IRRAS receives forgivness for loan from US Stimulus Package

Stockholm, May 25, 2021 – IRRAS, a global medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that its unsecured promissory note under the Paycheck Protection Program (the “PPP”) for a principal amount of USD 832,055 (approximately SEK 6.9 million) has been forgiven and will be reported as revenue in May. IRRAS is considered to have lived up to the requirements for foregivness based on the use of the loan according to the terms of the PPP.

The PPP was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) that was approved by the United States Congress to provide a USD 2.2 trillion package that allocates funding to small businesses to stimulate the economy and help businesses recover from the COVID-19 restrictions more quickly.

About IRRAS

IRRAS is a global medical care company focused on 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:

Sten Gustafsson
IR
+46 10 211 5172
sten.gustafsson@irras.com

 

This information is 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 May 25, 2021 at 17:30 CET.

 Release

IRRAS Announces Notified Body Transition from GMED to DEKRA, a Global Leader in Inspection and Certifications

Stockholm, May 11, 2021 – IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the CE Mark certificates for its IRRAflow system and the company’s ISO13485:2016 certification have been transferred to a new notified body, DEKRA. After the successful completion of a recent audit by DEKRA, these CE Mark certificates for IRRAflow will remain valid until May 2024.

“With DEKRA, we are building a relationship with one of the largest, most respected notified bodies in the world,” said Will Martin, President and Chief Commercial Officer of IRRAS. “DEKRA has resources in place near our US headquarters in Southern California, so important regulatory work has continued despite Covid-19. We believe that this transition can shorten our approval timelines and allow us to consistently plan our European product introductions moving forward.”

“Consolidating our regulatory relationships with DEKRA, a global leader in the space, as our notified body is an important step in the long-term growth of IRRAS,” said Kleanthis G. Xanthopoulos, PhD., Chief Executive Officer of IRRAS. “Regulatory requirements have changed dramatically in Europe, and, as guidelines evolve, it is critical that we take needed steps to ensure that our life-saving products remain available to patients in Europe.”

Founded more than 95 years ago, DEKRA is the leading expert organization and largest notified body in Europe. DEKRA is one of the five largest notified bodies globally and was also one of the first notified bodies to be approved under Europe’s new Medical Device Regulations. The company currently employs more than 43,000 people in approximately 60 countries on six continents.

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 is listed on Nasdaq Stockholm (ticker: IRRAS).

For more information, please contact:

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

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

The information was released for public disclosure, through the agency of the contact person above, on May 11, 2021 at 08:30 (CET).

IRRAS AB publishes Interim Report for the period January to March 2021

Meaningful Commercial Acceleration Seen Globally

During Q1, the global installed base for IRRAS products increased; the total number of IRRAflow systems increased from 73 to 84 and Hummingbird systems grew from 5 to 9.  An increase in the number of systems shipped is important, but it is more critical to convert evaluations into revenue-generating commercial customers. During the quarter, two influential US comprehensive stroke centers, Buffalo General Medical Center and West Virginia University, placed commercial disposable stocking orders for IRRAflow. The contracts signed by these customers more than doubled the number of commercial IRRAflow control units (from 9 to 19) and will generate recurring revenue as usage continues.

The patient impact was further confirmed as the team at Buffalo General also published an initial chronic subdural hematoma case series in a peer-reviewed journal that showed a 25% reduction in treatment time when using IRRAflow from 6 to 4.5 days. Such data and recent successful evaluations have provided our team with important tools to help successfully navigate the approval process for a growing list of centers interested in acquiring the IRRAflow system.

To date, more than 200 patients have been treated with IRRAflow at over 30 leading institutions globally. These treatments continue to show compelling results with zero catheter occlusions or major complications observed.”

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

First quarter, January – March 2021

  • Net revenue amounted to SEK 4.0 million (1.6).
  • Operating loss (EBIT) amounted to SEK -39.3 million (-35.2).
  • Loss after tax amounted to SEK -39.3 million (-34.3).
  • Earnings per share before and after dilution amounted to SEK -0.59 (-1.19).
     

Important events during the quarter

During Q1, the IRRAS manufacturing facility was successfully inspected by the US Food and Drug Administration (FDA) and the California Department of Public Health (CDPH) and received its manufacturing license. The IRRAflow control unit can now be manufactured in-house.

In Q1, two comprehensive stroke centers in the US, Buffalo General Medical Center and West Virginia University, analyzed the outcomes from their IRRAflow evaluations, placed disposable stocking orders, and began commercial use of the system.

During the quarter, IRRAS began to transfer its international regulatory activities to a new notified body, DEKRA. DEKRA completed audits of IRRAS quality system under ISO, MDR, and MDSAP guidelines, and in the near future, will assume the existing CE Mark certificates for IRRAflow.

IRRAS is in negotiations with the European Investment Bank (EIB) regarding a financial partnership that could provide non-dilutive financing that will allow IRRAS to borrow 7-9M € over the coming years based upon the achievement of agreed-upon performance criteria. The negotiations are in advanced stages; however, final approval is still subject to EIB’s internal review.

Important events after the end of the quarter

In April, the Board of Directors appointed Will Martin as President and Chief Executive Officer (CEO) of the Company. Will Martin, currently the company’s President and Chief Commercial Officer, will assume his new role on July 1, 2021. He will succeed current CEO, Kleanthis G. Xanthopoulos, Ph.D., who will remain on IRRAS’ Board of Directors.

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 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 May 4, 2021 at 8:00 a.m. (CET).

 IRRAS AB (publ) interim report for January to March 2021

Bulletin from Annual General Meeting in IRRAS on April 28, 2021

The Annual General Meeting (the "AGM") on April 28, 2021 resolved to adopt the balance sheet, income statement, consolidated income statement and consolidated balance sheet for 2020. Furthermore, it was resolved that no dividend will be distributed and disposable profits as of December 31, 2020 are carried forward.

The AGM also resolved to discharge the board members and the CEO from liability for 2020.

The AGM approved the nominating committee's proposal that the board shall consist of five board members. The AGM resolved that the total board remuneration shall amount to SEK 1,786,000 of which SEK 540,000 shall be paid to the Chairman of the Board of Directors and SEK 265,000 shall be paid to each of the other board members elected by the General Meeting and who are not employees of the group. Board members who are residents in the Unitied States shall be paid an additional amount of SEK 106,000. For work in the Audit Committee, the remuneration to the Chairman of the Committee amounts to SEK 130,000 and SEK 65,000 to the other member of the Committee. For work in the Remuneration Committee, the remuneration to the Chairman of the Committee amounts to SEK 100,000 and SEK 50,000 to the other member of the Committee. No extra compensation will be paid for participating in other committees. The total remuneration on a total of SEK 1,786,000 as stated above requires that the Audit Committee consists of two members and that the Renumeration Committe consists of two members. The AGM also resolved that the remuneration to the auditor, as previous, shall be paid in accordance with approved invoices.

The AGM resolved that the board until the end of the next AGM meeting will consist of the members Kleanthis G. Xanthopoulos, Marios Fotiadis, Anita Tollstadius, Eva Nilsagård and Catherine Gilmore-Lawless. Marios Fotiadis was elected chairman of the board. KPMG AB was re-elected as the company's auditor, with Duane Swanson as auditor in charge, until the end of the AGM of 2022.

The AGM approved the board's report on remunerations.

The AGM approved the board's proposal regarding a long-term incentive program 2021 (LTIP 2021) in accordance with items A and B of the proposal.

The AGM approved the board's proposal to be authorized to increase share capital through the issue of new shares, warrants and/or convertibles.                                                              

Complete proposals regarding the AGM's decisions are available on IRRAS AB:s website www.irras.com.

About IRRAS

IRRAS is a global medical care company focused on 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

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

The information was released for public disclosure, through the agency of the contact persons above, on April 28, 2021 at 19:30 (CET).

 Bulletin from Annual General Meeting in IRRAS on April 28, 2021

IRRAS Promotes Will Martin to Chief Executive Officer

Stockholm, April 21, 2021 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that its Board of Directors has appointed Will Martin as President and Chief Executive Officer (CEO) of the Company. Will Martin, currently the company’s President and Chief Commercial Officer, will assume his new role on July 1, 2021, He will succeed current CEO, Kleanthis G. Xanthopoulos, Ph.D., who will remain on IRRAS’ Board of Directors and will serve as a company advisor during a transition period.

Will Martin joined IRRAS in 2018. Prior to IRRAS, he served as General Manager of the Peripheral Vascular devices business for Philips Healthcare, Vice President of Commercial Operations at AtheroMed, Inc. prior to its acquisition by Volcano Corporation, and held other key commercial roles at other life science companies. He received a BA degree from The University of Notre Dame and an MBA from Johns Hopkins University and also served as a Lieutenant in the United States Navy.

“Dr. Xanthopoulos has built a strong medical and technical foundation for IRRAS within the expanding market for neurocritical care. Critical fundamental elements, such as establishing in-house manufacturing, strengthening our organization, securing key regulatory approvals, and growing sales, are now in place,” said Marios Fotiadis, Chairman of IRRAS’ Board of Directors. “We have been planning for a potential transition since Will Martin was promoted to President in June. With IRRAS now positioned for faster commercial expansion, the timing is right.”

“During my time at IRRAS, we’ve made meaningful progress in building a strong foundation for future expansion across all areas of our business,“ said Will Martin. “I am incredibly excited to lead our Company through its next phase of growth and will work closely with our team members to become a global leader in neurocritical care.”

“We have now treated over 200 patients with IRRAflow at more than 30 leading institutions in 18 countries across 3 continents with extremely positive treatment outcomes. Our other product line, Hummingbird, is well positioned to increase market share globally in the established market for intracranial pressure monitoring,” said Dr. Xanthopoulos. “During Q1, we more than doubled the number of commercial capital systems in the US, and sales are growing faster than ever before. The stage is set, and the time is right for Will to take over as IRRAS’ President and CEO. With his strong commercial skills and my continued engagement, IRRAS will have the right set up for the next step of growth and financial value creation.”

About IRRAS

IRRAS is a global medical care company focused on 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

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

This information is 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 April 21, 2021 at 20:00 (CET). 

 IRRAS Promotes Will Martin to Chief Executive Officer

IRRAS Announces Collaboration with Aarhus University Hospital, Scandinavian Leader in Neurosurgery, to Advance Use of IRRAflow

Stockholm, April 6th, 2021 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced a strategic collaboration with Aarhus University Hospital (AAUH) in Aarhus, Denmark, one of Scandinavia’s leading medical institutions.

Dr. Anders Korshøj, Associate Professor of Neurosurgery at Aarhus University Hospital, will lead the collaboration that will unite specialists from the hospital’s neurocritical care team and data analytics experts from The Aarhus University Center for Digitalization, Big Data and Data Analytics. The collaboration will focus initially upon the use of the company’s IRRAflow system to treat patients suffering from intraventricular hemorrhage (IVH). The facility’s use of IRRAflow in the treatment of IVH will be prospectively compared to the use of traditional drainage treatments in the pending ACTIVE clinical study. Beyond this study, other clinical and product development projects are also being planned.

Aarhus University Hospital is an 854-bed academic teaching hospital that, in 2020, was named Denmark’s best hospital for the 13th consecutive year by healthcare newspaper, Dagens Medicin. The institution was also recently ranked as the 11th best hospital in the world by the American publication, Newsweek. The hospital’s Departments of Neurosurgery and Neurointensive Care are leaders throughout all of Scandinavia as the departments are responsible for both general and highly specialized procedures for patients across all of Denmark.

IRRAflow is the world’s first “irrigating intracranial drain” and its unique mechanism of action addresses the complications associated with the current methods of managing intracranial fluid by using a dual-lumen catheter that combines automated irrigation, controlled drainage, and continuous monitoring of intracranial pressure (ICP), all within one system.

“It is my belief that the system’s combination of automated irrigation and controlled drainage should contribute to better long-term outcomes for these critically ill patients,” said Dr. Korshøj. “Furthermore, we believe that the system’s ability to measure pressure immediately after fluid movement is uniquely capable of measuring real-time intracranial compliance, and I am excited to partner with IRRAS to explore these hypotheses in greater detail.”

Traditional treatment options for IVH patients generally utilize an external ventricular drainage (EVD) system, which is a passive approach that relies solely on gravity to facilitate drainage. Although an EVD is currently the most common treatment option for intracranial bleeding or elevated ICP, the technology is associated with several well-known complications such as catheter blockage, infections, and incomplete drainage. All of these complications can negatively impact patient outcome, which can subsequently increase the length of time needed in the hospital and the overall cost of care.

“This collaboration with Aarhus University Hospital represents an important component of our launch strategy for IRRAflow,” said Will Martin, President and Chief Commercial Officer of IRRAS. “There is a compelling need in markets around the globe for transformative technologies, such as IRRAflow, to treat patients with intracranial bleeding, and we believe that our collaboration with Aarhus University Hospital to collect clinical data will advance the treatment of IVH and also accelerate the product’s awareness to a wider group of neurocritical care specialists.”

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

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

The information was released for public disclosure, through the agency of the contact person above, on April 6, 2021 at 08:30 (CET).

Notice to attend the Annual General Meeting of IRRAS AB (publ)

The shareholders of IRRAS AB (publ), org.nr 556872-7134 (”the Company”), are hereby invited to the Annual General Meeting to be held on Wednesday 28 April 2021. Due to the spread of the COVID-19, the Board of Directors has resolved that the Annual General Meeting should be conducted without the psysical presence of shareholders, representatives or third parties and that the shareholders before the General Meeting should be able to exercise their voting right only by absentee ballot.

Notice of Attendance

A shareholder who would like to participate in the General Meeting shall:

  1. be entered in the register of shareholders maintained by Euroclear Sweden AB by the record date Tuesday 20 April 2021; and
  2. announce their intention to attend the General Meeting, by having submitted an absentee ballot in accordance with the instructions under the heading ”Absentee Ballot” below such that the Company has received the advance vote no later than Tuesday 27 April 2021.

In order to be entitled to participate in the General Meeting, a shareholder who has registered their shares in the name of a nominee, in addition to announcing their intention to participate by submit its absentee ballot, must temporarily request that their shares be registered in their own name so the shareholder is entered into the register of shareholders by 20 April 2021.This registration may be temporary (so-called voting right registration) and is requested with the nominee in accordance with the nominee’s procedures and in advace as determined by the nominee. Voting right registrations completed no later than the 22 April 2021, will be considered when preparing the shareholder register.

Absentee Ballot

Shareholders may exercise their voting right at the General Meeting only by voting in advance, a so-called absentee ballot pursuant to section 22 of the Temporary Exemptions to Facilitate the Execution of General Meeting in Companies and Associations Act (2020:198).

A special form must be used for the absentee ballot. This is available on the Company’s website www.irras.com. Terms and conditions for the absentee ballot are included in the form. The completed and signed form for the absentee ballot must be sent by mail to IRRAS AB (publ), Attn: Sabina Berlin, P.O Box 160, 101 23 Stockholm or by e-mail to AGM@irras.com no later than 27 April 2021. The Shareholder may not add special instructions or conditions to the absentee ballot. If this occurs the vote (i.e. the absentee ballot in its entirety) will be invalid. If the shareholder submits an absentee ballot via proxy, the power of attorney must be attached to the form. The proxy form is available on the Company’s website, www.irras.com. If the shareholder is a legal person, the certificate of registration or other authorization document must be attached to the form.

Matters to be dealt with at the Meeting and proposed agenda

  1. Election of Chairman of the Meeting
  2. Election of at least one person to certify the minutes
  3. Preparation and approval of the voting list
  4. Approval of the agenda
  5. Establishment of whether the Meeting has been duly convened
  6. Presentation of the Annual Report and the Auditor’s Report and the Consolidated Financial Statement and the Group Auditor’s Report
  7. Resolution regarding adoption of the profit and loss statement and the balance sheet and the consolidated profit and loss statement and consolidated balance sheet
  8. Resolution regarding appropriation of the Company’s profit according to the adopted balance sheet
  9. Resolution regarding discharge from liability for the members of the Board of Directors and the Managing Director
  10. Determination of the number of board members and auditors
  11. Determination of fees for the Board of Directors and the Auditors
  12. Election of board members and chairman of the board
  13. Election of Auditor
  14. Approval of the remuneration report
  15. Resolution to implement an incentive scheme 2021 (LTIP 2021)
  16. Resolution in respect of authorisation for the board to issue shares, warrants and/or convertible bonds

Proposals

Proposals by the Nomination Committee

Determination of number of board members and auditors (item 10) 

The Nomination Committee has consisted of Christer Hellström, Chairman of the Nomination Committee, appointed by Bacara Holdings Limited, Carl-Mikael Lindholm, appointed by Carl-Olof and Jenz Hamrins Foundation, Salameh Sweis, appointed by Lexington Holding Assets Limited (BVI) and Marios Fotiadis, Chairman of the Board of Directors of IRRAS AB.

The Nomination Committee proposes that the Board of Directors shall consist of five board members elected by the General Meeting. The Nomination Committee also proposes that the Company shall have one registered auditing company as auditor.

Determination of fees for board members and auditors (item 11) 

The Nomination Committee proposes that the total remuneration for the Board of Directors shall amount to SEK 1,786,000 of which SEK 540,000 shall be paid to the Chairman of the Board of Directors and SEK 265,000 shall be paid to each of the other board members elected by the General Meeting and who are not employees of the group. Board members who are residents in the Unitied States shall be paid an additional amount of SEK 106,000. For work in the Audit Committee, the Nomination Committee proposes that, the remuneration shall be paid by SEK 130,000 to the Chairman of the Committee and 65,000 to the other member of the Committee. For work in the Remuneration Committee, the Nomination Committee proposes that, the remuneration shall be paid by SEK 100,000 to the Chairman of the Committee and 50,000 to the other member of the Committee. No extra compensation will be paid for taking part in other committees. The total remuneration on a total of SEK 1,786,000 as stated above requires that the Audit Committee consists of two members and that the Renumeration Committe consists of two members.

The Nomination Commitee proposes that the remuneration for the auditors shall be paid in accordance with approved invoices.

Election of board members and Chairman of the Board of Directors (item 12)

As members of the Board of Directors until the end of the next Annual General Meeting, the Nomination Committee proposes re-election of Kleanthis G. Xanthopoulos, Marios Fotiadis, Anita Tollstadius, Eva Nilsagård and Catherine Gilmore-Lawless.

The Nomination Committee also proposes election of Marios Fotiadis as the Chairman of the Board of Director.

Election of auditor (item 13)

The Nomination Committee proposes that the registered auditing company KPMG AB shall be re-elected as auditor for the period until the end of next Annual General Meeting. KPMG AB has informed that, if KPMG AB is re-elected as auditor, Duane Swanson will continue as the responsible auditor. The Nomination Committee’s proposal is recommended by the Company’s Audit Committee.

Approval of the remuneration report (item 14)

At the General Meeting 2020 it was resolved to adopt Guidelines for remuneration of the Senior Executives of the Company. In accordance with Chapter 8, section 53 a of the Swedish Companies Act (2005:551) the Board of Directors shall prepare a report for each financial year detailing unpaid and outstanding compensation that is covered under the Guidelines. The remuneration report shall be presented at the General Meeting for approval. The Board of Directors proposes that the remuneration report for the financial year 2020 is approved by the General Meeting. The report is available on the Company’s website www.irras.com.

Proposals by the Board of Directors

Dividend (item 8)

The Board of Directors proposes that the Annual General Meeting shall resolve not to distribute any dividends for the financial year 2020.

Resolution to implement an incentive scheme (LTIP 2021) (item 15)

IRRAS’s board proposes that the general meeting pass a resolution on the implementation of a Long Term Incentive Program 2021 (LTIP 2021) for a total of no more than 1,000,000 ordinary shares. This proposal is divided into four items:

A    Terms of LTIP 2021.

B    Hedging regarding LTIP 2021 shall be implemented through a direct issue of C-shares.

C    If item B is not approved, the board proposes that hedge of LTIP 2021 shall take place via an equity swap agreement with a third party.

D    Other matters related to LTIP 2021.

A Terms of LTIP 2021

A.1 Introduction

The board proposes that the general meeting approves LTIP 2021.

A.2 Rationale

The board wishes to introduce a long-term incentive program to employees in order to provide incentives for employees to exert maximum effort for the success of the Company and any affiliate and provide means by which the employees may benefit from the increase in value of the Company’s share. In addition, the incentive program is introduced to make it easier for the Company to recruit new employees and to retain the Company’s key employees.

A.3 Other share-related incentive programs

Information about IRRAS’s current incentive programs is available in the annual report for the financial year 2020, note 2 and 10, and on the Company’s website, www.irras.com.

A.4 Basic features of LTIP 2021

LTIP 2021 consists of employee stock options to be transferred to employees and consultants within the IRRAS group. The employee stock option entitles the holder to acquire shares in IRRAS in accordance with the following main conditions.

  • The employee stock options are granted free of charge.
  • The employee stock options can be transferred to participants, current or new employees and consultants, during the period until the end of the next Annual General Meeting.
  • The number of employee stock options granted to participants, will be based on fixed performance requirements.
  • Each employee stock option granted entitles the holder to acquire one ordinary share in the Company at a strike price corresponding to 110 percent of the average of the volume-weighted share price of the company’s share measured over ten trading days prior to the grant date.
  • The employee stock options will be subject to vesting during the term of the option. The options are not conditioned by measurable criteria since the Company is in an early commercialization phase.
  • The employee stock options, after being vested in accordance with the above, can be exercised for acquisition of ordinary shares from the third anniversary of the grant date up until the eighth anniversary of the grant date.
  • The employee stock options may not be transferred or pledged.
     
  • The employee stock options shall only be exercised if the holder is still employed by, or active as a consultant in, the group or within a certain time after the last day of employment or the day on which the consulting assignment is terminated.
  • The board shall design the structure and complete terms of the stock option program based on the guidelines resolved at the general meeting.

A.5 Participation in LTIP 2021

LTIP 2021 is directed towards a maximum of 90 employees and consultants, divided into five categories of participants:

Category Maximum number of employee stock options per person
A)  CEO (maximum 1 person)          175,000
B)  Executive management (maximum 4 persons) 150,000
C)  Managers (maximum 14 persons) 75,000
D)  Key contributor (maximum 56 persons) 35,000
E)  Individual contributor (maximum 15 persons) 15,000

A.6 Allocation

The right to receive employee stock options shall apply to current and future employees and consultants.

A.7 Implementation and administration etc.

The intention is that the board shall launch LTIP 2021 as soon as practically possible after the general meeting. The board will administer LTIP 2021, but the board may delegate all or part of the administration of LTIP 2021 to one or more committees or external service providers.

B. Hedge of LTIP 2021 via issuance of C-shares

B.1 Resolution to authorize the board to issue redeemable and convertible C-shares

The board shall be authorized to resolve on the directed issue of Class C Shares on the following terms and conditions:

a) The maximum number of Class C Shares to be issued is 4,332,000.

b) With a deviation from the shareholders’ preferential rights, the new shares may only be subscribed for by one external party after arrangement in advance.

c) The amount to be paid for each new share (the subscription price) shall equal the share’s quota value at the time of subscription.

d) The authorization may be exercised on one or several occasions until the Annual General Meeting 2022.

e) The new Class C Shares shall be subject to Chapter 4, Section 6 of the Swedish Companies Act (conversion restriction) and Chapter 20, Section 31 of the Swedish Companies Act (redemption restriction).

The purpose of the authorization is to hedge the undertakings of the company according to all of the Company’s outstanding incentive programs, including LTIP 2021. The authorization pertains to a total of 4,332,000 shares, of which a maximum of 1,000,000 C-shares can be issued to secure the Company’s commitments pursuant to LTIP 2021.

B.2 Resolution to authorize the board to decide on repurchase of C-shares

The board shall be authorized to decide on the repurchase of C-shares in the Company on the following terms:

a) Repurchase may be made through an acquisition offer addressed to all owners of C-shares in the Company.

b) The number of C-shares that may be repurchased may not exceed 4,332,000 shares.

c) Repurchases shall be made at a cash price per share corresponding to the quota value applicable at the time of repurchase.

d) The board shall have the right to determine remaining conditions for the repurchase.

e) It shall be possible to repurchase so-called interim shares regarding C-shares, from Euroclear Sweden AB designated Paid Subscribed Share (PSS).

f) The authorization may be exercised on one or more occasions until the Annual General Meeting 2022.

The purpose of the authorization is to secure the Company’s commitments in accordance with all of the Company’s outstanding incentive programs, including LTIP 2021.

B.3 Resolution on transfer of ordinary shares

The general meeting is proposed to decide on the transfer of ordinary shares to participants in all of the Company’s at each time outstanding incentive programs, including LTIP 2021, on the following terms and conditions.

a) A maximum number of 4,332,000 ordinary shares may be transferred free of charge to the participants.

b) The terms for these transfers, the number of shares in each transaction and the time of the transactions shall follow the terms of each outstanding incentive program at each time, including LTIP 2021.

c) The number of ordinary shares that may be transferred within each incentive program may be subject to customary recalculations as a result of cash dividends, bonus issue, split, rights issue and/or similar events.

C. Hedge of LTIP 2021 via an equity swap agreement with a third party

Should the majority required under item B above not be reached, the board proposes that the Annual General Meeting resolves that the expected financial exposure of LTIP 2021 shall be hedged by the Company being able to enter into an equity swap agreement with a third party on terms in accordance with market practice, whereby the third party in its own right shall be entitled to acquire and transfer ordinary shares covered by the LTIP 2021.

D. Other matters in relation to LTIP 2021

D.1 Costs

Costs related to employee stock options will be accounted for in accordance with IFRS 2 which stipulates that the employee stock options should be recorded as personnel expense in the income statement during the vesting period. A preliminary calculation, using a volatility of 37 percent, indicates an option value of approximately SEK 1.12 per employee stock option. Under the assumption of a share price of SEK 6.09 at the start of the program, a share price at the end of the three year period of SEK 12.18 (corresponding to a total share price increase of 100 percent during the vesting period), the total cost for the employee stock options amount to MSEK 1.7 before tax, which corresponds to an annual cost of about MSEK 0.6 before tax, provided that earnings take place over a 3-year period.

D.2 Effect on important key ratios

The annual costs for LTIP 2021 are calculated to amount to approximately 8.1 percent of IRRAS’s revenues for the financial year 2020 and approximately 0.8 percent of IRRAS’s salary costs for the financial year 2020.

D.3 Dilution of existing shares and votes

The number of ordinary shares outstanding in the company is 66,281,340. LTIP 2021 implies, upon exercise of all 1,000,000 of employee stock options, a full dilution corresponding to approximately 1.6 percent of the total number of shares and votes outstanding in the Company. If all outstanding incentive programs in the Company are included in the calculation, the corresponding maximum level of dilution at the time of the general meeting amounts to approximately 6.1 percent.

D.4 Adjustment authorization

The board, or a person appointed by the board, shall be authorized to make any minor adjustments to the above resolutions that may be necessary in connection with the registration with the Swedish Companies Registration Office and Euroclear Sweden AB respectively.

D.5 Preparation of the proposal

The basis for LTIP 2021 has been prepared by the board of the Company. The work has been supported by external advisors and has been made in consultation with shareholders. The board has thereafter decided to present this proposal for the general meeting. Except for the staff that have prepared the matter upon instruction from the board, no employee that may be a participant of LTIP 2021 has participated in the preparations of the program’s terms.

D.6 Majority requirements

The resolution by the general meeting regarding the implementation of LTIP 2021 according to item A above shall be conditional on the general meeting resolving either in accordance with the board’s proposal under item B above or in accordance with the Board’s proposal under item C above.

The resolution according to item A above shall require a majority of more than half of the votes cast at the general meeting. A valid resolution under item B above requires that shareholders representing not less than nine-tenths of the votes cast as well as the shares represented at the general meeting approve the resolution. A valid resolution under item C above shall require a majority of more than half of the votes cast at the general meeting.

Resolution in respect of authorization for the board to resolve to issue of shares, warrants and/or convertible bonds (item 16)

The Board of Directors proposes that the Annual General Meeting authorizes the Board of Directors to, on one or several occasions during the period until the next Annual General Meeting, with or without deviation from the shareholders’ preferential rights, resolve on share issues, issues of warrants and/or issues of convertible bonds that involve the issue of or conversion to a maximum of shares, corresponding to 20 percent of the share capital and the voting rights, based on the current number of shares in the Company.

The purpose of the authorization and the reason for the deviation from the shareholders’ preferential rights, if any, is to enable the Company to carry out issues in a time-efficient way to finance acquisitions or investments in new or existing businesses. The issuance of shares, warrants and/or convertible bonds under the authorisation shall, in case of deviation from the shareholders’ preferential rights, be made at a subscription price according to the prevailing market conditions at the time of the issuance of the shares, warrants and/or convertible bonds. Payment for subscribed shares, warrants and/or convertible bonds shall be made in cash, in kind or by way of set-off.

A valid resolution by the General Meeting pursuant to the proposal above requires that the resolution be supported by shareholders representing at least two-thirds of both the votes cast and the shares represented at the General Meeting.

The shareholders’ right to submit questions

The Board of Directors and the CEO shall, if any shareholder so requests and the board believes that it may be done without significantly harming the Company, provide information regarding circumstances that may affect the assessment of an item on the agenda. A request for such information shall be made in writing to the Company via mail to IRRAS AB (publ), Attn: Sabina Berlin, Box 160, 101 23 Stockholm or by e-mail to AGM@irras.com, no later than 18 April 2021. The information shall be available on the Company’s website www.irras.com and on the Company’s head office as stated above no later than 23 April 2021.

Other information

As per 30 March 2021 the total number of shares and votes in the Company amounts to 66, 281,340. The Company holds no shares in the Company. For information about how your personal data will be processed, see
https://www.euroclear.com/dam/ESw/Legal/Privacy-notice-bolagsstammor-engelska.pdf.

Documents

The proxy form and other documents in accordance with the Swedish Companies Act will be available at the Company’s office at the address set out above and will be sent free of charge to shareholders who so request and provide their postal address or e-mail address. The documents will also be available at the Company’s website, www.irras.com.

For more information, please contact:

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

The information was released for public disclosure, through the agency of the contact person above, on March 30, 2021 at 08:30 (CET).

 Notice to attend the annual general meeting of IRRAS AB 2021

IRRAS publishes annual report for 2020

IRRAS´s annual report 2020 has today been published on the company´s website.

The report is available on: https://investors.irras.com/en/reports-presentations

The financial year covers the period from 1 January to 31 December 2020.

About IRRAS

IRRAS is a global medical care company focused on 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 is listed on Nasdaq Stockholm (ticker: IRRAS). 

For more information, please contact:

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

Europe
Sabina Berlin
CFO
+46 73 951 95 02

sabina.berlin@irras.com

The information was released for public disclosure, through the agency of the contact person above, on March 30, 2020 at 8:30 p.m. (CET).

 IRRAS AB Annual Report 2020

IRRAS to Present at Redeye

Stockholm, March 23, 2021 – IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, today announced that company management will present at the Swedish Investment Bank Redeye on March 30 at 4:00 pm-5:00pm CET.

Kleanthis G. Xanthopoulos, Ph.D., CEO and Will Martin, President and CCO will present the IRRAS strategy and answer follow up questions. In total the presentation and the Q&A session is estimated to take one hour.

A link with an invitation which will be webcast live is presented below.

https://www.redeye.se/events/806966/strategy-update-irras

The presentation will also be made available on www.irras.com.

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  

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

The information was released for public disclosure, through the agency of the contact person above, on March 23, 2021 at 08:00 (CET).

IRRAS Announces the recruitment of Sten Gustafsson as Director of Investor Relations

Stockholm, March 9, 2021 – IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, today announced that the hiring of Sten Gustafsson as Director of Investor Relations, reporting directly to the company’s Chief Financial Officer, Sabina Berlin.

Sten Gustafsson worked closely with IRRAS for several years as a sell-side analyst at the leading Nordic investment bank ABG and knows the company and sector well.

“We have known Sten since 2017 through his previous investment banking experience,” said Sabina Berlin. “His thorough knowledge of IRRAS, our industry, and the investor community will be very valuable to the company and will make him a great addition to the team.”

“IRRAS is a company with world class products and enormous potential given the large clinical need,” said Gustafsson. “I have followed the company for years, and I am encouraged by recent developments with the company that have built the foundation for future growth. I am excited to join the team at this time as commercialization ramps up globally.”

Mr. Gustafsson’s most recent experience was with Nordea as a sell-side analyst covering the Healthcare sector. He has more than 20 years of experience in the financial markets, having worked in both Stockholm and New York in various positions.

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  

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

The information was released for public disclosure, through the agency of the contact person above, on March 9, 2021 at 08:30 (CET).

Irras Radio Irras Academy

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