Gilead Sciences to Acquire MiroBio

Acquisition Provides Gilead with MiroBio's Pipeline of Immune Checkpoint Agonists and Proprietary Discovery Platform –

– MiroBio's Scientific Approach to Restoring Immune Balance for the Treatment of Autoimmune Diseases Complements Gilead's Inflammation Research and Development Strategy –

Gilead Sciences, Inc. (Nasdaq: GILD) and MiroBio, a privately-held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, today announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in cash, subject to customary adjustments.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220803006081/en/

The acquisition will provide Gilead with MiroBio's proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio's lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed earlier this week. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.

MiroBio's I-ReSToRE platform ( RE ceptor S election and T argeting t o R einstate immune E quilibrium) has the potential to be used to develop best-in-class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases. The I-ReSToRE platform supports identification and development of therapeutics that utilize inhibitory signaling networks with the goal of restoring immune homeostasis for patients. Gilead anticipates advancing additional agonists derived from MiroBio's I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programs, over the next several years.

"The team at MiroBio has spearheaded foundational research for agonist antibodies following a rigorous scientific approach," said Flavius Martin, Executive Vice President, Research, Gilead Sciences. "We believe that MiroBio's unique platform technology has the potential to produce best-in-class agonist antibodies targeting immune inhibitory receptors."

"We are excited to be joining Gilead," said Eliot Charles, Chairman of MiroBio. "MiroBio has a deep understanding of checkpoint receptor signaling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead's drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease."

Under the terms of the agreement, Gilead will acquire all of the outstanding share capital of MiroBio for a total of $405 million in cash consideration, subject to customary adjustments, which is payable at closing. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with MiroBio to reduce Gilead's GAAP and non-GAAP 2022 EPS by approximately $0.30-$0.35. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

Cowen is acting as financial advisor to Gilead. Centerview Partners is acting as financial advisor to MiroBio. Davis Polk & Wardwell LLP, Mayer Brown LLP, and Mishcon de Reya LLP are serving as legal counsel to Gilead, and Goodwin Procter LLP and Wilson Sonsini Goodrich & Rosati are serving as legal counsel to MiroBio.

About MiroBio

MiroBio is a clinical-stage private biotechnology company whose mission is to develop a new class of therapeutic agents, checkpoint agonist antibodies, to restore immune balance in autoimmune patients. MiroBio has developed I-ReSToRE, a proprietary discovery platform, combining its Checkpoint Atlas™, a cutting-edge receptor mapping database and visualization tool, with proprietary antibody engineering. It was spun out of Oxford University in 2019 and is based on more than 15 years of foundational research from the labs of Professor Simon Davis and Professor Richard Cornall with the potential to create safer and more efficacious medicines for patients with autoimmune disease. MiroBio is backed by a strong group of international investors including Oxford Science Enterprises, Samsara BioCapital, SR One, Medicxi, Advent Life Sciences, OrbiMed and Monograph.

For more information on MiroBio, please visit the company website: https://www.mirobio.com/

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, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead 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 the ability of the parties to complete the transaction in a timely manner or at all; the possibility that various closing conditions for the transaction may not be satisfied or waived, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; uncertainties relating to the timing or outcome of any filings and approvals relating to the transaction; difficulties or unanticipated expenses in connection with integrating the companies, including the effects of the transaction on relationships with employees, other business partners or governmental entities; the risk that Gilead may not realize the expected benefits of this transaction; the ability of Gilead to advance MiroBio's product pipeline and successfully commercialize MiroBio's products; the ability of the parties to initiate and complete clinical trials involving such products in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such products; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not approve any such products in the anticipated indications or on the timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use; any assumptions underlying any of the foregoing; and other risks and uncertainties detailed from time to time in Gilead's periodic reports filed with the U.S. Securities and Exchange Commission (the "SEC"), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. 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. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are 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.

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 (@GileadSciences) 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/20220803006081/en/

Gilead Contacts:

Jacquie Ross, Investors
investor_relations@gilead.com

Hayley Home, Media
Hayley.Home@gilead.com

MiroBio Contact:

Tom Donovan, Media
tom@tenbridgecommunications.com

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Gilead Sciences GILD Biotech Investing

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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.

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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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Divesture of Non-US Assets for ~US$9.5M (~A$13.7M) Allowing for Payoff of A$8.2M Debt Facility while Funding Expansion of US Business

Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte North America” or “the Company”) is pleased to announce that it has entered into an Intellectual Property Sales Agreement (the ‘Agreement’) with Prestige Consumer Healthcare Inc. and associated subsidiaries (together, ‘Prestige’). Pursuant to the Agreement and associated arrangements, the Company will assign and transfer the exclusive right to sell Hydralyte products, and associated intellectual property rights, to Prestige in all relevant jurisdictions other than the United States of America.¹

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Cardiex Announces Publication of Breakthrough Study Validating Noninvasive Fingertip Photoplethysmography for Central Aortic Pressure Waveform Analysis

- Cardiex Limited (ASX: CDX), a global health technology company focused on cardiovascular diagnostics and arterial health solutions, today announced the publication of a peer-reviewed study validating its innovative method for measuring central aortic pressure—an important indicator of heart health—using a noninvasive fingertip sensor. The study, co-authored by Cardiex's team, was published in the respected journal Pulse.

The study, titled "Validation of Noninvasive Derivation of the Central Aortic Pressure Waveform from Fingertip Photoplethysmography Using a Novel Selective Transfer Function Method," demonstrates that Cardiex's technology can accurately capture key cardiovascular data from a simple fingertip sensor. The method leverages photoplethysmography (PPG)—an optical technique widely used in wearables such as fitness trackers and smartwatches—offering a powerful and accessible tool for advanced heart health monitoring.

Key findings include:

Strong correlation between fingertip sensor measurements and traditional methods, with heart health indicators showing excellent alignment.
The fingertip sensor offers a user-friendly, noninvasive way to measure central aortic pressure parameters without calibration, making heart health monitoring more accessible and comfortable.
Twenty clinically relevant parameters were captured from the converted PPG waveforms, including central systolic blood pressure, central diastolic blood pressure, central pulse pressure, central augmentation pressure, central augmentation index, subendocardial viability, and pulse pressure amplification, amongst others.

Relevance in the Wearable Health Market:

The use of PPG technology in this study is especially significant as the wearable market continues to expand, with consumers seeking more advanced health insights without the need for frequent calibration. Cardiex's innovation aligns with this trend offering consumers the ability to track clinical grade biomarkers in real-time. These biomarkers have applications in various healthcare fields, including cognitive, renal, maternal, metabolic health, and heart failure management. The technology's ease of use and capacity for continuous monitoring place Cardiex at the forefront of the growing wearable health sector, which increasingly prioritizes deeper and more accurate health data.

"This study is a significant validation of Cardiex's technology and its ability to deliver critical heart health insights in a simpler, more convenient way," said Craig Cooper , CEO of Cardiex. "Our PPG-based fingertip technology has the potential to transform heart health monitoring, offering a more accessible option for both patients and healthcare providers. This breakthrough also opens up exciting opportunities for integration into the wearable health tech market, where continuous and noninvasive monitoring is becoming the gold standard."

The study confirms that Cardiex's PPG-based solution can provide valuable cardiovascular data in a comfortable, portable format, paving the way for broader adoption in both medical and consumer-grade wearables.

The full study is now available online in the journal Pulse DOI: 10.1159/000540666.

View original content to download multimedia: https://www.prnewswire.com/news-releases/cardiex-announces-publication-of-breakthrough-study-validating-noninvasive-fingertip-photoplethysmography-ppg-for-central-aortic-pressure-waveform-analysis-302259185.html

SOURCE Cardiex Limited

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TEPEZZA® RECEIVES APPROVAL IN JAPAN FOR THE TREATMENT OF ACTIVE THYROID EYE DISEASE

Amgen (NASDAQ:AMGN) today announced TEPEZZA ® (JAN: Teprotumumab (Genetical Recombination)) has been approved for the treatment of active or high clinical activity score (CAS) Thyroid Eye Disease (TED) by Japan's Ministry of Health, Labour and Welfare (MHLW).

TED is a serious, progressive and potentially vision-threatening rare autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling. ¹ There are approximately 25,000 - 35,000 people living with TED in Japan , inclusive of both active and chronic (low CAS) TED. ² TEPEZZA is now the first and only medicine approved in Japan to treat active TED. A separate trial to study the efficacy of TEPEZZA in chronic TED patients in Japan is currently ongoing.

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AMGEN TO HOST CONFERENCE CALL TO DISCUSS NEW TOPLINE DATA IN INFLAMMATION AND RARE DISEASE

Amgen (NASDAQ:AMGN) will host a webcasted call for the investment community at 1:30 p.m. PT on Tuesday, Sept. 24, 2024 to discuss new topline clinical data from the rocatinlimab (AMG 451KHK4083) and UPLIZNA ® (inebilizumab-cdon) Phase 3 programs. Jay Bradner executive vice president of Research and Development and chief scientific officer at Amgen, and other members of the Amgen team will participate. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

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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.

PRODUCT NAME	TEPEZZA ^® for Intravenous Infusion 500 mg
Generic Name (JAN)	Teprotumumab (Genetical Recombination)
Indication	Active thyroid eye disease
Precautions related to indications	Hearing disorders (e.g., deafness, hypoacusis, Eustachian tube dysfunction, patulous Eustachian tube, hyperacusis, tinnitus, and tympanic membrane disorder) may occur during treatment with TEPEZZA, and serious and irreversible events have also been reported. Patients eligible for TEPEZZA therapy should be selected based on a thorough understanding of the information provided in "17. Clinical Results," the backgrounds of the patients in the clinical studies, and the results of the studies of the efficacy and safety of TEPEZZA. Clinical studies of the efficacy and safety in patients with mild active thyroid eye disease have not been conducted.
Dose and Administration	The usual adult dosage is 10 mg/kg as teprotumumab (genetical recombination) for the first dose and 20 mg/kg for the second and subsequent doses, administered intravenously every 3 weeks, for a total of 8 infusions.

Gilead Sciences to Acquire MiroBio

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