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Great news!

We are happy to announce that Bidi Vapor has been granted a stay order by the FDA.

Which means all 11 flavors of the BIDI®️ Stick are now legal to market and distribute as the FDA is currently reviewing the previously released MDO.

Kaival Looks Towards Fiscal 2023 Following Philip Morris International Distribution Agreement and Favorable Decision by Appellate Court Allowing for Renewed Non-Tobacco Flavored BIDI® Sticks Sales Outlook in US

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GRANT, Fla., Jan. 30, 2023 (GLOBE NEWSWIRE) — Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) (“Kaival Brands,” the “Company” or “we,” “our” or similar terms), the exclusive U.S. distributor of all products manufactured by Bidi Vapor, LLC (“Bidi Vapor”), including the BIDI® Stick electronic nicotine delivery system, which are intended for adults 21 and over, today announced its financial results for the fiscal 2022 fourth quarter and full year ended October 31, 2022.

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

Fourth Quarter and Full-Year 2022 Highlights

  • On or about May 13, 2022, the U.S. Food and Drug Administration (“FDA”) placed the tobacco-flavored Classic BIDI® Stick into the final Phase III scientific review.
  • In June, the Company’s wholly owned subsidiary, Kaival Brands International, LLC (“KBI”), entered into an international licensing agreement with Philip Morris Products S.A. (“PMPSA”), a wholly owned affiliate of Philip Morris International Inc., for the development and distribution of electronic nicotine delivery system (“ENDS”) products in markets outside the U.S., subject to market (or regulatory) assessment.
  • In July, the Company announced the launch of PMPSA’s custom-branded self-contained e-vapor product, VEEBA, being sold in Canada, with royalties due to KBI pursuant to the international licensing agreement.
  • In August, the U.S. Court of Appeals for the Eleventh (11th) Circuit ruled in favor of Bidi Vapor in its appeal of the FDA’s Marketing Denial Order (“MDO”) issued to the non-tobacco flavored BIDI® Sticks. The court set aside or vacated the MDO and remanded the PMTAs back to FDA for further review.
  • In December, KMS, Kaival’s marketing & sales vendor, hired Dean Simmons, a former Vice President of Sales of Swisher International, in preparation for an expected resurgence of revenue growth following a pivotal legal victory for Bidi Vapor this past summer.

Summary of Fourth Quarter and Full Year Fiscal Results

Revenues: Revenues for the fourth fiscal quarter ended October 31, 2022 were approximately $3.0 million, compared to approximately $0.1 million for the prior fourth fiscal quarter. Revenues for the full fiscal year ended October 31, 2022 were approximately $12.8 million, compared to approximately $58.8 million for fiscal year 2021. Revenues decreased in fiscal year 2022, primarily in the first two fiscal quarters, due to Bidi Vapor’s receipt of the MDO, our resulting inability to sell our products and also generally due to increased competition, which we believe was the result of the lack of enforcement by federal and state authorities against sub-par and low-priced vaping products, including illegal synthetic nicotine disposable ENDS, that continued to enter the market illegally without FDA authorization.
 
Following the 11th Circuit Court decision vacating the FDA’s MDO in August, we began to aggressively reignite sales efforts and expect an upturn in sales of all BIDI® Sticks, anticipated to begin to show results in the second quarter of fiscal year 2023 (which sales remain subject to FDA’s enforcement discretion). We also anticipate that if the FDA begins enforcement against illegally marketed or synthetic-nicotine vaping products, there may be an increased demand for compliant and legal vaping products, such as the BIDI® Stick.
 
Cost of Revenue, Net, and Gross Profit (Loss): Gross profit for the fourth fiscal quarter ended October 31, 2022 was approximately $1.1 million, compared to approximately $(1.0) million gross loss for the prior fourth fiscal quarter. Gross profit for the full fiscal year ended October 31, 2022 was approximately $1.2 million, compared to approximately $11.9 million for fiscal year 2021. Total cost of revenue for the fourth fiscal quarter ended October 31, 2022 was approximately $1.9 million, compared to approximately $0.9 million for the prior fourth fiscal quarter, and approximately $11.5 million for fiscal year 2022, compared to approximately $46.8 million for fiscal year 2021. The decrease in gross profit volume is primarily driven by the downturn in sales of our products, beginning in the third quarter and continuing through the end of fiscal year 2022, which was primarily the result of the negative impact the MDO and the overall impact the regulatory landscape had on our business. Additionally, the cost of the discounts, coupons and promotions programs, that we implemented in the third quarter of fiscal year 2021 to assist in growing and retaining the customer base and store shelf space, contributed a lower gross profit margin per unit of products sales for that period of time, as these discounts, coupons and promotions decreased our revenues.
 
Operating Expenses: Total operating expenses for the fourth fiscal quarter ended October 31, 2022 were approximately $3.8 million, compared to approximately $4.3 million for the prior fourth fiscal quarter, and were approximately $15.6 million for fiscal year 2022, compared to approximately $22.4 million for fiscal year 2021. For the fiscal year 2022, operating expenses consisted primarily of advertising and promotion fees of approximately $2.7 million, stock option compensation expense of approximately $6.0 million, professional fees of approximately $3.2 million, salaries and wages of $1.7 million, and all other general and administrative expenses of approximately $2.0 million. In fiscal year 2021, operating expenses consisted of advertising and promotional expenses of approximately $3.2 million, which included commissions paid to our third-party marketing consultant QuikfillRx, and general and administrative expenses of approximately $10.2 million. We expect future operating expenses to increase while we generate increased sales growth and invest in our infrastructure to support the planned revenue and business growth.
 
Net Loss: Net loss for the fourth fiscal quarter ended October 31, 2022 was approximately $(2.7) million, compared to approximately $(1.6) million for the prior fourth fiscal quarter, and approximately $(14.4) million for the full fiscal year 2022, or $(0.36) basic and diluted net loss per share, compared to a net loss of approximately $(9.0) million, or $(0.38) basic and diluted net loss per share, for fiscal year 2021. The increase in net loss for the fiscal year 2022, as compared to net loss in fiscal year 2021, is attributable to the revenue and expense factors noted above.
 
Cash Position: We consider all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. There were no cash equivalents on October 31, 2022, or October 31, 2021. Cash and restricted cash on October 31, 2022, and October 31, 2021, were $3.7 million and $7.8 million, respectively.
Restricted cash consists of cash held short-term in escrow as required. As of October 31, 2022, and October 31, 2021, we had $0 and $65,007 in restricted cash, respectively, for amounts held in escrow.
 
Additional information regarding the Company’s results of operations for the fiscal year ended October 31, 2022 will be available in the Company’s Annual Report on Form 10-K for such reporting period, which report will be filed with the Securities and Exchange Commission. Readers are encouraged to review such Annual Report in its entirety, including the risk factors related to the Company’s business described therein.
 

ABOUT BIDI VAPOR

Based in Melbourne, Florida, Bidi Vapor maintains a commitment to responsible, adult-focused marketing, supporting age-verification standards and sustainability through its BIDI® Cares recycling program. Bidi Vapor’s premier device, the BIDI® Stick, is a premium product made with high-quality components, a UL-certified battery and technology designed to deliver a consistent vaping experience for adult smokers 21 and over. Bidi Vapor is also adamant about strict compliance with all federal, state and local guidelines and regulations. At Bidi Vapor, innovation is key to its mission, with the BIDI® Stick promoting environmental sustainability, while providing a unique vaping experience to adult smokers.
 

Nirajkumar Patel, the Company’s Chief Science and Regulatory Officer and director, owns and controls Bidi Vapor. As a result, Bidi Vapor is considered a related party of the Company.

For more information, visit www.bidivapor.com.
 
February 2, 2023

Kaival Brands Reports Fiscal Fourth Quarter 2022 and Full-Year 2022 Financial Results

Kaival Looks Towards Fiscal 2023 Following Philip Morris International Distribution Agreement and Favorable Decision by Appellate Court Allowing for Renewed Non-Tobacco Flavored BIDI® Sticks Sales Outlook […]
February 15, 2023

BIDI® Stick Price Change Coming Soon

Bidi Vapor holds a limited time offer for partners to avail promotional allowance After two years of maintaining product pricing, Bidi Vapor announces updates regarding its […]
February 16, 2023

Legal Expert Examines Ban on Synthetic Nicotine

Bidi Vapor Webcast: Discussion over what’s legal and what’s not focuses on key ingredient  MELBOURNE, Florida – Despite a federal ban on electronic nicotine delivery systems […]
March 9, 2023

Kaival Brands Announces New Retail Distribution Agreements Providing Access to 13,500 New Locations

BIDI® Stick rollout activated in 700 initial new stores under agreements  MELBOURNE, Florida – GRANT-VALKARIA, Fla., March 07, 2023 (GLOBE NEWSWIRE) — Kaival Brands Innovations Group, […]
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Clarification of Role of Wholesalers and Distributors

Thank you for signing the Wholesalers and Direct Retailers Agreement & Terms (“Agreement”). By signing this Addendum, you agree to the following clarification of the intent of the Agreement with regard to the Age-Verification process and online sales as it relates to your role as a reseller to another reseller (those that resell to other resellers, herein “Wholesalers”). The following clarification does not apply or modify the terms of the Agreement related to any sales to, or marketing you may make directed to, end user customers of BIDI® Sticks (the “products”). 

With regard preventing underage access to the product and marketing to underage persons, to the extent you do not control the sales practices of your resellers, you agree to act responsibly and comply with your own obligations under the law and in support of the policies in the Agreement in your role as a reseller of the products you purchase and sell under the Agreement. For instance, although you may not control that a cashier checks IDs, you will not sell to those resellers who have a history of selling to minors, as indicated in the FDA’s retailer inspection database. You will not sell and will cease selling to resellers upon knowledge of underage sales of the products or other non-compliance with the law related to sales of such products. 

As a reminder, Kaival Brands Innovations Group, Inc. (“Kaival”) specifically prohibits any sellers at any level from selling the products via online sales to end user customers without prior written approval from Kaival. You as a Wholesaler agree you will not sell to those resellers that you know intend to sell the products online, and you will not permit such activity in terms with resellers or otherwise. 

You will make our requirements for resellers known to those you sell product to, which can include providing them a copy of Bidi Vapor’s Retailer Pledge, and a link to our website where our terms reside and/or passing down policies (including by posting them on an internal ordering portal) so that such resellers are aware of them. All other terms of the Agreement as it relates to Wholesaler shall continue to apply.

Please indicate your agreement by clicking below.

 

BIDI® Stick pricing
will be changing on
March 1, 2023!

Bidi vapor - forma

ADVISORY: We will temporarily stop all sales and shipping of Bidi Vapor products from March 27-31, 2021, due to systems upgrades and tax integration. We will resume regular business operations on April 1, 2021.

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