Xvivo Perfusion AB

STO:XVIVO

Earnings Call Transcript 2021-Q1

[Operator]

Ladies and gentlemen, welcome to the Xvivo Group interim report Q1 2021. [Operator Instructions] I will now hand it over to CEO, Dag Andersson. Please go ahead with your meeting.

[Dag Andersson, President & CEO]

Thank you very much for the introduction. So dear all, welcome to the first quarterly telephone conference 2021. And I am happy to present to you, together with my CFO, Kristoffer Nordstrom.And as mentioned in the quarterly report released this morning, the year has started well for XVIVO and quarter 1 was positive from many different aspects. And both sales margins, EBITDA showed positive performance or very positive performance, sales up 38% in the quarter. We had a gross margin of 75%, and EBITDA margin adjusted of 11%. And also worth mentioning strong organic growth of 10%.And particularly positive was the development of thoracic machine perfusion sales, which increased by 45% versus same quarter last year. This is actually an outstanding number, bearing in mind that first quarter last year was actually quite strong before the pandemic impacted the sales.Our price increases in Europe on January 1, contributed to the strong margins. In the U.S., we increased prices in October last year, and we are planning to repeat it also this year. And it's important to note that we've -- having excellent products, very outstanding products, we believe that we can continue to increase prices.Also worth noting is that the gross margin of 75% in the first quarter includes the abdominal product range gross margin. And as you know, this company -- the dominant product range was acquired last autumn through the acquisition of the Dutch company, Organ Assists. And the abdominal product range has a lower gross margin than the thoracic products, and we are working hard to narrow the gap, and the first steps have been taken.Some of the highlights of the quarter, which I think is worth sort of mentioning include, number one here, the publication in the New England Journal of Medicine with clinical evidence that there is better survival of transplanted livers after cold oxygenated machine perfusion, which is what the liver assist machine offers.We have also included the first patients in the Australian Heart Preservation study. We have recruited the very well-renowned university hospital AKH in Vienna to our European Heart Preservation trial and also Rigshospitalet in Copenhagen for the extended PrimECC study.Vienna is Center #9 now in Europe, included in the Heart Preservation study. Interesting to note as well as the commitment by AOPO, the American organ procurement organization to increase the number of transplants by 50% to 50,000 by 2026. And this will, of course, require more focus on machine perfusion to achieve this goal. And this is something that will benefit XVIVO positively since we are -- we have the machine profusion offering.And last but not least, our new brand identity is being rolled out. And our purpose and vision is that we believe in an extended life of organs. Nobody should die waiting for a new organ. As regards the COVID-19 impact on transplant activity, we saw already during the second half of 2020, a slight recovery, and the recovery has gained strength during the first quarter of this year.In the U.S., the number of transplants increased to all major organs, except for lungs, compared with quarter 1 2020. But last couple of weeks, we have actually seen in the U.S. a good increase also in the number of lung transplants before.There is, of course, continued uncertainty regarding COVID and its impact on intensive care unit capacity. In some countries, the pressure on ICU is falling rapidly, but not in all countries. There is a strong correlation between percentage of population vaccinated and the pressure on ICU related to COVID-19. I would like now to hand over to my CFO, Kristoffer. Will you talk a little bit about Q1 financial performance?

[Kristoffer Nordstrom, Chief Financial Officer]

Yes, of course, Dag. Happy to guide you through the financials.Starting with an overview of the profit and loss highlights and the key ratios. Net sales in the first quarter amounted to SEK 58 million. That corresponds to an increase of 26% in Swedish crown and 38% in local currencies. I will provide a deeper insight of the sales distribution on the next slide.Gross margin gross income amounted to SEK 43 million, representing a gross margin in total of 73%. That was similar to previous quarter, or I should say, similar to the previous quarter, the gross margin in the business area varies. So for thoracic, we showed a very strong margin. For nondurable goods, the margin was 82% compared with 79% last year. This increase is mainly explained by price increases for the full product range implemented in Q4 and Q1, as Dag mentioned previously.For abdominal, nondurable goods margin was 51%. Here, our sales price increase was carried out according to plan in the first quarter. However, as we wrote in the report, the positive effect on gross margin is temporarily absorbed by an increase of purchase prices on the disposable set. And the plan here is that we have an ongoing transition to a new supplier and, subject to regulatory approval, we will be able to sell the new products to a lower manufacturing costs later on.Adjusted EBITDA was 11%, and it was in line with the comparison quarter and in line with the full year 2020, a deeper insight of EBITDA will be followed as well.So let's shed some light on the sales for the first quarter. Next slide, please. Thank you. So the net sales in the first quarter amounted to SEK 58 million. The organic growth was 10% in local currency, and the acquired growth was 28% in local currencies. Machine perfusion, very strong, accounted for 53% of total sales. The thoracic business area showed a positive start of the year and constituted 80% of the total sales.As Dag mentioned, machine perfusion portion of the thoracic sales was 42% compared to 31% last year, which is, of course, very delighting. This increase was primarily driven by a recovery in the U.S. and in specific, a positive trend was seen at more established [ pediatric ] clinics.Also worth to mention was that we sold one XPS machine to a clinic in Louisville in U.S. regarding the abdominal sales, they amounted to SEK 12 million and constituted 20% of total sales. Here, the machine perfusion is almost 100% and will almost be 100%. The underlying business showed an organic growth of 35%, which is very good, and this was mainly driven by a growth in the sales of our livers disposables in Europe.Sales of durable goods, however, was a bit low, SEK 1 million. This was primarily due to carbon '19 and longer lead time for tenders.So next slide, please. EBITDA. Adjusted EBITDA amounted to SEK 6 million, which corresponds to an EBITDA margin of 11%, and this was in line with the comparison quarter and the full year 2020. Here, we always want to highlight that we have these items that we adjust for this quarter, it was a positive P&L effect of SEK 7 million from a decrease of a cost provision attributable to our cash-based incentive program. And we also adjusted for integration cost of SEK 2 million. So the net was SEK 5 million. These integration costs were split evenly on selling expenses and admin expenses. We can explain part on those increases.So next slide, please. Final one in the financial section. So our financial position and cash flow. Our financial position is continuously strong. We ended the quarter with SEK 350 million in cash. The cash flow from operating activities was strong and amounted to SEK 10 million. This was mainly due to a positive EBITDA and a positive cash flow from our working capital. SEK 20 million was spent on R&D projects, leading to a total cash flow in Q1 of minus SEK 10 million.So to summarize the financials of the Q1, sales started positively, especially on our largest market, U.S., we are pleased with the improved gross margin in thoracic. Abdominal showed a strong organic growth compared to last year. And the adjusted EBITDA was satisfying given the pandemic and given the fact that we are investing in our organization.So Dag, I will leave the word over to you again.

[Dag Andersson, President & CEO]

Thank you, Kristoffer. I will now go through a little bit in more depth the highlights during our first quarter. And in the beginning of my presentation today, I talked about the publication in the New England Journal of Medicine related to our oxygenated liver machine perfusion device. The reference group consisted of patients transplanted the traditional way, which means nonoxygenated liver machine perfusion. With just 2 hours of hypothermic oxygenated perfusion, the difference is significant between nonoxygenated and oxygenated perfusion.When it comes to our groundbreaking technology for heart preservation, our first patients have been enrolled in Australia. And the purpose of the Australian [indiscernible] is to investigate if our technology can safely extend the time that the donated heart can be outside the body from the current 4 hours, which is the maximum today in the world, transporting -- transportation time of heart to 8 hours. The European study is ongoing. And in the U.S., preparations to commence the study are also ongoing. The study will most likely not start until early next year.When it comes to the 50,000 transplant ambition or campaign by 2026 in the U.S. It is important here to note that we will be supporting the AOPO to achieve this. As mentioned earlier, machine perfusion is one of the initiatives, which will help realizing the ambition of 50,000 transplants by 2026.I also mentioned quickly rebranding. I mean our rebranding activities are being implemented. And our purpose as a company in terms of why we exist, what we believe in and what we want to achieve is as follows: That we believe in an extended life of organs. Nobody should die waiting for a new organ. The core values that we have defined are as follows, starting from top left here: Customer-centric than research driven, purposeful and collaborative. These are the core values of XVIVO as per now. And the rebranding will be implemented with all our customers and suppliers as per end of this month.When it comes to the strategic plan, I've talked about that before, the plan for the years 2020 to 2025 and the 5 strategic objectives, I just want to touch a little bit on these objectives and give an update. I mean, we continue to build the high performing team, and this means selectively recruiting great individuals in commercial and also other functions to deliver on the ambitious sales plan and ensure that we have the right competencies for the future.We also continue to work with combining solutions and machines to build a strong offering for all major organs. I mean we are an all organ company, and we will truly leverage the acquisition of organizations in the best possible way.Remember that there are approximately 160,000 transplants taking place each year in the world. And this only covers approximately 10% of the actual need. So increasing organs available and success rate of transplanted organs is what we are focusing on. We talk a lot about commercial excellence, and this includes expanding and developing the sales force, geographical expansion, focusing on reimbursement strategies in selected countries and, of course, also pricing, which I touched upon before. Customer-driven innovation and operations excellence are also strategic objectives for the plan 2020, 2025. And we collaborate with some of the best reputed hospitals and researchers in the world.Looking at the rest of 2021, looking at the sort of focus areas this year, we are now in the process of concluding the integration of Organ Assist. To a large extent, the integration is accomplished and focus now is on finalizing system integration. The Heart Preservation project is our most important R&D projects, and this is where we invest significant time money and resources. And we made good progress with this project, as mentioned before.Pricing will always be in focus. We have excellent products. We will price them accordingly, and price increases will continue every year for the foreseeable future. We are submitting documents later this month to FDA in the U.S. and authorities in Europe for the registration of our kidney transport device, which figured in a lancet publication end of last year. And we are also, of course, focusing hard on expanding the penetration of lung perfusion. And this means selling our lung machines and the world perfusion [indiscernible] solutions.We are the world leaders in this seat and have, by far, the best product offering on the market. And as also Kristoffer mentioned earlier, I mean, the year has started well for us, and I'm particularly happy with the warm perfusion sales development during the first quarter of this year.So this was actually all that we were going to present. So I hand the word over to the moderator again. Thank you.

[Operator]

[Operator Instructions] Seems like we have no questions from the line. I will hand it back to our speakers.

[Dag Andersson, President & CEO]

That is -- nobody likes getting some questions. But if there are no questions, it probably means that we have explained very clearly our performance during the first quarter. And if there are any questions afterwards, don't hesitate to contact Kristoffer Nordstrom or myself.So I don't think there is anything else that needs to be said. So I think we can conclude the call right now. Thank you.

[Operator]

This now concludes our presentation. Thank you for attending. You may. You may now disconnect.