Core Viewpoint - Gilead Sciences (GILD.US) has received approval from the European Commission for its HIV-1 capsid inhibitor Yeytuo (lenacapavir) as a pre-exposure prophylaxis (PrEP) therapy to reduce the risk of HIV-1 infection in high-risk adults and adolescents weighing at least 35 kilograms [1] Group 1 - Yeytuo is the first biannual HIV PrEP therapy approved in the EU [1] - The approval is based on the results of Phase 3 clinical trials, PURPOSE 1 and PURPOSE 2 [1] - Lenacapavir is a "first-in-class" long-acting HIV capsid inhibitor that interferes with the assembly and disassembly of the HIV capsid protein, acting at multiple stages of the viral life cycle [1]

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]

Core Insights - The global top-selling drugs for the first half of 2025 have been released, with Novo Nordisk's semaglutide leading the sales at 166.83 billion USD, followed by Merck's pembrolizumab and Eli Lilly's tirzepatide [1][3][4] Group 1: Top-Selling Drugs - Semaglutide from Novo Nordisk achieved sales of 166.83 billion USD, maintaining its position as the "king of drugs" [1][3] - Pembrolizumab from Merck recorded sales of 151.61 billion USD, ranking second [3] - Tirzepatide from Eli Lilly reached sales of 147.34 billion USD, securing the third position [3] Group 2: Sales Growth and Market Dynamics - Semaglutide's sales growth is driven by its three products: Ozempic (95.46 billion USD), Rybelsus (16.79 billion USD), and Wegovy (54.58 billion USD), with Wegovy showing a remarkable growth of 78% [5][6] - Tirzepatide has rapidly gained market share, with Mounjaro's sales skyrocketing from 4.83 billion USD in 2022 to an expected 115.4 billion USD in 2024 [7] - The competition between semaglutide and tirzepatide is intensifying, with both drugs exceeding 140 billion USD in sales for the first half of 2025 [7] Group 3: Market Challenges - The entry of biosimilars has impacted the sales of established drugs, with Janssen's ustekinumab dropping out of the top 10 due to a significant decline in sales [8] - Ustekinumab's sales fell by 38.6% in the first half of 2025, reaching only 32.78 billion USD [8] - Despite challenges, Johnson & Johnson's daratumumab saw a 21.7% increase in sales, reaching 67.76 billion USD, indicating strong demand in the multiple myeloma market [9][10]

Core Insights - Gilead Sciences, Inc. (GILD) shares fell 2.2% following CVS Health's decision not to include GILD's new HIV prevention drug, Yeztugo, in its commercial plans for the time being [1][8] - CVS Health's decision was influenced by clinical, financial, and regulatory factors, and Yeztugo will not be covered under its Affordable Care Act formularies [2] - GILD is negotiating with CVS regarding Yeztugo, which has a U.S. list price exceeding $28,000 annually [2] Gilead's Product Developments - Yeztugo received FDA approval in June 2025 for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg, and it is the first and only twice-yearly HIV PrEP option available in the U.S. [3][5] - GILD aims to secure 75% insurer coverage for Yeztugo by year-end 2025 and 90% within 12 months [3] Market Context - Currently, GILD markets two FDA-approved daily oral medications for PrEP: Truvada and Descovy [4] - GILD's shares have increased by 25.7% year-to-date, outperforming the industry growth of 4% [5] Acquisition Activity - Gilead's subsidiary, Kite, announced an agreement to acquire Interius BioTherapeutics for $350 million, which focuses on developing in vivo CAR therapeutics [7][9] - This acquisition is expected to impact GILD's earnings per share by approximately $0.23-$0.25 [8][9] Competitive Landscape - Gilead currently holds a Zacks Rank 3 (Hold), while CorMedix (CRMD) and ANI Pharmaceuticals (ANIP) have better rankings with Zacks Rank 1 (Strong Buy) [10] - CorMedix's earnings per share estimates have increased significantly, and its shares have rallied 49.1% year-to-date [11] - ANI Pharmaceuticals has also seen a slight increase in earnings estimates and a year-to-date share increase of 29.4% [12]

Group 1: Hong Kong Stocks Performance - Miniso (09896) surged over 20% after reporting a 10% year-on-year increase in adjusted net profit for Q2, with TOP TOY revenue skyrocketing by 87.0% [1] - Li Ning (02331) rose over 6% as it announced a 3.3% year-on-year increase in revenue and declared an interim dividend of HKD 0.3359 per share [1] - Innovent Biologics (02096) increased by over 6% following a 26% year-on-year growth in innovative drug revenue, expanding its commercialized innovative drug portfolio to ten products [1] - Tuhu-W (09690) gained over 10% after reporting a 14.6% year-on-year increase in adjusted net profit while continuing to optimize supply-side costs [1] - Kuaishou-W (01024) rose over 4% with impressive Q2 results and accelerated commercialization [1] - UBTECH (09880) increased over 3% as it led the establishment of two national technical standards for humanoid robots [1] - InnoCare Pharma (02577) saw a rise of over 5% after announcing a partnership with NVIDIA [1] Group 2: Other Notable Performances - China Communications Services (00552) fell over 2% despite a slight 0.18% year-on-year increase in net profit attributable to shareholders, with stable development among its three major clients [2] - Parkson Group (03368) surged nearly 25% after reporting a turnaround to profitability in the first half of the year and proposing an interim dividend of HKD 0.02 per share [2] - Esprit Holdings (00330) jumped over 37% after issuing a profit warning, expecting a net profit of approximately HKD 1 million for the six months ending June 30, 2025 [2] - XPeng Motors (09868) rose over 10% as CEO He Xiaopeng increased his stake by purchasing 3.1 million Class A ordinary shares at an average price of HKD 80.49 per share [2] Group 3: US Market Highlights - Coty (COTY.US) plummeted 21.60% due to weak performance in the US market, retailer destocking, and consumers seeking value, impacting Q4 results [3] - NIO (NIO.US) increased by 9.27% ahead of the launch of its new ES8 product and the start of pre-sales [3] - Huazhu Group (HTHT.US) continued to rise by 2.19% with a 41.3% year-on-year increase in revenue and net profit, benefiting from management franchise and licensing business [3] - Boss Zhipin (BZ.US) rose 6.61% after reporting an over 85% year-on-year increase in net profit for the mid-year and extending its share buyback plan [3] - Youlan Group (YOUL.US) surged 17.13% after announcing plans to acquire four companies to expand its online recruitment and regional market share [3] - Hesai Technology (HSAI.US) increased by 11.00% amid market speculation about a potential IPO in Hong Kong to raise approximately USD 300 million [3] Group 4: Additional US Stock Movements - Miniso (MNSO.US) rose 6.38% after reporting a revenue of CNY 9.39 billion for the first half of the year, a year-on-year increase of 21.1%, with adjusted net profit of CNY 1.28 billion [4] - Walmart (WMT.US) fell 4.49% as Q2 adjusted earnings per share fell short of expectations due to increased insurance claims, legal fees, and restructuring costs [4] - Gilead Sciences (GILD.US) dropped 2.18% after CVS Health decided not to include Gilead's new HIV prevention drug Yeztugo in its business plans [4] - XPeng Motors (XPEV.US) rose 11.68% following the CEO's purchase of 3.1 million Class A ordinary shares [5] - Aegon (AEG.US) increased by 7.64% after reporting a turnaround to profitability in the first half of 2025, primarily driven by growth in its US business [5]

Stock Performance - Gilead's shares experienced a decline [1] Market Dynamics - CVS has not yet included Gilead's new HIV prevention shot in its commercial drug plans [1]

Core Viewpoint - Gilead Sciences (GILD.US) shares fell over 3% to $115.16 following CVS Health's decision not to include Gilead's new HIV prevention drug Yeztugo in its commercial plans due to clinical, financial, and regulatory reasons [1] Group 1: Company Developments - CVS Health's decision is based on clinical, financial, and regulatory factors [1] - Gilead is still in negotiations with CVS regarding Yeztugo [1] Group 2: Product Pricing and Market Goals - The annual list price for Yeztugo in the U.S. exceeds $28,000 [1] - Gilead aims to achieve 75% coverage by U.S. insurers by the end of the year and 90% coverage by June 2026 [1]

Group 1 - The analysis focuses on Gilead Sciences Inc. (NASDAQ: GILD) and has maintained a bullish outlook on the company and its stock over several years [1] - The investment strategy emphasizes high-quality companies that can outperform the market in the long run due to competitive advantages and defensibility [1] - The analysis covers companies across various market capitalizations, specifically in European and North American markets [1] Group 2 - The analyst has a beneficial long position in Gilead Sciences shares through stock ownership, options, or other derivatives [2] - The article expresses the analyst's own opinions and is not influenced by compensation from any company mentioned [2]

Group 1 - The article provides a top-down analysis of the healthcare sector, focusing on industry metrics related to value, quality, and momentum [1] - It aims to assist in analyzing ETFs such as the Health Care Select Sector SPDR ETF [1] - The author, Fred Piard, has over 30 years of experience in technology and has been investing in data-driven systematic strategies since 2010 [1] Group 2 - The article does not provide specific financial data or performance metrics related to individual companies within the healthcare sector [2][3]

Core Insights - Gilead Sciences, Inc. (GILD) shares increased by 7.3% following strong Q2 2025 results and an upward revision of its annual guidance for 2025 [1][2] - Adjusted EPS was $2.01, surpassing the Zacks Consensus Estimate of $1.95, while total revenues reached $7.1 billion, exceeding the estimate of $6.9 billion, marking a 2% year-over-year growth [1][2] Financial Performance - Gilead raised its full-year product sales and EPS guidance, driven by robust demand for HIV treatments, particularly Biktarvy and Descovy [2] - Year-to-date, GILD's stock has risen 28.2%, outperforming the industry average gain of 3.7% [2] HIV Franchise Strength - The HIV treatment portfolio showed a strong performance with a 7% year-over-year growth, largely due to Biktarvy's sales growth of 9% to $3.5 billion [6][8] - Descovy's sales for pre-exposure prophylaxis (PrEP) surged 35% year-over-year to $653 million, marking its strongest quarter [7] - Gilead anticipates approximately 3% growth in HIV sales for 2025, up from previous flat growth expectations [7] New Product Launches - The FDA approved lenacapavir, branded as Yeztugo, enhancing Gilead's HIV portfolio amid competition from generics [9] - Yeztugo, a long-acting injectable PrEP, is expected to address barriers to broader PrEP adoption [10] - Gilead aims for up to eight additional HIV product launches by the end of 2033, with five expected by the end of 2030 [11] Oncology Portfolio - Trodelvy, a breast cancer drug, saw a 14% year-over-year sales increase to $364 million, outperforming estimates [12] - Gilead is pursuing approval for Trodelvy in first-line treatment settings based on trial results [13] Challenges in Other Franchises - The Cell Therapy franchise faced a 7% sales decline to $485 million due to competitive pressures [14] - Liver Disease portfolio sales decreased by 4% to $795 million, primarily due to lower chronic hepatitis C virus sales impacted by Medicare Part D redesign [15][16] Valuation and Estimates - GILD shares trade at a forward P/E ratio of 14.18, slightly below the large-cap pharma industry average of 14.45 [17] - Earnings estimates for 2025 have increased to $8.09 from $7.92 over the past month [18] Strategic Outlook - Gilead's innovation in the HIV portfolio and the approval of Yeztugo are seen as significant growth drivers [21] - Collaborations, such as with Merck for HIV treatment, and strategic acquisitions are viewed positively [22] - The company maintains a strong cash position, with $7.1 billion in cash and equivalents, supporting a sustainable dividend yield of 2.67% [25]