Financial Data and Key Metrics Changes - Total revenue grew 38% to $1.4 billion, with royalty revenue increasing 52% to $868 million for the full year 2025 [7][15][17] - Net income for the full year was $316.9 million, compared to $444.1 million reported in 2024 [17] - Adjusted EBITDA was $657.6 million, compared to $632.2 million in 2024 [17] - GAAP diluted EPS was $2.50, compared with $3.43 in 2024, while non-GAAP diluted EPS was $4.15, compared with $4.23 in 2024 [17][18] Business Line Data and Key Metrics Changes - DARZALEX Subcutaneous generated $483 million in royalty revenues, representing 29% year-over-year growth, with total sales growing 22% to $14.4 billion [8][9] - PHESGO delivered $105.6 million in royalty revenue, reflecting 51% year-over-year growth, with total sales increasing 48% to approximately $3 billion [9][10] - VYVGART and VYVGART Hytrulo generated $157.2 million in royalty revenue, representing 444% year-over-year growth, with total sales growing 90% to $4.15 billion [10][11] Market Data and Key Metrics Changes - The company now has 10 ENHANZE-enabled global blockbuster opportunities, with significant approvals in the U.S., Japan, and China [6][12] - Roche reported that there are now 17,500 patients on Ocrevus Zunovo, a 5,000 patient increase from the third quarter [11] - Analysts project that PHESGO will reach CHF 3.6 billion in 2028, and Ocrevus franchise sales expectations have been increased to CHF 9 billion, or approximately $11.5 billion [10][12] Company Strategy and Development Direction - The company expanded its portfolio from two to four subcutaneous drug delivery technologies through acquisitions, positioning itself as a one-stop shop for biopharma subcutaneous drug delivery [5][6] - The focus is on advancing the ENHANZE pipeline, with projections for 6 new ENHANZE programs entering phase one in 2026 [21][32] - The company aims to continue strategic M&A to enhance its drug delivery portfolio and maintain financial discipline while investing in long-term value creation [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the company, highlighting multiple revenue drivers that will support durable royalty revenue [20][36] - The company anticipates continued strong growth from its existing blockbusters and new product launches, with a focus on expanding into new therapeutic areas [20][21] - Management expects to enter discussions with Johnson & Johnson to extend the DARZALEX collaboration agreement closer to its expiration in 2032 [39][40] Other Important Information - The company signed three new ENHANZE collaboration and licensing agreements, expanding its reach beyond oncology into obesity and inflammatory bowel disease [6][7] - The acquisition of Surf Bio is expected to enhance the company's hyperconcentration technology capabilities [24] - The company ended the year with a net debt to EBITDA ratio of 2.1x, with expectations to deleverage to below 1x by the end of 2026 [19] Q&A Session Summary Question: Can you elaborate on the mechanics of the DARZALEX collaboration with J&J? - Management expects to enter discussions with J&J to extend the agreement closer to its expiration in 2032, as they do not anticipate J&J seeking another source of API [39][40] Question: What are the regulatory paths for ADCs with ENHANZE? - The regulatory pathway for converting from IV to subcutaneous is expected to follow traditional PK non-inferiority studies, while additional benefits would require phase trials [46][47] Question: What is the progress on Hypercon products? - The company is on track to support two partners in advancing to phase 1 clinical testing in 2026, with clinical scale-up batches being completed [61][62] Question: How will sales from auto-injectors be reported? - Sales from auto-injectors will be recognized similarly to API sales, with royalties recognized on commercial sales [76]
Halozyme(HALO) - 2025 Q4 - Earnings Call Transcript