Anaphylm NDA Resubmission On Track; Keeping An Eye On AQST-108

研报英文原文证据摘录

Anaphylm NDA Resubmission On Track; Keeping An Eye On AQST-108

C O M PA N Y N O T E

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Aquestive Therapeutics, Inc. (AQST) Overweight

CONCLUSION PRICE: US$4.13

Aquestive reported a 1Q26 diluted non-GAAP net loss per share of ($0.05) on revenue TARGET: US$8.00

of $14.4M, compared to Street estimates of ($0.13) and $10.9M, respectively. Regarding 25x EV/2029E EBITDA of $49M (assuming

the path forward for Anaphylm, management has noted that it has alignment with the cash of $111M, debt of $39M, and ~123M

FDA on the design of its pharmacokinetic (PK) and human factor (HF) studies, and shares outstanding), discounted by 12% for 3

continues to aim for an NDA resubmission sometime in 3Q26 (i.e., management expects years

topline data ahead of its 2Q26 earnings call in August). We continue to believe that peak

David AmsellemAnaphylm U.S. sales potential of $300M-$400M is realistic in the context of a highly under- Sr. Research Analyst, Piper Sandler & Co.

penetrated epinephrine rescue/anaphylaxis space that can readily accommodate multiple 212 284-9455, david.amsellem@psc.com

non-injectable modalities. We reiterate our Overweight rating and $8 PT. Alex von Riesemann

Research Analyst, Piper Sandler & Co.

• Details on the proposed PK study. Recall that per the complete response letter 212 284-9513, alex.vonriesemann@psc.com

(CRL) that AQST received earlier this year, the FDA requested an additional PK study Naoki Martin

to understand the impact of different Anaphylm administration scenarios (refer to our Research Analyst, Piper Sandler & Co.

212 284-9402, naoki.martin@psc.com

note on 2/2/26 for more details on the CRL). As a reminder, the proposed PK study

from management incorporated alternate site administration (i.e., top of the mouth Changes Previous Current