Treatment With Hepcludex® Meets Primary Endpoint and Achieves Significant Response in Chronic Hepatitis Delta Virus at 48 Weeks

-

Gilead Sciences, Inc. (Nasdaq: GILD) today announced Week 48 results from the Pivotal Phase 3 clinical trial evaluating the first-in-class entry inhibitor Hepcludex ^® (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection. Findings from the study underscore the efficacy and safety of bulevirtide for the treatment of chronic HDV and are being presented today in the International Liver Congress ^™ (ILC) 2022 Official Press Program. In addition, Week 48 data demonstrating the positive impact of bulevirtide on patient-reported outcomes (PROs) in people living with chronic HDV will also be presented. Together, these data reinforce the clinical utility of bulevirtide as monotherapy for the treatment of chronic HDV. There are currently no other approved treatment options for HDV and people living with HDV typically have a poor prognosis.

"As the most severe form of viral hepatitis, HDV presents a significant disease burden with high healthcare-related costs and until recently, no approved treatment options," said Heiner Wedemeyer, MD, Director, Clinic for Gastroenterology, Hepatology and Endocrinology at Hannover Medical School, and principal investigator of the study. "These results presented at ILC 2022 not only highlight the important clinical role that bulevirtide has to play as a safe and effective treatment option for chronic HDV, but critically also demonstrate that with prolonged treatment, we can achieve higher response rates so we can better manage this rare, life-threatening disease in more people."

At Week 48, study participants treated with bulevirtide monotherapy at 2 mg or 10 mg once daily achieved a significantly greater combined virological and biochemical response (45% and 48%, respectively) when compared to participants who had not received antiviral treatment at this stage of the study (2%). Combined response was defined as undetectable HDV RNA or a decrease by 2 log ₁₀ IU/mL from baseline and ALT normalization. Similarly, when the Week 48 data is considered alongside the integrated Week 24 analyses of the ongoing Phase 2 studies (MYR202 and MYR203) and the interim Week 24 Phase 3 MYR301 data presented at ILC 2021 , combined response rates of bulevirtide increased from Week 24 to Week 48, highlighting an improved response of bulevirtide with prolonged treatment.

The safety profile of bulevirtide at Week 48 is consistent with prior reports, with no participants having an adverse event (AE) leading to discontinuation of bulevirtide and no serious AEs attributed to bulevirtide treatment. The safety profile at both Week 24 and again at Week 48 reassert the safety and tolerability profile of bulevirtide, which is an important factor for people living with chronic HDV.

"The consequences of living with a serious and chronic condition like HDV can have a profound impact on the individual's quality of life, affecting the physical and mental well-being of people living with HDV," said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead. "What we now see is that treatment with bulevirtide not only improves clinical measures associated with viral control but can significantly improve, and maintain, a range of quality-of-life markers in people living with HDV, ultimately improving the overall management of the condition."

In an oral presentation, Gilead will also share an exploratory analysis of the Week 48 data from the Phase 3 MYR301 study, evaluating the impact of bulevirtide (2 mg once daily) on PROs in people living with chronic HDV. Participants treated with bulevirtide 2 mg (n=49) showed significant improvements from baseline at 48 weeks in almost all assessed health-related quality-of-life domains of the Hepatitis Quality of Life questionnaire. Participants in the control group (n=51) remained largely unchanged, apart from significant improvements in health distress and hepatitis-specific health distress. Of note, participants receiving bulevirtide 2 mg reported significant improvements in performance of daily activities related to hepatitis, emotional impact of hepatitis and improvement in work compared with controls.

Bulevirtide was granted Conditional Marketing Authorization by the European Commission and is an investigational agent in the U.S. and outside of the European Economic Area. In these regions, health authorities have not established the safety and efficacy of bulevirtide. A Biologics License Application (BLA) was submitted in Q4 2021 to the U.S. Food and Drug Administration (FDA) for bulevirtide for injection (2 mg) to treat adults with HDV and compensated liver disease. This Phase 3 data is included in the filing of bulevirtide to the FDA. Bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA. In 2020 bulevirtide 2 mg was granted Conditional Marketing Authorization by the European Commission and PRIority MEdicines (PRIME) scheme eligibility by the European Medicines Agency as the first approved treatment in Europe for adults with chronic HDV and compensated liver disease.

About MYR301
MYR301 is an ongoing Phase 3 clinical trial evaluating the long-term efficacy and safety of bulevirtide in 150 people living with chronic HDV randomly allocated to treatment with bulevirtide 2 mg once daily (n=49), 10 mg once daily (n=50) or no antiviral treatment (delayed treatment, n=51). Primary efficacy and safety data will be assessed at Week 48. After Week 48, participants in the delayed treatment group of the study will be switched to bulevirtide 10 mg once daily for an additional 96 weeks. The total duration of treatment across all groups in the study is 144 weeks. The primary endpoint, combined response, is defined as an undetectable HDV RNA ( 10 IU/ml decline from baseline and ALT normalization at Week 48. Secondary endpoints at Week 48 include undetectable HDV RNA (key secondary endpoint), ALT normalization, and a change from baseline in liver stiffness measured by transient elastography.

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 hepatitis B virus (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, there are more than 230,000 people living with HDV; however, it remains underdiagnosed globally.

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 FDA or EC may not approve Hepcludex 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, 2022, 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/20220623005008/en/

Jacquie Ross, Investors
investor_relations@gilead.com

Rhiannon Bid, Media (Europe)
rhiannon.bid@gilead.com

Jeff Eggert, Media (U.S.)
jeff.eggert@gilead.com

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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.

News Provided by Business Wire via QuoteMedia

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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	)

______________________________
⁽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.

$Millions, except percentages	Q3 '24			Q3 '23	YOY Δ
	U.S.	ROW	TOTAL	TOTAL	TOTAL
Repatha ^®	$ 281	$ 286	$ 567	$ 406	40 %
EVENITY ^®	289	110	399	307	30 %
Prolia ^®	683	362	1,045	986	6 %
BLINCYTO ^®	237	90	327	220	49 %
Vectibix ^®	132	150	282	252	12 %
KYPROLIS ^®	238	140	378	349	8 %
LUMAKRAS ^® /LUMYKRAS ^™	53	45	98	52	88 %
XGEVA ^®	373	168	541	519	4 %
Nplate ^®	345	111	456	419	9 %
IMDELLTRA ^™	36	—	36	—	N/A
MVASI ^®	136	59	195	213	(8 %)
TEZSPIRE ^®	269	—	269	161	67 %
Otezla ^®	460	104	564	567	(1 %)
Enbrel ^®	817	8	825	1,035	(20 %)
AMJEVITA ^® /AMGEVITA ^™	28	138	166	152	9 %
TEPEZZA ^®(1)	482	6	488	—	N/A
KRYSTEXXA ^®(1)	310	—	310	—	N/A
UPLIZNA ^®(1)	74	32	106	—	N/A
TAVNEOS ^®	74	6	80	37	*
Ultra-Rare products ⁽¹⁾	180	8	188	—	N/A
EPOGEN ^®	33	—	33	50	(34 %)
Aranesp ^®	105	232	337	323	4 %
Parsabiv ^®	32	38	70	95	(26 %)
Neulasta ^®	84	26	110	124	(11 %)
Other products ⁽²⁾	228	53	281	281	— %
Total product sales	$ 5,979	$ 2,172	$ 8,151	$ 6,548	24 %

N/A = not applicable
*Change in excess of 100%
⁽¹⁾ Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ^® , PROCYSBI ^® , ACTIMMUNE ^® , QUINSAIR ^® and BUPHENYL ^®
⁽²⁾ Consists of (i) Aimovig ^® , RIABNI ^® , KANJINTI ^® , AVSOLA ^® , NEUPOGEN ^® , IMLYGIC ^® , BEKEMV ^™ , Corlanor ^® , WEZLANA ^™ /WEZENLA ^™ and Sensipar ^® /Mimpara ^™ , where Biosimilars total $148 million in Q3 '24 and $104 million in Q3 '23; and (ii) Horizon-acquired products including RAYOS ^® and PENNSAID ^®

$Millions, except percentages	GAAP			Non-GAAP
	Q3 '24	Q3 '23	YOY Δ	Q3 '24	Q3 '23	YOY Δ
Cost of Sales	$ 3,310	$ 1,806	83 %	$ 1,454	$ 1,137	28 %
% of product sales	40.6 %	27.6 %	13.0 pts	17.8 %	17.4 %	0.4 pts
Research & Development	$ 1,450	$ 1,079	34 %	$ 1,440	$ 1,070	35 %
% of product sales	17.8 %	16.5 %	1.3 pts	17.7 %	16.3 %	1.4 pts
Selling, General & Administrative	$ 1,625	$ 1,353	20 %	$ 1,565	$ 1,293	21 %
% of product sales	19.9 %	20.7 %	(0.8) pts	19.2 %	19.7 %	(0.5) pts
Other	$ 71	$ 644	(89 %)	$ —	$ —	N/A
Total Operating Expenses	$ 6,456	$ 4,882	32 %	$ 4,459	$ 3,500	27 %

Operating Margin
operating income as % of product sales	25.1 %	30.9 %	(5.8) pts	49.6 %	52.0 %	(2.4) pts

Tax Rate	8.7 %	11.1 %	(2.4) pts	13.4 %	16.1 %	(2.7) pts

pts: percentage points
N/A = not applicable

$Billions, except shares	Q3 '24	Q3 '23	YOYΔ
Operating Cash Flow	$ 3.6	$ 2.8	$ 0.8
Capital Expenditures	$ 0.3	$ 0.2	$ 0.0
Free Cash Flow	$ 3.3	$ 2.5	$ 0.8
Dividends Paid	$ 1.2	$ 1.1	$ 0.1
Share Repurchases	$ 0.0	$ —	$ 0.0
Average Diluted Shares (millions)	542	538	4

Note: Numbers may not add due to rounding

$Billions	9/30/24	12/31/23	YTD Δ
Cash and Investments	$ 9.0	$ 10.9	$ (1.9)
Debt Outstanding	$ 60.4	$ 64.6	$ (4.2)

Note: Numbers may not add due to rounding

Amgen Inc.
Consolidated Statements of Income - GAAP
(In millions, except per-share data)
(Unaudited)
	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
Revenues:
Product sales	$ 8,151	$ 6,548	$ 23,310	$ 19,077
Other revenues	352	355	1,028	917
Total revenues	8,503	6,903	24,338	19,994

Operating expenses:
Cost of sales	3,310	1,806	9,746	5,339
Research and development	1,450	1,079	4,240	3,250
Selling, general and administrative	1,625	1,353	5,218	3,905
Other	71	644	187	874
Total operating expenses	6,456	4,882	19,391	13,368

Operating income	2,047	2,021	4,947	6,626

Other income (expense):
Interest expense, net	(776)	(759)	(2,408)	(2,054)
Other income, net	1,830	685	1,288	2,431

Income before income taxes	3,101	1,947	3,827	7,003

Provision for income taxes	271	217	364	1,053

Net income	$ 2,830	$ 1,730	$ 3,463	$ 5,950

Earnings per share:
Basic	$ 5.27	$ 3.23	$ 6.45	$ 11.12
Diluted	$ 5.22	$ 3.22	$ 6.40	$ 11.06

Weighted-average shares used in calculation of earnings per share:
Basic	537	535	537	535
Diluted	542	538	541	538

Amgen Inc.
Consolidated Balance Sheets - GAAP
(In millions)
	September 30,	December 31,
	2024	2023
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$ 9,011	$ 10,944
Trade receivables, net	7,317	7,268
Inventories	7,362	9,518
Other current assets	3,076	2,602
Total current assets	26,766	30,332

Property, plant and equipment, net	6,156	5,941
Intangible assets, net	28,920	32,641
Goodwill	18,658	18,629
Other noncurrent assets	10,383	9,611
Total assets	$ 90,883	$ 97,154

Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities	$ 16,768	$ 16,949
Current portion of long-term debt	3,544	1,443
Total current liabilities	20,312	18,392

Long-term debt	56,854	63,170
Long-term deferred tax liabilities	1,711	2,354
Long-term tax liabilities	2,280	4,680
Other noncurrent liabilities	2,199	2,326
Total stockholders' equity	7,527	6,232
Total liabilities and stockholders' equity	$ 90,883	$ 97,154

Shares outstanding	538	535

Amgen Inc.
GAAP to Non-GAAP Reconciliations
(Dollars in millions)
(Unaudited)
	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
GAAP cost of sales	$ 3,310	$ 1,806	$ 9,746	$ 5,339
Adjustments to cost of sales:
Acquisition-related expenses (a)	(1,856)	(668)	(5,546)	(2,008)
Certain net charges pursuant to our restructuring and cost-savings initiatives	—	(1)	—	(36)
Total adjustments to cost of sales	(1,856)	(669)	(5,546)	(2,044)
Non-GAAP cost of sales	$ 1,454	$ 1,137	$ 4,200	$ 3,295

GAAP cost of sales as a percentage of product sales	40.6 %	27.6 %	41.8 %	28.0 %
Acquisition-related expenses (a)	(22.8)	(10.2)	(23.8)	(10.5)
Certain net charges pursuant to our restructuring and cost-savings initiatives	0.0	0.0	0.0	(0.2)
Non-GAAP cost of sales as a percentage of product sales	17.8 %	17.4 %	18.0 %	17.3 %

GAAP research and development expenses	$ 1,450	$ 1,079	$ 4,240	$ 3,250
Adjustments to research and development expenses:
Acquisition-related expenses (b)	(10)	(9)	(60)	(27)
Certain net charges pursuant to our restructuring and cost-savings initiatives	—	—	—	(17)
Total adjustments to research and development expenses	(10)	(9)	(60)	(44)
Non-GAAP research and development expenses	$ 1,440	$ 1,070	$ 4,180	$ 3,206

GAAP research and development expenses as a percentage of product sales	17.8 %	16.5 %	18.2 %	17.0 %
Acquisition-related expenses (b)	(0.1)	(0.2)	(0.3)	(0.1)
Certain net charges pursuant to our restructuring and cost-savings initiatives	0.0	0.0	0.0	(0.1)
Non-GAAP research and development expenses as a percentage of product sales	17.7 %	16.3 %	17.9 %	16.8 %

GAAP selling, general and administrative expenses	$ 1,625	$ 1,353	$ 5,218	$ 3,905
Adjustments to selling, general and administrative expenses:
Acquisition-related expenses (c)	(60)	(47)	(255)	(138)
Certain net charges pursuant to our restructuring and cost-savings initiatives	—	(13)	—	(13)
Total adjustments to selling, general and administrative expenses	(60)	(60)	(255)	(151)
Non-GAAP selling, general and administrative expenses	$ 1,565	$ 1,293	$ 4,963	$ 3,754

GAAP selling, general and administrative expenses as a percentage of product sales	19.9 %	20.7 %	22.4 %	20.5 %
Acquisition-related expenses (c)	(0.7)	(0.8)	(1.1)	(0.7)
Certain net charges pursuant to our restructuring and cost-savings initiatives	0.0	(0.2)	0.0	(0.1)
Non-GAAP selling, general and administrative expenses as a percentage of product sales	19.2 %	19.7 %	21.3 %	19.7 %

GAAP operating expenses	$ 6,456	$ 4,882	$ 19,391	$ 13,368
Adjustments to operating expenses:
Adjustments to cost of sales	(1,856)	(669)	(5,546)	(2,044)
Adjustments to research and development expenses	(10)	(9)	(60)	(44)
Adjustments to selling, general and administrative expenses	(60)	(60)	(255)	(151)
Certain net charges pursuant to our restructuring and cost-savings initiatives (d)	—	(16)	4	(183)
Certain other expenses (e)	(71)	(628)	(191)	(691)
Total adjustments to operating expenses	(1,997)	(1,382)	(6,048)	(3,113)
Non-GAAP operating expenses	$ 4,459	$ 3,500	$ 13,343	$ 10,255



	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
GAAP operating income	$ 2,047	$ 2,021	$ 4,947	$ 6,626
Adjustments to operating expenses	1,997	1,382	6,048	3,113
Non-GAAP operating income	$ 4,044	$ 3,403	$ 10,995	$ 9,739

GAAP operating income as a percentage of product sales	25.1 %	30.9 %	21.2 %	34.7 %
Adjustments to cost of sales	22.8	10.2	23.8	10.7
Adjustments to research and development expenses	0.1	0.2	0.3	0.2
Adjustments to selling, general and administrative expenses	0.7	1.0	1.1	0.8
Certain net charges pursuant to our restructuring and cost-savings initiatives (d)	0.0	0.2	0.0	1.0
Certain other expenses (e)	0.9	9.5	0.8	3.7
Non-GAAP operating income as a percentage of product sales	49.6 %	52.0 %	47.2 %	51.1 %

GAAP interest expense, net	$ (776)	$ (759)	$ (2,408)	$ (2,054)
Adjustments to interest expense, net:
Interest expense on acquisition-related debt (f)	—	332	—	788
Non-GAAP interest expense, net	$ (776)	$ (427)	$ (2,408)	$ (1,266)

GAAP other income, net	$ 1,830	$ 685	$ 1,288	$ 2,431
Adjustments to other income, net
Interest income and other expenses on acquisition-related debt (f)	—	(313)	—	(607)
Net gains from equity investments (g)	(1,608)	(170)	(693)	(1,305)
Total adjustments to other income, net	(1,608)	(483)	(693)	(1,912)
Non-GAAP other income, net	$ 222	$ 202	$ 595	$ 519

GAAP income before income taxes	$ 3,101	$ 1,947	$ 3,827	$ 7,003
Adjustments to income before income taxes:
Adjustments to operating expenses	1,997	1,382	6,048	3,113
Adjustments to interest expense, net	—	332	—	788
Adjustments to other income, net	(1,608)	(483)	(693)	(1,912)
Total adjustments to income before income taxes	389	1,231	5,355	1,989
Non-GAAP income before income taxes	$ 3,490	$ 3,178	$ 9,182	$ 8,992

GAAP provision for income taxes	$ 271	$ 217	$ 364	$ 1,053
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (h)	228	271	1,007	442
Other income tax adjustments (i)	(33)	23	(44)	6
Total adjustments to provision for income taxes	195	294	963	448
Non-GAAP provision for income taxes	$ 466	$ 511	$ 1,327	$ 1,501

GAAP tax as a percentage of income before taxes	8.7 %	11.1 %	9.5 %	15.0 %
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (h)	5.6	4.2	5.4	1.6
Other income tax adjustments (i)	(0.9)	0.8	(0.4)	0.1
Total adjustments to provision for income taxes	4.7	5.0	5.0	1.7
Non-GAAP tax as a percentage of income before taxes	13.4 %	16.1 %	14.5 %	16.7 %

GAAP net income	$ 2,830	$ 1,730	$ 3,463	$ 5,950
Adjustments to net income:
Adjustments to income before income taxes, net of the income tax effect	161	960	4,348	1,547
Other income tax adjustments (i)	33	(23)	44	(6)
Total adjustments to net income	194	937	4,392	1,541
Non-GAAP net income	$ 3,024	$ 2,667	$ 7,855	$ 7,491

Note: Numbers may not add due to rounding

(a)		The adjustments related primarily to noncash amortization of intangible assets and fair value step-up of inventory acquired from business acquisitions.

(b)		For the three months ended September 30, 2024, the adjustments related primarily to noncash amortization of intangible assets from business acquisitions. For the nine months ended September 30, 2024, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the three and nine months ended September 30, 2023, the adjustments related primarily to noncash amortization of intangible assets from business acquisitions.

(c)		For the three and nine months ended September 30, 2024 and 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition.

(d)		For the three and nine months ended September 30, 2023, the adjustments related primarily to separation costs associated with our restructuring plan initiated in early 2023.

(e)		For the three and nine months ended September 30, 2024, the adjustments related primarily to impairment charges for in-process R&D assets and changes in the fair values of contingent consideration liabilities, both related to our Teneobio, Inc. acquisition from 2021. For the three and nine months ended September 30, 2023, the adjustments related primarily to a net impairment charge for AMG 340.

(f)		For the three and nine months ended September 30, 2023, the adjustments included (i) interest expense and income on senior notes issued in March 2023 and (ii) debt issuance costs and other fees related to our bridge credit and term loan credit agreements, incurred prior to the closing of our acquisition of Horizon.

(g)		For the three and nine months ended September 30, 2024, the adjustments related primarily to our BeiGene equity fair value adjustment. For the three and nine months ended September 30, 2023, the adjustments related primarily to our Neumora Therapeutics, Inc. and BeiGene equity fair value adjustments, respectively.

(h)		The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, the tax impact of adjustments, including the amortization of intangible assets and acquired inventory, gains and losses on our investments in equity securities and expenses related to restructuring and cost-savings initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes for the three and nine months ended September 30, 2024, was 58.6% and 18.8%, respectively, compared to 22.0% and 22.2% for the corresponding periods of the prior year.

(i)		The adjustments related to certain acquisition items, prior period and other items excluded from GAAP earnings.

Amgen Inc.
Reconciliations of Cash Flows
(In millions)
(Unaudited)

	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
Net cash provided by operating activities	$ 3,571	$ 2,760	$ 6,719	$ 7,933
Net cash (used in) provided by investing activities	(210)	(262)	(644)	885
Net cash (used in) provided by financing activities	(3,651)	(2,005)	(8,008)	18,294
(Decrease) increase in cash and cash equivalents	(290)	493	(1,933)	27,112
Cash and cash equivalents at beginning of period	9,301	34,248	10,944	7,629
Cash and cash equivalents at end of period	$ 9,011	$ 34,741	$ 9,011	$ 34,741


	Three months ended September 30,		Nine months ended September 30,
	2024	2023	2024	2023
Net cash provided by operating activities	$ 3,571	$ 2,760	$ 6,719	$ 7,933
Capital expenditures	(257)	(248)	(725)	(863)
Free cash flow	$ 3,314	$ 2,512	$ 5,994	$ 7,070

Amgen Inc.
Reconciliation of GAAP EPS Guidance to Non-GAAP
EPS Guidance for the Year Ending December 31, 2024
(Unaudited)

GAAP diluted EPS guidance	$ 8.71	—	$ 9.56
*Known adjustments to arrive at non-GAAP:**
Acquisition-related expenses (a)	11.33	—	11.38
Net gains from equity investments		(1.01)
Other		0.12
Non-GAAP diluted EPS guidance	$ 19.20	—	$ 20.00

Reconciliation of GAAP Tax Rate Guidance to Non-GAAP
Tax Rate Guidance for the Year Ending December 31, 2024
(Unaudited)

GAAP tax rate guidance	9.0 %	—	10.5 %
Tax rate of known adjustments discussed above	4.5 %	—	5.0 %
Non-GAAP tax rate guidance	14.0 %	—	15.0 %

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