Tag: Kaival Brands

Kaival Announces Reverse Stock Split
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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 Jan. 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,” the company wrote in a press release.
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.
January 26, 2024
Hopkins Promoted to CEO, President of Kaival

Photo: Gajus

A former Altria executive has been promoted to CEO and resident of Kaival Brands Innovations Group, Inc. The company announced that it has expanded the role of Executive Chairman Barry Hopkins to include the additional positions.

Former CEO and president, Eric Mosser, has been appointed CEO and president of Kaival Brands International, a Kaival Brands Innovations Group’s subsidiary with an international licensing relationship with Philip Morris Products.

Niraj Patel, founder and chief science officer of Kaival Brands, said that from the beginning he has envisioned a diverse platform that could “capture the tailwinds” generated by the company’s core offering, the BIDI Stick electronic nicotine delivery system (ENDS) product.

“Barry understands this vision, the importance of regulatory compliance and youth access prevention, and has done an exceptional job since joining Kaival Brands. He has eagerly taken on increasing levels of responsibility, leveraging his decades of experience in management in our industry,” said Patel in a press release. “His appointment as Interim CEO and president was a natural progression, and we look forward to potentially expanding our excellent management team further during 2024 with a permanent CEO and/or president as our needs dictate.

“Having Barry in this position now is particularly important since we are at a significant inflection point, as we remain hopeful that FDA will soon complete its review of the pending premarket tobacco product application (PMTA) for the tobacco-flavored BIDI Stick Classic. If we receive a marketing granted order for this product, we will have significant momentum in the new year with the ability to continue to transition adult cigarette smokers, drive revenue and grow our company.”

According to a recent U.S. Food and Drug Administration announcement, the agency’s next status report regarding its review of the still-pending PMTAs for major brands and market share leading ENDS products is due to be filed by January 22, 2024 with the U.S. District Court in Maryland.

Although FDA has not indicated publicly which PMTAs it is prioritizing for review, Kaival Brands is hopeful that the BIDI Stick Classic will be included in the January status report. The company also anticipates the PMTAs for the other 10 BIDI-branded SKUs will remain in scientific review, according to Patel.

Recently, the Kaival Brands has been encouraged by the coordinated efforts of the FDA, U.S. Customs and Border Protection, and other government agencies to increase their coordinated focus on enforcement. The company believes it has been hurt by illicit vaping products flooding the market, and it is now preparing to scale along with other legal products, assuming increased enforcement continues alongside the January announcement by the FDA.

“Hopkins will spearhead the company under the direction of the Board of Directors with a continued focus on accelerating revenue growth, improving operational efficiencies and executing Kaival Brands’ strategic growth and diversification initiatives, while remaining in compliance with applicable state and federal regulations.

“The company, alongside BIDI Vapor (the maker of the BIDI Stick), is also continuing to focus on working with Philip Morris to accelerate the international distribution of ENDS products using BIDI technology (which Philip Morris markets under the brand name ‘VEEV Now’), as part of Philip Morris’s plan to deliver a smoke-free future.”

December 29, 2023
Kaival Brands Earns Initial Royalties from Philip Morris

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Kaival Brands Innovations Group, parent to Bidi Vapor, received its first royalty payments from Philip Morris International for marketing Bidi Vapor products in multiple countries.
In a press release, Kaival Brands announced that PMI achieved a record level of monthly sales in July for its Bidi products that are marketed by PMI under the names VEEBA and VEEV NOW.
Eric Mosser, CEO and president of Kaival Brands, said he was pleased to see the positive trajectory of sales and royalties to the company.
“We are proud to work with Philip Morris and remain steadfast in our commitment to the responsible commercialization of better alternatives to cigarettes for adults who would otherwise continue smoking,” he said.

September 26, 2023
Kaival Amends Philip Morris Deal

Credit: More

Kaival Brands International (KBI) has amended its agreement with Philip Morris Products, a wholly owned affiliate of Philip Morris International, for the development and distribution of electronic nicotine-delivery system products in markets outside of the U.S.
Eric Mosser, CEO of Kaival Brands, the exclusive distributor of all products manufactured by Bidi Vapor, said in a press note that with more than a year of operational history for KBI and given the recent changes to regulations in international markets, it became clear that there were a number of opportunities to improve the terms of the original licensing agreement with PMI and reduce the burden of administering it.
“We are extremely pleased to reach an agreement that shall enable us to achieve our objectives. The revised licensing agreement simplifies the payment structure resulting in cost savings of approximately $2.7 million for the company over the lifetime of the license agreement,” said Mosser. “It also enables better predictability and forecasting for KBI and streamlines data reporting. Finally, we anticipate that the acceleration of royalty payments will be a net positive to our financial performance over the duration of the agreement.”
Under the terms of the amended agreement, the parties agreed to revise certain terms, which provide for, among other things, a fixed pricing structure with volume-driven increases and a recapture of nonrecurring engineering costs by KBI.
Accordingly, Kaival Brands expects a reconciliation payment of approximately $135,000. It projects approximately $300,000 in additional royalties to be earned through the end of 2023.

August 21, 2023
NASDAQ Grants Kaival Extension

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The NASDAQ Stock Market has granted Kaival Brands an additional 180 days to regain compliance with NASDAQ’s $1 minimum bid price rule requirement under NASDAQ Listing Rule 5550(a)(2) (the Bid Price Rule), following the expiration of the initial 180-day period to regain compliance on July 31, 2023, according to GlobeNewswire.
NASDAQ’s action follows the submission by Kaival Brands to NASDAQ of a plan for regaining compliance with the Bid Price Rule.
As a result of the extension, Kaival Brands now has until Jan. 29, 2024, to regain compliance with the $1.00 minimum bid price rule requirement. If at any time before Jan. 29, 2024, the bid price of Kaival Brands’ common stock closes at or above $1 per share for a minimum of 10 consecutive business days, NASDAQ will provide written notification to Kaival Brands that it has achieved compliance with the bid price requirement. If Kaival Brands chooses to implement a reverse stock split to regain compliance with the Bid Price Rule, it must complete the reverse split no later than 10 business days prior to the expiration of the additional 180-calendar-day period in order to timely regain compliance.
If Kaival Brands does not regain compliance with the bid price requirement by Jan. 29, 2024, NASDAQ will provide written notification to Kaival Brands that its common stock will be subject to delisting. At such time, Kaival Brands may appeal the delisting determination to a NASDAQ Hearings Panel. There can be no assurance that if Kaival Brands does appeal a subsequent delisting determination, such appeal would be successful. Kaival Brands’ common stock would remain listed pending the panel’s decision.
The current notification from NASDAQ has no immediate effect on the listing or trading of Kaival Brands’ common stock, which will continue to trade on the NASDAQ Capital Market under the symbol “KAVL.”

August 3, 2023
Poised for Growth

Photos: Kaival Brands Innovations Group

After the win of its merits case against the FDA, Kaival Brands and Bidi Vapor are back on track.

By Stefanie Rossel

The year 2022 has been both challenging and exciting for Kaival Brands Innovations Group. The Melbourne, Florida, USA-based company is the exclusive distributor of products manufactured by Bidi Vapor, which is best known for its Bidi Stick vape pen, a disposable electronic nicotine-delivery system (ENDS).
In September 2021, Bidi Vapor received a marketing denial order (MDO) from the U.S. Food and Drug Administration for its nontobacco-flavored Bidi Sticks. The company had submitted premarket tobacco product applications (PMTAs) for the product’s nine flavor varieties plus a tobacco and a menthol variant.
In response to Bidi Vapor’s petition for review, the FDA stayed the MDO until December 2021, after which the order was again stayed by the 11th Circuit Court of Appeals. On Aug. 23, 2022, Bidi Vapor won its merits case against the FDA. Granting Bidi Vapor’s petition for review, the 11th Circuit ruled that the MDO was “arbitrary and capricious,” primarily because the FDA failed to consider the relevant marketing and sales access restriction plans included in Bidi Vapor’s PMTAs.
Eric Mosser
At the time of writing, the FDA had yet to announce how it would move forward following the 11th Circuit’s decision. “FDA could seek to appeal the decision by requesting ‘en banc’ review, or a review by the entire 11th Circuit,” explains Eric Mosser, president and chief operating officer of Kaival Brands Innovations Group. “Or they might even try to petition the Supreme Court to review the decision. Regardless, we anticipate being able to continue selling and marketing our flavored products for the duration of any potential appeal, subject to FDA enforcement discretion. It is also possible FDA will simply follow the court’s instructions and review Bidi’s nontobacco PMTAs instead of trying to appeal.”
Flavors, insists Mosser, are a critical matter of public health, and Kaival is adamantly opposed to illegal underage use of tobacco and vape products. “The company has focused on limiting access via contracts with partners prioritizing retailers’ age verification policies, secret shopper audits, repackaging devices to better align with FDA guidance, no use of social media or influencers and no consumer-facing advertising,” he says. “The company even discontinued its online direct sales to consumers—while we had state-of-the-art verification practices, company leaders realized online access was a way that underage youth in general were gaining access to vaping products and decided to eliminate that potential for the Bidi Sticks.”
According to the most recent National Youth Tobacco Survey, Bidi Vapor was not among the top brands that appeal to youth. In 2021, among students who currently used e-cigarettes, Puff Bar was the most commonly reported usual brand (26.8 percent) followed by Vuse (10.5 percent), Smok (8.6 percent), Juul (6.8 percent) and Suorin (2.1 percent).

Niraj Patel

Victory for Vaping
The 11th Circuit’s decision is a victory not just for Bidi Vapor and Kaival Brands but for the entire vaping and tobacco harm reduction industry, according to Mosser—especially for those companies who have been rigorously following the FDA guidelines in their attempts to obtain market authorization. “We at Kaival Brands have done so on the belief that the FDA will follow the science and allow solid evidence to guide their decisions. If that is the case, then the company is on solid ground, and we are hopeful FDA will ultimately agree that our products, including our nontobacco flavored products, are appropriate for the protection of the public health.”
The PMTA for the company’s tobacco-flavored Classic Bidi Stick is currently undergoing Phase III scientific review. There is no timeline for this process, says Niraj Patel, chief science and regulatory officer for Kaival Brands Innovations Group and president and CEO of Bidi Vapor. The Arctic Bidi Stick, which Bidi Vapor maintains is a menthol product, was characterized as a flavored product by the FDA and subjected to the MDO that was vacated. “Barring an appeal, we anticipate that FDA will soon begin the scientific review of the Arctic Bidi Stick PMTA along with our other nontobacco-flavored products,” says Patel.
Patel founded both companies. With a wholesale distribution network of more than 54,000 stores across the United States, Kaival Brands helped Bidi Sticks, which entered the market prior to 2016 under a different brand name and with limited success, to become the fastest-growing and now No. 1 disposable vape brand in the U.S. market. Despite the MDO, the Bidi Stick is still the bestselling disposable ENDS product based on retail sales for the 52-week period ending on Aug. 27, 2022, Nielsen data shows, according to the companies.
Kaival Brands, which commenced business operations in March 2020, generated a cumulative $100 million in revenues in less than a year. In July 2021, Kaival Brands’ stock began trading on the Nasdaq. In April 2022, the company announced the expansion of additional wholesale and retail accounts, a move expected to increase the reach of Bidi Sticks by about 28,000 stores and to make up for the losses the company experienced in the wake of the MDO.

Difficult Times
In fiscal year 2021, which Patel described as “very challenging,” Kaival Brands reported a net loss of $9 million compared to net income of approximately $3.8 million for fiscal year 2020. In a press release, Patel said the MDO had caused “irreparable harm to both Bidi Vapor and Kaival Brands.”
The greatest revenue loss occurred in the last two quarters of fiscal year 2021, between the lifting of the FDA’s administrative stay and the ordering of the judicial stay, when the company was unable to market its Bidi Sticks. Revenues for fiscal year 2021 were approximately $58.8 million compared to $64.3 million in the prior fiscal year. 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, but revenues rose 11 percent compared with the first quarter of 2022, suggesting further recovery.
The 2021 year also presented challenges to Kaival Brands’ attempted foray into the modern oral nicotine market, a category that is still a niche but that has recently grown dramatically. The global nicotine pouches market size was valued at $1.5 billion in 2021. Grand View Research expects it to increase at a compound annual growth rate (CAGR) of 35.7 percent from 2022 to 2030.
Bidi Vapor had planned to introduce its Bidi Pouch in February 2021, but due to the Covid-19 pandemic, the launch had to be postponed. In September 2021, the company said in a press release that the launch would be further delayed while the company reformulated the product to utilize tobacco-derived nicotine and sought FDA marketing authorization. The company had originally envisioned the pouch to contain synthetic nicotine but pivoted following concerns about the legality of nontobacco-derived nicotine.
Congress subsequently changed the definition of a “tobacco product” to include synthetic nicotine products, with the FDA requiring manufacturers of nontobacco nicotine products to submit PMTAs by May 14, 2022. As of July 13, 2022, any new synthetic nicotine product that has not received premarket authorization from the FDA cannot be legally marketed. “We did not launch our nicotine pouch product,” Patel says. “Due to concerns with synthetic nicotine, we decided to focus on tobacco-derived nicotine and will launch in the U.S. only after we obtain FDA PMTA marketing authorization.”

Cooperating with PMI
In June 2022, Patel handed over the management of Kaival Brands to Eric Mosser. The leadership change had always been a part of the plan, according to Mosser. “I was preparing for the leadership role, which was set to occur as soon as plans for international expansion solidified. International distribution came sooner than later once Philip Morris International decided to license technology from Bidi Vapor and now also has distribution rights in certain markets outside the United States.”
Two weeks earlier, Kaival Brands’ newly created wholly owned subsidiary, Kaival Brands International, had entered into a licensing agreement with Philip Morris Products (PMP), a wholly owned affiliate of PMI. The agreement grants to PMP a license of certain intellectual property rights relating to Bidi Vapor’s premium ENDS device, the Bidi Stick, as well as potentially newly developed devices to permit PMP to manufacture, promote, sell and distribute such ENDS devices and newly developed devices in international markets outside of the U.S. Patel called the agreement a major milestone in Kaival Brands’ efforts to expand the global sales and distribution of the Bidi Stick.
Kaival Brands, in turn, announced the launch of Veeba, PMI’s first disposable e-cigarette utilizing Bidi Vapor’s intellectual property, in Canada in late July. PMI’s new product is now the lowest-priced disposable vape on the Canadian market. Mosser says he anticipates revenues through royalties paid by PMP, pursuant to the licensing agreement, in the fourth fiscal quarter. “I see Kaival Brands reclaiming its previous revenue growth trajectory and expanding into additional market segments with new innovative products that we exclusively distribute or own, not only here in the U.S. but also in profitable global markets.”
Disposable e-cigarettes are a growth market. According to report from Future Market Insights, the global disposable e-cigarette market size is expected to be valued at $6.34 billion in 2022. The overall demand for disposable e-cigarettes is projected to grow at a CAGR of 11.2 percent between 2022 and 2032, totaling around $ 18.32 billion by 2032.

Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

October 3, 2022
Kaival Expects Boost From Court Ruling

Photo: Kaival Brands Innovations Group

Kaival Brands, the U.S. distributor of products manufactured by Bidi Vapor, expects sales of its Bidi Stick vapor product to benefit from a recent court decision instructing the U.S. Food and Drug Administration to take another look at the company’s premarket tobacco product applications (PMTAs).
On Aug. 23, the U.S. Court of Appeals for the 11th Circuit granted petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications. According to Chief Judge William Pryor, the agency didn’t properly assess the companies’ marketing and sales-access-restriction plans designed to minimize youth exposure and access.
This ruling effectively reverses the marketing denial orders and allows Bidi Vapor to continue to market all flavor varieties of the Bidi Stick in the United States. The company submitted PMTAs for all 11 flavor of its Bidi Stick prior to the Sept. 9, 2020, PMTA deadline.
“As the exclusive U.S. distributor of Bidi Vapor’s products, this [ruling] is a significant event for us and our downstream partners, as many awaited the decision before expanding distribution, and paves the way for potential revenue growth for our company,” said Eric Mosser, president and chief operating officer of Kaival Brands, in a statement.
“But more than that, we are glad the appellate court recognized the potential importance and direct effects that an adult-focused marketing plan and strict sales and access restrictions may have on addressing the youth access problem.”
At press time, the FDA had not announced how it would respond to the court ruling. The agency could appeal the ruling or put Bidi Vapor’s PMTAs for its nontobacco-flavored devices into scientific review.

August 29, 2022
Kaival Brands Reports Quarterly Results

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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 the 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.”

June 21, 2022