IRRAS AB publishes Interim Report for the period, January to September 2021

Fifth Consecutive Quarter of Revenue Growth

“Q3 marked our company’s 5th consecutive quarter of growth, even with increased impact during the quarter from the COVID-19 Delta variant. This growth and the strengthening foundation of our business show that IRRAS is well positioned to continue this positive growth trajectory.”

“We are pleased with our accomplishments during the third quarter of 2021, and our continued progress across the key elements of our business – revenue growth, operational efficiency, and clinical data generation – confirms our forward momentum.”

Will Martin, President and CEO of IRRAS

Third Quarter, July – September 2021, Results

  • Net revenue amounted to SEK 6.1 million (2.1)
  • Operating loss (EBIT) amounted to SEK -27.0 million (-31.0)
  • Loss after tax amounted to SEK -26.9 million (-31.0)
  • Earnings per share before and after dilution amounted to SEK -0.34 (-0.47)

Period, January – September 2021, Results

  • Net revenue amounted to SEK 15.2 million (4.9)
  • Operating loss (EBIT) amounted to SEK -93.0 million (-97.5)
  • Loss after tax amounted to SEK -92.9 million (-97.8)
  • Earnings per share before and after dilution amounted to SEK -1.30 (-1.90)

Important events during the quarter

Company Leadership Transition Completed

  • On July 1, Will Martin assumed the role of IRRAS President & Chief Executive Officer.  Kleanthis G. Xanthopoulos, Ph.D. remains on the company’s Board of Directors.

Loan Financing Completed via European Investment Bank

  • IRRAS signed a 10M EUR loan agreement that provides non-dilutive financing for IRRAS to fund product development and clinical data generation activities being performed in the EU.

Ventriculitis Case Study Published

  • Helsinki University Hospital published a case series that confirmed the ability of IRRAflow to treat patients with pyogenic ventriculitis, an aggressive brain infection.
  • Publication documents the ability of IRRAflow to directly deliver antibiotics into the intracranial space for the first time in peer-reviewed literature.

Expanded Quality System Certifications Received after Onsite Inspection

  • IRRAS’ in-house manufacturing facility for IRRAflow capital equipment was added to its ISO 13485:2016 certification, and the company’s MDSAP certificate was extended for 3 years.

Important events after the end of the quarter

CE Mark certification received for enhanced IRRAflow Drainage Catheter

  • Enhanced catheter with improved kink resistance and increased drainage capabilities now available for patient treatments in Europe.

ACTIVE clinical study initiated by Aarhus University Hospital

  • Aarhus University Hospital, a leading hospital in Denmark, began commercial patient treatments with IRRAflow and will capture its results in the ACTIVE investigator-initiated clinical trial to prove the system’s superiority versus traditional drainage systems.

First patients enrolled in ARCH clinical study

  • Dr. Behnam Rezai Jahromi from Helsinki University Hospital enrolled the first patients in the ARCH clinical study, which compares use of IRRAflow with clot-busting medication versus traditional drainage systems in patients with intraventricular hemorrhage.

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
Will Martin
President and CEO
ir@irras.com

Europe

Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

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 November 9, 2021 at 8:00 a.m. (CET).