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

Commercial Growth Continues

“Q2 2021 marks the fourth consecutive quarter of growth for IRRAS despite the challenges of the COVID-19 pandemic, and the company is positioned to continue this positive growth trajectory."

“This is an exciting time for IRRAS as our forward progress accelerates. A record number of patients were treated with our products during Q2, and published clinical data and surgeon feedback both support our company’s positive impact on critically ill patients.”

Will Martin, President and CEO of IRRAS

Second Quarter, April – June 2021, Results

• Net revenue amounted to SEK 5.1 million (1.2)
• Operating loss (EBIT) amounted to SEK -26.7 million (-31.2)
• Loss after tax amounted to SEK -27.1 million (-32.5)
• Earnings per share before and after dilution amounted to SEK -0.40 (-0.55)

Period, January – June 2021, Results

• Net revenue amounted to SEK 9.1 million (2.8)
• Operating loss (EBIT) amounted to SEK -66.0 million (-66.5)
• Loss after tax amounted to SEK -66.9 million (-66.9)
• Earnings per share before and after dilution amounted to SEK -0.99 (-1.52)

Important events during the quarter

Strengthened Balance Sheet

• A directed share issue in June generated proceeds of SEK 66 million before fees.
• The company received forgiveness for the 832,055 USD (6.9M SEK) loan received as part of the US COVID-19 Paycheck Protection Program (PPP).

Key Quality System Certifications Received

• IRRAS transitioned its notified body partnership for global regulatory and quality system oversight to global leader, DEKRA.
• IRRAS received quality system certification under the EU Medical Device Regulation (MDR) 2017/745 and the Medical Device Single Audit Program (MDSAP), which allows the company to seek regulatory approval in key markets, such as Australia and Brazil.

Publication of case report

• Buffalo General Medical Center published a case report that documented clinical superiority of the IRRAflow system versus traditional passive drainage systems.

Management Transition Announced

• IRRAS announced that Kleanthis G. Xanthopoulos, Ph.D. would step down as CEO and remain on company’s Board of Directors.
• CFO Sabina Berlin departed IRRAS, and Griffen Stapp, the company’s Controller, assumed the role of Interim CFO.

Important events after the end of the quarter

New CEO Appointed

• Will Martin, the company’s President and Chief Commercial Officer, assumed the role of President and CEO.

Loan Agreement with European Investment Bank (EIB) Announced

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

Quality System Certifications Expanded

• After an on-site audit, IRRAS’ new in-house manufacturing facility was added to its ISO 13485:2016 certification, and the MDSAP certificate was extended for 3 years.

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 information is information that IRRAS is obliged to disclose pursuant to the EU market Abuse Regulation and the Swedish Securities Market Act. The information was released for public disclosure, through the agency of the contact person above, on August 26, 2021 at 08:00 (CET).