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Gilead's quarterly dividend keeps growing and its HIV cash machine runs hot, but the whole enterprise depends on a single blockbuster drug with a patent expiration already penciled onto a calendar a decade out. Here is what that risk actually…

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Income investors own Gilead Sciences (NASDAQ:GILD | GILD Price Prediction) for the check that lands every quarter. That check just got bigger, and the question is whether the biology behind it can keep it coming.

Gilead’s board declared a quarterly dividend of $0.82 per share on July 28, 2026, with an ex-dividend date of September 15, 2026 and a payment date of September 29, 2026. On a trailing twelve month basis, the payout runs to $3.22 per share. With shares closing at $151.22 on September 3, 2026, that translates into a dividend yield of 0.0215 as reported.

The stock itself has already done the heavy lifting for total return this year, rising 24.72% year to date and 37.33% over the past year. For a retiree focused on income, coverage matters more than price.

Coverage and Free Cash Flow: A Well-Funded Payout A quick look at the cash flow statement and the dividend looks fairly comfortable. In fiscal 2025, Gilead generated operating cash flow of $10.019 billion, spent $563 million on capital expenditures, and paid $4.003 billion in dividends. Free cash flow, in other words, covers the payout with room to spare.

GAAP net income for 2024 was only $480 million, hit by a large charge tied to an acquisition. Fiscal 2025 recovered to $8.51 billion in net income on revenue of $29.442 billion. The pattern repeated in the second quarter of 2026, when a $11.2 billion acquired in-process R&D charge from the Arcellx, Tubulis, and Ouro Medicines deals produced a quarterly net loss of $10.496 billion. Strip out the acquisition accounting, and management put underlying non-GAAP diluted EPS for the quarter at $2.27, with an illustrative full-year range of $8.50 to $8.85.

Second-quarter operating cash flow was still $3.573 billion. Gilead returned close to $1.4 billion to shareholders in the quarter, including $355 million in buybacks, and CFO Andrew Dickinson said the company returned roughly 49% of free cash flow to shareholders in the first half. That is the number that matters for dividend safety.

Raise Record: Small, Steady, Predictable Gilead’s quarterly dividend history reads as follows: $0.75 in 2023, $0.77 in 2024, $0.79 in 2025, and $0.82 in 2026. The raises are modest but consistent, which is what a scorecard rewards. This is a compounder that treats the check as a commitment.

Patent Cliffs Explained in Plain English A pharmaceutical dividend is only as durable as the drugs that fund it. Patents give a company a limited window of exclusive sales. When they expire, generic manufacturers enter, prices collapse, and revenue can drop sharply. That drop is called a patent cliff, or loss of exclusivity.

Gilead’s cash flow is concentrated in HIV. Second-quarter HIV sales were $5.7 billion, up 12% year-over-year, and Biktarvy alone contributed $3.8 billion. Concentration risk is real. The offset is time. Following patent settlements, the earliest generic Biktarvy entry has been pushed to April 2036, and no major loss of exclusivity is expected until 2036.

Pipeline: Building the Bridge to the Next Decade PrEP sales doubled year over year and exceeded $1 billion in a quarter for the first time, with a total PrEP business run rate of $4 billion. The twice-yearly Yeztugo prevention therapy is tracking toward approximately $1 billion in full-year sales, and management reported that more than 70% of users returned for their six-month reinjection.

In oncology, Trodelvy revenue reached $457 million in the quarter, up 26% year over year, approaching a $2 billion run rate. Livdelzi in liver disease more than doubled to $167 million. The cell therapy franchise slipped 14% year over year against competition, with NitoCell targeting a PDUFA date of December 23, 2026.

CEO Daniel O’Day framed the strategy directly: “Clearly, our objective is still to diversify the business, but in two different ways, just to clarify. One is within virology, and the second one is outside of virology.”

Balance Sheet After the Deal Wave As of the quarter ended June 30, 2026, Gilead reported cash and short-term investments of $3.179 billion, down from $7.628 billion at the end of the prior quarter. Total debt stood at $26.246 billion, with long-term debt of $23.832 billion. Total shareholder equity dropped to $11.828 billion following the IPR&D writedowns.

Leverage is elevated, but manageable given the operating cash flow profile. Dickinson said Gilead does not currently anticipate pursuing additional sizable M&A transactions during 2026, prioritizing integration.

Risks Worth Naming Out Loud Revenue concentration: HIV drives the profit engine, and Biktarvy drives HIV. Patent expirations: even with the extended runway to 2036, the eventual generic entry is a known event. Clinical and regulatory risk: BicLen, ISLEN, NitoCell, and the Tubulis ADC platform all carry trial and approval risk. Policy and pricing: management cited softer HIV treatment growth after Affordable Care Act tax subsidies were eliminated, and expects a return to 2% to 3% annual growth. Acquisition indigestion: the $11.2 billion in acquired IPR&D charges will keep GAAP earnings noisy. Verdict: Does the Check Keep Clearing? Grade: B+. The 0.0215 yield will not fund a retirement on its own, but the coverage is solid, the raise cadence is reliable, and the patent runway on the core HIV franchise stretches to 2036. Free cash flow of $10.019 billion against dividends of $4.003 billion in 2025 is the kind of cushion income investors want to see, and the whole point of a dividend ladder is never having to sell shares to live off the checks (we walked through how to build one in a free guide here). The pipeline, from Yeztugo to Trodelvy to NitoCell, is doing the work required to replace HIV revenue when the cliff eventually arrives.

For a retiree asking whether the check keeps clearing, the answer is yes. Gilead’s dividend is dependable.

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Key Takeaways Gilead won EU approval for Trodelvy plus Keytruda in first-line metastatic TNBC with PD-L1 expression.Trodelvy cut disease progression or death risk by 35% versus chemotherapy plus Keytruda in ASCENT-04.Trodelvy sales rose 26% to $457 million in Q2, driven by stronger demand across breast cancers. Gilead Sciences, Inc.  (GILD - Free Report) recently announced that the European Commission (EC) has approved label expansion of the breast cancer drug Trodelvy (sacituzumab govitecan-hziy).

The EC granted marketing authorization to Trodelvy in combination with Merck’s (MRK - Free Report) Keytruda (pembrolizumab) for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10).

Trodelvy, a first-in-class Trop-2-directed antibody-drug conjugate (ADC), is already approved in several countries for second-line or later metastatic TNBC and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC).

Per GILD, Trodelvy plus Keytruda is the first and only ADC plus immunotherapy combination to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.

Shares of GILD have gained 20.4% year to date compared with the industry’s growth of 10.7%.

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More on EC’s Latest Label Expansion of GILD’s TrodelvyThe latest EC approval is based on positive results from the late-stage ASCENT-04/KEYNOTE-D19 study, which showed a statistically significant and clinically meaningful improvement in progression-free survival with Trodelvy plus Keytruda compared with standard-of-care chemotherapy plus Keytruda as a first-line treatment. In the study, Trodelvy reduced the risk of disease progression or death by 35% in patients with PD-L1-positive metastatic TNBC.

The latest decision follows the EC’s recent approval of Trodelvy as a monotherapy for adults with unresectable, locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are not eligible for PD-1 or PD-L1 inhibitor treatment.

Together, the approvals position Trodelvy as a potential backbone therapy for first-line metastatic TNBC in Europe, regardless of PD-L1 status. The expanded indication offers a new treatment option for patients with this aggressive form of breast cancer at the onset of metastatic disease.

Trodelvy is also approved in first-line mTNBC in the United States, either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Keytruda (pembrolizumab) or Keytruda Qlex (subcutaneous injection of Keytruda) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.

The drug is currently being evaluated in multiple ongoing late-stage studies across a range of tumor types with high Trop-2 expression, including lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

Merck and Gilead Sciences had earlier announced discontinuation of the phase III KEYNOTE-D46/EVOKE-03 study evaluating Trodelvy in combination with Keytruda as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (TPS ≥50%).

GILD’s Efforts to Diversify Revenue BaseThe recent label expansions are expected to strengthen Trodelvy's commercial opportunity and reinforce its position as a key growth driver within Gilead's oncology portfolio.

Trodelvy sales increased 26% year over year to $457 million in the second quarter, driven by stronger demand across triple-negative and previously treated HR-positive/HER2-negative metastatic breast cancer.

GILD is looking to strengthen its oncology franchise and diversify its revenue base, which is highly concentrated on HIV business.

Gilead’s recent aggressive dealmaking strategy, including the acquisitions of Arcellx and Tubulis, underscores its commitment to diversifying beyond its core HIV franchise and expanding into higher-growth oncology and immunology markets.

Gilead recently delivered a strong second quarter, with both earnings and revenues exceeding expectations. The HIV franchise remains the principal growth engine, supported by Biktarvy's durability and rapid expansion of the prevention business.
Descovy and Yeztugo’s strong performance is boosting the top-line growth. Per GILD, Yeztugo has quickly become the leading long-acting PrEP option for new patient starts.

Approval of additional better treatments should bolster GILD’s HIV franchise in the wake of increasing competition from the likes of GSK plc (GSK - Free Report) .

HIV sales account for a major chunk of GSK’s Specialty Medicines portfolio. GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato. The solid growth from these drugs has helped GSK combat the decline in Triumeq sales.

GILD’s Zacks Rank

The U.S. Food and Drug Administration ‌has approved Gilead Sciences' (GILD.O) once-daily oral combination pill for treatment of adults whose HIV infection has already been reduced to very low levels, the company said on Thursday.

The drug, branded Bixlenvo, combines Gilead's ​HIV medicines bictegravir and lenacapavir.

The wholesale acquisition cost for a 30-day supply of ​Bixlenvo is $4,595, a Gilead spokesperson told Reuters.

Bictegravir, the key component of ⁠the blockbuster treatment Biktarvy, is a widely recommended HIV drug with a high barrier ​to resistance.

Lenacapavir, marketed as Sunlenca for HIV treatment and as Yeztugo for HIV prevention, ​is a capsid inhibitor that targets the virus's protective shell to disrupt its multiplication.

Patients must take an initial two-day dose of Sunlenca, before taking Bixlenvo once daily. Gilead expects Bixlenvo to become available ​within days of approval.

The human immunodeficiency virus (HIV) attacks the body's immune system. Without treatment, ​it can lead to AIDS. There is currently no effective cure.

"The main advantage of this combination is ‌that ⁠it potentially offers a simpler option, in terms of pill burden, to patients who might currently be on more complex regimens due to a history of drug resistant virus," said Monika Shah, an infectious disease specialist at Memorial Sloan Kettering Cancer Center.

The approval ​was based on two ​late-stage studies in ⁠which Bixlenvo was as effective as complex multi-pill regimens or Biktarvy in keeping the virus suppressed after 48 weeks.

Bixlenvo is part of ​Gilead's multi-year strategy to expand its HIV portfolio, grounded in ​lenacapavir, Jared ⁠Baeten, the company's head of clinical development for virology, told Reuters. About 5% of people living with HIV in the United States take complex regimens involving more than one tablet ⁠a day, ​Baeten said.

The combination enters a competitive HIV-treatment market ​that includes Merck's (MRK.N) Idvynso, a once-daily two-drug pill approved in April for certain adults whose HIV-1 is already suppressed.

BNP Paribas boosted its position in shares of Gilead Sciences, Inc. (NASDAQ:GILD – Free Report) by 20.7% during the second quarter, according to its most recent disclosure with the Securities & Exchange Commission. The institutional investor owned 118,671 shares of the biopharmaceutical company’s stock after buying an additional 20,329 shares during the period. BNP Paribas’ holdings in Gilead Sciences were worth $14,992,000 at the end of the most recent quarter.

Other large investors have also recently bought and sold shares of the company. BlackRock Inc. bought a new stake in Gilead Sciences during the 2nd quarter valued at $15,393,785,000. State Street Corp raised its holdings in shares of Gilead Sciences by 1.9% in the 4th quarter. State Street Corp now owns 60,240,518 shares of the biopharmaceutical company’s stock valued at $7,393,921,000 after acquiring an additional 1,151,213 shares in the last quarter. Price T Rowe Associates Inc. MD lifted its position in Gilead Sciences by 4.5% in the 4th quarter. Price T Rowe Associates Inc. MD now owns 27,698,660 shares of the biopharmaceutical company’s stock worth $3,399,734,000 after buying an additional 1,195,269 shares during the last quarter. Bank of America Corp DE grew its stake in shares of Gilead Sciences by 15.2% during the fourth quarter. Bank of America Corp DE now owns 23,121,620 shares of the biopharmaceutical company’s stock valued at $2,837,948,000 after buying an additional 3,046,688 shares during the last quarter. Finally, Norges Bank purchased a new stake in Gilead Sciences in the 4th quarter worth approximately $2,617,152,000. 83.67% of the stock is currently owned by institutional investors.

Insiders Place Their Bets In related news, Director Anthony Welters sold 18,000 shares of the business’s stock in a transaction that occurred on Wednesday, August 26th. The stock was sold at an average price of $148.62, for a total transaction of $2,675,160.00. Following the transaction, the director directly owned 12,894 shares of the company’s stock, valued at approximately $1,916,306.28. The trade was a 58.26% decrease in their position. The transaction was disclosed in a legal filing with the SEC, which is accessible through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CEO Daniel Patrick O’day sold 15,000 shares of the firm’s stock in a transaction that occurred on Monday, August 3rd. The stock was sold at an average price of $130.31, for a total transaction of $1,954,650.00. Following the sale, the chief executive officer directly owned 592,133 shares of the company’s stock, valued at $77,160,851.23. The trade was a 2.47% decrease in their position. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last quarter, insiders have sold 105,000 shares of company stock valued at $14,238,120. 0.30% of the stock is currently owned by insiders.

Wall Street Analysts Forecast Growth A number of analysts recently commented on the company. Daiwa Securities Group reduced their price objective on Gilead Sciences from $161.00 to $150.00 and set an “outperform” rating for the company in a research report on Tuesday, May 19th. Leerink Partners lowered Gilead Sciences from an “outperform” rating to a “market perform” rating and dropped their target price for the company from $146.00 to $127.00 in a research report on Tuesday, July 21st. Needham & Company LLC reaffirmed a “buy” rating and issued a $170.00 price objective on shares of Gilead Sciences in a research note on Wednesday, August 5th. Morgan Stanley cut their price objective on shares of Gilead Sciences from $166.00 to $165.00 and set an “overweight” rating on the stock in a report on Monday, July 27th. Finally, HSBC upgraded Gilead Sciences from a “hold” rating to a “buy” rating and upped their price objective for the stock from $133.00 to $155.00 in a research report on Monday, July 6th. Twenty-four investment analysts have rated the stock with a Buy rating and five have given a Hold rating to the company. Based on data from MarketBeat.com, the company currently has an average rating of “Moderate Buy” and an average target price of $158.04. Get Our Latest Stock Report on GILD

Key Stories Impacting Gilead Sciences Here are the key news stories impacting Gilead Sciences this week:

Positive Sentiment: The FDA approved Bixlenvo, a once-daily single-tablet regimen combining bictegravir and lenacapavir for virologically suppressed adults with HIV. It is the first and only single-tablet option for patients on complex regimens who cannot use currently available alternatives, potentially expanding Gilead’s HIV franchise and supporting its longer-term lenacapavir strategy. Reuters FDA approval article Positive Sentiment: The European Commission approved Trodelvy plus Keytruda for certain first-line metastatic triple-negative breast cancer patients, strengthening Gilead’s oncology portfolio and adding a potential growth opportunity outside its core HIV business. EU Trodelvy approval article Neutral Sentiment: Analysts remain broadly constructive, with a consensus “Moderate Buy” rating and an average price target of approximately $158. However, GILD’s strong multi-year advance may have raised expectations and limited the immediate upside from the Bixlenvo approval. Gilead valuation article Negative Sentiment: Director Anthony Welters sold 18,000 shares worth about $2.68 million, reducing his position by roughly 58%. The sale occurred under a pre-arranged Rule 10b5-1 plan, making it a limited bearish signal, but it may still weigh modestly on investor sentiment. SEC insider transaction filing Gilead Sciences Trading Down 2.1% Shares of GILD stock opened at $145.68 on Friday. The company has a 50 day moving average price of $134.25 and a 200 day moving average price of $136.62. The stock has a market capitalization of $180.64 billion, a P/E ratio of -54.56 and a beta of 0.32. Gilead Sciences, Inc. has a fifty-two week low of $108.46 and a fifty-two week high of $157.29. The company has a debt-to-equity ratio of 2.03, a quick ratio of 1.09 and a current ratio of 1.27.

Gilead Sciences (NASDAQ:GILD – Get Free Report) last released its quarterly earnings data on Monday, August 3rd. The biopharmaceutical company reported ($6.75) earnings per share for the quarter, topping analysts’ consensus estimates of ($7.25) by $0.50. The company had revenue of $7.80 billion for the quarter, compared to analysts’ expectations of $7.40 billion. Gilead Sciences had a negative net margin of 10.64% and a negative return on equity of 2.11%. The firm’s revenue for the quarter was up 10.6% on a year-over-year basis. During the same quarter last year, the company earned $2.01 earnings per share. Equities research analysts predict that Gilead Sciences, Inc. will post -0.5 EPS for the current fiscal year.

Gilead Sciences Announces Dividend The firm also recently disclosed a quarterly dividend, which will be paid on Tuesday, September 29th. Investors of record on Tuesday, September 15th will be given a $0.82 dividend. The ex-dividend date is Tuesday, September 15th. This represents a $3.28 annualized dividend and a dividend yield of 2.3%. Gilead Sciences’s payout ratio is currently -122.85%.

(Free Report)

Gilead Sciences, Inc, founded in 1987 and headquartered in Foster City, California, is a biopharmaceutical company focused on the discovery, development and commercialization of medicines in areas of high unmet medical need. The company initially built its reputation in antiviral therapies and has since expanded into oncology, cell therapy and inflammatory diseases. Gilead operates a global research and commercial organization, conducting clinical development and selling medicines in markets around the world.

Gilead’s product portfolio is anchored by antiviral therapies for HIV and viral hepatitis.

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Abacus FCF Advisors LLC bought a new stake in Gilead Sciences, Inc. (NASDAQ:GILD – Free Report) during the second quarter, according to the company in its most recent filing with the Securities and Exchange Commission. The institutional investor bought 59,974 shares of the biopharmaceutical company’s stock, valued at approximately $7,577,000.

A number of other hedge funds have also made changes to their positions in GILD. Persistent Asset Partners Ltd purchased a new stake in shares of Gilead Sciences during the second quarter worth $25,000. Strategic Investment Solutions Inc. IL acquired a new stake in shares of Gilead Sciences during the 4th quarter valued at about $25,000. Vermillion & White Wealth Management Group LLC grew its stake in shares of Gilead Sciences by 71.4% in the 4th quarter. Vermillion & White Wealth Management Group LLC now owns 204 shares of the biopharmaceutical company’s stock valued at $25,000 after buying an additional 85 shares in the last quarter. Quattro Advisors LLC acquired a new position in Gilead Sciences in the fourth quarter worth approximately $26,000. Finally, Wealth Preservation Advisors LLC increased its holdings in Gilead Sciences by 60.0% in the fourth quarter. Wealth Preservation Advisors LLC now owns 216 shares of the biopharmaceutical company’s stock worth $27,000 after buying an additional 81 shares during the last quarter. 83.67% of the stock is owned by hedge funds and other institutional investors.

Analysts Set New Price Targets GILD has been the subject of several recent research reports. Truist Financial decreased their target price on shares of Gilead Sciences from $157.00 to $156.00 and set a “buy” rating for the company in a research report on Tuesday, July 7th. Leerink Partners lowered shares of Gilead Sciences from an “outperform” rating to a “market perform” rating and reduced their price objective for the company from $146.00 to $127.00 in a research note on Tuesday, July 21st. Morgan Stanley decreased their price objective on shares of Gilead Sciences from $166.00 to $165.00 and set an “overweight” rating for the company in a report on Monday, July 27th. Royal Bank Of Canada increased their target price on shares of Gilead Sciences from $120.00 to $123.00 and gave the stock a “sector perform” rating in a research report on Wednesday, August 5th. Finally, Daiwa Securities Group cut their target price on Gilead Sciences from $161.00 to $150.00 and set an “outperform” rating on the stock in a report on Tuesday, May 19th. Twenty-four equities research analysts have rated the stock with a Buy rating and five have issued a Hold rating to the company’s stock. According to MarketBeat, the stock has a consensus rating of “Moderate Buy” and an average target price of $158.04.

View Our Latest Research Report on GILD Gilead Sciences Trading Up 2.9% Shares of NASDAQ:GILD opened at $147.60 on Thursday. The company has a debt-to-equity ratio of 2.03, a quick ratio of 1.09 and a current ratio of 1.27. The stock’s 50-day moving average is $131.21 and its 200-day moving average is $136.51. The company has a market cap of $183.02 billion, a P/E ratio of -55.28 and a beta of 0.32. Gilead Sciences, Inc. has a 52-week low of $108.46 and a 52-week high of $157.29.

Gilead Sciences (NASDAQ:GILD – Get Free Report) last announced its earnings results on Monday, August 3rd. The biopharmaceutical company reported ($6.75) earnings per share for the quarter, beating the consensus estimate of ($7.25) by $0.50. The firm had revenue of $7.80 billion during the quarter, compared to the consensus estimate of $7.40 billion. Gilead Sciences had a negative return on equity of 2.11% and a negative net margin of 10.64%.The firm’s revenue for the quarter was up 10.6% compared to the same quarter last year. During the same quarter in the prior year, the company earned $2.01 EPS. Equities research analysts predict that Gilead Sciences, Inc. will post -0.53 earnings per share for the current year.

Gilead Sciences Announces Dividend The business also recently declared a quarterly dividend, which will be paid on Tuesday, September 29th. Shareholders of record on Tuesday, September 15th will be issued a $0.82 dividend. The ex-dividend date of this dividend is Tuesday, September 15th. This represents a $3.28 dividend on an annualized basis and a yield of 2.2%. Gilead Sciences’s dividend payout ratio is -122.85%.

Gilead Sciences News Roundup Here are the key news stories impacting Gilead Sciences this week:

Positive Sentiment: BMO Capital reaffirmed its Buy rating on Gilead, supporting the bullish view that the company’s recent momentum can continue. BMO Capital reaffirms Buy rating Positive Sentiment: Zacks Research raised estimates for third-quarter 2026 EPS to $1.93 from $1.84, fourth-quarter 2026 EPS to $2.14 from $2.07, and full-year 2027 EPS to $9.30 from $9.11. It also lifted estimates for parts of 2027, indicating improving expectations for near-term earnings. Gilead Sciences analyst estimates Positive Sentiment: Investors remain focused on Gilead’s expanding HIV portfolio. Biktarvy continues to anchor sales, while Yeztugo and additional pipeline programs could create new treatment and prevention opportunities. The company’s latest reported revenue also increased 10.6% year over year to $7.8 billion, exceeding expectations. Gilead’s expanding HIV portfolio Positive Sentiment: Gilead’s quarterly dividend of $0.82, equivalent to $3.28 annually, provides ongoing income support and reinforces its appeal to defensive and healthcare-focused investors. Neutral Sentiment: Zacks reduced estimates for first-quarter 2028 EPS to $2.14 from $2.21, second-quarter 2028 EPS to $2.27 from $2.33, and full-year 2028 EPS to $9.58 from $10.00. These cuts temper the otherwise positive near-term revisions and suggest some uncertainty about longer-term growth. Negative Sentiment: Chief Commercial Officer Johanna Mercier sold 28,000 shares, while CFO Andrew Dickinson sold 3,000 shares. Both transactions were made under pre-arranged Rule 10b5-1 plans, limiting their significance, but the sales may modestly weigh on sentiment. Insiders Place Their Bets In other news, insider Johanna Mercier sold 28,000 shares of the business’s stock in a transaction dated Monday, August 17th. The shares were sold at an average price of $137.64, for a total transaction of $3,853,920.00. Following the transaction, the insider owned 118,234 shares in the company, valued at approximately $16,273,727.76. The trade was a 19.15% decrease in their position. The transaction was disclosed in a document filed with the SEC, which can be accessed through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CEO Daniel Patrick O’day sold 15,000 shares of the company’s stock in a transaction dated Monday, August 3rd. The shares were sold at an average price of $130.31, for a total transaction of $1,954,650.00. Following the transaction, the chief executive officer directly owned 592,133 shares of the company’s stock, valued at $77,160,851.23. This represents a 2.47% decrease in their position. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders have sold 82,000 shares of company stock worth $10,837,860 in the last ninety days. Insiders own 0.30% of the company’s stock.

(Free Report)

Gilead Sciences, Inc, founded in 1987 and headquartered in Foster City, California, is a biopharmaceutical company focused on the discovery, development and commercialization of medicines in areas of high unmet medical need. The company initially built its reputation in antiviral therapies and has since expanded into oncology, cell therapy and inflammatory diseases. Gilead operates a global research and commercial organization, conducting clinical development and selling medicines in markets around the world.

Gilead’s product portfolio is anchored by antiviral therapies for HIV and viral hepatitis.

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Gilead Sciences (GILD +0.41%) has shifted from a period of stagnant growth, driven by slowing hepatitis C revenues and declining sales of its COVID-19 therapy Veklury, to a turnaround led by new HIV and oncology drugs.

The pharmaceutical stock is up more than 12% so far this year and more than 5% over the past month. The driver for the bounce is the company's best second-quarter growth in three years. That growth was led by its HIV therapies; breast cancer drug Trodelvy; and Livdelz, used to treat primary biliary cholangitis (PBC), an autoimmune disease of the liver.

Here are three reasons that Gilead's turnaround has Wall Street excited.

Image source: Getty Images.

Gilead has updated its core portfolio of HIV therapies HIV treatment and HIV preexposure prophylaxis (PrEP) therapies remain Gilead's highest-margin cash drivers. Its treatment Biktarvy continues to deliver strong baseline revenue with $3.8 billion in second-quarter sales, up 7% year over year, and it maintains more than 52% of U.S. market share. The rollout of twice-yearly injectables such as Yeztugo expands the PrEP market; long-acting formulations increase adherence and secure durable, high-margin, sticky revenue for years to come.

On top of that, Gilead and partner Merck (MRK +0.10%) are close to an approval for the first weekly pill to treat HIV. This drug is a combination of Gilead's lenacapavir and Merck's islatravir. The Prescription Drug User Fee Act (PDUFA) action date for the combination therapy is Aug. 27.

In the second quarter, Gilead reported overall sales of $7.8 billion, up 10% year over year. That included HIV-related sales of $5.7 billion, up 12% year over year and 13% from the prior quarter. The key, though, was that the company's PrEP sales exceeded $1 billion for the first time, led by $801 million in Descovy sales, up 60% from the same quarter a year ago.

Its portfolio and pipeline of oncology treatments are growing Oncology now provides Gilead a second pillar of organic top-line growth.

Trodelvy has established solid positioning in breast and bladder cancers and had $457 million in second-quarter sales, up 26% year over year. Gilead's cell therapy assets, including Yescarta -- and pipeline therapies such as anitocabtagene autoleucel (anito-cel) for multiple myeloma (see more below) -- position the company in high-value hematology and oncology markets.

Hepcludex (bulevirtide) was given accelerated approval on May 22 by the Food and Drug Administration (FDA) as a first treatment for adults with chronic hepatitis delta virus (HDV) infection who do not have cirrhosis or who have compensated cirrhosis.

Anito-cel, a treatment for multiple myeloma, is expected to launch shortly after its PDUFA target date of Dec. 23. This is a BCMA-directed CAR T-cell therapy that showed a 96% overall response rate and 74% complete response rate in heavily pretreated patients.

The company reported an earnings-per-share (EPS) loss of $8.45 in the second quarter, compared to positive EPS of $1.56 in the same period a year ago. The markets shrugged off the loss because most of it was attributable to research and development (R&D) expenses related to Gilead's acquisitions of Arcellx, Tubulis, and Ouro Medicines.

It spent $7.8 billion on Arcellx in April, gaining anito-cel. The $1.675 billion deal for Ouro, completed in June, brought in gamgertamig and other promising autoimmune therapies.

Gilead's $5 billion deal for Tubulis, completed in May, expanded its oncology pipeline. The move added a next-generation antibody-drug-conjugate platform, including TUB-040 for ovarian cancer and TUB-030 for various solid tumors.

On Aug. 11, Gilead exercised its option to exclusively license a preclinical solid-tumor bispecific program from MacroGenics (MGNX -3.79%). The move triggered a $10 million milestone payment to MacroGenics, boosting the two companies' 2022 collaboration. The three-program agreement includes the clinical-stage bispecific MGD024 and two preclinical bispecific programs.

Solid cash flow helps both its dividend and R&D Gilead is on track to exceed $12 billion in free cash flow this year, including $3.6 billion in the second quarter. That number should grow as short-term integration charges roll off. This cash conversion supports a reliable dividend, steady share repurchases, and continuous internal research and development (R&D) funding without straining the balance sheet.

The company raised its quarterly dividend by 3.8% this year to $0.82, the 11th consecutive year it has increased its dividend. The current dividend yield is above-average at 2.3%. And Gilead has increased its dividend by nearly 75% over the past decade. That commitment to the dividend allows investors to be patient while they wait to see which of its acquisitions pay off.

Another big plus for long-term investors is that Biktarvy is unlikely to face any loss of patent protection until 2033. Descovy's patent landscape features a combination of long underlying patent exclusivity, successful litigation defense, and strategic generic settlements. Gilead Sciences boasts a relatively long runway before facing major generic exposure.

A court ruling this week in favor of Gilead Sciences could significantly impact a burgeoning class of health programs in the U.S. that federal authorities say are illegally importing medications from overseas.

Last year, a CNBC investigation found that these programs — called alternative funding programs, or AFPs — were becoming more pervasive around the country as drug costs skyrocket. Yet U.S. authorities say AFPs import the drugs from international markets in violation of Food and Drug Administration regulations.

A U.S. Court of Appeals on Thursday upheld a preliminary injunction in the case filed by Gilead against several AFPs and related businesses. Patient advocacy groups say the decision could force AFPs to shrink dramatically or even go out of business.

AFPs have defended their practices as both legal and safe and say their businesses are an antidote to high prescription drug prices.

In December 2024, Gilead sued several companies in connection with what it claimed was the illegal importation of its HIV drug Biktarvy. The suit was filed after a Maryland patient received the drug in the mail from Turkey with label instructions in Turkish.

The suit targeted an AFP called Rx Valet and several affiliated companies. Gilead also sued Meritain Health, which manages employee health plans and is part of CVS Health-owned Aetna, and Pro-Act, a pharmacy benefits manager.

"Meritain has long maintained a policy that it does not support programs for non-FDA-approved medications sourced from outside the United States and does not contract with companies to facilitate the importation of non-FDA-approved medications sourced from outside the United States," Aetna spokesperson Phil Blando said in a statement. "Despite this policy, Meritain was named as a defendant in a lawsuit filed by Gilead concerning international drug sourcing. Meritain strongly disputes the allegations and is vigorously defending itself against the complaint."

Rx Valet did not return a request for comment from CNBC.

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AFPs generally maintain the medicines they import from overseas are the same as ones sold in the U.S.

The court this week disagreed, finding that the differences between Gilead's U.S. medications and the international medications imported by defendants were "material, not theoretical," and that by importing medicines through unauthorized foreign channels, the defendants bypassed Gilead's supply chain.

"What Gilead sells in Turkey and what it sells in Maryland share a chemical formula but materially differ and travel through different quality-control system," the ruling said.

In a statement, a Gilead spokesman said the ruling helps protect patients by keeping medicines that are outside FDA oversight and quality safeguards out of the U.S. supply chain.

Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, a coalition of nonprofit and pharmaceutical industry groups, said the court's decision is clear that "you cannot import untraceable medicine with foreign-language labels, hand it to American patients, and call it equivalent to an FDA-approved medicine."

Gilead Sciences (GILD - Free Report) came out with a quarterly loss of $6.75 per share versus the Zacks Consensus Estimate of a loss of $7.07. This compares to earnings of $2.01 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +4.53%. A quarter ago, it was expected that this HIV and hepatitis C drugmaker would post earnings of $1.89 per share when it actually produced earnings of $2.03, delivering a surprise of +7.41%.

Over the last four quarters, the company has surpassed consensus EPS estimates four times.

Gilead, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $7.8 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 5.92%. This compares to year-ago revenues of $7.08 billion. The company has topped consensus revenue estimates four times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Gilead shares have added about 6.9% since the beginning of the year versus the S&P 500's gain of 11%.

What's Next for Gilead?While Gilead has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Gilead was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.16 on $7.8 billion in revenues for the coming quarter and -$0.78 on $30.38 billion in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

One other stock from the same industry, Axsome Therapeutics (AXSM - Free Report) , is yet to report results for the quarter ended June 2026. The results are expected to be released on August 10.

This biopharmaceutical company is expected to post quarterly loss of $0.99 per share in its upcoming report, which represents a year-over-year change of -7.6%. The consensus EPS estimate for the quarter has been revised 14.8% lower over the last 30 days to the current level.

Axsome Therapeutics' revenues are expected to be $224.52 million, up 49.6% from the year-ago quarter.

Key Takeaways Gilead to report Q2 results on Aug. 4, with HIV therapies likely to remain the primary growth driver.GILD raised 2026 Yeztugo sales guidance after a strong launch and improved HIV market trends.Gilead expects Cell Therapy sales to face competitive pressure, while Trodelvy demand remains solid. Biotech bigwig Gilead Sciences, Inc. (GILD - Free Report) is scheduled to report second-quarter results on Aug. 4, after market close. The Zacks Consensus Estimate for sales and loss per share is pegged at $7.37 billion and $7.07, respectively.

Bottom-line estimate for 2026 has decreased to a loss of 78 cents from earnings of 8 cents per share over the past 60 days.

The EPS estimate for 2027 has increased to $9.73 from $9.58 in the said time frame.

Image Source: Zacks Investment Research

GILD’s Earnings Surprise HistoryGILD has a good track record. Its earnings beat estimates in three of the trailing four quarters and missed in the remaining one, delivering an average surprise of 6.75%. In the last reported quarter, the company’s earnings beat estimates by 7.41%.

What Our Model Predicts for GILDPer our proven model, the combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. However, that is not the case here, as you can see below.

Earnings ESP for GILD is -0.75%. The company currently carries a Zacks Rank #3. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.

Factors Influencing GILD’s Q2 ResultsGilead has a market-leading HIV franchise, led by flagship HIV therapies — Biktarvy and Descovy.

Biktarvy is the top revenue generator for GILD. Per the company, Biktarvy accounts for more than 52% of the treatment market in the United States, and continues to be the market leader in major markets around the world.

Gilead’s HIV pre-exposure prophylaxis (PrEP) portfolio comprises daily oral Descovy and the first and only twice-yearly injectable Yeztugo.

Descovy’s performance continues to be strong, primarily driven by higher demand and average realized price.

The top-line estimate for Biktarvy and Descovy is pegged at $3.6 billion and $750 million, respectively, and our model estimate for the same is pinned at $3.7 billion and $701 million.

Yeztugo raked in sales of $166 million in the first quarter. Following better-than-expected first-quarter results and improving market trends, Gilead raised its 2026 sales guidance for Yeztugo to $1 billion, signaling the product’s potential to achieve blockbuster status in its first full year on the market.

Consequently, Yeztugo sales likely recorded strong growth in the second quarter.

Driven by increased Yeztugo sales expectations and strong first-quarter HIV performance, Gilead now projects total 2026 HIV sales growth of approximately 8%, up from its prior guidance of 6% issued in February. The updated outlook includes an estimated 2% headwind related to the U.S. government’s Medicaid drug pricing agreement and proposed Affordable Care Act changes.

The Liver Disease portfolio includes drugs for chronic hepatitis C virus, chronic hepatitis B virus and chronic hepatitis delta virus.

Sales from this franchise have likely increased in the second quarter, driven by higher demand for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis.  

Veklury sales likely remained highly variable.

Cell Therapy product sales (Yescarta and Tecartus) have likely decreased in the to-be-reported quarter due to competitive headwinds, both in the United States and internationally.

The Zacks Consensus Estimate and our model estimate for Cell Therapy product sales are pinned at $417 million and $419 million, respectively.

Trodelvy, indicated for second-line metastatic triple-negative breast cancer and pre-treated HR+/HER2- metastatic breast cancer, likely experienced strong demand in the second quarter, similar to the first quarter. The Zacks Consensus Estimate and our estimate for Trodelvy sales are pinned at $448 million and $427 million, respectively.

R&D expenses might have increased in the second quarter, caused by higher investment in virology clinical manufacturing, partially offset by lower oncology clinical study activity. SG&A expenses, too, must have increased, reflecting higher investments in sales and marketing to support commercial launches.

GILD’s Price Performance and ValuationShares of GILD have risen 9.4% year to date compared with the industry’s growth of 2%. The stock has outperformed the sector and the S&P 500 in this time frame.

GILD's Outperforms Industry, Sector & S&P 500 Index 
Image Source: Zacks Investment Research

Going by the price/earnings ratio, GILD’s shares currently trade at 25.48X forward earnings, higher than its mean of 12.01X but lower than 19.11X for the large-cap pharma industry.

Image Source: Zacks Investment Research

Investment Thesis for GILDGilead Sciences has a market-leading HIV portfolio that continues to deliver strong growth, supported by sustained demand for its flagship therapies. The company's ongoing innovation in HIV treatment has been well received by investors, while the strong initial launch of Yeztugo has provided an additional boost to the franchise.

Gilead is also investing to further strengthen its HIV leadership through internal pipeline development and its collaboration with Merck (MRK - Free Report) . Potential approvals of new HIV therapies should reinforce the company's dominant position in the market.

Beyond HIV, Gilead is making steady progress in diversifying its revenue base. Strong uptake of Livdelzi has strengthened its liver disease portfolio.

In oncology, Trodelvy continues to gain market share in second-line metastatic breast cancer and recently secured FDA approval for an expanded label in the first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC).

This followed a similar label expansion by the European Commission, significantly broadening Trodelvy's addressable market by moving the therapy into the first-line setting, where treatment options have historically been limited. These developments support Gilead's strategy of building a stronger oncology franchise and reducing its dependence on HIV revenues.

The company's strategic acquisitions and partnerships further enhance its long-term growth prospects. However, Gilead's Cell Therapy franchise, comprising Yescarta and Tecartus, continues to face competitive pressures in both the United States and Europe, which might have weighed on recent sales. Despite these challenges, the strength of Gilead's HIV business, expanding oncology portfolio and disciplined business development strategy position the company for sustained long-term growth.

Stay Invested in GILD StockContinued innovation across Gilead's HIV portfolio should drive sustained growth despite intensifying competition from GSK plc (GSK - Free Report) .

GSK continues to expand its HIV business, fueled by strong demand for its long-acting injectable therapies, Cabenuva and Apretude, as well as Dovato, which have more than offset the ongoing decline in Triumeq sales.

Gilead's strategic acquisitions and partnerships to diversify its revenue base further strengthen its long-term growth outlook.

However, we recommend that prospective investors adopt a wait-and-watch approach, as Gilead's Cell Therapy business continues to face competitive pressures.

For existing shareholders, holding the stock appears prudent, supported by the company's solid HIV franchise, pipeline strength and attractive dividend yield.

The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid/File Photo Purchase Licensing Rights, opens new tab

CompaniesJuly 21 (Reuters) - Gilead Sciences (GILD.O), opens new tab and Merck (MRK.N), opens new tab said on Tuesday their experimental once-weekly HIV pill kept the virus suppressed in two late-stage trials, ​supporting regulatory filings for what could become the first ‌regimen of its kind for the disease.

Here are some details:

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The combination of Merck's islatravir and Gilead's lenacapavir was tested as a single-tablet regimen in adults ​whose HIV was already controlled with daily antiretroviral therapy.

HIV ​attacks the body's immune system and, if left untreated, ⁠can progress to acquired immunodeficiency syndrome (AIDS), the most advanced stage of ​infection.

In one trial, none of the patients who switched to the ​weekly pill had detectable viral levels at 48 weeks, compared with 0.3% of those who remained on Gilead's daily Biktarvy.

In a second trial, 0.3% of ​patients taking the weekly pill had detectable HIV levels or ​higher at 48 weeks, compared with 1.3% of those who remained on standard ‌daily ⁠HIV regimens.

Investors are closely watching the rollout of lenacapavir, branded as Yeztugo, which was approved last year, as Gilead seeks to strengthen its HIV franchise alongside blockbuster treatment Biktarvy.

The companies said the weekly ​treatment was non-inferior ​to Biktarvy ⁠and other daily HIV regimens in the two studies, meaning it performed at least as well by ​the studies' main measure.

Side effects were generally similar ​to ⁠the daily treatments studied, and no new safety concerns were identified. The most common treatment-related side effects included headache, nausea and diarrhea.

Merck's once-daily ⁠HIV ​pill combo Idvynso was approved by the U.S. ​Food and Drug Administration in April, bringing another treatment option for patients suffering from ​the condition.

Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Vijay Kishore

Our Standards: The Thomson Reuters Trust Principles., opens new tab

Shares of Gilead Sciences (GILD 3.72%) have lagged the S&P 500 average this year, rising only 9% despite strong financials and a pipeline that promises to elevate the pharmaceutical company's base beyond its core of HIV therapies.

Gilead has spent heavily on its acquisitions of Arcellx, Ouro Medicines, and Tubulis, and while it will take time to integrate them, the upside is that they add to the company's pipeline, particularly in oncology and inflammation therapies.

In its first-quarter presentation, the company said it has four potential launches this year. Instead of focusing on the cost of its purchases, investors would do well to look beyond that and see how these new launches and acquisitions will diversify Gilead's platform, reducing its reliance on its HIV franchise.

Three reasons to buy Gilead right now:

Image source: Getty Images.

The company's continued financial strength In Q1, Gilead reported revenue of $7 billion, up 4% year over year, mainly from higher sales of its HIV products. Earnings per share (EPS) were $1.61, up 54.8% over the same period last year. It's not as if the company's HIV therapies are slowing down. Biktarvy and Descovy continue to dominate market share, driving a 10% year-over-year increase in HIV product sales to $5 billion.

The company is also seeing significant growth in its breast cancer drug, Trodelvy, with sales up 37% year over year. This dependable revenue gives it product gross margins of roughly 79%. The company said it sees no major loss-of-exclusivity patent cliffs for its top drugs until 2036. This means at least another decade of secure cash flows to fund research and development and dividend growth.

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High-impact 2026 commercial launches The primary reason to look at Gilead right now is its massive, immediate product-launch calendar.

Bulevirtide was given accelerated approval on May 22 by the Food and Drug Administration (FDA) as the first treatment for adults with chronic hepatitis delta virus (HDV) infection who do not have cirrhosis (severe liver scarring) or who have compensated cirrhosis. The FDA on April 29 granted Priority Review for a once-daily, single-tablet combo regimen of bictegravir + lenacapavir (BIC/LEN) for adults with suppressed HIV, with a critical Prescription Drug User Fee Act (PDUFA) action date set for Aug. 27, and launch expected shortly thereafter.

With its purchase of Arcellx, the company gains multiple myeloma therapy anito-cel, a BCMA CAR-T therapy with a PDUFA date scheduled for December. Trodelvy also continues to gain ground, with FDA approval on June 24 that allows it to move into crucial first-line metastatic triple-negative breast cancer (mTNBC) indication.

In addition, Gilead's twice-yearly injectable HIV prevention drug, Yeztugo, has entered its multimarket launch curve following a strong clinical performance, and the company said it expects $1 billion in 2026 sales from the drug.

The price is right, and so is its dividend Despite a strong five-year run and solid operational execution, Gilead's valuation remains highly attractive, trading at around 15 times forward earnings, well below its five-year average.

For income-oriented investors, Gilead pairs this growth inflection with a reliable 2.39% dividend yield at its current share price. The company has increased its dividend for 11 consecutive years, including a 3.7% bump this year.

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted marketing authorization for Trodelvy® (sacituzumab govitecan-hziy) as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. Trodelvy is the first antibody-drug conjugate (ADC) to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.

“This approval brings a profound sense of hope to a community that has long been waiting for progress,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, Madrid and Barcelona, Spain. “For women diagnosed with metastatic TNBC, particularly those who are younger, every second counts, and having an effective treatment option that can delay the progression of their disease is invaluable. This is the kind of meaningful advance our community needs.”

For many living with metastatic TNBC, the most aggressive form of breast cancer, first-line therapy may be their only line of treatment, creating an urgent need for effective treatment options to be used as early as possible.

“This approval represents a significant step forward in how we treat people with first-line metastatic TNBC in Europe,” said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. “We have long recognized the challenges that patients and clinicians face with this aggressive cancer, and we believe this approval will provide a much-needed new option for people with metastatic TNBC.”

The EC’s marketing authorization is based on data from the Phase 3 ASCENT-03 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival for Trodelvy compared to standard of care chemotherapy as a first-line treatment. In ASCENT-03, Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. The ASCENT-03 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed. The EC’s approval, based on the strength of the PFS data, confirms the study's objective to demonstrate using Trodelvy earlier provides a clinical benefit over chemotherapy for metastatic TNBC patients.

Continued Global Regulatory Filings for Trodelvy in First-Line Metastatic TNBC

Gilead has submitted a supplemental filing to the European Medicines Agency for Trodelvy in combination with Keytruda® (pembrolizumab) for patients with PD-L1 positive unresectable locally advanced or metastatic TNBC, based on data from the Phase 3 ASCENT-04 study. This application is currently under review. If approved, Trodelvy has the potential to be a backbone treatment in 1L metastatic TNBC, across PD-L1 status in Europe. In the U.S., Gilead has also submitted supplemental filings to the Food and Drug Administration (FDA) for Trodelvy for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy, or in combination with Keytruda or Keytruda Qlex in patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.

KEYTRUDA® and KEYTRUDA QLEX™ are trademarks of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

About Triple-Negative Breast Cancer In Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitors

TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy based on the ASCENT-03 and ASCENT-04 studies.

Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated since 2020. In addition to its first-line indication approval, Trodelvy is currently approved in more than 60 countries for patients with second-line or later mTNBC and in over 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer. It is the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer and the only Trop-2-directed ADC to demonstrate a meaningful overall survival benefit in two distinct types of metastatic breast cancer.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across different tumor types, including in small cell lung cancer and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

U.S. Indications for Trodelvy

TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. U.S. Important safety information FOR TRODELVY
BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY. WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.

About Gilead and Kite Oncology

Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Trodelvy; uncertainties relating to regulatory applications and related filing and approval timelines, including such as the pending applications for Trodelvy in 1L mTNBC and potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.

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