U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for Merck's PREVYMIS for Prophylaxis of Cytomegalovirus Disease in Kidney Transplant Recipients at High Risk

FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental new drug applications (sNDA) for PREVYMIS™ (letermovir). The FDA granted priority review for the sNDA for PREVYMIS for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (D+/R-); the Prescription Drug User Fee Act (PDUFA), or target action date, is June 5, 2023. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. A second sNDA to extend use of PREVYMIS from 100 days to 200 days in adults receiving an allogeneic hematopoietic stem cell transplant (HSCT) who are at risk for late CMV infection and disease was also accepted for review, with a PDUFA date of Sept. 7, 2023.

"Certain high-risk individuals who develop CMV infection following receipt of a kidney transplant are at increased risk for transplant failure and death. PREVYMIS has the potential to be an important new option with a favorable safety profile for patients at risk for CMV infection following a kidney transplant," said Dr. Nicholas Kartsonis, senior vice president, vaccines and infectious diseases, Global Clinical Development, Merck Research Laboratories. "We look forward to the FDA's review of our filings for PREVYMIS."

PREVYMIS is a first-in-class antiviral agent that was approved by the U.S. FDA in 2017 and is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

Data supporting the sNDA for CMV prophylaxis in kidney transplant recipients

The sNDA for use of PREVYMIS for CMV prophylaxis in kidney transplant recipients is supported by a Phase 3, randomized, double-blind clinical trial ( NCT03443869 ) that demonstrated non-inferior efficacy and a more favorable safety profile for PREVYMIS compared to valganciclovir, the current standard of care for CMV prophylaxis in kidney transplant recipients. Data from the trial were presented during a late-breaking oral session at the IDWeek Annual Meeting in October 2022.

Key safety results

In the study, PREVYMIS had a more favorable safety profile compared to valganciclovir, with fewer drug-related adverse events (AEs) and study drug discontinuations due to adverse events reported in the PREVYMIS group compared to the valganciclovir group. The incidence of leukopenia (decrease in leukocytes, or white blood cells) and neutropenia (decrease in neutrophils, the most common type of white blood cell) was lower with PREVYMIS than with valganciclovir:

The treatment difference in leukopenia/neutropenia was 38% lower in the PREVYMIS group versus the valganciclovir group and was statistically significant (95% CI, -45.1, -30.3; p value =
Neutropenia measured during treatment through week 28 post-transplant (absolute neutrophil count
Leukopenia and neutropenia leading to discontinuation of study drug during the 28-week treatment phase was reported in 1.0% (n=3) in the PREVYMIS group and 5.4% (n=16) in the valganciclovir group, and 1.4% (n=4) in the PREVYMIS group and 1.7% (n=5) in the valganciclovir group, respectively.

Additional safety information from the trial:

Drug-related AEs were reported in 19.9% (n=58) of PREVYMIS participants and 35.0% (n=104) of valganciclovir participants through week 28 post kidney transplant (95% CI, −22.2, −8.0). Serious drug-related AEs were reported in 1.4% (n=4) of PREVYMIS participants and 5.1% (n=15) of valganciclovir participants (95% CI, −7.0, −0.9);
Discontinuations due to an AE: 4.1% (n=12) in the PREVYMIS group and 13.5% (n=40) in the valganciclovir group (95% CI −14.1, −4.9);
Discontinuation due to a serious AE: 2.1% (n=6) of PREVYMIS participants versus 4.7% (n=14) of valganciclovir participants (95% CI −5.9, 0.3);
Discontinuation due to a drug-related AE: 2.7% (n=8) of PREVYMIS participants versus 8.8% (n=26) of valganciclovir participants (95% CI −10.1, −2.4);
Discontinuation due to serious drug-related AE: 0.7% (n=2) of PREVYMIS participants versus 2.4% (n=7) of valganciclovir participants (95% CI −4.2, 0.4);
Two participants (0.7%) in the PREVYMIS group and one participant in the valganciclovir group (0.3%) died (95% CI, −1.3, 2.2).

Data supporting the sNDA for 200 days of prophylaxis in HSCT patients

The sNDA for 200 days of prophylaxis with PREVYMIS is supported by a Phase 3, randomized, double-blind, placebo-controlled trial ( NCT03930615 ) that evaluated the safety and efficacy of extending prophylaxis with PREVYMIS from 100 to 200 days, compared to placebo, in CMV-seropositive recipients [R+] at high risk for clinically significant CMV infection following an HSCT. This trial met its primary endpoint and prophylaxis with PREVYMIS extended to 200 days was superior to placebo in reducing the rate of clinically significant CMV infection from Week 14 through Week 28 post-HSCT in allogeneic R+ HSCT recipients. PREVYMIS had an adverse event profile similar to placebo and was well-tolerated. These data will be presented on Saturday, Feb. 18, at the 2023 Tandem Meetings / Transplantation & Cellular Therapy Meetings of ASTCT™ (American Society for Transplantation and Cellular Therapy) and CIBMTR ^® (Center for International Blood & Marrow Transplant Research).

About PREVYMIS (letermovir)

PREVYMIS is the only drug approved in the United States for prophylaxis of CMV infection and disease in adults who are CMV-seropositive and have received an allogeneic HSCT. PREVYMIS is also approved in more than 60 countries outside of the United States, including EU member states, Canada, Japan and China. PREVYMIS is a first-in-class non-nucleoside CMV inhibitor (3,4 dihydro-quinazolines) and inhibits viral replication by specifically targeting the viral terminase complex. Cross resistance is not likely with drugs outside of this class. PREVYMIS is fully active against viral populations with substitutions conferring resistance to CMV DNA polymerase inhibitors. These DNA polymerase inhibitors are fully active against viral populations with substitutions conferring resistance to PREVYMIS. PREVYMIS has no activity against other viruses.

Selected Safety Information about PREVYMIS (letermovir)

PREVYMIS is contraindicated in patients receiving pimozide or ergot alkaloids. Increased pimozide concentrations may lead to QT prolongation and torsades de pointes. Increased ergot alkaloids concentrations may lead to ergotism. PREVYMIS is contraindicated with pitavastatin and simvastatin when co-administered with cyclosporine. Significantly increased pitavastatin or simvastatin concentrations may lead to myopathy or rhabdomyolysis.

The concomitant use of PREVYMIS and certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (PREVYMIS or concomitant drugs) or reduced therapeutic effect of PREVYMIS or the concomitant drug.

The rate of adverse events in the first 100 days following HSCT occurring in at least 10% of transplant recipients treated with PREVYMIS and at a frequency at least 2% greater than placebo were nausea (27% vs 23%), diarrhea (26% vs 24%), vomiting (19% vs 14%), peripheral edema (14% vs 9%), cough (14% vs 10%), headache (14% vs 9%), fatigue (13% vs 11%), and abdominal pain (12% vs 9%).

Hypersensitivity reaction, with associated moderate dyspnea, occurred in one subject following the first infusion of IV PREVYMIS after switching from oral PREVYMIS, leading to treatment discontinuation.

If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily.

Co-administration of PREVYMIS may alter the plasma concentrations of other drugs and other drugs may alter the plasma concentrations of PREVYMIS. Consult the full Prescribing Information prior to and during treatment for potential drug interactions.

Closely monitor serum creatinine levels in patients with CLcr less than 50 mL/min using PREVYMIS injection.

PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment.

The safety and efficacy of PREVYMIS in patients below 18 years of age have not been established.

For patients with CLcr greater than 10 mL/min (by Cockcroft-Gault equation), no dosage adjustment of PREVYMIS is required based on renal impairment. The safety of PREVYMIS in patients with end-stage renal disease (CLcr less than 10 mL/min), including patients on dialysis, is unknown.

About CMV

CMV is a common virus that infects people of all ages. Many adults in the United States are CMV-seropositive, meaning they have CMV antibodies in their blood, indicating a previous exposure to or primary infection with CMV. People with normal immune systems rarely develop CMV symptoms after initial infection, with the virus typically remaining inactive or latent in the body for life. A weakened immune system may give the virus a chance to reactivate, potentially leading to symptomatic disease or a secondary infection due to other pathogens. When a transplant recipient who is CMV-seronegative receives an organ from a donor who is CMV seropositive, the transplant recipient can get CMV from the donated organ. CMV disease can lead to end-organ damage, including gastrointestinal tract disease, pneumonia or retinitis. Transplant recipients who develop CMV infection post-transplant are at increased risk for transplant failure and death. CMV prophylaxis with certain existing antivirals has been associated with drug-specific effects, including myelosuppression and renal toxicity, in HSCT recipients.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2021 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).

Please see Prescribing Information for PREVYMIS at https://www.merck.com/product/usa/pi_circulars/p/prevymis/prevymis_pi.pdf and Patient Information/Medication Guide for PREVYMIS at https://www.merck.com/product/usa/pi_circulars/p/prevymis/prevymis_ppi.pdf .

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$ in millions, except EPS amounts	First Quarter
$ in millions, except EPS amounts	2023	2022	Change	Change Ex- Exchange
Sales	$14,487	$15,901	-9%	-5%
GAAP net income ¹	2,821	4,310	-35%	-29%
Non-GAAP net income that excludes certain items ^1,2*	3,564	5,429	-34%	-30%
GAAP EPS	1.11	1.70	-35%	-30%
Non-GAAP EPS that excludes certain items ^2*	1.40	2.14	-35%	-30%
*Refer to table on page 10.

	First Quarter
$ in millions	2023	2022	Change	Change Ex- Exchange
Total Sales	$14,487	$15,901	-9%	-5%
Pharmaceutical	12,721	14,107	-10%	-6%
KEYTRUDA	5,795	4,809	20%	24%
GARDASIL / GARDASIL 9	1,972	1,460	35%	43%
JANUVIA / JANUMET	880	1,233	-29%	-25%
PROQUAD, M-M-R II and VARIVAX	528	470	12%	14%
BRIDION	487	395	23%	27%
LAGEVRIO	392	3,247	-88%	-87%
ROTATEQ	297	216	38%	42%
Lynparza*	275	266	3%	8%
Lenvima*	232	227	2%	5%
SIMPONI	180	186	-3%	2%
Animal Health	1,491	1,482	1%	5%
Livestock	849	832	2%	8%
Companion Animals	642	650	-1%	2%
Other Revenues**	275	312	-12%	-22%
*Alliance revenue for this product represents Merck's share of profits, which are product sales net of cost of sales and commercialization costs.
**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.

$ in millions	GAAP	Acquisition- and Divestiture-Related Costs ⁴	Restructuring Costs	(Income) Loss From Investments in Equity Securities	Certain Other Items	Non-GAAP ²
First Quarter 2023
Cost of sales	$3,926	$545	$29	$-	$-	$3,352
Selling, general and administrative	2,479	20	1	-	-	2,458
Research and development	4,276	10	-	-	-	4,266
Restructuring costs	67	-	67	-	-	-
Other (income) expense, net	89	15	-	(429)	573	(70)

First Quarter 2022
Cost of sales	$5,380	$680	$46	$-	$-	$4,654
Selling, general and administrative	2,323	50	21	-	-	2,252
Research and development	2,576	22	7	-	-	2,547
Restructuring costs	53	-	53	-	-	-
Other (income) expense, net	708	(115)	-	684	-	139

	First Quarter
$ in millions, except EPS amounts	2023	2022
EPS
GAAP EPS	$1.11	$1.70
Difference	0.29	0.44
Non-GAAP EPS that excludes items listed below ²	$1.40	$2.14

Net Income
GAAP net income ¹	$2,821	$4,310
Difference	743	1,119
Non-GAAP net income that excludes items listed below ^1,2	$3,564	$5,429

Decrease (Increase) in Net Income Due to Excluded Items:
Acquisition- and divestiture-related costs ⁴	$590	$637
Restructuring costs	97	127
(Income) loss from investments in equity securities	(429)	684
Charge for Zetia antitrust litigation settlements	573	-
Net decrease (increase) in income before taxes	831	1,448
Estimated income tax (benefit) expense	(88)	(329)
Decrease (increase) in net income	$743	$1,119

	GAAP	Non-GAAP ²
Sales*	$57.7 to $58.9 billion	$57.7 to $58.9 billion
Gross margin	Approximately 73%	Approximately 77%
Operating expenses**	$23.5 to $24.3 billion	$23.3 to $24.1 billion
Effective tax rate	17% to 18%	17% to 18%
EPS***	$5.85 to $5.97	$6.88 to $7.00
*Includes approximately $1.0 billion of LAGEVRIO sales. The company does not have any non-GAAP adjustments to sales.
**Includes an aggregate $1.4 billion of R&D expenses related to the Imago acquisition and upfront payment for the license and collaboration agreement with Kelun-Biotech. Outlook does not assume the proposed acquisition of Prometheus or any additional significant potential business development transactions.
***Includes $0.52 of charges related to the Imago acquisition and upfront payment to Kelun-Biotech.
Assumes a share count (assuming dilution) of approximately 2.55 billion shares.

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U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for Merck's PREVYMIS for Prophylaxis of Cytomegalovirus Disease in Kidney Transplant Recipients at High Risk

Merck Announces First-Quarter 2023 Financial Results

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TOP STOCKS

$ in millions, except EPS amounts	Full Year 2023
GAAP EPS	$5.85 to $5.97
Difference	$1.03
Non-GAAP EPS that excludes items listed below ²	$6.88 to $7.00

Acquisition- and divestiture-related costs	$2,500
Restructuring costs	400
(Income) loss from investments in equity securities	(375)
Charge for Zetia antitrust litigation settlements	573
Net decrease (increase) in income before taxes	$3,098
Estimated income tax (benefit) expense	(470)
Decrease (increase) in net income	$2,628

________________________________
¹		Net income attributable to Merck & Co., Inc.
²		Merck is providing certain 2023 and 2022 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors' understanding of the company's results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, senior management's annual compensation is derived in part using a non-GAAP pre-tax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release.
³		Registered trademark of Seagen and Agensys.
⁴		Includes expenses for the amortization of intangible assets and purchase accounting adjustments to inventories recognized as a result of acquisitions, intangible asset impairment charges and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs related to acquisitions and divestitures.

MERCK & CO., INC.
CONSOLIDATED STATEMENT OF INCOME - GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1

	GAAP						% Change
	GAAP
		1Q23			1Q22
		1Q23			1Q22

Sales	$	14,487		$	15,901		-9	%

Costs, Expenses and Other
Cost of sales		3,926			5,380		-27	%
Selling, general and administrative		2,479			2,323		7	%
Research and development		4,276			2,576		66	%
Restructuring costs		67			53		26	%
Other (income) expense, net		89			708		-87	%
Income Before Taxes		3,650			4,861		-25	%
Income Tax Provision		825			554
Net Income		2,825			4,307		-34	%
Less: Net Income (Loss) Attributable to Noncontrolling Interests		4			(3	)
Net Income Attributable to Merck & Co., Inc.	$	2,821		$	4,310		-35	%

Earnings per Common Share Assuming Dilution	$	1.11		$	1.70		-35	%

Average Shares Outstanding Assuming Dilution		2,551			2,537
Tax Rate		22.6	%		11.4	%

MERCK & CO., INC.
FIRST QUARTER 2023 GAAP TO NON-GAAP RECONCILIATION
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2a


	GAAP			Acquisition and Divestiture-Related Costs ⁽¹⁾				Restructuring Costs ⁽²⁾				(Income) Loss from Investments in Equity Securities				Certain Other Items				Adjustment Subtotal		Non-GAAP

First Quarter
Cost of sales	$	3,926		545				29												574		$	3,352
Selling, general and administrative		2,479		20				1												21			2,458
Research and development		4,276		10																10			4,266
Restructuring costs		67						67												67			-
Other (income) expense, net		89		15								(429	)			573		⁽³	⁾	159			(70	)
Income Before Taxes		3,650		(590	)			(97	)			429				(573	)			(831	)		4,481
Income Tax Provision (Benefit)		825		(105	)	⁽⁴	⁾	(18	)	⁽⁴	⁾	95		⁽⁴	⁾	(60	)	⁽⁴	⁾	(88	)		913
Net Income		2,825		(485	)			(79	)			334				(513	)			(743	)		3,568
Net Income Attributable to Merck & Co., Inc.		2,821		(485	)			(79	)			334				(513	)			(743	)		3,564
Earnings per Common Share Assuming Dilution	$	1.11		(0.19	)			(0.03	)			0.13				(0.20	)			(0.29	)	$	1.40

Tax Rate		22.6	%																				20.4	%



Only the line items that are affected by non-GAAP adjustments are shown.

Merck is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing non-GAAP information enhances investors' understanding of the company's results because management uses non-GAAP measures to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, senior management's annual compensation is derived in part using a non-GAAP pretax income metric. The non-GAAP information presented should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP.

⁽¹⁾ Amounts included in cost of sales primarily reflect expenses for the amortization of intangible assets. Amounts included in selling, general and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures. Amounts included in research and development expenses primarily reflect the amortization of intangible assets. Amounts included in other (income) expense, net, reflect a $37 million loss on the sale of a business and an increase in the estimated fair value measurement of liabilities for contingent consideration related to the prior termination of the Sanofi-Pasteur MSD joint venture, partially offset by royalty income.

⁽²⁾ Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to activities under the company's formal restructuring programs.

⁽³⁾ Reflects a charge related to settlements with certain plaintiffs in the Zetia antitrust litigation.

⁽⁴⁾ Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.


MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3

	2023		2022										1Q
	1Q		1Q		2Q		3Q		4Q		Full Year		Nom %	Ex-Exch %
TOTAL SALES ⁽¹⁾	$	14,487	$	15,901	$	14,593	$	14,959	$	13,830	$	59,283	-9	-5
PHARMACEUTICAL		12,721		14,107		12,756		12,963		12,180		52,005	-10	-6
Oncology
Keytruda		5,795		4,809		5,252		5,426		5,450		20,937	20	24
Alliance Revenue – Lynparza ⁽²⁾		275		266		275		284		292		1,116	3	8
Alliance Revenue – Lenvima ⁽²⁾		232		227		231		202		216		876	2	5
Alliance Revenue – Reblozyl ⁽³⁾		43		52		33		39		41		166	-19	-19
Welireg		42		18		27		38		40		123	128	128
Vaccines ⁽⁴⁾
Gardasil / Gardasil 9		1,972		1,460		1,674		2,294		1,470		6,897	35	43
ProQuad / M-M-R II / Varivax		528		470		578		668		526		2,241	12	14
RotaTeq		297		216		173		256		139		783	38	42
Vaxneuvance		106		5		12		16		138		170	*	*
Pneumovax 23		96		173		153		131		145		602	-44	-40
Vaqta		40		36		35		64		39		173	12	13
Hospital Acute Care
Bridion		487		395		426		423		441		1,685	23	27
Prevymis		129		94		103		114		118		428	38	44
Primaxin		80		58		64		63		54		239	37	48
Dificid		65		52		66		77		67		263	25	25
Noxafil		60		57		60		62		58		238	5	14
Zerbaxa		50		30		46		43		49		169	66	70
Cardiovascular
Alliance Revenue - Adempas/Verquvo ⁽⁵⁾		99		72		98		88		82		341	38	38
Adempas ⁽⁶⁾		59		61		63		57		57		238	-3	5
Virology
Lagevrio		392		3,247		1,177		436		825		5,684	-88	-87
Isentress / Isentress HD		123		158		147		161		167		633	-23	-20
Neuroscience
Belsomra		56		69		69		62		59		258	-19	-9
Immunology
Simponi		180		186		181		173		166		706	-3	2
Remicade		51		61		53		49		44		207	-15	-10
Diabetes ⁽⁷⁾
Januvia		551		779		756		717		561		2,813	-29	-26
Janumet		329		454		476		417		353		1,700	-28	-24
Other Pharmaceutical ⁽⁸⁾		584		602		528		603		583		2,319	-3	1
ANIMAL HEALTH		1,491		1,482		1,467		1,371		1,230		5,550	1	5
Livestock		849		832		826		829		814		3,300	2	8
Companion Animals		642		650		641		542		416		2,250	-1	2
Other Revenues ⁽⁹⁾		275		312		370		625		420		1,728	-12	-22

*200% or greater

⁽¹⁾ Only select products are shown.

⁽²⁾ Alliance Revenue represents Merck's share of profits, which are product sales net of cost of sales and commercialization costs.

⁽³⁾ Alliance Revenue represents royalties and a milestone payment of $20 million received in the first quarter of 2022.

⁽⁴⁾ Total Vaccines sales were $3,133 million in the first quarter of 2023 and $2,481 million in the first quarter of 2022.

⁽⁵⁾ Alliance Revenue represents Merck's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs.

⁽⁶⁾ Net product sales in Merck's marketing territories.

⁽⁷⁾ Total Diabetes sales were $950 million in the first quarter of 2023 and $1,305 million in the first quarter of 2022.

⁽⁸⁾ Includes Pharmaceutical products not individually shown above.

⁽⁹⁾ Other Revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Other Revenues related to the receipt of upfront and milestone payments for out-licensed products were $51 million in the first quarter of 2023 and $114 million in the first quarter of 2022.