Kaival Brands Reports Fiscal 2022 Third Quarter Financial Recent Business Highlights
- In June, the Company’s wholly owned subsidiary, Kaival Brands International, LLC ("KBI"), entered into an international licensing agreement with Philip Morris Products S.A. (“PMPSA”), a wholly owned affiliate of Philip Morris International Inc., for the development and distribution of electronic nicotine delivery system ("ENDS") products in markets outside the U.S., subject to market (or regulatory) assessment.
- In July, the Company announced the launch of PMPSA's custom-branded self-contained e-vapor product, VEEBA, being sold in Canada, with royalties due to KBI pursuant to the international licensing agreement.
- In August, the U.S. Court of Appeals for the Eleventh (11th) Circuit ruled in favor of Bidi Vapor in its appeal of the U.S. Food and Drug Administration’s (“FDA”) Marketing Denial Order (“MDO”) issued to the non-tobacco flavored BIDI Sticks. The court set aside or vacated the MDO, and remanded the PMTAs back to FDA for further review. Separately, in May 2022, FDA placed the tobacco-flavored Classic BIDI® Stick into the final Phase III scientific review.
Eric Mosser, President and Chief Operating Officer of Kaival Brands, stated, "Revenues in our fiscal third quarter ended July 31, 2022 increased almost 11% from the second fiscal quarter and more than 25% from the first fiscal quarter. More importantly though, the recent 11th Circuit ruling in favor of Bidi Vapor alleviated a significant barrier to our adult-focused B2B sales efforts, which we believe will once again allow us to materially scale our business, grow revenue, move towards net profitability in the future and increase shareholder value. Anticipating this positive decision with us were prospective new wholesale distribution partners that represent a potential doubling over time of our historical active store count in the U.S. market. In addition, we are working diligently with Philip Morris to aggressively expand international distribution into new global markets. We expect to begin recognizing revenues from this international licensing agreement in our fiscal fourth quarter.”
Nirajkumar Patel, Chief Science and Regulatory Officer of Kaival Brands and owner of Bidi Vapor, stated, “On August 23, 2022, the 11th Circuit ruled in Bidi Vapor’s favor, granting the petition for review, setting aside the MDO and remanding the PMTA back to FDA for further review. Out of dozens of MDO appeals filed across the country, this is the first decision in favor of our industry. We are greatly encouraged by the recent favorable events vacating the MDO for our non-tobacco flavored products and the advancement of Bidi Vapor’s tobacco-flavored Classic BIDI® Stick into final Phase III scientific review. We look to the future of offering adult smokers a potentially safer alternative to combustible cigarettes and standardizing across the industry our particular approach to market leadership in preventing youth access and youth appeal.”
https://www.globenewswire.com/news-release/2022/09/12/2514038/0/en/Kaival-Brands-Reports-Fiscal-2022-Third-Quarter-Financial-Results.html