Market Newsdesk

April 21, 2026 6:49 am

MSCI Reports Financial Results for First Quarter 2026

MSCI Reports Financial Results for First Quarter 2026

NEW YORK–(BUSINESS WIRE)–
MSCI Inc. (“MSCI” or the “Company”) (NYSE: MSCI), a leading provider of critical decision support tools and services for the global investment community, today announced its financial results for the three months ended March 31, 2026 (“first quarter 2026”).

Financial and Operational Highlights for First Quarter 2026

(Note: Unless otherwise noted, percentage and other changes are relative to the three months ended March 31, 2025 (“first quarter 2025”) and Run Rate percentage changes are relative to March 31, 2025).

Operating revenues of $850.8 million, up 14.1%; Organic operating revenue growth of 13.3%
Recurring subscription revenues up 8.6%; Asset-based fees up 26.6%
Operating margin of 53.7%; Adjusted EBITDA margin of 59.3%
Diluted EPS of $5.53, up 49.1%; Adjusted EPS of $4.55, up 13.8%
Organic recurring subscription Run Rate growth of 8.2%; Retention Rate of 95.4%
In first quarter 2026 and through April 20, 2026, a total of $464 million or 835,591 shares were repurchased at an average repurchase price of $555.61
Approximately $150 million in dividends were paid to shareholders in first quarter 2026; Cash dividend of $2.05 per share declared by MSCI Board of Directors for second quarter 2026

	Three Months Ended
	Mar. 31,			Mar. 31,
In millions, except per share data (unaudited)		2026			2025		% Change
Operating revenues	$	850.8		$	745.8		14.1	%
Operating income	$	456.9		$	377.0		21.2	%
Operating margin %		53.7	%		50.6	%

Net income	$	406.0		$	288.6		40.7	%

Diluted EPS	$	5.53		$	3.71		49.1	%
Adjusted EPS	$	4.55		$	4.00		13.8	%

Adjusted EBITDA	$	504.7		$	425.6		18.6	%
Adjusted EBITDA margin %		59.3	%		57.1	%

“In the first quarter MSCI delivered strong financial and operating metrics, including a record asset-based-fee run rate and our best Q1 of recurring net-new subscription sales since 2022. Among product lines and client segments, we posted record levels of Q1 recurring sales in both Index and Analytics, along with our best-ever Q1 recurring net-new sales with hedge funds and with banks and broker-dealers,” said Henry A. Fernandez, Chairman and CEO of MSCI.

“These results affirmed MSCI’s foundational, mission-critical role in global capital markets, which is also reflected in the growing liquidity and scale of the investment ecosystem linked to our indexes and IP. The sales momentum we have achieved cuts across regions, product lines, client segments and asset classes, and we are building on it through relentless, AI-fueled product innovation,” Fernandez added.

First Quarter Consolidated Results

Operating Revenues: Operating revenues were $850.8 million, up 14.1%. Organic operating revenue growth was 13.3%. The $105.0 million increase was the result of a $47.6 million increase in recurring subscription revenues and a $47.1 million increase in asset-based fees, as well as a $10.3 million increase in non-recurring revenues.

Run Rate and Retention Rate: Total Run Rate at March 31, 2026 was $3,357.3 million, up 12.7%. Recurring subscription Run Rate increased by $203.3 million, and asset-based fees Run Rate increased by $174.8 million. Organic recurring subscription Run Rate growth was 8.2%. Retention Rate in first quarter 2026 was 95.4%, compared to 95.3% in first quarter 2025.

Expenses: Total operating expenses were $393.9 million, up 6.8%. Adjusted EBITDA expenses were $346.1 million, up 8.1%, primarily reflecting higher compensation and benefits costs as a result of increased headcount costs partially offset by lower severance costs. The increase was also driven by non-compensation costs, primarily reflecting higher professional fees, market data costs and information technology costs.

Total operating expenses excluding the impact of foreign currency exchange rate fluctuations (“ex-FX”) and adjusted EBITDA expenses ex-FX increased 4.4% and 5.4%, respectively.

Operating Income: Operating income was $456.9 million, up 21.2%. Operating income margin in first quarter 2026 was 53.7%, compared to 50.6% in first quarter 2025.

Headcount: As of March 31, 2026, we had 6,319 employees, reflecting a 2.2% increase, with 29% and 71% of employees located in developed market and emerging market locations, respectively.

Other Expense (Income), Net: Other expense (income), net was $67.7 million, up 47.5%, primarily driven by higher interest expense as a result of higher debt levels.

Income Taxes:The effective tax rate decreased to (4.3)% in first quarter 2026 compared to 12.8% in first quarter 2025. As previously disclosed, in the fourth quarter 2025, the Company commenced a multi-phase internal legal entity restructuring. In connection with the completion of the subsequent phase of this restructuring in the first quarter 2026, the Company recognized an $88 million discrete tax benefit which resulted in a decrease in the effective tax rate.

Net Income: As a result of the factors described above, net income was $406.0 million, up 40.7%.

Adjusted EBITDA: Adjusted EBITDA was $504.7 million, up 18.6%. Adjusted EBITDA margin in first quarter 2026 was 59.3%, compared to 57.1% in first quarter 2025.

Index Segment:

Table 1A: Results (unaudited)

Three Months Ended

Mar. 31,

Mar. 31,

In millions

2026

2025

% Change

Operating revenues:

Recurring subscriptions

$

254.2

$

233.3

9.0

%

Asset-based fees

224.5

177.4

26.6

%

Non-recurring

17.6

11.0

60.0

%

Total operating revenues

496.3

421.7

17.7

%

Adjusted EBITDA expenses

121.1

110.1

10.0

%

Adjusted EBITDA

$

375.2

$

311.6

20.4

%

Adjusted EBITDA margin %

75.6

%

73.9

%

Index operating revenues were $496.3 million, up 17.7%. The $74.6 million increase was primarily driven by $47.1 million in higher asset-based fees and $20.9 million in higher recurring subscription revenues. Organic operating revenue growth for Index was 17.6%.

Index Run Rate as of March 31, 2026, was $1.9 billion, up 16.8%. The $276.2 million increase was comprised of a $174.8 million increase in asset-based fees Run Rate and a $101.4 million increase in recurring subscription Run Rate. The increase in asset-based fees Run Rate was driven by higher AUM in both ETFs linked to MSCI equity indexes and non-ETF indexed funds linked to MSCI indexes. The increase in recurring subscription Run Rate was primarily driven by growth from market cap-weighted and custom Index products. The increase reflected growth across all regions. Organic recurring subscription Run Rate growth for Index was 10.4%.

Analytics Segment:

Table 1B: Results (unaudited)

Three Months Ended

Mar. 31,

Mar. 31,

In millions

2026

2025

% Change

Operating revenues:

Recurring subscriptions

$

183.2

$

169.8

7.9

%

Non-recurring

6.8

2.4

183.3

%

Total operating revenues

190.0

172.2

10.3

%

Adjusted EBITDA expenses

107.2

96.2

11.4

%

Adjusted EBITDA

$

82.8

$

76.0

8.9

%

Adjusted EBITDA margin %

43.6

%

44.2

%

Analytics operating revenues were $190.0 million, up 10.3%. Organic operating revenue growth for Analytics was 10.5%.

Analytics Run Rate as of March 31, 2026, was $763.4 million, up 7.9%. The increase of $55.6 million was driven by growth in both Multi-Asset Class and Equity Analytics products, and reflected growth across all regions, primarily led by hedge fund managers, banking and brokerages and asset managers client segments. Organic recurring subscription Run Rate growth for Analytics was 7.4%.

Sustainability and Climate Segment:

Table 1C: Results (unaudited)

Three Months Ended

Mar. 31,

Mar. 31,

In millions

2026

2025

% Change

Operating revenues:

Recurring subscriptions

$

90.9

$

82.7

9.9

%

Non-recurring

1.0

1.9

(47.4

)%

Total operating revenues

91.9

84.6

8.6

%

Adjusted EBITDA expenses

58.9

60.8

(3.1

)%

Adjusted EBITDA

$

33.0

$

23.8

38.7

%

Adjusted EBITDA margin %

35.9

%

28.2

%

Sustainability and Climate operating revenues were $91.9 million, up 8.6%. Organic operating revenue growth for Sustainability and Climate was 3.7%.

Sustainability and Climate Run Rate as of March 31, 2026, was $375.7 million, up 6.6%. The $23.4 million increase was driven by growth from Ratings, Climate and Screening products, primarily attributable to EMEA. Organic recurring subscription Run Rate growth for Sustainability and Climate was 4.2%.

All Other – Private Assets:

Table 1D: Results (unaudited)

Three Months Ended

Mar. 31,

Mar. 31,

In millions

2026

2025

% Change

Operating revenues:

Recurring subscriptions

$

71.9

$

66.8

7.6

%

Non-recurring

0.7

0.5

40.0

%

Total operating revenues

72.6

67.3

7.9

%

Adjusted EBITDA expenses

58.9

53.1

10.9

%

Adjusted EBITDA

$

13.7

$

14.2

(3.5

)%

Adjusted EBITDA margin %

18.9

%

21.1

%

All Other – Private Assets operating revenues, which reflect the Real Assets and Private Capital Solutions operating segments, were $72.6 million, up 7.9%. Organic operating revenue growth for All Other – Private Assets was 5.3%.

All Other – Private Assets Run Rate was $296.4 million as of March 31, 2026, up 8.4%. The increase in Run Rate was primarily driven by Private Capital Solutions related to Private Capital Transparency Data, Total Plan Manager and Private Capital Intel products. The increase reflected growth across all regions and was primarily driven by asset owner and asset manager client segments. Organic recurring subscription Run Rate growth for All Other – Private Assets was 7.8%.

Select Balance Sheet Items and Capital Allocation

Cash Balances and Outstanding Debt: Cash and cash equivalents was $385.3 million as of March 31, 2026. MSCI typically seeks to maintain minimum cash balances globally of approximately $225.0 million to $275.0 million for general operating purposes.

Total principal amount of debt outstanding as of March 31, 2026, was $6.5 billion. The total debt to net income ratio (based on trailing twelve months net income) was 4.9x. The total debt to adjusted EBITDA ratio (based on trailing twelve months adjusted EBITDA) was 3.2x.

MSCI seeks to maintain total debt to adjusted EBITDA in a target range of 3.0x to 3.5x.

Capex and Cash Flow: Capex was $28.8 million, and net cash provided by operating activities increased by 1.7% to $306.8 million, primarily reflecting higher cash collections from customers, partially offset by higher cash expenses, interest expense and income taxes paid in the quarter. Free cash flow for first quarter 2026 was up 3.4% year-over-year to $278.0 million.

Share Count and Share Repurchases: Weighted average diluted shares outstanding were 73.4 million in first quarter 2026, down 5.7% year-over-year. Total shares outstanding as of March 31, 2026 were 72.9 million. As of April 20, 2026, a total of approximately $1.7 billion remains available on the outstanding share repurchase authorization.

Dividends: Approximately $150.1 million in dividends were paid to shareholders in first quarter 2026. On April 20, 2026, the MSCI Board of Directors declared a cash dividend of $2.05 per share for second quarter 2026, payable on May 29, 2026 to shareholders of record as of the close of trading on May 15, 2026.

Full-Year 2026 Guidance

MSCI’s guidance for the year ending December 31, 2026 (“Full-Year 2026”) is based on assumptions about a number of factors, in particular related to macroeconomic factors and the capital markets. These assumptions are subject to uncertainty, and actual results for the year could differ materially from our current guidance, including as a result of the uncertainties, risks and assumptions discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of our Annual Report on Form 10-K, as updated in quarterly reports on Form 10-Q and current reports on Form 8-K filed or furnished with the SEC. See “Forward-Looking Statements” below.

Guidance Item

Current Guidance for Full-Year 2026

Prior Guidance for Full-Year 2026

Operating Expense

$1,490 to $1,530 million

$1,490 to $1,530 million

Adjusted EBITDA Expense

$1,305 to $1,335 million

$1,305 to $1,335 million

Interest Expense

(including amortization of financing fees)¹

$274 to $280 million

$274 to $280 million

Depreciation & Amortization Expense

$190 to $200 million

$185 to $195 million

Effective Tax Rate²

18.0% to 20.0%

18.0% to 20.0%

Capital Expenditures

$160 to $170 million

$160 to $170 million

Net Cash Provided by Operating Activities

$1,640 to $1,690 million

$1,640 to $1,690 million

Free Cash Flow

$1,470 to $1,530 million

$1,470 to $1,530 million

¹A portion of our annual interest expense is from our variable rate indebtedness under our revolving credit facility, while the majority is from fixed rate senior unsecured notes. Changes to the secured overnight funding rate (“SOFR”) and indebtedness levels can cause our annual interest expense to vary.

²Excludes the impact of a multi-phase internal legal entity restructuring that commenced in fourth quarter 2025 and was completed in the first quarter 2026. In connection with the completion of the subsequent phase of the restructuring in first quarter 2026, we recognized a tax benefit of $88 million, which is excluded from applicable non-GAAP measures when presented.

Conference Call Information

MSCI’s senior management will review the first quarter 2026 results on Tuesday, April 21, 2026 at 11:00 AM Eastern Time. To listen to the live event via webcast, visit the events and presentations section of MSCI’s Investor Relations website, https://ir.msci.com/events-and-presentations. Participants who wish to join via telephone should click here to register in advance. Registered participants will receive an email confirmation with a unique PIN to access the conference call. The earnings call webcast will include an accompanying slide presentation that can be accessed through MSCI’s Investor Relations website.

About MSCI Inc.

MSCI Inc. (NYSE: MSCI) strengthens global markets by connecting participants across the financial ecosystem with a common language. Our research-based data, analytics and indexes, supported by advanced technology, set standards for global investors and help our clients understand risks and opportunities so they can make better decisions and unlock innovation. We serve asset managers and owners, private-market sponsors and investors, hedge funds, wealth managers, banks, insurers and corporates. To learn more, please visit www.msci.com. MSCI#IR

Forward-Looking Statements

This earnings release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, MSCI’s Full-Year 2026 guidance. These forward-looking statements relate to future events or to future financial performance and involve underlying assumptions, as well as known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these statements. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” or the negative of these terms or other comparable terminology. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond MSCI’s control and that could materially affect actual results, levels of activity, performance or achievements.

Other factors that could materially affect actual results, levels of activity, performance or achievements can be found in MSCI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission (“SEC”) on February 6, 2026 and in quarterly reports on Form 10-Q and current reports on Form 8-K filed or furnished with the SEC. If any of these risks, uncertainties or other matters materialize, or if MSCI’s underlying assumptions prove to be incorrect, actual results may vary significantly from what MSCI projected. Any forward-looking statement in this earnings release reflects MSCI’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to MSCI’s operations, results of operations, growth strategy and liquidity. MSCI assumes no obligation to publicly update or revise these forward-looking statements for any reason, whether as a result of new information, future events, or otherwise, except as required by law.

Website and Social Media Disclosure

MSCI uses its investor relations website ir.msci.com and social media outlets, such as LinkedIn or X (@MSCI_Inc), as channels of distribution of company information. The information MSCI posts through these channels may be deemed material. Accordingly, investors should monitor these channels, in addition to following MSCI’s press releases, SEC filings and public conference calls and webcasts. In addition, you may automatically receive email alerts and other information about MSCI when you enroll your email address by visiting the “Email Alerts” section of MSCI’s Investor Relations homepage at http://ir.msci.com/email-alerts. The contents of MSCI’s website, including its quarterly updates, blog, podcasts and social media channels are not, however, incorporated by reference into this earnings release.

Notes Regarding the Use of Operating Metrics

MSCI has presented supplemental key operating metrics as part of this earnings release, including Run Rate, Retention Rate, subscription sales, subscription cancellations and non-recurring sales.

A substantial portion of MSCI’s operating revenues is derived from recurring subscriptions or licenses for products and services that are ongoing in nature and provided over contractually agreed periods, which are subject to renewal or cancellation upon the expiration of the then-current term. In addition, we generate non-recurring revenues from one-time sales and other transactions or services that are discrete in nature or that have a defined life. The operating metrics defined below help management assess the stability and growth of this recurring-revenue base and track non-recurring revenues. There have been no changes to the methodologies used to compute these metrics compared with prior periods.

Run Rate estimates, at a specific point in time, the annualized value of the recurring portion of executed client contracts (“Client Contracts”) expected to generate revenues over the next 12 months, assuming that all such Client Contracts are renewed and using fixed foreign exchange rates. Run Rate includes new Client Contracts upon execution, even if the license start date and related revenue recognition occur later.

For Client Contracts where fees are linked to an investment product’s assets or trading volume or fees (referred to as “Asset-based Fees”), the Run Rate calculation is based on:

For exchange-traded funds (“ETFs”): assets under management as of the last trading day of the period;

For non-ETF products: the most recent client-reported assets under management; and

For listed futures and options contracts: the most recent quarterly volumes and/or reported exchange fees.

Run Rate excludes fees associated with one-time or other non-recurring transactions. We remove from Run Rate the annualized fee value associated with products or services under any Client Contracts when (i) we have received a notice of termination, reduction in fees, non-renewal or other clear indication that the client does not intend to continue its subscription at then current fees; and (ii) management has determined that such notice or indication reflects the client’s final decision to terminate, not renew or renew at a lower fee the applicable products or services, even if such termination or non-renewal is not yet effective (each such event, a “Subscription Cancellation”).

In general, when a client reduces the fees paid to MSCI associated with a reduction in the number of products or services to which it subscribes within a segment, or a switch between products or services within a segment, unless the client switches to a product or service that management considers a replacement, such reduction or switch is treated as a Subscription Cancellation, including for purposes of calculating MSCI’s Retention Rate (as detailed below). In the cases where the client switches products or services to a replacement service, only the net decrease, if any, is reported as a cancellation.

In the Analytics and Sustainability and Climate operating segments, substantially all such product or service switches are treated as replacements and are netted accordingly.

In contrast, in the Index, Real Assets, and Private Capital Solutions operating segments, such netting treatment is applied only in limited circumstances.

Organic recurring subscription Run Rate growth is defined as the period-over-period growth in Run Rate, excluding:

The impact of changes in foreign currency exchange rates;

The impact of acquisitions during the first 12 months following the transaction date; and

The impact of divestitures, where Run Rate from divested businesses are excluded from prior period Run Rates.

Retention Rate is a key performance metric that provides insight into the stability and durability of MSCI’s recurring revenue base. Subscription cancellations reduce Run Rate and, over time, lower future operating revenues.

For full-year periods, Retention Rate is calculated as the retained subscription Run Rate, which is defined as the subscription Run Rate at the beginning of the fiscal year minus actual subscription cancellations during the fiscal year, expressed as a percentage of the subscription Run Rate at the beginning of the fiscal year.

For interim (non-annual) periods, Retention Rate is presented on an annualized basis. The annualized Retention Rate is calculated by:

Dividing annualized subscription cancellations in the period by the subscription Run Rate at the beginning of the fiscal year, to determine a cancellation rate; and

Subtracting that rate from 100%, to derive the annualized Retention Rate.

Retention Rate is calculated by operating segment and is based on an individual product or service level within each segment. We do not calculate Retention Rate for the portion of Run Rate attributable to Asset-based Fees.

Sales represents the annualized value of products and services that clients have committed to purchase from MSCI and that are expected to result in additional operating revenues.

Non-recurring sales represent the aggregate value of client agreements entered into during the period that generate non-recurring fees and are not included in Run Rate (as defined elsewhere herein), even if such agreements span multiple periods or years.

New recurring subscription sales represent the annualized value of additional client commitments entered into during the period – such as new Client Contracts, expansions of existing Client Contracts or price increases – that contribute to Run Rate.

Net new recurring subscription sales represent new recurring subscription sales minus the impact of Subscription Cancellations, capturing the net impact to Run Rate for the period.

Total gross sales is the sum of new recurring subscription sales and non-recurring sales.

Total net sales is total gross sales minus the impact of Subscription Cancellations.

Notes Regarding the Use of Non-GAAP Financial Measures

MSCI has presented supplemental non-GAAP financial measures as part of this earnings release. Reconciliations are provided in Tables 9 through 13 below that reconcile each non-GAAP financial measure with the most comparable GAAP measure. The non-GAAP financial measures presented in this earnings release should not be considered as alternative measures for the most directly comparable GAAP financial measures. The non-GAAP financial measures presented in this earnings release are used by management to monitor the financial performance of the business, inform business decision-making and forecast future results.

“Adjusted EBITDA” is defined as net income before (1) provision for income taxes, (2) other expense (income), net, (3) depreciation and amortization of property, equipment and leasehold improvements, (4) amortization of intangible assets and, at times, (5) certain other transactions or adjustments, including, when applicable, certain acquisition-related integration and transaction costs.

“Adjusted EBITDA expenses” is defined as operating expenses less depreciation and amortization of property, equipment and leasehold improvements and amortization of intangible assets and, at times, certain other transactions or adjustments, including, when applicable, certain acquisition-related integration and transaction costs.

“Adjusted EBITDA margin” is defined as adjusted EBITDA divided by operating revenues.

“Adjusted net income” and “adjusted EPS” are defined as net income and diluted EPS, respectively, before the after-tax impact of: the amortization of acquired intangible assets and, at times, certain other transactions or adjustments, including, when applicable, the impact related to certain acquisition-related integration and transaction costs, the impact related to the write-off of deferred fees on debt extinguishment, the impact related to certain gains or losses on investees, and the impact of certain discrete tax items.

“Capex” is defined as capital expenditures plus capitalized software development costs.

“Free cash flow” is defined as net cash provided by operating activities, less Capex.

“Organic operating revenue growth” is defined as operating revenue growth compared to the prior year period excluding the impact of acquired businesses, divested businesses and foreign currency exchange rate fluctuations.

Asset-based fees ex-FX does not adjust for the impact from foreign currency exchange rate fluctuations on the underlying assets under management (“AUM”).

We believe adjusted EBITDA, adjusted EBITDA margin and adjusted EBITDA expenses are meaningful measures of the operating performance of MSCI because they adjust for significant one-time, unusual or non-recurring items as well as eliminate the accounting effects of certain capital spending and acquisitions that do not directly affect what management considers to be our ongoing operating performance in the period.

We believe adjusted net income and adjusted EPS are meaningful measures of the performance of MSCI because they adjust for the after-tax impact of significant one-time, unusual or non-recurring items as well as eliminate the impact of any transactions that do not directly affect what management considers to be our ongoing operating performance in the period. We also exclude the after-tax impact of the amortization of acquired intangible assets and amortization of the basis difference between the cost of the equity method investment and MSCI’s share of the net assets of the investee at historical carrying value, as these non-cash amounts are significantly impacted by the timing and size of each acquisition and therefore not meaningful to the ongoing operating performance in the period.

We believe that free cash flow is useful to investors because it relates the operating cash flow of MSCI to the capital that is spent to continue and improve business operations, such as investment in MSCI’s existing products. Further, free cash flow indicates our ability to strengthen MSCI’s balance sheet, repay our debt obligations, pay cash dividends and repurchase shares of our common stock.

We believe organic operating revenue growth is a meaningful measure of the operating performance of MSCI because it adjusts for the impact of foreign currency exchange rate fluctuations and excludes the impact of operating revenues attributable to acquired and divested businesses for the comparable prior year period, providing insight into our ongoing operating performance for the period(s) presented.

We believe that the non-GAAP financial measures presented in this earnings release facilitate meaningful period-to-period comparisons and provide a baseline for the evaluation of future results.

Adjusted EBITDA expenses, adjusted EBITDA margin, adjusted EBITDA, adjusted net income, adjusted EPS, Capex, free cash flow and organic operating revenue growth are not defined in the same manner by all companies and may not be comparable to similarly-titled non-GAAP financial measures of other companies. These measures can differ significantly from company to company depending on, among other things, long-term strategic decisions regarding capital structure, the tax jurisdictions in which companies operate and capital investments. Accordingly, the Company’s computation of these measures may not be comparable to similarly-titled measures computed by other companies.

Notes Regarding Adjusting for the Impact of Foreign Currency Exchange Rate Fluctuations

Foreign currency exchange rate fluctuations reflect the difference between the current period results as reported compared to the current period results recalculated using the foreign currency exchange rates in effect for the comparable prior period. While operating revenues adjusted for the impact of foreign currency fluctuations includes asset-based fees that have been adjusted for the impact of foreign currency fluctuations, the underlying AUM, which is the primary component of asset-based fees, is not adjusted for foreign currency fluctuations. Approximately three-fifths of the AUM is invested in securities denominated in currencies other than the U.S. dollar, and any such impact is excluded from the disclosed foreign currency-adjusted variances.

Table 2: Condensed Consolidated Statements of Income (unaudited)

Three Months Ended

Mar. 31,

Mar. 31,

In millions, except per share data

2026

2025

Operating revenues

$

850.8

$

745.8

Operating expenses:

Cost of revenues (exclusive of depreciation and amortization)

141.8

136.8

Selling and marketing

85.7

78.7

Research and development

49.6

47.6

General and administrative

69.0

57.1

Amortization of intangible assets

41.9

43.9

Depreciation and amortization of property, equipment and leasehold improvements

5.9

4.7

Total operating expenses¹

393.9

368.8

Operating income

456.9

377.0

Interest income

(2.8

)

(3.9

)

Interest expense

69.1

46.5

Other expense (income)

1.4

3.3

Other expense (income), net

67.7

45.9

Income before provision for income taxes

389.2

331.1

Provision for income taxes

(16.8

)

42.5

Net income

$

406.0

$

288.6

Earnings per share:

Basic

$

5.54

$

3.72

Diluted

$

5.53

$

3.71

Weighted average shares outstanding used in computing earnings per share:

Basic

73.3

77.6

Diluted

73.4

77.8

¹ Includes stock-based compensation expense of $47.7 million and $40.1 million for the three months ended March 31, 2026 and 2025, respectively.

Table 3: Condensed Consolidated Balance Sheets (unaudited)

As of

Mar. 31,

Dec. 31,

In millions

2026

2025

ASSETS

Current assets:

Cash and cash equivalents

$

385.3

$

515.3

Accounts receivable

883.2

986.7

Other current assets

125.6

142.8

Total current assets

1,394.1

1,644.8

Property, equipment and leasehold improvements, net

87.3

87.3

Right of use assets

146.8

112.9

Goodwill

2,962.3

2,923.4

Intangible assets, net

851.0

832.5

Other non-current assets

103.8

101.6

Total assets

$

5,545.3

$

5,702.5

LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT)

Current liabilities:

Deferred revenue

$

1,184.0

$

1,231.8

Other current liabilities

429.2

598.0

Total current liabilities

1,613.2

1,829.8

Long-term debt

6,403.8

6,202.3

Long-term operating lease liabilities

143.9

107.5

Other non-current liabilities

158.5

217.4

Total liabilities

8,319.4

8,357.0

Total shareholders’ equity (deficit)

(2,774.1

)

(2,654.5

)

Total liabilities and shareholders’ equity (deficit)

$

5,545.3

$

5,702.5

Table 4: Condensed Consolidated Statements of Cash Flows (unaudited)

Three Months Ended

Mar. 31,

Mar. 31,

In millions

2026

2025

Cash flows from operating activities

Net income

$

406.0

$

288.6

Adjustments to reconcile net income to net cash provided by operating activities:

Amortization of intangible assets

41.9

43.9

Stock-based compensation expense

47.7

40.0

Depreciation and amortization of property, equipment and leasehold improvements

5.9

4.7

Amortization of right of use assets

6.8

5.9

Other adjustments

(85.9

)

12.0

Net changes in other operating assets and liabilities

(115.6

)

(93.4

)

Net cash provided by operating activities

306.8

301.7

Cash flows from investing activities

Capitalized software development costs

(26.0

)

(21.3

)

Capital expenditures

(2.8

)

(11.6

)

Business acquisitions, net of cash acquired¹

(41.7

)

—

Net cash used in investing activities

(70.5

)

(32.9

)

Cash flows from financing activities

Repurchase of common stock held in treasury

(414.8

)

(213.1

)

Payment of dividends

(150.5

)

(143.8

)

Repayment of borrowings

(175.0

)

(65.0

)

Proceeds from borrowings

375.0

100.0

Proceeds from exercise of stock options

1.3

0.4

Payment of contingent consideration and deferred purchase price from acquisitions

(0.5

)

(0.2

)

Net cash used in financing activities

(364.5

)

(321.7

)

Effect of exchange rate changes

(1.8

)

4.2

Net increase (decrease) in cash, cash equivalents and restricted cash

(130.0

)

(48.7

)

Cash, cash equivalents and restricted cash, beginning of period

515.3

409.4

Cash, cash equivalents and restricted cash, end of period

$

385.3

$

360.7

¹Includes cash paid for the acquisitions of Compass Financial Technologies and Vantager.

Table 5: Operating Results (unaudited)

Index

Three Months Ended

Mar. 31,

Mar. 31,

%

In millions

2026

2025

Change

Operating revenues:

Recurring subscriptions

$

254.2

$

233.3

9.0

%

Asset-based fees

224.5

177.4

26.6

%

Non-recurring

17.6

11.0

60.0

%

Total operating revenues

496.3

421.7

17.7

%

Adjusted EBITDA expenses

121.1

110.1

10.0

%

Adjusted EBITDA

$

375.2

$

311.6

20.4

%

Adjusted EBITDA margin %

75.6

%

73.9

%

Analytics

Three Months Ended

Mar. 31,

Mar. 31,

%

In millions

2026

2025

Change

Operating revenues:

Recurring subscriptions

$

183.2

$

169.8

7.9

%

Non-recurring

6.8

2.4

183.3

%

Total operating revenues

190.0

172.2

10.3

%

Adjusted EBITDA expenses

107.2

96.2

11.4

%

Adjusted EBITDA

$

82.8

$

76.0

8.9

%

Adjusted EBITDA margin %

43.6

%

44.2

%

Sustainability and Climate

Three Months Ended

Mar. 31,

Mar. 31,

%

In millions

2026

2025

Change

Operating revenues:

Recurring subscriptions

$

90.9

$

82.7

9.9

%

Non-recurring

1.0

1.9

(47.4

)%

Total operating revenues

91.9

84.6

8.6

%

Adjusted EBITDA expenses

58.9

60.8

(3.1

)%

Adjusted EBITDA

$

33.0

$

23.8

38.7

%

Adjusted EBITDA margin %

35.9

%

28.2

%

All Other – Private Assets

Three Months Ended

Mar. 31,

Mar. 31,

%

In millions

2026

2025

Change

Operating revenues:

Recurring subscriptions

$

71.9

$

66.8

7.6

%

Non-recurring

0.7

0.5

40.0

%

Total operating revenues

72.6

67.3

7.9

%

Adjusted EBITDA expenses

58.9

53.1

10.9

%

Adjusted EBITDA

$

13.7

$

14.2

(3.5

)%

Adjusted EBITDA margin %

18.9

%

21.1

%

Consolidated

Three Months Ended

Mar. 31,

Mar. 31,

%

In millions

2026

2025

Change

Operating revenues:

Recurring subscriptions

$

600.2

$

552.6

8.6

%

Asset-based fees

224.5

177.4

26.6

%

Non-recurring

26.1

15.8

65.2

%

Operating revenues total

850.8

745.8

14.1

%

Adjusted EBITDA expenses

346.1

320.2

8.1

%

Adjusted EBITDA

$

504.7

$

425.6

18.6

%

Operating margin %

53.7

%

50.6

%

Adjusted EBITDA margin %

59.3

%

57.1

%

Table 6: Sales and Retention Rate (unaudited)¹

Three Months Ended

Mar. 31,

Mar. 31,

%

In millions

2026

2025

Change

Index

New recurring subscription sales

$

32.8

$

22.5

45.8

%

Subscription cancellations

(8.0

)

(8.3

)

(3.6

)%

Net new recurring subscription sales

$

24.8

$

14.2

74.6

%

Non-recurring sales

$

16.7

$

12.4

34.7

%

Total gross sales

$

49.5

$

34.9

41.8

%

Total Index net sales

$

41.5

$

26.6

56.0

%

Index Retention Rate

96.9

%

96.5

%

Analytics

New recurring subscription sales

$

17.1

$

13.2

29.5

%

Subscription cancellations

(8.9

)

(7.9

)

12.7

%

Net new recurring subscription sales

$

8.2

$

5.3

54.7

%

Non-recurring sales

$

2.7

$

2.2

22.7

%

Total gross sales

$

19.8

$

15.4

28.6

%

Total Analytics net sales

$

10.9

$

7.5

45.3

%

Analytics Retention Rate

95.3

%

95.5

%

Sustainability and Climate

New recurring subscription sales

$

7.5

$

7.2

4.2

%

Subscription cancellations

(6.6

)

(4.7

)

40.4

%

Net new recurring subscription sales

$

0.9

$

2.5

(64.0

)%

Non-recurring sales

$

1.0

$

1.9

(47.4

)%

Total gross sales

$

8.5

$

9.1

(6.6

)%

Total Sustainability and Climate net sales

$

1.9

$

4.4

(56.8

)%

Sustainability and Climate Retention Rate

93.0

%

94.5

%

All Other – Private Assets

New recurring subscription sales

$

10.2

$

9.7

5.2

%

Subscription cancellations

(4.5

)

(5.6

)

(19.6

)%

Net new recurring subscription sales

$

5.7

$

4.1

39.0

%

Non-recurring sales

$

0.8

$

1.1

(27.3

)%

Total gross sales

$

11.0

$

10.8

1.9

%

Total All Other – Private Assets net sales

$

6.5

$

5.2

25.0

%

All Other – Private Assets Retention Rate

93.8

%

91.5

%

Consolidated

New recurring subscription sales

$

67.6

$

52.6

28.5

%

Subscription cancellations

(28.0

)

(26.5

)

5.7

%

Net new recurring subscription sales

$

39.6

$

26.1

51.7

%

Non-recurring sales

$

21.2

$

17.6

20.5

%

Total gross sales

$

88.8

$

70.2

26.5

%

Total net sales

$

60.8

$

43.7

39.1

%

Total Retention Rate

95.4

%

95.3

%

¹ See “Notes Regarding the Use of Operating Metrics” for details regarding the definition of new recurring subscription sales, subscription cancellations, net new recurring subscription sales, non-recurring sales, total gross sales, total net sales and Retention Rate.

Table 7: AUM in ETFs Linked to MSCI Equity Indexes (unaudited)^1,2

Three Months Ended

Mar. 31

Jun. 30

Sep. 30

Dec. 31

Mar. 31

In billions

2025

2025

2025

2025

2026

Beginning Period AUM in ETFs linked to MSCI equity indexes

$

1,725

$

1,783

$

2,025

$

2,211

$

2,341

Market Appreciation/(Depreciation)

16

193

140

63

(41

)

Cash Inflows

42

49

46

67

103

Period-End AUM in ETFs linked to MSCI equity indexes

$

1,783

$

2,025

$

2,211

$

2,341

$

2,403

Period Average AUM in ETFs linked to MSCI equity indexes

$

1,794

$

1,869

$

2,108

$

2,274

$

2,471

Period-End Basis Point Fee³

2.43

2.43

2.41

2.41

2.35

¹ The historical values of the AUM in ETFs linked to our equity indexes as of the last day of the month and the monthly average balance can be found under the link “AUM in ETFs Linked to MSCI Equity Indexes” on our Investor Relations homepage at http://ir.msci.com. Information contained on our website is not incorporated by reference into this Press Release or any other report furnished or filed with the SEC. The AUM in ETFs also includes AUM in Exchange Traded Notes, the value of which is less than 1.0% of the AUM amounts presented.

² The value of AUM in ETFs linked to MSCI equity indexes is calculated by multiplying the equity ETFs net asset value by the number of shares outstanding.

³ Based on period-end Run Rate for ETFs linked to MSCI equity indexes using period-end AUM.

Table 8: Run Rate (unaudited)¹

As of

In millions

Mar. 31,

2026

Mar. 31,

2025

%

Run Rate

Growth

%

Organic Run

Rate Growth

Index

Recurring subscriptions

$

1,049.8

$

948.4

10.7

%

10.4

%

Asset-based fees

872.0

697.2

25.1

%

24.9

%

Index Run Rate

1,921.8

1,645.6

16.8

%

16.6

%

Analytics Run Rate

763.4

707.8

7.9

%

7.4

%

Sustainability and Climate Run Rate

375.7

352.3

6.6

%

4.2

%

All Other – Private Assets Run Rate

296.4

273.5

8.4

%

7.8

%

Total Run Rate

$

3,357.3

$

2,979.2

12.7

%

12.1

%

Total recurring subscriptions

$

2,485.3

$

2,282.0

8.9

%

8.2

%

Total asset-based fees

872.0

697.2

25.1

%

24.9

%

Total Run Rate

$

3,357.3

$

2,979.2

12.7

%

12.1

%

¹ See “Notes Regarding the Use of Operating Metrics” for details regarding the definition of Run Rate.

Table 9: Reconciliation of Net Income to Adjusted EBITDA (unaudited)

Three Months Ended

Mar. 31,

Mar. 31,

In millions

2026

2025

Net income

$

406.0

$

288.6

Provision for income taxes

(16.8

)

42.5

Other expense (income), net

67.7

45.9

Operating income

456.9

377.0

Amortization of intangible assets

41.9

43.9

Depreciation and amortization of property, equipment and leasehold improvements

5.9

4.7

Consolidated adjusted EBITDA

$

504.7

$

425.6

Index adjusted EBITDA

$

375.2

$

311.6

Analytics adjusted EBITDA

82.8

76.0

Sustainability and Climate adjusted EBITDA

33.0

23.8

All Other – Private Assets adjusted EBITDA

13.7

14.2

Consolidated adjusted EBITDA

$

504.7

$

425.6

Table 10: Reconciliation of Net Income and Diluted EPS to Adjusted Net Income and Adjusted EPS (unaudited)

Three Months Ended

Mar. 31,

Mar. 31,

In millions, except per share data

2026

2025

Net income

$

406.0

$

288.6

Plus: Amortization of acquired intangible assets

19.6

25.8

Less: Tax impact of internal legal entity restructuring¹

(88.0

)

—

Less: Income tax effect²

(3.6

)

(3.3

)

Adjusted net income

$

334.0

$

311.1

Diluted EPS

$

5.53

$

3.71

Plus: Amortization of acquired intangible assets

0.27

0.33

Less: Tax impact of internal legal entity restructuring¹

(1.20

)

—

Less: Income tax effect²

(0.05

)

(0.04

)

Adjusted EPS

$

4.55

$

4.00

Diluted weighted average common shares outstanding

73.4

77.8

¹ This adjustment reflects discrete income tax expense recognized in connection with a multi-phase internal legal entity restructuring that commenced in fourth quarter 2025 and was completed in first quarter 2026. In fourth quarter 2025, the Company recognized discrete tax expense of $38 million related to the first phase and recognized a discrete tax benefit of approximately $88 million in first quarter 2026 related to the subsequent phases of this internal legal entity restructuring. Management excludes these discrete tax effects from non-GAAP results because they are not indicative of ongoing operating performance or the Company’s underlying tax profile.

² Adjustments relate to the tax effect of non-GAAP adjustments, which were determined based on the nature of the underlying non-GAAP adjustments and their relevant jurisdictional tax rates.

Table 11: Reconciliation of Operating Expenses to Adjusted EBITDA Expenses (unaudited)

Three Months Ended

Full-Year

Mar. 31,

Mar. 31,

2026

In millions

2026

2025

Guidance¹

Total operating expenses

$

393.9

$

368.8

$1,490 – $1,530

Amortization of intangible assets

41.9

43.9

Depreciation and amortization of property, equipment and leasehold improvements

5.9

4.7

$190 – $200

Consolidated adjusted EBITDA expenses

$

346.1

$

320.2

$1,305 – $1,335

Index adjusted EBITDA expenses

$

121.1

$

110.1

Analytics adjusted EBITDA expenses

107.2

96.2

Sustainability and Climate adjusted EBITDA expenses

58.9

60.8

All Other – Private Assets adjusted EBITDA expenses

58.9

53.1

Consolidated adjusted EBITDA expenses

$

346.1

$

320.2

$1,305 – $1,335

¹ We have not provided a full line-item reconciliation for total operating expenses to adjusted EBITDA expenses for this future period because we believe such a reconciliation would imply a degree of precision and certainty that could be confusing to investors and we are unable to reasonably predict certain items contained in the GAAP measure without unreasonable efforts. This is due to the inherent difficulty of forecasting the timing or amount of various items that have not yet occurred and are out of the Company’s control or cannot be reasonably predicted. For the same reasons, the Company is unable to address the probable significance of the unavailable information. Forward-looking non-GAAP financial measures provided without the most directly comparable GAAP financial measures may vary materially from the corresponding GAAP financial measures. See “Forward-Looking Statements” above.

Table 12: Reconciliation of Net Cash Provided by Operating Activities to Free Cash Flow (unaudited)

Three Months Ended

Full-Year

Mar. 31,

Mar. 31,

2026

In millions

2026

2025

Guidance¹

Net cash provided by operating activities

$

306.8

$

301.7

$1,640 – $1,690

Capital expenditures

(2.8

)

(11.6

)

Capitalized software development costs

(26.0

)

(21.3

)

Capex

(28.8

)

(32.9

)

($160 – $170)

Free cash flow

$

278.0

$

268.8

$1,470 – $1,530

¹ We have not provided a line-item reconciliation for free cash flow to net cash provided by operating activities for this future period because we believe such a reconciliation would imply a degree of precision and certainty that could be confusing to investors and we are unable to reasonably predict certain items contained in the GAAP measure without unreasonable efforts. This is due to the inherent difficulty of forecasting the timing or amount of various items that have not yet occurred and are out of the Company’s control or cannot be reasonably predicted. For the same reasons, the Company is unable to address the probable significance of the unavailable information. Forward-looking non-GAAP financial measures provided without the most directly comparable GAAP financial measures may vary materially from the corresponding GAAP financial measures. See “Forward-Looking Statements” above.

Table 13: First Quarter 2026 Reconciliation of Operating Revenue Growth to Organic Operating Revenue Growth (unaudited)

Comparison of the Three Months Ended March 31, 2026 and 2025

Total

Recurring Subscription

Asset-Based Fees

Non-Recurring Revenues

Index

Change Percentage

Change Percentage

Change Percentage

Change Percentage

Operating revenue growth

17.7

%

9.0

%

26.6

%

60.0

%

Impact of acquisitions and divestitures

(0.1

)%

(0.1

)%

(0.1

)%

—

%

Impact of foreign currency exchange rate fluctuations

—

%

0.1

%

(0.1

)%

—

%

Organic operating revenue growth

17.6

%

9.0

%

26.4

%

60.0

%

Total

Recurring Subscription

Asset-Based Fees

Non-Recurring Revenues

Analytics

Change Percentage

Change Percentage

Change Percentage

Change Percentage

Operating revenue growth

10.3

%

7.9

%

—

%

183.3

%

Impact of acquisitions and divestitures

—

%

—

%

—

%

—

%

Impact of foreign currency exchange rate fluctuations

0.2

%

0.1

%

—

%

8.4

%

Organic operating revenue growth

10.5

%

8.0

%

—

%

191.7

%

Total

Recurring Subscription

Asset-Based Fees

Non-Recurring Revenues

Sustainability and Climate

Change Percentage

Change Percentage

Change Percentage

Change Percentage

Operating revenue growth

8.6

%

9.9

%

—

%

(47.4

)%

Impact of acquisitions and divestitures

—

%

—

%

—

%

—

%

Impact of foreign currency exchange rate fluctuations

(4.9

)%

(4.9

)%

—

%

(5.2

)%

Organic operating revenue growth

3.7

%

5.0

%

—

%

(52.6

)%

Total

Recurring Subscription

Asset-Based Fees

Non-Recurring Revenues

All Other – Private Assets

Change Percentage

Change Percentage

Change Percentage

Change Percentage

Operating revenue growth

7.9

%

7.6

%

—

%

40.0

%

Impact of acquisitions and divestitures

—

%

—

%

—

%

—

%

Impact of foreign currency exchange rate fluctuations

(2.6

)%

(2.5

)%

—

%

—

%

Organic operating revenue growth

5.3

%

5.1

%

—

%

40.0

%

Total

Recurring Subscription

Asset-Based Fees

Non-Recurring Revenues

Consolidated

Change Percentage

Change Percentage

Change Percentage

Change Percentage

Operating revenue growth

14.1

%

8.6

%

26.6

%

65.2

%

Impact of acquisitions and divestitures

(0.1

)%

—

%

(0.1

)%

—

%

Impact of foreign currency exchange rate fluctuations

(0.7

)%

(1.0

)%

(0.1

)%

—

%

Organic operating revenue growth

13.3

%

7.6

%

26.4

%

65.2

%

View source version on businesswire.com: https://www.businesswire.com/news/home/20260421877853/en/

MSCI Inc. Contacts

Investor Inquiries

[email protected]

Jeremy Ulan +1 646 778 4184

[email protected]

Jisoo Suh +1 917 825 7111

Media Inquiries

[email protected]

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Posted on April 21, 2026 6:49 am
Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC)

Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC)

RAHWAY, N.J. & NUTLEY, N.J.–(BUSINESS WIRE)–
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced results from the Phase 3 LITESPARK-012 trial evaluating combination regimens for the first-line treatment of patients with advanced clear cell renal cell carcinoma (RCC). The trial evaluated the triplet therapy of KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA^® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus WELIREG^® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. The study also evaluated MK-1308A, the coformulation of KEYTRUDA and quavonlimab, Merck’s investigational anti-CTLA-4 antibody, plus LENVIMA. Both combination regimens were compared to KEYTRUDA plus LENVIMA for these patients.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260421205834/en/

At a pre-specified interim analysis, the combination regimens did not meet the dual primary endpoints of progression-free survival (PFS) and overall survival (OS) for the first-line treatment of patients with RCC compared to KEYTRUDA plus LENVIMA. The safety profiles of the combination regimens were consistent with those observed in previously reported studies evaluating the individual medicines and the KEYTRUDA plus LENVIMA combination. A full evaluation of the data from this study is ongoing, and Merck and Eisai will work with investigators to share the results with the scientific community.

“With the LITESPARK-012 trial, we explored whether combining therapies with established activity could improve upon well-established standards set by KEYTRUDA-based regimens, reflecting our commitment to continuously explore ways to improve outcomes for the kidney cancer community,” said Dr. M. Catherine Pietanza, Vice President, Global Clinical Development, Merck Research Laboratories. “While these regimens did not demonstrate the results we hoped, the data deepen our understanding of advanced renal cell carcinoma and will help shape the next generation of treatment approaches.”

“While we are disappointed that LITESPARK-012 did not meet its primary endpoints, the findings reinforce the central role of KEYTRUDA plus LENVIMA in the first-line treatment of patients with advanced renal cell carcinoma,” said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc. “Findings from trials such as this play an important role in shaping health care providers’ perspectives as the treatment paradigm for advanced renal cell carcinoma continues to evolve. We are committed to advancing the care of people living with this disease and we are grateful to the patients, caregivers and investigators whose participation and dedication made this research possible.”

Results from the LITESPARK-012 trial do not affect other ongoing trials from the LITESPARK clinical program, including those conducted jointly with Eisai. As previously announced, the U.S. Food and Drug Administration (FDA) has accepted two supplemental New Drug Applications (sNDA) for review based on the Phase 3 LITESPARK-011 trial evaluating WELIREG in combination with LENVIMA for certain previously treated patients with advanced RCC and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 4, 2026.

KEYTRUDA is currently approved as adjuvant monotherapy and in combination regimens for appropriate patients with RCC in the U.S., European Union (EU), Japan and other countries around the world. For more information, please see the “Selected KEYTRUDA^® (pembrolizumab) Indications in the U.S.” section below.

KEYTRUDA plus LENVIMA is approved in the U.S., EU, Japan and other countries for the first-line treatment of adult patients with advanced RCC. Lenvatinib is approved as KISPLYX for advanced RCC in the EU.

LENVIMA in combination with everolimus is approved in the U.S., EU and other regions for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy.

WELIREG is approved in the U.S., EU, Japan and other countries for the treatment of adult patients with advanced clear cell RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.

About LITESPARK-012

LITESPARK-012 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT04736706) evaluating either the triplet therapy of KEYTRUDA plus LENVIMA plus WELIREG or MK-1308A plus LENVIMA compared to KEYTRUDA plus LENVIMA for the first-line treatment of patients with advanced clear cell RCC. The primary endpoints are PFS, as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and OS. Secondary endpoints are objective response rate and duration of response as assessed by BICR according to RECIST v1.1, as well as safety. The study enrolled 1,688 patients who were randomized to receive:

KEYTRUDA (400 mg intravenously [IV] every six weeks [Q6W]) plus LENVIMA (20 mg orally once daily [QD]) plus WELIREG (120 mg orally QD);

MK-1308A (coformulation of pembrolizumab [400 mg] and quavonlimab [25 mg] IV Q6W) plus LENVIMA (20 mg orally QD);

KEYTRUDA (400 mg IV Q6W) plus LENVIMA (20 mg orally QD).

All study drugs were continued until protocol-specified discontinuation criteria. KEYTRUDA and MK-1308A were administered for up to two years (approximately 18 cycles). WELIREG and LENVIMA may have been administered in combination or as a single agent until progressive disease or discontinuation.

About renal cell carcinoma

Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer diagnosed and approximately 156,000 deaths from the disease worldwide. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases, and about 70% are a form called clear cell RCC, which tends to be more aggressive and faster spreading. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage.

About Merck’s research in genitourinary cancers

Merck is advancing research aimed at helping transform the treatment landscape and broaden options for people with genitourinary (GU) cancers, including bladder, kidney and prostate cancers. Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equaling over 1 in 8 of all cancer incidences. Through a robust clinical development program with more than 50 ongoing clinical trials evaluating more than 22,000 patients around the world, Merck is investigating the potential of several portfolio medicines and pipeline assets, leveraging multiple novel combination strategies, across various stages of disease, to help address unmet needs in GU cancers.

About KEYTRUDA^® (pembrolizumab) injection for intravenous use, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA^® (pembrolizumab) Indications in the U.S.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti– PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other anti–PD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after anti–PD-1/PD-L1 treatments. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between anti–PD-1/PD-L1 treatments and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using anti–PD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an anti–PD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (≥20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-054, when KEYTRUDA was administered as a single agent to patients with stage III melanoma, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (≥1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (≥20%) with KEYTRUDA was diarrhea (28%). In KEYNOTE-716, when KEYTRUDA was administered as a single agent to patients with stage IIB or IIC melanoma, adverse reactions occurring in patients with stage IIB or IIC melanoma were similar to those occurring in 1011 patients with stage III melanoma from KEYNOTE-054.

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (≥20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (≥20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (≥20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

In KEYNOTE-671, adverse reactions occurring in patients with resectable NSCLC receiving KEYTRUDA in combination with platinum-containing chemotherapy, given as neoadjuvant treatment and continued as single-agent adjuvant treatment, were generally similar to those occurring in patients in other clinical trials across tumor types receiving KEYTRUDA in combination with chemotherapy.

The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy or chemoradiotherapy were fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss, abdominal pain, arthralgia, myalgia, insomnia, palmar-plantar erythrodysesthesia, urinary tract infection, hypothyroidism, radiation skin injury, dysphagia, dry mouth, and musculoskeletal pain.

In the neoadjuvant phase of KEYNOTE-671, when KEYTRUDA was administered in combination with platinum-containing chemotherapy as neoadjuvant treatment, serious adverse reactions occurred in 34% of 396 patients. The most frequent (≥2%) serious adverse reactions were pneumonia (4.8%), venous thromboembolism (3.3%), and anemia (2%). Fatal adverse reactions occurred in 1.3% of patients, including death due to unknown cause (0.8%), sepsis (0.3%), and immune-mediated lung disease (0.3%). Permanent discontinuation of any study drug due to an adverse reaction occurred in 18% of patients who received KEYTRUDA in combination with platinum-containing chemotherapy; the most frequent adverse reactions (≥1%) that led to permanent discontinuation of any study drug were acute kidney injury (1.8%), interstitial lung disease (1.8%), anemia (1.5%), neutropenia (1.5%), and pneumonia (1.3%).

Of the KEYTRUDA-treated patients who received neoadjuvant treatment, 6% of 396 patients did not receive surgery due to adverse reactions. The most frequent (≥1%) adverse reaction that led to cancellation of surgery in the KEYTRUDA arm was interstitial lung disease (1%).

In the adjuvant phase of KEYNOTE-671, when KEYTRUDA was administered as a single agent as adjuvant treatment, serious adverse reactions occurred in 14% of 290 patients. The most frequent serious adverse reaction was pneumonia (3.4%). One fatal adverse reaction of pulmonary hemorrhage occurred. Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 12% of patients who received KEYTRUDA as a single agent, given as adjuvant treatment; the most frequent adverse reactions (≥1%) that led to permanent discontinuation of KEYTRUDA were diarrhea (1.7%), interstitial lung disease (1.4%), increased aspartate aminotransferase (1%), and musculoskeletal pain (1%).

Adverse reactions observed in KEYNOTE-091 were generally similar to those occurring in other patients with NSCLC receiving KEYTRUDA as a single agent, with the exception of hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%). Two fatal adverse reactions of myocarditis occurred.

Adverse reactions observed in KEYNOTE-483 were generally similar to those occurring in other patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy.

In KEYNOTE-689, the most common adverse reactions (≥20%) in patients receiving KEYTRUDA were stomatitis (48%), radiation skin injury (40%), weight loss (36%), fatigue (33%), dysphagia (29%), constipation (27%), hypothyroidism (26%), nausea (24%), rash (22%), dry mouth (22%), diarrhea (22%), and musculoskeletal pain (22%).

In the neoadjuvant phase of KEYNOTE-689, of the 361 patients who received at least one dose of single agent KEYTRUDA, 11% experienced serious adverse reactions. Serious adverse reactions that occurred in more than one patient were pneumonia (1.4%), tumor hemorrhage (0.8%), dysphagia (0.6%), immune-mediated hepatitis (0.6%), cellulitis (0.6%), and dyspnea (0.6%). Fatal adverse reactions occurred in 1.1% of patients, including respiratory failure, clostridium infection, septic shock, and myocardial infarction (one patient each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 2.8% of patients who received KEYTRUDA as neoadjuvant treatment. The most frequent adverse reaction which resulted in permanent discontinuation of neoadjuvant KEYTRUDA in more than one patient was arthralgia (0.6%).

Of the 361 patients who received KEYTRUDA as neoadjuvant treatment, 11% did not receive surgery. Surgical cancellation on the KEYTRUDA arm was due to disease progression in 4%, patient decision in 3%, adverse reactions in 1.4%, physician’s decision in 1.1%, unresectable tumor in 0.6%, loss of follow-up in 0.3%, and use of non-study anti-cancer therapy in 0.3%.

Of the 323 KEYTRUDA-treated patients who received surgery following the neoadjuvant phase, 1.2% experienced delay of surgery (defined as on-study surgery occurring ≥9 weeks after initiation of neoadjuvant KEYTRUDA) due to adverse reactions, and 2.8% did not receive adjuvant treatment due to adverse reactions.

In the adjuvant phase of KEYNOTE-689, of the 255 patients who received at least one dose of KEYTRUDA, 38% experienced serious adverse reactions. The most frequent serious adverse reactions reported in ≥1% of KEYTRUDA- treated patients were pneumonia (2.7%), pyrexia (2.4%), stomatitis (2.4%), acute kidney injury (2.0%), pneumonitis (1.6%), COVID-19 (1.2%), death not otherwise specified (1.2%), diarrhea (1.2%), dysphagia (1.2%), gastrostomy tube site complication (1.2%), and immune-mediated hepatitis (1.2%). Fatal adverse reactions occurred in 5% of patients, including death not otherwise specified (1.2%), acute renal failure (0.4%), hypercalcemia (0.4%), pulmonary hemorrhage (0.4%), dysphagia/malnutrition (0.4%), mesenteric thrombosis (0.4%), sepsis (0.4%), pneumonia (0.4%), COVID-19 (0.4%), respiratory failure (0.4%), cardiovascular disorder (0.4%), and gastrointestinal hemorrhage (0.4%). Permanent discontinuation of adjuvant KEYTRUDA due to an adverse reaction occurred in 17% of patients. The most frequent (≥1%) adverse reactions that led to permanent discontinuation of adjuvant KEYTRUDA were pneumonitis, colitis, immune-mediated hepatitis, and death not otherwise specified.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (≥20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (≥20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (≥20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-204, KEYTRUDA was discontinued due to adverse reactions in 14% of 148 patients with cHL. Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA; those ≥1% were pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis. Three patients died from causes other than disease progression: 2 from complications after allogeneic HSCT and 1 from unknown cause. The most common adverse reactions (≥20%) were upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), and pyrexia, fatigue, rash, and cough (20% each).

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those ≥1% were pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression: 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (≥20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (≥20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-A39, when KEYTRUDA was administered in combination with enfortumab vedotin to patients with locally advanced or metastatic urothelial cancer (n=440), fatal adverse reactions occurred in 3.9% of patients, including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%). Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with enfortumab vedotin; the serious adverse reactions in ≥2% of patients were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Permanent discontinuation of KEYTRUDA occurred in 27% of patients. The most common adverse reactions (≥2%) resulting in permanent discontinuation of KEYTRUDA were pneumonitis/ILD (4.8%) and rash (3.4%). The most common adverse reactions (≥20%) occurring in patients treated with KEYTRUDA in combination with enfortumab vedotin were rash (68%), peripheral neuropathy (67%), fatigue (51%), pruritus (41%), diarrhea (38%), alopecia (35%), weight loss (33%), decreased appetite (33%), nausea (26%), constipation (26%), dry eye (24%), dysgeusia (21%), and urinary tract infection (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those ≥2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (≥20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those ≥2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (≥20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-905, the most common adverse reactions (≥20%) occurring in cisplatin-ineligible patients with MIBC treated with KEYTRUDA in combination with enfortumab vedotin (n=167) were rash (54%), pruritus (47%), fatigue (47%), peripheral neuropathy (39%), alopecia (35%), dysgeusia (35%), diarrhea (34%), constipation (28%), decreased appetite (28%), nausea (26%), urinary tract infection (24%), dry eye (21%), and weight loss (20%).

In the neoadjuvant phase of KEYNOTE-905, serious adverse reactions occurred in 27% (n=167) of patients; the most frequent (≥2%) were urinary tract infection (3.6%) and hematuria (2.4%). Fatal adverse reactions occurred in 1.2% of patients, including myasthenia gravis and toxic epidermal necrolysis (0.6% each). Additional fatal adverse reactions were reported in 2.7% of patients in the post-surgery phase before adjuvant treatment started, including sepsis and intestinal obstruction (1.4% each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 15% of patients; the most frequent (>1%) were rash (2.4%, including generalized exfoliative dermatitis), increased alanine aminotransferase, increased aspartate aminotransferase, diarrhea, dysgeusia, and toxic epidermal necrolysis (1.2% each). Of the 167 patients in the KEYTRUDA in combination with enfortumab vedotin arm who received neoadjuvant treatment, 7 (4.2%) patients did not receive surgery due to adverse reactions. The adverse reactions that led to cancellation of surgery were acute myocardial infarction, bile duct cancer, colon cancer, respiratory distress, urinary tract infection, and the two deaths due to myasthenia gravis and toxic epidermal necrolysis (0.6% each).

Of the 146 patients who received neoadjuvant treatment with KEYTRUDA in combination with enfortumab vedotin and underwent radical cystectomy, 6 (4.1%) patients experienced delay of surgery (defined as time from last neoadjuvant treatment to surgery exceeding 8 weeks) due to adverse reactions.

In the adjuvant phase of KEYNOTE-905, serious adverse reactions occurred in 43% (n=100) of patients; the most frequent (≥2%) were urinary tract infection (8%); acute kidney injury and pyelonephritis (5% each); urosepsis (4%); and hypokalemia, intestinal obstruction, and sepsis (2% each). Fatal adverse reactions occurred in 7% of patients, including urosepsis, intracranial hemorrhage, death, myocardial infarction, multiple organ dysfunction syndrome, and pseudomonal pneumonia (1% each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 28% of patients; the most frequent (>1%) were diarrhea (5%), peripheral neuropathy, acute kidney injury, and pneumonitis (2% each).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those ≥2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (≥20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with MSI-H or dMMR CRC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158 and KEYNOTE-164, adverse reactions occurring in patients with MSI-H or dMMR cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-811, fatal adverse reactions occurred in 3 patients who received KEYTRUDA in combination with trastuzumab and CAPOX (capecitabine plus oxaliplatin) or FP (5-FU plus cisplatin) and included pneumonitis in 2 patients and hepatitis in 1 patient. KEYTRUDA was discontinued due to adverse reactions in 13% of 350 patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma. Adverse reactions resulting in permanent discontinuation of KEYTRUDA in ≥1% of patients were pneumonitis (2.0%) and pneumonia (1.1%). In the KEYTRUDA arm vs placebo, there was a difference of ≥5% incidence between patients treated with KEYTRUDA vs standard of care for diarrhea (53% vs 47%), rash (35% vs 28%), hypothyroidism (11% vs 5%), and pneumonia (11% vs 5%).

In KEYNOTE-859, when KEYTRUDA was administered in combination with fluoropyrimidine- and platinum-containing chemotherapy, serious adverse reactions occurred in 45% of 785 patients. Serious adverse reactions in >2% of patients included pneumonia (4.1%), diarrhea (3.9%), hemorrhage (3.9%), and vomiting (2.4%). Fatal adverse reactions occurred in 8% of patients who received KEYTRUDA, including infection (2.3%) and thromboembolism (1.3%). KEYTRUDA was permanently discontinued due to adverse reactions in 15% of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were infections (1.8%) and diarrhea (1.0%). The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were peripheral neuropathy (47%), nausea (46%), fatigue (40%), diarrhea (36%), vomiting (34%), decreased appetite (29%), abdominal pain (26%), palmar-plantar erythrodysesthesia syndrome (25%), constipation (22%), and weight loss (20%).

In KEYNOTE-590, when KEYTRUDA was administered with cisplatin and fluorouracil to patients with metastatic or locally advanced esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation, KEYTRUDA was discontinued due to adverse reactions in 15% of 370 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were pneumonitis (1.6%), acute kidney injury (1.1%), and pneumonia (1.1%). The most common adverse reactions (≥20%) with KEYTRUDA in combination with chemotherapy were nausea (67%), fatigue (57%), decreased appetite (44%), constipation (40%), diarrhea (36%), vomiting (34%), stomatitis (27%), and weight loss (24%).

Adverse reactions occurring in patients with esophageal cancer who received KEYTRUDA as a monotherapy were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-A18, when KEYTRUDA was administered with CRT (cisplatin plus external beam radiation therapy [EBRT] followed by brachytherapy [BT]) to patients with FIGO 2014 Stage III-IVA cervical cancer, fatal adverse reactions occurred in 1.4% of 294 patients, including 1 case each (0.3%) of large intestinal perforation, urosepsis, sepsis, and vaginal hemorrhage. Serious adverse reactions occurred in 34% of patients; those ≥1% included urinary tract infection (3.1%), urosepsis (1.4%), and sepsis (1%). KEYTRUDA was discontinued for adverse reactions in 9% of patients. The most common adverse reaction (≥1%) resulting in permanent discontinuation was diarrhea (1%). For patients treated with KEYTRUDA in combination with CRT, the most common adverse reactions (≥10%) were nausea (56%), diarrhea (51%), urinary tract infection (35%), vomiting (34%), fatigue (28%), hypothyroidism (23%), constipation (20%), weight loss (19%), decreased appetite (18%), pyrexia (14%), abdominal pain and hyperthyroidism (13% each), dysuria and rash (12% each), back and pelvic pain (11% each), and COVID-19 (10%).

In KEYNOTE-826, when KEYTRUDA was administered in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab (n=307), to patients with persistent, recurrent, or first-line metastatic cervical cancer regardless of tumor PD-L1 expression who had not been treated with chemotherapy except when used concurrently as a radio-sensitizing agent, fatal adverse reactions occurred in 4.6% of patients, including 3 cases of hemorrhage, 2 cases each of sepsis and due to unknown causes, and 1 case each of acute myocardial infarction, autoimmune encephalitis, cardiac arrest, cerebrovascular accident, femur fracture with perioperative pulmonary embolus, intestinal perforation, and pelvic infection. Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with chemotherapy with or without bevacizumab; those ≥3% were febrile neutropenia (6.8%), urinary tract infection (5.2%), anemia (4.6%), and acute kidney injury and sepsis (3.3% each).

KEYTRUDA was discontinued in 15% of patients due to adverse reactions. The most common adverse reaction resulting in permanent discontinuation (≥1%) was colitis (1%).

For patients treated with KEYTRUDA, chemotherapy, and bevacizumab (n=196), the most common adverse reactions (≥20%) were peripheral neuropathy (62%), alopecia (58%), anemia (55%), fatigue/asthenia (53%), nausea and neutropenia (41% each), diarrhea (39%), hypertension and thrombocytopenia (35% each), constipation and arthralgia (31% each), vomiting (30%), urinary tract infection (27%), rash (26%), leukopenia (24%), hypothyroidism (22%), and decreased appetite (21%).

For patients treated with KEYTRUDA in combination with chemotherapy with or without bevacizumab, the most common adverse reactions (≥20%) were peripheral neuropathy (58%), alopecia (56%), fatigue (47%), nausea (40%), diarrhea (36%), constipation (28%), arthralgia (27%), vomiting (26%), hypertension and urinary tract infection (24% each), and rash (22%).

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with previously treated recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (≥20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

In KEYNOTE-394, KEYTRUDA was discontinued due to adverse reactions in 13% of 299 patients with previously treated hepatocellular carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was ascites (2.3%). The most common adverse reactions in patients receiving KEYTRUDA (≥10%) were pyrexia (18%), rash (18%), diarrhea (16%), decreased appetite (15%), pruritus (12%), upper respiratory tract infection (11%), cough (11%), and hypothyroidism (10%).

In KEYNOTE-966, when KEYTRUDA was administered in combination with gemcitabine and cisplatin, KEYTRUDA was discontinued for adverse reactions in 15% of 529 patients with locally advanced unresectable or metastatic biliary tract cancer. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA (≥1%) was pneumonitis (1.3%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 55% of patients. The most common adverse reactions or laboratory abnormalities leading to interruption of KEYTRUDA (≥2%) were decreased neutrophil count (18%), decreased platelet count (10%), anemia (6%), decreased white blood cell count (4%), pyrexia (3.8%), fatigue (3.0%), cholangitis (2.8%), increased ALT (2.6%), increased AST (2.5%), and biliary obstruction (2.3%).

In KEYNOTE-017 and KEYNOTE-913, adverse reactions occurring in patients with MCC (n=105) were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (≥1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (≥20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

In KEYNOTE-581, when KEYTRUDA was administered in combination with LENVIMA to patients with advanced renal cell carcinoma (n=352), fatal adverse reactions occurred in 4.3% of patients. Serious adverse reactions occurred in 51% of patients; the most common (≥2%) were hemorrhagic events (5%), diarrhea (4%), hypertension, myocardial infarction, pneumonitis, and vomiting (3% each), acute kidney injury, adrenal insufficiency, dyspnea, and pneumonia (2% each).

Permanent discontinuation of KEYTRUDA, LENVIMA, or both due to an adverse reaction occurred in 37% of patients; 29% KEYTRUDA only, 26% LENVIMA only, and 13% both. The most common adverse reaction (≥2%) resulting in permanent discontinuation of KEYTRUDA, LENVIMA, or the combination were pneumonitis, myocardial infarction, hepatotoxicity, acute kidney injury, rash (3% each), and diarrhea (2%).

The most common adverse reactions (≥20%) observed with KEYTRUDA in combination with LENVIMA were fatigue (63%), diarrhea (62%), musculoskeletal disorders (58%), hypothyroidism (57%), hypertension (56%), stomatitis (43%), decreased appetite (41%), rash (37%), nausea (36%), weight loss, dysphonia and proteinuria (30% each), palmar-plantar erythrodysesthesia syndrome (29%), abdominal pain and hemorrhagic events (27% each), vomiting (26%), constipation and hepatotoxicity (25% each), headache (23%), and acute kidney injury (21%).

In KEYNOTE-564, when KEYTRUDA was administered as a single agent for the adjuvant treatment of renal cell carcinoma, serious adverse reactions occurred in 20% of patients receiving KEYTRUDA; the serious adverse reactions (≥1%) were acute kidney injury, adrenal insufficiency, pneumonia, colitis, and diabetic ketoacidosis (1% each). Fatal adverse reactions occurred in 0.2% including 1 case of pneumonia. Discontinuation of KEYTRUDA due to adverse reactions occurred in 21% of 488 patients; the most common (≥1%) were increased ALT (1.6%), colitis (1%), and adrenal insufficiency (1%). The most common adverse reactions (≥20%) were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%), and hypothyroidism (21%).

In KEYNOTE-868, when KEYTRUDA was administered in combination with chemotherapy (paclitaxel and carboplatin) to patients with advanced or recurrent endometrial carcinoma (n=382), serious adverse reactions occurred in 35% of patients receiving KEYTRUDA in combination with chemotherapy, compared to 19% of patients receiving placebo in combination with chemotherapy (n=377). Fatal adverse reactions occurred in 1.6% of patients receiving KEYTRUDA in combination with chemotherapy, including COVID-19 (0.5%) and cardiac arrest (0.3%). KEYTRUDA was discontinued for an adverse reaction in 14% of patients. Adverse reactions occurring in patients treated with KEYTRUDA and chemotherapy were generally similar to those observed with KEYTRUDA alone or chemotherapy alone, with the exception of rash (33% all Grades; 2.9% Grades 3-4).

In KEYNOTE-775, when KEYTRUDA was administered in combination with LENVIMA to patients with advanced endometrial carcinoma that was pMMR or not MSI-H (n=342), fatal adverse reactions occurred in 4.7% of patients. Serious adverse reactions occurred in 50% of these patients; the most common (≥3%) were hypertension (4.4%) and urinary tract infections (3.2%).

Discontinuation of KEYTRUDA due to an adverse reaction occurred in 15% of these patients. The most common adverse reaction leading to discontinuation of KEYTRUDA (≥1%) was increased ALT (1.2%).

The most common adverse reactions for KEYTRUDA in combination with LENVIMA (reported in ≥20% patients) were hypothyroidism and hypertension (67% each), fatigue (58%), diarrhea (55%), musculoskeletal disorders (53%), nausea (49%), decreased appetite (44%), vomiting (37%), stomatitis (35%), abdominal pain and weight loss (34% each), urinary tract infections (31%), proteinuria (29%), constipation (27%), headache (26%), hemorrhagic events (25%), palmar-plantar erythrodysesthesia (23%), dysphonia (22%), and rash (20%).

Adverse reactions occurring in patients with MSI-H or dMMR endometrial carcinoma who received KEYTRUDA as a single agent were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.

Adverse reactions occurring in patients with TMB-H cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

Adverse reactions occurring in patients with recurrent or metastatic cSCC or locally advanced cSCC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-522, when KEYTRUDA was administered with neoadjuvant chemotherapy (carboplatin and paclitaxel followed by doxorubicin or epirubicin and cyclophosphamide) followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent (n=778) to patients with newly diagnosed, previously untreated, high-risk early-stage TNBC, fatal adverse reactions occurred in 0.9% of patients, including 1 each of adrenal crisis, autoimmune encephalitis, hepatitis, pneumonia, pneumonitis, pulmonary embolism, and sepsis in association with multiple organ dysfunction syndrome and myocardial infarction. Serious adverse reactions occurred in 44% of patients receiving KEYTRUDA; those ≥2% were febrile neutropenia (15%), pyrexia (3.7%), anemia (2.6%), and neutropenia (2.2%). KEYTRUDA was discontinued in 20% of patients due to adverse reactions. The most common reactions (≥1%) resulting in permanent discontinuation were increased ALT (2.7%), increased AST (1.5%), and rash (1%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA were fatigue (70%), nausea (67%), alopecia (61%), rash (52%), constipation (42%), diarrhea and peripheral neuropathy (41% each), stomatitis (34%), vomiting (31%), headache (30%), arthralgia (29%), pyrexia (28%), cough (26%), abdominal pain (24%), decreased appetite (23%), insomnia (21%), and myalgia (20%).

In KEYNOTE-355, when KEYTRUDA and chemotherapy (paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin) were administered to patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting (n=596), fatal adverse reactions occurred in 2.5% of patients, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with chemotherapy; the serious reactions in ≥2% were pneumonia (2.9%), anemia (2.2%), and thrombocytopenia (2%). KEYTRUDA was discontinued in 11% of patients due to adverse reactions. The most common reactions resulting in permanent discontinuation (≥1%) were increased ALT (2.2%), increased AST (1.5%), and pneumonitis (1.2%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%).

In KEYNOTE-B96, when KEYTRUDA was administered in combination with paclitaxel, with or without bevacizumab, serious adverse reactions occurred in 54% of patients. Serious adverse reactions in ≥2% of patients were pneumonia (4.3%), urinary tract infection (3.9%), adrenal insufficiency (3%), hyponatremia (3%), COVID-19, decreased neutrophil count, pulmonary embolism (2.6% each), abdominal pain, anemia, colitis, diarrhea, febrile neutropenia, pyrexia, and vomiting (2.1% each).

Fatal adverse reactions occurred in 3.9% of patients receiving KEYTRUDA and paclitaxel, with or without bevacizumab, including assisted suicide (0.9%), death, intestinal perforation, sepsis, COVID-19, cardio-respiratory arrest, colitis, and embolic stroke (0.4% each).

KEYTRUDA was permanently discontinued for adverse reactions in 16% of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were colitis and increased alanine aminotransferase (1.3% each). Adverse reactions leading to the interruption of KEYTRUDA occurred in 44% of patients. The most common adverse reactions leading to interruption of KEYTRUDA in ≥2% were urinary tract infection (3.9%), adrenal insufficiency, pyrexia, pneumonitis, upper respiratory tract infection (2.6% each), neutropenia, diarrhea, and COVID-19 (2.1% each).

The most common adverse reactions (≥20%) for patients treated with KEYTRUDA in combination with paclitaxel, with or without bevacizumab, were diarrhea (45%), fatigue (43%), nausea (41%), alopecia, peripheral neuropathy (38% each), epistaxis (31%), urinary tract infection (27%), constipation (25%), abdominal pain, decreased appetite, vomiting (24% each), hypothyroidism (21%), cough, hypertension, and rash (20% each).

For patients treated with KEYTRUDA in combination with paclitaxel and bevacizumab (N=169), decreased white blood cell count (27%), stomatitis (22%), and pyrexia (21%) were also reported as adverse reactions.

Lactation

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose.

Pediatric Use

In KEYNOTE-051, 173 pediatric patients (65 pediatric patients aged 6 months to younger than 12 years and 108 pediatric patients aged 12 years to 17 years) were administered KEYTRUDA 2 mg/kg every 3 weeks. The median duration of exposure was 2.1 months (range: 1 day to 25 months).

Adverse reactions that occurred at a ≥10% higher rate in pediatric patients when compared to adults were pyrexia (33%), leukopenia (30%), vomiting (29%), neutropenia (28%), headache (25%), abdominal pain (23%), thrombocytopenia (22%), Grade 3 anemia (17%), decreased lymphocyte count (13%), and decreased white blood cell count (11%).

Geriatric Use

Of the 564 patients with locally advanced or metastatic urothelial cancer treated with KEYTRUDA in combination with enfortumab vedotin, 44% (n=247) were 65-74 years and 26% (n=144) were 75 years or older. No overall differences in effectiveness were observed between patients 65 years of age or older and younger patients. Patients 75 years of age or older treated with KEYTRUDA in combination with enfortumab vedotin experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older.

Of the 167 patients with MIBC treated with KEYTRUDA in combination with enfortumab vedotin, 37% (n=61) were 65-74 years and 46% (n=77) were 75 years or older. Patients 75 years of age or older treated with KEYTRUDA in combination with enfortumab vedotin experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 4% in patients younger than 75 and 12% in patients 75 years or older.

Additional Selected KEYTRUDA Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is:

Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or

metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

Malignant Pleural Mesothelioma

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

Head and Neck Squamous Cell Cancer

KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Cancer

KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma:

who are not eligible for any platinum-containing chemotherapy, or

who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test.

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.

KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥1), or

as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.

Cervical Cancer

KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.

Biliary Tract Cancer

KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Endometrial Carcinoma

KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting are not candidates for curative surgery or radiation.

KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.

Ovarian Cancer

KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.

Please see Prescribing Information for KEYTRUDA (pembrolizumab) at https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.

About LENVIMA^® (lenvatinib); available as 10 mg and 4 mg capsules

LENVIMA, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. The combination of LENVIMA and everolimus showed increased antiangiogenic and antitumor activity as demonstrated by decreased human endothelial cell proliferation, tube formation, and VEGF signaling in vitro and tumor volume in mouse xenograft models of human renal cell cancer greater than each drug alone.

LENVIMA^® (lenvatinib) Indications in the U.S.

For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).

In combination with pembrolizumab, for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

In combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.

For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Selected Safety Information for LENVIMA

Warnings and Precautions

Hypertension. In differentiated thyroid cancer (DTC), hypertension occurred in 73% of patients on LENVIMA (44% grade 3-4). In advanced renal cell carcinoma (RCC), hypertension occurred in 42% of patients on LENVIMA + everolimus (13% grade 3). Systolic blood pressure ≥160 mmHg occurred in 29% of patients, and 21% had diastolic blood pressure ≥100 mmHg. In unresectable hepatocellular carcinoma (HCC), hypertension occurred in 45% of LENVIMA-treated patients (24% grade 3). Grade 4 hypertension was not reported in HCC.

Serious complications of poorly controlled hypertension have been reported. Control blood pressure prior to initiation. Monitor blood pressure after 1 week, then every 2 weeks for the first 2 months, and then at least monthly thereafter during treatment. Withhold and resume at reduced dose when hypertension is controlled or permanently discontinue based on severity.

Cardiac Dysfunction. Serious and fatal cardiac dysfunction can occur with LENVIMA. Across clinical trials in 799 patients with DTC, RCC, and HCC, grade 3 or higher cardiac dysfunction occurred in 3% of LENVIMA-treated patients. Monitor for clinical symptoms or signs of cardiac dysfunction. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Arterial Thromboembolic Events. Among patients receiving LENVIMA or LENVIMA + everolimus, arterial thromboembolic events of any severity occurred in 2% of patients in RCC and HCC and 5% in DTC. Grade 3-5 arterial thromboembolic events ranged from 2% to 3% across all clinical trials.

Among patients receiving LENVIMA with KEYTRUDA, arterial thrombotic events of any severity occurred in 5% of patients in CLEAR, including myocardial infarction (3.4%) and cerebrovascular accident (2.3%).

Permanently discontinue following an arterial thrombotic event. The safety of resuming after an arterial thromboembolic event has not been established, and LENVIMA has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months.

Hepatotoxicity. Across clinical studies enrolling 1,327 LENVIMA-treated patients with malignancies other than HCC, serious hepatic adverse reactions occurred in 1.4% of patients. Fatal events, including hepatic failure, acute hepatitis and hepatorenal syndrome, occurred in 0.5% of patients. In HCC, hepatic encephalopathy occurred in 8% of LENVIMA-treated patients (5% grade 3-5). Grade 3-5 hepatic failure occurred in 3% of LENVIMA-treated patients. 2% of patients discontinued LENVIMA due to hepatic encephalopathy and 1% discontinued due to hepatic failure.

Monitor liver function prior to initiation, then every 2 weeks for the first 2 months, and at least monthly thereafter during treatment. Monitor patients with HCC closely for signs of hepatic failure, including hepatic encephalopathy. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Renal Failure or Impairment. Serious, including fatal renal failure or impairment, can occur with LENVIMA. Renal impairment was reported in 14% and 7% of LENVIMA-treated patients in DTC and HCC, respectively. Grade 3-5 renal failure or impairment occurred in 3% of patients with DTC and 2% of patients with HCC, including 1 fatal event in each study. In RCC, renal impairment or renal failure was reported in 18% of LENVIMA + everolimus–treated patients (10% grade 3).

Initiate prompt management of diarrhea or dehydration/hypovolemia. Withhold and resume at reduced dose upon recovery or permanently discontinue for renal failure or impairment based on severity.

Proteinuria. In DTC and HCC, proteinuria was reported in 34% and 26% of LENVIMA-treated patients, respectively. Grade 3 proteinuria occurred in 11% and 6% in DTC and HCC, respectively. In RCC, proteinuria occurred in 31% of patients receiving LENVIMA + everolimus (8% grade 3). Monitor for proteinuria prior to initiation and periodically during treatment. If urine dipstick proteinuria ≥2+ is detected, obtain a 24-hour urine protein. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Diarrhea. Of the 737 LENVIMA-treated patients in DTC and HCC, diarrhea occurred in 49% (6% grade 3). In RCC, diarrhea occurred in 81% of LENVIMA + everolimus–treated patients (19% grade 3). Diarrhea was the most frequent cause of dose interruption/reduction, and diarrhea recurred despite dose reduction. Promptly initiate management of diarrhea. Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Fistula Formation and Gastrointestinal Perforation. Of the 799 patients treated with LENVIMA or LENVIMA + everolimus in DTC, RCC, and HCC, fistula or gastrointestinal perforation occurred in 2%. Permanently discontinue in patients who develop gastrointestinal perforation of any severity or grade 3-4 fistula.

QT Interval Prolongation. In DTC, QT/QTc interval prolongation occurred in 9% of LENVIMA-treated patients and QT interval prolongation of >500 ms occurred in 2%. In RCC, QTc interval increases of >60 ms occurred in 11% of patients receiving LENVIMA + everolimus and QTc interval >500 ms occurred in 6%. In HCC, QTc interval increases of >60 ms occurred in 8% of LENVIMA-treated patients and QTc interval >500 ms occurred in 2%.

Monitor and correct electrolyte abnormalities at baseline and periodically during treatment. Monitor electrocardiograms in patients with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or those who are taking drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics. Withhold and resume at reduced dose upon recovery based on severity.

Hypocalcemia. In DTC, grade 3-4 hypocalcemia occurred in 9% of LENVIMA-treated patients. In 65% of cases, hypocalcemia improved or resolved following calcium supplementation with or without dose interruption or dose reduction. In RCC, grade 3-4 hypocalcemia occurred in 6% of LENVIMA + everolimus–treated patients. In HCC, grade 3 hypocalcemia occurred in 0.8% of LENVIMA-treated patients. Monitor blood calcium levels at least monthly and replace calcium as necessary during treatment. Withhold and resume at reduced dose upon recovery or permanently discontinue depending on severity.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS). Across clinical studies of 1,823 patients who received LENVIMA as a single agent, RPLS occurred in 0.3%. Confirm diagnosis of RPLS with MRI. Withhold and resume at reduced dose upon recovery or permanently discontinue depending on severity and persistence of neurologic symptoms.

Hemorrhagic Events. Serious including fatal hemorrhagic events can occur with LENVIMA. In DTC, RCC, and HCC clinical trials, hemorrhagic events, of any grade, occurred in 29% of the 799 patients treated with LENVIMA as a single agent or in combination with everolimus. The most frequently reported hemorrhagic events (all grades and occurring in at least 5% of patients) were epistaxis and hematuria. In DTC, grade 3-5 hemorrhage occurred in 2% of LENVIMA-treated patients, including 1 fatal intracranial hemorrhage among 16 patients who received LENVIMA and had CNS metastases at baseline. In RCC, grade 3-5 hemorrhage occurred in 8% of LENVIMA + everolimus–treated patients, including 1 fatal cerebral hemorrhage. In HCC, grade 3-5 hemorrhage occurred in 5% of LENVIMA-treated patients, including 7 fatal hemorrhagic events. Serious tumor-related bleeds, including fatal hemorrhagic events, occurred in LENVIMA-treated patients in clinical trials and in the postmarketing setting. In postmarketing surveillance, serious and fatal carotid artery hemorrhages were seen more frequently in patients with anaplastic thyroid carcinoma (ATC) than other tumors. Safety and effectiveness of LENVIMA in patients with ATC have not been demonstrated in clinical trials.

Consider the risk of severe or fatal hemorrhage associated with tumor invasion or infiltration of major blood vessels (eg, carotid artery). Withhold and resume at reduced dose upon recovery or permanently discontinue based on severity.

Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction. LENVIMA impairs exogenous thyroid suppression. In DTC, 88% of patients had baseline thyroid stimulating hormone (TSH) level ≤0.5 mU/L. In patients with normal TSH at baseline, elevation of TSH level >0.5 mU/L was observed post baseline in 57% of LENVIMA-treated patients. In RCC and HCC, grade 1 or 2 hypothyroidism occurred in 24% of LENVIMA + everolimus–treated patients and 21% of LENVIMA-treated patients, respectively. In patients with normal or low TSH at baseline, elevation of TSH was observed post baseline in 70% of LENVIMA-treated patients in HCC and 60% of LENVIMA + everolimus–treated patients in RCC.

Monitor thyroid function prior to initiation and at least monthly during treatment. Treat hypothyroidism according to standard medical practice.

Impaired Wound Healing. Impaired wound healing has been reported in patients who received LENVIMA. Withhold LENVIMA for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of LENVIMA after resolution of wound healing complications has not been established.

Osteonecrosis of the Jaw (ONJ). ONJ has been reported in patients receiving LENVIMA. Concomitant exposure to other risk factors, such as bisphosphonates, denosumab, dental disease or invasive dental procedures, may increase the risk of ONJ.

Perform an oral examination prior to treatment with LENVIMA and periodically during LENVIMA treatment. Advise patients regarding good oral hygiene practices and to consider having preventive dentistry performed prior to treatment with LENVIMA and throughout treatment with LENVIMA.

Avoid invasive dental procedures, if possible, while on LENVIMA treatment, particularly in patients at higher risk. Withhold LENVIMA for at least 1 week prior to scheduled dental surgery or invasive dental procedures, if possible. For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk of ONJ.

Withhold LENVIMA if ONJ develops and restart based on clinical judgement of adequate resolution.

Embryo-Fetal Toxicity. Based on its mechanism of action and data from animal reproduction studies, LENVIMA can cause fetal harm when administered to pregnant women. In animal reproduction studies, oral administration of LENVIMA during organogenesis at doses below the recommended clinical doses resulted in embryotoxicity, fetotoxicity, and teratogenicity in rats and rabbits. Advise pregnant women of the potential risk to a fetus; and advise females of reproductive potential to use effective contraception during treatment with LENVIMA and for 30 days after the last dose.

Adverse Reactions

In DTC, the most common adverse reactions (≥30%) observed in LENVIMA-treated patients were hypertension (73%), fatigue (67%), diarrhea (67%), arthralgia/myalgia (62%), decreased appetite (54%), decreased weight (51%), nausea (47%), stomatitis (41%), headache (38%), vomiting (36%), proteinuria (34%), palmar-plantar erythrodysesthesia syndrome (32%), abdominal pain (31%), and dysphonia (31%). The most common serious adverse reactions (≥2%) were pneumonia (4%), hypertension (3%), and dehydration (3%). Adverse reactions led to dose reductions in 68% of LENVIMA-treated patients; 18% discontinued LENVIMA. The most common adverse reactions (≥10%) resulting in dose reductions were hypertension (13%), proteinuria (11%), decreased appetite (10%), and diarrhea (10%); the most common adverse reactions (≥1%) resulting in discontinuation of LENVIMA were hypertension (1%) and asthenia (1%).

In RCC, the most common adverse reactions (≥20%) observed in LENVIMA + KEYTRUDA-treated patients were fatigue (63%), diarrhea (62%), musculoskeletal pain (58%), hypothyroidism (57%), hypertension (56%), stomatitis (43%), decreased appetite (41%), rash (37%), nausea (36%), decreased weight (30%), dysphonia (30%), proteinuria (30%), palmar-plantar erythrodysesthesia syndrome (29%), abdominal pain (27%), hemorrhagic events (27%), vomiting (26%), constipation (25%), hepatotoxicity (25%), headache (23%), and acute kidney injury (21%). Fatal adverse reactions occurred in 4.3% of patients receiving LENVIMA in combination with KEYTRUDA, including cardio-respiratory arrest (0.9%), sepsis (0.9%), and one case (0.3%) each of arrhythmia, autoimmune hepatitis, dyspnea, hypertensive crisis, increased blood creatinine, multiple organ dysfunction syndrome, myasthenic syndrome, myocarditis, nephritis, pneumonitis, ruptured aneurysm and subarachnoid hemorrhage. Serious adverse reactions occurred in 51% of patients receiving LENVIMA and KEYTRUDA. Serious adverse reactions in ≥2% of patients were hemorrhagic events (5%), diarrhea (4%), hypertension (3%), myocardial infarction (3%), pneumonitis (3%), vomiting (3%), acute kidney injury (2%), adrenal insufficiency (2%), dyspnea (2%), and pneumonia (2%). Permanent discontinuation of LENVIMA, KEYTRUDA, or both due to an adverse reaction occurred in 37% of patients; 26% LENVIMA only, 29% KEYTRUDA only, and 13% both drugs. The most common adverse reactions (≥2%) leading to permanent discontinuation of LENVIMA, KEYTRUDA, or both were pneumonitis (3%), myocardial infarction (3%), hepatotoxicity (3%), acute kidney injury (3%), rash (3%), and diarrhea (2%). Dose interruptions of LENVIMA, KEYTRUDA, or both due to an adverse reaction occurred in 78% of patients receiving LENVIMA in combination with KEYTRUDA. LENVIMA was interrupted in 73% of patients and both drugs were interrupted in 39% of patients. LENVIMA was dose reduced in 69% of patients. The most common adverse reactions (≥5%) resulting in dose reduction or interruption of LENVIMA were diarrhea (26%), fatigue (18%), hypertension (17%), proteinuria (13%), decreased appetite (12%), palmar-plantar erythrodysesthesia (11%), nausea (9%), stomatitis (9%), musculoskeletal pain (8%), rash (8%), increased lipase (7%), abdominal pain (6%), vomiting (6%), increased ALT (5%), and increased amylase (5%).

In RCC, the most common adverse reactions (≥30%) observed in LENVIMA + everolimus–treated patients were diarrhea (81%), fatigue (73%), arthralgia/myalgia (55%), decreased appetite (53%), vomiting (48%), nausea (45%), stomatitis (44%), hypertension (42%), peripheral edema (42%), cough (37%), abdominal pain (37%), dyspnea (35%), rash (35%), decreased weight (34%), hemorrhagic events (32%), and proteinuria (31%). The most common serious adverse reactions (≥5%) were renal failure (11%), dehydration (10%), anemia (6%), thrombocytopenia (5%), diarrhea (5%), vomiting (5%), and dyspnea (5%). Adverse reactions led to dose reductions or interruption in 89% of patients. The most common adverse reactions (≥5%) resulting in dose reductions were diarrhea (21%), fatigue (8%), thrombocytopenia (6%), vomiting (6%), nausea (5%), and proteinuria (5%). Treatment discontinuation due to an adverse reaction occurred in 29% of patients.

In HCC, the most common adverse reactions (≥20%) observed in LENVIMA-treated patients were hypertension (45%), fatigue (44%), diarrhea (39%), decreased appetite (34%), arthralgia/myalgia (31%), decreased weight (31%), abdominal pain (30%), palmar-plantar erythrodysesthesia syndrome (27%), proteinuria (26%), dysphonia (24%), hemorrhagic events (23%), hypothyroidism (21%), and nausea (20%). The most common serious adverse reactions (≥2%) were hepatic encephalopathy (5%), hepatic failure (3%), ascites (3%), and decreased appetite (2%). Adverse reactions led to dose reductions or interruption in 62% of patients. The most common adverse reactions (≥5%) resulting in dose reductions were fatigue (9%), decreased appetite (8%), diarrhea (8%), proteinuria (7%), hypertension (6%), and palmar-plantar erythrodysesthesia syndrome (5%). Treatment discontinuation due to an adverse reaction occurred in 20% of patients. The most common adverse reactions (≥1%) resulting in discontinuation of LENVIMA were fatigue (1%), hepatic encephalopathy (2%), hyperbilirubinemia (1%), and hepatic failure (1%).

In endometrial carcinoma, the most common adverse reactions (≥20%) observed in LENVIMA + KEYTRUDA-treated patients were hypothyroidism (67%), hypertension (67%), fatigue (58%), diarrhea (55%), musculoskeletal disorders (53%), nausea (49%), decreased appetite (44%), vomiting (37%), stomatitis (35%), decreased weight (34%), abdominal pain (34%), urinary tract infection (31%), proteinuria (29%), constipation (27%), headache (26%), hemorrhagic events (25%), palmar-plantar erythrodysesthesia (23%), dysphonia (22%), and rash (20%). Fatal adverse reactions among these patients occurred in 4.7% of those treated with LENVIMA and KEYTRUDA, including 2 cases of pneumonia, and 1 case of the following: acute kidney injury, acute myocardial infarction, colitis, decreased appetite, intestinal perforation, lower gastrointestinal hemorrhage, malignant gastrointestinal obstruction, multiple organ dysfunction syndrome, myelodysplastic syndrome, pulmonary embolism, and right ventricular dysfunction. Serious adverse reactions occurred in 50% of these patients receiving LENVIMA and KEYTRUDA. Serious adverse reactions with frequency ≥3% were hypertension (4.4%), and urinary tract infection (3.2%). Discontinuation of LENVIMA due to an adverse reaction occurred in 26% of these patients. The most common (≥1%) adverse reactions leading to discontinuation of LENVIMA were hypertension (2%), asthenia (1.8%), diarrhea (1.2%), decreased appetite (1.2%), proteinuria (1.2%), and vomiting (1.2%). Dose reductions of LENVIMA due to adverse reactions occurred in 67% of patients. The most common (≥5%) adverse reactions resulting in dose reduction of LENVIMA were hypertension (18%), diarrhea (11%), palmar-plantar erythrodysesthesia syndrome (9%), proteinuria (7%), fatigue (7%), decreased appetite (6%), asthenia (5%), and weight decreased (5%). Dose interruptions of LENVIMA due to an adverse reaction occurred in 58% of these patients. The most common (≥2%) adverse reactions leading to interruption of LENVIMA were hypertension (11%), diarrhea (11%), proteinuria (6%), decreased appetite (5%), vomiting (5%), increased alanine aminotransferase (3.5%), fatigue (3.5%), nausea (3.5%), abdominal pain (2.9%), weight decreased (2.6%), urinary tract infection (2.6%), increased aspartate aminotransferase (2.3%), asthenia (2.3%), and palmar-plantar erythrodysesthesia (2%).

Use in Specific Populations

Because of the potential for serious adverse reactions in breastfed children, advise women to discontinue breastfeeding during treatment and for 1 week after last dose. LENVIMA may impair fertility in males and females of reproductive potential.

No dose adjustment is recommended for patients with mild (creatinine clearance [CLcr] 60-89 mL/min) or moderate (CLcr 30-59 mL/min) renal impairment. LENVIMA concentrations may increase in patients with DTC, RCC, or endometrial carcinoma and severe (CLcr 15-29 mL/min) renal impairment. Reduce the dose for patients with DTC, RCC, or endometrial carcinoma and severe renal impairment. There is no recommended dose for patients with HCC and severe renal impairment. LENVIMA has not been studied in patients with end stage renal disease.

No dose adjustment is recommended for patients with HCC and mild hepatic impairment (Child-Pugh A). There is no recommended dose for patients with HCC with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. No dose adjustment is recommended for patients with DTC, RCC, or endometrial carcinoma and mild or moderate hepatic impairment. LENVIMA concentrations may increase in patients with DTC, RCC, or endometrial carcinoma and severe hepatic impairment. Reduce the dose for patients with DTC, RCC, or endometrial carcinoma and severe hepatic impairment.

Please see Prescribing Information for LENVIMA (lenvatinib) at http://www.lenvima.com/pdfs/prescribing-information.pdf.

About WELIREG^® (belzutifan) 40 mg tablets, for oral use

WELIREG, Merck’s first-in-class hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor, is an orally administered small-molecule designed to reduce transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis and tumor growth. By inhibiting HIF-2α signaling, WELIREG aims to disrupt key pathways certain tumors may use to adapt to low-oxygen conditions, including those that help promote abnormal blood vessel formation and support tumor survival.

WELIREG has demonstrated antitumor activity in certain von Hippel-Lindau (VHL) disease-associated tumors, renal cell carcinoma and in pheochromocytoma or paraganglioma. As part of a broader clinical program, Merck continues to research WELIREG monotherapy and combination approaches for people with genitourinary, breast and gynecologic cancers across a range of treatment settings to further define where HIF-2α inhibition may provide clinical benefit and to better understand which patients are most likely to respond.

Indications in the U.S.

Certain von Hippel-Lindau (VHL) disease-associated tumors

WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Advanced Renal Cell Carcinoma (RCC)

WELIREG is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) with a clear cell component following a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Pheochromocytoma or Paraganglioma (PPGL)

WELIREG is indicated for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL).

Selected Safety Information for WELIREG

Warning: Embryo-Fetal Toxicity

Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception as WELIREG can render some hormonal contraceptives ineffective.

Anemia

WELIREG can cause severe anemia that can require blood transfusion. Monitor for anemia before initiation of, and periodically throughout, treatment. Transfuse patients as clinically indicated. For patients with hemoglobin <8 g/dL, withhold WELIREG until ≥8 g/dL, then resume at the same or reduced dose or permanently discontinue WELIREG, depending on the severity of anemia. For life-threatening anemia or when urgent intervention is indicated, withhold WELIREG until hemoglobin ≥8 g/dL, then resume at a reduced dose or permanently discontinue WELIREG.

In LITESPARK-004 (N=61), decreased hemoglobin occurred in 93% of patients with VHL disease and 7% had Grade 3 events. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months).

The safety of erythropoiesis-stimulating agents (ESAs) for treatment of anemia in patients with VHL disease treated with WELIREG has not been established.

In LITESPARK-005 (n=372), decreased hemoglobin occurred in 88% of patients with advanced RCC with a clear cell component and 29% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 16.6 months). Of the patients with anemia, 22% received transfusions only, 20% received ESAs only, and 12% received both transfusion and ESAs.

In LITESPARK-015, anemia occurred in 96% of patients and 22% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 22.1 months). Of the patients with anemia, 20% received transfusions only, 26% received ESAs only, and 6% received both transfusion and ESAs.

Hypoxia

WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization.

Monitor oxygen saturation before initiation of, and periodically throughout, treatment. For decreased oxygen saturation with exercise (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same dose or a reduced dose. For decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or when urgent intervention is indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue. For life-threatening hypoxia or recurrent symptomatic hypoxia, permanently discontinue WELIREG. Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider.

In LITESPARK-004, hypoxia occurred in 1.6% of patients.

In LITESPARK-005, hypoxia occurred in 15% of patients and 10% had Grade 3 events. Of the patients with hypoxia, 69% were treated with oxygen therapy. Median time to onset of hypoxia was 30.5 days (range: 1 day to 21.1 months).

In LITESPARK-015, hypoxia occurred in 13% of patients and 10% had Grade 3 hypoxia. Median time to onset of hypoxia was 35 days (range: 6 days to 23.9 months). Of the patients with hypoxia, 67% were treated with oxygen therapy.

Embryo-Fetal Toxicity

Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman.

Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. WELIREG can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Adverse Reactions

Adverse Reactions in LITESPARK-004

Serious adverse reactions occurred in 15% of patients, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).

WELIREG was permanently discontinued due to adverse reactions in 3.3% of patients for dizziness and opioid overdose (1.6% each).

Dosage interruptions due to an adverse reaction occurred in 39% of patients. Those which required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache, and influenza-like illness.

Dose reductions due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%).

The most common adverse reactions (≥25%), including laboratory abnormalities, that occurred in patients who received WELIREG were decreased hemoglobin (93%), fatigue (64%), increased creatinine (64%), headache (39%), dizziness (38%), increased glucose (34%), and nausea (31%).

Adverse Reactions in LITESPARK-005

Serious adverse reactions occurred in 38% of patients. The most frequently reported serious adverse reactions were hypoxia (7%), anemia (5%), pneumonia (3.5%), hemorrhage (3%), and pleural effusion (2.2%). Fatal adverse reactions occurred in 3.2% of patients who received WELIREG, including sepsis (0.5%) and hemorrhage (0.5%).

WELIREG was permanently discontinued due to adverse reactions in 6% of patients. Adverse reactions which resulted in permanent discontinuation (≥0.5%) were hypoxia (1.1%), anemia (0.5%), and hemorrhage (0.5%).

Dosage interruptions due to an adverse reaction occurred in 39% of patients. Of the patients who received WELIREG, 28% were 65 to 74 years, and 10% were 75 years and over. Dose interruptions occurred in 48% of patients ≥65 years of age and in 34% of younger patients. Adverse reactions which required dosage interruption in ≥2% of patients were anemia (8%), hypoxia (5%), COVID-19 (4.3%), fatigue (3.2%), and hemorrhage (2.2%).

Dose reductions due to an adverse reaction occurred in 13% of patients. Dose reductions occurred in 18% of patients ≥65 years of age and in 10% of younger patients. The most frequently reported adverse reactions which required dose reduction (≥1.0%) were hypoxia (5%) and anemia (3.2%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (88%), fatigue (43%), musculoskeletal pain (34%), increased creatinine (34%), decreased lymphocytes (34%), increased alanine aminotransferase (32%), decreased sodium (31%), increased potassium (29%), and increased aspartate aminotransferase (27%).

Adverse Reactions in LITESPARK-015

Serious adverse reactions occurred in 36% of patients. The most frequently reported serious adverse reactions were anemia and hypertension (4.2% each) and pyelonephritis, pneumonia, hypoxia, dyspnea and hemorrhage (2.8% each).

WELIREG was permanently discontinued due to adverse reactions in 2 patients (2.8%). Adverse reactions which resulted in permanent discontinuation were increased alanine aminotransferase and paraparesis (1.4% each).

Dosage interruptions due to an adverse reaction occurred in 40% of patients. Of the patients who received WELIREG, 13% were ≥65 years old and 4.2% were ≥75 years. Adverse reactions which required dosage interruption in >3% of patients were hypoxia, nausea and fatigue (4.2% each).

Dose reductions due to an adverse reaction occurred in 14% of patients. The most frequently reported adverse reaction which required dose reduction was hypoxia (4.2%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, that occurred in patients were anemia (96%), fatigue (56%), musculoskeletal pain (56%), decreased lymphocytes (54%), increased alanine aminotransferase (51%), increased aspartate aminotransferase (42%), increased calcium (34%), dyspnea (33%), increased potassium (31%), decreased leukocytes (30%), headache (29%), increased alkaline phosphatase (25%), dizziness (26%) and nausea (25%).

Drug Interactions

Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended.

Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates or lead to therapeutic failures. Avoid coadministration with sensitive CYP3A4 substrates. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information. Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding.

Lactation

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.

Females and Males of Reproductive Potential

WELIREG can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG.

Use of WELIREG may reduce the efficacy of hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential and the reversibility of this effect is unknown.

Pediatric Use

The safety and effectiveness of WELIREG have been established in pediatric patients aged 12 years and older for the treatment of locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma.

Renal Impairment

For patients with severe renal impairment (eGFR 15-29 mL/min estimated by MDRD), monitor for increased adverse reactions and modify the dosage as recommended.

Hepatic Impairment

WELIREG has not been studied in patients with severe hepatic impairment (total bilirubin >1.5 x ULN and any AST). For patients with moderate and severe hepatic impairment, monitor for increased adverse reactions and modify the dosage as recommended.

Please see Prescribing Information, including information for the Boxed Warning about embryo-fetal toxicity, for WELIREG (belzutifan) at https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_pi.pdfand Medication Guide for WELIREG at https://www.merck.com/product/usa/pi_circulars/w/welireg/welireg_mg.pdf.

About the Merck and Eisai strategic collaboration

In March 2018, Eisai and Merck, known as MSD outside of the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, and HIF-2α inhibitor, WELIREG.

Merck’s focus on cancer

Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 20 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Eisai’s focus on cancer

Eisai positions Oncology as one of its key strategic areas, and aims to contribute to the cure of cancers through the discovery of innovative new drugs with new targets and mechanisms of action under the Deep Human Biology Learning (DHBL) drug discovery and development organization.

By utilizing biomarker data obtained from our products to elucidate the mechanisms of the incidence and root causes of cancer, as well as drug resistance, and using Eisai Group’s precision chemistry technology to turn undruggable intracellular therapeutic targets into druggable ones, we will create new backbone therapeutic drugs.

About Eisai

Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept [also known as our human health care (hhc) Concept], we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia, and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on Twitter (U.S. and global) and LinkedIn (for U.S. and EMEA).

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

View source version on businesswire.com: https://www.businesswire.com/news/home/20260421205834/en/

Media Contacts:

Merck:

Julie Cunningham

[email protected]

John Infanti

[email protected]

Eisai:

Marie Ronda

[email protected]

Investor Contacts:

Merck:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

MEDIA:

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Posted on April 21, 2026 6:49 am
BioNTech to Report First Quarter 2026 Financial Results and Corporate Update on May 5, 2026

MAINZ, Germany, April 21, 2026 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the first quarter 2026 on Tuesday, May 5, 2026. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (2:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update.

To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast will be available via this link.

Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page in the Investor Relations section of the Company’s website at www.BioNTech.com. A replay of the webcast will be made available shortly after the call and archived on the Company’s website for 30 days following the call.

About BioNTech

Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, Pfizer and Regeneron.

For more information, please visit www.BioNTech.com.

CONTACTS

Investor Relations

Douglas Maffei, PhD
[email protected]

Media Relations

Jasmina Alatovic
[email protected]

Posted on April 21, 2026 6:49 am
Eaton to announce first quarter 2026 earnings on May 5, 2026

Eaton to announce first quarter 2026 earnings on May 5, 2026

DUBLIN–(BUSINESS WIRE)–
Intelligent power management company Eaton (NYSE:ETN) will announce first quarter 2026 earnings on Tuesday, May 5, 2026, before the opening of the New York Stock Exchange. The company will host a conference call at 11 a.m. Eastern time that day to discuss first quarter 2026 earnings results.

The conference call will be available through a live webcast that can be accessed at Eaton.com/investor under “Presentations.” The call replay and news release will also be available at the same link.

Eaton is an intelligent power management company dedicated to protecting the environment and improving the quality of life for people everywhere. We make products for the data center, utility, industrial, commercial and institutional, machine building, residential, aerospace and mobility markets. We are guided by our commitment to do business right, to operate sustainably and to help our customers manage power ─ today and well into the future. By capitalizing on the global growth trends of electrification and digitalization, we’re helping to solve the world’s most urgent power management challenges and building a more sustainable society for people today and generations to come.

Founded in 1911, Eaton has continuously evolved to meet the changing and expanding needs of our stakeholders. With revenues of $27.4 billion in 2025, the company serves customers in 180 countries. For more information, visit www.eaton.com. Follow us on LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260421817432/en/

Jennifer Tolhurst

Media Relations

+1 (440) 523-4006

[email protected]

Yan Jin

Investor Relations

+1 (440) 523-7558

KEYWORDS: Ohio Europe Ireland United States North America

INDUSTRY KEYWORDS: Other Energy Utilities Energy Machine Tools, Metalworking & Metallurgy Engineering Automotive Manufacturing Aerospace Manufacturing

MEDIA:

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Posted on April 21, 2026 6:48 am
AIMEI HEALTH TECHNOLOGY CO., LTD RECEIVES NASDAQ NOTICE REGARDING DELAYED ANNUAL REPORT

New York, NY, April 21, 2026 (GLOBE NEWSWIRE) — Aimei Health Technology Co., Ltd (the “Company”) (Nasdaq: AFJK) today announced that on April 17, 2026, it received a notice (the “Notice”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, as a result of the Company’s delay in filing its Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the “Annual Report”) with the U.S. Securities and Exchange Commission (the “SEC”), the Company is not in compliance with the requirements for continued listing under Nasdaq Listing Rule 5250(c)(1) (the “Listing Rule”). The Annual Report was due on March 31, 2026, and the Company filed a Notification of Late Filing on Form 12b-25 with the SEC on April 1, 2026.

The Notice has no immediate effect on the listing or trading of the Company’s securities on Nasdaq. However, if the Company fails to timely regain compliance with the Listing Rule, the Company’s securities will be subject to delisting from Nasdaq.

Under Nasdaq rules, the Company has 60 calendar days from the date of the Notice to either file the Annual Report or submit a plan to Nasdaq to regain compliance with Nasdaq’s listing rules. If a plan is submitted and accepted, the Company may be granted up to 180 calendar days from the Annual Report’s due date to regain compliance. If Nasdaq does not accept the Company’s plan, the Company will have the opportunity to appeal that decision to a Nasdaq hearings panel.

The Company is working diligently to complete and file the Annual Report and expects to regain compliance with the Listing Rule.

This announcement is made in compliance with Nasdaq Listing Rule 5810(b), which requires prompt disclosure of receipt of a deficiency notification.

About Aimei Health Technology Co., Ltd

Aimei Health Technology Co., Ltd is a blank check company incorporated as a Cayman Islands exempted company with limited liability for the purpose of entering into a merger, share exchange, asset acquisition, share purchase, recapitalization, reorganization, or similar business combination with one or more businesses or entities. The Company’s efforts to identify a prospective target business will not be limited to a particular industry or geographic region, although the Company intends to pursue prospective targets focused on healthcare innovation.

Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of the federal securities laws. These statements are based on management’s current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. The Company undertakes no obligation to update any forward-looking statements except as required by applicable law.

For investor and media inquiries, please contact:

Aimei Health Technology Co., Ltd
10 East 53rd Street, Suite 3001
New York, NY 10022
Attention: Junheng Xie
Email: [email protected]

Posted on April 21, 2026 6:48 am
Stantec releases 19th annual Sustainability Report, highlighting 68% (C$5.5 billion) in sustainability-driven revenue

EDMONTON, Alberta and NEW YORK, April 21, 2026 (GLOBE NEWSWIRE) — TSX, NYSE:STN

Stantec, a global leader in sustainable design and engineering, released its 19th annual Sustainability Report, showcasing how sustainability is integrated into the Company’s strategy, growth, and operations. The report details Stantec’s sustainability practices, contributions, and accomplishments for the year ending December 31, 2025.

The firm’s 2025 sustainability milestones include:

C$5.5 billion in revenue from work that supports the United Nations’ core Sustainable Development Goals, representing 68 percent of total gross revenue. This reflects steady growth since the Company began tracking this work in 2019, when it represented 43 percent of total gross revenue.

Global operational carbon neutrality achieved for the fourth consecutive year, with continued progress toward net zero emissions under Canada’s Net Zero Challenge, an effort to help the country move toward a cleaner economy

Recognition by the Carbon Disclosure Project, earning an A- score for the eighth straight year for demonstrating consistent climate action

“The choices we make today shape communities, economies, and the environment of tomorrow,” said Gord Johnston, president and chief executive officer of Stantec. “This is why sustainability is embedded into everything we do—guiding how we live, move, work, and connect. By putting people first, we’re helping create a more resilient and sustainable environment where communities can thrive for generations to come.”

The report also brings Stantec’s impact to life through projects that demonstrate how sustainability translates into real-world outcomes:

Canada: Advancing cleaner, smarter manufacturing, Stantec supported Duravit’s new facility in Québec—one of the world’s first carbon-neutral manufacturing facilities in the hygienic ceramic industry. Stantec’s building engineering services enabled hydro-powered electric kilns, reducing emissions by nearly 9,000 tonnes of carbon dioxide equivalent annually.

United States: In the Klamath Basin of Oregon and California, one of the nation’s largest restoration efforts is revitalizing ecosystems and reconnecting communities. Working alongside Indigenous Nations and local partners, Stantec’s engineers and ecologists are restoring five fish-bearing tributaries, nearly 3.4 miles (5.5 kilometers) of stream channel, 2,200 acres (890 hectares) of native vegetation, and more than 400 miles (644 kilometers) of salmon habitat.

United Kingdom: Supporting the transition to cleaner, more reliable energy, the Vyrnwy Frankton Grid Connection in Mid-Wales enables new wind-generated electricity to reach the national grid. Stantec contributed early planning and design for the overhead line, substation, and underground cable infrastructure.

New Zealand: Following severe flooding and landslides that damaged over 311 miles (500 kilometers) of roads, Stantec partnered with the Marlborough District Council to shape a future access survey. The study engaged more than 1,500 participants through workshops, hui (gatherings), surveys, webinars, and community events—ensuring local voices informed long-term resilience planning.

Egypt: Protecting freshwater resources and expanding access to sanitation, Stantec supported the design of eight wastewater treatment plants around Lake Qarun in the Fayoum region. The project aims to increase access to safe sanitation from 33 percent to 70 percent during the first phase, benefiting approximately 700,000 people while safeguarding the lake’s ecosystem.

Stantec’s Sustainability Report is compliant with the Global Reporting Initiative and the Sustainability Accounting Standards Board. Explore the full report and learn more about Stantec’s Corporate Sustainability program.

About Stantec

Stantec empowers clients, people, and communities to rise to the world’s greatest challenges at a time when the world faces more unprecedented concerns than ever before. 

We are a global leader in sustainable engineering, architecture, and environmental consulting. Our professionals deliver the expertise, technology, and innovation communities need to manage aging infrastructure, demographic and population changes, the energy transition, and more.

Today’s communities transcend geographic borders. At Stantec, community means everyone with an interest in the work that we do—from our project teams and industry colleagues to our clients and the people our work impacts. The diverse perspectives of our partners and interested parties drive us to think beyond what’s previously been done on critical issues like climate change, digital transformation, and future-proofing our cities and infrastructure.

We are designers, engineers, scientists, project managers, and strategic advisors. We innovate at the intersection of community, creativity, and client relationships to advance communities everywhere, so that together we can redefine what’s possible.

Stantec trades on the TSX and the NYSE under the symbol STN. Visit us at stantec.com or find us on social media.

Cautionary Note Regarding Forward-Looking Statements

This news release contains forward-looking statements regarding the initiatives and projects described above. Forward-looking statements also include any other statements that do not refer to historical facts. By their nature, forward-looking statements are based on assumptions and subject to inherent risks and uncertainties. There is a risk that the initiatives and projects described above may be delayed, cancelled, suspended or terminated. This could cause future results to differ materially from the forward-looking statements made in this news release. Except as may be required by law, Stantec undertakes no obligation to publicly update or revise any forward-looking statements. Forward-looking statements are provided herein for the purpose of giving information about the initiatives and projects referred to above and their expected impact. Readers are cautioned that such information may not be appropriate for other purposes.

Media Contact

Susan Bender
Stantec Media Relations
Ph: (267) 773-9593
[email protected]
            Investor Contact

Jess Nieukerk
Stantec Investor Relations
Ph: (403) 569-5389
[email protected]

Posted on April 21, 2026 6:48 am
Atlantic Union Bankshares Reports First Quarter Financial Results

Atlantic Union Bankshares Reports First Quarter Financial Results

RICHMOND, Va.–(BUSINESS WIRE)–
Atlantic Union Bankshares Corporation (the “Company” or “Atlantic Union”) (NYSE: AUB) reported net income available to common shareholders of $119.2 million and both basic and diluted earnings per common share of $0.84, for the first quarter of 2026 and adjusted operating earnings available to common shareholders⁽¹⁾ of $126.2 million and adjusted diluted operating earnings per common share⁽¹⁾ of $0.89 for the first quarter of 2026.

“Atlantic Union had a solid first quarter, reflecting disciplined execution and a successful conclusion of the Sandy Spring Bancorp, Inc. integration,” said John C. Asbury, president and chief executive officer of Atlantic Union. “Asset quality remains strong, our annualized first quarter loan growth rate improved year over year during a seasonally slow period and we continued to reduce higher costing brokered deposits. The underlying operating performance supports our continued confidence in achieving the financial metrics we established for the full year 2026 —namely, the targets for adjusted operating return on assets, return on tangible common equity, and efficiency ratio.

“Atlantic Union is a story of transformation from a Virginia community bank to the largest regional bank headquartered in the lower Mid-Atlantic, with operations in Virginia, Maryland, and a growing presence in North Carolina. Operating under the mantra of soundness, profitability, and growth – in that order of priority – Atlantic Union remains committed to generating sustainable, profitable growth and building long-term value for our shareholders.”

NET INTEREST INCOME

For the first quarter of 2026, net interest income was $312.4 million, a decrease of $17.8 million from $330.2 million in the fourth quarter of 2025. Net interest income – fully taxable equivalent (“FTE”)⁽¹⁾was $316.9 million in the first quarter of 2026, a decrease of $17.9 million from $334.8 million in the fourth quarter of 2025. The decreases from the prior quarter in both net interest income and net interest income (FTE)⁽¹⁾ were driven primarily by a decrease in interest income on loans held for investment (“LHFI”), reflecting lower loan accretion income, the lower day count in the first quarter, as well as the impact of lower yields on variable-rate loans following the cumulative 75 basis point reduction in the federal funds rate between September and December in 2025. The decreases were partially offset by a decrease in interest expense, primarily due to lower deposit costs, resulting from reduced brokered deposit balances and lower customer deposit rates due to reductions in the federal funds rate.

For the first quarter of 2026, the Company’s net interest margin decreased 10 basis points and net interest margin (FTE)⁽¹⁾ decreased 11 basis points from the prior quarter to 3.80% and 3.85%, respectively, due to a decline in earning asset yields, partially offset by lower cost of funds. Earning asset yields for the first quarter of 2026 decreased 20 basis points to 5.79% compared to the fourth quarter of 2025, reflecting the lower loan yields driven by the Federal Reserve rate cuts and the impact of lower accretion income. Cost of funds decreased 9 basis points from the prior quarter to 1.94% for the first quarter of 2026, reflecting the impact of lower deposit costs.

The Company’s net interest margin (FTE)⁽¹⁾ includes the impact of acquisition accounting fair value adjustments. Net accretion income for the quarter ended March 31, 2026 was $13.0 million lower than the prior quarter, as the prior quarter included elevated accelerated loan accretion income primarily due to higher prepayment activity and this quarter included a measurement period adjustment related to the acquisition of Sandy Spring Bancorp, Inc. (the “Sandy Spring acquisition”), which reduced loan accretion income by $3.5 million. The impact of accretion and amortization for the periods presented are reflected in the following table (dollars in thousands):

Loan

Deposit

Borrowings

Accretion

Accretion

Amortization

Total

For the quarter ended December 31, 2025

$

48,363

$

762

$

(3,178)

$

45,947

For the quarter ended March 31, 2026

35,602

366

(3,044)

32,924

ASSET QUALITY

Overview

At March 31, 2026, nonperforming assets (“NPAs”) as a percentage of total LHFI was 0.36%, a decrease of 6 basis points from the prior quarter and included nonaccrual loans of $97.8 million. Accruing past due loans as a percentage of total LHFI totaled 0.45% at March 31, 2026, an increase of 4 basis points from December 31, 2025. Net charge-offs were 0.02% of total average LHFI (annualized) for the first quarter of 2026, an increase of 1 basis point compared to December 31, 2025. The allowance for credit losses (“ACL”) totaled $321.9 million at March 31, 2026, a $658 thousand increase from the prior quarter.

Nonperforming Assets

The following table shows a summary of NPA balances at the quarters ended (dollars in thousands):

March 31,

December 31,

September 30,

June 30,

March 31,

2026

2025

2025

2025

2025

Nonaccrual loans

$

97,828

$

115,051

$

131,240

$

162,615

$

69,015

Foreclosed properties

1,856

1,826

2,001

774

404

Total nonperforming assets

$

99,684

$

116,877

$

133,241

$

163,389

$

69,419

The following table shows the activity in nonaccrual loans for the quarters ended (dollars in thousands):

March 31,

December 31,

September 30,

June 30,

March 31,

2026

2025

2025

2025

2025

Beginning Balance

$

115,051

$

131,240

$

162,615

$

69,015

$

57,969

Net customer payments and other activity⁽¹⁾

(33,934

)

(21,667

)

(17,947

)

(4,595

)

(898

)

Additions ^{(1) (2)}

17,679

7,816

25,333

98,975

13,197

Charge-offs

(909

)

(2,307

)

(37,410

)

(780

)

(1,253

)

Loans returning to accruing status

—

(31

)

(77

)

—

—

Transfers to foreclosed property

(59

)

—

(1,274

)

—

—

Ending Balance

$

97,828

$

115,051

$

131,240

$

162,615

$

69,015

_________________________________

⁽¹⁾ The Company recorded measurement period adjustments related to the fair values of certain loans associated with the Sandy Spring acquisition, which impacted the nonaccrual activity for the quarters ended September 30, 2025, December 31, 2025, and March 31, 2026.

⁽²⁾ The increase in additions during the quarter ended June 30, 2025 was primarily due to purchased credit deteriorated loans acquired from Sandy Spring.

Past Due Loans

At March 31, 2026, past due loans still accruing interest totaled $125.0 million or 0.45% of total LHFI, compared to $113.0 million or 0.41% of total LHFI at December 31, 2025, and $50.0 million or 0.27% of total LHFI at March 31, 2025. The increase in past due loans from the prior quarter was primarily within the multifamily real estate and commercial real estate (“CRE”) – owner occupied loan portfolios. The increase from the prior year was primarily due to loans acquired by the Company as a result of the Sandy Spring acquisition.

Allowance for Credit Losses

Effective January 1, 2026, the Company made certain changes to its ACL methodology as part of the continued enhancement of its credit modeling practices, resulting in more dynamic and precise modeling that allows for more granularity in the monitoring of our credit losses. The ACL methodology changes were accounted for prospectively as a change in accounting estimate and did not have a material impact on the Company’s Consolidated Financial Statements.

At March 31, 2026, the ACL was $321.9 million, an increase of $659 thousand from the prior quarter, comprised of an allowance for loan and lease losses (“ALLL”) of $291.1 million and a reserve for unfunded commitments (“RUC”) of $30.8 million. At March 31, 2026, the ACL as a percentage of total LHFI remained relatively consistent at 1.15%, compared to 1.16% at December 31, 2025. The ALLL as a percentage of total LHFI decreased by 2 basis points, from 1.06% at December 31, 2025 to 1.04% at March 31, 2026. The RUC coverage ratio increased 1 basis point from December 31, 2025 to 0.11% at March 31, 2026, primarily driven by higher construction and land development unfunded commitments.

Net Charge-offs

Net charge-offs were $1.6 million or 0.02% of total average LHFI on an annualized basis for the first quarter of 2026, compared to $916 thousand or 0.01% (annualized) for the fourth quarter of 2025, and $2.3 million or 0.05% (annualized) for the first quarter of 2025.

Provision for Credit Losses

For the first quarter of 2026, the Company recorded a provision for credit losses of $2.7 million, compared to $2.2 million in the prior quarter, and $17.6 million in the first quarter of 2025. The provision for credit losses decreased as compared to the prior year primarily due to higher uncertainty in the economic outlook in the prior year, as well as specific reserves recorded in the prior year on two impaired commercial and industrial loans.

NONINTEREST INCOME

Noninterest income decreased $2.2 million to $54.8 million for the first quarter of 2026 from $57.0 million in the prior quarter, primarily driven by a $4.4 million decrease in loan-related interest rate swap fees due to seasonally lower transaction volumes. This decrease was partially offset by a $1.5 million increase in other operating income, primarily due to an increase in capital markets income.

NONINTEREST EXPENSE

Noninterest expense decreased $33.4 million to $209.8 million for the first quarter of 2026 from $243.2 million in the prior quarter, primarily driven by a $29.6 million decrease in pre-tax merger-related costs and a $2.3 million decrease in amortization of intangible assets.

Adjusted operating noninterest expense⁽¹⁾, which excludes merger-related costs ($9.0 million in the first quarter 2026 and $38.6 million in the fourth quarter 2025) and amortization of intangible assets ($15.4 million in the first quarter 2026 and $17.7 million in the fourth quarter 2025) decreased $1.6 million to $185.3 million, compared to $186.9 million in the prior quarter. This decrease was primarily due to a $3.1 million decrease in other expenses, primarily due to a decrease in non-credit-related losses on customer transactions, a $2.3 million decrease in professional services related to strategic projects that occurred in the prior quarter, and a $1.9 million decrease in technology and data processing expense. These decreases were partially offset by a $5.0 million increase in salaries and benefits expense, primarily due to seasonal increases in payroll taxes and 401(k) contribution expenses.

INCOME TAXES

The Company’s effective tax rate for each of the quarters ended March 31, 2026 and December 31, 2025 was 21.0%.

KEY BALANCE SHEET COMPONENTS AND CAPITAL RATIOS

The following tables summarize the Company’s key balance sheet components and capital ratios as of the dates presented (dollars in millions, except per share data):

3/31/2026

12/31/2025⁽³⁾

QoQ

QoQ % change⁽¹⁾

3/31/2025

YoY

YoY % change

(unaudited)

(unaudited)

Assets

$

37,315

$

37,586

$

(271

)

(2.92

)

%

$

24,633

$

12,682

51.49

%

LHFI (net of unearned income)

27,946

27,796

150

2.19

%

18,428

9,519

51.65

%

Quarterly Average LHFI (net of unearned income)

27,830

27,433

397

5.87

%

18,429

9,401

51.01

%

Securities

5,059

5,269

(210

)

(16.13

)

%

3,405

1,654

48.57

%

Securities available for sale (“AFS”)

4,011

4,194

(183

)

(17.68

)

%

2,484

1,528

61.50

%

Securities held to maturity (“HTM”)

870

884

(14

)

(6.39

)

%

821

49

6.00

%

Goodwill

1,755

1,733

22

5.05

%

1,214

541

44.55

%

Deposits

30,391

30,472

(80

)

(1.07

)

%

20,503

9,888

48.23

%

Quarterly Average Deposits

30,210

30,884

(674

)

(8.85

)

%

20,466

9,744

47.61

%

Borrowings

1,305

1,497

(193

)

(52.20

)

%

476

829

NM

Cash dividends paid per common share

$

0.37

$

0.37

$

—

—

%

$

0.34

$

0.03

8.82

%

Dividends on each share of Series A preferred stock ⁽²⁾

$

171.88

$

171.88

$

—

—

%

$

171.88

$

—

—

%

_____________________________

⁽¹⁾Quarter over quarter percentage changes are calculated on an annualized basis except for dividends, which are presented on a per share basis.

⁽²⁾The preferred stock dividend was equivalent to $0.43 per outstanding depositary share for each period presented.

⁽³⁾Period-end balances as of December 31, 2025 were audited. Quarterly average balances are unaudited.

NM = Not Meaningful

3/31/2026

12/31/2025

3/31/2025

Common equity Tier 1 capital ratio ⁽¹⁾

10.21

%

10.10

%

10.07

%

Tier 1 capital ratio ⁽¹⁾

10.75

%

10.64

%

10.87

%

Total capital ratio ⁽¹⁾

14.01

%

13.90

%

13.88

%

Leverage ratio (Tier 1 capital to average assets) ⁽¹⁾

9.31

%

9.10

%

9.45

%

Common equity to total assets

13.09

%

12.88

%

12.26

%

Tangible common equity to tangible assets ⁽²⁾

8.03

%

7.85

%

7.39

%

_________________________

⁽¹⁾ All ratios at March 31, 2026 are estimates and subject to change pending the Company’s filing of its FR Y9-C. All other periods are presented as filed.

⁽²⁾ These are financial measures not calculated in accordance with generally accepted accounting principles (“GAAP”). For a reconciliation of these non-GAAP financial measures see the “Alternative Performance Measures (non-GAAP)” section of the Key Financial Results.

The key drivers of the consolidated balance sheet changes for the periods presented are summarized below:

Total assets decreased from December 31, 2025, primarily due to decreases in investments and cash and cash equivalents, partially offset by increases in LHFI. Total assets increased from March 31, 2025 primarily driven by the Sandy Spring acquisition.

Goodwill increased from the prior year due to the Sandy Spring acquisition and reflects the fair value of assets acquired and liabilities assumed, inclusive of measurement period adjustments primarily related to loans, other assets, and other liabilities. The measurement period concluded and goodwill was finalized as of March 31, 2026.

LHFI and quarterly average LHFI both increased compared to December 31, 2025 and March 31, 2025. The increase from the prior quarter is primarily due to an increase in the commercial and industrial portfolio. The increase from the same period in the prior year was primarily due to the Sandy Spring acquisition, as well as organic loan growth.

Total investments decreased from December 31, 2025, primarily due to principal repayments and maturities of AFS securities. Total investments increased year over year due to the Sandy Spring acquisition.

Total deposits and quarterly average deposits decreased from the prior quarter due to a decline in brokered deposits, partially offset by an increase in interest-bearing customer deposits. Total deposits and quarterly average deposits at March 31, 2026 increased from the same period in the prior year due to the addition of the Sandy Spring acquired deposits.

Total borrowings decreased from December 31, 2025 and increased from March 31, 2025. The decrease in borrowings from the prior quarter was primarily due to higher short-term borrowings in the prior quarter that were repaid in the current quarter using proceeds from customer deposits, while the increase from the same period in the prior year was primarily due to increases in Federal Home Loan Bank advances and additional borrowings in connection with the Sandy Spring acquisition.

ABOUT ATLANTIC UNION BANKSHARES CORPORATION

Headquartered in Richmond, Virginia, Atlantic Union Bankshares Corporation (NYSE: AUB) is the holding company for Atlantic Union Bank. Atlantic Union Bank has branches and ATMs located in Virginia, Maryland, North Carolina and Washington, D.C. Certain non-bank financial services affiliates of Atlantic Union Bank include: Atlantic Union Equipment Finance, Inc., which provides equipment financing; AUB Investments, Inc., which provides investment services; and Atlantic Union Capital Markets, Inc., which provides capital market services.

FIRST QUARTER 2026 EARNINGS RELEASE CONFERENCE CALL

The Company will hold a conference call and webcast for investors at 9:00 a.m. Eastern Time on Tuesday, April 21, 2026, during which management will review our financial results for the first quarter 2026 and provide an update on our recent activities.

The listen-only webcast and the accompanying slides can be accessed at: https://edge.media-server.com/mmc/p/ow964rjw.

For analysts who wish to participate in the conference call, please register at the following URL: https://register-conf.media-server.com/register/BIf8f441eb451449cfa3e411b650b2ab58.

To participate in the conference call, you must use the link to receive an audio dial-in number and an Access PIN.

A replay of the webcast, and the accompanying slides, will be available on the Company’s website for 90 days at: https://investors.atlanticunionbank.com/.

NON-GAAP FINANCIAL MEASURES

In reporting the results as of and for the period ended March 31, 2026, we have provided supplemental performance measures determined by methods other than in accordance with GAAP. These non-GAAP financial measures are a supplement to GAAP, which we use to prepare our financial statements, and should not be considered in isolation or as a substitute for comparable measures calculated in accordance with GAAP. In addition, our non-GAAP financial measures may not be comparable to non-GAAP financial measures of other companies. We use the non-GAAP financial measures discussed herein in our analysis of our performance. Management believes that these non-GAAP financial measures provide additional understanding of our ongoing operations, enhance the comparability of our results of operations with prior periods and show the effects of significant gains and charges in the periods presented without the impact of items or events that may obscure trends in our underlying performance. For a reconciliation of these measures to their most directly comparable GAAP measures and additional information about these non-GAAP financial measures, see “Alternative Performance Measures (non-GAAP)” in the tables within the section “Key Financial Results.”

FORWARD-LOOKING STATEMENTS

This press release and statements by our management may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that include, without limitation, statements made in Mr. Asbury’s quotations, statements regarding the acquisition of Sandy Spring, including expectations with regard to the benefits of the Sandy Spring acquisition; statements regarding our strategic expansion into North Carolina; statements regarding our future ability to recognize the benefits of certain tax assets; statements regarding our business, financial and operating results, including our deposit base and funding; the impact of changes in economic conditions, anticipated changes in the interest rate environment and the related impacts on our net interest margin, changes in economic, fiscal or trade policy and the potential impacts on our business, loan demand and economic conditions in our markets and nationally; management’s beliefs regarding our liquidity, capital resources, asset quality, CRE loan portfolio and our customer relationships; and statements that include other projections, predictions, expectations, or beliefs about future events or results or otherwise are not statements of historical fact. Such forward-looking statements are based on certain assumptions as of the time they are made, and are inherently subject to known and unknown risks, uncertainties, and other factors, some of which cannot be predicted or quantified, that may cause actual results, performance, or achievements to be materially different from those expressed or implied by such forward-looking statements. Forward-looking statements are often characterized by the use of qualified words (and their derivatives) such as “expect,” “believe,” “estimate,” “plan,” “project,” “anticipate,” “intend,” “will,” “may,” “view,” “opportunity,” “seek to,” “potential,” “continue,” “confidence,” or words of similar meaning or other statements concerning opinions or judgment of the Company and our management about future events. Although we believe that our expectations with respect to forward-looking statements are based upon reasonable assumptions within the bounds of our existing knowledge of our business and operations, there can be no assurance that actual future results, performance, or achievements of, or trends affecting, us will not differ materially from any projected future results, performance, achievements or trends expressed or implied by such forward-looking statements. Actual future results, performance, achievements or trends may differ materially from historical results or those anticipated depending on a variety of factors, including, but not limited to, the effects of or changes in:

market interest rates and their related impacts on macroeconomic conditions, customer and client behavior, our funding costs and our loan and securities portfolios;

economic conditions, including inflation and recessionary conditions and their related impacts on economic growth and customer and client behavior;

U.S. and global trade policies and tensions, including changes in, or the imposition of, tariffs and/or trade barriers and the economic impacts, volatility and uncertainty resulting therefrom, and geopolitical instability;

volatility in the financial services sector, including failures or rumors of failures of other depository institutions, along with actions taken by governmental agencies to address such turmoil, and the effects on the ability of depository institutions, including us, to attract and retain depositors and to borrow or raise capital;

legislative or regulatory changes and requirements, including changes in federal, state or local tax laws and changes impacting the rulemaking, supervision, examination and enforcement priorities of the federal banking agencies;

the sufficiency of liquidity and changes in our capital position;

general economic and financial market conditions, in the United States generally and particularly in the markets in which we operate and which our loans are concentrated, including the effects of declines in real estate values, an increase in unemployment levels, U.S. fiscal debt, budget, and tax matters, U.S. government shutdowns, and slowdowns in economic growth;

the impact of purchase accounting with respect to the Sandy Spring acquisition, or any change in the assumptions used regarding the assets acquired and liabilities assumed to determine the fair value and credit marks;

the possibility that the anticipated benefits of our acquisition activity, including our acquisition of Sandy Spring, including anticipated cost savings and strategic gains, are not realized when expected or at all, including as a result of the strength of the economy, competitive factors in the areas where we do business, or as a result of other unexpected factors or events;

potential adverse reactions or changes to business or employee relationships, including those resulting from our acquisition of Sandy Spring;

our ability to identify, recruit and retain key employees;

monetary, fiscal and regulatory policies of the U.S. government, including policies of the U.S. Department of the Treasury and the Federal Reserve;

the quality or composition of our loan or investment portfolios and changes in these portfolios;

demand for loan products and financial services in our market areas;

our ability to manage our growth or implement our growth strategy;

the effectiveness of expense reduction plans;

the introduction of new lines of business or new products and services;

real estate values in our lending area;

changes in accounting principles, standards, rules, and interpretations, and the related impact on our financial statements;

an insufficient ACL or volatility in the ACL resulting from the Current Expected Credit Losses (“CECL”) methodology, either alone or as that may be affected by changing economic conditions, credit concentrations, inflation, changing interest rates, or other factors;

concentrations of loans secured by real estate, particularly CRE;

the effectiveness of our credit processes and management of our credit risk;

our ability to compete in the market for financial services and increased competition from fintech companies;

technological risks and developments, and cyber threats, attacks, or events;

emerging issues related to the development and use of artificial intelligence that could give rise to legal or regulatory action or increase the risk of a cybersecurity attack or the probability that such an attack would be successful;

operational, technological, cultural, regulatory, legal, credit, and other risks associated with the exploration, consummation and integration of potential future acquisitions, whether involving stock or cash consideration;

the potential adverse effects of unusual and infrequently occurring events, such as weather-related disasters, terrorist acts, geopolitical conflicts or public health events (such as pandemics), and of governmental and societal responses thereto; these potential adverse effects may include, without limitation, adverse effects on macroeconomic conditions, the ability of our borrowers to satisfy their obligations to us, on the value of collateral securing loans, on the demand for our loans or our other products and services, on supply chains and methods used to distribute products and services, on incidents of cyberattack and fraud, on our liquidity or capital positions, on risks posed by reliance on third-party service providers, on other aspects of our business operations and on financial markets and economic growth;

performance by our counterparties or vendors;

deposit flows;

the availability of financing and the terms thereof;

the level of prepayments on loans and mortgage-backed securities;

actual or potential claims, damages, and fines related to litigation or government actions, which may result in, among other things, additional costs, fines, penalties, restrictions on our business activities, reputational harm, or other adverse consequences;

any event or development that would cause us to conclude that there was an impairment of any asset, including intangible assets, such as goodwill; and

other factors, many of which are beyond our control.

Please also refer to such other factors as discussed throughout Part I, Item 1A. “Risk Factors” and Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Annual Report on Form 10‑K for the year ended December 31, 2025, and related disclosures in other filings, which have been filed with the U.S. Securities and Exchange Commission (“SEC”) and are available on the SEC’s website at www.sec.gov. All risk factors and uncertainties described herein and therein should be considered in evaluating forward-looking statements, and all the forward-looking statements are expressly qualified by the cautionary statements contained or referred to herein and therein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on the Company or our businesses or operations. Readers are cautioned not to rely too heavily on forward-looking statements. Forward-looking statements speak only as of the date they are made. We do not intend or assume any obligation to update, revise or clarify any forward-looking statements that may be made from time to time by or on behalf of the Company, whether as a result of new information, future events or otherwise, except as required by law.

ATLANTIC UNION BANKSHARES CORPORATION AND SUBSIDIARIES

KEY FINANCIAL RESULTS (UNAUDITED)

(Dollars in thousands, except share data)

As of & For Three Months Ended

3/31/26

12/31/25

3/31/25

Results of Operations

Interest and dividend income

$

471,735

$

501,842

$

305,836

Interest expense

159,362

171,674

121,672

Net interest income

312,373

330,168

184,164

Provision for credit losses

2,737

2,211

17,638

Net interest income after provision for credit losses

309,636

327,957

166,526

Noninterest income

54,783

57,000

29,163

Noninterest expenses

209,810

243,243

134,184

Income before income taxes

154,609

141,714

61,505

Income tax expense

32,444

29,748

11,687

Net income

122,165

111,966

49,818

Dividends on preferred stock

2,967

2,967

2,967

Net income available to common shareholders

$

119,198

$

108,999

$

46,851

Interest earned on earning assets (FTE) ⁽¹⁾

$

476,285

$

506,463

$

309,593

Net interest income (FTE) ⁽¹⁾

316,923

334,789

187,921

Total revenue (FTE) ⁽¹⁾

371,706

391,789

217,084

Pre-tax pre-provision earnings (FTE) ⁽¹⁾

161,896

148,546

82,900

Key Ratios

Earnings per common share, diluted

$

0.84

$

0.77

$

0.52

Return on average assets (ROA)

1.33

%

1.19

%

0.82

%

Return on average equity (ROE)

9.78

%

8.97

%

6.35

%

Return on average tangible common equity (ROTCE) ^{(2) (3)}

18.63

%

17.85

%

12.04

%

Efficiency ratio

57.14

%

62.83

%

62.90

%

Efficiency ratio (FTE) ⁽¹⁾

56.45

%

62.09

%

61.81

%

Net interest margin

3.80

%

3.90

%

3.38

%

Net interest margin (FTE) ⁽¹⁾

3.85

%

3.96

%

3.45

%

Yields on earning assets (FTE) ⁽¹⁾

5.79

%

5.99

%

5.68

%

Average cost of interest-bearing liabilities

2.60

%

2.74

%

2.97

%

Average cost of deposits

1.90

%

2.03

%

2.29

%

Average cost of funds

1.94

%

2.03

%

2.23

%

Operating Measures⁽⁴⁾

Adjusted operating earnings

$

129,119

$

141,366

$

54,542

Adjusted operating earnings available to common shareholders

126,152

138,399

51,575

Adjusted operating pre-tax pre-provision earnings (FTE) ⁽¹⁾⁽⁷⁾

170,928

186,713

87,942

Adjusted operating earnings per common share, diluted

$

0.89

$

0.97

$

0.57

Adjusted operating ROA

1.41

%

1.50

%

0.90

%

Adjusted operating ROE

10.33

%

11.33

%

6.95

%

Adjusted operating ROTCE ^{(2) (3)}

19.62

%

22.12

%

13.15

%

Adjusted operating efficiency ratio (FTE) ⁽¹⁾⁽⁶⁾

49.86

%

47.77

%

57.02

%

Per Share Data

Earnings per common share, basic

$

0.84

$

0.77

$

0.53

Earnings per common share, diluted

0.84

0.77

0.52

Cash dividends paid per common share

0.37

0.37

0.34

Market value per share

35.74

35.30

31.14

Book value per common share

34.39

34.14

33.79

Tangible book value per common share ⁽²⁾

19.93

19.69

19.32

Price to earnings ratio, diluted

10.52

11.60

14.76

Price to book value per common share ratio

1.04

1.03

0.92

Price to tangible book value per common share ratio ⁽²⁾

1.79

1.79

1.61

Unvested shares of restricted stock awards

1,100,123

857,866

806,420

Weighted average common shares outstanding, basic

141,901,606

141,758,460

89,222,296

Weighted average common shares outstanding, diluted

142,280,978

142,118,797

90,072,795

Common shares outstanding at end of period

142,060,496

141,776,886

89,340,541

ATLANTIC UNION BANKSHARES CORPORATION AND SUBSIDIARIES

KEY FINANCIAL RESULTS (UNAUDITED)

(Dollars in thousands, except share data)

As of & For Three Months Ended

3/31/26

12/31/25

3/31/25

Capital Ratios

Common equity Tier 1 capital ratio ⁽⁵⁾

10.21

%

10.10

%

10.07

%

Tier 1 capital ratio ⁽⁵⁾

10.75

%

10.64

%

10.87

%

Total capital ratio ⁽⁵⁾

14.01

%

13.90

%

13.88

%

Leverage ratio (Tier 1 capital to average assets) ⁽⁵⁾

9.31

%

9.10

%

9.45

%

Common equity to total assets

13.09

%

12.88

%

12.26

%

Tangible common equity to tangible assets ⁽²⁾

8.03

%

7.85

%

7.39

%

Financial Condition

Assets

$

37,315,011

$

37,585,754

$

24,632,611

LHFI (net of unearned income)

27,946,424

27,796,167

18,427,689

Securities

5,059,211

5,268,717

3,405,206

Earning Assets

33,358,287

33,818,712

22,085,559

Goodwill

1,754,875

1,733,287

1,214,053

Amortizable intangibles, net

300,099

315,544

79,165

Deposits

30,391,256

30,471,636

20,502,874

Borrowings

1,304,587

1,497,292

475,685

Stockholders’ equity

5,052,316

5,006,398

3,185,216

Tangible common equity ⁽²⁾

2,830,985

2,791,210

1,725,641

Loans held for investment, net of unearned income

Construction and land development

$

1,748,413

$

1,666,381

$

1,305,969

Commercial real estate – owner occupied

4,319,847

4,305,796

2,363,509

Commercial real estate – non-owner occupied

7,212,035

7,178,515

5,072,694

Multifamily real estate

2,321,504

2,418,250

1,531,547

Commercial & Industrial

5,384,856

5,229,728

3,819,415

Residential 1-4 Family – Commercial

1,053,303

1,100,157

738,388

Residential 1-4 Family – Consumer

2,839,216

2,825,259

1,286,526

Residential 1-4 Family – Revolving

1,257,079

1,248,284

778,527

Auto

156,843

183,720

279,517

Consumer

109,755

121,488

101,334

Other Commercial

1,543,573

1,518,589

1,150,263

Total LHFI

$

27,946,424

$

27,796,167

$

18,427,689

Deposits

Interest checking accounts

$

7,515,409

$

7,193,204

$

5,336,264

Money market accounts

6,985,315

6,863,981

4,602,260

Savings accounts

2,691,144

2,747,622

1,033,315

Customer time deposits of more than $250,000

1,767,455

1,737,345

1,141,311

Customer time deposits of $250,000 or less

3,977,869

3,956,571

2,810,070

Time deposits

5,745,324

5,693,916

3,951,381

Total interest-bearing customer deposits

22,937,192

22,498,723

14,923,220

Brokered deposits

610,338

1,128,284

1,108,481

Total interest-bearing deposits

$

23,547,530

$

23,627,007

$

16,031,701

Demand deposits

6,843,726

6,844,629

4,471,173

Total deposits

$

30,391,256

$

30,471,636

$

20,502,874

Averages

Assets

$

37,254,857

$

37,356,117

$

24,678,974

LHFI (net of unearned income)

27,830,037

27,433,274

18,428,710

Loans held for sale

16,207

24,387

8,172

Securities

5,207,502

5,269,097

3,387,627

Earning assets

33,377,790

33,555,065

22,108,618

Deposits

30,210,336

30,884,349

20,466,081

Time deposits

6,039,778

6,229,539

4,715,648

Interest-bearing deposits

23,454,604

23,919,801

16,062,478

Borrowings

1,373,627

914,352

525,889

Interest-bearing liabilities

24,828,231

24,834,153

16,588,367

Stockholders’ equity

5,068,069

4,950,858

3,183,846

Tangible common equity ⁽²⁾

2,860,550

2,733,470

1,721,647

ATLANTIC UNION BANKSHARES CORPORATION AND SUBSIDIARIES

KEY FINANCIAL RESULTS (UNAUDITED)

(Dollars in thousands, except share data)

As of & For Three Months Ended

3/31/26

12/31/25

3/31/25

Asset Quality

Allowance for Credit Losses (ACL)

Beginning balance, Allowance for loan and lease losses (ALLL)

$

295,108

$

293,035

$

178,644

Add: Recoveries

1,307

3,043

607

Less: Charge-offs

2,901

3,959

2,885

Add: (Release) provision for loan losses

(2,414

)

2,989

17,430

Ending balance, ALLL

$

291,100

$

295,108

$

193,796

Beginning balance, Reserve for unfunded commitment (RUC)

$

26,161

$

26,951

$

15,041

Add: Provision (release) for unfunded commitments

4,667

(790

)

208

Ending balance, RUC

$

30,828

$

26,161

$

15,249

Total ACL

$

321,928

$

321,269

$

209,045

ACL / total LHFI

1.15

%

1.16

%

1.13

%

ALLL / total LHFI

1.04

%

1.06

%

1.05

%

Net charge-offs / total average LHFI (annualized)

0.02

%

0.01

%

0.05

%

Provision for loan losses/ total average LHFI (annualized)

(0.04

)

%

0.04

%

0.38

%

Nonperforming Assets

Construction and land development

$

2,485

$

4,303

$

2,794

Commercial real estate – owner occupied

6,416

6,034

2,932

Commercial real estate – non-owner occupied

12,221

11,301

1,159

Multifamily real estate

20,564

45,369

124

Commercial & Industrial

18,959

10,288

43,106

Residential 1-4 Family – Commercial

6,416

6,657

1,610

Residential 1-4 Family – Consumer

24,426

23,297

12,942

Residential 1-4 Family – Revolving

5,364

5,643

3,593

Auto

515

572

641

Consumer

12

12

16

Other Commercial

450

1,575

98

Nonaccrual loans

$

97,828

$

115,051

$

69,015

Foreclosed property

1,856

1,826

404

Total nonperforming assets (NPAs)

$

99,684

$

116,877

$

69,419

Construction and land development

$

186

$

1,481

$

—

Commercial real estate – owner occupied

4,362

4,788

714

Commercial real estate – non-owner occupied

1,793

2,099

—

Multifamily real estate

4,195

6,140

—

Commercial & Industrial

3,675

9,114

1,075

Residential 1-4 Family – Commercial

1,161

2,379

1,091

Residential 1-4 Family – Consumer

4,449

5,633

1,193

Residential 1-4 Family – Revolving

4,340

3,458

2,397

Auto

239

404

196

Consumer

70

55

94

Other Commercial

—

—

22

LHFI ≥ 90 days and still accruing

$

24,470

$

35,551

$

6,782

Total NPAs and LHFI ≥ 90 days

$

124,154

$

152,428

$

76,201

NPAs / total LHFI

0.36

%

0.42

%

0.38

%

NPAs / total assets

0.27

%

0.31

%

0.28

%

ALLL / nonaccrual loans

297.56

%

256.50

%

280.80

%

ALLL/ nonperforming assets

292.02

%

252.49

%

279.17

%

ATLANTIC UNION BANKSHARES CORPORATION AND SUBSIDIARIES

KEY FINANCIAL RESULTS (UNAUDITED)

(Dollars in thousands, except share data)

As of & For Three Months Ended

3/31/26

12/31/25

3/31/25

Past Due Detail

Construction and land development

$

2,866

$

1,455

$

458

Commercial real estate – owner occupied

8,223

7,241

1,455

Commercial real estate – non-owner occupied

5,445

9,482

3,760

Multifamily real estate

6,944

52

1,353

Commercial & Industrial

10,396

8,935

4,192

Residential 1-4 Family – Commercial

4,076

2,634

1,029

Residential 1-4 Family – Consumer

22,015

17,911

11,005

Residential 1-4 Family – Revolving

4,094

3,994

2,533

Auto

2,212

3,332

3,662

Consumer

268

444

479

Other Commercial

2,714

3,242

6,875

LHFI 30-59 days past due

$

69,253

$

58,722

$

36,801

Construction and land development

$

3,299

$

94

$

35

Commercial real estate – owner occupied

8,767

3,171

971

Commercial real estate – non-owner occupied

4,084

1,455

—

Multifamily real estate

—

247

981

Commercial & Industrial

10,432

3,552

838

Residential 1-4 Family – Commercial

323

1,306

19

Residential 1-4 Family – Consumer

1,841

5,628

348

Residential 1-4 Family – Revolving

1,218

2,157

1,137

Auto

411

797

539

Consumer

333

171

384

Other Commercial

525

143

1,123

LHFI 60-89 days past due

$

31,233

$

18,721

$

6,375

Past Due and still accruing

$

124,956

$

112,994

$

49,958

Past Due and still accruing / total LHFI

0.45

%

0.41

%

0.27

%

Alternative Performance Measures (non-GAAP)

Net interest income (FTE) ⁽¹⁾

Net interest income (GAAP)

$

312,373

$

330,168

$

184,164

FTE adjustment

4,550

4,621

3,757

Net interest income (FTE) (non-GAAP)

$

316,923

$

334,789

$

187,921

Noninterest income (GAAP)

54,783

57,000

29,163

Total revenue (FTE) (non-GAAP)

$

371,706

$

391,789

$

217,084

Less: Noninterest expense (GAAP)

209,810

243,243

134,184

Pre-tax pre-provision earnings (FTE) (non-GAAP)

$

161,896

$

148,546

$

82,900

Average earning assets

$

33,377,790

$

33,555,065

$

22,108,618

Net interest margin

3.80

%

3.90

%

3.38

%

Net interest margin (FTE)

3.85

%

3.96

%

3.45

%

Tangible Assets ⁽²⁾

Ending assets (GAAP)

$

37,315,011

$

37,585,754

$

24,632,611

Less: Ending goodwill

1,754,875

1,733,287

1,214,053

Less: Ending amortizable intangibles

300,099

315,544

79,165

Ending tangible assets (non-GAAP)

$

35,260,037

$

35,536,923

$

23,339,393

Tangible Common Equity ⁽²⁾

Ending equity (GAAP)

$

5,052,316

$

5,006,398

$

3,185,216

Less: Ending goodwill

1,754,875

1,733,287

1,214,053

Less: Ending amortizable intangibles

300,099

315,544

79,165

Less: Perpetual preferred stock

166,357

166,357

166,357

Ending tangible common equity (non-GAAP)

$

2,830,985

$

2,791,210

$

1,725,641

Average equity (GAAP)

$

5,068,069

$

4,950,858

$

3,183,846

Less: Average goodwill

1,733,527

1,726,933

1,214,053

Less: Average amortizable intangibles

307,636

324,099

81,790

Less: Average perpetual preferred stock

166,356

166,356

166,356

Average tangible common equity (non-GAAP)

$

2,860,550

$

2,733,470

$

1,721,647

ROTCE ⁽²⁾⁽³⁾

Net income available to common shareholders (GAAP)

$

119,198

$

108,999

$

46,851

Plus: Amortization of intangibles, tax effected

12,202

13,977

4,264

Net income available to common shareholders before amortization of intangibles (non-GAAP)

$

131,400

$

122,976

$

51,115

Return on average tangible common equity (ROTCE)

18.63

%

17.85

%

12.04

%

ATLANTIC UNION BANKSHARES CORPORATION AND SUBSIDIARIES

KEY FINANCIAL RESULTS (UNAUDITED)

(Dollars in thousands, except share data)

As of & For Three Months Ended

3/31/26

12/31/25

3/31/25

Operating Measures⁽⁴⁾

Net income (GAAP)

$

122,165

$

111,966

$

49,818

Plus: Merger-related costs, net of tax

6,956

29,742

4,643

Less: Gain (loss) on sale of securities, net of tax

2

2

(81

)

Less: Gain on sale of equity interest in CSP, net of tax

—

340

—

Adjusted operating earnings (non-GAAP)

129,119

141,366

54,542

Less: Dividends on preferred stock

2,967

2,967

2,967

Adjusted operating earnings available to common shareholders (non-GAAP)

$

126,152

$

138,399

$

51,575

Operating Efficiency Ratio⁽¹⁾⁽⁶⁾

Noninterest expense (GAAP)

$

209,810

$

243,243

$

134,184

Less: Amortization of intangible assets

15,446

17,692

5,398

Less: Merger-related costs

9,034

38,626

4,940

Adjusted operating noninterest expense (non-GAAP)

$

185,330

$

186,925

$

123,846

Noninterest income (GAAP)

$

54,783

$

57,000

$

29,163

Less: Gain (loss) on sale of securities

2

2

(102

)

Less: Gain on sale of equity interest in CSP

—

457

—

Adjusted operating noninterest income (non-GAAP)

$

54,781

$

56,541

$

29,265

Net interest income (FTE) (non-GAAP)⁽¹⁾

$

316,923

$

334,789

$

187,921

Adjusted operating noninterest income (non-GAAP)

54,781

56,541

29,265

Total adjusted revenue (FTE) (non-GAAP) ⁽¹⁾

$

371,704

$

391,330

$

217,186

Efficiency ratio

57.14

%

62.83

%

62.90

%

Efficiency ratio (FTE) ⁽¹⁾

56.45

%

62.09

%

61.81

%

Adjusted operating efficiency ratio (FTE) ⁽¹⁾⁽⁶⁾

49.86

%

47.77

%

57.02

%

Operating ROA & ROE ⁽⁴⁾

Adjusted operating earnings (non-GAAP)

$

129,119

$

141,366

$

54,542

Average assets (GAAP)

$

37,254,857

$

37,356,117

$

24,678,974

Return on average assets (ROA) (GAAP)

1.33

%

1.19

%

0.82

%

Adjusted operating return on average assets (ROA) (non-GAAP)

1.41

%

1.50

%

0.90

%

Average equity (GAAP)

$

5,068,069

$

4,950,858

$

3,183,846

Return on average equity (ROE) (GAAP)

9.78

%

8.97

%

6.35

%

Adjusted operating return on average equity (ROE) (non-GAAP)

10.33

%

11.33

%

6.95

%

Operating ROTCE ^(2)(3)(4)

Adjusted operating earnings available to common shareholders (non-GAAP)

$

126,152

$

138,399

$

51,575

Plus: Amortization of intangibles, tax effected

12,202

13,977

4,264

Adjusted operating earnings available to common shareholders before amortization of intangibles (non-GAAP)

$

138,354

$

152,376

$

55,839

Average tangible common equity (non-GAAP)

$

2,860,550

$

2,733,470

$

1,721,647

Adjusted operating return on average tangible common equity (non-GAAP)

19.62

%

22.12

%

13.15

%

Operating pre-tax pre-provision earnings (FTE) ⁽⁷⁾

Net income (GAAP)

$

122,165

$

111,966

$

49,818

Plus: Provision for credit losses

2,737

2,211

17,638

Plus: Income tax expense

32,444

29,748

11,687

Plus: Merger-related costs

9,034

38,626

4,940

Plus: FTE adjustment

4,550

4,621

3,757

Less: Gain (loss) on sale of securities

2

2

(102

)

Less: Gain on sale of equity interest in CSP

—

457

—

Adjusted operating pre-tax pre-provision earnings (FTE) (non-GAAP)

$

170,928

$

186,713

$

87,942

Less: Dividends on preferred stock

2,967

2,967

2,967

Adjusted operating pre-tax pre-provision earnings available to common shareholders (FTE) (non-GAAP)

$

167,961

$

183,746

$

84,975

Weighted average common shares outstanding, diluted

142,280,978

142,118,797

90,072,795

Adjusted operating pre-tax pre-provision earnings per common share, diluted (FTE)

$

1.18

$

1.29

$

0.94

ATLANTIC UNION BANKSHARES CORPORATION AND SUBSIDIARIES

KEY FINANCIAL RESULTS (UNAUDITED)

(Dollars in thousands, except share data)

As of & For Three Months Ended

3/31/26

12/31/25

3/31/25

Mortgage Origination Held for Sale Volume

Refinance Volume

$

25,375

$

20,179

$

10,035

Purchase Volume

60,543

79,089

33,733

Total Mortgage loan originations held for sale

$

85,918

$

99,268

$

43,768

% of originations held for sale that are refinances

29.5

%

20.3

%

22.9

%

Wealth

Assets under management

$

15,246,694

$

15,146,318

$

6,785,740

Other Data

End of period full-time equivalent employees

3,034

3,001

2,128

_________________________________

(1)

These are non-GAAP financial measures. The Company believes net interest income (FTE), total revenue (FTE), total adjusted revenue (FTE), which are used in computing net interest margin (FTE), efficiency ratio (FTE) and adjusted operating efficiency ratio (FTE), provide valuable additional insight into the net interest margin and the efficiency ratio by adjusting for differences in tax treatment of interest income sources. The entire FTE adjustment is attributable to interest income on earning assets, which is used in computing the yield on earning assets. Interest expense and the related cost of interest-bearing liabilities and cost of funds ratios are not affected by the FTE components.

(2)

These are non-GAAP financial measures. Tangible assets and tangible common equity are used in the calculation of certain profitability, capital, and per share ratios. The Company believes tangible assets, tangible common equity and the related ratios are meaningful measures of capital adequacy because they provide a meaningful base for period-to-period and company-to-company comparisons, which the Company believes will assist investors in assessing the capital of the Company and its ability to absorb potential losses. The Company believes tangible common equity is an important indication of its ability to grow organically and through business combinations as well as its ability to pay dividends and to engage in various capital management strategies.

(3)

These are non-GAAP financial measures. The Company believes that ROTCE is a meaningful supplement to GAAP financial measures and is useful to investors because it measures the performance of a business consistently across time without regard to whether components of the business were acquired or developed internally.

(4)

These are non-GAAP financial measures. Adjusted operating measures exclude, as applicable, merger-related costs, gain (loss) on sale of securities, and gain on sale of equity interest in CSP. The Company believes these non-GAAP adjusted measures provide investors with important information about the continuing economic results of the Company’s operations.

(5)

All ratios at March 31, 2026 are estimates and subject to change pending the Company’s filing of its FR Y9 C. All other periods are presented as filed.

(6)

The adjusted operating efficiency ratio (FTE) excludes, as applicable, the amortization of intangible assets, merger-related costs, gain (loss) on sale of securities, and gain on sale of equity interest in CSP. This measure is similar to the measure used by the Company when analyzing corporate performance and is also similar to the measure used for incentive compensation. The Company believes this adjusted measure provides investors with important information about the continuing economic results of the Company’s operations.

(7)

These are non-GAAP financial measures. Adjusted operating pre-tax pre-provision earnings (FTE) excludes, as applicable, the provision for credit losses, which can fluctuate significantly from period-to-period under the CECL methodology, income tax expense, merger-related costs, gain (loss) on sale of securities, and gain on sale of equity interest in CSP. The Company believes this adjusted measure provides investors with important information about the continuing economic results of the Company’s operations.

ATLANTIC UNION BANKSHARES CORPORATION AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Dollars in thousands, except share data)

March 31,

December 31,

March 31,

2026

2025

2025

ASSETS

(unaudited)

(audited)

(unaudited)

Cash and cash equivalents:

Cash and due from banks

$

451,370

$

234,257

$

194,083

Interest-bearing deposits in other banks

321,302

706,014

236,094

Federal funds sold

7,456

26,191

3,961

Total cash and cash equivalents

780,128

966,462

434,138

Securities available for sale, at fair value

4,011,410

4,194,301

2,483,835

Securities held to maturity, at carrying value

870,288

884,216

821,059

Restricted stock, at cost

177,513

190,200

100,312

Loans held for sale

20,776

18,486

9,525

Loans held for investment, net of unearned income

27,946,424

27,796,167

18,427,689

Less: allowance for loan and lease losses

291,100

295,108

193,796

Total loans held for investment, net

27,655,324

27,501,059

18,233,893

Premises and equipment, net

162,549

166,752

111,876

Goodwill

1,754,875

1,733,287

1,214,053

Amortizable intangibles, net

300,099

315,544

79,165

Bank owned life insurance

675,816

672,890

496,933

Other assets

906,233

942,557

647,822

Total assets

$

37,315,011

$

37,585,754

$

24,632,611

LIABILITIES

Noninterest-bearing demand deposits

$

6,843,726

$

6,844,629

$

4,471,173

Interest-bearing deposits

23,547,530

23,627,007

16,031,701

Total deposits

30,391,256

30,471,636

20,502,874

Securities sold under agreements to repurchase

144,605

75,432

57,018

Other short-term borrowings

385,000

650,000

—

Long-term borrowings

774,982

771,860

418,667

Other liabilities

566,852

610,428

468,836

Total liabilities

32,262,695

32,579,356

21,447,395

STOCKHOLDERS’ EQUITY

Preferred stock, $10.00 par value

173

173

173

Common stock, $1.33 par value

188,940

188,563

118,823

Additional paid-in capital

3,890,335

3,888,841

2,280,300

Retained earnings

1,251,356

1,184,908

1,119,635

Accumulated other comprehensive loss

(278,488

)

(256,087

)

(333,715

)

Total stockholders’ equity

5,052,316

5,006,398

3,185,216

Total liabilities and stockholders’ equity

$

37,315,011

$

37,585,754

$

24,632,611

Common shares issued and outstanding

142,060,496

141,776,886

89,340,541

Common shares authorized

200,000,000

200,000,000

200,000,000

Preferred shares issued and outstanding

17,250

17,250

17,250

Preferred shares authorized

500,000

500,000

500,000

ATLANTIC UNION BANKSHARES CORPORATION AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF INCOME (UNAUDITED)

(Dollars in thousands, except share data)

Three Months Ended

March 31,

December 31,

March 31,

2026

2025

2025

Interest and dividend income:

Interest and fees on loans

$

419,628

$

443,714

$

271,515

Interest on deposits in other banks

2,146

6,134

2,513

Interest and dividends on securities:

Taxable

41,008

43,038

23,648

Nontaxable

8,953

8,956

8,160

Total interest and dividend income

471,735

501,842

305,836

Interest expense:

Interest on deposits

141,779

157,886

115,587

Interest on short-term borrowings

5,227

957

909

Interest on long-term borrowings

12,356

12,831

5,176

Total interest expense

159,362

171,674

121,672

Net interest income

312,373

330,168

184,164

Provision for credit losses

2,737

2,211

17,638

Net interest income after provision for credit losses

309,636

327,957

166,526

Noninterest income:

Service charges on deposit accounts

12,116

11,742

9,683

Other service charges, commissions and fees

1,938

1,726

1,762

Interchange fees

3,326

3,660

2,949

Fiduciary and asset management fees

20,178

19,848

6,697

Mortgage banking income

2,026

2,084

973

Bank owned life insurance income

5,200

5,040

3,537

Loan-related interest rate swap fees

3,975

8,381

2,400

Other operating income

6,024

4,519

1,162

Total noninterest income

54,783

57,000

29,163

Noninterest expenses:

Salaries and benefits

113,413

108,405

75,415

Occupancy expenses

13,202

13,222

8,580

Furniture and equipment expenses

5,555

5,331

3,914

Technology and data processing

15,602

17,495

10,188

Professional services

5,768

8,044

4,687

Marketing and advertising expense

7,328

6,786

3,184

FDIC assessment premiums and other insurance

6,846

7,392

5,201

Franchise and other taxes

4,705

4,874

4,643

Loan-related expenses

2,851

2,216

1,249

Amortization of intangible assets

15,446

17,692

5,398

Merger-related costs

9,034

38,626

4,940

Other expenses

10,060

13,160

6,785

Total noninterest expenses

209,810

243,243

134,184

Income before income taxes

154,609

141,714

61,505

Income tax expense

32,444

29,748

11,687

Net Income

$

122,165

$

111,966

$

49,818

Dividends on preferred stock

2,967

2,967

2,967

Net income available to common shareholders

$

119,198

$

108,999

$

46,851

Basic earnings per common share

$

0.84

$

0.77

$

0.53

Diluted earnings per common share

$

0.84

$

0.77

$

0.52

ATLANTIC UNION BANKSHARES CORPORATION AND SUBSIDIARIES

AVERAGE BALANCES, INCOME AND EXPENSES, YIELDS AND RATES (TAXABLE EQUIVALENT BASIS) (UNAUDITED)

(Dollars in thousands)

For the Quarter Ended

March 31, 2026

December 31, 2025

Average

Balance

Interest

Income /

Expense ⁽¹⁾

Yield /

Rate ⁽¹⁾⁽²⁾

Average

Balance

Interest

Income /

Expense⁽¹⁾

Yield /

Rate ⁽¹⁾⁽²⁾

Assets:

Securities:

Taxable

$

3,877,982

$

41,008

4.29

%

$

3,938,289

$

43,038

4.34

%

Tax-exempt

1,329,520

11,333

3.46

%

1,330,808

11,337

3.38

%

Total securities

5,207,502

52,341

4.08

%

5,269,097

54,375

4.09

%

LHFI, net of unearned income ⁽³⁾⁽⁴⁾

27,830,037

421,299

6.14

%

27,433,274

445,296

6.44

%

Other earning assets

340,251

2,645

3.15

%

852,694

6,792

3.16

%

Total earning assets

33,377,790

$

476,285

5.79

%

33,555,065

$

506,463

5.99

%

Allowance for loan and lease losses

(296,795

)

(295,879

)

Total non-earning assets

4,173,862

4,096,931

Total assets

$

37,254,857

$

37,356,117

Liabilities and Stockholders’ Equity:

Interest-bearing deposits:

Transaction and money market accounts

$

14,701,490

$

79,333

2.19

%

$

14,850,122

$

88,616

2.37

%

Regular savings

2,713,336

10,894

1.63

%

2,840,140

12,521

1.75

%

Time deposits ⁽⁵⁾

6,039,778

51,552

3.46

%

6,229,539

56,749

3.61

%

Total interest-bearing deposits

23,454,604

141,779

2.45

%

23,919,801

157,886

2.62

%

Other borrowings⁽⁶⁾

1,373,627

17,583

5.19

%

914,352

13,788

5.98

%

Total interest-bearing liabilities

$

24,828,231

$

159,362

2.60

%

$

24,834,153

$

171,674

2.74

%

Noninterest-bearing liabilities:

Demand deposits

6,755,732

6,964,548

Other liabilities

602,825

606,558

Total liabilities

32,186,788

32,405,259

Stockholders’ equity

5,068,069

4,950,858

Total liabilities and stockholders’ equity

$

37,254,857

$

37,356,117

Net interest income (FTE)

$

316,923

$

334,789

Interest rate spread

3.19

%

3.25

%

Cost of funds

1.94

%

2.03

%

Net interest margin (FTE)

3.85

%

3.96

%

_____________________________

(1)

Income and yields are reported on a taxable equivalent basis using the statutory federal corporate tax rate of 21%.

(2)

Rates and yields are annualized and calculated from rounded amounts in thousands, which appear above.

(3)

Nonaccrual loans are included in average loans outstanding.

(4)

Interest income on loans includes $35.6 million and $48.4 million for the three months ended March 31, 2026 and December 31, 2025, respectively, in accretion of the fair market value adjustments related to acquisitions.

(5)

Interest expense on time deposits includes $366 thousand and $762 thousand for the three months ended March 31, 2026 and December 31, 2025, respectively, in accretion of the fair market value adjustments related to acquisitions.

(6)

Interest expense on borrowings includes $3.0 million and $3.2 million for the three months ended March 31, 2026 and December 31, 2025, respectively, in amortization of the fair market value adjustments related to acquisitions.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260421828720/en/

Alexander D. Dodd – (804) 486-2634

Executive Vice President / Chief Financial Officer

KEYWORDS: Virginia United States North America

INDUSTRY KEYWORDS: Banking Professional Services Finance

MEDIA:

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Posted on April 21, 2026 6:48 am
Unitil Schedules First Quarter 2026 Earnings Release and Conference Call

HAMPTON, N.H., April 21, 2026 (GLOBE NEWSWIRE) — Unitil Corporation (NYSE: UTL) (unitil.com) has scheduled the release of its first quarter 2026 earnings after the market closes on May 4, 2026. Unitil will host its conference call and webcast on May 5, 2026 at 2:00 p.m. (ET) to review its quarterly results. Related presentation materials will be available before the call on the Company’s Investors page at investors.unitil.com.

The conference call will be broadcast live in listen-only mode on the Company’s Investors page at investors.unitil.com. Interested parties may access dial information for the call by registering via web link here. An archive of the webcast will be available for one year on the website at investors.unitil.com.

About Unitil Corporation

Unitil Corporation provides energy for life by safely and reliably delivering electricity and natural gas in New England. We are committed to the communities we serve and to developing people, business practices, and technologies that lead to the delivery of dependable, more efficient energy. Unitil Corporation is a public utility holding company with operations in Maine, New Hampshire and Massachusetts. Together, Unitil’s operating utilities serve approximately 110,000 electric customers and 105,000 natural gas customers. For more information about our people, technologies, and community involvement please visit unitil.com.

For more information please contact:

Christopher Goulding – Investor Relations
Phone: 603-773-6466
Email: [email protected]

Amanda Vicinanzo – External Affairs
Phone: 603-691-7784
Email: [email protected]

Posted on April 21, 2026 6:48 am
Halliburton Announces First Quarter 2026 Results

Halliburton Announces First Quarter 2026 Results

Net income of $0.55 per diluted share.

Revenue of $5.4 billion and operating margin of 13%.

Cash flow from operations of $273 million and free cash flow¹ of $123 million.

Approximately $100 million of share repurchases.

HOUSTON–(BUSINESS WIRE)–
Halliburton Company (NYSE: HAL) announced today net income of $461 million, or $0.55 per diluted share, for the first quarter of 2026. This compares to net income for the first quarter of 2025 of $204 million, or $0.24 per diluted share, and adjusted net income²,^{excluding impairments and other charges, of $517 million, or $0.60 per diluted share, in the first quarter of 2025. Halliburton’s total revenue for the first quarter of 2026 was $5.4 billion, flat when compared to the first quarter of 2025. Operating income was $679 million in the first quarter of 2026, compared to operating income of $431 million in the first quarter of 2025, and adjusted operating income³,^{excluding impairments and other charges, of $787 million in the first quarter of 2025.}}

“I am pleased with Halliburton’s performance this quarter,” commented Jeff Miller, Chairman, President and CEO.

“In North America, I see clear signs that we are in the early innings of a recovery.

“In international markets, our performance around the world outpaced disruptions from the Middle East conflict.

“I expect that our consistent focus on returns and capital discipline will drive long-term success for Halliburton and its shareholders,” concluded Miller.

Operating Segments

Completion and Production

Completion and Production revenue in the first quarter of 2026 was $3.0 billion, a decrease of $104 million, or 3%, when compared to the first quarter of 2025, while operating income was $439 million, a decrease of $92 million, or 17%, when compared to first quarter of 2025. These results were primarily driven by lower stimulation activity in North America, and lower completion tool sales and decreased pressure pumping services in the Middle East. Partially offsetting these decreases were higher completion tool sales in the Western Hemisphere, and improved pressure pumping services in Africa.

Drilling and Evaluation

Drilling and Evaluation revenue in the first quarter of 2026 was $2.4 billion, an increase of $89 million, or 4%, when compared to the first quarter of 2025, while operating income was $351 million, flat when compared to the first quarter of 2025. These results were primarily driven by higher project management activity in Latin America and increased drilling-related services in Europe and the Western Hemisphere. Partially offsetting these increases were lower activity across multiple product service lines in the Middle East, lower wireline activity in the Eastern Hemisphere, and decreased fluid services in the Gulf of America.

In the first quarter of 2026, the geopolitical conflict in the Middle East affected both divisions, with an impact of approximately 2 to 3 cents of net income per diluted share.

Geographic Regions

North America

North America revenue in the first quarter of 2026 was $2.1 billion, a 4% decrease when compared to the first quarter of 2025. This decline was primarily driven by lower stimulation activity and decreased artificial lift activity in US Land, and lower stimulation activity and decreased fluid services in the Gulf of America. Partially offsetting these decreases were increased drilling-related services in US Land and higher completion tool sales in the region.

International

International revenue in the first quarter of 2026 was $3.3 billion, an increase of 3% when compared to the first quarter of 2025.

Latin America revenue in the first quarter of 2026 was $1.1 billion, an increase of 22% year over year. This increase was primarily driven by higher activity across multiple product service lines in Ecuador, the Caribbean, and Brazil, and improved stimulation activity in Mexico and Argentina. Partially offsetting these increases were lower project management activity and decreased drilling-related services in Mexico.

Europe/Africa revenue in the first quarter of 2026 was $858 million, an increase of 11% year over year. This increase was primarily driven by increased drilling-related services and higher completion tool sales in Norway, and improved pressure pumping services in Angola. Partially offsetting these increases were lower completion tool sales in the Caspian Area and decreased drilling-related services in Namibia.

Middle East/Asia revenue in the first quarter of 2026 was $1.3 billion, a decrease of 13% year over year. This decrease was primarily driven by lower activity across multiple product service lines in Saudi Arabia and decreased drilling-related services in Qatar. Partially offsetting these decreases were higher completion tool sales and improved fluid services in Asia.

Other Financial Items

During the first quarter of 2026, Halliburton:

Repurchased approximately $100 million of its common stock.

Paid dividends of $0.17 per share.

Spent $42 million on SAP S4 migration.

Selective Technology & Highlights

Halliburton launched the HyperSteer^™ MX directional drill bit, an industry-first shankless matrix-body bit that improves durability and maximizes directional control. The bit delivers longer runs and fewer trips, resists erosion and abrasion, and performs reliably in high-flow, abrasive environments. HyperSteer^™ MX directional drill bits utilize advanced matrix materials to resist erosion and abrasion, extend bit life in abrasive, high-flow environments, and improve efficiency and reliability during operations.

Halliburton and the Agency for Science, Technology and Research (A*STAR), Singapore’s lead public sector research and development agency, announced the launch of the Next-Generation Energy Xccelerator Joint Lab. This initiative aims to accelerate the development and commercialization of advanced well completion technologies for the energy industry. The project is also supported by the Singapore Economic Development Board.

Halliburton launched the XTR^™ CS injection system, a wireline-retrievable safety valve solution engineered for CO₂ injection in carbon capture, utilization, and storage wells. The system provides flexibility as a primary or contingency safety valve or as a deep-set reservoir fluid-flowback prevention device. Unlike traditional surface-controlled wireline valves, the XTR injection system’s non-elastomeric design helps minimize leak paths and eliminate reliance on hydraulic operation systems. This system remains at steady performance at any setting depth, to simplify operations and inventory management.

Halliburton launched the RangeStar™ Geothermal Well Spacing and Intercept Service, a part of the family of RangeStar™ magnetic ranging services, a next-generation solution that supports geothermal development through faster, more accurate, and fully integrated well placement. Designed for complex geothermal environments, the RangeStar Geothermal Well Spacing and Intercept Service delivers reliable performance that reduces uncertainty and simplifies operations. Rapid ranging determination reduces decision time from hours to minutes, supports detection distances up to 130 meters, and improves accuracy within formations and depths.

Halliburton, in collaboration with ExxonMobil Guyana, Sekal, and Noble, delivered a groundbreaking step forward in digital well construction to achieve the deepwater industry’s first fully automated geological well placement with complete rig automation in offshore Guyana. The project combined rig automation, automated subsurface interpretation and well placement, and real-time hydraulics to establish a new benchmark for well construction performance, reservoir contact, and execution efficiency.

(1)

Free cash flow is a non-GAAP financial measure; please see reconciliation of Cash Flows from Operating Activities to Free Cash Flow in Footnote Table 3.

(2)

Adjusted net income is a non-GAAP financial measure; please see reconciliation of Net Income to Adjusted Net Income in Footnote Table 2.

(3)

Adjusted operating income is a non-GAAP financial measure; please see reconciliation of Operating Income to Adjusted Operating Income in Footnote Table 1.

About Halliburton

Halliburton is one of the world’s leading providers of products and services to the energy industry. Founded in 1919, we create innovative technologies, products, and services that help our customers maximize their value throughout the life cycle of an asset and advance a sustainable energy future. Visit us at www.halliburton.com; connect with us on LinkedIn, YouTube, Instagram and Facebook.

Forward-looking Statements

The statements in this press release that are not historical statements are forward-looking statements within the meaning of the federal securities laws. These statements are subject to numerous risks and uncertainties, many of which are beyond the company’s control, which could cause actual results to differ materially from the results expressed or implied by the statements. These risks and uncertainties include, but are not limited to: changes in the demand for or price of oil and/or natural gas, including as a result of development of alternative energy sources, general economic conditions such as inflation and recession, the ability of the OPEC+ countries to agree on and comply with production quotas, and other causes; changes in capital spending by our customers; the modification, continuation or suspension of our shareholder return framework, including the payment of dividends and purchases of our stock, which will be subject to the discretion of our Board of Directors and may depend on a variety of factors, including our results of operations and financial condition, growth plans, capital requirements and other conditions existing when any payment or purchase decision is made; potential catastrophic events related to our operations, and related indemnification and insurance; protection of intellectual property rights; cyber-attacks and data security; compliance with environmental laws; changes in government regulations and regulatory requirements, particularly those related to oil and natural gas exploration, the environment, radioactive sources, explosives, chemicals, hydraulic fracturing services, and climate-related initiatives; assumptions regarding the generation of future taxable income, and compliance with laws related to and disputes with taxing authorities regarding income taxes; risks of international operations, including risks relating to unsettled political conditions, war, including the current conflict in Iran, the effects of terrorism, foreign exchange rates and controls, international trade and regulatory controls, tariffs, and sanctions, and doing business with national oil companies; weather-related issues, including the effects of hurricanes and tropical storms; delays or failures by customers to make payments owed to us; infrastructure issues in the oil and natural gas industry; availability and cost of highly skilled labor and raw materials; completion of potential dispositions, and acquisitions, and integration and success of acquired businesses and joint ventures. Halliburton’s Form 10-K for the year ended December 31, 2025, Current Reports on Form 8-K and other Securities and Exchange Commission filings discuss some of the important risk factors identified that may affect Halliburton’s business, results of operations, and financial condition. Halliburton undertakes no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.

HALLIBURTON COMPANY

Condensed Consolidated Statements of Operations

(Millions of dollars and shares except per share data)

(Unaudited)

Three Months Ended

March 31,

December 31,

2026

2025

2025

Revenue:

Completion and Production

$

3,016

$

3,120

$

3,268

Drilling and Evaluation

2,386

2,297

2,389

Total revenue

$

5,402

$

5,417

$

5,657

Operating income:

Completion and Production

$

439

$

531

$

570

Drilling and Evaluation

351

352

367

Corporate and other

(69

)

(66

)

(66

)

SAP S4 upgrade expense

(42

)

(30

)

(42

)

Impairments and other charges (a)

—

(356

)

(83

)

Total operating income

679

431

746

Interest expense, net

(82

)

(86

)

(86

)

Other, net

(28

)

(39

)

(25

)

Income before income taxes

569

306

635

Income tax provision (b)

(105

)

(103

)

(46

)

Net income

$

464

$

203

$

589

Net (income) loss attributable to noncontrolling interest

(3

)

1

—

Net income attributable to Company

$

461

$

204

$

589

Basic and diluted net income per share

$

0.55

$

0.24

$

0.70

Basic weighted average common shares outstanding

837

866

839

Diluted weighted average common shares outstanding

839

866

840

(a)

See Footnote Table 1 for details of the impairments and other charges recorded during the three months ended March 31, 2025 and December 31, 2025.

(b)

The income tax provision during the three months ended March 31, 2026 includes a $32 million tax benefit associated with a valuation allowance release. The income tax provision during the three months ended March 31, 2025 includes a tax effect on impairments and other charges. The income tax provision during the three months ended December 31, 2025 includes an $86 million discrete tax benefit from the Foreign-Derived Intangible Income (FDII) deduction attributable to a royalty prepayment, as well as the tax effect on impairments and other charges.

See Footnote Table 1 for Reconciliation of Operating Income to Adjusted Operating Income.

See Footnote Table 2 for Reconciliation of Net Income to Adjusted Net Income.

HALLIBURTON COMPANY

Condensed Consolidated Balance Sheets

(Millions of dollars)

(Unaudited)

March 31,

December 31,

2026

2025

Assets

Current assets:

Cash and equivalents

$

2,003

$

2,206

Receivables, net

5,197

4,942

Inventories

3,019

2,976

Other current assets

1,316

1,274

Total current assets

11,535

11,398

Property, plant, and equipment, net

5,182

5,261

Goodwill

2,992

2,938

Deferred income taxes

2,339

2,298

Operating lease right-of-use assets

895

938

Other assets

2,199

2,177

Total assets

$

25,142

$

25,010

Liabilities and Shareholders’ Equity

Current liabilities:

Accounts payable

$

3,211

$

3,133

Accrued employee compensation and benefits

622

767

Current portion of operating lease liabilities

243

263

Current maturities of long-term debt

90

—

Other current liabilities

1,371

1,425

Total current liabilities

5,537

5,588

Long-term debt

7,070

7,158

Operating lease liabilities

678

712

Employee compensation and benefits

395

428

Other liabilities

637

619

Total liabilities

14,317

14,505

Company shareholders’ equity

10,780

10,461

Noncontrolling interest in consolidated subsidiaries

45

44

Total shareholders’ equity

10,825

10,505

Total liabilities and shareholders’ equity

$

25,142

$

25,010

HALLIBURTON COMPANY

Condensed Consolidated Statements of Cash Flows

(Millions of dollars)

(Unaudited)

Three Months Ended

March 31,

2026

2025

Cash flows from operating activities:

Net income

$

464

$

203

Adjustments to reconcile net income to cash flows from operating activities:

Depreciation, depletion, and amortization

295

277

Impairments and other charges

—

356

Working capital (a)

(252

)

(154

)

Other operating activities

(234

)

(305

)

Total cash flows provided by operating activities

273

377

Cash flows from investing activities:

Capital expenditures

(192

)

(302

)

Payments to acquire businesses

(97

)

(116

)

Purchases of marketable securities

(2

)

(96

)

Proceeds from sales of property, plant, and equipment

42

49

Sales of marketable securities

27

41

Purchase of an equity investment

—

(345

)

Other investing activities

(21

)

(15

)

Total cash flows used in investing activities

(243

)

(784

)

Cash flows from financing activities:

Dividends to shareholders

(142

)

(147

)

Stock repurchase program

(100

)

(250

)

Other financing activities

5

(9

)

Total cash flows used in financing activities

(237

)

(406

)

Effect of exchange rate changes on cash

4

(1

)

Decrease in cash and equivalents

(203

)

(814

)

Cash and equivalents at beginning of period

2,206

2,618

Cash and equivalents at end of period

$

2,003

$

1,804

(a)

Working capital includes receivables, inventories, and accounts payable.

See Footnote Table 3 for Reconciliation of Cash Flows from Operating Activities to Free Cash Flow.

HALLIBURTON COMPANY

Revenue and Operating Income Comparison

By Operating Segment and Geographic Region

(Millions of dollars)

(Unaudited)

Three Months Ended

March 31,

December 31,

Revenue

2026

2025

2025

By operating segment:

Completion and Production

$

3,016

$

3,120

$

3,268

Drilling and Evaluation

2,386

2,297

2,389

Total revenue

$

5,402

$

5,417

$

5,657

By geographic region:

North America

$

2,136

$

2,236

$

2,207

Latin America

1,090

896

1,066

Europe/Africa/CIS

858

775

928

Middle East/Asia

1,318

1,510

1,456

Total revenue

$

5,402

$

5,417

$

5,657

Operating Income

By operating segment:

Completion and Production

$

439

$

531

$

570

Drilling and Evaluation

351

352

367

Total operations

790

883

937

Corporate and other

(69

)

(66

)

(66

)

SAP S4 upgrade expense

(42

)

(30

)

(42

)

Impairments and other charges

—

(356

)

(83

)

Total operating income

$

679

$

431

$

746

See Footnote Table 1 for Reconciliation of Operating Income to Adjusted Operating Income.

FOOTNOTE TABLE 1

HALLIBURTON COMPANY

Reconciliation of Operating Income to Adjusted Operating Income

(Millions of dollars)

(Unaudited)

Three Months Ended

March 31,

December 31,

2026

2025

2025

Operating income

$

679

$

431

$

746

Impairments and other charges:

Severance costs

—

107

23

Impairment of assets held for sale

—

104

24

Impairment of real estate facilities

—

53

—

Equity in earnings loss

—

—

50

Other

—

92

(14

)

Total impairments and other charges (a)

—

356

83

Adjusted operating income (b) (c)

$

679

$

787

$

829

(a)

During the three months ended March 31, 2025, Halliburton recognized a pre-tax charge of $356 million as a result of severance costs, an impairment of assets held for sale, an impairment on real estate facilities, and other items, primarily related to legacy environmental remediation cost estimate increases. During the three months ended December 31, 2025, Halliburton recognized a pre-tax charge of $83 million as a result of an equity in earnings loss, an impairment of assets held for sale, severance costs, and other items.

(b)

Adjusted operating income is a non-GAAP financial measure which is calculated as: “Operating income” plus “Total impairments and other charges” for the respective periods. Management believes that operating income adjusted for impairments and other charges is useful to investors to assess and understand operating performance, especially when comparing those results with previous and subsequent periods or forecasting performance for future periods, primarily because management views the excluded items to be outside of the company’s normal operating results. Management analyzes operating income without the impact of these items as an indicator of performance, to identify underlying trends in the business, and to establish operational goals. The adjustments remove the effect of these items.

(c)

We calculate operating margin by dividing operating income by revenue. We calculate adjusted operating margin, a non-GAAP financial measure, by dividing adjusted operating income by revenue. Management believes adjusted operating margin is useful to investors to assess and understand operating performance.

FOOTNOTE TABLE 2

HALLIBURTON COMPANY

Reconciliation of Net Income to Adjusted Net Income

(Millions of dollars and shares except per share data)

(Unaudited)

Three Months Ended

March 31,

December 31,

2026

2025

2025

Net income attributable to company

$

461

$

204

$

589

Adjustments:

Impairments and other charges (a)

—

356

83

Total adjustments, before taxes

—

356

83

Tax benefit from prepayment (b)

—

—

(86

)

Tax adjustment (b)

—

(43

)

(10

)

Total adjustments, net of taxes (c)

—

313

(13

)

Adjusted net income attributable to company (c)

$

461

$

517

$

576

Diluted weighted average common shares outstanding

839

866

840

Net income per diluted share (d)

$

0.55

$

0.24

$

0.70

Adjusted net income per diluted share (d)

$

0.55

$

0.60

$

0.69

(a)

See Footnote Table 1 for details of the impairments and other charges recorded during the three months ended March 31, 2025 and December 31, 2025.

(b)

During the three months ended March 31, 2025, the tax adjustment includes the effect on impairments and other charges. During the three months ended December 31, 2025, the adjustments include an $86 million discrete tax benefit from the FDII deduction attributable to a royalty prepayment as well as the tax effect on impairments and other charges.

(c)

Adjusted net income attributable to company is a non-GAAP financial measure which is calculated as: “Net income attributable to company” plus “Total adjustments, net of taxes” for the respective periods. Management believes net income adjusted for impairments and other charges, along with the tax adjustments is useful to investors to assess and understand operating performance, especially when comparing those results with previous and subsequent periods or forecasting performance for future periods, primarily because management views the excluded items to be outside of the company’s normal operating results. Management analyzes net income without the impact of these items as an indicator of performance to identify underlying trends in the business and to establish operational goals. Total adjustments remove the effect of these items.

(d)

Net income per diluted share is calculated as: “Net income attributable to company” divided by “Diluted weighted average common shares outstanding.” Adjusted net income per diluted share is a non-GAAP financial measure which is calculated as: “Adjusted net income attributable to company” divided by “Diluted weighted average common shares outstanding.” Management believes adjusted net income per diluted share is useful to investors to assess and understand operating performance.

FOOTNOTE TABLE 3

HALLIBURTON COMPANY

Reconciliation of Cash Flows from Operating Activities to Free Cash Flow

(Millions of dollars)

(Unaudited)

Three Months Ended

March 31,

December 31,

2026

2025

2025

Total cash flows provided by operating activities

$

273

$

377

$

1,165

Capital expenditures

(192

)

(302

)

(337

)

Proceeds from sales of property, plant, and equipment

42

49

47

Free cash flow (a)

$

123

$

124

$

875

(a)

Free Cash Flow is a non-GAAP financial measure which is calculated as “Total cash flows provided by operating activities” less “Capital expenditures” plus “Proceeds from sales of property, plant, and equipment.” Management believes that Free Cash Flow is a key measure to assess liquidity of the business and is consistent with the disclosures of Halliburton’s direct, large-cap competitors.

Conference Call Details

Halliburton Company (NYSE: HAL) will host a conference call on Tuesday, April 21, 2026, to discuss its first quarter 2026 financial results. The call will begin at 8:00 a.m. CT (9:00 a.m. ET).

Please visit the Halliburton website to listen to the call via live webcast. A recorded version will be available for seven days under the same link immediately following the conclusion of the conference call. You can also pre-register for the conference call and obtain your dial in number and passcode by clicking here.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260421419280/en/

Investor Relations Contact

David Coleman

[email protected]

281-871-2688

Media Relations

Alexandra Franceschi

[email protected]

281-871-2601

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Energy Other Energy Oil/Gas

MEDIA:

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Posted on April 21, 2026 6:48 am
Jacobs introduces Flood IQ to help utilities and cities anticipate and manage flood risk

Jacobs introduces Flood IQ to help utilities and cities anticipate and manage flood risk

AI-enabled solution integrates data, rapid forecasting and operations intelligence to support faster, more informed decisions

DALLAS–(BUSINESS WIRE)–Jacobs (NYSE: J) introduces Flood IQ, an artificial intelligence (AI)-enabled solution to help cities, utilities and government agencies anticipate, manage and recover from flooding events. The solution brings together Jacobs’ decades of flood engineering expertise with advanced AI to transform fragmented water and drainage system data into actionable intelligence for preparedness, response and long-term resilience planning.

Flood risk is increasing worldwide as weather extremes, aging infrastructure and urban growth place greater pressure on water systems. At the same time, communities face constrained budgets and rising expectations for transparency and protection. Flood IQ addresses these challenges by applying machine learning and AI to improve situational visibility across critical infrastructure, surface water and sewer networks, and to enable rapid flood forecasting, multi-scenario operational planning and data-based emergency response.

Jacobs Executive Vice President Amer Battikhi said: “Flood IQ represents a fundamental shift in how flood resilience is delivered, helping cities and utilities move beyond static models and reactive responses. It provides continuous intelligence into how water systems are performing, supporting real-time decisions and long-term planning, while boosting resilience against recurring and major events. It reflects how Jacobs is applying artificial intelligence across infrastructure to help clients make faster, more informed decisions in increasingly complex environments, as part of our growing portfolio of AI-enabled solutions supporting critical infrastructure systems worldwide.”

Flood IQ brings together capabilities already deployed across multiple projects globally, integrating sensors, hydraulic models, operational data, AI analytics and mobile emergency response applications.

Examples of project deployment include:

United Utilities (U.K.) – Applied machine learning across 78,000 kilometers of sewer network, reducing sewer flooding and pollution events by approximately 20% through predictive operations.

Oxford–Cambridge Arc (U.K.) – Evaluated billions of mitigation pathways across 27 climate and growth scenarios to inform long-term resilience planning.

Puerto Rico Aqueduct and Sewer Authority – Integrated more than 7,700 sensors and 3,000 assets into a unified digital storm-response platform, strengthening operational coordination across the island during hurricanes.

These deployments demonstrate how AI-enabled flood intelligence can reduce flood impacts, improve service continuity and guide smarter infrastructure investment.

Flood IQ provides a unified operational view by combining rainfall radar, river and coastal conditions, stormwater and wastewater network data, and critical infrastructure data. Using AI-powered analytics, the platform forecasts where flooding may occur and when, identifies system stress points and supports coordinated actions during severe weather events to protect communities.

Flood IQ leverages Jacobs’ novel combination of decades-long infrastructure expertise and advanced digital capabilities, including AI development, cloud-scale data engineering and rapid application development. The solution integrates seamlessly with existing tools including Aqua DNA, Flood Modeller and Flood Platform, creating a comprehensive ecosystem for flood resilience.

Learn more about Flood IQ at https://www.jacobs.com/flood-iq.

Notes to editors

About Flood IQ

Flood IQ includes two integrated solution suites:

Preparedness Suite

Rapid forecasting to provide 24- to 72-hour lead times ahead of potential flooding

AI resilience planning to evaluate mitigation strategies across future climate scenarios

Smart asset upgrades to provide predictive identification of infrastructure most at risk of failure

Real-Time Response Suite

System-wide visibility across rainfall, runoff, water infrastructure, local drainage systems, rivers, and coastal conditions; multi-agency visibility enabling coordinated emergency response and traffic management

AI operational decision support for pumps, gates and storage assets

Public alerts and localized risk updates for communities and stakeholders

Through this approach, organizations can expand flood forecasting coverage more quickly, evaluate thousands of resilience strategies, prioritize infrastructure investment and improve coordination during severe weather events.

At Jacobs, we’re challenging today to reinvent tomorrow – delivering outcomes and solutions for the world’s most complex challenges. With approximately $12 billion in annual revenue and a team of approximately 47,000, we provide end-to-end services in advanced manufacturing, cities & places, energy, environmental, life sciences, transportation and water. From advisory and consulting, feasibility, planning, design, program and lifecycle management, we’re creating a more connected and sustainable world. See how at jacobs.com and connect with us on LinkedIn, Instagram, X and Facebook.

Certain statements contained in this press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that do not directly relate to any historical or current fact. When used herein, words such as “expects,” “anticipates,” “believes,” “seeks,” “estimates,” “plans,” “intends,” “future,” “will,” “would,” “could,” “can,” “may,” and similar words are intended to identify forward-looking statements. We base these forward-looking statements on management’s current estimates and expectations, as well as currently available competitive, financial and economic data. Forward-looking statements, however, are inherently uncertain. There are a variety of factors that could cause business results to differ materially from our forward-looking statements including, but not limited to, uncertainties as to, the timing of the award of projects and funding and potential changes to the amounts provided for under the Infrastructure Investment and Jobs Act and other legislation and executive orders related to governmental spending, including any directive to federal agencies to reduce federal spending or the size of the federal workforce, and changes in U.S. or foreign tax laws, including the tax legislation enacted in the U.S. in July 2025, statutes, rules, regulations or ordinances, including the impact of, and changes to tariffs and retaliatory tariffs or trade policies, that may adversely impact our future financial positions or results of operations, as well as general economic conditions, including inflation and the actions taken by monetary authorities in response to inflation, changes in interest rates and foreign currency exchange rates, changes in capital markets, the possibility of a recession or economic downturn, and increased uncertainty and risks, including policy risks and potential civil unrest, relating to the outcome of elections across our key markets and elevated geopolitical tension and conflicts, among others. For a description of these and additional factors that may occur that could cause actual results to differ from our forward-looking statements, see our filings with the U.S. Securities and Exchange Commission. The company is not under any duty to update any of the forward-looking statements after the date of this press release to conform to actual results, except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260421531752/en/

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