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01/09 23:39
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
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.
Total Revenue (Q2 2025) $10 million, a decrease from $20.1 million in Q2 2024. The decline was due to the onetime recognition of deferred revenue in the prior year. Excluding this, revenue increased by $0.3 million or 3% year-over-year, driven by growth in international products.
Manufacture and Supply Revenue (Q2 2025) $9.6 million, an increase from $8.1 million in Q2 2024. This growth was primarily due to increases in Ondif revenue, partially offset by decreases in Suboxone revenues.
Total Revenue (6 months ended June 30, 2025) $18.7 million, a decrease from $32.2 million for the same period in 2024. Excluding onetime recognition of deferred revenue, total revenues decreased by $2.8 million or 13% year-over-year, primarily due to decreases in Suboxone revenues.
Research and Development Expenses (6 months ended June 30, 2025) $9.5 million, a decrease from $10.1 million for the same period in 2024. The decline was primarily due to reduced clinical trial costs for the Anaphylm program, partially offset by increased personnel costs and share-based compensation.
Selling, General, and Administrative Expenses (Q2 2025) $12.7 million, an increase from $11.4 million in Q2 2024. The rise was driven by higher commercial spending for prelaunch activities ($2 million), regulatory and licensing fees ($0.8 million), personnel costs ($0.4 million), share-based compensation ($0.2 million), and consulting fees ($0.2 million), partially offset by lower legal fees ($2.5 million) and insurance expenses ($0.2 million).
Net Loss (Q2 2025) $13.5 million or $0.14 per share, compared to $2.7 million or $0.03 per share in Q2 2024. Excluding onetime recognition of deferred revenue, the net loss in Q2 2024 was $13.2 million.
Non-GAAP Adjusted EBITDA Loss (Q2 2025) $9.3 million, compared to $1.8 million income in Q2 2024. Excluding onetime recognition of deferred revenue, the adjusted EBITDA loss in Q2 2024 was $8.6 million.
Cash and Cash Equivalents (as of June 30, 2025) $60.5 million, sufficient for initial launch activities but requiring additional funding for full-scale launch.
Anaphylm epinephrine sublingual film: Potentially the first and only oral product for severe allergic reactions, including anaphylaxis. FDA action date is January 31, 2026. Pre-commercial launch activities and FDA review are on track. Pediatric study data included in the NDA submission. Market potential estimated at $2 billion annually globally.
AQST-108 epinephrine topical gel: Targeting alopecia areata. IND submission to FDA planned by end of 2025, with human studies starting in early 2026.
International expansion for Anaphylm: Meetings secured in Canada and EU for regulatory discussions. Filing preparations to begin after meetings by year-end.
Manufacturing and supply revenue: Increased to $9.6 million in Q2 2025 from $8.1 million in Q2 2024, driven by growth in Ondif, partially offset by Suboxone decline.
Base business growth: Year-over-year growth in Q2 2025, driven by international product performance.
Launch financing for Anaphylm: Multiple proposals in process, including EU-only rights and alternate financing vehicles. Confident in securing financing before launch.
Market access strategy for Anaphylm: Patient-first approach with a cash pay program to ensure immediate access despite payer barriers. Engaging with payers for pricing and reimbursement.
Market Access Barriers: The company has expressed concerns about significant barriers to market access for their product Anaphylm, including pricing issues, delay tactics, NDC blocks, and prior authorization documentation. These barriers could increase costs and limit patient access to the product.
Launch Financing Challenges: Aquestive Therapeutics has acknowledged the need for additional funding to support the commercial launch of Anaphylm. While they are exploring multiple financing options, the lack of secured funding poses a risk to the timely and effective launch of the product.
Regulatory Uncertainty: The company is awaiting FDA approval for Anaphylm, with a PDUFA action date set for January 31, 2026. Any delays or negative outcomes in the regulatory process could adversely impact their strategic plans.
Revenue Decline: The company has reported a decline in total revenues year-over-year, primarily due to the decrease in Suboxone revenues. This decline could affect their financial stability and ability to fund future projects.
Increased Operating Costs: Selling, general, and administrative expenses have increased significantly due to prelaunch activities, regulatory fees, and personnel costs. This rise in costs could strain the company's financial resources.
Dependence on Key Product Approval: The company's future growth heavily depends on the approval and successful launch of Anaphylm. Any setbacks in this area could have a significant negative impact on their operations and financials.
FDA Approval and Launch of Anaphylm: Aquestive Therapeutics is on track for the FDA action date for Anaphylm, scheduled for January 31, 2026. The company is preparing for a potential advisory committee meeting and has completed its 120-day safety update submission. Pre-commercial launch activities are underway, and the company is securing launch financing.
Market Opportunity for Anaphylm: The rescue market for severe allergic reactions is expected to grow significantly, potentially doubling from 5 million to 10 million prescriptions annually. The market could reach $2 billion globally, with a shift from injectables to non-injectable products like Anaphylm.
International Expansion: Meetings with regulatory bodies in Canada and the EU are planned by the end of 2025 to prepare for international filings for Anaphylm.
Launch Financing: Aquestive is exploring multiple financing options, including EU-only rights and alternative financing vehicles, to support the launch of Anaphylm. The company expects to secure financing before the product launch.
Future Product Development: The company plans to open an IND for AQST-108, an epinephrine topical gel for alopecia areata, by the end of 2025 and begin human studies in early 2026.
2025 Financial Guidance: Aquestive expects total revenue of $44 million to $50 million and a non-GAAP adjusted EBITDA loss of $47 million to $51 million for 2025. This includes significant pre-approval launch spending for Anaphylm.
The selected topic was not discussed during the call.
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.
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.
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.
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%.
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