Krystal(KRYS) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the year 2024, net income per share was $3.12, up from$0.40 per share in 2023, marking the sixth consecutive quarter of positive EPS and fourth straight quarter of sequential earnings growth [10] - Net revenue for VYJUVEK in Q4 was $91.1 million, bringing total revenue for 2024 to$290.5 million, with gross margins consistent with prior quarters [12][46] - The company ended Q4 with $344.9 million in cash on hand and$749.6 million in total cash plus short-term and long-term investments, reflecting a quarterly growth of about $55 million [49] Business Line Data and Key Metrics Changes - VYJUVEK's U.S. launch is progressing well, tracking in the top tier of rare disease launches, with strong early signs of efficacy [7] - Jeune Aesthetics reported strong Phase 1 data for KB301, with plans to start a Phase 2 study later in 2025, achieving$341 million in net revenue within 18 months of launch [11] Market Data and Key Metrics Changes - The U.S. market for VYJUVEK has seen over 500 reimbursement approvals, with a strong access landscape continuing into 2025 [14] - The company expects to launch VYJUVEK in the EU and Japan, with over 1,000 identified deaf patients in Germany and France [30][72] Company Strategy and Development Direction - The company aims to successfully launch VYJUVEK in the EU and Japan, translate early efficacy signs into strong results across cystic fibrosis and alpha-1 antitrypsin programs, and prepare for the anticipated launch of B-VEC for treating lesions in the eye of DEB patients [8][9] - The company is committed to treating DEB globally and is progressing its second product, KB803, for ocular complications associated with DEB [33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a global peak sales estimate of over $1 billion for VYJUVEK, emphasizing the strong patient benefits and compliance rates observed [51][56] - The company is aware of potential competition in the DEB market but believes the value proposition of VYJUVEK will maintain its market share [90][91] Other Important Information - Research and development expenses for Q4 were$13.5 million, driven by increased clinical trial-related costs and manufacturing costs for pipeline candidates [47] - Selling, general, and administrative expenses for Q4 were $31.3 million, reflecting increased personnel-related costs and VYJUVEK sales and marketing costs [47] Q&A Session Summary Question: Was there any year-end stocking in Q4 for VYJUVEK? - Management confirmed there was no substantial difference in Q4 compared to previous quarters regarding stocking or inventory [61][62] Question: How is enrollment going for the CF study? - Enrollment in Cohort 3 has begun, and it is progressing well with several active sites [64][66] Question: What are the expectations for Europe in the second half of the year? - Approximately 600 patients are identified in Germany and 400 in France, with pricing strategies discussed for both markets [72][73] Question: Can you quantify the impact of the annual cap on VYJUVEK in 2024? - About 8% of commercial patients have been on the cap consistently since the beginning [102] Question: What is the update on the regulatory process? - The delay in the CHMP decision was due to the need for a favorable label, which has now been achieved [88]