GETINGE AB UNSP/ADR - GNGBY STOCK NEWS

Getinge has received premarket approval from the U.S. FDA for its iCast™ covered stent system, designed to treat patients with iliac arterial occlusive disease, a form of peripheral arterial disease (PAD) affecting 8 million individuals in the U.S.

The global market for covered stents is projected to grow at an annual rate of 5%. Getinge plans to increase production capacity to meet rising demand. The iCast stent, also known as the Advanta V12 outside the U.S., boasts over 20 years of clinical use and is the most clinically evaluated covered stent worldwide, supported by over 550 published articles.

Getinge reported a 6.4% decline in net sales and a 4.4% drop in organic order intake for Q1 2022. Excluding strong ventilator sales from 2021, there was organic growth. The order book grew by 8% and is 21% higher than the previous year. Supply chain challenges delayed SEK 300 M in sales. Adjusted gross profit decreased to SEK 3,261 M (margin 52.7%), adjusted EBITA fell to SEK 839 M (margin 13.6%), and earnings per share dropped to SEK 2.11. The company anticipates recovery in margins later this year.

Getinge reported a 6.4% increase in organic order intake for Q4 2021, driven by growth across all business areas. However, net sales declined 9.6% compared to Q4 2020 due to fewer ICU ventilator deliveries. The company maintained a strong demand for ECMO therapy products, and Surgical Workflows showed solid margin expansion. Getinge's adjusted gross profit was SEK 4,150 M with a margin of 52.0%. For the full year 2022, organic sales growth is expected to range between 4-6%.

Getinge has inaugurated its new Experience Center in Wayne, New Jersey, aimed at showcasing cutting-edge healthcare technology. The virtual launch event featured demonstrations of advanced solutions, including enhancements in ventilator technology and a heart-lung support system for critically ill patients. U.S. leaders expressed strong support for Getinge's commitment to innovation and job creation in the region. The center aims to enhance hospital efficiencies and patient care, providing a hands-on experience with Getinge's latest advancements in healthcare.

Getinge has appointed Elin Frostehav as President of Acute Care Therapies and Eric Honroth as President of Life Science, effective April 1, 2022. Frostehav, previously Vice President of Critical Care, has been with Getinge since 2019, bringing extensive experience in product development and digitalization. Honroth, who has been with Getinge since 2018, previously led the North America Region and has over 20 years of experience in medical devices. These appointments follow the retirement of Harald Castler and the reassignment of Jens Viebke.

Getinge has acquired Talis Clinical LLC, a US-based provider of high acuity cloud-based software solutions, for SEK 596 M. The acquisition aims to enhance patient care documentation throughout critical care processes. Talis Clinical offers advanced applications built on the ACG-Engine™, which integrates with medical devices and patient data management systems. With a global market potential exceeding SEK 50 B, and expected net sales of SEK 40 M in 2021, this acquisition aligns with Getinge's digital strategy to improve patient outcomes and reduce treatment costs.

Getinge's subsidiary, Atrium Medical Corporation, has reached a settlement agreement in the U.S. related to surgical mesh product liability, totaling SEK 600 million in provisions plus ongoing litigation costs. The agreement, part of a multidistrict litigation involving approximately 3,200 plaintiffs, is expected to finalize in the first half of 2022. While this settlement does not imply company wrongdoing, Getinge maintains its defense against unresolved claims. The existing provision of SEK 1.8 billion from 2018 will be impacted in Q4 2021 results.