Core Insights - Gilead Sciences, Inc. announced positive interim results from a late-stage study of lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, showing a 96% reduction in HIV infections compared to daily Truvada [1][3] - The study demonstrated that 99.9% of participants in the lenacapavir group did not acquire HIV, with only two infections among 2,180 participants [3] - Gilead's stock rose 2.74% following the announcement, reflecting investor confidence in the drug's potential [1] Study Details - The PURPOSE 2 study involved over 3,200 participants, including cisgender men, transgender individuals, and gender non-binary individuals aged 16 and older [3] - The study met its primary efficacy endpoint, confirming lenacapavir's superiority over both background HIV incidence and Truvada [4] - The independent Data Monitoring Committee recommended stopping the blinded phase of the trial and offering lenacapavir to all participants [4] Market Implications - The success of lenacapavir in the PURPOSE 2 study positions Gilead to initiate global regulatory filings by the end of 2024, with a potential launch in 2025 [6] - Lenacapavir's twice-yearly administration offers a competitive advantage over daily oral medications, addressing a broader population in need of HIV prevention options [7] - Gilead is a dominant player in the HIV market, having developed the first single-tablet regimen and the first long-acting injectable treatment [7] Competitive Landscape - GSK's Apretude, another long-acting injectable for HIV prevention, was approved by the FDA in 2021, representing a key competitor for Gilead [8] - GSK reported a 13% growth in HIV sales in the second quarter, driven by demand for its long-acting drugs [8]

Core Insights - Gilead Sciences experienced a nearly 3% increase in stock price following positive results from a late-stage clinical trial of its investigational HIV drug lenacapavir, which significantly outperformed the S&P 500 index's 0.8% increase on the same day [1]. Group 1: Clinical Trial Results - The second phase 3 trial of lenacapavir met key efficacy endpoints, demonstrating a 96% reduction in new HIV infections compared to background incidence [2]. - Lenacapavir, administered biannually, proved to be more effective than the daily medication Truvada, which has been a standard treatment for HIV [2]. - Gilead's CEO highlighted the potential of lenacapavir to transform HIV prevention and contribute to ending the epidemic [2]. Group 2: Regulatory Approval Process - Gilead plans to utilize data from both clinical trials for regulatory approval submissions, expected to begin by the end of this year [3]. - Specific details regarding the timing and locations of these submissions were not disclosed [3].

Gilead's twice-yearly shot reduced HIV infections by 96% in a second large study, the company said Thursday.The positive phase three trial data on Lenacapavir sets the stage for likely approval by the U.S. Food and Drug Administration for HIV prevention."Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide, ...

Summary of Gilead Sciences, Inc. Conference Call Company Overview - Gilead Sciences is primarily a virology organization, focusing on HIV treatment and prevention, while also diversifying into oncology and inflammation [2][4] Key Points on HIV Treatment - Gilead holds approximately 70% market share in HIV treatment, with Biktarvy being the standard-of-care, generating an annual run-rate of about $13 billion [2][7] - Biktarvy continues to grow at a rate of about 3% year-on-year, despite new market entrants [7][8] - The company is developing a pipeline to support its leadership in HIV treatment, including weekly and monthly oral medications, as well as subcutaneous injectables [2][8] Lenacapavir and HIV Prevention - Lenacapavir has shown 100% efficacy in the PURPOSE 1 trial, which is unprecedented in HIV prevention trials [3][11] - The current PrEP market in the US has about 400,000 users, primarily white MSMs, with significant potential for growth by targeting underserved populations [12][13] - Gilead aims to differentiate lenacapavir in the market, competing against daily oral medications like Descovy and Truvada, and plans to expand into new geographies [13][14] - The adherence rate for daily oral PrEP is around 50-60%, while a biannual injection of lenacapavir could achieve 100% adherence [16][19] Oncology Pipeline - Gilead is expanding its oncology portfolio, particularly with Trodelvy in breast cancer, where it has established a strong market presence [30][31] - The company is focusing on moving Trodelvy into earlier lines of therapy and is awaiting data from ASCENT-03 and ASCENT-04 trials [32][33] - Gilead is also exploring opportunities in lung cancer and endometrial cancer, with ongoing studies to support its expansion [35][36] Livdelzi for Primary Biliary Cholangitis (PBC) - Livdelzi was launched in mid-August and is positioned as a differentiated product in the rare disease market for PBC, with an estimated 130,000-140,000 patients in the US [21][22] - The drug has shown significant improvement in pruritus, a common and debilitating symptom of PBC, which is a key differentiator from competitors [23][27] - Gilead expects modest revenue growth from Livdelzi in 2024, with more substantial growth anticipated in 2025 and beyond [24] Business Development Strategy - Gilead's current strategy focuses on bolt-on acquisitions and partnerships, particularly in oncology and inflammation, rather than large-scale deals [39] - The company is confident in its internal pipeline and is open to exploring opportunities in virology if they align with its strategic goals [39] Conclusion - Gilead is at a critical juncture in diversifying its portfolio, with significant advancements in HIV treatment and prevention, oncology, and rare diseases [42] - The company aims to leverage its strong market position and innovative products to drive future growth and improve patient outcomes [42]

Core Insights - Gilead Sciences is focusing on expanding its portfolio beyond virology, particularly in oncology and inflammation, while maintaining its leadership in HIV treatment [2][5][42] - The company has a strong market position in HIV treatment, with Biktarvy holding approximately 70% market share and an annual run-rate of about $13 billion [2][7][8] - Lenacapavir, a new molecule for HIV prevention, has shown 100% efficacy in trials, presenting a significant opportunity to transform the PrEP market [3][11][12] HIV Treatment - Gilead holds a 70% share in the HIV treatment market, with Biktarvy growing at approximately 3% year-on-year [2][7] - The company is developing a pipeline that includes weekly and monthly oral treatments, as well as long-acting injectables [2][8] - Lenacapavir is expected to enhance Gilead's position in the PrEP market, targeting a broader demographic beyond the current 400,000 users in the U.S. [11][12][13] Oncology - Gilead is expanding its oncology portfolio with Trodelvy, which is currently used in breast cancer treatment and is being explored for earlier lines of therapy [4][30] - The company is also investigating opportunities in lung cancer and endometrial cancer, with ongoing clinical trials [36][30] - ASCENT-03 and ASCENT-04 trials are expected to provide data that could support the use of Trodelvy in earlier treatment lines [32][30] Inflammation - Livdelzi, recently approved for primary biliary cholangitis (PBC), is positioned as a differentiated product with a focus on alleviating pruritus, a significant symptom for patients [21][22] - The PBC market in the U.S. consists of approximately 130,000 to 140,000 patients, with Livdelzi expected to capture a share of the second-line treatment market [22][24] - Gilead aims to leverage its established liver team to promote Livdelzi effectively among prescribers [21][22] Business Development - Gilead's strategy includes pursuing smaller, bolt-on acquisitions to enhance its oncology and inflammation portfolios, rather than large-scale deals [39][38] - The company is open to exploring opportunities in virology if they align with its strategic goals [39][38] - Gilead's focus remains on building a diversified pipeline while maintaining strong internal capabilities [39][38]

Financial Data and Key Metrics Changes - The company's base business grew by 8% two years ago, 7% last year, and 6% in the first half of this year, indicating consistent growth [3] - Strong financial leverage was highlighted with significant growth in EPS due to a beat on both the top line and expense management [3] Business Line Data and Key Metrics Changes - Gilead has a strong presence in three areas: virology, oncology, and inflammation/immunology, with a focus on HIV treatment and prevention, liver diseases, and oncology [2] - The HIV prevention market has seen substantial growth, with the introduction of lenacapavir expected to significantly impact market dynamics [6][9] - Seladelpar, a new treatment for primary biliary cholangitis (PBC), was recently launched and is expected to drive growth in the liver disease segment [35][39] Market Data and Key Metrics Changes - The PrEP market is estimated to be a $3 billion to $3.5 billion market today, with significant growth potential as awareness increases [16][17] - The company anticipates expanding the market for HIV prevention both in the U.S. and globally, particularly with the upcoming PURPOSE II study [8][18] Company Strategy and Development Direction - Gilead is diversifying its business and building a larger portfolio through new product launches and acquisitions, such as the acquisition of seladelpar [3][35] - The company aims to leverage its existing relationships with healthcare providers to enhance the market penetration of new treatments [36] - Gilead is focusing on internal innovation while maintaining a regular cadence of business development activities, targeting smaller acquisitions and partnerships [55][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of the HIV business despite potential headwinds from Part D reform, which may mask growth in the short term [41][42] - The company expects to see overall growth driven by multiple business segments, including oncology and liver diseases, alongside HIV [42][43] - Management highlighted the importance of raising awareness for cell therapies to increase patient access and utilization [51] Other Important Information - The company is making progress in developing next-generation HIV treatment regimens, with several candidates in various phases of clinical development [26][29] - Gilead's cell therapy business is expected to grow significantly, with a focus on expanding access to treatments in the U.S. and internationally [50] Q&A Session Summary Question: What is the current status of the PrEP market? - Management noted that the PrEP market is still in its early stages, with significant growth potential as awareness increases and new products are introduced [16][18] Question: How does Gilead plan to compete in the cell therapy market? - Management emphasized the unique advantages of their cell therapy manufacturing capabilities and the potential for their new BCMA cell therapy to be best-in-class [46][48] Question: What are the expectations for seladelpar in the PBC market? - Management believes seladelpar represents a best-in-class treatment for PBC and sees significant growth potential in this underappreciated market [35][39] Question: How does Gilead view business development moving forward? - Management indicated a shift in focus towards smaller acquisitions and partnerships, reflecting a more mature and diversified portfolio [55][56]

Gilead Sciences, Inc. (NASDAQ:GILD) Morgan Stanley 22nd Annual Global Healthcare Conference September 5, 2024 12:20 PM ET Company Participants Daniel O'Day - Charman & CEO Andrew Dickinson - Chief Financial Officer Conference Call Participants Terence Flynn - Morgan Stanley Terence Flynn Thanks for joining us, everybody. I'm Terence Flynn, the U.S. biopharma analyst here at Morgan Stanley. Before we get started, for important disclosures, please see the Morgan Stanley research disclosure website at www.morg ...

Core Insights - Gilead Sciences is undergoing a transformation to create a more sustainable and diversified portfolio, focusing on growth in HIV and expanding into other therapeutic areas [4][11] - The company has made significant investments in virology, particularly in HIV, and is optimistic about the long-acting treatment market and its potential for growth [5][6] - Gilead's clinical pipeline includes 36 trials in oncology and inflammation, with a focus on innovative therapies and cell therapy advancements [7][9] Group 1: Strategic Focus - The company aims to sustain and grow its HIV business while diversifying into other therapeutic areas [4] - Key investments have been made in virology, particularly with the recent advancements in PrEP, which could reshape the market [5] - Gilead is optimistic about the long-acting treatment market, with various options being explored [6] Group 2: Clinical Pipeline and Development - Gilead currently has 36 clinical stage trials in oncology and inflammation, with a focus on Trodelvy and cell therapies [7][8] - The company is developing a Phase II portfolio in oncology and inflammation, with innovative mechanisms being explored [9][10] - The partnership with Arcellx for multiple myeloma presents a significant opportunity for Gilead [9] Group 3: Financial Performance and Growth - Gilead's base business has shown consistent growth, with an 8% increase two years ago, 7% last year, and over 6% this year [21] - The company achieved a 47% operating margin in the second quarter, reflecting effective cost management and growth strategies [22] - Gilead plans to maintain a strong dividend policy while also exploring opportunities for share repurchases [26] Group 4: Market Expansion and Pricing Strategy - The U.S. PrEP market is estimated to be over $3 billion, with potential growth to $4.5 billion through increased adherence and market penetration [43][44] - Gilead is focused on pricing lenacapavir for PrEP based on its unique market position and efficacy data, rather than comparing it to existing treatments [35] - The company is optimistic about expanding PrEP access globally, leveraging strong clinical data to engage with payers [41][42] Group 5: Oncology Strategy - Gilead's oncology business is now a $3 billion run rate, driven by Trodelvy and cell therapy products [52] - The company is focused on expanding Trodelvy's use in earlier lines of breast cancer and exploring its potential in lung cancer [55][59] - Upcoming data from the Arcellx partnership in multiple myeloma is highly anticipated and could significantly impact Gilead's growth in oncology [63]

Merck & Co. MRK and Gilead Sciences Inc. GILD are two pharmaceutical heavyweights whose stocks tell very different stories.Rahway, New Jersey-based Merck just flashed a Death Cross, signaling potential trouble ahead. Foster City, California-based Gilead is basking in a Golden Cross, a sign of bullish momentum.Merck: Treading On Thin IceMerck, known for its diverse lineup of drugs and vaccines, is seeing its stock wobble. Despite a decent climb of 8.72% over the past year, recent technical signals are turnin ...

Sundry Photography When looking at the last few weeks, we can make statements about Gilead Sciences Inc. (NASDAQ:GILD), which we could seldom make in the last few years. Gilead Sciences not only outperformed the market, but we also had a streak of nine up days in a row. Looking at the last three months, Gilead Sciences performed great and especially since the beginning of July 2024, Gilead Sciences started to outperform the S&P 500 (SPY). Data by YCharts My last article about Gilead Sciences was publish ...