On April 2, 2025, H.C. Wainwright & Co. analyst Dr. Raghuram Selvaraju reiterated a Buy rating and US$10.00 price target on Aquestive Therapeutics Inc. (AQST:NASDAQ), following the company's announcement of its completed New Drug Application (NDA) submission for Anaphylm™ and positive pediatric study data for the non-device-based epinephrine product candidate.
Aquestive announced on April 1, 2025, that it had completed the submission of its NDA for Anaphylm™, a sublingual epinephrine product designed for the emergency treatment of severe allergic reactions, including anaphylaxis. The company successfully completed all adult clinical trials for Anaphylm in late 2024 and received positive feedback in its pre-NDA meeting with the FDA. The recently completed pediatric study, which was a multi-site, single-treatment trial evaluating the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of Anaphylm, showed consistent results with previous adult studies. A total of 32 pediatric patients between the ages of seven and 17 who weighed over 30 kilograms completed the study. The product demonstrated a consistent PK profile in this pediatric population and was shown to be safe and well-tolerated, with no serious adverse events reported.
Aquestive expects to receive FDA acceptance of the Anaphylm NDA submission during the second quarter of 2025. In the pre-NDA meeting minutes received from the FDA in the fourth quarter of 2024, the agency noted that a Pulmonary-Allergy Drugs Advisory Committee may be necessary during the review process for Anaphylm. Dr. Selvaraju believes that such an advisory committee meeting would be "significantly less burdensome than the one held for the nasal spray-based epinephrine product neffy since Anaphylm is administered sub-lingually and does not involve any of the complications associated with nasal spray-based administration."
The company previously received positive pre-NDA written response feedback from the FDA regarding the proposed Chemistry, Manufacturing, Controls (CMC) submission for Anaphylm and is continuing to prepare for the potential product launch. Aquestive's initial focus on launch preparations has been optimizing market access for patients and raising awareness through its medical affairs strategy, including presenting scientific data at medical forums throughout 2025. The company remains committed to launching Anaphylm in the U.S. during the first quarter of 2026 if approved by the FDA.
Dr. Selvaraju notes that the Anaphylm NDA would be classified as a 505(b)(2) pathway application, which would benefit from a statutory 10-month review period. He also expresses confidence that recent FDA headcount reductions should have minimal impact on NDA reviews, as no user fee-supported personnel were affected by these cuts.
Aquestive reported US$71.6 million in cash and US$38.0 million in total debt as of the most recent reporting period. The company reported a full-year 2024 loss per share of US$0.51 on revenue of US$57.6 million.
Dr. Selvaraju's valuation is based on a discounted cash flow assessment, utilizing a 12% discount rate and 30% effective tax rate, which derives a total risk-adjusted net present value of US$981 million. With a share price at the time of the report of US$2.86, the US$10.00 price target represents a potential 250% upside.
Key risks include faster-than-projected erosion of the Suboxone franchise by generics, challenges with Libervant, slower-than-projected market penetration of products post-approval, failure or delays with other drug candidates, partnership risks, and potential dilution.
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Disclosures for H.C. Wainwright & Co., Aquestive Therapeutics Inc., April 2, 2025
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H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, 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. None of the research analysts or the research analyst’s household has a financial interest in the securities of Aquestive Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of March 31, 2025 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Aquestive Therapeutics, Inc.. 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. Mr. Selvaraju, who is [the][an] author of this report, is the Chairman of and receives compensation from Relief Therapeutics Holding SA, a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis ("Relief"). You should consider Mr. Selvaraju's position with Relief when reading this research report. The firm or its affiliates received compensation from Aquestive Therapeutics, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from Aquestive Therapeutics, Inc. 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 Aquestive Therapeutics, Inc. 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.
