WARREN, N.J., May 01, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that it will report results for the first quarter ended March 31, 2025 and provide an update on recent developments in its business after market close on Monday, May 12, 2025. Management will host a conference call for inve ...

Core Insights - Aquestive Therapeutics, Inc. is participating in the Piper Sandler Spring Biopharma Symposium in Boston, with investor meetings scheduled for April 17, 2025 [1] Company Overview - Aquestive is a pharmaceutical company focused on advancing medicines through innovative science and delivery technologies, aiming to improve patients' lives [2] - The company is developing orally administered and topical gel products to deliver complex molecules, providing alternatives to standard therapies [2] - Currently, Aquestive has four commercialized products marketed by licensees in the U.S. and globally, and it is the exclusive manufacturer of these products [2] - The company collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm® [2] - Aquestive is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel for dermatology conditions [2]

WARREN, N.J., April 01, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced positive topline results from its pediatric study for Anaphylm™ (epinephrine) sublingual film in patients aged seven to seventeen and weighing greater that thirty kilograms with a personal history of allergic reactions. Th ...

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Financial Data and Key Metrics Changes - Total revenue decreased to $11.9 million in Q4 2024 from $13.2 million in Q4 2023, a 10% decrease primarily due to declines in license and royalty revenue [31] - For the full year 2024, total revenues increased to $57.6 million from $50.6 million in 2023, a 14% increase driven by increases in license and royalty revenue [32] - Net loss for Q4 2024 was $17.1 million or $0.19 per share, compared to a net loss of $8.1 million or $0.12 per share in Q4 2023 [36] - Non-GAAP adjusted EBITDA loss was $11 million in Q4 2024 compared to $2.8 million in Q4 2023 [38] Business Line Data and Key Metrics Changes - Manufacture and supply revenue decreased to $10.7 million in Q4 2024 from $11 million in Q4 2023, primarily due to a decrease in Suboxone revenues [31] - License and royalty revenue decreased to $0.8 million in Q4 2024 from $1.9 million in Q4 2023, mainly due to prior year milestone royalty revenue [31] - Research and development expenses increased to $4.9 million in Q4 2024 from $2.9 million in Q4 2023, driven by clinical trial costs for Anaphylm [34] Market Data and Key Metrics Changes - The company plans to submit applications for Anaphylm in international markets including the EU, UK, and Canada [22] - The estimated market opportunity for JAK inhibitors, which are existing therapies for alopecia areata, is over $1 billion [24] Company Strategy and Development Direction - The company has begun the filing process with the FDA for Anaphylm and expects to launch in Q1 2026 if approved [9][10] - Plans to focus on international markets and partnerships for Anaphylm post-FDA submission [22] - The company is preparing for a potential advisory committee meeting for Anaphylm, expected in the second half of 2025 [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Anaphylm's profile and its potential to be preferred by patients due to its rapid absorption and ease of use [48] - The company anticipates total revenues of approximately $47 million to $56 million for 2025, including some erosion in Suboxone demand [41] - Management remains committed to ensuring access to Libervant for young patients despite recent legal challenges [26][66] Other Important Information - The company raised over $78 million in capital from institutional investors to support strategic priorities [30] - Cash and cash equivalents were $71.5 million as of December 31, 2024, with a pro forma adjustment to approximately $93 million after recent fundraising [39] Q&A Session Summary Question: Key topics for FDA advisory committee meeting - Management discussed confidence in Anaphylm's profile and the importance of rapid epinephrine uptake during allergic reactions [44][45] Question: Early adopters of Anaphylm - Management believes that anyone at risk of anaphylaxis will be an early adopter, with a focus on teenagers and young adults [49][50] Question: Commercialization strategy - The company is prepared to launch Anaphylm independently but is open to partnerships if beneficial [54][60] Question: Libervant's future - Management emphasized the importance of Libervant for patients and the ongoing efforts to ensure access despite legal challenges [66][102] Question: Market seasonality for epinephrine products - Management highlighted the seasonal nature of the epinephrine market, with a peak in demand during summer months [72][73] Question: Safety profile of Anaphylm - Management expressed confidence in the safety and efficacy data supporting Anaphylm, noting a robust clinical package submitted to the FDA [77][78]

Core Insights - Aquestive Therapeutics reported a revenue of $11.87 million for Q4 2024, reflecting a year-over-year decline of 10.2% and an EPS of -$0.19 compared to -$0.12 a year ago [1] - The revenue fell short of the Zacks Consensus Estimate of $13.5 million by 12.11%, while the EPS also missed the consensus estimate of -$0.14 by 35.71% [1] Revenue Breakdown - Manufacture and supply revenue was $10.66 million, below the average estimate of $11.38 million, representing a year-over-year decline of 3% [4] - License and royalty revenue was $0.83 million, significantly lower than the average estimate of $1.86 million, indicating a year-over-year decrease of 55.6% [4] - Co-development and research fees amounted to $0.27 million, compared to the average estimate of $0.43 million, reflecting an 18.2% year-over-year decline [4] - Proprietary product sales, net, were $0.10 million, below the average estimate of $0.20 million [4] Stock Performance - Shares of Aquestive Therapeutics have decreased by 11.1% over the past month, while the Zacks S&P 500 composite has declined by 4.1% [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Aquestive Therapeutics (AQST) came out with a quarterly loss of $0.19 per share versus the Zacks Consensus Estimate of a loss of $0.14. This compares to loss of $0.12 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -35.71%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.12 per share when it actually produced a loss of $0.13, delivering a surprise of -8.33%.Over the last four q ...

Financial Position - As of December 31, 2024, the company had an accumulated deficit of $363.2 million, reflecting a history of net losses [162]. - The company has $45.0 million of outstanding indebtedness represented by 13.5% Notes as of December 31, 2024, with interest payable quarterly [168]. - The company has incurred substantial losses since inception and does not expect to become profitable in the near future, with net operating loss carryforwards subject to limitations under federal tax law [310]. - The company has never declared or paid any cash dividends on its common stock, anticipating that any return to stockholders will be limited to stock appreciation [311]. - The company is subject to significant quarterly and annual fluctuations in operating results, which could lead to substantial declines in stock price if results fall below investor expectations [308]. Revenue Dependence - Indivior accounted for approximately 62% and 80% of the company's revenues for 2024 and 2023, respectively, indicating a significant reliance on a single customer [172]. - Indivior accounted for 62% and 80% of the company's total revenue in 2024 and 2023, respectively [246]. Capital Raising and Financing - The company sold 4,557,220 shares through its ATM facility in 2024, generating net proceeds of approximately $11.8 million after transaction costs [163]. - The company anticipates needing to raise significant additional capital in the future to manage expenses and further product development [159]. - The company may face challenges in obtaining additional financing due to substantial debt service obligations and existing restrictions under current debt instruments [169]. Product Development and Commercialization - The company plans to commercialize its product Libervant for pediatric patients aged two to five years, which is critical for future revenue generation [171]. - Libervant received FDA approval for U.S. market access for ARS patients aged two to five years, but this approval is currently under legal challenge, which could delay market entry until January 2027 [176][177]. - The establishment of a commercial infrastructure for product candidates is expected to be expensive and time-consuming, with potential regulatory compliance challenges across multiple jurisdictions [194]. - The company has received orphan drug market exclusivity for Libervant for ARS patients aged two to five years, which could provide a competitive advantage if maintained [185]. - The company has limited commercialization experience, having only launched its first self-developed product, Sympazan, in December 2018, and scaled back operations after licensing it to Assertio in October 2022 [193]. Regulatory and Compliance Challenges - The FDA's approval process for product candidates is lengthy and uncertain, with significant resources required for successful submissions [182]. - Regulatory approval from the FDA is limited to specific indications, and failure to comply with these could adversely affect sales efforts [200]. - The company is subject to intense competition from larger pharmaceutical companies, which may have more resources and faster regulatory approval processes [205]. - Regulatory compliance is critical; failure to meet requirements may lead to product recalls or market withdrawal [265]. - The company is subject to various federal and state transparency laws requiring reporting of payments to healthcare providers, which could complicate compliance efforts [215]. Intellectual Property Risks - The company relies on a combination of patents and trade secrets for intellectual property protection, which can be uncertain [274]. - The outcome of litigation regarding patent rights is unpredictable, and a loss could materially impact the company's business [295]. - The company may need to obtain licenses from third parties to advance research or commercialize product candidates, which may not be available on reasonable terms [289]. - Legal proceedings to enforce patents are costly and time-consuming, potentially diverting resources from core business activities [284]. Operational Risks - The company relies on third-party licensees for commercialization and may face difficulties in establishing suitable relationships for product launches [195]. - The company expects to continue relying on third parties for API manufacturing, which limits control over quality and compliance [229]. - Manufacturing difficulties, including quality control and resource constraints, could jeopardize the ability to meet commercial demand and lead to significant revenue loss [232]. - The company relies on two third-party manufacturers for thin film foil, and any disruption could significantly impact production and commercialization timelines [227]. Legal and Regulatory Environment - The company may face significant civil, criminal, and administrative penalties if found in violation of healthcare laws, which could include exclusion from government-funded healthcare programs like Medicare and Medicaid [214]. - Legislative changes, such as the 2% reduction in Medicare payments for drugs and biologics, are expected to extend to 2032, potentially affecting pricing and reimbursement for the company's products [217]. - The Inflation Reduction Act of 2022 introduced drug pricing reforms, including a drug price negotiation program starting in 2026 and rebate payment requirements for price increases exceeding inflation [220]. Workforce and Management - The company plans to expand its workforce to support the commercialization of Libervant and Anaphylm, which may lead to increased expenses without guaranteed revenue growth [247][248]. - The company is highly dependent on its executive team, and the loss of key personnel could adversely impact its objectives and operations [317]. Data Privacy and Cybersecurity - Compliance with evolving data privacy laws incurs significant costs and resources, with potential liabilities for non-compliance [319]. - The company is subject to HIPAA regulations, which impose strict privacy and security obligations on healthcare-related information [321]. - Non-compliance with data privacy laws could lead to significant costs, damages, and erosion of trust, adversely impacting business operations [326].

Revenue and Market Potential - In 2023, Aquestive Therapeutics generated over $50 million in revenue and has over $1.5 billion in potential peak annual net sales from pipeline assets[5]. - The Anaphylm (epinephrine) Sublingual Film is the first non-device based, orally delivered epinephrine product, targeting a U.S. market projected to grow to approximately $2 billion[27]. - The annual scripts written for epinephrine have increased at a 15% compound annual growth rate (CAGR) from 2021 to 2023[29]. - The market opportunity for JAK inhibitors is estimated to exceed $1 billion[110]. Product Development and Launch Timeline - The company expects to launch two new products in the U.S. by 2027, including Libervant for patients aged 2-5, which has already been FDA approved[9]. - Libervant is expected to be launched for patients aged 12 and up in 2027, with additional launches planned for ages 6-11[10]. - The expected clinical and regulatory timeline for Anaphylm includes key milestones through Q4 2024, indicating a proactive approach to market entry[43]. - The planned Phase 2a clinical study for AQST-108 in alopecia areata is set to commence in Q2 2025, with interim data expected in 12 weeks[114]. Intellectual Property and Manufacturing - The company has over 150 patents worldwide, showcasing its intellectual property strength in drug delivery technologies[13]. - The company has two manufacturing and packaging facilities located in Indiana, supporting its production capabilities[13]. - The company has commercialized its proprietary PharmFilm® technology across six FDA-approved products, establishing itself as a world leader in oral thin film delivery[36]. Clinical Studies and Efficacy - Anaphylm demonstrated a time to maximum concentration (Tmax) of 12-15 minutes, with pharmacodynamic effects onset within 2-5 minutes, comparable to standard of care[40]. - The pivotal study for Anaphylm showed a Cmax of 403.5 pg/mL when administered with allergen, significantly higher than the Manual IM administration[92]. - Anaphylm's pharmacokinetics were consistent across various temperature and pH conditions, with no significant differences observed[66]. - The OASIS study indicated that complete symptom resolution occurred within a median time of 20 minutes after Anaphylm administration[78]. - Anaphylm's self-administration study results showed no significant difference in systolic blood pressure increase whether self-administered or administered by healthcare professionals[74]. - Anaphylm's repeat dose administration achieved a Cmax of 1194.0 pg/mL, demonstrating robust pharmacokinetic performance[95]. - The pediatric study for Anaphylm™ is underway, focusing on pharmacokinetics and treatment-emergent adverse events[99]. Leadership and Team Experience - The leadership team includes experienced professionals with a track record of FDA approvals and clinical trial execution[14]. Market Access and Commercialization - Libervant's market access is established, and prescriptions are being filled[103]. - The company is pursuing the development of Adrenaverse™ to address limitations in the treatment of medical conditions related to epinephrine[107]. Pipeline and Growth Drivers - The company has a diversified pipeline with multiple growth drivers, including the Anaphylm and AQST-108 products[9]. - AQST-108 is a topical gel targeting moderate to severe alopecia areata, with a planned administration of once in the morning[109]. - The Phase 2a study will assess safety and efficacy based on a change from baseline ≥10% in Severity of Alopecia Tool (SALT) score at week 12[115]. - Combined prescriptions for Olumiant and Litfulo in Q2 2024 totaled approximately 30,000, representing a small fraction of the severe alopecia areata patient population[113].

Core Viewpoint - Aquestive Therapeutics, Inc. has reported its financial results for Q4 and the full year 2024, highlighting significant advancements in its product pipeline, particularly the Anaphylm application process with the FDA and the development of AQST-108 for alopecia areata. Financial Performance - Total revenues for Q4 2024 decreased to $11.9 million from $13.2 million in Q4 2023, a 10% decline primarily due to reduced license and royalty revenue [17] - For the full year 2024, total revenues increased to $57.6 million from $50.6 million in 2023, marking a 14% increase driven by higher license and royalty revenue [25] - The net loss for Q4 2024 was $17.1 million, or ($0.19) per share, compared to a net loss of $8.1 million, or ($0.12) per share in Q4 2023 [23] - The full year net loss for 2024 was $44.1 million, or ($0.51) per share, compared to a net loss of $7.9 million, or ($0.13) per share in 2023 [29] Product Development Updates - The company has initiated the Anaphylm application process with the FDA, expecting to complete it in Q1 2025 and achieve FDA acceptance by the end of Q2 2025 [2][4] - Anaphylm, a non-device based epinephrine product, has shown clinical results comparable to autoinjectors and completed all adult clinical trials with positive feedback from the FDA [3][4] - AQST-108 (epinephrine) Topical Gel is set to enter Phase 2a clinical trials in Q2 2025, targeting alopecia areata, which affects approximately 6.7 million people in the U.S. [7][8] Market Strategy and Outlook - The company is preparing for the launch of Anaphylm, focusing on market access and increasing awareness through medical affairs strategies [6] - The estimated market opportunity for JAK inhibitors for alopecia areata exceeds $1 billion, indicating significant potential for AQST-108 if approved [10] - The company expects total revenue for 2025 to be between $47 million and $56 million, with a non-GAAP adjusted EBITDA loss projected between $46 million and $53 million [33][34] Cash Position - As of December 31, 2024, cash and cash equivalents were approximately $71.5 million, with proforma cash and cash equivalents around $93.0 million following a capital raise [31]