Next Biomedical seeks IPO…knocks on global GI mkt

Signed a global licensing agreement with Medtronic…generates sales in the US and Europe

CEO Don-Haeng Lee develops a GI endoscopic hemostasis system based on his professor background

Next Biomedical will seek KOSDAQ listing in August based on its achievements in the GI field.

 

The company has been collaborating with the global company Medtronic to expand into the endoscopic hemostatic agent market with its flagship product.

 

Based on the revenue growth, the company plans to establish the drug as a standard-of-care in the global market.

 

Don-Haeng Lee, CEO of Next Biomedical, is making a presentation

Established in 2014, Next Biomedical is an innovative bio-solution company that develops therapeutic materials based on its polymer and drug delivery system technologies.

 

Its main products include an endoscopic hemostatic powder (Nexpowder), an endovascular embolization microsphere (Nexsphere), and an arthritis pain embolization treatment (Nexsphere-F).

 

Of these, the product that generates significant sales is the endoscopic hemostatic powder Nexpowder, which is a powder-type hemostatic treatment that can be used through endoscopes to hemorrhage bleeding sites and prevent rebleeding in the event of gastrointestinal bleeding.

 

In particular, Next Biomedical signed a global licensing agreement (excluding Korea, Japan, and Greater China) with Medtronic in 2020 to sell its products in 29 countries including the United States, Canada, and Europe.

 

The company's prominence in the digestive field can be attributed to CEO Lee's background as a professor of gastroenterology at Inha University Hospital.

 

Based on Lee’s clinical experience, the company was able to build a consortium of academic and university hospital collaborations and secure a network of key stakeholders in the GI field in Korea and abroad.

 

"The rise in endoscopic procedures has also led to the rise in GI bleeding amongst patients, rendering hemostasis and rebleeding prevention an important task for all surgeons including gastroenterologists,” said Lee.

 

"After feeling the need while performing endoscopic procedures in the field, we developed a product, which is being exported to the US and Europe." The company has succeeded in rapidly commercializing the finished product of the therapeutic material in Korea and abroad, which has shown results in terms of sales and exports.

 

Excerpt from Next Biomedical

Last year, Next Biomedical posted sales of KRW 4.8 billion, which was nearly double the KRW 2.7 billion it had posted in 2022.

 

In Q1 this year, sales were KRW 2.3 billion and are expected to exceed KRW 10 billion.

 

However, the company is still recording an operating loss due to an increase in SG&A expenses caused by the increase in R&D expenses.

 

However, this is expected to turn into a profit after the IPO, supported by the growth in overseas sales in the U.S.

 

and Europe, which accounted for 88% of sales last year.

 

"We estimate sales of about KRW 12 billion this year and consider the operating profit break-even point to be KRW 15 billion,” said Lee.

 

"We don't have much cost burden because Dong-A ST is in charge of sales and marketing in Korea and Medtronic is in charge overseas, so we think we will able to record a surplus next year." Will seek to enter the U.S.

 

guidelines as a standard of care...is conducting post-marketing clinical trials In particular, the company is conducting post-marketing clinical trials to enter the endoscopic hemostasis guidelines as a standard of care with its Nexpowder.

 

It plans to build clinical evidence with 278 patients in 10 hospitals in the U.S., Canada, and Europe.

 

Don-Haeng Lee, CEO of Next Biomedical

The trial is being led by Dr.

 

Loren Laine, Past President of the American Gastroenterological Association (AGA) and Professor of Medicine at Yale University School of Medicine, and sponsored by Medtronic.

 

The company believes the number of patients in the trial is sufficient to build evidence for its use as a hemostatic agent after endoscopic bleeding.

 

"We aim to be listed as a standard of care by utilizing the clinical evidence obtained from the clinical trial,” said Lee.

 

"If the guidelines include the use of Nexpowder as a first-line treatment, the demand for the product is expected to increase significantly due to its differentiated competitiveness." In addition, the company is focusing on occupying the market with Nexsphere-F, a fast-resorbable hydrophilic gelatin-based embolic microsphere for endovascular embolization.

 

The drug reduces pain without side effects by embolizing abnormal blood vessels that cause arthritis pain with fast-acting microspheres that break down within a short period of time (2 to 6 hours).

 

Post-marketing clinical trials are already underway for the drug in Korea for a new health technology application, and post-marketing clinical trials are also soon to begin in Europe.

 

In addition, the company recently completed filing an Investigational Device Exemption application to the U.S.

 

FDA to confirm the efficacy and safety of Nexsphere-F, with plans to receive approval by 2026.

 

"Based on our rapid product commercialization experience and abundant clinical evidence, we will take the initiative to open and preoccupy new markets by listing all our products as the global standard of care,” said Lee.

 

“We will successfully enter the US market by completing the ongoing clinical trials and KOSDAQ listing."