Nutriband Inc. (NASDAQ: NTRB) Solution To Fentanyl Abuse Could Translate To $200 Million In Peak Revenue

Nutriband Inc. (NASDAQ:NTRB) is a pharmaceutical company with a specific focus on developing a portfolio of transdermal pharmaceutical products. The company's lead product under development is AVERSA Trademark Fentanyl, which is on track to becoming the first-ever abuse-deterrent transdermal fentanyl patch. AVERSA Fentanyl is currently pursuing a 505(b)(2) registration pathway, which should make it eligible for a more expedited review.

For context, AVERSA is Nutriband's proprietary technology that can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with the potential for abuse, like opioids. What makes AVERSA unique is its aversive agent coating, which leverages taste aversion to deter oral abuse and accidental exposure to transdermal opioid patch products.

More than 70% of fentanyl patch abusers choose oral routes to abuse, so taste aversion addresses primary routes of abuse. That means AVERSA 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.

In one of the company's recent major corporate milestones, Nutriband announced that it had received notification that its patent had been granted in Macao, which protects its AVERSA abuse-deterrent transdermal technology. The technology is now covered by a broad international intellectual property portfolio with patents issued in 46 countries, including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia, as well as two regions of China: Hong Kong and Macao.

Interestingly, the company hasn't been structured to follow the typical biotech standard when it comes to time and cost. The company already has two revenue-generating subsidiaries, 4P Therapeutics and Pocono Pharmaceutical, along with Active Intelligence, which specializes in sports recovery products. Nutriband's revenues keep its development burn at a minimum.

The company also owns its manufacturing and clinical development capabilities, which significantly reduces its costs for AVERSA and other technologies. Most notably, Nutriband partnered with Kindeva Drug Delivery to develop AVERSA Fentanyl, which combines Nutriband's AVERSA abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch. Kindeva Drug Delivery is a leading global contract development and manufacturing organization (CDMO) that has a rich history in pharmaceutical innovation and manufactures millions of transdermal patches distributed worldwide.

This strong partnership for AVERSA Fentanyl's commercial development has led to significant progress in the abuse-deterrent patch's development and manufacturing. Recently the two companies revised their agreement to formalize their exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments.

At the same time, Nutriband revealed that it had signed an Associate Partnership agreement with Charlotte FC, which would be instrumental in helping build visibility for its brands, such as AI Tape. Management noted, "We are very excited to partner with an organization such as Charlotte FC as an Associate Partner. Manufacturing many of our products locally in the Charlotte region through our Pocono subsidiary makes this relationship special.''

AVERSA's addressable market is huge, depending on how you look at it. For instance, accidental fentanyl misuse is a growing problem, as illustrated by a recent report that revealed there had been 32 cases of accidental fentanyl exposure, which occurred, resulting in 12 deaths and dozens of hospitalizations, mostly involving young children. This is where the technology comes into play, as it significantly reduces the likelihood of accidental exposure to fentanyl for children.

Furthermore, AVERSA Fentanyl is well aligned with the FDA's Opioids Action Plan mission to expand access to abuse-deterrent formulations (ADFs) and to reduce the risks of misuse not just by the patient but also by other persons who obtain opioids. Upon approval of AVERSA fentanyl, the company expects that the FDA will consider requiring all fentanyl patches to be abuse deterrent, as was required for all oxycontin generics, which could potentially translate to more market share.

To put the opportunity here into better context, consider this. According to Health Advances' assessment, once approved by the FDA, AVERSA Fentanyl is expected to reach peak annual sales of about $200 million.

The company believes that conservative pricing will be a key component of capturing and maintaining market share in addition to real-world data and marketing. According to the Health Advances' report on AVERSA Fentanyl, Nutriband can expect to comfortably charge a 20% premium versus generics while maintaining insurance coverage and support, ideally capturing the market as the safest fentanyl patch in its class.

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