Yesterday, post-market, XVIVO confirmed a delay in CE mark clearance for its heart perfusion solution and supplement, citing an extended consultation process with EU regulatory bodies. While the Heart Assist Transport device and perfusion set have been cleared, the remaining component, its propriet
Yesterday, XVIVO enroled the first patient under the CAP study for heart technology in the US, allowing its continued use in up to 60 patients following the successful completion of the US pivotal study back in November 2024, with 1-year follow-up data to be analysed before PMA submission. This new
Following the broad Q2 miss, we revisited our expectations across all business segments, leading to a 2025E sales cut, now expecting 1.1% YoY growth instead of 18%. The major cut comes from the US Lung outlook as the destocking from their largest US client (which represented ~50% of US EVLP sales a
Following a solid Q1 2025, XVIVO delivered a weaker-than-expected Q2, with sales of SEK178m missing CSS by 20% as US destocking from one of the largest US Lung clients weighed on Thoracic performance. The absence of a US heart trial, although anticipated, further impacted the YoY comparison of SEK9
At the ISHLT 2025 meeting, XVIVO presented the final 12-month results from its European NIHP2019 heart transplantation trial, further validating the benefits of its Heart Assist Transport system. The data showed a 38% reduction in severe post-transplant complications (33% for XVIVO vs 47% for cold
Q1 sales were SEK219m (up 18% YOY; we forecast 11%, consensus 13%), with an EBITDA margin of 20% (we forecast 23%). After a quarter marked by regulatory progress, the key potential milestone ahead remains CE approval of the heart technology in 2025e, in our view. We reiterate our BUY and SEK520 target price.
XVIVO began 2025 with solid momentum, reporting Q1 net sales of SEK 218.6m (+18% YoY, +14% in local currencies), slightly ahead of CSS (SEK213m) and in line with BG estimates (SEK220m), driven by 14% organic and 2% acquired growth. Thoracic, although representing a -5% dop QoQ, remained the main gr
We expect a soft start to 2025, with Q1e revenue growth of c11% YOY, sales of SEK207m, and EBITDA of SEK47m. However, the temporary revenue-growth issue does not affect our long-term view. We reiterate our BUY, but have cut our target price to SEK520 (567).
XVIVO concluded 2024 with robust performance, driven by broad-based organic growth and clinical advancements. Q4 net sales reached SEK227.6m (+46% YoY, 45% in local currencies), including 44% organic growth and 1% acquired, while FY sales rose to SEK822.4m (+38% YoY, 39% in local currencies), fully
We expect a solid end to the year, with Q4 revenue growth of 32% YOY, sales of SEK206m and EBIT of SEK25m. Following a change of analyst, we reiterate our BUY but have cut our target price to SEK567 (584) on our updated model and revised valuation approach.
We revisited our FY 2024 estimates following the softer traction in the abdominal segment in Q3 and slightly delayed EU heart trial launch, now awaiting CE-mark approval anticipated in Q1 2025 (instead of Q4 2024). Our revised 2024 sales estimate is SEK816m (down from SEK925.8m), while the EBITDA m
Yesterday post-market, XVIVO announced that it has completed enrolment in its US clinical trial, PRESERVE evaluating its heart preservation technology, five months ahead of schedule. Initially, enrolment was expected to take 18 months, as the trial involves 141 patients across 14 leading heart tran
XVIVO reported Q3 2024 results, with sales coming in below expectations at SEK198.5m (vs. consensus SEK206m). The miss was largely due to slower progress in the abdominal segment, where sales increased by only 12% year-on-year but dropped 16% quarter-on-quarter. Additionally, the service segment un
XVIVO is expanding its service offering with the acquisition of the FlowHawk software platform from OmniLife, aiming to streamline the complex planning and communication involved in organ transplantation, ensuring that "no one should die waiting for a new organ." The FlowHawk platform has proven it
Following the outstanding Q2 2024 earnings report on Friday, we updated our DCF model (WACC 9%, TGR 3%) (unchanged) reflecting XVIVO's improved Lung outlook, Abdominal sales to pick up from Q4 2023, as well as the positive progress on gross margin and EBITDA, which we anticipate to reach 30% in 202
XVIVO reported Q2 2024 results demonstrating continued financial growth and solid clinical progress. Revenues hit over cons. at SEK 210m (BG est. of SEK SEK 205m) representing a YoY organic growth of 35% (adj. for currency), and 13% QoQ. The solid performance was driven by the thoracic business rep
We expect total Q2 sales growth of 31% YOY, at a 13.9% adj. EBIT margin, with solid momentum in most segments. We reiterate our BUY and have raised our target price to SEK520 (468) on 2024–2026e sales and peer-group multiple changes.
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