CHMP Adopts Positive Opinion Recommending Hepcludex® for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus

-- If Granted by the European Commission, Hepcludex will Become the Only Approved Treatment for HDV in the EU --

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Hepcludex ^® (bulevirtide) for the treatment of adults with chronic HDV and compensated liver disease, and recommended granting full Marketing Authorisation (MA) that is no longer subject to specific obligations. Bulevirtide was initially granted conditional marketing authorisation in July 2020 to provide people living with HDV urgent access to treatment. The CHMP recommendation for full Marketing Authorisation of bulevirtide follows the submission of the Phase 3 MYR301 Week 48 study data, which reinforces the efficacy and safety profile of bulevirtide for the treatment of HDV.

HDV is the most severe form of viral hepatitis and affects an estimated 5% of people living with hepatitis B (HBV), with a global prevalence of over 12 million people worldwide. For people living with HDV with advanced disease progression, including cirrhosis, mortality rates can be as high as 50% within five years, presenting significant disease burden and high healthcare-related costs.

"People living with HDV have had very limited treatment options and without treatment, they often rapidly progress to severe liver disease or liver cancer. Until bulevirtide, we have not had any approved options to treat these patients, but we now have a treatment conditionally approved specifically for HDV with a positive recommendation for full approval," said Heiner Wedemeyer, MD, Director, Clinic for Gastroenterology, Hepatology and Endocrinology at Hannover Medical School. "It gives clinicians additional confidence on the efficacy and safety with longer-term use."

"The MYR301 Week 48 data supporting this recommendation for full approval demonstrates that with longer treatment with bulevirtide, higher response rates are achieved, meaning this rare, life-threatening disease can be better managed," said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. "As a company that is a leader in liver disease and virology, we have been committed to improving the lives of people living with viral hepatitis for more than two decades. This marks a significant step forward as it offers real hope to people living with HDV, who have previously faced an uncertain future."

The positive opinion from the CHMP is based on the review of the pivotal Phase 3 MYR301 Week 48 study data demonstrating the efficacy and safety of bulevirtide, resulting in the removal of the specific obligation related to the conditional marketing authorization. The European Commission (EC) will review the CHMP recommendation, and if adopted, bulevirtide will be fully authorized in the European Union for the treatment of adults with chronic HDV and compensated liver disease.

Gilead is working with several regulatory authorities on marketing applications for bulevirtide in other parts of the world. In the U.S. bulevirtide was granted Breakthrough Therapy and Orphan Drug designations by the Food and Drug Administration (FDA). While bulevirtide is currently not approved in the U.S., Gilead remains in active discussions with the FDA, with the aim of bringing bulevirtide to people living with HDV in the U.S. as soon as possible.

About HDV
Chronic HDV is the most severe form of viral hepatitis and can have mortality rates as high as 50% within five years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have HBV. It is estimated that at least 12 million people worldwide are currently co-infected with HDV and HBV. HDV co-infection is associated with a faster progression to liver fibrosis, cirrhosis and hepatic decompensation and an increased risk of liver cancer and death. In the U.S. and Europe, it is estimated that there are more than 230,000 people living with HDV; however, it remains widely underdiagnosed around the world.

About Gilead Sciences in Liver Disease
For more than 20 years, Gilead has sought to address some of the biggest challenges in liver disease. The company has transformed the trajectory of multiple liver diseases through a relentless pursuit of innovation and pioneering access programs to bring meaningful therapies to people around the world. More work is required, and Gilead is committed to advancing innovative therapeutics to address the most pressing unmet needs in liver disease and overcoming barriers to better care.

About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving Hepcludex; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the European Commission may not grant full Marketing Authorization of Hepcludex for the treatment of adults with chronic HDV and compensated liver disease, and the FDA and other regulatory authorities may not approve bulevirtide for the treatment of HDV, and the risk that any such approvals, if granted, may be subject to significant limitations on use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

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

For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230504005222/en/

Jacquie Ross, Investors
investor_relations@gilead.com

Meaghan Smith, Media
public_affairs@gilead.com

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Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

Covid-19 has proven to be the "great revealer" of disparities in healthcare
Contakt World (CSE: HELP) and Satcher Health Leadership Institute, Morehouse School of Medicine executed a strategic collaboration in October 2020

Health Equity Tracker, supported by Google.org, Gilead Sciences (Nasdaq: GILD), Annie E. Casey Foundation, and CDC Foundation, is now operational

Contakt World's SaaS Platform, Smart Health RM, will help drive de-identified data to Health Equity Tracker to improve health equity and reduce disparities of care

Contakt World Technologies Corp. (CSE: HELP) (OTC: TLOOF) (FSE: B2I0) (the "Company" or "Contakt World") today announced its agreement in principle with Satcher Health Leadership Institute, Morehouse School of Medicine ("SHLI") to help collect de-identified demographic data for the Health Equity Tracker Project through Smart Health RM and other products and services provided by Contakt World like Engagency. This updates the previously announced collaboration between Contakt World and SHLI now that Health Equity Tracker is operational.

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AbbVie Reports First-Quarter 2025 Financial Results

Reports First-Quarter Diluted EPS of $0.72 on a GAAP Basis, a Decrease of 6.5 Percent; Adjusted Diluted EPS of $2.46 , an Increase of 6.5 Percent; These Results Include an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense
Delivers First-Quarter Net Revenues of $13.343 Billion , an Increase of 8.4 Percent on a Reported Basis or 9.8 Percent on an Operational Basis
First -Quarter Global Net Revenues from the Immunology Portfolio Were $6.264 Billion , an Increase of 16.6 Percent on a Reported Basis, or 18.1 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $3.425 Billion ; Global Rinvoq Net Revenues Were $1.718 Billion ; Global Humira Net Revenues Were $1.121 Billion
First-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.282 Billion , an Increase of 16.1 Percent on a Reported Basis, or 17.0 Percent on an Operational Basis; Global Vraylar Net Revenues Were $765 Million ; Global Botox Therapeutic Net Revenues Were $866 Million ; Combined Global Ubrelvy and Qulipta Net Revenues Were $433 Million
First-Quarter Global Net Revenues from the Oncology Portfolio Were $1.633 Billion , an Increase of 5.8 Percent on a Reported Basis, or 7.5 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $738 Million ; Global Venclexta Net Revenues Were $665 Million ; Global Elahere Net Revenues Were $179 Million
First -Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.102 Billion , a Decrease of 11.7 Percent on a Reported Basis, or 10.2 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $556 Million ; Global Juvederm Net Revenues Were $231 Million
Raises 2025 Adjusted Diluted EPS Guidance Range from $11.99 - $12.19 to $12.09 - $12.29 , which Includes an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the First Quarter 2025

- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2025 .

"AbbVie's first-quarter results were well ahead of our expectations and reflect an excellent start to the year," said Robert A. Michael , chief executive officer, AbbVie. "The fundamentals of our business are strong and we continue to bolster our outlook with pipeline advancements and strategic investments. Based on the progress we are making, AbbVie is well positioned for the long term."

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AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE for the Treatment of Glabellar Lines

TrenibotE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration (earliest assessment time) and shorter duration of effect of 2-3 weeks. If approved, TrenibotE will be the first neurotoxin of its kind available to patients. –Submission is supported by data from over 2,100 patients treated with TrenibotE throughout the clinical program.

NORTH CHICAGO, Ill. , April 24, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) for the treatment of moderate to severe glabellar lines.

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Gilead Sciences, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)

	Three Months Ended
	March 31,
(in millions, except per share amounts)	2023			2022
Revenues:
Product sales	$	6,306		$	6,534
Royalty, contract and other revenues		46			56
Total revenues		6,352			6,590
Costs and expenses:
Cost of goods sold		1,401			1,424
Research and development expenses		1,447			1,178
Acquired in-process research and development expenses		481			8
In-process research and development impairment		—			2,700
Selling, general and administrative expenses		1,319			1,083
Total costs and expenses		4,647			6,393
Operating income		1,705			197
Interest expense		(230	)		(238	)
Other income (expense), net		(174	)		(111	)
Income (loss) before income taxes		1,300			(152	)
Income tax benefit (expense)		(316	)		164
Net income		985			12
Net loss attributable to noncontrolling interest		26			7
Net income attributable to Gilead	$	1,010		$	19
Basic earnings per share attributable to Gilead	$	0.81		$	0.02
Shares used in basic earnings per share attributable to Gilead calculation		1,248			1,255
Diluted earnings per share attributable to Gilead	$	0.80		$	0.02
Shares used in diluted earnings per share attributable to Gilead calculation		1,261			1,262
Cash dividends declared per share	$	0.75		$	0.73

Research and development expenses as a % of revenues		22.8	%		17.9	%
Selling, general and administrative expenses as a % of revenues		20.8	%		16.4	%

Gilead Sciences, INC.
TOTAL REVENUE SUMMARY
(unaudited)

	Three Months Ended
	March 31,
(in millions, except percentages)	2023		2022		Change
Product sales:
HIV	$	4,190	$	3,707	13	%
Oncology		670		420	59	%
Liver Disease		675		635	6	%
Other		199		236	(16	)%
Total product sales excluding Veklury		5,733		4,998	15	%
Veklury		573		1,535	(63	)%
Total product sales		6,306		6,534	(3	)%
Royalty, contract and other revenues		46		56	(18	)%
Total revenues	$	6,352	$	6,590	(4	)%

Gilead Sciences, INC.
NON-GAAP FINANCIAL INFORMATION ⁽¹⁾
(unaudited)

	Three Months Ended
	March 31,
(in millions, except percentages)	2023			2022			Change
Non-GAAP:
Cost of goods sold	$	871		$	825		6	%
Research and development expenses	$	1,439		$	1,150		25	%
Acquired IPR&D expenses	$	481		$	8		NM
Selling, general and administrative expenses	$	1,318		$	1,083		22	%
Other income (expense), net	$	82		$	(15	)	NM
Diluted EPS	$	1.37		$	2.12		(35	)%

Product gross margin		86.2	%		87.4	%	-118 bps
Research and development expenses as a % of revenues		22.6	%		17.5	%	519 bps
Selling, general and administrative expenses as a % of revenues		20.7	%		16.4	%	432 bps
Operating margin		35.3	%		53.5	%	-1817 bps
Effective tax rate		18.9	%		18.4	%	51 bps

________________________________
NM - Not Meaningful
⁽¹⁾		Refer to Non-GAAP Financial Information section above for further disclosures on non-GAAP financial measures. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 9 - 10.

Gilead Sciences, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION
(unaudited)

	Three Months Ended
	March 31,
(in millions, except percentages and per share amounts)	2023			2022
Cost of goods sold reconciliation:
GAAP cost of goods sold	$	1,401		$	1,424
Acquisition-related – amortization ⁽¹⁾		(530	)		(557	)
Other ⁽²⁾		—			(42	)
Non-GAAP cost of goods sold	$	871		$	825

Product gross margin reconciliation:
GAAP product gross margin		77.8	%		78.2	%
Acquisition-related – amortization ⁽¹⁾		8.4	%		8.5	%
Other ⁽²⁾		—	%		0.6	%
Non-GAAP product gross margin		86.2	%		87.4	%

Research and development expenses reconciliation:
GAAP research and development expenses	$	1,447		$	1,178
Acquisition-related – other costs ⁽³⁾		(8	)		(10	)
Other ⁽²⁾		—			(18	)
Non-GAAP research and development expenses	$	1,439		$	1,150

IPR&D impairment reconciliation:
GAAP IPR&D impairment	$	—		$	2,700
IPR&D impairment		—			(2,700	)
Non-GAAP IPR&D impairment	$	—		$	—

Selling, general and administrative expenses reconciliation:
GAAP selling, general and administrative expenses	$	1,319		$	1,083
Acquisition-related – other costs ⁽³⁾		(1	)		—
Non-GAAP selling, general and administrative expenses	$	1,318		$	1,083

Operating income reconciliation:
GAAP operating income	$	1,705		$	197
Acquisition-related – amortization ⁽¹⁾		530			557
Acquisition-related – other costs ⁽³⁾		9			10
IPR&D impairment		—			2,700
Other ⁽²⁾		—			60
Non-GAAP operating income	$	2,243		$	3,524

Operating margin reconciliation:
GAAP operating margin		26.8	%		3.0	%
Acquisition-related – amortization ⁽¹⁾		8.3	%		8.5	%
Acquisition-related – other costs ⁽³⁾		0.1	%		0.2	%
IPR&D impairment		—	%		41.0	%
Other ⁽²⁾		—	%		0.9	%
Non-GAAP operating margin		35.3	%		53.5	%

Other income (expense), net reconciliation:
GAAP other income (expense), net	$	(174	)	$	(111	)
Loss from equity securities, net		256			96
Non-GAAP other income (expense), net	$	82		$	(15	)

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______________________________
⁽¹⁾		Relates to amortization of acquired intangibles and inventory step-up charges.
⁽²⁾		Adjustments to Cost of goods sold and Research and development expenses primarily include various restructuring expenses during the first quarter of 2022.
⁽³⁾		Adjustments include employee-related expenses, contingent consideration fair value adjustments and other expenses associated with Gilead's acquisitions of MYR GmbH, MiroBio, Ltd. and Tmunity Therapeutics, Inc.
⁽⁴⁾		Represents discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States.

Gilead Sciences, INC.
RECONCILIATION OF GAAP TO NON-GAAP 2023 FULL-YEAR GUIDANCE ⁽¹⁾
(unaudited)

(in millions, except percentages and per share amounts)	Provided February 2, 2023	Updated April 27, 2023
Projected product gross margin GAAP to non-GAAP reconciliation:
GAAP projected product gross margin	79.0%	77.0%
Acquisition-related expenses	~ 7%	~ 9%
Non-GAAP projected product gross margin	86.0%	86.0%

Projected operating income GAAP to non-GAAP reconciliation:
GAAP projected operating income	$9,200 - $9,800	$8,600 - $9,200
Acquisition-related expenses	~ 1,800	~ 2,400
Non-GAAP projected operating income	$11,000 - $11,600	$11,000 - $11,600

Projected effective tax rate GAAP to non-GAAP reconciliation:
GAAP projected effective tax rate	~ 22%	~ 22%
Discrete and related tax adjustments, and income tax effect of adjustments above and fair value adjustments of equity securities	(~ 2%)	(~ 2%)
Non-GAAP projected effective tax rate	~ 20%	~ 20%

Projected diluted EPS GAAP to non-GAAP reconciliation:
GAAP projected diluted EPS	$5.30 - $5.70	$4.75 - $5.15
Acquisition-related expenses, fair value adjustments of equity securities and discrete and related tax adjustments	~ 1.30	~ 1.85
Non-GAAP projected diluted EPS	$6.60 - $7.00	$6.60 - $7.00

________________________________
⁽¹⁾		Our full-year guidance excludes the potential impact of any (i) acquisitions or business development transactions that have not been executed, (ii) future fair value adjustments of equity securities and (iii) discrete tax charges or benefits associated with changes in tax related laws and guidelines that have not been enacted, as Gilead is unable to project such amounts. The non-GAAP full-year guidance includes non-GAAP adjustments to actual current period results as well as adjustments for the known future impact associated with events that have already occurred, such as future amortization of our intangible assets and the future impact of discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States.

Gilead Sciences, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)

	March 31,		December 31,
(in millions)	2023		2022
Assets
Cash, cash equivalents and marketable securities	$	7,200	$	7,630
Accounts receivable, net		4,162		4,777
Inventories		3,010		2,820
Property, plant and equipment, net		5,479		5,475
Intangible assets, net		28,348		28,894
Goodwill		8,314		8,314
Other assets		5,364		5,262
Total assets	$	61,876	$	63,171
Liabilities and Stockholders' Equity
Current liabilities	$	10,528	$	11,237
Long-term liabilities		30,409		30,725
Stockholders' equity ⁽¹⁾		20,939		21,209
Total liabilities and stockholders' equity	$	61,876	$	63,171

________________________________
⁽¹⁾		As of March 31, 2023 and December 31, 2022, there were 1,248 and 1,247 shares of common stock issued and outstanding, respectively.

Gilead Sciences, INC.
SELECTED CASH FLOW INFORMATION
(unaudited)

	Three Months Ended
	March 31,
(in millions)	2023			2022
Net cash provided by operating activities	$	1,744		$	1,840
Net cash used in investing activities		(826	)		(1,070	)
Net cash used in financing activities		(1,406	)		(1,794	)
Effect of exchange rate changes on cash and cash equivalents		13			(18	)
Net change in cash and cash equivalents		(476	)		(1,042	)
Cash and cash equivalents at beginning of period		5,412			5,338
Cash and cash equivalents at end of period	$	4,936		$	4,296

________________________________
⁽¹⁾		Free cash flow is a non-GAAP liquidity measure. Please refer to our disclosures in the Non-GAAP Financial Information section above.

Gilead Sciences, INC.
PRODUCT SALES SUMMARY
(unaudited)

	Three Months Ended
	March 31,
(in millions)	2023		2022
HIV
Biktarvy – U.S.	$	2,161	$	1,706
Biktarvy – Europe		304		261
Biktarvy – Other International		212		184
		2,677		2,151

Complera / Eviplera – U.S.		14		17
Complera / Eviplera – Europe		22		24
Complera / Eviplera – Other International		3		4
		39		44

Descovy – U.S.		395		311
Descovy – Europe		25		32
Descovy – Other International		29		31
		449		374

Genvoya – U.S.		417		457
Genvoya – Europe		55		77
Genvoya – Other International		29		48
		501		582

Odefsey – U.S.		230		232
Odefsey – Europe		76		96
Odefsey – Other International		11		11
		317		339

Stribild – U.S.		20		22
Stribild – Europe		6		8
Stribild – Other International		2		3
		28		32

Truvada – U.S.		23		28
Truvada – Europe		3		4
Truvada – Other International		5		6
		32		38

Revenue share – Symtuza ⁽¹⁾ – U.S.		98		86
Revenue share – Symtuza ⁽¹⁾ – Europe		36		44
Revenue share – Symtuza ⁽¹⁾ – Other International		4		3
		138		132

Other HIV ⁽²⁾ – U.S.		4		5
Other HIV ⁽²⁾ – Europe		1		4
Other HIV ⁽²⁾ – Other International		3		5
		9		14

Total HIV – U.S.		3,364		2,862
Total HIV – Europe		528		550
Total HIV – Other International		298		295
		4,190		3,707

Gilead Sciences, INC.
PRODUCT SALES SUMMARY - (Continued)
(unaudited)

	Three Months Ended
	March 31,
(in millions)	2023	2022
Oncology
*Cell Therapy*
Tecartus – U.S.	59	47
Tecartus – Europe	27	15
Tecartus – Other International	3	1
	89	63

Yescarta – U.S.	210	125
Yescarta – Europe	121	77
Yescarta – Other International	28	9
	359	211

Total Cell Therapy – U.S.	269	172
Total Cell Therapy – Europe	148	92
Total Cell Therapy – Other International	31	10
	448	274

*Trodelvy*
Trodelvy – U.S.	162	119
Trodelvy– Europe	54	25
Trodelvy – Other International	6	2
	222	146

Total Oncology – U.S.	431	292
Total Oncology – Europe	202	117
Total Oncology – Other International	37	11
	670	420
Liver Disease
*HCV*
Ledipasvir / Sofosbuvir ⁽³⁾ – U.S.	3	13
Ledipasvir / Sofosbuvir ⁽³⁾ – Europe	7	4
Ledipasvir / Sofosbuvir ⁽³⁾ – Other International	5	18
	15	35

Sofosbuvir / Velpatasvir ⁽⁴⁾ – U.S.	204	162
Sofosbuvir / Velpatasvir ⁽⁴⁾ – Europe	90	83
Sofosbuvir / Velpatasvir ⁽⁴⁾ – Other International	90	85
	385	330

Other HCV ⁽⁵⁾ – U.S.	24	24
Other HCV ⁽⁵⁾ – Europe	18	8
Other HCV ⁽⁵⁾ – Other International	4	2
	45	34

Total HCV – U.S.	232	199
Total HCV – Europe	114	95
Total HCV – Other International	99	105
	445	399

______________________________
⁽¹⁾		Represents Gilead's revenue from cobicistat ("C"), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company.
⁽²⁾		Includes Atripla, Emtriva, Sunlenca and Tybost.
⁽³⁾		Amounts consist of sales of Harvoni and the authorized generic version of Harvoni sold by Gilead's separate subsidiary, Asegua Therapeutics LLC.
⁽⁴⁾		Amounts consist of sales of Epclusa and the authorized generic version of Epclusa sold by Gilead's separate subsidiary, Asegua Therapeutics LLC.
⁽⁵⁾		Includes Vosevi and Sovaldi.
⁽⁶⁾		Includes Hepcludex and Hepsera.
⁽⁷⁾		Includes Cayston, Jyseleca, Ranexa and Zydelig.

Media:	Investors:
Gabby Tarbert	Liz Shea
(224) 244-0111	(847) 935-2211

	Todd Bosse
	(847) 936-1182

	Jeffrey Byrne
	(847) 938-2923

AbbVie Inc. Key Product Revenues Quarter Ended March 31, 2025 (Unaudited)

				% Change vs. 1Q24
	Net Revenues (in millions)			Reported			Operational ^a
	U.S.	Int'l.	Total	U.S.	Int'l.	Total	Int'l.	Total
NET REVENUES	$9,979	$3,364	$13,343	10.4 %	2.9 %	8.4 %	8.3 %	9.8 %

Immunology	4,883	1,381	6,264	17.6	13.4	16.6	20.1	18.1
Skyrizi	2,919	506	3,425	76.2	43.9	70.5	52.3	72.0
Rinvoq	1,220	498	1,718	68.3	35.3	57.2	42.8	59.7
Humira	744	377	1,121	(58.0)	(24.4)	(50.6)	(19.5)	(49.5)

Neuroscience	1,972	310	2,282	15.0	24.0	16.1	31.0	17.0
Vraylar	763	2	765	10.3	13.1	10.3	20.2	10.3
Botox Therapeutic	723	143	866	18.2	4.8	15.8	11.4	17.0
Ubrelvy	233	7	240	17.6	23.3	17.8	29.3	18.0
Qulipta	172	21	193	34.2	>100.0	47.6	>100.0	48.3
Vyalev	6	57	63	n/m	>100.0	>100.0	>100.0	>100.0
Duodopa	20	76	96	(19.4)	(16.0)	(16.7)	(11.7)	(13.3)
Other Neuroscience	55	4	59	(9.5)	(1.0)	(8.9)	6.5	(8.4)

Oncology	1,027	606	1,633	6.0	5.4	5.8	10.0	7.5
Imbruvica ^b	529	209	738	(13.3)	(8.2)	(11.9)	(8.2)	(11.9)
Venclexta	312	353	665	11.0	6.0	8.3	13.4	12.3
Elahere	165	14	179	>100.0	n/m	>100.0	n/m	>100.0
Epkinly ^c	21	30	51	66.7	>100.0	89.8	>100.0	94.8

Aesthetics	640	462	1,102	(17.4)	(2.4)	(11.7)	1.6	(10.2)
Botox Cosmetic	295	261	556	(24.3)	6.9	(12.3)	11.1	(10.7)
Juvederm Collection	75	156	231	(29.0)	(18.5)	(22.2)	(15.0)	(20.0)
Other Aesthetics	270	45	315	(3.5)	18.1	(0.9)	23.2	(0.3)

Eye Care	221	285	506	(2.6)	(8.0)	(5.7)	(2.0)	(2.2)
Ozurdex	30	93	123	(12.1)	(3.8)	(6.0)	1.1	(2.4)
Lumigan/Ganfort	48	58	106	69.2	(6.8)	17.0	(0.5)	21.4
Alphagan/Combigan	26	34	60	68.5	(21.4)	1.9	(15.4)	6.3
Other Eye Care	117	100	217	(21.4)	(7.1)	(15.4)	(0.2)	(12.5)

Other Key Products	636	173	809	(7.2)	(19.4)	(10.1)	(14.8)	(9.0)
Mavyret	142	164	306	(0.7)	(20.4)	(12.3)	(15.8)	(9.6)


^a	"Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.
^b	Reflects profit sharing for Imbruvica international revenues.
^c	Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories.
n/m = not meaningful

AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited)

1. Specified items impacted results as follows:

	Quarter Ended March 31, 2025
(in millions, except per share data)	Earnings		Diluted
	Pre-tax	After-tax ^a	EPS
As reported (GAAP)	$ 1,661	$ 1,286	$ 0.72
Adjusted for specified items:
Intangible asset amortization	1,858	1,574	0.89
Change in fair value of contingent consideration	1,518	1,477	0.83
Other	62	33	0.02
As adjusted (non-GAAP)	$ 5,099	$ 4,370	$ 2.46

AbbVie Inc. Consolidated Statements of Earnings (Unaudited)

(in millions, except per share data)	First Quarter Ended March 31
	2025	2024
Net revenues	$ 13,343	$ 12,310
Cost of products sold	4,002	4,094
Selling, general and administrative	3,293	3,315
Research and development	2,067	1,939
Acquired IPR&D and milestones	248	164
Total operating costs and expenses	9,610	9,512

Operating earnings	3,733	2,798

Interest expense, net	627	453
Net foreign exchange loss	4	4
Other expense, net	1,441	586
Earnings before income tax expense	1,661	1,755
Income tax expense	372	383
Net earnings	1,289	1,372
Net earnings attributable to noncontrolling interest	3	3
Net earnings attributable to AbbVie Inc.	$ 1,286	$ 1,369

Diluted earnings per share attributable to AbbVie Inc.	$ 0.72	$ 0.77

Adjusted diluted earnings per share ^a	$ 2.46	$ 2.31

Weighted-average diluted shares outstanding	1,772	1,773


^a	Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details.

2. The impact of the specified items by line item was as follows:

	Quarter Ended March 31, 2025
(in millions)	Cost of products sold	SG&A	R&D	Other expense, net
As reported (GAAP)	$ 4,002	$ 3,293	$ 2,067	$ 1,441
Adjusted for specified items:
Intangible asset amortization	(1,858)	—	—	—
Change in fair value of contingent consideration	—	—	—	(1,518)
Other	(28)	(13)	(16)	(5)
As adjusted (non-GAAP)	$ 2,116	$ 3,280	$ 2,051	$ (82)


3. The adjusted tax rate for the first quarter of 2025 was 14.2 percent, as detailed below:

	Quarter Ended March 31, 2025
(dollars in millions)	Pre-tax earnings	Income taxes	Tax rate
As reported (GAAP)	$ 1,661	$ 372	22.4 %
Specified items	3,438	354	10.3 %
As adjusted (non-GAAP)	$ 5,099	$ 726	14.2 %

AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited)

1. Specified items impacted results as follows:

	Quarter Ended March 31, 2024
(in millions, except per share data)	Earnings		Diluted
	Pre-tax	After-tax ^a	EPS
As reported (GAAP)	$ 1,755	$ 1,369	$ 0.77
Adjusted for specified items:
Intangible asset amortization	1,891	1,603	0.90
Acquisition and integration costs	511	486	0.27
Change in fair value of contingent consideration	660	643	0.36
Other	21	19	0.01
As adjusted (non-GAAP)	$ 4,838	$ 4,120	$ 2.31