Aquestive(US:AQST)2025-05-13 13:02Financial Data and Key Metrics Changes - Total revenues decreased to $8.7 million in Q1 2025 from $12.1 million in Q1 2024, representing a 28% decrease primarily driven by declines in manufacturer and supply revenue and license and royalty revenue [28] - Manufacturer and supply revenue decreased to $7.2 million in Q1 2025 from $10.5 million in Q1 2024, primarily due to decreases in Suboxone revenues, partially offset by an increase in ONDIF revenues [28] - License and royalty revenue decreased by 30% or $300,000 in Q1 2025 compared to the same period in the prior year [28] - Net loss for Q1 2025 was $22.9 million or $0.24 per share compared to a net loss of $12.8 million or $0.17 per share in Q1 2024 [29] - Non-GAAP adjusted EBITDA loss was $17.6 million in Q1 2025 compared to a loss of $7.2 million in Q1 2024 [30] - Cash and cash equivalents were $68.7 million as of March 31, 2025 [30] Business Line Data and Key Metrics Changes - The manufacturing business remained steady, with a gradual decline of Suboxone being partially offset by growth across newer collaborations, including licensed products ONDIF, SYMPAZAN, and EMILYF [27] - Research and development expenses decreased to $5.4 million in Q1 2025 from $5.9 million in Q1 2024, primarily due to lower clinical trial costs associated with the antifilm development program [29] Market Data and Key Metrics Changes - The rescue medication market for severe allergic reactions is expected to grow into a multi-billion dollar opportunity [8] - The company anticipates receiving its FDA acceptance letter next month, with an FDA assigned action date in late January or early February 2026 [8] Company Strategy and Development Direction - The company is focused on ensuring a successful commercial launch of ANNAFILM in Q1 2026 if approved by the FDA, with emphasis on building a strong marketing team and increasing awareness of anaphylaxis [9][10] - The company plans to leverage existing payer contracts established during the marketing of Libervant to enhance launch efficiency for ANNAFILM [12] - The company is also engaging with international markets, including Canada, the UK, and the European Medicines Agency, to strengthen its balance sheet through potential partnerships [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to weather economic uncertainties and tariffs, noting minimal risk to price or supply volatility [22] - The company is committed to strengthening its balance sheet through potential out-licensing of ANNAFILM and refinancing its debt [18] - Management acknowledged the passing of a key team member, emphasizing the impact on the company and its commitment to honor his contributions [23] Other Important Information - The company has revised its full-year 2025 financial guidance, now expecting total revenue of $44 million to $50 million and a non-GAAP adjusted EBITDA loss of $47 million to $51 million [30] - The revenue guidance for 2025 no longer includes revenue for Libervant for ages between two and five years [30] Q&A Session Summary Question: Update on commercial readiness efforts for ANNAFILM - Management confirmed that manufacturing capabilities are well-prepared and products will be ready for launch [33][34] Question: Goals for hiring a field force for ANNAFILM - The company plans to start with around 50 sales representatives targeting top epinephrine prescribers [35] Question: Interaction with payers for broader access to ANNAFILM - The company is leveraging existing contracts from Libervant and aims for 80% coverage within the first six months post-launch [39][40] Question: Learnings from the launch of Nephi - Management noted that market expansion and disease state awareness are critical for driving demand [44][46] Question: Potential for an AdCom - Management is prepared for an advisory committee meeting and believes they have a robust data set for the application [49][50] Question: Influence of new division head on the review process - Management indicated that interactions have been with the deputy division head, and the review team remains unchanged [55][56] Question: Awareness of ANNAFILM with providers - The company has conducted extensive outreach and believes awareness is growing significantly [62] Question: Cash needed for the launch of ANNAFILM - Management stated that they will not hire sales reps until approval and have multiple paths to finance the launch [96][97] Question: Libervant revenue in Q2 - Revenue for Libervant in Q2 is expected to be minimal, and guidance for the year has been revised to exclude it [98]