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Biogen(BIIB) - 2025 Q2 - Earnings Call Presentation
2025-07-31 12:30
Financial Performance - Total revenue increased by 7% year-over-year to $265 billion[53] - Launch products generated $252 million in revenue, a 26% increase quarter-over-quarter and a 91% increase year-over-year[53] - Non-GAAP diluted EPS increased by 4% year-over-year to $547[53] - The company generated $134 million of free cash flow, which includes a $745 million impact from Q2 2025 tax payments[53] - The company expects full-year 2025 Non-GAAP diluted EPS between $1550 and $1600, up from the previous guidance of $1450 to $1550[53] - The company expects full-year 2025 total revenue to be approximately flat at constant currency versus FY 2024, an increase from a mid-single-digit decline previously[53] Product Performance - SKYCLARYS worldwide sales reached $130 million in Q2, up 30% year-over-year and 5% quarter-over-quarter[47] - SKYCLARYS U S sales were $78 million, up 3% year-over-year and 13% quarter-over-quarter[47] - ZURZUVAE U S sales were $46 million in Q2, up 213% year-over-year and 68% quarter-over-quarter[48] - LEQEMBI worldwide sales were $160 million in Q2, excluding $35 million in stocking in China; U S sales increased 20% quarter-over-quarter to $63 million[49] Pipeline and Development - Phase 3 studies were initiated for felzartamab in IgAN and PMN, and for SKYCLARYS in pediatric FA[18] - Positive Phase 1b results for salanersen support moving to registrational status for SMA, with a Phase 3 study expected to start by early 2026[18,32] - New analyses of dapirolizumab pegol Phase 3 data in SLE show improvement in fatigue and reduction in disease activity[18]
Biogen (BIIB) Earnings Call Presentation
2025-07-11 08:08
Biogen's Strategic Direction - Biogen is broadening its portfolio across Neuro, Immunology & Rare Disease, aiming for long-term sustainable growth[4,17] - Approximately 50% of Biogen's total company revenue is projected to come from outside of MS, including Biosimilars[17] Felzartamab's Potential in Nephrology - Felzartamab targets CD38-expressing cells, offering a differentiated approach for antibody-mediated diseases[27,29] - Phase 3 programs for Felzartamab are underway, targeting Antibody Mediated Rejection (AMR), IgA Nephropathy (IgAN), and Primary Membranous Nephropathy (PMN)[106] Antibody Mediated Rejection (AMR) - Late AMR affects approximately 11,000 patients in the U S, with >75% transplant loss and a median graft survival of ~2 years after diagnosis[36,37,40] - In a Phase 2 study, Felzartamab treatment resulted in >80% biopsy late AMR resolution at week 24, compared to 20% in the placebo group[53] - A Phase 3 study for Felzartamab in late AMR is underway, with data expected in 2027[56] IgA Nephropathy (IgAN) - IgAN affects approximately 130,000 patients in the U S, with up to 40% of patients reaching end-stage kidney disease within 20 years of diagnosis[61] - Phase 2 data showed that with 5 months of Felzartamab treatment, patients had sustained clinical benefit out to 2 years, with ~50% UPCR reduction at 24 months in the 9-dose group[69,71] - A Phase 3 study for Felzartamab in IgAN is designed to demonstrate improvement in kidney function, with data expected in 2029[74] Primary Membranous Nephropathy (PMN) - PMN affects approximately 36,000 patients in the U S, with up to 40% progressing to end-stage kidney disease within 15 years[80,81,103] - Phase 2 data showed robust and sustained reductions in anti-PLA2R and improvements in both newly diagnosed/relapsed (NDR) and refractory PMN patients[103] - A Phase 3 study for Felzartamab in PMN is designed to demonstrate complete remission of proteinuria, with data expected in 2029[100]