aXichem AB (publ), Interim Report January – June 2023
aXichem’s development during the period 2023-01-01—2023-06-30
In this interim report, the aXichem group is presented, which consists of aXichem AB (publ), Incendia Pharma AB and aXichem AS (Norway). Amounts in brackets refer to the corresponding period of the previous year.
aXichem’s development 2023-01-01 – 2023-06-30
Turnover and results
The group's net sales amounted to SEK 1,247 thousand (SEK 1,205 thousand).
Operating profit amounted to SEK -8,164 thousand (SEK -7,994 thousand).
The group's profit after tax amounted to SEK -10,215 thousand (SEK -8,761 thousand).
Financial net SEK -2 051 thousand (SEK -767 thousand).
Cash flow and financial position
The group's cash and cash equivalents on June 30, 2023 amounted to SEK 20,900 thousand (SEK 19,907 thousand).
The equity ratio amounted to 72% (68%).
Investments
Investments in intangible, tangible or financial fixed assets have been made so far this year with SEK 4,067 thousand (SEK 1,387 thousand).
Depreciation
Depreciation of intangible and tangible fixed assets has been done so far this year with SEK 1,826 thousand (SEK 1,709 thousand).
Stock data
Profit as of June 30, 2023 corresponds after tax to a profit per share of SEK -0,54 (SEK -0.53).
Equity per share at the end of the period amounted to SEK 2,74 (SEK 2.94).
aXichem's development 2023-04-01 – 2023-06-30
Turnover and results
Net sales amounted to SEK 693 thousand (SEK 700 thousand).
The operating profit amounted to SEK -4,354 thousand (SEK -4,434 thousand).
The group's profit after tax amounted to SEK -5,454 thousand (SEK -5,201 thousand).
Financial net SEK -1,100 thousand (SEK -767 thousand).
Investments
Investments in intangible, tangible or financial fixed assets amounted to SEK 3 414 thousand (SEK 554 thousand).
Depreciation
Depreciation of intangible and tangible fixed assets amounted to SEK 942 thousand (SEK 872 thousand).
Share data
After tax, the periods result corresponds to a result per share of SEK -0.25 (SEK -0.31).
Significant events during the period
- On April 3, it was announced that aXichem answered and submitted the questions that EFSA asked, and that were announced on January 3, regarding the company's Feed Additive application. The submission is now registered with EFSA and the so-called "clock stop", i.e. the break in the time of a total of six months established by EFSA to process this type of application, has been lifted. The new legal deadline for EFSA's review process is now set to 17 June 2023.
- On April 24, a scientific article describing the study "Effects of different doses of phenylcapsaicin on strength training performance, muscle damage, protein breakdown, metabolic response, and estimation of perceived exertion and recovery: A randomized, triple-blind, placebo-controlled, crossover study." has been published in the Journal of the International Society of Sports Nutrition (JISSN). The published study is supported by aXichem, in collaboration with the Spanish companies LIFEPro Nutrition and Indiex Sport Nutrition, and was carried out in 2022 at the University of Pablo Olavide - High Performance Center (CIRFED)
- On April 24, the company announces that a new order has been received from the distributor Res Pharma in Italy. The order concerns aXivite and the ordered volume will be used for the development of consumer products in collaboration with two different producers. The order value amounts to SEK 120,000.
- On April 25, it was announced that aXichem submitted a patent application for aXivite® as a performance-enhancing ingredient in dietary supplements intended for physical training. The title of the patent is "Physical performance aid" and has its background in significant effect data from above all the study described in the recently published scientific article in the Journal of the International Society of Sports Nutrition.
- On May 5, the company announces that a new clinical trial regarding aXivite has been published in an article in the scientific journal Frontiers in Physiology, "Effects of phenylcapsaicin on aerobic capacity and physiological parameters in active young males: a randomized, triple-blinded, placebo-controlled, crossover trial ". The results of the study add further compelling evidence supporting the remarkable benefits of aXivite, a breakthrough capsaicin analog with enhanced bioavailability.
- On May 25, aXichem published its Annual Report for the year 2022. The Annual General Meeting took place on June 16 and the resolutions from the meeting was published the same day.
- On May 29, the company communicated that a new order had been received for its phenylcapsaicin product aXivite® from the Polish distributor BART. The ordered volume will be used in continued production of the product for weight control that was launched last year. The total order value amounts to approximately SEK 400,000.
- On June 8, the company announces that the Ministry of Agriculture, Livestock and Food Supply in Brazil (MAPA) has granted approval of phenylcapsaicin as a new raw material for zootechnical feed additive applications, to be utilized in both poultry and piglet feed. This constitutes the safety assessment in the regulatory process. The forthcoming phase will scrutinize the efficacy of phenylcapsaicin in accordance with the applications.
- On June 13, aXichem announces that the European Food Safety Authority (EFSA) has informed the company that the authority needs additional time to review the company's application for Feed Additive approval in the EU for the product phenylcapsaicin as a feed ingredient, under the brand name aXiphen. EFSA communicates that the new date for a statement is 5 August 2023.
- On June 27, it was announced that aXichem’s Spanish partner, Life Pro Nutrition, has introduced two new products — Life Pro Wild Ripped and Life Pro Wild Ripped Low Stim — targeting the weight loss segment. Both products prominently feature aXivite, a patented form of phenylcapsaicin, as the key ingredient. Life Pro Nutrition has also placed a smaller order worth SEK 70,000 for the development of additional products with aXivite.
- On June 27, the company communicated the signing of an exclusive agreement with Uriach, one of Europe's oldest and steadily growing pharmaceutical companies, regarding aXivite in the sleeping aid category of the dietary supplement market. Under the Supply and Research Agreement Uriach is granted exclusivity in a melatonin formulation with aXivite in the territories of Spain, Portugal, Germany, Austria, and Romania. To achieve this exclusivity Uriach is committed to a yearly minimum purchase of aXivite of 400,000 Euro. Uriach will also fund a new the clinical trial, and the results of this trial will be jointly owned by Uriach and aXichem. Each party will have the right to use and exploit the results.
Significant events after the end of the reporting period - On August 3, today announces the publication of a new research article focused on the role of phenylcapsaicin in sports performance enhancement. The article, the third of its kind, was published in the respected scientific journal, Frontiers in Physiology, and reinforces aXichem's dedicated path of research and development for a deeper understanding of the effects of phenylcapsaicin.
CEO’s statement
During the second quarter, we have seen continued increased interest in aXivite. The exciting results from our completed studies published during the period, regarding the effect of phenylcapsaicin, have received a lot of attention and mean that we are now seeing new supplements with aXivite being introduced and planned. We expect to see increased demand for phenylcapsaicin as an ingredient in dietary supplements in the second half of the year and still see good opportunities to achieve our goals for the financial year.
The result for the second quarter of 2023 amounts to SEK -4 354 thousand. The net turnover amounts to SEK 693 thousand. The costs for the period are mainly costs linked to the completed new share issue.
aXiphen – on its way to the market
On June 13, the European Food Safety Authority (EFSA) provided information to the company stating that the authority needed additional time to review our application for Feed Additive approval in the EU for phenylcapsaicin as a feed ingredient. At the time of writing, we have not received any new information from EFSA or any new questions. The process is transparent in that all documentation is posted in an open portal, Open EFSA, and there everyone can follow what is happening. As soon as we have new information from EFSA, we will inform the market via press release. We are currently awaiting the results of EFSA's review of our application and are preparing for the upcoming launch of aXiphen.
The work on market approval of phenylcapsaicin in Brazil took an important step forward when in June we received the news that the Ministry of Agriculture, Livestock and Food Supply in Brazil (MAPA) granted approval of phenylcapsaicin as a new raw material for zootechnical feed additives, to be used in both poultry and pig feed. This constitutes the safety assessment in the approval process. The application has now entered the next phase, where the effect of phenylcapsaicin, in accordance with the applications, will be reviewed. We have made some changes to the format for how data regarding product stability (shelf life) is presented and the review is ongoing. As I have said earlier, it is not a simple matter to predict the time consumption of authority processes. Chr. Olesen, which is our distributor in the EU, is also our partner for Brazil/South America and monitors developments on site, which is a big advantage. There is currently nothing to suggest that aXiphen could not be approved in Brazil before the end of the year. Brazil is the world's largest exporter of chicken meat and the world's second largest producer, which makes it a particularly interesting market for our product.
For US and GRAS Feed approval, the documentation has been updated with the details requested under the changed regulations. We will move forward in the process in the US, as well as in Thailand where we have interest from major producers to obtain market approval. However, we have decided to prioritize the EU and Brazil in the short term and focus on the market launches there. Together with Chr. Olesen, we have made the assessment that these markets based on legal requirements regarding salmonella-free production facilities, productivity needs of feed producers to achieve export and production volumes and Chr. Olesen's anchoring and established relationships can give us a good start on aXiphen's commercialization and a gradual increase in volume. In other words, an establishment in the EU and Brazil gives us a good platform and resources for further expansion into additional markets.
aXvite is an ingredient in several new dietary supplements
During the quarter, very interesting data from two studies with phenylcapsaicin were published in two leading scientific journals, the Journal of the International Society of Sports Nutrition (JISSN) and Frontiers in Physiology, respectively. We have, as I mentioned in last quarter's commentary, received a positive response to these articles from many players in the industry. The new products with aXivite as the main ingredient, which were launched by our Spanish partner Life Pro Nutrition, got off to a flying start with this and I am very happy that we can contribute to lifting new products with the help of solid data from our studies. It will be exciting to follow the sales of the products: Life Pro Wild Ripped, for increased performance in sports and training, and Life Pro Wild Ripped Low Stim aimed at weight control.
In the US, Iovate continues to market aXivite as a new effective ingredient in products under the Muscletech brand. BurnIQ has received very good user reviews and is surrounded by a lavish marketing campaign. We look forward to being part of the activities for the new products to be launched under one of Iovate's other leading brands, Hydroxycut, in the coming months. This should also appear as incoming orders for aXivite.
A new cooperation agreement was signed at the end of June. The partner is called Uriach and, like Lif Pro Nutrition, is based in Spain. The agreement, which is a supply and research agreement, gives Uriach exclusivity for a melatonin formulation with aXivite in the markets of Spain, Portugal, Germany, Austria and Romania. Uriach works with both pharmaceuticals and dietary supplements and is one of Europe's oldest and steadily growing companies in the industry. Uriach became interested in phenylcapsaicin when they learned that the product had been tested as a bio-enhancer for several active substances. Phenylcapsaicin was found to be able to inhibit a specific substrate of Cytochrome P450, the one that, among other things, regulates melatonin. Melatonin is a body hormone produced by the pineal gland in the brain and regulates human sleep-wake cycles. For the short-term treatment of sleep problems, synthetically produced melatonin is a common over-the-counter drug. Because phenylcapsaicin causes melatonin to break down more slowly in the body, the dose of the active substance, in this case melatonin, can be smaller compared to the standard dose, which means a number of benefits. This means fewer administrations, longer time between administrations and less amount for each administration. For the producers, of which Uriach is one, this means that the new EU rules limiting the amount of melatonin do not impair the product's effectiveness, while the smaller amount of raw material used increases the margin.
In order for Uriach to obtain exclusivity on the markets specified in the agreement, Uriach has undertaken to annually purchase aXivite in volumes corresponding to a value of at least 400,000 Euro. Uriach will also fund a smaller study, the results of which will be owned jointly by Uriach and aXichem. This study is currently in its final stages.
In early February this year aXichem communicated a sales target for aXivite® of approximately SEK 20-25 million during the coming 12 months. It's a lofty goal, but if Iovate in the US in particular continues to market and sell as planned and we get continued order intake from our EU partners, such as BART, LifePro and Uriach, it's still achievable. Tough, but possible.
See you on August 30 in Malmö?
On June 16, the annual general meeting was held in aXichem. Christian Månsson was elected as a new member of the board and we extend a warm welcome to him. At the same time, I would like to thank Jakob Axelsson, who declined re-election, for his good work during the years he contributed his knowledge to the board. Minutes from the annual general meeting are available as usual on our website under Investor Relations.
On August 30, we will try a different approach. We would like to meet those who are interested in aXichem "live" and be able to present the company in a slightly different way than is possible via the established organizers of investor meetings. Therefore, we invite you to an evening event at Elite Hotel in Malmö, on August 30 at 18:00 - approximately 20:00. We have a maximum of 30 places, so first come, first served. Read more on our website. We promise interesting presentations and nice mingling. I hope to see you!
Torsten Helsing, CEO
About aXichem AB (publ)
aXichem's business concept is to develop, patent and market nature-analog industrial compounds. aXichem's product is a natural analog substance called phenylcapsaicin, which is a synthetically produced and patented capsaicin. As phenylcapsaicin is synthetically produced and has a number of advantages compared to natural capsaicin, such as controllable quality and production process.
The product has benefits that makes it commercially interesting in several application areas, for example as ingredient in animal feed, as ingredient in dietary supplements, as a bio-enhancer and as a bio-repellent in marine applications. aXichem is currently marketing the product under different brands in two prioritized areas: aXivite® for dietary supplements and aXiphen® for poultry feed. aXiphen® has shown properties as a growth promoter and anti-salmonella ingredient in studies made in commercial poultry production settings. In the market segment for sports nutrition products aXivite® is today included in several products for weight control, improved metabolism and gut health.
aXichem aims to become a global supplier of industrial natural analogue chemicals to players in the chemical industry who manufacture products containing aXichem's raw materials. The company’s share is listed on NASDAQ First North since 2013.
Future prospects
aXichem's commercialization of phenylcapsaicin under the brands aXiphen®, in the animal feed market, and aXivite®, in dietary supplements market continues. The production capabilities and logistics through subcontractors are in place as well as a production process optimized for commercial volumes.
The pace of development in the establishment of the products is determined by obtaining market approvals in the strategically important countries or regions, starting with EU, U.S., Brazil and India.
aXichem cooperates with specialized distributors, who either have their own production or collaborate with innovative leading producers.
The company has market approval for aXivite in the EU and in North America. On February 7, 2023 the company communicated that a continued positive development for aXivite can result in revenues of approximately SEK 20-25 million in the next twelve months.
aXiphen is not yet approved for the animal feed market, but is expected to obtain approval in EU, U.S., and Brazil during 2023. The interest in aXiphen continues to be high and the company expect sales of approximately SEK 60–80 million are possible during the first 12–18 months after market approval in the EU and in Brazil.
Financing
The board of aXichem decided on 5 April 2022 to take out a convertible loan of SEK 20 million from Formue Nord Fokus A/S. The nominal amount of the convertible loan amounted to SEK 20 million and ran with an annual interest rate of 12 percent and would be due for payment on October 31, 2023, unless the convertibles were converted before then. The conversion rate amounted to SEK 20. In the event that the convertible loan was converted in its entirety, the number of shares in the company would have increased by 1,000,000 and the share capital increased by SEK 200,000.
On February 23, 2023, the company announced that the board, with the support of the general meeting's authorization, decided to carry out an issue of shares with preferential rights for existing shareholders for approximately SEK 50 million before issue costs. The rights issue was covered to 70 percent by subscription and guarantee commitments. The issue was carried out to scale up operations in connection with the planned commercialization of aXiphen® in poultry feed and to repay part of the convertible loan taken out in April 2022. The board has also decided to take out a new convertible loan from Formue Nord of approximately SEK 10.53 million. On March 24, the outcome of the completed rights issue was announced. A total of 4,960,689 shares were subscribed and the rights issue was thus 70 percent subscribed. Through the rights issue, approximately SEK 34.7 million will be added to aXichem before issue costs. A total of 3,608,646 shares, corresponding to approximately 51 percent of the rights issue, were subscribed with the support of subscription rights. In addition, 1,352,043 shares were subscribed without the support of subscription rights, corresponding to approximately 19 percent of the rights issue, of which approximately 12 percent of the rights issue refers to subscription attributable to issue guarantees.
Incentive program – Employee stock options
At the annual general meeting on May 31, 2022, it was decided on an option program of series 2022/2026 for employees and key persons in the company comprising 400,000 options with the right to subscribe for 400,000 A shares. As of the balance sheet date, 270,000 options were allocated to staff and key persons, of which 33,750 were vested.
The employee options are earned over 4 years, with a quarter each year, provided that the participant is employed by or otherwise engaged in the company on the grant date. The staff options are awarded free of charge. Earned employee options can be exercised during a three-year period, however no earlier than three years after the respective grant date. Each employee option gives the right to subscribe for 1 A share at a subscription price that corresponds to 140 percent of the volume-weighted average price for the company's A share during the five trading days immediately preceding the day on which the employee options are awarded. The subscription price and the number of A shares to which each employee option entitles may be subject to recalculation as a result of a bonus issue, split, issues or similar measures. In order to enable the delivery of shares according to the incentive program, it was also decided to issue a maximum of 400,000 warrants.
Certified Adviser
Västra Hamnen Corporate Finance is aXichem’s Certified Adviser.
Ownership structure
For information about the company's owners, see the company's website www.axichem.com. under Investor Relations/investor structrue. For information on insider trading, see the Financial Supervisory Authority's register.
Significant risks and uncertainties
Regulatory issues are considered to be the single largest risk for the company. The effects of Covid-19 still have some impact on the company’s operations in Asia. The changed security situation in Europe and the tragic development in Ukraine do not currently affect aXichem’s operations, but we are following the development closely in order to be able to manage any possible effects.
Review
This interim report has not been reviewed by the company’s auditor.
Financial calendar
Q3 Report, Jan – Sept 2023 2023-11-22
Year End Report 2023 2024-02-21
The Board of Directors and the CEO assures that the interim report provides a fair overview of the company’s operations, position and results, and describes the significant risks and uncertainties that the company faces.
Lund, 23 August, 2023
The Board of Directors of aXichem AB (publ)
The information was submitted, by the contact person, for publication on August 23, 2023, at 08:30 AM CET. The report is published on the company's website under Investor Relations. Direct link to the report: https://www.axichem.com/investors-relations/#financial-reports