Morgan Stanley (NYSE:MS) has maintained its Equalweight rating and $79.00 price target on Gilead (NASDAQ: GILD), following Gilead Sciences (NASDAQ:GILD)' announcement of successful Phase 3 trial results for its HIV prevention drug, lenacapavir.
The trial, named PURPOSE-2, showed that lenacapavir, administered biannually, reduced HIV infections by 96% and was superior to the daily oral medication Truvada in preventing HIV among a broad high-risk population.
The PURPOSE-2 trial involved 2,180 participants, with only two cases of HIV infection reported in the lenacapavir group, indicating that 99.9% of participants did not acquire HIV infection. The trial's results showed that lenacapavir had a superior efficacy compared to the background HIV incidence and to Truvada.
No significant or new safety concerns were identified, and the independent Data Monitoring Committee has recommended that all trial participants be offered lenacapavir in an open-label phase.
The data from this trial, along with results from the previous PURPOSE-1 trial, will support Gilead's global regulatory filings, which are expected to begin by the end of 2024. The company anticipates launching lenacapavir for pre-exposure prophylaxis (PrEP) as early as late 2025.
Morgan Stanley's analysis suggests that lenacapavir for PrEP could represent 7% of Gilead's total 2030 revenue estimate, with projected sales of $156 million in 2025 increasing to $2.2 billion by 2030.
Gilead is committed to understanding the reasons behind the two HIV infections that occurred during the trial and plans to present more detailed data from the PURPOSE-2 study at a future medical conference.
In other recent news, Gilead Sciences' HIV-1 inhibitor, lenacapavir, showed a 96% reduction in HIV infections in a Phase 3 trial, with plans to make the drug available as a semi-annual HIV prevention option by 2025.
Additionally, Gilead reported a 6% year-over-year rise in total product sales during its second quarter of 2024, reaching $6.7 billion, driven by an 8% rise in sales for its HIV treatment, Biktarvy, and a 23% increase for the oncology drug, Trodelvy.
Gilead also announced a strategic collaboration with Genesis Therapeutics to accelerate the discovery of new small molecule therapies, which is expected to impact Gilead's 2024 earnings per share by approximately $0.02. The company also received accelerated FDA approval for Livdelzi, a treatment for Primary Biliary Cholangitis.
Analysts from BMO Capital Markets, Piper Sandler, RBC Capital, and TD Cowen have
maintained positive outlooks on Gilead's stock, reflecting confidence in the company's trajectory.
InvestingPro Insights
As Gilead Sciences (NASDAQ:GILD) advances its HIV prevention drug lenacapavir, the company's financial health and market performance provide a broader context for evaluating its potential impact on the market. With a robust market capitalization of $102.86 billion and a high gross profit margin of 77.44% over the last twelve months as of Q2 2024, Gilead demonstrates significant financial strength. The company's commitment to shareholder returns is evident, having raised its dividend for 9 consecutive years, coupled with a current dividend yield of 3.81%. Additionally, Gilead has showcased a strong return over the last three months, with a 27.34% price total return, reflecting investor optimism.
These financial metrics, along with the company's low price volatility and position as a prominent player in the Biotechnology industry, underscore its stability and potential for sustained growth. While analysts have revised their earnings expectations downwards for the upcoming period, Gilead's track record of profitability, as indicated by the InvestingPro Tips, suggests resilience in its business model. Investors can find further insights and additional InvestingPro Tips for Gilead Sciences at InvestingPro, where detailed analysis and projections are available to help make informed decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.