Kaival Brands Innovations stock was up slightly today as the company’s stock value has decreased sharply after the U.S. Food and Drug Administration issued the company marketing denial orders for some of its Bidi Stick flavored products. It’s third-quarter report results sent them even lower. Shares (NASDAQ: KAVL) were down 43 percent to $2.58 after the company reported Q3 earnings results.
Tuesday, the company announced its third-quarter report, which stated that the company earned drastically lower revenues of $3.4 million for the three months ended July 31, 2021, compared to $32.4 million for the three months ended July 31, 2020.
The company now expects revenues for the year to be approximately $68 million, as compared to previous guidance of $400 million. The company stated that now that 93 percent of the vaping market has been eliminated by the FDA, the company expects Bidi Vapor’s market share to, at a minimum, reach pre-premarket tobacco product applications (PMTA) levels, according to Market Watch.
“We believe that the [PMTA] process undertaken by the [FDA] has had a significant impact on the e-cigarette industry. Prior to the September 9, 2021 court-ordered deadline for the FDA to make PMTA determinations for pending applications, we believe that many retailers and distributors were reluctant to take on new inventory, the statement reads. “We believe these retailers were concerned with the potential for being left with inventory that after September 9, 2021 could be ruled adulterated or misbranded by the FDA and, thus, illegal to sell.”
The FDA, which had faced a Sept. 9 deadline to declare which e-cigarettes can remain on the market, said last week that it needed more time before making a decision on products from Juul Labs Inc. and other companies.
In August, Kaival said that it expressed strong support of “enforcement of rules and regulations governing the electronic nicotine delivery systems industry” and that it exceeded stringent FDA compliance mandates.
Bidi Vapor also announced it will continue to manufacture and market its Artic (menthol) Bidi Stick in the United States despite receiving a marketing denial order (MDO) for the product, according to a trading update issued by Kaival Brands Innovations Group.
The company said Tuesday that it believes that in the longer term, the removal of all synthetic nicotine products in the U.S. market could prove to be a positive event for it. Based on previous FDA decisions, it said it expects that Bidi Vapor’s naturally derived nicotine products will remain on the market following the completion of the FDA’s premarket tobacco application process.