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Arctic Bioscience — Interim / Quarterly Report 2021
May 31, 2021
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Interim / Quarterly Report
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Arctic Bioscience Q1 Company Update
Arctic Bioscience Q1 Company Update
Highlights
· Raised NOK 300 million to fund pharmaceutical development program and new
production facility
· Listed at Euronext Growth on February 24[th]
· Signed 3-year agreement with Smerud Medical Research International for phase
II study of mild to moderate psoriasis drug candidate
· HRO350 pharmaceutical project developing according to plan
· Initiated research collaboration for development of new drug candidate for
extremely premature infants
· Maintain full year revenue growth target of 40%+, mainly driven by H2 sales
"The year this far has been an eventful one for Arctic Bioscience. We continued
our ambitious plan for pharmaceutical development of the investigational
medicinal product HRO350 and announced a new development project for extremely
premature infants. The nutraceutical business has experienced revenue growth vs
2020, with interesting opportunities in the pipeline. In addition, we are well
on our way with the state-of-the-art production facility in Ørsta, which will
support both the pharmaceutical and nutraceutical businesses when finalized.
Combined with financial support from our shareholders, we are in a good position
to develop the company further", says CEO Ole Arne Eiksund in Arctic Bioscience.
Operations
Arctic Bioscience is a biotech company with a clinical phase pharmaceutical
business unit and a commercial nutraceutical business unit. The company is built
upon expertise in bioactive herring roe compounds and proprietary platform
technology.
During the first quarter of 2021, Arctic Bioscience completed a private
placement raising NOK 300 million. The proceeds from the transaction will be
used to invest in the development of the company's novel treatment against mild
-to-moderate psoriasis and to invest in a new state-of-the-art production and
process facility. The proceeds will also be used to strengthen the company's
financial capacity, to investigate new pharmaceutical indications, and conduct
other selected pre-clinical trials.
The company is in the process of developing a pharmaceutical drug candidate
(HRO350) based on herring roe - a novel oral treatment for mild-to-moderate
psoriasis. Psoriasis prevalence rates range from 2% to 6% of the
population in western countries, and approximately 90% of patients suffering
from mild-to-moderate
disease. This corresponds to around 21 million psoriasis patients based in the
USA and the EU-5 alone and an annual revenue opportunity of more than $1
billion. A large, randomized Phase IIb study scheduled to start in 2022. The
company plans to manufacture HRO350 at the company's new facility in Ørsta.
On March 3[rd], Arctic Bioscience signed a 3-year agreement worth NOK 75 million
with Smerud Medical Research International to conduct a phase IIb clinical study
on psoriasis. The purpose of the study is to investigate the efficacy and safety
of HRO350 and to establish the optimal dose. The study will include more than
500 patients and is planned to be conducted in seven countries, including
Norway. Recruitment of patients will start in H1 2022, with a planned 6-month
inclusion time and 6-month data read-out in mid-2023.
Nutraceuticals from Arctic Bioscience are sold worldwide as bulk ingredients to
companies making dietary supplements and as finished goods under the ROMEGAT
brand. Arctic Bioscience's go-to-market strategy for nutraceutical products is
multi-dimensional including: 1) B2C sales of premium branded ROMEGA products on
a subscription basis, 2) B2B sales of finished goods and bulk ingredients
globally and 3) B2B2C strategic partnerships where all sales, marketing and
distribution is outsourced to a partner with specific geographic capabilities.
Through its strategic partnership with Kotler Marketing Group, Arctic Bioscience
has developed a strong relationship for efficient market entry and sales growth
in China.
Financials
(NOK million) Q1 2021
Revenues 5.01
Gross profit 1.97
EBITDA -14.77
Adjustments * 8.47
Adjusted EBITDA -6.30
CAPEX 4.72
Cash holdings 282.41
* Adjustments to operating expenditures are made for costs associated with the
listing on Euronext Growth.
Sales revenues during the first quarter amounted to NOK 5.01 million. This is in
line with expectations and full year forecast, with a significant part of
revenues skewed towards the second half of the year.
Adjusted EBITDA during the quarter amounted to NOK -6.30 million which is again
in line with quarterly and full year expectations.
Total capital expenditures (CAPEX) amounted to NOK 4.72 million during the
period, including the start of clinical material preparation for the HRO350
project and the basic design phase of the factory. CAPEX is expected to increase
in line with plans from Q2 onwards for the Phase IIb development program and the
construction of the factory.
Following the capital raise in February, the company has a solid financial
position with liquidity to fund planned and ongoing projects through 2023. At
the end of Q1, the company's cash and cash equivalents amounted to NOK 282.41
million.
Subsequent events
On May 25th, Arctic Bioscience and Smerud Medical Research International
announced the initiation of a collaboration to develop a new drug candidate for
extremely premature infants based on phospholipid esters from herring roe.
Docosahexaenoic acid (DHA) is important for normal development of brain and
vision in the fetus. Herring roe is a natural source of the omega-3 fatty acid
DHA. Thus, there is a sound scientific rationale for a drug candidate based on
phospholipid esters from this raw material. Based on patented technology, Arctic
Bioscience will develop a new liquid drug formulation with a high content of
phospholipid bound DHA which can be administered through feeding tubes.
Outlook
Arctic Bioscience will continue to pursue commercialization of its
pharmaceutical business as well as revenue growth and profitability within its
nutraceutical business. The company maintains its annual revenue growth target
of 40%+, with the majority of revenue in the second half of the year as
expected.
Based on successful completion of the Phase IIb study, the company currently
expects to run a Phase III clinical trial in collaboration with a commercial
partner between 2024 to 2026, with plans to have results reviewed by the
European Medicines Agency (EMA) and the Food & Drug Administration (FDA) for
marketing authorization application thereafter.
For more information, please contact
Danielle Glenn
CFO Arctic Bioscience
Email: [email protected]
Phone: +47 909 98 201
Ole Arne Eiksund
CEO Arctic Bioscience
Email: [email protected]
Phone: +47 908 43 944
About Arctic Bioscience
Arctic Bioscience is a biotech company developing pharmaceutical and
nutraceutical products based on the unique properties of herring roe oil,
composed of complex bioactive marine compounds, including lipids essential to
maintaining cell membranes. The nutraceutical products contain lipids which
contribute to the normal functioning of brain, heart and vision.
The company is developing a novel drug candidate (HRO350) for mild-to-moderate
psoriasis, a large global patient population where there is substantial need for
effective, convenient and cost-effective new medicines with beneficial safety
profiles. Nutraceuticals from Arctic Bioscience are sold worldwide as bulk
ingredients to other companies making dietary supplements (B2B) and as finished
goods under the ROMEGAT brand (B2C), with significant expansion potential all
channels and regions.
To support its long-term growth strategy, Arctic Bioscience is planning a state
-of-the-art manufacturing facility in Ørsta. Easy access to the raw material and
proprietary production processes will increase control of the value chain,
improve margins and enable large-scale, high-quality manufacturing.
Arctic Bioscience is led by a highly competent team with significant expertise
developing marine oils and extensive experience from some of the world's leading
pharmaceutical, technology and financial services companies.