H.C. Wainwright & Co. Raises Price Target on Biotech Following Positive Regulatory Updates
Research Report

1. This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company. 
2. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for H.C. Wainwright & Co. DBV Technologies S.A., October 23, 2024

Important Disclaimers This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to unsubscribe@hcwresearch.com and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet.

H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Andrew S. Fein, Matthew Caufield, Andres Y. Maldonado, PhD and Ananda Ghosh, PhD , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of DBV Technologies S.A. (including, without limitation, any option, right, warrant, future, long or short position). As of September 30, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of DBV Technologies S.A.

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from DBV Technologies S.A. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from DBV Technologies S.A. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in DBV Technologies S.A. as of the date of this research report.

The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

H.C. Wainwright & Co. analysts Andrew S. Fein, Matthew Caufield, Dr. Andres Y. Maldonado, and Dr. Ananda Ghosh, in a research report published on October 23, 2024, maintained a Buy rating on DBV Technologies SA (DBVT:NASDAQ) while raising their price target to US$7.00 from US$5.00. The report follows DBV's announcement of regulatory clarity regarding the path forward for its Viaskin Peanut patch.

The analysts highlighted the significance of the FDA agreement, stating, "DBV Technologies has reached an agreement with the FDA regarding the regulatory pathway for the Viaskin Peanut patch in toddlers aged one to three, under the Accelerated Approval pathway."

Regarding the company's development timeline, the analysts noted, "The Biologics License Application (BLA) submission for Viaskin Peanut in this age group is expected to be supported by positive efficacy and safety data from DBV's completed EPITOPE Phase 3 study, as well as additional safety data from the upcoming six-month COMFORT Toddlers supplemental safety study, which is expected to begin in 2Q25."

The report emphasized the strength of DBV's regulatory position, stating, "The FDA has stated that DBV has already satisfied two of the three criteria: the product treats a serious condition, and the product candidate provides a meaningful advantage over available therapies."

The analysts also highlighted progress in Europe, noting, "The EMA confirmed that the successfully completed EPITOPE Phase 3 efficacy and safety trial in the one to three-year-old population, along with positive results from the VITESSE study in the four to seven-year-old population, and a new safety study using the modified circular patch in one to three-year-olds, could support an MAA for the one to seven-year-old indication with the modified patch."

The analysts' valuation methodology for DBV Technologies is based on a composite approach. They explained, "Our US$7 price target is based on an equally weighted composite of: (a) US$5.10/share, as a 20x multiple of taxed and diluted FY34 GAAP EPS of US$5.13 discounted back to FY24 at 35%; and (b) an NPV of US$8.52/share with a 13% discount rate and 1% growth rate."

The report included commercial projections, with the analysts stating, "We continue to model initial approval in 2027, with projected initial sales of US$17.5M, growing to US$1,182.8M by 2034."

The analysts also outlined several risk factors, including potential clinical study failures, regulatory approval challenges, and market size uncertainties.

In conclusion, H.C. Wainwright & Co.'s increased price target to US$7 reflects growing confidence in DBV Technologies' regulatory pathway for the Viaskin Peanut patch. The share price at the time of the report of US$0.70 represents a potential return of approximately 900% to the analysts' target price, highlighting the significant upside potential if the company successfully navigates the regulatory process and commercializes its product.