Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Q2 2025 Earnings Presentation
15 slides from Aquestive Therapeutics's earnings presentation, Aug 12, 2025
Slide 1: Second Quarter 2025 Earnings Supplemental Materials
Second Quarter 2025 Earnings Supplemental Materials September 2024 August 11, 2025 Advancing medicines. Solving problems. Improving lives.
Slide 2: Disclaimer
Disclaimer Certain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and simil
Slide 3: Q2 2025 earnings key messages
Q2 2025 earnings key messages Anaphylm (epinephrine) Sublingual Film for severe allergic reactions, including anaphylaxis • FDA accepted the NDA in Q2 2025; PDUFA date is scheduled for January 31, 2026 • Preparing for a U.S. launch in Q1 2026, if approved by FDA • Established team with significant e
Slide 4: Upcoming expected key milestones
Upcoming expected key milestones Meeting with Potential ex-U.S. Health Canada Approval Filings PDUFA action date is AnaphlymTM NDA Accepted scheduled for Initial briefing Potential Advisory January 31, 2026 book submitted to Committee Meeting EMA AQST – 108 Open IND Potential licensee-led Libervant®
Slide 5: Anaphylm Pediatric Study Results
Anaphylm Pediatric Study Results
Slide 6: Pediatric study objectives
Pediatric study objectives Primary objective: • To evaluate the epinephrine pharmacokinetics (PK) following administration of Anaphylm in pediatric participants from the ages of 7 to 17 weighing ≥30 kg Secondary objectives: • To evaluate the following in pediatric participants from the ages of 7 to
Slide 7: Cross Study Epinephrine Pharmacokinetic (PK) Comparison of Adult and Pediatric Anaphylm Studies
Cross Study Epinephrine Pharmacokinetic (PK) Comparison of Adult (AQ109301) and Pediatric (AQ109302) Anaphylm Studies Takeaway: 12 mg Anaphylm administration demonstrated comparable PK curves in adult and pediatric subjects. • While the study goals were PK descriptive in nature, cross study statisti
Slide 8: Baseline-corrected epinephrine plasma Pharmacokinetic (PK) parameters
Baseline-corrected epinephrine plasma Pharmacokinetic (PK) parameters¹ • Study (N= 32) was powered based on similarity Overall² between pediatric and Parameter Unit (N=29) adult populations 568.6 (175.8) Cmax pg/mL • The parameters shown AUC0-10 h*pg/mL 24.7 (183.1) [n=27] were evaluated and there w
Slide 9: Cross Study Pharmacodynamic (PD) Comparison of Adult and Pediatric Anaphylm Studies
Cross Study Pharmacodynamic (PD) Comparison of Adult (AQ109301) and Pediatric (AQ109302) of Anaphylm Studies¹ • The study demonstrated, directionally, a similar pharmacodynamic response with elevation of SBP, DBP and HR in the pediatric subjects after dosing² • The magnitude of these changes in pedi
Slide 10: Pharmacodynamic (PD) outcomes
Pharmacodynamic (PD) outcomes¹ Overall Parameter Unit (N=32) • As illustrated on the prior Heart Rate² slide and denoted here, the Emax bpm 12.5 (17.3) direction remains positive TEmax (median) min 12.0 • HR, SBP and DBP have a AUEC0-60 h*bpm 5.9 (7.8) [n=31] positive inflection after Systolic Blood
Slide 11: Second Quarter Results
| << Aquestive’ Second Quarter Results
Slide 12: Ending Cash Balance by Quarter
Positioned to meet near-term milestones with projected cash runway into 2026 Ending Cash Balance by Quarter 120 100 $93.0 80 $77.9 USD (Millions) $68.7 $60.5 60 40 20 0 Q3 24 Q4 24 Q1 25 Q2 25 12
Slide 13: Doses Shipped by Quarter
Manufacturing operations continue to generate cash Doses Shipped by Quarter 60,000 50,000 47,953 46,241 45,328 43,818 DOSES SHIPPED (000’S) 42,516 43,032 40,000 36,863 37,204 33,458 34,418 30,000 27,392 20,000 10,000 0 Q4 22 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 QUARTER 13
Slide 14: 2025 guidance as of August 11, 2025
2025 guidance as of August 11, 2025 2025 Outlook • Total revenues of approximately $44-$50 million • Non-GAAP adjusted EBITDA loss of approximately $47-$51 million 14
Slide 15: Thank You
| << Aquestive’ Thank You
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