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High-growth medical device company and market leader within single-use endoscopy.

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10

Jun. 2024

Ambu announces new Chief Operations Officer

Henrik Birk steps down from his position as Chief Operations Officer at Ambu. Former Novozymes COO, Graziela Malucelli, takes on the position, effective immediately.


Effective today, Ambu appoints Graziela Malucelli as the company’s new Chief Operations Officer (COO). She succeeds Henrik Birk who will regrettably be stepping down, due to personal circumstances, a decision made with the support of Ambu’s Executive Management. 

During Henrik Birk’s time at Ambu, he has been a truly respected leader with a great impact on Ambu teams and operations worldwide. However, given Henrik’s pressing personal priorities, he and CEO Britt Meelby Jensen have collaboratively agreed that this transition serves the best interests of both Henrik and the organisation.

"I am sad to be saying goodbye to Henrik, and I extend my heartfelt gratitude to him for his positive impact on Ambu. As Graziela Malucelli steps into the COO role, I am thrilled that we have been able to secure such a highly accomplished leader. I am confident that Graziela’s dynamic leadership and extensive operational expertise will take our organisation to the next level, as she leverages her extensive capabilities and expertise in driving global operations at scale."

BRITT MEELBY JENSEN
Chief Executive Officer


HIGHLY EXPERIENCED COO TO SPEARHEAD AMBU'S GLOBAL OPERATIONS

Taking on the role as Chief Operations at Ambu will be Graziela Malucelli, former COO at Novozymes. At Ambu, Graziela will step into Ambu’s Executive Leadership Team, dedicated to leading Ambu’s global operations teams and ensuring efficient innovation scale-up, reliable market supply and sustainable profitable growth.

Graziela is a highly experienced operational leader, possessing 25 years of experience leading large-scale operational teams across Europe, Asia-Pacific, Latin-America and North America. During her decades-long and notable career at Novozymes, she has held several key leadership roles. In her most recent position as COO, she successfully drove profitable growth and operational excellence across more than 15 global sites, supplying customers with innovative solutions to 140 markets and leading over 3,500 team members.

Above all, she is a purpose-driven and forward-thinking leader, with a strong strategic mindset, a keen customer focus and a passion for driving transformational change. Alongside her results-oriented leadership approach, she has a proven track-record of fostering engaged and collaborative global teams, and she is excited to join Ambu to make her mark on the company’s growth journey:

"I’m honoured and excited to take on the position as COO and to get the opportunity to contribute with my experience to strengthen Ambu’s position as the leader in single-use endoscopy, in our shared efforts to save lives. Together with Britt Meelby Jensen, the Executive Leadership Team and the talented Ambu colleagues, I am looking forward to bringing innovative healthcare solutions to patients and healthcare providers around the world."

GRAZIELA MALUCELLI
New Chief Operations Officer


Read the press release here.

14

May. 2024

Interim report for Q2 2023/24 and the half-year (no. 11)

In the second quarter of the 2023/24 financial year, Ambu delivered 15.5% organic revenue growth and a 14.2% EBIT margin before special items. This was driven by Endoscopy Solutions growing 22.3% and Anaesthesia & Patient Monitoring growing 7.0%.

On April 10, 2024, Ambu raised its financial guidance by upgrading its full-year organic revenue growth to 10-12% from 7-10% and EBIT margin before special items to 10-12% from 8-10%. In addition, the company raised its free cash flow expectations to DKK +370m from DKK +270m. This was mainly driven by better-than-expected outcomes of contract negotiations in Anaesthesia & Patient Monitoring.

I am pleased with the performance within the second quarter of our fiscal year 2023/24, where our Endoscopy Solutions business delivered 22.3% organic revenue growth, and we improved both our profitability and free cash flow, slightly ahead of our ongoing transformation to deliver profitable growth.

Our Endoscopy Solutions business grew in all segments, and we recently expanded and strengthened our offering within gastroenterology by obtaining North American regulatory clearance (FDA) of aScope™ Gastro Large and aScope™ Duodeno 2. All in all, strengthening our customer value proposition and foundation for long-term growth, and I am thankful for the great work by colleagues across Ambu.

BRITT MEELBY JENSEN
Chief Executive Officer

HIGHLIGHTS FOR THE QUARTER

Last year’s comparative figures are presented in brackets.

Financial highlights

  • Revenue for Q2 increased organically by 15.5% (4.2%) to DKK 1,367m (DKK 1,189m), with reported growth of 15.0% (6.0%). Organic growth for the half-year was 14.9% (4.0%), with reported growth of 12.9% (7.8%).
  • Endoscopy Solutions revenue increased organically by 22.3% (10.6%) and by 23.6% (6.7%) for the half-year. Pulmonology posted 13.9% (-3.4%) organic growth, and Endoscopy Solutions excluding pulmonology posted 33.3% (36.3%) organic growth, driven by high double-digit growth in urology and ENT.
  • Anaesthesia & Patient Monitoring increased organically by 7.0% (-2.8%) and by 4.2% (0.9%) for the half-year, driven by positive outcomes of contract negotiations.
  • EBIT before special items for the quarter was DKK 194m (DKK 46m), with an EBIT margin before special items of 14.2% (3.9%). EBIT for the half-year ended at DKK 320m (DKK 114m), with an EBIT margin of 12.2% (4.9%). The improved EBIT margin was driven by organic revenue growth, resulting in operational leverage, slightly offset by investment in resources to drive organic growth. The investments are expected to increase for the remaining fiscal year.
  • Free cash flow before acquisitions totalled DKK 128m (DKK 21m) for the quarter and DKK 263m (DKK -153m) for the half-year.
  • The adjusted FY 2023/24 financial guidance stated on 10 April 2024 is maintained:
    • Organic revenue growth: 10-12% (7-10%)
    • EBIT margin before special items: 10-12% (8-10%)
    • Free cash flow: DKK +370m (DKK +270m)

Business highlights

  • Strengthened gastroenterology (GI) offering, with North American regulatory clearance (FDA) of:
    • aScope™ Gastro Large & aBox™ 2. With the European clearance (CE mark) obtained in September 2023, the global commercialisation begins
    • aScope™ Duodeno 2 & aBox™ 2, initialising an extended controlled market release with key hospitals in North America. European clearance (CE mark) is expected to be obtained later in the 2024 calendar year.
  • Announcing Ambu Broncho Simulator - a software-based training platform developed with Artificial Intelligence for pulmonology training purposes.

DOWNLOAD
Download the full report for Q2 2023/34 and the half-year here

Q2 2023/24 CONFERENCE CALL
A conference call is broadcast live today, Tuesday 14 May 2024, at 11:00 (CET), via ambu.com/webcastQ22024. To ask questions during the Q&A session, please register prior to the call via ambu.com/conferencecallQ22024register. Upon registration, you will receive an e-mail with information to access the call.

The presentation can be downloaded at Ambu.com/presentations

19

Apr. 2024

Ambu obtains FDA clearance for new generation duodenoscopy solution

To meet the unique needs of gastroenterologists performing ERCP procedures, Ambu’s new generation aScope Duodeno 2 solution constitutes a step change from previous generations, driven by valuable collaboration with healthcare professionals.


Today, Ambu announces 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) of its new generation duodenoscopy solution, Ambu® aScope™ Duodeno 2 and Ambu® aBox™ 2, for use in ERCP1 procedures.

In the development of the new generation solution, Ambu has worked closely with a range of experienced gastroenterology professionals and ERCP specialists to rethink its duodenoscopy solution, with a clear focus on enhancing critical performance factors and enabling integration with the aBox™ 2 endoscopy system.

"I am impressed with the improvements in the new aScope Duodeno 2, and I believe that it holds potential for ERCP in the future. Ambu has clearly taken the customer feedback into the development of this new duodenoscope. I highly valued the collaboration throughout the development phase, and I am looking forward to continuing to engage with Ambu on future innovations."

ABHITABH PATIL, M.D.2
Interventional Gastroenterology
President of Florida Gastroenterologic Society
St. Petersburg, FL, USA


PROVIDING FLEXIBILITY AND STERILITY WITH PATIENT-READY DUODENOSCOPES

The new generation aScope™ Duodeno 2 solution is designed to meet the high-performance expectations in ERCP and furthermore relieve the burden of complex and time-consuming reprocessing conducted today. As aScope™ Duodeno 2 is 100% sterile, the solution enables physicians and hospital systems to adhere to the safety recommendations issued by the FDA3 in 2019 and 2022, urging U.S. hospitals and endoscopy facilities to transition to duodenoscopes that are partially or completely single-use.

Furthermore, given the often long and physically demanding nature of ERCP procedures, the handle of Ambu’s new generation aScope Duodeno 2 solution aims to alleviate strain on endoscopists through improved ergonomics. In addition, Ambu is planning to include bioplastic materials in the handle of the new generation solution over time – materials that are derived from a mix of fossil-based and second-generation bio-based feedstock, e.g., recycled food waste, ensuring a raw material with a lower carbon footprint.

"Our new generation duodenoscope solution is a result of a close partnership with gastroentero­logists. Based on their feedback, we have developed a solution to meet the distinct procedural needs in ERCP. We are dedicated to continuing Ambu’s focused journey within GI, anchored in profound customer understanding as a pivotal driver for unlocking long-term potential – for gastroenterologists, patients and Ambu."

BRITT MEELBY JENSEN
Chief Executive Officer, Ambu


Ambu will conduct an extended controlled market release with key hospitals to evaluate the clinical perfor­mance in a real-life setting. The solution will be available in the market from 2024/25, and the FDA clearance will therefore not change the financial guidance for 2023/24.

 

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  1. ERCP stands for endoscopic retrograde cholangiopancreatography and serves both diagnostic and therapeutic purposes for various conditions affecting the bile ducts and pancreas, including gallstones, strictures and tumours.
  2. Dr. Patil a paid consultant of Ambu A/S. He has not been compensated for his quote in this press release.
  3. Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication | FDA.

 

You can read the full press release here.

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30

Aug. 2024

Earnings release Q3 2023/24

30

Sep. 2024

End of fiscal year 2023/24

05

Nov. 2024

Annual Report 2023/24

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