Core Viewpoint - Aquestive Therapeutics has announced that the FDA has determined that an advisory committee meeting is not required for the approval of Anaphylm™ (dibutepinephrine) Sublingual Film, with a target action date set for January 31, 2026 [1][7]. Product Overview - Anaphylm has the potential to be the first FDA-approved, non-invasive, orally delivered epinephrine product for treating severe allergic reactions, including anaphylaxis [2][3]. - The product is designed as a thin, dissolvable film that is placed under the tongue, offering a device-free and needle-free option for patients at risk of severe allergic reactions [2][3]. - Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve upon contact, requiring no water or swallowing for administration [4]. Clinical Development - Eleven clinical studies have been completed, totaling 967 administrations (840 single-dose and 127 repeat-dose) for adults and children over 30 kg [3]. - The development program includes a novel trial for oral allergy syndrome, demonstrating Anaphylm's real-world effectiveness [3]. Company Positioning - The company is well-positioned for the launch of Anaphylm, supported by recent financing activities totaling $160 million, which will facilitate outreach to healthcare providers, caregivers, and patients post-FDA approval [3]. - Aquestive Therapeutics is focused on advancing medicines through innovative science and delivery technologies, with four commercialized products marketed globally [5].

Core Viewpoint - Aquestive Therapeutics, Inc. is actively engaging with investors through participation in three upcoming conferences in September 2025, showcasing its commitment to transparency and investor relations [1]. Company Overview - Aquestive Therapeutics is a pharmaceutical company focused on advancing medicines that significantly improve patients' lives through innovative science and delivery technologies [2]. - The company is developing orally administered products to deliver complex molecules, providing alternatives to invasive and inconvenient standard therapies [2]. - Currently, Aquestive has four commercialized products marketed by its licensees globally and is the exclusive manufacturer of these products [2]. - The company collaborates with other pharmaceutical firms to bring new molecules to market using proprietary technologies, such as PharmFilm [2]. - A late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis, is under development, along with an early-stage epinephrine prodrug topical gel for dermatological conditions like alopecia areata [2]. Upcoming Events - The company will participate in the Cantor Healthcare Conference with a fireside chat scheduled for 8:00 am ET on September 4, 2025, and will host investor meetings on September 3 and 4 [4]. - At the Wells Fargo Healthcare Conference, the company will be available for investor meetings on September 5 [4]. - The H.C. Wainwright 26th Annual Global Investor Conference will feature a presentation at 10:00 am ET on September 9, 2025, with investor meetings available on September 8 and 9 [4].

Company Performance - Aquestive Therapeutics (AQST) has returned approximately 12.6% year-to-date, outperforming the Medical sector, which has returned an average of -4.9% [4] - The Zacks Consensus Estimate for AQST's full-year earnings has increased by 0.5% over the past 90 days, indicating improving analyst sentiment [3] Industry Ranking - Aquestive Therapeutics is part of the Medical - Drugs industry, which consists of 153 companies and currently ranks 84 in the Zacks Industry Rank [5] - The average return for the Medical - Drugs industry so far this year is 8.3%, suggesting that AQST is performing better than its industry peers [5] Sector Overview - The Medical sector includes 978 individual stocks and is currently ranked 8 in the Zacks Sector Rank, which evaluates 16 different sector groups [2] - Arbutus Biopharma (ABUS), another stock in the Medical sector, has returned 3.1% year-to-date and has a Zacks Rank of 2 (Buy) [4][5]

Company Overview - Aquestive Therapeutics, Inc. is a pharmaceutical company focused on advancing medicines to improve patients' lives through innovative science and delivery technologies [5] - The company is developing orally administered products to deliver complex molecules, providing alternatives to invasive therapies [5] - Currently, Aquestive has four commercialized products marketed by its licensees globally and is the exclusive manufacturer of these products [5] Offering Details - The company announced an underwritten offering of 21,250,000 shares of common stock at a price of $4.00 per share, expecting gross proceeds of $85 million before expenses [1] - The net proceeds will primarily be used to advance the launch and commercialization of Anaphylm™ (epinephrine) Sublingual Film for treating severe allergic reactions, pending FDA approval [1] - The offering is expected to close around August 15, 2025, subject to customary closing conditions [1] Underwriters and Management - The offering was led by RTW Investments, LP, with participation from several investment firms including Samsara BioCapital and EcoR1 Capital [2] - Leerink Partners, Cantor, and Oppenheimer & Co. are acting as joint bookrunning managers, while H.C. Wainwright & Co. is the lead manager [2] Regulatory Information - A shelf registration statement relating to the offering was filed with the SEC and declared effective on April 23, 2024 [3] - A final prospectus supplement and accompanying prospectus will be filed with the SEC and made available on their website [3]

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)