Group 1 - The company has a strong academic foundation with an MBA in Finance and an MD, enhancing its expertise in the financial sector [1] - The firm specializes in income investing and biotech/pharma investing, with nearly a decade of experience in these areas [2] - The organization focuses on identifying both short-term catalyst-driven opportunities and long-term investment strategies in the biotech sector [3] Group 2 - Subscribers receive regular portfolio trade alerts and have access to an interactive chat feature, promoting engagement and addressing inquiries [4] - The company has published a best-selling book on biotech investing and offers an online course, showcasing its commitment to educating investors [4] - The firm provides custom biotech analysis upon request, ensuring tailored insights for its audience [3][4]

Financial Data and Key Metrics Changes - Total revenues decreased to $8.7 million in Q1 2025 from $12.1 million in Q1 2024, representing a 28% decrease primarily driven by declines in manufacturer and supply revenue and license and royalty revenue [28] - Manufacturer and supply revenue decreased to $7.2 million in Q1 2025 from $10.5 million in Q1 2024, primarily due to decreases in Suboxone revenues, partially offset by an increase in ONDIF revenues [28] - License and royalty revenue decreased by 30% or $300,000 in Q1 2025 compared to the same period in the prior year [28] - Net loss for Q1 2025 was $22.9 million or $0.24 per share compared to a net loss of $12.8 million or $0.17 per share in Q1 2024 [29] - Non-GAAP adjusted EBITDA loss was $17.6 million in Q1 2025 compared to a loss of $7.2 million in Q1 2024 [30] - Cash and cash equivalents were $68.7 million as of March 31, 2025 [30] Business Line Data and Key Metrics Changes - The manufacturing business remained steady, with a gradual decline of Suboxone being partially offset by growth across newer collaborations, including licensed products ONDIF, SYMPAZAN, and EMILYF [27] - Research and development expenses decreased to $5.4 million in Q1 2025 from $5.9 million in Q1 2024, primarily due to lower clinical trial costs associated with the antifilm development program [29] Market Data and Key Metrics Changes - The rescue medication market for severe allergic reactions is expected to grow into a multi-billion dollar opportunity [8] - The company anticipates receiving its FDA acceptance letter next month, with an FDA assigned action date in late January or early February 2026 [8] Company Strategy and Development Direction - The company is focused on ensuring a successful commercial launch of ANNAFILM in Q1 2026 if approved by the FDA, with emphasis on building a strong marketing team and increasing awareness of anaphylaxis [9][10] - The company plans to leverage existing payer contracts established during the marketing of Libervant to enhance launch efficiency for ANNAFILM [12] - The company is also engaging with international markets, including Canada, the UK, and the European Medicines Agency, to strengthen its balance sheet through potential partnerships [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to weather economic uncertainties and tariffs, noting minimal risk to price or supply volatility [22] - The company is committed to strengthening its balance sheet through potential out-licensing of ANNAFILM and refinancing its debt [18] - Management acknowledged the passing of a key team member, emphasizing the impact on the company and its commitment to honor his contributions [23] Other Important Information - The company has revised its full-year 2025 financial guidance, now expecting total revenue of $44 million to $50 million and a non-GAAP adjusted EBITDA loss of $47 million to $51 million [30] - The revenue guidance for 2025 no longer includes revenue for Libervant for ages between two and five years [30] Q&A Session Summary Question: Update on commercial readiness efforts for ANNAFILM - Management confirmed that manufacturing capabilities are well-prepared and products will be ready for launch [33][34] Question: Goals for hiring a field force for ANNAFILM - The company plans to start with around 50 sales representatives targeting top epinephrine prescribers [35] Question: Interaction with payers for broader access to ANNAFILM - The company is leveraging existing contracts from Libervant and aims for 80% coverage within the first six months post-launch [39][40] Question: Learnings from the launch of Nephi - Management noted that market expansion and disease state awareness are critical for driving demand [44][46] Question: Potential for an AdCom - Management is prepared for an advisory committee meeting and believes they have a robust data set for the application [49][50] Question: Influence of new division head on the review process - Management indicated that interactions have been with the deputy division head, and the review team remains unchanged [55][56] Question: Awareness of ANNAFILM with providers - The company has conducted extensive outreach and believes awareness is growing significantly [62] Question: Cash needed for the launch of ANNAFILM - Management stated that they will not hire sales reps until approval and have multiple paths to finance the launch [96][97] Question: Libervant revenue in Q2 - Revenue for Libervant in Q2 is expected to be minimal, and guidance for the year has been revised to exclude it [98]

Financial Data and Key Metrics Changes - Total revenues decreased to $8.7 million in Q1 2025 from $12.1 million in Q1 2024, representing a 28% decrease primarily driven by declines in manufacturer and supply revenue and license and royalty revenue [26][28] - Manufacturer and supply revenue decreased to $7.2 million in Q1 2025 from $10.5 million in Q1 2024, primarily due to decreases in Suboxone revenues, partially offset by an increase in ONDIF revenues [26] - License and royalty revenue decreased by 30% or $300,000 in Q1 2025 compared to the same period in the prior year [27] - Net loss for Q1 2025 was $22.9 million or $0.24 per share compared to a net loss of $12.8 million or $0.17 per share in Q1 2024 [28] - Non-GAAP adjusted EBITDA loss was $17.6 million in Q1 2025 compared to a loss of $7.2 million in Q1 2024 [28] Business Line Data and Key Metrics Changes - Research and development expenses decreased to $5.4 million in Q1 2025 from $5.9 million in Q1 2024, primarily due to lower clinical trial costs associated with the antifilm development program [27] - Selling, general and administrative expenses increased to $19.1 million in Q1 2025 from $10.7 million in Q1 2024, primarily due to regulatory fees, higher legal fees, and increased commercial spending [27] Market Data and Key Metrics Changes - The rescue medication market for severe allergic reactions is anticipated to grow into a multi-billion dollar opportunity [6] - The company expects to have attended 25 conferences and published 16 posters and manuscripts by the end of the year to increase awareness of anaphylaxis and clinical data among healthcare professionals [8] Company Strategy and Development Direction - The company is focused on ensuring a successful commercial launch of ANNAFILM in Q1 2026 if approved by the FDA, with a strong emphasis on building a capable marketing team and increasing awareness among healthcare providers [6][7] - The company plans to leverage existing payer contracts established during the marketing of Libervant to facilitate the launch of ANNAFILM [9][10] - The company aims to strengthen its balance sheet through potential ex-US out-licensing of ANNAFILM and refinancing its debt [16][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning to weather economic uncertainties and supply chain risks, noting minimal risk to price or supply volatility [20] - The company is actively engaging with the FDA regarding the review of its application and is prepared for an advisory committee meeting if required [18][22] - Management acknowledged the passing of a key team member and emphasized the importance of continuing the development of ANNAFILM in his memory [21] Other Important Information - The company has revised its full-year 2025 financial guidance, now expecting total revenue of $44 million to $50 million and a non-GAAP adjusted EBITDA loss of $47 million to $51 million [28][29] - The company will not hire sales representatives until it receives FDA approval for ANNAFILM, focusing on preparatory work in the meantime [92][93] Q&A Session Summary Question: Update on commercial readiness efforts for ANNAFILM - The company is well-prepared for CMC manufacturing scale-up and has plans in place for product readiness on day one [31][32] Question: Goals for hiring a field force for ANNAFILM - The company plans to start with around 50 sales representatives targeting top epinephrine prescribers, including allergists and pediatricians [33] Question: Key goals in interacting with payers for ANNAFILM - The company aims for 80% coverage by the end of the first six months post-launch, aligning with the back-to-school season [37] Question: Learnings from the launch of Nephi - The company sees market expansion as critical and expects the market to double over the coming years [41][44] Question: Potential for an advisory committee meeting - The company is hopeful to know about an AdCom by day 74 of the review process, but it is at the FDA's discretion [97] Question: Awareness of ANNAFILM with providers - The company has conducted over 1,000 interviews and is actively engaging with healthcare providers to increase awareness [60] Question: Cash needed for the launch of ANNAFILM - The company has multiple paths to finance the launch and will not hire sales reps until approval is received [92][93]

Core Viewpoint - Aquestive Therapeutics reported a significant decline in revenue and earnings for the quarter ended March 2025, indicating potential challenges in financial performance and market expectations [1][3]. Revenue Performance - Total revenue for the quarter was $8.72 million, a decrease of 27.6% compared to the same period last year, and a miss of 28.14% against the Zacks Consensus Estimate of $12.14 million [1]. - Revenue from manufacturing and supply was $7.19 million, falling short of the three-analyst average estimate of $10.07 million, representing a year-over-year decline of 31.6% [4]. - License and royalty revenue amounted to $0.79 million, compared to the average estimate of $1.68 million, reflecting a year-over-year decrease of 30.2% [4]. - Co-development and research fees were reported at $0.42 million, slightly above the two-analyst average estimate of $0.40 million, showing a year-over-year increase of 3.7% [4]. Earnings Performance - The earnings per share (EPS) for the quarter was -$0.24, compared to -$0.17 in the same quarter last year, indicating a worsening in profitability [1]. - The EPS surprise was -41.18% against the consensus estimate of -$0.17 [1]. Stock Performance - Over the past month, shares of Aquestive Therapeutics have returned +13%, outperforming the Zacks S&P 500 composite's +3.8% change [3]. - The stock currently holds a Zacks Rank 4 (Sell), suggesting potential underperformance relative to the broader market in the near term [3].

Company Performance - Aquestive Therapeutics reported a quarterly loss of $0.24 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.17, representing an earnings surprise of -41.18% [1] - The company posted revenues of $8.72 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 28.14%, and down from $12.05 million in the same quarter last year [2] - Over the last four quarters, the company has surpassed consensus EPS estimates only once and has topped consensus revenue estimates two times [2] Stock Performance - Shares of Aquestive Therapeutics have declined approximately 21.6% since the beginning of the year, compared to a decline of -3.8% for the S&P 500 [3] - The current Zacks Rank for the stock is 4 (Sell), indicating expectations of underperformance in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.17 on revenues of $11.87 million, and for the current fiscal year, it is -$0.65 on revenues of $49.55 million [7] - The estimate revisions trend for Aquestive Therapeutics is currently unfavorable, which may change following the recent earnings report [6] Industry Context - The Medical - Drugs industry, to which Aquestive Therapeutics belongs, is currently ranked in the top 27% of over 250 Zacks industries, suggesting a relatively strong industry performance [8]

Financial Position - The company reported a strong balance sheet with approximately $68.7 million in cash as of March 31, 2025 [10] - The company projects a cash runway into 2026 [10, 19] - The company expects total revenues of approximately $44-$50 million for 2025 [26] - The company anticipates a Non-GAAP adjusted EBITDA loss of approximately $47-$51 million for 2025 [26] Product Development & Regulatory Milestones - The NDA for Anaphylm (epinephrine) Sublingual Film was submitted in Q1 2025 [11] - The FDA acceptance of the NDA for Anaphylm is expected in Q2 2025 [11, 18] - The pediatric clinical trial for Anaphylm has been completed with positive top-line results [11] - The company is preparing for a potential Anaphylm launch in Q1 2026, pending FDA approval [11] Market & Manufacturing - Manufacturing operations continue to generate cash flow [21] - The company shipped 27,392 doses in Q1 2025 [22] - Market research indicates that 80% of patients and HCPs prefer a non-injection dosing method for epinephrine [14] - Market research indicates that 95% of patients and HCPs are interested in a film-dosing option [14] - Market research indicates that 85% of healthcare providers indicated they would prescribe a film-dosing option [16]

[PART I – FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Presents Aquestive Therapeutics' unaudited condensed financial statements for Q1 2025 and 2024, including balance sheets, operations, cash flows, and detailed notes [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) Provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' deficit as of March 31, 2025, and December 31, 2024 Condensed Balance Sheets (in thousands) | Metric (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $68,657 | $71,546 | | Total current assets | $89,169 | $88,220 | | Total assets | $102,234 | $101,424 | | Total current liabilities | $18,298 | $18,865 | | Total liabilities | $163,164 | $161,580 | | Total stockholders' deficit | $(60,930) | $(60,156) | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Summarizes the company's financial performance, including revenues, expenses, and net loss for the three months ended March 31, 2025, and 2024 Condensed Statements of Operations and Comprehensive Loss (in thousands) | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Revenues | $8,720 | $12,053 | | Total costs and expenses | $28,085 | $21,010 | | Loss from operations | $(19,365) | $(8,957) |\ | Net loss | $(22,930) | $(12,828) |\ | Basic and diluted loss per share | $(0.24) | $(0.17) |\ | Weighted average common shares outstanding | 95,497,056 | 73,614,710 | [Condensed Statements of Changes in Stockholders' Deficit](index=8&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Stockholders%27%20Deficit) Details changes in equity components, including common stock, additional paid-in capital, and accumulated deficit, for the three months ended March 31, 2025 Condensed Statements of Changes in Stockholders' Deficit (in thousands) | Metric (in thousands) | Balance at Dec 31, 2024 | Balance at Mar 31, 2025 | | :-------------------- | :---------------------- | :---------------------- | | Common Stock Shares | 91,413,742 | 99,317,153 | | Common Stock Amount | $91 | $99 | | Additional Paid-in Capital | $302,967 | $325,115 | | Accumulated Deficit | $(363,214) | $(386,144) | | Total Stockholders' Deficit | $(60,156) | $(60,930) | **Key Changes (Three Months Ended March 31, 2025):** * Common Stock issued under public equity offering-ATM: 7,457,627 shares, **$22,000** (net of costs) * Share-based compensation expense: **$1,587** * Net loss: **$(22,930)** [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Presents the cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2025, and 2024 Condensed Statements of Cash Flows (in thousands) | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Net cash used for operating activities | $(23,400) | $(10,384) |\ | Net cash used for investing activities | $(135) | $(29) |\ | Net cash provided by financing activities | $20,646 | $81,741 |\ | Net (decrease) increase in cash and cash equivalents | $(2,889) | $71,328 |\ | Cash and cash equivalents at end of period | $68,657 | $95,200 | [Notes to Unaudited Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Provides detailed explanations and disclosures supporting the unaudited condensed financial statements [Note 1. Company Overview and Basis of Presentation](index=10&type=section&id=Note%201.%20Company%20Overview%20and%20Basis%20of%20Presentation) Introduces Aquestive Therapeutics, Inc. as a pharmaceutical company focused on innovative delivery technologies and outlines its financial presentation basis - Aquestive Therapeutics, Inc. is a pharmaceutical company focused on developing and commercializing innovative medicines using alternative delivery technologies, particularly for complex molecules. The company is advancing its Anaphylm™ and Adrenaverse™ epinephrine prodrug platforms for severe allergic reactions and manufactures four licensed commercialized products[22](index=22&type=chunk) - The company has actively utilized its At-The-Market (ATM) facility, selling **7,457,627 shares** for net proceeds of approximately **$21,306 thousand** during the three months ended March 31, 2025. A public offering in March 2024 also generated **$70,500 thousand** in net proceeds[23](index=23&type=chunk)[25](index=25&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=11&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) Details the company's significant accounting policies, including recent ASU adoptions and the evaluation of upcoming pronouncements - The company adopted ASU 2023-07 (Segment Reporting) as of December 31, 2024, requiring enhanced disclosures for segment profit or loss and significant segment expenses. ASU 2020-06 (Convertible Instruments) and ASU 2022-03 (Fair Value Measurement) were adopted on January 1, 2024, without material impact[31](index=31&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk) - Upcoming pronouncements, ASU 2024-03 (Expense Disaggregation) and ASU 2023-09 (Income Tax Disclosures), effective for fiscal years beginning after December 15, 2026, and 2025 respectively, are currently being evaluated for their potential impact on financial statement disclosures[34](index=34&type=chunk)[36](index=36&type=chunk) [Note 3. Risks and Uncertainties](index=12&type=section&id=Note%203.%20Risks%20and%20Uncertainties) Highlights Aquestive's history of net losses, accumulated deficits, and its reliance on cash, equity, and debt for funding operations and near-term liquidity - Aquestive has a history of net losses, with accumulated deficits totaling **$386,144 thousand** as of March 31, 2025. The company relies on cash and cash equivalents (**$68,657 thousand** as of March 31, 2025), equity, and debt offerings to fund operations[37](index=37&type=chunk)[38](index=38&type=chunk) - Near-term liquidity for at least the next twelve months is supported by existing cash, expense management (including ceasing R&D activities), and access to equity capital markets via its ATM facility[39](index=39&type=chunk) [Note 4. Segment Reporting](index=12&type=section&id=Note%204.%20Segment%20Reporting) Describes the company's single operating segment focused on developing products for severe allergic reactions and manufacturing proprietary and licensed products - The company operates as a single operating and reportable segment, with the CEO serving as the Chief Operating Decision Maker (CODM). The segment focuses on developing products for severe allergic reactions (Anaphylm, Adrenaverse platform) and manufacturing proprietary and licensed products[40](index=40&type=chunk) - Revenues for the three months ended March 31, 2025, and 2024 were **$8,720 thousand** and **$12,053 thousand**, respectively. Management anticipates continued significant expenses and operating losses due to product development and clinical trials[41](index=41&type=chunk) Expense Category (in thousands) | Expense Category (in thousands) | 3 Months Ended Mar 31, 2025 | 3 Months Ended Mar 31, 2024 | | :------------------------------ | :-------------------------- | :-------------------------- | | Total Manufacture and Supply Expenses | $3,652 | $4,389 | | Total Research and Development Expenses | $5,361 | $5,932 | | Total Selling expenses | $2,956 | $1,072 | | Total General and Administrative Expenses | $16,116 | $9,617 | | Total costs and expenses | $28,085 | $21,010 | | Loss from operations | $(19,365) | $(8,957) | | Net loss | $(22,930) | $(12,828) | [Note 5. Revenues and Trade Receivables, Net](index=13&type=section&id=Note%205.%20Revenues%20and%20Trade%20Receivables%2C%20Net) Outlines revenue recognition policies across various categories and provides a breakdown of revenues by type and geographic area - Revenues are categorized into manufacture and supply, license and royalty, co-development and research fees, and proprietary product revenue. Revenue recognition follows a five-step model, with recognition occurring when performance obligations are satisfied[43](index=43&type=chunk)[44](index=44&type=chunk) Revenue Type (in thousands) | Revenue Type (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Manufacture and supply revenue | $7,193 | $10,518 | | License and royalty revenue | $790 | $1,132 | | Co-development and research fees | $418 | $403 | | Proprietary product revenue, net | $319 | $— |\ | Total revenues | $8,720 | $12,053 | Geographic Area (in thousands) | Geographic Area (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :----------------------------- | :-------------------------------- | :-------------------------------- | | United States | $5,201 | $10,427 | | Ex-United States | $3,519 | $1,626 | | Total revenues | $8,720 | $12,053 | - For Q1 2025, Indivior and Hypera accounted for approximately **67%** and **17%** of total revenue, respectively, and **56%** and **14%** of total trade and other receivables[64](index=64&type=chunk) [Note 6. Material Agreements](index=17&type=section&id=Note%206.%20Material%20Agreements) Summarizes key agreements, including license amendments, royalty sales, and terminations, impacting product commercialization and revenue streams - The Indivior License Agreement for Suboxone was amended in March 2023, extending its term until August 16, 2026, with automatic one-year renewals, and adjusting transfer pricing and payment terms[67](index=67&type=chunk) - The company sold its rights to KYNMOBI royalties and milestone payments to Marathon in November 2020 for **$50,000**. Sunovion voluntarily withdrew KYNMOBI from U.S. and Canadian markets in June 2023, making additional contingent payments unlikely[73](index=73&type=chunk)[74](index=74&type=chunk) - The Haisco Agreement for Exservan in China was terminated in June 2024, meaning no further contingent payments will be received. The MTPA license for Exservan in the US was also mutually terminated in June 2024[76](index=76&type=chunk)[81](index=81&type=chunk) - The Pharmanovia Agreement for Libervant was expanded in March 2023 to cover global territories (excluding U.S., Canada, China), with Aquestive receiving a **$2,000 thousand** non-refundable payment[79](index=79&type=chunk) - The Assertio Agreement for Sympazan, effective October 2022, granted Assertio an exclusive worldwide license, with Aquestive receiving an upfront payment of **$9,000 thousand** and a **$6,000 thousand** milestone payment. Aquestive remains the exclusive manufacturer[80](index=80&type=chunk) [Note 7. Financial Instruments – Fair Value Measurements](index=20&type=section&id=Note%207.%20Financial%20Instruments%20%E2%80%93%20Fair%20Value%20Measurements) Explains the categorization of fair value measurements and the valuation methodologies for warrants and royalty right agreements using unobservable inputs - Fair value measurements are categorized into Level 1 (observable quoted prices), Level 2 (observable prices corroborated by market data), and Level 3 (unobservable inputs). Warrants and Royalty Right Agreements are valued using Level 3 inputs[82](index=82&type=chunk)[84](index=84&type=chunk) - Royalty Right Agreements, issued with the 13.5% Notes, were initially valued based on significant unobservable inputs including discount rate (**15%**), probability of success (**75%**), and projected payment years (**2025-2034**)[87](index=87&type=chunk)[109](index=109&type=chunk) [Note 8. Inventories](index=22&type=section&id=Note%208.%20Inventories) Details the composition of inventories, including raw materials, packaging, and finished goods, and changes over the reporting period Inventory Component (in thousands) | Inventory Component (in thousands) | March 31, 2025 | December 31, 2024 | | :--------------------------------- | :------------- | :---------------- | | Raw material | $2,964 | $3,266 | | Packaging material | $2,344 | $2,135 | | Finished goods | $1,890 | $643 | | Total inventory | $7,198 | $6,044 | - Total inventory increased by **$1,154 thousand** from December 31, 2024, to March 31, 2025, primarily driven by an increase in finished goods[88](index=88&type=chunk) [Note 9. Property and Equipment, Net](index=22&type=section&id=Note%209.%20Property%20and%20Equipment%2C%20Net) Presents the net book value of property and equipment by category and reports depreciation, amortization, and impairment expenses Asset Category (in thousands) | Asset Category (in thousands) | March 31, 2025 | December 31, 2024 | | :---------------------------- | :------------- | :---------------- | | Machinery | $20,348 | $20,317 | | Leasehold improvements | $21,419 | $21,419 | | Construction in progress | $2,069 | $2,110 | | Total property and equipment, net | $3,801 | $3,799 | - Total depreciation, amortization, and impairment related to property and equipment was **$139 thousand** for the three months ended March 31, 2025, a decrease from **$168 thousand** in the prior year period[90](index=90&type=chunk) [Note 10. Right-of-Use Assets and Lease Obligations](index=23&type=section&id=Note%2010.%20Right-of-Use%20Assets%20and%20Lease%20Obligations) Describes the company's operating leases for facilities, detailing lease terms, liabilities, and associated expenses - The company leases its production, warehouse, corporate, and research facilities under operating leases with remaining terms of **3.0 to 8.5 years**. Lease liabilities are measured at the present value of lease payments using an incremental borrowing rate of **14.8% to 15.6%**[92](index=92&type=chunk)[94](index=94&type=chunk) - Total operating lease expenses for the three months ended March 31, 2025, were **$427 thousand**, including **$93 thousand** in variable lease expenses[95](index=95&type=chunk) Total Future Lease Payments (in thousands) | Period | Total Future Lease Payments (in thousands) | | :--------------- | :--------------------------------------- | | Remainder of 2025 | $966 | | 2026 | $1,318 | | 2027 | $1,346 | | 2028 | $1,180 | | 2029 and thereafter | $3,915 | | **Total** | **$8,725** | | Less: imputed interest | $(3,363) | | **Total operating lease liabilities** | **$5,362** | [Note 11. Intangible Assets, Net](index=23&type=section&id=Note%2011.%20Intangible%20Assets%2C%20Net) Provides a breakdown of intangible assets, including purchased intangibles and patents, and reports amortization expenses Intangible Asset (in thousands) | Intangible Asset (in thousands) | March 31, 2025 | December 31, 2024 | | :------------------------------ | :------------- | :---------------- | | Purchased intangible | $3,858 | $3,858 | | Purchased patent | $509 | $509 | | Less: accumulated amortization | $(4,367) | $(4,367) | | Intangible assets, net | $— | $— | - No amortization expense was incurred for intangible assets during the three months ended March 31, 2025, compared to **$39 thousand** in the prior year period. An adjustment of **$1,200 thousand** was recorded in June 2024 due to an agreement termination[97](index=97&type=chunk) [Note 12. Other Non-current Assets](index=24&type=section&id=Note%2012.%20Other%20Non-current%20Assets) Lists other non-current assets, primarily royalty receivables from the Monetization Agreement, and their changes Other Non-current Assets (in thousands) | Other Non-current Assets (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------------------------- | :------------- | :---------------- | | Royalty receivable | $3,000 | $3,000 | | Other | $1,215 | $1,223 | | Total other non-current assets | $4,215 | $4,223 | - Royalty receivable of **$3,000 thousand** as of March 31, 2025, consists of four annual minimum payments due from Sunovion, with the last payment due in March 2028. This receivable is related to the Monetization Agreement[98](index=98&type=chunk) [Note 13. Accrued Expenses](index=24&type=section&id=Note%2013.%20Accrued%20Expenses) Details the components of accrued expenses, including compensation, taxes, and distribution costs, and explains period-over-period changes Accrued Expense (in thousands) | Accrued Expense (in thousands) | March 31, 2025 | December 31, 2024 | | :----------------------------- | :------------- | :---------------- | | Accrued compensation | $2,189 | $4,732 | | Real estate and personal property taxes | $417 | $365 | | Accrued distribution expenses and sales returns provision | $609 | $665 | | Interest payable | $17 | $17 | | Other | $82 | $128 | | Total accrued expenses | $3,314 | $5,907 | - The reduction in accrued compensation is primarily due to payments of accrued bonuses during the three months ended March 31, 2025[100](index=100&type=chunk) [Note 14. Long-Term Debt](index=24&type=section&id=Note%2014.%20Long-Term%20Debt) Outlines the terms of the 13.5% Senior Secured Notes, associated royalty right agreements, and scheduled principal payments - On November 1, 2023, Aquestive issued **$45,000 thousand** aggregate principal amount of 13.5% Senior Secured Notes due 2028, receiving net proceeds of approximately **$4,326 thousand** after debt repayment and costs[102](index=102&type=chunk) - The 13.5% Notes bear interest at **13.5% annually**, payable quarterly, with principal amortization beginning June 30, 2026. An Exit Fee of **$2,000 thousand** is also applicable[103](index=103&type=chunk) - In connection with the 13.5% Notes, Royalty Right Agreements were granted, entitling noteholders to tiered royalties (**1.0%-2.0%**) on worldwide net sales of Anaphylm and Libervant. The fair value of these agreements was allocated **$13,856 thousand** from the proceeds[106](index=106&type=chunk)[110](index=110&type=chunk) Debt Component (in thousands) | Debt Component (in thousands) | March 31, 2025 | December 31, 2024 | | :---------------------------- | :------------- | :---------------- | | Total outstanding notes | $45,000 | $45,000 | | Unamortized discount, including Exit Fee | $(11,392) | $(12,646) | | Notes payable, long-term | $33,608 | $32,354 | | Royalty obligations | $56,917 | $56,922 | | Unamortized discount (Royalty) | $(35,269) | $(36,706) | | Royalty obligations, net | $21,559 | $20,129 | Scheduled Principal Payments (in thousands) | Year | Scheduled Principal Payments (in thousands) | | :--- | :---------------------------------------- | | 2025 | $— | | 2026 | $9,540 | | 2027 | $14,535 | | 2028 | $20,925 | | **Total** | **$45,000** | [Note 15. Warrants](index=27&type=section&id=Note%2015.%20Warrants) Describes outstanding warrants, their exercise prices, expiration dates, and the number of shares they entitle holders to purchase - Warrants issued with 12.5% Senior Secured Notes (Initial and Additional Warrants) expire on June 30, 2025, entitling holders to purchase up to **2,143,000 shares** of Common Stock. No exercises occurred in Q1 2025 or Q1 2024[118](index=118&type=chunk) - In June 2022, pre-funded warrants (fully exercised in 2022) and Common Stock warrants (up to **8,850,000 shares** at **$0.96** exercise price, expiring June 8, 2027) were issued. In August 2023, **5,000,000** existing warrants were exercised, and new warrants for **2,750,000 shares** at **$2.60** exercise price were issued, exercisable after February 2, 2024[120](index=120&type=chunk)[121](index=121&type=chunk) - As of March 31, 2025, outstanding warrants include **1,683,784 shares** from the 12.5% Notes (exercise prices **$4.25** and **$5.38**), **160,548 shares** at **$0.96**, and **2,750,000** new warrants at **$2.60**[119](index=119&type=chunk)[123](index=123&type=chunk) [Note 16. Sale of Future Revenue](index=27&type=section&id=Note%2016.%20Sale%20of%20Future%20Revenue) Explains the sale of KYNMOBI royalty rights to Marathon and the impact of product withdrawal on future contingent payments and interest expense - In November 2020, Aquestive sold its contractual rights to KYNMOBI royalties and milestone payments to Marathon for an aggregate of **$50,000 thousand** through March 31, 2025. This was recorded as a liability related to the sale of future revenue[124](index=124&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk) - Due to Sunovion's voluntary withdrawal of KYNMOBI from U.S. and Canadian markets in June 2023, the company is unlikely to receive additional contingent payments, and recording of interest expense related to this sale was discontinued in Q4 2022[129](index=129&type=chunk) Liability Related to the Sale of Future Revenue (in thousands) | Metric (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Liability related to the sale of future revenue, net at beginning of the period | $63,718 | $64,490 | | Royalties related to the sale of future revenue | $— | $(1,008) | | Amortization of issuance costs | $59 | $236 | | Liability related to the sale of future revenue, net at end of the period | $63,777 | $63,718 | [Note 17. Net Loss Per Share](index=29&type=section&id=Note%2017.%20Net%20Loss%20Per%20Share) Calculates basic and diluted net loss per share, noting that potentially dilutive instruments are anti-dilutive due to net loss - Basic and diluted net loss per share are the same due to the company's net loss, which renders all potentially dilutive instruments anti-dilutive[131](index=131&type=chunk) Net Loss Per Share | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :----- | :-------------------------------- | :-------------------------------- | | Net loss | $(22,930) | $(12,828) | | Weighted-average common shares outstanding (basic and diluted) | 95,497,056 | 73,614,710 | | Loss per common share (basic and diluted) | $(0.24) | $(0.17) | [Note 18. Share-Based Compensation](index=29&type=section&id=Note%2018.%20Share-Based%20Compensation) Reports share-based compensation expenses by category and details unrecognized compensation for restricted stock units and stock options Share-Based Compensation Expense (in thousands) | Expense Category (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------ | :-------------------------------- | :-------------------------------- | | Manufacture and supply | $100 | $70 |\ | Research and development | $330 | $170 |\ | Selling, general and administrative | $1,157 | $1,340 |\ | Total share-based compensation expenses | $1,587 | $1,580 |\ | From Restricted stock units | $1,102 | $933 |\ | From Stock options | $485 | $647 | - As of March 31, 2025, total unrecognized compensation expenses for unvested service-based restricted stock units were **$8,369 thousand** (weighted average period of **2.14 years**) and for market condition vesting-based restricted stock units were **$2,798 thousand** (weighted average period of **1.87 years**)[135](index=135&type=chunk)[136](index=136&type=chunk) - Unrecognized compensation expense for non-vested stock options was **$3,849 thousand** as of March 31, 2025, expected to be recognized over a remaining weighted average period of **1.97 years**[143](index=143&type=chunk) [Note 19. Income Taxes](index=31&type=section&id=Note%2019.%20Income%20Taxes) Explains the company's income tax accounting, including deferred tax assets and liabilities, and the application of a full valuation allowance - The company uses the asset and liability method for income taxes, recognizing deferred tax assets and liabilities. A full valuation allowance is provided against net deferred tax assets due to the likelihood of non-realization[144](index=144&type=chunk)[145](index=145&type=chunk) - For the three months ended March 31, 2025, and 2024, the effective income tax rate was **0%**, with no income tax expense recorded on pretax losses of **$22,930 thousand** and **$12,828 thousand**, respectively[146](index=146&type=chunk) [Note 20. Contingencies](index=32&type=section&id=Note%2020.%20Contingencies) Summarizes ongoing legal proceedings, including product liability and regulatory challenges, and their potential impact on the company - Kentucky Litigation (Humana v. Indivior et al.): A settlement was reached in November 2024, with Aquestive having no obligation or liability as all were assumed by Indivior[149](index=149&type=chunk) - California Litigation (Neurelis, Inc. v. Aquestive Therapeutics, Inc.): The trial is scheduled for July 18, 2025. The company cannot predict the ultimate outcome or estimate potential loss[150](index=150&type=chunk) - Neurelis FDA Lawsuit (Neurelis v. Califf, et al.): The U.S. District Court ruled in favor of Neurelis on February 14, 2025, vacating FDA approval of Libervant for ARS patients aged two to five years, converting it to 'tentative approval'. Aquestive has ceased marketing activities in the U.S. and is appealing the decision[151](index=151&type=chunk)[152](index=152&type=chunk) - Suboxone Product Liability Litigation: Aquestive is a defendant in MDL and Canadian class action lawsuits alleging dental injuries from Suboxone. Indivior has agreed to defend Aquestive in the MDL. The company cannot predict the outcome or estimate potential loss[153](index=153&type=chunk)[154](index=154&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Analyzes Aquestive Therapeutics' financial condition and results for Q1 2025 vs. 2024, covering business overview, product pipeline, revenues, expenses, and liquidity [Overview](index=35&type=section&id=Overview) Provides a general business overview of Aquestive Therapeutics, highlighting its focus on innovative delivery technologies and manufacturing capabilities - Aquestive is a pharmaceutical company focused on innovative science and delivery technologies, developing products for severe allergic reactions (Anaphylm™, Adrenaverse™ platform) and manufacturing four licensed commercialized products globally[161](index=161&type=chunk) - The company's manufacturing facilities in Portage, Indiana, are deemed sufficient for current and developing products and are subject to inspections by regulatory bodies like the FDA, TGA, DEA, ANVISA, and EMA[162](index=162&type=chunk) [Complex Molecule Portfolio](index=36&type=section&id=Complex%20Molecule%20Portfolio) Details the development progress of Anaphylm™ and AQST-108, including NDA submission, clinical trial results, and future development plans - Anaphylm™ (epinephrine) Sublingual Film: The company completed its NDA submission to the FDA in Q1 2025. Positive topline data from a pediatric study (ages 7-17) was reported on April 1, 2025, showing PK results consistent with adult studies and a favorable safety profile. A product launch is planned for Q1 2026, pending FDA acceptance of the NDA in Q2 2025[173](index=173&type=chunk) - AQST-108 (epinephrine) Topical Gel: The company completed its first human clinical trial, demonstrating safety and local tolerability. Pre-IND FDA feedback was received in Q4 2024, and an IND is planned for Q4 2025, with a Phase 2a clinical trial initiation in H1 2026 for alopecia areata[174](index=174&type=chunk)[175](index=175&type=chunk) [Proprietary CNS Product](index=38&type=section&id=Proprietary%20CNS%20Product) Discusses the regulatory status of Libervant®, including the vacating of FDA approval for certain age groups and ongoing appeal efforts - Libervant® (diazepam) Buccal Film: FDA approval for U.S. market access for ARS patients aged two to five years was vacated by a U.S. District Court ruling on February 14, 2025, converting it to 'tentative approval'. Aquestive has ceased marketing activities and is appealing the decision, while also requesting FDA confirmation of approval based on clinical superiority[177](index=177&type=chunk)[178](index=178&type=chunk) - The District Court's ruling was not based on safety or efficacy but on the interpretation of orphan drug exclusivity for a competing nasal spray product (Valtoco). Final approval for any age group is restricted until the expiration of Valtoco's ODE or a reversal of the court's ruling[177](index=177&type=chunk)[179](index=179&type=chunk)[180](index=180&type=chunk) [Licensed Commercial Products, Product Candidates and Other Products](index=39&type=section&id=Licensed%20Commercial%20Products%2C%20Product%20Candidates%20and%20Other%20Products) Summarizes revenue generation from licensed products and provides updates on agreements for Exservan, Suboxone, Sympazan, KYNMOBI, and Azstarys - Licensed products generated **$8,720 thousand** and **$12,053 thousand** in revenue for the three months ended March 31, 2025, and 2024, respectively[181](index=181&type=chunk) - Exservan (Riluzole Oral Film): The MTPA license for U.S. commercialization and the Haisco license for China were mutually terminated in June 2024. Zambon continues to market Emylif in the EU, with Aquestive receiving a **$0.5 million** milestone payment in Q2 2023[181](index=181&type=chunk)[182](index=182&type=chunk)[183](index=183&type=chunk) - Suboxone®: Aquestive is the sole manufacturer. Branded products hold approximately **27%** film market share as of March 31, 2025, facing generic competition. The company is involved in patent infringement lawsuits[183](index=183&type=chunk) - Sympazan®: Aquestive licensed its intellectual property to Assertio in October 2022, receiving **$9.0 million** upfront and a **$6.0 million** milestone payment. Aquestive remains the exclusive manufacturer[187](index=187&type=chunk) - KYNMOBI®: Sunovion voluntarily withdrew the product from U.S. and Canadian markets in June 2023, impacting potential contingent payments from the Monetization Agreement[187](index=187&type=chunk) - Azstarys®: Aquestive receives milestone and royalty revenues from Zevra (formerly KemPharm, Inc.) for this ADHD treatment, based on a 2012 termination agreement[187](index=187&type=chunk) [Critical Accounting Policies and Use of Estimates](index=40&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) Confirms no material changes to critical accounting policies and estimates since the 2024 Annual Report on Form 10-K - There have been no material changes to the company's critical accounting policies and use of estimates as previously disclosed in its 2024 Annual Report on Form 10-K[185](index=185&type=chunk) [JOBS Act and Smaller Reporting Company](index=40&type=section&id=JOBS%20Act%20and%20Smaller%20Reporting%20Company) Explains the company's status as a 'smaller reporting company' and the associated exemptions from certain disclosure requirements - Aquestive remains a 'smaller reporting company,' allowing it to leverage exemptions from certain disclosure requirements, including reduced executive compensation and financial disclosures in periodic reports[186](index=186&type=chunk) - The company's status as a smaller reporting company is maintained if its public float is less than **$250 million** or if its public float is less than **$700 million** with annual revenues under **$100 million**[186](index=186&type=chunk) [Financial Operations Overview](index=41&type=section&id=Financial%20Operations%20Overview) Describes the company's revenue recognition methods, expense categories, and interest expense components, outlining key operational drivers - Revenues are generated from manufacture and supply, license and royalty, co-development and research fees, and proprietary product sales. Manufacture and supply revenue is based on purchase orders from licensees, with Aquestive as the exclusive manufacturer[189](index=189&type=chunk)[190](index=190&type=chunk) - License and royalty revenue is recognized based on the transfer of intellectual property rights or over the license term if ongoing obligations exist. Royalty revenue is estimated and recognized when sales occur[192](index=192&type=chunk) - Co-development and research fees are earned through specific tasks or development stages, with project durations ranging from several months to three years[193](index=193&type=chunk) - Proprietary product revenue is recognized upon shipment, with allowances for discounts and returns estimated based on historical trends and contract terms[194](index=194&type=chunk) - Costs and expenses include manufacture and supply, research and development, and selling, general and administrative expenses. R&D expenses are expected to remain significant due to ongoing product development[195](index=195&type=chunk)[196](index=196&type=chunk)[199](index=199&type=chunk) - Interest expense includes costs on 13.5% Notes, amortization of debt discounts, and interest related to royalty obligations and the sale of future revenue (discontinued in Q4 2022 for KYNMOBI)[203](index=203&type=chunk)[205](index=205&type=chunk)[207](index=207&type=chunk) [Results of Operations](index=43&type=section&id=Results%20of%20Operations) Compares revenues, expenses, and other income for Q1 2025 and Q1 2024, highlighting significant changes and their underlying causes Revenue Comparison (in thousands) | Revenue Type | March 31, 2025 | March 31, 2024 | Change ($) | Change (%) | | :------------- | :------------- | :------------- | :--------- | :--------- | | Manufacture and supply revenue | $7,193 | $10,518 | $(3,325) | (32%) | | License and royalty revenue | $790 | $1,132 | $(342) | (30%) | | Co-development and research fees | $418 | $403 | $15 | 4% | | Proprietary product revenue, net | $319 | $— | $319 | N/M | | **Total revenues** | **$8,720** | **$12,053** | **$(3,333)** | **(28%)** | - Total revenues decreased by **28%** (**$3,333 thousand**) primarily due to a **$4,463 thousand** decrease in Suboxone revenues, partially offset by a **$1,471 thousand** increase in Ondif revenues and **$319 thousand** from proprietary product revenue[212](index=212&type=chunk)[213](index=213&type=chunk)[215](index=215&type=chunk) Expenses and Other Income Comparison (in thousands) | Category | March 31, 2025 | March 31, 2024 | Change ($) | Change (%) | | :------------- | :------------- | :------------- | :--------- | :--------- | | Manufacture and supply | $3,652 | $4,389 | $(737) | (17%) | | Research and development | $5,361 | $5,932 | $(571) | (10%) | | Selling, general and administrative | $19,072 | $10,689 | $8,383 | 78% | | Interest expense | $2,782 | $2,784 | $(2) | —% | | Interest expense related to royalty obligations | $1,437 | $1,358 | $79 | 6% | | Interest expense related to the sale of future revenue | $59 | $58 | $1 | 2% | | Interest income and other income, net | $(713) | $(329) | $(384) | 117% | - Selling, general and administrative expenses increased significantly by **78%** (**$8,383 thousand**), driven by a **$4,310 thousand** Anaphylm PDUFA fee, **$2,250 thousand** higher legal fees, and **$2,130 thousand** higher commercial spending[221](index=221&type=chunk) - Research and development expenses decreased by **10%** (**$571 thousand**) due to lower clinical trial costs for Anaphylm, partially offset by increases in product research, preclinical expenses, personnel costs, and share-based compensation[218](index=218&type=chunk)[219](index=219&type=chunk)[220](index=220&type=chunk) - Interest income and other income, net, increased by **117%** (**$384 thousand**) due to higher cash balances invested in interest-bearing accounts[225](index=225&type=chunk) [Liquidity and Capital Resources](index=46&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's cash position, funding sources, and cash flow activities, emphasizing the need for additional capital for future development - As of March 31, 2025, cash and cash equivalents totaled **$68,657 thousand**. The company relies on existing cash, expense management, potential asset sales/outlicensing, and equity capital markets (ATM facility) for near-term liquidity[226](index=226&type=chunk) - Net cash used for operating activities increased by **$13,016 thousand** in Q1 2025 compared to Q1 2024, primarily due to a higher net loss and increases in trade and other receivables[237](index=237&type=chunk) - Net cash provided by financing activities decreased by **$61,095 thousand** in Q1 2025 compared to Q1 2024, mainly because there were no proceeds from a public offering in Q1 2025, unlike the **$70,126 thousand** received in Q1 2024. This was partially offset by higher ATM proceeds[239](index=239&type=chunk) - The company expects to incur significant operating losses and negative cash flows, requiring additional capital and/or financing to develop and commercialize Anaphylm and AQST-108, and to meet debt service obligations for its 13.5% Notes[244](index=244&type=chunk)[245](index=245&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a 'smaller reporting company,' Aquestive Therapeutics is exempt from providing quantitative and qualitative market risk disclosures - The company is exempt from providing quantitative and qualitative disclosures about market risk as it qualifies as a 'smaller reporting company' under SEC regulations[251](index=251&type=chunk) [Item 4. Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - As of March 31, 2025, management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[253](index=253&type=chunk) - No material changes in internal control over financial reporting were identified during the last fiscal quarter[254](index=254&type=chunk) [PART II – OTHER INFORMATION](index=50&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings) Refers to Note 20, Contingencies, for detailed information on legal proceedings, including product liability, intellectual property, and regulatory matters - For detailed information on legal proceedings, refer to Note 20, Contingencies, in the Financial Statements section[255](index=255&type=chunk) [Item 1A. Risk Factors](index=50&type=section&id=Item%201A.%20Risk%20Factors) Highlights significant risks, including tariffs, trade restrictions, and potential disruptions at regulatory agencies, which could impact business and product approvals - The company faces significant risks from existing and potential new tariffs and trade restrictions, including a **10%** baseline reciprocal tariff on imports and potential tariffs on pharmaceutical imports, which could adversely affect operating costs and financial condition[257](index=257&type=chunk)[258](index=258&type=chunk)[259](index=259&type=chunk) - Disruptions at the FDA and other government agencies (e.g., due to funding shortages, staffing limitations, or global health concerns) could hinder timely review and approval of new or modified products, negatively impacting the business[260](index=260&type=chunk)[261](index=261&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=51&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports no unregistered sales of equity securities or use of proceeds during the reporting period - No unregistered sales of equity securities or use of proceeds occurred during the reporting period[262](index=262&type=chunk) [Item 3. Defaults Upon Senior Securities](index=51&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Reports no defaults upon senior securities during the reporting period - No defaults upon senior securities occurred during the reporting period[263](index=263&type=chunk) [Item 4. Mine Safety Disclosures](index=51&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company's operations - Mine safety disclosures are not applicable to the company's operations[264](index=264&type=chunk) [Item 5. Other Information](index=51&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted or terminated Rule 10b5-1 trading arrangements during Q1 2025 - No directors or executive officers adopted or terminated any Rule 10b5-1 trading arrangements during the fiscal quarter ended March 31, 2025[265](index=265&type=chunk) [Item 6. Exhibits](index=51&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with the report, including consulting agreements, officer certifications, and XBRL documents - Exhibits include a Consulting Agreement for Mark Schobel, certifications of the Principal Executive Officer and Principal Financial Officer (pursuant to Rules 13a-14(a) and 15d-14(a), and 18 U.S.C. Section 1350), and various XBRL taxonomy documents[266](index=266&type=chunk) [SIGNATURES](index=52&type=section&id=SIGNATURES) Contains the required signatures for the financial report

[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) This section outlines Aquestive's strategic shift towards Anaphylm's commercialization and FDA approval, highlighted by the recent NDA submission and Q1 2025 achievements [CEO Statement & Strategic Focus](index=1&type=section&id=CEO%20Statement%20%26%20Strategic%20Focus) Aquestive's CEO highlighted the Anaphylm NDA submission as a major milestone, signaling a strategic shift to fully focus resources on Anaphylm's pre-commercial preparedness and FDA approval process, involving de-emphasizing AQST-108 advancement and not appealing the Libervant court decision - Submitted NDA for Anaphylm, a critical step towards the first oral, non-invasive epinephrine treatment[3](index=3&type=chunk) - Anticipate FDA's determination of NDA acceptance for Anaphylm in Q2 2025[3](index=3&type=chunk) - Actively preparing for a potential U.S. launch of Anaphylm in Q1 2026, if approved[3](index=3&type=chunk) - Company will have complete focus on Anaphylm's pre-commercial preparedness and FDA approval process, de-emphasizing AQST-108 advancement and not appealing the Libervant court decision[3](index=3&type=chunk) [Q1 2025 Highlights](index=1&type=section&id=Q1%202025%20Highlights) Key achievements for the first quarter of 2025 include the submission of the New Drug Application (NDA) for Anaphylm and the advancement of commercial readiness efforts for its planned Q1 2026 launch - Submitted NDA for Anaphylm™ (epinephrine), the first and only oral sublingual film for patients with severe allergic reactions[7](index=7&type=chunk) - Advancing commercial readiness efforts with a planned Q1 2026 launch of Anaphylm, subject to FDA approval[7](index=7&type=chunk) [Product Pipeline & Commercial Activities](index=1&type=section&id=Product%20Pipeline%20%26%20Commercial%20Activities) This section details the progress of Aquestive's product pipeline, including Anaphylm's NDA submission and commercial preparations, the revised timeline for AQST-108, and the regulatory status change for Libervant [Anaphylm™ (epinephrine) Sublingual Film](index=1&type=section&id=Anaphylm%E2%84%A2%20%28epinephrine%29%20Sublingual%20Film) Aquestive completed the NDA submission for Anaphylm, including positive pediatric study results, and is actively preparing for a potential Q1 2026 U.S. launch, with efforts including establishing broad market access, expanding teams, and planning international regulatory submissions - Completed NDA submission for Anaphylm with the FDA, including data from adult clinical program and pediatric study[4](index=4&type=chunk) - Pediatric trial (ages 7-17) demonstrated a pharmacokinetic (PK) profile consistent with prior adult data, supporting a proposed label aligned with the 0.3 mg epinephrine autoinjector[4](index=4&type=chunk) - Anticipate FDA acceptance notice for NDA review in Q2 2025[4](index=4&type=chunk) - Launch preparations are well underway for a potential U.S. commercial introduction in H1 2026, focusing on broad market access[5](index=5&type=chunk) - Plans to initiate regulatory submissions in key international markets (Europe, UK, Canada) following FDA acceptance[5](index=5&type=chunk) - Preparing for a potential Advisory Committee meeting during the FDA review process; regulatory timeline unaffected by recent HHS changes[6](index=6&type=chunk) [AQST-108 (epinephrine) Topical Gel](index=2&type=section&id=AQST-108%20%28epinephrine%29%20Topical%20Gel) The Phase 2a clinical trial for AQST-108, a topical gel for alopecia areata, is now scheduled for H1 2026, after the Anaphylm launch, to allow for focused resource allocation, offering a potential systemic side-effect-free alternative to existing JAK inhibitors in a multi-billion dollar market - Phase 2a clinical trial for AQST-108, a topical gel for alopecia areata (AA), planned for H1 2026, after the launch of Anaphylm[8](index=8&type=chunk) - AQST-108, if approved, has the potential to avoid systemic side effects associated with existing JAK inhibitors for AA[9](index=9&type=chunk) - The current estimated market opportunity for JAK inhibitors in AA is over **$1 billion**[9](index=9&type=chunk) [Libervant® (diazepam) Buccal Film](index=2&type=section&id=Libervant%C2%AE%20%28diazepam%29%20Buccal%20Film) Libervant's full FDA approval was converted to tentative status due to a court decision on orphan drug exclusivity, not safety or efficacy concerns, leading to a pause in sales and marketing, with U.S. patient access now anticipated in 2027 upon exclusivity expiration, and the company will not appeal the court decision to prioritize Anaphylm - FDA revised Libervant's full approval (April 2024) to tentative approval status due to a court's interpretation of the orphan drug statute, not safety or efficacy concerns[10](index=10&type=chunk) - Sales and marketing activities for Libervant have paused due to the change in regulatory status[11](index=11&type=chunk) - U.S. patient access to Libervant is planned for 2027, upon the expiration of orphan drug market exclusivity granted to a competitor's intranasal product, or sooner if market access is granted by the FDA[11](index=11&type=chunk) - Company decided not to pursue an appeal of the court's decision to ensure focus on the launch of Anaphylm[11](index=11&type=chunk) [Commercial Collaborations](index=2&type=section&id=Commercial%20Collaborations) Aquestive's manufacturing business remains stable, with growth in newer collaborations (Ondif, Sympazan, Emylif) offsetting the gradual decline of Suboxone, while its U.S.-based facility supports a diverse product range and its supply chain is largely unaffected by tariffs, ensuring production reliability - Manufacturing business remains steady, with growth across newer collaborations (Ondif, Sympazan, Emylif) offsetting the decline of Suboxone[12](index=12&type=chunk) - Supply chain remains largely unaffected by implemented and proposed tariffs, providing continued reliability and stability in production[12](index=12&type=chunk) - Royalty-based products, including Sympazan and Azstarys, continued to contribute to revenue in Q1 2025[12](index=12&type=chunk) [First Quarter 2025 Financial Results](index=3&type=section&id=First%20Quarter%202025%20Financial%20Results) This section provides a detailed analysis of Aquestive's financial performance for Q1 2025, including revenue, operating expenses, net loss, EBITDA, and cash position [Revenue Analysis](index=3&type=section&id=Revenue%20Analysis) Total revenues decreased by 28% year-over-year, primarily driven by decreases in manufacture and supply revenue (due to Suboxone) and license and supply revenue, partially offset by an increase in proprietary product revenue Total Revenue (Q1 2025 vs. Q1 2024) | Metric | Q1 2025 (Millions) | Q1 2024 (Millions) | Change (%) | | :----- | :----------------- | :----------------- | :--------- | | Total Revenue | **$8.7** | **$12.1** | **-28%** | Manufacture and Supply Revenue (Q1 2025 vs. Q1 2024) | Metric | Q1 2025 (Millions) | Q1 2024 (Millions) | | :----- | :----------------- | :----------------- | | M&S Revenue | **$7.2** | **$10.5** | - Manufacture and supply revenue decreased primarily due to lower Suboxone revenues, partially offset by an increase in Ondif revenues[14](index=14&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Research and development expenses saw a slight decrease, while selling, general and administrative expenses significantly increased, primarily due to higher regulatory fees, legal fees, and commercial spending related to Anaphylm Research and Development Expenses (Q1 2025 vs. Q1 2024) | Metric | Q1 2025 (Millions) | Q1 2024 (Millions) | Change (%) | | :----- | :----------------- | :----------------- | :--------- | | R&D Expenses | **$5.4** | **$5.9** | **-8.5%** | - Decrease in R&D expenses primarily due to lower clinical trial costs for Anaphylm, partially offset by increases in product research, preclinical expenses, personnel, and share-based compensation[15](index=15&type=chunk) Selling, General and Administrative Expenses (Q1 2025 vs. Q1 2024) | Metric | Q1 2025 (Millions) | Q1 2024 (Millions) | Change (%) | | :----- | :----------------- | :----------------- | :--------- | | SG&A Expenses | **$19.1** | **$10.7** | **+78.5%** | - Increase in SG&A expenses primarily due to **$4.8 million** in regulatory fees (including Anaphylm PDUFA fee), **$2.3 million** in higher legal fees, and approximately **$2.1 million** in higher commercial spending[16](index=16&type=chunk) [Net Loss & EBITDA](index=3&type=section&id=Net%20Loss%20%26%20EBITDA) The company reported a significantly increased net loss and non-GAAP adjusted EBITDA loss for Q1 2025 compared to Q1 2024, primarily driven by higher selling, general and administrative expenses and decreased revenues Net Loss and EPS (Q1 2025 vs. Q1 2024) | Metric | Q1 2025 (Millions) | Q1 2024 (Millions) | Basic & Diluted EPS (Q1 2025) | Basic & Diluted EPS (Q1 2024) | | :----- | :----------------- | :----------------- | :---------------------------- | :---------------------------- | | Net Loss | **$(22.9)** | **$(12.8)** | **$(0.24)** | **$(0.17)** | - Increase in net loss primarily driven by increases in selling, general and administrative expenses and decreases in revenues[17](index=17&type=chunk) Non-GAAP Adjusted EBITDA Loss (Q1 2025 vs. Q1 2024) | Metric | Q1 2025 (Millions) | Q1 2024 (Millions) | | :----- | :----------------- | :----------------- | | Non-GAAP Adj. EBITDA Loss | **$(17.6)** | **$(7.2)** | | Non-GAAP Adj. EBITDA Loss (excl. R&D) | **$(12.6)** | **$(1.4)** | [Cash Position](index=3&type=section&id=Cash%20Position) As of March 31, 2025, Aquestive Therapeutics reported cash and cash equivalents of $68.7 million - Cash and cash equivalents were **$68.7 million** as of March 31, 2025[19](index=19&type=chunk) [2025 Financial Outlook](index=3&type=section&id=2025%20Financial%20Outlook) This section outlines Aquestive's revised financial guidance for the full year 2025, reflecting adjustments due to recent regulatory changes [Revised Full-Year 2025 Guidance](index=3&type=section&id=Revised%20Full-Year%202025%20Guidance) Aquestive revised its full-year 2025 financial guidance, lowering total revenue expectations and slightly adjusting the non-GAAP adjusted EBITDA loss range, a direct result of the change in Libervant's regulatory status and the subsequent pausing of its sales and marketing activities - Revised full-year 2025 financial guidance due to the change in regulatory status of Libervant and pausing sales and marketing activities[20](index=20&type=chunk) Revised 2025 Financial Guidance (in millions) | Metric | Prior Guidance | Current Guidance | | :------------------------ | :------------- | :--------------- | | Total Revenue | **$47 to $56** | **$44 to $50** | | Non-GAAP Adjusted EBITDA Loss | **$46 to $53** | **$47 to $51** | [Product Information](index=3&type=section&id=Product%20Information) This section provides detailed descriptions of Aquestive's key product candidates: Anaphylm, Libervant, and AQST-108 [About Anaphylm™](index=3&type=section&id=About%20Anaphylm%E2%84%A2) Anaphylm is a polymer matrix-based epinephrine prodrug sublingual film designed for non-invasive administration without water or swallowing, with compact, credit card-sized, and weather-resistant packaging enhancing portability and usability - Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product[25](index=25&type=chunk) - It is similar in size to a postage stamp, weighs less than an ounce, and dissolves on contact, requiring no water or swallowing for administration[25](index=25&type=chunk)[26](index=26&type=chunk) - The primary packaging is thinner and smaller than an average credit card, designed to withstand weather excursions[26](index=26&type=chunk) - The Anaphylm trade name has been conditionally approved by the FDA, pending final product approval[26](index=26&type=chunk) [About Libervant®](index=4&type=section&id=About%20Libervant%C2%AE) Libervant is a buccally administered diazepam film for the acute treatment of seizure clusters in epilepsy patients; while initially fully approved for ages 2-5, its status was converted to tentative due to a competitor's orphan drug exclusivity, with U.S. market access now contingent on the expiration of this exclusivity in January 2027 - Libervant (diazepam) Buccal Film is a buccally administered film formulation of diazepam for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) in epilepsy patients[27](index=27&type=chunk) - Developed as an alternative to device-based products like rectal gel and nasal spray[27](index=27&type=chunk) - FDA approval for U.S. market access for patients aged two to five years was converted to 'tentative approval' due to existing orphan drug market exclusivity granted to an intranasal spray of another company[27](index=27&type=chunk) - U.S. market access for Libervant is currently subject to the expiration of this orphan drug market exclusivity, scheduled for January 2027[27](index=27&type=chunk) [About AQST-108](index=4&type=section&id=About%20AQST-108) AQST-108 is a topically delivered adrenergic agonist prodrug gel, part of Aquestive's Adrenaverse™ platform, with a first-in-human study completed, and the platform aims to control absorption and conversion rates across various dosage forms and delivery sites - AQST-108 (epinephrine) Topical Gel is a topically delivered adrenergic agonist prodrug gel product candidate[28](index=28&type=chunk) - Aquestive completed a first-in-human study for AQST-108[28](index=28&type=chunk) - It is based on Aquestive's Adrenaverse™ platform, which contains a library of over twenty epinephrine prodrug product candidates intended to control absorption and conversion rates[28](index=28&type=chunk) [Important Safety Information (Libervant®)](index=4&type=section&id=Important%20Safety%20Information%20%28Libervant%C2%AE%29) This section outlines critical safety warnings and potential adverse effects associated with Libervant, emphasizing risks related to co-administration with other depressants, abuse, dependence, and neurological impacts [Key Safety Warnings](index=4&type=section&id=Key%20Safety%20Warnings) Libervant carries significant safety warnings, including risks of severe drowsiness, breathing problems, coma, and death when taken with opioids, alcohol, or other CNS depressants, as well as risks of abuse, misuse, addiction, physical dependence, withdrawal reactions, and potential suicidal thoughts or actions - Do not give Libervant to children aged two to five if allergic to diazepam or ingredients, or if they have acute narrow angle glaucoma[29](index=29&type=chunk) - Taking Libervant with opioid medicines, alcohol, or other CNS depressants can cause severe drowsiness, breathing problems, coma, and death[32](index=32&type=chunk) - Risk of abuse, misuse, and addiction, which can lead to overdose and serious side effects including coma and death[32](index=32&type=chunk) - Libervant can cause physical dependence and withdrawal reactions, especially if used daily; sudden cessation can lead to serious and life-threatening side effects[34](index=34&type=chunk) - May cause sleepiness, dizziness, slowed thinking and motor skills, and suicidal thoughts or actions (about 1 in 500 people)[33](index=33&type=chunk) - The most common side effects of Libervant are sleepiness and headache[37](index=37&type=chunk) [Company Information](index=6&type=section&id=Company%20Information) This section provides an overview of Aquestive Therapeutics, Inc., highlighting its mission, technological capabilities, and product development focus [About Aquestive Therapeutics, Inc.](index=6&type=section&id=About%20Aquestive%20Therapeutics%2C%20Inc.) Aquestive is a pharmaceutical company dedicated to improving patient lives through innovative science and delivery technologies, particularly orally administered products using its proprietary PharmFilm® technology, with four licensed commercialized products and advancing late-stage Anaphylm and early-stage AQST-108 - Aquestive is a pharmaceutical company advancing medicines through innovative science and delivery technologies[36](index=36&type=chunk) - Developing orally administered products to deliver complex molecules, offering alternatives to invasive therapies[36](index=36&type=chunk) - Has four licensed commercialized products marketed globally and is their exclusive manufacturer[36](index=36&type=chunk) - Utilizes proprietary, best-in-class technologies like PharmFilm®[36](index=36&type=chunk) - Advancing a late-stage proprietary product candidate (Anaphylm) for severe allergic reactions and an early-stage epinephrine prodrug topical gel (AQST-108) for dermatological conditions[36](index=36&type=chunk) [Non-GAAP Financial Measures](index=7&type=section&id=Non-GAAP%20Financial%20Measures) This section explains Aquestive's use of non-GAAP financial measures, their purpose in supplementing GAAP results, and the rationale for their presentation [Explanation and Use of Non-GAAP Measures](index=7&type=section&id=Explanation%20and%20Use%20of%20Non-GAAP%20Measures) This section clarifies that Aquestive uses non-GAAP financial measures, such as adjusted EBITDA loss and adjusted expenses, to supplement GAAP results, excluding specific non-cash expenses and certain interest/income items to provide additional insight into the company's ongoing operating performance and aid managerial decision-making, but are not substitutes for GAAP measures - Non-GAAP financial measures (e.g., adjusted EBITDA loss, adjusted gross margins, adjusted expenses) are used to supplement U.S. GAAP results[38](index=38&type=chunk) - These measures exclude certain non-cash expenses like share-based compensation, depreciation, amortization, interest expense, and income taxes[38](index=38&type=chunk)[39](index=39&type=chunk) - Management uses non-GAAP measures to analyze financial results, assess operating strategies, and make managerial decisions, providing added transparency into operating performance[40](index=40&type=chunk) - Non-GAAP measures are intended to supplement, not act as substitutes for, comparable GAAP measures and should not be read as a measure of liquidity[40](index=40&type=chunk) - Outlook for non-GAAP measures is provided because the company cannot predict certain GAAP adjustments (e.g., share-based compensation, income tax, amortization) with reasonable certainty for the forward-looking period[41](index=41&type=chunk) [Forward-Looking Statements](index=8&type=section&id=Forward-Looking%20Statements) This section provides a disclaimer regarding forward-looking statements, outlining the inherent risks and uncertainties that could cause actual results to differ from projections [Disclaimer and Risk Factors](index=8&type=section&id=Disclaimer%20and%20Risk%20Factors) This section provides a standard disclaimer, identifying forward-looking statements and outlining numerous risks and uncertainties that could cause actual results to differ materially from projections, encompassing regulatory approval delays, clinical trial outcomes, commercialization challenges, market competition, financial resources, intellectual property, and broader economic and political factors - Identifies forward-looking statements by terms such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'estimate,' 'intend,' 'may,' 'will,' or their negatives[42](index=42&type=chunk) - Statements are based on current expectations and beliefs, subject to risks and uncertainties that could cause actual results to differ materially[42](index=42&type=chunk) - Key risks include: delays in Anaphylm approval, sufficiency of clinical data, FDA requirements for additional studies, Libervant market access issues, competition, insufficient capital, manufacturing capabilities, Suboxone market share erosion, intellectual property, regulatory changes, and general economic/political conditions[42](index=42&type=chunk)[43](index=43&type=chunk) - Caution against undue reliance on these forward-looking statements, which speak only as of the date made[43](index=43&type=chunk) - The Company assumes no obligation to update forward-looking statements or outlook/guidance after the date of the press release, except as required by applicable law[43](index=43&type=chunk) [Financial Statements](index=10&type=section&id=Financial%20Statements) This section presents Aquestive's key financial statements, including condensed balance sheets, statements of operations, and reconciliations of non-GAAP adjustments [Condensed Balance Sheets](index=10&type=section&id=Condensed%20Balance%20Sheets) The condensed balance sheets present the company's financial position as of March 31, 2025, and December 31, 2024, showing a slight decrease in cash and cash equivalents and an overall increase in total liabilities Condensed Balance Sheets (in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :---------------------------------- | :--------------- | :---------------- | | **Assets** | | | | Cash and cash equivalents | **$68,657** | **$71,546** | | Trade and other receivables, net | **$10,444** | **$7,344** | | Inventories | **$7,198** | **$6,044** | | Total current assets | **$89,169** | **$88,220** | | Total assets | **$102,234** | **$101,424** | | **Liabilities and Stockholders' Deficit** | | | | Accounts payable | **$12,280** | **$10,287** | | Total current liabilities | **$18,298** | **$18,865** | | Total liabilities | **$163,164** | **$161,580** | | Total stockholders' deficit | **$(60,930)** | **$(60,156)** | | Total liabilities and stockholders' deficit | **$102,234** | **$101,424** | [Condensed Statements of Operations and Comprehensive Loss](index=11&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The condensed statements of operations for the three months ended March 31, 2025, and 2024, indicate a significant increase in net loss, primarily due to decreased revenues and a substantial rise in selling, general, and administrative expenses Condensed Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Revenues | **$8,720** | **$12,053** | | Manufacture and supply | **$3,652** | **$4,389** | | Research and development | **$5,361** | **$5,932** | | Selling, general and administrative | **$19,072** | **$10,689** | | Total costs and expenses | **$28,085** | **$21,010** | | Loss from operations | **$(19,365)** | **$(8,957)** | | Net loss | **$(22,930)** | **$(12,828)** | | Basic and diluted loss per share | **$(0.24)** | **$(0.17)** | | Weighted average common shares outstanding | **95,497,056** | **73,614,710** | [Reconciliation of Non-GAAP Adjustments - Net Loss to Non-GAAP Adjusted EBITDA](index=12&type=section&id=Reconciliation%20of%20Non-GAAP%20Adjustments%20-%20Net%20Loss%20to%20Non-GAAP%20Adjusted%20EBITDA) This reconciliation table details the adjustments made to GAAP net loss to arrive at non-GAAP adjusted EBITDA for the three months ended March 31, 2025, and 2024, highlighting the impact of non-cash expenses and specific interest/income items Reconciliation of Non-GAAP Adjustments - Net Loss to Non-GAAP Adjusted EBITDA (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | GAAP net loss | **$(22,930)** | **$(12,828)** | | Share-based compensation expense | **$1,587** | **$1,580** | | Interest expense | **$2,782** | **$2,784** | | Interest expense related to royalty obligations | **$1,437** | **$1,358** | | Interest income and other income, net | **$(713)** | **$(329)** | | Depreciation and Amortization | **$139** | **$207** | | Total non-GAAP adjustments | **$5,291** | **$5,658** | | Non-GAAP adjusted EBITDA | **$(17,639)** | **$(7,170)** | | Non-GAAP adjusted EBITDA excluding Non-GAAP adjusted R&D expenses | **$(12,623)** | **$(1,428)** | [Reconciliation of Non-GAAP Adjustments - GAAP Expenses to Non-GAAP Adjusted Expenses](index=13&type=section&id=Reconciliation%20of%20Non-GAAP%20Adjustments%20-%20GAAP%20Expenses%20to%20Non-GAAP%20Adjusted%20Expenses) This table reconciles GAAP expenses (total costs, manufacture and supply, R&D, and SG&A) to their non-GAAP adjusted counterparts for the three months ended March 31, 2025, and 2024, primarily by adjusting for share-based compensation and depreciation/amortization to provide a clearer view of operational costs Reconciliation of Non-GAAP Adjustments - GAAP Expenses to Non-GAAP Adjusted Expenses (in thousands, except percentages) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Total costs and expenses (GAAP) | **$28,085** | **$21,010** | | Non-GAAP adjusted costs and expenses | **$26,359** | **$19,223** | | Manufacture and Supply Expense (GAAP) | **$3,652** | **$4,389** | | Gross Margin on total revenue (GAAP) | **58 %** | **64 %** | | Non-GAAP adjusted manufacture and supply expense | **$3,437** | **$4,143** | | Non-GAAP Gross Margin on total revenue | **61 %** | **66 %** | | Research and Development Expense (GAAP) | **$5,361** | **$5,932** | | Non-GAAP adjusted research and development expense | **$5,016** | **$5,742** | | Selling, General and Administrative Expenses (GAAP) | **$19,072** | **$10,689** | | Non-GAAP adjusted selling, general and administrative expenses | **$17,906** | **$9,338** |

Core Insights - Aquestive Therapeutics announced significant progress with the submission of the New Drug Application (NDA) for Anaphylm, an oral, non-invasive epinephrine treatment for severe allergic reactions, with expectations for FDA acceptance in Q2 2025 and a potential U.S. launch in Q1 2026 if approved [2][3][4] Financial Performance - Total revenues for Q1 2025 decreased to $8.7 million from $12.1 million in Q1 2024, marking a 28% decline primarily due to reduced manufacture and supply revenue [14] - Manufacture and supply revenue fell to $7.2 million from $10.5 million year-over-year, largely due to decreased Suboxone revenues [15] - Research and development expenses decreased slightly to $5.4 million from $5.9 million, attributed to lower clinical trial costs for Anaphylm [16] - Selling, general and administrative expenses rose significantly to $19.1 million from $10.7 million, driven by regulatory fees and increased commercial spending [17] - The net loss for Q1 2025 was $22.9 million, or $0.24 per share, compared to a net loss of $12.8 million, or $0.17 per share, in Q1 2024 [18] Product Development and Market Strategy - Anaphylm is positioned as a potential best-in-class epinephrine therapy in a growing multi-billion dollar market, with commercialization efforts ramping up ahead of the spring allergy season [2][4] - The company plans to initiate regulatory submissions for Anaphylm in key international markets following FDA approval [4][5] - Preparations for an Advisory Committee meeting during the FDA review process are underway to present Anaphylm's clinical profile [5] - The launch of AQST-108, a topical gel for alopecia areata, is planned for the first half of 2026, post-Anaphylm launch [6][9] Regulatory and Legal Updates - Libervant's approval status was downgraded to tentative due to a court ruling, impacting sales and marketing activities, with plans to provide access in 2027 [10][11] - The company has decided not to appeal the court decision regarding Libervant to focus resources on Anaphylm's launch [11] Market Outlook - The company revised its full-year 2025 financial guidance, expecting total revenue between $44 million and $50 million, down from a prior estimate of $47 million to $56 million [20] - Non-GAAP adjusted EBITDA loss is now projected to be between $47 million and $51 million, slightly adjusted from previous guidance [20]

Summary of the Conference Call for Aquestive Therapeutics (AQST) Company Overview - **Company**: Aquestive Therapeutics - **Focus**: Development of ANIFILM, an oral film epinephrine formulation for severe allergies [1][2] Key Points and Arguments Product Development and FDA Submission - **NDA Submission**: Recently submitted the New Drug Application (NDA) for ANIFILM, marking a significant milestone for the company [5] - **FDA Timeline**: Expecting acceptance letter from the FDA in June, with potential advisory committee meeting between mid-October and Thanksgiving, and PDUFA date anticipated in January or early February [7][8] - **Interactions with FDA**: Positive interactions noted, with the company feeling well-prepared for the submission process [8][12] Product Attributes and Clinical Data - **Key Product Attributes**: - Pharmacokinetics (PK) curve matches auto-injectors in the first 15 minutes, which is crucial for efficacy [12] - Storage conditions allow for portability, making it user-friendly [13] - **OASIS Study**: Demonstrated significant symptom relief within five minutes of administration, providing strong clinical evidence to support product claims [25][26] Market Dynamics and Competitive Landscape - **Market Size**: Current market estimated at 5 million doses per year, valued at approximately $1 billion, with expectations to double in the coming years [32][33] - **Growth Potential**: The market is projected to grow significantly, with estimates suggesting it could reach between $2 billion and $3 billion [33] - **Competitor Analysis**: Acknowledgment of a recent competitor's nasal spray product, with a focus on increasing awareness and acceptance among healthcare providers [27][28] Commercial Strategy - **Pre-Commercial Activities**: Emphasis on building awareness through community engagement, medical conferences, and presentations [15][16] - **Physician Engagement**: Targeting high decile allergists for initial product adoption, with plans to expand outreach post-launch [43][44] - **Payer Interactions**: Ongoing discussions with payers to ensure product access and equitable treatment in the marketplace [39][40] Financial Position and Launch Readiness - **Cash Position**: Company has a healthy financial position with multiple funding options available, ensuring readiness for product launch [41][42] - **Manufacturing Control**: The company controls its supply chain, allowing for flexibility and readiness as it approaches the final stages of FDA approval [49] Future Focus - **Primary Focus**: The company is fully committed to the successful launch of ANIFILM, prioritizing it above all other initiatives [50] Additional Important Insights - **Patient Demand**: There is a pent-up demand for alternative delivery methods for epinephrine, indicating a favorable market environment for ANIFILM [28][29] - **Clinical Experience Building**: Plans to create clinical use profiles to enhance physician comfort and familiarity with the product post-approval [30]