Summary of Gilead Sciences (GILD) 2025 Conference Call Company Overview - **Company**: Gilead Sciences (GILD) - **Focus**: CAR T franchise, specifically the development of a new BCMA CAR T therapy for myeloma Key Points Efficacy and Safety of BCMA CAR T Therapy - **Efficacy Data**: - Average follow-up of 12.6 months shows a high overall response rate of 97% and a complete response (CR) rate of 68% [3][4] - Minimal residual disease (MRD) rate is reported at 93% [3] - **Safety Profile**: - Grade 3 or above CRS or ICANS events are at 1% or less, indicating a favorable safety profile [4][5] - No delayed neurotoxicity, such as parkinsonism or Guillain-Barré syndrome, has been observed [5][6] Manufacturing and Production - **Manufacturing Facilities**: - Three manufacturing facilities are operational, with production for clinical trials occurring at the Maryland facility [7][8] - Aiming for 96% reliability in turnaround times comparable to existing products like Yescarta and TACARTIS [9][15] - **Tech Transfer**: - Successful tech transfer with no reported issues, allowing for efficient production processes [16][18] Market Opportunity and Patient Access - **Target Population**: - Launching into the fourth-line plus population for myeloma, where currently only 10% of eligible patients receive CAR T therapy [20][21] - Emphasis on outpatient therapy to increase patient access, as 90% of myeloma patients are treated in community settings [21][22] - **Authorized Treatment Centers**: - Currently have 555 authorized treatment centers globally, with plans for expansion by the time of product launch in 2026 [25] Competitive Landscape - **Market Challenges**: - Facing competition from new entrants in the CAR T space and T cell engagers, leading to a 22% decline in the TACARTICE franchise [29] - Despite challenges, lymphoma segment grew by 2% [30] Future Developments - **New Constructs**: - Development of bisistronic constructs targeting CD19 and CD20, with a focus on improving efficacy and safety [40][42] - Plans to expand into autoimmune diseases and solid tumors, with ongoing studies in conditions like lupus and glioblastoma [50][52] Regulatory and Data Expectations - **Regulatory Strategy**: - Engaging with regulatory agencies for the submission of data from ongoing studies, including the IMGIGN-one trial [13] - **Upcoming Data Releases**: - Anticipated data presentations at ASCO and EHA, including updates on new constructs and manufacturing improvements [38][52] Additional Insights - **Patient-Centric Approach**: - Emphasis on reaching patients in community settings and exploring outpatient treatment options to alleviate hospital capacity issues [22][24] - **Innovative Manufacturing Techniques**: - Implementation of automation and rapid sterility testing to enhance production efficiency [34][36] This summary encapsulates the critical insights from the Gilead Sciences conference call, highlighting the company's strategic focus on CAR T therapies, manufacturing capabilities, market opportunities, and future developments.

Core Insights - Gilead Sciences is focused on executing its strategy to drive top-line growth while maintaining operational discipline and advancing its pipeline [2] Group 1: Company Operations - Gilead is managing its operations amidst changing macroeconomic conditions, including potential impacts from MFN, tariffs, and IRA [2] - The company has a small team dedicated to scenario planning to navigate the fluid market environment [2]

Gilead Sciences (GILD) 2025 Conference May 13, 2025 02:20 PM ET Speaker0 For joining us, I'm Tim Anderson, the US large cap pharma and biotech analyst of Bank of America, and excited to have Gilead with us today, specifically Joanna Mercer, who serves as the company's Chief Commercialization Officer overseeing the global commercialization of the company's medicines across really all areas. She's been with the company since 2019. Prior to Gilead, I think twenty five years at Bristol Myers, so quite a long ti ...

Financial Performance - Total revenues for Q1 2025 were $6,667 million, a slight decrease of 0.3% compared to $6,686 million in Q1 2024[15] - Product sales amounted to $6,613 million in Q1 2025, down from $6,647 million in Q1 2024, reflecting a decrease of 0.5%[15] - Net income for Q1 2025 was $1,315 million, a significant recovery from a net loss of $4,170 million in Q1 2024[15] - Operating income for Q1 2025 was $2,237 million, compared to an operating loss of $4,322 million in the same period last year[15] - Basic earnings per share attributable to Gilead for Q1 2025 was $1.06, a recovery from a loss of $3.34 per share in Q1 2024[15] - Gilead's income before income taxes for Q1 2025 was $1,649 million, compared to a loss of $4,486 million in Q1 2024[86] Cash Flow and Investments - Cash provided by operating activities for the three months ended March 31, 2025, was $1,757 million, down from $2,219 million in the same period of 2024[24] - Net cash used in investing activities was $415 million for Q1 2025, compared to $2,207 million in Q1 2024, indicating a reduction in cash outflow[24] - The company reported a net cash used in financing activities of $3,426 million for Q1 2025, an increase from $1,361 million in Q1 2024[24] - Cash and cash equivalents at the end of the period were $7,926 million, up from $4,718 million at the end of Q1 2024[24] - Total cash and cash equivalents at the beginning of the period were $9,991 million, reflecting a strong liquidity position[24] Assets and Liabilities - Total current assets decreased to $16,901 million as of March 31, 2025, down from $19,173 million as of December 31, 2024[13] - Total assets decreased to $56,434 million as of March 31, 2025, compared to $58,995 million as of December 31, 2024[13] - Long-term debt decreased to $22,146 million as of March 31, 2025, down from $24,896 million as of December 31, 2024[13] - As of March 31, 2025, total debt, net amounted to $24,952 million, a decrease from $26,710 million as of December 31, 2024[69] - The company repaid $1.75 billion of principal balance related to senior unsecured notes due at maturity in February 2025[70] Research and Development - Research and development expenses decreased to $1,379 million in Q1 2025 from $1,520 million in Q1 2024, a reduction of approximately 9.3%[15] - A partial impairment charge of $2.4 billion was recorded for certain acquired in-process research and development assets during the three months ended March 31, 2024[38] - A partial impairment charge of $2.4 billion was recognized for the NSCLC IPR&D intangible asset due to a failed Phase 3 study[58] Legal and Regulatory Matters - The company intends to vigorously defend against various lawsuits, including those related to product liability involving approximately 22,000 active plaintiffs[79] - The company is involved in litigation with generic manufacturers regarding the exclusivity of its products, which could significantly impact revenues[73] - The company has approximately $220 million in accruals for legal matters as of March 31, 2025, down from $242 million as of December 31, 2024[72] - A settlement agreement was reached in April 2025 with the U.S. Attorney's Office for the Southern District of New York related to a government investigation[80] - The company accrued approximately $200 million for a settlement with the U.S. Attorney's Office for the Southern District of New York in April 2025[72] Segment Performance - Product sales in the HIV segment totaled $4,587 million for Q1 2025, up from $4,342 million in Q1 2024, representing an increase of 5.6%[29] - The company recognized $54 million in royalty, contract, and other revenues for Q1 2025, compared to $39 million in Q1 2024[29] Expenses - Selling and marketing expenses increased to $753 million in Q1 2025 from $743 million in Q1 2024, while general and administrative expenses decreased to $505 million from $632 million[89] - Gilead's total selling, general, and administrative expenses for Q1 2025 were $1,258 million, down from $1,375 million in Q1 2024[89] - Other (income) expense, net reported a loss of $328 million in Q1 2025, compared to a gain of $91 million in Q1 2024[68] Tax Matters - The effective tax rate for Q1 2025 was 20.2%, up from 7.0% in Q1 2024, primarily due to tax benefits from stock-based compensation and adjustments[86][87] - The company is currently under examination by the IRS for tax years 2019 to 2021, which may lead to disputes regarding tax deductions and income allocations[88] - Gilead's effective income tax rate in Q1 2024 was impacted by $3.9 billion of non-deductible acquired IPR&D expenses related to the acquisition of CymaBay[87] Other Financial Metrics - Unrealized losses related to equity securities amounted to $436 million for the three months ended March 31, 2025, compared to $15 million in the same period of 2024[44] - The fair value of the contingent consideration liability related to the acquisition of MYR GmbH increased to $216 million as of March 31, 2025, from $206 million at the beginning of the period[36] - The total estimated fair value of senior unsecured notes was $21.886 billion as of March 31, 2025, down from $23.335 billion at the end of 2024[39] - The liability related to future royalties from the acquisition of Immunomedics, Inc. was approximately $0.9 billion as of March 31, 2025[40] Acquisitions and Investments - Gilead made a $250 million upfront payment to LEO Pharma for a strategic partnership to develop STAT6 programs, with potential additional milestone payments of up to $1.5 billion[54] - Gilead acquired approximately 15.2 million additional shares of Arcus for $320 million, increasing its stake to approximately 30%[55] - The acquisition of CymaBay Therapeutics, Inc. was completed for total consideration of $3.9 billion in March 2024[51] Subsequent Events - There were no subsequent events or transactions to disclose beyond those already mentioned in the financial statements[90]

Core Viewpoint - Gilead Sciences, Inc. reported lower-than-expected first-quarter 2025 results, with adjusted earnings per share (EPS) of $1.81 and total revenues of $6.7 billion, both missing consensus estimates [1][2] Group 1: Financial Performance - Adjusted EPS of $1.81 missed the Zacks Consensus Estimate by a penny, while the previous year reported a loss per share of $1.32 [1] - Total revenues of $6.7 billion were flat year over year and missed the Zacks Consensus Estimate of $6.8 billion [1] - Key drugs Biktarvy and Trodelvy missed sales expectations, leading to a decline in stock price post-announcement [2] Group 2: HIV Portfolio Strength - Gilead's HIV product sales contributed $4.6 billion in the first quarter, with Biktarvy sales increasing 7% year over year to $3.15 billion despite missing estimates [4] - Biktarvy holds over 51% market share in the U.S. treatment market, indicating strong momentum [5] - The pipeline candidate lenacapavir showed 100% efficacy for HIV prevention in women, with FDA priority review expected by June 19, 2025 [6][7] Group 3: Liver Disease Portfolio - FDA approval of seladelpar for primary biliary cholangitis (PBC) strengthens Gilead's liver disease portfolio, with initial uptake being encouraging [8] Group 4: Oncology Business Challenges - Gilead's oncology portfolio faces competitive pressures, particularly in the Cell Therapy franchise and breast cancer drug Trodelvy, which saw lower-than-expected sales [10] - Potential launches of anito-cel and Trodelvy in 2026 may bolster the oncology business [11] Group 5: Stock Performance and Valuation - Gilead's shares have gained 13.6% year to date, outperforming the industry and S&P 500 [12] - The stock trades at a price/earnings ratio of 12.80x forward earnings, lower than the large-cap pharma industry's average of 15.77x [15] - The bottom-line estimate for 2025 has slightly decreased to $7.91, while the estimate for 2026 has increased to $8.69 [16] Group 6: Strategic Outlook - Gilead's continuous innovation in the HIV portfolio and strategic acquisitions are seen as positive for long-term growth [19][20] - The company maintains a strong cash position of $7.9 billion as of March 31, 2025, supporting a sustainable dividend yield of 2.97% [21]

Gilead Sciences (GILD) has been one of the most searched-for stocks on Zacks.com lately. So, you might want to look at some of the facts that could shape the stock's performance in the near term.Shares of this HIV and hepatitis C drugmaker have returned -6.4% over the past month versus the Zacks S&P 500 composite's -0.2% change. The Zacks Medical - Biomedical and Genetics industry, to which Gilead belongs, has lost 6.2% over this period. Now the key question is: Where could the stock be headed in the near t ...

Core Points - Gilead Sciences has agreed to pay $202 million to settle claims of using speaker programs to provide kickbacks to doctors for prescribing its HIV medications [1][2] - The funds were reportedly used for honoraria payments, meals, and travel expenses for doctors participating in these programs [1][3] - The U.S. Attorney's Office stated that Gilead unlawfully sought to increase sales of its HIV drugs through these kickbacks [2][3] Financial Implications - Gilead spent tens of millions of dollars on these speaker programs, including over $20 million specifically on speaking fees [3] - Additional costs included millions spent on meals, alcohol, and travel, all aimed at incentivizing doctors to prescribe Gilead's HIV drugs [3]

Core Insights - Gilead Sciences reported a mixed first quarter, with a revenue of $6.67 billion, remaining flat compared to the same quarter of 2024, leading to a decline in share price by over 2% [1][2][4] Revenue Performance - The revenue of $6.67 billion was attributed to declines in sales of the COVID drug Veklury and oncology products, which were offset by improvements in liver disease and HIV medications [2] - Analysts had projected revenue of $6.78 billion, indicating that Gilead's performance fell short of expectations [4] Profitability - Gilead achieved a non-GAAP net income of just under $2.3 billion, or $1.81 per share, a significant turnaround from a loss of $1.6 billion in the previous year [3] - The first quarter results were impacted by the acquisition of CymaBay Therapeutics and a $2.4 billion impairment related to a previous deal with Immunomedics [3] Guidance Adjustments - Gilead revised its full-year earnings per share guidance for 2025 to a range of $5.65 to $6.05, down from the previous forecast of $5.95 to $6.35, which disappointed some investors [5] - The adjusted profitability estimate remained unchanged at $7.70 to $8.10 per share, with revenue expectations still set at $28.2 billion to $28.6 billion [5]

Core Viewpoint - Gilead Sciences, Inc. reported disappointing first-quarter 2025 results, with adjusted earnings per share (EPS) of $1.81 and total revenues of $6.7 billion, both missing consensus estimates [1][2][3] Financial Performance - Adjusted EPS of $1.81 missed the Zacks Consensus Estimate by a penny, compared to a loss per share of $1.32 in the same quarter last year [1] - Total revenues of $6.7 billion were flat year over year and missed the Zacks Consensus Estimate of $6.8 billion [1] - Total product sales decreased 1% year over year to $6.6 billion, while excluding Veklury, product sales increased 4% to $6.3 billion [3] Product Sales Breakdown - HIV product sales grew 6% year over year to $4.6 billion, exceeding both the Zacks Consensus Estimate and model estimate of $4.5 billion [3] - Biktarvy sales increased 7% year over year to $3.15 billion but missed the Zacks Consensus Estimate of $3.2 billion [4] - Descovy sales surged 38% year over year to $586 million, beating the Zacks Consensus Estimate of $479 million [5] - Liver Disease portfolio sales rose 3% to $758 million, driven by higher demand for HBV and HDV drugs [6] - Veklury sales plummeted 45% to $302 million, missing the Zacks Consensus Estimate of $387 million [7] - Cell Therapy product sales decreased 3% to $464 million, missing the Zacks Consensus Estimate of $491 million [7] Cost and Margin Analysis - Adjusted product gross margin slightly increased to 85.5% from 85.4% in the year-ago quarter [11] - Research and development expenses totaled $1.3 billion, down from $1.4 billion in the previous year [11] - SG&A expenses amounted to $1.2 billion, down from $1.3 billion [11] Dividend and Guidance - Gilead declared a quarterly dividend of $0.79 per share for Q2 2025, payable on June 27, 2025 [12] - The company reiterated its 2025 guidance, projecting product sales between $28.2 billion and $28.6 billion, with adjusted EPS anticipated in the range of $7.70-$8.10 [13] Pipeline Updates - The FDA accepted new drug application submissions for lenacapavir for HIV prevention, with a target action date of June 19, 2025 [14] - Gilead received conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis [14] Overall Performance Assessment - Gilead's first-quarter results were disappointing, particularly due to a decline in oncology drugs affecting revenue growth [15] - Despite challenges, Biktarvy maintained its dominant position in the HIV market, and Descovy showed strong performance [15] - The potential approval of lenacapavir could further strengthen Gilead's HIV franchise amid increasing competition [16]

Financial Data and Key Metrics Changes - The base business, excluding Veclury, grew 4% year over year, primarily driven by growth in the HIV business [6][50] - Total product sales, including Veclury, were down by 1% from last year, reflecting fewer COVID-19 related hospitalizations [8][50] - Non-GAAP diluted EPS was $1.81, with a product gross margin flat year over year at 85% [52][54] Business Line Data and Key Metrics Changes - HIV sales were up 6% year over year, with Biktarvy sales increasing by 7% [7][22] - Livedelzi achieved first-quarter sales of $40 million, reflecting early momentum in its launch [27] - Veclury sales were down 45% year over year, reflecting lower rates of COVID-19 related hospitalizations [28] - Trodelvy sales were down 5% year over year, impacted by inventory dynamics and lower average realized price [29][98] - Cell therapy sales were down 3% year over year, with Yescarta sales up 2% year over year [31] Market Data and Key Metrics Changes - The HIV treatment market continues to grow at an expected rate of 23% annually [22] - Descovy sales increased by 38% year over year, driven by higher average realized price and demand [23][78] - The liver disease segment saw sales of $758 million, up 3% year over year [26] Company Strategy and Development Direction - The company is focused on multiple upcoming launches, including lenacapavir, anetocel, and Trodelvy [13][34] - Gilead Sciences, Inc. has no major loss of exclusivity (LOE) until the end of 2033, positioning itself for top-line growth across therapeutic areas [14] - The company is increasing investment in US manufacturing and R&D infrastructure [15][89] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA decision on lenacapavir for PrEP, with a potential launch immediately following [9][38] - The company remains well-positioned to adapt to potential policy outcomes in the US [14] - Management noted that the first quarter was lighter than expected but emphasized the variability of the business [54][93] Other Important Information - Gilead Sciences, Inc. received an upgrade in its long-term debt rating from BBB+ to A- [58] - The company returned $1.7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases [58] Q&A Session Summary Question: Expectations for lenacapavir for PrEP and reimbursement dynamics - Management is excited about the upcoming PDUFA date and expects around 75% access within the first six months post-launch, reaching about 90% at the twelve-month mark [62] Question: Impact of HHS and CDC cuts on launch dynamics - Management has not seen anything that would alter plans for the lenacapavir launch and is actively engaging with policymakers [68] Question: Implications of COVID-19 on Descovy and lenacapavir - Descovy saw a 38% growth year over year, driven by market development initiatives, which supports the opportunity for lenacapavir [78] Question: Tariff risks and US market supply - Management indicated that the majority of Gilead's IP is in the US, which suggests lower value for pharmaceutical imports, and they have invested significantly in US manufacturing [86][89] Question: Cannibalization of Descovy by lenacapavir - Management believes lenacapavir will attract both switch patients from daily orals and naive patients, potentially accelerating market growth [124]