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Enzymatica’s partners await MDR certification and study results


Enzymatica’s partners await MDR certification and study results

26 February, 2024

Enzymatica has published its year-end report, revealing an operating result of SEK -48.1 million and net sales of SEK 50.9 million for the full year. While sales increased in Sweden, the order intake from partners in other markets has been below expectations. To reverse this trend, MDR certification and study result will be crucial factors, according to CEO Claus Egstrand. 

Enzymatica has developed ColdZyme, a mouth spray for colds that has been launched in more than 30 markets on four continents. The product is based on the enzyme formulation Penzyme, which reduces the amount of virus in the throat. ColdZyme can prevent colds, shorten the duration of colds and relieve symptoms. 

Sweden is growing but other markets are declining

In Sweden, sales of ColdZyme were up 31 percent in 2023 as a result of active campaigning. However, the other markets have not delivered the same results. Sales for the full year amounted to SEK 50.9 million, which is lower than the company had hoped for. 

The lower than expected sales were mainly due to low order intake from Enzymatica’s international distribution partners. The company therefore has ongoing constructive dialogues with its partners and has also initiated discussions with other potential partners. 

However, several partners have indicated that they are awaiting MDR approval for ColdZyme before placing new orders, which gives Enzymatica hope that order intake can pick up once the certification is in place. 

Working with MDR certification

During 2023, Enzymatica has been actively working to obtain CE marking according to MDR (Medical Device Regulation), which is the new European regulatory framework for medical devices, replacing MDD (Medical Devices Directive). 

ColdZyme is already certified according to MDD Class III, but Enzymatica is now striving to obtain MDR certification during the spring. With the certification, the company can also strengthen and clarify the health claims used in the marketing of the product. The CE mark also affirms that ColdZyme meets the regulatory and scientific requirements. With the certification, the company can also strengthen and clarify the health claims used in the marketing of the product. 

Study results from independent research groups

Enzymatica may not have achieved the sales they wanted in 2023, but they took many significant steps, especially during the second half when independent research groups presented new research findings for ColdZyme. A research group at Medical University Innsbruck demonstrated that ColdZyme reduces the viral load in cells infected with influenza A virus. The researchers believe that the product would also have a similar effect on other respiratory viruses. 

In addition, interim results from an ongoing study at the University of Kent were presented, showing that endurance athletes who use ColdZyme for symptoms of upper respiratory tract infections get a significantly reduced amount of rhinovirus in the throat, the most common cause of colds. Those who used ColdZyme also experienced milder sore throat symptoms compared to placebo. The study has been expanded with more participants to be able to show statistical significance for more symptoms and virus types. The final results will be presented in the second quarter of 2024. 

International interest

In addition, the interim results will be presented by Professor Glen Davison at the International Olympic Committee’s Conference on Sports Health in Monaco in a couple of weeks. Davison also recently participated in the American TV show The Balancing Act, together with Enzymatica’s CEO Claus Egstrand. In the interview, they talked about ColdZyme’s study results and how the product works – see the interview here. 

This shows that ColdZyme’s research results are generating international interest, which is important for increasing sales in both existing and new markets. Enzymatica is now evaluating several possible ways to establish ColdZyme in major new markets. 

Ready for growth

In order to be ready for rapid expansion, Enzymatica has chosen to upgrade its manufacturing facility in Iceland. 

In addition, the Board of Directors has decided to carry out a rights issue of SEK 27.4 million, before issue costs, to finance the company’s activities and strengthen its position in negotiations with stakeholders. The rights issue is secured to 100 per cent through subscription commitments and underwriting commitments from the three largest shareholders, members of the Board of Directors and the CEO. 

Comments from the CEO

Claus Egstrand
Claus Egstrand, CEO Enzymatica

BioStock reached out to the company’s CEO Claus Egstrand to find out more about how the company is preparing for growth. 

First of all, what are the key messages in the year-end report? 

– The most important message is that we are poised for strong growth. We anticipate achieving significant milestones in 2024, including MDR certification and new research findings, which will garner considerable attention for our unique product. Another crucial message is that we observe international interest sparked by the outstanding research results presented last fall. This opens up additional opportunities for new international collaborations and expansion. 

»The most important message is that we are poised for strong growth. We anticipate achieving significant milestones in 2024, including MDR certification and new research findings«

You mention that you are pleased with the growth in sales in Sweden. How much of the total turnover comes from Sweden and your other home markets (UK and Iceland)?  

– Since partner sales have been so low in recent years, almost all sales come from our own markets. There is a great deal of interest in ColdZyme and we have a very high repurchase rate. Nine out of ten people who test ColdZyme say they intend to buy again. So we know we have a really good product – what has been lacking is our partners’ commitment to their local markets. 

What will you do to increase sales outside your own markets?  

– It is primarily about meeting the markets with the right partners. They need to feel the same commitment as we do to the product. Therefore, we are looking at adding additional partners for certain markets, in parallel with discussing launches in new markets together with others. The MDR certification will be important as it once again confirms our strong regulatory and scientific foundation. In addition, MDR would mean that we can sharpen our product health claims. The clinical results from the University of Kent are also important as they expand our scientific documentation and confirm our unique product. 

What steps remain before you can obtain MDR certification?  

– We have completed the entire process and are basically just waiting for information about the certification. I do not intend to claim victory in advance, but we have invested a great deal of internal and external resources in this and feel confident with the documentation we have submitted. 

Finally, why do you believe that 2024 could be a turnaround financially?  

– We never give forecasts, but as I said, we expect strategically important breakthroughs in several areas during the spring. In particular, we look forward to receiving MDR certification as well as the final report from the ongoing study at the University of Kent. These will generate further interest in our unique product from many stakeholders, which in turn lays the foundation for long-term growth.  

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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