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Aker BioMarine

Earnings Release Nov 14, 2023

3527_rns_2023-11-14_49631cce-b1e8-4ede-ba53-ba2c20bdb96b.pdf

Earnings Release

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AKER BIOMARINE JEFFERIES HEALTHCARE CONFERENCE

November 2023

We control the entire krill value chain from harvesting and production all the way to the consumer

of total global krill catch

55,000T Annual expected krill meal production

~200

published studies

>13m

individual units sold to US consumers the last year

The Antarctica krill fishery is among the most sustainable in the world…

… and Aker BioMarine is the world leading krill harvest

%: max share of precautionary catch limit per area

Improving financial performance

Adj. EBITDA USD million

  • Solid revenue growth last twelve months
  • LTM EBITDA margin of 22%
  • Business model with high operating levearge, but margin hampered by:
  • Low production of Suberba in Houston to reduce inventory level
  • Elevated fuel price in Montevideo

Ambition of long-term annual average sales growth of around 15% p.a.

1) Aker BioMarine evaluates the performance based on Adjusted EBITDA. This metric is defined as operating profit before depreciation, amortization, write-downs and impairments, and special operating items. Special operating items include gains or losses on sale of assets, if material, restructuring expenses and other material transactions of either non-recurring nature or special in nature compared to ordinary operational income or expenses. See description of the Alternative Performance Measures (APM) in Annual Report.

Aker BioMarine's new operating segments – from Q1 2024 Feed Ingredients Emerging Businesses ▪ Venture phase business areas under development via growth models specific to each area ▪ Kori: Leading US mass market krill oil brand ▪ Understory: Novel protein ingredient ▪ CAPRE: option to pursue pharmaceutical opportunities originated from Acasti Pharma Inc ▪ Delivering ingredients to growing aquaculture market faced with raw material scarcity ▪ Growing demand from tier-1 customers for our premium, scientifically documented krill meal ▪ Leading and dominating position of krill harvesting in the Antarctica Human Health Ingredients ▪ Growing dietary supplements B2B market, benefitting from omega 3 scarcity ▪ Leading manufacturer and supplier of premium krill oil ingredient – clear plan for continued sales growth ▪ IP protection, strong science and secure supply Consumer Health Products ▪ Sustainable long-term tailwinds in US supplements market from consumer's health focus ▪ Steady business with strong cash conversion ▪ Exclusive supplier of innovative consumer products for the largest retail chains in the US ▪ Platform with rapid consumer product launches 150 Revenues 82 Revenues 120 Revenues LTM 3Q '23 estimated revenue split1) 14 Revenues 2) Focus for this presentation

1) Non audited and subject to change 2) 2022 financial year

Superba krill oil offers differentiated, premium product…

… with high gross margin, in the solid and growing Omega3 category

>67 patents across 40 geographies and strong IP protection

▪ Retailers and brand owners sharing a much larger gross margin per unit

+50 clinical trials enabling claims across multiple need states

Global sales team supported by strong science

  • In-house global sales and marketing of krill Local sales force in all key markets
  • (China, India, US, Japan, SEA, Australia, SEA)
  • Regulatory approvals and presence in the US, Europe and Asia
  • R&D documents product benefits and establish claims
  • Independently and in collaboration with universities
  • Regulatory teams opening access to global markets 17 PhDs

Large and growing human omega-3 B2B supplements market

Omega-3 supplements B2B market1 USDm

  • Omega-3 is one of the most clinically researched and scientifically proven supplements
  • 5000+ studies
  • Well known for heart health benefits
  • Government daily intake recommendations
  • Krill oil is positioned as a differentiated, premium product
  • Large opportunity for krill oil to increase market share 20- 30% market share in most successful markets (USD retail)

Estimated krill oil market share2

  • Few competitors, protected by raw material sourcing, IP and proprietary production know-how
  • Superba best in class krill oil
  • Significantly better smell
  • Improved encapsulation
  • Best color and clarity

Industry-leading manufacturing with high operational leverage

2) Direct business unit SG&A costs, not including Corporate costs such as HR, IT, Finance dep., non-dedicated EMT 3) Net Nutra costs = net raw material costs of Nutra meal at USD 3,500/Mt after deducting revenues received for QHP

Estimated Revenue

Estimated cost drivers and illustration of operational leverage1

Expanding through new innovations and new ingredients

Innovation pipeline

Lysoveta

▪ Brain and eye health ingredient derived from krill

▪ Utilizing the potential of phospholipids from krill oil

  • Omega-3 in the form of LPC more targeted delivery to the brain
  • Received regulatory approval for commercial launch in US

▪ Combining PL's with other ingredients to boost and enhance

PL+

Expanding into new product categories

Algae Oil

uptake

  • Houston set up to produce Algae based Omega 3
  • First phase with capacity of up to 100mt in addition to krill capacity
  • First purchase order received in October

Protein / Understory

  • New protein ingredient brand, based on krill rawmaterial
  • Launch plant completed, production of commercial product has started
  • Customer dialogues are ongoing

Krill oil well positioned to target new needs states

Lysoveta: innovative brain and eye health ingredient derived from krill

  • Dietary supplement featuring essential nutrients such as choline and Omega 3 in the form of Lysophosphatidylcholine (LPC)
  • LPC is a molecule with the unique ability to be transported across the blood brain barrier
  • IP-protected production process with dedicated production line in Houston up and running
  • Production costs are significantly lower than known peers

LPC transports DHA/EPA into the brain

Broad application potential in large and growing markets

Source: Sugasini, Dhavamani, et al. "Dietary docosahexaenoic acid (DHA) as lysophosphatidylcholine, but not as free acid, enriches brain DHA and improves memory in adult mice." Scientific Reports 7.1 (2017): 11263. Sugasini, Yalagala, Subbaiah:"Efficient enrichment of Retinal DHA with Dietary Lysophosphatidylcholine-DHA: Potential Application for Retinopathies". Nutrients 2020, 12(10), 3114

Important information

This presentation has been prepared by Aker BioMarine ASA (the "Company"). The presentation does not constitute or form part of, and should not be construed as, an offer, solicitation or invitation to subscribe for, underwrite or otherwise acquire, any securities of the Company or any of its subsidiaries nor should it or any part of it for m the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of the Company or any of its subsidiaries, nor shall it or any part of it form the basis of or be relied on in con nection with any contract or commitment whatsoever. No reliance may be or should be placed by any person for any purposes whatsoever on the information contained in this presentation, or on its completeness, accuracy or fairness.

This presentation contains summary information only and does not purport to be comprehensive and is not intended to be (and s hould not be used as) the sole basis of any analysis or other evaluation. No representation, warranty, or undertaking, express or implied, is made by the Company, its affiliates or representatives as to, and no relianc e should be placed on, the fairness, accuracy, completeness or correctness of the information or the opinions contained herein, for any purpose whatsoever. Neither the Company nor any of its affiliates or representatives shall have any responsibility or liability whatsoever (for negligence or otherwise) for any loss whatsoever and howsoever arising from any use of this presentation or its contents or otherwise arising in connection with this presenta tion. All information in this presentation is subject to updating, revision, verification, correction, completion, amendment and may change materially and without notice. In giving this presentation, none of the Company, its affiliates or representatives undertake any obligation to provide the recipient with access to any additional information or to update this presentation or any information or to correct any inaccuracies in any such informati on. The information contained in this presentation should be considered in the context of the circumstances prevailing at the time and has not been, and will not be, updated to reflect material developments which may oc cur after the date of the presentation.

Several factors could cause the actual results, performance or achievements that may be expressed or implied by statements an d information in this Presentation. By reviewing this Presentation, you acknowledge that you will be solely responsible for your own assessment of the market position of the Company and that you will conduct your own analys is and be solely responsible for forming your own view of the potential future performance of the Company's business.

Matters discussed in this document and any materials distributed in connection with this presentation may constitute or inclu de forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as "believes", "expects", "anticipates", "intends", "estimates", "will", "may", "co ntinues", "should" and similar expressions. These forward-looking statements reflect the Company's beliefs, intentions and current expectations concerning, among other things, the Company's results of operations, financial c ondition, liquidity, prospects, growth and strategies. Forward-looking statements include statements regarding: objectives, goals, strategies, outlook and growth prospects; future plans, events or performance and po tential for future growth; liquidity, capital resources and capital expenditures; economic outlook and industry trends; developments of the Company's markets; the impact of regulatory initiatives; and the strength of the Com pany's competitors. Forward-looking statements involve 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, including without limitation, management's examination of historical operating trends, data contained in the Com pany's records and other data available from third parties. Although the Company believe that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Forward-looking statements are not guarantees of future performance and such risks, uncertainties, contingencies and other important factors could cause the actual results of operations, financial condition and liquidity of the Company or the industry to differ materially from those results expressed or implied in this presentation by such forward looking statements. No representation is made that any of these forward-looking statements or forecasts will come to pass or that any forecast result will be achieved and you are cautioned not to place any undue influence on any forward-looking statement.

This presentation and the information contained herein are not an offer of securities for sale in the United States and are n ot for publication or distribution to persons in the United States (within the meaning of Regulation S under the U.S. Securities Act of 1933, as amended (the "Securities Act")). The securities referred to herein have not been an d will not be registered under the Securities Act and may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act. Neither this document nor any copy of it may be taken or transmitted into the United States, Australia, Canada or Japan or to any securities analyst or other person in any of those jurisdictions. Any failure to comply with this restriction may constitute a violation of United States securities laws. Neither this document nor any copy of it may be taken, released, published, transmitted or distributed, directly or indirectly, in or into the United States, Canada, Australia or J apan. Any failure to comply with this restriction may constitute a violation of United States, Canadian, Australian or Japanese Securities laws. This document is also not for publication, release or distribution in any other jurisdiction where to do so would constitute a violation of the relevant laws of such jurisdiction nor should it be taken or transmitted into such jurisdiction and persons into whose possession this document comes should inform themsel ves about and observe any such relevant laws.

No money, securities or other consideration is being solicited, and, if sent in response to this presentation or the information contained herein, will not be accepted.

This Presentation shall be governed by Norwegian law and any dispute arising in respect of this Presentation is subject to th e exclusive jurisdiction of the Norwegian courts with Oslo District Court as legal venue.

Introduction to CaPre A New Therapeutic Candidate

November 2023

CaPre: An innovative approach to managing hypertriglyceridemia

• CaPre® is a uniquely formulated omega-3 (OM3) phospholipid developed to treat Hypertriglyceridemia* (HTG)

• 34 studies & trials conducted on CaPre, with Phase 1 and 2 clinical results indicate "best-in-class" potential

  • High TG is a major risk factor for Cardiovascular Disease
  • OM3s lower TGs by inhibiting triglyceride synthesis in the liver, enhancing breakdown of triglycerides, and modulating gene expression related to lipid metabolism

Mechanism of action

• CaPre utilizes a unique phospholipid form of omega-3 fatty acids to reduce triglyceride (TG) levels

  • Some patients on existing OM3 drugs experience a fishy aftertaste or gastrointestinal discomfort, impacting adherence to the medication. Existing drugs are recommended to "take with a meal"
  • CaPre aims to provide a safer and more tolerable option compared to fish oil derivatives, with no increase in LDL ("bad cholesterol") and fewer gastrointestinal side effects

Competitive

• CaPre has superior fasting bioavailability and can be taken on an empty stomach edge CONFIDENTIAL

and PROPRIETARY to AKBM. This document is not intended to provide recommendatio ns on pricing or

Acasti achieved promising results with CaPre in 32 studies and trials from preclinical to Phase 2

Pre-clinical Phase I Phase II

Objective: To evaluate the safety and efficacy of CaPre in reducing triglyceride (TG) levels in animal models

Design: Multiple studies including ADME, DDI, pharmacology, safety pharmacology, repeat dose toxicity, genotoxicity, carcinogenicity and DART

Key Takeaways:

  • Efficacy: Demonstrated a significant reduction in TG levels
  • Safety: No significant adverse effects noted, indicating a good safety profile

Objective: To assess the safety, tolerability, and bioavailability of CaPre in comparison to Lovaza under fasting and fed conditions

Design: Single-dose, comparative bioavailability study involving 56 healthy volunteers in a randomized, four-way crossover design

Key Takeaways:

  • Safety and Tolerability: CaPre demonstrated a safety profile comparable to Lovaza, a standard treatment for hypertriglyceridemia
  • Bioavailability: Showed better bioavailability than Lovaza, particularly in the fasting state, indicating potential for effective absorption without dietary fat restrictions

Objective: To determine the efficacy of CaPre in lowering TG levels in patients with hypertriglyceridemia and to understand the dose-response relationship

Design: Multiple trials with varying doses to observe the impact on TG levels and overall lipid profiles

Key Takeaways:

  • Efficacy: CaPre was effective in lowering TG levels with a clear dose-response, indicating increased efficacy with higher dosages
  • Lipid Profile: Positive effects also on other lipid parameters, including HDL (good cholesterol) and LDL (bad cholesterol)
  • Patient Demographics: The range of patients included suggested the results could be generalizable to the wider HTG patient population

The Phase 3 TRILOGY trials faced unexpected challenges due to a higher-than-anticipated placebo response

  • 2 double blinded, randomized, placebo-controlled trials
  • TRILOGY 1 enrolled 242 patients across 54 clinical sites
  • TRILOGY 2 enrolled 278 patients across 71 sites
  • Participants were assessed at both 12 and 26 weeks
  • The treatment group received 4g CaPre
  • The Placebo group received 4g corn starch

  • Treatment groups showed a combined reduction in blood TG levels of 26% after 12 weeks and 33.5% after 26 weeks

  • The placebo groups also showed a considerable reduction,15.1% after 12 weeks and 20.8% after 26 weeks
  • None of the trials reached statistical significance
  • No significant differences in treatment-related serious adverse events between the groups
  • No increase in LDL (bad) cholesterol

As a result of not meeting the primary endpoint, Acasti Pharma announced it would not file a New Drug Application (NDA) for CaPre and would not conduct further trials

However, when the results of the two TRILOGY trials are pooled, the treatment effect of CaPre is statistically significant

The pooled results are statistically significant both at 12 and 26 weeks

The treatment had even stronger effect in those who also took medication for HTG

Percentage changes in fasting TG levels between baseline and week 26 (Pooled results from TRILOGY 1 and 2, subgroup patients on statins, N=254)

Status: Successful progress for CaPre until end of Phase 2, but Phase 3 was not conclusive

Reason for failure of Phase 3:

▪ An unusual reduction in triglyceride levels in the placebo group meant that statistical significance was not achieved

Key takeaways from Phase 3:

▪ Results from pooled data sets from both phase 3 studies shows significant difference between CaPre and Placebo

Next step, two main alternatives:

  • A. Repeat phase 3 study with revised study protocol
  • B. New phase 3 study with sub-population (Statins)

Going forward: Alternative A – Repeat Phase 3 study

Acasti result from pooled data sets from Phase 3 studies Placebo-adjusted change from baseline

The two Phase 3 studies failed individually, but results from pooled analysis of the studies shows a significant difference between CaPre and placebo

  • Persistent reduction of TG of 32% following CaPre administration over 26 weeks, significantly different from Placebo
  • Persistent reduction of 10% in non-HDL-C following CaPre administration over 26 weeks, significantly different from Placebo

Insight from previous AKBM studies:

  • Clinical trial with patients with boarder line high TG > 150 mg/dL shows that krill oil is effective in reducing serum triglycerides without increasing serum LDL levels
  • In a study with type-2 diabetic monkeys the overall trend showed that the TG values in the treated group is decreasing and that the difference between the percent changes of placebo and krill groups is increasing with time and dose

* Acasti study using population with TG levels over 500 mg/dL **AKBM study using population with TG levels between 150-500 mg/dL

Going forward: Alternative B – New phase 3 study combined with statins

Favorable results compared to other OM3s in Statin User subgroups in severe HTG

The effect of CaPre is even larger when looking at a subgroup of the patients that are already on statins (in the non-statin population the effect of CaPre and Placebo is almost identical)

  • Synergistic effect between CaPre and statins, or
  • the statin population is a proxy for "true" hypertriglyceridemia patients

CaPre's total treatable population is ~73M in the US alone The primary indication (TG>500 mg/dL) will provide access to ~2M patients

  1. NOTE: M = mn patients

Source: Expert interviews; PubMed

All HTG or dyslipidemia as extended indication(s) would enable CaPre to address unmet medical need in the largest patient pools

Patient pool, M Treatment today Differentiated from
other OM3 products?
Prescribing
HCPs
Commercial
potential
Clinical
feasibility
Overall potential
for CaPre
High LDL or
low HDL
18
55
51
18
55
51
Statins, improved lifestyle CaPre has no LDL effect
and might increase HDL
Cardiologists,
PCPs
Combination
drug is
attractive, but
statins compete
TG stays as end
point, incl. LDL+
HDL at end, no
extra trial needed
Easy target for
primary
indication aiding
approval
Comb. use
with statin
44
29
40
44
29
40
Statin, OM3, fibrate, niacin,
antihypertensive drug if
needed, antiplatelet if
needed, glucose-lowering if
needed, improved lifestyle
Vascepa used in comb.
CaPre TBD
Internists,
cardiologists,
PCPs
Large patient
pool, will
compete w.
Vascepa
PhIII
showed
significant TG
red. in patients
on statins
High potential
to be eligible
for use in statin
patients
Elevated
blood glucose
37
37
91
37
37
91
Insulin, Metformin, Ozempic
or other
glucose-reg. drug,
improved lifestyle
CaPre can lower long-term
blood glucose. No OM3
drug on market for this
indication
Internists,
cardiologists,
PCPs
Other diabetes
drugs will likely
have better
therapeutic
effect
HbA1C reduced
in PhIII,
depends on
2
PTRS
Potential
depends on PTRS
and trial results,
slightly crowded
market
HTG btw.
150-500mg/dL
~70 Statins, OM3, fibrates,
niacin, improved lifestyle
Vascepa used for all HTG
patients with CV risks
Cardiologists,
PCPs
Large patient
pool
If TG-lowering
effect in
severe, then
likely
Could have to
show MACE red.
Easy to show TG
blood level red.
CVD risk fact.
(1 or more)
51
22
137
27
46
16
Statin if needed, antiplatelet
if needed, antihypertensive
drug, glucose –lowering if
needed, improved lifestyle
Vascepa used in CVD
patients. CaPre TBD
Cardiologists,
neurologists,
internists,
PCPs
Increasing
prevalence of
CVD and room for
therapies for CVE
Requires long,
extensive trials
Requires long
randomized,
controlled trial
spanning years
NAFLD 27
46
16
51
22
137
Improved lifestyle (incl.
alcohol cessation), statins if
tolerable risk and need, Vit E
(trial data), OM3 (studies, not
guideline)1
No OM3 products for this
indication on market
Internists, gastro
enterologists
Huge potential
due to few
therapies
available
Has been know
to be difficult
to develop
NAFLD drugs
Cardiologists,
neurologists,
TBD
internists,
PCPs
HTG only HTG and secondary indication Only secondary indication

Source: PubMed search; Expert interviews 1.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5019889/ 2. Probability of technical and regulatory success

CaPre could offer therapeutic benefits over main competitors

Therapeutic
effect
Importance for
severe HTG
Lovaza and Gx Vascepa 1
CaPre
Triglyceride
reduction1
(%)
45-61% 17-39% 13-33%
Change in LDL
("bad cholesterol")
10-50% increase 0-10% decrease 0-5% decrease
Change in HDL
("good cholesterol")
10-15% increase 0-5% decrease 0-5% increase
Effect on blood
glucose
Indications suggesting
risk of increasing blood
glucose level (HbA1c)
Neutral effect Indications suggesting
potential to lower blood
glucose level (HbA1c)
Bioavailability Low bioavailability
under fasting
conditions
TBD: CaPre trial claims
superiority to Vascepa-like
drugs (ethyl esters), while
Vascepa
claims sup. to
drugs with DHA
Superior
bioavailability under
fasting conditions, no
significant food effect
Score Medium High High
1.
Source: Web search and expert interviews
The range between the absolute to Placebo-corrected mean Positive effect Limited
effect
Negative effect

CaPre's has several potential differentiating clinical and commercial factors vs main competitors Lovaza, Vascepa and their Gx

Clinical
Higher bioavailability (no food required as krill-oil
based phospholipid)

No negative effects on LDL

Limited side effects or AE

Higher bioavailability (double Vascepa's, no food
required as krill-oil based phospholipid)

No negative effects on LDL

Limited side effects or AE
Payor/PBM
Equal/better clinical superiority with very limited
other side effects

Reasonable unit value for patients

Equal/better clinical superiority with very limited
other side effects

Solid supply chain to avoid unit value uptick
Commercial
Strong M&S force compared with limited existing
M&S forces from Lovaza (and Gx)

No placebo baseline problem compared with Vascepa
(Vascepa used mineral oil as placebo for 1st
label as well)
  • Superiority of potential measurement /methodology of TG compared with measurement defects of Lovaza
  • No placebo baseline problem compared with Vascepa (Vascepa used mineral oil as placebo for 1st label as well)
  • Superiority of potential measurement /methodology of TG compared with measurement defects of Lovaza
  • Expected CVD risk reduction due to the similar EPA component as Vascepa

Vascepa success with primary indication is mainly driven by a strong commercial team (alliance with Kowa)

Numbers are from PHAST, where ~20-30% discrepancy are noted cf. IQVIA data

Between 2013-2017 (w/o REDUCE-IT trial completion), Vascepa has been increasing it's market share from Lovaza with several commercial actions:

1) Showing superior clinical efficacy towards TG lowering for SHTG pt. , incl. no LDL increase cf., with Lovaza

2) Taking advantage of M&S gaps from GSK (Lovaza) due to LoE (GSK withdrew all M&S forces ~2014)

3) M&S forces from Vascepa heavily mentioning the on-going "REDUCE-IT" trial (2011-2018) to indicate strong potential in CVD risk reduction

4) Partnering with Kowa (statin PharmaCo) on co-promotion for combinational use with Statin

  1. Incl. both retail and non-retail sales/volume

  2. https://investor.amarincorp.com/news-releases/news-release-details/amarins-right-promote-vascepar-label-affirmed-under-first

Source: PHAST database

In a world with increasing OM3 supply challenges, Aker BioMarine can ensure consistency and security of supply across CaPre's value chain

Vertical integration, leading position and strong IP portfolio in the krill space makes AKBM a unique supplier of OM3 for pharmaceutical applications

Summary and next steps

  • CaPre was a very promising drug candidate until it failed Phase 3 due to unexpected placebo-effect
  • Acasti noted a phenomenon called "Pre-Randomization Triglyceride Normalization" in TRILOGY 1, where some patients exhibited a significant reduction in triglyceride levels before the treatment started. This could have skewed the results
  • Consultations with the FDA and experts in the field following the TRILOGY trials have suggested various modifications to the study protocol1 for future trials. These adjustments aim to decrease the likelihood of experiencing another substantial placebo effect
  • Another option is to combine CaPre with statins in the next Phase 3 study
  • Aker BioMarine is the largest player in the krill oil space, vertically integrated with full control over the supply chain and a strong krill oil patent portfolio
  • Aker BioMarine has taken over the CaPre asset from Acasti Pharma and is exploring partnerships to take the asset over the finish line with a new Phase 3 study

1) Potential changes that can be made: Tightening the inclusion criteria to ensure a more homogeneous patient population could reduce variability in response, implementing a longer run-in period before randomization could help stabilize patients' triglyceride levels and lifestyle behaviors, reducing the chance of significant changes due to non-treatment-related factors, ensuring that all clinical sites and investigators follow the protocol strictly and understand the importance of minimizing bias and variability in how the trial is conducted

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