Xvivo Perfusion : Interim ReportQ32023

Interim report January- September 2023

XVIVO Perfusion AB (publ)

Interim report January-September 2023

Third quarter 2023 (July 1 - September 30)

• Net sales amounted to SEK 146.6 million (96.8), corresponding to an increase of 51 percent in SEK and 42 percent in local currencies. Organic growth accounted for 37 percent and acquired growth for 5 percent.
• All business areas delivered underlying organic growth adjusted for currency effects: Thoracic disposables 23 percent, Abdominal disposables 100 percent and Services 68 percent.
• The gross margin for disposables increased to 80 percent (79). The total gross margin was 73 percent (72).
• Operating income (EBIT) amounted to SEK 5.3 million (-4.7). Adjusted EBIT amounted to SEK 14.4 million (-0.7).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 18.9 million (5.9), corresponding to an EBITDA margin of 13 percent (6). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 28.0 million (9.9), corresponding to an adjusted EBITDA margin of 19 percent (10).
• Net profit amounted to SEK 2.3 million (5.4). Earnings per share amounted to SEK 0.08 (0.18).
• Cash flow from operating activities increased to SEK 24.8 million (17.0), primarily due to strong operating income before depreciation and amortization. Total cash flow amounted to SEK 424.4 million (-18.4), mainly comprising net proceeds from a new issue of SEK 440 million, and investments in R&D projects totaling SEK -21.5 million (-27.9).

The period 2023 (January 1 - September 30)

• Net sales amounted to SEK 441.8 million (283.8), corresponding to an increase of 56 percent in SEK and 45 percent in local currencies. Organic growth accounted for 39 percent and acquired growth for 6 percent.
• All business areas delivered underlying organic growth adjusted for currency effects: Thoracic disposables 34 percent, Abdominal disposables 71 percent and Services 75 percent.
• Gross margin for disposables increased to 80 percent (79). The total gross margin was 74 percent (71).
• Operating income (EBIT) amounted to SEK 20.3 million (4.1). Adjusted operating income (EBIT) amounted to SEK 41.9 million (5.7).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 59.8 million (35.0), corresponding to an EBITDA margin of 14 percent (12). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 81.4 million (36.6), corresponding to an adjusted EBITDA margin of 18 percent (13).
• Net profit increased to SEK 23.3 million (17.7). Earnings per share amounted to SEK 0.78 (0.60).
• Cash flow from operating activities was SEK 28.2 million (6.1). Total cash flow amounted to SEK 341.4 million (-118.5), primarily comprising net proceeds from a new issue totaling SEK 440 million, payment of contingent consideration from the acquisition of Avionord (XVIVO S.r.l.) of SEK -10.9 million, the final part payment of the initial purchase consideration regarding the acquisition of STAR Teams of SEK -6.8 million and investments in R&D projects of SEK -66.9 million (-85.4).

Significant events during the quarter

• A directed share issue raised SEK 440 million before transaction costs and was completed with no discount
• US FDA grants XVIVO approval to include DCD hearts in IDE Clinical Trial
• XVIVO's heart preservation technology was used in a second successful xenotransplant (heart from pig to human)
• Strategic collaboration with MTJ Aviation aimed at strengthening XVIVO's service for organ retrieval in the US
• Further patient inclusion in the PrimECC study concluded Study data will be analyzed and strategic opportunities evaluated

Significant events in the reporting period

• Successful integration of Avionord M&P
• A pre-clinical study published in The Journal of Heart and Lung Transplantation demonstrated advantages associated with XVIVO's heart preservation technology, even in DCD donations
• Significant interest in XVIVO's heart technology in Australia and New Zealand. Approximately 30 percent of these countries' heart transplants were performed using our technology in the period
• A large multicenter study published in The Journal of Hepathology demonstrated improved evidence for the advantages of oxygenation cold perfusion of liver in donation after brain death (DBD)
• IDE application for XVIVO's heart preservation technology was approved by the US FDA
• Patient inclusion completed in European clinical trial using heart preservation technology
• US service offering strengthened by commercial integration of STAR Teams
• During the period, the number of shares and votes in XVIVO Perfusion AB (publ) has increased by 1,667,551. As of September 30, 2023, there were a total of 31,499,470 shares and votes.

Significant events after the end of the period

• First transplant completed in the US heart preservation trial

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Key ratios

	January-	January-		July-September	Full year
	September	September	July-September
TSEK	2023	2022	2023	2022	2022
Net sales	441 802	283 778	146 614	96 835	415 292
Gross margin, %	74	71	73	72	72
Gross margin disposables %	80	79	80	79	79
EBIT	20 311	4 105	5 302	-4 657	6 409
EBIT (adjusted)1)	41 936	5 744	14 357	-653	14 285
EBITDA	59 791	34 996	18 931	5 904	48 576
EBITDA (adjusted)1)	81 416	36 635	27 986	9 908	56 452
Cash flow from operating activities	28 160	6 067	24 840	16 971	27 856
Earnings per share, SEK	0.78	0.60	0.08	0.18	0.62
Changes in net sales
Organic growth in local currency, %	39	32	37	35	30
Acquired growth, %	6	18	5	22	15
Currency effect, %	11	14	9	19	16
Total growth, %	56	64	51	76	61

1. Adjusted for effect from costs attributable to business integration. Net adjustment totals SEK -9.1(-4.0, which related to acquisition costs) million for the quarter. Net adjustment for the period totals SEK -21.6(-1.6, which consisted of a reversal of a provision for cash-based incentive program for employees outside Sweden of SEK 6.3 million, integration costs of SEK -3.9 million and acquisition costs of SEK -4.0 million) million.

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CEO comment

Successful capital raising and sharp focus on delivery

The company's growth in the first half-year continued into the third quarter, driven by increased use of machine perfusion. We completed a successful capital raising in the quarter, raising SEK 440 million before transaction costs. The strong support from our shareholders means that we are now ready to deliver on our strategy to achieve market leadership in all organs.

Christoffer Rosenblad, CEO

Total sales in the quarter amounted to SEK 147 million (97), equivalent to growth of 51 percent. Organic growth accounted for 37 percent and acquired growth amounted to 5 percent. The remaining growth related to currency effects.

Sales in the Thoracic business area amounted to SEK 91 million (71), an increase of 28 percent year-on-year and an increase of 20 percent adjusted for currency effects. Disposables delivered organic growth of 23 percent. Market growth and increased use of EVLP (Ex Vivo Lung Perfusion) remain the primary growth factors, with favorable progress in both the US and Europe.

Abdominal delivered another strong quarter, primarily driven by continued positive sales growth for liver perfusion in Europe. Sales amounted to SEK 35 million (14) in the quarter, equivalent to growth of 138 percent adjusted for currency effects. Disposables delivered organic growth of 100 percent.

Production of Kidney Assist Transport (KAT) is gradually increasing, although the introduction continues on a selective basis. KAT has now been fully launched in the Netherlands, where it is used for all DCD kidneys with favorable results. To date, we have completed a selective launch in the US, Australia, Sweden and Spain. The initial customer response is positive, confirming the positive clinical results seen in studies such as the one published in The Lancet (2020). There has been considerable interest in the US, and XVIVO took the important step of introducing KAT in the first OPO (Organ Procurement Organization) in October. OPOs provide a majority of kidney perfusion in the US and are an important target group, while also providing a contact point with new transplant centers. XVIVO's top priority is to continue to increase volumes of produced sterile disposables. At a pace with production improving, we are seeing gradually increased product sales.

The Services business area, which includes our organ recovery service in the US, had organic growth of 68 percent. We strengthened our organization during the year, focusing on establishing stable, regional hubs that can serve our customers more efficiently. The organizational integration of STAR Teams into XVIVO was completed in the quarter and we are now marketing our services relating to organ retrieval under the XVIVO brand. The work continues to strengthen the customer offering under the joint brand, with a focus on clinical quality as well as efficient logistics and communication.

We continue to deliver healthy gross margins in both Thoracic and Abdominal. The margin in Thoracic was 86 percent (84), and the Abdominal margin was 61 percent (51). We presented a strong EBITDA margin again in the quarter - adjusted for previously announced integration costs, the margin was 19 (10) percent.

The new issue in September raised SEK 440 million for the company before transaction costs and was completed with no discount in an accelerated book-building procedure. The net proceeds are intended for three important purposes, all of which represent a fundamental part of our strategic plan: to bring our heart preservation technology, which now also includes DCD donors, and our liver perfusion technology to the US market after clinical trials in the shortest time possible. We will also finance a strong increase in the production of disposables, with the aim of ensuring delivery capacity and reducing the cost of goods sold. We feel that we have strong support from our shareholders and are determined to deliver according to plan.

"Strong support from our shareholders means that we are now ready to deliver on our strategy"

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In the third quarter we saw further indications of the potential of our heart preservation technology. In the US, the protocol has been updated to include DCD donors and on October 14, Duke University Hospital became the first clinic to complete a heart transplant in the US trial. In Australia, use of the technology through special permits continued with favorable clinical results, and to date in the year approximately 30 percent of the country's heart transplants have been carried out using our technology.

In May, we announced in a press release that we had included all of the 202 patients in the European study. This study forms the basis for obtaining regulatory approval in Europe, known as CE-marking, which enables marketing and sales of the heart technology. According to schedule, we submitted the technical documentation for inspection by our Notified Body in the third quarter.

Last, but not least, for the second time in history a successful xenotransplant has been completed where a human received a heart from a pig. This was achieved by a team of researchers at University of Maryland School of Medicine in the US, where XVIVO's technology enabled preservation of the pig heart before transplant.

Given the continued growth in machine perfusion, our strong financial position and the great interest in our US clinical studies, we are looking to next year with confidence.

Christoffer Rosenblad, CEO

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This is XVIVO

Founded in 1998, XVIVO is the only MedTech 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 organ transplantation. XVIVO is a global company headquartered in Gothenburg, Sweden. The company is listed on Nasdaq.

Business concept and goals

XVIVO's business concept is to develop and market effective, innovative technology for preserving, transporting and assessing organs outside the body while awaiting transplant, and to facilitate the transplant process by offering services in the form of organ recovery and organ perfusion.

Our goals

To become the world leader in the preservation of organs outside the body for all major organs (lung, heart, liver and kidney) and establish machine perfusion as the standard method for preserving, transporting and assessing donated organs ahead of transplantation.

Purpose and vision

We believe in an extended life of organs. Nobody should die waiting for a new organ.

some

SEK 1.5

million

organ transplants d d

With only

150,000

organ transplants each year, only

10%

of total global demand is met

XVIVO's offer increases the availability of transplantable organs

Our business areas

	Thoracic	Abdominal	Services

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Compilation of net sales and

EBITDA

	January-	January-			January-
	September	September	July-September	July-September	December
SEK Thousands	2023	2022	2023	2022	2022
Net Sales Thoracic	285 908	208 188	90 884	71 226	296 353
Net Sales Abdominal	95 866	43 510	35 118	13 683	70 861
Net Sales Services	60 028	32 080	20 612	11 926	48 078
Net Sales Total	441 802	283 778	146 614	96 835	415 292
Gross income Thoracic	238 483	163 113	77 644	57 528	235 676
Gross margin Thoracic, %	83%	78%	85%	81%	80%
Gross income Abdominal	62 112	23 003	21 717	6 516	37 733
Gross margin Abdominal, %	65%	53%	62%	48%	53%
Gross income Services	27 282	15 983	8 237	5 327	23 547
Gross margin Services, %	45%	50%	40%	45%	49%
Gross income Total	327 877	202 099	107 598	69 371	296 956
Gross margin Total, %	74%	71%	73%	72%	72%
Selling expenses	-167 457	-106 680	-66 554	-39 387	-152 398
Administrative expenses	-59 635	-47 913	-13 392	-18 734	-70 979
Research and development expenses	-84 928	-45 384	-27 126	-16 651	-69 343
Other operating revenues and expenses	4 454	1 983	4 776	744	2 173
Operating Income	20 311	4 105	5 302	-4 657	6 409
Amortization and depreciation cost of goods sold	311	543	86	180	744
Depreciation administrative expenses	3 227	2 524	1 134	849	3 402
Amortization of research and development expenses	26 688	22 936	9 060	7 655	31 024
Depreciation selling expenses	9 254	4 888	3 349	1 877	6 997
EBITDA (Operating income before depreciation and amortization)	59 791	34 996	18 931	5 904	48 576
EBITDA, %	14%	12%	13%	6%	12%
EBITDA (adjusted) 1)	81 416	36 635	27 986	9 908	56 452
EBITDA (adjusted), %	18%	13%	19%	10%	14%

1. Adjusted for effect from costs attributable to business integration. Net adjustment totals SEK -9.1(-4.0, which related to acquisition costs) million for the quarter. Net adjustment for the period totals SEK -21.6(-1.6, which consisted of a reversal of a provision for cash-based incentive program for employees outside Sweden of SEK 6.3 million, integration costs of SEK -3.9 million and acquisition costs of SEK -4.0 million) million.

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Summary

The quarter July - September 2023

Net sales and income

After two strong quarters at the start of the year, XVIVO followed up with an equally strong third quarter. Net sales in the quarter amounted to SEK 146.6 million (96.8), equivalent to growth of 51 percent year-on-year. The organic growth was 37 percent, acquired growth was 5 percent and the remaining 9 percent constituted currency effects. All business areas demonstrated solid growth. For a description of developments in each business area, see pages 13-14.

The total gross margin for the quarter was 73 percent (72). During the quarter, the gross margin for disposables increased year-on-year for both Thoracic and Abdominal, with a margin of 86 percent (84) for Thoracic and 61 percent (51) for Abdominal. For comments regarding the margins in each business area, see pages 13-14.

Operating income before depreciation and amortization (EBITDA) amounted to SEK 18.9 million (5.9), corresponding to an EBITDA margin of 13 percent (6). EBITDA was affected by integration costs of SEK -9.1 million (-4.0, which related to acquisition costs). Adjusting for these items, EBITDA amounted to SEK 28.0 million (9.9), corresponding to an adjusted EBITDA margin of 19 percent (10).

Operating income (EBIT) amounted to SEK 5.3 million (-4.7). EBIT adjusted for the aforementioned costs amounted to SEK 14.4 million (-0.7).

Selling expenses in relation to total sales amounted to 45 percent (40) for the quarter and included integration costs of SEK -7.7 million (-2.0). R&D expenses amounted to 19 percent (17) of sales. Administrative expenses amounted to 9 percent (19) and included integration costs of SEK -1.6 million (-6.0).

Capitalization and amortization

During the quarter, SEK 21.5 million (27.9) of development expenses were capitalized as intangible assets. Development expenses essentially relate to expenses for R&D projects with the aim of obtaining regulatory approvals in heart and liver transplantation in the US and Europe. Amortization of capitalized development expenditure amounted to SEK 7.3 million (6.5) in the quarter.

Cash flow

Cash flow from operating activities strengthened in the quarter and amounted to SEK 24.8 million (17.0), primarily as a result of strong operating income before depreciation and amortization. Cash flow from investing activities amounted to SEK -28.1 million (-33.7), of which SEK -21.7 million (-28.0) was invested in intangible assets and SEK -6.5 million (-6.1) was invested in tangible assets. Cash flow from financing activities amounted to a net SEK -427.6 million (-1.6), primarily due to proceeds from the new issue of SEK 429.9 million net of transaction costs. Exchange rate differences impacted the cash flow for the quarter by SEK -1.6 million (15.0). Cash and cash equivalents at the end of the quarter amounted to SEK 594.3 million (314.6).

Net sales by business area (R12)

SEKm

600

550

500

450

400

350

300

250

200

150

100

50

0

Q3 22 Q4 22 Q1 23 Q2 23 Q3 23

Thoracic

Abdominal

Services

EBITDA and EBITDA margin (adjusted, R12)

SEKm
110											20,0%
100											17,5%
90
										15,0%
80
70											12,5%
60											10,0%
50
										7,5%
40
30											5,0%
20											2,5%
10
0											0,0%

Q3 22 Q4 22 Q1 23 Q2 23 Q3 23 EBITDA R!2 (adjusted) EBITDA margin R12 (adjusted)

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Significant events during the quarter

Directed new share issue raised SEK 440 million.

XVIVO carried out a directed share issue of 1,600,000 shares at a subscription price of SEK 275 per share, raising gross proceeds of SEK 440 million before transaction costs of approximately SEK 10 million for the company. The subscription price was determined in an accelerated book-building procedure. Investors in the directed issue include existing and new shareholders such as Bure Equity AB, the Fourth AP Fund, Swedbank Robur Fonder, Eccenovo, Handelsbanken Fonder AB through the investment fund Hälsovård Tema, the Third AP Fund and a tier-one global international investor.

The net proceeds from the Directed Issue are intended to be used for:

1. Increased investments in US clinical trial infrastructure and support to create an efficient FDA PMA regulatory approval process for the heart preservation technology;
2. Fast-trackthe preparation and start of the clinical trial and FDA PMA regulatory approval process for Liver Assist; and
3. Scale-upof disposable production to ensure delivery capacity and decrease in cost of goods sold.

Through the Directed Issue, the number of shares and votes in XVIVO Perfusion AB (Publ) increased by 1,600,000, as announced on September 29, 2023. As of September 30, the total number of shares and votes was 31,499,470.

US FDA grants XVIVO approval to include DCD hearts in IDE Clinical Trial

The US Food & Drug Administration (FDA) has approved XVIVO's Investigational Device Exemption (IDE) supplement for its heart preservation clinical trial to now include Donation after Circulatory Death (DCD) hearts. This permits clinical trial sites to utilize XVIVO's heart technology to preserve hearts from DCD donors. 141 patients will be enrolled at up to 20 US hospitals. The number of patients is unchanged, but this change will allow five additional clinics to participate in the trial.

XVIVO's heart preservation technology was used in a second successful xenotransplant (heart from pig to human)

On September 20, 2023, the world's second successful heart xenotransplant from pig to human was completed. Like for the first transplantation, a team of researchers at University of Maryland School of Medicine in the US were behind the achievement. After removing the heart from the pig, XVIVO's preservation technology and patented solution was used to preserve the heart in optimal condition before transplant. The patient was a 58-year-old critically ill man with terminal heart failure who did not qualify for conventional treatment methods.

One of the biggest challenges in transplantation is the shortage of organs. Xenotransplantation, i.e. transplantation between species, presents a potential solution to the critical organ shortage. Groundbreaking research using XVIVO's heart preservation technology has achieved long-term survival after xenotransplants of hearts from genetically modified pigs to primates in recent years.

XVIVO initiates strategic collaboration with MTJ Aviation to strengthen organ retrieval services in the US

XVIVO has signed a strategic collaboration agreement with MTJ Aviation, a US company specializing in healthcare transport. The agreement is a positive consequence of the decision to integrate STAR Teams with the XVIVO brand. Reliable organ transports have become increasingly important for transplantation clinics in the US following recent changes to US organ allocation policy. Escalating logistics complexity and ensuing increased costs to clinics have led to the emergence of a more customized and efficient transportation process. Alongside MTJ Aviation, XVIVO will address this need by establishing shared flight hubs on the US East Coast and in the Mid West. Each hub will have a dedicated surgical team and a light jet plane dedicated to XVIVO's operations.

XVIVO has decided to conclude further patient inclusion in the PrimECC® study

PrimECC is a solution used to prepare heart-lung machines ahead of heart surgery. The product is both CE marked and patent protected and has been developed with the aim of reducing complications after surgery. A clinical trial in PrimECC was initiated in 2020, with the aim of expanding and strengthening existing clinical data. Unfortunately, the rate of patient inclusion did not live up to expectations, and the study is not expected to be completed within a reasonable time frame. XVIVO has therefore decided to halt further patient inclusion in the study. The study data will be analyzed and the strategic potential evaluated.

So far, SEK 14 million has been invested in the clinical trial in PrimECC. If XVIVO eventually decides to terminate the product, this would result in impairment of intangible assets totaling SEK 14 million. XVIVO expects to make a decision regarding the future of PrimECC within a three-six month period.

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The period January - September 2023

Net sales and income

Sales in the period amounted to SEK 441.8 million (283.8), equivalent to growth of 56 percent year-on-year. Organic growth was 39 percent, acquired growth 6 percent, and the remaining 11 percent constituted currency effects. All business areas demonstrated solid growth. For a description of development within each business area, see pages 13-14.

The total gross margin for the period was 74 percent (71). During the period, the gross margin for disposables increased year-on-year both for Thoracic and Abdominal, with a margin of 85 percent (84) for Thoracic and 65 percent (53) for Abdominal. For comments regarding the margins in each business area, see pages 13-14.

Operating income before depreciation and amortization (EBITDA) amounted to SEK 59.8 million (35.0), corresponding to an EBITDA margin of 14 percent (12). EBITDA was affected by integration costs of SEK -21.6 million (-1.6, which consisted of a reversal of a provision for cash-based incentive program for employees outside Sweden of SEK 6.3 million, integration costs of SEK -3.9 million and acquisition costs of SEK -4.0 million). Adjusting for these items, EBITDA amounted to SEK 81.4 million (36.6), corresponding to an adjusted EBITDA margin of 18 percent (13).

Operating income (EBIT) amounted to SEK 20.3 million (4.1). EBIT adjusted for the aforementioned costs amounted to SEK 41.9 million (5.7).

Selling expenses as a proportion of sales amounted to 38 percent (37) for the period. R&D expenses amounted to 19 percent (16) of sales. The increase was primarily due to changes in internal resource allocation and investments in the organization. Administrative expenses amounted to 13 percent (17) of sales.

Capitalization and amortization

During the period, SEK 66.9 million (85.4) of development expenses were capitalized as intangible assets. Development expenses essentially relate to expenses for R&D projects with the aim of obtaining regulatory approvals in heart and liver transplantation in the US and Europe. Amortization of capitalized development expenditure amounted to SEK 21.8 million (19.6) in the period.

Cash flow

Cash flow from operating activities strengthened in the period, amounting to SEK 28.2 million (6.1). Cash flow from investing activities amounted to SEK -109.0 million (-120.6), impacted by contingent consideration related to the acquisition of Avionord (XVIVO S.r.l.) of SEK -10.9 million, the final part payment of the initial purchase consideration regarding the acquisition of STAR Teams of SEK -6.8 million, investments in intangible assets of SEK -67.6 million (-86.4) and investments in property, plant and equipment of SEK -23.7 million (-14.1). Cash flow from financing activities amounted to a net of SEK 422.3 million (-4.0) primarily attributable to proceeds from the new issue of SEK 429.9 million net of transaction costs. Cash and cash equivalents at the end of the period amounted to SEK 594.3 million (314.6).

Financing

XVIVO's operations shall be conducted with a sustainable and efficient capital structure. The company's equity/assets ratio is strong and amounted to 86 percent (84) 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.

Net sales

SEK 442 million

Gross margin

74%

Adjusted EBITDA

18%

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