Investor Relations

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.

Today, Ambu announces preliminary results for the first half-year of 2023/24 and adjusts its expectations for the full financial year 2023/24. As a result of solid financial performance year-to-date and expected continued momentum in revenue growth, Ambu increases its financial outlook for organic revenue growth to 10-12% (previously 7-10%) and for EBIT margin before special items to 10-12% (previously 8-10%).  
 
In addition, the company raises its free cash flow expectations to DKK +370m (previously DKK +270m). 

The raised outlook is mainly driven by better-than-expected outcomes of contract negotiations in Anaesthesia & Patient Monitoring, strong organic growth in Endoscopy Solutions and continued strengthened operational leverage.  
 

PRELIMINARY AND UNAUDITED FINANCIAL HIGHLIGHTS FOR Q2 2023/24
Last year’s comparative figures are stated in brackets.

• Revenue was DKK 1,367m (DKK 1,189m), with organic revenue growth of 15.5% (4.2%). Reported growth for the quarter was 15.0% (6.0%). Year-to-date, organic growth was 14.9% (4.0%), with reported growth of 12.9% (7.8%).
• EBIT before special items was DKK 194m (DKK 46m) and year-to-date was DKK 320m (DKK 114m). EBIT margin before special items was 14.2% (3.9%) and ended year-to-date at 12.2% (4.9%). The strengthened EBIT margin was mainly driven by organic growth in revenue and operational leverage on OPEX, although partially offset by increased investments in resources to drive organic growth. The investments in resources are expected to increase for the remaining financial year. 
• Free cash flow was DKK 128m (DKK 21m), bringing the year-to-date free cash flow to a total of DKK 263m (DKK -153m). 

REVISED OUTLOOK FOR THE FISCAL YEAR 2023/24
Driven by the development in the first half of the 2023/24 financial year, Ambu’s 2023/24 financial outlook is set as per below:

                         
In addition, Ambu’s free cash flow expectations are set for DKK +370m (previously DKK +270m), while the expectation for Endoscopy Solutions organic revenue growth is maintained at ~15%.

Ambu will publish its full Q2 and half-year 2023/24 interim results, as previously announced, on 14 May 2024.


View the PDF version of the company announcement here.
 

Ambu’s aScope™ Gastro Large, with its 4.2 mm working channel and endoscope handle made with bioplastics, expands the company’s single-use portfolio for upper gastroenterology (GI) procedures. The expanded portfolio allows physicians to address an extended range of needs across the ICU, OR and endoscopy suite.

Today, Ambu announces 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) of its therapeutic gastroscope solution, Ambu® aScope™ Gastro Large and Ambu® aBox™ 2.

The clearance signifies an extended solution offering for surgeons and gastroenterologists performing upper GI procedures. With the expanded endoscope portfolio – consisting of the aScope™ Gastro and the aScope™ Gastro Large physicians are now equipped to address a wider range of needs in various hospital settings, covering the operating room (OR), the intensive care unit (ICU) and the endoscopy unit. Globally, the aScope™ Gastro Large targets 1.5 million annual procedures, while the aScope™ Gastro is expected to meet needs within a market of 2 million annual procedures.

The aScope™ Gastro Large is, with its 4.2 mm working channel and powerful suction performance, designed to addresses acute therapeutic procedures in the ICU, such as bleed management and food impaction, as well as direct endoscopic necrosectomy and stenting in the endoscopy unit. Compared to the industry-leading 3.7 mm therapeutic gastroscopes on the market, the working channel of the aScope™ Gastro Large delivers significantly higher suction performance1, both with and without tools, thereby constituting a valuable tool for managing acute upper GI bleeding. Complimentarily, the aScope™ Gastro targets procedures outside of the endoscopy unit, such as surgical gastroscopies in the OR and bedside procedures in the ICU.

I look forward to utilizing the innovative aScope Gastro Large single-use gastroscope technology for interventions that require superior suction. The gastroscope’s 4.2 mm working channel will facilitate clot and blood clearance and removal of necrotic debris during direct endoscopic necrosectomy. Operationally, the immediate availability of a disposable scope to be utilized in urgent cases in various locations without the need for reprocessing will improve downstream efficiencies and minimize barriers to providing urgent endoscopic care to our patients.

MARK A. GROMSKI, MD, FASGE²
Director, Advanced Endoscopy, Indiana University School of Medicine

TWO WORLD’S FIRSTS: 4.2 MM WORKING CHANNEL AND HANDLE MADE WITH BIOPLASTICS

The aScope™ Gastro Large represents two world firsts within the endoscopy market. Not only is it the first single-use therapeutic gastroscope with a 4.2 mm working channel; it is also the world’s first endoscope made with bioplastics.

The bioplastic materials in the gastroscope handle are derived from a mix of fossil based and second-generation feedstock, e.g., recycled food waste, ensuring that it has a lower carbon footprint. The large gastroscope is the first of Ambu’s fleet of endoscopes to be manufactured with bioplastics and thus represents an important step forward in the company’s commitment to integrating bioplastics in all future endoscope handles by the end of 2024.

Ambu announced European regulatory clearance (CE mark) of the aScope™ Gastro Large in September 2023 and now extends its commercialisation to North America. CEO Britt Meelby Jensen is excited about the FDA clearance and to bringing an expanded and advanced gastroscopy portfolio to customers in Ambu’s biggest market:

Our therapeutic gastroscope solution is a vital step forward in our gastroenterology journey. Not only does it expand and strengthen our gastroscope portfolio, empowering U.S. physicians with two complimentary high-performance solutions for upper GI procedures targeting diverse clinical needs; it also marks an important way forward for hospitals and GI professionals wishing to alleviate the strain of reprocessing, optimise workflow and bring faster care to patients.

BRITT MEELBY JENSEN
Chief Executive Officer, Ambu

¹ Suction data based on bench top test with 10 Fr bipolar probe.
² Dr. Gromski is a paid consultant of Ambu A/S. He has not been compensated for his quote in this press release