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OFFON

TURNING POINT BRANDS, INC.

(TPB)
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Turning Point Brands, Inc. Announces FDA Rescinds Previously Disclosed Marketing Denial Order for Turning Point Brands’ Vapor Products

10/11/2021 | 07:30am EST

Turning Point Brands, Inc. was informed by the Food and Drug Administration (“FDA”) that the agency had rescinded its September 14 Marketing Denial Order (“MDO”) for certain of its vapor products with pending Premarket Tobacco Product Applications (“PMTAs”) under review. All of TPB’s proprietary vapor products, including its Solace™ branded e-liquids, will continue to be marketed while they remain under review. In its rescission letter to TPB, the FDA stated, “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed. Specifically, your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.” The letter further clarified that “at present, in light of the unusual circumstances, FDA has no intention of initiating an enforcement action against” the products. In response to the September 14 MDO, the Company had filed a petition for relief and motion to stay the decision in the 6th Circuit Court of Appeals. On October 8, as a result of the rescission letter, TPB withdrew both the petition and motion.


© S&P Capital IQ 2021
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Financials (USD)
Sales 2021 440 M - -
Net income 2021 51,3 M - -
Net Debt 2021 - - -
P/E ratio 2021 17,6x
Yield 2021 0,58%
Capitalization 715 M 715 M -
Capi. / Sales 2021 1,62x
Capi. / Sales 2022 1,60x
Nbr of Employees 408
Free-Float 91,6%
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Mean consensus BUY
Number of Analysts 4
Last Close Price 37,88 $
Average target price 57,75 $
Spread / Average Target 52,5%
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Managers and Directors
Lawrence S. Wexler President, Chief Executive Officer & Director
Louie Reformina Chief Financial Officer
David E. Glazek Chairman
Christian Allen Senior Vice President-Information Technology
Sarah Evans Director-Scientific & Regulatory Affairs