Gilead Endorses The Kigali Declaration On Preventing, Controlling and Eliminating Neglected Tropical Diseases

- By signing the Kigali Declaration, Gilead joins the global community committed to ending neglected tropical diseases by 2030 -

Gilead Sciences today announced that the company has signed onto the Kigali Declaration on neglected tropical diseases (NTDs) which succeeds the London Declaration on NTDs. It was launched on the margins of the Commonwealth Heads of Government Meeting (CHOGM), at a high-level session that was attended by Heads of State, other global dignitaries, industry partners and global community as part of a joint malaria and NTDs Summit. This high-level political declaration is an important milestone for the World Health Organization's 2030 road map which includes global targets to prevent, control and in some cases eliminate 20 diseases and disease groups by 2030.

"Gilead has a long history of supporting the control and elimination of neglected tropical diseases. In signing the Kigali Declaration, we are reaffirming our commitment as part of our ongoing efforts to advance global health equity," said Daniel O'Day, Chairman and Chief Executive Officer, Gilead Sciences. "The progress made against NTDs to date demonstrates the power of collaboration and unrelenting focus."

As Gilead marks 30 years of partnership with the World Health Organization (WHO) to end visceral leishmaniasis (VL), the company also commits to driving private sector engagement towards the Sustainable Development Goals for health and global partnership to achieve not only the control of NTDs but the elimination of their root causes, as well. In particular, Gilead will:

Continue its product donation to the VL elimination program led by WHO between 2023- and 2027.
Support and invest in innovative global initiatives that will address health equity.
Spearhead and contribute to a broad stakeholder dialogue driving pharmaceutical sector engagement and investment in tackling environmental issues causing NTDs, such as climate change and lack of access to clean water.

Find more information about the 2030 Neglected Tropical Disease road map here: https://www.who.int/teams/control-of-neglected-tropical-diseases/ending-ntds-together-towards-2030

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.

Gilead and the Gilead logo are 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/20220624005468/en/

Jacquie Ross, Investors
(408) 656-8793

Bahar Turkoglu, Media
+44 7768 555517

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GILD

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.

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Gilead Remains Steadfast in Support for Hepatitis C Elimination Efforts

The recent national conversation on hepatitis C (HCV) is an encouraging step towards viral hepatitis elimination in the U.S. With its long history of leadership in viral hepatitis, Gilead continues to support efforts that focus on HCV elimination. Gilead is proud that its medicines have treated over four million individuals living with HCV globally. Today, some 2.4 million people are living with HCV in the U.S., even though ~95% of those treated with direct-acting antivirals (DAAs) are cured. Prices of HCV medicines have dropped significantly, and many acknowledge that price is not a barrier for most payers and patients. Curative HCV drug therapies are just one part of an elimination strategy that needs to dedicate considerable resources and attention to screening and linkage to care so that all patients in need of HCV treatment can access it in a timely manner and achieve a cure

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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.