Tag: Kaival Brands Innovation Group

Leadership Changes at Kaival

Photo: Nirajkumar Patel
(Photo: Kaival Brands Innovations Group)
Kaival Brands Innovations Group Founder and CEO Nirajkumar Patel will transition to chief science and regulatory officer. Eric Mosser, the company’s current chief operating officer, will become president and remain COO. Mosser will serve as the company’s principal executive officer for purposes of its filings with the Securities and Exchange Commission. Patel will remain on the board of directors for Kaival Brands.
The management changes follow the company’s recently announced international licensing agreement with Philip Morris Products (PMP) on June 13, 2022.
The agreement grants to PMP a license of certain intellectual property rights relating to Bidi Vapor’s premium electronic nicotine delivery system (END”) device, the Bidi Stick, in the U.S., as well as potentially newly developed devices, to permit PMP to manufacture, promote, sell and distribute such ENDS device and newly developed devices, in markets outside of the U.S.
Eric Mosser
“What Mr. Patel has accomplished, from initial concept to an international distribution agreement with Philip Morris is extraordinary,” said Mosser in a statement. “With unwavering belief and integrity, he established himself as a true visionary within the vaping category.
Mr. Patel has been both inventor and salesman, developing a product and everything that goes around it to make it successful. We have grown from a no-name brand to the No. 1-selling self-contained disposable ENDS device in the U.S based on the Nielsen retail sales data for the 52-week period ending June 4, 2022, according to a recent Goldman Sachs’ Equity Research Report.”
The transition will allow Patel to focus on developing new products and expanding the Bidi Vapor product portfolio, which is directly related to the new agreement with PMP, and allow Mosser to focus on expanding sales distribution channels and increasing the revenues and profits of Kaival Brand.
“My passion for the business is in creating, designing and delivering new products for adult tobacco users to the market,” said Patel. “Mr. Mosser understands the core values, mission and goals of the Company, and I am confident he will take Kaival Brands to new levels.”
The management changes are effective immediately, with roles and responsibilities to transfer over the coming weeks.
June 27, 2022
Kaival and PMI Sign Distribution Agreement

Photo: khwanchai
Kaival Brands Innovations Group, the U.S. distributor of all products manufactured by Bidi Vapor, has reached an agreement with Philip Morris Products (PMP), a wholly owned affiliate of Philip Morris International, for the development and distribution of electronic nicotine-delivery system (ENDS) products in markets outside of the U.S., subject to market (or regulatory) assessment.
The company’s recently formed wholly owned subsidiary, Kaival Brands International (KBI), entered into a licensing agreement with (PMP) on June 13, 2022. The agreement grants to PMP a license of certain intellectual property rights relating to Bidi Vapor’s premium ENDS device, known as the Bidi Stick in the U.S., as well as potentially newly developed devices, to permit PMP to manufacture, promote, sell and distribute such ENDS device and newly developed devices in international markets outside of the U.S.
The parties believe this agreement promotes their joint vision of a smoke-free future.
“We believe that in addition to the Bidi Stick having wide acceptance among legal-age nicotine users in the United States, Bidi Vapor’s numerous decisions around design; responsible adult-oriented marketing and stringent youth-access prevention measures; and sustainability bolstered its appeal to PMI,” said Niraj Patel, CEO of Kaival Brands, in a statement.
“We, along with PMI and Bidi Vapor, share the vision of a smoke-free future. The Bidi Stick offers legal-age nicotine users a high-quality alternative to cigarettes that satisfies their taste preferences. Further, we, along with Bidi Vapor, are committed to prioritizing the appropriate regulation and responsible commercialization, inclusive of taking the necessary measures to make sure these products do not appeal to unintended audiences, including youth. By example, Bidi Vapor does not engage in direct online sales to consumers and requires age verification contracts with our distributors and retailers.
“While Bidi Vapor continues to pursue the U.S. Food and Drug Administration premarket tobacco product authorization, cooperation with a major multinational company like PMI, a leader in scientifically substantiated smoke-free products, opens doors on a global scale. Kaival Brands looks forward to a long, productive relationship with PMI to accelerate the end of smoking.”
“We have previously mentioned our intention to broaden our current smoke-free product portfolio for adults who would otherwise continue to smoke cigarettes or use other nicotine products. This agreement supports that vision and is another step toward accelerating the delivery of a smoke-free future. We are excited to start our agreement with Kaival Brands—led by CEO Niraj Patel—who shares the same vision as we do, to accelerate the end of combustible cigarette smoking,” says PMI President of E-Vapor Ashok Rammohan.
June 14, 2022
Kaival Expands Distribution for Bidi Vapor

Photo: Kaival Brands Innovations Group
“We are encouraged by growing sales volumes in our second fiscal quarter generated by both established wholesalers and retailers selling the Bidi Stick in new stores, as well as new wholesale and retail accounts being added to our distribution network,” said Kaival Brands CEO Niraj Patel in a statement. “We anticipate the activation of approximately 3,900 new store locations over the next 45 days, including one new major retailer having already placed orders totaling more than $1.1 million.”
According to Kaival Brands, the expansion represents a positive development for the company since the U.S. Food and Drug Administration (FDA) issued its marketing denial order (MDO) to Bidi Vapor this past September, as it did for about 96 percent of all manufacturers of flavored electronic nicotine delivery systems.
In February 2022, the U.S. Court of Appeals for the Eleventh Circuit granted Bidi Vapor a judicial stay of the MDO, pending the resolution of Bidi Vapor’s ongoing merits-based litigation. In effect, the judicial stay means that the MDO, which covered the non-tobacco flavored Bidi Sticks, is not legally in force.
Accordingly, Kaival Brands anticipates marketing and selling all 11 flavored Bidi Sticks, subject to the FDA’s enforcement discretion, while Bidi Vapor continues with its merits case challenging the legality of the MDO.
The FDA has indicated that it is prioritizing enforcement against companies that have either not submitted premarket tobacco product applications (PMTAs), or whose PMTAs have been refused acceptance or filing by FDA, or whose PMTAs remain subject to MDOs.
Patel says he sees signs of growing confidence in the vaping industry as the MDOs for Bidi Sticks and products of several other companies have been placed on hold.
“This was a significant event not only for Kaival Brands and Bidi Vapor, but the entire industry,” said Patel of the court decision. “The judicial stay granted in February allowed us to resume sale of all 11 flavored products in the Bidi Stick lineup. We are eager to return our flavored products to the shelves of retailers that comply with the Prevent All Cigarette Trafficking Act so adult consumers can enjoy their preferred flavors once again. As a result of the judicial stay, we expect revenues to resume an upward trajectory as renewed distribution ramps up and sales of flavored Bidi Sticks increase.
“Additionally, we believe that the FDA’s new authority over products using synthetic nicotine will only bolster Kaival Brands’ market position, as more retailers understand the nearly insurmountable compliance hurdles facing those manufacturers of non-compliant, synthetic products. “
“Products in the vaping industry should be developed and placed in the market under a high degree of supervision, such as the FDA’s PMTA process or the FDA’s drug-approval process,” continued Patel. “We anticipate that as the FDA begins enforcement against illegally marketed and synthetic-nicotine vaping products, there may be an increased demand for compliant and legal vaping products, such as the Bidi Stick.”
April 19, 2022
Kaival Brands Reports ‘Challenging’ Year
Niraj Patel (Photo: Kaival Brands
Kaival Brands reported revenues of approximately $58.8 million in the fiscal year that ended on Oct. 31, 2021. The company’s performance was worse than 2020, primarily due to the U.S. Food and Drug Administration’s marketing denial orders, which prevented Kaival Brands from marketing the nontobacco flavored Bidi Sticks in the United States toward the end of fiscal year 2021.
In addition, the company faced increased competition, which it attributes to the lack of enforcement by federal and state authorities against subpar and low-priced vaping products that continued to enter the market illegally without FDA authorization.
Net loss for fiscal year 2021 was approximately $9 million compared to net income of approximately $3.8 million for fiscal year 2020. The decrease in net income year-over-year was largely due to the decrease in revenues and the increase in operating expenses.
“Fiscal year 2021 was a very challenging year, especially because of FDA’s marketing denial order, or MDO, for Bidi Vapor’s nontobacco flavored Bidi Stick ENDS [electronic nicotine-delivery system], which caused irreparable harm to both Bidi Vapor and Kaival Brands,” said Kaival Brands’ CEO Niraj Patel in a statement.
“However, we were pleased that the court ultimately agreed to stay the MDO and that we were able to make key strategic decisions to stay in business and continue maturation of the company in 2021, including uplisting to Nasdaq and completing our first underwritten public offering.”

February 16, 2022
Bidi Vapor to Market Product Despite MDO
Bidi Vapor 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 exclusive distributor of Bidi Vapor products.
As of Sept. 10, the U.S. Food and Drug Administration has issued MDOs for some 992,000 electronic nicotine-delivery system (ENDS) products from 168 companies. Bidi Vapor received an MDO for its nontobacco flavored Bidi Sticks, including its Artic (menthol) Bidi Stick.
The company, however, insists the FDA mischaracterized the Artic (menthol) Bidi Stick as flavored. Because its Arctic Bidi Stick is menthol, Bidi Vapor believes that this product is not subject to the MDO.
“This position is aligned with the FDA’s public statements and press releases stating that tobacco and menthol ENDS are not deemed flavored products subject to the MDOs,” the company wrote in a press note. “Accordingly, along with the Classic (tobacco) Bidi Stick, Bidi intends to continue to manufacture and market its Arctic (menthol) Bidi Stick for distribution by us.”
The company, which has historically derived nearly all its revenues from sales of flavored Bidi Sticks, appears willing to accept the risk of enforcement.
“If the FDA disagrees with Bidi Vapor’s position, issues a warning letter or takes other action against Bidi Vapor resulting in us not being able to distribute the menthol (Arctic) Bidi Stick in the United States, or consumers do not purchase the tobacco (Classic) or menthol (Arctic) Bidi Sticks, our revenues and, thereby our financial results and condition, would be materially adversely affected,” Kaival Innovations Group wrote in its news release.
For the three and nine months ended July 31, 2021, the Arctic (menthol) Bidi Stick constituted approximately 15.2 percent and 18.5 percent, respectively, of the company’s total Bidi Sticks sales.
September 15, 2021
Kaival Brands to trade on NASDAQ

Image: immimagery
Kaival Brands Innovations Group, the exclusive global distributor of products manufactured by Bidi Vapor, has been approved to list the company’s common stock on the Nasdaq Capital Market. The ticker symbol will remain unchanged, as “KAVL,” and the stock will begin trading on Nasdaq at the opening of the market on July 29, 2021.
“I am pleased to announce that the company has been approved to begin trading on Nasdaq,” said Niraj Patel, Kaival’s founder and CEO, in a statement. “This event represents another monumental milestone in our company’s short history.”
“We have worked diligently to achieve this goal and are humbled and grateful on the inclusion to the Nasdaq,” said Patel. “We are more enthusiastic than ever about being able to harness Kaival’s exciting potential.”
“Step by step, we continue our work to build a world-class global organization—our elevation to Nasdaq represents a very large strategic evolution for the company,” noted Eric Mosser, chief operating officer of Kaival Brands.
July 28, 2021
Next Generation Nixes Kaival Patent Deal

Photo: sorapop
Next Generation Labs, which manufactures and markets bulk R-S, R- and S-isomer synthetic nicotine under its TFN brand, has terminated its Sept. 28, 2020, patent contribution agreement with Kaival Brands Innovation Group and Kaival Labs.
The Patent Contribution Agreement related to the acquisition and commercial exploitation by Kaival of Next Generation Labs’ IP portfolio on combinational use of synthetic R- and S-isomer nicotine ratios in tobacco cessation products.
In a press note, Next Generation Labs said Kaival Labs had published inaccurate and misleading statements relating to the use of patented synthetic nicotine for tobacco cessation products on its website. “Next Generation Labs wants to clarify that as a consequence of Kaival’s failure to perform its obligations under the Patent Contribution Agreement, all rights to the R-S synthetic nicotine cessation patent portfolio fully reverted to Next Generation Labs in May 2021,” Next Generation Labs wrote.
Additionally, Kaival executed a confirmatory transfer agreement with Next Generation Labs relinquishing all rights to the Next Generation Labs patent portfolio for the commercialization of combinational TFN R-S nicotine relating to tobacco cessation products. Kaival is not an authorized agent of Next Generation Labs nor is it authorized to use Next Generation Labs’ name, intellectual property or its TFN trademark on its products, in its product marketing or in any financial prospectus to investors, according to Next Generation Labs.
July 26, 2021
Kaival Restarts Pouch Production
Kaival Brands Innovations Group is restarting production of its Bidi Pouch ahead of an anticipated September launch.
The Bidi Pouch rollout had been delayed because of Covid-related manufacturing and supply chain constraints. Due to these complications and to prevent future bottlenecks, the company decided to move manufacturing in-house. One of the few pouch products on the market formulated without the Swedish Match formula, the Bidi Pouch provides a proprietary tobacco-free nicotine formulation packed in a convenient plastic can, according to Kaival Brands.
“I am pleased to confirm that we expect to take delivery of the pouch manufacturing machines to our warehouse the end of August and anticipate beginning production in September with our first run expected to yield up to 500,000 cans,” said Niraj Patel, founder and CEO of Kaival Brands and Bidi Vapor, in a statement.
“We are excited to launch distribution of the Bidi Pouch and have been working behind the scenes during Covid-based delays to secure initial distribution. To that extent, we are proud to announce that 8,000 points of distribution have been secured and are ready to receive our product,” said Eric Mosser, chief operating officer of Kaival Brands.
The company believes that the nicotine pouch category represents a significant market opportunity. The category has witnessed significant growth recently, with New York-based Nielsen reporting an increase in unit sales of 59.9 percent in U.S. convenience stores over the 52-week period ended June 19, 2021.
This growth is expected to continue as evidenced by publicly available material from MarketResearch.com in which it indicated that the global nicotine pouches market is expected to reach $32.8 billion by the end of 2026, with an expected compound annual growth rate of 54.9 percent through 2026.
July 23, 2021
Kaival Brands Secures Patents in China

Photo: vegefox.com
Kaival Brands Innovations Group has been granted two copyright protections and two patents by China.
The first patent, China Patent No. 202020067263.5, is a utility model patent and relates to the nozzle components of the Bidi Stick. The nozzle components play an integral role in delivering a consistent user experience. The second patent, China Patent No. 202030052391.8, is a design patent that covers the entire Bidi Stick product. Bidi Vapor has also secured copyrights for both the Bidi Stick and Bidi Cares names.
Kaival believes that the Chinese vapor market presents a considerable business opportunity. Statista data projects the China combustible cigarette market to top $220 billion in 2021. Vape products are quickly gaining market share in China, and if a mere 10 percent of combustible cigarette smokers transition to vape, China would be a $22 billion vape market opportunity. By comparison, Grandview Research anticipates the U.S. vape market to reach $7.4 billion in 2021.
“The copyright and patent protection representations received from China are the first step in our planned journey to introducing the Bidi Stick into one of the world’s largest markets for vape products, China,” said George Chuang, independent director of Kaival Brands, in a statement. “I look forward to advising the company in my role as a board member in interfacing with potential distribution partners in China.”
“Receiving two patents from China, along with copyright protections, should enhance our efforts to more effectively eliminate counterfeit players from the market, and being afforded these protections within a difficult market further validates our best-in-class product lineup,” says Niraj Patel, founder and chief executive officer of Kaival Brands and Bidi Vapor. “Both Bidi Vapor and Kaival Brands are adamant about exceeding compliance standards in every global market, and as such, our products are intended exclusively for adults 21 and over.”
Following the latest patents, Kaival has intellectual property protections in the United States, the European Union, Australia and China. “We believe this puts us in a strong position to pursue new global markets that we have already received regulatory approval to enter,” says Patel.
July 18, 2021
Kaival Splits Stock for NASDAQ Listing

Photo: Randy Harris
Kaival Brands, the exclusive global distributor of all products manufactured by Bidi Vapor, has implemented a 1-for-12 reverse split of its common stock, effective prior to the opening of the market on July 20, 2021. The reverse stock split was implemented by the company in support of its application to list on the NASDAQ Capital Market.
As a result of the reverse split at the 1-for-12 ratio, every 12 shares will be exchanged for one share of the common stock.
“We are excited for the new phase of Kaival’s capital markets development as we progress to listing on the NASDAQ,” said Niraj Patel, CEO of Kaival Brands, in a statement.
“Our board carefully considered the decision to effect the reverse split of our shares, which is critical for us to list on NASDAQ based on our current stock price. A reverse split is designed as an economically neutral, mathematical event that does not affect the intrinsic value of the company. While many companies execute reverse splits to avoid being delisted, our reverse split is in fact being done for just the opposite reason: to become qualified to list on the NASDAQ, which we believe will have many benefits for our company and shareholders.”
The reverse split is intended to increase the per share stock price of the company’s common stock in order to meet NASDAQ’s requirement that the company’s common stock be $4 or higher as of the listing date. Prior to listing its common stock on NASDAQ, the company’s application must be approved.
The company does not intend to issue fractional shares in connection with the reverse stock split. In order to avoid fractional shares of common stock, the number of shares issued to each stockholder will be rounded up to the nearest whole number in the event a stockholder would be entitled to receive less than one share of common stock as a result of the split. The reverse split will not affect any holder of the company’s common stock’s proportionate voting power, and all shares of common stock will remain fully paid and nonassessable.
July 15, 2021