Tag: bidi stick

  • Kaival Brands Group Announces Reverse Stock Split

    Kaival Brands Group Announces Reverse Stock Split

    Photo: Kaival Brands Innovations Group

    Kaival Brands Innovation Group, the parent to Bidi Stick vaping products, announced a 1-for-21 reverse stock split that became effective at the opening of trading today, Thursday, January 25.

    It’s not the first time the company has made such a move. In 2021, when the company applied to list on NASDAQ, the company implemented a 1-for-12 reverse split of its common stock, effective before the opening of the market on July 20. As a result of that reverse split every 12 shares were exchanged for one share of the common stock.

    Kaival Brands’ Common Stock will continue to trade on the Nasdaq Capital Market under the symbol KAVL. The new CUSIP number for the Common Stock following the Reverse Stock Split will be 483104402.

    The company’s board approved the Reverse Stock Split. The material effects of the Reverse Stock Split are:

    • Every 21 shares of the issued and outstanding Common Stock has been combined into one (1) share of Common Stock.
    • The number of outstanding shares of Common Stock has been proportionally reduced from 58,661,090 shares to approximately 2,793,386 shares.
    • The Reverse Stock Split will not reduce the total number of Kaival Brands’ authorized shares of Common Stock.
    • The ownership percentage of each Kaival Brands stockholder will remain unchanged, other than as a result of fractional shares. No fractional shares of Common Stock will be issued in connection with the Reverse Stock Split. Stockholders that would hold a fractional share of Common Stock as a result of the Reverse Stock Split will have such fractional shares of Common Stock rounded up to the nearest whole share of Common Stock.
    • The number of shares of Common Stock available for issuance under the Company’s equity incentive plans and the Common Stock issuable pursuant to outstanding equity awards and common stock purchase warrants immediately prior to the Reverse Stock Split will be proportionately adjusted by the ratio of the Reverse Stock Split. The exercise prices of such outstanding options and warrants will also be adjusted in accordance with their respective terms.

    “Among other considerations, the Reverse Stock Split is intended to assist in bringing Kaival Brands into compliance with the $1.00 minimum bid price requirement for maintaining the listing of its Common Stock on the Nasdaq Capital Market, and to make the prevailing prices of the Common Stock more attractive to a broader group of institutional investors,” a press release states.

    Stockholders owning shares via a broker, bank, trust or other nominee will have their positions automatically adjusted to reflect the Reverse Stock Split, subject to such broker’s particular processes. Such stockholders will not be required to take any action in connection with the Reverse Stock Split.

  • FDA Issues MDO for Tobacco-Flavored Bidi Stick

    FDA Issues MDO for Tobacco-Flavored Bidi Stick

    The U.S. Food and Drug Administration has issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick classic e-cigarette. The Bidi Stick is a closed-system, disposable, tobacco-flavored vaping device.

    “FDA has a key role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products (CTP). “Integral to that role, our tobacco application review process relies on scientific evidence that demonstrates a product provides a net benefit to public health that outweighs the known risks. The science in this application did not show that.”

    The company must not market or distribute this product in the United States or they risk FDA enforcement action. The company may submit a new application to the agency for review that addresses these deficiencies.

    After reviewing the company’s PMTA, the FDA determined that the application lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act, an FDA press release states. Specifically, evidence submitted by the applicant did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.

    “The Center has made considerable progress in reviewing the massive volume of tobacco product applications submitted to the agency, thanks to the tireless efforts of our dedicated legion of civil servant scientists,” said Brian King, director of the CTP. “The Center remains committed to processing submitted applications as expeditiously as possible while ensuring the utmost scientific integrity of the reviews.”

    Kavial Brands, the manufacturer of Bidi Stick, is expected to appeal the decision.

    China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed an appeal with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit after it received an MDO and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.

    on Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.

    The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.

    The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.

  • Bidi Makes First Shipment to 900 Kwik Trip, Mapco Stores

    Bidi Makes First Shipment to 900 Kwik Trip, Mapco Stores

    Credit: Aaron

    Kaival Brands Innovations Group, the distributor of products manufactured by Bidi Vapor, today announced the initial shipment of Bidi Sticks to over 900 Kwik Trip and Mapco locations

    According to a press release, the company expects to ramp up shipments to over 1,200 locations planned by the end of 2023, with Kwik Trip representing over 900 of those locations.

    On Thursday, the company made its first shipment of Bidi Sticks to over 1,000 Circle K locations, with a ramp-up to 5,000 locations by the end of the year within the South Atlantic and Midwest regions of the United States.

    “Ultimately, our goal is to ramp up to over 1,200 locations this year within those two retailers, both of whom adhere to our strict requirements for adult-only sales and youth-access prevention,” stated Eric Mosser, president and COO of Kaival Brands.

    “We are encouraged by the renewed momentum we are experiencing (subject as always to FDA enforcement discretion) with retailers like Circle K, Kwik Trip, and Mapco who champion compliance and youth-access prevention and recognize our ongoing efforts since last year to educate retailers and distributors of the business value of marketing Bidi Stick versus non-compliant competition.”

    In March, Kaival Brands Innovations Group entered into a sales broker agreement with a prominent U.S. broker to expand access to Bidi Vapor products from its current foundation of convenience store distribution into new retail channels, including discount, grocery and mass merchandisers.

  • Kaival Brands’ MDO Stay Boosts its Quarterly Results

    Kaival Brands’ MDO Stay Boosts its Quarterly Results

    Photo: crizzystudio

    Kaival Brands Innovations Group reported revenues of $3.8 million for the third quarter of fiscal year 2022, up from $3.2 million for the same period of 2021. Gross profit was $442,100 compared to a loss of $84,300 for comparable 2021 period.

    Kaival attributed its improved revenues in part to an August court ruling that set aside a marketing denial order issued by the U.S. Food and Drug Administration to the company’s nontobacco flavored Bidi Stick e-cigarettes. Arguing that the agency had insufficiently considered Kaival Brands’ marketing and sales access restriction plans, the U.S. Court of Appeals for the Eleventh Circuit ordered the FDA to further review Kaival’s premarket tobacco product applications, allowing the company to continue to market its products.

    “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 toward net profitability in the future and increase shareholder value,” said Kaival Brands President and Chief Operating Officer Eric Mosser in a statement.

    Mosser added that the company is working with Philip Morris to expand international distribution into new global markets. In June, Kaival Brands Innovations Group’s subsidiary, Kaival Brands International (KBI), entered into a licensing agreement with Philip Morris Products (PMP) for the development and distribution of electronic nicotine-delivery system products outside the U.S.

    “We expect to begin recognizing revenues from this international licensing agreement in our fiscal fourth quarter,” said Mosser.

    In July, Kaival announced the launch of PMP’s Veeba vapor product in Canada, with royalties due to KBI pursuant to the international licensing agreement.

  • Licensing Agreement Brings Leadership Changes at Kaival

    Licensing Agreement Brings Leadership Changes at Kaival

    Photo: adragan

    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.

    “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.

  • Bidi Parent Kaival Brands Reports Quarterly Results

    Bidi Parent Kaival Brands Reports Quarterly Results

    Photo: Song about Summer

    Kaival Brands’ revenues decreased by approximately $15.7 million in the second quarter of fiscal year 2022, compared to the same period of fiscal year 2021. Compared with the first quarter of 2022, however, revenues rose 11 percent.

    Gross profit in the second quarter of fiscal year 2022 was approximately $387,700, or approximately 12.7 percent of revenues, net, compared to approximately $6.3 million gross profit, or approximately 34.6 percent of revenues, net, for the second quarter of fiscal year 2021.

    In February 2022, Bidi Vapor was granted a judicial stay on the marketing denial order (MDO) previously issued by the U.S. Food and Drug Administration prohibiting the marketing and sale of nontobacco flavored Bidi Sticks, which had significantly impacted Kaival Brands’ revenues in previous quarters.

    As a result of the grant of the judicial stay of the MDO, the company’s revenues increased in the second quarter of fiscal 2022, as compared to first quarter of fiscal 2022. Kaival Brands expect this trend to continue as renewed distribution ramps up and sales of nontobacco flavored Bidi Sticks increase, subject to the court ruling in Bidi Vapor’s favor in the pending merits-based case, and subject to the FDA’s enforcement discretion.

    “Our results demonstrate strong execution and resiliency in our business, as revenues in the second quarter of fiscal year 2022 rose 11 percent as compared to revenues in the first quarter of fiscal year 2022,” said Kaival Brands founder and CEO Niraj Patel in a statement.

    “The recently announced international licensing agreement with Philip Morris Products, a wholly owned affiliate of Philip Morris International, is a major milestone in the company’s efforts to expand the global sales and distribution of the Bidi Stick. From a balance sheet perspective, the international licensing agreement has the potential to generate substantial returns on capital for the company, given the low cash investment needed to reach a significant number of potential new consumers.”

  • Kaivel and PMI Reach Global Distribution Agreement

    Kaivel and PMI Reach Global 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.

  • Kaival Grows Bidi Vapor Distribution by 28,000 Stores

    Kaival Grows Bidi Vapor Distribution by 28,000 Stores

    Kaival Brands Innovations Group, the distributor of all products manufactured by Bidi Vapor, LLC, today announced the expansion of additional wholesale and retail accounts. The move is expected to bring the Bidi Vapor disposable e-cigarette’s reach to approximately 28,000 additional stores, according to a press release.

    “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,” Niraj Patel, CEO of Kaival Brands said. “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.”

    Credit: Bidi Vapor

    The expansion represents a positive development for the company since the U.S. Food and Drug Administration 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 (ENDS).

    In February 2022, the U.S. Court of Appeals for the 11th 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, according to the release.

    “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.”

    The company states 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.”

  • Third-Quarter Report Causes 43% Drop in Kaival Stock

    Third-Quarter Report Causes 43% Drop in Kaival Stock

    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.

    Credit: Argus

    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.

  • Kaival Brands Reports Second-Quarter Results

    Kaival Brands Reports Second-Quarter Results

    Kaival Brands Innovations Group reported revenue of $18.1 million for its fiscal second quarter, which ended April 30, 2021.

    The company also received two significant Bidi Stick orders with a combined value of $41.6 million. According to Kaival Brands CEO Niraj Patel, these orders represent some of the largest individual orders since the company started business. “We believe [they] are indicative of our robust pipeline for the innovative Bidi Stick and our shift to large wholesalers and distributors versus smaller retailers,” he said in a statement.

    “This shift in strategy also helps us remain an industry leader in our effort to continually exceed Prevent All Cigarette Trafficking (PACT) Act compliance requirements. The Bidi Stick experience is unrivalled as evidenced by our leading market share within the ENDS category,” said Patel.

    While the potential contract values of additional national retailers are significantly higher than those of smaller retailers and wholesalers, the process to navigate these contracts is more onerous and time consuming, according to Kaival Brands. However, Patel believes such contracts are worth the investment because the company expects more large orders to follow.

    Kaival Brands recently received approval to market and sell Bidi Vapor products in 11 countries. Despite Covid-19 related delays in building its international infrastructure, the company is confident it soon will be able to launch the Bidi Stick in the U.K. as well.

    Kaival Brands is also enthusiastic regarding the opportunity for its Bidi Pouch, which has been developed without Swedish Match intellectual property.