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Emerging SARS-COv-2 Variant Is Revenue Growth Opportunity for Vaccine Developer

Source: Streetwise Reports

December 1, 2021 ( Newswire) Just a few days after the WHO deemed the COVID-19 Omicron variant a serious global health concern, leading mRNA-based vaccine developers BioNTech and Pfizer, along with rival Moderna, advised that if needed, the companies would be capable of developing a vaccine for the new mutating strains within roughly 100 days. H.C. Wainwright & Co. commented in a research note that it reiterates its "Buy" rating for BioNTech SE.

In a November 29 research note, H.C. Wainwright & Co. LLC Healthcare Analysts Robert Burns and Raghuram Selvaraju, Ph.D. commented that as the novel SARSCoV-2 Omicron variant spreads, biotechnology company BioNTech SE's (BNTX:NASDAQ) development partner Pfizer Inc. (PFE:NYSE) claimed that "it could produce a tailor-made vaccine in roughly 100 days."

The H.C. Wainwright & Co. report mentioned that within the last couple of days, the World Health Organization (WHO) officially designated Omicron (B.1.1.529) as a variant of concern (VOC). Since the WHO made its announcement, the Omicron variant has been detected in several additional countries.

The analysts stated that at present only a limited amount of scientific data is available regarding the Omicron variant's transmissibility, disease severity and the effectiveness of existing vaccines in combating the new strain. The WHO reported that it suspects that mutation occurring within Omicron may carry the potential to increase transmission and disease severity.

H.C. Wainwright commented that, "preliminary evidence suggests an increased risk of reinfection with this variant." The research firm added that with the rising concern associated with Omicron, BioNTech expects that it will receive the lab test results for the Omicron variant within two weeks.

The report noted that if the new data gathered for Omicron demonstrates significantly lower vaccine efficacy or resistance to existing vaccines, BioNTech and its partner Pfizer, as well as Moderna Inc. (MRNA:NASDAQ), believe that they would be able to develop a targeted vaccine for use against Omicron within about 100 days.

H.C. Wainwright advised that if this scenario were to occur, then it anticipates that the resulting increased demand for new or updated vaccines would have positive impact on BioNTech's top-line revenue. The analysts commented that they expect the Omicron strain is highly likely to continue its global spread over the coming weeks. H.C. Wainwright stated that it believes that mRNA-based vaccines such as Pfizer/BioNTech's would be more amenable to adaptations to confront new emerging virus strains compared to peptide- or protein-based vaccines.

The report pointed out that late last week, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion for COMIRNATY vaccine deployment for children from ages five to eleven years old. H.C. Wainwright advised that it is expected that the European Commission (EC) will issue a final decision on a variation to the Conditional Marketing Authorization (CMA) very soon.

The analysts explained that positive data collected in a Phase 2/3 clinical study offer strong support for a positive ruling by the EC. The report mentioned that in the referenced study, "two doses of COMIRNATY 10μg administered 21 days apart resulted in a vaccine efficacy rate of 90.7% in participants without prior SARSCoV-2 infection, measured from 7 days after the second dose, during a period when Delta was the prevalent strain."

H.C. Wainwright also advised that earlier this month, the FDA amended the COMIRNATY's booster dose Emergency Use Authorization (EUA) and approved the booster shot for adults 18 years of age or older. The report listed that the expanded EUA was authorized based upon a randomized Phase 3 trial of more than 10,000 individuals who were administered a 30μg COMIRNATY booster dose.

Importantly, the top-line data from this study applied to participants that were given a booster and previously had completed the two-dose series of COMIRNATY vaccine and that testing was performed at a time when the Delta variant was the prevalent strain. The analysts indicated that in the study, the COMIRNATY booster group demonstrated vaccine efficacy of 95.6%.

H.C. Wainwright stated that from its perspective, broad-based booster deployment is an important key step in the process of achieving and maintaining herd immunity and is an integral part of COMIRNATY's long-term commercial success.

The analysts advised that their valuation methodology for BioNTech is based upon a tiered discounted cash flow (DCF) model employing a 9% discount rate, 3% terminal growth rate and 31% projected effective tax rate. Using these metrics results in a market value of approximately $88.7 billion, or $360/share based on an estimated 246.5 million shares outstanding at the end of Q3/22.

H.C. Wainwright & Co. LLC stated that it is reiterating its "Buy" rating and 12-month price target of $360/share for BioNTech SE. The company's American Depository Receipt (ADR) shares trade on the Nasdaq Exchange under the symbol "BNTX" and last closed for trading at $362.50 on Monday, November 29, 2021.


1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.

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Important Disclaimers for H.C. WAINWRIGHT & Co., BioNTech SE, Nov. 29, 2021

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

H.C. Wainwright & Co, LLC (the "Firm") is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Robert Burns and Raghuram Selvaraju, Ph.D. , 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.

A research analyst of the firm and/or the research analyst's household has a financial interest in and own the securities of BioNTech SE (including, without limitation, any option, right, warrant, future, long or short position).

As of October 31, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of BioNTech SE.

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 did not receive compensation from BioNTech SE for investment banking services within 12 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 BioNTech SE 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.

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.

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