A. Ernest Toth
Thank you, Dan, and good morning, everyone. By now, you will have seen our financial results in our earnings release that was issued last evening. As we typically do, we will address most of the discussion related to the second quarter 2025 results in the Q&A. During the second quarter, we continued to execute on our strategy to support the continued development of the recently filed NDA for Anaphylm, our lead product candidate that has no needle, is not a device, is orally administered and it's easy to carry. This includes supporting pre-approval launch activities for Anaphylm to increase awareness among physicians, payers and the advocacy community as we approach the PDUFA action date of January 31, 2026. As Dan mentioned, we continue to evaluate all financing alternatives to support the commercial launch of Anaphylm, if approved by the FDA. This includes non-dilutive alternatives such as sale of global rights, EU-only rights, refinancing our existing debt, additional debt as well as revenue interest financing. We are evaluating all options to find the best financing structure to support the future growth of Aquestive. Aquestive's manufacturing business remains steady with the gradual decline of Suboxone being offset by growth across newer collaborations, including for the licensed products Ondif, Sympazan and Emylif. Aquestive's manufacturing facility continues to diversify its operations to support a broader range of products and collaborations. In addition, the company being a U.S.-based manufacturer with intellectual property domiciled in the U.S. has a supply chain, which currently remains unaffected by both implemented and proposed tariffs, providing continued reliability and stability in production and global distribution for the near term. Now let's turn to the second quarter results. Excluding the impact of onetime recognition of deferred revenue in the second quarter of 2024, total revenues increased by $0.3 million or 3% year-over-year to $10 million in the second quarter of 2025. As a reminder, the onetime recognition of deferred revenue in the prior year was due to the termination of licensing and supply agreements. Including the deferred revenue recognized in the prior year, total revenues decreased to $10 million in the second quarter of 2025 from $20.1 million in the second quarter of 2024. Manufacture and supply revenue increased to $9.6 million in the second quarter of 2025 from $8.1 million in the second quarter of 2024, primarily due to increases in Ondif partially offset by decreases in Suboxone revenues. Total revenues decreased to $18.7 million for the 6 months ended June 30, 2025 from $32.2 million for the 6 months ended June 30, 2024, due to onetime recognition of deferred revenue in the prior year. Excluding this onetime recognition of deferred revenue, total revenues decreased by $2.8 million or 13% year-over-year. Manufacture and supply revenue decreased to $16.8 million for the 6 months ended June 30, 2025, from $18.6 million for the 6 months ended June 30, 2024, primarily due to decreases in Suboxone revenues partially offset by increases in Ondif revenue. Research and development expenses in the second quarter '25 remained relatively consistent compared to the second quarter of 2024. Research and development expenses decreased to $9.5 million for the 6 months ended June 30, 2025, from $10.1 million for the 6 months ended June 30, 2024. The decrease in research and development expenses was primarily due to a decrease in clinical trial costs associated with the continued advancement of the Anaphylm program, partially offset by increases in personnel costs and an increase in share-based compensation. Selling, general and administrative expenses increased to $12.7 million in the second quarter of 2025 from $11.4 million in the second quarter of 2024, primarily due to higher commercial spending for prelaunch activities of approximately $2 million, higher regulatory and licensing fees of approximately $0.8 million, higher personnel costs of approximately $0.4 million, higher share-based compensation expenses of approximately $0.2 million and higher consulting fees of approximately $0.2 million, partially offset by lower legal fees of approximately $2.5 million and lower insurance expenses of $0.2 million. Selling, general and administrative expenses increased to $31.8 million for the 6 months ended June 30, 2025, from $22 million for the 6 months ended June 30, 2024. The increase primarily represents regulatory fees related to the Anaphylm PDUFA fee of approximately $4.3 million, higher commercial spending on prelaunch activities for Anaphylm of approximately $4.2 million, higher regulatory and licensing fees of approximately $1.5 million, higher personnel costs of approximately $0.8 million, higher share-based compensation expenses of approximately $0.5 million and higher consulting fees of approximately $0.3 million, all partially offset by decreases in severance costs of approximately $1.1 million, lower insurance expenses of approximately $0.5 million and lower legal fees of approximately $0.4 million. Aquestive's net loss for the second quarter 2025 was $13.5 million or $0.14 for both basic and diluted loss per share compared to the net loss for the second quarter of 2024 of $2.7 million or $0.03 for both basic and diluted loss per share. Excluding the impact of onetime recognition of deferred revenue, the net loss in the second quarter 2024 was $13.2 million. Aquestive's net loss for the 6 months ended June 30, 2025, was $36.5 million or $0.37 for both basic and diluted loss per share compared to the net loss for the 6 months ended June 30, 2024, of $15.6 million or $0.19 for both basic and diluted loss per share. Excluding the impact of onetime recognition of deferred revenue, the net loss for the 6 months ended June 30, 2024, was $26 million. Non-GAAP adjusted EBITDA loss was $9.3 million in the second quarter of 2025 compared to non-GAAP adjusted EBITDA income of $1.8 million in the second quarter of 2024. Excluding the impact of the onetime recognition of deferred revenue, non-GAAP adjusted EBITDA loss in the second quarter of 2024 was $8.6 million. Non-GAAP adjusted EBITDA loss was $27 million for the 6 months ended June 30, 2025, compared to non-GAAP adjusted EBITDA loss of $5.4 million for the 6 months ended June 30, 2024. Again, excluding the impact of onetime recognition of deferred revenue, non-GAAP adjusted EBITDA loss for the 6 months ended June 30, 2024, was $15.8 million. Cash and cash equivalents were $60.5 million as of June 30, 2025. Aquestive's full year 2025 financial guidance remains unchanged. The company expects total revenue of $44 million to $50 million, and non-GAAP adjusted EBITDA loss of $47 million to $51 million. Our revenue guidance for 2025 no longer includes revenue for Libervant for ages between 2 and 5. As a reminder, our 2024 revenue included onetime nonrecurring recognition of deferred revenue related to the termination of certain licensing and supply agreements. Our non-GAAP adjusted EBITDA loss guidance for 2025 includes significant preapproval launch spending for Anaphylm, costs associated with the recent submission of the Anaphylm NDA and related filing fee, completion of the Anaphylm pediatric clinical trial and preparations for a potential advisory committee meeting, if required by the FDA for approval of Anaphylm. With that, I will now turn the line back to the operator to open the line for questions.