Tag: Kaival Brands Innovation Group

  • Kaival Brands Appeals MDO of Tobacco Bidi Stick

    Kaival Brands Appeals MDO of Tobacco Bidi Stick

    A recent marketing denial order issued for a tobacco-flavored Bidi Stick only applies to one Bidi device. The company, Bidi Vapor, currently has 10 other flavors still in the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process.

    Bidi Vapor’s “Classic” tobacco-flavored Bidi Stick ENDS device is the only product affected. Kaival Brands, parent to Bidi Vapor, holds the worldwide license to distribute products made by Bidi Vapor.

    In response to the MDO, Bidi Vapor filed a petition requesting that the U.S. Court of Appeals for the 11th Circuit review the MDO, which Bidi Vapor believes was, among other things, “arbitrary and capricious, in violation of the Administrative Procedure Act.” Bidi Vapor will also be seeking a stay of the MDO pending the outcome of the litigation.

    “Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly,” said Niraj Patel, the founder and CEO of Bidi Vapor and Chief Science Officer and founder of Kaival Brands. “In the meantime, it is important to note that the decision only affects the ‘Classic’ or tobacco-flavored Bidi Stick. The remaining ten Bidi Stick flavors are still under FDA scientific review and remain in distribution in the United States through Kaival Brands, subject to the FDA’s enforcement discretion.”

    Bidi Vapor has a history of successful outcomes when contesting adverse FDA decisions, having received a favorable 11th Circuit ruling in August 2022 that set aside the original MDOs received for its 10 non-tobacco flavored products, according to a press release.

    “While we are disappointed with the FDA’s decision, we are in close contact with Bidi Vapor and laser-focused on selling the Bidi Vapor products that we are permitted to,” said Barry Hopkins, executive chairman of Kaival Brands. “Like Bidi Vapor, we are fully committed to the legal and responsible use of our products. Moreover, we are committed to increasing Kaival Brands’ revenues by strengthening our existing business and also diversifying our product portfolio, as evidenced by the intellectual property we acquired in May 2023 from GoFire, Inc.”

  • 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.

  • Kaival Brands Promotes Hopkins to CEO, President

    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.”

  • Kaival Appoints Hopkins as Executive Chairman

    Kaival Appoints Hopkins as Executive Chairman

    Image: Monster-Ztudio

    Kaival Brands Innovations Group has expanded the role of Barry Hopkins, chairman of the board, to the new position of executive chairman. In this role, Hopkins will serve as Kaival Brands’ principal executive officer. Current President and CEO Eric Mosser will continue to manage day-to-day operations of the company.

    Hopkins joined Kaival Brands as chairman of the board in March 2023. He is a 40-year tobacco industry veteran with deep operational experience and industry contacts. With his expanded responsibilities, Hopkins will play a more active role in the strategic direction and oversight of the company, with a focus on accelerating revenue growth, improving operational efficiencies and executing on Kaival Brands’ strategic initiatives.

    “Since I joined Kaival Brands in March, I have become even more energized by the opportunities for our company and look forward to working with Eric and our excellent senior leadership team to refine our strategic business plan and reignite growth,” said Hopkins in a statement. “I aim to foster a culture of performance and accountability and to establish clear decision-making processes and strong communication, which are essential for moving our promising business forward.”

    Hopkins spent most of his decades-long career primarily in senior sales and marketing roles for Turning Point Brands and Altria.

  • Kaival Brands Promotes Stephen Sheriff to COO

    Kaival Brands Promotes Stephen Sheriff to COO

    Photo: akub Jirsák | Dreamstime.com

    Kaival Brands Innovations Group has promoted Stephen Sheriff to chief operating officer.

    Sheriff succeeds Eric Mosser, who was recently promoted to CEO, and joins Mosser and recently appointed Chief Financial Officer Thomas Metzler as a part of Kaival Brands’ expanded senior management team.

    “Promoting Stephen to the role of chief operating officer was a natural and logical next step given his contributions to the success of Kaival Brands to date and his experience helping businesses navigate through rapid periods of growth and change,” said Mosser in a statement. “He has a strong entrepreneurial spirit and will be instrumental in helping us take our business to the next level. With a deep understanding of our operations, the capital markets and what it takes to develop and execute a strategy with proven results, he is a great addition to our C-suite leadership team.”

    Sheriff brings more than a decade of finance and entrepreneurial leadership to his new role. Most recently, he served as the director of administration and communications at Kaival Brands. In this role, he managed the company’s investor and public relations and human resource programs in addition to overall responsibility for the development and implementation of key programs and initiatives, including customer and vendor relations.

    Prior to Kaival Brands, Sheriff co-founded Riverhill Group, a capital markets advisory and consulting firm.

  • Kaival Brands Amends Agreement With Philip Morris

    Kaival Brands Amends Agreement With Philip Morris

    Photo: Kaival Brands Innovations Group

    Kaival Brands Innovations Group, announced that its wholly-owned subsidiary, Kaival Brands International (KBI), has amended its agreement with Philip Morris Products, a wholly owned affiliate of Philip Morris International (PMI), for the development and distribution ENDS products in markets outside of the U.S.

    Eric Mosser, CEO of Kaival Brands, the exclusive distributor of all products manufactured by Bidi Vapor, including the BIDI Stick electronic nicotine delivery system (ENDS), 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 non-recurring 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.

  • Kaival Brands Group Changes Top-Level Leadership

    Kaival Brands Group Changes Top-Level Leadership

    Credit: Mia B

    Kaival Brands Innovations Group, parent to Bidi Vapor, today announced the promotion of Eric Mosser, its current president and chief operating officer, to the position of CEO. Mosser brings over a decade of senior leadership experience, including since 2020 at Kaival Brands. Mosser will retain the position of president, according to a press release.

    The company also also appointed Thomas J. Metzler as the company’s chief financial officer (CFO), treasurer and secretary, effective as of August 1, 2023, replacing Mark Thoenes, who has served as Interim CFO since 2021.

    Metzler brings over 20 years of finance and operational experience in the vaping and consumer products sector, previously serving as managing director of a division of Turning Point Brands.

    At Turning Point Brands, Metzler led a team to transform the process of financial management efficiencies, which improved cost controls, managed inventory turn, developed strategic product promotions to accelerate product distribution, and built strategic alliances with suppliers.

    “We are very excited to have Tom join our senior management team and believe his hiring represents a key building block for the future of Kaival Brands, said Mosser. “Tom brings to us a wealth of experience and knowledge across all of the key elements of the CFO’s office including treasury, finance, and accounting.

    “He also has tremendous knowledge of business operations in our industry and will therefore greatly contribute to the crafting and implementation of our growth plans. On behalf of our board of directors, we welcome Tom and give thanks to Mark Thoenes for his excellent work as our interim CFO the past few years.”

  • Kaival Brands Reports Flat Quarterly Revenues

    Kaival Brands Reports Flat Quarterly Revenues

    Photo: wichayada

    Kaival Brands Innovations Group reported revenues of $3 million in the second quarter of fiscal 2023, down from $3.1 million in the comparable 2022 quarter. Gross loss was $100,000 compared with a gross profit of $400,000 in the prior-year period.

    While sales were slightly down versus the prior year quarter due to customer credits, discounts and rebates, Kaival believes that continued U.S. Food and Drug Administration enforcement of noncompliant electronic nicotine-delivery system products has allowed the company to position its Bidi Stick as a compliant alternative subject to FDA enforcement discretion. The company believes this should also help in securing new orders for the Bidi Stick.

    “We remain excited and confident in the future of Kaival Brands,” said Eric Mosser, president and CEO of Kaival Brands, in a statement. “Over the past four months, we signed new broker and distribution agreements for our core Bidi Stick distribution business, focusing on partners that share our vision of regulatory compliance and youth access prevention. We believe we have positioned ourselves for increased sales in the second half of the year.”

    In addition to its quarterly results, Kaival announced the renewed distribution of its Bidi Stick in Circle K convenience stores. “As of this week, we have activated over 1,000 new Circle K locations, with the goal of ramping up to 5,000 this year,” said Mosser.

    The company also announced the initial shipment of Bidi Sticks to over 900 Kwik Trip and Mapco locations.

  • Kaival Releases Details of GoFire Patents Deal

    Kaival Releases Details of GoFire Patents Deal

    Kaival Brands Innovations Group provided additional details of its recently acquired extensive patent portfolio from GoFire as it looks to expand its current product offerings to explore near-term and long-term revenue opportunities, according to GlobeNewswire.

    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, the company believes it can utilize the acquired patents to create innovative and market-disruptive products for its growing base of adult consumers, including patent protected vaporizer devices and related hardware and software applications.

    The consideration for the purchased patents consisted primarily of Kaival Brands equity securities, consisting of common stock, newly designated Series B Preferred Stock and a warrant to purchase common stock. Importantly, in certain key aspects, the equity consideration was structured in a forward-looking manner with valuations or exercise prices struck at premiums to the current market price of Kaival Brands’ common stock. The weighted price per share of the common stock issued and the common stock underlying the Series B Preferred Stock was $1.53 per share on the May 30 closing date, accompanied by warrants with exercise prices ranging from $3 and $6.

    Included in the acquired technologies are patented systems and methods that are designed to overcome common issues regarding reliability and consistent dispensing over the entire life of a cartridge or reservoir as well as improvements to the vaporizing chamber to ensure complete vaporization with minimum residue.

    The acquired patent portfolio includes the following: Bluetooth Child Safety App and Mechanical Cartridge Protection; Controlled Delivery; Flavor Delivery and Experience to Last Puff; Leak Proof Design and Removal of Cutting Agents; Authentication System/Counterfeit Protection; Dry Puff Protection; 510 and Pod Compatibility; Product Remaining Indicators; and MHRA Requirements.

    The GoFire patent portfolio includes 12 existing patents and 46 pending applications 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 EPO (European Patent Organization), 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.

    The acquired assets are housed in Kaival Labs, a wholly owned subsidiary of Kaival Brands, which develops new branded and white label products and services in the vaporizer and inhalation technology sectors.

  • Kaival Brands Appoints James Cassidy to Board

    Kaival Brands Appoints James Cassidy to Board

    Kaival Brands Innovations Group appointed James P. Cassidy as a new member of its board of directors, according to a press release.

    Cassidy joins the board of directors as part of Kaival Brands’ recently announced acquisition of an extensive vaporizer and inhalation technology patent portfolio from GoFire. Cassidy is an investor in, and serves as board advisor to, GoFire.

    “We are excited to announce Jim Cassidy as our newest independent director,” said Eric Mosser, chief operating officer, president and a director of Kaival Brands. “Jim’s background as a private equity investor and advisor to growing companies not only in the tobacco space but within the consumer and healthcare spaces will be of tremendous value as we look to expand into new verticals and opportunities following our GoFire patent portfolio acquisition.”

    Cassidy currently serves as the founder and CEO of Preposterous Holdings, a family-run private equity firm with offices in Asheville, North Carolina, USA, which he established in 2013. Cassidy has over 25 years of extensive experience and expertise as a private equity investor and advisor across several industries, including the key areas of tobacco, healthcare, consumer packaged goods and technology.

    Prior to his current roles, from 2000 to 2007, Cassidy was partner in the Strata Group, a wealth management advisory group at Smith Barney. He started his career in 1983 at UST, a tobacco business holding company, working in various roles in the government relations department and as director of corporate services.