Gilead (GILD) Gains EMA Nod for Veklury Use in Young Children | GILD Stock News

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Gilead Sciences (GILD, Financial) has received a positive endorsement from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use, expanding the approved use of its drug, Veklury. The new approval allows the treatment of infants as young as four weeks old, provided they weigh at least 3 kilograms. This adaptation targets children who are not in need of supplemental oxygen but are at heightened risk of developing severe COVID-19 symptoms.

The committee's decision is a significant step forward in managing COVID-19 among vulnerable pediatric populations. By extending the existing marketing authorization, Gilead aims to address the medical needs of young patients in Europe, offering a critical therapeutic option for those who may progress to severe illness.

Wall Street Analysts Forecast

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Based on the one-year price targets offered by 24 analysts, the average target price for Gilead Sciences Inc (GILD, Financial) is $112.48 with a high estimate of $140.00 and a low estimate of $82.00. The average target implies an upside of 10.03% from the current price of $102.23. More detailed estimate data can be found on the Gilead Sciences Inc (GILD) Forecast page.

Based on the consensus recommendation from 30 brokerage firms, Gilead Sciences Inc's (GILD, Financial) average brokerage recommendation is currently 2.1, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Based on GuruFocus estimates, the estimated GF Value for Gilead Sciences Inc (GILD, Financial) in one year is $80.55, suggesting a downside of 21.21% from the current price of $102.23. GF Value is GuruFocus' estimate of the fair value that the stock should be traded at. It is calculated based on the historical multiples the stock has traded at previously, as well as past business growth and the future estimates of the business' performance. More detailed data can be found on the Gilead Sciences Inc (GILD) Summary page.

GILD Key Business Developments

Release Date: February 11, 2025

  • Total Product Sales (Excluding Veklury): $26.8 billion for the full year 2024, up 8% year-over-year.
  • Fourth Quarter Product Sales (Excluding Veklury): $7.2 billion, up 13% year-over-year.
  • HIV Sales: $19.6 billion for the full year 2024, up 8% year-over-year.
  • Biktarvy Sales Growth: 13% year-over-year.
  • Livdelzi Sales: $30 million in the fourth quarter of 2024.
  • Oncology Sales: $3.3 billion for the full year 2024, up 12% year-over-year.
  • Trodelvy Sales: $1.3 billion for the full year 2024, up 24% year-over-year.
  • Cell Therapy Sales: $2 billion for the full year 2024.
  • Veklury Sales: $1.8 billion for the full year 2024, down 18% year-over-year.
  • Operating Income: $8.5 billion for the full year 2024.
  • Non-GAAP EPS: $4.62 for the full year 2024.
  • SG&A Expenses: $5.9 billion for the full year 2024, down 3% year-over-year.
  • R&D Expenses: $5.7 billion for the full year 2024, flat year-over-year.
  • Dividend Increase: 2.6% increase to $0.79 per share for 2025.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • Gilead Sciences Inc (GILD, Financial) reported strong revenue growth, with total product sales excluding Veklury increasing by 8% year-over-year to $26.8 billion.
  • The HIV segment showed significant growth, with full-year sales increasing by 8% to $19.6 billion, driven by the success of Biktarvy, which grew 13%.
  • The company is making progress in its oncology segment, with Trodelvy sales increasing by 24% year-over-year, highlighting its role in metastatic breast cancer treatment.
  • Gilead Sciences Inc (GILD) is advancing its pipeline with promising developments in HIV prevention, including the potential launch of lenacapavir, which has received Breakthrough Therapy designation.
  • The liver disease portfolio, including the launch of Livdelzi, contributed to a 9% increase in sales, reflecting strong demand and market acceptance.

Negative Points

  • The anticipated impact of Medicare Part D reform is expected to affect 2025 revenue by approximately $1.1 billion, with $900 million impacting the HIV segment.
  • Veklury sales declined by 53% year-over-year in the fourth quarter, reflecting lower COVID-19 hospitalizations and contributing to overall revenue headwinds.
  • Competitive dynamics in the cell therapy market pose challenges, with new launches affecting sales growth in the US and Europe.
  • The company faces potential litigation costs related to promotional speaker programs for HIV medicines, impacting SG&A expenses.
  • Foreign exchange headwinds are expected to offset approximately 1% of expected growth in 2025, adding to the financial challenges.

Disclosures

I/We may personally own shares in some of the companies mentioned above. However, those positions are not material to either the company or to my/our portfolios.