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01/09 20:14
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call presents a mixed outlook. Financial performance shows a slight decline in total product sales but growth in key areas like HIV and liver disease. The shareholder return program is strong, but challenges like competitive headwinds in cell therapy and potential impacts from Medicare Part D and funding cuts raise concerns. Management's optimism in the Q&A is tempered by their vague responses to potential risks. Overall, while there are positive aspects, uncertainties and competitive pressures balance the sentiment, resulting in a neutral prediction.
Total Product Sales $6,600,000,000, down 1% year over year, reflecting fewer COVID-19 related hospitalizations.
Base Business Sales (excluding VICLORY) $6,300,000,000, up 4% year over year, primarily driven by growth in HIV and liver disease.
HIV Sales $4,600,000,000, up 6% year over year, driven by higher average realized price and higher demand.
Biktarvy Sales $3,100,000,000, up 7% year over year, primarily driven by higher demand.
Descovy Sales $586,000,000, up 38% year over year, driven by higher average realized price and higher demand.
Liver Disease Sales $758,000,000, up 3% year over year, reflecting increased demand across PBC, HBV, and HDV.
Vecluri Sales $302,000,000, down 45% year over year, reflecting lower rates of COVID-19 related hospitalizations.
Trodelvy Sales $293,000,000, down 5% year over year, reflecting inventory dynamics and lower average realized price.
Cell Therapy Sales $464,000,000, down 3% year over year, reflecting competitive headwinds.
Operating Margin 43%, highlighting ongoing commitment to operating expense discipline.
Non-GAAP Effective Tax Rate 16%, below historic average due to tax benefits from stock-based compensation.
Non-GAAP Diluted EPS $1.81.
R&D Expenses Down 5% year over year, primarily due to lower clinical manufacturing activities.
SG&A Expenses Down 6% year over year, reflecting lower corporate expenses.
Product Gross Margin Flat year over year at 85%, in line with full year guidance.
Cash Returned to Shareholders $1,700,000,000 in the first quarter through dividends and share repurchases.
Long-term Debt Rating Upgraded from BBB+ with a positive outlook to A- with a stable outlook.
Livedelzi Sales: Livedelzi continues its strong launch momentum with $40,000,000 in sales in its second full quarter since launch.
Lenacapavir for PrEP: We are now only weeks away from the anticipated FDA decision on twice yearly lenacapavir for PrEP, with a PDUFA date set for June 19.
Trodelvy Phase III Results: Positive results from the Phase three ASCENT-four study of Trodelvy in combination with pembrolizumab for first line PD L1 positive metastatic triple negative breast cancer were announced.
Libdelzi Expansion: We are launching Libdelzi in additional markets following approval from the European Commission in February.
Anitosel Launch: We remain on track to potentially launch Anitosel in late line relapsed refractory multiple myeloma in 2026.
HIV Market Growth: HIV sales were up 6% year over year, with Biktarvy up 7%, despite headwinds from the Part D redesign.
Trodelvy Market Position: Trodelvy remains the leading regimen in second line metastatic triple negative breast cancer in both The United States and Europe.
Libdelzi Market Share: Libdelzi has achieved about a third of the market share in its category within the first quarter.
Operating Margin: Strong operating margin and earnings per share results highlight our continued focus on expense management.
R&D Expenses: R&D expenses were down 5% year over year primarily due to lower clinical manufacturing activities.
SG&A Expenses: SG&A expenses were down 6% year over year reflecting lower corporate expenses.
Investment in U.S. Manufacturing: Gilead has been increasing its investment in U.S. manufacturing over the last several years with two large scale cell therapy sites.
Policy Engagement: We continue to engage with the administration to encourage a balanced policy agenda that prioritizes innovation and the needs of patients.
Regulatory Issues: The anticipated FDA decision on lenacapavir for PrEP is set for June 19, 2025, with potential implications for market access and reimbursement dynamics.
Competitive Pressures: Gilead faces competitive headwinds in cell therapy, particularly for TICARDA, and is experiencing lower demand for Trodelvy due to inventory dynamics and competition.
Supply Chain Challenges: Gilead has invested significantly in U.S. manufacturing to mitigate risks associated with tariffs and supply chain disruptions, but ongoing competitive pressures remain.
Economic Factors: The company is monitoring macroeconomic factors, including tariffs and inflation, which could increase indirect costs but are expected to be manageable.
Medicare Part D Redesign: The redesign is expected to impact HIV sales, with an estimated $900 million effect on the HIV segment, leading to flat sales growth in 2025.
Market Access: There are concerns regarding potential cuts to HHS and CDC funding, which could disrupt HIV awareness and education efforts, impacting the launch of lenacapavir.
HIV Business Growth: HIV sales were up 6% year over year, driven by demand-led volume growth, despite headwinds from Medicare Part D redesign.
Upcoming Product Launches: Gilead is preparing for the anticipated FDA decision on lenacapavir for PrEP, with a PDUFA date set for June 19, 2025.
Trodelvy Phase III Results: Positive results from the Phase III ASCENT-four study for Trodelvy in combination with pembrolizumab for first-line metastatic triple-negative breast cancer.
Libdelzi Launch: Libdelzi is being launched in additional markets following its approval from the European Commission.
Anitosel Launch Timeline: Potential launch of Anitosel for relapsed/refractory multiple myeloma is expected in 2026.
Investment in U.S. Manufacturing: Gilead has been increasing its investment in U.S. manufacturing, with projects expected to run through 2028.
2025 Revenue Expectations: Total product sales are expected to be approximately $28.2 billion to $28.6 billion, with HIV sales flat compared to 2024.
Operating Margin Guidance: Operating margin is expected to be between 43% and 44% for the full year.
R&D Expenses: R&D expenses are expected to be roughly flat from 2024, with acquired IPR&D expenses around $400 million.
Diluted EPS Guidance: Diluted EPS is expected to be between $7.70 and $8.10 for the full year.
Tax Rate Guidance: Effective tax rate is expected to be approximately 19% for the full year.
Shareholder Return Program: Gilead has returned $1,700,000,000 to shareholders in the first quarter of 2025 through dividends and share repurchases.
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