Tag: Kaival Brands

Kaival Brands Revenues and Profits Growing

Photo: David
Kaival Brands Innovations Group reported revenues of $3.2 million for the first quarter of fiscal year 2024 compared with $2.5 million in the same period of the prior fiscal year. Gross profit was approximately $1.2 million in the quarter, up from $500,000 gross profit for the first quarter of fiscal year 2023. The increases in revenues and gross profit was due primarily to a decrease in credits being issued to customers, according to the company.
Nirajkumar Patel, who was recently appointed CEO at Kaival, assured investors that despite recent challenges, the company remains focused on preserving and improving shareholder value.
“We have experienced a number of stalled starts related to the FDA’s [U.S. Food and Drug Administration] denial of Bidi Vapor’s premarket tobacco product application for Bidi Vapor’s ‘Classic’ tobacco-flavored Bidi Stick ENDS [electronic nicotine-delivery system] device, and we are navigating a number of transitions,” Patel said in a statement.
Patel also noted the company is appealing the FDA decision on Bidi Stick.
“However, we continue to believe there is tremendous value related to our international business as well as new, potential opportunities to monetize the extensive and valuable inhalation patent portfolio that we acquired from GoFire in May of last year.”
According to Patel, the purchase of the portfolio marks the beginning of Kaival’s diversification efforts and move away from reliance on revenues from Bidi Sticks. “Our efforts to explore profitability of this portfolio are underway, and we are incredibly energized by the interest and revenue opportunities we believe could be available to us through this portfolio,” said Patel.
April 1, 2024
Kaival Brands Promotes Hopkins to CEO, President

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 S.A., a wholly owned affiliate of Philip Morris International Inc.
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
Bidi Vapor Calls for Removal of Non-Compliant Vapes

Credit: Iama Sing
During a recent webcast, Bidi Vapor leadership called on the U.S. Food and Drug Administration to do more to stop the flood of non-compliant vaping products from entering the market.
In a recently produced webcast, “Vape Update: Getting Noncompliant Devices Off the Market,” Bidi Vapor executives detailed current enforcement activities the agency has been ramping up throughout the industry and touched on potential solutions, such as tracking scan data to identify unlawful companies.
“It’s a major public health concern when these illicit, noncompliant and non-regulated products are overtaking the legal products,” said Niraj Patel, CEO of Bidi Vapor. “These illegal products used to be in just mom-and-pop stores, but now, these products are breaking into the franchise market, and showing up in the Nielsen numbers. But this list also puts pressure on the FDA and all other law enforcement agencies to do their jobs.”
Data from Nielsen, a New York-based data-collection firm, has the ability to provide the information needed to make a larger impact on the illicit market, according to Russell Quick, president of Bidi Vapor’s marketing firm, Kaival Marketing Services, reports CStoreDecisions.
Photo: Kaival Brands Innovations Group
“Law enforcement can now track the supply chain,” Quick said in the webcast. “We can identify the distributors and retailers that are selling these non-compliant, illegal, illicit products. So both federal and state level authorities can issue warnings, fines, civil penalties or even harsher monetary penalties to these companies that are participating in and distributing these illegal products.”
Bidi Vapor also produced two related infographics on illicit vape products and the illicit market to accompany the webcast. To download the graphics: “How to Spot Illicit Vape” and “Rise of Illicit Vape.”
The full webcast can be found here.
November 30, 2023
Kaival Brands Earns Initial Royalties From Philip Morris

Kaival Brands Innovations Group, Inc, parent to Bidi Vapor, LLC (“Bidi Vapor”), received its first royalty payments from Philip Morris International, Inc. (PMI) for marketing Bidi Vapor products in multiple countries.
In a press re le ase, Kaival Brands announced that PMI achieved a record level of monthly sales in July for of its Bidi products that are marketed by PMI under the names VEEBA and VEEV NOW.
Eric Mosser, Chief Executive Officer 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 25, 2023
NASDAQ Grants Kaival Brands 180-Day Extension

Image: Tobacco Reporter archive
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
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.
June 16, 2023
Kaival Brands Acquires GoFire Patent Portfolio

Credit: Olivier le Moal
Kaival Brands Innovations Group announced it has acquired an extensive patent portfolio from GoFire, Inc. with the goal of diversifying its product offerings and creating near- and longer-term revenue opportunities.
The GoFire patent portfolio includes 12 existing and 46 pending with novel technologies across extrusion dose control, product preservation, tracking and tracing usage, multiple modalities (i.e., different methods of vaporizing) and child safety.
The patents and patent applications cover territories including the United States, Australia, Canada, China, the European Patent Organisation, Israel, Japan, Mexico, New Zealand and South Korea. The portfolio also includes a proprietary mobile device software application that is used in conjunction with certain patents in the portfolio.
“We are excited to place these valuable assets into Kaival’s hands. After working hard to create this intellectual property with a goal of providing safer and healthier products to the marketplace, we engaged in a comprehensive assessment of how best to further its development into actual products and services with consumer reach,” Peter Calfee, CEO of GoFire, stated. “At the end of that process, we chose to invest our patent portfolio in Kaival in exchange for Kaival equity as the right fit for our technology.”
The acquired assets will be housed in Kaival Labs, Inc., a subsidiary of Kaival Brands that develops new branded and white-label products and services in the vaporizer and inhalation technology sectors, according to a press release.
In the near term, Kaival Brands expects to seek third-party licensing opportunities in the cannabis, hemp/CBD, nicotine and nutraceutical markets as a means of monetizing its new patents.
Longer term, Kaival Brands believes it can utilize the acquired patents to create innovative and market-disruptive products, including patent-protected vaporizer devices and related hardware and software applications.
“This is a transformative asset acquisition for Kaival Brands,” stated Eric Mosser, president and chief operating officer of Kaival Brands. “As we look to the future of our company beyond our core BIDI Stick distribution business, the purchase of this extensive patent portfolio marks the first step in diversifying our product offerings for adult consumers and potential revenue streams.
“We believe this forward-looking acquisition, with the acquisition consideration structured in key respects at premiums to the current market value of our common stock, broadens and strengthens our company and our prospects considerably as we seek to drive value for our stockholders.”
June 1, 2023
Kaival’s Fiscal 2022 Hit by Marketing Denial Order

Photo: Kaival Brands
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 subpart 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 Poised for Growth With Bidi Stick

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 27, 2022
Kaival Launches PMI’s Veeba Disposable in Canada

Credit: Kristina Blokhin
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