Growth despite COVID-19 resurgence  

"During the course of the 4th quarter, challenges associated with the COVID-19 global pandemic increased and impacted the company's commercial activity. In both the European Union (EU) and the United States (US), another round of lockdowns was instituted, limiting hospital access, reducing the ability to travel, and reducing focus on neurosurgical procedures in hospital intensive care units (ICUs). Despite these challenges, our IRRAS team increased the number of IRRAflow control units installed globally from 55 to 68 during the quarter and delivered annual revenue growth of 40%.

IRRAflow evaluations were completed at Buffalo General Medical Center, one of the most influential neurosurgical centers in the world, and with West Virginia University Medicine, another important academic comprehensive stroke center. In both evaluations, 10 patients were treated with positive results. In Germany, BGU Kliniken Halle Bergmannstrost also completed a 90-day evaluation of IRRAflow. Feedback received during these evaluations indicated that patients experienced improved outcomes and fewer complications with IRRAflow compared to established treatment methods. IRRAS is currently in discussions to convert all three centers into commercial customers early in 2021.

As the launch of IRRAflow continues, expanding the network of reference accounts that have adopted the system is an important part of our growth strategy. The reputation and influence of these centers will positively impact the company's ability to attract other stroke centers around the world as customers. Additionally, multiple scientific publications are being prepared for submission to peer-reviewed journals describing the outcomes of the patients treated during these evaluations. When released, such publications will further highlight the advantages of our technology and will help IRRAS accelerate IRRAflow's commercialization."

Kleanthis G. Xanthopoulos, Ph.D., CEO of IRRAS

• Net revenue amounted to SEK 2.5 million (3.4).
• Operating loss (EBIT) amounted to SEK -36.8 million (-35.7).
• Loss after tax amounted to SEK -38.1 million (-36.5).
• Earnings per share before and after dilution amounted to SEK -0.57 (-1.27).

• Net revenue amounted to SEK 7.4 million (5.3).
• Operating loss (EBIT) amounted to SEK -134.3 million (-151.5).
• Loss after tax amounted to SEK -135.9 million (-151.1).
• Earnings per share before and after dilution amounted to SEK -2.46 (-5.61).

• Agreement for Hummingbird signed with purchasing network Premier
• Collaboration agreement signed with Karolinska University Hospital
• IRRAflow launched in the Netherlands, Latin America and South Eastern Europe through distributors
• Evaluation agreements signed with hospitals in the US, Denmark and Germany and multiple evaluations in the US completed with positive outlook
• The company's first FDA quality audit performed without remarks
• Transition to inhouse manufacturing of IRRAflow for improved quality and reduced cost
• The Board of Directors proposes no dividend 

• Patient treatments started at multiple hospitals in the US, where personnel have been trained during 2020
• Additional evaluation agreements signed in the US

The report is available on the company's website: https://investors.irras.com/en/reports-presentations
 

About IRRAS

IRRAS is a global medical care company focused on delivering innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercializes neurocritical care products that transform patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methodologies. IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners. 

IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com.

IRRAS AB (publ) is listed on Nasdaq Stockholm (ticker: IRRAS).
 

For more information, please contact:

USA
Kleanthis G. Xanthopoulos, Ph.D.
CEO
ir@irras.com

Europa
Sabina Berlin
CFO
+46 73 951 95 02
sabina.berlin@irras.com

This document is considered information that IRRAS is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on February 16, 2021 at 8:00 a.m. (CET).