Financial Data and Key Metrics Changes - The company reported a strong second quarter with increased guidance for both top-line and bottom-line growth, driven by strong performance across all business units [3] - The HIV prevention business saw significant growth, with Descovy sales up 37% quarter over quarter [7] Business Line Data and Key Metrics Changes - The launch of YES2Go for HIV prevention has been described as the strongest execution seen in a launch, with 73% unaided awareness and 95% aided awareness [6][7] - The company is on track to achieve 75% coverage in the U.S. by the end of the year, with significant early wins with commercial and Medicaid payers [11][12] Market Data and Key Metrics Changes - The HIV prevention market is currently underpenetrated, with only 50,000 to 400,000 patients on the drug, compared to a potential 1.2 to 3 million [25] - The company anticipates significant market growth as awareness and access to HIV prevention therapies increase [29] Company Strategy and Development Direction - The company is focused on expanding its HIV prevention market, targeting individuals already on HIV prevention therapies and those at risk of HIV [27][30] - The company is also investing in its oncology pipeline, with multiple launches expected, including a CAR T therapy for multiple myeloma [56][65] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of the HIV treatment business despite headwinds from Part D reforms, expecting a 3% growth rate [34][38] - The company is preparing for potential macroeconomic headwinds but believes its strong clinical profile will help mitigate risks [51][52] Other Important Information - The company has made substantial investments in internal research and development, enhancing the quality and breadth of its portfolio [72] - The approval of a reimbursement code (J code) for YES2Go was granted earlier than expected, which is crucial for the launch [13] Q&A Session Summary Question: How is the launch of YES2Go performing? - The launch has been strong, with high awareness and a solid execution plan in place [5][6] Question: What challenges are anticipated with the new injectable model? - The company acknowledges logistical challenges but is confident in its execution strategy and coverage goals [9][10] Question: How does the company view the competitive landscape for HIV treatments? - Management believes Biktarvy remains the gold standard and expects to maintain market share despite upcoming generic competition [40][41] Question: What is the outlook for the oncology pipeline? - The company is optimistic about the potential of its CAR T therapy and other oncology products, viewing them as significant growth opportunities [56][65] Question: How is the company preparing for potential Medicaid funding cuts? - The company is actively engaging with policymakers and believes it can manage any changes due to its strong clinical data [51][52]

Core Insights - GSK's new drug application for linerixibat has been accepted by the FDA for review, with a decision expected on March 24, 2026 [1][7] - If approved, linerixibat could fulfill a significant unmet medical need for patients suffering from cholestatic pruritus associated with primary biliary cholangitis (PBC) [2][5] GSK's Drug Development - The NDA for linerixibat is based on positive results from the phase III GLISTEN study, which demonstrated significant improvement in cholestatic pruritus and related sleep interference compared to placebo [4][7] - Cholestatic pruritus is a common symptom of PBC, a rare autoimmune disease that can lead to liver failure [5] Competitive Landscape - Other companies are also pursuing treatments for PBC, including Gilead Sciences, which received accelerated approval for seladelpar in August 2024 [8] - Seladelpar was acquired by Gilead for $4.3 billion and is now part of their liver disease portfolio [9] - Mirum Pharmaceuticals is developing volixibat, another oral IBAT inhibitor, currently in phase IIb trials [9]