Welcome to this presentation of the First Half Year Results for Arctic Bioscience. My name is Christer Valderhaug, the CEO. With me today, I have the CFO, Jone R. Slinning, and our Medical Director, Runhild Gammelsæter. Arctic Bioscience is developing and commercializing pharma and nutra products based on unique bioactive marine compounds by utilizing proprietary methodology and technology. In this presentation, we will start with the highlights of the period before we turn to the operational review, financial review, and the business outlook. After the presentation, we will open up for questions from the audience. First, we'll turn our attention to the key drivers in Arctic Bioscience. HRO350 is our novel oral drug candidate for mild-to-moderate psoriasis at the clinical phase IIb stage. The candidate has a strong scientific basis with promising clinical effects demonstrated in the pilot trial.
There is a significant unmet medical need for new treatment options in mild to moderate psoriasis. The market potential is more than $20 billion in a market for moderate psoriasis alone. Our global Nutra business is cash generating and fast-growing with a strong partnership still established in the Chinese market. Both businesses are based on the same unique and proprietary technology platform. The company has a solid ESG footprint utilizing a byproduct from wild herring fisheries on the Norwegian coast. The business is managed by a team with broad experience within the pharma and the Nutra industries. We will look at the highlights from the first half year. The phase IIb clinical study on HRO350 is largely on track, with the first patient expected to be enrolled in Q4 2022, which leads to an expected six months data readout on the second h alf of 2023.
So far in 2022, we have seen a 20% year-on-year revenue growth. Equally interesting is the order book and positive sales prospects for the second half of the year. The overall financial results are in line with expectations, and the cash position is strong. In the period, we also received positive opinion from the European Medicines Agency on our Paediatric Investigation Plan. This outlines the group's intention to investigate HRO350 for children with psoriasis, which increases the potential addressable market for HRO350. On the Nutra side, ABS renewed and extended a strategic partnership agreement with Kotler for the Chinese market. During the first half year, we have seen significant changes and strengthening of the management team, including the CEO and the CFO. Moving on to more details on the Nutra performance.
In the B2B, we've had continued growth with existing customers and gaining new customers in key markets, with a 24% year-on-year growth in sales. Also, an increasing sales of finished products versus bulk oil, improving the value add for the company. We participated in several trade conferences in Europe and U.S. during first half year, which helped increase the pipeline for 2022. COVID continued to impact the ability to meet with customers, but the situation is improving. If we look at the B2C area, the Romega BRAIN product is developing well in the market. High Romega DHA content supports brain health. Our B2C subscriber base is stable but expected to increase during the second half. Moving on to the Chinese market, we see a very positive Nutra progress through the Kotler partnership. Kotler is focusing on three product areas: prenatal, eye health, and brain.
They are also running several observational studies with data gathered here expected to contribute to long-term growth in Romega sales. On the next slide, we will look into the GMP manufacturing facility. Back in April, the board of directors of ABS decided to postpone the investment decision for the construction of a full-scale manufacturing facility. Since then, the group has evaluated alternative solutions to manufacture materials for the planned phase III clinical trial. A final decision on next steps is expected during the second half of 2022. Financial implication is that overall 2022 CapEX for ABS will be significantly lower than anticipated. Moving on to the pharma operational review, I will hand it over to our Medical Director, Runhild Gammelsæter.
Thank you, Christer. I will first remind you about our investigational medicinal product called HRO350, which is extracted from herring roe and contains phospholipid esters and other biologically important lipids. We've developed a method for producing HRO350 in accordance with good manufacturing practice, and we've developed appropriate soft capsules for oral administration for use in our upcoming phase IIb clinical trial. I'd also like to mention that we've received NOK 5 million from The Research Council of Norway to conduct cellular studies to explore mode of action of HRO350 in cellular models. The disease state, we are studying psoriasis. Specifically, we're looking at the patient population with mild to moderate disease. There are approximately 21 million patients that have mild to moderate psoriasis in the U.S. and E.U. alone. These patients have few treatment options today.
This is confirmed by international experts that ask for new well-tolerated and cost-effective medicines for patients with mild to moderate disease. About 90% of psoriasis patients have mild to moderate disease, and the severity of this disease is often indicated by the PASI score, Psoriasis Area and Severity Index. PASI of less than 10 is considered mild or moderate disease. This is the patient population that was studied in our pilot clinical trial, and it is the patient population we'll be studying moving forward. I'll briefly review data on the next slide. We conducted a randomized placebo-controlled pilot clinical trial in patients with mild to moderate psoriasis. The left graph shows the primary endpoint, which was the change in PASI.
Patients treated with HRO, which you'll see in the dark blue line, in the left graph, they had a larger improvement in PASI versus patients treated with placebo in the orange line at week 26. This was statistically significant. The largest effect was observed in patients with a PASI between 5.5 and 10. This study had an open-label extension period lasting until week 65, and here the patients who had received placebo in the first 26 weeks were switched to also receive HRO. These patients achieved similar results as the group who had been treated throughout. Furthermore, we see that the efficacy appears to be sustained and even improved further over time.
The study had a number of secondary endpoints, and in the right side bar graph, you will see the Dermatology Life Quality Index, which indicates the quality of life of these patients. This shows that the patients who were treated with HRO throughout the study had a reduction of 4.9 points on the DLQI scale by week 65, and that's considered clinically relevant. To remind you about the milestone overview in our drug development program, all medicinal products need to be assured for quality, efficacy, and safety before they're approved for use. Our drug development program for HRO350 leading up to Marketing Authorization Application was designed after receiving scientific advice from the European Medicines Agency, and this includes the first phase IIb clinical trial.
Following the study, we're planning a smaller pharmacokinetic study, which will be designed based on the findings both from the phase IIb and from the cellular studies we are running. After that, phase III clinical trial, following that, Marketing Authorisation Application for psoriasis in adults. In the scientific advice procedure, the EMA also requested a PIP, Paediatric Investigation Plan. We have provided that, and we've added it to the drug development program. Our focus is currently on the phase IIb clinical trial. We've conducted site feasibility as planned. Production of study drug, which took more time than anticipated due to global situation, material delays, et cetera. We've been compiling documentation for the IMPD, Investigational Medicinal Product Dossier, and that's an essential part of the clinical trial application.
The preparatory phase took longer than anticipated, but enrollment is still planned for six months. Status quo is that we're following the plan made prior to listing and largely on track. As part of the regulatory pathway for drug development of HRO350, we've prepared a Paediatric Investigation Plan, and this was recently agreed with the European Medicines Agency. This plan was necessary for us to move forward with the clinical development program, and it also demonstrates our dedication to investigate HRO350 for pediatric psoriasis. I'd like to mention that not all medicines being developed for children developed for adults are deemed suitable for use in children. Based on the data we submitted, the pediatric committee noted no concerns on potential long-term safety in pediatric use. The process for developing this plan included a comprehensive,
toxicology review, it's also increased our knowledge of the challenges that children with psoriasis have today. Also, in our pipeline, we've entered a collaboration with Smerud Medical Research International to develop a new drug candidate based on phospholipid esters for brain development in extremely premature infants. We will seek scientific advice from regulatory authorities, and we plan to apply for orphan designation for this drug candidate. The drug development program will run in parallel with our clinical development of HRO350 for psoriasis. In the next and final slide, we'll look further at future potential pipeline. Through the psoriasis development program, we will investigate immunomodulating properties of HRO350, and insights gained in this program may provide useful in other conditions involving chronic systemic inflammation.
In the future, our pipeline could be extended to explore HRO350 and other drug leads in a range of inflammatory conditions. With that, we'd like to move on to a review of the financial results with our CFO, Jone R. Slinning.
Thank you, Runhild. I will speak a little bit about the financial results for the first half year of 2022. We start with a brief look at some of the key financial figures. The group's revenues comes from the nutraceutical business, with sales of our omega products both to B2B and B2C customers. We see a positive development the last 12 months, with an increase of 20% year-on-year when it comes to the revenues. Compared to the last half year of 2021, we see an even stronger positive development in these operations, and we have a strong outlook for the remaining of the year of 2022. The gross margin is 1.6 percentage point above the same period in 2021. Also here we see a stronger positive development compared to the last six months of 2021.
We are affected by increasing sub-supplier costs and, for example, higher freight costs. We are working diligently to make sure that these costs increases are reflected in our prices of our products. We have a strong liquidity position, with a bank balance of NOK 177.8 million at end of first half year. We are a solid company with an equity ratio of approximately 93%. Looking more into the details from the income statement, we see here that the total revenues from the nutraceutical business amounted to NOK 14.4 million. We have a stable development in the revenues from the B2C segment, which are in line with our expectations.
The revenues from the Chinese market, which are included in the B2B segment, has shown a very positive development, and we expect that the relative share of these revenues will go up going forward. We have here received a large order intake for the last six months of 2022, which will bring a positive effect, contributing to the fact that we have increased our full year forecast for the revenues of 2022 compared to what we have earlier been communicating. I mentioned the gross margin a little bit earlier. This is an area which we pay a lot of focus to when it comes to the nutraceutical business. As said, we are experience cost increases from our suppliers, among other things, because of the global situation that are facing us.
The operating loss of NOK 16.2 million is in line with our expectations for the first half year. We have taken actions, and we have implemented measures on cost focus for other OpEx, which we believe also will contribute positive in the months to come. In first half year of 2022, we had a positive currency contribution to our figures, which contributed to net income from financial items of NOK 1.3 million. As you can see of this slide, this underlines the fact that we have had a positive development from the Chinese market over the last 12 months. In the first half of 2022, the Chinese market accounted for 14% of our total revenue, and we believe this share will increase during the rest of the year. The American market is important to us.
We see in this market that we manage to keep both existing customers at the same time as we get new business in that region. We have a strong team located both in the U.S. and in Canada with established customer relationships, which will contribute positive to us going forward. Our liquidity position is strong, with a total liquidity end June of NOK 177.8 million. The last 12 months, the liquidity has been reduced with NOK 80.9 million. Of this, NOK 49.6 million the last six months. This is in line with our expectations, as the main pharmaceutical projects are moving forward in the development phase. Compared to first half year of 2021, the negative cash flow from operations has been reduced with approximately NOK 9 million.
Some of this is explained by the listing process we had in 2021. We have invested NOK 31.4 million in our different Pharma and development projects the last six months, where the main investment is, of course, connected to our HRO350 phase IIb study. Due to an exercise of share options in February this year, we had a limited equity increase of NOK 750,000. We have a strong financial position at end of first half year 2022. The total assets amounts to NOK 327.9 million, of which fixed assets amounts to NOK 104.1 million, and the liquidity amounts to NOK 177.8 million.
Arctic Bioscience has no long-term debt, which then gives a total equity ratio of 93.4% at end of first half-year. With that, I will hand the word back over again to Christer, who will speak a little bit more about our business outlook. Thank you.
Thank you, Jone and Runhild, for thorough walkthrough. For the Pharma business, we're focusing on submitting the clinical trial application in Q3 2022. First patient to be enrolled in phase IIb clinical study, we expect in Q4 2022 for the six months inclusion period. We've also continued the research collaboration with Smerud on new drug candidate for brain development in extremely premature children. Our process regarding commercial partnership for the Pharma will start and run concurrently with the clinical trial of HRO350. For the Nutra business, we are focusing on especially delivering on positive sales prospects and receive order intake for the second half of the year. Especially also entering new geographies for the B2B, including South America and further access to the APAC regions. Intensifying participation at customer clients events, trade fairs post-COVID.
We will continue to benefit from the relationship with Kotler regarding sales and marketing activities in the Chinese market. We'll continue to establish GMP manufacturing of materials for the planned phase III clinical trial according to timeline in previously disclosed plans. We will also continue with further product development for the Nutra business. Moving on to the financial outlook. HRO350 phase IIb study is fully funded. As Jone mentioned, the cash position year-end will be strong for the group. We also see that positive sales prospects and receive order intake for second half of the year indicates a year-on-year revenue growth in the range of 60%-70%, which is somewhat higher than previously guided. The financial year EBITDA is expected around - 35 to - 30 million NOK.
That concludes our presentation, and we'll shortly move on to the Q&A session. Thank you.
We start with the Q&A session. We have received some questions from the viewers. We will try to answer these questions. We start first, and I believe this one is for you, Christer. In the press release dated June 13th, you informed about an expanded and extended cooperation with Kotler Group. I would appreciate if you can go a little bit deeper in the contents of the continued and expanded cooperation, in particular in relation to Pharma, which is a new element.
Okay. Yeah, that's a good question. The extension is through 2025 in this first instance, and it covers on a Nutra side, a more thorough and more stronger collaboration or marketing cooperation and campaigns in the Chinese market, as well as governmental processes to approve our new products into the market. On the Pharma side, we see the potential of developing Pharma products also for the Chinese market in the future. In this context, Kotler will become a partner in terms of finding development partners in the Chinese market and also help us with the commercialization process.
Okay. We have a few more questions here. Can you give some more details into the thought process behind in delay of the investment decision of the new facility and what other options are you exploring? Will it have any implications for long-term gross margin development for the Nutra business?
Given the uncertainty in the market given by the COVID and the Ukraine war, we've seen extensive cost increases on material, equipment and also severe delays and increased lead times. That's kind of the rationale behind the delay. We are looking into several options. One is definitely outside sourcing, developing the phase III clinical trial material with external partners, as well as Nutra sourcing also with development partners. The final decision we are talking about, second half year is also looking at an internal in-house production, somewhat down scaled from the full manufacturing facility previously disclosed.
This will give us phase III clinical trial GMP production, as well as a certain volume of Nutra production, which again, yes, will positively influence the gross margin for the Nutra products.
Good. We have, another questions, regarding, the Kotler agreement. You seem upbeat about the development with Kotler Marketing. Can you give some detail on the order volumes you are seeing currently and how should we think about sales in China H2 and 2023?
What we see is that the order volume and the sales for 2022 is more than double of what we forecasted earlier. With this volume increase going forward, we expect probably doubling, maybe even more for 2023, but it all, you know, depends on the campaigns being run in the Chinese market and there will be some huge campaigns on Double 11, Double 12 this year, which will give us a good indication of the future growth potential in the Chinese market.
Good. I think we have two questions here for Runhild. The first one is, you have mentioned that you plan to study in further details the actual mechanism of action of your drug candidate. Could you speculate on the actual anti-inflammatory mechanism and do you consider that it could be mediated by pro-resolution mechanisms related to the formation of, for example, pro-resolving lipid mediators such as resolvins, et cetera?
I can't disclose too much at this time, but it's a really good scientific question. Naturally, these kinds of lipid mediators would be something that we would be exploring moving forward. The metabolic pathways in lipids is very interesting and it hasn't been explored fully. I'm gonna be a little bit careful as a scientist in providing any results, but I'd say that this is definitely something we're looking into.
The questions are coming in, so that's a good thing. In the press release today, you state that there are several drug developments in the pipeline. In the presentation, you refer to many indications related to inflammation-related diseases. Can you shed some more light on a time perspective, financing, possible partnerships, et cetera, in this regard?
I start and then you follow up. Yeah. I think this follows directly actually from that mode of action question and looking into the inflammatory mechanisms. Many of these diseases like psoriasis, psoriatic arthritis, Crohn's disease even, they have some common mechanism on systemic inflammation. And if and when we're able to elucidate this, we can explore if HRO350 itself may have some plausible effects in these disease states. And if so, I would be thinking indication extrapolation, for example, with same drug into other indications. But again, the scientific knowledge that we as a company build with the chemists that we do have in-house for developing new products, is of course something also we'll be looking into. For financing, do you want to answer that?
Yes. Obviously we will have to finance phase III of the HRO350. On the, on the premature infant drug candidate, we already have financing for the first phase. But new product development in the Pharma area will need further financing. That can be, of course, through finding development partners, as well as, you know, commercial partners going in and financing these candidates, new candidates at an early stage, as well as potential license partners. We are working, you know, along several lines to seek future financing for the Pharma.
I think the next question is in line with the commercial partner you mentioned here because the question is: The clinical study HRO350 is about to enter into phase IIb. You announced that you intend to start to pursue a partner from the second half of 2022. Have you initiated this and have you had information, provisional contacts earlier? If so, how is your take on the interest among the possible partners?
Yes, we are starting to pursue commercial partnerships, and this is a process that will take time. We see that there are many areas. We've done some analysis in terms of which partners could fit this kind of disease states medicine in the future. We have a certain overview of that. On the... What was the second part? Sorry.
If you have initiated it, have you had contacts earlier?
Yes.
if so, if you have take on the interest among the possible partners.
Yes. We have had some incoming interest already, which we have kind of, worked out and discussed with. There are no current processes ongoing with a specific partner-
Mm
at this point.
Yeah. Many good questions. I think that was the last one we have received. Do you have some final comments, Christer?
I just wanted to say that feel free to contact us, Jone and myself or Runhild, if you have any further questions about the Pharma side, Nutra, or generally, you know, developing the business. By that, I would just thank you all for joining this webcast and for all the good questions in the Q&A session. Thank you very much.