Nutriband Issues Letter to Shareholders
Nutriband (NASDAQ: NTRB) has released its 2024 shareholder letter highlighting significant achievements and 2025 outlook. The company reported record Q3 revenue of $645,796, a 51% year-over-year increase. Key developments include advancing their AVERSA™ Fentanyl product, projected to achieve peak annual U.S. sales of $80-200 million, toward commercialization with partner Kindeva Drug Delivery.
The company secured patent approvals in China and Hong Kong, expanding their intellectual property portfolio to 46 countries. Nutriband raised $8.4 million through a private placement and established an exclusive supplier agreement with Fit For Life Group for major fitness brands. The company plans to submit the New Drug Application (NDA) for AVERSA™ Fentanyl in 2025, with potential regulatory approval expected by year-end.
Nutriband (NASDAQ: NTRB) ha pubblicato la sua lettera agli azionisti per il 2024, evidenziando traguardi significativi e le prospettive per il 2025. L'azienda ha registrato un fatturato record nel terzo trimestre di $645,796, un aumento del 51% rispetto all'anno precedente. Tra gli sviluppi chiave c'è l'avanzamento del loro prodotto AVERSA™ Fentanyl, previsto per raggiungere vendite annuali di picco negli Stati Uniti tra $80 e $200 milioni, verso la commercializzazione in collaborazione con Kindeva Drug Delivery.
L'azienda ha ottenuto approvazioni di brevetti in Cina e Hong Kong, ampliando il proprio portafoglio di proprietà intellettuale a 46 paesi. Nutriband ha raccolto $8.4 milioni tramite un collocamento privato e ha stabilito un accordo di fornitura esclusiva con Fit For Life Group per importanti marchi del fitness. L'azienda prevede di presentare la Domanda di Nuovo Farmaco (NDA) per AVERSA™ Fentanyl nel 2025, con un'approvazione normativa potenziale prevista entro la fine dell'anno.
Nutriband (NASDAQ: NTRB) ha lanzado su carta a los accionistas de 2024 destacando logros significativos y perspectivas para 2025. La compañía reportó un ingreso récord en el tercer trimestre de $645,796, un aumento del 51% en comparación con el año anterior. Los desarrollos clave incluyen el avance de su producto AVERSA™ Fentanyl, que se proyecta alcanzará ventas anuales máximas en EE. UU. de entre $80 y $200 millones, hacia la comercialización con su socio Kindeva Drug Delivery.
La compañía aseguró aprobaciones de patentes en China y Hong Kong, expandiendo su portafolio de propiedad intelectual a 46 países. Nutriband recaudó $8.4 millones a través de una colocación privada y estableció un acuerdo de proveedor exclusivo con Fit For Life Group para importantes marcas de fitness. La compañía planea presentar la Solicitud de Nuevo Medicamento (NDA) para AVERSA™ Fentanyl en 2025, con una posible aprobación regulatoria esperada para finales de año.
누트리밴드 (NASDAQ: NTRB)는 2024년 주주편지를 발표하며 주요 성과와 2025년 전망을 강조했습니다. 회사는 3분기 기록 매출 $645,796을 발표하며 전년 대비 51% 증가했습니다. 주요 발전 사항으로는 AVERSA™ 펜타닐 제품이 있으며, 이는 미국에서 연간 최대 판매가 $80~200백만 달러에 이를 것으로 예상되며, 파트너인 킨데바 드러그 딜리버리와 상업화를 향해 나아가고 있습니다.
회사는 중국과 홍콩에서 특허 승인을 확보하여 지적 재산권 포트폴리오를 46개국으로 확대했습니다. 누트리밴드는 개인 배치를 통해 $8.4백만을 모금하고, 주요 피트니스 브랜드에 대한 Fit For Life Group과의 독점 공급 계약을 체결했습니다. 회사는 2025년 AVERSA™ 펜타닐에 대한 신약 신청(NDA)을 제출할 계획이며, 연말까지 규제 승인이 예상됩니다.
Nutriband (NASDAQ: NTRB) a publié sa lettre aux actionnaires pour 2024, mettant en avant des réalisations significatives et les perspectives pour 2025. L'entreprise a annoncé un chiffre d'affaires record pour le troisième trimestre de 645 796 $, soit une augmentation de 51 % par rapport à l'année précédente. Les développements clés incluent l'avancement de leur produit AVERSA™ Fentanyl, qui devrait atteindre des ventes annuelles maximales aux États-Unis de 80 à 200 millions de dollars, en collaboration avec le partenaire Kindeva Drug Delivery.
L'entreprise a obtenu des approbations de brevets en Chine et à Hong Kong, élargissant son portefeuille de propriété intellectuelle à 46 pays. Nutriband a levé 8,4 millions de dollars par le biais d'un placement privé et a établi un accord de fournisseur exclusif avec le groupe Fit For Life pour les grandes marques de fitness. L'entreprise prévoit de soumettre la Demande de Nouveau Médicament (NDA) pour AVERSA™ Fentanyl en 2025, avec une approbation réglementaire potentielle attendue d'ici la fin de l'année.
Nutriband (NASDAQ: NTRB) hat seinen Aktionärsbrief für 2024 veröffentlicht, in dem bedeutende Erfolge und die Aussichten für 2025 hervorgehoben werden. Das Unternehmen meldete einen Rekordumsatz im dritten Quartal von $645,796, was einem Anstieg von 51 % im Jahresvergleich entspricht. Zu den wichtigen Entwicklungen gehört der Fortschritt ihres Produkts AVERSA™ Fentanyl, das voraussichtlich jährliche Spitzenumsätze in den USA zwischen $80 und $200 Millionen erreichen wird, in Zusammenarbeit mit dem Partner Kindeva Drug Delivery.
Das Unternehmen sicherte sich Patenterteilungen in China und Hongkong und erweiterte sein Portfolio an geistigem Eigentum auf 46 Länder. Nutriband brachte $8,4 Millionen durch eine Privatplatzierung ein und etablierte eine exklusive Liefervereinbarung mit der Fit For Life Group für große Fitnessmarken. Das Unternehmen plant, 2025 den Antrag auf Zulassung eines neuen Arzneimittels (NDA) für AVERSA™ Fentanyl einzureichen, wobei eine regulatorische Genehmigung bis Ende des Jahres erwartet wird.
- Record Q3 revenue of $645,796, up 51% year-over-year
- Secured $8.4 million in capital through private placement
- Expanded patent portfolio to 46 countries with new approvals in China and Hong Kong
- AVERSA™ Fentanyl projected peak annual U.S. sales of $80-200 million
- AVERSA Buprenorphine estimated annual revenues of $130 million
- Expanded retail presence to major chains including Target, Walmart, Walgreens, and CVS
- None.
Insights
The shareholder letter reveals substantial financial and operational milestones. Q3 revenue hit $645,796, marking a
The expansion of contract manufacturing partnerships with major retailers (Target, Walmart, Walgreens, CVS) and exclusive supplier agreements with global fitness brands diversifies revenue streams. The company's patent portfolio across 46 countries creates strong barriers to entry and intellectual property monetization opportunities.
AVERSA™ technology's progression toward becoming the first abuse-deterrent opioid transdermal patch represents a breakthrough in addressing the opioid crisis. The simplified regulatory pathway requiring only Phase 1 Human Abuse Potential study, without Phase 2 or 3 trials, accelerates time-to-market. Partnership with Kindeva Drug Delivery, a respected CDMO, adds credibility to the manufacturing process.
The expansion into additional applications like AVERSA™ Buprenorphine demonstrates platform technology potential. The technology's focus on preventing accidental exposure and abuse while maintaining therapeutic efficacy addresses a critical unmet need in pain management, particularly considering the ongoing opioid epidemic.
The company's strategic positioning in the abuse-deterrent pharmaceutical market, coupled with its diversification into consumer health products, creates multiple value drivers. The successful launch of the Mosquito Repellent Patch in Costa Rica, with planned expansion across South and Central America, demonstrates market penetration capabilities.
The combination of proprietary technology (AVERSA™), strong manufacturing partnerships and global patent protection creates a compelling competitive advantage. The potential 2025 regulatory approval timeline and commercial launch preparations suggest near-term catalysts that could significantly impact market valuation, particularly given the company's current market cap of
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 million 1, 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 a51% 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
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
FAQ
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