FOSTER CITY, Calif. & MBABANE, Eswatini--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the delivery of first shipments of lenacapavir – Gilead's twice-yearly injectable HIV-1 capsid inhibitor – for the prevention of HIV as pre-exposure prophylaxis (PrEP) to Eswatini and Zambia. The deliveries advance ongoing efforts to accelerate equitable access to long-acting HIV prevention options across sub-Saharan Africa, which is home to approximately two-thirds of all people livin. ...

Core Insights - Gilead Sciences, Inc. announced that its investigational single-tablet regimen (STR) of bictegravir and lenacapavir for HIV-1 treatment met the primary endpoint in the late-stage ARTISTRY-1 study [1][5] Study Results - The ARTISTRY-1 study is a multicenter phase II/III trial comparing the once-daily combination of bictegravir and lenacapavir against current therapy in HIV patients who are virologically suppressed on complex regimens [2][4] - The study showed that the STR met the primary success criterion for non-inferiority to baseline multi-tablet antiretroviral therapy regimens, with the primary efficacy endpoint being the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at week 48 [5][8] - The combination was generally well tolerated, with no significant or new safety concerns identified [5][8] Market Performance - Gilead's shares have surged 35.6% year to date, outperforming the industry growth of 15.4% [3] Future Plans - Gilead plans to file the late-stage data from the ARTISTRY trials with regulatory authorities [6][10] - The company is also conducting the double-blind, phase III ARTISTRY-2 trial, evaluating the safety and efficacy of switching from Biktarvy to the fixed-dose combination of bictegravir and lenacapavir in virologically suppressed people with HIV-1, with top-line data expected before the end of 2025 [10] HIV Franchise Strength - Gilead has a market-leading HIV franchise, with Biktarvy and Descovy as flagship therapies driving top-line growth [11] - Biktarvy accounts for over 52% of the treatment market in the U.S., while Descovy holds more than 45% of the U.S. PrEP market [11][12] - The FDA approval of lenacapavir under the brand name Yeztugo for twice-yearly PrEP has further strengthened Gilead's HIV portfolio [12][13] - Yeztugo generated $39 million in sales in the third quarter, achieving a 75% coverage goal ahead of schedule, with a target of 90% coverage by mid-2026 [14] Competitive Landscape - Positive data from the ARTISTRY studies is expected to bolster Gilead's position amid increasing competition from companies like GSK, which is expanding its HIV business with long-acting injectable medicines [15]

Core Viewpoint - The AIDS Healthcare Foundation (AHF) is launching a mobile billboard to criticize Gilead Sciences for its pricing strategy regarding the HIV prevention drug lenacapavir, demanding that it be made affordable and accessible [1] Group 1: Company Actions - AHF's mobile billboard will circle the venue of the Global Pharma & Biotech Summit in London on November 11-12 [1] - The billboard carries a message directed at Gilead and its CEO Daniel O'Day, urging them to "Make Lenacap" [1] Group 2: Industry Context - The event coincides with the Global Pharma & Biotech Summit, highlighting ongoing discussions in the pharmaceutical industry regarding drug pricing and accessibility [1]

Core Insights - A new generic version of lenacapavir, an HIV prevention tool, is set to reach millions, priced at approximately $40 per patient annually, compared to Gilead's list price of over $28,000 [1][8] - The collaboration between Indian manufacturers and organizations like Unitaid and the Clinton Health Access Initiative aims to expand the supply of lenacapavir, potentially accelerating its availability to high-risk populations [2][8] - Despite advancements in HIV treatment, 1.3 million new infections occurred last year, with two-thirds of those living with HIV located in Africa, where prevention tools are limited [3][6] Group 1 - Lenacapavir offers a six-month protection with a single injection, which is particularly beneficial for women facing challenges with daily pill adherence [4][5] - The cost of lenacapavir previously limited access, especially for participants in clinical trials in South Africa, compounded by cuts to US foreign aid affecting African health systems [5][6] - Gilead's announcement to allow generic manufacturers to produce lenacapavir for 120 resource-limited countries marks a significant step towards improving access, although historical timelines for such arrangements have been lengthy [7][8] Group 2 - New agreements with Indian manufacturers could significantly reduce the time required to make lenacapavir widely available, with only 18% of those who could benefit from PrEP currently having access [8] - Gilead plans to complete regulatory submissions for lenacapavir for PrEP in 18 countries by the end of the year, with expectations for the first supplies to reach low and lower middle-income countries [8] - A modest rollout of lenacapavir could potentially prevent up to 20% of new HIV infections in high-burden countries, with distribution through national HIV programs and procurement channels like the Global Fund [9]

Core Insights - Gilead Sciences, Inc. is recognized for its leadership in antiviral and oncology therapies, leveraging AI to enhance precision medicine and global patient access [1][2] Group 1: Investment and Infrastructure - Gilead Sciences is investing $32 billion in the U.S. through 2030 to strengthen domestic manufacturing and integrate AI into operations [2][4] - A new 180,000-square-foot Pharmaceutical Development and Manufacturing Technical Development Center is being established, featuring advanced technologies like autonomous robotics and real-time digital monitoring [2][3] Group 2: Product Development and Global Health Impact - The new facility aims to improve data-driven insights and process automation for therapies, including CAR-T treatments and next-generation antivirals [3] - Gilead is partnering with PEPFAR to provide lenacapavir for HIV prevention, targeting up to two million individuals in low- and lower-middle-income countries by the end of 2025 [4]

Core Insights - Gilead Sciences, Inc. has received marketing authorization from the European Commission for its HIV prevention drug lenacapavir, branded as Yeytuo, which is administered twice a year [1][8] - The approval follows an accelerated review process by the European Medicines Agency, highlighting the drug's significance for public health [3][8] - Lenacapavir has shown superior efficacy in preventing HIV infections compared to daily oral Truvada, with clinical trial data supporting its effectiveness [5][10] Regulatory Approvals - Lenacapavir was also approved by the FDA in June 2025 for the same indication, branded as Yeztugo [2] - The European Commission's approval was based on positive recommendations from the CHMP and data from late-stage trials [3][4] Clinical Efficacy - In the phase III PURPOSE 1 study, lenacapavir demonstrated a 100% reduction in HIV infections among 2,134 participants [5] - The phase III PURPOSE 2 study reported only two HIV infections among 2,179 participants, indicating a 99.9% prevention rate [6] Market Position - The approval of lenacapavir strengthens Gilead's HIV portfolio, especially as its other prevention drug, Truvada, faces generic competition [10] - Gilead holds a leading market share in HIV treatments, with its flagship drug Biktarvy accounting for over 51% of the U.S. treatment market [12] Competitive Landscape - Lenacapavir is positioned as a long-acting injectable PrEP, addressing barriers associated with daily oral medications [11] - The competitive landscape includes ViiV Healthcare's Apretude, which is also a long-acting injectable approved for PrEP [13][14] Pricing and Coverage Issues - Gilead's Yeztugo has a U.S. list price exceeding $28,000 per year, and negotiations with CVS Health regarding coverage are ongoing [15]

Group 1 - The medical sector is active, with the largest medical ETF in A-shares (512170) seeing a price increase of over 1% and a trading volume of 322 million yuan, ranking first among similar ETFs [1] - The latest fund size of the medical ETF is 27.36 billion yuan, with significant gains in constituent stocks such as Meihao Medical, Kaili Medical, and Huaxi Biological, where Meihao Medical hit a 20% limit up [1] - Major weighted stocks like Mindray Medical and United Imaging also experienced gains exceeding 3% [1] Group 2 - Gilead Sciences announced a 100% prevention efficacy of its HIV-1 capsid inhibitor lenacapavir in phase 3 clinical trials [3] - Major companies like Midea and Haier are accelerating their investments in the healthcare sector, focusing on medical imaging and low-temperature storage [3] - The medical device sector is benefiting from policy support and innovation, with a focus on high-certainty performance in specific sub-sectors during the mid-year reporting period [3] Group 3 - The National Healthcare Security Administration has published an initial review list for innovative drugs, indicating a significant increase in the number of drug generic names passing initial review compared to 2024 [3] - The "anti-involution" principle in centralized procurement is established, leading to a gradual easing of policy impacts, which may improve profitability in the medical device industry [3] - The domestic leading companies in the in-vitro diagnostics field are rapidly increasing their market share, and high-value consumables are expected to see a recovery in performance and valuation due to the easing of centralized procurement policies [3]

Core Viewpoint - Gilead Sciences, Inc. is set to report its Q2 2025 results on August 7, with consensus estimates for sales at $6.95 billion and earnings per share (EPS) at $1.95, reflecting a positive trend in earnings estimates for 2025 and 2026 [1][4][6]. Financial Performance - The earnings estimate for 2025 has risen to $8.02 from $7.91 per share over the past 60 days, while the estimate for 2026 has increased to $8.53 from $8.39 [1]. - Gilead's earnings surprise history shows that the company has beaten estimates in three of the last four quarters, with an average surprise of 16.48% [2][3]. Sales Drivers - Strong sales from Gilead's HIV drugs, particularly Biktarvy and Descovy, are expected to support top-line growth in Q2, with estimates for Biktarvy at $3.4 billion and Descovy at $577 million [4][8]. - The company has recently received FDA approval for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, which is anticipated to enhance its HIV portfolio [8][16]. Market Dynamics - The introduction of a new Medicare Part D model may have impacted HIV sales due to increased cost-sharing obligations for low-income patients, which could affect overall sales [7][6]. - Gilead's liver disease portfolio is expected to benefit from higher demand for viral hepatitis medicines, with incremental sales from the newly approved drug Livdelzi [9][10]. Competitive Landscape - Gilead's cell therapy sales, particularly for Yescarta and Tecartus, are likely to have declined due to competitive pressures in both the U.S. and global markets [11][17]. - The oncology portfolio, including Trodelvy, is showing strong demand, although the cell therapy segment faces ongoing challenges [13][17]. Stock Performance and Valuation - Gilead's shares have increased by 22.5% year-to-date, outperforming the industry and the S&P 500 [14]. - The stock currently trades at a price/earnings ratio of 13.60x forward earnings, which is higher than its historical mean but lower than the large-cap pharma industry average [15]. Strategic Outlook - Gilead's strategic deals and acquisitions are seen as positive for diversifying its business, with ongoing collaborations to enhance its HIV treatment offerings [18][22]. - The company is viewed as a safe haven for investors in the biotech sector, with a strong dividend yield adding to its attractiveness [19][23].

Core Viewpoint - The FDA has approved Gilead's lenacapavir, a twice-yearly antiviral injection for HIV prevention, which could significantly impact global public health and help in the fight against the HIV epidemic [2][5]. Product Efficacy and Impact - Lenacapavir has shown the ability to virtually eliminate new HIV infections when administered every six months, outperforming existing daily pills and monthly injections [3][12]. - In clinical trials, the injection demonstrated a 99.9% efficacy rate, with only two infections among over 2,000 patients, proving to be 89% more effective than Gilead's daily pill Truvada [12][13]. Market Potential and Pricing - Analysts estimate lenacapavir could achieve peak sales of around $4 billion globally for both prevention and treatment [7]. - The current price for lenacapavir, under its treatment brand Sunlenca, exceeds $42,200 per year, but it could potentially be produced for as low as $26 to $40 annually [6]. Access and Distribution - Gilead plans to align the pricing of lenacapavir for HIV prevention with existing branded PrEP options, which are around $2,000 per month for daily pills [8]. - The company has licensed six generic manufacturers to produce lower-cost versions of the injection for 120 low- and lower-middle-income countries, and will supply doses for up to 2 million people at no profit before generics are available [9]. Challenges to Implementation - Proposed cuts to federal funding for HIV prevention, particularly affecting Medicaid, pose a significant threat to access for underserved populations [14][15]. - The potential reduction in funding could destabilize HIV prevention efforts and make it harder to distribute Gilead's injection effectively [16][17].

Core Insights - Gilead Sciences, Inc. (GILD) has announced that the FDA has placed a clinical hold on studies for pipeline candidates GS-1720 and GS-4182 for HIV treatment due to safety concerns regarding CD4+ T-cell and lymphocyte counts [1][3][4] - Following the announcement, GILD shares fell by 2.6%, although the stock has gained 20% year-to-date, contrasting with a 0.5% decline in the industry [1] Gilead's HIV Treatment Pipeline - The clinical hold affects two phase II/III studies comparing the combination of GS-1720 and GS-4182 with Biktarvy in both virologically suppressed and treatment-naive HIV-1 patients, as well as three additional phase I studies [4][7] - Despite the setback, Gilead remains a market leader in HIV treatments, with Biktarvy accounting for over 51% of the U.S. treatment market [5][6] Market Performance and Future Prospects - Biktarvy continues to be the leading prescribed regimen for HIV-1 infection, while Descovy maintains over 40% market share in the PrEP market [6][7] - Gilead's late-stage studies for lenacapavir, which is under priority review for HIV prevention, could further solidify its position in the market [8] - However, Biktarvy sales may face pressure due to changes in Medicare Part D, impacting overall HIV growth [9] Competitive Landscape - Gilead faces competition from GSK plc, which is seeing strong demand for its HIV portfolio, including Cabenuva and Apretude [9][10]