Nutriband CEO Publishes Letter to Shareholders

Rhea-AI Summary

Nutriband CEO Gareth Sheridan released a shareholder letter highlighting the company's achievements in 2024 and outlook for 2025. The company is developing AVERSA technology, aimed at creating the world's first abuse-deterrent transdermal drug delivery system.

In partnership with Kindeva Drug Delivery, Nutriband is developing AVERSA Fentanyl, projected to reach peak annual sales of $80M-$200M. Their second product, AVERSA Buprenorphine, is estimated to achieve $70M-$130M in peak annual sales. The company secured $8.4M through private placement in April 2024 and expanded its patent portfolio to 46 countries.

Key 2025 objectives include:

• Conducting Human Abuse Liability clinical trials for AVERSA Fentanyl
• Filing an Investigational New Drug application with FDA
• Exploring international partnerships
• Growing revenue through Pocono Pharma subsidiary's kinesiology tape manufacturing

Positive

• AVERSA Fentanyl projected peak annual sales of $80M-$200M
• AVERSA Buprenorphine projected peak annual sales of $70M-$130M
• Secured $8.4M funding in April 2024 through non-brokered private placement
• Strong revenue reported from Pocono Pharma subsidiary
• Expanded patent portfolio to 46 countries including China, Hong Kong, and Macao
• Formalized exclusive partnership with Kindeva Drug Delivery with shared development costs
• Confirmed viability of high profit margins for AVERSA technology integration

Negative

• Still in pre-clinical phase, pending IND filing and clinical trials
• Requires significant regulatory approvals including FDA NDA filing
• Dependent on successful completion of Human Abuse Liability clinical trial
• Heavy reliance on single partnership with Kindeva Drug Delivery

Insights

Pharmaceutical Industry Expert

Nutriband advances AVERSA abuse-deterrent technology toward commercialization with $8.4M funding and Kindeva partnership, targeting NDA for potential $80M-$200M market.

Nutriband's shareholder letter reveals substantial progress in commercializing their AVERSA technology, positioned to become the first abuse-deterrent technology in the transdermal space. The company has transitioned from feasibility to commercial development for AVERSA Fentanyl, their lead candidate developed with Kindeva Drug Delivery. This strategic progression significantly improves their regulatory timeline toward an eventual NDA filing.

The advancement to pivotal Human Abuse Liability clinical trials in 2025 represents a critical regulatory milestone. This specialized trial type is specifically required for abuse-deterrent formulations and will generate the essential data package needed for FDA approval. The company has also confirmed commercial manufacturing viability with high margins typical of NDA pharmaceutical products, addressing a crucial feasibility question.

Their expanded intellectual property portfolio now covers 46 countries globally, including recent approvals in China and its territories. This robust patent protection enhances both their market exclusivity and potential licensing opportunities as they approach commercialization.

The formalized exclusive partnership with Kindeva demonstrates external validation from an established transdermal drug delivery company. This relationship provides specialized manufacturing expertise critical for transdermal products, which have unique production challenges compared to conventional dosage forms.

Financial Analyst

Nutriband secures $8.4M funding, finalizes Kindeva partnership, and projects $150-330M combined peak sales potential for its abuse-deterrent transdermal drug portfolio.

Nutriband's successful $8.4M capital raise through a non-brokered private placement primarily with existing shareholders demonstrates strong investor confidence while minimizing dilution - a key priority highlighted by management. This funding strengthens their position as they advance toward capital-intensive clinical trials in 2025.

The market potential estimates are substantial, with AVERSA Fentanyl projected at $80M-$200M peak annual sales and AVERSA Buprenorphine at $70M-$130M. These projections reflect the significant unmet need in pain management for safer opioid delivery systems with abuse-deterrent properties.

The formalized exclusive product development partnership with Kindeva represents a critical business milestone, structuring shared development costs in exchange for milestone payments. This arrangement helps Nutriband manage cash burn while leveraging Kindeva's specialized manufacturing expertise.

Revenue diversification through their Pocono Pharma subsidiary provides financial stability during the development phase. Management projects record revenue from this division in 2025 through their expanded manufacturing collaboration with KT Tape, the market leader in kinesiology tape.

The expanded global patent portfolio covering 46 countries positions Nutriband for potential international licensing opportunities as they approach key regulatory milestones, creating multiple potential revenue streams beyond direct commercialization in their primary US market.

ORLANDO, Fla., April 30, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW) today announced that CEO Gareth Sheridan has published a letter to shareholders providing insights on achievements and milestones through 2024 and the potential outlook for 2025. The full text of the letter is below.

Dear Shareholders,

Following the filing of our annual report as we wrap up a successful year packed with milestones and advances towards the commercialization of our AVERSA technology, the entire team at Nutriband would like to extend our warmest appreciation to all of you for your continued support throughout 2024 and into 2025.

Many of you have been with us from the beginning and many more joined our mission to change the pharmaceutical industry for the better by developing our Aversa technology designed to improve the safety of easily abused transdermal drugs, such as pain medications, while making them available to patients who need them.   Pain patients have been struggling with inadequate care for too long, and they deserve to be able to access the medication they need. Aversa gives them this access. Today we are on track to be the world’s first and only abuse deterrent technology in the transdermal space targeting abusable medications such as fentanyl and buprenorphine.

Nutriband is primarily focused on working with our partner Kindeva Drug Delivery, a leading global contract development and manufacturing organization focused on drug-device combination products, to develop our lead product, AVERSA™ Fentanyl, which incorporates Nutriband’s AVERSA™ abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch.

AVERSA Fentanyl has the potential to become the world’s first opioid pain patch with abuse deterrent properties and is estimated to potentially reach peak annual sales of $80M - $200M. In addition, AVERSA Buprenorphine, our next candidate for AVERSA is projected to reach peak annual sales of $70M - $130M. Nutriband recently performed an extensive evaluation of the commercial cost of goods of incorporating the Aversa technology into existing FDA-approved transdermal patches and have confirmed the viability of achieving high margins that are typically found in NDA pharmaceutical products.

This past year we have made significant strides in the development and scale-up of the manufacturing process to bring the AVERSA technology closer towards commercialization. This has involved the development and refinement of our proprietary technology for commercial scale manufacturability as well as the establishment of the commercial supply chain and validation of the analytical methods required to meet FDA regulatory standards for a pharmaceutical product.

The new year has already been highlighted by a significant milestone with our partner Kindeva Drug Delivery to formalize our exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments. It solidifies a transition to commercial scale development for AVERSA Fentanyl. We have confidently shifted our focus from feasibility towards commercial development in support of an NDA filing and commercialization.   This was a very strong show of support from our partner Kindeva which also allowed us to reduce the impact of dilution to our existing shareholders which I stress has been and will remain a core focus of the company. This was evident through our raise of $8.4M USD in April 2024 in a non-brokered private placement primarily through existing shareholders.

In addition, we continued to further expand the worldwide intellectual property portfolio for our Aversa™ abuse deterrent technology, with approvals in China and its territories, Hong Kong and Macao, and a new patent recently allowed in the United States. This improves our position to bring our leading abuse deterrent platform to market and we are now patented in 46 countries around the world. While initially concentrating on the US market, the unmet medical need for adequate pain management is a global problem, and our goal is to make AVERSA a global solution strategically targeting all major medical markets in the world.

Our 2025 goals are ambitious yet achievable, focused on getting into the clinic to evaluate our lead product, Aversa Fentanyl, in a pivotal Human Abuse Liability (HAL) clinical trial to support an NDA filing. This involves manufacturing clinical supplies using a commercial scale process and filing an Investigational New Drug application with the FDA. We are also excited to explore new potential partnerships, internationally for our AVERSA intellectual property and will be turning our focus to potential licensing and partnership opportunities as we near closer to filing our NDA with the FDA.

Financially, the team is excited by strong revenue in our Pocono Pharma subsidiary for our kinesiology tape contract manufacturing services. We strongly believe that 2025 is shaping up to be our best year on record at Pocono Pharma due to our expanding manufacturing collaboration with KT Tape, the world leader in kinesiology tape.

If you haven’t already taken a moment to sign up for our email alerts, be sure to do so by visiting our website: www.Nutriband.com. Signing up will ensure that you receive the latest news and announcements as they become available.

Your continued support and belief in our vision have been pivotal to our reaching these milestones and others as we forge ahead. We remain committed to delivering innovative solutions and generating value for our shareholders. Thank you for your trust, confidence and investment in Nutriband Inc.

Sincerely,

Gareth Sheridan

CEO, Nutriband Inc.

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband's AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company's website is www.nutriband.com. Any material contained in or derived from the Company's websites or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘'believes," "anticipates," "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company's ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Form 10-K for the year ended January 31, 2025, filed April 28, 2025, the Forms 10-Q’s filed subsequent to the Form 10-K in 2025, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contact Information:

Nutriband Inc.
Phone: 407-377-6695
Email: info@nutriband.com

SOURCE: Nutriband Inc.

Photos accompanying this announcement are available at: 
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FAQ

What is Nutriband's (NTRB) AVERSA Fentanyl projected revenue potential?

According to the 2025 shareholder letter, AVERSA Fentanyl is projected to reach peak annual sales of $80M - $200M as the world's first opioid pain patch with abuse deterrent properties.

How many countries has Nutriband (NTRB) secured patents for AVERSA technology in 2024?

Nutriband has secured patents for its AVERSA abuse deterrent technology in 46 countries worldwide, including recent approvals in China, Hong Kong, and Macao, plus a new patent in the United States.

What is the funding status of Nutriband (NTRB) as of April 2024?

Nutriband raised $8.4M USD in April 2024 through a non-brokered private placement, primarily from existing shareholders, minimizing dilution impact.

What are Nutriband's (NTRB) main development goals for 2025?

Nutriband aims to conduct a pivotal Human Abuse Liability (HAL) clinical trial for AVERSA Fentanyl, manufacture clinical supplies at commercial scale, and file an Investigational New Drug application with the FDA.

What is the market potential for Nutriband's (NTRB) AVERSA Buprenorphine product?

AVERSA Buprenorphine, Nutriband's second candidate, is projected to achieve peak annual sales of $70M - $130M according to the shareholder letter.

What partnership did Nutriband (NTRB) establish with Kindeva Drug Delivery in 2025?

Nutriband formalized an exclusive product development partnership with Kindeva Drug Delivery, involving shared development costs in exchange for milestone payments, focusing on commercial scale development of AVERSA Fentanyl.