Investor Relations

The new clearance marks Ambu’s rapidly growing presence in urology, advancing the company’s urology portfolio in the U.S. market.

Today, Ambu announces 510(k) regulatory clearance from the U.S. Food & Drug Administration (FDA) for its ureteroscopy solution, consisting of the single-use ureteroscope, aScope™ 5 Uretero, and the full-HD endoscopy system, aBox™ 2.

The aScope™ 5 Uretero is designed to function as an all-purpose endoscope for urologists performing ureteroscopy procedures, both diagnostically and therapeutically. It is developed in collaboration with leading urologists for multifaceted use, versatility and reliability, requiring high-quality imaging, robustness and manoeuvrability.

From development and manufacturing to distribution and sale, Ambu oversees the entire product lifecycle for its full endoscopy portfolio. Back in November 2023, the company obtained CE mark of the new ureteroscopy solution in Europe. Following the FDA clearance, the company will proceed with a controlled market release in the U.S., where the solution will be evaluated in selected healthcare centres. Ambu expects to initiate a full-scale global launch by the end of the 2023/24 financial year.

"As an endourologist, I am excited to work with Ambu’s growing single-use endoscopy portfolio. The quality and performance of Ambu’s current aScope 4 Cysto has been an asset to my practice and the system I work in. I am confident that aScope 5 Uretero will provide similar value. The aScope 5 Uretero incorporates a variety of interesting features, including improved optics, small size and it being the first ureteroscope manufactured with bioplastics. I look forward to testing the clinical performance of aScope 5 Uretero in a variety of endourologic procedures."

DR. MICHAEL PALESE
Mount Sinai, New York, NY, USA

The ureteroscopy solution represents an advancement of Ambu’s urology portfolio in the U.S. market. Building on the success of Ambu’s cystoscopy solution, the aScope 4 Cysto, since 2020, the new ureteroscopy solution reflects a target market expansion of approximately 1 million annual procedures globally.

FUELLING THE TRANSITION TOWARDS SINGLE-USE
Ureteroscopy procedures primarily address kidney stones, strictures or cancer in the upper urinary tract, requiring a thin, flexible endoscope to pass through the urethra and bladder to the ureter. Single-use ureteroscopes remove the necessity for maintenance, due to breakage of the thin scope, and thereby present a strong potential for urologists and health systems to reduce downtime and enhance workflow efficiency.

Furthermore, Ambu’s ureteroscope is the world’s first ureteroscope made with bioplastics - materials derived from a mix of fossil-based and second-generation feedstock, e.g., recycled food waste. As previously communicated, Ambu plans to integrate bioplastics in the handles of its entire fleet of endoscopes by the end of 2024 – as the first and only endoscopic solutions provider in the world.

CEO Britt Meelby Jensen is excited about the U.S. clearance and the inherent prospects of fuelling the transition towards single-use with an expanded urology portfolio:

"This clearance in the U.S. of our new ureteroscopy solution not only demonstrates a market expansion for Ambu; it is a testament to the progressive shift towards single-use solutions within the field of urology. I am confident that our continuous technology advancements will rapidly pave the way for better and more efficient patient care in the future – improving outcomes for patients, physicians and health systems alike."

BRITT MEELBY JENSEN
Chief Executive Officer, Ambu

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Download and read the full press release here.

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.

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