– The MDR certification was a labor-intensive and costly process, but now that ColdZyme has been certified as one of the first cold products in Europe, it opens up major commercial opportunities, says CEO Claus Egstrand.
Enzymatica develops and sells products that treat and relieve infections and symptoms in the upper respiratory tract. The products are based on a barrier technology with the company's patented enzyme Penzyme as a key component.
Enzymatica's best-selling product is ColdZyme, a mouth spray that protects against and relieves colds. ColdZyme has been launched in over 30 markets on four continents.
CE certification opens up opportunities
In March, ColdZyme received CE certification under the new EU regulation, MDR, for medical devices. This demonstrates that the product meets regulatory requirements for, among other things, clinical validation and safe design.
- The MDR certification during the quarter is a testament to our solid scientific and regulatory documentation, which will help create new and exciting opportunities for Enzymatica, says the CEO Claus Egstrand in the Q1 report.
Through the CE marking, ColdZyme receives clearer and expanded health claims, which strengthens the marketing of the product. Read more hereThe company has now started work on developing new packaging in accordance with the MDR.
– We have secured our ability to sell in the European markets for a long time to come, while MDR certification helps when we seek permission for new markets.
Reduced sales in the first quarter
Now that MDR certification is in place, the company hopes to see sales increase. The first quarter report showed net sales of SEK 9,4 million, a decrease of 27,7 percent compared to the same period last year.
– Sales for the first quarter were lower than the same period last year, which is entirely due to low partner sales. We are working intensively, and on a broad front, to reverse this trend
At the same time, sales increased by 21 percent in Sweden, where Enzymatica handles marketing in-house instead of through distributors.
Aiming to establish itself in larger cold markets
As sales to partners remain low, Enzymatica is continuing negotiations with other potential partners who can take over existing markets or expand into new ones. The company will focus on establishing itself in some of the larger cold markets globally, such as China, Japan and the USA.
– For Enzymatica, it is more important that we have a well-functioning operation in the larger markets than that we are present in many small ones. In retrospect, I can see that we have historically placed too much emphasis on increasing the number of markets.
Exploring business opportunities
In addition, Enzymatica is evaluating its business model to strengthen growth. Today, the company manufactures the enzyme Penzyme in-house, which they plan to continue to do. However, the company sees an opportunity to provide Penzyme to other players.
– We should challenge ourselves in other parts of the value chain. One absolute possibility would be for us to become a “content provider”. With “Penzyme Inside” we could broaden our business model and facilitate international expansion.
Barrier technology has proven effectiveness against viruses in the upper respiratory tract, but there are also other possible applications.
– There are more possible uses in consumer health and other areas. This is something we will explore in the future – on our own and in collaboration with new partners and the research community.
Looking forward to 2024 with confidence
Claus Egstrand concludes the CEO's statement in the report by saying that he expects Enzymatica to take several important steps in 2024. The company is particularly looking forward to receiving the final results from the ongoing study at University of Kent with ColdZyme on elite athletes.
– 2024 has every chance of being an important and exciting year for Enzymatica. We have the MDR certification in place, we hope for good research results in the second quarter and we are in dialogue with potential partners with great faith in our technology, our product and our capabilities.
In addition, the company has upgraded production capacity at its manufacturing facility in Iceland, which means they are ready for increased sales volumes. In addition, the company has strengthened its cash position through a rights issue of SEK 25,5 million, which means they are financially ready to take advantage of the opportunities in 2024.
– Although it is always difficult to predict the future, I expect that the many long-term shareholders who have shown so much patience will see Enzymatica take big steps during the year, says CEO Claus Egstrand.
