Financial Data and Key Metrics Changes - The net product revenue for the first quarter of 2025 was $88.2 million, representing a 95% increase from the first quarter of 2024 [49] - Cost of goods sold was $5 million, up from $2.4 million in the prior year's first quarter, with gross margin remaining consistent at 94% [49] - Research and development expenses increased to $14.3 million from $11 million in the prior year, primarily due to personnel-related expenses and clinical development costs [49] - General and administrative expenses rose to $32.7 million from $26.1 million in the prior year, driven by personnel-related expenses and increased professional service expenses [49] - Net income for the quarter was $35.7 million, equating to $1.24 per basic share and $1.20 per diluted share [49] - The company ended Q1 with $765.3 million in total cash plus investments, indicating strong financial health for upcoming launches and clinical programs [49] Business Line Data and Key Metrics Changes - The U.S. patient access to VYJUVEC exceeded 540 patients with reimbursement approvals as of April 2025, maintaining strong nationwide commercial and Medicaid coverage [23] - The company observed a slowdown in reimbursement approvals in Q1, attributed to the pace of patient start forms received [32] - The treatment success of VYJUVEC is leading to meaningful treatment pauses and maintenance treatment, which is expected to drive long-term growth [25][26] Market Data and Key Metrics Changes - The company plans to launch VYJUVEC in Germany and France in Q3 2025, with expectations that the opportunity in the EU could exceed current market anticipations [10] - The regulatory review in Japan is progressing well, with approval expected in Q3 2025 [10] Company Strategy and Development Direction - The company aims to build a geographically diversified business to limit exposure to regulatory or trade dynamics in any single market [22] - The focus is on establishing VYJUVEC as a lifelong first-line therapy for wound management, with ongoing efforts to enhance patient experience [15][22] - The clinical pipeline includes upcoming readouts for CF, AATD, aesthetic skin conditions, and ocular lesions in DEB, with optimism surrounding molecular data updates [16][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential driven by patient outcomes and the effectiveness of VYJUVEC therapy [52] - The company is insulated from external turbulence due to all commercial and pipeline products being manufactured in the U.S. [20] - Management acknowledged the challenges in patient start forms but remains optimistic about the total market opportunity and long-term profitability [59] Other Important Information - The company has had seven consecutive quarters of profitable EPS, indicating strong financial management [21] - The upcoming ASCO presentation will showcase efficacy and safety data from inhaled KB707, highlighting the company's commitment to innovative therapies [47] Q&A Session Summary Question: Impact of insurance changes on VYJUVEC sales in Q1 - Management acknowledged that insurance changes had an impact but noted it was less prominent than in the previous year due to existing contracts [57] Question: Slowing reimbursement approvals and addressable population - Management clarified that while reimbursement approvals have slowed, the total market opportunity remains robust, with approximately 1,200 identified patients in the U.S. [59] Question: Long-term compliance rates and patient restart experiences - Management indicated that compliance rates are ahead of expectations, with patients pausing and restarting treatment based on individual needs [65][66] Question: Trajectory of the German launch compared to the U.S. - Management expects the German launch to have a strong trajectory due to lower patient identification issues and existing demand [70] Question: Increase in salesforce headcount and its purpose - Management confirmed that the increase in salesforce is aimed at enhancing educational efforts in the community rather than responding to competitive pressures [74][76] Question: Utilization of VYJUVEC in light of competitor products - Management does not view the newly approved competitor product as a direct threat due to significant differences in safety and efficacy [103][104]

Financial Data and Key Metrics Changes - The net product revenue for the first quarter of 2025 was $88.2 million, representing a 95% increase from the first quarter of 2024 [46] - Cost of goods sold was $5 million, up from $2.4 million in the prior year's first quarter, with gross margin remaining consistent at 94% [46] - Research and development expenses increased to $14.3 million from $11 million, primarily due to higher personnel-related expenses and clinical development costs [46] - General and administrative expenses rose to $32.7 million from $26.1 million, driven by increased personnel-related expenses and charitable contributions [46] - Net income for the quarter was $35.7 million, translating to $1.24 per basic share and $1.20 per diluted share [46] - The company ended Q1 with $765.3 million in total cash and investments, indicating strong financial stability [46] Business Line Data and Key Metrics Changes - The U.S. patient access to VYJUVEC continued to grow, with reimbursement approvals exceeding 540 as of April 2025 [21] - The access landscape in the U.S. remains strong, with full nationwide commercial and Medicaid coverage [21] - Treatment success on VYJUVEC is leading to meaningful treatment pauses and maintenance treatment, which is expected to drive long-term growth [23][24] Market Data and Key Metrics Changes - The company plans to launch VYJUVEC in Germany and France in Q3 2025, with expectations that the opportunity in the EU could be larger than currently anticipated [7] - Regulatory review in Japan is progressing well, with approval expected in Q3 2025 [7] Company Strategy and Development Direction - The company is focused on establishing VYJUVEC as a lifelong first-line therapy for wound management and is enhancing patient experience through various support initiatives [12][24] - Upcoming clinical readouts for CF, AATD, aesthetic skin conditions, and ocular lesions are anticipated in 2025, with optimism surrounding the clinical pipeline [13][38] - The company aims to build a geographically diversified business to limit exposure to regulatory or trade dynamics in any single market [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential driven by patient outcomes and the upcoming launches in Europe [49] - The company is insulated from external turbulence due to all commercial and pipeline products being manufactured in the U.S. [17] - Management acknowledged the unpredictability of patient pausing patterns but remains optimistic about long-term growth [11] Other Important Information - The company has had seven consecutive quarters of profitable EPS, indicating strong financial management [18] - The launch of VYJUVEC in the U.S. has been characterized by strong patient outcomes, which are expected to support long-term market adoption [50] Q&A Session Summary Question: Impact of insurance changes on VYJUVEC sales in Q1 - Management noted that while there was an impact from insurance changes, it was less prominent than in previous years due to an established JCORD [55] Question: Slowing new reimbursement approvals - Management clarified that the slowing approvals are due to longer interaction times with physicians as the company reaches deeper into communities [57] Question: Long-term compliance rate expectations - Management indicated that compliance is ahead of expectations, with a target of 50% compliance in the long term [62] Question: Trajectory of the German launch compared to the U.S. - Management expects the German launch to have a similar growth target of achieving 60% market share in two years, with existing demand already noted [66] Question: Increase in Salesforce headcount - Management confirmed that the increase in headcount is focused on enhancing field sales efforts to engage more effectively with healthcare providers [70] Question: Compliance tracking on a quarterly basis - Management stated that while compliance has been consistent since launch, quarterly behavior may vary due to patient-specific factors [80] Question: EU launch and patient start cadence - Management acknowledged that the time to secure the first appointment with a physician may be a gating factor but is actively addressing this issue [90] Question: Coexistence with competitor products - Management emphasized that they do not consider the newly approved competitor product as direct competition due to significant differences in safety and efficacy [96]