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Gilead Stock Gains 15.4% in a Year: Should You Buy, Sell or Hold?
GILDGilead(GILD) ZACKS·2024-12-20 19:00

Core Insights - Gilead Sciences, Inc. (GILD) has experienced a positive shift in investor sentiment due to new drug approvals, encouraging pipeline developments, and strong quarterly results, leading to an increase in annual sales and earnings guidance driven by COVID-19 treatment Veklury sales [1] Group 1: HIV Franchise Performance - Gilead's leading HIV franchise continues to show momentum, with a market share exceeding 49% in the U.S. as of Q3, primarily driven by its flagship therapy, Biktarvy [5] - The company anticipates filing for approval of lenacapavir for HIV prevention by year-end, which could enhance its HIV franchise as it requires administration only twice a year compared to daily oral pills [3][15] - Gilead has raised its HIV sales target for 2024 to 5% from an earlier estimate of 4% due to strong performance in its HIV portfolio [5] Group 2: Drug Approvals and Acquisitions - Gilead's portfolio has been strengthened by the approval of additional drugs, including Livdelzi for liver disease, and the acquisition of CymaBay Therapeutics for 4.3billion,whichaddsSeladelpartoitspipeline[6]TheFDAhasgrantedacceleratedapprovalforseladelparfortreatingprimarybiliarycholangitis(PBC),withafinaldecisionfromtheEuropeanMedicinesAgencyexpectedinQ12025[16][17]Group3:OncologyChallengesGileadsoncologyfranchisefaceschallenges,particularlywiththebreastcancerdrugTrodelvy,whichhasseensetbacksinexpandingitslabelduetofailedlatestagestudies[8][26]Despitethesechallenges,TrodelvyhasreceivedBreakthroughTherapyDesignationfortreatingextensivestagesmallcelllungcancer[19]Group4:FinancialPerformanceandEstimatesGileadsshareshaveincreasedby15.44.3 billion, which adds Seladelpar to its pipeline [6] - The FDA has granted accelerated approval for seladelpar for treating primary biliary cholangitis (PBC), with a final decision from the European Medicines Agency expected in Q1 2025 [16][17] Group 3: Oncology Challenges - Gilead's oncology franchise faces challenges, particularly with the breast cancer drug Trodelvy, which has seen setbacks in expanding its label due to failed late-stage studies [8][26] - Despite these challenges, Trodelvy has received Breakthrough Therapy Designation for treating extensive-stage small cell lung cancer [19] Group 4: Financial Performance and Estimates - Gilead's shares have increased by 15.4% over the past year, outperforming the industry, which has declined by 10.8% [4] - The Zacks Consensus Estimate for Gilead's 2024 earnings per share (EPS) has risen by 59 cents to 4.36, reflecting a positive trend despite acquisition-related expenses [21] - Gilead's current dividend yield of 3.38% is supported by a strong cash position of $5 billion as of September 30, 2024, indicating sustainability [12] Group 5: Strategic Collaborations - Gilead has entered a multi-target research collaboration with Terray Therapeutics to develop novel small-molecule therapies [7] - The company is also collaborating with Merck to evaluate a combination treatment of islatravir and lenacapavir for HIV, which has shown promising results in maintaining viral suppression [11]