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Arctic Bioscience — Investor Presentation 2022
Sep 21, 2022
3536_rns_2022-09-21_dc9232d1-11a1-4603-806e-9460a9b9a076.pdf
Investor Presentation
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Arctic Bioscience
Company Presentation
Capital Markets Update, Oslo 21 September 2022
Christer L. Valderhaug (CEO)
Developing and commercializing pharmaceutical and nutraceutical products based on unique bioactive marine compounds, utilizing proprietary technology and methodology
Agenda
- Introduction and company presentation Christer Valderhaug, CEO Arctic Bioscience
- Psoriasis symptom relief through Herring Caviar Oil Dr. Kåre Steinar Tveit, Chief Physician Haukeland University Hospital
- Arctic Bioscience Pharmaceutical Development Program Runhild Gammelsæter, Medical Director Arctic Bioscience
- Brain development in extremely premature infants Knut Smerud, Founder & CEO Smerud Medical Research
- DHA, Alfa & Omega for The Brain Ole Petter Hjelle, MD PhD
- Closing remarks & Q&A CEO Christer Valderhaug, Medical Director Runhild Gammelsæter, CFO Jone Slinning
- Lunch and social
TECHNOLOGY / R&D
Proprietary technology platform and specialized know-how of bioactive marine compound
Two unique businesses built upon a proprietary technology and IP platform
NUTRA Premium Omega-3 products with benefits for brain, heart, eye health, prenatal and sports nutrition in global markets
PHARMA
Drug candidate for mild to moderate psoriasis with demonstrated promising effect in pilot clinical trial
Orphan drug candidate in pipeline for brain development in extremely premature children
Founding story: Arctic Bioscience
| 2020 Scientific Advice from the EMA |
2021 | 2022 |
|---|---|---|
| Dr. Mercola sales in USA pass 3m in single order 2020 |
IPO Euronext Growth, Oslo |
HRO350 Phase IIb Scaling Nutra globally |
2019-2022: Developing the organization to prepare for future growth
2017-2022: Building the foundation framework for a robust clinical program
- Cash generating business with revenue traction and strong growth
- Vast global omega-3 market set for further growth
- International customers in Europe, Americas and APAC
- B2C and B2B channels as well as distribution partners
-
Multiple products ranging from bulk oil to finished goods
-
China an ideal target market for Romega (USD 2 billion and growing)
- Strong relationship with Kotler for efficient market entry and sales growth
- Foundation for long-term export success story set strategic partnership model to be replicated
Nutra highlights
Successful launch in China through Kotler partnership
Premium Omega-3 products extracted, produced and distributed via B2B, B2C and partner channels
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
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
Arctic Bioscience
21 September 2022
Runhild Gammelsæter (Medical Director)
Pharmaceutical Development
Brief update
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)
IMP: Investigational Medicinal Product
GMP medicinal products from natural raw materials
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
| Split of disease severity in 5 largest countries in EU51 | |||
|---|---|---|---|
| Mild | Moderate | Severe | |
| This usually means isolated patches on limbs and scalp. |
The disease will usually be spread to the arms and legs. It may also affect the patient's quality of life. |
The disease will usually be spread to the arms, legs, torso and scalp. It is likely affecting the patient's quality of life. |
" " |
| 4E | " | ||
| 66% of patients1 |
25% of patients1 |
11% of patients1 |
|
| PASI < 3/5 | 3/5* < PASI < 10 | PASI > 10 |
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
Oral (soft capsules)
Efficacy in mild to moderate disease demonstrated in pilot clinical trial
- First-in-class active product ingredient
- Mild-to-moderate disease
- Few treatment options for non-severe disease
Improvement in quality of life demonstrated in pilot clinical trial
50% of competitive products require monitoring – unlikely needed for HRO350
Well tolerated in pilot clinical trial
Unmet medical need for patients with non-severe psoriasis
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
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
To investigate efficacy, safety and dose of drug candidate HRO350 versus placebo
Large randomized Phase IIb study: 519 patients
Fully funded
Smerud Medical Research as CRO
Given successful Phase IIb study, phase III study to be initiated
Large phase IIb study to drive pharma forward
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
Pharma Pipeline
~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
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.
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This Presentation is not a prospectus and does not contain the same level of information as a prospectus.
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Contact
CEO - Christer L. Valderhaug: [email protected]
CFO - Jone R. Slinning [email protected]
Medical Director – Runhild Gammelsæter: [email protected]