Xvivo Perfusion : Year-end ReportQ42022

Report on Operations 2022

XVIVO Perfusion AB (publ)

Report on Operations 2022

Fourth quarter 2022 (October 1 - December 31)

• Net sales amounted to SEK 131.5 million (85.9), corresponding to an increase of 53 percent in SEK and 34 percent adjusted for currency effects. Organic growth accounted for 27 percent and acquired growth for 7 percent.
• All business areas delivered underlying growth adjusted for currency effects: Thoracic 26 percent, Abdominal 27 percent and Services 44 percent.
• The gross margin for disposables increased to 79 percent (77). The total gross margin was 72 percent (73).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 13.6 million (-0.1) corresponding to an EBITDA margin of 10 percent (0). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 19.8 million (9.6), corresponding to an adjusted EBITDA margin of 15 percent (11).
• Operating income (EBIT) amounted to SEK 2.3 million (-8.3). Adjusted EBIT amounted to SEK 8.5 million (1.4).
• Net profit amounted to SEK 0.7 million (12.2). Earnings per share amounted to SEK 0.02 (0.42).
• Cash flow from operating activities increased to SEK 21.8 million (-0.6), a result of increased sales and positive EBITDA. Total cash flow amounted to SEK -58.1 million (111.2) and was primarily impacted by the initial purchase price for XVIVO S.r.l. of SEK -39.4 million, payment of the withheld portion of the purchase price for STAR Teams Inc. of SEK -7.0 million and investments in R&D projects of SEK -26.2 million.

The period 2022 (January 1 - December 31)

• Net sales amounted to SEK 415.3 million (258.4), corresponding to an increase of 61 percent in SEK and 45 percent adjusted for currency effects. Organic growth accounted for 30 percent and acquired growth for 15 percent.
• All business areas delivered underlying growth adjusted for currency effects: Thoracic 32 percent, Abdominal 24 percent and Services 39 percent.
• The gross margin for disposables increased to 79 percent (76). The total gross margin was 72 percent (73).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 48.6 million (13.8) corresponding to an EBITDA margin of 12 percent (5). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 56.5 million (29.5), corresponding to an adjusted EBITDA margin of 14 percent (11).
• Operating income (EBIT) amounted to SEK 6.4 million (-18.5). Adjusted operating income (EBIT) amounted to SEK 14.3 million (-2.7).
• Net profit increased to SEK 18.4 million (8.2). Earnings per share amounted to SEK 0.62 (0.28).
• Cash flow from operating activities increased to SEK 27.9 million (-12.1). Total cash flow amounted to SEK -176.6 million (34.8), and included a final additional purchase price payment relating to the acquisition of Organ Assist (XVIVIO B.V.) of SEK -21.0 million, an initial purchase price relating to XVIVO S.r.l. of SEK -39.4 million, payment of the withheld portion of the purchase price for STAR Teams Inc. of SEK -7.0 million and investments in R&D projects of SEK -111.6 million.

Significant events during the quarter

• Positive results presented from the Australian and New Zealand heart preservation study.
• XVIVO completes the acquisition of the machine and perfusion business from its Italian distributor Avionord S.r.l.
• The new share issue directed at the shareholders of Avionord S.r.l. increased the number of shares and votes in XVIVO Perfusion AB (publ) by 269,952.
• XVIVO's Board of Directors appoints Christoffer Rosenblad as CEO.
• XVIVO strengthens its management team by appointing Lena Hagman as Chief Operating Officer, COO.

Significant events in the reporting period

• XVIVO's heart technology is used in the world's first ever successful heart xenotransplantation (pig to human)
• Kidney Assist Transport granted 510(k) clearance by the US FDA
• XVIVO obtains its first certificate under EU Medical Device Regulation (MDR) for Kidney Assist Transport
• An IDE application for the heart preservation study in the US was submitted to the FDA
• XVIVO gains regulatory approval in China for PERFADEX® Plus
• XVIVO signs an agreement to acquire 100 percent of the shares in Avionord S.r.l's machines and perfusion business - the company's distributor in Italy.
• Liver Assist granted a Breakthrough Device Designation by the US FDA
• XVIVO holds its second capital markets day
• XVIVO's CEO, Dag Andersson, passes away and Christoffer Rosenblad takes over as Acting CEO

XVIVO Perfusion AB (publ) org.nr 556561-0424 - Report on Operations 2022

2 | 29

Events after the end of the period

• The Board of Directors proposes that no dividend be paid for the 2022 financial year and that retained earnings be carried forward.

Key ratios

	January-December	January-December	October-December	October-December
TSEK	2022	2021	2022	2021
Net sales	415 292	258 386	131 514	85 863
Gross margin, %	72	73	72	73
Gross margin disposables %	79	76	79	77
EBIT	6 409	-18 498	2 304	-8 300
EBIT (adjusted)1)	14 285	-2 716	8 541	1 361
EBITDA	48 576	13 759	13 580	-96
EBITDA (adjusted)1)	56 452	29 541	19 817	9 565
Cash flow from operating activities	27 856	-12 059	21 789	-562
Earnings per share, SEK	0.62	0.28	0.02	0.42
Changes in net sales
Organic growth in local currency, %	30	27	27	32
Acquired growth, %	15	22	7	10
Currency effect, %	16	-5	19	-
Total growth, %	61	44	53	42

1. Adjusted for effect from cost provision attributable to cash-based incentive program for employees outside of Sweden, acquisition costs and integration costs. Net adjustment totals SEK -6.2(-9.7) million for the quarter. Net adjustment for the period totals SEK -7.9(-15.8) million.

XVIVO Perfusion AB (publ) org.nr 556561-0424 - Report on Operations 2022

3 | 29

CEO comment

Record quarter finishes a strong year

2022 was a strong year for XVIVO. Sales amounted to SEK 415 million (258) with organic growth of 30 percent in local currencies. The final fourth quarter testifies to a continued recovery of transplant activity worldwide and strong momentum for machine perfusion in particular. XVIVO's sales during the quarter set new records and totaled SEK 132 million (86). All of the business areas delivered strong growth, both year-on-year and sequentially.

Total sales in the quarter amounted to SEK 132 million (86), equivalent to growth of 53 percent. Organic growth amounted to 27 percent and acquired growth amounted to 7 percent.

Sales in the Thoracic business area amounted to SEK 88 million (59) - an increase of 49 percent year-on-year and an increase of 26 percent adjusted for currency effects. Machine perfusion constituted 50 percent (44) of sales. North America and Europe both had a strong finish to the year.

Abdominal delivered a strong quarter and it is pleasing that we are developing our leading position in liver transplantation in Europe. Sales amounted to SEK 27.4 million (20.6) in the quarter, which is equivalent to an increase of 33 percent year-on-year. Adjusted for currency effects, growth totaled 27 percent.

The Services business area, which includes our organ recovery service in the US, had organic growth of 44 percent due to new customer contracts during the quarter.

EBITDA margin for the quarter, adjusted for non-recurring costs such as acquisition costs, was 15 (11) percent. We continued to invest in our organization in order to support and accelerate our commercial and clinical plans.

On an operational level, the fourth quarter was eventful. The acquisition of Italian distributor XVIVO S.r.l, together with its machines and perfusion business, was completed on November 30. The Italian business model of combining technology with perfusion services is profitable and forges strong relationships with transplant clinics. I am confident that the company's leadership and former owner will contribute their valuable experience to XVIVO as we develop our service offering.

Another highlight during the quarter was that we followed up a successful XVIVO Masterclass Lung, held just over a year ago, with a by the customers highly appreciated XVIVO Masterclass Liver. Over 90 surgeons and opinion leaders from around the world participated and exchanged experiences with each other during the event hosted by XVIVO and its partners

In summing up 2022, it is clear that XVIVO has achieved several significant milestones during the year toward our goal of becoming the leading transplantation company for all major organs. We received 510(k) clearance from the FDA for Kidney Assist Transport in the US, the world's largest kidney transplantation market. Initial feedback from customers has been positive, and we are now ready to accelerate the launch in both the US and Europe in the first quarter of 2023. In the past year, XVIVO also received MDR certification for its entire abdominal product portfolio, which secures future sales opportunities in Europe.

In heart transplantation, XVIVO's technology facilitated two major clinical advances that have the potential to revolutionize the entire heart transplant field in the long term. The two advances are the groundbreaking first successful pig-to-human xenotransplantation, which took place in the US in early 2022, and the presentation of data from the heart preservation study in Australia and New Zealand with a focus on longer transport times. The study demonstrates that transport times of up to nine hours are possible with good clinical results, which is twice the current practice and recommended upper limit.

The strong finish to 2022 means we have the wind in our sails and self-confidence, and we are determined to make 2023 yet another successful year for XVIVO.

Christoffer Rosenblad, CEO

Christoffer Rosenblad, CEO

"The strong finish to 2022 means we have the wind in our sails and self- confidence"

XVIVO Perfusion AB (publ) org.nr 556561-0424 - Report on Operations 2022

4 | 29

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.

	Vision				Purpose		Target
	Nobody should die waiting				We believe in an extended		Establish machine perfusion as a standard method for preserving,
	for a new organ.				life for donated organs.		evaluating and transporting donated organs before transplantation.

>160.000

organs transplanted per year, representing ~10% of the need*

*WHO estimate

NET SALES PER GEOGRAPHICAL REGION IN THE QUARTER

Americas (57%)

EMEA (38%)

APAC (5%)

~98%

of the market is covered by XVIVO's total offering

Kidney

64%

Liver	Lung
4%
24%
	Heart
Small bowel	6%
0%	Pancreas
	2%

Strategic drivers

CUSTOMER-DRIVEN		HIGH-PERFORMING
INNOVATION		ORGANIZATION	COMMERCIAL POTENTIAL	OPERATIONAL STRENGTH

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

XVIVO has developed its leadingresearch 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.

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

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

XVIVO Perfusion AB (publ) org.nr 556561-0424 - Report on Operations 2022

5 | 29