Yescarta® Now Approved in Japan for Initial Treatment of Relapsed/Refractory Large B-Cell Lymphoma

Based on Landmark ZUMA-7 Study, Patients with LBCL Treated with Yescarta in Second-Line Achieved Four-Fold Greater Improvement in Event-Free Survival of 8.3 Months vs. Two Months for Standard of Care (SOC)

– In ZUMA-7, Patients Treated with Yescarta Were 2.5 Times More Likely than SOC to be Alive at Two Years Without Disease Progression or Need for Additional Treatments –

Kite Pharma, Inc., a Gilead Company, (hereafter, Kite) (NASDAQ: GILD) and Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo) (TSE: 4568) today jointly announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, for the initial treatment of patients with relapsed/refractory large B-cell lymphoma ( R/R LBCL): diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, and high-grade B-cell lymphoma. Yescarta should be used only in patients who have not received prior transfusion of CAR T-cells targeted at CD19 antigen.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221222005384/en/

The Standard of Care (SOC) to treat LBCL patients has historically been a multi-step process that starts with chemoimmunotherapy, followed by high-dose chemotherapy (HDT) and then ends with a stem cell transplant (ASCT). Although approximately 60% of newly diagnosed LBCL patients will respond to the initial treatment with chemotherapy, 40% will relapse or will not respond and need second-line treatment. Yescarta is now approved for the initial treatment of R/R LBCL patients in Japan.

"We are very proud of this additional Yescarta approval in Japan," said Christi Shaw, CEO of Kite. "As Japan has the second-largest number of people diagnosed with non-Hodgkin lymphoma globally, this approval marks an important step in bringing this innovative therapy earlier to more patients."

"We are glad to have achieved this important milestone in order to provide an innovative treatment option to more patients with large B-cell lymphoma in Japan," said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. "It also further demonstrates the expertise of our Daiichi Sankyo R&D organization as we had successfully expanded the indication for this CAR-T modality."

The approval of Yescarta for the initial treatment of R/R LBCL patients in Japan is based on clinical data, including the results of the global pivotal trial conducted by Kite (ZUMA-7). ZUMA-7 is the largest and longest trial of a CAR T-cell therapy versus SOC in this patient population. Results from the study demonstrated that at a median follow-up of two years, Yescarta-treated patients had a four-fold greater improvement in the primary endpoint of event-free survival (EFS; hazard ratio 0.40; 95% CI: 0.31-0.51, P

This indication was first approved by the U.S. FDA in April 2022 followed by the European Commission in October 2022 .

On December 7, 2022, Daiichi Sankyo and Kite jointly announced that the Marketing Authorization for Yescarta will be transferred to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc., in 2023. The Kite Cell Therapy Business Unit at Gilead Sciences K.K. will manage the sales and promotion activities of the product in Japan after the Marketing Authorization transfer.

Kite's manufacturing facility in El Segundo, California, U.S., has been approved by Japanese regulatory authorities to commence manufacturing Yescarta for the Japan market in 2023.

About Zuma-7

ZUMA-7 is an ongoing, randomized, open-label, global, multicenter (US, Australia, Canada, Europe, Israel) Phase 3 study of 359 patients at 77 centers, evaluating the safety and efficacy of a single-infusion of Yescarta versus current SOC for second-line therapy (platinum-based salvage combination chemotherapy regimen followed by high-dose chemotherapy and autologous stem cell transplant in those who respond to salvage chemotherapy) in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy. The primary endpoint is event free survival (EFS). Key secondary endpoints include objective response rate (ORR) and overall survival (OS). Additional secondary endpoints include patient reported outcomes and safety.

About YESCARTA ^®

Yescarta (axicabtagene ciloleucel) is a CAR T-cell therapy directed against CD19 (a cell membrane protein), which harnesses a patient's own immune system to fight cancer. Axicabtagene ciloleucel is made by removing a patient's T cells from their blood and engineering them in the lab to express chimeric antigen receptors so that they can recognize and destroy cancer cells when they are infused back to the patient's body. The CAR T-cell therapy is manufactured specifically for each patient and administered only once. Axicabtagene ciloleucel received Orphan Drug Designation from the Japan MHLW in 2018 for the treatment of diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma and high-grade B-cell lymphoma. Yescarta was approved in Japan for the treatment of patients with relapsed or refractory large B-cell lymphomas, a type of non-Hodgkin lymphoma, in January 2021.

Please see full U.S. Prescribing Information , including BOXED WARNING and Medication Guide.

Yescarta ^® is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. (1.1)
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Limitations of Use : Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. (1.1)

Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2)

For the full European Prescribing Information, please visit: : https://www.ema.europa.eu/en/medicines/human/EPAR/yescarta .

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society." For more information, please visit: www.daiichisankyo.com .

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. For more information on Kite, please visit www.kitepharma.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 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead Sciences acquired Kite in 2017.

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 companies to consummate the transactions contemplated under and as a result of the revised arrangement in a timely manner or at all, including the transfer of the Marketing Authorization for Yescarta in Japan to Gilead Sciences K.K. and the manufacture and supply of Yescarta in Japan; the risk that Gilead and Kite may not realize the anticipated benefits of the revised arrangement with Daiichi Sankyo; difficulties or unanticipated expenses in connection with implementing the revised arrangement; the potential effect on Gilead and Kite's earnings; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 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 Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Yescarta including BOXED WARNING , is available at www.kitepharma.com and www.gilead.com .

Kite, the Kite logo, Yescarta, and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221222005384/en/

Jacquie Ross, Investors
investor_relations@gilead.com

Anna Padula, Kite Media
apadula@kitepharma.com

Koji Ogiwara
Daiichi Sankyo Co., Ltd.
ogiwara.koji.ay@daiichisankyo.co.jp

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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.

Yescarta® Now Approved in Japan for Initial Treatment of Relapsed/Refractory Large B-Cell Lymphoma

Deals, patent cliffs, M&A, partnerships

Price Negotiations, Profits, IRA

Research Areas: Neuro. cancer/targeted therapies/rare diseases/obesity

Trends that might impact the market

Which biotech companies should investors consider?

1. Vertex Pharmaceuticals (NASDAQ:VRTX)

2. Regeneron Pharmaceuticals (NASDAQ:REGN)

3. Moderna (NASDAQ:MRNA)

4. Argenx (NASDAQ:ARGX)

5. BioNTech (NASDAQ:BNTX)

How to invest in biotechnology stocks?

How to invest in biotechnology ETFs?

What's the outlook for biotechnology?

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