in Norway and in China (by Kotler Marketing Group)
- Enter new geographies including Brazil, Australia and Singapore.
- Launch B2C in USA
- Expand B2B salesforce beyond Europe and USA
- Continue regulatory processes for novel food approval in USA and China
Outlook and milestones
Summary
On track in all business areas
Significant potential in unmet medical need for new treatment options in mild-to-moderate psoriasis
Cash generating and growing nutraceutical business
Proprietary technology platform with control over value chain underpins both businesses
Robust ESG footprint
Strong management team with broad experience within the pharmaceutical and nutraceutical industries
Providing people with unique nutraceutical and pharmaceutical products based on herring roe
Contact
CEO Ole Arne Eiksund: [email protected] CFO and Investor Relations Danielle Glenn: [email protected]