Earnings Release • Nov 14, 2023
Earnings Release
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November 2023
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
… and Aker BioMarine is the world leading krill harvest
%: max share of precautionary catch limit per area
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.
… 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
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
▪ Brain and eye health ingredient derived from krill
▪ Utilizing the potential of phospholipids from krill oil
▪ Combining PL's with other ingredients to boost and enhance
uptake
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
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November 2023
• 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
Mechanism of action
• CaPre utilizes a unique phospholipid form of omega-3 fatty acids to reduce triglyceride (TG) levels
• 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
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:
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
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
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
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
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)
▪ An unusual reduction in triglyceride levels in the placebo group meant that statistical significance was not achieved
▪ Results from pooled data sets from both phase 3 studies shows significant difference between CaPre and Placebo
* Acasti study using population with TG levels over 500 mg/dL **AKBM study using population with TG levels between 150-500 mg/dL
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)
Source: Expert interviews; PubMed
| 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
| 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 |
| 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) |
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
Incl. both retail and non-retail sales/volume
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
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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