NEXGEL and STADA Partner to Launch Leading European DAO Enzyme Supplement, Histasolv, in North America

Rhea-AI Summary

NEXGEL has partnered with STADA Arzneimittel AG to launch Histasolv, a leading Diamine Oxidase (DAO) enzyme supplement, in North America. Histasolv, known as DAOSIN in Europe, generates over $10 million annually in Europe, treating histamine food intolerance. NEXGEL will start direct-to-consumer sales in Q3 2024. The product's unique formulation ensures high potency, addressing migraines, gut issues, and skin conditions caused by histamine intolerance. STADA, a top European healthcare company, aims to strengthen its North American presence through this partnership. Both companies express confidence in the collaborative potential and future expansion opportunities.

Positive

• Partnership with STADA, a top European healthcare leader, enhances NEXGEL's credibility.
• Histasolv generates over $10 million annually in Europe, indicating strong market potential.
• Direct-to-consumer sales starting in Q3 2024 promises new revenue streams.
• Unique product formulation ensures high potency and effectiveness, differentiating it from competitors.
• Potential for future expansion with STADA, indicating long-term growth opportunities.

Negative

• initial market presence as the product launch is confined to direct-to-consumer sales.
• Dependence on STADA for product supply and market success in North America.
• Uncertainty about consumer acceptance and competition in the North American market.

Insights

Market Research Analyst

The introduction of Histasolv into the North American market represents a significant step for both NEXGEL and STADA. For retail investors, understanding market dynamics in the over-the-counter (OTC) health supplement sector is key. North America has a growing segment of consumers seeking solutions for food intolerances and digestive health issues, providing a fertile ground for new product launches.

Histasolv’s performance in Europe, where it leads with $10 million in annual revenue, indicates a strong consumer demand and proven efficacy. This established success reduces the risk associated with its introduction in a new market. However, competition in the North American digestive health supplement market is fierce, with numerous established brands and products. The unique selling points of Histasolv, such as its stable and potent formulation, should help differentiate it. Investors should consider the potential for rapid market penetration given the robust distribution network and brand recognition STADA brings.

In the short term, the partnership offers an immediate revenue stream and brand diversification for NEXGEL. Long-term benefits hinge on successful consumer adoption and potential for product expansion. It’s also important to consider the overall growth strategy and how this fits within NEXGEL’s broader product portfolio.

Financial Analyst

From a financial perspective, NEXGEL's partnership with STADA to launch Histasolv in North America is promising. The direct-to-consumer sales model set to commence in the third quarter of 2024 aligns with current market trends favoring convenience and direct access. Investors should note the absence of any disclosed financial terms of the partnership, which could affect profit margins and revenue sharing.

With the European market generating over $10 million annually for this product, the North American market could present a similar or even greater revenue opportunity if penetration is successful. However, the cost of marketing and establishing brand presence in a new market should not be underestimated. Initial costs might impact short-term profitability but could lead to substantial long-term gains if Histasolv gains traction.

Investors should monitor NEXGEL’s upcoming financial reports for early indicators of market reception and sales growth. Additionally, the scalability of this partnership to include more products should be watched, as it could signify a deeper and lucrative alliance.

Medical Research Analyst

The medical aspect of Histasolv’s entry into the North American market is noteworthy. Histamine intolerance can cause various health issues such as migraines, digestive problems and skin conditions. Histasolv’s unique formulation, which allows it to deliver the DAO enzyme effectively to the lower intestine, addresses these issues in a way existing supplements might not.

This product’s success in Europe provides a strong validation of its effectiveness, which could translate well to the North American market. However, it will be important to see if clinical data supporting its benefits in the European context holds in the more diverse North American population.

For investors, the key will be to observe consumer feedback and clinical endorsements that could bolster the product’s credibility and adoption. Any positive results from local studies or endorsements from North American healthcare professionals could significantly enhance its marketability and sales potential.

LANGHORNE, Pa., June 11, 2024 (GLOBE NEWSWIRE) -- NEXGEL, Inc. (“NEXGEL” or the “Company”) (NASDAQ: NXGL), a leading provider of medical and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogels for healthcare and consumer applications, today announced the first product to be distributed under its recently formed partnership with STADA Arzneimittel AG (“STADA”), a European leader in consumer health. Histasolv^®, sold as DAOSIN^® in Europe, is Europe’s number one selling Diamine Oxidase (‘DAO’) enzyme supplement generating well over $10 million in annualized revenue to treat histamine food intolerance, which can cause migraines and headaches, gut issues, and skin conditions. Headquartered in Germany, STADA is one of the fastest growing top ten companies in consumer healthcare and the fourth largest manufacturer in this segment in Europe.

Adam Levy, CEO of NEXGEL, commented, “After several months of collaboration and planning, we are pleased to announce our distribution of Histasolv, the first product to be released through our partnership with the well-recognized European healthcare leader, STADA. Histasolv is one of STADA’s leading consumer products in Europe and stands out as the preferred choice among consumers seeking effective and safe histamine management due to its superior ability to reduce symptoms of histamine intolerance. We always strive to offer products that have the potential to disrupt the traditional consumer health industry with innovative formulation and technology, and Histasolv fits perfectly within our business model.”

Histasolv’s innovative formulation and packaging strongly differentiate it from competing products in the market today. Due to its unique formulation, Histasolv can withstand the upper intestinal tract to deliver the highest potency of DAO, an important digestive enzyme in the body, to the lower intestine where it is needed. Additionally, each tablet is Individually sealed and preserved with nitrogen in a blister pack and secured in a foil pouch, enhancing stability and ensuring potency. NEXGEL will begin selling Histasolv direct-to-consumer in the third quarter of 2024.

STADA Chief Business Officer USA Patrick Genestin, stated, “We are delighted to take this important step of expansion into North America. This partnership further strengthens STADA´s role as a partner of choice in consumer healthcare. Our strategy of focusing on strong local hero brands in Europe provides a rich assortment of appealing consumer products that are available for licensing. With NEXGEL, we are confident we have found a partner with the right strategy and experience and we can imagine expanding our co-operation in the future.”

Volker Sydow, STADA EVP for Consumer Healthcare, stated, “As Europe's No. 1 DAO enzyme supplement, we are proud to bring our histamine expertise to the North American market, in line with our corporate purpose of Caring for People's Health as a trusted partner. We are particularly pleased to have found such a strong and committed partner in NEXGEL to help us realize our growth ambitions in the North American food intolerance market.”

About NEXGEL, Inc.

NEXGEL is a leading provider of healthcare, beauty, and over-the-counter (OTC) products including ultra-gentle, high-water-content hydrogels. Based in Langhorne, Pa., the Company has developed and manufactured electron-beam, cross-linked hydrogels for over two decades. NEXGEL brands include Silverseal^®, Hexagels^®, Turfguard^®, Kenkoderm^® and Silly George^®. Additionally, NEXGEL has strategic contract manufacturing relationships with leading consumer healthcare companies.

About STADA Arzneimittel AG

STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2022, STADA achieved group sales of EUR 3,797.2 million and reported earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 884.7 million. As of 31 December 2022, STADA employed 13,183 people worldwide.

Forward-Looking Statement

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (which Sections were adopted as part of the Private Securities Litigation Reform Act of 1995). Statements preceded by, followed by or that otherwise include the words “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “project,” “prospects,” “outlook,” and similar words or expressions, or future or conditional verbs, such as “will,” “should,” “would,” “may,” and “could,” are generally forward-looking in nature and not historical facts. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the Company's actual results, performance, or achievements to be materially different from any anticipated results, performance, or achievements for many reasons. The Company disclaims any intention to, and undertakes no obligation to, revise any forward-looking statements, whether as a result of new information, a future event, or otherwise. For additional risks and uncertainties that could impact the Company's forward-looking statements, please see the Company's Annual Report on Form 10-K for the year ended December 31, 2022, including but not limited to the discussion under “Risk Factors” therein, which the Company filed with the SEC and which may be viewed at http://www.sec.gov/.

Investor Contact:
Valter Pinto, Managing Director
KCSA Strategic Communications
212.896.1254
valter@kcsa.com

FAQ

What is Histasolv?

Histasolv is a Diamine Oxidase (DAO) enzyme supplement used to treat histamine food intolerance.

When will NEXGEL start selling Histasolv in North America?

NEXGEL plans to start direct-to-consumer sales of Histasolv in North America in the third quarter of 2024.

How much revenue does Histasolv generate in Europe?

Histasolv, known as DAOSIN in Europe, generates over $10 million annually.

What are the benefits of Histasolv's formulation?

Histasolv's unique formulation ensures high potency and effectiveness by delivering DAO to the lower intestine.

Who is STADA?

STADA is a leading European healthcare company, and the fourth largest manufacturer in consumer healthcare in Europe.

Why is the partnership between NEXGEL and STADA important?

The partnership allows NEXGEL to introduce a successful European product into the North American market, potentially boosting revenue and market presence.

What market does Histasolv target?

Histasolv targets individuals with histamine food intolerance, addressing symptoms like migraines, gut issues, and skin conditions.