Untitled

ANNUAL REPORT 2020

XVIVO PERFUSION AB (PUBL)

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

CONTENT

XVIVO Perfusion in brief 2

Key events in 2020 3

CEO has the oor 4

Business concept, goals and strategies 7

Business model 12

Sustainability 15

Transplantation 20

Organ donation - the gift of life 25

XVIVO Perfusion’s offer 26

Trends and market 34

Research and Development 38

The Share 40

FINANCIAL REPORT

Administration Report 42

Corporate Governance Report 48

Financial statements - Group 52

Financial statements - Parent Company 55

Additional information and notes 58

Auditor’s report 69

Board of Directors, auditors

and senior management 72

Glossary and denitions 74

XVIVO PERFUSION IN BRIEF

More and more people in the world are in favor of donating their

organs, but despite this, there is still a great shortage of available organs.

According to the WHO, more than 160,000 organ transplants are

performed annually worldwide, but this represents only 10 percent of

the total need. The lack of organs means that many patients die while

waiting for an organ, or become so deconditioned from their illness

that they would not survive the transplant procedure and are therefore

removed from the waiting list. In the United States alone, 20 people a

day die waiting for a new organ.

XVIVO Perfusion is a medical device company that develops and

markets innovative solutions and systems for preserving and evaluating

donated organs outside the body while waiting for transplantation.

The company is active in all four major organ areas (kidney, liver, heart

and lung) and consists of two business areas: Thoracic (heart and lung)

and Abdominal (liver and kidney). In lung transplantation, the company’s

product Perfadex Plus has a market share of approximately 90 percent

in the traditional static preservation of lungs for transplantation. The

company’s products for warm perfusion, XPS and STEEN Solution,

have gained regulatory approval in all major markets, and were the rst

products that received regulatory approval from the FDA for warm

perfusion of marginal lungs. In liver and kidney transplantation, XVIVO

Perfusion develops and sells machine perfusion products, which clinical

studies have shown to increase organ survival rates. XVIVO Perfusion

also develops the next generation pre-transplant heart preservation

products that optimize storage and transport of donor hearts through

non-ischemic heart perfusion.

XVIVO Perfusion employs around 80 people. The head ofce is located

in Gothenburg and its subsidiaries are located in Lund, Sweden, Denver,

USA and Groningen, Netherlands. XVIVO Perfusion’s share is listed on

NASDAQ Stockholm and trades under the XVIVO ticker.

We are dedicated to our vision that “Nobody should die waiting for a

new organ” and are proud that our groundbreaking innovations have

helped more patients to undergo transplantation and thereby have the

chance of a longer and better life. Alongside leading researchers and

transplantation clinics, we help to develop solutions that make a differ-

ence – for the patient, the transplant team and for society.

PERFADEX® and PrimECC® are registered trademarks of XVIVO Perfusion. STEEN Solution™,

XPS™, XVIVO LS™, XVIVO Disposable Lung Set™, XVIVO Organ Chamber™, XVIVO Lung

Cannula Set™, XVIVO Silicone Tubing Set™ are trademarks of XVIVO Perfusion.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

SIGNIFICANT EVENTS IN 2020

• First patient enrolled in the European Heart

preservation study.

• A study published in the Lancet showed better survival

of transplanted kidneys after cold machine perfusion

with added oxygen.

• XVIVO Perfusion acquired Dutch med tech company

Organ Assist.

• Directed share issue raised SEK 500 million.

• First patient in the extended PrimECC study enrolled.

• Strategic plan 2025 adopted and new organization

launched

• Magnus Nilsson passed the baton as CEO to

Dag Andersson.

• Heart preservation study from Skåne University Hospital

published in Nature Communications demonstrating

safety of the technology.

• International launch of enhanced and more user-friendly

version of Perfadex Plus with Click Port.

SEK180 million

SALES

43%

SHARE, MACHINE PERFUSION**

11%

ADJUSTED EBITDA MARGIN**

SIGNIFICANT EVENTS IN 2020

HEART PRESERVATION STUDY, PAGE 31 ACQUISITION OF ORGAN ASSIST, PAGE 26

GROUP KEY RATIOS

2020 2019

Gross margin excluding durable goods, % 77 77

Gross margin, % 74 74

EBITDA,%** -9 13

Adjusted EBITDA, %** 11 16

Operating margin,% -25 2

Net margin, % -24 2

Equity ratio, % 88 91

Earnings per share, SEK -1.61 0.19

Equity per share, SEK 35.11 21.71

Share price as of the balance sheet date, SEK 314 170

SALES, SEK MILLION

2014 2015 2016 2017 2018 2019 2020

221

180

188

148

138

120

Sales excluding durable goods

Durable goods

Machine perfusion is a new technology that improves preservation and evaluation of organs, which means more organs can be used for transplants. In the Thoracic business area, this includes

STEEN Solution, XPS, XVIVO LS and Lung Assist, as well as other products and services related to the use of these machines. In the Abdominal business area, this includes Kidney Assist

Transport, Kidney Assist, Liver Assist and Donor Assist, as well as other products and services related to the use of these machines. The share of machine perfusion corresponds to sales of

products and services for machine perfusion as a proportion of total sales of products and services. | ** Adjusted EBITDA represents EBITDA for the period adjusted for costs of warrants

programs for employees outside Sweden, integration costs attributable to acquisitions and reorganization costs.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

FIRST IN THE

WORLD TO OFFER

PRODUCTS IN

ALL FOUR MAJOR

ORGAN AREAS

CEO HAS THE FLOOR

For XVIVO Perfusion, 2020 was a successful

year in several respects. We appointed a new

management during the year and determined the

strategy for the period until 2025. There is now a

clear and distinct plan for how XVIVO Perfusion

will continue to grow protably in the coming

years and become an even stronger contender in

the transplant area.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

In September 2020, we acquired an exciting Dutch company,

Organ Assist, active primarily in machine preservation of liver and

kidney. The acquisition means that we are now able to address all

four major organ areas. Of all organs that are transplanted annu-

ally, lung and heart account for 10 percent and kidney and liver

for 88 percent.

The strong condence in XVIVO and the company’s strategy

was demonstrated by last fall’s successful capital raising, which

strengthened and broadened the company’s ownership base.

In 2020, we strengthened the organization in several areas. We

added new sales resources in North America, Europe and China.

We also strengthened our research and development organiza-

tion to ensure our ability to deliver prioritized projects.

Sales recovered

Our sales were negatively affected by the COVID-19 pandemic

from the second quarter onwards. However, the market started

to recover at the beginning of the third quarter, which contrib-

uted to total net sales for the full year of SEK 180 million (221).

EBITDA for the period, adjusted for costs relating to the issue of

warrants for employees outside Sweden and integration costs

attributable to acquisitions, amounted to SEK 20 million (36). This

corresponds to an EBITDA margin of 11 percent (16), which I

am satised with considering the challenges the pandemic has

caused.

It is my belief that we will have to live with the reality that the

pandemic brings for a large part of 2021. We have an ambitious

commercial plan for the full year, but should expect that 2021

will start weaker than a normal year, then gradually improve in

conjunction with the recovery of the global transplant industry.

R&D in focus

In 2021, we intend to increase investments in research and devel-

opment more than we have done in any previous year. We have

several prioritized projects underway. In 2020, our clinical studies

were affected by the Covid-19 pandemic as many hospitals in

many countries temporarily halted their research programs. The

clinical studies linked to our heart project started in earnest in

the fourth quarter with recruitment of patients in both Belgium

and Sweden.

Another very interesting advance in research was highlighted

in an article published in the prestigious scientic journal, The

Lancet last fall. The article shows that oxygenated perfusion of

kidneys using XVIVO’s products during transport to the hospital

has a signicant positive impact on rst-year results after trans-

plantation. Researchers found that in the group with oxygenated

perfusion, signicantly fewer patients experienced a complete

loss of kidney function after the transplant, only 3 percent

compared to 10 percent in the group that did not receive this

treatment. One of our goals for 2021 is to commercialize the

upgraded kidney transport unit that enabled the positive results

achieved in the study.

New company – new brand

In 2021, there will also be important changes to our brand plat-

form and our brand guidelines. As a consequence of the acquisi-

tion of Organ Assist, we need a platform and visual identity that

clearly shows that the new XVIVO Perfusion has machines and

solutions for all major organ areas.

Priorities in 2021

A very exciting period lies ahead. The integration of Organ Assist

is one of our priorities for 2021. We will primarily focus on

ensuring that the sales organization can handle our more com-

plete range of machines and solutions for all major organ areas.

Our heart preservation project will remain the focus of our

research and development work. In addition to the studies

started in Europe, we plan to initiate studies in Australia in the

beginning of the year and to initiate our study in the USA before

year end.

We will also seek regulatory approval for the new oxygenated

kidney transport unit in Europe and North America. We are

convinced that there is great potential in this product. Another

product with a great potential is our liver perfusion machine, for

which we aim to submit an application to FDA during 2021 to

obtain regulatory approval on the American market.

Finally, we will continue to clarify the positive results, effects and

values generated by our products. With a product portfolio that

is best in class we can actively work on our price strategy and

ensure continued great margins on our products.

It has been a rewarding rst year for me in my role as CEO. I

am very impressed by my colleagues’ high level of competences

and strong commitment. I would like to thank my colleagues at

XVIVO Perfusion for their efforts and resilience during the year,

and welcome you to join me in developing the company during

2021 and in future.

Dag Andersson, CEO

CEO HAS THE FLOOR

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

OUR VISION IS

THAT “NO ONE

SHOULD HAVE TO

DIE WAITING FOR A

NEW ORGAN”

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

BUSINESS CONCEPT, GOALS AND STRATEGIES

Vision

XVIVO Perfusion’s vision is that “no one should have to die

waiting for a new organ”.

Business concept

The business concept is to develop and market effective prod-

ucts for preserving and evaluating organs outside the body while

awaiting transplant.

This means that XVIVO Perfusion can increase availability of

organs with good survival potential during transplantation.

Strategy and targets to 2020

Between 2018 and 2020, XVIVO Perfusion’s strategy focused on

increasing the number of available organs for transplantation by:

• Maintaining its position as market leader in cold preservation

of lungs

• Establishing warm perfusion as a standard treatment in lung

transplantation

• Expanding operations to other organs

In 2020, XVIVO Perfusion worked towards the following specic

targets:

• Continued establishment of the use of XPS and STEEN

Solution worldwide

• Begin multicenter clinical studies for heart transplantation

• Expand the clinical documentation of PrimECC with multi-

center clinical studies

Operational targets

The operational targets from 2021 are:

• Obtain FDA approval in the US for Kidney Assist Transport

machine

• Establish organization for the Abdominal area in the US.

The operational targets to 2025 are:

• Offer a complete product portfolio for lung, heart, liver and

kidney transplantation by 2025

• Become the world leader in preservation and evaluation of

donated organs.

BUSINESS CONCEPT, GOALS

AND STRATEGIES

XVIVO Perfusion’s vision is that no one should have to die waiting for a new organ. For more than 20

years, the company has developed innovative products to make more organs available for transplantation.

We are the market leaders in lung transplants and the leaders in research in organ perfusion. During the

year, we adopted a new strategy for 2021–2025 focused on becoming world-leading in all major organs

and strengthening our commercial potential.

1998 XVIVO Perfusion is

founded by Magnus Nilsson

when he acquired the rights to

PERFADEX.

XVIVO Perfusion initiates

collaboration with Professor

Stig STEEN at Lund University.

The aim is to develop new

technology for warm perfusion

of lungs.

2006 STEEN Solution for

warm perfusion of lungs is

approved for sales in Europe.

2008-2014 Intensive

development work resulted in

the XPS, a machine for warm

perfusion of lungs. Plus FDA

HDE approval.

2012 XVIVO Perfusion is

distributed to the shareholders

of Vitrolife and listed on the

NASDAQ OMX First North.

2016 XVIVO Perfusion

acquires Vivoline Medical AB

and expanded the product

portfolio within lungs as well

as took over control of an

advanced development project

for the storage and evaluation

of heart.

2017 The rst clinical heart

transplant using the new heart

preservation technology for

donated hearts developed by

XVIVO Perfusion carried out.

2019 XVIVO Perfusion

received PMA (Pre Market

Approval) approval from the

US FDA for the products XPS

and STEEN Solution system.

2020 XVIVO Perfusion

acquires the Dutch medical

technology company Organ

Assist and becomes rst in

the world to actively conduct

business in all four major organ

areas.

OUR JOURNEY TO DATE

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

BUSINESS CONCEPT, GOALS AND STRATEGIES

STRATEGIC GOALS 2020 DEVELOPMENTS IN 2020

Maintaining its position as market leader in cold

preservation of lungs

PERFADEX has been the market standard for lung

preservation for over 15 years. The solution is used

in more than 90 percent of all lung transplants

performed worldwide.

The enhanced and more user-friendly Perfadex Plus with Click Port was

launched worldwide. This was a key milestone as this version is easier to use,

which reduces the risk of error handling and increases patient safety.

Establish machine perfusion as the standard

treatment for lung transplantation

Only 20-30 percent of all donated lungs go to trans-

plantation. Meanwhile, approximately 20 percent of

patients on the waiting list die while waiting for new

lungs. The EVLP method with STEEN Solution pro-

vides more available organs. This results in life-saving

treatments for more patients, improved quality of life

and socio-economic benets.

Total sales from machine perfusion for the year represented 37 percent (47)

of total sales. The decrease was due to fewer EVLPs carried out as healthcare

operators on many markets have been forced to prioritize emergency care as

a result of the Covid-19 pandemic.

University Hospital AKH in Vienna, one of the largest clinics for lung transplants

in Europe, was one of the clinics that purchased an XPS.

Expand to other organs

XVIVO focuses on enabling more transplantations

of organs other than lungs. To begin with, the goal

was to expand to heart transplants, and later also

to liver and kidney. The initiative is based on XVIVO

Perfusion’s strong position in lung transplantation, and

its established network in thoracic surgery.

During the year, XVIVO Perfusion acquired the Dutch medical technology

company Organ Assist B.V. Organ Assist develops machines and consumables

for perfusion of liver and kidney. The acquisition made XVIVO Perfusion the

rst company in the world, within preservation and evaluation of transplant-

able organs, to actively conduct business in all four major organ areas, and the

company achieved its strategic goal of expanding to liver and kidney.

The scientic journal Nature Communications published an article about

XVIVO Perfusion’s use of heart preservation technology. The single-center

study describes the heart preservation method as safe.

The rst patient in XVIVO’s European Heart preservation study

received a transplant at the end of the year. The patented technology devel-

oped by Professor Stig Steen and commercialized by XVIVO Perfusion, uses

a novel technique for preservation of the donor heart during transport. The

study forms the basis of a European regulatory approval application and will

investigate if the new technology can improve patient outcomes and reduce

complications after heart transplantation.

An article published in the scientic journal The Lancet shows that oxygenated

perfusion of kidneys before transplantation has a signicant positive impact on

how the body reacts to the transplanted organ in the rst year after transplan-

tation. The Kidney Assist Transport device, used in the trial, has been developed

by Organ Assist and is CE-marked. XVIVO Perfusion plans to apply for FDA

approval for the machine in 2021 in order to launch the product in the US.

GOALS 2020 ACTUAL

Continued establishment of the use of XPS and

STEEN Solution worldwide.

Progress in the year was limited as a result of the Covid-19 pandemic.

Begin multicenter clinical studies for heart

transplantation

One of three studies started as planned in the year, the others are expected to

start in 2021. This is also a result of the outbreak of the pandemic.

Expand clinical documentation of PrimECC

with multicenter clinical studies.

First patient included in XVIVO Perfusion’s extended PrimECC study. PrimECC

is a uid used to prime heart-lung machines for surgery. The uid aims to

reduce complications after heart surgery. The extended study that has now

begun intends to expand the clinical documentation for PrimECC and will

include a total of 366 patients

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

OUR STRENGTHS

XVIVO Perfusion is a strong

brand in lung transplantation and

is the market leader in both cold

preservation and warm perfusion

of donated lungs.

THE WORLD

LEADER IN LUNG

TRANSPLANTATION

XVIVO Perfusion returned growth

and positive EBITDA every quarter

since the share was listed in

October 2012, a trend that was

interrupted in 2020 as a result of

the Covid-19 pandemic.

PROFITABLE

GROWTH

XVIVO Perfusion has a global

market presence and long

established relationships with

world-leading researchers and

transplant clinics around the

world.

ESTABLISHED

NETWORK IN ORGAN

TRANSPLANTATION

Together with Igelösa Life Science

and Professor Stig STEEN, XVIVO

Perfusion has developed unique

solutions for caring for organs

outside the body for more than 20

years.

EXPERTS IN ADVANCED

SOLUTIONS FOR

TRANSPLANTATION

XVIVO Perfusion has extensive

experience in research and

development, through the process of

obtaining regulatory approval and the

various phases of market launch.

SUCCESSFUL

ORGANIZATION FOR

INNOVATION

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

NEW STRATEGY 2021–2025

XVIVO Perfusion’s strategy for the period 2021 to 2025 focuses on commercial

operations and optimizing availability of relevant products for organ donation

when and where they are needed. The goal is that no one should have to die while

waiting for a new organ.

In the period since the company was founded more than 20 years ago, we have

built solid competences and capacity in research, development and the regulatory

eld. We are now developing further with a new management and organization,

and are focusing on ve strategic areas: an offer that includes all four major organs,

bringing innovation closer to our customers, building a high-performing organization,

strengthening our commercial ability and developing the company’s operations.

THE WORLD LEADER IN

ALL MAJOR ORGANS

XVIVO Perfusion will build on its strong

position in lung transplantation and

develop the offer to include machines,

solutions and other products for pres-

ervation and evaluation of all four major

organs; lungs, heart, kidney and liver. The

transition from what was essentially

one product group for a single organ

to a product portfolio that includes

multiple organs is equally important and

challenging. XVIVO Perfusion’s progress

in kidney and liver is largely due to the

acquisition of Organ Assist.

CUSTOMER-DRIVEN

INNOVATION

To develop XVIVO Perfusion

commercially, we will bring innovation

and progress even closer to our

customers. This allows us to benet

from our good relationships with

institutions and clinics, and our strong

position in research and development.

By increasingly proceeding from

customer insights, we reduce the time

needed for commercialization of new

products and strengthen our customers’

perception of and loyalty towards

XVIVO Perfusion and our products.

STRATEGIC

AREAS

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

HIGH-PERFORMING

ORGANIZATION

XVIVO Perfusion has developed its

leading research and development

competences and capacity over many

years. The next phase consists of build-

ing an even more efcient organization

to ensure the successful commercializa-

tion of XVIVO Perfusion’s products in

the shortest possible time.

The rst steps were taken in the year

and included a reorganization and the

appointment of several key positions.

COMMERCIAL

POTENTIAL

To expand in the manner we want,

XVIVO Perfusion will become com-

mercially stronger. This includes devel-

oping our competences and capacity

in marketing and sales. We are also

preparing the company for geographical

expansion in Asia (particularly China),

the Middle East (particularly Saudi

Arabia) and Latin America (particularly

Brazil). Finally, we will clarify the positive

results, effects and values generated by

our products. The aim is also that

pricing will mainly be based on results

and value.

OPERATIONAL

STRENGTH

XVIVO Perfusion’s commercial potential

is closely associated with our opera-

tional strength. A clearer operational

focus will imply careful review and

selection of projects, designs that are

adapted to manufacture, fewer distribu-

tion points and improved cost efciency

and delivery reliability. The aim is a rel-

evant and protable product portfolio

that generates the greatest possible

benet for customers and patients.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

BUSINESS MODEL

BUSINESS MODEL – FROM

RESEARCH TO SALES

XVIVO Perfusion’s business model aims to strengthen our leading position in organ transplantation

by successfully taking groundbreaking innovations from idea to marketable product. The business

model includes long-term relationships in innovation and research as well as close collaborations with

selected partners.

XVIVO Perfusion’s research is

mainly carried out in collaboration

with world-leading institutions and

researchers. By conducting different

research projects alongside with

partners in the US, Canada and

EMEA, we ensure our level of

competence in the clinical eld and

that we remain at the forefront of

clinical development.

Product development largely takes

place in-house at our head ofce in

Gothenburg (for solutions), at the

subsidiaries in Lund (for heart), in

Denver (for lung) and Groningen (for

kidney and liver). Good knowledge

of manufacturing methods and

regulatory requirements allows us to

streamline the process and shorten

the time to market.

Clinical studies are of great

importance to XVIVO Perfusion,

partly because they form the basis

for approval of products, but also for

expanding the elds of application.

Pre-clinical and clinical studies are

conducted in collaboration with

hospitals and universities. In order

to introduce the products to each

market, regulatory approval is

required. The regulatory landscape

has become increasingly complex

as the demands of the authorities

have increased. XVIVO Perfusion’s

regulatory work ensures that our

innovations reach all markets in the

shortest possible time.

INNOVATION

AND RESEARCH

PRODUCT

DEVELOPMENT

CLINICAL STUDIES

& REGISTRATION

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Patent protection for intellectual property rights

XVIVO Perfusion invests heavily in research and development.

Patent protection is important to XVIVO Perfusion’s business

areas, as product cycles are long and investments in product

development are signicant. XVIVO Perfusion continuously les

applications for patents to protect existing and future products.

Currently XVIVO Perfusion has 15 families of patents or patent

applications at different stages.

XVIVO has two main patents in the eld of heart transplantation.

One covers the solution used in heart preservation; this patent

is valid until 2035. The second includes important parts of

the equipment used for heart evaluation after preservation,

but before transplantation. The patent is valid until 2036.

Together, these patents strengthen XVIVO’s position in heart

transplantation on all major global markets. In addition to the two

main patents, XVIVO Perfusion also holds patents for products

and product families:

STEEN Solution: STEEN Solution, our liquid for warm

perfusion of lungs, is protected by patents in 15 countries,

including EP validations. The patents are valid until 2021/2022 and

protect both the product and the use of STEEN Solution.

PrimECC: PrimECC, XVIVO Perfusion’s solution for use in

heart-lung machines, is currently protected by patents in 15

countries, including EP validations. The patents are valid until

2031. The U.S. patent protects the use of a solution similar to

PrimECC for use in priming heart-lung machines.

PERFADEX Plus: PERFADEX Plus is protected by a patent

approved in Europe to date.

XVIVO Perfusion owns all rights to the products it markets.

BUSINESS MODEL

The production of XVIVO Perfusion’s

products mainly takes place through

carefully selected subcontractors.

By outsourcing the manufacturing

process, we avoid costly investments

in production equipment and can

focus on our core business.

At the same time, it provides

greater exibility in the event of

increased/reduced demand. Long-

term and close cooperation with

our subcontractors is of great

importance in order to meet XVIVO

Perfusion’s high quality standards.

XVIVO Perfusion’s products

are marketed by its commercial

organization in Europe and North

America and is mainly distributed

directly from Gothenburg, Denver

and Groningen. On other markets

the company uses distributors. The

commercial organization works

closely with transplantation centers

to support the use of XVIVO

Perfusion’s products. Our customers’

experience and opinions are taken

into account in relation to all market

innovation, product development and

market processing.

User training and technical training

are an important part of our

customer and after-market support.

XVIVO Perfusion’s in-house

organization is responsible for

installation, training, service and

support. XVIVO Perfusion provides

training locally and at the company’s

training facilities in Denver, Lund and

Groningen. In addition, the company

offers clinics advanced training and

exchange of experience.

MANUFACTURE MARKETING

& SALES

AFTER-MARKET

SUPPORT

& SERVICE

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

“OUR EMPLOYEES’

COMMITMENT,

COMPETENCES AND

EFFICIENCY ARE KEY

TO OUR SUCCESS”

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

SUSTAINABILITY

INTERNAL CONTROL AND ORGANIZATION

The Board has the overall responsibility for XVIVO Perfusion’s

organization and internal control under the Companies Act. The

Board monitors management’s work through monthly reports

that include nancial results, key gures and results in prioritized

activities. The work also includes follow-up of the company’s sus-

tainability work. XVIVO Perfusion’s sustainability work is led and

coordinated by the company’s CFO. The company’s task force

for sustainability includes representatives from key functions such

as research and development, purchasing and production, quality

control, HR and markets.

Code of Conduct

The company’s Code of Conduct is XVIVO Perfusion’s primary

sustainability policy. This includes guidelines for business principles,

human rights and working principles.

The Code of Conduct is based on the United Nations

Universal Declaration of Human Rights, the International Labour

Organisation Declaration on Fundamental Principles and Rights

in the Workplace, the UN’s Global Compact and the OECD

Guidelines for Multinational Enterprises. The Code is reviewed

and approved annually by the Board. The Code applies to all

employees and sets the standard for professionalism and integrity,

with the aim of ensuring that all employees act legally and appro-

priately in relation to the company’s stakeholders.

XVIVO Perfusion’s Code of Conduct is available at

xvivoperfusion.com.

EMPLOYEES

Our employees are proud to contribute to recipients of new

organs being able to live longer and better lives.

XVIVO Perfusion employs around 80 people. The head ofce is

located in Gothenburg and our subsidiaries are in Lund, Sweden,

Denver, USA and Groningen, Netherlands. XVIVO Perfusion

also has employees in several other European countries, and in

several US states and Australia. In 2021, we will also establish a

sales organization in China.

The number of employees increased signicantly in the year. 37

new colleagues were employed in XVIVO Perfusion, of which

19 came from Organ Assist, the Dutch company we acquired in

2020. As a result, we have focused sharply on integration, com-

munication and streamlining the organization in the year. Our

employees’ commitment, competences and efciency are critical

to XVIVO Perfusion’s success. We are continuing the expansion

and development of the organization.

XVIVO Perfusion is a knowledge-intensive company where our

employees are the single most important asset for our long-term

competitiveness and protability. XVIVO Perfusion prioritizes and

secures our employees’ commitment, talent and competence

development, market-based remuneration and wellbeing.

SUSTAINABILITY

XVIVO Perfusion seeks to contribute to social progress and improve human health. Our responsibility

includes both our employees and relationships with external stakeholders. XVIVO Perfusion’s opera-

tions are global, and a sustainable business strategy that contributes to a healthier and cleaner world is

an important key to success.

EMPLOYEES PER FUNCTION

Administration

Clinical

Commercial

Operations

QA/RA

R&D

EMPLOYEES PER COUNTRY

Australia

China

Germany

Spain

France

The Netherlands

Sweden

United Kingdom

USA

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Policies and internal control

XVIVO Perfusion’s management of personnel-related matters is

based on a number of policies and routines. The most important

are our Code of Conduct, the HSEQ policy (including diversity

and inclusion), health and safety routines and our integrity policy.

The purpose and aims of the company’s HR strategy are largely

the same throughout XVIVO Perfusion, although local strate-

gies may vary. XVIVO Perfusion introduced the role of Global

HR Manager at the end of 2020. The intention is to drive HR

initiatives focusing on commitment, productivity and business

value. Another priority is to clarify and streamline HR processes

throughout the organization.

XVIVO Perfusion plans to rationalize and strengthen the com-

pany’s HR processes by implementing a company-wide HR

information system. This is part of the strategy aimed at increas-

ing collaboration and efciency throughout the organization. This

will be implemented at the beginning of 2021.

Employee rights

XVIVO Perfusion respects human rights. Respect for individu-

als and their integrity and dignity is fundamental to all relations,

both within XVIVO Perfusion and in relation to our customers,

partners and other external stakeholders. Naturally, XVIVO

Perfusion has a special responsibility towards the employees of

the company. All XVIVO Perfusion’s sustainability-related policies

and principles are outlined in the company’s Code of Conduct.

XVIVO Perfusion’s employees are entitled to join or establish any

form of association and to organize themselves and negotiate

collectively and individually in accordance with local legislation

and regulations. No member of staff shall risk harassment or

retribution for exercising these rights.

XVIVO Perfusion is an organization with global operations where

language skills and the ability to operate in different cultures are

key factors for success. XVIVO Perfusion is a workplace where

diversity is respected regardless of gender, gender identity, ethnic-

ity, religion or faith, disability, sexual orientation and age.

Employment and benefits

In order to attract and retain skilled and competent staff, XVIVO

Perfusion increasingly focuses on ensuring efcient working meth-

ods and collaboration processes, competitive performance-based

remuneration, programs for variable remuneration for key staff

and an attractive benets package.

Remuneration includes insurance benets. All employees are

covered by insurance policies intended to secure employees’

and their families’ health, wellbeing and safety. Arrangements vary

slightly between countries.

Health and safety

XVIVO Perfusion’s seeks to ensure a positive working environ-

ment and employee health and wellbeing by matching the right

person to the right assignment, which provides opportunities

for variety and professional development. XVIVO Perfusion also

SUSTAINABILITY

”People have the potential to create

magnicent companies. I started

at XVIVO Perfusion to ensure

that every individual employee

feels enthusiastic and is ready to

contribute to our vision and success.”

Natalia Ala, global HR director

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

SUSTAINABILITY

seeks to meet requests for exible working hours. The aim is to

facilitate a positive work-life balance.

Our employees work in a modern ofce environment with ergo-

nomic work stations and the opportunity to move around during

work. XVIVO Perfusion’s main health and safety risks relate to

repetitive strain injuries and stress-related illnesses. No accidents

in the workplace were reported in 2020. XVIVO Perfusion also

provides extensive health benets, including rehabilitation plans

when needed.

Performance review and personal development

XVIVO Perfusion has a formalized process for following up

results in biannual performance reviews. This process involves

setting expectations and dening key targets and priorities linked

to the company’s strategic goals and core values. The reviews

also include planning individual development, including leadership,

teamwork and working environment. The results of the perfor-

mance review form the basis for talent development, individual

development and salary reviews. The purpose is to develop and

retain talented and competent employees.

We take a transparent and constructive approach to the formal

performance follow-up as well as in day-to-day work. Mutual

exchange and feedback ensure commitment and gives our

employees the opportunity to develop as individuals as well as

part of a team and the company.

SOCIAL RESPONSIBILITY

Corporate culture and core values

Everyone who works at XVIVO Perfusion is dedicated to our vision

that “nobody should die waiting for a new organ” and is proud that

our innovations help give patients the opportunity to live longer

and better lives. For more than two decades we have focused on

developing, manufacturing and marketing technology that contrib-

utes to making more donated organs available for transplant.

XVIVO Perfusion has a strong corporate culture with clear

values. During the year, we worked on developing our shared

values and formulated the core values that guide us in our work.

The starting point for this work came from input from our

employees, customers and distributors and other collaboration

partners. Employees were given the opportunity to make their

voices heard in ve workshops across all sites, and feedback from

other stakeholders was collated in a survey. The work resulted

in dening our core values: research-driven, customer-oriented,

collaborative and meaningful. The core values will be applied even

more in our day-to-day work in future, and in the communication

with our employees.

Research and development

XVIVO Perfusion provides nancial support to various research

projects carried out by clinics, academic institutions and other

external parties. We want to increase the body of knowledge in

the eld of transplantation, both in order to improve our prod-

ucts and to nd new and better solutions for preserving organs

outside the body ahead of transplantation.

Product safety and quality

The high quality and safety of our products is critical to our

operations. We assure the quality and safety of our products

by complying with applicable legislation and regulations, as well

as our internal process-based quality management system. We

analyze and review quality continuously throughout the product

lifecycle.

AGE DISTRIBUTION

Managers Non-managers All employees Management

59%

13%

28%

62%

10%

28%

57%

43%

72%

28%

<30 30–50 >50

Managers Non-managers All employees Management The Board

GENDER DISTRIBUTION

50% 50%

56%

44%

57%

43%

71%

29%

Men Women

61%

39%

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Quality management system

XVIVO Perfusion has established, documented and implemented

a global process-based quality management system. We are

dedicated to upholding the efciency of the system and to con-

tinuous improvement. Our unit in Groningen has a local quality

control system and staff that are responsible for local quality

management and compliance.

Our quality management systems are certied according to the

standards that apply to the products we manufacture. XVIVO

Perfusion complies with the regulations that apply on markets

where our products are sold. Certication includes ISO 13485

and MDSAP (Medical Device Single Audit Program) for compli-

ance with standards and legal requirements on markets for medi-

cal technology products in Australia, Brazil, Canada and the US.

Following up product performance

In order to continuously deliver improvements and benets to

customers, we focus on design and quality control, audits, man-

agement reviews, supplier management and following up on the

products we have launched and sold.

Our product development process ensures that customer

needs are satised and that safety standards are met. All ideas

are evaluated in depth and potential design risks are identied

and eliminated or minimized. We use vivisection restrictively in

our product development and actively seek to develop alterna-

tive test methods. We test our products on animals only when

it is required by law. Clinical trials carried out or outsourced are

planned and completed in accordance with the ethical principles

indicated in the Helsinki declaration and follow GCP principles

(Good Clinical Practice) and applicable legislation and standards.

XVIVO Perfusion continuously monitors processes and products

during the production phase to ensure that our products satisfy

quality requirements.

We implement continuous improvements in our CAPA pro-

cess (Corrective and Preventive Action) and conduct extensive

investigations of root causes. This is followed up with correc-

tive measures aimed at solving problems and preventing repeat

occurrences. We follow up compliance with the quality manage-

ment system in our internal audit process. We are also subject to

external auditing, which drives improvements.

The company’s quality management system is reviewed at

management level and is organization-wide. The efciency of our

quality management system is analyzed in the review process. We

identify areas of improvement and introduce necessary measures

when we do not meet our quality targets and demands.

All our suppliers are evaluated to ensure that they meet our

quality requirements. When necessary, we conduct on-site

inspections based on a risk assessment. We require all suppliers

to accept and adhere to our supplier demands.

After a product has been launched, we monitor progress in clini-

cal follow-up and risk management processes, and aftermarket

follow-up. We review how our products are being used to ensure

that they satisfy customer needs. We investigate all customer

complaints relating to our products. Customer satisfaction is

measured regularly in surveys to ensure that our products meet

customer expectations. We use this feedback and the lessons

learned from it to continuously adapt and improve our products.

Training aimed at our customers and distributors ensures the

safe and effective use of our products. We offer training and

workshops at our customers’ clinics and in our premises.

”OUR OPERATIONS ARE

BASED ON THE PRINCIPLE

THAT ALL OPERATIONS ARE

FOUNDED ON SOUND

BUSINESS ETHICS”

NEW EMPLOYEES 2020 NEW EMPLOYEES BY FUNCTION INCL. ACQUISITIONS

Company-wide Management 0 5 10 15 20 25

22%

43%

56%

57%

Administration

Clinical

Commercial

Operations

QA/RA

R&D

New employees New employeesNew employees via acquisitions New employees via acquisitionsOther Beginning of year

SUSTAINABILITY

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

How we conduct clinical trials

All clinical trials that XVIVO Perfusion carries out or outsources are

planned and completed in accordance with the ethical principles

indicated in the Helsinki declaration and follow the GCP principles

(Good Clinical Practice) and applicable legislation and guidelines.

XVIVO Perfusion undertakes to carry out clinical trials in accord-

ance with applicable local regulations and international legal

requirements. These include 95/46/EG (on the protection of

individuals with regard to the processing of personal data and

on the free movement of such data) and ISO standard 14155

(Clinical investigation of medical devices for human subjects —

Good clinical practice).

To ensure that patient rights, safety and wellbeing are protected,

that reported data is reliable and robust and that the conduct of

clinical trials corresponds to MDR 2017/745, XVIVO Perfusion

undertakes to subject itself to sufcient oversight of all clinical

operations. The extent of such oversight is determined on the

basis of assessments that include all the characteristics of the

clinical trial.

Human rights

XVIVO Perfusion promotes diversity and equality. Equal treat-

ment and equal opportunity shall apply to all regardless of

gender, gender identity, ethnicity, religion or faith, disability, sexual

orientation and age. XVIVO Perfusion does not accept any form

of mental or physical punishment, threat of punishment, discrimi-

nation in connection with job opportunities or employment,

bullying in the workplace or sexual or other forms of harassment.

XVIVO Perfusion shall not utilize forced labor and/or child labor

in any part of its operations and shall ensure that business part-

ners act in the same manner.

It is critical that XVIVO Perfusion’s suppliers maintain the highest

standards in terms of regulatory compliance, human rights, work-

ing conditions and environmental considerations. All our major

suppliers are obliged to follow our Code of Conduct.

Our contribution to society

In addition to the values that XVIVO Perfusion’s products gener-

ate, our primary social contribution comes from our extensive

research work. In 2020, approximately 60 percent of revenue

was reinvested in research and development.

One example of signicant advances resulting from XVIVO

Perfusion’s development work is our offering in machine perfu-

sion of lungs, liver and kidney. Clinical studies show that these

products allow more donated organs to be used for transplanta-

tion. This gives more people the opportunity to live longer and

more active lives, which ultimately increases quality of life and

generates socioeconomic benets.

XVIVO Perfusion supports and collaborates with organiza-

tions and associations that work to increase organ donation

and improve the lives of the families affected. In Sweden,

XVIVO Perfusion supports MOD (More Organ Donation) and

Jontefonden, as well as other funds. In the US, we have recently

made donations to institutions such as Transplant House in

Philadelphia and Donate Life Float.

BUSINESS ETHICS AND

ANTI-CORRUPTION POLICY

XVIVO Perfusion’s operations are based on the fundamental

principle that good business ethics must prevail in all business

operations and relationships with our customers, business part-

ners and the authorities.

We fully comply with anti-trust legislation and all applicable

competition laws regulations in force in the countries where we

operate.

XVIVO Perfusion does not accept that bribes – regardless of

form, method or purpose – are offered, demanded or accepted.

No employee is permitted to demand or accept gifts, entertain-

ment or personal services that could reasonably be considered

to inuence business transactions or that contravene applicable

legislation or business practice. Our business ethics also mean

that we do not take a political standpoint. Therefore, our funds or

assets are not used to support political campaigns or candidates,

or otherwise provide services for political purposes.

ENVIRONMENTAL RESPONSIBILITY

XVIVO Perfusion’s environmental impact is primarily derived

from the production of and materials for our products (mainly

single use articles), and transports and travel (mainly by air).

We strive to rationalize our processes and transport in dialog

with our customers and suppliers. In addition, we offer a global

product range and extended durability for our products, which

contributes to reducing the environmental impact. Because

XVIVO Perfusion’s employees are based on several different

continents, we hold digital internal meetings as far as possible and

only travel when necessary.

SUSTAINABILITY

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

ENORMOUS NEED

FOR NEW ORGANS

In 2019, approximately 163,000 organ transplants were performed from more than 38,000 donors.

Although the number of donors is increasing it is not enough - according to the WHO the number

of transplants performed only corresponds to 10 percent of the need. Because of the acute shortage

of organs, patients are subject to a strict selection process before being added to the waiting list to

receive a new organ.

ORGAN TRANSPLANTATION

Over 250,000 people in the US and Europe are waiting for a

new organ. Most people are waiting for a kidney, many for a

liver and some for lungs or a heart. The background could be a

congenital and potentially hereditary condition, but also exposure

to tobacco, alcohol or infectious diseases. The people waiting for

new organs are seriously ill and are expected to live for less than

two years. Approximately 25 percent of the people waiting for

new lungs or a new heart die while waiting for the new organ or

are removed from the waiting list because they become too ill to

undergo a transplant.

LUNG TRANSPLANTATION

Lung transplantation is the last option for treating a

patient with terminal lung disease, where other medi-

cal or surgical options are excluded and the expected survival

rate is less than 2 years without a new organ.

Causes. The top four underlying diseases that cause a patient to

need new lungs are mainly chronic obstructive pulmonary dis-

ease (COPD), cystic brosis (CF), idiopathic pulmonary brosis

(IPF) and pulmonary arterial hypertension (PAH).

Common causes of COPD are tobacco smoking and exposure

to various types of pollutants. The WHO estimates that 200

million people suffer from COPD and the disease causes 3 mil-

lion deaths each year. Cystic Fibrosis is a progressive disease that

causes abnormal mucus formation, which affects the lungs and

digestive organs in particular. The thick mucus leads to signicant

and chronic respiratory infections often requiring antibiotic and

nebulized treatment and hospitalization. These infections result

in progressive loss of lung function and decreased survival and

is marked by acute worsening of symptoms often requiring hos-

pitalization which are called “pulmonary exacerbations.” IPF is a

disease progressively worsening scar tissue in the lungs, whereby

the lung cannot take in enough oxygen. Pulmonary arterial

hypertension is a life-threatening progressive disorder where the

pressure in the pulmonary artery is too high, thereby destroying

blood vessels in the lungs.

Background. The rst lung transplant was performed in 1963,

but it took until 1982 for the rst lung transplant patient to live

long enough to leave the hospital. Survival after a lung transplant

has increased as surgical techniques have been rened, immuno-

suppressive drugs have been introduced, aftercare improved and

preservation solutions and techniques become more advanced.

Today, lung transplantation is an established standard treatment

for patients with terminal lung disease.

Advances. Although the survival rate after lung transplantation

is relatively good – about 80 percent after the rst year – lung

transplantation is carried out to a limited extent. The main

reason is a lack of organ donors. Another limitation is that the

lungs often suffer from rapidly impaired function once the donor

dies. In as much as 80 percent of cases, the lungs are in too

poor a condition to be transplanted. With the help of Ex Vivo

Lung Perfusion, the proportion of transplantable organs can be

increased from 20% to 40%.

WAITING LISTS IN THE US

Waiting listDonors Transplants

140 000

120 000

100 000

80 000

60 000

40 000

20 000

1992 20192000

VäntelistaDonatorer Transplantationer

1992 20192000

A GROWING GAP BETWEEN

THE NEED FOR ORGAN

TRANSPLANTATION AND THE

AVAILABILITY OF DONATED

ORGANS SINCE THE WAITING

LISTS ARE GETTING LONGER.

THE CURVE ILLUSTRATES THE

WAITINGLIST SITUATION IN USA.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

ORGAN TRANSPLANTATION

HEART TRANSPLANTATION

Heart transplantation is the last option for treating severe

heart failure, where other medical and surgical treatment

options have been exhausted.

Causes. The main causes of heart failure are the destruction

of parts of the myocardium after one or more heart attacks,

congenital heart defects (usually unicameral hearts), severe heart

muscle disease, very high blood pressure and certain metabolic

diseases. The prognosis for severe heart failure is very poor and

half of patients die within one year of diagnosis. The WHO esti-

mates that cardiovascular diseases (including stroke) cause more

than 17 million deaths each year.

Background. The rst heart transplant was performed in 1967,

but the results of the rst transplants were disappointing. It was

not until the 1980s that heart transplantation was established as

a method. Like for those receiving lung transplants, patients that

have received a new heart now live longer as surgical tech-

niques have been rened, immunosuppressive drugs have been

introduced, aftercare improved and preservation solutions and

techniques have become more advanced. Today, heart trans-

plantation is an established standard treatment for patients with

severe heart failure.

Advances. While research has led to many advances and better

treatments, unfortunately the number of people with cardiovas-

cular disease is on the increase. The cause is unhealthy lifestyles

such as smoking, insufcient exercise and unhealthy eating habits.

Nowadays some patients can receive mechanical heart pumps,

known as the Left Ventricular Assist Device (LVAD). The heart

pump helps the diseased heart and restores blood circulation in

the body. These are used as a supplement while awaiting heart

transplantation.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

KIDNEY TRANSPLANTATION

Kidney transplantation is the primary treatment for

chronic kidney failure. It is possible to transplant kidneys

from both deceased and living donors.

Causes. The most common causes of chronic kidney failure are

diabetes and high blood pressure, although it can also be caused

by hereditary kidney disease and kidney inammation.

People suffering from serious kidney failure, with uremia, require

regular dialysis or a kidney transplant to survive. A transplant is

often the best treatment, as the patient is able to avoid dialysis,

pharmaceuticals and frequent medical check-ups and often feels

better. Dialysis is also a very costly life preserving treatment.

According to the WHO, kidney disease is the number 10 cause

of death globally. Mortality has increased from 813,000 deaths

in 2000 to 1.3 million in 2019. Demand for kidneys far exceeds

supply; in the US, there are more than 90,000 people on the

waiting list compared to just over 24,000 completed transplants

(in 2019).

Background. Attempted kidney transplants were carried out

in the Ukraine in the 1930s, and the rst successful transplanta-

tion was completed in 1950. The rst transplants between live

patients were carried out in the 1950s, and the rst successful

surgery of this kind was completed in 1954. In that case, the

donor and recipient were identical twins, which reduced the risk

of immunoreaction. Joseph Murray, one of the surgeons behind

the transplant, was awarded the Nobel Prize in medicine in 1990.

Today, some 62,000 kidney transplants from deceased donors are

carried out each year in more than 2,200 clinics.

Advances. Advances in kidney transplantation have ensured

better care of donated organs, surgical techniques and anesthesia.

Also, the introduction of immunosuppressive pharmaceuticals,

which prevent and treat organ rejection, has been critical to

progress. The next important step is to increase the number of

kidneys available for transplantation through new machine perfu-

sion techniques.

LIVER TRANSPLANTATION

Liver transplant is a treatment option for terminal liver

disease and acute liver failure.

Causes. There are many causes of liver disease – the most com-

mon in the western world is over-consumption of alcohol. The

causes of acute liver failure vary between and within different

parts of the world. Viral hepatitis was previously the most com-

mon cause in Europe and the US, although pharmaceuticals (such

as overdoses of paracetamol) are now behind most cases of liver

failure. In many patients, it is not possible to determine the cause

of liver failure.

Background. Liver transplants were rst trialed in dogs in the

1950s and the rst trials in humans were carried out in the

1960s. In 1967, Thomas E. Starzl, a pioneer in modern trans-

plantation, successfully transplanted a liver into a girl with liver

cancer who survived for one year before dying from metastasiz-

ing disease. Liver transplantation was an experimental treatment

in the 1970s and became standard in the 1980s, largely due to

the introduction of ciclosporin, which is an immunosuppressant.

Today, some 28,000 liver transplants from deceased donors are

carried out each year in close to 1,000 clinics.

Advances. Advances in liver transplantation have ensured better

care of donated organs, surgical techniques and anesthesia as well

as optimizing the timing of transplantation. All this has ensured

that the one-year survival rate now exceeds 90 percent. The

next important step is to increase the number of livers available

for transplantation through new machine perfusion techniques.

>160 000 ORGANS

TRANSPLANTED PER YEAR,

REPRESENTING

~10% OF THE NEED*

*WHO estimate

ORGAN TRANSPLANTATION

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

ORGAN TRANSPLANTATION

XPS (XVIVO Perfusion System)

enables data registration o lung

values throughout the EVLP

procedure, which provides a

basis for analysis and evaluation

ahead of the nal clinical decision

regarding use of the lung.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

“ONE SINGLE

DONOR CAN

SAVE UP TO

EIGHT PATIENTS”

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Donation after primary brain damage

Most of the organs that are transplanted come from brain-dead

donors (donation after brain death, DBD). Brain death means

that the patient is declared dead based on neurological criteria

and that the person is dead medically and according to law. The

introduction of the denition of brain death has been critical to

organ donation and transplantation surgery.

In DBD donation, the heart maintains circulation while a respira-

tor oxygenates the blood, which facilitates the transplantation

process. There is also time to talk to relatives and to take care of

the organs.

Donation after circulatory death

DBD donation is still the rst choice but the acute shortage of

brain-dead donors has led to the re-introduction of donation

after heart death/circulatory death (DCD). This has also meant

that more people have been offered the opportunity to donate

organs after their death.

In the case of DCD, the donation process must be much faster

from when circulation stops until the organs are taken care

of. If the process takes too long, the organ becomes unusable.

Uncertainty relating to the function of these donated organs is

usually higher.

Expanded criteria donation

Another possibility that an increasing number of clinicians are

investigating is whether methods can be found to take advan-

tage of organs that have previously been abandoned, known as

expanded criteria donation. This is possible thanks to improved

technology and preservation solutions.

Organs considered marginal may come from older donors,

infected donors (such as Hepatitis B&C and HIV) or donors

with high BMI, diabetes or high blood pressure. The inclusion of

marginal organs in the donation process has made the decision

of whether or not to accept an organ more complex than previ-

ously. However, for most patients waiting for an organ the benet

outweighs the risk of receiving a marginal organ.

Major differences in donation frequency

Different countries have different success rates in terms of organ

donation. This is visible in the donation frequency, i.e. the number

of donations per capita.

The Spanish model:

There are many factors that contribute to Spain having more than

twice as many organ donors compared to Sweden in relation to

population. In Spain, it is assumed that a person is in favor of donat-

ing their organs unless they explicitly state the opposite. Sweden has

a similar system but has not achieved the same result. The reason for

the success is probably that Spain established a national transplan-

tation organization (ONT) in 1989 that improved coordination of

the donation and transplantation process. Early on, Spain introduced

donor managers (often intensive care physicians) in hospitals who

identied potential donors in intensive care units, on wards and in

emergency departments at an early stage. ONT has also trained

more than 15,000 healthcare workers in the donation process.

Another factor that has led to high donation frequency is that donors

who have died of heart death, and organs from older donors, are

accepted to a greater extent than in many countries (more than 10

percent of donors are over 80 years of age at present).

ORGAN DONATION

– THE GIFT OF LIFE

One of the biggest challenges in the eld of transplantation is the shortage of suitable organ donors.

If the availability of donated organs were greater, more patients could receive transplanted organs

and thus have the opportunity to live longer and better lives. An individual donor can save up to eight

people by transplanting the heart, lungs, kidneys, liver, pancreas and small bowel.

ORGAN DONATION

ORGAN DONORS PER MILLION INHABITANTS

49,6

SPAIN

36,1

USA

16,9

EUROPE

Source: Data from WHO-ONT Global Observatory

on Donation and Transplantation 2019.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

THORACIC OFFERING

Lung transplantation

Today, donated lungs can be taken care of in a static cold pres-

ervation process, or in combination with evaluation during warm

perfusion. XVIVO Perfusion offers products for cold static stor-

age and warm perfusion.

Products for cold static preservation

Cold preservation means that the organ is cooled by major

blood vessels being circulated with a cold solution. The lungs are

then stored in a solution in bags on ice. Cooling slows metabo-

lism and thus preserves organ function.

Products. XVIVO Perfusion main product for cold preservation

is PERFADEX Plus. The product has been the standard treat-

ment in lung transplantation for 20 years.

How it works. In addition to lowering the temperature and

decreasing metabolism, PERFADEX Plus also ushes out donor

blood that contains substances that can damage the lungs. After

that, the lungs are cooled during transport to the recipient hospi-

tal and until transplantation. In a cooled state, lungs can normally

be stored for 6-10 hours outside the body and transplanted with

good results.

Advantages. PERFADEX Plus is the standard for cold preserva-

tion of donated lungs – around 90 percent of all lung transplants

are carried out using PERFADEX Plus, and so far more than

50,000 transplants have been carried out with PERFADEX/

PERFADEX Plus.

Cold preservation is an established and safe method. However,

one limitation is that it is not possible to evaluate donated lungs

in the cooled state. Since lung transplantation is a complicated

and life-changing procedure for the patient, surgeons refrain

from using donor organs where they are uncertain of the quality.

This means that up to 80 percent of donated lungs are rejected

and not used for transplantation. Accordingly, XVIVO Perfusion

focuses on warm perfusion.

Products for warm perfusion

Warm perfusion of lungs, or normothermic ex vivo lung per-

fusion (EVLP), means that the organ is heated to body tempera-

ture outside the body and circulated with a solution.

Products. XVIVO Perfusion offers three methods and systems

for EVLP:

• XPS (XVIVO Perfusion System), an integrated machine with all

components required for normothermic EVLP

• XVIVO LS, a machine for evaluating lungs with EVLP

• Lung Assist, a machine for evaluating lungs with EVLP and

• Manually with the help of STEEN Solution and the accessories

XVIVO Organ Chamber and XVIVO Lung Cannula.

OFFERS IN ALL FOUR MAJOR

ORGAN AREAS

XVIVO Perfusion’s core competence and offer is caring for organs outside the body, from being

removed from a donor to transplantation. This year’s acquisition of Dutch company Organ Assist

expands XVIVO Perfusion’s offering to include products for storage and evaluation of kidney

and liver.

XVIVO PERFUSION’S OFFER

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

XVIVO PERFUSION’S OFFER

Machine

perfusion

platforms

Disposables

for machine

perfusion

Static preservation

THE XVIVO PRODUCT RANGE

XPS

Kidney Assist Transport

STEEN Solution

Liver Assist

Donor Assist

Lung Assist

Kidney Assist

XPS Disposable Lung Kit

XVIVO Heart Device

XVIVO Disposable Heart Set

PERFADEX Plus

XVIVO Silicone Tubing Set

UNDER EVALUATION

IN CLINICAL TRIALS

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

XVIVO PERFUSION’S OFFER

Since October 2020 we also offer Lung Assist for EVLP which

has been developed by Organ Assist.

Both XPS, XVIVO LS, our manual system and Lung Assist are

used with STEEN Solution. STEEN Solution is XVIVO Perfusion’s

solution for warm perfusion of donated lungs. XPS and STEEN

Solution are approved on all major markets. XVIVO LS and Lung

Assist have CE-marking.

How it works. In normothermic EVLP, donated lungs are cir-

culated with STEEN Solution and heated to body temperature.

During the process, the lungs are connected to a pump for cir-

culation and to a ventilator to simulate breathing. Normothermic

EVLP recreates a non-harmful environment, similar to that in the

body (in vivo), which gives the lung and its cells the opportunity

to recover.

Advantages. Several studies show that patients who received

lungs that were initially deemed to be marginal, but were judged

to be acceptable after STEEN Solution treatment, achieved

equivalent results as patients that had been transplanted with

standard lungs. Our method has potential to increase utilization

of donated lungs from around 20 to 40 percent.

It has been clinically demonstrated that EVLP with the STEEN

Solution method extends the time that lungs can be stored

outside the body for up to 24 hours in some cases, compared to

6 to 10 hours for the standard method. This provides clinics with

more opportunities to nd the right recipient and to plan and

streamline their work.

DBD: Donation after Brain Death DCD: Donation after Circulatory (or Cardiac) Death

Today, about 20 percent of all donated DBD lungs can be used. The use of warm perfusion allows

about 40 percent of all donated DBD and DCD lungs to be utilized, including marginal lungs.

MORE LUNGS AVAILABLE WITH WARM PERFUSION

Procurement

Cold storage

Transplantation

TODAY

20%

Procurement

Cold storage

Evaluation

of organs by

warm perfusion

Transplantation

POTENTIAL

40%

Extensive studies of EVLP with the

STEEN Solution method

HELP study. In 2012, Toronto published the results of 50 lung

transplants performed after EVLP. The conclusion was that trans-

plantation of donated “high-risk” lungs is safe after 4 hours of

EVLP and produces equivalent results as conventional transplan-

tation. EVLP also increased the use of donated lungs.

THE NOVEL/NOVEL Extension study. The rst part of the

NOVEL study took place between 2012 and 2014 in the US,

and formed the basis for XVIVO Perfusion’s application for HDE

approval in the US. The study was designed to show that EVLP

can safely increase the number of usable lungs from the donor

pool. The study compared the clinical results after transplanta-

tion of lungs that had undergone warm perfusion after initially

being deemed unusable, with a control group of lungs deemed

useful. The NOVEL study then continued (NOVEL Extension)

and the inclusion of 220 patients was completed in 2017, which

formed the basis of the PMA application submitted in 2018

and subsequently approved in 2019. Data from the NOVEL

Extension study demonstrates that EVLP with XPS and STEEN

Solution is safe and effective.

The Vienna study. In a study conducted in Vienna, cold static

preservation was compared with PERFADEX and cold static

preservation with PERFADEX followed by EVLP on so-called

standard lungs. The study was the rst of its kind to examine

the effect of EVLP in a randomized prospective design. The

study demonstrated no statistically reliable difference between

the groups, but showed a trend towards minor primary graft

dysfunction (PGD) in the EVLP group.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

XVIVO PERFUSION’S OFFER

PROBLEM STEEN SOLUTION ADVANTAGE

• Patients die on transplant waiting list

due to lack of organs

• >70 percent of sampled lungs are

deemed to be untransplantable

• Very limited potential donor group

(brain-dead) = few organs to

transplant

• Limited time to match organs with

recipients due to a maximum of 6-10

hours outside the body

• Emergency surgery (normally night

time) due to a maximum of 6-10

hours outside the body

• High total cost of emergency surgery

due to a maximum of 6-10 hours

outside the body

• More patients can receive new lungs

• Functional testing, perfusion of

organs outside the body, possible

reconditioning effect

• Use of heart-dead donors enables a

large number of potential donors

• Maximum time of approximately 24

hours outside the body gives more

time to match organs with recipients

• Maximum time of approximately 24

hours outside the body gives more

time to plan procedures

• Maximum time of approximately 24

hours outside the body gives more

time to plan procedures

• More patients on waiting list are

given the opportunity to receive

transplantation

• More donated organs can be used

• More organs available for

transplantation

• More organs can be used

• Daytime surgery, reduces burden

on healthcare services

• Lower total cost due to better

opportunity for healthcare planning

THE ADVANTAGES OF THE STEEN SOLUTION METHOD

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

XVIVO PERFUSION’S OFFER

”NEW

METHOD

COMING:

NON-ISCHEMIC

PRESERVATION

(NIHP)”

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

XVIVO PERFUSION’S OFFER

HEART TRANSPLANTATION

Today, donated hearts are stored using cold static preservation.

XVIVO develops methods for preservation through oxygenated

perfusion of hearts (non-ischemic heart preservation, NIHP).

New method coming: non-ischemic heart

preservation (NIHP)

How it works. In connection with conventional heart trans-

plants, the lack of circulation and oxygen supply during transport

of the donor heart can lead to poorer clinical results. XVIVO

Perfusion’s new technology means that the heart is circulated

during transport with the help of a machine and a patented

solution that provides oxygen and important substances. The

technology is patented and has been developed alongside Igelösa

Life Science and Professor Stig Steen, and has been commercial-

ized by XVIVO Perfusion.

In animal trials, non-ischemic, that is oxygenated, heart preserva-

tion means that donated heats can be successfully stored outside

the body (ex vivo) for up to 24 hours.

Advantages. NIHP generates a signicantly longer window

compared to the four hours provided by the standard method

of cold preservation. The time outside the body is directly cor-

related to the survival of the recipient. This is even more evident

if the donor is older - then the time outside the body should not

exceed 2 hours. The time factor limits the distance a heart can

be transported and reduces the ability to nd the most suitable

recipient. With a method that allows longer storage outside the

body while waiting for transplantation, more hearts could be

transplanted, while reducing the cost of logistics and transport.

Status. XVIVO Perfusion’s heart project is our highest prior-

ity and is in the early clinical phase. Towards the end of the year,

the rst patient was transplanted within the framework of our

European heart preservation study. During the year, the scientic

journal Nature Communications published an article describing

the initial nding of an ongoing study of our technology for heart

preservation at Skåne University Hospital. The study shows that

the technology is safe.

In addition to the European study, XVIVO Perfusion is planning a

multicenter study in the US, and one in Australia. The objective is

to investigate whether the new technology can improve clini-

cal results and reduce complications after heart transplantation.

The overarching purpose is to make more hearts available and

to transplant them with good results. The clinical documentation

from the planned studies will form the basis for an application for

regulatory approval on all major markets.

Hazard ratio of 1 year mortality

2,5

2,0

1,5

1,0

0,5

0,0

15 20 25 30 35 40 45 50 55

Donor age (years)

Hazard ratio of 1 year mortality

2,5

2,0

1,5

1,0

0,5

0,0

1,5 2,0 2,5 3,0 3,5 4,0 4,5 5,0

Ischemic time (h)

https://ishltregistries.org/

Pre-clinical and clinical experience of NIHP

In pre-clinical studies on pigs conducted by Professor Stig Steen

and his research team, the new method for storing donated

hearts for up to 24 hours has been shown to be safe.

A research team in Munich, under the leadership of Professor

Bruno Reichart, has published data from experiments in

xenotransplantation, i.e. transplantation between species

. XVIVO

Perfusion’s s non-ischemic heart preservation technology was

used to transplant hearts of genetically modied pigs into

baboons. For the rst time, recipients of donated hearts achieved

long-term survival in the experiments. In future, the hope is that

pig hearts can be used for human heart transplantation, which

would address the organ shortage. Our technology and solution

has been chosen for this promising research project.

Skåne University Hospital in Lund successfully completed the rst

clinical heart transplants using the new XVIVO Perfusion technol-

ogy in a recent study in patients

3,4

. The results of the rst six heart

transplant patients in Lund indicate that the method is safe to use

in humans.

1. Steen S, et al. Safe orthotopic transplantation of hearts harvested 24 hours after

brain death and preserved for 24 hours. Scand Cardiovasc J. 2016 May 3; 50 (3):

193-200.

2. Längin M, et al. “Consistent success in life-supporting porcine heart xenotransplan-

tation”. Nature. 2018 Dec;564(7736):430-433.

3. Nilsson J, Conference Paper in The Journal of Heart and Lung Transplantation

37(4):S13 · April 2018.

4. Nilsson, J et al. ”A nonrandomized open-label phase 2 trial of nonischemic heart

preservation for human heart transplantation”. Nat Commun 11, 2976 (2020).

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

ABDOMINAL OFFER

With the acquisition of Organ Assist, XVIVO Perfusion has

extended its offer to include the abdominal area. From the end

of the year, we offer machines for perfusion of liver and kidney.

The machines enable preservation, reconditioning and evaluation

of organs.

Today, kidneys can be transplanted after static cold storage, or

alternatively after machine perfusion. Machine perfusion can be

normothermic (maintains normal body temperature; 35–37°C),

sub-normothermic (below normal body temperature; 20–34°C)

or hypothermic (signicantly below normal body temperature;

0–12°C).

Products. XVIVO Perfusion offers the following products for

oxygenated machine perfusion in the abdominal area:

• Kidney Assist Transport, a portable machine for hypothermic

preservation of kidneys during transportation for up to 24

hours.

• Kidney Assist, a machine for hypothermic reconditioning and

normothermic evaluation of kidneys for up to 6 hours.

• Liver Assist, a machine for hypothermic reconditioning and

normothermic evaluation of liver for up to 6 hours.

• Donor Assist, machine for isolated oxygenated normothermic

perfusion of organs in the deceased donor’s body, during the

donation surgery.

How it works. The technology the machines are based on is

essentially the same, but the machines are adapted as different

organs require different treatment.

All machines for perfusion of kidney and liver are based on regu-

lating oxygen, temperature and ow. The machines can be used

in several different phases; during the donation process, during

storage and transport and immediately prior to transplantation.

The machines for kidney and liver are modular, with at least one

pump, oxygen supply and a set of single-use articles for each unit.

One extra pump, a heating unit and a trolley or cool box can be

added, depending on which organ the machine is being used for.

Advantages. The most important function and advantage is that

the machines for kidney and liver enable non-ischemic (oxy-

genated) perfusion. Several research studies have shown that

oxygenated perfusion solution has positive effects on organs and

clinical results.

The machines also offer temperature control and for liver and

kidney we are unique in the world to offer machines for both

cold and warm perfusion.

Furthermore, the machines have one or several pumps that cre-

ate a pulsating ow and thus provides the organs with circulation

and microcirculation. This occurs regardless of pressure.

Finally, the pressure is also variable. The machines have a number

of pre-settings, to ensure that the pressure is optimal for the

relevant perfusion temperature and the organ treated.

Overall, XVIVO Perfusion’s machines for kidney and liver ensure

better quality of donated organs, which means that more

donated organs can be transplanted and fewer are rejected.

An article published in scientic journal The Lancet in November 2020

shows that oxygenated perfusion of kidneys before transplantation has

a signicant impact on outcomes in the rst year after transplantation:

lower risk of of terminal kidney failure, improved kidney function and

less cases of rejection of the kidney compared to only cold perfusion.

The randomized study, using kidneys from donors aged 50 or above

and which were donated after circulatory death, was carried out in 19

European transplantation centers and included 212 patients.

Jochmans I, et al. “Oxygenated versus standard cold perfusion preservation in kidney transplantation

(COMPARE): a randomized, double-blind, paired, phase 3 trial”, The Lancet, November 2020

XVIVO PERFUSION’S OFFER

Arjan van der Plaats, Research and Development Director in the

Abdominal business area and founding partner of Organ Assist.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Study where Kidney Assist

Transport was used shows

improved survival of trans-

planted kidneys after cold

machine perfusion with added

oxygen.

XVIVO PERFUSION’S OFFER

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

TRENDS AFFECTING US

TREND 1: Growing and aging population

The global population continues to grow, and the proportion of

elderly people is rising. According to the UN, 1 in 6 people are

expected to be over the age of 65 in 2050, compared to 1 in 11

in 2019. In addition, an increased proportion of life will be spent

above the age of 65.

Potential for XVIVO Perfusion. An increased proportion of

elderly people in the population is an important factor affect-

ing supply and demand for organs for transplantation. Older

patients can both donate and receive organs – age is no longer a

signicant contraindication. In the past, transplantation teams have

been reluctant to receive organs from donors above the age of

55 due to concerns about poor outcomes for the recipient. The

shortage of standard organs, coupled with the technology for

evaluating organs, opens up the possibility of older donors and

more donated organs.

STRONGER POSITION ON A

GROWING MARKET

In 2019, approximately 163,000 organ transplants were performed from more than 38,000 donors.

North America is the largest market in the world for organ transplantation, followed by Europe, while

China is a rapidly growing market. XVIVO Perfusion has strengthened its position as a result of the

acquisition of Organ Assist. In addition, there is signicant unutilized potential – we expect to expand

our market, mainly through new methods for preservation, evaluation and reconditioning of lungs,

hearts, kidneys and livers.

TRENDS AND MARKET

AMERICA

15 16 17 18 19

EUROPE

15 16 17 18 19 15 16 17 18 19

REST OF THE WORLDDISTRIBUTION

OF LUNG

TRANSPLANTATION

PERFORMED

2015-2019

Source: GODT, OPTN

and company’s own analyses

LARGEST MARKETS

REST OF THE WORLD 34%

AMERICA 38%

EUROPE 28%

SALES MACHINE PERFUSION EXCLUDING

CAPITAL GOODS*, SEK M

* Sales warm perfusion excluding capital goods is sales of STEEN Solution and

other sterile disposables used in lung evaluation.

2014

2015 2016 2017 2018 2019 2020

60 000

50 000

40 000

30 000

20 000

10 000

70 000

60 000

50 000

40 000

30 000

20 000

10 000

50 000

40 000

30 000

20 000

10 000

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

TREND 2: Increase in chronic disease

Chronic disease (or non-contagious disease, NCD) causes 41

million deaths annually, representing 71 percent of all deaths

globally. 52 million people are expected to die from chronic

disease in 2030.

Cardiovascular disease causes most deaths (17.9 million), fol-

lowed by cancer, pulmonary disease and diabetes. Four main

factors increase the risk of dying from a NCD: tobacco, an

unhealthy diet, insufcient physical activity and harmful alcohol

consumption.

Potential for XVIVO Perfusion. NCD increases the need

for organ transplantation and this is where XVIVO Perfusion

can make a signicant difference. For example, COPD (chronic

obstructive pulmonary disease) is the most common reason for

patients needing lung transplants. Over 200 million people suffer

from COPD and the disease causes 3 million deaths each year, In

addition, COPD is socioeconomically costly, which also increases

demand for transplantations.

TREND 3: Increased healthcare expenditure

The healthcare sector continues to outgrow the global economy

generally. In 2016, expenditure totaled USD 7.5 Bn or 10 percent

of global GDP. Healthcare expenditure in low and middle-income

countries is growing faster than in high-income economies,

although the gap is still signicant – the 20 percent of the global

population living in high-income countries generates 80 percent

of healthcare expenditure. A shift is also underway in terms of

healthcare funding, away from privately nanced/cash payment

and towards publicly nanced healthcare.

Potential for XVIVO Perfusion. Many transplants tend to

coincide with higher total healthcare expenditure and a low pro-

portion of privately nanced. Increased healthcare expenditure

and a higher proportion of public nancing is expected to benet

XVIVO Perfusion.

Impact of the Covid-19 pandemic

The Covid-19 pandemic immediately impacted activity in dona-

tions and transplantations globally. The extent of the decline was

closely related to the effect of the pandemic on intensive care

on each market. Many clinics decided to limit transplantation to

emergencies. At a later stage, the US, the EU and other national

authorities decided that organ transplants must continue as

they represent a life-saving treatment for patients without other

options. Transplantation activity has now slowly started to return

to more normal levels.

TRENDS AND MARKET

SHARE OF DONATION AFTER CIRCULATORY DEATH

2013

2018

23%

THE OPIOID CRISIS According to the U.S. Centers for Disease

Control and Prevention (CDC), more than 67,000 people died as

a result of overdoses in 2018 in the United States, with two-thirds

related to opioid use. According to an OECD report from 2019, there

is an increase in opioid-related deaths in Europe as well, and Sweden

is one of the countries most affected. The number of opioid-related

deaths in Sweden has more than doubled between 2011. An effect

of . One effect of the opioid crisis is that more people become

organ donors. The reason is that an overdose of opioids can cause

respiratory arrest and lead to suffocation and brain death. In 2017,

one in eight donors in the United States had died as a result of opioid

overdose compared to one in 100 in 2000.

Opioid-related deaths per million inhabitants for

selected OECD countries, 2011-2016**

Opoid-related deaths per million inhabitants, selected OECD

countries, 2011-16.

Frankrike

Australien

OECD

England & Wales

Irland

Norge

Sverige

Estland

Kanada

USA

Källa: EMCDDA and OECD (2019), Addressing Problemativ Opoid USE in OECD Countries

140

120

100

2011 2016

WAITING LISTS IN THE US

Waiting listDonors Transplants

140 000

120 000

100 000

80 000

60 000

40 000

20 000

1992 20192000

VäntelistaDonatorer Transplantationer

1992 20192000

** Source: EMCDDA and OECD (2019), Addressing Problematic Opioid USE in OECD Countries

THE OPOID CRISIS LEADS TO MORE ORGAN DONORS

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

OUR MARKET

Of transplanted organs, kidney and liver represent the absolute

majority; 64 and 24 percent respectively. Heart represents six

percent and lung four percent. Transplantation of other organs is

very unusual (pancreas and small bowel) or does not occur at all.

North America is the world’s largest market for organ trans-

plants – almost half of all lung and heart transplants occur there.

Lung

Total market. In 2019, some 6,700 lung transplants were

reported, of which 41 percent in the US, 35 percent in Europe

and 24 percent in the rest of the world. The 10 most active

countries represent 81 percent of the total market.

According to GODT (Global Observatory on Donation and

Transplantation) there are 383 lung clinics, of which we estimate

that around 250 are active.

Position and competitors. XVIVO Perfusion is world-leading

in the cold preservation of lungs and PERFADEX Plus is cur-

rently used in over 90 percent of all lung transplantations. French

Institute Georges Lopez (IGL) offers Celsior for cold preserva-

tion of several different organs, including lungs. In addition, there

are two generic versions of PERFADEX: Servator P from Italian

S.A.L.F. and LungProtect from Polish Carnamedica. In some mar-

kets there are locally produced solutions, for example in China

and Japan. These competitor products have a combined market

share of 5-10 percent. None of these products are approved

by the US FDA for the storage of lungs and none are as user-

friendly as PERFADEX Plus.

For warm perfusion of lungs, OCS Lung from US-based

Transmedics offers a CE-marked and FDA-approved machine

with associated solution. OCS Lung is used for bilateral lungs only

and with a different protocol than those used with XPS, XVIVO

LS and LungAssist, and is used for warm transport of lungs

between donors and recipients.

Heart

Total market. In 2019, some 8,600 heart transplants were

reported, of which 42 percent in the US, 34 percent in Europe

and 24 percent in the rest of the world. The 10 most active

countries represent 77 percent of the total market.

According to GODT there are 780 cardiac clinics which has per-

formed heart transplants historically, of which we estimate that

around 350 are active.

Position and competitors. In perfusion of donated hearts,

there are two US-based competitors: Transmedics OCS Heart

for warm perfusion of beating heart, as well as Paragonix

SherpaPak Heart Transport System for cold static storage. OCS

Heart is CE-marked and in addition to CE-marking, SherpaPak

Heart System has also been approved for sales by the FDA.

Kidney

Total market. In 2019, a total of 98,000 kidney transplants

were reported. We are primarily interested in the number of

transplants from deceased donors, because that is where XVIVO

Perfusion’s machines can make the biggest difference. In 2019,

62,000 transplants from deceased donors were carried out,

which is 63 percent of all kidney transplants. The US represented

28 percent of these transplants, Europe 33 percent and the rest

of the world 30 percent. The 10 most active countries represent

72 percent of the total market.

According to GODT there are 2,529 kidney clinics, of which we

estimate that around 2,200 are active.

Kidney

Lung

of global market

addressable

market in thoracic

organs

XVIVO’s

Lung & Heart

of global market

Heart

Liver

64%

10%

(~6,400) (~8,300)

24%

2% Pancreas

Small Bowel

~98%

of the market

addressed with

combined XVIVO

and Organ Assist

offering

TRANSPLANTATIONS PER ORGAN

TRENDS AND MARKET

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Position and competitors. XVIVO Perfusion’s machine

Kidney Assist lacks direct competitors. In the area of transport

of donated kidneys, there are three products with CE-marking.

LifePort Kidney Transporter from Organ Recovery Systems

(USA) and RM3 Kidney Perfusion System and Waves from

Waters Medical Systems (USA) and IGL (France)

Liver

Total market. In 2019, a total of 34,000 liver transplants were

reported, of which 28,000 (82 percent) from deceased donors.

The US represented 30 percent of these transplants, Europe 32

percent and the rest of the world 38 percent. The 10 most active

countries represent 72 percent of the total market, with the US

providing 24 percent.

According to GODT there are 1,181 liver clinics, of which we

estimate that around 1,000 are active.

Position and competitors. In the area of liver transplants,

two competitors offer products with CE-marking: OrganOx of

the UK, and Transmedics (USA). Also, Organ Recovery Systems

and Bridge to Life (USA) have products waiting for regulatory

approvals.

GROWTH POTENTIAL

The number of donors and transplantations is increasing, and the

global market is expected to grow by an average of 5–7 percent

annually over the coming ve years. However, this only covers 10

percent of the need for donated organs and shortages are acute.

This means that it is not the waiting list that determines the size

and growth of the market, but how many organs are available

for transplantation. We want to contribute to closing the gap

between supply and demand and make more organs available for

transplantation. This will save lives, have positive socioeconomic

consequences and strengthen XVIVO Perfusion’s position and

results of operations.

The market could be expanded by increasing the donation

frequency. XVIVO Perfusion can contribute to market growth

by increasing the frequency of use and by expanding on growth

markets.

More donations

Organ shortages can be addressed by increasing the number

of available organs to improve the frequency of donations. This

can become possible by introducing the concept of presumed

consent (i.e. the population is presumed to be in favor of dona-

tion unless expressly stating otherwise), improving the infrastruc-

ture and logistics surrounding donation and the transplantation

process, and raising public awareness.

More donated organs transplanted

However, the greatest potential for increasing the number is to

increase the actual utilization of donated organs. In practice, this

means that organs from older donors and marginal organs will

need to be accepted for transplantation. With regard to marginal

organs, there is signicant potential in DCD donation, i.e. taking

organs from circulatory dead (DCD) patients, unlike for brain-

dead (DBD) patients. DCD is expected to increase signicantly

more than DBD; 14 percent annually for DCD against 5 percent

for DBD. In order to appropriately evaluate, preserve and poten-

tially improve the condition of marginal organs, new technologies

are needed for preservation, evaluation and reconditioning– this

is where our opportunity lies. After the acquisition of Organ

Assist, XVIVO Perfusion is stronger than ever. As a company

with a unied offer we are active in all major organs and address

approximately 98 percent of the market.

Potential on growth markets

North America dominates the market for organ transplants

(38 percent in 2019), followed by Europe (37 percent in 2018).

Asia Pacic represents a signicantly smaller share of the market,

although the distribution will be very different in just 3–4 years’

time. Signicant growth is expected in Asia and on other markets,

particularly China, India and Brazil.

TRENDS AND MARKET

“THE NUMBER OF DONORS

AND TRANSPLANTS

PERFORMED ARE INCREASING

AND THE GLOBAL MARKET

IS EXPECTED TO GROW IN

AVERAGE 5-7 PERCENT PER

YEAR IN THE NEXT FIVE YEARS”

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

RESEARCH IN NEW INDICATIONS

A proportion of XVIVO Perfusion’s research focuses on nding

new uses for existing products, particularly STEEN Solution and

PrimECC.

XVIVO Perfusion seeks to develop new indications where we

have leading-edge competences, and where we see clear syner-

gies with existing areas of sales and signicant market potential. In

this area, we benet from several strengths:

• Extensive research experience

• The ability to drive a project from research, through regula-

tory approval and all the way to market launch

• Established relationships with world-leading researchers and

transplantation centers

• Global distribution and market presence

ONGOING DEVELOPMENT PROJECTS

Next generation products for heart transplantation

Projects and potential. The current limitation on the number

of heart transplants mainly relates to the number of available

and viable donated organs, and the period a donated heart

can survive outside the body. Alongside Professor Stig STEEN,

XVIVO Perfusion has developed the next generation of products

for preservation (treatment and transport) of donated hearts

ahead of heart transplantation. This relates to a combination of

solutions and a circulation machine. The purpose is to effectively

preserve heart function during transport and to improve trans-

plantation outcomes and give patients the chance to live better

and longer lives.

Status. XVIVO Perfusion is developing a program of clinical

multicenter studies involving nine centers in seven countries

in Europe. The studies will form the basis for an application for

regulatory approval of the products on all our main markets.

Our European study started in 2020 and the rst patient was

transplanted at the end of the year. The study will include a total

of 202 patients in at least 9 centers in 7 countries. Patients are

randomly allocated for transplantation of donated hearts trans-

ported with our new method, or stored conventionally, i.e. with

the icebox method.

A similar multicenter study is also planned in the US, where

XVIVO Perfusion has been granted breakthrough device designa-

tion which implies prioritized processing and communication with

the FDA. Discussions with the FDA are currently in an intensive

phase.

PrimECC

Projects and potential. PrimECC is a uid developed in collab-

oration with Professor Stig STEEN. PrimECC is used in heart-

lung machines that drive blood circulation and take over the

oxygenation of the blood from the heart and lungs during heart

surgery. Before the machine is connected to a patient, it needs

to be lled with uid. Today, as a rule, a simple saline solution is

used, but the intention is to replace this with PrimECC. PrimECC

can protect bodily organs and limit reduced kidney function and

other side effects caused by the use of a heart-lung machine.

Status. XVIVO Perfusion holds patents for PrimECC on impor-

tant markets in the US, the EU, China and Japan, and the product

already has CE-marking. In 2016 and 2017, a randomized clinical

study on 80 patients was completed that showed positive clinical

results from the use of PrimECC.

During the year, Sahlgrenska University Hospital included the rst

patients of a total of 366 in a new study. The patients included in

the study are undergoing heart surgery at one of Sweden’s uni-

versity hospitals. More centers are being recruited to the study.

XVIVO Perfusion will launch the products after the results of the

study have been analyzed.

RESEARCH AND

DEVELOPMENT FOR FUTURE

TRANSPLANTATIONS

RESEARCH AND DEVELOPMENT

XVIVO Perfusion’s overarching strategy is to make more high-quality organs available for

transplantation. We do this by developing and offering products for preservation, evaluation and

reconditioning of organs. Most of the company’s resources are allocated to research in heart and lung

transplantation.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Kidney transplantation

Projects and potential. Kidneys are no exception – far more

kidneys are needed than are available. Studies have shown that

transport of kidneys with ongoing perfusion improves the results

after transplantation. It has recently been demonstrated that

supplying oxygen during perfusion can improve results further.

Additionally: evaluating kidney function with warm perfusion can

make it possible to use kidneys that would otherwise have been

disqualied for transplantation.

Status. Towards the end of the year, the scientic journal The

Lancet published the results of a European study where trans-

plantation of kidneys that had been transported with oxygenated

perfusion from Organ Assist were compared with perfusion

without added oxygen. A total of 212 patients were included

in the study. Patients who received kidney transplants that had

been oxygenated during transport with Organ Assist’s technol-

ogy experienced fewer cases of kidney failure in the recently

transplanted kidney: 3 percent compared to 10 percent for the

control group. In addition, there were signicantly fewer cases of

rejection of the new kidneys. Our future research will focus on a

combination of new perfusion technology and XVIVO

Perfusion’s solutions.

ONGOING RESEARCH PROJECTS

Liver transplantation

Projects and potential. It is the same for liver as for other

organs – there are signicant shortages of transplantable livers.

Several studies suggest that cold oxygenated perfusion of liver

before transplantation improves organ quality and reduces

the risk of complications. In addition, warm perfusion enables

the objective evaluation of donated livers, which can result in

more organs that would previously have been disqualied being

transplanted.

Status. The acquisition of Organ Assist contributed valuable

technology and research and development expertise in cold and

warm perfusion of liver. This relates to both pre-clinical and clini-

cal studies, of which several clinical studies are in the nal phase.

The combination of new technology for perfusion developed by

Organ Assist and XVIVO Perfusion’s solutions will be the focus of

our research looking ahead.

Xenotransplantation

Projects and potential. Xenotransplantation is transplantation

between species. For us, this relates to transplanting organs from

animals, particularly genetically modied pigs, into humans. The

method is at the research stage for multiple organs.

Status. XVIVO Perfusion’s technology for preserving heart func-

tion is currently used by two world-leading research teams and

has been critical to successful outcomes when genetically modi-

ed hearts from pigs are transplanted into primates. During the

year, the research teams made important advances – the trials

resulted in over three months’ survival after transplantation from

genetically modied pigs into primates.

RESEARCH AND DEVELOPMENT

The heart preservation

technique has been developed

by Professor Stig Steen at the

University of Lund in close

collaboration with XVIVO

Perfusion.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Share structure

As of December 31, 2020, the share capital of XVIVO Perfusion

AB (publ) amounted to SEK 734,025 (679,875) divided into

28,719,136 shares. Trading takes place on Nasdaq Stockholm, Mid

Cap. All shares have equal voting rights and have equal rights to a

share in XVIVO Perfusion’s assets and earnings.

Share price and turnover

On December 31, 2020, the share price was SEK 314 per share

last paid, which represents an increase of 85 (29) percent com-

pared to the closing price on December 31, 2019. OMX Health

Care index increased by 15 percent (22) and OMX Stockholm

index increased by 13 percent (30) in the same period. At the

end of 2020, XVIVO Perfusion’s market capitalization amounted

to SEK 9,018 million (4,522) based on the latest price paid. The

highest price quoted in the year was SEK 330.00 (204.00) and

was quoted on December 2. The lowest price quoted in the year

was SEK 72.80 (126.40), which was quoted on March 19.

The number of XVIVO Perfusion shares in the year amounted to

11,934,005 (8,708,709) at a value of SEK 2,236 million (1,513).

The number of trades was 96,489 (73,125). Share turnover corre-

sponded to 44 percent (33) of the average number of outstand-

ing shares during the year.

Dividend policy and dividend

XVIVO Perfusion’s Board of Directors believes that the company

should have a strong capital base to enable continued growth,

both organically and through acquisitions. The Board of Directors

and the CEO propose that no dividend be paid for 2020.

Ongoing information

XVIVO Perfusion’s share is listed on Nasdaq Stockholm, Mid

Cap. Continuous information about the company such as press

releases, quarterly reports and annual reports can be found on

the company’s website www.xvivoperfusion.com.

Insiders

XVIVO Perfusion is obliged to notify the Swedish Financial

Supervisory Authority of persons that have insight into the com-

pany. These individuals must notify their holdings of shares and

any changes in the holdings.

THE SHARE

+85%

THE SHARE

SHARE PRICE 2020

XVIVO PERFUSION’S SHARE IN 2020 XVIVO PERFUSION’S SHARE SINCE LISTING IN 2012

XVIVO Perfusion’s share has been listed on Nasdaq Stockholm under the ticker symbol

XVIVO since 2016. The share was listed on Nasdaq First North between 2012 and 2016.

One trading block comprises 1 share.

350

300

250

200

150

100

1000

800

600

400

200

-13 -14 -15 -16 -17 -19 -20-18

XVIVO Perfusion OMX Health Care PI

OMXSPI Number of shares traded

Shares thousands

350

300

250

200

150

100

500

400

300

200

100

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

XVIVO Perfusion OMX Health Care PI

OMXSPI Volume

Shares thousands

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

The Board members and the CEO and CFO are considered to

have an insider position in XVIVO Perfusion. A full list of individu-

als with an insider position and their holdings is presented on the

company’s website www.xvivoperfusion.com.

Warrant program

In total, there are 725,000 outstanding warrants in two programs.

The 2019 Annual General Meeting resolved to issue a maximum

of 351,000 warrants (series 2019/2020) with the accompany-

ing right to subscribe for a maximum of 351,000 new shares to

employees of the XVIVO Perfusion Group. Of these warrants,

all 351,000 have been subscribed for by employees. The warrant

program 2019/2020 gives the warrant holder the right to sub-

scribe for a new share at SEK 278.91 during May 2021.

The 2020 Annual General Meeting resolved to issue a maximum

of 408,000 warrants (series 2020/2022) with the accompany-

ing right to subscribe for a maximum of 408,000 new shares to

employees of the XVIVO Perfusion Group. Of these warrants,

374,000 have been subscribed for by employees. The warrant

program 2020/2022 gives the warrant holder the right to sub-

scribe for a new share at SEK 205.88 during May 2022.

If all warrants under the respective programs are converted to

shares at the end of the period, the dilution effect for existing

shares would be 2.5 percent as of 31 December 2020.

Analysts

Pareto Securities and Danske Bank analyze XVIVO Perfusion

regularly.

FINANCIAL REPORTS 2021

Interim Report January-March 2021:

Wednesday, April 21, 2021

Interim Report January-June 2021:

Friday, July 13, 2021

Interim Report January-September 2021:

Thursday, October 28, 2021

Year-End Report 2021:

Thursday, January 27, 2022.

INVESTOR RELATIONS

Dag Andersson, CEO

Telephone: +46 31 766 43 30 31

E-mail: dag.ander[email protected]

Christoffer Rosenblad, COO & IR

Telephone: +46 735 19 21 59

E-mail: christoffer[email protected]

Kristoffer Nordström, CFO

Telephone +46 735 19 21 64

E-mail: kristoffer[email protected]

THE SHARE

OWNERSHIP STRUCTURE

According to Euroclear’s ofcial shareholder register, XVIVO

Perfusion had 6,346 shareholders as of December 31, 2020. XVIVO

Perfusion AB’s (publ) ten largest shareholders as of December 31,

2020 are listed below.

Shareholder Number of shares Shares and votes, %

Bure AB Equity 4 322 504 15,1

Swedbank Robur 2 994 542 10,4

Fjärde AP-Fonden 1 875 000 6,5

Eccenovo AB 1 675 893 5,8

Handelsbanken Fonder 1 083 824 3,8

Lannebo Fonder 1 044 759 3,6

Miton Asset Management 1 011 340 3,5

Invesco 1 000 000 3,5

Tredje AP-fonden 520 000 1,8

Leif Bergwall 427 147 1,5

Övriga 12 764 127 44,5

Total 28 719 136 100,0

Source: Monitor’s gures as of 31 December 2020.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

ADMINISTRATION REPORT

The Board of Directors and the CEO of XVIVO Perfusion AB

(publ), corporate registration number 556561-0424, hereby

submit the Annual Report and consolidated nancial statements

for the 2020 nancial year.

Business

XVIVO Perfusion AB is a medical technology company which

develops solutions and systems for selecting usable organs and

maintaining them in optimal condition pending transplantation.

The company is active within all major organ areas and consists

of two business areas: Thoracic (heart and lung) and Abdominal

(liver and kidney).

XVIVO Perfusion employs around 80 people at its headquarters

in Gothenburg, Sweden, its ofces in Lund, Sweden, Groningen,

Netherlands, and its ofce for North & South America in Denver,

CO, USA. The XVIVO share is listed on NASDAQ Stockholm

and is traded under the ticker symbol XVIVO. The total number

of shares and votes are 28 719 136.

Thoracic

Within the lung transplantation area, the company´s product

Perfadex

has a market share of approximately 90 percent

in traditional static preservation of lungs prior to transplanta-

tion. A major problem in transplant care is the lack of available

lungs. Today, scarcely 20 percent of available donation organs

are used in the company’s largest market, the United States,

as it is deemed too risky to use the other donated lungs in

transplantation. By using XVIVO Perfusion’s product – STEEN

Solution™ – the organ is cleared from harmful substances from

the donor, creating a better environment for the organ’s cells.

The technology thereby allows the organ to ”recover” when

possible. It also allows for functional testing to be performed on

the organ outside of the body. In clinical use in the US, Europe,

Australia and Canada it has become apparent that once STEEN

Solution™ perfusion has been carried out, many of the organs

that were initially “rejected” are assessed as being usable and have

been successfully transplanted into patients with end-stage lung

disease. The use of STEEN Solution™ therefore has the potential

to increase the total number of lung transplants. The company’s

products for warm perfusion, XPS™ and STEEN Solution™, have

regulatory approval in all major markets in the world, and were

the rst products to receive regulatory approval from the FDA

for warm perfusion of marginal lungs.

Based on the world leading research of Professor Stig Steen

and his research group, XVIVO Perfusion’s heart transplantation

competence center in Lund (Sweden) has developed a machine

and solutions for heart preservation. The products are developed

to increase the availability of donated hearts so that more heart

transplants can be performed, and more patients can be given a

last chance of a longer life. Clinical multicenter trials are underway

in Europe and in the USA and Australia trials are in the planning

phase. The trials form the basis for applications for regulatory

approvals for the products in all major markets.

Abdominal

The shortage of transplantable kidneys is great. Studies have

shown that transport of kidneys with ongoing perfusion in many

cases improves post-transplant results. A high-quality international

study has been published in The Lancet that shows signicant

benets for the recipient when the kidney is transported in an

oxygenated solution. This is the technology that is unique to

XVIVO. XVIVO’s technology, research and development in kidney

perfusion is being used in both preclinical and clinical, investigator-

driven studies.

Similarly to other organs, there is a shortage of transplantable

livers. By preserving and evaluating the function of the donated

liver in an optimized way, potentially more well-functioning

organs could be transplanted. XVIVO’s technology, research, and

development in warm perfusion of the liver is being used in both

preclinical and clinical, investigator-driven studies. The combina-

tion of new perfusion technology and XVIVO’s solutions will be

in focus for research and development within kidney and liver

transplantation.

Other indications

The company also invests in preclinical and clinical research in

xenotransplantation, perfusion of organs remaining in the body,

for example drug administration to isolated organs and priming

solutions for heart-lung machines. An extended trial for the com-

pany’s priming solution PrimECC

is taking place in Sweden.

Business concept

XVIVO Perfusion’s business concept is to increase the survival

rate of patients in need of an organ transplant by providing effec-

tive products that increase the availability of organs that have a

good potential to survive after transplantation.

Vision

The company’s vision is that no-one should need to die while

waiting for a new organ.

Objective

The company’s objective is to establish machine perfusion of

organs with STEEN Solution™ and other advanced solutions as

the standard treatment in organ transplantation so that more of

these lifesaving treatments can be performed.

Strategy

XVIVO Perfusion’s strategy is focused on increasing the number

of organs available for transplantation. Through development of

products for perfusion of organs and through clinical trials on all

major markets in the world, XVIVO Perfusion shows that perfu-

sion of organs gives more organs available for transplantation and

thus gives a larger number of patients a life-saving treatment.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Significant events

XVIVO completes the acquisition of the Dutch medical

technology company Organ Assist B.V

On September 23rd, XVIVO entered into an agreement to

acquire 100 percent of the shares in the Dutch medical technol-

ogy company Organ Assist B.V. Organ Assist focuses mainly on

developing machines and consumables for perfusion of liver and

kidney. Through the acquisition, XVIVO became the rst company

in the world who actively conducts business within preservation

and evaluation of organs in all major organ areas. The acquisition

accelerates the company’s strategy to become a global supplier

of solutions and systems in all major organ areas. The purchase

price amounted to a maximum of EUR 24 million, with an initial

payment of EUR 20 million and a conditioned, additional pur-

chase price of maximum EUR 4 million. The additional payments

are divided between two different payments of SEK 2 million

each, where one is dependent on sales targets for 2021 and

the other on regulatory FDA approval for the kidney transport

device.

The acquisition of Organ Assist was nanced through a directed

share issue which took place in the same day as the acquisition.

Investors included both existing and new shareholders, including

Bure Equity AB, Swedbank Robur, Eccenovo AB (publ.), Fjärde

AP-Fonden, Lannebo Fonder and Handelsbanken Fonder. The

issue took place without discount at a subscription price of SEK

236 and the company raised approximately SEK 500 million.

Issuance costs amounted to SEK 13.0 million. The number of

shares and votes in XVIVO Perfusion AB (publ) was increased by

2,118,640 shares and amounts to 28,719,136.

Organizational changes

Dag Andersson was appointed as the new President and CEO in

April and took ofce in June. XVIVO Perfusion’s founder and for-

mer CEO, Magnus Nilsson, remains as Senior Advisor to primarily

work with R&D. Dag has a background in healthcare as CEO of

Diaverum AB from 2008 up until 2018 and before that worked

for 15 years in leading positions at the medical technology com-

pany Mölnlycke Health Care. A reorganization, which affected

the company’s management team and all departments, has taken

place with the aim of creating a more efcient and focused

organization. The management team has been strengthened with

a new Commercial Director and a new R&D Director.

First patient in the European Heart Preservation study was

transplanted

The rst patient in XVIVOs European Heart preservation study

was transplanted during the month of November. The patent

protected Heart Preservation device, developed by Professor

Stig Steen and commercialized by XVIVO, uses a novel tech-

nique for preservation of the donor heart during transport. Nine

European transplant centers will include a total of 202 patients in

the trial that forms the basis of a European regulatory approval

application and will investigate if the new technology can

improve patient outcome and reduce complications after heart

transplantation.

Heart preservation study from Lund published in Nature

Communications

During the period, the scientic journal Nature Communications

published an article written by Professor Johan Nilsson, describ-

ing the use of XVIVO Perfusion’s heart preservation technology

developed by Professor Stig Steen. The results from the study

show that our method is safe and functional for clinical use.

Publication in The Lancet shows better survival of transplanted

kidneys after cold machine perfusion with oxygen

In November, a study was published in the scientic journal The

Lancet that shows that oxygenated perfusion of kidneys before

transplantation has a signicant impact on the rst-year result

after transplantation: less graft failure, better function and lower

rejection of the kidney when compared to cold perfusion alone.

The randomized trial, with kidneys from donors aged 50 years or

older and donated after circulatory death, was performed in 19

European transplant centers and included 212 patients. The tech-

nology used in the study is CE-marked and XVIVO intends to

submit an application during 2021 to the FDA, whose approval is

required to enable a launch in the US market.

First patient in the extended PrimECC

study included

PrimECC

, a CE-marked and patent-protected product, is devel-

oped to reduce complications after heart surgery. PrimECC

a solution used to prime the heart-lung machine before open

heart-surgery. Hundreds of thousands of heart surgeries are per-

formed today each year worldwide using a heart-lung machine.

The extended study that has now begun intends to expand and

strengthen the clinical documentation for PrimECC

and will

include a total of 366 patients.

GROUP’S KEY RATIOS – 5-YEAR SUMMARY

2020 2019 2018 2017 2016

Net sales, MSEK 180 221 188 148 138

Gross margin without

capital goods, % 77 77 77 78 80

Gross margin, % 74 74 72 76 74

EBITDA,%* -9 13 16 15 12

Operating margin % -25 2 7 5 2

Net margin, % -24 2 7 4 1

Total assets, MSEK 1 150 634 587 539 350

Equity/assets ratio, % 88 91 92 94 90

Earnings per share, SEK -1,61 0,19 0,48 0,25 0,07

Equity per share, SEK 35,11 21,71 20,47 19,26 13,40

Share price at

closing day, SEK 314 170 132 94 88

Antal anställda i medeltal 63 46 35 29 24

*Operating prot before depreciation and amortization (EBITDA), adjusted for

costs associated with organizational change, cost reservation for the share-based

bonus programs for employees outside Sweden as well as integration and acquisi-

tion costs, amounts to SEK 20.2 million (35.8), corresponding to an EBITDA margin

of 11 percent (16). Reported operating prot before depreciation and amortization

(EBITDA) amounted to SEK -15.6 million (28.8), corresponding to an EBITDA margin

of -9 percent (13).

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Warrant program 2020/2022 nal report

The Annual General Meeting 2020 resolved to issue no more

than of 408,000 warrants (series 2020/2022) with the accom-

panying right to subscribe for no more than 408,000 new shares

for employees of the XVIVO Perfusion Group. Of these warrants,

374,000 have been subscribed for by employees. The warrant

program 2020/2022 gives the warrant holder the right to sub-

scribe for one new share at a price of SEK 205.88 in May 2022.

The Covid-19 pandemic

In 2020, XVIVO has been affected by the ongoing Covid-19 pan-

demic through the reduction in transplants. Available healthcare

resources have largely focused on Covid-19 patients and thus the

number of donated organs has decreased and waiting lists have

increased. During March to May, the decline was substantial. The

important markets, the USA and Europe, gradually recovered

during the third quarter.

Research and development

XVIVO Perfusion mainly conducts product development on its

own, while research is mainly carried out in collaboration with

world-leading institutions and researchers in all major markets

in the world. Considerable resources are spent on research and

development and the company is one of the leading innovators

in the industry. Of the total operating expenses of SEK 179 mil-

lion (159), research and development costs accounted for SEK 56

million (63), corresponding to 31 (40) percent. During the year,

development expenses of SEK 60 million (70) were capitalized as

intangible assets.

Within lung transplantation, there is ongoing development

together with our customers to ensure that our products are

market leaders. During 2020, the company´s focus has been on

further developing machines and solutions to promote the use

of EVLP.

Within heart transplantation the preservation machine with the

solution and disposable kit, developed together with Professor

Stig Steen, has now been used in clinical studies. First up was

the European multicenter study, which was started in the fourth

quarter of 2020. A similar multicenter study is in the planning

phase in the US as well, where the company has received a so-

called “breakthrough device designation” and the conditions for

starting the study are under discussion with the FDA. In addition

to the studies that XVIVO conducts, the Swedish investigator-

driven study that uses XVIVO’s technology continues to include

patients. A supplementary investigator-driven study is also being

launched in Australia. The Covid-19 pandemic have resulted in

several hospitals putting their clinical studies on hold during the

year.

In connection to the acquisition of Organ Assist, XVIVO

Perfusion took over interesting development projects within

kidney and liver transplants. The company’s technical solutions

within each organ area are CE-marked and thus approved for

sale in Europe. Within the kidney area, the R&D during 2020

has focused on upgrading the unique technology of oxygenated

perfusion of kidneys prior to FDA approval, as well as the global

rollout to utilize the competitive advantages of the recently

published article in the Lancet. Within the liver area, R&D has

focused on rening the technology prior to FDA approval,

expanding clinical evidence through several European trials and

investing in new protocols. During the year, XVIVO Perfusion

continued to support clinical research on liver perfusion with

STEEN Solution

. The combination of new perfusion technology

and XVIVO’s solutions will be in focus for future research within

kidney transplants.

Beyond the R&D projects within the transplant area, the com-

pany also conducts a clinical study for the patented product

PrimECC

- a priming solution which is being analysed in an

extended study in several Swedish hospitals. The study included

its rst patient during the year.

Furthermore, the company supports research in a pre-clinical

phase to potentially extend the use of warm perfusion with

STEEN Solution ™ for Xenotransplantation and administration

of pharmaceuticals to isolated organs. In the longer term, it is

interesting to treat isolated organs and tissues that remain in the

body with adapted techniques, to avoid side effects in other parts

of the body. An example of this is cancer treatment.

Significant risks and uncertainty factors

There are several risk factors which impact XVIVO Perfusion

AB’s business, and which may do so in the future.

The risks are presented in the following areas:

• Market risks

• Operational risks

• Legal and regulatory risks

• Financial risks

Market risks

Lung transplantations are an expensive but life-saving procedure

for which there are no medical treatment alternatives. The cost

of a transplantation is largely balanced by the decreased treat-

ment costs that are otherwise associated with the patient. Today

there is a lack of organs, which is most often the main obstacle

to performing more transplants. Other market risks are access

to funding and medical resources at clinics in the world. In the

assessment of XVIVO Perfusion, the business is not currently

signicantly impacted by changes in the world economy.

Operational risks

These primarily comprise risks that limit or prevent XVIVO

Perfusion from developing, manufacturing and selling qualitative,

effective and safe products. The risks have been identied and

essentially reduced to manageable levels, amongst other things by

the signing of agreements with suppliers, collaboration partners

and customers. XVIVO Perfusion is a company of limited size and

the organization is still in the process of being built up. XVIVO

Perfusion’s future development is partly dependent on key per-

sons with specialist knowledge remaining in the organization.

Legal and regulatory risks

The market for XVIVO Perfusion is impacted by the appropriate

legislation and other regulations. Changes in legislation or political

decisions may impact the company’s ability to run or develop the

business. XVIVO Perfusion’s products need regulatory approval

in the markets where they are marketed. The market for medical

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

device products is being regulated to a greater and greater

extent with a view to increasing patient safety and reducing

the risk of incorrect treatment. This means increased product

development costs for XVIVO but also greater barriers for new

competitors who want to break into the market.

Due to the nature of the business, there is a risk of claims for

damages and liability. To protect the Group against the economic

effects of any claims, XVIVO Perfusion is insured against general

and business-related claims for damages.

Financial risks

XVIVO Perfusion has most of its sales in other currencies than

SEK. The US dollar and the Euro are the most important curren-

cies. Expenses are largely in SEK but a considerable portion is

in USD. XVIVO Perfusion does not currently hedge its revenues

in foreign currency, which means that there is a currency risk for

the business (see note 27 for further information).

Insurances

XVIVO Perfusion regularly meets insurance brokers and advisors

both locally and globally, which ensures that the business and the

area of responsibility are properly insured.

Sustainability and responsibility

The Board of Directors of XVIVO Perfusion has adopted a Code

of Conduct which is anchored throughout the global organiza-

tion. The Code of Conduct is based on the UN Declaration of

Human Rights, the ILO Declaration on Fundamental Principles

and Rights at Work, the UN Global Compact and the OECD

Guidelines for Multinational Enterprises. The Code is reviewed

and approved annually by the Board. The Code applies to all

employees and sets the level of employee professionalism and

integrity, with the aim of ensuring that each employee acts legally

and appropriately in relation to the company’s stakeholders.

The handling of personnel-related matters at XVIVO Perfusion

is based on several policies and procedures. The most impor-

tant ones are our Code of Conduct, work environment policy

(including diversity and inclusion), health and safety practices and

our privacy policy.

The high quality and safety of our products is crucial for our

business. We constantly analyze and review the quality of the

product’s entire life cycle. Our quality management systems are

certied according to standards applicable to the products we

manufacture. XVIVO Perfusion follows the rules that apply where

our products are being sold.

XVIVO Perfusion’s business does not entail any specic environ-

mental risks and does not require any special environmentally

related permits or decisions from authorities. However, our

business impacts the environment in several ways. Our custom-

ers are to be found all over the world, which means that our

products are partly transported by air. The company strives to

make its processes efcient in dialogue with customers and

suppliers and tries to minimize the amount of transportation as

far as possible. Global product ranges and extended shelf-life for

products are examples of initiatives in recent years which reduce

the company’s impact on the environment. XVIVO Perfusion has

employees in most continents and internal meetings are thus

held digitally to as great extent as possible and travel within the

company only takes place when necessary. The company assesses

that the business is run in accordance with the applicable health

and safety rules and offers its employees a safe and healthy

environment. Since transplantations are life-saving treatments, the

products are governed by regulatory authorities.

Legal disputes

The company was not involved in any legal disputes during 2020.

Outlook for 2021

Sales development during 2021 will depend on the extent to

which the Covid-19 pandemic affects intensive care in important

markets. Transplantation is a life-sustaining treatment and trans-

plants are prioritized by health authorities around the world. For

this reason, the company estimates that the number of trans-

plants, and thus the demand for XVIVO’s products, will continue

to increase long-term.

The company will intensify its efforts to receive regulatory

approval of the Kidney Assist Transport device in the USA, which

is the company’s product for improved kidney transport. In 2020,

very good study results were published in the Lancet which

shows the benets of XVIVOs technology, and the company aims

to apply for 510K approval to the FDA in 2021. Costs for regula-

tory approval in the US will be capitalized on an on-going basis.

The company will continue to focus heavily on clinical stud-

ies and product development in all major organ areas. In heart

transplantation, the goal is to make great progress in the clinical

multi centre studies in Europe, the USA and Australia. In kidney

transplantation, the goal is to obtain regulatory approval in the

USA for the kidney transport device during the second half of

2021. The PrimECC

study in Sweden should be able to pick up

speed as the pressure on intensive care decreases.

The Board of Directors’ proposal for guidelines for

executive remuneration

The executive management of XVIVO Perfusion AB (publ)

(“XVIVO Perfusion”) and the board of directors, insofar as remu-

neration other than that decided by the general meeting is paid

to board members, fall within the provisions of these guidelines.

The executive management includes the CEO, the deputy CEO

and other members of the executive management. Other mem-

bers of the executive management refer to senior managers and

those who report directly to the CEO. Managers who report

directly to the CEO are in the company’s case CFO, COO,

CCO, CMO, Global QA&RA Director and Global Research and

Development Director.

The guidelines are forward-looking, i.e. they are applicable to

remuneration agreed, and amendments to remuneration already

agreed, after adoption of the guidelines by the annual general

meeting 2021. These guidelines do not apply to any remunera-

tion decided or approved by the general meeting.

For employments governed by rules other than Swedish, pension

benets and other benets may be duly adjusted for compliance

with mandatory rules or established local practice, considering, to

the extent possible, the overall purpose of these guidelines.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

The guidelines’ promotion of the company’s business strategy,

long-term interests and sustainability

XVIVO Perfusion is a medical device company that develops and

markets solutions and systems for assessing usability, enabling

treatment of organs and preserving organs in good condition

outside the body while waiting for a transplantation. The com-

pany is active within all of the major organ areas; heart, lung, liver

and kidney.

The company is currently the market leader within lung trans-

plantation and provides transplant clinics all over the world

with high-tech products for storing and evaluating lungs. XVIVO

Perfusion has around 80 employees that works at its head ofce

in Gothenburg, ofces in Lund, Groningen in the Netherlands and

at the ofce for North and South America in Denver, USA. For

further information about the company’s business strategy, see

www.xvivoperfusion.com.

Successful implementation of the company’s business strategy

and taking care of the company’s long-term interests, including its

sustainability, presuppose that the company can recruit, motivate

and retain skilled employees through competitive remunera-

tion that is line with market rates. These guidelines enable senior

executives to be offered a competitive total remuneration.

The company has established two long-term share-related

incentive programs. They have been resolved by the General

Meeting and are therefore not covered by these guidelines. For

the same reason, the long-term share-related incentive program

proposed by the Board for the 2021 Annual General Meeting is

also not covered. The proposed program essentially corresponds

to existing programs, but the number of participants has been

limited. The programs include key employees in the Group as well

as senior executives in the company. The programs have a clear

connection to the business strategy and thus to the company’s

long-term value creation, including its sustainability. The programs

also impose requirements regarding longer period of holding. For

more information about these programs, see www.xvivoperfu-

sion.com.

Types of remuneration, etc.

The remuneration shall be on market terms and may consist of

the following components: xed cash salary, variable cash remu-

neration, pension benets and other benets. Additionally, the

general meeting may – irrespective of these guidelines – resolve

on, among other things, share-related or share price-related

remuneration. The xed cash salary shall be determined with

consideration of the concerned individual’s responsibilities and

experience. The xed salary shall be reviewed annually.

The satisfaction of criteria for awarding variable cash remunera-

tion shall be possible to measure over a period of one year.

The variable cash remuneration may amount to not more than

50 percent of the xed annual cash salary for the CEO and 30

percent of the xed annual cash salary for other members of the

executive management.

Additional variable remuneration may be awarded in extraordi-

nary circumstances, provided that such extraordinary arrange-

ments are limited in time and only made on an individual basis,

either for the purpose of recruiting or retaining executives, or

as remuneration for extraordinary performance beyond the

individual’s ordinary tasks. Such remuneration may not exceed

an amount corresponding to 30 percent of the xed annual

cash salary and may not be paid more than once each year per

individual. Any resolution on such remuneration shall be made by

the board of directors based on a proposal from the remunera-

tion committee.

Pension

For the CEO of the company, pension benets, including health

insurance (Sw: sjukförsäkring), shall be premium dened. Variable

cash remuneration shall not qualify for pension benets. The

pension premiums for premium dened pension shall amount

to not more than 35 percent of the xed annual cash salary. For

other executives, pension benets, including health insurance, shall

be premium dened unless the individual concerned is subject

to dened benet pension under mandatory collective agree-

ment provisions. Variable cash remuneration shall not qualify for

pension benets. The pension premiums for premium dened

pension shall amount to not more than 31,5 percent of the xed

annual cash salary.

Other benets may include, for example, life insurance, medi-

cal insurance (Sw: sjukvårdsförsäkring) and company cars. Such

benets shall be determined on the criteria of marketability and

competitiveness.

For executives stationed in another country then their home

country, additional remuneration and other benets may be

awarded to a reasonable extent with consideration of the special

circumstances that are associated with such foreign stay, whereby

the general purpose of these guidelines shall be satised to the

furthest extent possible.

Termination of employment

The notice period may not exceed six months if notice of

termination of employment is made by the company. If notice of

termination of employment is made by the company, severance

pay corresponding to no more than the same amount as twelve

monthly salaries shall be awarded to the CEO. No severance pay

shall be awarded to other members of the executive manage-

ment upon termination of their employment. The period of

notice may not to exceed six months when termination is made

by the executive, without any right to severance pay.

Additionally, remuneration may be paid for non-compete

undertakings. Such remuneration shall compensate for loss of

income and shall only be paid insofar as the previously employed

executive is not entitled to severance pay. The remuneration shall

be based on the xed cash salary at the time of termination of

employment and be paid during the time that the non-compete

undertaking applies, which shall be not more than 12 months fol-

lowing termination of employment.

Criteria for awarding variable cash remuneration, etc.

The variable cash remuneration shall be linked to predetermined

and measurable criteria which can be nancial or non-nancial

and be individualized quantitative or qualitative targets. The

criteria shall be designed to contribute to the company’s business

strategy and long-term interests, including its sustainability, by for

example being clearly linked to the business strategy or promote

the executive’s long-term development.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

To which extent the criteria for awarding variable cash remunera-

tion has been satised shall be evaluated/determined when the

measurement period has ended. The remuneration committee is

responsible for the evaluation so far as it concerns variable remu-

neration to the CEO. For variable cash remuneration to other

executives, the CEO is responsible for the evaluation. For nancial

objectives, the evaluation shall be based on the latest nancial

information made public by the company.

Salary and employment conditions for employees

In the preparation of the board of directors’ proposal for these

remuneration guidelines, salary and employment conditions for

employees of the company have been taken into account by

including information on the employees’ total remuneration, the

components of the remuneration and increase and growth rate

of the remuneration over time, in the remuneration committee’s

and the board of directors’ basis of decision when evaluating

whether the guidelines and the limitations set out herein are

reasonable. The development of the gap between the remunera-

tion to executives and remuneration to other employees will be

disclosed in the remuneration report.

The decision-making process to determine, review and

implement the guidelines

The board of directors has established a remuneration com-

mittee. The committee’s tasks include preparing the board of

directors’ decision to propose guidelines for executive remu-

neration. The board of directors shall prepare a proposal for

new guidelines at least every fourth year and submit it to the

annual general meeting. The guidelines shall be in force until new

guidelines are adopted by the general meeting. The remuneration

committee shall also monitor and evaluate programs for variable

remuneration for the executive management, the application of

the guidelines for executive remuneration as well as the current

remuneration structures and compensation levels in the com-

pany. The ordinary members of the remuneration committee are

independent of the company and its executive management. The

CEO and other members of the executive management do not

participate in the board of directors’ processing of and resolu-

tions regarding remuneration-related matters in so far as they are

affected by such matters.

Board of directors’ service assignments

Directors elected by the general meeting shall in special cases be

eligible for remuneration for services within their respective area

of competence, which is not board work. Remuneration for such

services shall be made on market terms and approved by the

board of directors and may not exceed SEK 300,000 excluding

VAT per year and director.

Derogation from the guidelines

The board of directors may resolve to temporarily derogate

from the guidelines, in whole or in part, if in a specic case there

is special cause for such action and a derogation is necessary to

serve the company’s long-term interests, including its sustainability,

or to ensure the company’s nancial viability. As set out above,

the remuneration committee’s tasks include preparing the board

of directors’ resolutions in remuneration-related matters, which

includes resolutions to derogate from the guidelines.

Description of signicant changes to the guidelines and how

the views of shareholders’ have been taken into consideration

The proposal for guidelines submitted at the 2021 annual general

meeting includes several clarications, in accordance with appli-

cable law. However, the proposal does not include any signi-

cant changes in relation to the company’s current guidelines for

remuneration. XVIVO Perfusion has not received any views from

shareholders to take into consideration in the preparation of this

proposal.

Parent Company

The business focuses on sales of lung transplant products outside

of North America, global research and development and global

marketing. During the year SEK 57 million (75) was invested in

the business, of which SEK 56 million (71) was invested in intan-

gible assets.

Proposal for profit appropriation

The following equity is at the disposal of the Annual General

Meeting:

Share premium reserve 992 291 064SEK

Retained earnings -151 942 686 SEK

Net income for the year -38 436 084 SEK

801 912 294 SEK

The Board of Directors proposes that the non-restricted equity

is allocated as follows:

To be carried forward 801 912 294 SEK

The nancial reports were approved for issuance by the Board of

the Parent Company on March 29, 2021.

Regarding the company’s results and nancial position, please

refer to the following income statements and balance sheets,

together with the accompanying notes to the nancial statements.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

“Good corporate governance means ensuring that companies

are run sustainably, responsibly and as efciently as possible on

behalf of their shareholders. The condence of legislators and the

public that companies act responsibly is crucial if companies are

to have the freedom to realize their strategies to create value.

The condence of existing and potential shareholders that such is

the case is crucial to their interest in investing in companies, thus

securing corporate Sweden’s freedom to develop and its supply

of competence and venture capital.” (Extract from the Swedish

Corporate Governance Code)

XVIVO Perfusion AB (publ) is a Swedish public limited company

listed on Nasdaq Stockholm’s main market since November

28, 2016. The corporate governance policies applied by XVIVO

Perfusion are based on Swedish legislation, primarily the Swedish

Companies Act and the Swedish Annual Accounts Act, and

NASDAQ Stockholm AB’s regulations. The company has applied

the Swedish Corporate Governance Code (“the Code”) as from

the day the company’s shares were listed on Nasdaq Stockholm’s

main market. XVIVO Perfusion has deviated from the code only

regarding the design of cash-based incentive programs for partici-

pants in countries where allocation of warrants is not appropri-

ate. The time period of the two cash-based incentive programs,

which as far as is practically possible have been designed so that

they correspond to the terms and conditions of the two war-

rant programs outstanding, is less than the three years stipulated

in the code. The two warrant programs outstanding are further

described in the 2020 Annual Report in note 24. Further informa-

tion on corporate governance in XVIVO Perfusion is to be found

at www.xvivoperfusion.com.

Ownership

According to Monitor’s shareholder register, XVIVO Perfusion had

6,346 shareholders as of December 31, 2020, an increase of 16%

compared to the previous year. XVIVO Perfusion AB’s (publ) ten

largest shareholders as of December 31,2020 are listed below:

Number Shares and

Shareholder of shares votes, %

Bure Equity AB 4 322 504 15,1

Swedbank Robur 2 994 542 10,4

Fjärde AP-Fonden 1 875 000 6,5

Eccenovo AB 1 675 893 5,8

Handelsbanken Fonder 1 083 824 3,8

Lannebo Fonder 1 044 759 3,6

Miton Asset Management 1 011 340 3,5

Invesco 1 000 000 3,5

Tredje AP-fonden 520 000 1,8

Leif Bergwall 427 147 1,5

Övriga 12 955 009 44,4

Total 28 719 136 100,0

Source: Monitor’s compilation on 31 December2020.

As of December 31, 2020, the share capital of XVIVO Perfusion

AB (publ) was SEK 734,025 allocated among 28,719,136 shares.

The shares are traded on Nasdaq Stockholm’s main market. All

shares carry the same number of votes and entitle shareholders

to equal shares in XVIVO Perfusion’s assets and earnings.

At the XVIVO Perfusion Annual General Meeting on Mars 31,

2020, it was resolved that for the period until the next Annual

General Meeting and on one or more occasions, the Board of

Directors is authorized to issue a maximum of 2,660,000 shares,

corresponding to 10 % of the total number of shares and votes in

the company.

A resolution was adopted at XVIVO Perfusion’s Annual General

Meeting held on Mars 31, 2020 to issue no more than 408,000

warrants entitling warrant holders to subscribe for new shares.

The warrants were offered to all employees in the two Swedish

group companies. Of these warrants, a total of 374,000 has been

subscribed by employees. If these warrants are fully utilized, the

share capital will increase by SEK 9,724, corresponding to a dilu-

tion of approximately 1.3 percent of the total number of shares

and votes in the company.

A directed rights issue was carried out during the third quarter of

2020. The company received SEK 500,000,000 in connection with

the share issue. The share capital increased by SEK 54,150 and the

excess part, SEK 499,945,850, was recognized as share premium.

The issue expenses were 12,954,550 SEK.

Corporate governance

The gure below illustrates XVIVO Perfusion’s corporate govern-

ance model and who appoints the central bodies.

Nomination

Committee

External

auditors

Annual

General Meeting

CEO

Board of Directors

Remuneration

Committee

Audit Committee

Annual General Meeting

XVIVO Perfusion’s highest decision-making body is the general

meeting of shareholders. The Annual General Meeting shall be

held within six months of the end of the nancial year. A notice

convening the AGM is issued no earlier than six and no later than

four weeks prior to the meeting. All shareholders entered in the

shareholders’ register and who have notied their intent to attend

in time are entitled to participate in and vote at the meeting.

Shareholders who are unable to attend may be represented by a

proxy.

Annual General Meeting 2020

The last Annual General Meeting was held on March 31, 2020

in Gothenburg. At the Meeting it was decided to re-elect the

board members Gösta Johannesson, Camilla Öberg, Folke Nilsson,

Yvonne Mårtensson and Dag Andersson. Gösta Johannesson

was elected Chairman of the Board. A resolution was passed to

adopt board fees of a total of SEK 1,005,000 SEK, of which SEK

CORPORATE GOVERNANCE REPORT

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

250,000 to the Chairman, SEK 150,000 to each of the other

board members and SEK 40,000 to the Chairman of the Audit

Committee, SEK 40,000 to the Chairman of the Remuneration

Committee and SEK 25,000 to each of the other members of

these committees.

The proposal not to pay any dividend for the nancial year 2019

was approved.

The Board was authorized, for the period up until the next

Annual General Meeting, to decide on one or more occasions to

make a new issue of a maximum of 2,660,000 shares, correspond-

ing to slightly less than 10% of the total number of shares and

votes in the company.

The proposed policies for remuneration and other terms of

employment for the executive management were adopted. The

proposed issue of 408,000 warrants entitling warrant holders to

subscribe for new shares was approved.

Extraordinary General Meeting 2020

An Extraordinary General Meeting was held on 14 October

2020. The Annual General Meeting decided that the Board of

Directors shall consist of six members until the next Annual

General Meeting. The Meeting elected Lena Höglund and Lars

Henriksson as board members. Dag Andersson resigned from the

board, due to his appointment as CEO of the company as of June

1, 2020. It was decided that board fees should be adjusted to a

total of SEK 1,092,500.

Annual General Meeting 2021

The Annual General Meeting will be held on Thursday, April

22, 2021 at 3:00 p.m. at the Svenska Mässan, visiting address:

Mässans gata 24, in Gothenburg. Advance voting by postal voting

will be allowed in accordance with information in the notice.

Shareholders who wish to participate in the Annual General

Meeting shall be registered in the share register kept by Euroclear

Sweden AB no later than Wednesday, April 14, 2021.

Shareholders who wish to attend the Annual General Meeting

shall notify the Company no later than April 16, 2021. Either

by writing to XVIVO Perfusion AB (publ), the Annual General

Meeting 2021, c/o Advokatrman Vinge KB, Box 110 25, 404 21

Gothenburg, by e-mail to [email protected], or by sending

their postal vote in accordance with the instructions in the notice.

The Board

General

The Board is responsible for the company’s administration of

its affairs and organization. At the Annual General Meeting held

in Mars 2020, ve Board members were elected, and at the

Extraordinary General Meeting in October 2020 six members

were elected, with competence in both medical devices and

biotechnology as well as within the areas of nance and strategy.

The company’s CFO served as the Board’s secretary. In 2020,

the Board held 17 meetings (11), and minutes were kept at all

meetings.

Board members’ attendance at each meeting is presented in the

following table:

Attendance Attendance Attendance

board Remuneration Audit

Name Dependent* meetings Committee Committee

Gösta Johannesson Yes 17/17 3/3

Folke Nilsson 17/17 5/5

Camilla Öberg 17/17 5/5

Yvonne Mårtensson 17/17 2/2 3/3

Alan Raffensperger 3/3 2/2

Dag Andersson 15/15 1/1

Lena Höglund 2/2 1/1

Lars Henriksson 2/2 1/1

* Dependent in relation to the company’s major shareholders

The CEO has participated at all the Board meetings. Other senior

executives have attended dependent on the addressed issues.

Remuneration and other benets paid to the Board of XVIVO

Perfusion are detailed in Note 7 of the 2020 Annual Report.

The Board’s work

Each year, the Board is to convene for a minimum of seven

scheduled meetings, equally distributed over the year, and one

statutory Board meeting. The meetings are normally held in the

form of physical meetings at XVIVO Perfusion’s headquarters in

Gothenburg. If it is preferable for practical reasons, the meetings

are held by telephone or in special cases per capsulam.

2020 was a special year in the wake of the Covid-19 pandemic,

since all individuals and organizations had to take a great respon-

sibility in order to limit the spread of infection. For this reason, the

Board of Directors changed its way of working during the year.

Physical board meetings have been kept to a minimum in favor of

digital meetings. Travel within the board assignment has also been

reduced. During the year, focus has been on the effects of the

pandemic on XVIVO’s operations. In early spring 2020, the com-

pany developed and expanded its forecasting to be able to quickly

address the effects of the pandemic on sales and studies, which

resulted in a cost-cutting program. During the year, the Board of

Directors followed and assessed sales and cost forecasts carefully.

The Chairman leads and organizes the Board’s work. A pro-

posed agenda and decision data regarding the items to be

addressed at the meeting are sent ahead of each meeting. The

proposed agenda is drawn up by the CEO in consultation with

the Chairman. Items presented to the Board are for information

purposes, discussion, or decision. Decisions are only taken fol-

lowing discussion and after all members present have been given

the opportunity to be heard. The Board’s extensive experience in

various areas generates constructive and open discussion. During

the year, no Board member registered dissent with regard to any

Board decision. Any open issues are followed up on an ongoing

basis.

One of the meetings held during the year focused on strategic

questions. In addition, parts of the Board have met on several

occasions to discuss questions they have been tasked with inves-

tigating further. The Board’s formal work plan was adopted at the

statutory Board meeting on Mars 31, 2020. The Board’s formal

work plan is reviewed at least once a year. The plan regulates

areas such as the allocation of responsibilities, the number of

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

scheduled meetings, the form of notications, decision data and

minutes, conicts of interest, mandatory items to be submitted

by the CEO to the Board and authorized signatories. The Board

addresses ongoing items such as business conditions, interim

reports, budgets, strategies, and external information.

In addition to the Board material, the CEO distributes monthly

reports containing a nancial report and a description of current

events in operations and in the market. The aim is to keep the

Board informed about the development of the company’s opera-

tions to enable the Board to take well-founded decisions. Once

each year, the Board holds a meeting that evaluates the work

of the CEO, which the executive management does not attend.

The Board ensures the quality of the nancial reporting through

its own work and through contact with the auditor. The com-

pany’s auditor participated at the meeting addressing the annual

accounts, where the audit results were reported. At the autumn

of 2019, the Board evaluated its work by doing a self-evaluation

procedure where each Board member assesses just over fty

statements about the Board’s role and function, the Board meet-

ings, Board material, Board members, the Chairman of the Board

and the CEO. The board members also weighted the importance

of each statement for the boards work and the company’s long-

term value growth. The responses were compiled by independent

third parties and compared with the benchmark index of listed

companies in the Nordic region. The evaluation is a part of con-

stantly developing the board work and the next evaluation will

take place in autumn 2021.

Members of the Board

XVIVO Perfusion’s Board comprises six members, including the

Chairman. For details about the Board members and their share-

holdings, please refer to the 2020 Annual Report, page 72, and

the company’s website (www.xvivoperfusion.com).

Remuneration Committee

At the inaugural Board meeting, the Board of XVIVO Perfusion

appoints a remuneration committee, which prepares propos-

als concerning questions of remuneration The Remuneration

Committee’s areas of responsibility are dened in the Board’s for-

mal work plan and in the Remuneration Committee’s instructions.

The Group’s guidelines for remuneration of executive manage-

ment are included in the Administration Report on pages 46-47

of the 2020 Annual Report and on the company’s website (www.

xvivoperfusion.com). The Remuneration Committee consists of

three Board members: Gösta Johannesson (Chairman of the

Remuneration Committee), Lars Henriksson and Lena Höglund.

Audit Committee

At the inaugural Board meeting, the Board of Directors of

XVIVO Perfusion appoints an audit committee. The tasks of the

Audit Committee are described in an instruction for the Audit

Committee. The purpose of the Audit Committee’s activities is

to assist the Board of Directors of XVIVO Perfusion in ques-

tions regarding nancial reporting, auditing and risk management.

The Audit Committee is a preparatory body and the Board has

overriding responsibility for the questions related to auditing. The

members of the Audit Committee shall consist of at least three

board members appointed by the Board at the inaugural Board

meeting or whenever otherwise necessary. The members of the

Committee may not be employed by the Company. At least one

member shall be independent in relation to the company’s major

shareholders and should have accounting or audit experience. The

Audit Committee consists of Camilla Öberg (Chairman of the

Audit Committee), Yvonne Mårtensson and Folke Nilsson.

The Audit Committee shall in particular monitor (i) the audit of

the Annual Report and the consolidated nancial statements, (ii)

transactions with related parties, important accounting principles

and important correspondence between the company’s auditors

and management, (iii) the effectiveness of the company’s internal

controls regarding nancial reporting, (iv) the company’s rou-

tines concerning comments on the company’s accounts, internal

control and auditing, (v) the scope, focus and quality of auditing

work, including follow-up of the audit performed, (vi) budgeted

and actual auditing expenses, (vii) the auditors’ recommendations,

conclusions, observations and proposals after an audit has been

performed, (viii) the auditor’s impartiality and independence and

in this connection pay particular attention to whether the auditor

provides the company with other services than auditing work

and (ix) assist in the drawing up of proposals for adoption by the

Annual General Meeting regarding election of an auditor.

Management Team

For information on members of the management team and their

shareholdings, please refer to page 73 of the 2020 Annual Report

and the company’s website (www.xvivoperfusion.com). XVIVO

Perfusion’s management team consists of seven members, CEO

included. The management team has competence and experience

from research and development, quality assurance, regulatory

affairs, quality assurance, marketing, production and distribution

of medical device equipment. Furthermore, the members of the

management team have the necessary competence in economics

and nance. The management team meets every other week. Two

times a year the team meets for all-day meetings, which provides

the opportunity to deal with issues of a more strategic nature.

The instruction for the Board of Directors and the CEO was

determined on the statutory Board meeting on Mars 31, 2020

and regulates the segregation of duties between the Board of

Directors, the Chairman of the Board and the CEO. The opera-

tive management is based on the decision-making that has been

determined by the Board.

Election of auditor

At the Annual General Meeting 2020, KPMG AB was appointed

as the company´s audit rm. During the year, KPMG AB have

appointed authorized public accountant Daniel Haglund as audi-

tor in charge up until the end of 2021 Annual General Meeting.

Daniel Haglund has reported his observations from the audit to

the to the board. The annual report, accounts and the administra-

tion of the Board and the CEO were examined within the scope

of the above work.

Nomination Committee

The Nomination Committee for the 2021 Annual General

Meeting has been appointed in accordance with the principles

adopted at the 2018 Annual General Meeting. These stipulate that

the Chairman of the Board – no later than the end of the third

quarter of 2021 – shall contact the three largest shareholders of

XVIVO Perfusion AB (publ) on the basis of known shareholdings

at the end of August 2020 and ask them to appoint one member

each to be included in the Nomination Committee. In addition

to these three members, the Chairman of the Board shall also be

part of the Nomination Committee. If any of the three sharehold-

ers waives their right to appoint a member of the Nomination

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Committee, or if a member resigns from the Nomination

Committee without being replaced by a new member appointed

by the same shareholder, the next shareholder in terms of size

shall be afforded the opportunity of appointing a member of

the Nomination Committee. Unless otherwise agreed by the

members of the committee, the Chairman of the Nomination

Committee shall be the committee member appointed by the

largest shareholder. The mandate period shall run until a new

Nomination Committee has taken over.

If during the mandate period of the Nomination Committee

one or more shareholders who have appointed Nomination

Committee members are no longer one of the three largest

shareholders, committee members appointed by these share-

holders shall step down and the shareholder or shareholders

who have become one of the three largest shareholders shall be

entitled to appoint their committee members. Except in special

circumstances, there shall be no changes in the composition of the

Nomination Committee if only marginal changes in the number

of votes have occurred or if the change occurs later than three

months before the Annual General Meeting. The composition of

the Nomination Committee was published on the website at least

six months before the Annual General Meeting.

The work of the Nomination Committee includes making

proposals before the Annual General Meeting regarding (i) elec-

tion of a Chairman for the meeting, (ii) a resolution regarding

the number of Board members, (iii) election of and a resolution

regarding fees for the Chairman of the Board and the Board

members, (iv) election of and a resolution regarding the fees for

the auditor, and (v) a resolution regarding a new Nomination

Committee procedure, if the Nomination Committee deems this

appropriate.

The Board’s description of the key elements in the

company’s system for internal control, follow-up and

risk management.

The Board is responsible for internal control pursuant to the

Swedish Companies Act. This report is limited to a description of

how the internal control regarding nancial reporting is organized.

It pertains to the 2020 nancial year.

The objective of internal nancial control regarding nancial

reporting at XVIVO Perfusion is to create an efcient decision

process in which requirements, targets and frameworks are clearly

dened. Ultimately, the controls aim to protect the company’s

assets and, thereby, the shareholders’ investments.

Control environment

The control environment forms the basis for the internal control.

XVIVO Perfusion’s control environment includes healthy val-

ues, integrity, competence, leadership philosophy, organizational

structure, responsibility and authorities. XVIVO Perfusion’s internal

work procedures, instructions, policies, guidelines and manu-

als provide guidance to employees. At XVIVO Perfusion, a clear

allocation of roles and responsibilities for efcient management

of operational risks is ensured through measures including the

Board’s formal work plan and the instruction for the CEO. The

CEO reports regularly to the Board. The CEO is responsible, in

terms of the operating activities, for the system of internal con-

trols required to construct a control environment for signicant

risks. XVIVO Perfusion also has guidelines and policies for nancial

governance and follow-up as well as for communication issues etc.

The Group’s ve companies essentially have the same structure,

nancial system and accounting plan. XVIVO Perfusion continually

reviews this system.

Risk assessment and control activities

XVIVO Perfusion works with risk analysis on an ongoing basis

to identify potential sources of error in the nancial report-

ing. Traceability in the nancial statements is ensured by good

documentation. A system has been developed which follows up

various activities in detail and compares them with the budget.

The follow-up ensures communication with the different parts

of the company, so that the Finance Department is also well

acquainted with future activities and any deviations from the

budget. The work on securing the processes where it has been

identied that the risk of material error in the nancial reporting

may be assumed to be relatively higher than in other processes is

continuously ongoing.

Normal control activities comprise monthly reconciliation of

accounts and supplementary checks. The aim of all control activi-

ties is to prevent, detect and correct any errors or deviations in

the nancial reporting. The company intends to continue develop-

ing and following up selected control activities during the coming

nancial year. The company has a system for scanning invoices

from suppliers which includes automatic approval control, and this

raises the level of security in the internal control.

Follow-up

The Board continuously evaluates the information submitted by

the executive management, which comprises both nancial infor-

mation and material issues pertaining to the internal control. The

Board continuously follows up the effectiveness of the internal

control, which, in addition to ongoing updates in the event of

deviations, is carried out, inter alia, by ensuring that measures are

implemented in respect of the proposed actions that may have

arisen after external audits.

Information and communication

Proper disclosures and clear lines of communication, both internal

and external, mean that all parts of operations exchange and

report relevant, signicant operational data in an efcient man-

ner. To achieve this, XVIVO Perfusion has issued a communication

policy regarding information management in the nancial process,

as well as policies and guidelines for other types of information.

The executive management has communicated these to employ-

ees and employees are acquainted with the communication

policy. Guidelines have been set out for how communication with

external parties should take place, who is authorized to provide

certain types of information and when a logbook should be kept.

The ultimate aim of the aforementioned policies is to ensure

compliance with disclosure requirements pertaining to legisla-

tion and listing agreements, and that investors receive the correct

information in time.

Internal auditing

XVIVO Perfusion has so far not had reason to set up a special

internal audit function in the nancial area. This is because the

company is relatively small in size and the constantly ongoing

work on internal control has led to awareness of internal control

in the Group being perceived as high and to a number of control

activities being in place. The issue of a special internal audit func-

tion will be reviewed as the company grows.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

1 JANUARY – 31 DECEMBER

SEK thousands Note 2020 2019

Net sales 2 179 861 220 837

Cost of goods sold -46 886 -58 024

Gross Income

132 975 162 813

Selling expenses -59 899 -60 786

Administrative expenses -30 342 -24 739

Research and development costs -56 178 -62 651

Other operating revenues 5 1 468 1 738

Other operating expenses 6 -33 699 -12 435

Operating income

7, 8, 9, 10, 12

-45 675 3 940

Financial income 890 1 690

Financial expenses -12 478 -340

Net financial income

11, 12

-11 588 1 350

Income before taxes -57 263 5 290

Tax on income for the year 14 13 528 -351

Net income for the year -43 735 4 939

Net income for the year attributable to:

Parent Company shareholders -43 735 4 939

Basic earnings per share, SEK -1,61 0,19

Diluted earnings per share, SEK* -1,60 0,18

Average number of outstanding shares before dilution 27 171 352 26 518 546

Average number of outstanding shares after dilution* 27 354 518 26 799 996

Number of shares at closing day before dilution 28 719 136 26 600 496

Number of shares at closing day after dilution* 29 444 136 26 879 496

* After dilution. See Note 24 for information about warrant programs. .

1 JANUARY – 31 DECEMBER

SEK thousands Note 2020 2019

Net income for the year -43 735 4 939

Other comprehensive income

Items that have been or may be reclassified to the income statement

Exchange-rate differences -16 410 3 721

Tax attributable to items that have been or may be transferred to the income statement 14 0 -514

Total other comprehensive income for the year, net after tax 23 -16 410 3 207

Total comprehensive income for the year -60 145 8 146

Total comprehensive income for the year attributable to:

Parent Company shareholders -60 145 8 146

CONSOLIDATED STATEMENT OF NET INCOME

CONSOLIDATED STATEMENT OF TOTAL

COMPREHENSIVE INCOME

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

CONSOLIDATED STATEMENT OF

FINANCIAL POSITION

SEK thousands Note 2020-12-31 2019-12-31

ASSETS

27, 28

Non-current assets

INTANGIBLE ASSETS

Capitalized development expenditure 393 969 266 517

Patents, licenses and trademarks 5 467 5 382

Goodwill 223 938 65 773

Computer programs 1 283 837

TANGIBLE ASSETS

Machinery, equipment, fixtures and fittings 21 334 23 554

FINANCIAL ASSETS

Deferred tax asset 14 40 334 12 316

Other financial assets 754 223

Total non-current assets 687 079 374 602

Current assets

INVENTORIES

18 59 351 43 871

CURRENT RECEIVABLES

Accounts receivable - trade 20 40 183 43 725

Tax assets 156 491

Other receivables 3 361 4 894

Prepaid expenses and accrued income 21 5 943 6 958

CASH AND CASH EQUIVALENTS

22 354 236 159 946

Total current assets 463 230 259 885

TOTAL ASSETS 1 150 309 634 487

SEK thousands Note 2020-12-31 2019-12-31

SHAREHOLDERS’ EQUITY

23, 24

Shareholders’ equity attributable to Parent Company shareholders

Share capital 734 680

Other capital contributed 1 006 784 515 753

Reserves -182 16 228

Retained earnings incl. net income for the year 1 125 44 860

TOTAL SHAREHOLDERS’ EQUITY

1 008 461 577 521

LIABILITIES

Other provisions 1 311 1 314

Deferred tax liability 14 24 853 899

Other long-term liabilities 27 40 150

Interest-bearing liabilities, non-current 10 3 286 2 154

Total long-term liabilities

27, 28, 29

69 600 4 367

Interest-bearing liabilities, current 10 3 926 3 396

Accounts payable 14 468 14 406

Current tax liability - -

Other liabilites 1 239 1 765

Accured expenses and deferred income 26 52 615 33 032

Total current liabilities

27, 28, 29

72 248 52 599

TOTAL LIABILITIES 141 848 56 966

TOTAL SHAREHOLDERS’ EQUITY AND LIABILITIES 1 150 309 634 487

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

CONSOLIDATED CHANGES IN

SHAREHOLDERS’ EQUITY

Attributable to Parent Company shareholders

Total

shareholder´s

equity

SEK thousands

capital

Other

capital

contributed Reserves

Retained

earnings incl.

net income

for the year

Opening shareholders’ equity at 2019-01-01 675 486 860 13 021 39 921 540 477

COMPREHENSIVE INCOME FOR THE YEAR

Net income for the year - - - 4 939 4 939

Other comprehensive income for the year - - 3 207 - 3 207

Total comprehensive income for the year - - 3 207 4 939 8 146

TRANSACTIONS WITH GROUP’S SHAREHOLDERS

Contributions from and value transfers to shareholders

New share issue minus transaction expenses, net after tax* 5 27 296 - - 27 301

Premium paid upon issue of warrants - 1 597 - - 1 597

Total contributions from and value transfers to shareholders 5 28 893 - - 28 898

Closing shareholders’ equity at 2019-12-31 680 515 753 16 228 44 860 577 521

COMPREHENSIVE INCOME FOR THE YEAR

Net income for the year - - - -43 735 -43 735

Other comprehensive income for the year - - -16 410 - -16 410

Total comprehensive income for the year - - -16 410 -43 735 -60 145

TRANSACTIONS WITH GROUP’S SHAREHOLDERS

Contributions from and value transfers to shareholders

New share issue minus transaction expenses, net after tax* 54 489 640 - - 489 694

Premium paid upon issue of warrants - 1 391 - - 1 391

Total contributions from and value transfers to shareholders 54 491 031 - - 491 085

Closing shareholders’ equity at 2020-12-31 734 1 006 784 -182 1 125 1 008 461

* Transaction costs in connection with new share issue amount to SEK 10 286 thousand (84).

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

CONSOLIDATED CASH FLOW STATEMENT

1 JANUARY – 31 DECEMBER

SEK thousands Note 2020 2019

Operating activities 31

Income after financial items -57 263 5 290

Adjustment for non-cash items 49 355 28 862

Taxes paid 142 -2 945

-7 766 31 207

Increase (-)/Decrease (+) in inventories -14 155 -8 478

Increase (-)/Decrease (+) in operating receivables 20 584 -542

Increase (-)/Decrease (-) in operating liabilities -10 929 7 318

Cash flow from operating activities -12 266 29 505

Investing activities

Acquisition of intangible fixed assets -62 046 -73 190

Acquisition of property, plant and equipment -2 631 -10 503

Divestment of property, plant and equipment - -

Acquisition of subsidiaries -201 319 -

Acquisition of other financial assets -536 -151

Cash flow from investing activities -266 532 -83 844

Financing activities

Warrants program 1 391 1 475

New share issue 487 044 27 425

Part-payment of lease liability -5 667 -3 349

Cash flow from financing activities 482 768 25 551

Cash flow for the year 203 970 -28 788

Cash and cash equivalents at beginning of year 159 946 187 064

Exchange-rate difference in cash and cash equivalents -9 680 1 669

Exchange-rate difference in cash and cash equivalents 22 354 236 159 946

INCOME STATEMENT FOR THE PARENT COMPANY

1 JANUARY – 31 DECEMBER

SEK thousands Note 2020 2019

Net sales 2 134 122 169 608

Cost of goods sold -36 107 -50 677

Gross income 98 015 118 931

Selling expenses -36 675 -35 842

Administrative expenses -27 602 -18 485

Research and development costs -65 268 -65 937

Other operating revenues 5 1 269 4 034

Other operating expenses 6 -11 343 -4 875

Operating income

7, 8, 9, 10, 12

-41 604 -2 174

PROFIT/LOSS FROM FINANCIAL ITEMS

Interest income and similar items 1 581 5 838

Interest expenses and similar items -12 190 -1 064

Income after financial items

11, 12

-52 213 2 600

Appropriations 13 4 200 -2 300

Tax on income for the year 14 9577 -299

Net income for the year -38 436 1

The Parent Company has no items to be recognized in other comprehensive income and therefore no statement of total comprehensive income has been presented.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

SEK thousands Note 2020-12-31 2019-12-31

ASSETS

27, 28

Non-current assets

INTANGIBLE ASSETS

Capitalized development expenditure 239 509 200 672

Patents, licenses and trademarks 4 985 4 696

Computer programs 1283 837

PROPERTY, PLANT AND EQUIPMENT

Machinery, equipment, fixtures and fittings 5 902 7 924

FINANCIAL ASSETS

Participating interests in Group companies 4, 17 404 467 161 174

Receivables from Group companies 19 34 550 25 771

Deferred tax liability 14 13 921 1 677

Other financial assets 660 125

Total non-current assets 705 277 402 876

Current assets

INVENTORIES

18 16 561 15 070

CURRENT RECEIVABLES

Accounts receivable - trade 20 17 987 22 216

Receivables to Group companies 56 224

Current tax assets 1 1 275

Other receivables 2 904 5 266

Prepaid expenses and accrued income 21 4 654 5 371

CASH AND BANK BALANCES

22 333 318 150 362

Total current assets 375 481 199 784

TOTAL ASSETS 1 080 758 602 660

BALANCE SHEET FOR THE PARENT COMPANY

SEK thousands Note 2020-12-31 2019-12-31

SHAREHOLDERS’ EQUITY

23, 24

RESTRICTED EQUITY

Share capital 734 680

Statutory reserve 20 20

Reserve for development costs 198 151 148 855

NON-RESTRICTED EQUITY

Share premium reserve 992 291 501 242

Balanserat resultat -151 943 -102 648

Net income for the year -38 436 1

TOTAL SHAREHOLDERS’ EQUITY

1 000 817 548 150

Untaxed reserves

- 4 200

PROVISIONS

Other provisions 1 311 1 315

Total provisions 1 311 1 315

NON-CURRENT LIABILITIES

Other liabilities 40 150 11 552

Total non-current liabilities

40 150 48 995

CURRENT LIABILITIES

Accounts payable 8 349 11 552

Liabilities to Group companies 19 3 574 19 002

Current tax liability -

Other liabilities 1133 654

Accrued expenses and deferred income 26 25 424 17 787

Total current liabilities

27, 28, 29

38 480 48 995

TOTAL LIABILITIES 79 941 54 510

TOTAL SHAREHOLDER’S EQUITY AND LIABILITIES 1 080 758 602 660

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

CASH FLOW STATEMENT FOR THE PARENT COMPANY

1 JANUARY – 31 DECEMBER

SEK thousands Note 2020 2019

Operating activities 31

Income after financial items -52 213 2 600

Adjustment for non-cash items 35 211 17 524

Taxes paid 1 276 -2 199

-15 726 17 925

Increase (-)/Decrease (+) in inventories -7 321 -2 554

Increase (-)/Decrease (+) in operating receivables -1 735 -5 563

Increase (-)/Decrease (-) in operating liabilities -13 525 -4 355

Cash flow from operating activities -38 307 5 453

Investing activities

Investments in intangible fixed assets -55 848 -71 379

Acquisition of property, plant and equipment -1 611 -4 053

Change in loan to Group company - 11 804

Acquisition of group companies -201 320 -

Acquisition of other financial assets - -54

Cash flow from investing activities -258 779 -63 682

Financing activities

Warrants program 1 391 1 599

New share issue, net after transaction expenses 487 044 27 301

Cash flow from financing activities 488 435 28 900

Cash flow for the year 191 349 -29 329

Cash and cash equivalents at beginning of year 150 362 178 248

Exchange-rate difference in cash and cash equivalents -8 393 1 443

Cash and cash equivalents at end of year 22 333 318 150 362

Restricted shareholders’ equity Non-restricted shareholders’ equity

Total share-

holder´s

equitySEK thousands

capital

Statutory

reserve

Development

expenditure

fund

premium

reserve

Retained

earnings

Net income

for the year

Opening shareholders’ equity at 2019-01-01 675 20 84 348 472 345 -45 939 7 798 519 247

Net income for the year - - - - - 1 1

Other comprehensive income for the year - - - - - - -

Total comprehensive income for the year - - - - - 1 1

Proposed appropriation of profits - - - - 7 798 -7 798 0

New share issue minus transaction expenses,

net after tax* 5 - - 27 336 - - 27 341

Premium paid upon issue of warrants - - - 1 561 - - 1 561

Allocation to reserve for development

expenditure - - 64 507 - -64 507 - 0

Closing shareholders´equity at 2019-12-31 680 20 148 855 501 242 -102 648 1 548 150

Net income for the year - - - - - -38 436 -38 436

Other comprehensive income for the year - - - - - - 0

Total comprehensive income for the year - - - - - -38 436 -38 436

Proposed appropriation of profits - - - - 1 -1 0

New share issue minus transaction expenses,

net after tax* 54 - - 489 659 - - 489 713

Premium paid upon issue of warrants - - - 1 390 - - 1 390

Allocation to reserve for development

expenditure - - 49 296 - -49 296 - 0

Closing shareholders’ equity at 2020-12-31 734 20 198 151 992 291 -151 943 -38 436 1 000 817

* Transaction costs in connection with new share issue amounted to SEK 10 286 thousand (84).

CHANGES IN SHAREHOLDERS’ EQUITY

FOR THE PARENT COMPANY

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

SUPPLEMENTARY DISCLOSURES

AND NOTES TO THE FINANCIAL REPORTS

Notes to the financial statements for the full year 2020 for the XVIVO Perfusion

Group and its Parent Company, XVIVO Perfusion AB (publ), corporate identity

number 556561-0424, with its registered office in Gothenburg, Sweden, visiting

address Mässans gata 10, postal address Box 53015, SE-400 14 Gothenburg. The

Parent Company is listed on the Mid Cap list of NASDAQ Stockholm.

NOTE 1. ACCOUNTING POLICIES

COMPLIANCE WITH STANDARDS AND LEGISLATION

The consolidated financial statements have been prepared in accordance with

IFRS published by the International Accounting Standards Board (IASB) such as

they have been adopted by the EU. Furthermore, recommendation RFR 1 of the

Swedish Financial Reporting Board, “Supplementary Accounting Rules for Groups”,

has been applied.

The annual financial statements of the Parent Company have been prepared

pursuant to the Swedish Annual Accounts Act (1995:1554) and recommendation

RFR 2 of the Swedish Financial Reporting Board, “Accounting for Legal Entities”,

has been applied. This means that IFRS measurement and disclosure requirements

are applied. Deviations are presented in the “Parent Company accounting policies”

section.

MEASUREMENT PRINCIPLES APPLIED IN PRESENTATION OF THE

FINANCIAL STATEMENTS

Assets and liabilities are recognized at historical cost, except for additional purchase

price related to business acquisitions, which is measured at fair value.

FUNCTIONAL CURRENCY AND REPORTING CURRENCY

The Parent Company’s functional currency is SEK, which is also the reporting

currency for the Parent Company and the Group. This means that the financial

statements are presented in SEK. All figures, unless otherwise stated, are rounded

off to the nearest thousand.

ASSUMPTIONS WHEN PRESENTING THE PARENT COMPANY’S

AND CONSOLIDATED FINANCIAL STATEMENTS

The presentation of reports pursuant to IFRS requires the use of a number of

important estimates for reporting purposes. Furthermore, it is necessary for the

company management to make certain assessments when applying the Group’s

accounting policies. The areas which include a high degree of assessment, which

are complex or such areas where assumptions and estimates are of considerable

importance for the consolidated financial statements are stated in note 34.

CLASSIFICATION

Non-current assets, long-term liabilities and provisions essentially consist only of

amounts that are expected to be recovered or paid more than 12 months after

closing day. Current assets and current liabilities essentially consist only of amounts

that are expected to be recovered or paid within 12 months of closing day.

CONSOLIDATION POLICIES

SUBSIDIARIES

The consolidated financial statements include the Parent Company XVIVO

Perfusion AB (publ), the wholly-owned American subsidiary XVIVO Perfusion Inc,

the wholly-owned subsidiary XVIVO Perfusion Lund AB (formerly Vivoline Medical

AB), the wholly-owned French subsidiary XVIVO Perfusion SAS, the Australian

subsidiary XVIVO Perfusion Pacific Pty Ltd and the Dutch subsidiary Organ Assist

B.V with subsidiaries, which were acquired in 2020.

CONSOLIDATION POLICIES - GROUP

The acquisition of XVIVO Perfusion Inc. was a so-called common control acquisi-

tion where both the purchaser and the object had a common owner with a

controlling interest. Assets and liabilities were taken over and recognized in the

acquisition analysis at consolidation values. See XVIVO Perfusion’s 2012 Annual

Report for the acquisition analysis.

The acquisition of other subsidiaries was recognized pursuant to the acquisition

method, whereby assets and liabilities are recognized at fair value according to an

acquisition analysis. The difference between the cost of the subsidiary’s shares and

the fair value of the acquired assets, liabilities taken over and contingent liabilities

constitutes goodwill on consolidation. The purchase price also includes the fair

value of all assets or liabilities that are a consequence of a contingent consideration

agreement. Acquisition-related costs are expensed when they arise.

Subsidiaries’ financial reporting is included in the consolidated financial statements

as from the acquisition date until the date when the controlling interest ceases.

Intra-Group receivables and liabilities, income and expenses, and unrealized profits

or losses arising from intra-Group transactions are eliminated in their entirety in the

presentation of the consolidated financial statements.

FOREIGN CURRENCY

Transactions in foreign currency are translated to the functional currency at the

exchange rate prevailing on the transaction date. Monetary assets and liabilities

denominated in foreign currency are translated to the functional currency at the

exchange rate prevailing at closing day. Exchange-rate differences arising on transla-

tion are recognized in the income statement. Non-monetary assets and liabilities

that are recognized at historical cost are translated at the exchange rate applicable

on the transaction date. Non-monetary assets and liabilities that are recognized at

fair value are translated to the functional currency at the exchange rate applicable

on the date of fair-value measurement. The change in exchange rates is then

recognized in the same manner as other changes in value for the asset or liability.

The functional currency is the currency in the primary economic environments in

which the companies included in the Group conduct their business. The companies

included in the Group are the Parent Company and the subsidiaries. The Parent

Company’s functional currency, as well as the reporting currency, is SEK. The

Group’s reporting currency is SEK.

Assets and liabilities in foreign operations, including goodwill and other fair value

adjustments arising on consolidation, are translated to SEK at the exchange rate

applicable at closing day. Revenue and expenses in foreign operations are transla-

ted to SEK at average rates that approximate the foreign exchange rates applicable

at each transaction date. Translation differences arising in currency translations of

foreign operations are recognized in the statement of total comprehensive income.

The following exchange rates have been applied in these statements:

Average exchange rate Closing rate

Currency 2020 2019 2020-12-31 2019-12-31

USD

9,2037 9,4604

8,1886 9,3172

EUR

10,4867 10,5892

10,0375 10,4336

AUD

6,3380 6,5724

6,2646 6,5125

Source: Sweden´s Riksbank

REVENUE

The group’s net sales are divided into three categories: sales of non-durable goods,

revenues from sales and rental of durable goods and finally revenues from freight,

service and other sales (see note 2). Sale of non-durable goods and revenues

from freight, service and other sales comprise products and services that clearly

represent separate performance obligations. Revenue from sales of goods is recog-

nized in the income statement when significant risks and rewards associated with

ownership of the goods have been transferred to the purchaser, which normally

occurs upon delivery.

SEGMENT REPORTING

Operating segments are presented according to a management approach, which

means that they are presented in the way they are used in internal reporting. The

basis for identification of reportable segments is the internal reporting such as it is

reported to and followed up by the chief operating decision maker. The Group has

identified the Group’s CEO as the chief operating decision maker. Two segments

are used in internal reporting to the CEO. For further information, see Note 3.

FINANCIAL INCOME AND EXPENSES

Financial income and expenses consist of interest income on bank balances and

receivables and interest-bearing securities, interest expenses on loans, income from

dividends, exchange-rate differences, unrealized and realized profits from financial

investments and derivative instruments used in financial operations.

LEASING

LESSEE

In accordance with IFRS 16, right-of-use such as rental agreements for premises

and equipment is recognized as an asset in the balance sheet and a lease liability is

recognized, which represents an obligation to make future lease payments related

to the right-of-use. An exemption has been utilized, whereby short-term leases

and lease contracts of low value are not recognized as an asset but are expensed in

the period when use occurs. The company defines short-term leases as contracts

whose remaining lease term is less than 12 months and by contracts of low value

is meant contracts whose cost is less than SEK 50 thousand. The Parent Company

does not apply IFRS 16, in accordance with the exception in RFR 2.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

LESSOR

At December 31, 2020 XVIVO Perfusion had entered into 3 (4) leases with custo-

mers regarding XPS machines and 1 (1) lease regarding LS machines. Due to the

fact that XVIVO Perfusion is liable for all risk regarding the machines’ residual value

and service needs, the assessment has been made that by and large all financial risks

and benefits associated with the machines relate to XVIVO Perfusion. Based on

these qualitative factors, the conclusion is drawn that that the leases are operating

leases. Lease payments pursuant to operating lease contracts, including an initial

higher rent payment but excluding expenses for services that are insurance and

maintenance, are recognized as revenue on a straight-line basis over the term of

the lease.

FINANCIAL INSTRUMENTS

IFRS 9 Financial instruments is applied by the Group. Financial instruments recogni-

zed in the balance sheet on the assets side include cash and cash equivalents, trade

accounts receivable, other receivables and other long-term holdings of securities.

On the liabilities side there are accounts payable and other liabilities.

A financial asset or a financial liability is recognized in the balance sheet when the

company becomes a party to the contractual provisions of the instrument. Trade

accounts receivable are recognized in the balance sheet when an invoice has been

sent. Accounts payable are recognized when an invoice has been received. A

financial asset is removed from the balance sheet when the contractual rights are

realized or expire or when the company loses control over them. The same app-

lies to part of a financial asset. A financial liability is removed from the balance sheet

when the contractual obligation is fulfilled or in some other way expires. The same

applies to part of a financial liability. At each reporting date, the Group evaluates

whether there is objective evidence that that there is an impairment requirement

for a financial asset or group of assets. Objective evidence comprises observable

events that have occurred and which have a negative impact on the ability to reco-

ver the cost of acquisition as well as a considerable or extensive decline in the fair

value of a financial investment classified as a financial asset that can be sold.

Receivables and liabilities in foreign currency are measured at the closing day

exchange rate. Exchange-rate differences for operating receivables and operating

liabilities are included in operating income while exchange-rate differences for

financial receivables and liabilities are included in financial income and expenses.

Regarding impairment of financial assets, the company uses a model based on

expected future credit losses, the “expected credit loss model”. The impairment

model is applied to financial assets measured at amortized cost or at fair value via

other comprehensive income, except for investments in equity instruments (shares

and participations) and contract assets. There were not any significant credit losses

during the year and the Group’s provisions for future credit losses at closing day do

not amount to a significant amount either.

In connection to business acquisitions, additional purchase price is valued at fair

value with changes in value in the income statement.

TRADE ACCOUNTS RECEIVABLE AND OTHER RECEIVABLES

These types of receivables are stated at amortized cost. Where the duration of

the receivables is short, they are recognized at nominal value with no discounting

pursuant to the amortized cost method. If the expected holding period is longer

than 12 months they are long-term receivables and if it is shorter they are other

receivables. Trade accounts receivable are initially measured at fair value and

subsequently at amortized cost. When the expected duration of trade receivables

is short, they are recognized at nominal value with no discounting. A deduction is

made for doubtful receivables, which are assessed individually. Impairment of trade

accounts receivable is recognized in operating expenses.

CASH AND CASH EQUIVALENTS

Cash and cash equivalents comprise cash in hand, immediately available bank

balances and other money market instruments with an original duration of less

than three months. Fixed interest items are measured at amortized cost.

ACCOUNTS PAYABLE

Accounts payable are initially recognized at fair value and subsequently at amorti-

zed cost by applying the effective interest method.

INTANGIBLE FIXED ASSETS

The items recognized in the consolidated balance sheet are goodwill, capitalized

development expenditure, patents, licenses, trademarks and computer programs.

CAPITALIZED DEVELOPMENT EXPENDITURE

Research costs are expenditure for research with the aim of gaining new scientific

or technical knowledge. Development expenditure is expenditure where research

results or other knowledge are applied to achieve new or improved products or

processes.

Expenditure for research is expensed in the period when it arises. In the Group,

development expenditure is recognized as an intangible asset if it is assessed that

the asset is able to generate future financial rewards, but only if it is technically and

financially possible to complete the asset, the aim is and it is possible that the asset

can be used in the business or sold, and the value can be estimated in a reliable

way.

Capitalized development expenditure is recognized in the Group’s balance sheet

at cost minus accumulated amortization and write-downs.

ADDITIONAL EXPENSES

Additional expenses for an intangible asset are added to cost only if they increase

the future financial rewards that exceed the original assessment and the expenses

can be estimated in a reliable manner. All other expenses are expensed when they

arise.

AMORTIZATION

Straight-line amortization is applied in the income statement over intangible assets’

estimated useful life, unless the useful life is indefinite. Goodwill is tested for any

impairment requirement annually or as soon as there are indications that the asset

in question has decreased in value pursuant to IFRS. Intangible assets that can

be amortized are amortized from the date when they are available for use. The

estimated useful life of the assets is as follows:

Capitalized development expenditure 5-10 years

Patents 10 years

Licenses and trademarks 10 years

Computer programs 5 years

PROPERTY, PLANT AND EQUIPMENT

Property, plant and equipment is recognized as an asset in the balance sheet if it is

probable that future financial rewards will accrue to the company and the cost of

the asset can be estimated in a reliable manner. All tangible fixed assets are booked

at cost, with a deduction for depreciation. Cost includes expenses that are directly

attributable to acquisition of the asset. Additional expenses are added to the carry-

ing amount of the asset or are recognized as a separate asset, depending on which

is appropriate, only when it is probable that the future financial rewards associated

with the asset will accrue to the Group and the cost of the asset can be measured

in a reliable manner. All other forms of repairs and maintenance are recognized as

expenses in the income statement when they arise.

DEPRECIATION OF PROPERTY, PLANT AND EQUIPMENT

Depreciation according to plan of property, plant and equipment is based on a

determined useful life. Straight-line depreciation is applied over the assets’ estima-

ted useful life and taking residual value into account. The estimated useful life of the

assets is as follows:

Plant and machinery 10 years

Equipment, tools, fixtures and fittings 5 years

Computer equipment 3 years

Cars and means of transport 5 years

Assessment of an asset’s residual value and useful life is performed annually.

Assets’ residual value and useful life are tested each closing day and adjusted when

necessary. An asset’s carrying amount is immediately depreciated down to its reco-

verable amount if the asset’s carrying amount exceeds its estimated recoverable

amount. Profit or loss that arises when divesting or disposing of property, plant

and equipment comprises the difference between the sales price and the carrying

amount with a deduction for direct selling expenses. The item is recognized as

other operating revenues or as other operating expenses in the income statement.

INVENTORIES

Inventories are recognized at cost or net realizable value, whichever is the lower.

The risk of obsolescence is taken into account, and this is assessed on an individual

basis. Cost is estimated in accordance with weighted average prices. The cost of

in-house produced semi-finished products and finished products consists of direct

manufacturing costs and a reasonable share of indirect manufacturing costs based

on normal capacity.

WRITE-DOWNS

Each time a report is to be published, an assessment is made as to whether there

is any indication of a decrease in the value of the Group’s tangible and intangible

assets. Any impairment requirement regarding goodwill and other intangible assets

not amortized on an ongoing basis is tested annually or more often if there are

indications that the asset may have decreased in value. If this is the case, the Group

makes an assessment of the asset’s recoverable amount. The recoverable amount

is either the asset’s fair value, with a deduction for selling expenses, or the value in

use, whichever is the higher. The value in use is the present value of all payments

received and made which are attributable to the asset during the period it is

expected to be used in the business, with the addition of the present value of the

net realizable value at the end of the useful life of the asset.

If the estimated recoverable amount is less than the carrying amount, the asset

is written down to its recoverable amount. A previous write-down is reversed

when there has been a change in the assumptions on the basis of which the asset’s

recoverable amount was determined when it was written down and consequently

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

the write-down is no longer assessed to be required. Reversals of previously

performed write-downs are tested individually and are recognized in the income

statement. Write-downs of goodwill are not reversed in a subsequent period.

EARNINGS PER SHARE

Calculation of earnings per share is based on the Group’s net income for the year

attributable to the Parent Company shareholders and on the weighted average

number of shares outstanding during the year. Potential ordinary shares are only

seen as diluting in periods when they lead to a lower profit or a greater loss per

share.

PENSIONS

All employees’ pension plans are defined contribution plans. The premiums are

expensed on an ongoing basis and there are no commitments to pay further

fees. Expenses are charged against income in the Group as and when benefits are

earned. For further information, see Note 7.

PROVISIONS

Provisions are recognized in the balance sheet when XVIVO Perfusion has a legal

or informal commitment as a consequence of an event that has occurred and

when it is likely that an outflow of resources is required to settle the commitment.

Furthermore, it shall be possible to make a reliable estimate of the amount.

Provisions are recognized in the amount that corresponds to the best estimate

of the payment required to settle the commitment. When it is assessed that the

outflow of resources is a long time in the future, the expected future cash flow is

discounted, and the provision is recognized at present value. The discount rate

corresponds to the market rate before tax and the risks related to the liability.

SHAREHOLDERS’ EQUITY

Transaction costs that are directly attributable to an issue of new shares or war-

rants are recognized, net after tax, in shareholders’ equity as a deduction from the

funds raised through the share issue.

WARRANTS PROGRAMS

Share-based incentive programs are recognized pursuant to IFRS 2. There are two

outstanding warrants programs directed at the company’s employees. Employees

who have wished to participate in a warrants program have paid a premium

corresponding to the market value of the warrant calculated pursuant to Black

& Scholes’ formula. As the market value has been paid, there is no effect on the

company’s net income for the period or on its financial position. A description of

the warrants programs is to be found in Note 24.

INCOME TAXES

The current tax expense is calculated on the basis of the tax rules that are in force

at closing day or de facto in force in countries where the Parent Company and the

subsidiary operate and generate taxable revenues. Management regularly evaluates

claims made in tax returns regarding situations where applicable tax rules are

subject to interpretation and, when it is assessed appropriate, provisions are made

for amounts that will probably be paid to the tax authority.

Deferred tax is stated in its entirety, pursuant to the balance sheet method, for all

temporary differences that arise between the taxable value of assets and liabilities

and their carrying amounts in the consolidated accounts. Deferred income tax is

estimated by applying tax rates (and laws) which are in force or will be in force at

closing day and which are expected to apply when the relevant deferred tax asset

is realized or the deferred tax liability is settled.

Deferred tax is estimated for temporary differences that arise in participations in

subsidiaries, except where the time for reversal of the temporary difference can

be controlled by the Group and it is likely that the temporary difference will not be

reversed in the foreseeable future.

Total tax is current tax and deferred tax.

Taxes are stated in the income statement except when the underlying transac-

tion is stated in Other comprehensive income, in which case the accompanying

tax effect is stated in Other comprehensive income. Current tax is tax that is to

be paid or received regarding the current year. This also includes adjustment of

current tax attributable to earlier periods. Deferred tax is estimated in accordance

with the balance sheet method on the basis of temporary differences between

recognized and taxable values for assets and liabilities. The amounts are estimated

on the basis of how the temporary differences are expected to be settled and by

applying the tax rates and tax rules that are in force or will be in force at closing

day. Temporary differences are not taken into consideration in consolidated good-

will and normally not in differences attributable to participations in subsidiaries

which are not expected to be taxed in the foreseeable future. In the consolidated

accounts untaxed reserves are divided up into a deferred tax liability and sharehol-

ders’ equity.

Deferred tax assets regarding tax deductible temporary differences and tax loss

carry forward are recognized only to the extent that it is likely that these will entail

lower tax payments in the future.

CONTINGENT LIABILITIES

A contingent liability is recognized when there is a possible commitment stem-

ming from events that have occurred and whose occurrence is confirmed only

by one or more uncertain future events or when there is a commitment which is

not recognized as a liability or provision due to the fact that it is not likely that an

outflow of resources will be required.

PARENT COMPANY’S ACCOUNTING POLICIES

The Parent Company has prepared its annual financial statements pursuant to the

Swedish Annual Accounts Act (1995:1554) and recommendation RFR 2 of the

Swedish Financial Reporting Board, “Accounting for Legal Entities”. The pronoun-

cements that the Swedish Financial Reporting Board has published regarding listed

companies have also been applied. Under RFR2 the Parent Company shall apply in

the annual financial statements for the legal entity all the IFRS and pronouncements

adopted by the EU as far as is possible within the framework of the Swedish

Annual Accounts Act and the Pension Obligations Vesting Act and taking into

account the connection between accounting and taxation. The recommendation

states which exceptions and additions shall be made in respect of IFRS.

DIFFERENCES BETWEEN THE GROUP’S AND THE PARENT

COMPANY’S ACCOUNTING POLICIES

The differences between the Group’s and the Parent Company’s accounting

policies are stated below. The accounting principles stated below for the Parent

Company have been applied consistently in all periods presented in the Parent

Company’s financial reports.

CLASSIFICATION AND FORMAT

The term income statement is used for the Parent Company while for the Group

the term statement of net income is used. Furthermore, the term balance sheet

is used for the Parent Company whereas for the Group the term statement of

financial position is used. The Parent Company income statement and balance

sheet follow the format stipulated in the Swedish Annual Accounts Act, while the

statement of total comprehensive income, changes in shareholders’ equity and the

cash flow statement are based on IAS 1 “Presentation of Financial Statements” and

IAS 7 “Statement of Cash Flows”. The differences in the Parent Company’s income

statement and balance sheet compared to the Group’s financial statements prima-

rily concern shareholders’ equity and the occurrence of provisions as a heading of

its own in the balance sheet.

SUBSIDIARIES

Participations in subsidiaries are recognized in accordance with the cost method.

This means that transaction expenses are included in the carrying amount for hol-

dings in subsidiaries. In the consolidated financial statements transaction expenses

attributable to subsidiaries are recognized directly in the statement of net income

when they arise. Testing of the value of subsidiaries is carried out when there is an

indication of a decrease in value.

INCOME TAXES

In the Parent Company, untaxed reserves are recognized including a deferred tax

liability. In the consolidated accounts, however, untaxed reserves are divided up

into a deferred tax liability and shareholders’ equity.

LEASED ASSETS

In the Parent Company, all leases are classified as operating leases when the Parent

Company is the lessee. Lease payments pursuant to operating lease contracts,

including an initial higher rent payment but excluding expenses for services that are

insurance and maintenance, are recognized as an expense on a straight line basis

over the term of the lease.

NOTE 2. NET SALES

DISTRIBUTION OF NET SALES

Group Parent Company

2020 2019 2020 2019

Sales of non-durable goods

161 762 198 271 126 516 159 292

Revenues from sales and

rental of durable goods 10 436 13 981 5 511 6 227

Revenues from freight,

service and other sales 7 663 8 586 2 095 4 090

Total 179 861 220 837 134 122 169 608

The Group had no customer during 2020 and 2019 that constituted more than

10% of total sales.

Of the Group’s and the Parent Company’s total revenues, SEK 1,866 thousand

(2,208 thousand) relates to operating lease income (see Note 10 Leases).

It has been assessed that revenues have come from similar products and services.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

GEOGRAPHICAL AREAS

Group

Revenues from

external customers

Non-current

assets

2020 2019 2020 2019

Sweden 1 306 1 165 608 096 353 269

Americas 108 132 137 603 6 076 8 795

EMEA excluding Sweden 60 989 65 097 31 819 -

Asia/Pacific 9 434 16 972 - -

Total 179 861 220 837 645 991 362 063

Revenues from external customers have been allocated to individual countries

according to the country sales were made to. Non-current assets refer to all of the

Group’s intangible non-current assets and property, plant and equipment.

NOTE 3. SEGMENTS

The Group’s business is divided up into segments on the basis of what parts of

the business the company’s chief operating decision maker follows up, a so-called

”management approach”.

The Group’s business is organized so that Group management follows up sales

and the gross income that the Group’s various revenue flows generate. As Group

management follows up the sales and gross margin of the business and makes deci-

sions regarding the distribution of resources on the basis of the goods the Group

develops and sells, these constitute the Group’s segments.

The Group’s internal reporting is thus constructed so that Group management can

follow up all goods’ performance. It is on the basis of this internal reporting that

the Group’s segments have been identified, as the various parts have undergone

a process that has aimed at combining segments that are similar. This means that

segments have been combined when they have similar financial characteristics,

such as similar gross margins and sales trends.

The following segments have been identified:

• Durable goods: sales and rental revenues from machines.

• All non-durable goods: revenue flows from sales of goods and services that are

not durable goods.

GROUP SEGMENTS - TOTAL

All business except

durable goods

Durable goods Consolidated

total

2020 2019 2020 2019 2020 2019

Revenues from external

customers

169 425 206 857 10 436 13 981 179 861 220 837

Cost of goods sold

-38 980 -47 439 -7 906 -10 585 -46 886 -58 024

Gross income 130 445 159 417 2 530 3 396 132 975 162 813

The segments’ gross margin includes directly attributable items and items that

can be divided up into segments in a reasonable and reliable manner. The items

recognized in the segments’ gross income are measured in accordance with the

gross margin that Group management follows up.

Since 2020, the company’s operations have been conducted in two business

areas; Thoracic, which includes sales of lung and heart transplant products, as well

as Abdominal, which includes sales of liver and kidney transplant products. The

Group’s operating segments can be found in each business area.

GROUP SEGMENTS – PER BUSINESS AREA – THORACIC

All business except

durable goods

Durable goods Consolidated

total

2020 2019 2020 2019 2020 2019

Revenues from external

customers

155 572 206 857 7 720 13 981 163 292 220 837

Cost of goods sold

-32 048 -47 439 -6 291 -10 585 -38 339 -58 024

Gross income 123 524 159 417 1 429 3 396 124 953 162 813

GROUP SEGMENTS – PER BUSINESS AREA - ABDOMINAL

All business except

durable goods

Durable goods Consolidated

total

2020 2019 2020 2019 2020 2019

Revenues from external

customers

13 853 - 2 716 - 16 569 -

Cost of goods sold

-6 932 - -1 615 - -8 547 -

Gross income 6 921 - 1 101 - 8 022 -

NOTE 4 ACQUISITION OF SUBSIDIARIES

On September 1, XVIVO entered into an agreement to acquire 100 percent

of the shares in the Dutch medical technology company Organ Assist B.V. The

purchase price amounted to a maximum of EUR 24 million, with an initial payment

of EUR 20 million and a conditioned, additional purchase price of maximum EUR

4 million. The additional payments are divided between two different payments

of SEK 2 million each, where one is dependent on sales targets for 2021 and the

other on regulatory FDA approval for the kidney transport device. The acquisition

of Organ Assist was successfully financed through a directed share issue in which

SEK 500 million were raised through a directed share issue.

Costs related to the acquisition have so far amounted to SEK 2.7 million and have

been charged to administrative expenses in the Group’s income statement during

the year. Transaction costs directly attributable to the share issue have been recog-

nized as equity and amount to SEK 10.3 million net after tax.

Organ Assist focuses mainly on developing machines and consumables for

perfusion of the liver and kidneys. Through the acquisition, XVIVO will be the first

company for the preservation and evaluation of organs in the world to actively

conduct activities that include all major organs, which accelerates the company’s

strategy to become a global supplier of solutions and systems for all major organs.

The companies’ synergies enable greater market opportunities for XVIVO’s and

Organ Assist’s product portfolios by integrating XVIVO’s unique and patented

STEEN Solution™ technology with Organ Assist’s kidney and liver devices, as

well as by utilizing XVIVO’s international market presence. The combined offering

expands XVIVO’s addressable market to approximately 98 percent of the organ

transplant market with the goal of positioning the company as the first choice for

all multi-organ clinics.

Goodwill primarily consists of synergy effects that do not meet the requirements

for accounting as intangible assets at the time of the acquisition. Primary synergies

are potentially increased sales values per client as well as increased sales potential

for new clients, which can be achieved through XVIVOS knowledge and expe-

rience within global marketing and regulatory issues. Synergies which could contri-

bute to future net sales is also to be found within research and development.

The acquisition date is October 1 and income and cash flow are not included

in the consolidated financial statements until this date. During the time after the

acquisition, Organ Assist contributed with SEK 16.6 million to the net sales of the

group and SEK 1.1 million to the net result. If the acquisition had taken place on

January 1st 2020, the entity would have contributed with net sales of SEK 41.8

million and a net result of -3.1 million.

Transferred compensation Fair value (TSEK)

Cash and cash equivalents 201 320

Conditional purchase price 41 973

Total 243 293

Acquired net assets

Intangible assets 87 372

Property, plant and equipment 1 475

Inventories 14 360

Accounts receivable and other receivables 18 155

Cash and cash equivalents 1

Deferred tax liability -12 706

Accounts payable and other liabilities -31 257

Fair value of acquired net assets 77 400

Goodwill 165 893

Total 243 293

Effect on cash flow from acquisition of business

Purchase price, initial cash part 201 320

Less cash and cash equivalents in acquired company 1

Impact on the Group's cash and cash equivalents 201 319

NOTE 5. OTHER OPERATING REVENUES

Group Parent Company

2020 2019 2020 2019

Exchange-rate gains

936 1 369 904 1 354

Other Revenues 532 369 365 2 680

Total 1 468 1 738 1 269 4 034

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

NOTE 6. OTHER OPERATING EXPENSES

Group Parent Company

2020 2019 2020 2019

Exchange-rate losses

-2 425 -1 342 -2 123 -1 260

Other Intra-Group services - - - -128

Cost of share-based bonus program* -18 260 -7 046 -3 342 -660

Cost of reorganization -9 873 - -3 584 -

Capital loss, sale of non-current asset - -58 - -

Depreciation of durable goods -3 141 -3 989 -2 294 -2 827

Total -33 699 -12 435 -11 343 -4 875

*See notes 5 and 7 for information.

NOTE 7. EMPLOYEES, EMPLOYEE BENEFIT

EXPENSES AND BOARD FEES

AVERAGE NUMBER OF EMPLOYEES

Total Number of men

2020 2019 2020 2019

Parent Company, Sweden

28 18 12 7

Subsidiary, Sweden

10 10 8 8

Subsidiary, USA

19 16 13 10

Subsidary, Netherlands

4 - 3 -

Subsidiary, France

1 1 - -

Subsidiary, Australia

1 1 1 1

Total 63 46 37 26

PERCENTAGE OF WOMEN IN SENIOR POSITIONS

2020 2019

Group

Board

50 % 33 %

Senior management

29 % 17 %

EMPLOYEE BENEFIT EXPENSES

Group

2020 2019

Salary and other remuneration

75 793 51 131

Pension expenses, defined contribution plans

7 789 6 293

Social security contributions

16 566 13 359

Total 100 148 70 783

Parent Company

2020 2019

Salary and other remuneration 34 598 23 025

Pension expenses, defined contribution plans 6 247 4 199

Social security contributions 11 832 7 908

Total 52 677 35 132

SALARY AND OTHER REMUNERATION DIVIDED UP

BETWEEN BOARD MEMBERS/CEO AND OTHER EMPLOYEES

Board/CEO Other employees

2020 2019 2020 2019

Parent Company 4 392 8 784 31 214 15 467

- of which bonus payments and

similar remuneration

( -) (2 219) (2 140) (1 358)

Subsidiaries -14 2 341 41 209 25 765

- of which bonus payments and

similar remuneration

(-14) (719) (22 500) (10 267)

Total 4 378 11 125 72 423 41 232

- of which bonus payments and

similar remuneration

( -14) (2 938) (24 640) (11 625)

BOARD

Board fees of SEK 1 180 thousand (1 035) were paid during the year, in accordance

with the resolution adopted at the 2019 Annual General Meeting. SEK 250 thou-

sand (205) was paid to Gösta Johannesson and SEK 150 thousand (130) to each

of the other Board members, as well as SEK 40 thousand (40) to the Chairman of

the Audit Committee, SEK 40 thousand (40) to the Chairman of the Remuneration

Committee and SEK 25 thousand (25) to each of the other members of these

committees. There are no pension expenses or pension obligations for the Board

members.

At the Annual General Meeting held on April 31, 2020 in Gothenburg a resolu-

tion was adopted that Board fees will remain unchanged on individual level totaling

SEK 1 180 thousand (1 180) until the next Annual General Meeting. SEK 250

thousand (250) will be paid to Chairman of the Board and SEK 150 thousand

(150) to each of the other Board members, as well as SEK 40 thousand (40) to

the Chairman of the Audit Committee, SEK 40 thousand (40) to the Chairman

of the Remuneration Committee and SEK 25 thousand (25) to each of the other

members of these committees.

CEO

During the past year of 2020, XVIVO Perfusion AB has had two CEOs, since Dag

Andersson succeeded Magnus Nilsson on June 1 2020. During the year, CEO Mag-

nus Nilsson was paid renumeration totaling SEK 1 620 (9 173) thousand including

vacation allowance and other benefits of which SEK- thousand (2 219) was variable

renumeration. A car allowance and health-insurance benefit of SEK 58 thousand

(84) was paid. During 2020, CEO Dag Andersson was paid renumeration totaling

SEK 1 862 (-) thousand including vacation allowance and other benefits of which

SEK - thousand (-) was variable renumeration. A car allowance and health-insurance

benefit of SEK 54 thousand (-) was paid.

As long as the CEO is based in Sweden, his pension follows a defined contribution

plan and pension premiums of 35% of his salary are paid by the company. If the

company terminates the CEO’s employment, notice of 6 months shall be given.

Similarly, if the CEO resigns, he must give notice of 6 months. If the company termi-

nates the CEO’s employment, separation pay of 12 months’ salary shall be paid. The

CEO’s retirement age is 65. His employment is regulated by a CEO agreement.

OTHER SENIOR EXECUTIVES

Salary of SEK 10 463 thousand (10 057) was paid during the 2020 financial year

to senior executives, the Group’s management team of 6 (5) people excluding

the CEO, including a vacation allowance, of which SEK 4 485 thousand (3 134)

was variable remuneration. The variable remuneration is based on the outcome

of various parameters compared with set objectives. The parameters relate to

the company’s sales and results as well as individually set objectives. Premiums for

normal occupational pension were paid. The retirement age is 65 for these senior

executives. If the company terminates the senior executives’ employment, notice

of 3-6 months shall be given. Similarly, if the senior executives resign, they must give

notice of 3-6 months. No-one is entitled to separation pay. There are no loans to

senior executives.

DEFINED CONTRIBUTION PENSION PLANS

In Sweden the Group has defined contribution pension plans for employees. The

entire cost of these is met by the company. Outside Sweden there are defined

contribution plans which are partly paid for by the subsidiaries and partly covered

by fees paid by the employees. Payment for these plans is done on an ongoing basis

according to the rules of each individual plan.

Group Parent Company

2020 2019 2020 2019

Costs for defined contribution

pension plans

7 789 6 293 6 247 4 199

ENDOWMENT INSURANCE

The company has a pension obligation to the CEO that is covered by the outcome

of endowment insurance owned by the company. Pursuant to IAS 19, the pension

obligation has been classified as a defined contribution pension plan. During 2020

and 2019 nothing was paid for this endowment insurance.

COSTS FOR SHARE-BASED WARRANTS PROGRAM FOR

EMPLOYEES ABROAD

The 2019 and 2020 Annual General Meetings adopted a resolution to approve

a cash-based incentives program for Group employees in countries outside of

Sweden as these employees are not entitled to participate in the Swedish war-

rants programs. The cash-based programs shall as far as practically possible be

designed so that they correspond to the Swedish warrants programs but have a

ceiling for maximum outcome. The cost of these cash-based incentive programs

is recognized in the periods XVIVO’s share price is higher than the strike price

for each Swedish warrants program. The Group’s cost amounted to SEK 18 260

(7 046) (see notes 6 and 24) and is included in the item bonus payments/variable

remuneration above. In the functionally divided income statement, this expense is

recognized as other operating expenses.

GOVERNMENT SUPPORT

Government support has been received in the USA and Australia of SEK 4.2 mil-

lion, which has been reported as reduced personnel cost, mainly within the sales

and R&D functions. In Sweden, government support has been received through

reduced employer contribution fees. No layoffs or furlough has occurred. Informa-

tion on labor costs listed in this note is reported before deduction of contributions

received.

NOTE 8. AUDITOR´S FEES AND

REIMBURSEMENT OF COSTS

Group Parent Company

KPMG

2020 2019 2020 2019

Auditing 650 420 250 250

Auditing activities in addition to auditing

31 5 31 5

Tax consulting

297 8 254 8

Other services

96 67 96 67

Total 1 074 500 631 330

Auditing involves review of the Annual Report, of the accounting records, and

of the management of the Board of Directors and CEO, and other tasks that

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

the company’s auditors are required to undertake, as well as advice and other

assistance that arise from observations as a result of this review or the carrying out

of these other tasks. Auditing activities in addition to auditing involve quality assu-

rance services, including assistance as a result of such review as shall be carried out

in accordance with national statutes, the articles of association, company statutes

or agreements and which result in a report intended for other parties than the

client. Tax consulting is recognized separately. Anything else is other services.

NOTE 9. OPERATING EXPENSES DIVIDED UP

ACCORDING TO TYPE OF COST

Group

2020 2019

Raw materials and consumables

-25 897 -28 850

Change in inventories of finished goods and products in

progress

-8 169

-22 563

Employee benefit expenses

-103 726

-88 012

Depreciation, amortization and impairment

-30 038

-24 860

Other external expenses

-56 911

-52 950

Other operating expenses -2 263 -1 400

Total -227 004 -218 635

NOTE 10. LEASES

The Group rents office premises and warehouse facilities in Gothenburg. The

current rental agreement for office premises expires on December 31, 2023.

The rental agreements for warehouse facilities expire on March 31, 2021 with

an option for extension. The Group also rents office premises and warehouse

facilities in Denver, Colorado. The current rental agreement expires on August

1, 2022 with an option for extension. The Group also rents office premises and

warehouse facilities in Lund. This rental agreement expires on October 31, 2022

with an option for extension. The Group also rents office premises and warehouse

facilities in Groningen, Netherlands. This rental agreement expires on December 1,

2021 with an option for extension.

Rental payments are linked to CPI and vary with the market as a whole. Variable

payments are invoiced 1:1 in arrears after an annual review. There are no restric-

tions as a result of lease agreements already entered into. Where rebuilding or

extension work has been paid by the Group, individual testing is carried out to

ascertain whether the costs can be included in the balance sheet or whether they

are to be expensed in their entirety. Otherwise, the Group has entered into lease

agreements for three company cars and some office equipment.

Group

Cost disclosures, leases:

2020 2019

Depreciation of right-of-use assets 5 667 3 349

- Of which buildings

5 361 3 166

- Of which cars

306 183

Interest expense, lease liability

222 161

Lease expense for short-term leases

130 142

Lease expense for assets of low value

- -

Variable lease expenses

282 150

Total 6 301 3 802

Group

Cash flow disclosures, leases

2020 2019

Part-payment of lease liability 5 667 3 349

Interest expense, lease liability

222 161

Lease expense for short-term leases

130 142

Lease expense for assets of low value

- -

Variable lease expenses

282 150

Total 6 301 3 802

Group

Additional right-of use assets

2020 2019

Buildings 6 869 -

Cars

500 425

Total 7 329 425

Group

Carrying amount of right-of-use assets

2020 2019

Byggnader 6 550 5 082

Bilar

662 468

Total 7 212 5 550

Group

Carrying amount of lease liabilities

2020 2019

Lease liabilities 7 212 5 550

Total 7 212 5 550

A lease analysis for agreed minimum future lease payments payable pursuant to

non-reversible contracts is presented in note 27.

Payments expensed for operating leases are as follows:

Group

2020 2019

Minimum lease payments 2 214 1 907

Total lease expenses 2 214 1 907

The Group rents out machines for lung perfusion pursuant to operating leases.

Revenues amounted to SEK 1 866 thousand (2 208). Future non-reversible lease

payments fall due as follows:

Group Parent Company

2020 2019 2020 2019

Year 1 1 022 2 208 1 022 2 208

Year 2

- 944 - 944

Year 3

- - - -

Year 4

- - - -

Year 5

- - - -

Later than 5 years

- - - -

Total 1 022 3 152 1 022 3 152

NOTE 11. NET FINANCIAL INCOME

Group Parent Company

2020 2019 2020 2019

Interest income 80 469 725 1 358

Exchange-rate gains 810 1 230 856 4 480

Financial income 890 1 699 1 581 5 838

Interest expenses -361 -285 -129 -120

Exchange-rate losses -11 916 - -11 890 -900

Other financial expenses -201 -64 -171 -44

Financial expenses -12 478 -349 -12 190 -1 064

Total -11 588 1 350 -10 609 4 774

NOTE 12. EXCHANGE-RATE DIFFERENCES

Group Parent Company

2020 2019 2020 2019

In operating income, net -1 333 27 -1 219 94

In financial items, net

-11 106 1 230 -11 034 3 580

Total -12 439 1 257 -12 253 3 674

NOTE 13. YEAR-END ADJUSTMENTS

Parent Company

2020 2019

Change in tax allocation reserve 4 200 5 950

Group contributions paid - -8 250

Total 4 200 -2 300

NOTE 14. INCOME TAXES

RECOGNIZED IN STATEMENT OF TOTAL COMPREHENSIVE

INCOME AND INCOME STATEMENT

Group Parent Company

2020 2019 2020 2019

Current tax expense (-)

Tax expense for the year -782 -1 212 - -574

Adjustment of tax pertaining to

previous years 561 759 2 -

Total current tax expense -221 -453 2 -574

Deferred tax expense (-)

Deferred tax on temporary differences 1 475 109 480 275

Deferred tax in taxable value

capitalized/utilized during the year in

loss carry-forwards 12 680 -7 9 448 -

Effects from changed income tax rates -406 - -352 -

Total deferred tax expense 13 749 102 9 575 275

Total tax expense recognized 13 528 -351 9 577 -299

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Group Parent Company

2020 2019 2020 2019

Reconciliation effective tax rate

Income before tax -57 263 5 290 -48 013 301

Tax pursuant to current tax rate for

Parent Company (21.4 %) 12 254 -1 132 10 275 -64

Difference in foreign tax rates -59 17 - -

Non-deductible expenses -1 120 -126 -343 -189

Non-taxable income 2 303 180 1 3

Tax effect of standard interest rate on

tax allocation reserve -4 -49 -4 -49

Effect of changed income tax rates -406 - -352 -

Difference in recorded and paid tax

previous year 561 759 2 -

Total tax expense 13 528 -351 9 577 -299

Tax attributable to other comprehensive income

Group

2020 2019

Before

tax Tax

After

tax

Before

tax Tax

After

tax

Translation differences for the

year after translation of foreign

businesses -8 674 - -8 674 1 319 - 1 319

Translation differences for

the year after translation of

foreign businesses (extended

investment) -7 736 - -7 736 2 402 -514 1 888

Other comprehensive income -16 410 - -16 410 3 721 -514 3 207

RECOGNIZED DIRECTLY IN SHAREHOLDERS´EQUITY

Group Parent Company

2020 2019 2020 2019

Tax items recognized directly in

shareholders’ equity

Tax expense (-)

Current tax related to transaction

expenses for new share issue - 2 669 - -2 669 -

Total tax items recognized directly in

shareholders’ equity -2 669 - - 2 669 -

RECOGNIZED IN STATEMENT OF FINANCIAL POSITION AND

BALANCE SHEET

Group Parent Company

2020 2019 2020 2019

Deferred tax asset

Deferred tax related to internal profit

on inventories 2 972 2 875 - -

Deferred tax related to pensions and

similar obligations 2 157 1 677 2 157 1 677

Deferred tax related to capitalized loss

carry-forwards 35 205 7 764 11 764 -

Total deferred tax asset 40 334 12 316 13 921 1 677

Deferred tax liability

Deferred tax on tax allocation reserve - 899 - -

Deferred tax on acquired excess value 24 852 - - -

Total deferred tax liability 24 852 899 - -

NOTE 15. INTANGIBLE NON-CURRENT

ASSETS

Group Parent Company

2020 2019 2020 2019

Goodwill

Opening acquisition cost 65 773 65 614 - -

Acquired assets for the year 165 893 - - -

Exchange-rate differences for the year -7 728 159 - -

Closing accumulated acquisition cost 223 938 65 773 - -

Closing carrying amount 223 938 65 773 - -

Group Parent Company

2020 2019 2020 2019

Capitalized development

expenditure

Opening acquisition cost 336 141 266 390 258 167 190 227

Capitalized expenditure for the year 60 497 69 751 54 299 67 940

Acquired assets for the year 87 372 - - -

Exchange-rate differences for the year -3 791 - - -

Closing accumulated acquisition cost 480 209 336 141 312 466 258 167

Opening amortization -69 624 -55 930 -57 495 -43 800

Amortization for the year -16 668 -13 694 -15 462 -13 695

Exchange-rate differences for the year 52 - - -

Closing accumulated amortization -86 240 -69 624 -72 957 -57 495

Closing carrying amount 393 969 266 517 239 509 200 672

Patents, licenses and trademarks

Opening acquisition cost 10 038 7 482 7 302 4 745

Capitalized expenditure for the year 990 2 556 990 2 557

Closing accumulated acquisition cost 11 028 10 038 8 292 7 302

Closing accumulated acquisition cost -4 656 -3 858 -2 606 -2 019

Amortization for the year -905 -798 -701 -587

Closing accumulated amortization -5 561 -4 656 -3 307 -2 606

Closing carrying amount 5 467 5 382 4 985 4 696

Data programs

Opening acquisition cost 882 - 882 -

Capitalized expenditure for the year 559 882 559 882

Closing accumulated acquisition cost 1 441 882 1 441 882

Closing accumulated acquisition cost -46 - -46 -

Amortization for the year -113 -46 -113 -46

Closing accumulated amortization -159 -46 -159 -46

Closing carrying amount 1 283 837 1 283 837

Amortization has been divided up per function in the income statement as

follows:

Group Parent Company

2020 2019 2020 2019

Cost of goods sold - - - -

Selling expenses - - - -

Administrative expenses -113 -46 - 113 - 46

Research and development costs -17 572 -14 493 -16 162 -14 280

Other operating expenses - - - -

Total -17 685 -14 539 -16 275 -14 326

The Group’s goodwill is attributable to acquisitions of subsidiaries and their busi-

nesses. Goodwill primarily consists of synergy effects that do not meet the requi-

rements for accounting as intangible assets at the time of the acquisition. Primary

synergies are potentially increased sales values per client as well as increased sales

potential for new clients, which can be achieved through XVIVOS knowledge and

experience within global marketing and regulatory issues. Synergies which could

contribute to future net sales is also to be found within research and development.

Goodwill has been tested for impairment on the basis of budgets and forecasts,

where the first year of the forecast is based on the company’s budget and the

subsequent four years on the basis of the historical growth rate adjusted by

the company management’s forecasts for the future. The forecasts have been

produced internally by the company management on the basis of historical data,

management’s cumulative experience and their best assessment of the company’s

development potential and market growth.

The forecast cash flows have been calculated with a discount rate of 8.9 per cent

before tax for assets in the lung business, and 9.6-11.4 per cent before tax for

assets in the abdominal business. The main variables in the forecast are market

share and growth, gross margin, sales costs and investments. The calculation

is based on continued good gross margin and the investment need to replace

existing assets has been deemed to be relatively low. The labour capital has been

assumed to change in proportion to turnover and the debt/equity ratio is expec-

ted to remain unchanged as growth has been assumed to take place within the

framework of the existing operations and with own resources. The recoverable

amount, which is calculated in the Group as value in use, exceeds the carrying

amount. Management believes that no reasonable changes in the important variab-

les and assumptions result in the entity’s recoverable amount being lower than the

carrying amounts.

In order to support the impairment testing of goodwill that has been carried out,

a comprehensive analysis has been made of the sensitivity of the variables used in

the model. An assumed increase in the discount rate to 15 percent demonstrates

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

that the recoverable amounts are still greater than the carrying amounts. Other

assumptions, such as the gross margin, capital expenditure requirements and the

growth rate, have been assumed to be constant. Conceivable changes in these

assumptions over time are not expected to lead to any indication that the carrying

amount for goodwill cannot be defended.

NOTE 16. PROPERTY, PLANT AND

EQUIPMENT

Group Parent Company

2020 2019 2020 2019

Machinery, equipment, fixtures and

fittings

Opening acquisition cost 49 753 32 872 20 213 16 160

Adjustment for changed accounting

principle* - 8 712 - -

Acquisitions for the year 9 944 10 690 1 611 4 053

Acquired assets for the year 1 480

Sales/disposals for the year -628 -1 581 -1 -

Exchange-rate differences for the year -1 777 -940 - -

Closing accumulated acquisition cost 58 772 49 753 21 823 20 213

Opening depreciation -26 199 -17 257 -12 290 -8 793

Sales/disposals for the year 179 158 1 -

Depreciation for the year -12 343 -10 321 -3 632 -3 497

Exchange-rate differences for the year 925 1 221 - -

Closing accumulated depreciation -37 438 -26 199 -15 921 -12 290

Closing carrying amount 21 334 23 554 5 902 7 924

* Adjustment for changed accounting principle refers to introduction of IFRS 16 Leases.

Depreciation has been divided up per function in the income statement as

follows:

Group Parent Company

2020 2019 2020 2019

Cost of goods sold -462 -815 - -

Selling expenses -2 148 -1 215 - -

Administrative expenses -3 041 -2 170 -1 338 -670

Research and development costs -3 561 -2 132 - -

Other operating expenses -3 141 -3 989 -2 294 -2 827

Total -12 353 -10 321 -3 632 -3 497

NOTE 17. PARTICIPATIONS IN GROUP

COMPANIES

Parent Company

2020 2019

Opening acquisition cost 161 174 161 174

Acquisitions for the year 243 293 -

Closing carrying amount 404 467 161 174

COMPANIES OWNED BY XVIVO PERFUSION AB (PUBL):

Book value

Company Corp. Reg. No. Domicile No. of shares

Partici-

pation

in % 2020 2019

XVIVO Perfusion Inc. 45-5472070 Denver,

USA

1 000 100 14 475 14 475

XVIVO Perfusion

Lund AB

556761-1701 Lund,

Sverige

11 402 818 100 146 651 146 651

XVIVO Perfusion

SAS

531 229 219 Lyon,

Frankrike

5 000 100 48 48

XVIVO Perfusion

Pacific Pty Ltd

637303381 Melbourne,

Australien

1 100 - -

Organ Assist B.V 02082540 Groningen,

Netherlands

1 035 170 100 243 293 -

- Organ Assist

Products B.V.

01135421 Groningen,

Netherlands

18 000 100 - -

Total 404 467 161 174

NOTE 18. INVENTORIES

Group Parent Company

2020 2019 2020 2019

Raw materials and consumables 17 311 21 131 3 558 8 670

Work in progress 3 055 2 899 1 647 -

Finished goods and goods for resale 38 985 19 841 11 356 6 400

Total 59 351 43 871 16 561 15 070

The Group’s closing inventories include impairment of SEK 8 879 thousand (3

016) for obsolescence of inventories. In the Parent Company there is impairment

of SEK 7 010 thousand (TSEK 1 179).

NOTE 19. RECEIVABLES FROM AND

LIABILITIES TO GROUP COMPANIES

The Parent Company has net receivables from the subsidiary XVIVO Perfusion

Inc. in the amount of SEK 14 375 thousand (25 750) and receivables on Organ

Assist B.V of SEK 20 175 thousand (-), liabilities to the subsidiary XVIVO Perfusion

Lund AB in the amount of SEK 2 276 thousand (17 379), liabilities to the subsidiary

XVIVO Perfusion Pacific Pty Ltd of SEK 218 thousand (-) and net liabilities to the

subsidiary XVIVO Perfusion SAS in the amount of SEK 1 024 thousand (1 399)

NOTE 20. TRADE ACCOUNTS RECEIVABLE

Trade accounts receivable are recognized after bad debt losses that have arisen

during the year have been taken into account. Recorded bad debt losses in the

Group for 2020 amounted to SEK 340 thousand (-), of which SEK 226 thousand

(-) was in the Parent Company. Bad debt losses in the Group for which provisions

were made during the year amount to SEK 298 thousand (272), of which SEK 298

thousand (82) was in the Parent Company.

Group Parent Company

2020 2019 2020 2019

Accounts receivable - trade 40 563 43 997 18 367 22 298

Minus provisions for doubtful receivables -380 -272 -380 -82

Total 40 183 43 725 17 987 22 216

Age structure – trade accounts receivable

Not due 22 749 27 866 6 476 13 160

Due 0-30 days ago 4 079 8 082 1 967 2 091

Due 31-90 days ago 7 123 5 390 4 574 4 428

Due 91-180 days ago 1 004 1 476 601 1 454

Due >180 days ago 5 607 1 183 4 749 1 165

Total 40 563 43 997 18 367 22 298

NOTE 21. PREPAID EXPENSES AND

ACCRUED INCOME

Group Parent Company

2020 2019 2020 2019

Rent and other property costs 460 467 361 369

Prepaid insurance 2 953 2 860 2 491 2 370

Other prepaid expenses 2 530 3 631 1 802 2 632

Total 5 943 6 958 4 654 5 371

NOTE 22. CASH, CASH EQUIVALENTS

AND BANK OVERDRAFT FACILITY

Cash and cash equivalents in the cash flow statement consist of the following sub-

components:

Group Parent Company

2020 2019 2020 2019

Cash and bank balances 354 236 159 946 333 318 150 362

Total 354 236 159 946 333 318 150 362

There were no short-term investments.

Cash and cash equivalents include bank balances frozen as security for bank gua-

rantees of SEK 0.8 million (0.8) in both the Parent Company and the Group.

A bank overdraft facility was utilized in the amount of SEK 0 million (0) in the

Group and SEK 0 million (0) in the Parent Company. The bank overdraft facility

granted is in the amount of SEK 30 million (30) in the Group and SEK 30 million

(30) in the Parent Company.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

NOTE 23. SHAREHOLDERS’ EQUITY

SHARE CAPITAL

There is only one class of shares and all shares carry the same rights. At December

31, 2020 the registered share capital comprised 28,719,136 shares (26,600,496).

OTHER CAPITAL PROVIDED

This is equity contributed by shareholders.

RESERVES

Reserves consist of a statutory reserve in the Parent Company and translation

reserves including all exchange-rate differences that arise when translating financial

reports from foreign businesses that have prepared their financial reports in

another currency than the currency that the Group’s financial reports are presen-

ted in. The Parent Company and the Group present their financial reports in SEK.

ACCUMULATED EXCHANGE-RATE DIFFERENCE IN

SHAREHOLDERS’ EQUITY

Group

2020 2019

Opening value 16 228 13 021

Exchange-rate difference for the year in foreign subsidiaries,

net after tax -16 410 3 207

Total -182 16 228

The disclosure requirement pursuant to chapter 5 § 14 of the Swedish Annual

Accounts Act regarding specification of a change in shareholders’ equity compared

with the previous year’s balance sheet is presented in the report “Changes in

shareholders’ equity”.

RETAINED EARNINGS INCLUDING NET INCOME FOR THE YEAR

Retained earnings including net income for the year include profits earned in the

Parent Company and its subsidiaries.

RESTRICTED RESERVES

Restricted reserves in the Parent Company may not be reduced by the distribution

of profits.

Statutory reserve

The purpose of the statutory reserve has been to save part of net profits. These

are not to be used to cover an accumulated loss.

Development expenditure reserve

The amount capitalized regarding development expenditure shall be transferred

from non-restricted equity to a development expenditure reserve in restricted

equity. The reserve shall be reduced as and when the capitalized expenditure is

amortized or written down. It is managed in a similar way to a revaluation reserve.

NON-RESTRICTED EQUITY

Retained earnings in the Parent Company, that is the previous year’s retained ear-

nings and income minus dividend paid during the year, together with net income

for the year, constitute non-restricted equity, which is the amount that is available

for dividend to the shareholders.

XVIVO Perfusion is in an expansion phase and the company’s policy is that the

company’s profits are best used to finance continued development and expansion

of the business rather than as dividend to the shareholders.

NOTE 24. EARNINGS PER SHARE

Calculations have been made in accordance with IAS 33 Earnings per share.

Earnings per share are based on net income for the year in the Group attributable

to the Parent Company’s shareholders divided by the weighted average number of

shares outstanding during the year.

Earnings per share 2020 2019

Consolidated net income for the year -43 735 4 939

Weighted average number of shares before dilution 27 171 352 26 518 546

Dilution effect of warrants program 183 167 281 450

Weighted average number of shares after dilution 27 354 518 26 799 996

Earnings per share before dilution, SEK -1,61 0,19

Earnings per share after dilution, SEK -1,60 0,18

WARRANTS PROGRAM

In total there are 725,000 outstanding warrants in two programs.

The 2019 Annual General Meeting resolved to issue no more than 351,000 war-

rants (series 2019/2021), entitling employees of the XVIVO Perfusion Group to

subscribe for no more than 351,000 new shares. All these 351,000 warrants have

been subscribed for by employees. Warrants program 2019/2021 entitles warrant

holders to subscribe for new shares in May 2021 at a price of SEK 278.91.

The 2020 Annual General Meeting resolved to issue no more than 408,000 war-

rants (series 2020/2022), entitling employees of the XVIVO Perfusion Group to

subscribe for no more than 408,000 new shares. Of these warrants, 374,000 have

been subscribed for by employees. Warrants program 2020/2022 entitles warrant

holders to subscribe for new shares in May 2022 at a price of SEK 205.88.

During the period January-December 2020, both the average share price for the

period and the closing share price per December 31 exceeded the strike price of

warrant program series 2019/2021. Upon maturity, the warrants program is esti-

mated to entail a total dilution effect for existing shares of approximately 2.58 %.

The 2019 and 2020 Annual General Meetings adopted a resolution to approve

a cash-based incentive program for Group employees in countries outside of

Sweden as these employees are not entitled to participate in the Swedish war-

rants programs. The cash-based programs shall as far as practically possible be

designed so that they correspond to the Swedish warrants programs but have a

ceiling for maximum outcome. The cost of these cash-based incentive programs

is recognized in the periods XVIVO’s share price is higher than the strike price for

each Swedish warrants program. The cost is accounted for under “other operating

expenses” and is described in note 6.

NOTE 25. UNTAXED RESERVES

Parent Company

Tax allocation reserves 2020 2019

Allocation, assessment of tax 2017 - 700

Allocation, assessment of tax 2018 - 3 500

Total - 4 200

NOTE 26. ACCRUED EXPENSES

AND DEFERRED INCOME

Group Parent Company

2020 2019 2020 2019

Vacation pay 8 034 5 977 5 788 4 259

Accrued social security contributions 4 317 2 705 2 607 1 812

Accrued special employer’s contribution

for pension expenses 2 530 1 751 1 903 1 274

Accr ued salary, pension and bonus 26 587 11 140 10 359 6 144

Board fees 1 378 1 551 1 378 1 551

Auditing 285 290 210 250

Other accrued expenses 5 769 7 840 2 703 2 247

Deferred income 3 715 1 778 476 250

Total 52 615 33 032 25 424 17 787

NOTE 26. FINANCIAL INSTRUMENTS AND

FINANCIAL RISK MANAGEMENT

Through its operations the Group is exposed to various types of financial risk.

Financial risk pertains to fluctuations in the company’s earnings and cash flow as a

result of changes in exchange rates and interest rates, refinancing risks and credit

risks.

CAPITAL RISK

The Group’s aim regarding the capital structure is to secure the Group’s ability to

continue operations, so that it can continue to generate returns for shareholders

and benefits for other stakeholders, and to maintain an optimal capital structure to

keep the cost of capital down. The Group can change the dividend to sharehol-

ders, repay capital to shareholders, issue new shares, buy back its own shares or

sell/buy assets with the aim of maintaining or adjusting the capital structure.

XVIVO Perfusion’s Board considers that the Group should have a strong capital

base to enable continued high growth, both organic and through acquisitions. The

aim is that the Group will be able to meet its financial obligations in good times and

bad without significant unforeseen costs and without risking the Group’s reputa-

tion. Liquidity risks are managed centrally for the entire Group by the Finance

Department.

FINANCIAL POLICY

XVIVO Perfusion has a Group policy for its financial operations, which defines

financial risks and states how the company should manage these risks. Further-

more, the policy states which reports must be prepared. Under this policy, the

company must always maintain liquidity corresponding to known future net cash

outflows over a period of not less than three months.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

LEASE ANALYSIS

Maturity structure of financial liabilities:

Within 1

year 2 years 3 years 4 years 5 years >5 years Total

2019-12-31

Interest-bearing liabilities

(leases) 3 396 1 127 142 - - - 5 550

Accounts payable 14 406 - - - - - 14 406

Other liabilities 34 797 - - - - - 34 797

2020-12-31

Interest-bearing liabilities

(leases) 3 926 2 356 930 - - - 7 212

Other long-term liabilties

(non interest-bearing) - 40 150 40 150

Accounts payable 14 468 - - - - - 14 468

Other liabilities 53 854 - - - - - 53 854

XVIVO Perfusion’s total credit facilities amounted to SEK 30 million (30), of which

SEK 0 million (0) was utilized.

CREDIT RISKS

The Group’s financial assets are recognized at SEK 404 million (354), of which

SEK 354 million (160) is cash and cash equivalents. Historically, the Group has had

low credit losses and this was also true for 2020. Risk is limited through the use of

credit assessments and advance payments from new customers, as well as through

close customer monitoring by the finance and marketing functions conjunctively.

Furthermore, individual testing is performed of accounts receivable in terms of

solvency and credit rating at closing day.

CURRENCY RISKS

Currency risk is the risk of fluctuations in the value of financial instruments due to

exchange-rate changes. This risk is related to changes in expected and contracted

payment flows (transaction exposure), the revaluation of foreign subsidiaries’

assets and liabilities in foreign currencies (translation exposure) and financial expo-

sure in the form of currency risks in payment flows for loans and investments. The

company is impacted by variations in exchange rates. The aim is to minimize the

impact of these changes wherever practically possible.

Changes in EUR and USD have the greatest impact. External sales from the US

subsidiary are entirely in USD. Inflows are matched with the subsidiary’s outflows

in the form of costs, which are also primarily in USD. External sales from the Swe-

dish Parent Company during 2020 was primarily in EUR, 81 percent (85). Most

of the costs for the Swedish units are in SEK, but there are some costs in EUR.

These outflows are matched as far as possible with inflows in EUR. In the other

subsidiaries intra-Group revenues in local currency are matched with costs, which

are essentially in the same local currency.

SENSITIVITY ANALYSIS

In order to manage interest and currency risks, the Group aims to reduce the

impact of short-term fluctuations on the Group’s results. However, in the long

term lasting changes in exchange rates and interest rates will have an impact on the

consolidated results.

It has been calculated that a general increase of 4 percent in SEK against all other

foreign currencies reduced the Group’s operating income before tax by approx-

imately SEK 2 million (4) for the year that ended on December 31, 2020.

NOTE 28. FAIR VALUE AND CARRYING

AMOUNTS OF FINANCIAL ASSETS AND

LIABILITIES

GROUP

Financial assets and liabilities amounted to SEK 240 million (216) and SEK 76

million (55), respectively. There has been no forward cover for the currency com-

ponents included in the above figures.

PARENT COMPANY

Financial assets and liabilities amounted to SEK 359 million (185) and SEK 38

million (49), respectively. There has been no forward cover for the currency

components included in the above figures.

Financial assets measured at amortized cost

Group Parent Company

2020 2019 2020 2019

Assets in balance sheet

Loans and receivables 40 183 43 725 17 987 22 216

Other current receivables 9 460 12 343 7 615 12 136

Cash and cash equivalents 354 236 159 946 333 318 150 362

Total 403 879 216 014 358 920 184 714

Financial liabilities measured at

amortized cost

Group Parent Company

2020 2019 2020 2019

Liabilities in balance sheet

Interest-bearing liabilities (leases) 7 212 5 550 - -

Accounts payable 14 468 14 406 8 349 11 552

Other liabilities 53 854 34 797 30 131 37 443

Total 75 534 54 753 38 480 48 995

Financial liabilities measured at fair value

Group Parent Company

2020 2019 2020 2019

Liabilities in balance sheet

Other liabilities 40 150 - 40 150 -

Total 40 150 - 40 150 -

The Group’s assets and liabilities in the balance sheet are measured at amortized

cost except for liabilities for additional purchase price related to acquisition

of businesses, which is measured at fair value. The carrying amount is an

approximation of the fair value, and these items are thus not divided into levels in

accordance with the measurement hierarchy.

NOTE 29. PLEDGED ASSETS FOR OWN

LIABILITIES

Group Parent Company

2020 2019 2020 2019

Chattel mortgages 30 000 30 000 27 000 27 000

Bank guarantees 750 770 750 770

Total 30 750 30 770 27 750 27 770

NOTE 30. APPROPRIATION OF

NON-RESTRICTED EQUITY

PROPOSED ALLOCATION OF NON-RESTRICTED EQUITY

Share premium reserve 992 291 064

Retained earnings -151 942 686

Net income for the year -38 436 084

Earnings at the disposal of the AGM 801 912 294

To be carried forward 801 912 294 kr

NOTE 31. CASH FLOW STATEMENT

Group Parent Company

2020 2019 2020 2019

Interest received

Interest paid 80 469 725 1 358

Total -361 -281 -129 -120

Summa -281 188 596 1 238

Adjustment for non-cash items

Depreciation, amortization and

impairment of assets 30 038 24 860 19 907 17 823

Provisions for doubtful trade accounts

receivable 380 272 380 83

Inventory obsolescence 6 641 2 678 5 830 1 179

Capital gain from sales of fixed assets 391 1 440 - -

Changes in provisions -4 -14 -4 -14

Translation differences/exchange-rate

differences 11 909 -374 9 098 -1 547

Total 49 355 28 862 35 211 17 524

NOTE 32. TRANSACTIONS WITH

RELATED PARTIES

The Parent Company is closely associated with the subsidiaries. Of the Parent

Company’s total revenues and purchases, SEK 70,329 thousand (83,427) are reve-

nues from the subsidiaries and SEK 50,060 thousand (80,245) purchases from the

subsidiaries.Internal pricing within the Group is based on the arm’s length principle,

that is between parties that are independent of each other, well-informed and with

a vested interest in the transactions.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

TRANSACTIONS WITH KEY PERSONS IN SENIOR POSITIONS

The Board members of XVIVO Perfusion did not receive any other remuneration

in addition to Board fees during 2019 and 2020, except in one case: The Board

member Folke Nilsson invoiced the company SEK 69 thousand (93) in 2020 for

consultancy services in the field of heart transplantation. Total remuneration paid

is presented in the note “Employees, employee benefit expenses and Board fees”

(see note 7).

NOTE 33. EVENTS AFTER CLOSING DAY

No events have occurred after the end of the reporting period that significantly

affect the assessment of the financial information in this report.

During 2020, XVIVO has been affected by the ongoing Covid-19 pandemic by a

decrease in the number of transplants. The impact on sales in 2021 will depend on

the extent to which the pandemic will affect intensive care in the US and Europe.

Transplantation is a life support treatment and transplants are prioritized by health

authorities around the world. The company therefore estimates that the number

of transplants, and thus the demand for XVIVO Perfusion products, will continue

to increase in the long term.

NOTE 34. CRITICAL ASSESSMENTS

AND ESTIMATES

RECOVERY OF VALUE OF DEVELOPMENT EXPENDITURE

There are no indications of further impairment requirements as at December 31,

2020. The projects that have been entered as assets can reasonably be assumed

to lead to products that will generate revenues in the near future. For further

information, see Note 1, Accounting Policies.

IMPAIRMENT TESTING OF GOODWILL

When calculating cash-generating units’ recoverable amount for the assessment

of any impairment requirement for goodwill, several assumptions regarding future

conditions and estimates of parameters have been made. An account of these is to

be found in Note 15.

NOTE 35. RECONCILIATION OF

ALTERNATIVE PERFORMANCE MEASURES

For definitions of performance measures, see page 74

EBITDA

SEK thousands 2020 2019

Operating income -45 675 3 940

Amortization and impairment of intangible assets 17 685 14 539

Depreciation and impairment of tangible assets 12 353 10 321

EBITDA (Operating income before depreciation

and amortization)

-15 637 28 800

BRUTTOMARGINAL

SEK thousands 2020 2019

Operating income

Net sales 179 861 220 837

Operating expenses

Cost of goods sold -46 886 -58 024

Gross income 132 975 162 813

Gross margin % 74 74

Gross margin, non-durable goods

Operating income

Net sales of non-durable goods 169 425 206 857

Operating expenses

Cost of non-durable goods sold -38 980 -47 439

Gross income, non-durable goods 130 445 159 418

Gross margin, non-durable goods % 77 77

EQUITY/ASSETS RATIO

SEK thousands 201231 191231

Shareholders’ equity 1 008 461 577 521

Total assets 1 150 309 634 487

Equity/assets ratio % 88 91

CERTIFICATION

The Board of Directors and the CEO hereby certify that the annual accounts have

been prepared in accordance with generally accepted accounting principles in

Sweden and have been drawn up in accordance with the international accounting

standards referred to in Regulation (EC) No 1606/2002 of the European

Parliament and of the Council of July 19, 2002 on the application of international

accounting standards. The annual accounts and the consolidated accounts provide

a fair representation of the Parent Company’s and the Group’s position and

performance. The Administration Report for the Parent Company and the Group

provides a true and fair overview of the development of the company’s operations,

financial position and earnings, and describes the significant risks and uncertainty

factors to which the Parent Company and the companies included in the Group

are exposed.

As indicated above, the annual accounts and the consolidated annual accounts

were approved for release by the Board of Directors and the CEO on March 29,

2021. The consolidated statement of net income and the consolidated statement

of total comprehensive income as well as the consolidated statement of financial

position and the income statement and balance sheet for the Parent Company are

subject to adoption at the Annual General Meeting to be held on April 22, 2021.

March 29, 2021

Gothenburg

Gösta Johannesson Dag Andersson

Chairman of the board CEO

Folke Nilsson Camilla Öberg

Boardmember Boardmember

Yvonne Mårtensson Lars Henriksson

Boardmember Boardmember

Lena Höglund

Boardmember

Our audit report was issued on March 29, 2021

KPMG AB

Daniel Haglund

Authorized public Accountant

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

To the general meeting of the shareholders of XVIVO Perfusion AB (publ),

corp. id 556561-0424

REPORT ON THE ANNUAL ACCOUNTS AND

CONSOLIDATED ACCOUNTS

OPINIONS

We have audited the annual accounts and consolidated accounts of XVIVO Perfu-

sion AB (publ) for the year 2020, except for the corporate governance statement

on pages 48-51. The annual accounts and consolidated accounts of the company

are included on pages 42-68 in this document.

In our opinion, the annual accounts have been prepared in accordance with the

Annual Accounts Act, and present fairly, in all material respects, the financial posi-

tion of the parent company as of 31 December 2020 and its financial performance

and cash flow for the year then ended in accordance with the Annual Accounts

Act. The consolidated accounts have been prepared in accordance with the

Annual Accounts Act and present fairly, in all material respects, the financial

position of the group as of 31 December 2020 and their financial performance

and cash flow for the year then ended in accordance with International Financial

Reporting Standards (IFRS), as adopted by the EU, and the Annual Accounts Act.

Our opinions do not cover the corporate governance statement on pages 48-51.

The statutory administration report is consistent with the other parts of the annual

accounts and consolidated accounts.

We therefore recommend that the general meeting of shareholders adopts the

income statement and balance sheet for the parent company and the group.

Our opinions in this report on the the annual accounts and consolidated accounts

are consistent with the content of the additional report that has been submitted

to the parent company’s audit committee in accordance with the Audit Regulation

(537/2014) Article 11.

BASIS FOR OPINIONS

We conducted our audit in accordance with International Standards on Auditing

(ISA) and generally accepted auditing standards in Sweden. Our responsibilities

under those standards are further described in the Auditor’s Responsibilities sec-

tion. We are independent of the parent company and the group in accordance

with professional ethics for accountants in Sweden and have otherwise fulfilled our

ethical responsi-bilities in accordance with these requirements.This includes that,

based on the best of our knowledge and belief, no prohibited services referred to

in the Audit Regulation (537/2014) Article 5.1 have been provided to the audited

company or, where applicable, its parent company or its controlled companies

within the EU.

We believe that the audit evidence we have obtained is sufficient and appropriate

to provide a basis for our opinions.

KEY AUDIT MATTERS

Key audit matters of the audit are those matters that, in our professional judgment,

were of most significance in our audit of the annual accounts and consolidated

accounts of the current period. These matters were addressed in the context of

our audit of, and in forming our opinion thereon, the annual accounts and conso-

lidated accounts as a whole, but we do not provide a separate opinion on these

matters.

REVENUE RECOGNITION

See disclosure 2 and accounting principles on pages 58-60 in the annual account and consolidated accounts for detailed information and description of the matter.

VALUATION OF GOODWILL CAPITALIZED EXPENDITURE FOR DEVELOPMENT

See disclosure 15 and accounting principles on page 59 in the annual account and consolidated accounts for detailed information and description of the matter.

Description of key audit matter

Revenue for 2020 in the Group amounted to 179,9 MSEK. Revenue for sale of

goods is reported in the income statement when significant risks and benefits

associated with the ownership of the goods have been transferred to the buyer,

which normally occurs in connection with the loan loss. Normally revenue is

reported when the buyer accepts delivery, and installation and control have been

made. Revenue can also be reported as soon as delivery has taken place but not

installation, if it is stipulated in the agreement that risks and benefits with delivery

have passed to the buyer.

Sales refers to revenue from sales of goods and services and invoiced freight and

is reported excluding VAT, returns and discounts. Billing takes place in connection

with delivery. Revenue is reported at the fair value of what has been received or

will be received for goods and services sold in the Group’s ongoing operations.

Response in the audit

We have assessed the design of the company’s controls regarding revenue

reporting of goods and services and how these controls have been implemented.

We have reviewed a selection of contracts to analyze the relevant contractual

relationships and how these have been reported, as well as the assessment of the

profitability of the applied income statement. We have examined, on a selection

basis, sales transactions reported before and after the year-end to assess whether

correct terms have been applied to the contract and that risks and benefits have

been transferred to customers.

We have checked by sampling that reported revenues are consistent with infor-

mation in the delivery system. We have also verified the security of IT systems

and that there are controls between the systems and accounts so that revenue is

recognized in the accounting period when delivery has taken place.

Description of key audit matter

As of 31 December 2020, the Group reported goodwill of SEK 223,9 million and

capitalized development costs of SEK 394 million, representing 54% of total assets.

Goodwill will be subject to at least one so-called impairment test, which contains

both complexity and significant elements of assessments from the management of

the Group. An impairment test must be prepared for each of the cash-generating

units, which for the Group is a unit.

Goodwill refers in its entirety to operations in perfadex sales and the acquisition

of Organ Assist. Capitalized expenses for development work mainly pertain to

the operations within heart transplantation, sales of XPS and STEEN Solution

in the US market as well as acquired assets relating to the kidney and liver areas

identified in connection with the acquisition of Organ Assist.

Balanced expenses for development work primarily relate to the activities of

cardiac transplantation and sales of XPS and STEEN Solution in the US market.

In the Parent Company, shares in subsidiaries are reported for an amount of 404,5

MSEK, the value is largely affected by the assess-ment of goodwill and capitalized

expenses for development work carried out in the Group.

The test should be carried out according to the applicable regulations according

to a certain technique where management must make future assessments of the

company’s internal and external conditions and plans. Examples of such assess-

ments are future payments and deposits, which imply assumptions about future

market outlets indirectly about how competitors can be expected to act. Another

important assumption is which discount rate should be used to take into account

that future assessed payments are associated with risk and are therefore less than

liquid funds that are directly available to the Group.

Response in the audit

We have inspected the company’s impairment tests to assess whether they are

implemented in accordance with the technology provided. In addition, we have

assessed the fairness of future payments and the assumed discount rate by taking

part in and evaluating management’s written documentation and plans. We have

also interviewed management and evaluated previous years’ assessments in rela-

tion to actual outcomes.

We have involved our own valuation specialists in the audit team in order to

ensure experience and expertise in the field, primarily regarding assumptions rela-

ted to external markets and competitors as well as assessment of the company’s

assumptions regarding future payments.

An important part of our work has also been to evaluate how changes in assump-

tions can affect the valuation, that is, performing and taking part in the Group’s

so-called sensitivity analysis.

We have also checked the completeness of the disclosures in the annual report

and assessed whether they are consistent with the assumptions applied by the

Group in its impairment test and if the information is sufficiently comprehensive to

understand manage-ment’s assessments.

AUDITOR’S REPORT

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

OTHER INFORMATION THAN THE ANNUAL ACCOUNTS AND

CONSOLIDATED ACCOUNTS

This document also contains other information than the annual accounts and

consolidated accounts and is found on pages 42-68. The Board of Directors and

the Managing Director are responsible for this other information.

Our opinion on the annual accounts and consolidated accounts does not cover

this other information and we do not express any form of assurance conclusion

regarding this other information.

In connection with our audit of the annual accounts and consolidated accounts,

our responsibility is to read the information identified above and consider

whether the information is materially inconsistent with the annual accounts and

consolidated accounts. In this procedure we also take into account our knowledge

otherwise obtained in the audit and assess whether the information otherwise

appears to be materially misstated.

If we, based on the work performed concerning this information, conclude that

there is a material misstatement of this other information, we are required to

report that fact. We have nothing to report in this regard.

RESPONSIBILITIES OF THE BOARD OF DIRECTORS AND THE

MANAGING DIRECTOR

The Board of Directors and the Managing Director are responsible for the

preparation of the annual accounts and consolidated accounts and that they give a

fair presentation in accordance with the Annual Accounts Act and, concerning the

consolidated accounts, in accord-ance with IFRS as adopted by the EU. The Board

of Directors and the Managing Director are also responsible for such internal con-

trol as they determine is necessary to enable the preparation of annual accounts

and consolidated accounts that are free from material misstatement, whether due

to fraud or error.

In preparing the annual accounts and consolidated accounts The Board of

Directors and the Managing Director are responsible for the assessment of the

company’s and the group’s ability to continue as a going concern. They disclose,

as applicable, matters related to going concern and using the going concern basis

of accounting. The going concern basis of accounting is however not applied if the

Board of Directors and the Managing Director intend to liquidate the company, to

cease operations, or has no realistic alternative but to do so.

The Audit Committee shall, without prejudice to the Board of Director’s respon-

sibilities and tasks in general, among other things oversee the company’s financial

reporting process.

AUDITOR’S RESPONSIBILITY

Our objectives are to obtain reasonable assurance about whether the annual

accounts and consolidated accounts as a whole are free from material misstate-

ment, whether due to fraud or error, and to issue an auditor’s report that includes

our opinions. Reasonable assurance is a high level of assurance, but is not a gua-

rantee that an audit con-ducted in accordance with ISAs and generally accepted

auditing standards in Sweden will always detect a material misstatement when it

exists. Misstatements can arise from fraud or error and are considered material

if, individually or in the aggregate, they could reasonably be expected to influence

the economic decisions of users taken on the basis of these annual accounts and

consolidated accounts.

As part of an audit in accordance with ISAs, we exercise professional judgment

and maintain professional scepticism throughout the audit. We also:

• Identify and assess the risks of material misstatement of the annual accounts

and consolidated accounts, whether due to fraud or error, design and perform

audit procedures responsive to those risks, and obtain audit evidence that is

sufficient and appropriate to provide a basis for our opinions. The risk of not

detecting a material misstatement resulting from fraud is higher than for one

resulting from error, as fraud may involve collusion, forgery, intentional omis-

sions, misrepresentations, or the override of internal control.

• Obtain an understanding of the company’s internal control rele-vant to our

audit in order to design audit procedures that are appropriate in the circums-

tances, but not for the purpose of expressing an opinion on the effectiveness of

the company’s internal control.

• Evaluate the appropriateness of accounting policies used and the reasonable-

ness of accounting estimates and related dis-closures made by the Board of

Directors and the Managing Director.

• Conclude on the appropriateness of the Board of Directors’ and the Managing

Director’s, use of the going concern basis of accounting in preparing the annual

accounts and consolidated accounts. We also draw a conclusion, based on the

audit evi-dence obtained, as to whether any material uncertainty exists related

to events or conditions that may cast significant doubt on the company’s and

the group’s ability to continue as a going concern. If we conclude that a material

uncertainty exists, we are required to draw attention in our auditor’s report

to the related disclosures in the annual accounts and consolidated accounts

or, if such disclosures are inadequate, to modify our opinion about the annual

accounts and consolidated accounts. Our conclusions are based on the audit

evidence obtained up to the date of our auditor’s report. However, future

events or conditions may cause a company and a group to cease to continue as

a going concern.

• Evaluate the overall presentation, structure and content of the annual accounts

and consolidated accounts, including the dis-closures, and whether the annual

accounts and consolidated accounts represent the underlying transactions and

events in a manner that achieves fair presentation.

• Obtain sufficient and appropriate audit evidence regarding the financial

information of the entities or business activities within the group to express an

opinion on the consolidated accounts. We are responsible for the direction,

supervision and perfor-mance of the group audit. We remain solely responsible

for our opinions.

We must inform the Board of Directors of, among other matters, the planned

scope and timing of the audit. We must also inform of significant audit findings

during our audit, including any significant deficiencies in internal control that we

identified.

We must also provide the Board of Directors with a statement that we have

complied with relevant ethical requirements regarding independence, and to com-

municate with them all relationships and other matters that may reasonably be

thought to bear on our independence, and where applicable, related safeguards.

From the matters communicated with the Board of Directors, we determine

those matters that were of most significance in the audit of the annual accounts

and consolidated accounts, including the most important assessed risks for mate-

rial misstatement, and are therefore the key audit matters. We describe these

matters in the auditor’s report unless law or regulation precludes disclosure about

the matter.

REPORT ON OTHER LEGAL AND REGULATORY

REQUIREMENTS

OPINIONS

In addition to our audit of the annual accounts and consolidated accounts, we

have also audited the administration of the Board of Directors and the Managing

Director of XVIVO Perfusion AB (publ) for the year 2020 and the proposed

appropriations of the company’s profit or loss.

We recommend to the general meeting of shareholders that the profit be app-

ropriated in accordance with the proposal in the statutory admi-nistration report

and that the members of the Board of Directors and the Managing Director be

discharged from liability for the financial year.

BASIS FOR OPINIONS

We conducted the audit in accordance with generally accepted auditing standards

in Sweden. Our responsibilities under those standards are further described in the

Auditor’s Responsibilities section. We are independent of the parent company

and the group in accordance with professional ethics for accountants in Sweden

and have otherwise fulfilled our ethical responsibilities in accordance with these

requirements.

We believe that the audit evidence we have obtained is sufficient and appropriate

to provide a basis for our opinions.

RESPONSIBILITIES OF THE BOARD OF DIRECTORS AND THE

MANAGING DIRECTOR

The Board of Directors is responsible for the proposal for appropri-ations of the

company’s profit or loss. At the proposal of a dividend, this includes an assessment

of whether the dividend is justifiable considering the requirements which the

company’s and the group’s type of operations, size and risks place on the size of

the parent company’s and the group’s equity, consolidation requirements, liquidity

and position in general.

The Board of Directors is responsible for the company’s organization and the

administration of the company’s affairs. This includes among other things continu-

ous assessment of the company’s and the group’s financial situation and ensuring

that the company’s organi-zation is designed so that the accounting, management

of assets and the company’s financial affairs otherwise are controlled in a reas-

suring manner.

The Managing Director shall manage the ongoing administration according to the

Board of Directors’ guidelines and instructions and among other matters take

measures that are necessary to fulfill the company’s accounting in accordance with

law and handle the management of assets in a reassuring manner.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

AUDITOR’S RESPONSIBILITY

Our objective concerning the audit of the administration, and thereby our opinion

about discharge from liability, is to obtain audit evidence to assess with a reaso-

nable degree of assurance whether any member of the Board of Directors or the

Managing Director in any material respect:

• has undertaken any action or been guilty of any omission which can give rise to

liability to the company, or

• in any other way has acted in contravention of the Companies Act, the Annual

Accounts Act or the Articles of Association.

Our objective concerning the audit of the proposed appropriations of the

company’s profit or loss, and thereby our opinion about this, is to assess with

reasonable degree of assurance whether the proposal is in accordance with the

Companies Act.

Reasonable assurance is a high level of assurance, but is not a guarantee that an

audit conducted in accordance with generally accepted auditing standards in

Sweden will always detect actions or omissions that can give rise to liability to the

company, or that the proposed appropriations of the company’s profit or loss are

not in accordance with the Companies Act.

As part of an audit in accordance with generally accepted auditing standards in

Sweden, we exercise professional judgment and main-tain professional scepticism

throughout the audit. The examination of the administration and the proposed

appropriations of the company’s profit or loss is based primarily on the audit of

the accounts. Additio-nal audit procedures performed are based on our professio-

nal judg-ment with starting point in risk and materiality. This means that we focus

the examination on such actions, areas and relationships that are material for the

operations and where deviations and violations would have particular importance

for the company’s situation. We examine and test decisions undertaken, support

for decisions, actions taken and other circumstances that are relevant to our opi-

nion concerning discharge from liability. As a basis for our opinion on the Board of

Directors’ proposed appropriations of the company’s profit or loss we examined

whether the proposal is in accordance with the Companies Act.

THE AUDITOR’S EXAMINATION OF THE CORPORATE

GOVERNANCE STATEMENT

The Board of Directors is responsible for that the corporate governance state-

ment on pages 48-51 has been prepared in accordance with the Annual Accounts

Act.

Our examination of the corporate governance statement is conducted in

accordance with FAR´s auditing standard RevU 16 The auditor´s examination

of the corporate governance statement. This means that our examination of the

corporate governance statement is different and substantially less in scope than

an audit conducted in accordance with International Standards on Auditing and

generally accepted auditing standards in Sweden. We believe that the examination

has provided us with sufficient basis for our opinions.

A corporate governance statement has been prepared. Disclosures in accordance

with chapter 6 section 6 the second paragraph points 2-6 of the Annual Accounts

Act and chapter 7 section 31 the second paragraph the same law are consistent

with the other parts of the annual accounts and consolidated accounts and are in

accordance with the Annual Accounts Act.

KPMG AB, Box 11908, 404 39 , Göteborg, was appointed auditor of XVIVO

Perfusion AB (publ) by the general meeting of the shareholders on the 26 April

2017. KPMG AB or auditors operating at KPMG AB have been the company’s

auditor since 2013.

Göteborg 29 March 2021

KPMG AB

(Signature on the original document)

Daniel Haglund

Authorized Public Accountant

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

Gösta Johannesson

Chairman of the Board

Born 1959, MBA from Uppsala University. Senior

advisor at Bure Equity AB.

Other assignments: Deputy Chairman of interora

AB, board member of Mentice AB, Scandinova

Systems AB and Yubico AB. Gösta Johannesson was

previously a partner in Provider Venture Partners,

before that in leading positions within Öhman

Fondkommission and Handelsbanken Markets.

Gösta Johannesson is dependent on the company’s

major owners. Gösta Johannesson has been a board

member of the company since 2013.

Shareholding in XVIVO Perfusion: 2,000 shares

Folke Nilsson

Born 1950, trained doctor and Thoracic surgeon.

Previously responsible for the Heart and Lung

Transplant operations at Sahlgrenska University

Hospital and is currently working as a general prac-

titioner. No other board assignments. Folke Nilsson

is independent of the company and the company’s

major owners. Folke Nilsson has been a board

member of the company since 2013.

Shareholding in XVIVO Perfusion: 0 shares.

Camilla Öberg

Born 1964, MBA from the Stockholm School of

Economics. Chief Financial Ofcer at Yubico AB.

Other assignments: Board member of Instalco

Intressenter AB. Former CFO at Cybercom

Group AB and Logica Sweden, leading positions

in WM-data, Swegro Group and Lexicon. Camilla

Öberg is independent in relation to the company

and the company’s major owners. Camilla Öberg

has been a board member of the company since

2016.

Shareholding in XVIVO Perfusion: 1,076 shares.

Yvonne Mårtensson

Born 1953, MSc from the Institute of Technology at

Linköping University. Thirty years’ experience from

medtech companies such as Viggo, Hemocue and

Cellavision.

Other assignments: Chairman of the Board of Elos

Medtech AB and member of the bord of Lyfstone

A/S. Former CEO of CellaVision AB during the

years 1998-2014. Yvonne Mårtensson is independ-

ent in relation to the company and the company’s

major owners. Yvonne Mårtensson has been a

board member of the company since 2018.

Shareholding in XVIVO Perfusion: 3,000 shares.

Lena Höglund

Born 1960, management training at The Centre

for Outstanding Leadership AB, Stockholm and

Management Centre Europé, Bryssel. VP Clinical

Marketing Neuro. Thirty years’ experience from

leading commercial positions at Elekta.

Other board assignments: Board member at Bergvik

Group AB and Chairman in Leksell Gamma Knife

Society. Lena Höglund is independent in relation

to the company and the company’s major owners.

Lena Höglund has been a board member of the

company since 2020.

Shareholding in XVIVO Perfusion: 0 shares

Lars Henriksson

Born 1955. DDM at Gothenburg University. Over

thirty years’ experience from medtech companies

such as Astra Tech and and Dentsply Sirona.

Other Board assignments: Board member at

AddBio. Lars Henriksson is independent in relation

to the company and the company’s major owners.

Lars Henriksson has been a board member of the

company since 2020.

Shareholding in XVIVO Perfusion: 900 shares

BOARD OF DIRECTORS

AUDITORS

The company’s auditor is KPMG AB. The principal auditor is

Authorized Public Accountant Daniel Haglund (born 1974).

KPMG AB Visiting Address: Norra Hamngatan 22

404 39 Göteborg

Phone +46 31 61 48 00

Shareholdings include the holdings of spouses,

minor children and related companies.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

SENIOR MANAGEMENT

Dag Andersson

CEO

Born 1961, MBA from INSEAD and a B.A. (Hons)

in Business and Commerce from Stockholm School

of Economics. Long experience from the MedTech

and life science industry, most recently from the

role as CEO for Diaverum AB 2008-2018, and

before that leading positions at Mölnlycke Health

Care AB 1993 – 2007. Other assignments: Board

member in GHP AB and Terveystalo Oy.

Shareholding in XVIVO Perfusion: 54 392 shares

and 34 000 warrants

Christoffer Rosenblad

COO and Deputy CEO

Born 1975. M.Sc. Mech. Eng. and B.Sc. Fin Ec.

Previous assignments: Business Controller at Ciba

Vision Nordic AB and nancial positions at LG

Electronics. Other assignments: Board member in

Sedana Medical AB.

Shareholding in XVIVO Perfusion: 54 392 shares

and 39 000 Warrants

Kristoffer Nordström

CFO

Born 1985, M.Sc. Business and Economics from

University of Borås. Previously Head of Accounting

and Controlling at XVIVO Perfusion. 10 years of

experience as Authorized Public Accountant and

Senior Manager at KPMG Sweden.

Shareholding in XVIVO Perfusion: 500 shares and

17 000 warrants.

Johan Holmström

CCO (Chief Commercial Officer)

Born 1970, M.Sc. Business Administration and

Finance at University of Gothenburg. Previously

Executive VP Marketing at Permobil, before that

various senior management positions within sales,

marketing and business development at Lohmann &

Rauscher and Mölnlycke Health Care.

Shareholding in XVIVO Perfusion: 1000 shares and

16 000 warrants.

Charlotte Walldal

Global research and development director

Born 1967, M.Sc. Chemistry. Eng. at Chalmers

University of Technology and Ph.D Physical

Chemistry. at University of Gothenburg. Previously

VP R&D Personal Care at Essity and before that

management positions within development and

innovation.

Shareholding in XVIVO Perfusion: 0 shares and

16 000 warrants.

Andreas Wallinder

CMO (Chief Medical Officer)

Born 1977, Doctor of Medicine from Karolinska

Institutet. Board exam in Cardiothoracic surgery.

PhD in Lung Transplantation at University of

Gothenburg. Previously Consultant Cardiothoracic

Surgeon at Sahlgrenska University Hospital and

before that Cardiothoracic Surgery Fellow at Alfred

Health, Melbourne.

Shareholding in XVIVO Perfusion: 0 shares and

34 000 warrants.

Katrin Gisselfält

Global QA & RA Director (Quality Assurance &

Regulatory affairs)

Born 1969, Ph.D., Polymer Chemistry, Chalmers

University of Technology. Previously R&D and

Regulatory Affairs Director at Abigo Medical AB

and before that VP R&D with responsibility for R&D,

Regulatory and clinical studies at Artimplant AB.

Shareholding in XVIVO Perfusion: 0 shares and

30 000 warrants.

Dag Andersson

CEO

Kristoffer Nordström

CFO

Andreas Wallinder

CMO

Johan Holmström

CCO

Christoffer Rosenblad

COO and Deputy CEO

Charlotte Walldal

Global research and

development director

Katrin Gisselfält

Global QA & RA Director

Shareholdings include the holdings of spouses,

minor children and related companies.

XVIVO PERFUSION AB (PUBL) ANNUAL REPORT 2020

The following explanations are intended to help

the reader understand certain specic terms and

expressions in XVIVO Perfusion’s reports:

Evaluation

Evaluation of the function of an organ.

Ex vivo (Latin for “outside a living organism”)

Biological processes in living cells and tissues when

they are in an articial environment outside the

body. “Opposite” of in vivo.

EVLP or Ex Vivo Lung Perfusion

Perfusion of a lung outside the body. The procedure

is normally done to evaluate a lung before

transplantation.

FDA or US Food and Drug Administration

The FDA is the USA’s food and drug authority

with responsibility for food, dietary supplements,

drugs, cosmetics, medical equipment, radiology

equipment, and blood products. FDA approval

is required to market a medical device on the

American market.

HDE or Humanitarian Device Exemption

A humanitarian device exemption (HDE)

application can be submitted to the FDA for a

device that is intended to benet patients by

treating or diagnosing a disease or condition

that affects or is manifested in fewer than 8,000

individuals in the United States per year. An HDE

is similar in both form and content to a Premarket

Approval (PMA) application but is exempt from

the efcacy requirements of a PMA.

Hypothermic non-ischemic perfusion of heart

Circulation of the cooled, dormant donated heart

with the supply of oxygen and necessary nutrients

during transport to the recipient.

In vivo

Biological processes in living cells and tissues when

they are in their natural place in intact organisms

Clinical study/trial

An investigation in healthy or sick people to study

the effect of a drug or method of treatment.

Machine perfusion

New technology that improves preservation and

evaluation of organs, which means more organs

can be used for transplants. Within the business

area Thoracic this includes STEEN Solution™,

XPS™, LS™, Lung Assist and Heart Assist as well

as other products and services related to the

use of those products. Within the business area

Abdominal this includes Kidney Assist Transport,

Kidney Assist and Liver Assist as well as other

products and services related to the use of those

machines.

Medical device

Comprises devices used to diagnose a disease or

treat a disease and as rehabilitation.

Obstructive lung disease

Disease where there is airway obstruction.

OPO or Organ Procurement Organization

In the United States, an organ procurement

organization (OPO) is a non-prot organization

that is responsible for the evaluation and

procurement of deceased-donor organs for organ

transplantation. There are approximately 58 such

organizations in the United States.

Perfusion

Passage of a uid through an organ’s blood vessels.

PMA or Premarket Approval

Premarket approval (PMA) is the FDA process of

scientic and regulatory review to evaluate the

safety and efcacy of Class III medical devices. Class

III devices support or sustain human life, are of

substantial importance in preventing impairment

of human health, or potentially present an

unreasonable risk of illness or injury.

Preclinical study

Research performed before a drug or method of

treatment is sufciently documented to be studied

in humans, for example the testing of substances

in tissue samples and subsequent testing in

experimental animals.

Preservation

Storage and maintenance of an organ outside the

body before transplantation.

Reimbursement

Reimbursement is relevant within the health

insurance system for healthcare providers to be

paid faster and more easily for accrued expenses

from a private or public insurance company (in the

United States, e.g. Medicare).

Static preservation

Static preservation refers to preservation methods

where the organ is kept cold during transport and

before transplantation. Within the business area

Thoracic this includes Perfadex

Plus as well as

other products and services related to the use of

that product.

KPI DEFINITION MOTIVATION

Gross margin,

non-durable goods, %

Gross income for the period segment all non-durable

goods divided by the period's net sales segment all

non-durable goods.

The company believes that this key figure provides an in-depth

understanding of the Company's profitability regarding its non-

durable goods operations. Since the pricing strategy for durable

goods differs from the pricing strategy for all other operations,

the gross margin is reported separately for non-durable goods.

Gross margin, %

Gross income for the period divided by net sales for

the period.

The company believes that this key figure provides an in-depth

understanding of the Company's profitability.

EBITDA margin, %

EBITDA (Operating income before depreciation and

amortization for the period) divided by the period's

net sales.

The company believes that this key figure provides an in-depth

understanding of the Company's profitability.

Operating margin, %

Operating income for the period divided by the

period's net sales.

The company believes that this key figure provides an in-depth

understanding of the Company's profitability.

Net margin, %

Profit of the period divided by net sales of the period. The company believes that this key figure provides an in-depth

understanding of the Company's profitability.

Equity/assets ratio, %

Shareholders' equity divided by balance sheet total. The equity/assets ratio shows the size of equity in relation to

the balance sheet total and has been included to give investors

a picture of the Company's capital structure.

Equity per share, SEK

Shareholders' equity divided by the number of shares

outstanding on the balance sheet date.

This key figure has been included to give investors an overview

of how the Company's equity per share has developed.

Earnings per share, SEK

Profit for the period divided by the average number

of shares, before dilution, for the period.

This key figure has been included to give investors an overview

of each period's dividends.

Earnings per share after dilution, SEK

Profit for the period divided by the average number

of shares, after dilution, for the period.

This key figure has been included to give investors an overview

of how the Company's share price has developed.

DEFINITIONS

GLOSSARY

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