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Gilead Sciences (NasdaqGS:GILD) 2025 Conference Transcript
2025-11-19 15:02
Summary of Gilead Sciences Conference Call Company Overview - **Company**: Gilead Sciences (NasdaqGS:GILD) - **Event**: Jefferies Healthcare London Conference - **Date**: November 19, 2025 Key Points Industry and Company Performance - Gilead has experienced significant growth in its base business over the past three years, with base revenues (excluding COVID antiviral) growing 7% in 2023 and 5% in the current year despite a $1.1 billion headwind from Medicare Part D reform, indicating a potential 9%-10% growth in the base business [3][4] - The company has diversified its portfolio into virology, HIV, oncology, and inflammation, with a notable increase in R&D spending, which has more than doubled since 2016 [2][3] Capital Allocation and M&A Strategy - Gilead is focused on building a commercial infrastructure around assets rather than pursuing bolt-on acquisitions, with an annual business development budget of over $1 billion for partnerships and small acquisitions [5][6] - Recent acquisitions include a STAT6 degrader for inflammation and an in vivo cell therapy company, Interius, for a couple hundred million dollars [6] - The company is prioritizing late-stage, de-risked assets that synergize with its existing commercial infrastructure, with no major patent cliffs until 2036 [7][8] Market Dynamics and Opportunities - Gilead is increasingly looking to China for partnerships and acquisitions, with over half of its business development priorities for 2025 coming from Chinese companies, a significant increase from 5% five years ago [9][10] - The launch of Yeztugo, a long-acting HIV prevention drug, is underway, with $54 million in sales reported and guidance of nearly $100 million for the fourth quarter [11][14] - The HIV prevention market is transitioning from daily oral medications to long-acting injectables, with over 75% of covered lives having unrestricted access to Yeztugo [15][16] Product Launch and Market Potential - Yeztugo is positioned to open a new chapter in HIV prevention, with groundbreaking studies showing 100% and 99.9% prevention rates in different populations [12][13] - The CDC has recently doubled its estimates for the addressable PrEP market from 1.2 million to 2.2 million, indicating significant growth potential [33] - Gilead expects the market to be split 50% oral and 50% injectables by 2030, with ongoing development of a once-yearly injectable version of Yeztugo [32][35] Future Pipeline and Innovations - Gilead is advancing multiple late-stage trials in its HIV treatment portfolio, including a new daily combination regimen and a six-month infusion treatment for patients not controlled on existing therapies [38][41] - The company is also developing anito-cel, a BCMA cell therapy for multiple myeloma, with plans to file for approval by the end of 2025 and launch by late 2026 [44][46] Manufacturing and Competitive Advantage - Gilead has built a robust manufacturing infrastructure for cell therapies, with the capacity to treat up to 24,000 patients by 2026, providing a competitive edge in reliability and speed compared to competitors [46][47] Additional Insights - The company emphasizes the importance of adherence in HIV prevention, noting that long-acting injectables guarantee adherence, which is a significant advantage over daily oral medications [36] - Gilead's approach to market growth is characterized by steady, durable, and consistent growth rather than rapid spikes, reflecting a long-term strategy for its product launches [27][28]
GILD's Investigational Regimen for HIV Treatment Meets Primary Goal
ZACKS· 2025-11-14 14:16
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]
HIV, Livdelzi Fuel GILD's Q3 Top Line Amid Cell Therapy Sales Decline
ZACKS· 2025-11-04 14:41
Core Insights - Gilead Sciences, Inc. (GILD) reported a 3% year-over-year growth in total revenues for Q3 2025, driven by higher royalty, contract, and other revenues, alongside strong product sales from its HIV franchise and liver disease drug Livdelzi [1][10] Revenue Breakdown - Total revenues include product sales and royalty, contract, and other revenues [1] - Excluding Veklury, product sales increased by 4% to $7.1 billion [2] HIV Franchise Performance - Gilead's HIV franchise remains strong, with flagship therapies Biktarvy and Descovy contributing significantly to revenue growth [3] - Biktarvy sales rose 6% year-over-year to $3.7 billion, capturing over 52% of the U.S. treatment market [4] - Descovy sales increased by 20% year-over-year to $701 million, with approximately 75% of sales for HIV prevention [6] - Newly approved Yeztugo generated $39 million in sales, achieving a 75% coverage goal ahead of schedule [7] - Gilead anticipates approximately 5% HIV revenue growth in 2025, despite challenges from Medicare Part D redesign [7] Liver Disease Portfolio - Sales from the liver disease portfolio increased by 12% to $819 million, primarily due to demand for Livdelzi [9] - Livdelzi surpassed $100 million in quarterly sales for the first time and is now the first-line treatment for second-line PBC in the U.S. [10][11] Cell Therapy Franchise - Sales from the Cell Therapy franchise decreased by 11% to $432 million, missing consensus estimates [12] - Yescarta sales fell by 10% to $349 million, while Tecartus sales decreased by 15% to $83 million due to lower demand [12] Overall Performance and Market Position - Despite declines in Veklury and Cell Therapy sales, the strong performance of the HIV franchise and Livdelzi supports future growth [10][14] - Gilead's shares have surged 32.2% year-to-date, outperforming the industry growth of 12.1% [14]
Gilead's HIV Drugs Power Earnings Beat, Company Eyes Multiple Launches By 2026
Benzinga· 2025-10-31 17:41
Core Insights - Gilead Sciences Inc reported adjusted earnings of $2.47 per share, surpassing the consensus estimate of $2.13 [1] - The company achieved revenues of $7.77 billion, exceeding the consensus of $7.45 billion, despite a 2% decline in product sales to $7.3 billion [2] Financial Performance - HIV product sales increased by 4% to $5.3 billion, while liver disease portfolio sales rose by 12% to $819 million [3] - Biktarvy sales grew by 6% to $3.7 billion, and Descovy revenues surged by 20% to $701 million [3] Guidance and Outlook - Gilead raised its fiscal 2025 adjusted earnings guidance from $7.95-$8.25 per share to $8.05-$8.25, compared to the consensus of $8.03 [4] - The sales guidance was also increased from $28.3 billion-$28.7 billion to $28.4 billion-$28.7 billion, exceeding the consensus of $28.84 billion [4] Analyst Ratings - Needham reiterated its Buy rating for Gilead with a price forecast of $133, highlighting upcoming catalysts related to HIV treatment and cell therapy [5] - Cantor Fitzgerald maintained an Overweight rating with a price forecast of $135, while RBC Capital raised its price forecast from $100 to $105 [6] Market Performance - Gilead Sciences shares were up 0.29% at $118.78 at the time of publication [6]
Is Wall Street Bullish or Bearish on Gilead Sciences Stock?
Yahoo Finance· 2025-10-31 09:44
Valued at $147.4 billion by market cap, Gilead Sciences, Inc. (GILD) is a leading U.S. biopharmaceutical company headquartered in Foster City, California. The company specializes in treatments for HIV/AIDS, hepatitis B and C, COVID-19, and other serious infectious diseases, along with oncology and inflammatory diseases as growing focus areas. Shares of this HIV giant have outperformed the broader market over the past year. GILD has gained 34.2% over this time frame, while the broader S&P 500 Index ($SPX) ...
Gilead(GILD) - 2025 Q3 - Earnings Call Transcript
2025-10-30 21:30
Financial Data and Key Metrics Changes - The company reported third quarter product sales of $7.3 billion, a 4% increase year over year and a 2% increase sequentially, driven by strength across the HIV portfolio, offset by lower oncology revenue [11][42] - Non-GAAP EPS grew 22% year over year, with a 10% increase excluding a $0.25 benefit from a non-recurring accounting item [5][43] - The company raised its full-year HIV revenue growth expectations to approximately 5%, up from 3% previously, despite a $900 million headwind from Medicare Part D redesign [5][46] Business Line Data and Key Metrics Changes - HIV sales reached $5.3 billion, representing a 4% growth year over year, primarily driven by higher demand and favorable inventory dynamics [12] - Biktarvy sales were $3.7 billion, up 6% year over year, achieving a record market share of approximately 52% in the U.S. [12][13] - Descovy sales increased to $701 million, a 20% year over year growth, with a record market share of over 45% for PrEP [14][15] - Libdelzi contributed to 12% year over year growth in the liver portfolio, exceeding $100 million in quarterly sales for the first time [7][20] Market Data and Key Metrics Changes - The PrEP market grew approximately 14% year over year, with Yes2Go achieving $39 million in third quarter sales and $54 million since its launch [15][18] - The company achieved 75% payer coverage for Yes2Go nearly three months ahead of target, setting a strong foundation for continued growth [6][18] Company Strategy and Development Direction - The company is focused on expanding its HIV portfolio and pipeline, with upcoming updates on next-generation HIV treatments expected before the end of the year [6][9] - The company plans to launch Trodelvy for first-line metastatic triple-negative breast cancer in 2026, following positive clinical trial results [8][34] - The company is actively seeking additional business development opportunities across liver disease and oncology [70][72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the HIV business, citing strong product leadership and an innovative pipeline [6][9] - The company anticipates continued growth driven by strong demand for Biktarvy and Descovy, despite challenges from Medicare Part D redesign [62][64] - Management highlighted the importance of access and reimbursement logistics for Yes2Go, indicating a gradual ramp-up in sales as practices integrate new coverage [76][90] Other Important Information - The company reported a third quarter operating margin of 50%, reflecting disciplined operating expense management [43] - The company returned $1.4 billion to shareholders in the third quarter, including $435 million in share repurchases [49] Q&A Session Summary Question: Insights on Yes2Go patient demographics and demand drivers - Management noted that Yes2Go is attracting a balanced mix of patients switching from existing therapies and new patients, with expectations for continued growth as market awareness increases [52][53] Question: Clarification on Yes2Go sales figures - Management provided context on the $39 million sales figure, indicating that it reflects true demand rather than inventory stocking, with a focus on achieving 75% coverage ahead of schedule [56][57] Question: Discussion on HIV treatment growth despite Medicare Part D impact - Management confirmed that strong growth in the HIV segment is driven by both treatment and prevention, with Biktarvy and Descovy leading the way [62][64] Question: Update on inventory impact for Yes2Go and CVS pricing discussions - Management clarified that there was no significant inventory buy-in during Q3, and discussions with CVS and other payers are ongoing to secure access [66][67] Question: Appetite for additional business development in liver-focused indications - Management expressed interest in pursuing additional late-stage assets in liver disease and other strategic areas, emphasizing a disciplined approach to business development [70][72]
Gilead(GILD) - 2025 Q3 - Earnings Call Presentation
2025-10-30 20:30
Financial Performance - Total product sales excluding Veklury increased by 4% year-over-year to $7.1 billion[8], driven by the strength of the HIV portfolio[8] - Total HIV product sales also increased by 4% year-over-year[8], with Biktarvy up by 6%[8] and Descovy up by 20%[8], and Yeztugo sales of $39 million[8] - Non-GAAP diluted EPS was $2.47, or $2.22 excluding non-recurring revenue[8] - Livdelzi sales grew 35% quarter-over-quarter to $105 million[61] - Veklury sales decreased by 60% year-over-year due to fewer COVID-19 related hospitalizations[60], resulting in $400 million lower sales[60] Product and Pipeline Updates - Yeztugo achieved 75% payer access in the U S [8], with a target of 90% by the end of Q226[8] - The European Commission approved Yeytuo, a twice-yearly injection for HIV prevention[8] - Trodelvy sales increased by 7% year-over-year[8], driven by higher demand[34] - Cell Therapy sales decreased by 11% year-over-year[8] due to competitive headwinds[37] - The company expects HIV business to grow approximately 5% year-over-year, revised from a prior guidance of approximately 3%[17]
Should You Buy, Hold, or Sell GILD Stock Ahead of Q3 Earnings?
ZACKS· 2025-10-29 14:02
Core Insights - Gilead Sciences, Inc. (GILD) is set to report its Q3 2025 results on October 30, with sales and earnings estimates of $7.46 billion and $2.15 per share respectively [1][7] - Earnings estimates for 2025 and 2026 have seen slight declines, with 2025 dropping from $8.09 to $8.07 and 2026 from $8.53 to $8.50 over the past month [1][2] Financial Performance - GILD has a strong earnings surprise history, beating estimates in three of the last four quarters with an average surprise of 11.04% [4][5] - The earnings estimate for Q3 2025 is $2.15 per share, consistent over the past 30 days, while the earnings surprise prediction is currently at -1.34% [8][2] Product Performance - The HIV portfolio, particularly Biktarvy and Descovy, continues to drive top-line growth, with Q3 sales estimates of $3.6 billion for Biktarvy and $629 million for Descovy [9][10] - The recent FDA approval of lenacapavir (Yeztugo) is expected to enhance Gilead's HIV franchise, with projected growth in HIV sales of approximately 3% in 2025 [11][22] Market Dynamics - Gilead's liver disease portfolio, including Livdelzi, is expected to perform well despite some challenges in hepatitis C virus sales [12][14] - Cell Therapy product sales are anticipated to decline due to competitive pressures, with estimates of $476 million for Q3 [15][23] Stock Performance - GILD shares have increased by 27.7% year-to-date, outperforming the industry average of 10.8% [18][19] - The current price/earnings ratio for GILD is 13.98x, higher than its historical mean but lower than the large-cap pharma industry average of 15.57x [21] Strategic Outlook - Gilead's ongoing innovation in the HIV sector and strategic acquisitions are viewed positively, although the Cell Therapy segment faces challenges [22][26] - The company is collaborating with Merck to evaluate a new HIV treatment, with updates expected in 2026 [27]
Healthy Returns: What to expect from Eli Lilly, Merck, Gilead and AbbVie third-quarter earnings
CNBC· 2025-10-28 14:40
Industry Overview - The pharmaceutical industry is facing challenges including changing drug pricing policies, tariffs, and pressure to increase U.S. manufacturing [2][3] - Investors are particularly focused on potential "most favored nation" drug pricing deals with the Trump administration, following agreements with major companies [3] Company Earnings Preview - **Merck**: Expected to show topline growth driven by demand for immunotherapy Keytruda and new drug launches, though growth may be offset by sluggish sales of Gardasil in China [4] - **Eli Lilly**: Anticipated to report strong results due to growth in diabetes injection Mounjaro and weight loss drug Zepbound, with potential for an increase in full-year guidance [4] - **Bristol Myers Squibb**: Expected to have modest upside, with significant attention on upcoming phase three trial data for Cobenfy in Alzheimer's disease psychosis, which could represent a multi-billion-dollar opportunity [4] - **Gilead**: Core business improvement expected, particularly in the HIV sector, with focus on the launch of the twice-yearly HIV prevention injection Yeztugo and implications of Trump's pricing policy [4] - **AbbVie**: Anticipated to have a solid quarter with improvements in its aesthetics business and continued strength in Skyrizi and Rinvoq, positioning the company to exceed expectations [4]
What's in Store for These 5 Pharma Bigwigs This Earnings Season?
ZACKS· 2025-10-27 16:06
Core Insights - The third-quarter 2025 reporting cycle for the Medical sector is commencing, with major firms expected to release earnings results in the coming weeks, particularly in pharma/biotech and medical devices [1] - Johnson & Johnson has set a positive tone for the earnings season by exceeding estimates and raising its sales expectations for 2025 [1] - Roche has reported solid growth in the first nine months of 2025, driven by high demand for key drugs, leading to an upward revision of its earnings per share growth expectations for 2025 [2] Earnings Trends - As of October 22, 13.3% of Medical sector companies, representing 26.8% of the sector's market capitalization, have reported earnings, with 87.5% exceeding earnings estimates and the same percentage surpassing revenue expectations [3] - Year-over-year earnings increased by 7.4%, while revenues rose by 9.8%. However, third-quarter earnings for the Medical sector are projected to decrease by 4.3%, with sales expected to rise by 8.1% compared to the previous year [3] Company Performance Expectations - Eli Lilly is expected to report strong results driven by demand for GLP-1 drugs and other oncology and immunology products, with a consensus estimate of $16.01 billion in sales and $6.02 per share in earnings [7][8] - Merck is anticipated to see growth from its cancer drug Keytruda, with estimates of $17.06 billion in sales and $2.36 per share in earnings [12] - AbbVie is projected to benefit from sales of Rinvoq, Skyrizi, and newer drugs, with estimates of $15.59 billion in sales and $1.80 per share in earnings [13][14] - Bristol Myers is expected to report revenues influenced by growth portfolio sales, with estimates of $11.83 billion in sales and $1.51 per share in earnings [15][16] - Gilead Sciences is likely to see revenue support from its HIV therapies, with estimates of $7.46 billion in sales and $2.15 per share in earnings, although impacted by changes in Medicare Part D [19][20]