Aquestive Therapeutics, Inc. (AQST) Q3 2025 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call summary presents a mixed outlook. Positive aspects include the FDA approval track for Anaphylm, international expansion plans, and new patents. However, financial guidance indicates a significant EBITDA loss, and management was vague on pricing and partnerships. The Q&A revealed cautious optimism but also highlighted uncertainties, such as pricing and international strategies. Considering these factors, the overall sentiment is neutral, anticipating limited stock price movement.

Key Financial Performance

Total revenues (Q3 2025) $12.8 million, a decrease from $13.5 million in Q3 2024. Excluding the impact of one-time recognition of deferred revenue in Q3 2024, total revenues increased by $0.5 million or 4% year-over-year. The decrease was due to the one-time recognition of deferred revenue in the prior year.

Manufacturer and supply revenue (Q3 2025) $11.5 million, an increase from $10.7 million in Q3 2024. The increase was primarily due to increases in Sympazan and Suboxone revenues.

Total revenues (9 months ended September 30, 2025) $31.5 million, a decrease from $45.7 million for the same period in 2024. Excluding the one-time recognition of deferred revenue in 2024, total revenues decreased by $2.6 million or 8% year-over-year. The decrease was primarily due to decreases in Suboxone revenues, partially offset by increases in Ondif revenues.

Research and development expenses (Q3 2025) $4.5 million, a decrease from $5.3 million in Q3 2024. The decrease was primarily due to lower clinical trial costs associated with the Anaphylm program, partially offset by increases in share-based compensation.

Research and development expenses (9 months ended September 30, 2025) $14 million, a decrease from $15.4 million for the same period in 2024. The decrease was primarily due to lower clinical trial costs associated with the Anaphylm program, partially offset by increases in share-based compensation, product research expenses, and personnel costs.

Selling, general and administrative expenses (Q3 2025) $15.3 million, an increase from $12.1 million in Q3 2024. The increase was due to higher pre-commercial spending, legal fees, regulatory expenses related to Anaphylm, personnel costs, and share-based compensation expenses, partially offset by lower regulatory and licensing fees and consulting fees.

Selling, general and administrative expenses (9 months ended September 30, 2025) $47 million, an increase from $34.2 million for the same period in 2024. The increase was due to higher commercial spending on prelaunch activities for Anaphylm, regulatory fees, personnel costs, share-based compensation expenses, and legal fees, partially offset by decreases in severance costs and insurance expenses.

Net loss (Q3 2025) $15.4 million or $0.14 per share, compared to $11.5 million or $0.13 per share in Q3 2024. Excluding the one-time recognition of deferred revenue, the net loss in Q3 2024 was $12.7 million.

Net loss (9 months ended September 30, 2025) $51.9 million or $0.51 per share, compared to $27.1 million or $0.32 per share for the same period in 2024. Excluding the one-time recognition of deferred revenue, the net loss for the same period in 2024 was $38.6 million.

Non-GAAP adjusted EBITDA loss (Q3 2025) $8.6 million, compared to $6.6 million in Q3 2024. Excluding the one-time recognition of deferred revenue, the non-GAAP adjusted EBITDA loss in Q3 2024 was $7.8 million.

Non-GAAP adjusted EBITDA loss (9 months ended September 30, 2025) $35.5 million, compared to $11.9 million for the same period in 2024. Excluding the one-time recognition of deferred revenue, the non-GAAP adjusted EBITDA loss for the same period in 2024 was $23.4 million.

Cash and cash equivalents (as of September 30, 2025) $129.1 million, providing financial stability for the company.

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Operating Highlights

Anaphylm (dibutepinephrine Sublingual Film): Anaphylm is positioned to be the first and only oral medication for severe allergic reactions, including anaphylaxis, if approved by the FDA. Prelaunch activities are on track for a Q1 2026 launch, with marketing materials ready and supply chain prepared. The FDA has confirmed an on-time review of the application, with no Advisory Committee meeting required.

Adrenaverse platform: Aquestive plans to restart R&D efforts for the Adrenaverse platform in 2026, focusing on clinical proof points. The AQST-108 program for alopecia areata is progressing, with an IND submission planned and a safety study in men starting in January 2026.

International expansion for Anaphylm: Aquestive had positive interactions with Health Canada and plans to file an application in Canada in H1 2026. Discussions with the European Medicines Agency are ongoing, with feedback expected in early Q1 2026.

South American market growth: Significant growth observed in the South American partnership, particularly in the Brazilian market.

Leadership changes: Dr. Gary Slatko appointed as interim Chief Medical Officer, Peter Boyd promoted to Chief People Officer, and Dr. Matthew Davis added as Chief Development Officer to support Anaphylm launch and Adrenaverse platform development.

Financial positioning: Completed $85M equity raise and $75M commercial launch financing, ensuring funding through 2027. Refinancing of existing debt is underway, expected to close by year-end.

Focus on Anaphylm launch: Aquestive is prioritizing the launch of Anaphylm and leveraging the Adrenaverse platform for future growth. The company is also advancing regulatory applications for Anaphylm outside the U.S.

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Risk or Challenges

Regulatory Approval Risks: The company is awaiting FDA approval for Anaphylm, scheduled for January 31, 2026. Any delays or negative outcomes from the FDA could significantly impact the planned Q1 2026 launch and overall business strategy.

Financial Stability: The company has raised significant funds to support operations through 2027, but it is still pursuing refinancing of existing debt. Failure to secure favorable refinancing terms could strain financial resources.

Product Launch Risks: The success of Anaphylm's launch depends on timely FDA approval, effective marketing, and supply chain readiness. Any disruptions in these areas could hinder the product's market entry and revenue generation.

Supply Chain and Manufacturing: While the supply chain is currently stable, any unforeseen disruptions could impact the production and distribution of Anaphylm and other products.

Market Competition: Anaphylm will compete with existing auto-injectors and nasal sprays for severe allergic reactions. The product's success depends on differentiating itself in a competitive market.

Revenue Dependence on Existing Products: A significant portion of current revenue comes from Suboxone, which is experiencing a gradual decline. This dependency poses a risk to financial stability if new products do not perform as expected.

International Regulatory Challenges: The company is pursuing regulatory approvals in Canada and Europe. Delays or additional requirements from these regulatory bodies could impact international expansion plans.

Increased Operating Costs: Pre-commercial spending for Anaphylm and higher regulatory expenses have significantly increased operating costs. If revenue growth does not offset these costs, it could lead to financial strain.

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Guidance & Outlook

FDA Approval and Launch of Anaphylm: Aquestive anticipates FDA approval for Anaphylm by January 31, 2026, with a planned commercial launch in Q1 2026. Prelaunch activities, including marketing materials, hiring district managers, and supply chain preparations, are on track.

Adrenaverse Platform Development: The company plans to accelerate R&D efforts for the Adrenaverse platform in 2026, with a focus on clinical proof points and pipeline advancement. The AQST-108 program for alopecia areata is expected to begin a safety study in January 2026.

International Expansion for Anaphylm: Aquestive plans to file for regulatory approval in Canada in H1 2026 and expects feedback from the European Medicines Agency by early Q1 2026.

Financial Position and Revenue Guidance: Aquestive is financially positioned to support operations through 2027, with 2025 revenue guidance of $44 million to $50 million and a non-GAAP adjusted EBITDA loss of $47 million to $51 million.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:Any new comments on your competitors' citizens petition and how that may or may not impact the timing of the FDA decision? Have you responded to the citizens petition?

A:The CEO, Daniel Barber, stated that the competitor's citizen petition was likely a defensive move due to concerns about their product. He mentioned that their review of the petition found it to be factually incorrect and misinformed, which they believe hurts the competitor's credibility with the FDA. He also noted that there has been zero impact on their FDA review and they expect no impact.

Q:How are you thinking about pricing relative to the nasal spray and the generic EpiPen? How does that play into your strategy on access?

A:Sherry Korczynski, Chief Commercial Officer, stated that while they have not disclosed their WAC price, they plan to price responsibly with a patient-first approach. They are exploring options to ensure broad access, including cash pay and co-pay savings programs, and are actively working with payers for coverage. They aim to provide a range of options for patients to access Anaphylm.

Q:How do you think about the optimal timing from a value perspective as to when to partner out ex U.S.? What are those potential partner conversations like at this stage?

A:Daniel Barber explained that they see Anaphylm as a global product and have started work in major markets outside the U.S., such as EMA, Canada, the U.K., and Japan. They plan to license the product outside the U.S. and believe that the closer they are to approval, the more valuable the product and partnership will be. Conversations are ongoing, and they expect inflection points as they progress with regulatory interactions.

Q:What are some of the takeaways you're hearing around the conference, especially around your medical affairs booth as it relates to excitement for new potential additional needless epinephrine options?

A:Daniel Barber noted that the main part of the conference was yet to begin, but there was palpable excitement about their product and a strong desire to learn more. He mentioned that these are good signs of addressing a meaningful need.

Q:Could you give a sense of how you are thinking about the parameters you anticipate sharing with the investment community as Anaphylm gets to the market? What specific takeaways are you planning to get from the neffy commercial introduction?

A:Daniel Barber stated that their PDUFA date is January 31, and they plan to launch in Q1 with sales reps trained and supply chain ready. He mentioned that they are monitoring the most favored nation pricing but do not see any immediate impact on ex U.S. partnerships. Sherry Korczynski added that they are taking a patient-centric approach and focusing on differentiation, emphasizing ease of use, portability, and stability.

Q:What are the alternative routes of administration and formulations being considered for the Adrenaverse platform beyond AQST-108?

A:Daniel Barber mentioned that they are exploring various delivery systems, including film, capsules, and potentially injectables, depending on what is right for the patient. They are not limiting themselves to specific routes of delivery.

Q:How are the current launch dynamics with neffy informing your initial commercialization strategy? Are you considering DTC?

A:Daniel Barber and Sherry Korczynski explained that they are taking a focused and disciplined approach, targeting the most productive prescribers, particularly allergists. They are not planning large-scale DTC campaigns initially but will use digital and print media to drive awareness among consumers over time.

Q:Can you remind us what components of the data the FDA is focused on and key considerations for approval?

A:Daniel Barber stated that the FDA is completing its checklist and asking expected questions. He noted that their review group has remained consistent, and they have not been affected by recent FDA leadership changes.

Q:How should we think of scripts per patient per year? Is it multipack?

A:Daniel Barber explained that patients often desire multiple scripts to have the product available in various locations. Their goal is to enable patients to have as many scripts as possible, considering pricing and market access realities.

Q:Can you break down the allergist segment and how many reps could help you target them?

A:Sherry Korczynski stated that allergists are the most productive segment, prescribing an average of 200 prescriptions annually. They plan to launch with 50-60 sales reps and managers to target the approximately 5,000 allergists.

Q:Where is the 9% market growth coming from?

A:Daniel Barber explained that the 8.8% growth in Q3 and 7.5% year-to-date growth is primarily from auto-injectors, with some growth in nasal spray scripts. He attributed this to increased awareness and market expansion.

Q:What aspects of the product profile are physicians focusing on aside from administration route and convenience?

A:Daniel Barber and Gary Slatko highlighted that physicians focus on safety, efficacy, and the ability to administer the product successfully. Anaphylm's speed of absorption, sustained effect, and robust human factors program were noted as key advantages.

Q:Does the Adrenaverse platform involve applying prodrug technology to other molecules beyond epinephrine?

A:Daniel Barber stated that their intellectual property is focused on epinephrine in a prodrug form, but they are exploring other technologies and expansions to bring better products to patients.

Q:Can you talk more about the two new patents for Anaphylm and their importance?

A:Daniel Barber explained that the two new patents focus on absorption and rapid release of epinephrine, which are significant and will be Orange Book listable, providing expansive and blocking protection for the product.

Q:How quickly could you get drug into the channel and the first prescription filled post-approval?

A:Daniel Barber stated that there is some work to finalize the label post-approval, but they are prepared to have supply in the channel in Q1.

Q:Has there been any impact on your FDA review due to recent leadership changes at the FDA?

A:Daniel Barber stated that their review group has remained the same, and they have not been affected by recent FDA leadership changes. They continue to believe they are in good shape.

Q:What is the manufacturing capacity for Anaphylm, and where is it manufactured?

A:Daniel Barber stated that they manufacture 150 million doses of film annually, which is sufficient to meet the less than 10 million doses required for the epinephrine market. Manufacturing is based in Indiana, with all components sourced from the U.S.

Q:What pushback have you received from physicians on Anaphylm?

A:Daniel Barber noted that physicians primarily want assurance of safety and efficacy, which they are addressing through their medical affairs team and robust data package.

Q:What is the timeline and size of the Phase II trial for AQST-108?

A:Daniel Barber stated that the first study will be a small safety study in a handful of men, followed by a 24-week Phase IIa study involving 40-60 individuals to evaluate hair follicle growth.

Q:Review of Unclear Management Responses

A:Management appeared to avoid giving a direct answer to the specific pricing of Anaphylm, stating that they have not disclosed the WAC price but plan to price responsibly. They also did not provide specific details on the timing of ex U.S. partnerships, stating that conversations are ongoing and will align with regulatory progress. Additionally, they did not specify the exact size of the Phase II trial for AQST-108, only providing a range of participants.

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Earnings Word Cloud

The most frequently occurring keywords in this quarter's earning call

AQST Transcript

Aquestive Therapeutics, Inc. (AQST) Q3 2025 Earnings Call Transcript

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Aquestive Therapeutics, Inc. (AQST) Q2 2025 Earnings Call Transcript

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The earnings call reveals a decline in revenue, increased expenses, and a substantial net loss, which are negative indicators. The Q&A session highlights uncertainties regarding FDA approval and payer engagement, further dampening sentiment. Despite robust clinical data, the lack of clear guidance on coverage and the need for additional funding for a full-scale launch contribute to a negative outlook. The absence of a new partnership announcement or positive financial metrics, coupled with the increased net loss and EBITDA loss, supports a negative stock price reaction.

Earnings call transcript: Aquestive’s Q1 2025 earnings miss, stock drops 7%

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The earnings call highlights several concerning elements: a significant revenue decline, increased losses, and vague management responses in the Q&A. Despite preparations for ANNAFILM's launch, the lack of clear guidance on AdCom topics and potential impacts of new FDA personnel raises uncertainty. Additionally, the competitive pressure from existing products like EpiPen and NEFI, combined with potential operational risks, further contribute to a negative sentiment. The market may react negatively due to these uncertainties, leading to a predicted stock price movement of -2% to -8% over the next two weeks.

Aquestive Therapeutics, Inc. (AQST) Q1 2025 Earnings Call Transcript

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The earnings call reveals significant negative factors: a 28% revenue drop, increased net loss, and no share repurchase program. Legal risks and higher expenses further strain financial health. Despite a stable supply chain and Anaphylm's commercial readiness, uncertainties in payer coverage timelines and partnership details add concerns. Management's evasive responses in the Q&A amplify these uncertainties. The market is likely to react negatively, given the financial struggles and lack of clear positive catalysts. The prediction is a negative stock price movement of -2% to -8%.

AQST Slides

Aquestive Q1 2025 slides reveal Anaphylm progress but weakening financials

2025-05-12

Aquestive Q2 2025 slides: Anaphylm advances toward FDA decision, cash burn continues

2025-08-11

AQST Report

Aquestive Therapeutics, Inc. 10-Q

10-Q

2024-11-04

Aquestive Therapeutics, Inc. 10-Q

10-Q

2024-08-06

Aquestive Therapeutics, Inc. 10-Q

10-Q

2024-05-07

Aquestive Therapeutics, Inc. 10-K

10-K

2024-03-05

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