Tag: Kaival Brands

  • 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.”

  • 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.

  • Kaival Expands Distribution for Bidi Stick to 46,000 Stores

    Kaival Expands Distribution for Bidi Stick to 46,000 Stores

    Kaival Brands has three new distribution partners for its Bidi Vapor products: Smoker Friendly International, Avail Vapor and Hilmes Distributing. These three additional distributors push the potential U.S. store count for Bidi Vapor products above 46,000, up from 10,000 in 2020.

    According to Bidi Vapor, distributor interest in its products has increased greatly following its receipt of a premarket tobacco product application filing letter from the Food and Drug Administration. As the company’s product moves into the substantive review phase, Bidi Vapor anticipates it will continue to update investors on additional new distribution agreements.

    “These new partners will become a large new revenue stream for Bidi and Kaival,” said Niraj Patel, CEO of Kaival Brands, in a statement. “It is important to note our 2020 sales of just under $100 million were achieved with a distribution network of 10,000 stores and in less than 10 months of operation.

    “Today’s new distribution partner announcements bring our network to over 46,000 store locations. The strength and breadth of these partnerships fuels our confidence in our ability to meet or exceed our 2021 projection of $400 [million] to 450 million in sales.”

  • Bidi Vapor PMTA Moves to Substantive Review Phase

    Bidi Vapor PMTA Moves to Substantive Review Phase

    Kaival Brands Innovations Group, the global distributor of all Bidi Vapor products, announced its premarket tobacco product application (PMTA) has moved the substantive review phase of the regulatory process. Bidi’s disposable e-cigarettes, Bidi Stick, comes in 11 flavor varieties, according to a press release.

    Substantive Review is where the scientific review of the U.S. FDA’s regulatory process is undertaken. The company received its acceptance letter, the first step, on Feb. 9. The FDA will determine if Bidi products meet the criteria for “appropriate for the protection of the public health” established in the Tobacco Control Act. The agency issues marketing orders that authorize the continued marketing and sale of products meeting the criteria.

    “Seeking an order for the continued marketing of Bidi Sticks in the United States is a long process. But it was always our goal to provide a premium vaping experience and an option to traditional, combustible tobacco that meets the needs of every adult smoker,” said Niraj Patel, the president and CEO of Kaival Brands. “This substantive review phase is where months of extensive information collection and hard work gathering together 285,000 pages of science-based evidence will pay off, as we continually put consumer health and the environment first.”

    Bidi Vapor also announced they have discontinued their online direct-to-consumer (DTC) sales through its website as of February 22, 2021. The company will allow sales through gopuff.com. “With a long history of distribution of alcoholic beverages, goPuff has pioneered a very stringent and dynamic compliance program and age-gating process,” the release states.

    “We are extremely excited to partner with one of the fastest growing and most secure online delivery services in the country,” stated Kaival Brands’ Chief Executive Officer, Niraj Patel. “More importantly, goPuff’s commitment to protecting minors and stringent procedural implementations will allow Kaival Brands to focus on our rapidly developing additional wholesaler distribution agreements.”

    While Kaival Brands will continue its business-to-business (B2B) online sales to retailers, it believes its decision to halt online DTC sales specifically through www.bidivapor.com will set an example for the industry and help reduce the larger problem of underage access to vaping devices. “The decision also bolsters its commitment to brick-and-mortar retail, which Kaival Brands believes to be a stronger age-verification distribution model than online sales,” the release states.

  • Bidi Vapor Announces PMTA Acceptance Letter

    Bidi Vapor Announces PMTA Acceptance Letter

    After submitting its PMTA application to the U.S. FDA on Sept. 8, 2020, Bidi Vapor, the producer of the Bidi Stick closed system, announced yesterday that it had received a PMTA acceptance letter from the regulatory agency.

    “It has always been our goal to provide a premium vape experience as an option to traditional, combustible tobacco that meets the needs of every adult smoker, age 21 and older,” said Niraj Patel, the president and CEO of Bidi Vapor and Kaival Brands Innovations Group, global distributor of all Bidi brand products “We couldn’t be more pleased that we are one step further in achieving this goal.”

    The company now waits for a filing letter from the FDA. The Bidi Stick PMTAs would then move on to the Substantive Review phase where the scientific data is analyzed. The Bidi Stick, is the fastest-growing closed system vaping product in the U.S., based on Goldman Sachs’ equity research report on the Nielsen data for total nicotine volumes in 2020. Nielsen data showed the Bidi Stick as the second-largest disposable electronic nicotine-delivery system (ENDS) offering based on retail sales for previous 52-week period.

    The acceptance letter covers all 11 flavors in the Bidi Stick lineup. “Moving to the filing and, we anticipate, to the substantive review phase of the PMTA process is where our months of extensive data collection, investment and hard work assembling 285,000 pages of science-based evidence will pay off,” Patel said. “Receipt of the acceptance letter is a major step, as we await the FDA’s filing letter and then substantive review of our products.”

    The press release also states that the Bidi Stick is also the only adult-focused vape product on the market with an ecologically friendly, mass-recycling program. Kaival Brands also recently launched Bidi Vapor ‘s Bidi Pouch, a tobacco-free nicotine pouch.

  • Bidi Stick Disposable Vape Submits PMTA to U.S. FDA

    Bidi Stick Disposable Vape Submits PMTA to U.S. FDA

    Bidi Vapor, the manufacturer of the disposable vape pen Bidi Stick, has submitted its Premarket Tobacco Product application (PMTA) to the U.S. Food and Drug Administration (FDA). The announcement was made by Kaival Brands Innovations Group, a company focused on growing and incubating innovative and profitable products into mature, dominant brands, in a press release.

    “We are confident that, upon review, the FDA will authorize Bidi Vapor’s Bidi™ Stick for continued marketing in the United States,” said Niraj Patel, president and CEO of Kaival Brands. “It is a premium-quality product that adult smokers have discovered can be a viable alternative to combustible tobacco, and we look forward to meeting the increasing market demand for the innovative Bidi Stick.”

    The application detailed 11 flavored varieties with nicotine concentrations of 6 percent weight/volume. The Bidi Stick is a disposable pod system, similar to Juul. “Starting from a science-based foundation, Bidi Vapor has engineered its electronic nicotine-delivery system (ENDS) products using its own patented technology, ensuring quality control and assurance from the raw chemicals and components purchased through to the manufacturing process in a cGMP (current Good Manufacturing Practice) facility,” the release states.

    Bidi states that its product went through various in-vitro and in-vivo toxicity testing (including genotoxicity tests) at a GLP (Good Laboratory Practice) approved lab, as well as HPHC (Harmful and Potentially Harmful Constituents) analysis of both the aerosol and e-liquid in ISO 17025 certified labs. Also included in its PMTA submission, Bidi Vapor conducted three independent surveys and one “combined” consumer survey of people aged 21 and over.

    Bidi Vapor’s application was more than 285,000 pages, according to the release. “Both Kaival Brands and Bidi Vapor fully support proper regulation of the category so that all ENDS products meet the highest manufacturing, safety and marketing standards for adult smokers, with the ultimate goal of improving the public health,” said Patel. “We look forward to working with Bidi Vapor as they work with the FDA to construct its regulatory policy based on science and facts.”