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]

Financial 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]

Financial 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 [26][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 [26] - License and royalty revenue decreased by 30% or $300,000 in Q1 2025 compared to the same period in the prior year [27] - 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 [28] - Non-GAAP adjusted EBITDA loss was $17.6 million in Q1 2025 compared to a loss of $7.2 million in Q1 2024 [28] Business Line Data and Key Metrics Changes - 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 [27] - Selling, general and administrative expenses increased to $19.1 million in Q1 2025 from $10.7 million in Q1 2024, primarily due to regulatory fees, higher legal fees, and increased commercial spending [27] Market Data and Key Metrics Changes - The rescue medication market for severe allergic reactions is anticipated to grow into a multi-billion dollar opportunity [6] - The company expects to have attended 25 conferences and published 16 posters and manuscripts by the end of the year to increase awareness of anaphylaxis and clinical data among healthcare professionals [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 a strong emphasis on building a capable marketing team and increasing awareness among healthcare providers [6][7] - The company plans to leverage existing payer contracts established during the marketing of Libervant to facilitate the launch of ANNAFILM [9][10] - The company aims to strengthen its balance sheet through potential ex-US out-licensing of ANNAFILM and refinancing its debt [16][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning to weather economic uncertainties and supply chain risks, noting minimal risk to price or supply volatility [20] - The company is actively engaging with the FDA regarding the review of its application and is prepared for an advisory committee meeting if required [18][22] - Management acknowledged the passing of a key team member and emphasized the importance of continuing the development of ANNAFILM in his memory [21] 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 [28][29] - The company will not hire sales representatives until it receives FDA approval for ANNAFILM, focusing on preparatory work in the meantime [92][93] Q&A Session Summary Question: Update on commercial readiness efforts for ANNAFILM - The company is well-prepared for CMC manufacturing scale-up and has plans in place for product readiness on day one [31][32] Question: Goals for hiring a field force for ANNAFILM - The company plans to start with around 50 sales representatives targeting top epinephrine prescribers, including allergists and pediatricians [33] Question: Key goals in interacting with payers for ANNAFILM - The company aims for 80% coverage by the end of the first six months post-launch, aligning with the back-to-school season [37] Question: Learnings from the launch of Nephi - The company sees market expansion as critical and expects the market to double over the coming years [41][44] Question: Potential for an advisory committee meeting - The company is hopeful to know about an AdCom by day 74 of the review process, but it is at the FDA's discretion [97] Question: Awareness of ANNAFILM with providers - The company has conducted over 1,000 interviews and is actively engaging with healthcare providers to increase awareness [60] Question: Cash needed for the launch of ANNAFILM - The company has multiple paths to finance the launch and will not hire sales reps until approval is received [92][93]

Financial Position - The company reported a strong balance sheet with approximately $68.7 million in cash as of March 31, 2025 [10] - The company projects a cash runway into 2026 [10, 19] - The company expects total revenues of approximately $44-$50 million for 2025 [26] - The company anticipates a Non-GAAP adjusted EBITDA loss of approximately $47-$51 million for 2025 [26] Product Development & Regulatory Milestones - The NDA for Anaphylm (epinephrine) Sublingual Film was submitted in Q1 2025 [11] - The FDA acceptance of the NDA for Anaphylm is expected in Q2 2025 [11, 18] - The pediatric clinical trial for Anaphylm has been completed with positive top-line results [11] - The company is preparing for a potential Anaphylm launch in Q1 2026, pending FDA approval [11] Market & Manufacturing - Manufacturing operations continue to generate cash flow [21] - The company shipped 27,392 doses in Q1 2025 [22] - Market research indicates that 80% of patients and HCPs prefer a non-injection dosing method for epinephrine [14] - Market research indicates that 95% of patients and HCPs are interested in a film-dosing option [14] - Market research indicates that 85% of healthcare providers indicated they would prescribe a film-dosing option [16]

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]