Key Highlights Aquestive reported significant progress in Q1 2024, including meeting all endpoints in the Anaphylm™ Phase 3 pivotal study, receiving FDA approval for Libervant™ for patients aged 2-5, and strengthening its financial position with a $77.5 million public offering, extending its cash runway into 2026 - Met all endpoints in the Phase 3 pivotal study for Anaphylm™ (epinephrine) Sublingual Film, comparing it favorably to EpiPen and other injectors1 - Received FDA approval and initiated U.S. market access for Libervant™ (diazepam) Buccal Film for patients aged two to five1 - Completed a $77.5 million underwritten public offering, extending the company's cash runway into 20261 - The company is on track to file a New Drug Application (NDA) for Anaphylm™ with the FDA by the end of 20241 Pipeline Development The company is advancing its key product candidates. Anaphylm™ is progressing towards an NDA submission by year-end 2024 following positive Phase 3 results and constructive FDA feedback. Libervant™ gained approval for a pediatric sub-population. AQST-108 completed its first human clinical study with positive initial data Anaphylm™ (epinephrine) Sublingual Film Aquestive reported positive topline data from its Phase 3 pivotal study for Anaphylm™, meeting all primary and secondary PK endpoints compared to injectors like EpiPen®. The company received favorable FDA feedback on key study aspects and is on track to complete remaining pre-submission studies (temperature/pH, self-administration, allergen exposure) in Q2 and Q3 2024, targeting an NDA filing by the end of 2024 - The Phase 3 study met all predefined primary and secondary pharmacokinetic (PK) endpoints when compared to epinephrine intramuscular (IM) injections and autoinjectors (EpiPen® and Auvi-Q®)3 - Following a Type C meeting, the FDA indicated that Aquestive has "adequately addressed" previous concerns regarding product hold time and characterization of emesis (vomiting)3 - The company is on track to complete the temperature/pH study in Q2 2024, and the self-administration and allergen exposure studies in Q3 20244 - The goal is to file the New Drug Application (NDA) with the FDA before the end of 2024, with a pre-NDA meeting targeted for the second half of 20245 Libervant™ (diazepam) Buccal Film Libervant™ received FDA approval in April 2024 for treating seizure clusters in pediatric patients aged two to five and is now commercially available for this group. The NDA for patients twelve and older remains tentatively approved but is blocked by an orphan drug market exclusivity for a competitor's product until January 2027 - Received FDA approval in April 2024 for the acute treatment of seizure clusters in patients with epilepsy aged two to five6 - The product is immediately available for non-Medicaid prescriptions for this pediatric population in various dosages (5mg, 7.5mg, 10mg, 12.5mg, and 15mg)6 - The NDA for patients aged twelve and older is tentatively approved but faces an orphan drug market exclusivity block from a competitor's nasal spray product until January 20277 AQST-108 (epinephrine) Topical Gel Aquestive is advancing AQST-108, an epinephrine prodrug topical gel, through its Adrenaverse™ platform. The first human clinical study was successfully completed in Q1 2024, showing positive data. Further clinical studies are planned for the second half of 2024 - Completed the first human clinical study for AQST-108 in the first quarter of 20248 - Initial data from the study, which measured epinephrine levels on the skin and in circulation, was positive. Further clinical studies are expected in the second half of 20248 Commercial and Corporate Developments The company's manufacturing operations saw a significant increase in production volume compared to the prior year, driven by demand for Suboxone®. Royalty-based products continue to be a key revenue contributor. Aquestive significantly strengthened its balance sheet by closing a $77.5 million public offering Commercial Collaborations Manufacturing volume for licensing and supply collaborations increased significantly year-over-year. The company produced approximately 42 million doses in Q1 2024, up from 33 million in Q1 2023, driven by consistent demand for Indivior's Suboxone® Sublingual Film. Revenue from royalty-based products like Sympazan® and Azstarys® also contributed to Q1 results - Manufactured approximately 42 million doses in Q1 2024, a 27% increase from 33 million doses in Q1 20239 - Continued consistent order demand for manufacturing Indivior's Suboxone® Sublingual Film and supported other global collaborations9 - Sales of royalty-based products, including Sympazan® and Azstarys®, continued to contribute to the Company's revenue in Q1 20249 Public Offering In March and April 2024, Aquestive completed an underwritten public offering, raising total gross proceeds of approximately $77.5 million. The funds are intended to advance the development and commercialization of Anaphylm™ and Libervant™, as well as for general corporate purposes - Closed an underwritten public offering with total gross proceeds of approximately $77.5 million from the sale of common stock at $4.50 per share10 - Net proceeds will be used to advance the development and commercialization of Anaphylm™ and Libervant™ (for ages 2-5), and for working capital and general corporate purposes10 Financial Performance For Q1 2024, Aquestive reported an 8% increase in total revenues to $12.1 million. However, the company posted a net loss of $12.8 million, a significant shift from a net income of $8.1 million in Q1 2023, primarily due to a one-time income event in the prior year and increased R&D and SG&A expenses. The company ended the quarter with $95.2 million in cash First Quarter 2024 Financials Total revenues grew to $12.1 million in Q1 2024 from $11.1 million in Q1 2023. The increase was driven by a 30% rise in manufacture and supply revenue (excluding a one-time 2023 item) and a 23% increase in license and royalty revenue. Operating expenses rose, with R&D expenses increasing to $5.9 million and SG&A expenses to $10.7 million, leading to a net loss of $12.8 million, or $0.17 per share Q1 2024 vs. Q1 2023 Financial Highlights | Metric | Q1 2024 (in millions) | Q1 2023 (in millions) | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $12.1 | $11.1 | +8% | | R&D Expenses | $5.9 | $3.5 | +68% | | SG&A Expenses | $10.7 | $7.5 | +43% | | Net (Loss) Income | ($12.8) | $8.1 | N/A | | (Loss) Earnings Per Share (basic) | ($0.17) | $0.15 | N/A | | Non-GAAP Adj. EBITDA Loss | ($7.2) | ($3.9) | +85% | - The change to a net loss was primarily driven by a one-time $14.5 million of other income recognized in Q1 2023, combined with increases in SG&A, R&D, and non-cash interest expenses in Q1 202413 - Cash and cash equivalents were $95.2 million as of March 31, 202414 2024 Outlook Aquestive provides its full-year 2024 financial guidance, projecting total revenues between $48 million and $51 million and a Non-GAAP adjusted EBITDA loss between $22 million and $26 million Full-Year 2024 Financial Guidance | Metric | Guidance (in millions) | | :--- | :--- | | Total Revenue | $48 to $51 | | Non-GAAP Adjusted EBITDA Loss | $22 to $26 | Financial Statements The condensed financial statements provide detailed, unaudited figures for the company's financial position as of March 31, 2024, and its performance for the three months then ended. Key tables include the Condensed Balance Sheets, Condensed Statements of Operations, and Reconciliation of GAAP to Non-GAAP measures Condensed Balance Sheets As of March 31, 2024, Aquestive had total assets of $129.5 million and total liabilities of $165.8 million, resulting in a stockholders' deficit of $36.3 million. Cash and cash equivalents significantly increased to $95.2 million from $23.9 million at year-end 2023, primarily due to the recent public offering Balance Sheet Summary | Account | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $95,200 | $23,872 | | Total current assets | $113,379 | $40,966 | | Total assets | $129,523 | $57,418 | | Liabilities & Stockholders' Deficit | | | | Total liabilities | $165,824 | $163,905 | | Total stockholders' deficit | ($36,301) | ($106,487) | Condensed Statements of Operations For the three months ended March 31, 2024, the company recorded a net loss of $12.8 million on total revenues of $12.1 million. This contrasts with a net income of $8.1 million on revenues of $11.1 million in the same period of 2023. The loss per share for Q1 2024 was $0.17 Q1 Statement of Operations | Line Item | Q1 2024 (in thousands) | Q1 2023 (in thousands) | | :--- | :--- | :--- | | Revenues | $12,053 | $11,134 | | Total costs and expenses | $21,010 | $15,739 | | Loss from operations | ($8,957) | ($4,605) | | Net (loss) income | ($12,828) | $8,068 | | Basic (Loss) earnings per share | ($0.17) | $0.15 | Reconciliation of Non-GAAP Adjustments The company provides a reconciliation from GAAP net (loss) income to Non-GAAP adjusted EBITDA. For Q1 2024, the GAAP net loss of $12.8 million was adjusted to a Non-GAAP adjusted EBITDA loss of $7.2 million. This compares to a Non-GAAP adjusted EBITDA loss of $3.9 million in Q1 2023 Non-GAAP Adjusted EBITDA Reconciliation | Line Item | Q1 2024 (in thousands) | Q1 2023 (in thousands) | | :--- | :--- | :--- | | GAAP net (loss) income | ($12,828) | $8,068 | | Total non-GAAP adjustments | $5,658 | ($12,004) | | Non-GAAP adjusted EBITDA | ($7,170) | ($3,936) |
Aquestive(AQST) - 2024 Q1 - Quarterly Results