US FDA Approves Intramuscular Administration for Merck's MMRV Family of Vaccines: M-M-RII , VARIVAX , and ProQuad

With this additional route of administration, the MMRV Family now joins other routinely recommended vaccines that can be administered intramuscularly

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved the addition of the intramuscular (IM) route of administration to the United States Product Insert (USPI) for Merck's MMRV family of vaccines: M-M-R ^®_II , VARIVAX ^® , and ProQuad ^® .

While these vaccines have a long history in the U.S., until now they have only been administered via subcutaneous (SC) injection.

"Building on our history of innovation in the world of vaccines, we're proud to introduce another method of administration for M-M-R ^®_II , VARIVAX ^® , and ProQuad ^® vaccines, which have been important in the fight against measles, mumps, rubella, and varicella in the U.S.," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

With these approvals, healthcare professionals now have the option to choose to administer all routinely recommended injectable pediatric vaccinations included in the CDC immunization schedule, via the same IM route. In the U.S., the only measles, mumps, rubella, and varicella vaccines that can be administered IM are M-M-R ^®_II , VARIVAX ^® , and ProQuad ^® . Additionally, the MMRV family of vaccines has already been licensed for IM administration in the European Union.

"As a pediatrician who routinely vaccinates children, I am excited to now have the option to administer these vaccines intramuscularly," said Dr. Todd Wolynn, co-founding pediatrician of Kids Plus Pediatrics. "This approval provides our practice with an additional route of administration."

About the MMRV Family of Vaccines

ProQuad ^® is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age. It was approved by the FDA in 2005. VARIVAX ^® is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older. It received FDA approval in 1995 and remains the only varicella vaccine available for use in the U.S. M-M-R ^®_II is indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age or older and received FDA approval in 1978.

Indications and Usage

ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age.

VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older.

M-M-R ^®_II is indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age or older.

Selected Safety Information

Hypersensitivity: ProQuad, M-M-R ^®_II, and VARIVAX are contraindicated in patients with a history of anaphylactic reaction or hypersensitivity to any component of the vaccine (including gelatin or neomycin) or to a prior dose of measles, mumps, rubella, or varicella-containing vaccine. Use caution when administering ProQuad and M-M-R ^®_II to individuals with anaphylaxis or immediate hypersensitivity to eggs.

ProQuad, M-M-R ^®_II , and VARIVAX are contraindicated in certain individuals, including those with: immunodeficiency or who are immunosuppressed; an active febrile illness; untreated tuberculosis.

Pregnancy: ProQuad, M-M-R ^®_II , and VARIVAX are contraindicated for use in pregnant women. Do not administer ProQuad or VARIVAX to individuals who are planning to become pregnant in the next 3 months. Do not administer M-M-R ^®_II to individuals who are planning to become pregnant in the next month.

Febrile Seizures: Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with a first dose of both M-M-R ^®_II and VARIVAX administered concomitantly.

Febrile Seizures: Use caution when administering ProQuad and M-M-R ^®_II to individuals with a history of febrile seizures.

Family History of Immunodeficiency: Vaccination with ProQuad, M-M-R ^®_II , and VARIVAX should be deferred in individuals with a family history of congenital or hereditary immunodeficiency until the individual's immune status has been evaluated and the individual has been found to be immunocompetent.

Thrombocytopenia: Transient thrombocytopenia has been reported within 4-6 weeks following vaccination with measles, mumps, and rubella vaccine. Carefully evaluate the potential risk and benefit of vaccination in children with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous dose of a measles, mumps, and rubella-containing vaccine.

Varicella Transmission and Precautions: Advise vaccinees administered ProQuad or VARIVAX to avoid: close contact with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination since transmission of varicella vaccine virus to susceptible contacts has been reported. Varicella vaccine virus transmission may occur between vaccine recipients and contacts susceptible to varicella including healthy individuals.

Immune Globulins and Transfusions: Immune Globulins and other blood products should not be given concomitantly with ProQuad, M-M-R ^®_II , or VARIVAX.

Use of Salicylates: Avoid use of salicylates in children and adolescents administered ProQuad or VARIVAX for 6 weeks following vaccination due to the association of Reye Syndrome with salicylate therapy and wild-type varicella infection.

Adverse Events: The following adverse events have been reported for both subcutaneous and intramuscular injections of ProQuad, M-M-R ^®_II , and VARIVAX: fever, injection-site reactions (pain/tenderness/soreness, erythema, and swelling); and rash on the body or at the injection site. Additionally, irritability has been reported for the subcutaneous injections of ProQuad, M-M-R ^®_II , and VARIVAX.

ProQuad Systemic Vaccine-Related Adverse Events: Systemic vaccine-related adverse events that were reported at a significantly greater rate in recipients of subcutaneous ProQuad than in recipients of the component vaccines administered concomitantly were fever and measles-like rash.

VARIVAX Dose-related Adverse Events: In a clinical trial involving children who received 2 doses of VARIVAX 3 months apart, the incidence of injection-site clinical complaints observed in the first 4 days following vaccination was slightly higher post-dose 2 (overall incidence 25.4%) than post-dose 1 (overall incidence 21.7%), whereas the incidence of systemic clinical complaints in the 42-day follow-up period was lower post-dose 2 (66.3%) than post-dose 1 (85.8%).

Concomitant Vaccines With ProQuad: ProQuad may be administered concomitantly with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP), Haemophilus influenzae type b conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine. It may also be administered concomitantly with pneumococcal 7-valent conjugate vaccine and/or hepatitis A vaccine (inactivated) at separate injection sites.

Concomitant Vaccines With VARIVAX: VARIVAX can be administered with other live viral vaccines. If not given concurrently, at least 1 month should elapse between a dose of a live attenuated measles virus-containing vaccine and a dose of VARIVAX. In children, at least 3 months should elapse between administration of 2 doses of a live attenuated varicella virus-containing vaccine.

Tuberculin Testing: If a tuberculin test is to be done with M-M-R ^®_II and ProQuad, it should be administered either any time before, simultaneously with, or at least 4 to 6 weeks after vaccination. With VARIVAX, tuberculin testing may be performed before the vaccine is administered or at least 4 weeks following vaccination.

Additional M-M-R ^®_II Precautions: Additional adverse reactions, which have been reported without regard to causality, include febrile convulsions, arthritis, thrombocytopenia, anaphylaxis, anaphylactoid reactions, arthritis, encephalitis and encephalopathy in their diverse clinical presentations.

Additional VARIVAX Precautions: It is not known if varicella vaccine virus is excreted in human milk. A boost in antibody levels has been observed in vaccinees following exposure to wild-type varicella, which could account for the apparent long-term persistence of antibody levels in studies. The duration of protection from varicella infection after vaccination is unknown.

ProQuad/VARIVAX and Herpes Zoster: The long-term effect of VARIVAX on the incidence of herpes zoster, particularly in those vaccinees exposed to wild-type varicella, is unknown at present.

Efficacy: Vaccination with ProQuad, VARIVAX, or M-M-R ^®_II may not result in protection in 100% of vaccinees.

Dosage and Administration

ProQuad:

Each dose of ProQuad is approximately 0.5 mL and is administered intramuscularly or subcutaneously.

At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R ^®_II and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad.

VARIVAX:

Each dose is approximately 0.5 mL and is administered intramuscularly or subcutaneously.

The first dose is administered at 12 to 15 months of age.
The second dose is administered at 4 to 6 years of age.
There should be a minimum interval of 3 months between doses.
12 months to 12 years of age: If a second dose is administered, there should be a minimum interval of 3 months between doses.
Adolescents (≥13 years of age) and Adults: 2 doses, to be administered with a minimum interval of 4 weeks between doses.

M-M-R ^®_II :

The dose for any age is approximately 0.5 mL administered intramuscularly or subcutaneously.

The recommended age for primary vaccination is 12 to 15 months and the second dose should be given at 4 to 6 years of age.

Before administrating VARIVAX ^® (Varicella Virus Vaccine Live), M-M-R ^®_II (Measles, Mumps, and Rubella Virus Vaccine Live), or ProQuad ^® (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), please read the Prescribing Information. The Patient Information also is available for VARIVAX , M-M-R ^®_II , and ProQuad .

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 M-M-R ^®_II at https://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf and Patient Information for M-M-R ^®_II at https://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_ppi.pdf .

Please see Prescribing Information for VARIVAX ^® at https://www.merck.com/product/usa/pi_circulars/v/varivax/varivax_pi.pdf and Patient Information for VARIVAX ^® at https://www.merck.com/product/usa/pi_circulars/v/varivax/varivax_ppi.pdf .

Please see Prescribing Information for ProQuad ^® at https://www.merck.com/product/usa/pi_circulars/p/proquad/proquad_pi_4171.pdf and Patient Information for ProQuad ^® at https://www.merck.com/product/usa/pi_circulars/p/proquad/proquad_ppi.pdf .

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Merck Announces First-Quarter 2023 Financial Results

First Quarter 2023 Reflected Continued Strong Underlying Performance Across Key Growth Drivers, Particularly in Oncology and Vaccines
Total Worldwide Sales Were $14.5 Billion, a Decrease of 9% From First Quarter 2022; Excluding LAGEVRIO, Growth Was 11%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 15%
- KEYTRUDA Sales Grew 20% to $5.8 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 24%
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- LAGEVRIO Sales Declined 88% to $392 Million; Excluding the Impact of Foreign Exchange, Sales Declined 87%
GAAP EPS Was $1.11; Non-GAAP EPS Was $1.40; GAAP and Non-GAAP EPS Include $0.52 of Charges Related to Acquisition of Imago and Collaboration and Licensing Agreement With Kelun-Biotech
Announced Proposed Acquisition of Prometheus Biosciences to Strengthen Immunology Pipeline
Presented Compelling Data From Innovative Cardiovascular Pipeline With:
- Positive Phase 3 Results for Sotatercept
- Positive Phase 2b Results for MK-0616; Plans to Start Phase 3 Studies in 2023
Advanced Oncology Research Efforts, Sharing Notable Progress for Earlier Stages of Disease in Certain Tumor Types, Including:
- Positive Topline Results From Phase 3 KEYNOTE-671 Trial
- Positive Detailed Results in Collaboration With Moderna From Phase 2b KEYNOTE-942/mRNA-4157-P201 Trial
2023 Financial Outlook
- Raises and Narrows Expected Full-Year 2023 Worldwide Sales Range To Be Between $57.7 Billion and $58.9 Billion, Including Negative Impact of Foreign Exchange of Approximately 2 Percentage Points; Outlook Includes Approximately $1.0 Billion of LAGEVRIO Sales
- Lowers and Narrows Expected Full-Year 2023 GAAP EPS Range To Be Between $5.85 and $5.97, Reflecting Zetia Antitrust Litigation Settlement
- Raises and Narrows Expected Full-Year 2023 Non-GAAP EPS Range To Be Between $6.88 and $7.00, Including Negative Impact of Foreign Exchange of Approximately 4 Percentage Points
- Outlook Does Not Reflect Any Impact From Proposed Acquisition of Prometheus Biosciences, Which Is Expected to Close in Third Quarter 2023, and Would Result in a One-Time Charge to Both GAAP and Non-GAAP Results of Approximately $10.3 Billion or Approximately $4.00 per Share

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2023.

�Inspired by our commitment to bring bold science forward to address critical unmet patient needs, we began 2023 with significant advancements across our innovative pipeline," said Robert M. Davis, chairman and chief executive officer, Merck. "Our first-quarter results are a reflection of the focused execution of our science-led strategy, strong performance across our key growth drivers, continued momentum commercially and operationally, and most importantly the collective and dedicated efforts of our colleagues around the world. I'm proud of the progress we've made, and we will continue to move with speed and agility to deliver value for patients and shareholders, now and well into the future."

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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.

$ 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.

US FDA Approves Intramuscular Administration for Merck's MMRV Family of Vaccines: M-M-RII , VARIVAX , and ProQuad

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Non-melanoma Skin Cancer

Anogenital Cancers (Peter Mac Collaboration)

Prostate Cancer (Phase II Completed)

Glioblastoma and Oesophageal Cancer (Hanlim Pharma Collaboration)

HPV and Infectious Diseases (Dr.inB Collaboration)

Management Team

Thian Chew – Executive Chairman & CEO

Robert Ramsay – Scientific Advisor

Scott Carpenter – Program Director

Sebastian Marcuccio – Medicinal Chemistry Lead

Kim Steel – Clinical Trial Director

Alexander Bennett – Technical Advisor, Light Devices

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