DEF 14A: Gilead Sciences Aims for Long-Term Growth with HIV Breakthroughs, Oncology Expansion, and Strategic Partnerships

Gilead Sciences is focusing on innovation in virology, oncology, and inflammation to drive long-term growth, highlighted by the potential FDA approval of lenacapavir, a twice-yearly injection for HIV prevention.

Summary

• Gilead Sciences is focused on driving innovation in virology, oncology, and inflammation to achieve long-term growth.
• A key breakthrough is lenacapavir, a twice-yearly injection for HIV prevention, potentially transforming the global fight against HIV, pending FDA approval in the summer of 2025.
• Biktarvy, a once-daily HIV prevention tablet, continues to hold the majority of the U.S. market share.
• Gilead anticipates nine upcoming HIV launches with no patent expirations until 2033, aiming to extend global leadership in HIV through the 2030s.
• In oncology, Gilead has a broad portfolio with 29 clinical and 28 preclinical programs, expecting to launch anito-cel, a potential best-in-class cell therapy, in multiple myeloma in 2026.
• Trodelvy remains the only approved Trop-2 antibody drug conjugate with overall survival benefit in two types of breast cancer, with six ongoing Phase 3 trials.
• Gilead's oncology therapies have reached over 80,000 people through 2024.
• In inflammatory diseases, Livdelzi, a treatment for primary biliary cholangitis (PBC), was launched in 2024, with initial U.S. demand exceeding expectations.
• A strategic partnership with LEO Pharma will accelerate the development and commercialization of an oral STAT6 program for inflammatory diseases.
• Gilead is improving operational efficiency, focusing on growth areas while reducing costs elsewhere.
• The company believes it can simultaneously drive revenue growth and cost savings, creating value for stockholders.
• In 2024, HIV sales totaled $19.6 billion, up 8% from the previous year, while oncology sales totaled $3.3 billion, a 12% increase from 2023.
• Liver disease sales, including viral hepatitis and PBC, totaled $3.0 billion in 2024, a 9% increase from 2023.
• Total product sales were $28.6 billion, up 6% from 2023, exceeding the initial guidance range of $27.1 billion to $27.5 billion.
• Excluding Veklury, the base business grew 8% year-over-year to $26.8 billion.
• Gilead returned $5.1 billion to shareholders through dividends and share repurchases.
• The company achieved a 19% total shareholder return in 2024, exceeding both its compensation peer group and the Nasdaq Biotech Index.
• Gilead is committed to providing access to lenacapavir for prevention in over 120 lowand lower-middle-income countries through voluntary licensing agreements and global partnerships.
• The company extended its RADIAN partnership with the Elton John AIDS Foundation with a $25 million investment to address the growing HIV epidemic in Eastern Europe and Central Asia.

Sentiment

Score: 8

Explanation: The document presents a positive outlook for Gilead Sciences, highlighting strong financial performance, key breakthroughs in HIV treatment and prevention, and strategic expansion in oncology and inflammation. The company's commitment to shareholder value and global health access further contributes to the positive sentiment.

Positives

• Strong commercial performance in HIV, with sales up 8% from the prior year.
• Trodelvy sales increased 24% from the prior year.
• FDA approval of Livdelzi for the treatment of primary biliary cholangitis (PBC).
• Innovative medicines reached more than 4 million people globally.
• Total product sales were $28.6 billion, up 6% from 2023.
• Returned $5.1 billion to shareholders through dividends and share repurchases.
• Signed royalty-free voluntary licensing agreements to increase access to lenacapavir for HIV prevention in high-incidence, resource-limited countries.
• Advanced leadership in manufacturing by reducing the median turnaround time for Yescarta in the U.S. from 16 to 14 days.

Risks

• The document does not explicitly detail risks, but potential risks include failure to obtain FDA approval for lenacapavir, competition in the HIV and oncology markets, and challenges in expanding access to medicines in resource-limited countries.

Future Outlook

Gilead believes it is well-positioned to increase both total revenues and net income, leading to continuing stockholder returns in 2025, with growing portfolio diversity and revenue drivers as well as significantly improved operational efficiencies.

Management Comments

• Following the investments we have made in recent years and the results they are driving we are in an exceptionally strong position to deliver on our mission in 2025 and beyond.
• We have strong conviction in our ability to simultaneously drive revenue growth and cost savings, which we believe will continue to drive compelling value for our stockholders.
• We finished 2024 at a strong vantage point, with growing portfolio diversity and revenue drivers as well as significantly improved operational efficiencies.
• We believe we have unrivaled performance and opportunities in HIV, which position us to extend our leadership for years to come.
• We are also inspired by the growing momentum in oncology and inflammation.

Industry Context

Gilead is a major player in the biopharmaceutical industry, competing with companies like Roche, Bristol Myers Squibb, and Merck in the development and commercialization of therapeutics for HIV, cancer, and liver diseases. The company's focus on innovation and strategic partnerships is consistent with industry trends.

Comparison to Industry Standards

• Gilead's total shareholder return (TSR) of 19% in 2024 exceeded both its compensation peer group and the Nasdaq Biotech Index, indicating strong performance relative to industry benchmarks.
• The company's reduction in median turnaround time for Yescarta in the U.S. to 14 days is the shortest in the industry, demonstrating leadership in cell therapy manufacturing.
• Gilead's commitment to providing access to lenacapavir in lowand lower-middle-income countries aligns with industry efforts to address global health inequities, similar to initiatives by companies like Novartis and Pfizer.
• The company's focus on strategic collaborations and acquisitions, such as the acquisition of CymaBay Therapeutics and partnerships with LEO Pharma and Genesis Therapeutics, is a common strategy among large pharmaceutical companies to expand their pipelines and capabilities.

Management Changes

Stakeholder Impact

• Shareholders: Continued commitment to delivering shareholder returns through growing quarterly cash dividend and share repurchases.
• Patients: Innovative medicines reached more than 4 million people whose lives are impacted by life-threatening diseases globally.
• Employees: Progressed toward long-term ambition to be a biotech employer of choice.
• Communities: Committed to breaking down barriers to care in communities worldwide.

Next Steps

• Anticipate FDA decision on lenacapavir in June 2025.
• Anticipate European Commission decision on lenacapavir in the second half of 2025.
• Commercial launch for fourth-line or later treatment of RRMM for anito-cel in 2026, if approved.
• Continue to advance clinical trials and expand the oncology portfolio.
• Continue to expand and advance the inflammation pipeline.

Key Dates

Keywords

Gilead Sciences, lenacapavir, HIV, oncology, Livdelzi, Biktarvy, Trodelvy, financial performance, shareholder value, corporate strategy, clinical trials, pharmaceuticals