Financial Data and Key Metrics - Year-to-date group sales grew by 6% at constant exchange rates, driven by strong base business growth of 8% [3] - COVID-19 sales decreased by approximately CHF 800 million, and the loss of exclusivity (LOE) impact was also around CHF 800 million, both in line with guidance [3] - Full-year COVID-19 sales decline is expected to be CHF 1.1 billion, with a CHF 300 million impact in Q4 due to a rapid antigen order from the previous year [7][12] - Core EPS growth guidance was raised, with group sales expected to grow in the mid-single-digit range [12] Business Line Performance - Pharma division grew by 9%, while Diagnostics grew by 8% in the base business [3] - Oncology sales increased by 2% to CHF 11.9 billion, driven by strong performance in HER2 franchise and Tecentriq [22][23] - Hematology sales grew by 12% to CHF 5.8 billion, with Hemlibra achieving a 42% market share [28] - Neurology franchise grew by 14%, reaching CHF 7 billion in sales, driven by Ocrevus and Elevidys [31][33] - Immunology sales increased by 1% to CHF 4.6 billion, with Xolair growing by 12% [36][37] - Ophthalmology franchise grew by 47%, reaching CHF 3 billion in sales, led by Vabysmo [38] Market Performance - North America base business grew by 10%, EMEA by 6%, and APAC by 5%, excluding COVID-19 sales [50] - China experienced a slowdown due to macroeconomic conditions, but the company remains the market leader [50] - The US market saw strong growth in Vabysmo, with market shares increasing in AMD, DME, and RVO [38] Strategic Direction and Industry Competition - The company expects to launch two new NMEs (PiaSky and Itovebi) in 2024, with the new and young portfolio now making up 56% of Pharma sales [9][10] - Key growth opportunities include Itovebi EU approval, Evrysdi GYM329 readout, and anti-TL1A Phase 3 trials in UC and Crohn's disease [10][11] - The company completed the acquisition of LumiraDx, which is expected to contribute significantly to Diagnostics sales in the coming years [55] Management Commentary on Operating Environment and Future Outlook - The company expects strong base business growth to continue into Q4 and next year, with no significant COVID-19 impact expected in 2025 [7][12] - Management highlighted cost discipline and confidence in achieving core EPS growth, with plans to increase dividends in Swiss francs [12] - The company remains optimistic about its pipeline, with several key readouts and regulatory events expected in 2025 [45][46] Other Important Information - The company received five regulatory approvals in Q3, including Itovebi in the US and Vabysmo in the EU [4][5] - Key launches in Diagnostics include the cobas pro serology solution and the Respiratory flex test, which leverages TAGS technology [5][53] - The company expects to deliver 12 key launches in Diagnostics by the end of 2024, with nine already achieved by Q3 [55][56] Q&A Session Summary Question: Impact of Amgen's EYLEA biosimilar on Vabysmo - The company does not expect material impact on Vabysmo's growth trajectory, as the ophthalmology market has been about 50% generic biosimilar [58] Question: Tecentriq sales outlook - Tecentriq is expected to grow low single digits for the next year, with competitive pressure in adjuvant lung in the US [59] Question: Xolair biosimilar entry in 2025 - The company confirmed no biosimilar entry for Xolair in 2025, but did not provide specific reasons [63] Question: Elevidys sales and market traction - Elevidys sales reached CHF 137 million, with strong adoption in Gulf states and health tourism observed [65] Question: Fenebrutinib in MS - The company is pleased with the results so far and does not plan to change the primary endpoint [66] Question: TL1A opportunity in IBD - The TL1A pathway is well-validated in IBD, with a potential $10 billion market opportunity and significant unmet need [84][85] Question: Ocrevus subcutaneous formulation - The company expects the subcut formulation to expand Ocrevus use in settings where IV is not available, with an incremental CHF 2 billion sales opportunity [77] Question: Inavolisib physician feedback - Physicians are excited about inavolisib, and the company is working to generate additional data with other CDK4/6 backbones [90] Question: Prasinezumab and Lunsumio outlook - Prasinezumab is a high-risk, high-reward trial, and Lunsumio's real opportunity lies in moving beyond third-line follicular lymphoma [93][94]
Roche(RHHBY) - 2024 Q3 - Earnings Call Transcript