Financial Data and Key Metrics Changes - The company announced a successful financing round of $160 million to support the launch of ANNAFILM, indicating a strong financial position for upcoming operations [52][68]. - The recent funding includes an $85 million equity raise and a $75 million revenue interest financing, providing sufficient runway through 2026 and into 2027 [68][69]. Business Line Data and Key Metrics Changes - ANNAFILM, the lead product, is a prodrug of epinephrine designed to improve the delivery and usability for patients at risk of severe allergic reactions [8][12]. - The company is also developing AQST-108 for alopecia areata, showcasing a commitment to expanding its product pipeline beyond ANNAFILM [9][65]. Market Data and Key Metrics Changes - The potential market for ANNAFILM includes over 30 million individuals at risk of severe allergic reactions, with only 5 million prescriptions written annually, indicating a significant opportunity for market penetration [12]. - The company plans to target college-age individuals, teenagers, and parents concerned about their children's safety as early adopters of ANNAFILM [52][53]. Company Strategy and Development Direction - The company aims to leverage its unique oral administration of epinephrine to differentiate itself from existing injectable products, focusing on convenience and accessibility [23][50]. - Plans for international expansion include outreach to key markets such as Europe, Canada, and Japan, with ongoing discussions with regulatory bodies like EMA and Health Canada [60][62]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's decision not to require an advisory committee meeting, viewing it as a positive sign for the approval process [42][46]. - The company is preparing for a robust commercial launch and anticipates a strong market response to ANNAFILM, particularly among demographics that prefer non-injectable options [51][52]. Other Important Information - The company has conducted extensive studies to ensure the safety and efficacy of ANNAFILM, including unique studies to assess its performance in various scenarios [23][40]. - The management emphasized the importance of transparency in their interactions with the FDA, which has been consistent and constructive throughout the review process [22][46]. Q&A Session Summary Question: What items would you say that you had in common with the Nefi product, and what are the key differences? - The company acknowledged similarities in the goal of helping patients but emphasized the unique aspects of their product and the thoroughness of their FDA submission process [16][18]. Question: How do you think about the time it takes to actually take the product compared to an EpiPen? - Management believes that the oral product will be used more quickly than an EpiPen due to behavioral factors and the convenience of not using a needle [36]. Question: What is the plan for ex-US markets? - The company is prioritizing outreach in Europe, Canada, and Japan, with plans to submit filings in these regions as they progress [60][62]. Question: Why should an investor own Aquestive now versus waiting for approval? - Management highlighted the momentum and readiness of the company for commercial launch, suggesting that now is an opportune time for investment [66]. Question: What is your DTC strategy and social media strategy? - The company plans to utilize social media for cost-effective marketing while reserving traditional DTC advertising for later stages of the product lifecycle [72][74].

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]