Key Takeaways GILD's ARTISTRY-2 showed once-daily BIC/LEN was non-inferior to Biktarvy at week 48.GILD randomized virologically suppressed patients 2:1 to switch to BIC/LEN or stay on Biktarvy.GILD plans regulatory filings combining phase III results from ARTISTRY-1 and ARTISTRY-2.Gilead Sciences, Inc. (GILD) announced that the investigational single-tablet regimen of bictegravir and lenacapavir for the treatment of HIV met the primary endpoint in the late-stage ARTISTRY-2 study.ARTISTRY-2 is a multicenter, ...

Key Takeaways GSK's shares have climbed 18.6% on strong Q3 results and increased full-year sales and profit guidance. Specialty Medicines sales are rising, driven by HIV, Respiratory and Oncology growth.U.S. vaccine sales are declining, though GSK sees sales toward the high end of its 2025 guidance range.GSK (GSK) stock has risen 18.6% in the past three months. The price recovery was backed by strong third-quarter results, wherein the British drugmaker beat estimates for both earnings and sales. The company ...

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 Insights - GSK plc reported third-quarter 2025 core earnings of $1.48 per American depositary share (ADS), exceeding the Zacks Consensus Estimate of $1.26, with core earnings increasing 11% year over year on a reported basis and 14% at a constant exchange rate (CER) [1][10] - Quarterly revenues rose 7% on a reported basis and 8% at CER to $11.52 billion (£8.55 billion), driven by rising sales across all business segments, particularly in HIV, oncology, and respiratory medicines, surpassing the Zacks Consensus Estimate of $11.16 billion [2][10] Segment Performance - GSK operates under three segments: General Medicines, Specialty Medicines, and Vaccines. Specialty Medicines sales increased by 16%, General Medicines rose by 4%, and Vaccine sales were up by 2% [3] - HIV sales rose 12% during the quarter, driven by increased demand for Dovato and long-acting medications like Apretude and Cabenuva, with Dovato sales increasing by 24% [4][5] - Oncology sales surged by 39%, led by strong demand for Jemperli, which saw a 79% increase due to expanded treatment indications [6][7] - Respiratory drug Nucala sales increased by 14%, while Benlysta sales rose by 17%, reflecting strong demand across markets [9] Financial Guidance - GSK raised its 2025 guidance, now expecting sales growth of 6-7%, up from a previous forecast of 3-5%, and core EPS growth of 10-12% [10][17][19] - Specialty Medicines are now expected to grow at a mid-teens percentage at CER, while General Medicines are anticipated to remain stable [18] - The company reiterated its guidance for R&D and SG&A expenses, with R&D expected to grow slightly faster than sales [20] Long-term Strategy - GSK is focusing on HIV, immunology/respiratory, and oncology therapeutic areas, with 80 assets in clinical development, including 16 in late-stage development or under regulatory review [24] - The company plans to launch five new products/line extensions this year, with four already approved by the FDA [25] - GSK aims to launch 15 new drugs between 2025 and 2031, each with peak sales potential exceeding £2 billion [26]

29 October 2025 Q3 2025 Results Conference call and webcast for investors and analysts gsk.com Agenda Q3 2025 strong performance improves further Emma Walmsley Performance: growth drivers 2 Cautionary statement regarding forward-looking statements Luke Miels and Deborah Waterhouse Q3 2025 financial performance Julie Brown Summary and Q&A Emma Walmsley, Luke Miels, Deborah Waterhouse, Julie Brown, Tony Wood and David Redfern This presentation may contain forward-looking statements. Forward-looking statements ...

Core Insights - Gilead Sciences, Inc. has reached settlement agreements with generic manufacturers to resolve patent litigations regarding its HIV treatment Biktarvy, which generated $6.7 billion in sales in the first half of 2025 [1][4][7] - The company's shares have increased by 25.6% year to date, outperforming the industry growth of 10.1% [2] Patent Settlements - Gilead has settled with Lupin Ltd., Cipla Ltd., and Laurus Labs Ltd., preventing generic versions of Biktarvy from entering the U.S. market before April 1, 2036 [4][5][7] - These agreements provide nearly a decade of patent protection for Biktarvy, which holds over 51% of the U.S. HIV treatment market [5][7] HIV Portfolio Growth - Gilead's HIV portfolio has been bolstered by the FDA approval of lenacapavir (Yeztugo), the first twice-yearly injectable HIV-1 capsid inhibitor for prevention [6][8] - The company anticipates a 3% growth in HIV sales for 2025, up from previous expectations of flat revenue growth, driven by strong performances from Biktarvy and Descovy [8] Competitive Landscape - The European Commission has granted marketing authorization for lenacapavir under the brand name Yeytuo, enhancing Gilead's competitive position [9] - Gilead's innovation efforts are crucial for maintaining growth amid competition from GSK, which has strong demand for its HIV products [9] Collaborations and Future Developments - Gilead is collaborating with Merck to evaluate a combination treatment for HIV, with a phase III update expected in 2026 [10] - Merck has also submitted a new drug application for a once-daily oral regimen for HIV treatment, with a target action date set for April 28, 2026 [11]

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 - 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]