Xvivo Perfusion — Interim / Quarterly Report 2021

Apr 21, 2021

Interim report January March 2021

XVIVO Perfusion AB (publ)

XVIVO Interim report January -March 2021

01 2021

First quarter 2021 (1 Jan - 31 Mar)

• · Net sales amounted to SEK 58.3 million (46.5), corresponding to an increase of 26 percent in SEK and 38 percent in local currencies. Net sales of non-durable goods amounted to SEK 54.9 million (44.2), corresponding to an increase of 24 percent in SEK and 36 percent in local currencies.
• · Machine perfusion constituted 53 percent (31) of net sales.
• · Adjusted operating profit before depreciation and amortization (EBITDA) amounted to SEK 6.3 million (5.1), corresponding to an adjusted EBITDA margin of 11 percent (11). Reported EBITDA amounted to SEK 11.2 million (7.6), corresponding to an EBITDA margin of 19 percent (16).
• Adjusted operating profit (EBIT) amounted to SEK -1.8 million (-2.5). Reported EBIT amounted to SEK 3.2 million (0.0).
• Net profit amounted to SEK 6.0 million (6.5). Earnings per share amounted to SEK 0.21 (0.25).
• · Cash and cash equivalents at the end of the quarter amounted to SEK 350.3 million (158.7).

Significant events during the quarter

• of Medicine, shows that oxygenated perfusion of the donated liver before transplantation has a significant positive impact on the outcomes after transplantation.
• · First patients transplanted in the Australian heart preservation study.

Key ratios

	January-March	January-March	Full year
TSEK	2021	2020	2020
Net sales	58,325	46,455	179,861
Non-Durable goods	54,861	44,186	169,425
Durable goods	3,464	2,269	10,436
Machine perfusion share of net sales, %	53	31	43
Gross margin, %	73	76	74
Non-Durable goods	75	79	77
Durable goods	37	13	24
EBITDA	11,207	7,550	-15,637
EBITDA (adjusted)	6,268	5,009	20,172
Earnings per share, SEK	0.21	0.25	-1.61
Cash flow from operating activities	10,324	9,229	-12,266
I I Adustry for northy offect from dorestion of the vestigative program for anyoney or corporative of Sunday of Sunday SEV

7,1 million, and integration costs amounting SEK -2,2 million. Net adjustment totals SEK 4,9 (2,5) million for the

Many highlights in the first quarter

The first quarter of the year was positive in several respects. Sales of machine perfusion in Thoracic totaled SEK 21 million, an increase of 45 percent year-on-year. In the US, the AOPO (the Association of Organ Procurement Organizations) presented a new groundbreaking target of increasing the number of transplants by 50 percent in the period until 2026, which creates important business opportunities for XVIVO. The main highlight in the first quarter was an article in the New England Journal of Medicine in February which emphasized the significant advantages of oxygenated perfusion of liver before transplantation.

Dag Andersson, CEO

Sales totaled SEK 58 million (46), corresponding to an increase of 38 percent in local currency. The Covid-19 pandemic has continued to have an effect on global healthcare. During the first quarter, we could see some recovery in the number of transplants, primarily on the American market.

Thoracic presented a strong first quarter for machine perfusion, driven by positive progress in North America, which was pleasing. In Abdominal, preparations have started ahead of the coming launch of Kidney Assist Transport in Europe and the US. We expect to submit an application to the US Food and Drug Administration, FDA, shortly. Following approval by the FDA, our commercial organization will be ready to roll out this important product to customers. Price increases have been undertaken according to plan within both Thoracic and Abdominal.

In the US, our most important market, the AOPO (the Association of Organ Procurement Organizations) presented a new target on 18 February. The goal is to increase the number of transplantations in the US by 50 percent in the period until 2026, from today's levels to 50,000 transplantations annually. The goal will be achieved through an increased rate of utilization of donated organs and a sharper focus on innovation. For XVIVO, this is likely to imply significant growth opportunities.

In January, respected scientific publication the New England Journal of Medicine published an article that demonstrated that oxygenated machine perfusion of donated liver has a significant positive effect on posttransplant results. The machine used in the study is CE-marked by XVIVO and is uniquely positioned as the only machine on the market for double oxygenated cold perfusion of liver. This is a major success for XVIVO and an important step in our strategy of becoming the world leader in transplantation in all major organ areas. Our goal is to apply for regulatory approval by the FDA before the end of the year.

We are seeing an increased rate of inclusion in the European heart preservation study. University Hospital AKH in Vienna, one of Europe's largest transplantation centers, has been recruited as the ninth participating center. In the Australian investigator-driven heart preservation study, the first patients received transplants in the quarter. This study is based on a critical question, namely whether XVIVO's heart preservation method can double the maximum period a heart can be transported between donor and recipient with maintained safety. To conclude, Rigshospitalet in Copenhagen will be added to the hospitals included in the PrimECC study. Interest in this study remains significant and it is pleasing that Scandinavia's largest center for heart surgery is now participating.

From April, XVIVO is rolling out a new brand identity that clarifies who we are, what we do and where we are heading. Our vision that no one should need to die while waiting for a new organ has been complemented with a purpose: "Extending Horizons in Organ Transplantation". We are updating our logo and the new design communicates precision, forward motion and technology, but is still warm and human.

Dag Andersson, CEO

XVIVO

"The number of transplants in the US shall increase by 50 percent in the period until 2026"

This is XVIVO

Founded in 1998, XVIVO is the only medical technology company dedicated to extending the life of all major organs - so transplant teams around the world can save more lives. Our solutions and researchers to push the boundaries of transplantation medicine. XVIVO is headquartered in Gothenburg, Sweden, and has offices and research sites on two continents. The company is listed on Nasdaq.

Target

Vision

Purpose

Nobody should die waiting for a new organ.

We believe in an extended life of organs.

Establish machine perfusion as a standard method for preserving, evaluating and transporting donated organs before transplantation

Strategic areas

THE WORLD LEADER IN ALL MAJOR ORGANS

XVIVO will build on its strong position in lung transplantation and develop the offer to include technology platforms and solutions for all four major organs: lungs, heart, kidney and liver.

THE WORLD LEADER IN ALL MAJOR ORGANS

XVIVO will build on its strong position in lung transplantation and develop the offer to include technology platforms and solutions for all four major organs: lungs, heart, kidney and liver.

THE WORLD LEADER IN ALL MAJOR ORGANS

XVIVO will build on its strong position in lung transplantation and develop the offer to include technology platforms and solutions for all four major organs: lungs, heart, kidney and liver.

THE WORLD LEADER IN ALL MAJOR ORGANS

XVIVO will build on its strong position in lung transplantation and develop the offer to include technology platforms and solutions for all four major organs: lungs, heart, kidney and liver.

THE WORLD LEADER IN ALL MAJOR ORGANS

XVIVO will build on its strong position in lung transplantation and develop the offer to include technology platforms and solutions for all four major organs: lungs, heart, kidney and liver.

Compilation of Net Sales and EBITDA

SEK Thousands	January-March 2021	January-March 2020	January-December 2020
Net Sales non-Durable Goods	54,861	44,186	169,425
Net Sales Durable Goods	3,464	2,269	10,436
Net Sales Total	58,325	46,455	179,861
Cost of Goods non-Durable Goods	-13,467	-9.099	-38,980
Cost of Goods Durable goods	-2,178	-1.974	-7,906
Cost of Goods Total	-15.645	-11,073	-46,886
Gross income non-Durable Goods	41,394	35,087	130,445
Gross margin non-Durable Goods, %	75%	79%	77%
Gross income Durable Goods	1,286	295	2,530
Gross margin Durable Goods, %	37%	13%	24%
Gross income Total	42,680	35,382	132,975
Gross margin Total, %	73%	76%	74%
Selling expenses	-19,696	-14,840	-59,899
Administrative expenses	-11,033	-5,648	-30,342
Research and development expenses	-15,529	-16,873	-56,178
Other operating revenues and expenses 1/	6,761	2,0002	-32,231
Operating Income	3,183	23	-45,675
Amortization and depreciation cost of goods sold	-79	-215	-462
Depreciation administrative expenses	-1,380	-763	-3,154
Amortization of research and development expenses	-5,934	-5,032	-21,133
Depreciation other operative expenses	-631	-1,517	-5,289
EBITDA (Operating income before depreciation and amortization)	11,207	7,550	-15,637
EBITDA, %	19%	16%	-9%
EBITDA (adjusted) 2)	6,268	5,009	20,172
EBITDA (adjusted), %	11%	11%	11%

1) See note 4 for "Other operating revenues and expenses"

²) Adjusted for positive effect from decrease of cost provision attributable to cash-based incentive program for employees outside of Sweden, SEK

7,1 million, and integration costs amounting SEK -2,2 million. Net adjustment totals SEK 4,9 (2,5) million for the quarter.

Overview

January - March 2021

Net sales and income

Net sales increased by 26 percent during the second quarter and amounted to SEK 58.3 million (45.5). That corresponds to an increase of 38 percent in local currencies. Net sales of non-durable goods increased by 24 percent and amounted to SEK 54.9 million (44.2). The increase corresponds to 36 percent in local currency.

We can conclude that the Covid-19 pandemic continued to affect the number of transplantations globally in the first quarter of 2021. Available hospital resources have largely focused on caring for Covid-19 patients and thereby the number of transplanted organs have decreased and waiting lists grown.

Organic sales growth amounted to 10 percent in local currencies. Acquired growth amounted to 28 percent in local currencies.

Machine perfusion constituted 53 percent (31) of net sales. Static preservation and other sales (revenue from service and training etc.) accounted for the remaining part of sales.

Gross margin for the quarter amounted to 73 percent (76) and gross margin of non-durable goods amounted to 75 percent (79). The decrease is explained partly by the fact that the comparison quarter does not include the Abdominal business area, which margins are lower than Thoracic, and partly by a changed product mix as sales of static preservation was lower than for the comparison quarter.

Operating profit before depreciation and amortization (EBITDA) profit was positively affected by the dissolution of a cost provision for cash-based incentive programs for employees outside Sweden by SEK 7.1 million and was charged with integration costs by SEK 2.2 million. Adjusted for these items with a net of SEK 4.9 million (2.5), adjusted EBITDA amounts to SEK 6.3 million (5.1), corresponding to an EBITDA margin of 11 percent (11). Reported EBITDA amounted to SEK 11.2 million (7.6), corresponding to an EBITDA margin of 19 percent (16).

Operating income (EBIT) adjusted for the above-mentioned itemsamounted to SEK -1,8 million (2.5). Reported EBIT amounted to SEK 3.2 million (0.0).

Selling expenses in relation to sales amounted to 34 percent (32) for the quarter. R&D expenses amounted to 27 percent (36) of sales. Administrativeexpenses amounted to 19 percent (12) of sales.

The quarter was charged with costs for the integration of Organ Assist. The acquisition was consolidated into XVIVO on October 1, 2020 and since then, the focus has primarily been on integrating the sales and administration functions. During the first quarter, integration costs affected sale expenses by SEK 1.0 million (-) and administration expenses by SEK 1.1 million (-). During the second quarter, work on centralizing distribution of goods to XVIVO´s office in the Netherlands will be intensified. The work is expected to be completed at the beginning of the third quarter and as of that, the integration costs from this acquisition are expected to cease.

Other operating income and operating expenses amounted to SEK 6.8 million (2.0) during the quarter. The item primarily consists of positive effect from the cash-based incentive program for employees abroad of SEK 7.1 million. The remainder primarily consists of currency conversion effects and depreciation. See Note 4 for more information.

Net financial income and expenses for the quarter amounted to SEK 5.1 million (6.6). The positive contribution is mainly due to positive effects in currency conversion of the Group's cash and cash equivalents.

During the quarter, SEK 16.0 million (15.3) ofdevelopment expenses were capitalized as intangible assets. Development expenditure in all material respects relates to expenditure in R&D projects with the aim of obtaining regulatory approvals in the US and Europe. Amortization of capitalized development expenditures amounted to SEK 5.2 million (3.9) during the quarter, of which SEK 3.9 million (3.9) is attribution of regulatory approvals for the company's products within lung transplantation. The remainder relates to depreciation of R&D projects within the abdominal business.

Net sales per segment (R12)

■ Non-durable goods ■ Durable goods

Net sales per product category (R12)

EBITDA och EBITDA-margin (adjusted, R12)

Cashflow

Cash flow from operating activities during the quarter amounted to SEK 10.3 million (9.2), primarily as a result of the positive operating income during the quarter. Cash flow from investing activities amounted to SEK -19.5 million (-15.9), of which SEK-16.7 million (-15.3) was invested in intangible assets and SEK -2.7 million (-0.5) was invested in tangible assets. Cash flow from financing activities amounted to net SEK -1.0 million (-1.5). Exchange rate translation in the quarter had a positive effect on the cash flow by SEK 6.3 million (6.8). Cash and cash equivalents at the end of the quarter amounted to SEK 350.3 million (158.7).

Financing

XVIVOs operations shall be conducted with a sustainable and efficient capital structure. The company's equity/assets ratio is strong and amounted to 87 percent (91) at the end of the period. The company's total credit facility consist of an overdraft facility which at the end of the period amounted to SEK 30 million (30), of which SEK 0.0 million (0.0) was used.

Significant events during the quarter

Publication in The New England Journal of Medicine shows complications after liver transplantation significantly reduced with cold, oxygenated machine perfusion

An article published in the scientific journal The New England Journal of Medicine, shows that oxygenated perfusion of the donated liver before transplantation has a significant positive impact on the outcomes after transplantation. The article presents the results from a study performed by a large international consortium of liver transplant centers, lead by by Professor Robert Porte, liver surgeon at the University Medical Center Groningen in the Netherlands Transplant centers in the Netherlands, Belgium and United Kingdom participated.

Livers from 156 high risk donors (Donation after Circulatory Death) were included in the study and randomized to either the current treatment regime, static cold storage or to 2 hours of cold oxygenated machine perfusion after static cold storage. The main purpose of the study was to investigate the presence of bilary complications within six months after transplantation.

This study demonstrated a significant benefit when oxygenated machine perfusion was used. During the followup period only 6 percent of the patients that received a machine perfused liver developed biliary complications, compared to 18 percent in the static cold storage group. Furthermore, recipients of a machine perfused liver were less likely to develop compromised hemodynamics after graft reperfusion (so called post-reperfusion syndrome) and had the incidence of early graft dysfunction reduced by nearly half.

The risk of complications for patients that are transplanted with a liver donated after circulatory arrest are greater than if the liver comes from a donation after brain death. Because of this, many transplant centres are hesitant to accept donor livers of this kind. This is especially true in the USA where few livers are used from donors after circulatory death compared to in countries such as the Netherlands, Belgium and the UK. The machine perfusion technology used in the trial prevents complications after transplant and has the potential to increase the number of transplanted patients.

The Liver Assist device that was used for oxygenated perfusion in the trial, is CE-marked. XVIVO intends to submit an application for regulatory approval of the device to the FDA before the end of 2021.

First patients transplanted in the Australian heart preservation study

In the approximately 7,500 heart transplants performed in the world each year the absence of blood flow and oxygen during donor heart transport may translate into poor patient outcome after transplantation. The time that the donated heart may be stored on ice outside of the body is limited to four hours. The detrimental effects of a prolonged out-of-body time of the donor heart is reflected in an increased rate of complications and impaired survival after transplantation.

The first patients in an investigator initiated heart preservation study using XVIVOs technology were transplanted during the first quarter of 2021. The trial including Australian and New Zealand transplant centers will investigate if the novel preservation technology may safely double the transport time for donor heart beyond the current limit of 4 hours.

XVIV Os novel preservation method includes a machine that supplies the heart with continuous circulation of a propriety oxygenated solution during transport. A safety study published in Nature Communications in June 2020, showed that the use of this heart preservation technology developed by Professor Stig Steen is a safe method for preservation of human hearts.

Business area development

Thoracic

Business area Thoracic consists of XVIVO's lung and heart transplantation business. Within lung transplantation, the company's product Perfadex® Plus has a market share of approximately 90 percent in traditional static preservation of lungs. The company's products for warm perfusion, XPS™ and STEEN Solution™, have market approval in all major markets and in 2019, they were the first products to receive FDA approval for warm perfusion of marginal lungs. Within heart transplantation, XVIVO's products are in a clinical study phase. Some pre-clinical salestake place in heart transplantation - mainly within xeno-transplantation.

Overview

	January-March	January-March
SEK Thousands	2021	2020
Net sales	46,418	46,455
Non-Durable goods	43,763	44.186
Durable goods	2,655	2.269
Gross margin, %	79	76
Non-Durable goods	82	79
Durable goods	31	13

January - March 2021

Net sales during the quarter were in line with the previous year and amounted to SEK 46.4 million (46.5). In local currencies, this represented growth of 10%. Net sales of non-durable goods decreased by 1 percent to SEK 43.8 million (44.2). In local currencies, however, this represented growth of 9%. During the quarter, one XPS machine was sold to a clinic in Louisville, US.

Machine perfusion accounted for 42 percent (31) of net sales. The increase was primarily driven by a recovery at the established EVLP-clinics in the US. Static preservation and other sales accounted for the remainder of net sales.

Gross margin for the quarter was 79 percent (76). Gross margin of non-durable goods was 82 percent (79). The increases are primarily explained by implemented price increases on the US market in the fourth quarter of 2020 and the European market in the first quarter of 2021.

Abdominal

Business area Abdominal consists of XVIVO's business within liver and kidney transplantation. XVIVO offers machine perfusion products for both organs. They are currently sold in Europe, but also in smaller markets outside North America.

Overiew

	January-March	January-March
SEK Thousands	2021	2020
Net sales	11.907
Non-Durable goods	11.098
Durable goods	809
Gross margin, %	52
Non-Durable goods	51
Durable goods	59

January - March 2021

Net sales during the quarter amounted to SEK 11.9 million (-). Net sales of non-durable goods amounted to SEK 11.1 million (-). Since XVIVO's abdominal operations were acquired in the fourth quarter of 2020, there are no comparative figures for the Group for the first quarter of 2021. The underlying business showed organic growth of 35 percent. Machine perfusion constituted 96 percent (-) of net sales.

Gross margin of non-durable goods was 51 percent (-). Price increases were implemented according to plan during the first quarter, but the positive effect on the gross profit margin is temporarily absorbed by increased purchase prices. A change of supplier is in progress and the gross margin is estimated to be strengthened after receiving regulatory approval as the new products have a lower manufacturing cost.

Net sales per business area (R12)

Net sales per produc category, Thoracic (Q1)

Machine perfusion, 42% ■ Static preservation, 55% ■Other, 3%

Net sales per produc category, Abdominal (Q1)

■ Static preservation, 0% ■ Other, 4%

R&D Portfolio

Developement projects

Project	Description	Status
Heart transplantation	What primarily limits how many people can receive a heart transplant today is the number available, and with today's technology, usable donated organs, in combination with the time that a donated heart can be outside the body. In collaboration with Professor Stig Steen, XVIVO has developed a holistic solution consisting of fluids and machinery that better preserve the function of the donated heart during transport and thus can contribute to improved results after heart transplantation.	XVIVO is developing a program of clinical multicentre studies. These will form the basis for the application for regulatory approval for the products in all major markets in the world. In Europe, four clinics are now actively including patients at a rate that increased during the quarter. Patients are selected by lottery to be transplanted either with donated hearts transported by XVIVO's method or preserved by conventional ice-box method. A similar multicentre study is also in the planning phase in the US, where the company has received a breakthrough device designation from FDA. In addition to the studies conducted by XVIVO, another Swedish research- initiated study is also conducted using XVVO's technology. A research-initiated study in Australia transplanted its first patients during the first quarter.
Kidney transplantation	Similarly toother organs, there is a shortage of transplantable kidneys. Studies have demonstrated that transport of kidneys with ongoing perfusion in many cases improves post-transplant outcomes. The optimal method for transporting donated kidneys is being studied in several ongoing international studies.	An international study of high quality was published in The Lancet in the fourth quarter of 2020. The study demonstrates significant benefits for the recipient when the kidney is transported perfused with an oxygenated solution. This technology is unique for XVIVO and the company intends to apply for regulatory approval in the US during the second quarter of 2021. The combination of new perfusion technology and solutions will be the focus of future research in the organ field.
Liver transplantation	Similarly toother organs, there is a shortage of transplantable livers. By preserving and evaluating the function of donated liver in an optimized way, potentially more organs with good function could be transplanted. Studies have shown that oxygenated perfusion of the liver before transplantation in some cases reduces the risk of serious complications.	Study results published in The New England Journal of Medicine in the first quarter of 2021 demonstrate significant benefits of oxygenated machine perfusion of the liver prior to transplantation in post-cardiac donation (DCD). XVIVO's technology was used in the study and XVIVO is the only actor on the market that offers this unique technology. Work to apply for regulatory approval in the US for the company's products will be intensified during the year. The combination of new perfusion technology and solutions will be the focus of future research in the field.
PrimECC®	PrimECC® is a fluid developed in collaboration with Professor Stig Steen and is intended for use in a so- called heart-lung machine. Before connecting the cardiopulmonary machine to a patient, the machine must be filled with fluid, today usually simple saline solutions. In 2016 and 2017, a randomized clinical trial was conducted on 80 patients indicating reduced side effects related to the use of cardiac lung machine when using PrimECC®.	XVIVO has patents for PrimECC® in the key markets USA, EU, China, and Japan. Several hundred thousand heart surgeries are performed annually, which means great sales potential if good clinical results can be demonstrated. The company is awaiting product launch until the results of the current expanded study in Sweden has been analysed. During the first quarter of 2021, patients continued to be included at Sahlgrenska University Hospital, and Rigshospitalet in Copenhagen was recruited as additional study center.

Research projects

Project	Description	Status
Xeno-transplantation X	Xeno-transplantation involves the use of non-human organs in transplantation. The method is currently in the research stage for several organs.	XVIVO's technology for preserving heart function is currently used continuously by two world-leading research groups and has been crucial for successful results when genetically modified hearts from pig are transplanted into primates.

Other information

Sustainability

Everyone who works at XVIVO 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 contributes to making more donated organs available for transplant.

XVIVO's Code of Conduct is our primary sustainability policy. This includes guidelines for business principles, human rights and working principles. For more detailed information relating to our sustainability work, see the Company's Annual Report for 2020 which, alongside the Code of Conduct, is available at www.xvivoperfusion.com.

Organization and staff

XVIVO employs 88 people, whereof 37 women and 51 men. Of these, 39 people are employed in Sweden and 49 outside Sweden. The head office is located in Gothenburg, Swedenand our subsidiaries are located in Lund, Sweden, Denver, USA and Groningen, The Netherlands. XVIVO also has employees based in several other countries in Europe, the US, China and Australia.

Related party transactions

During the period, no transaction with related parties has been carried out.

Risk management

XVIVO works continuously to identify, evaluate, and manage risks in different systems and processes. Risk analyses are carried out continuously regarding normal operations and in connection with activities that are outside XVVO's regular quality system.

The market risks that are deemed to have a particular impact on XVVO's future development are linked to the availability of financial and medical resources in clinics around the world. Operational risks are risks that limit or prevent XVIVO from developing, manufacturing and selling qualitative, efficient and safe products. The number of organ transplants is marginally affected by seasonal effects. Mainly in new treatment methods such as hot perfusion of lungs, slightly less activity occurs during the summer months due to the fact that training and learning are allowed to stand back during the summer holidays. Legal and regulatory risks may arise from changes in legislation or policy decisions that may affect the Group's ability to conduct or develop the business. Financial risks include currency risks.

The crucial strategic risks and operative risks for the Group is to be found in the Administration report as part of the Annual report for 2020, which is available at www.xvivoperfusion.com.

Annual general meeting

The Annual General Meeting of XVIVO Perfusion AB (publ) will be held on April 22, 2021 at 15:00. in Gothenburg. XVIVO cares about the health and well-being of its shareholders and employees. It is important for the Company to take social responsibility and help limit the risk of spreading Covid-19. As a precautionary measure, XVIVO intends to keep the Annual General Meeting short and effective. A speech by the CEO will be posted on the Company's website after the end of the meeting. Furthermore, the issues at the meeting will be concentrated on the decision items on the agenda. Shareholders should carefully consider using the possibility of advance voting and the possibility to participate by proxy.

The following have been appointed to be part of XVIVOs Nomittee for the 2021 Annual General Meeting:

Henrik Blomquist, appointed by Bure Equity AB Martin Lewin, appointed by Eccenovo AB Caroline Sjösten, appointed by Swedbank Robur Fonder AB Gösta Johannesson. Chairman of the Board

The above have been appointed in accordance with the principles adopted at the 2018 Annual General Meeting on April 27th 2018. The Nomination Committee represents 30 percent of the total number of votes as per August 31st 2020.

Outlook

XVIVO can conclude that the Covid-19 pandemic continued to affect the number of transplantations globally in the first quarter of 2021. Available hospital resources have largely focused on caring for Covid-19 patients and thereby the number of transplanted organs have decreased and waiting lists grown. The impact on sales and studies for the remainder of 2021 will depend on to what extent the pandemic affects intensive care on the main markets in the US and Europe. Transplantation is a life-sustaining treatment and transplants are prioritized by health authorities around the world and for this reason, the company estimates that the number of transplants, and thus the demand for XVIVO's products, will continue to increase long-term.

In 2021, XVIVO will continue to focus sharply on regulatory applications, clinical studies and product development in all major organ areas. In the second quarter, the Company intends to submit a 510k application to the FDA for regulatory approval in the US for Kidney Assist Transport. For Liver Assist, the aim is to file an application for deNovo approval to the FDA towards the end of 2021. In heart transplantation, the goal is to take significant steps forward in the clinical multi-center studies in Europe, the US and Australia. The PrimECC® study in Sweden is expected to accelerate in line with pressure on intensive care easing.

Significant events after the reporting period

No events have occurred after the end of the reporting period that affect the assessment of the financial information in this report.

Gothenburg

April 21, 2021

Dag Andersson CEO

This report has not been reviewed by the company's auditors.

This is a translation of the Swedish version of the report. When in doubt, the Swedish wording prevails.

This information is information that XVIVO Perfusion AB (publ) is obliged to make public pursuant to the EU Market Abuse Requlation. The information was submitted for publication, through the agency of the contact person set out above on April 21, 2021 at 7.30 am.

Financial calendar

• Interim Report January-June 2021: Tuesday, July 13, 2021
• Interim Report January-September 2021: Thursday October 28, 2021
• · Report on Operations 2021: Thursday, January 27, 2022

CEO and CFO will present the report in a conference call at 2.00 p.m. CET on Wednesday, April 21, 2021. Telephone USA: +1 631 913 1422 Telephone UK: +44 333 300 0804 PIN: 16950415#

Conference call

Dag Andersson, CEO tel: +46 31-788 21 50 email: dag.andersson@xvivoperfusion.com

Kristoffer Nordström, CFO tel: +46 735 19 21 64 email: kristoffer.nordstrom@xvivoperfusion.com

Financial statements

Condensed consolidated statement of net income

	January-March	January-March	January-December
SEK Thousands	2021	2020	2020
Net sales	58,325	46,455	179,861
Cost of goods sold	-15,645	-11,073	-46,886
Gross income	42,680	35,382	132,975
Selling expenses	-19,696	-14.840	-59,899
Administrative expenses	-11,033	-5,648	-30,342
Research and development expenses	-15,529	-16,873	-56,178
Other operating revenues and expenses "	6,761	2,002	-32,231
Operating income	3,183	23	-45,675
Financial income and expenses	5,081	6,550	-11,588
Income after financial items	8,264	6,573	-57,263
Taxes	-2,231	-30	13,528
Net income	6,033	6,543	-43,735
Attributable to
Parent Company's shareholders	6,033	6,543	-43,735
Earnings per share, SEK	0.21	0.25	-1.61
Earnings per share, SEK 21	0.20	0.25	-1.60
Average number of outstanding shares	28,719,136	26,600,496	27,171,352
Average number of outstanding shares 21	29,444,136	26,600,496	27,354,518
Number of shares at closing day	28,719,136	26,600,496	28,719,136
Number of shares at closing day 21	29,444,136	26,600,496	29.444.136
EBITDA (Operating income before depreciation and amortization)	11,207	7,550	-15,637
Depreciation and amortization on intangible assets	-5,470	-4.115	-17,685
Depreciation and amortization on tangible assets	-2,554	-3.412	-12,353
Operating income	3,183	23	-45,675
1) See note 4 for "Other operating revenues and expenses"

2) After dilution

Consolidated statement of total comprehensive income

	January-March	January-March	January-December
SEK Thousands	2021	2020	2020
Net income	6,033	6,543	-43,735
Other comprehensive income
ltems that may be reclassified to the income statement
Exchange rate differences	7,418	5,649	-16,410
Tax attributable to items that have been transferred, or can be transferred to net		-465	O
Total other comprehensive income	7,418	5,184	-16,410
Total comprehensive income	13,451	11,727	-60,145
Attributable to
Parent Company's shareholders	13.451	11,727	-60.145

Condensed consolidated statement of financial position

SEK Thousands	210331	201231
ASSETS
Goodwill	227,348	223,938
Capitalized development expenditure	406,464	393,969
Other intangible fixed assets	7,174	6.750
Fixed assets	22,533	21,334
Financial assets	39,120	41,088
Total non-current assets	702,639	687,079
Inventories	65,220	59,351
Current receivables	49,956	49.643
Liquid funds	350,324	354,236
Total current assets	465,500	463,230
Total assets	1,168,139	1,150,309
SHAREHOLDERS' EQUITY AND LIABILITIES
Shareholders' equity, attributable to the Parent Company's shareholders	1,021,922	1,008,461
Long-term interest-bearing liabilities	2,160	1,474
Long-term non-interest-bearing liabilities	68,376	66,314
Short-term interest-bearing liabilities	4,740	5,738
Short-term non-interest-bearing liabilities	70,941	68,322
Total shareholders' equity and liabilities	1,168,139	1,150,309

Condensed consolidated cash flow statements

	January-March	January-March	January-December
	2021	2020	2020
Income after financial items	8,264	6,574	-57,263
Adjustment for items not affecting cash flow	-1,159	1,373	49,355
Paid taxes	-272	-807	142
Change in inventories	-1,620	-5.173	-14.155
Change in trade receivables	2,665	13,635	20,584
Change in trade payables	2.446	-6,373	-10,929
Cash flow from operating activities	10,324	9,229	-12,266
Cash flow from investing activities	-19,505	-15,852	-266,532
Cash flow from financing activities	-1.059	-1.489	482,768
Cash flow for the period	-10,240	-8,112	203,970
Liquid funds at beginning of period	354,236	159,946	159,946
Exchange rate difference in liquid funds	6,328	6.774	-9.680
Liquid funds at end of period	350,324	158,608	354,236

Consolidated changes in shareholders equity

	Attributable to Parent Company's shareholders
				Retained earnings	Sum
		Other paid in		incl. profit for the shareholders
SEK Thousands	Share capital	capital	Reserves	year	equity
Shareholders' equity as of January 1, 2020	680	515,753	16,228	44,860	577,521
Total comprehensive income January - March 2020			5.184	6,543	11.727
Share warrant program		14			14
Shareholders' equity as of March 31, 2020	680	515,767	21,412	51,403	589,262
Total comprehensive income April - December 2020			-21,595	-50,277	-71.872
Issuing of new shares efter deduction of incremental costs directly related to	54	489,640			489,694
Share warrant program		1,377			1,377
Shareholders' equity as of December 31, 2020	734	1,006,784	-183	1,126	1,008,461
Other		10			10
Total comprehensive income January - March 2021			7,418	6.033	13.451
Shareholders equity as of March 31, 2021	734	1,006,794	7,235	7,159	1,021,922

Condensed Consolidated statement of net income per quarter

	Jan-Mar	Oct-Dec	Jul-Sep	Apr-Jun	Jan-Mar	Oct-Dec	Jul-Sep	Apr-Jun
SEK Thousands	2021	2020	2020	2020	2020	2019	2019	2019
Net sales	58,325	60,277	42,736	30,393	46,455	62,416	54,334	56,437
Cost of goods sold	-15,645	-18,920	-9,602	-7,291	-11,073	-16,710	-15,791	-14,789
Gross income	42,680	41,357	33,134	23,102	35,382	45,706	38,543	41,648
Selling expenses	-19,696	-19,229	-13,470	-12,360	-14,840	-18,372	-14,376	-15,957
Administrative expenses	-11,033	-11,163	-8,462	-5,069	-5.648	-7.152	-6.029	-6.148
Research and development costs	-15,529	-15,886	-11,233	-12,186	-16,873	-17,964	-16.827	-12,898
Other operating revenues and expenses	6,761	-9,406	-18,631	-6.196	2,002	-622	966	-4,716
Operating income	3,183	-14,328	-18,661	-12,709	23	1,596	2,277	1,929
Financial income and expenses	5,081	-11,610	-481	-6,047	6,550	-3,838	3,210	527
Income after financial items	8,264	-25,938	-19,142	-18,756	6,573	-2,242	5,487	2,456
Taxes	-2,231	6,363	4,457	2,738	-30	340	-558	-229
Net income	6,033	-19,575	-14,685	-16,018	6,543	-1,902	4,929	2,227
Attributable to
Parent Company's shareholders	6,033	-19,575	-14,685	-16,018	6,543	-1,902	4,929	2,227
Earnings per share, SEK	0.21	-0.68	-0.51	-0.60	0.25	-0.07	0.19	0.08
Earnings per share, SEK 2)	0.20	-0.67	-0.51	-0.60	0.25	-0.07	0.18	0.08
Average number of outstanding shares	28,719,136	28,719,136			28,601,434 26,600,496 26,600,496 26,600,496 26,600,496 26,532,296
Average number of outstanding shares2)	29,444,136	29,327,136			28,975,434 26,600,496 26,600,496 26,879,496 26,879,496 26,879,496
Number of shares at closing day	28,719,136	28,719,136			28,719,136 26,600,496 26,600,496 26,600,496 26,600,496 26,600,496
Number of shares at closing day 20	29,444,136				29,444,136 29,093,136 26,600,496 26,600,496 26,879,496 26,879,496 26,879,496
EBITDA (Operating income before	11,207	-6,506	-11,229	-5,452	7,550	8,479	9,025	8,055
Depreciation and amortization on	-5,470	-5,349	-4.114	-4,107	-4,115	-4,107	-4,099	-3.618
Depreciation and amortization on	-2,554	-2.473	-3,318	-3,150	-3,412	-2,776	-2,649	-2,508
Operating income	3,183	-14,328	-18,661	-12,709	23	1,596	2,277	1,929
1) See note 3 for "Other operating revenues and expenses"
2) After dilution

Consolidated statement of total comprehensive income per quarter

	Jan-Mar	Oct-Dec	Jul-Sep	Apr-Jun	Jan-Mar	Oct-Dec	Jul-Sep	Apr-Jun
SEK Thousands	2021	2020	2020	2020	2020	2019	2019	2019
Net income	6,033	-19,575	-14,685	-16,018	6,543	-1,902	4,929	2,227
Other comprehensive income ltems that may be reclassified to the
income statement:
Exchange rate differences	7,418	-13,179	-3,654	-5,226	5.649	-3,691	4,531	30
Tax attributable to items that have been
transferred, or can be transferred to net		-153	299	319	-465	343	-487	-20
income
Total other comprehensive income	7,418	-13,332	-3,355	-4,907	5,184	-3,348	4,044	10
Total comprehensive income	13,451	-32,907	-18,040	-20,925	11,727	-5,250	8,973	2,237
Attributable to
Parent Company's shareholders	13.451	-32,907	-18.040	-20,925	11.727	-5,250	8,973	2,237

Consolidated key ratios

	January-March	January-March	January-December
SEK Thousands	2021	2020	2020
Gross margin non-Durable goods, %	75	79	77
Gross margin, %	73	76	74
EBITDA. %	19	16	-9
EBITDA (adjusted), %	11	11	11
Operating margin, %	5	O	-25
Net margin, %	5	14	-24
Equity/assets ratio, %	87	91	88
Income per share, SEK	0.21	0.25	-1.61
Shareholders' equity per share, SEK	35.58	22.15	35.11
Share price on closing day, SEK	274.10	99.10	314.00
Market cap on closing day, MSEK	7,872	2,636	9.018

Condensed income statement for the parent company

	January-March	January-March	January-December
SEK Thousands	2021	2020	2020
Net sales	38,942	33,174	134,122
Cost of goods sold	-4,324	-9.106	-36,107
Gross income	34,618	24,068	98,015
Selling expenses	-9,946	-8.633	-36,675
Administrative expenses	-8,262	-5,017	-27,602
Research and development expenses	-13,113	-14.208	-65,268
Other operating revenues and expenses	-468	38	-10.074
Operating income	2,829	-3,752	-41,604
Financial income and expenses	5,375	8,927	-10,609
Income after financial items	8,204	5,175	-52,213
Year end dispositions			4.200
Taxes	-2,546		9.577
Net income	5,658	5,175	-38,436

The parent company has no items to be recognized incomeand therefore no statement of total comprehensive income has been presented. Depreciation during the period amounts to SEK 4 868 (5 015) thousands.

Condensed balance sheet for the parent company

SEK Thousands	210331	201231
ASSETS
Intangible fixed assets	256,529	245,777
Property, plant and equipment	6,587	5,902
Financial assets	463,001	453,598
Total non-current assets	726,117	705,277
Inventories	23,863	16.561
Current receivables	21,538	25,602
Cash and bank	313,478	333,318
Total current assets	358,879	375,481
Total assets	1,084,996	1,080,758
SHAREHOLDERS' EQUITY AND LIABILITIES
Shareholders' equity	1,006,475	1,000,817
Untaxed reserves
Provisions	1,307	1,311
Long-term non-interest-bearing liabilities	41,973	41,392
Short-term non-interest-bearing liabilities	35,241	37,238
Total shareholders' equity and liabilities	1,084,996	1,080,758

Supplementary notes

Disclosures in accordance with IAS 34.16A occur in the financial statements and the related notes, as well as elsewhere in parts of the interim report.

Note 1. Accounting principles

For the Group, the report is presented pursuant to the Swedish Annual Accounts Act and IAS 34, Interim Financial Reporting, and for the Parent Company pursuant to the Swedish Annual Accounts Act and the Swedish Financial Reporting Board's recommendation RFR 2 Accounting for Legal Entities. Accounting principles applied for the Group and the parent company correspond, unless otherwise stated below, with the accounting policies used for the preparation of the latest annual report.

Note 2. Financial instruments

The Group's financial assets and liabilities valuated at acquisition value amount to SEK 400 million (204) and SEK 71 million (43) respectively. The book value is considered to be a reasonable approximation of the fair value of these assets and liabilities in the balance sheet. Furthermore, the Group recognises a liability of SEK 42 million (-), in respect of an additional purchase price linked to acquisitions, at fair value.

Not 3. Koncernens rörelsesegment

Net sales and costs of goods sold are divided into the segments durable goods and non-durable goods. Durable goods refer to income from the sale and rental of machinery for use within organ perfusion.

	January-March
	Non-Durable goods			Durable goods		Total consolidated
SEK Thousands	2021	2020	2021	2020	2021	2020
Net sales	54,861	44.186	3.464	2.269	58,325	46,455
Cost of goods sold	-13.467	-9.099	-2,178	-1.974	-15.645	-11,073
Gross income	41,394	35,087	1,286	295	42,680	35,382
Gross margin (%)	75	79	37	13	73	76

Note 4. Other operating revenues and expenses

	Jan-Mar				Oct-Dec July-Sep April-June Jan-March Oct-Dec July-Sep April-June
SEK Thousands	2021	2020			2020	2019	2019	2019
Cost of cash-based incentive program for employees outside					2.541			237
Cost of reorganization				-5.375 -4.498
Other	-323	-1.074	-786	-1.698	-539 -	-859	-1.287	-716
Total	6.761				-9,406 -18,630 - -6,196 - 2,002	-622	966 -	-4.716

Reconciliation of alternative performance measures

This report includes key figures that are not defined in IFRS, but is included in the report as management believes that this data facilitates investors to analyze the Group's performance and financial position. Investors should consider alternative ratios as a complement rather than a substitute for financial information under IFRS.

EBITDA

			January-
	January-March	January-March	December
SEK Thousands	2021	2020	2020
Operating income	3,183	23	-45.675
Depreciation and amortization on intangible assets	5.470	4.115	17.685
Depreciation and amortization on tangible assets	2.554	3,412	12,353
EBITDA (Operating income before depreciation and
amortization)	11.207	7.550	-15.637

Gross margin

			January-
	January-March	January-March	December
SEK Thousands	2021	2020	2020
Operating income
Net sales	58.325	46.455	179.861
Operating expenses
Cost of goods sold	-15.645	-11.073	-46.886
Gross income	42,680	35,382	132,975
Gross margin %	73	76	74

Gross margin non-durable goods

			January-
	January-March	January-March	December
SEK Thousands	2021	2020	2020
Operating income
Net sales of non-Durable goods	54.861	44.186	169.425
Operating expenses
Cost of non-Durable goods sold	-13.467	-9.099	-38,980
Gross income, non-Durable goods	41.394	35,087	130,445
Gross margin, non-Durable goods %	75	79	77

When calculating the gross margin, gross profit is first calculated by subtracting the cost of goods sold from net sales. Gross profit is then set in relation to net sales to obtain the gross margin ratio. The gross margin thus indicates the proportion of net sales traded in profit after the cost of the goods sold, and is affected by factors such as pricing, raw material and manufacturing costs, inventory write-downs and exchange rate developments.

Equity/Assets ratio

SEK Thousands	210331	201231
Shareholders' equity	1,021,922	1,008,461
Total assets	1,168,139	1,150,309
Equity/assets ratio %	87	88

Equity consists of share capital, other contributed capital, reserves, retained earnings including profit for the year in the Group and non-controlling interests. The equity/assets ratio is calculated by placing equity in relation to the total assets and is thus a measure of the proportion of assets financed by equity.

KPI Definitions

Key ratio	Definition	Justification to use of key ratio
Gross margin non- Durable goods, %	Gross income segment non- Durable goods as a percentage of the net sales of segment non-Durable goods.	The company believes that the key ratio provides an in-depth understanding of the company's profitability for operations for non-Durable goods. Since the pricing strategy for durable goods differs from the pricing strategy from all other operations, the gross margin is excluded separately from durable goods.
Gross margin, %	Gross income as a percentage of the net sales for the period	The company believes that the key ratio provides an in-depth understanding of the company's profitability
EBITDA margin, %	Operating income before depreciation and amortization as a percentage of net sales for the period.	Operating income before depreciation and amortization as a percentage of net sales for the period.
Operating margin, %	Operating income as a percentage of net sales for the period.	The company believes that the key ratio provides an in-depth understanding of the company's profitability
Net margin, %	Income for the period as a percentage of net sales for the period.	The company believes that the key ratio provides an in-depth understanding of the company's profitability
Equity/assets ratio, %	Shareholders' equity and non- controlling interests as a percentage of total assets	The company believes that the equity to asset ratio provides an in-depth understanding of the company's capital structure
Shareholders' equity per share, SEK	Shareholders' equity in relation to the number of shares outstanding at closing day	The key ratio has been included to give investors an overview of how the company's equity per share has evolved.
Earnings per share, SEK	Income for the period in relation to the average number of outstanding shares for the period.	The key ratio has been included to give investors an overview of how the company's earnings per share has evolved
Earnings per share after dilution, SEK	Income for the period in relation to the average number of outstanding shares after dilution for the period	The key ratio has been included to give investors an overview of how the company's equity per share after dilution has evolved.

Glossary

The following explanations are intended to help the reader understand certain specific 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 artificial environment outside the body. "Opposite" of in vivo
Perfusion)	EVLP or (Ex Vivo Lung 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 benefit 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 efficacy 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.
Durable goods	Revenues from the sale or rental of machinery for mechanical perfusion and preservation of organs.
Clinical study/trial	A study in healthy or sick people to study the effect of a drug or treatment method.
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.
OPO or Organ Procurement Organization	In the United States, an organ procurement organization (OPO) is a non-profit 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 fluid through an organ's blood vessels
PMA or Premarket Approval	Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and efficacy 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 sufficiently 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

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.
Other Sales	In terms of product category, Other sales refers to income relating to freight, service and training.

Xeno-transplantation Transplantation of living cells, tissues or organs from one species to another.

Extending horizons

XVIVO Box 53015 SE-400 14 Göteborg Sweden

info@xvivoperfusion.com xvivoperfusion.com