Financial Data and Key Metrics Changes - For the full year 2025, total revenue was $84.3 million, consisting of $72.2 million in U.S. net product revenue, $9.7 million from collaboration agreements, and $2.4 million in supply revenue from international partners [19][20] - R&D expenses were $13.2 million, while SG&A expenses reached $230.1 million, reflecting significant investment in commercialization efforts [20][21] - The company ended 2025 with a cash balance of $245 million, providing a strong financial position for ongoing commercial expansion [22] Business Line Data and Key Metrics Changes - The neffy product generated $72.2 million in net product revenue during its first full year of commercial sales, indicating strong market penetration [3][19] - Approximately 93% of commercial coverage was achieved by year-end 2025, with 57% of covered lives having access without prior authorization [8][12] Market Data and Key Metrics Changes - The company reported that 90% of patients experiencing anaphylaxis are effectively treated with a single dose of neffy, supporting its profile as a reliable treatment [3] - Aided awareness of neffy increased from approximately 20% pre-campaign to 60% by year-end 2025, indicating successful direct-to-consumer marketing efforts [14] Company Strategy and Development Direction - The company plans to expand its sales force from 106 to 150 representatives in 2026, funded through reallocating existing resources rather than increasing overall SG&A expenses [6][21] - The focus for 2026 will be on access, adoption, and advancement, with efforts to reduce administrative barriers and improve workflow integration for prescribers [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the neffy product's potential, emphasizing the need for continued education and engagement with healthcare providers [4][24] - The company anticipates that as the installed patient base matures, renewal contributions will become increasingly relevant starting in late 2026 [8][18] Other Important Information - The company is advancing its pipeline for chronic spontaneous urticaria, with interim data expected in the second half of 2026 [9] - The gross-to-net retention rate was in the low to mid 50% range, with expectations for greater predictability in revenue modeling as coverage broadens [22] Q&A Session Summary Question: How are you thinking about inventory dynamics in 1Q and into 2Q? - Management indicated they are comfortable with current inventory levels and will monitor closely as the back-to-school season approaches [26][27] Question: How are you looking at the direct-to-consumer spend in 2026? - The company expects direct-to-consumer spending in 2026 to be similar to 2025, around $100 million [30] Question: Can you provide more color on the contribution from the Get neffy program? - Currently, over 10% of prescriptions are coming through the Get neffy program, which is expected to grow as awareness increases [34] Question: Can you elaborate on the funding for the sales force expansion? - Funding for the sales force expansion will come from reallocating budgets from advertising and market research [45][51] Question: What are you seeing from the direct-to-consumer campaign beyond awareness? - The campaign has shown strong advertisement recall and positive feedback on messaging, indicating it resonates well with consumers [55][56] Question: How should we think about the timing and cadence of refills? - Most prescriptions are currently new, but refill dynamics are expected to pick up significantly by the end of 2026 as initial prescriptions expire [60][64]

Financial Data and Key Metrics Changes - The company reported total revenue of $15.7 million for Q2 2025, with U.S. net product revenue for NEFI at $12.8 million, reflecting a 64% increase compared to Q1 2025 [18][19] - Gross to net retention improved from about 70% in 2024 to the low 50% range in Q2 2025, indicating successful payer access strategies [22] Business Line Data and Key Metrics Changes - NEFI prescriptions increased by 180% in weekly two-pack unit volume from the end of Q1 to the end of Q2 2025, with 35,000 two-packs shipped in Q2 compared to 19,000 in Q1 [5][29] - The company achieved 93% commercial coverage for NEFI, with 57% of commercial payers not requiring prior authorization for prescriptions [11][12] Market Data and Key Metrics Changes - NEFI is gaining traction globally, with successful launches in Germany and the UK, and expected regulatory decisions in Canada, Australia, Japan, and China by 2026 [7][8] - The direct-to-consumer (DTC) campaign has significantly increased brand awareness, with nearly 50% of respondents recognizing the NEFI advertisement [15] Company Strategy and Development Direction - The company aims to sustain and accelerate market share growth through DTC investments and global expansion of NEFI [25] - The focus is on changing the treatment landscape for type one allergies by addressing barriers such as needle fear and device complexity with NEFI [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth in NEFI prescriptions, driven by the DTC campaign and seasonal demand [58] - The company anticipates a positive impact from the DTC campaign during the back-to-school season, which is a peak period for epinephrine prescriptions [58] Other Important Information - The company maintains a strong cash position with over $240 million in cash and short-term investments, providing a solid foundation for commercial efforts [23] - Significant investments in sales and marketing, particularly in the DTC campaign, are expected to continue through 2026 [20][50] Q&A Session Summary Question: Can you confirm the number of prescriptions written during the quarter? - The company reported approximately 35,000 two-packs shipped in Q2, compared to 19,000 in Q1 [29] Question: Are there early signs that the DTC campaign is translating into prescribing behavior? - Feedback indicates that many patients are inquiring about NEFI after seeing the ads, suggesting a potential uptick in prescriptions in the near future [31] Question: What is the realistic ceiling for coverage without prior authorization? - Currently, about 25% of CVS Caremark's coverage is without prior authorization, and there is no indication of a ceiling for further coverage improvements [39][40] Question: What factors are driving growth in the second half of the year? - Major drivers include the DTC campaign, expanded sales force, and seasonal increases in prescriptions [46] Question: How long will the DTC campaign last? - The DTC campaign is expected to continue at a similar pace through 2026, with potential budget increases based on effectiveness [50] Question: Are patients ordering multiple packs during the back-to-school season? - The company is seeing an increase in orders for multiple packs, indicating strong demand as parents prepare for the school year [51][52]