Gilead Sciences, Inc. GILD hit a 52-week high of $119.96 on March 10. The stock is currently trading at $111.44.
Shares have also gained 5.5% in the past month compared with the industry’s growth of 1.2%. The stock has outperformed the sector and the S&P 500 Index in this timeframe. Positive data readouts and encouraging pipeline progress have boosted investors’ sentiment.
GILD Outperforms Industry, Sector & S&P 500
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GILD’s Leading HIV Franchise Maintains Momentum
Gilead has a market-leading portfolio of HIV treatments. The company’s consistent efforts to develop additional innovative HIV treatments are being appreciated by investors.
GILD’s HIV franchise sales have consistently grown in the last three years, propelling the top line.
With a market share of more than 50% in the United States at the end of the fourth quarter, its flagship HIV therapy Biktarvy continues to fuel sales.
Descovy (FTC 200 mg/TAF 25 mg) for pre-exposure prophylaxis (PrEP) is also witnessing good uptake. It maintained more than 40% market share in the PrEP market in the United States.
Gilead’s efforts to innovate its HIV portfolio are impressive. The company’s pipeline candidate, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women. Data reinforce that twice-yearly lenacapavir could be a highly effective and potentially game-changing HIV prevention option.
Gilead’s application for the approval of lenacapavir is currently under review in both the United States and the European Union.
The successful development and potential approval of lenacapavir for the prevention of the disease should solidify Gilead’s HIV franchise, as lenacapavir needs to be taken twice yearly unlike daily oral pills.
Gilead recently announced positive data from its ongoing phase I study evaluating lenacapavir as a once-yearly injectable HIV-1 capsid inhibitor for PrEP.
Gilead presented data on two novel, once-yearly formulations of lenacapavir for PrEP during an oral abstract session at the Conference on Retroviruses and Opportunistic Infections (CROI 2025).
The data from the phase I study showed that the two different formulations of once-yearly lenacapavir (administered via intramuscular injection) achieved and maintained plasma concentrations exceeding those associated with HIV prevention efficacy observed in the late-stage PURPOSE 1 and PURPOSE 2 studies.
Gilead plans to launch a phase III study on once-yearly lenacapavir for PrEP in the second half of 2025.
New Drug Approvals Strengthen GILD’s Portfolio
In August 2024, the FDA granted accelerated approval to seladelpar for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA), in adults who have had an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
The candidate was approved under the brand name Livdelzi. In March 2024, GILD acquired CymaBay Therapeutics Inc. for $4.3 billion, adding seladelpar to its portfolio/pipeline. Livdelzi's approval strengthens GILD’s liver disease portfolio and validates its CymaBay acquisition.
Last month, the drug was also approved by the European Commission.
Gilead earlier announced a strategic partnership with LEO Pharma, a Danish company. The deal strengthens the company’s inflammation research portfolio by adding LEO Pharma’s preclinical oral STAT6 Program, including targeted protein degraders.
The company had earlier entered into a multi-target research collaboration with Terray Therapeutics to discover and develop novel small-molecule therapies for multiple targets.
GILD’s Trodelvy Performs Well
The breast cancer drug Trodelvy has performed well since its approval. The FDA also granted the Breakthrough Therapy Designation to the drug for the treatment of adult patients with extensive-stage small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy. GILD has multiple ongoing studies looking to expand Trodelvy’s label further.
However, Gilead’s efforts to expand Trodelvy’s label suffered a setback due to the failure of its late-stage confirmatory TROPiCS-04 study on Trodelvy in locally advanced or metastatic urothelial cancer. The late-stage study evaluating Trodelvy in previously treated metastatic non-small cell lung cancer also failed.
GILD’s Cell Therapy Franchise Faces Challenges
Gilead’s oncology portfolio, comprising the Cell Therapy franchise and breast cancer drug Trodelvy, has diversified its overall business. However, the Cell Therapy franchise, comprising Yescarta and Tecartus, is currently under pressure due to competitive headwinds both in the United States and Europe that are expected to continue in 2025.
GILD’s Valuation and Estimate Revision
According to the price/earnings ratio, GILD’s shares currently trade at 14.01x forward earnings, lower than the large-cap pharma industry’s average of 16.60X but higher than its mean of 10.52X.
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The bottom-line estimate for 2025 has risen from $7.81 to $7.87 per share while that for 2026 has increased from $8.03 to $8.27 over the past 30 days.
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Invest in GILD stock
Gilead’s efforts to constantly innovate its HIV portfolio should enable it to maintain growth amid competition from GSK plc GSK. The company’s strategic deals and acquisitions to diversify its business are encouraging.
GILD has also collaborated with Merck MRK to evaluate the investigational combination of islatravir and lenacapavir for the treatment of HIV. Islatravir is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation in multiple ongoing early and late-stage clinical studies in combination with other antiretrovirals for the treatment of HIV-1.
Despite the recent rally, we believe there is more room for growth buoyed by solid fundamentals and recent positive estimate revisions. Gilead has been consistently increasing and paying out dividends. The company announced that its board had declared an increase of 2.6% in its quarterly cash dividend, beginning the first quarter of 2025. The increase should result in a quarterly dividend of $0.79 per share of common stock.
Its strong cash position (as of Dec. 31, 2024, GILD had $10 billion of cash, cash equivalents and marketable debt securities) indicates that the current yield of 2.84% is sustainable.
Gilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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