Key Takeaways Gilead reached patent settlements with Lupin, Cipla, and Laurus over generic Biktarvy.No Biktarvy generic entry is expected in the U.S. before April 1, 2036.FDA approval of Yeztugo and strong Biktarvy sales drive Gilead's HIV portfolio growth.Gilead Sciences, Inc., (GILD) announced that it has entered into settlement agreements to resolve the patent litigations with a few generic manufacturers who were looking to market generic versions of its flagship HIV treatment, Biktarvy.Biktarvy is one o ...

Core Insights - Gilead Sciences, Inc. (GILD) has demonstrated strong performance in 2025, with shares rising 26.5% year to date, significantly outperforming the industry growth of 6% [1][9] - The FDA approval of lenacapavir, branded as Yeztugo, for HIV prevention has been a pivotal event, marking it as the first twice-yearly injectable pre-exposure prophylaxis (PrEP) option in the U.S. [3][7] Gilead's HIV Portfolio - Gilead holds a leading position in the HIV treatment market, with its flagship drug Biktarvy commanding over 51% market share in the U.S. [4] - The company anticipates a 3% growth in HIV sales for 2025, up from previous expectations of flat revenue, driven by strong performances from Biktarvy and Descovy [5] - The approval of Yeztugo enhances Gilead's HIV portfolio, especially as Truvada faces generic competition [6] Oncology and Cell Therapy - Gilead's oncology portfolio includes Trodelvy, which has shown strong performance in treating metastatic triple-negative breast cancer, with plans for further approvals [11] - However, the Cell Therapy franchise, including Yescarta and Tecartus, is facing competitive pressures in the U.S. and Europe [12] - Gilead's subsidiary Kite has acquired Interius BioTherapeutics for $350 million, enhancing its capabilities in CAR T-cell therapies [13] Liver Disease Portfolio - The FDA approval of seladelpar, branded as Livdelzi, for primary biliary cholangitis (PBC) has strengthened Gilead's liver disease portfolio [14][15] Financial Performance and Estimates - Gilead's shares are currently trading at a price/earnings ratio of 13.62x forward earnings, lower than the large-cap pharma industry's average of 14.83x [16] - Earnings estimates for 2025 have increased to $8.10 from $8.02, while the estimate for 2026 has slightly decreased to $8.50 from $8.53 [17] Strategic Collaborations - Gilead has partnered with the U.S. State Department to deliver lenacapavir, indicating a commitment to expanding its HIV prevention efforts [10] - The company is also collaborating with Merck to evaluate a combination treatment for HIV, with updates expected in 2026 [20] Dividend and Cash Position - Gilead has maintained a strong cash position, with $7.1 billion in cash and equivalents as of June 30, 2025, supporting its sustainable dividend yield of 2.76% [22] - In Q2 2025, Gilead paid out $994 million in dividends and repurchased $527 million of common stock, reflecting its commitment to returning value to shareholders [21]

Core Insights - GSK stock has increased by 6.4% over the past month, adding nearly $5 billion to its market value, driven by strong performance in the Specialty Medicines unit and a positive long-term outlook despite challenges in the Vaccines unit and economic pressures [1][9]. Group 1: Specialty Medicines Performance - The Specialty Medicines unit is experiencing significant sales growth, with a 16% increase in the first half of 2025, attributed to successful launches in Oncology and long-acting HIV medicines [3][9]. - Key products driving growth include Nucala, Dovato, Cabenuva, Apretude, Jemperli, and Ojjaara, with expectations for low teens percentage growth in sales for this segment in 2025 [4][9]. - Specialty Medicines currently account for approximately 40% of GSK's sales and are projected to exceed 50% of total revenues by 2031 [4]. Group 2: Promising Pipeline and R&D - GSK is increasing its R&D investment in long-acting and specialty medicines across various therapeutic areas, including Respiratory, Immunology & Inflammation, Oncology, and HIV [5]. - Recent approvals include the pentavalent MenABCWY meningococcal vaccine and Blujepa/gepotidacin for uncomplicated urinary tract infections, with additional regulatory applications under review [6][7]. - GSK plans to launch five new products/line extensions in 2025, including Blenrep and depemokimab, which are already approved in the U.S. [7]. Group 3: Vaccine Sales Challenges - Vaccine sales in the U.S. are declining, particularly for the shingles vaccine Shingrix and the RSV vaccine Arexvy, with total vaccine sales down 11% at CER in the first half of 2025 [8][11]. - Revised recommendations for RSV vaccinations have negatively impacted sales of Arexvy, particularly among adults aged 60-74 [10][11]. - GSK anticipates a low single-digit percentage decrease in vaccine sales for 2025, reflecting broader challenges in this segment [11]. Group 4: Stock Performance and Valuation - GSK stock has outperformed the industry and the S&P 500, rising 21.2% year-to-date compared to a 1.4% increase for the industry [12]. - The stock is trading at a forward price/earnings ratio of 8.58, significantly lower than the industry average of 14.78, indicating attractive valuation [14]. - Analysts have raised the earnings consensus estimate for 2025 from $4.34 to $4.37 per share, reflecting optimism around profit growth [18]. Group 5: Future Growth Expectations - GSK expects over 7% sales growth and more than 11% core operating profit growth on a CAGR basis from 2022 to 2026, driven by the Specialty Medicines segment [21]. - The growth in Specialty Medicines is expected to offset the slowdown in the Vaccines unit, with General Medicines also contributing to overall sales growth [21].

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 - Bristol Myers Squibb (BMY) and GSK PLC (GSK) are leading global biopharma companies with diverse portfolios [1][2] - BMY focuses on transformational drugs across various therapeutic areas, while GSK has a strong presence in HIV, oncology, and respiratory diseases [1][2] BMY Overview - BMY's growth portfolio includes drugs like Opdivo, Reblozyl, Breyanzi, Camzyos, and Opdualag, stabilizing revenue amid generic competition [4] - Opdivo's sales are driven by strong launches in specific cancer types and volume growth internationally [4][5] - The FDA approved Opdivo Qvantig for subcutaneous use, showing strong initial uptake [5] - Strategic acquisitions have broadened BMY's portfolio, including the approval of Cobenfy for schizophrenia [6] - Legacy drug sales are declining due to generic competition, impacting overall revenue [7] - A collaboration with BioNTech enhances BMY's pipeline for solid tumor treatments [8] GSK Overview - GSK's Specialty Medicines unit is experiencing strong sales growth, driven by successful launches in oncology and long-acting HIV medicines [9] - Key growth drivers include drugs like Nucala and Dovato, with new products like Cabenuva and Jemperli contributing to revenue [9][10] - GSK's vaccine portfolio is diversified but faces pressure from lower sales of certain products, though new approvals may help [11] - GSK has a deep pipeline with promising candidates in late-stage development for various conditions [12] Financial Estimates - BMY's 2025 sales are estimated to decrease by 2.37%, while EPS is expected to increase by 465.22% due to low EPS in 2024 [13] - GSK's 2025 sales are projected to grow by 5.96%, with EPS improving by 7.16% [16] Price Performance and Valuation - GSK shares have increased by 18.5% year-to-date, while BMY shares have decreased by 14.3% [19] - GSK's shares trade at a forward P/E of 8.74, compared to BMY's 7.79, with both companies offering attractive dividend yields [19] Investment Considerations - Both companies are rated Hold, making the choice between them complex [21] - GSK's diversified revenue base and strong portfolio position it favorably compared to BMY, which is facing challenges from generic competition [23]

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]

Core Insights - GSK plc reported second-quarter 2025 core earnings of $1.23 per American depositary share (ADS), exceeding the Zacks Consensus Estimate of $1.12, with a year-over-year increase of 7% on a reported basis and 15% at a constant exchange rate (CER) [1][9] - Quarterly revenues rose 1% on a reported basis and 6% at CER to $10.67 billion (£7.99 billion), driven by increased sales of HIV, oncology, and vaccine products, surpassing the Zacks Consensus Estimate of $10.33 billion [2][9] Segment Performance - GSK operates under three segments: General Medicines, Specialty Medicines, and Vaccines. Specialty Medicines sales increased by 15%, while Vaccine sales rose by 9%. General Medicines experienced a decline of 6% [3][9] - HIV sales grew by 12%, supported by increased demand for Dovato and long-acting medications Apretude and Cabenuva, with Apretude and Cabenuva sales rising by 50% and 46%, respectively [4][6] - Oncology sales surged by 42%, driven by strong demand for Jemperli and Ojjaara/Omjjara, with Jemperli sales increasing by 91% [6][7] - Vaccine sales were bolstered by increased uptake of meningitis and shingles vaccines, with Shingrix sales rising by 6% [12] Financial Guidance - GSK raised its 2025 sales and profit guidance, now expecting sales to increase toward the top end of the previously issued range of 3-5%, with Specialty Medicines projected to grow at a low teens percentage at CER [15][16] - The company anticipates core operating profit and core EPS to grow toward the top end of the previously issued guided range of 6-8% [16][17] Long-term Strategy - GSK has prioritized focus on HIV, immunology/respiratory, and oncology therapeutic areas, with 84 assets in clinical development, including 16 candidates in late-stage development or under regulatory review [24] - The company plans to launch five new products/line extensions in 2025, with three already approved in the first half of the year [25][26]

Q2 2025 Performance Highlights - Q2 2025 sales reached £7,986 million, a 6% increase[9] - Core EPS increased by 15% to 465 pence[9] - Core operating profit increased by 12% to £2,631 million[10] - Cash generated from operations year-to-date is £37 billion[10] Specialty Medicines Growth - Specialty Medicines sales increased by 15%[9] - Specialty medicines largest business: 40% sales[14] - HIV sales increased by 12% to £1,880 million[56] - Vaccines sales increased by 22%[71] Financial Outlook and Guidance - Expect to deliver towards the top end of 2025 guidance range[9] - Sales growth is projected at 3-5%[24] - Core OP growth is projected at 6-8%[24] - Expect sales of >£40 billion in 2031[18]

Core Insights - Merck has initiated two late-stage clinical studies for MK-8527, a once-monthly oral pill for HIV pre-exposure prophylaxis (PrEP) [1][8] - The studies aim to enroll nearly 9,000 participants and will compare MK-8527 with Gilead's daily oral PrEP pill, Truvada [2][8] - The initiation of these studies is backed by positive Phase II results showing similar adverse event rates between treatment and placebo [3] Company Developments - Merck is expanding its HIV portfolio, focusing on both prevention and treatment, with MK-8527 being a key component [6][10] - The FDA has accepted a regulatory filing for Merck's once-daily, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for treating HIV-1, with a decision expected by April 28, 2026 [7] - Merck is also collaborating with Gilead on a once-weekly, two-drug, single-tablet regimen of islatravir/lenacapavir (ISL/LEN) [9][10] Competitive Landscape - Merck's growing HIV portfolio positions it to compete with Gilead, which currently leads the market with its PrEP medications, Truvada and Descovy [11] - If approved, MK-8527 could challenge Gilead's dominance in the PrEP market [11] - Gilead's recent approval of lenacapavir, a twice-yearly injectable for HIV prevention, adds to the competitive pressure in the HIV therapeutic space [13] Market Context - GSK is another significant player in the HIV market, with strong sales driven by products like Cabenuva, Apretude, and Dovato [14] - The competitive dynamics in the HIV space are intensifying as companies innovate and expand their product offerings [11][14]

Core Insights - GSK's Specialty Medicines segment is a significant contributor to its sales, accounting for nearly 40% of total revenue and expected to exceed 50% by 2031 [6] Sales Growth - The Specialty Medicines unit has experienced a 17% sales increase in Q1 2025, driven by successful launches in Oncology and long-acting HIV medicines [2][10] - Key products such as Nucala and Dovato are major revenue drivers, alongside new long-acting HIV treatments like Cabenuva and Apretude, and oncology drugs Jemperli and Ojjaara [3] Research and Development - GSK is increasing R&D investments in long-acting and specialty medicines across various therapeutic areas, including Respiratory, Immunology & Inflammation, Oncology, and HIV [4] - The approval of Blujepa for uncomplicated urinary tract infections and Nucala for chronic obstructive pulmonary disease (COPD) supports the growth trajectory [4][10] Regulatory Approvals - Regulatory applications for Blenrep combinations for multiple myeloma and depemokimab for chronic rhinosinusitis and asthma are under review, with FDA decisions expected in 2025 [5] Competitive Landscape - GSK faces significant competition in the Specialty Medicines segment from major pharmaceutical companies such as AstraZeneca, Merck, and Pfizer [7][8] Stock Performance and Valuation - GSK's stock has increased by 16.3% year-to-date, outperforming the industry average of 0.3% [9] - The company's shares are trading at a forward price/earnings ratio of 8.34, which is lower than the industry average of 14.93 and below its 5-year mean of 10.21 [12] Earnings Estimates - The Zacks Consensus Estimate for GSK's earnings per share has risen from $4.38 to $4.41 for 2025, while the estimate for 2026 has slightly declined [14]