Xvivo Perfusion — Interim / Quarterly Report 2021

Jul 13, 2021

Interim Report January – June 2021

XVIVO Perfusion AB (publ)

Q2 2021 Interim Report January – June 2021

Second quarter 2021 (Apr 1 - Jun 30) The period (Jan 1 - Jun 30)

• Net sales amounted to SEK 59.3 million (30.4), corresponding to an increase of 95 percent in SEK and 116 percent in local currencies. Net sales of non-durable goods amounted to SEK 56.3 million (28.0), corresponding to an increase of 101 percent in SEK and 124 percent in local currencies.
• Machine perfusion accounted for 52 percent (39) of net sales.
• Adjusted operating profit before depreciation and amortization (EBITDA) amounted to SEK 8.4 million (-1.0), corresponding to an adjusted EBITDA margin of 14 percent (-3). Reported EBITDA amounted to SEK -1.5 million (-5.5), corresponding to an EBITDA margin of -3 percent (-18).
• Adjusted operating profit (EBIT) amounted to SEK 0.6 million (-8.2). Reported EBIT amounted to SEK -9.3 million (-12.7).
• Net profit amounted to SEK -8.9 million (-16.0). Earnings per share amounted to SEK -0.31 (-0.60).
• Cash and cash equivalents at the end of the quarter amounted to SEK 311.4 million (140.0).

Significant events during the quarter Significant events in the period

• A 510(k) application for Kidney Assist Transport was filed with the FDA in the US.
• In the UK, NICE issued guidelines recommending EVLPas the standard arrangement for preservation of lungs.

• The number of shares and votes in XVIVO Perfusion AB (publ) increased by 33,261 following exercise of warrants under incentive program 2019/2021.

• Net sales amounted to SEK 117.6 million (76.9), corresponding to an increase of 53 percent in SEK and 68 percent in local currencies. Net sales of non-durable goods amounted to SEK 111.1 million (72.2), corresponding to an increase of 54 percent in SEK and 70 percent in local currencies.

• Machine perfusion accounted for 52 percent (34) of net sales.
• Adjusted operating profit before depreciation and amortization (EBITDA) amounted to SEK 14.7 million (4.1), corresponding to an adjusted EBITDA margin of 12 percent (5). Reported EBITDA amounted to SEK 9.7 million (2.1), corresponding to an EBITDA margin of 8 percent (3).
• Adjusted operating profit (EBIT) amounted to SEK -1.2 million (-10.7). Reported EBIT amounted to SEK -6.2 million (-12.7).
• Net profit amounted to SEK -2.9 million (-9.5). Earnings per share amounted to SEK -0.10 (-0.36).

• Cash and cash equivalents at the end of the period amounted to SEK 311.4 million (140.0).

• An article published in The New England Journal of Medicine, shows that oxygenated perfusion of 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-June	January-June	April - June	April - June	Full year
TSEK	2021	2020	2021	2020	2020
Net sales	117 588	76 848	59 263	30 393	179 861
Non-Durable goods	111 120	72 189	56 259	28 003	169 425
Durable goods	6 468	4 659	3 004	2 390	10 436
Machine perfusion share of net sales, %	52	34	52	39	43
Gross margin, %	74	76	75	76	74
Non-Durable goods	76	80	76	81	77
Durable goods	51	15	66	17	24
EBITDA	9 674	2 098	-1 533	-5 452	-15 637
EBITDA (adjusted)1)	14 670	4 055	8 402	-954	20 172
Earnings per share, SEK	-0,10	-0,36	-0,31	-0,60	-1,61
Cash flow from operating activities	-3 042	11 615	-13 366	2 386	-12 266

1) Adjusted for effect from cost provision attributable to cash-based incentive program for employees outside of Sweden, integration costs and cost relating to acquistion process. Net adjustment totals SEK 9.9 (-4.5) million for the quarter. Net adjustment for the period totals SEK 5.0 (-2.0) million.

Continued recovery in the second quarter

The impact of the pandemic on hospitals varies between countries, which means that the rate at which transplant centers are returning to normal activity levels varies. The US, XVIVO's largest market, was quick to introduce an effective vaccination program, and the number of transplants for all major organs increased sharply in 2021 compared to 2020 and is now just above 2019 numbers. Other markets, such as certain European countries, started to recover later on, which has led to more patients waiting for new organs and the demand for transplants has never been higher. XVIVO's vision that "Nobody should die waiting for a new organ" has become even more relevant during the pandemic.

Dag Andersson, CEO

Total sales in the second quarter amounted to SEK 59 million, corresponding to growth of 95 percent. The positive trend in the Thoracic business area continued, and income from machine perfusion totaled SEK 20 million, an increase of 67 percent compared to the corresponding quarter 2020. In Thoracic, the North American market was a major driver with 75 percent growth in year-on-year terms. In Europe, the recovery has not been as pronounced to date, particularly within machine perfusion and in several countries the number of lung transplants has not yet recovered to 2019 levels.

In Abdominal, growth compared to corresponding quarter 2020 was as high as 126 percent. However, the second quarter of 2020 was weak. The main markets, southern and central Europe, were affected by continued lockdowns and high pressure on hospitals in the quarter, which impacted on operations and for example postponed sales of machines.

It is pleasing that XVIVO returned strong quarterly margins once again. Thoracic's gross margin on sales of nondurable goods amounted to 80 percent. Inflation is expected to increase globally and raw materials costs are expected to increase in many sectors, including ours. However, I am positive about our ability to defend Thoracic's margins and to significantly improve our margins in Abdominal over time. World-leading products should generate high margins.

With regard to our goal of launching Kidney Assist Transport on the US market, we reached an important milestone in the second quarter. Towards the end of April, we filed an 510(k) application with the FDA in the US, according to schedule. Correspondence with FDA is now underway and we are intensifying our preparations for a successful launch later in the year.

In May, we received some very positive news in the UK relating to Ex VivoLung Perfusion (EVLP), when the NationalInstitute for Health and Care Excellence (NICE)issued guidelines that recommend using EVLPfor the preservation of lungs. The support of EVLP is given as a standard arrangement, which is the most positive recommendation by NICE.

Another center is now actively participating in the European Heart preservation study, and a further four leading European centers have also been included - more solid evidence of the clinical relevance and significant interest in this groundbreaking study.

To conclude, I would like to highlight that XVIVO has now taken its first steps on the digital transformation journey. We have initiated a partnership with UMC Groningen where an initial pilot study will develop a method for analyzing data from liver perfusion machines. The method will provide data-based decision-making support for surgeons and transplantation teams. I am convinced that digitalization and artificial intelligence will play a key role in transplantation in many areas within a few years time, and that this will generate significant business opportunities for XVIVO.

Dag Andersson, CEO

"XVIVO's vision that "Nobody should die waiting for a new organ" has become even more relevant during the pandemic."

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 allow leading clinicians 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 Stockholm.

Nobody should die waiting for a new organ.

We believe in an extended life of donated organs.

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

Strategic focus areas

THE WORLD LEADER IN ALL MAJOR ORGANS

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

CUSTOMER-DRIVEN INNOVATION

To develop XVIVO commercially, we will bring innovation and progress even closer to our customers. Our established relationships with clinics, scientists and opinion formers are an important asset in this context.

HIGH-PERFORMING ORGANIZATION

XVIVO has developed its leading research and development competences and capacity over many years. The next phase consists of building a more efficient organization to ensure the successful commercialization of our entire product portfolio.

COMMERCIAL POTENTIAL

XVIVO's commercial ability will be developed. Our active pricing strategy will be driven by clinical relevance and we will expand into new geographical markets.

OPERATIONAL STRENGTH

Our commercial potential is closely associated with our operational strength. A clearer operational focus will improve cost efficiency and delivery reliability.

Compilation of Net Sales and EBITDA

					January
SEK Thousands	January-June 2021	January-June 2020	April-June 2021	April-June 2020	December 2020
Net Sales non-Durable Goods	111 120	72 189	56 259	28 003	169 425
Net Sales Durable Goods	6 468	4 659	3 004	2 390	10 436
Net Sales Total	117 588	76 848	59 263	30 393	179 861
Cost of Goods non-Durable Goods	-27 174	-14 415	-13 707	-5 316	-38 980
Cost of Goods Durable goods	-3 187	3 949	-1 009	-1 975	-7 906
Cost of Goods Total	-30 361	-18 364	-14 716	-7 291	-46 886
Gross income non-Durable Goods	83 946	57 774	42 552	22 687	130 445
Gross margin non-Durable Goods, %	76%	80%	76%	81%	77%
Gross income Durable Goods	3 281	710	1 995	415	2 530
Gross margin Durable Goods, %	51%	15%	66%	17%	24%
Gross income Total	87 227	58 484	44 547	23 102	132 975
Gross margin Total, %	74%	76%	75%	76%	74%
Selling expenses	-40 309	-27 200	-20 613	-12 360	-59 899
Administrative expenses	-25 638	-10 717	-14 605	-5 069	-30 342
Research and development expenses	-29 563	-29 059	-14 034	-12 186	-56 178
Other operating revenues and expenses 1)	2 116	-4 194	-4 645	-6 196	-32 231
Operating Income	-6 167	-12 686	-9 350	-12 709	-45 675
Amortization and depreciation cost of goods sold	-169	-431	-90	-216	-462
Depreciation administrative expenses	-1 646	-1 520	-266	-757	-3 154
Amortization of research and development expenses	-11 561	-10 025	-5 627	-4 993	-21 133
Depreciation other operative expenses	-2 465	-2 808	-1 834	-1 291	-5 289
EBITDA (Operating income before depreciation and amortization)	9 674	2 098	-1 533	-5 452	-15 637
EBITDA, %	8%	3%	-3%	-18%	-9%
EBITDA (adjusted) 2)	14 670	4 055	8 402	-954	20 172
EBITDA (adjusted), %	12%	5%	14%	-3%	11%

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

1) Adjusted for effect from cost provision attributable to cash-based incentive program for employees outside of Sweden, integration costs and cost relating to acquistion process. Net adjustment totals SEK 9.9 (-4.5) million for the quarter. Net adjustment for the period totals SEK 5.0 (-2.0) million.

Summary

The quarter April - June 2021

Net sales and income

We can conclude that the Covid-19 pandemic continued to affect the number of transplants globally in the second quarter of 2021. On several markets, available hospital resources have continued to focus on caring for Covid-19 patients, which means that the number of transplanted organs in some markets has decreased, and more patients are now waiting for a new organ.

Net sales increased by 95 percent during the quarter, amounting to SEK 59.3 million (30.4). This corresponds to an increase of 116 percent in local currencies. Net sales of non-durable goods increased by 101 percent, amounting to SEK 56.3 million (28.0). The increase corresponds to 124 percent in local currency.

Organic growth amounted to 82 percent in local currencies. Acquired growth amounted to 34 percent in local currencies.

Machine perfusion accounted for 52 percent (39) 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 75 percent (76) and gross margin for non-durable goods amounted to 76 percent (81). The decrease is explained by the fact that the comparison quarter does not include the Abdominal business area, which has lower margins than Thoracic.

Operating profit before depreciation and amortization (EBITDA) profit was negatively affected by cash-based incentive programs for employees outside Sweden by SEK -3.9 million and was charged with integration costs of SEK -2.7 million. Furthermore, the quarter also included costs of SEK -3.4 million attributable to an acquisition process, which the company chose to cancel after due diligence. Adjusted for these items totaling SEK -9.9 million (-4.5), adjusted EBITDA amounts to SEK 8.4 million (-1.0), corresponding to an EBITDA margin of 14 percent (-3). Reported EBITDA amounted to SEK -1.5 million (-5.5), corresponding to an EBITDA margin of -3 percent (-18).

Operating income (EBIT) adjusted for the above-mentioned items amounted to SEK 0,6 million (-8.2). Reported EBIT amounted to SEK -9.4 million (-12.7).

Selling expenses in relation to sales amounted to 35 percent (41) for the quarter. R&D expenses amounted to 24 percent (40) of sales. Administrative expenses amounted to 25 percent (17) of sales. The company received US government support totaling SEK 3.8 million, which has been recognized as reduced personnel expenses mainly in selling expenses and R&D.

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 second quarter, integration costs affected sale expenses by SEK 1.3 million (-) and administration expenses by SEK 1.4 million (-). Work is underway to centralize goods distribution to XVIVO's office in the Netherlands. The work is expected to be completed at the end of the third quarter and the integration costs from the acquisition are subsequently expected to cease.

Other operating income and operating expenses amounted to SEK -4.6 million (-6.2) during the quarter. The item primarily consists of costs from the cash-based incentive program for employees abroad of SEK -3.9 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 -1.4 million (-6.0). This was mainly due to negative currency conversion effects relating to the Group's cash and cash equivalents.

During the quarter, SEK 19.2 million (13.3) of development expenditures 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 expenses amounted to SEK 4.9 million (3.8) during the quarter, of which SEK 3.9 million (3.8) is attributed to 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)

Other Static preservation Machine perfusion

EBITDA och EBITDA-margin (adjusted, R12)

Cash flow

Cash flow from operating activities during the quarter amounted to SEK -13.4 million (2.4) and was marked by one-time items such as costs for acquisition process and payment of cash-based incentive programs for foreign employees. Furthermore, the capital tied-up in inventories has increased as part of securing the availability of the company's lung and kidney transplant products and the upcoming product launch of Kidney Assist Transport. Cash flow from investing activities amounted to SEK -22.8 million (-13.9), of which SEK -20.3 million (-13.5) was invested in intangible assets and SEK -2.5 million (-0.4) was invested in tangible assets. Cash flow from financing activities amounted to net SEK 0.1 million (-0.1). Exchange rate differences in the quarter had a negative effect on the cash flow by SEK -2.8 million (-7.0). Cash and cash equivalents at the end of the quarter amounted to SEK 311.4 million (140.0).

Significant events during the quarter

510(k) application for Kidney Assist Transport filed with the FDA in the US

In the second quarter, XVIVO filed a 510(k) application with the FDA for Kidney Assist Transport, with the aim of obtaining regulatory approval for product sales on the US market later in 2021.

Kidney Assist Transport is XVIVO's transportable system for kidney preservation. The system enables isolated hypothermic oxygen perfusion of donated kidneys during transport between donor and recipient in connection with kidney transplants.

Following the announcement of XVIVO's acquisition of Organ Assist B.V. on 1 October 2020, the filing of a 510(k) application for Kidney Assist Transport is an important milestone in XVIVO's strategy of establishing a commercial presence in abdominal transplantation in the US. In 2019, approximately 62,000 kidney transplants from deceased donors were carried out globally. The US is the largest market by some margin, with approximately 17,500 kidney transplants from deceased donors in 2019. There are more than 90,000 patients on the waiting list in the US, so demand for organs for transplantation by far exceeds supply.

National Institute for Health and Care Excellence (NICE) supports EVLP

In the UK, the National Institute for Health and Care Excellence (NICE) has issued interventional procedure guidance recommending the use of Ex Vivo Lung Perfusion (EVLP) for preservation of lungs. The support of EVLP is given as standard arrangement, which is the most positive recommendation by NICE, and EVLP is described as a method that enables longer and better preservation of donated lungs.

The NICE guidelines are evidence-based recommendations that guide decisions in health, public health and social care in the UK and Wales. The interventional procedure program assesses the safety and efficacy of interventional procedures.

Today only one in five donated lungs are used for transplant in the UK. The lack of deceased donor lungs leads to deterioration and death in up to 30 percent of patients awaiting a lung transplant. There are currently 257 patients waiting for a lung transplant in the UK and the average wait is 18 months.

Change in number of shares and votes in XVIVO Perfusion AB (publ)

The number of shares and votes in XVIVO Perfusion AB (publ) increased by 33,261 shares and votes in June 2021 as a result of the utilization of warrants under the company's incentive scheme 2019. As of 30 June 2021, there were a total of 28,752,397 shares and votes in the company.

The period January - June 2021

Net sales and income

We can conclude that the Covid-19 pandemic is continuing to affect the number of transplantations globally in 2021. Available hospital resources have largely focused on caring for Covid-19 patients and thus the number of transplanted organs in several markets has decreased and more patients are now waiting for a new organ.

Net sales increased by 53 percent in the period, amounting to SEK 117.6 million (76.9). That corresponds to an increase of 68 percent in local currencies. Net sales of non-durable goods increased by 54 percent, amounting to SEK 111.1 million (72.2). The increase corresponds to 70 percent in local currency.

Organic growth amounted to 38 percent in local currencies. Acquired growth amounted to 31 percent in local currencies.

Machine perfusion accounted for 52 percent (34) 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 period amounted to 74 percent (76) and gross margin for non-durable goods amounted to 76 percent (80). The decrease is explained by the fact that the comparative period does not include the Abdominal business area, where the margins are lower than Thoracic.

Operating profit before depreciation and amortization (EBITDA) was positively affected by the dissolution of a cost provision for cash-based incentive programs for employees outside Sweden of SEK 3.2 million and was charged with integration costs by SEK -4.8 million. Furthermore, the quarter also included costs of SEK -3.4 million attributable to an acquisition process, which the company chose to cancel after due diligence. Adjusted for these items by a net SEK -5.0 million (-2.0), EBITDA amounts to SEK 14.7 million (4.1), corresponding to an adjusted EBITDA margin of 12 percent (5). Reported EBITDA amounted to SEK 9.7 million (2.1), corresponding to an EBITDA margin of 8 percent (3).

Operating income (EBIT) adjusted for the above-mentioned items amounted to SEK -1,2 million (-10.7). Reported EBIT amounted to SEK -6.2 million (-12.7).

Selling expenses as a proportion of sales amounted to 34 percent (35) in the period. R&D expenses amounted to 25 percent (38) of sales. Administrative expenses amounted to 22 percent (14) of sales. The company received US government support totaling SEK 3.8 million, which has been recognized as reduced personnel expenses mainly in selling expenses and R&D.

The period 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 administrative functions. During the period, integration costs affected sale expenses by SEK 2.3 million (-) and administration expenses by SEK 2.5 million (-).

Other operating income and operating expenses amounted to SEK 2.1 million (-4.2) in the period. The item primarily consists of positive effects from the cash-based incentive program for employees abroad of SEK 3.2 million. The remainder primarily consists of currency conversion effects and depreciation. See Note 4 for more information.

Net financial income and expenses for the period amounted to SEK 3.7 million (0.5). The positive contribution is mainly due to positive currency conversion effects relating to the Group's cash and cash equivalents.

During the period, SEK 35.2 million (28.5) of development expenditure were capitalized as intangible assets. Development expenditure essentially relate to R&D expenses in connection with obtaining regulatory approvals in the US and Europe. Amortization of capitalized development expenses amounted to SEK 10.1 million (7.8) in the period, of which SEK 7.8 million (7.8) was attributed to regulatory approvals for the company's products in lung transplantation. The remainder relates to depreciation of R&D projects in the Abdominal business area.

Net sales

SEK 118 million

Gross margin

74%

Adjusted EBITDA

12%

Cash flow

Cash flow from operating activities in the period amounted to SEK -3.0 million (11.6), primarily due to an increase in capital tied up in inventories and payment of operating liabilities. One-time items such as costs for acquisition process and payment of cash-based incentive programs for foreign employees have also affected the cash flow. Cash flow from investing activities amounted to SEK -42.3 million (-29.7), of which SEK -37.1 million (-28.9) was invested in intangible assets and SEK -5.2 million (-0.8) was invested in tangible assets. Cash flow from financing activities amounted to net SEK -0.9 million (-1.6). Exchange rate differences in the period had a positive cash flow effect of SEK 3.5 million (-0.2). Cash and cash equivalents at the end of the period amounted to SEK 311.4 million (140.0).

Financing

XVIVOs operations shall be conducted with a sustainable and efficient capital structure. The company's equity/assets ratio is strong and amounted to 88 percent (92) at the end of the period. The company's total credit facility consists of an overdraft facility, which amounted to SEK 30 million (30) at the end of the period, of which SEK 0.0 million (0.0) was utilized.

Significant events in the reporting period

A study published in The New England Journal of Medicine shows significant advantages with oxygenated, cold machine perfusion prior to liver transplantation

An article in The New England Journal of Medicine shows that oxygenated perfusion of donated liver before transplantation has a significant positive impact on post-transplantation outcomes. The article presents the results from a study performed by a large international consortium of liver transplant centers led 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 2 hours of cold oxygenated machine perfusion after static cold storage. The main purpose of the study was to investigate the presence of biliary 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 patients that received a machine perfused liver developed biliary complications, compared to 18 percent in the static cold storage group. Furthermore, the risk of circulatory instability in these patients and the incidence of early graft dysfunction reduced by nearly half.

The risk of complications for patients 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 centers 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 countries such as the Netherlands, Belgium and the UK. The machine perfusion technology used in the trial sharply decreases complications after transplant and has the potential to increase the number of transplanted patients.

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

First patients transplanted in Australian heart preservation study

Approximately 7,500 heart transplants are performed globally each year. The absence of blood flow and oxygen during donor heart transport may translate into poor patient outcomes after transplantation. The period a donated heart can be stored on ice outside the body is limited to four hours. The detrimental effects of a prolonged out-ofbody 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 study will include Australian and New Zealand transplant centers and is set to investigate whether the novel preservation technology can safely double the transport time for donor hearts beyond the current limit of 4 hours.

XVIVO's innovative preservation method has been developed alongside Professor Stig Steen. The method includes a machine that supplies the cooled 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 the heart preservation technology developed by Professor Stig Steen is a safe method for preservation of human hearts.

Business area development

XVIVO's operations are conducted in two business areas: Thoracic (lung and heart transplantation) and Abdominal (liver and kidney transplantation). Both business areas conduct commercial and R&D activities.

Thoracic

Business area Thoracic consists of XVIVO's lung and heart transplantation business. In 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. In heart transplantation, XVIVO's products are in a clinical study phase. Some sales take place in heart transplantation – mainly in pre-clinical xeno-transplantation.

Summary

	January-June	January-June	April-June	April-June
SEK Thousands	2021	2020	2021	2020
Net sales	96 288	76 848	49 870	30 393
Non-Durable goods	92 808	72 189	49 045	28 003
Durable goods	3 480	4 659	825	2 390
Gross margin, %	79	76	80	76
Non-Durable goods	80	80	80	81
Durable goods	43	15	82	17

The quarter April - June 2021

Net sales increased in the quarter compared to the corresponding period in the previous year, amounting to SEK 49.9 million (30.4). In local currencies, this represented growth of 82 percent. Net sales of non-durable goods increased by 75 percent, amounting to SEK 49.0 million (28.0). This was mainly due to strong recovery on the US market. In Europe, the recovery has not been as clear to date. Extensive lockdowns and continued pressure on hospitals in several European countries have temporarily restricted sales opportunities.

Machine perfusion accounted for 40 percent (39) of net sales. Static preservation and other sales accounted for the remainder of net sales.

Gross margin was 80 percent (76) in the quarter. Gross margin for non-durable goods was 80 percent (81).

The period January - June 2021

Net sales increased in the period compared to the corresponding period in the previous year, amounting to SEK 96.3 million (76.9). In local currencies, this represented growth of 38 percent. Net sales of non-durable goods increased by 29 percent, amounting to SEK 92.8 million (72.2). In local currencies, this represented growth of 42 percent. During the period, one XPS machine was sold to a clinic in Louisville, US.

Machine perfusion accounted for 41 percent (34) of net sales. The increase was primarily driven by a recovery at the established EVLP-clinics in the US. XVIVO's ten largest customers in the US are all returning growth in year-on-year terms. Static preservation and other sales accounted for the remainder of net sales.

Gross margin for the period was 79 percent (76). Gross margin excluding non-durable goods was 80 percent (80).

Net sales per business area

Net sales per product category, Thoracic (Q2)

Machine perfusion, 40% Static preservation, 56% Other, 4%

Abdominal

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

Summary

	January-June	January-June	April-June	April-June
SEK Thousands	2021	2020	2021	2020
Net sales	21 300	-	9 393	-
Non-Durable goods	18 312	-	7 214	-
Durable goods	2 988	-	2 179	-
Gross margin, %	52	-	52	-
Non-Durable goods	50	-	50	-
Durable goods	60	-	60	-

The quarter April - June 2021

In Abdominal, where the customer base is currently largely focused on certain southern and central European key markets, the pandemic continued to significantly impact operations in the second quarter. Extensive lockdowns and continued pressure on hospitals in several European countries has temporarily restricted sales and led to postponed machine sales, for example.

Net sales in the quarter amounted to SEK 9.4 million (-). Net sales of non-durable goods amounted to SEK 7.2 million (-). Because XVIVO's abdominal operations were acquired in the fourth quarter of 2020, there are no comparative figures for the Group for the second quarter of 2021. The underlying business showed organic growth of 126 percent. Machine perfusion accounted for 96 percent (-) of net sales.

Gross margin for non-durable goods was 50 percent (-) in the quarter.

The period January - June 2021

Net sales amounted to SEK 21.3 million (-) in the period. Net sales of non-durable goods amounted to SEK 18.3 million (-). Because XVIVO's abdominal operations were acquired in the fourth quarter 2020, there are no comparative figures for the Group for the period January - June 2021. The underlying business returned organic growth of 64 percent.Machine perfusion accounted for96 percent (-) of net sales.

Gross margin for non-durable goods was 50 percent (-) in the period. Price increases were implemented according to plan during the first quarter, but the positive effect on gross profit margin was 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 product category, Abdominal (Q2)

Machine perfusion, 96% Static preservation, 0% Other, 4%

R&D Portfolio

Development projects

Project	Description	Status
Heart transplantation	The primary restriction on the number of heart transplants possible today comes from the number of available, usable donated organs based on current technology, in combination with the period that a donated heart can be outside the body. In collaboration with Professor Stig Steen, XVIVO has developed a total solution consisting of fluids and machinery that better preserve the function of the donated heart during transport, which contributes to improved outcomes after heart transplantation. In the ongoing clinical trials, patients are selected by lottery to be transplanted either with donated hearts transported by XVIVO's method or by the conventional ice-box method.	XVIVO is developing a program of clinical multicenter studies. These will form the basis for an application for regulatory approval for the products on all major global markets.In Europe, five clinics are currently actively enrolling patients in the XVIVO study. A further 4–6 clinics are in the start-up phase. Several centers contacted XVIVO requesting to participate in the second quarter 2021. A similar multicenter study is also at the planning stage in the US, where the company received 'breakthrough device designation' by the FDA. In addition to the studies carried out by XVIVO, another Swedish research-initiated study is also underway using XVVO's technology. A research-initiated study has also started in Australia during the first quarter 2021.
Kidney transplantation	Like for other organs, there is a shortage of transplantable kidneys. Studies have demonstrated that transport of kidneys with ongoing perfusion improves post-transplant outcomes in many cases. The optimal method for transporting donated kidneys is being studied in several ongoing international trials.	The results of an international high-quality study were published in The Lancet in the fourth quarter 2020. The study demonstrated significant benefits for the recipient when the kidney is transported perfused with an oxygenated solution. This technology is unique to XVIVO. The company filed an application for regulatory approval in the US in the second quarter 2021. The combination of new perfusion technology and solutions will be the focus of future research in the organ field.
Liver transplantation	Like for other organs, there is a shortage of transplantable livers. By preserving and evaluating the function of donated liver optimally, more organs with good function are potentially available for transplant. Studies show that oxygenated perfusion of liver before transplantation reduces the risk of serious complications in some cases.	The results of a study published in The New England Journal of Medicine in the first quarter 2021 demonstrate significant benefits of oxygenated machine perfusion of liver prior to transplantation in post-cardiac donation (DCD). XVIVO's technology was used in the study and XVIVO is the only market operator offering this unique technology. The work associated with applying for regulatory approval for the company's products in the US will be intensified during the year. Future research in the field will focus on the combination of new perfusion technology and solutions.
PrimECC®	PrimECC® is a fluid developed in collaboration with Professor Stig Steen intended for use in heart-lung machines. Before connecting the cardiopulmonary machine to a patient, the machine must be filled with fluid, usually simple saline solutions. In 2016 and 2017, a randomized clinical trial on 80 patients indicated reduced side effects related to the use of cardiac lung machine when using PrimECC®.	XVIVO has patents for PrimECC® on key markets in the US, EU, China, and Japan. Several hundred thousand heart surgeries are performed each year, which means considerable sales potential if good clinical results can be demonstrated. The company is awaiting product launch until the results of the current expanded study has been analyzed. In addition to Sahlgrenska University Hospital, Rigshospitalet in Copenhagen was recruited as an additional study center in the first quarter, and preparations are underway to also include Rikshospitalet in Oslo in the study.

Research projects

Project	Description	Status
Xeno-transplantation	Xeno-transplantation involves the use of non-human organs in transplantation. The method is currently at the research stage for several organs.	XVIVO's technology for preserving heart function is currently used continuously by two world-leading research teams and has been crucial for attaining successful outcomes 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 we are 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.xvivogroup.com.

Organization and staff

XVIVO employs 90 people, of which 41 women and 49 men. Of these, 42 people are employed in Sweden and 48 outside Sweden. The head office is located in Gothenburg, Sweden and 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

There were no transactions with related parties during the period.

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 progress 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 exchange rate 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.xvivogroup.com.

Outlook

The extent to which the Covid-19 pandemic will affect our sales and clinical trials during the remainder of 2021 is largely determined by the speed of the vaccine roll-out globally, and how fast intensive care operations on the company's main markets in the US and Europe return to normal capacity. 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 demand for XVIVO's products, will continue to increase longterm.

In 2021, XVIVO will continue to focus sharply on regulatory applications, clinical studies and product development in all major organ areas. The company aims to obtain regulatory approval for Kidney Assist Transport in the US in the fourth quarter. For Liver Assist, the aim is to file an application for deNovo approval with 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 is expected to accelerate in line with more clinics being included.

Significant events after the reporting period

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

The Board of Directors and CEO hereby give their assurance that the Interim Report presents an accurate summary of the Group's and Parent Company's operations, position and results of operations and describes the material risks and uncertainty factors the Parent Company and the companies included in the Group face.

Gothenburg, July 13, 2021

Gösta Johannesson Chairman of the Board

Camilla Öberg Board member

Folke Nilsson Board member

Yvonne Mårtensson Board member

Lars Henriksson Board member

Lena Höglund Board member

Dag Andersson CEO

This report has not been audited 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 Regulation and the Market Securities Act. The information was submitted for publication, through the agency of the contact person set out below on July 13, 2021 at 7.30 am.

Financial calendar Conference call Contact

• Interim Report January-September 2021: Thursday, October 28, 2021
• Year-end Report 2021: Thursday, January 27, 2022
• Interim Report January-March 2022: Monday, April 25, 2022
• Interim Report January-June 2022: Wednesday, July 13, 2022

CEO Dag Andersson and CFO Kristoffer Nordström will present the report in a conference call at 2.00 p.m. CET on Tuesday, July 13, 2021.

Telephone SWE: +46 (0)8 566 426 51 Telephone UK: +44 3333 000804 Telephone US: +1 6319 131422 PIN: 52713996#

Dag Andersson, CEO tel: +46 31-788 21 50 e-mail: dag.andersson@xvivogroup.com

Kristoffer Nordström, CFO tel: +46 735 19 21 64 e-mail: kristoffer.nordstrom@xvivogroup.com

Financial statements

Condensed Consolidated Statement of Net Income

					January
	January-June	January-June	April-June	April-June	December
SEK Thousands	2021	2020	2021	2020	2020
Net sales	117 588	76 848	59 263	30 393	179 861
Cost of goods sold	-30 361	-18 364	-14 716	-7 291	-46 886
Gross income	87 227	58 484	44 547	23 102	132 975
Selling expenses	-40 309	-27 200	-20 613	-12 360	-59 899
Administrative expenses	-25 638	-10 717	-14 605	-5 069	-30 342
Research and development expenses	-29 563	-29 059	-14 034	-12 186	-56 178
Other operating revenues and expenses 1)	2 116	-4 194	-4 645	-6 196	-32 231
Operating income	-6 167	-12 686	-9 350	-12 709	-45 675
Financial income and expenses	3 670	503	-1 411	-6 047	-11 588
Income after financial items	-2 497	-12 183	-10 761	-18 756	-57 263
Taxes	-411	2 708	1 820	2 738	13 528
Net income	-2 908	-9 475	-8 941	-16 018	-43 735
Attributable to
Parent Company's shareholders	-2 908	-9 475	-8 941	-16 018	-43 735
Earnings per share, SEK	-0,10	-0,36	-0,31	-0,60	-1,61
Earnings per share, SEK 2)	-0,10	-0,36	-0,31	-0,60	-1,60
Average number of outstanding shares	28 723 201	26 600 496	28 727 266	26 600 496	27 171 352
Average number of outstanding shares 2)	29 097 201	26 600 496	29 101 266	26 600 496	27 354 518
Number of shares at closing day	28 752 397	26 600 496	28 752 397	26 600 496	28 719 136
Number of shares at closing day 2)	29 126 397	26 600 496	29 126 397	26 600 496	29 444 136
EBITDA (Operating income before depreciation and amortization)	9 674	2 098	-1 533	-5 452	-15 637
Depreciation and amortization on intangible assets	-10 605	-8 222	-5 135	-4 107	-17 685
Depreciation and amortization on tangible assets	-5 236	-6 562	-2 682	-3 150	-12 353
Operating income	-6 167	-12 686	-9 350	-12 709	-45 675
1) See note 4 for "Other operating revenues and expenses"

2) After dilution

Consolidated Statement of Comprehensive Income

					January
	January-June	January-June	April-June	April-June	December
SEK Thousands	2021	2020	2021	2020	2020
Net income	-2 908	-9 475	-8 941	-16 018	-43 735
Other comprehensive income
Items that may be reclassified to the income statement
Exchange rate differences	3 714	423	-3 704	-5 226	-16 410
Tax attributable to items that have been or can be transferred to net income	-	-146	-	319	-
Total other comprehensive income	3 714	277	-3 704	-4 907	-16 410
Total comprehensive income	806	-9 198	-12 645	-20 925	-60 145
Attributable to
Parent Company's shareholders	806	-9 198	-12 645	-20 925	-60 145

Condensed Consolidated Statement of Financial Position

SEK Thousands	210630	200630	201231
ASSETS
Goodwill	225 468	65 788	223 938
Capitalized development expenditure	419 891	287 282	393 969
Other intangible fixed assets	8 020	6 115	6 750
Fixed assets	22 140	23 981	21 334
Financial assets	40 823	15 194	41 088
Total non-current assets	716 342	398 360	687 079
Inventories	72 735	48 025	59 351
Current receivables	48 835	34 030	49 643
Liquid funds	311 419	139 993	354 236
Total current assets	432 989	222 048	463 230
Total assets	1 149 331	620 408	1 150 309
SHAREHOLDERS' EQUITY AND LIABILITIES
Shareholders' equity, attributable to the Parent Company's shareholders	1 010 507	569 653	1 008 461
Long-term interest-bearing liabilities	1 646	2 585	1 474
Long-term non-interest-bearing liabilities	66 877	2 889	66 314
Short-term interest-bearing liabilities	4 148	6 061	5 738
Short-term non-interest-bearing liabilities	66 153	39 220	68 322
Total shareholders' equity and liabilities	1 149 331	620 408	1 150 309

Condensed Consolidated Cash Flow Statement

					January
	January-June	January-June	April-June	April-June	December
	2021	2020	2021	2020	2020
Income after financial items	-2 497	-12 184	-10 761	-18 758	-57 263
Adjustment for items not affecting cash flow	8 958	18 660	10 117	17 287	49 355
Paid taxes	-1 743	-379	-1 471	428	142
Change in inventories	-9 452	-4 279	-7 832	894	-14 155
Change in trade receivables	4 725	23 456	2 060	9 821	20 584
Change in trade payables	-3 033	-13 659	-5 479	-7 286	-10 929
Cash flow from operating activities	-3 042	11 615	-13 366	2 386	-12 266
Cash flow from investing activities	-42 338	-29 746	-22 833	-13 894	-266 532
Cash flow from financing activities	-927	-1 629	132	-140	482 768
Cash flow for the period	-46 307	-19 760	-36 067	-11 648	203 970
Liquid funds at beginning of period	354 236	159 946	350 324	158 608	159 946
Exchange rate difference in liquid funds	3 490	-193	-2 838	-6 967	-9 680
Liquid funds at end of period	311 419	139 993	311 419	139 993	354 236

Consolidated Change in Shareholders Equity

				Retained
				earnings incl.	Sum
		Other paid in		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 - June 2020	-	-	277	-9 476	-9 199
Share warrant program	-	1 331	-	-	1 331
Shareholders´ equity as of June 30, 2020	680	517 084	16 505	35 384	569 653
Total comprehensive income July - December 2020	-	-	-16 688	-34 258	-50 946
Issuing of new shares efter deduction of incremental costs directly related to issuing new shares net of tax	54	489 640	-	-	489 694
Share warrant program	-	60	-	-	60
Shareholders´ equity as of December 31, 2020	734	1 006 784	-183	1 126	1 008 461
Total comprehensive income January - June 2021	-	-	3 714	-2 908	806
Issuing of new shares efter deduction of incremental costs directly related to issuing new shares net of tax	1	-	-	-	1
Share warrant program	-	1 239	-	-	1 239
Shareholders´ equity as of June 30, 2021	735	1 008 023	3 531	-1 782	1 010 507

Attributable to Parent Company's shareholders

Condensed Consolidated Statement of Net Income per quarter

	Apr-Jun	Jan-Mar	Oct-Dec	Jul-Sep	Apr-Jun	Jan-Mar	Oct-Dec	Jul-Sep
SEK Thousands	2021	2021	2020	2020	2020	2020	2019	2019
Net sales	59 263	58 325	60 277	42 736	30 393	46 455	62 416	54 334
Cost of goods sold	-14 716	-15 645	-18 920	-9 602	-7 291	-11 073	-16 710	-15 791
Gross income	44 547	42 680	41 357	33 134	23 102	35 382	45 706	38 543
Selling expenses	-20 613	-19 696	-19 229	-13 470	-12 360	-14 840	-18 372	-14 376
Administrative expenses	-14 605	-11 033	-11 163	-8 462	-5 069	-5 648	-7 152	-6 029
Research and development costs	-14 034	-15 529	-15 886	-11 233	-12 186	-16 873	-17 964	-16 827
Other operating revenues and expenses 1)	-4 645	6 761	-9 406	-18 631	-6 196	2 002	-622	966
Operating income	-9 350	3 183	-14 328	-18 661	-12 709	23	1 596	2 277
Financial income and expenses	-1 411	5 081	-11 610	-481	-6 047	6 550	-3 838	3 210
Income after financial items	-10 761	8 264	-25 938	-19 142	-18 756	6 573	-2 242	5 487
Taxes	1 820	-2 231	6 363	4 457	2 738	-30	340	-558
Net income	-8 941	6 033	-19 575	-14 685	-16 018	6 543	-1 902	4 929
Attributable to
Parent Company's shareholders	-8 941	6 033	-19 575	-14 685	-16 018	6 543	-1 902	4 929
Earnings per share, SEK	-0,31	0,21	-0,68	-0,51	-0,60	0,25	-0,07	0,19
Earnings per share, SEK 2)	-0,31	0,20	-0,67	-0,51	-0,60	0,25	-0,07	0,18
Average number of outstanding shares		28 727 266 28 719 136 28 719 136 28 601 434 26 600 496 26 600 496 26 600 496 26 600 496
Average number of outstanding shares 2)		29 101 266 29 444 136 29 327 136 28 975 434 26 600 496 26 600 496 26 879 496 26 879 496
Number of shares at closing day		28 752 397 28 719 136 28 719 136 28 719 136 26 600 496 26 600 496 26 600 496 26 600 496
Number of shares at closing day 2)		29 126 397 29 444 136 29 444 136 29 093 136 26 600 496 26 600 496 26 879 496 26 879 496
EBITDA (Operating income before depreciation and amortization)	-1 533	11 207	-6 506	-11 229	-5 452	7 550	8 479	9 025
Depreciation and amortization on intangible assets	-5 135	-5 470	-5 349	-4 114	-4 107	-4 115	-4 107	-4 099
Depreciation and amortization on tangible assets	-2 682	-2 554	-2 473	-3 318	-3 150	-3 412	-2 776	-2 649
Operating income	-9 350	3 183	-14 328	-18 661	-12 709	23	1 596	2 277

1) See note 3 for "Other operating revenues and expenses"

2) After dilution

Consolidated Statement of Comprehensive Income per quarter

	Apr - Jun	Jan-Mar	Oct-Dec	Jul-Sep	Apr-Jun	Jan-Mar	Oct-Dec	Jul-Sep
SEK Thousands Net income	2021 -8 941	2021 6 033	2020 -19 575	2020 -14 685	2020 -16 018	2020 6 543	2019 -1 902	2019 4 929
Other comprehensive income
Items that may be reclassified to the income statement:
Exchange rate differences	-3 704	7 418	-13 179	-3 654	-5 226	5 649	-3 691	4 531
Tax attributable to items that have been transferred, or can be transferred to net income	-	-	-153	299	319	-465	343	-487
Total other comprehensive income	-3 704	7 418	-13 332	-3 355	-4 907	5 184	-3 348	4 044
Total comprehensive income	-12 645	13 451	-32 907	-18 040	-20 925	11 727	-5 250	8 973
Attributable to
Parent Company's shareholders	-12 645	13 451	-32 907	-18 040	-20 925	11 727	-5 250	8 973

Consolidated key ratios

					January
	January-June	January-June	April-June	April-June	December
SEK Thousands	2021	2020	2021	2020	2020
Gross margin non-Durable goods, %	76	80	76	81	77
Gross margin, %	74	76	75	76	74
EBITDA, %	8	3	-3	-18	-9
EBITDA (adjusted), %	12	5	14	-3	11
Operating margin, %	-5	-17	-16	-42	-25
Net margin, %	-5	-12	-16	-53	-24
Equity/assets ratio, %	88	92	88	92	88
Income per share, SEK	-0,10	-0,36	-0,31	-0,60	-1,61
Shareholders' equity per share, SEK	35,15	21,42	35,15	21,42	35,11
Share price on closing day, SEK	350	180	350	180	314
Market cap on closing day, MSEK	10 063	4 788	10 063	4 788	9 018

Condensed Income Statement, Parent Company

					January
	January-June	January-June	April-June	April-June	December
SEK Thousands	2021	2020	2021	2020	2020
Net sales	95 995	58 547	57 053	25 373	134 122
Cost of goods sold	-18 252	-13 757	-13 928	-4 651	-36 107
Gross income	77 743	44 790	43 125	20 722	98 015
Selling expenses	-21 200	-16 421	-11 254	-7 788	-36 675
Administrative expenses	-26 300	-9 681	-18 038	-4 664	-27 602
Research and development expenses	-23 948	-31 353	-10 835	-17 145	-65 268
Other operating revenues and expenses	-331	-5 858	137	-5 896	-10 074
Operating income	5 964	-18 523	3 135	-14 771	-41 604
Financial income and expenses	4 353	1 594	-1 022	-7 333	-10 609
Income after financial items	10 317	-16 929	2 113	-22 104	-52 213
Year end dispositions	-	-	-	-	4 200
Taxes	-3 063	3 409	-517	3 409	9 577
Net income	7 254	-13 520	1 596	-18 695	-38 436

The parent company has no items to be recognized in other comprehensive income and therefore no statement of comprehensive income has been presented. Depreciation in the period amounted to SEK 9,763 thousand (9,915), of which SEK 4,895 thousand (4,413) in the quarter.

Condensed Balance Sheet, Parent Company

SEK Thousands	210630	200630	201231
ASSETS
Intangible fixed assets	268 862	224 707	245 777
Property, plant and equipment	6 219	6 756	5 902
Financial assets	488 806	186 921	453 598
Total non-current assets	763 887	418 384	705 277
Inventories	18 210	21 602	16 561
Current receivables	18 775	21 833	25 602
Cash and bank	284 798	116 814	333 318
Total current assets	321 783	160 249	375 481
Total assets	1 085 670	578 633	1 080 758
SHAREHOLDERS' EQUITY AND LIABILITIES
Shareholders' equity	1 009 311	535 961	1 000 817
Untaxed reserves	-	4 200	-
Provisions	1 418	1 315	1 311
Long-term non-interest-bearing liabilities	40 500	-	41 392
Short-term non-interest-bearing liabilities	34 441	37 157	37 238
Total shareholders' equity and liabilities	1 085 670	578 633	1 080 758

Supplementary notes

Disclosures in accordance with IAS 34.16A are included in the financial statements and notes, as well as elsewhere in 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 to 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 valued at cost amounted to SEK 360 million (174) and SEK 66 million (39) 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 recognizes a liability of SEK 40.5 million (-) relating to an additional purchase price linked to acquisitions, at fair value.

Note 3. Consolidated operating segments

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 used in organ perfusion. 'Non-durable goods' refers to income from sales of consumables used in preservation and perfusion of organs.

		January-June
	Non-Durable goods		Durable goods		Total consolidated
SEK Thousands	2021	2020	2021	2020	2021	2020
Net sales	111 120	72 189	6 468	4 659	117 588	76 848
Cost of goods sold	-27 174	-14 415	-3 187	-3 949	-30 361	-18 364
Gross income	83 946	57 774	3 281	710	87 227	58 484
Gross margin (%)	76	80	51	15	74	76

			April-June
	Non-Durable goods		Durable goods		Total consolidated
SEK Thousands	2021	2020	2021	2020	2021	2020
Net sales	56 259	28 003	3 004	2 390	59 263	30 393
Cost of goods sold	-13 707	-5 316	-1 009	-1 975	-14 716	-7 291
Gross income	42 552	22 687	1 995	415	44 547	23 102
Gross margin (%)	76	81	66	17	75	76

Note 4. Other operating revenue and expenses

	Apr - Jun	Jan-Mar	Oct-Dec	July-Sep	April-June	Jan-March	Oct-Dec	July-Sep
SEK Thousands	2021	2021	2020	2020	2020	2020	2019	2019
Cost of cash-based incentive program for employees outside Sweden	-3 860	7 084	-8 332	-12 469	-	2 541	237	2 253
Cost of reorganization	-	-	-	-5 375	-4 498	-	-	-
Other	-785	-323	-1 074	-786	-1 698	-539	-859	-1 287
Total	-4 645	6 761	-9 406	-18 630	-6 196	2 002	-622	966

Reconciliation of alternative performance measures

This report includes key figures not defined in IFRS, but have been included in the report as management considers that this data enables 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 June	January June	April - June	April - June	January December
SEK Thousands	2021	2020	2021	2020	2020
Operating income	-6 167	-12 686	-9 350	-12 709	-45 675
Depreciation and amortization on intangible assets	10 605	8 222	5 135	4 107	17 685
Depreciation and amortization on tangible assets	5 236	6 562	2 682	3 150	12 353
EBITDA (Operating income before depreciation and amortization)	9 674	2 098	-1 533	-5 452	-15 637

Gross margin

SEK Thousands	January June 2021	January June 2020	April - June 2021	April - June 2020	January December 2020
Operating income
Net sales	117 588	76 848	59 263	30 393	179 861
Operating expenses
Cost of goods sold	-30 361	-18 364	-14 716	-7 291	-46 886
Gross income	87 227	58 484	44 547	23 102	132 975
Gross margin %	74	76	75	76	74

Gross margin non-durable goods

SEK Thousands	January June 2021	January June 2020	April - June 2021	April - June 2020	January December 2020
Operating income
Net sales of non-Durable goods	111 120	72 189	56 259	28 003	169 425
Operating expenses
Cost of non-Durable goods sold	-27 174	-14 415	-13 707	-5 316	-38 980
Gross income, non-Durable goods	83 946	57 774	42 552	22 687	130 445
Gross margin, non-Durable goods %	76	80	76	81	77

When calculating 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. Gross margin thus indicates profit after cost of goods sold as a proportion of net sales, and is affected by factors such as pricing, raw materials and manufacturing costs, inventory write-downs and exchange rate effects.

Equity/assets ratio

SEK Thousands	210630	200630	201231
Shareholders' equity	1 010 507		569 653 1 008 461
Total assets	1 149 331	620 408	1 150 309
Equity/assets ratio %	88	92	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 indicates equity as a proportion of total assets and is 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 presented separately from durable goods.
Gross margin, %	Gross 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
EBITDA margin, %	Operating income before depreciation and amortization 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
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, %	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
Equity/assets ratio, %	Shareholders' equity and non controlling interests as a percentage of total assets.	The company believes that the equity/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 on the reporting date.	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 before dilution 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 earnings 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.
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 US 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 supply of oxygen and necessary nutrients during transport to the recipient.
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. In the Thoracic business area 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. In the Abdominal business area this includes Kidney Assist Transport, Kidney Assist and Liver Assist as well as other products and services related to the use of those machines
OPO or Organ Procurement Organization	In the United States, an organ procurement organization (OPO) is a non-profit organization 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 a medical device.
Preclinical study	Research performed before a drug or method of treatment is sufficiently documented to be studied in humans.
Preservation	Storage and maintenance of an organ outside the body before transplantation.
Reimbursement	Reimbursement is used in the health insurance system in order for healthcare providers to be reimbursed 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 cooled during transport and before transplantation. In the Thoracic business area, this includes Perfadex® Plus as well as other products and services related to the use of that product.
Xeno-transplantation	Transplantation of living cells, tissues or organs from one species to another.
Other Sales	In terms of product category, Other sales refers to income relating to freight, service and training.

Extending horizons

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