GETINGE AB Capital Market Update
Getinge 2024-2028
Mattias Perjos, CEO
Agneta Palmér, CFO
FDA Letter, May 8 - what has happened?
FDA sent a letter to US healthcare providers, with regards to Cardiohelp, Cardiosave and HLS
No new field actions were referred to in the letter
However, the letter
recommends:
Transition away from | If not any alternative |
Cardiosave, | |
Cardiohelp, and HLS | available, continue to |
products where | use Getinge products |
possible |
Getinge | Capital Market Update | May 2024
2
What do we do about it - short term?
In alignment with FDA recommendations
For the US market
- Suspend Cardiohelp and Cardiosave promotional activities until regulatory and safety concerns are addressed and improvements receive approval
- Sales restricted to when customers have no available alternatives
- Inform all customers about the regulatory requirements regarding indications for use of Cardiohelp
- Continue supplying the installed base with IAB and HLS
- Continue servicing the installed hardware base
For the OUS market
- Continue to sell Cardiosave & Cardiohelp where allowed in various markets
- Continue to provide IAB Balloons & HLS in various markets where approved
Getinge | Capital Market Update | May 2024
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Will most likely have a
negative impact, but too early
to have a firm view on the magnitude, as it depends on multiple factors such as:
Remediation &
product development Regulatory process
Customers' behaviour Competitors' activities
What do we do about it - long term?
Progress in ongoing remediation activities and activities in plan
Substantial reduction | Focus on product |
of quality record | |
upgrades to remediate | |
backlog (90%) | |
regulatory and safety | |
No new material | |
concerns | |
findings | |
Submitting for | Cardiohelp: Cardiohelp | |
approval for | II (cardiopulmonary) | |
expected to be | End of H1 2025 | |
new platforms | submitted for FDA | |
clearance: |
Getinge | Capital Market Update | May 2024
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Filed for approval for
new packaging
solution for HLS-sets
for the CE-market
Intra-aortic Balloon
pumps: Cardiosave Plus
(Intra-aortic BalloonH2 2025 Pump) expected to be
submitted for FDA
clearance:
Examples of recent progress across key markets
Regulatory accomplishments
Hemopro 3 - 510k
Clearance 27-February 2024
Advanta VXT Vascular Graft,
Flixene Vascular Graft - 510k
Clearance 28-March-2024
iCast Covered Stent System -
Original PMA Approval
22-March-2023
Auto Transfusion (ATS) Chest
Drains - 510k Clearance
03-September-2021
Servo-AirLite Ventilator System
510k Clearance 06-July-2023
Talis EMR with Talis+ACG - 510k Clearance 01-April-2024
Getinge | Capital Market Update | May 2024
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Successful transition of Notified
Body from DEKRA to TÜV SÜD for Maquet Cardiopulmonary GmbH
EU MDR Approval for HLS Set
Advanced - 16 Feb 2024
32% of product groups in ACT
Portfolio MDR Certified
7/8 QMSs MDR certified
100% of the Stents, Chest Drains,
and Vascular Grafts portfolio
is MDR approved
EVH System - Renewal approved
27 June 2022
Rotaflow II New Registration
Approved 01-Aug-2023 (Expiry
Date 31-July-2028)
We have improved customer satisfaction during this critical period
Global Customer Net Promoter Score* 2021 vs 2023
+5 pp
0
2021 | 2023 |
Weighted Customer Net Promoter Score globally
*The Net Promoter Score is determined by subtracting the percentage of customers who are not likely to recommend the company and its products from the percentage who are extremely likely to recommend (promoters). The result in 2023 is significantly better than the one in 2021, which was already net positive with high margin.
Getinge | Capital Market Update | May 2024
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Getinge's expected growth as normalization takes place
2024-2028
Projected organic growth in net sales 2024-2028
- 3-6%
Key factors in projection
- Negative financial impact from Cardiopulmonary and Cardiac Assist
- Normalization in mix towards high margin products in Life Science and Surgical Workflows
- Inflation continuing to normalize
- China's expected growth expected to still be strong, but rather high single digits than mid-teens
- Productivity focus (Quality Value engineering, Portfolio pruning, Consolidation of supplier base etc.)
Additional growth potential from acquisitions
- Selective areas - strategic fit and appropriate risk profile
- Financial restrictions: aim to be below 2.5x Net Debt/EBITDA
Getinge | Capital Market Update | May 2024
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Acute Care Therapies
Challenges still impacting - expecting continued negative effects
Projected organic growth in net sales 2024-2028
- 3-5%
Key factors in projection
- Product challenges in Cardiac Assist and Cardiopulmonary in US impacting negatively in 2024-2028 (as presented previously)
- Consolidation in ventilator market
- US and China remain our two largest markets
- New product launches from successful innovation and indication/therapy expansions
In addition: potential growth from acquisitions
- Focus on Acute Heart & Lung Support segment
35 | |||||||||||||
30 | |||||||||||||
25 | |||||||||||||
Share of | Acute Care Therapies | Net sales | Americas | 20 | |||||||||
15 | |||||||||||||
net sales | Rest of Getinge | split | EMEA | ||||||||||
10 | |||||||||||||
2023 | 2023 | APAC | |||||||||||
5 | Adj EBITA Margin, % | ||||||||||||
0 | |||||||||||||
2019 | 2020 | 2021 | 2022 | 2023 |
Growth projection assumes current quality challenges are solved according to plan and no new major issues evolve from ongoing remediation and launches of related hardware
Getinge | Capital Market Update | May 2024
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Life Science
Biopharma segment expected to bottom out in 2024-2025
Projected organic growth in net sales 2024-2028
- 6-10%
Key factors in projection
- Low to mid-teen growth in Biopharma
•GLP-1 supporting healthy capital goods business
- Uncertainty when it comes to China
- Continued partnerships with key Biopharma companies and their expansion plans
In addition: potential growth from acquisitions
- Focus on Bioprocessing, mainly US
25 | |||||||||||||
20 | |||||||||||||
Share of | Life Science | Net sales | Americas | 15 | |||||||||
net sales | Rest of Getinge | split | EMEA | 10 | |||||||||
2023 | 2023 | APAC | 5 | Adj EBITA Margin, % | |||||||||
0 | |||||||||||||
2019 | 2020 | 2021 | 2022 | 2023 |
Getinge | Capital Market Update | May 2024
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Surgical Workflows
Main growth opportunities in consumables, new segments and digital solutions
Projected organic growth in net sales 2024-2028
- 4-6%
Key factors in projection
- Low single digit growth in core capital equipment and service segments
- Double digit growth expected in digital solutions and IC consumables from acquisitions and increased presence in new segments (low temp sterilization and endoscopy reprocessing)
- Growing exposure to the US market, headwinds expected in China
In addition: potential growth from acquisitions
- Opportunistic tuck-in acquisitions in Consumables & Digital
8 | |||||||||||||
6 | |||||||||||||
Share of | Surgical Workflows | Net sales | Americas | 4 | Adj EBITA Margin, % | ||||||||
net sales | Rest of Getinge | split | EMEA | 2 | |||||||||
2023 | 2023 | APAC | 0 | ||||||||||
2020 | 2021 | 2022 | 2023 | ||||||||||
2019 |
Getinge | Capital Market Update | May 2024
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Disclaimer
Getinge AB published this content on 15 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 May 2024 11:12:20 UTC.
