Interim report Q1/2024: MDR certification opens up great commercial opportunities

First quarter

• Net sales reached SEK 9.4 (13.0) million.
• The operating result totaled SEK -18.4 (-14.4) million.
• Earnings per share, basic and diluted, were SEK -0.11 (-0.09).
• Cash flow from operating activities totaled SEK -7.3 (-12.2) million.

 

CEO Comment

“Sales for the first quarter were lower than the same period last year, which in its entirety is due to the low partner sales. In the Swedish market, sales were up by 21% compared to the same quarter last year, and our market share continues to increase. During the quarter, ColdZyme was MDR certified as one of the first cold products in Europe, which opens up great commercial opportunities. We can make stronger and better health claims, that will fortify our marketing, and we have received validation of the high quality of our scientific and regulatory documentation. I see that 2024 has every chance of being an important and exciting year for Enzymatica. We have the MDR certification in place, we are hoping for good research results during the second quarter, and we are engaged in discussions with potential partners with great faith in our technology, our product and our capabilities”, said Claus Egstrand, CEO.
 

Significant events during the quarter

• On February 16, 2024, the Board of Directors decided to carry out a rights issue, with preferential rights for existing shareholders, of SEK 27.4 million before issue expenses. The rights issue was 72.7 percent subscribed with the support of subscription rights and 7.9 percent without the support of subscription rights. The remaining part of the rights issue was subscribed through guarantee commitments from Enzymatica’s three largest owners, through wholly or partly owned companies, and the Chairman of the Board and CEO. After issue expenses, the company receives SEK 25.5 million.
• ColdZyme® was certified in March 2024 under the EU MDR (Class III) regulation. The MDR replaces the EU’s Medical Device Directive (MDD) and imposes stricter requirements on the evidence for clinical validity, safe design and market surveillance. ColdZyme is one of the first cold and flu products to be certified under the regulation.
   

Significant events after the quarter

• No significant events were reported after the quarter.
   

Other events during and after the quarter

• On March 2, 2024, Professor Glen Davison presented the first results from his ongoing clinical trial on ColdZyme at the IOC's 7th World Conference on Prevention of Injury and Illness in Sport, the premier international conference on clinical aspects of sports and exercise medicine.
• The British Journal of Sports Medicine published an abstract about the ongoing clinical trial on ColdZyme at the University of Kent. The initial results from the study showed that ColdZyme significantly reduced the quantity of rhinovirus and symptoms of sore throat compared with placebo. The final results of the study are expected in the first half of 2024.
• Enzymatica will participate in the Global Health Campaign initiative that brings together consumer health and life science companies. At the end of May 2024, participating companies will join researchers and experts for the Global Health Summit in Geneva.
• The Swedish government has tasked the Swedish Agency for Health Technology Assessment and Assessment of Social Services with the task of investigating the state of knowledge regarding the effect of products that are claimed to combat colds. The assignment must be reported by 1 September 2024 at the latest.

The full report is available on: www.enzymatica.com/investors/financial-reports

 

 

This information is information that Enzymatica is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CET on April 25, 2024.

   

For more information, please contact:

Claus Egstrand, Chief Executive Officer, Enzymatica AB
Phone: +44 7780 22 8385 | Email: [email protected]

Stefan Olsson, Communication Manager, Enzymatica AB
Phone: +46 708 55 11 85 | Email: [email protected]

    

Enzymatica AB is headquartered in Lund, Sweden, and is listed on Nasdaq First North Growth Market.
For more information, please visit www.enzymatica.se. Enzymatica’s Certified Adviser is Carnegie Investment Bank AB (publ).