ORLANDO, Fla., Dec. 31, 2024 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) today announced that CEO Gareth Sheridan has published a letter to shareholders highlighting the company's achievements in 2024 and the outlook for 2025.
Dear Fellow Shareholders,
As we close out 2024, I want to extend my deepest gratitude to you, our loyal shareholders, for your continued trust and support. This year has been one of exceptional progress, strategic execution, and transformative milestones for Nutriband. We remain steadfast in our mission to enhance patient safety through innovative transdermal technologies, with a particular focus on combating the opioid crisis and improving the safety profile of abusable medications through our pioneering AVERSA abuse-deterrent technology. This is not just a technology to combat opioid misuse, but also making sure that adequate treatment is available to the pain management community and instances of accidental exposure, particularly with children, can be drastically reduced.
In 2024, we fortified our position in abuse-deterrent pharmaceutical products, delivered strong revenue growth, and laid the groundwork for pivotal milestones in 2025. Let me take this opportunity to reflect on our achievements and share the path forward.
AVERSA Fentanyl Advances Toward Commercialization
Our lead product, AVERSA Fentanyl, is poised to become the world's first abuse-deterrent opioid transdermal patch. We made significant strides toward commercialization in 2024:
- Successfully advanced development with our partner, Kindeva Drug Delivery, a leading global contract development and manufacturing organization focused on drug-device combination products.
- Completed pivotal validation studies and progressed toward finalizing the commercial manufacturing process for regulatory submission.
- Maintained our New Drug Application (NDA) submission timeline for 2025, underscoring a clear, efficient regulatory path relying on a single Phase 1 Human Abuse Potential study.
- If approved, AVERSA Fentanyl is projected to achieve peak annual U.S. sales of $80 million to $200 million1, demonstrating its significant commercial potential.
Expanding Global Intellectual Property Protection
Our AVERSA technology received continued recognition and protection worldwide:
- Secured patent approvals in China and Hong Kong, extending our international intellectual property portfolio to 46 countries.
- Achieved a U.S. Notice of Allowance for the AVERSA trademark, further solidifying our brand.
These developments strengthen our ability to defend and commercialize AVERSA globally, setting the stage for Nutriband to become the leader in abuse-deterrent technology.
Record Financial Performance
In 2024, we delivered record financial results, driven by strong growth in our contract manufacturing business, Pocono Pharma:
- Q3 revenue reached a record $645,796, reflecting a 51% year-over-year increase.
- Expanded partnerships with major retail brands, with Pocono-manufactured products now available at Target, Walmart, Walgreens, and CVS.
- Strengthened our balance sheet with $8.4 million in capital from a successful non brokered private placement, leaving us well-positioned to fund the final development stages of AVERSA Fentanyl.
Strengthening Manufacturing and Strategic Partnerships
We expanded our reach in kinesiology tape manufacturing and grew our portfolio of high-profile clients:
- Entered into an exclusive supplier agreement with Fit For Life Group, a leading brand licensee for Adidas, Reebok, and New Balance.
- Our Active Intelligence subsidiary delivered strong growth, showcasing its manufacturing excellence and innovation for top global fitness brands.
- Announced the launch of our Mosquito Repellent Patch in Costa Rica following approval from the Ministry of Health, with plans to expand into South and Central America.
These milestones not only diversify our revenue streams but also solidify Nutriband's reputation as a trusted manufacturing partner for innovative products.
A Transformative Year Ahead
Looking forward to 2025, Nutriband is laser-focused on achieving regulatory and commercial success for AVERSA Fentanyl while driving continued growth across our diversified operations.
The highlight of 2025 will be the submission of the AVERSA Fentanyl NDA. Our submission will rely on pivotal data from the Phase 1 Human Abuse Potential study and laboratory manipulation studies, aligning with FDA guidance.
With no need for Phase 2 or Phase 3 clinical trials, we expect an expedited review process, potentially positioning Nutriband to achieve regulatory approval before the end of 2025.
Commercial Preparation for AVERSA Fentanyl
With the potential for regulatory approval in 2025, are actively preparing for the commercialization of AVERSA Fentanyl by scaling up our partnership with Kindeva Drug Delivery to ensure seamless commercial manufacturing capabilities. At the same time, we are pursuing strategic licensing and distribution agreements internationally to maximize market penetration and expand our global reach.
Expansion of the AVERSA Product Pipeline
Beyond AVERSA Fentanyl, we are advancing additional candidates for AVERSA technology, including AVERSA Buprenorphine and other high-potential transdermal applications. AVERSA Buprenorphine represents an additional revenue stream with estimated annual revenues of $130 million.
Growth in Contract Manufacturing
Pocono Pharma and Active Intelligence will continue to drive revenue growth in 2025 by expanding our partnerships and delivering exceptional manufacturing solutions. With increased demand for kinesiology and specialized consumer products, we aim to further penetrate major retail markets worldwide.
Strong Financial Foundation
We enter 2025 with a robust financial position, including significant cash reserves to hit major milestones for our NDA submission and prepare for commercial launch. Our focus remains on delivering shareholder value while maintaining fiscal discipline.
A Shared Vision for a Safer Future
Nutriband is on the brink of a transformative period in its history. With the potential to bring the first-ever abuse-deterrent transdermal opioid patch to market, we are positioned to save lives, improve patient safety, and deliver long-term shareholder value. The opioid crisis remains a critical public health challenge, and our AVERSA technology represents a groundbreaking solution with the potential for global impact.
Your trust and support have been instrumental in getting us to this point. As we enter 2025, I assure you that our team remains laser-focused on achieving our goals, delivering results, and creating a safer future for patients and communities worldwide. We have never been closer than we are now in terms of revolutionizing the safety profile of easily abused drugs such as opioids.
I invite all shareholders to stay connected through our email alerts at www.Nutriband.com for updates on our progress. Together, we are building something extraordinary and something I strongly believe will become an industry standard.
Thank you for being part of this journey.
Sincerely,
Gareth Sheridan
CEO, Nutriband Inc.
1 Health Advances market analysis report 2022
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, 2024, filed May 1, 2024, the Forms 10-Q's filed subsequent to the Form 10-K in 2024, 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.
For more information, contact:
Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
NTRB@Redchip.com
Nutriband Inc.
1-407-377-6695
info@nutriband.com
