Kaival Brands Innovation Group - Tobacco Reporter

Kaival Reports First-Quarter Results

Kaival Brands Innovations Group, distributor of Bidi Vapor products, reported revenues of approximately $2.5 million for the first quarter of fiscal year 2023 compared to revenues of approximately $2.8 million in the same period of the prior fiscal year.

Gross profit was approximately $500,000 compared to approximately a $700,000 gross loss for the first quarter of fiscal year 2022. The net loss for the first quarter of fiscal year 2023 was approximately $3 million compared to a net loss of approximately $2.8 million for the first quarter of fiscal year 2022.

“Despite a slight decrease in revenues versus the comparable quarter last year and our fiscal fourth quarter, primarily due to an unusually large amounts of credits, discounts and rebates to customers, which we do not expect to continue, we are continuing to focus on broadening distribution channels and driving revenue, all with the goal of materially expanding our business and increasing shareholder value,” said Eric Mosser, president and chief operating officer of Kaival Brands, in a statement.

On March 9, 2023, Kaival announced it had signed an agreement with a prominent national broker, increasing distribution by upward of 40,000 retail stores.

On March 7, 2023, the company announced it entered into new retail distribution agreements representing potential new distribution to approximately 13,500 locations.

March 20, 2023

Kaival Brands Signs Sales Broker Agreement

Kaival Brands Innovations Group, the U.S. distributor of all Bidi Vapor products, has 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.

“As we look to push distribution into more channels beyond the convenience stores, we are excited to announce a new agreement that gives us potential access to over 40,000 new locations,” said Eric Mosser, president and chief operating officer of Kaival Brands, in a statement. “We believe this agreement, along with our recent announcement of other new distribution agreements, further validates our reputation as a good actor providing adult consumers with the highest quality vape experience possible, and we look forward to working with all of our commercial channel partners to expand our revenue opportunities.”

“We are excited to further increase the reach of Bidi Vapor and its premium vaping device, the Bidi Stick, into potentially more distribution opportunities throughout multiple retail channels,” stated Russell Quick, president of QuikfillRx, the company’s third-party sales and marketing vendor. “With our feet firmly in the convenience store space, it is time not only to grow our existing footprint but to extend into more channels, like dollar and grocery stores, that meet our robust identification verification and youth access prevention requirements.”

March 13, 2023

Kaival Signs New Distribution Agreements

Kaival Brands Innovations Group, the exclusive U.S. distributor of Bidi Vapor products, has entered into agreements representing potential new distribution to approximately 13,500 locations.

Under the terms of the agreements, Bidi Vapor’s Bidi Stick will initially be activated in 700 locations, with another 1,500 locations expected within the next 90 days. All of the new locations meet Kaival Brand’s and Bidi Vapor’s requirements for customer identification verification and youth-access prevention.

“We are excited to announce these significant new distribution agreements, totaling up to 13,500 new locations, as we look to continue the ramp up of marketing and sales activity for Bidi Stick. Since Bidi Vapor succeeded in its merits case against the FDA vacating FDA’s marketing denial order for ENDS products in August 2022, we have seen a resurgence of interested retailers and potential distributors,” said Kaival Brands President and Chief Operating Officer Eric Mosser in a statement.

“While the FDA continues to move slowly in enforcing against bad actors, major retailers are showing their commitment to e-cigarettes as a category and using corporate discretion to select brands that are committed to youth-access prevention and responsible marketing of adult products. We believe our products fit squarely in this category, and we are hopeful that this positioning will lead to greater revenues for Kaival Brands during 2023.”

“We are excited to increase the reach of the Bidi Stick by up to 13,500 new stores,” stated Russell Quick, president of QuikfillRx, which operates under the name Kaival Marketing Services. “These new agreements represent an immediate impact of 700 new locations to start and we believe represents a vote of confidence that retailers have in us and our products.”

March 8, 2023

Kaival’s Fiscal 2022 Hit by Marketing Denial

Kaival Brands Innovations Group reported revenues of $3 million for the fourth quarter that ended Oct. 31, 2022, compared with revenues of $100,000 million for the prior fourth fiscal quarter. Revenues for the full fiscal year were approximately $12.8 million, down from $58.8 million for fiscal year 2021.

Kaival attributed the full-year decrease to the U.S. Food and Drug Administration’s marketing denial orders (later overturned), which temporarily prevented the company from selling its products, and to increased competition in general, which Kaival suspects resulted from lax enforcement by federal and state authorities against subpar and low-priced vaping products that continued to enter the market illegally without FDA authorization.

“Fiscal 2022 was an exceptionally challenging year for us, primarily due to regulatory action by the FDA that was ultimately overturned in August,” said Kaival Brands President and Chief Operating Officer Eric Mosser in a statement.

“For a portion of fiscal 2022, we were prohibited from selling our flavored Bidi Sticks, and our 2022 revenues reflect the significant extended impact of this. The good news is that this impediment is behind us. Moreover, despite the challenges, we accomplished several important milestones during the year, which we believe has laid the foundation for renewed growth and progress in 2023, including expanding existing sales channel relationships and initiating significant new ones. We expect and hope that the FDA will continue to pull bad actors from the marketplace, paving the way for companies like ours to provide our products to adult smokers deserving of premium e-cigarette product and experience.”

February 6, 2023

Kaival Brands Inks Marketing Deal

Kaival Brands Innovations Group, the U.S. distributor of Bidi Vapor products, has reached a three-year extension agreement with QuikfillRx, the third-party vendor responsible for executing Kaival Brands’ marketing and sales strategies.

As part of the deal, QuikfillRx will be rebranded as Kaival Marketing Services (KMS) to more properly reflect the commitment of KMS to the success of Kaival Brands.

On Aug. 23, 2022, the 11th Circuit Court of Appeals overruled the Food and Drug Administration’s marketing denial order related to Bidi Vapor’s Bidi Stick electronic nicotine-delivery system. That decision has allowed Bidi Vapor to continue to market, through Kaival Brands, all flavor varieties of the Bidi Stick in the United States.

The three-year extension with KMS was executed in preparation to support the anticipated improved sales volumes arising from this decision and the increase of Bidi Stick sales and marketing activities. In addition to monthly cash payments, which will be lower than during the initial term of the agreement, and a one-time upfront vested common stock option award, KMS will be eligible to receive performance-based common stock option awards from Kaival Brands that can vest annually based on total net revenues and profit margins achieved by Kaival Brands from KMS’ efforts over the term of the agreement, with a maximum vesting to occur upon achievement of $180 million in total net revenues reported within the three-year term.

“KMS has been an integral part of the Kaival story since our inception. Their industry knowledge and expertise, experience working with our team and unmatched around-the-clock service is best in class.”

Eric Mosser, president and chief operating officer, Kaival Brands

“KMS has been an integral part of the Kaival story since our inception,” said Kaival Brands President and Chief Operating Officer Eric Mosser in a statement. “Their industry knowledge and expertise, experience working with our team and unmatched around-the-clock service is best in class. As part of ongoing corporate efforts in anticipation of increasing sales activity following Bidi Vapor’s merits case win, it became clear that reaffirming our relationship with KMS was an important step to manage growth.”

“We are happy to continue our service with Kaival Brands and its commitment to responsible marketing,” said KMS President Russell Quick. “Our combined efforts at preventing underage use of vaping devices and focus on the needs of legal-age smokers looking for an alternative to combustible cigarettes stands as a model for the industry.”

November 15, 2022

MDO Stay Boosts Kaival’s Results

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.

September 13, 2022

Bidi Vapor Prevails Over FDA in PMTA Denial Suit

The U.S. Court of Appeals for the Eleventh Circuit has ruled that the U.S. Food and Drug Administration’s marketing denial orders (MDOs) for Kaival Brands’ Bidi Vapor products are arbitrary and capricious.

“The Administration refused to consider the marketing and sales access restrictions plans based on both its need for efficiency and its experience that the marketing and sales access restrictions do not sufficiently reduce youth use of electronic nicotine products,” Chief Judge William Pryor wrote. “Because ‘agency action is lawful only if it rests on a consideration of the relevant factors,’ and the Administration failed to consider the marketing and sales access restrictions plans, the marketing denial orders were arbitrary and capricious.”

In the court’s 2-1 split decision, additionally, the majority stated:

The court recognizes relevant distinctions between closed/cartridge systems (that are easy to conceal and use) and the open tank liquids sold in vape shops;
FDA’s refusal to review marketing plans was error and not harmless (disagreeing with Fifth and DC Circuits).

In the 70-page opinion, Bidi Vapor, Diamond Vapor, Johnny Copper, Vapor Unlimited, Union Street Brands and Pop Vapor, the petitioners in the case, had all appeals granted, denial orders vacated and remanded.

In her dissent, Judge Robin Stacie Rosenbaum wrote, “Spoiler alert: This opinion contains spoilers on how the U.S. Food and Drug Administration will resolve petitioner vaping product companies’ premarket tobacco product applications on remand from this appeal.”

She then stated “never mind. There’s nothing to spoil here. Anyone who knows all the relevant facts necessarily already knows how this one ends.”

She stated that the while the majority faulted the FDA for not considering the companies’ proposed restrictions on youth use, the FDA’s framework for evaluating PMTAs leaves “no room for doubt that the FDA will deny—in fact, under the Family Smoking Prevention and Tobacco Control Act, must deny—the applications on remand. To paraphrase the Borg, then, remand is futile.”

August 24, 2022

Kaival Launches PMI’s Veeba in Canada

Kaival Brands Innovations Group (KBI) announced the launch of Philip Morris International’s Veeba disposable e-cigarette in Canada.

In June, Kaival and PMI signed an agreement for the development and distribution of electronic nicotine-delivery system products in markets outside of the U.S.

“The agreement with Philip Morris Products was a remarkable accomplishment for the company, and now we have advanced to the next phase of international distribution with the actual launch of their custom branded product, Veeba,” said Eric Mosser, president and chief operating officer of Kaival Brands, in a statement.

“We are excited to support PMI’s efforts to provide a range of alternatives compared to cigarettes. The commercialization of Veeba complements PMI’s already strong smoke-free portfolio, providing adult smokers with an even broader range of usage, taste, price and technology options.”

The agreement licenses PMI to manufacture, promote, sell and distribute the Bidi Stick and any newly developed devices in certain markets outside of the United States, with potential royalties owed to KBI.

July 26, 2022

Leadership Changes at Kaival

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.

June 27, 2022

Kaival and PMI Sign Distribution Agreement

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

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