Nutriband Inc. Quarterly Report Highlights Strong Cash Position, and Strategic Progress Toward NDA Filing for AVERSA Fentanyl in 2025

Rhea-AI Summary

Nutriband Inc. (NASDAQ:NTRB) has released its Q2 2024 financial report, highlighting a strong cash position of $6.75 million and strategic progress towards its NDA filing for AVERSA Fentanyl in 2025. The company is expanding its kinesiology tape contract manufacturing through Pocono Pharma, targeting major retailers. Nutriband aims to submit an NDA for AVERSA Fentanyl to the FDA in Q1/Q2 2025, relying on a single phase 1 Human Abuse Potential study. If approved, AVERSA Fentanyl could be the first abuse-deterrent transdermal patch globally, with estimated peak annual sales of $80-$200 million. The company's total assets are valued at $13.63 million, with stockholders' equity at $12.5 million.

Positive

• Strong cash position of $6.75 million to support AVERSA Fentanyl development
• Expansion of kinesiology tape contract manufacturing with major retail partners
• AVERSA Fentanyl NDA submission targeted for Q1/Q2 2025
• Potential peak annual sales of $80-$200 million for AVERSA Fentanyl
• Total assets valued at $13.63 million with $12.5 million in stockholders' equity

Negative

• None.

Insights

Financial Analyst

Nutriband's Q2 report reveals a robust financial position with $6.75 million in cash reserves, important for advancing AVERSA Fentanyl towards NDA submission. The $13.63 million in total assets and $12.5 million in stockholders' equity indicate a healthy balance sheet. The company's strategic focus on contract manufacturing for kinesiology tapes, using penetration pricing, could drive near-term revenue growth. However, investors should note that this strategy might impact margins initially. The projected peak annual sales of $80-$200 million for AVERSA Fentanyl and up to $130 million for AVERSA Buprenorphine present significant long-term revenue potential, but realization depends on successful FDA approval and market penetration.

Medical Research Analyst

The streamlined development pathway for AVERSA Fentanyl is a significant advantage. Relying primarily on a single phase 1 Human Abuse Potential study for NDA submission, without the need for Phase 2 or 3 trials, could substantially reduce time and costs to market. This approach suggests confidence in the product's safety profile and abuse-deterrent properties. If approved, AVERSA Fentanyl's position as the first and only abuse-deterrent transdermal patch globally could be a game-changer in pain management, addressing the critical issue of opioid abuse. The potential expansion to buprenorphine further broadens the platform's applicability, potentially revolutionizing addiction treatment approaches.

Market Research Analyst

Nutriband's strategic expansion into kinesiology tape manufacturing, targeting major brands and retailers, demonstrates a savvy market penetration strategy. This move could provide a stable revenue stream while the company develops its flagship products. The estimated market potential for AVERSA Fentanyl and Buprenorphine is substantial, but investors should consider the competitive landscape and potential regulatory hurdles. The company's focus on abuse-deterrent technology aligns well with current healthcare priorities, potentially giving it a strong market position if approved. However, actual market performance will depend on factors such as pricing, reimbursement policies and adoption rates among healthcare providers.

ORLANDO, FL / ACCESSWIRE / September 4, 2024 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW) has reported its financial results for the second quarter ended July 31, 2024. The Company reported a strong cash position at quarter end, reinforcing its ability to advance the development of its lead product, AVERSA™ Fentanyl, with an NDA submission targeted for the first half of 2025.

Nutriband is expanding its kinesiology tape contract manufacturing services through its Pocono Pharma subsidiary, with a focus on penetration pricing to gain a foothold with some of the industry's largest brands, including KT Tape and Fit For Life Group. Products are rolling out to prominent retail locations nationwide, including Target, Walmart, Walgreens and CVS.

Progress continues on the development of AVERSA Fentanyl, with the Company maintaining its goal of submitting an NDA to the FDA in Q1/Q2 2025. Nutriband recently updated shareholders on its development pathway, emphasizing that the NDA will primarily rely on data from a single phase 1 Human Abuse Potential study. Importantly, no Phase 2 or Phase 3 clinical trials will be required before to submission.

If approved, AVERSA Fentanyl could become the first and only abuse-deterrent transdermal patch available globally. AVERSA Fentanyl is estimated to have the potential to reach peak annual sales of $80-$200 million, according to a market analysis report from Health Advances. AVERSA Buprenorphine, which is the company's second application for AVERSA, is projected to reach peak annual sales of up to $130 million.

As of July 31, 2024, Nutriband's cash reserves stand at $6.75 million, supporting the Company's ongoing development and commercialization efforts for AVERSA Fentanyl. The Company's total assets are valued at $13.63 million, with stockholders' equity amounting to $12.5 million.

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, 2023, filed April 26, 2023, the Forms 10-Q's filed subsequent to the Form 10-K in 2023, 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:

RedChip Companies, Inc.
Email: NTRB@Redchip.com
Phone: 1-407-644-4256
Address:
431 E Horatio Ave, Suite #100
Maitland, FL 32751

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

SOURCE: Nutriband, Inc.

View the original press release on accesswire.com

FAQ

When does Nutriband (NTRB) plan to submit the NDA for AVERSA Fentanyl?

Nutriband plans to submit the New Drug Application (NDA) for AVERSA Fentanyl to the FDA in the first or second quarter of 2025.

What is the estimated peak annual sales potential for Nutriband's (NTRB) AVERSA Fentanyl?

According to a market analysis report from Health Advances, AVERSA Fentanyl is estimated to have the potential to reach peak annual sales of $80-$200 million.

How much cash does Nutriband (NTRB) have as of July 31, 2024?

As of July 31, 2024, Nutriband's cash reserves stand at $6.75 million.

What is unique about Nutriband's (NTRB) AVERSA Fentanyl product?

If approved, AVERSA Fentanyl could become the first and only abuse-deterrent transdermal patch available globally.