H.C. Wainwright & Co. Raises Price Target on Biotech Following Positive Regulatory Updates
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Disclosures for H.C. Wainwright & Co. DBV Technologies S.A., October 23, 2024

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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.