Core Viewpoint - Aquestive Therapeutics has announced a $75 million strategic funding agreement with RTW Investments to support the commercialization of Anaphylm, a sublingual film for emergency treatment of allergic reactions, pending FDA approval [1][2]. Company Overview - Aquestive Therapeutics is focused on advancing medicines through innovative science and delivery technologies, with a portfolio that includes four commercialized products and a late-stage product candidate for severe allergic reactions [5]. - The company aims to provide novel alternatives to invasive therapies, utilizing proprietary technologies like PharmFilm® [5]. Product Details - Anaphylm™ (epinephrine) Sublingual Film is designed to be a convenient, oral rescue medication for severe allergic reactions, weighing less than an ounce and dissolving on contact without the need for water [4]. - The product's packaging is compact and weather-resistant, making it easy to carry [4]. Funding Agreement - The $75 million funding will be available upon FDA approval of Anaphylm and satisfaction of certain refinancing conditions related to the company's existing debt [2][7]. - RTW Investments will receive a tiered single-digit percentage of annual net sales of Anaphylm in the U.S., subject to a cap [2]. Strategic Importance - The financing is critical for supporting the company through 2027 and aims to transform how patients access their rescue medication [2]. - RTW Investments expresses confidence in the commercial prospects of Anaphylm as a rescue treatment for severe allergic reactions [2].

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 increased by $300,000 or 3% year over year to $10,000,000, excluding the impact of one-time recognition of deferred revenue in 2024 [21][22] - Net loss for Q2 2025 was $13,500,000 or $0.14 per share, compared to a net loss of $2,700,000 or $0.03 per share in Q2 2024 [24][25] - Non-GAAP adjusted EBITDA loss was $9,300,000 in Q2 2025, compared to a non-GAAP adjusted EBITDA income of $1,800,000 in Q2 2024 [25] Business Line Data and Key Metrics Changes - Manufacturer and supply revenue increased to $9,600,000 in Q2 2025 from $8,100,000 in Q2 2024, primarily due to increases in ONDEEP revenues, partially offset by decreases in Suboxone revenues [22] - Research and development expenses decreased to $9,500,000 for the six months ended June 30, 2025, from $10,100,000 for the same period in 2024 [23] Market Data and Key Metrics Changes - The rescue market for severe allergic reactions is expected to grow from approximately 5,000,000 prescriptions a year to as many as 10,000,000 prescriptions a year, potentially generating over $2,000,000,000 annually in global market [9][10] - A survey indicated that 90% of the market is expected to shift from injectables to non-injectable products over the coming years [10] Company Strategy and Development Direction - The company is focused on the launch of ANNAFILM, an oral product for treating severe allergic reactions, with an FDA action date set for January 31, 2026 [6][19] - The company is exploring multiple financing options to support the launch of ANNAFILM, including non-dilutive alternatives [20][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data package for ANNAFILM, highlighting a robust set of studies conducted [31] - The company is committed to addressing market access challenges and ensuring patients have access to ANNAFILM, including a cash pay program for patients [12][13] Other Important Information - The company ended Q2 2025 with $60,500,000 in cash, which is deemed sufficient for the initial launch but will require additional funding for ongoing support [15][26] - The company’s full-year 2025 financial guidance remains unchanged, expecting total revenue of $44,000,000 to $50,000,000 [26] Q&A Session Summary Question: Likelihood of FDA Advisory Committee Meeting - Management indicated that the likelihood of an Advisory Committee meeting remains uncertain and will depend on the FDA's mid-cycle review [30] - The clinical data package is robust, consisting of 10 independent studies with over 350 subjects [31] Question: Out-of-Pocket Exposure and Payer Landscape - Discussions with payers are focused on awareness rather than coverage at this stage, with cash pay expected to be a significant part of the market [38][39] Question: Pediatric Study Safety and NDA Submission - The pediatric study showed no significant differences in safety outcomes compared to adults, and the data is expected to support the NDA submission [52] Question: Commercial Preparation and Awareness of ANNAFILM - The company is actively increasing awareness through various channels, receiving positive feedback from the allergy community [56] Question: Business Development Strategy for ANNAFILM - The company is considering partnerships for ANNAFILM but emphasizes the importance of broad patient access [61] Question: Characteristics of Ideal Prescribers - The ideal prescribers for ANNAFILM are allergists, who are expected to be key targets upon launch due to their enthusiasm for the product [68]

Anaphylm (Epinephrine) Sublingual Film - FDA accepted the NDA for Anaphylm in Q2 2025, with a PDUFA date scheduled for January 31, 2026[8] - The company is preparing for a U S launch of Anaphylm in Q1 2026, pending FDA approval[8] - A pediatric study showed that 12 mg Anaphylm administration demonstrated comparable PK curves in adult and pediatric subjects, with no statistical differences between PK parameters[16] - Pharmacodynamic (PD) outcomes in the pediatric study showed a positive inflection for Heart Rate (HR), Systolic Blood Pressure (SBP), and Diastolic Blood Pressure (DBP) after Anaphylm exposure[25] Financial Performance and Outlook - As of June 30, 2025, the company had a cash balance of approximately $60.5 million[8] - The company projects its cash runway into 2026[8] - The company is guiding for total revenues of approximately $44-$50 million for 2025[34] - The company anticipates a Non-GAAP adjusted EBITDA loss of approximately $47-$51 million for 2025[34] Manufacturing Operations - Manufacturing operations continue to generate cash[30] - Doses shipped in Q2 2025 were 37204 (thousands)[31]

Core Insights - Aquestive Therapeutics reported $10 million in revenue for Q2 2025, a year-over-year decline of 50.2% [1] - The EPS for the same period was -$0.14, compared to -$0.03 a year ago, with a surprise of +22.22% against the consensus estimate of -$0.18 [1] Revenue Breakdown - Manufacture and supply revenue was $9.58 million, exceeding the average estimate of $8.49 million, representing an 18% year-over-year increase [4] - License and royalty revenue was $0.84 million, significantly below the estimated $2.09 million, reflecting a 92.5% decline compared to the previous year [4] - Co-development and research fees amounted to $0.38 million, slightly below the estimated $0.5 million, marking a 50% decrease year-over-year [4] Stock Performance - Shares of Aquestive Therapeutics have returned -2.7% over the past month, contrasting with the Zacks S&P 500 composite's +2.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Company Performance - Aquestive Therapeutics reported a quarterly loss of $0.14 per share, better than the Zacks Consensus Estimate of a loss of $0.18, representing an earnings surprise of +22.22% [1] - The company posted revenues of $10 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 9.62%, and a decline from year-ago revenues of $20.1 million [2] - Over the last four quarters, the company has surpassed consensus EPS estimates just once and topped consensus revenue estimates only once [2] Stock Movement and Outlook - Shares of Aquestive Therapeutics have increased by approximately 9.6% since the beginning of the year, outperforming the S&P 500's gain of 8.6% [3] - The sustainability of the stock's price movement will depend on management's commentary during the earnings call and future earnings expectations [3][4] - The current consensus EPS estimate for the upcoming quarter is -$0.17 on revenues of $12.33 million, and for the current fiscal year, it is -$0.72 on revenues of $45.27 million [7] Industry Context - The Medical - Drugs industry, to which Aquestive Therapeutics belongs, is currently in the top 35% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5][6]

[PART I – FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents the unaudited financial statements, management's discussion and analysis of financial condition and results of operations, market risk disclosures, and internal controls and procedures [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed financial statements, highlighting changes in financial position, operations, and cash flows for the period [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheets (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $60,536 | $71,546 | | Total current assets | $81,721 | $88,220 | | Total assets | $93,698 | $101,424 | | **Liabilities and Stockholders' Deficit** | | | | Total current liabilities | $23,155 | $18,865 | | Total liabilities | $166,288 | $161,580 | | Total stockholders' deficit | $(72,590) | $(60,156) | | Total liabilities and stockholders' deficit | $93,698 | $101,424 | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Revenues | $10,003 | $20,099 | $18,723 | $32,152 | | Total costs and expenses | $21,371 | $20,044 | $49,456 | $41,054 | | Loss from operations | $(11,368) | $55 | $(30,733) | $(8,902) | | Net loss | $(13,548) | $(2,745) | $(36,478) | $(15,573) | | Loss per share (basic and diluted) | $(0.14) | $(0.03) | $(0.37) | $(0.19) | [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Condensed Statements of Cash Flows (in thousands) | | Six Months Ended June 30, | | :--- | :--- | | | **2025** | **2024** | | Net cash used for operating activities | $(31,314) | $(17,390) | | Net cash used for investing activities | $(242) | $(64) | | Net cash provided by financing activities | $20,546 | $83,452 | | Net (decrease) increase in cash and cash equivalents | $(11,010) | $65,998 | | Cash and cash equivalents at beginning of period | $71,546 | $23,872 | | Cash and cash equivalents at end of period | $60,536 | $89,870 | [Notes to Unaudited Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) - For the six months ended June 30, 2025, the company sold **7,457,627 shares** of common stock through its At-The-Market (ATM) facility, generating net proceeds of approximately **$21.3 million**[26](index=26&type=chunk) - In June 2024, the company terminated its licensing agreements with Haisco and Mitsubishi Tanabe Pharma America (MTPA), resulting in the one-time recognition of **$7.0 million** and **$3.3 million** in deferred revenue, respectively[79](index=79&type=chunk)[83](index=83&type=chunk) - The company is involved in multiple legal proceedings, including litigation with Neurelis, Inc. regarding Libervant's FDA approval and numerous product liability lawsuits related to Suboxone, for which Indivior has agreed to defend the company[153](index=153&type=chunk)[154](index=154&type=chunk)[156](index=156&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses the company's financial performance, liquidity, and capital resources, highlighting key operational developments and future outlook [Overview](index=36&type=section&id=Overview) - The company is advancing its pipeline, focusing on Anaphylm™ (epinephrine) Sublingual Film for severe allergic reactions and the Adrenaverse™ epinephrine prodrug platform[164](index=164&type=chunk) - The New Drug Application (NDA) for Anaphylm was accepted by the FDA on June 16, 2025, with a PDUFA target action date of **January 31, 2026** The company plans for a product launch in **Q1 2026** if approved[180](index=180&type=chunk) - A U.S. District Court ruling on February 14, 2025, vacated the FDA's approval of Libervant® for patients aged two to five, converting it to a "tentative approval" Consequently, Aquestive has ceased marketing activities for Libervant in the United States[182](index=182&type=chunk) - The company is pursuing development of AQST-108, a topical gel for alopecia areata, with plans to open an IND in **Q4 2025** and initiate a Phase 2a clinical trial in the **first half of 2026**[180](index=180&type=chunk) [Results of Operations](index=44&type=section&id=Results%20of%20Operations) Revenue Comparison (in thousands) | Revenue Category | Q2 2025 | Q2 2024 | Change (%) | YTD 2025 | YTD 2024 | Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Manufacture and supply | $9,583 | $8,123 | 18% | $16,776 | $18,641 | (10%) | | License and royalty | $839 | $11,220 | (93%) | $1,629 | $12,352 | (87%) | | Co-development and research | $378 | $756 | (50%) | $796 | $1,159 | (31%) | | Proprietary product, net | $(797) | $— | N/M | $(478) | $— | N/M | | **Total revenues** | **$10,003** | **$20,099** | **(50%)** | **$18,723** | **$32,152** | **(42%)** | - The significant decrease in license and royalty revenue for Q2 and YTD 2025 was primarily due to the one-time recognition of **$10.3 million** in deferred revenues in Q2 2024 from the termination of agreements with Haisco and MTPA[218](index=218&type=chunk)[223](index=223&type=chunk) Expense Comparison (in thousands) | Expense Category | Q2 2025 | Q2 2024 | Change (%) | YTD 2025 | YTD 2024 | Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Manufacture and supply | $4,561 | $4,526 | 1% | $8,213 | $8,915 | (8%) | | Research and development | $4,105 | $4,162 | (1%) | $9,466 | $10,094 | (6%) | | Selling, general and administrative | $12,705 | $11,356 | 12% | $31,777 | $22,045 | 44% | - Selling, general and administrative expenses for the six months ended June 30, 2025 increased by **44%** (**$9.7 million**) year-over-year, driven by the Anaphylm PDUFA fee (~**$4.3M**), increased commercial spending (~**$4.2M**), and higher regulatory fees for Libervant (~**$1.1M**)[240](index=240&type=chunk) [Liquidity and Capital Resources](index=49&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **$60.5 million** in cash and cash equivalents[245](index=245&type=chunk) - The company believes its existing cash, expense management, and access to equity capital markets (including a **$100 million** ATM facility with **$78 million** remaining) provide sufficient liquidity to fund operations for at least the next twelve months[245](index=245&type=chunk)[246](index=246&type=chunk)[247](index=247&type=chunk) Cash Flow Summary (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used for operating activities | $(31,314) | $(17,390) | | Net cash used for investing activities | $(242) | $(64) | | Net cash provided by financing activities | $20,546 | $83,452 | - Net cash from financing activities decreased significantly in the first six months of 2025 compared to 2024, primarily because the 2024 period included **$72.0 million** in net proceeds from an underwritten public offering, whereas 2025 financing was mainly from ATM proceeds of **$21.2 million**[256](index=256&type=chunk)[247](index=247&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company, as a smaller reporting entity, is exempt from providing quantitative and qualitative disclosures about market risk - The company is a "smaller reporting company" and is therefore exempt from providing quantitative and qualitative disclosures about market risk[267](index=267&type=chunk) [Item 4. Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Management concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[269](index=269&type=chunk) - No material changes in internal control over financial reporting were identified during the last fiscal quarter[270](index=270&type=chunk) [PART II – OTHER INFORMATION](index=54&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section provides additional information including legal proceedings, updated risk factors, and disclosures regarding equity sales and other relevant corporate matters [Item 1. Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) The company refers to Note 20 of the financial statements for detailed information on ongoing legal proceedings - For detailed information on legal proceedings, the report directs readers to Note 20 of the financial statements[271](index=271&type=chunk) [Item 1A. Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) The company identifies risks related to tariffs and trade restrictions that could increase operating costs and negatively impact financial performance - The company faces risks from tariffs and trade restrictions imposed by the U.S. and other countries, which could increase costs for foreign-sourced raw materials and adversely impact operations[273](index=273&type=chunk)[275](index=275&type=chunk) - The current U.S. administration has expressed intent to impose tariffs on pharmaceutical imports, and the Department of Commerce has initiated an investigation into the national security effects of importing pharmaceuticals, which could lead to new tariffs[274](index=274&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=54&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - There were no unregistered sales of equity securities or use of proceeds to report for the period[276](index=276&type=chunk) [Item 5. Other Information](index=54&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted or terminated Rule 10b5-1 trading plans during the quarter ended June 30, 2025 - No directors or executive officers adopted or terminated any Rule 10b5-1 trading plans during the fiscal quarter ended June 30, 2025[279](index=279&type=chunk)

[Aquestive Therapeutics Q2 2025 Business Update and Financial Results](index=1&type=section&id=Aquestive%20Therapeutics%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Provides%20Business%20Update) Aquestive Therapeutics provides a comprehensive update on its Q2 2025 business performance, strategic advancements, and financial results, highlighting key pipeline progress and future outlook [Business and Strategic Highlights](index=1&type=section&id=Business%20and%20Strategic%20Highlights) Aquestive Therapeutics advanced Anaphylm™ with FDA NDA acceptance, preparing for a 2026 U.S. launch and initiating global expansion efforts - The FDA has accepted the New Drug Application (NDA) for **Anaphylm™**, the company's oral, sublingual film epinephrine product, and has set a PDUFA target action date of **January 31, 2026**[3](index=3&type=chunk)[4](index=4&type=chunk)[7](index=7&type=chunk) - The company is advancing preparations for a potential **U.S. launch of Anaphylm™ in the first quarter of 2026**, contingent on FDA approval[3](index=3&type=chunk)[5](index=5&type=chunk)[7](index=7&type=chunk) - Aquestive is accelerating its **global expansion strategy** for Anaphylm™, with initial regulatory meetings planned in Canada and the European Union[3](index=3&type=chunk)[5](index=5&type=chunk)[7](index=7&type=chunk) [Pipeline and Commercial Update](index=1&type=section&id=Pipeline%20and%20Commercial%20Update) Updates on Anaphylm™ commercial readiness, AQST-108 IND submission, Libervant® relaunch, and stable manufacturing collaborations highlight pipeline and commercial progress [Anaphylm™ (epinephrine) Sublingual Film](index=1&type=section&id=Anaphylm%E2%84%A2%20(epinephrine)%20Sublingual%20Film) The Anaphylm™ program is advancing with FDA NDA acceptance, ongoing review, and preparations for a potential Advisory Committee meeting - The **FDA accepted the NDA for Anaphylm™** and is initiating its review, with preparations ongoing for a possible Advisory Committee meeting ahead of the **January 31, 2026 PDUFA date**[4](index=4&type=chunk) - The clinical program for Anaphylm™ includes **10 completed studies** with approximately **935 total administrations** across **379 subjects**[4](index=4&type=chunk) - Anaphylm™ is positioned as an **orally administered, non-device product** with a **pharmacokinetic profile comparable to leading injectables**, aiming to address barriers like fear of needles and device complexity[6](index=6&type=chunk) [AQST-108 (epinephrine) Topical Gel](index=2&type=section&id=AQST-108%20(epinephrine)%20Topical%20Gel) AQST-108 is progressing towards an IND submission in late 2025 as a potential topical treatment for alopecia areata - Aquestive anticipates submitting an **Investigational New Drug (IND) Application for AQST-108** for the treatment of alopecia areata (AA) to the FDA in the **fourth quarter of 2025**[8](index=8&type=chunk) - AQST-108 is being developed as a **potential topical treatment for AA**, which could offer an alternative to systemic JAK inhibitors that have known side effects and "black box" warnings[8](index=8&type=chunk) [Libervant® (diazepam) Buccal Film](index=2&type=section&id=Libervant%C2%AE%20(diazepam)%20Buccal%20Film) Libervant® faces a temporary regulatory hurdle due to orphan drug exclusivity, with a relaunch targeted for 2027 or sooner upon full approval - Libervant's regulatory status was revised from full to **tentative approval** due to a court decision related to another drug's **orphan drug exclusivity**, a change not related to the product's safety or efficacy[9](index=9&type=chunk) - The company remains committed to **relaunching Libervant in 2027 or sooner**, should it receive full marketing approval from the FDA[9](index=9&type=chunk) [Commercial Collaborations](index=2&type=section&id=Commercial%20Collaborations) Manufacturing collaborations provide steady revenue, offsetting Suboxone's decline with growth from newer products, and the U.S. supply chain remains stable - The company's **manufacturing business remains steady**, with the **gradual decline of Suboxone** being offset by **growth from newer collaborations** for products like Sympazan, Ondif, and Emylif[10](index=10&type=chunk) - The company's **U.S.-based supply chain** is confirmed to be **largely unaffected by both implemented and proposed tariffs**, ensuring production stability[10](index=10&type=chunk) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financials) Aquestive reported **$10.0 million** in Q2 2025 revenues, a **3% increase** excluding a prior-year one-time item, with a net loss of **$13.5 million** and **$60.5 million** in cash Q2 2025 Financial Summary | Financial Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :--- | :--- | :--- | :--- | | Total Revenues | $10.0 | $20.1 | -50.2% | | Revenue (ex. one-time item) | $10.0 | $9.7 | +3% | | Net Loss | ($13.5) | ($2.7) | Increased Loss | | Loss Per Share (Basic & Diluted) | ($0.14) | ($0.03) | Increased Loss | | Non-GAAP Adjusted EBITDA | ($9.3) | $1.8 | Decreased | | Cash and Cash Equivalents | $60.5 | N/A | N/A | - The significant **year-over-year decrease in total revenues** was primarily due to a **one-time recognition of deferred revenue** in Q2 2024 from terminated agreements, with revenues **grew by $0.3 million** excluding this impact[11](index=11&type=chunk) - Selling, general and administrative (SG&A) expenses **increased to $12.7 million from $11.4 million** in Q2 2024, mainly due to higher commercial spending, regulatory fees, and personnel costs, partially offset by lower legal fees[13](index=13&type=chunk)[14](index=14&type=chunk) [2025 Financial Outlook](index=3&type=section&id=2025%20Outlook) Aquestive has provided its financial guidance for the full year of 2025, anticipating total revenues between **$44 million and $50 million** and a non-GAAP adjusted EBITDA loss of **$47 million to $51 million** 2025 Full-Year Financial Guidance | Guidance Metric | 2025 Full-Year Outlook (in millions) | | :--- | :--- | | Total Revenue | $44 to $50 | | Non-GAAP Adjusted EBITDA Loss | $47 to $51 | [About Our Products](index=3&type=section&id=About%20Our%20Products) This section describes the company's key product candidates: Anaphylm™ for epinephrine delivery, Libervant® for acute seizures, and AQST-108 for dermatological conditions - **Anaphylm™ (epinephrine) Sublingual Film** is a polymer matrix-based epinephrine prodrug candidate, similar in size to a postage stamp, that dissolves on contact without water[23](index=23&type=chunk) - **Libervant® (diazepam) Buccal Film** is administered inside the cheek for the acute treatment of seizure clusters in epilepsy patients[24](index=24&type=chunk) - **AQST-108 (epinephrine) Topical Gel** is a topically delivered adrenergic agonist prodrug gel product candidate based on the company's AdrenaVerse™ platform[26](index=26&type=chunk) [Disclosures and Financial Statements](index=4&type=section&id=Disclosures%20and%20Financial%20Statements) This section provides essential disclosures, including product safety information, company overview, non-GAAP financial explanations, forward-looking statements, and detailed unaudited financial statements [Important Safety Information](index=4&type=section&id=Important%20Safety%20Information) This section outlines critical safety warnings for Libervant®, including risks with opioids, potential for abuse, dependence, and common side effects like sleepiness - A key warning states that taking benzodiazepines like Libervant with opioids, alcohol, or other CNS depressants can cause **severe drowsiness, respiratory depression, coma, and death**[30](index=30&type=chunk) - The information outlines the **risk of abuse, misuse, and addiction**, as well as **physical dependence and withdrawal reactions**, emphasizing that Libervant is not intended for daily use[30](index=30&type=chunk) - The most common side effects of Libervant are listed as **sleepiness and headache**[35](index=35&type=chunk) [About Aquestive Therapeutics, Inc.](index=5&type=section&id=About%20Aquestive%20Therapeutics%2C%20Inc.) Aquestive Therapeutics develops orally administered products, has four licensed commercialized products, and is advancing late-stage Anaphylm™ and early-stage AQST-108 candidates - Aquestive develops **orally administered products** to provide novel alternatives to invasive and inconvenient standard of care therapies[34](index=34&type=chunk) - The company has **four licensed commercialized products** marketed by licensees and serves as the exclusive manufacturer for them[34](index=34&type=chunk) [Non-GAAP Financial Information](index=7&type=section&id=Non-GAAP%20Financial%20Information) This section explains the company's use of non-GAAP financial measures, such as adjusted EBITDA loss and other adjusted expenses, to analyze operating performance by excluding certain non-cash or non-recurring items - The company uses non-GAAP measures like **adjusted EBITDA loss**, which exclude items such as **share-based compensation, interest expense, depreciation, amortization, and income taxes**[37](index=37&type=chunk) - Management believes these non-GAAP measures provide **added transparency** into the company's operating performance and the effectiveness of its strategies[39](index=39&type=chunk) [Forward-Looking Statement](index=8&type=section&id=Forward-Looking%20Statement) This section contains the company's safe harbor statement, cautioning that forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially - Forward-looking statements include those regarding the advancement and timing of **Anaphylm™ and AQST-108** through clinical development and FDA approval[41](index=41&type=chunk) - The company outlines significant risks, such as **delays in the FDA approval process**, the ability to generate **sufficient clinical data**, **competition**, and the need for **sufficient capital resources**[42](index=42&type=chunk) [Financial Statements (Unaudited)](index=10&type=section&id=Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed financial statements for the period ended June 30, 2025, including balance sheets, statements of operations, and non-GAAP reconciliations [Condensed Balance Sheets](index=10&type=section&id=Condensed%20Balance%20Sheets) This table presents the company's condensed balance sheets as of June 30, 2025, and December 31, 2024, detailing assets, liabilities, and stockholders' deficit | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $60,536 | $71,546 | | Total current assets | $81,721 | $88,220 | | Total assets | $93,698 | $101,424 | | Total current liabilities | $23,155 | $18,865 | | Total liabilities | $166,288 | $161,580 | | Total stockholders' deficit | ($72,590) | ($60,156) | [Condensed Statements of Operations and Comprehensive Loss](index=11&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This table presents the condensed statements of operations and comprehensive loss for the three months ended June 30, 2025 and 2024 | Statement of Operations (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenues | $10,003 | $20,099 | | Total costs and expenses | $21,371 | $20,044 | | Loss from operations | ($11,368) | $55 | | Net loss | ($13,548) | ($2,745) | | Loss per share (basic and diluted) | ($0.14) | ($0.03) | [Reconciliation of 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 table reconciles GAAP net loss to non-GAAP adjusted EBITDA for the three months ended June 30, 2025 and 2024 | Reconciliation to Adj. EBITDA (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | GAAP net loss | ($13,548) | ($2,745) | | Total non-GAAP adjustments | $4,204 | $4,544 | | Non-GAAP adjusted EBITDA | ($9,344) | $1,799 | [Reconciliation of 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 to non-GAAP adjusted expenses for the three months ended June 30, 2025 and 2024 | Expense Reconciliation (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | GAAP Total costs and expenses | $21,371 | $20,044 | | Non-GAAP adjusted costs and expenses | $19,347 | $18,300 | | GAAP R&D Expense | $4,105 | $4,162 | | Non-GAAP adjusted R&D expense | $3,681 | $3,836 | | GAAP SG&A Expenses | $12,705 | $11,356 | | Non-GAAP adjusted SG&A expenses | $11,345 | $10,213 |

Core Insights - Aquestive Therapeutics announced pivotal progress with the FDA's acceptance of the NDA for Anaphylm, which could become the first oral, sublingual film epinephrine product if approved [2][3] - The company is preparing for a potential U.S. launch in 2026 and is also engaging in regulatory discussions for global expansion in Canada and the EU [2][4] - Financial results for Q2 2025 showed total revenues of $10.0 million, a decrease from $20.1 million in Q2 2024, primarily due to the prior year's one-time revenue recognition [11][14] Regulatory and Product Development - The FDA has accepted the NDA for Anaphylm, with a PDUFA date set for January 31, 2026, and the company is preparing for an Advisory Committee meeting [3][7] - Anaphylm has completed 10 clinical studies with approximately 935 administrations across 379 subjects, addressing the unmet need for non-invasive epinephrine delivery options [3][5] - The company is also advancing AQST-108, a topical gel for alopecia areata, with an anticipated IND submission in Q4 2025 [6] Commercial Strategy - Aquestive is building a commercial launch team for Anaphylm and leveraging existing infrastructure for execution [4] - The company views international markets as critical for long-term strategy and is actively pursuing regulatory meetings in Canada and the EU [4][5] - Anaphylm is positioned to address barriers to epinephrine adoption, such as fear of needles and device complexity, potentially transforming emergency allergy treatment [5] Financial Performance - Total revenues for Q2 2025 increased by $0.3 million, or 3%, year-over-year, excluding the impact of one-time deferred revenue recognition [11] - Manufacturing and supply revenue rose to $9.6 million in Q2 2025 from $8.1 million in Q2 2024, driven by increased Ondif revenues [12] - The net loss for Q2 2025 was $13.5 million, compared to a net loss of $2.7 million in Q2 2024, primarily due to decreased revenues and increased administrative expenses [14][15] Future Outlook - The company expects total revenue for the full year 2025 to be between $44 million and $50 million, with a non-GAAP adjusted EBITDA loss projected between $47 million and $51 million [17] - Cash and cash equivalents were reported at $60.5 million as of June 30, 2025, indicating a stable financial position for ongoing operations [16]

Company Overview - Aquestive Therapeutics is a publicly traded pharmaceutical company (NASDAQ: AQST) focused on advancing medicines through innovative science and delivery technologies[7] - The company has shipped over 25 billion PharmFilm doses worldwide[10] - Aquestive Therapeutics reported over $57 million in revenue in 2024[13, 14] - The company anticipates 2 product launches in the U S by 2027[17] - The company estimates over $15 billion in potential peak annual net sales from pipeline assets[18] Anaphylm (epinephrine) Sublingual Film - The U S epinephrine market has the potential to grow to approximately $2 billion in value by 2031[54] - The current market size in 2024 is approximately $800 million[55] - The epinephrine market has experienced a 15% CAGR from 2021 to 2023[55, 56] - 95% of patients are interested in a film-dosing option for epinephrine[66] - The PDUFA action date for Anaphylm is scheduled for January 31, 2026[27, 69] AQST-108 (epinephrine) Topical Gel - The company is pursuing alopecia areata (AA) as a potential initial indication for AQST-108[75] - The market opportunity for JAK inhibitors for alopecia areata is estimated at over $1 billion[80]

Core Viewpoint - Aquestive Therapeutics, Inc. is set to report its second quarter results for the period ending June 30, 2025, and will provide updates on recent business developments on August 11, 2025 [1]. Company Overview - Aquestive is a pharmaceutical company focused on advancing medicines that significantly improve patients' lives through innovative science and delivery technologies [3]. - The company is developing orally administered products to deliver complex molecules, offering alternatives to invasive and inconvenient standard therapies [3]. - Currently, Aquestive has four commercialized products marketed by its licensees in the U.S. and globally, and it is the exclusive manufacturer of these licensed products [3]. - The company collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies, such as PharmFilm® [3]. - Aquestive is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis, and an earlier-stage epinephrine prodrug topical gel for various dermatological conditions, including alopecia areata [3]. Upcoming Events - Management will host a conference call for investors on August 12, 2025, at 8:00 a.m. ET, with registration required for participation [2]. - A live webcast of the call will be available on the Investors section of the company's website, and a replay will be archived for 30 days [2].