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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported) July 30, 2024 (July 30, 2024)

 

Merck & Co., Inc.

(Exact name of registrant as specified in its charter)

 

New Jersey

(State or other jurisdiction

of incorporation)

 

1-6571

(Commission

File Number)

 

22-1918501

(I.R.S. Employer

Identification No.)

 

126 East Lincoln Avenue, Rahway, NJ

(Address of principal executive offices)

 

07065

(Zip Code)

 

(Registrant’s telephone number, including area code) (908) 740-4000

 

Not Applicable

(Former name, former address and former fiscal year, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class  Trading Symbol(s)  Name of each exchange on which registered
       
Common Stock ($0.50 par value)  MRK  New York Stock Exchange
0.500% Notes due 2024  MRK 24  New York Stock Exchange
1.875% Notes due 2026  MRK/26  New York Stock Exchange
3.250% Notes due 2032  MRK/32  New York Stock Exchange
2.500% Notes due 2034  MRK/34  New York Stock Exchange
1.375% Notes due 2036  MRK 36A  New York Stock Exchange
3.500% Notes due 2037  MRK/37  New York Stock Exchange
3.700% Notes due 2044  MRK/44  New York Stock Exchange
3.750% Notes due 2054  MRK/54  New York Stock Exchange

 

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

The following information, including the exhibits hereto, is being furnished pursuant to this Item 2.02.

 

Incorporated by reference is a press release issued by Merck & Co., Inc. on July 30, 2024, regarding earnings for the second quarter of 2024, attached as Exhibit 99.1. Also incorporated by reference is certain supplemental information not included in the press release, attached as Exhibit 99.2.

 

This information shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, and is not incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

  (d) Exhibits
   
  Exhibit 99.1 Press release issued July 30, 2024, regarding earnings for the second quarter of 2024
   
  Exhibit 99.2 Certain supplemental information not included in the press release
   
  Exhibit 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Merck & Co., Inc.
 
Date: July 30, 2024 By: /s/ Kelly E. W. Grez
    Kelly E. W. Grez
    Corporate Secretary

 

 

 

Exhibit 99.1

 

  News Release
   

 

Merck Announces Second-Quarter 2024 Financial Results

 

-Total Worldwide Sales Were $16.1 Billion, an Increase of 7% From Second Quarter 2023; Excluding the Impact of Foreign Exchange, Growth Was 11%
-KEYTRUDA Sales Grew 16% to $7.3 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 21%
-GAAP EPS Was $2.14; Non-GAAP EPS Was $2.28
-Successful Initial Launch of WINREVAIR in the U.S.; Received Positive EU CHMP Opinion for Adults With PAH
-Achieved Key Milestones in Vaccine Programs
oFollowing FDA Approval, CAPVAXIVE Unanimously Recommended by the CDC’s ACIP for Pneumococcal Vaccination for Certain Adults
oAnnounced Positive Results From Phase 2b/3 Trial of Clesrovimab (MK-1654), an Investigational RSV Preventative Monoclonal Antibody for Infants
-Completed Acquisitions of EyeBio and Elanco’s Aqua Business in July 2024
-Full-Year 2024 Financial Outlook
oRaises and Narrows Expected Worldwide Sales Range To Be Between $63.4 Billion and $64.4 Billion
oNow Expects Non-GAAP EPS To Be Between $7.94 and $8.04; Outlook Reflects Negative Impact From One-Time Charge of Approximately $1.3 Billion, or $0.51 per Share, for the Acquisition of EyeBio

 

RAHWAY, N.J., July 30, 2024 Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2024.

 

“Our business is demonstrating strong momentum as we exit the first half of the year,” said Robert M. Davis, chairman and chief executive officer, Merck. “Through excellent scientific, commercial and operational execution, we’re achieving significant milestones for our company and for patients, including the launch of WINREVAIR. I am proud of our dedicated teams around the world that are working tirelessly to advance our deep pipeline as we continue delivering innovation that solves unmet medical needs.”

 

 

- 2 -

 

Financial Summary

 

   Second Quarter 
$ in millions, except EPS amounts  2024   2023   Change   Change Ex-
Exchange
 
Sales  $16,112   $15,035    7%   11%
GAAP net income (loss)1   5,455    (5,975)   N/M    N/M 
Non-GAAP net income (loss) that excludes certain items1,2*    5,809    (5,220)   N/M    N/M 
GAAP EPS   2.14    (2.35)   N/M    N/M 
Non-GAAP EPS that excludes certain items2*   2.28    (2.06)   N/M    N/M 

 

*Refer to table on page 7.

N/M – Not meaningful

 

For the second quarter of 2024, Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $2.14 and non-GAAP EPS was $2.28. GAAP and non-GAAP loss per share for the second quarter of 2023 include a charge of $4.02 per share for the acquisition of Prometheus Biosciences, Inc. (Prometheus). Non-GAAP EPS in both periods excludes acquisition- and divestiture-related costs, costs related to restructuring programs, as well as income and losses from investments in equity securities. Non-GAAP EPS in the second quarter of 2024 also excludes a tax benefit due to a reduction in reserves for unrecognized income tax benefits, resulting from the expiration of the statute of limitations for assessments related to the 2019 federal tax return year.

 

Year-to-date results can be found in the attached tables.

 

 

1 Net income (loss) attributable to Merck & Co., Inc.

2 Merck is providing certain 2024 and 2023 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, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax 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 -

 

Second-Quarter Sales Performance

 

The following table reflects sales of the company’s top products and significant performance drivers.

 

   Second Quarter
$ in millions  2024   2023   Change   Change
Ex-
Exchange
   Commentary
Total Sales  $16,112   $15,035    7%   11%  Approximately 2 percentage points of the negative impact of foreign exchange was due to devaluation of Argentine peso, which was largely offset by inflation-related price increases, consistent with practice in that market.
Pharmaceutical   14,408    13,457    7%   11%  Increase driven by growth in oncology, cardiovascular and vaccines, partially offset by declines in diabetes and virology.
KEYTRUDA   7,270    6,271    16%   21%  Growth driven by increased global uptake in earlier-stage indications, including triple-negative breast cancer (TNBC) and renal cell carcinoma, as well as non-small cell lung cancer in the U.S., and continued strong global demand from metastatic indications. Approximately 4 percentage points of the negative impact of foreign exchange was due to devaluation of Argentine peso, which was largely offset by inflation-related price increases.
GARDASIL/GARDASIL 9   2,478    2,458    1%   4%  Growth primarily due to higher sales in the U.S. driven by higher pricing, demand and public-sector buying patterns, as well as higher demand in certain ex-U.S. markets. Growth was largely offset by lower sales in China due to timing of shipments compared with prior year.
JANUVIA/JANUMET   629    864    -27%   -23%  Decline primarily due to lower pricing and demand in the U.S., as well as ongoing generic competition in many international markets, particularly in Europe and the Asia Pacific region.
PROQUAD, M-M-R II and VARIVAX   617    582    6%   7%  Growth largely from higher pricing and demand in the U.S.
BRIDION   455    502    -9%   -8%  Decline primarily due to generic competition in certain ex-U.S. markets, particularly in Europe and the Asia Pacific region, partially offset by higher demand in the U.S.
Lynparza*   317    310    2%   4%  Growth due to higher demand in the U.S. and certain international markets, particularly in China and Europe.
Lenvima*   249    242    3%   4%  Growth primarily from higher demand in the U.S.
VAXNEUVANCE   189    168    13%   16%  Growth largely driven by continued uptake from launches in Japan and Europe, partially offset by lower demand and public-sector buying patterns in the U.S.
PREVYMIS   188    143    31%   35%  Growth primarily due to higher global demand, particularly in the U.S., China and Europe.

 

 

- 4 -

 

ROTATEQ   163    131    25%   26%  Growth primarily due to timing of shipments to China and public-sector buying patterns in the U.S., partially offset by lower demand in the U.S.
WELIREG   126    50    150%   150%  Growth primarily driven by higher demand in the U.S., largely attributable to launch of a new indication.
LAGEVRIO   110    203    -46%   -42%  Decline due to lower demand and pricing in certain markets in the Asia Pacific region, partially offset by higher demand in Japan and the U.S.
WINREVAIR   70    -    -    -   Represents sales in the U.S. following approval in March 2024. About 40% of sales were attributable to doses administered to patients and remainder was due to distributors building inventory in support of increasing demand.
Animal Health   1,482    1,456    2%   6%  Growth primarily driven by higher pricing in both Livestock and Companion Animal product portfolios, as well as higher demand for Livestock products, partially offset by a decline in Companion Animal distributor inventory. Approximately 3 percentage points of the negative impact of foreign exchange was due to devaluation of Argentine peso, which was largely offset by inflation-related price increases.
Livestock   837    807    4%   11%  Growth primarily driven by higher demand for ruminant and poultry products, as well as higher pricing across product portfolio.
Companion Animal   645    649    -1%   1%  Sales were relatively flat compared with prior year reflecting lower distributor inventory, largely offset by higher pricing across product portfolio. Sales of BRAVECTO were $331 million and $326 million in current and prior-year quarters, respectively, which represented growth of 2%, or 3% excluding impact of foreign exchange.
Other Revenues**   222    122    82%   53%  Growth primarily due to higher royalty income and favorable impact of revenue hedging activities.

 

*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.

 

 

 

- 5 -

 

Second-Quarter Expense, EPS and Related Information

 

The table below presents selected expense information.

 

$ in millions  GAAP   Acquisition-
and
Divestiture-
Related
Costs3
   Restructuring
Costs
   (Income)
Loss From
Investments
in Equity
Securities
   Non-
GAAP2
 
Second Quarter 2024                         
Cost of sales  $3,745   $606   $66   $-   $3,073 
Selling, general and administrative   2,739    24    31    -    2,684 
Research and development   3,500    20    -    -    3,480 
Restructuring costs   80    -    80    -    - 
Other (income) expense, net   42    (17)   -    (49)   108 
                          
Second Quarter 2023                         
Cost of sales  $4,024   $467   $32   $-   $3,525 
Selling, general and administrative   2,702    25    52    -    2,625 
Research and development   13,321    9    1    -    13,311 
Restructuring costs   151    -    151    -    - 
Other (income) expense, net   172    (3)   -    194    (19)

 

GAAP Expense, EPS and Related Information

 

Gross margin was 76.8% for the second quarter of 2024 compared with 73.2% for the second quarter of 2023. The increase was primarily due to the favorable impact of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9), partially offset by higher amortization of intangible assets.

 

Selling, general and administrative (SG&A) expenses were $2.7 billion in the second quarter of 2024, an increase of 1% compared with the second quarter of 2023. The increase was primarily due to higher administrative and promotional costs, largely offset by the favorable impact of foreign exchange and lower restructuring costs.

 

Research and development (R&D) expenses were $3.5 billion in the second quarter of 2024 compared with $13.3 billion in the second quarter of 2023. The decrease was primarily due to a $10.2 billion charge in the second quarter of 2023 for the acquisition of Prometheus, partially offset by higher clinical development spending and increased compensation and benefit costs.

 

Other (income) expense, net, was $42 million of expense in the second quarter of 2024 compared with $172 million of expense in the second quarter of 2023. The decrease was primarily due to income from investments in equity securities in 2024 compared with losses in 2023, partially offset by higher net interest expense in 2024.

 

 

3Reflects expenses related to acquisitions of businesses, including the amortization of intangible assets, 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 associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations and licensing arrangements.

 

 

- 6 -

 

The effective tax rate of 9.1% for the second quarter of 2024 includes a 4.3 percentage point favorable impact due to a reduction in reserves for unrecognized income tax benefits, resulting from the expiration of the statute of limitations for assessments related to the 2019 federal tax return year.

 

GAAP EPS was $2.14 for the second quarter of 2024 compared with GAAP loss per share of $2.35 for the second quarter of 2023. GAAP loss per share in the second quarter of 2023 includes a charge of $4.02 per share for the acquisition of Prometheus.

 

Non-GAAP Expense, EPS and Related Information

 

Non-GAAP gross margin was 80.9% for the second quarter of 2024 compared with 76.6% for the second quarter of 2023. The increase was primarily due to the favorable impact of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9).

 

Non-GAAP SG&A expenses were $2.7 billion in the second quarter of 2024, an increase of 2% compared with the second quarter of 2023. The increase was primarily due to higher administrative and promotional costs, largely offset by the favorable impact of foreign exchange.

 

Non-GAAP R&D expenses were $3.5 billion in the second quarter of 2024 compared with $13.3 billion in the second quarter of 2023. The decrease was primarily due to a $10.2 billion charge in the second quarter of 2023 for the acquisition of Prometheus, partially offset by higher clinical development spending and increased compensation and benefit costs.

 

Non-GAAP other (income) expense, net, was $108 million of expense in the second quarter of 2024 compared with $19 million of income in the second quarter of 2023, primarily due to higher net interest expense.

 

The non-GAAP effective tax rate was 14.1% for the second quarter of 2024.

 

Non-GAAP EPS was $2.28 for the second quarter of 2024 compared with non-GAAP loss per share of $2.06 for the second quarter of 2023. Non-GAAP loss per share in the second quarter of 2023 includes a charge of $4.02 per share for the acquisition of Prometheus.

 

 

- 7 -

 

A reconciliation of GAAP to non-GAAP net income (loss) and EPS is provided in the table that follows.

 

   Second Quarter 
$ in millions, except EPS amounts  2024   2023 
EPS          
GAAP EPS  $2.14   $(2.35)
Difference   0.14    0.29 
Non-GAAP EPS that excludes items listed below2  $2.28   $(2.06)
           
Net Income (Loss)          
GAAP net income (loss)1  $5,455   $(5,975)
Difference   354    755 
Non-GAAP net income (loss) that excludes items listed below1,2  $5,809   $(5,220)
           
Excluded Items:          
Acquisition- and divestiture-related costs3  $633   $498 
Restructuring costs   177    236 
(Income) loss from investments in equity securities   (49)   194 
Decrease to net income/increase to net loss before taxes   761    928 
Income tax (benefit) expense4   (407)   (173)
Decrease to net income/increase to net loss  $354   $755 

 

Pipeline and Portfolio Highlights

 

In the second quarter, Merck demonstrated further progress in its strong and diverse pipeline, achieving multiple regulatory and clinical milestones.

 

In vaccines, Merck recently received approval from the U.S. Food and Drug Administration (FDA) for CAPVAXIVE, now the first pneumococcal conjugate vaccine specifically designed to address the serotypes responsible for approximately 85% of invasive pneumococcal disease cases in adults age 65 and older, based on the U.S. Centers for Disease Control and Prevention (CDC) data from 2018-2021. The CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend CAPVAXIVE for adults age 65 and older who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown, for adults 19 to 64 with certain risk conditions, and for adults 19 and older who have started their pneumococcal vaccine series with PCV13. Additionally, shared clinical decision-making is recommended for a supplemental dose of CAPVAXIVE for adults over 65 who completed their vaccine series with both PCV13 and PPSV23.

 

The company also recently announced positive topline results from its Phase 2b/3 trial of clesrovimab (MK-1654), an investigational respiratory syncytial virus (RSV) preventative monoclonal antibody for infants, which met all primary safety and efficacy endpoints.

 

In cardiometabolic disease, Merck continued to make progress in its launch of WINREVAIR in the U.S. As of the end of June, more than 1,000 patients have received WINREVAIR. The company also announced that the European Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for WINREVAIR. If approved by the European Commission, WINREVAIR will be the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to be approved in Europe, offering a new treatment option for certain adults with this rare, progressive disease. Additional worldwide regulatory filings for WINREVAIR are underway.

 

 

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, as well as a $259 million benefit in the second quarter of 2024, due to a reduction in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to the 2019 federal tax return year.

 

 

- 8 -

 

In oncology, Merck received FDA approval for KEYTRUDA in combination with chemotherapy, followed by KEYTRUDA as a single agent, for the treatment of certain patients with endometrial carcinoma. This marks the 40th indication for KEYTRUDA in the U.S., reinforcing its importance as a foundational therapy for certain types of cancer.

 

At the 2024 American Society of Clinical Oncology Annual Meeting, new data were presented on four approved oncology medicines and four pipeline candidates in more than 25 types of cancer. In collaboration with Moderna, Inc., Merck announced encouraging three-year follow-up data for V940 (mRNA-4157) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk stage III and IV melanoma following complete resection. In addition, new Phase 3 data from a study conducted in China and independently led by Kelun-Biotech evaluating sacituzumab tirumotecan (MK-2870/SKB264), an investigational anti-TROP2 antibody-drug conjugate being developed by Merck in collaboration with Kelun-Biotech, were presented in previously treated patients with locally recurrent or metastatic TNBC.

 

Merck Animal Health launched the 12-month injectable formulation of BRAVECTO for use in dogs in a number of markets in Europe for the treatment and persistent killing of fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, Ixodes hexagonus, and Dermacentor reticulatus). In addition, in July 2024, Merck completed the acquisition of the aqua business of Elanco Animal Health Incorporated.

 

In July 2024, Merck also completed the acquisition of Eyebiotech Limited (EyeBio), which includes the lead candidate Restoret™/MK-3000 that is being evaluated for the treatment of patients with certain retinal diseases, including diabetic macular edema and neovascular age-related macular degeneration, as well as preclinical candidates. And, Merck and Orion Corporation announced the mutual exercise of an option to convert the companies’ ongoing co-development and co-commercialization agreement for opevesostat (MK-5684/ODM-208), an investigational CYP11A1 inhibitor, and other candidates, into an exclusive global license for Merck.

 

 

- 9 -

 

Notable recent news releases on Merck’s pipeline and portfolio are provided in the table that follows.

 

Oncology FDA Approved KEYTRUDA Plus Carboplatin and Paclitaxel as Treatment for Adult Patients With Primary Advanced or Recurrent Endometrial Carcinoma, Based on Results From Phase 3 NRG-GY018/KEYNOTE-868 Trial (Read Announcement)
FDA Granted Priority Review to Merck’s Application for KEYTRUDA Plus Chemotherapy as First-Line Treatment of Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma, Based on Results From Phase 3 KEYNOTE-483 Trial; FDA Set Prescription Drug User Fee Act (PDUFA) Date of Sept. 25, 2024 (Read Announcement)
Merck Received Positive EU CHMP Opinion for KEYTRUDA Plus Padcev as First-Line Treatment for Patients With Unresectable or Metastatic Urothelial Carcinoma, Based on Results From Phase 3 KEYNOTE-A39/EV-302 Trial (Read Announcement)
Moderna and Merck Announced Three-Year Data for mRNA-4157 (V940) in Combination With KEYTRUDA Demonstrated Sustained Improvement in Recurrence-Free Survival and Distant Metastasis-Free Survival Versus KEYTRUDA in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection (Read Announcement)
Merck Announced Phase 3 KEYNOTE-522 Trial Met Its Overall Survival (OS) Endpoint in Patients With High-Risk Early-Stage TNBC (Read Announcement)
Merck Announced Phase 3 KEYNOTE-811 Trial Met Dual Primary Endpoint of OS as First-Line Treatment in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Read Announcement)
Patritumab Deruxtecan Biologics License Application Submission Received Complete Response Letter From FDA Due to Inspection Findings at Third-Party Manufacturer (Read Announcement)
Vaccines FDA Approved CAPVAXIVE for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults, Based on Results From Four Phase 3 Trials (Read Announcement)
CDC’s ACIP Unanimously Recommended CAPVAXIVE for Pneumococcal Vaccination in Appropriate Adults (Read Announcement)
Merck Announced Topline Results From Phase 2b/3 Trial of Clesrovimab (MK-1654), an Investigational RSV Preventative Monoclonal Antibody for Infants, Met All Primary Safety and Efficacy Endpoints (Read Announcement)
Cardiometabolic Merck Received Positive EU CHMP Opinion for WINREVAIR (sotatercept) in PAH (Read Announcement)

 

 

- 10 -

 

Full-Year 2024 Financial Outlook

 

The following table summarizes the company’s full-year financial outlook.

 

   Full Year 2024
   Updated  Prior
Sales*  $63.4 to $64.4 billion  $63.1 to $64.3 billion
Non-GAAP Gross margin2  Approximately 81%  Approximately 81%
Non-GAAP Operating expenses2**  $26.8 to $27.6 billion  $25.2 to $26.1 billion
Non-GAAP Other (income) expense, net2  Approximately $350 million expense  Approximately $250 million expense
Non-GAAP Effective tax rate2  15.5% to 16.5%  14.5% to 15.5%
Non-GAAP EPS2***  $7.94 to $8.04  $8.53 to $8.65
Share count (assuming dilution)  Approximately 2.54 billion  Approximately 2.55 billion

 

*The company does not have any non-GAAP adjustments to sales.

**Includes one-time R&D charges of $656 million for Harpoon Therapeutics, Inc. (Harpoon) acquisition and $1.3 billion for EyeBio acquisition. Outlook does not assume any additional significant potential business development transactions.

***Includes one-time charges totaling $0.77 per share for the Harpoon and EyeBio acquisitions.

 

Merck has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and gains and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the company’s future GAAP results.

 

Merck continues to experience strong global demand for key growth products, particularly in oncology, and despite impacts related to the lower sell out of GARDASIL from Zhifei Biological Products Co., Ltd. (the company’s distributor and commercialization partner in China) into the points of vaccination in the market during the quarter, Merck is raising and narrowing its full-year sales outlook.

 

Merck now expects its full-year sales to be between $63.4 billion and $64.4 billion, including a negative impact of foreign exchange of approximately 3 percentage points, at mid-July 2024 exchange rates. Approximately 2 percentage points of the negative impact of foreign exchange is due to the devaluation of the Argentine peso, which the company expects will largely be offset by inflation-related price increases, consistent with practice in that market.

 

Merck now expects its full-year non-GAAP effective income tax rate to be between 15.5% and 16.5%, which includes an unfavorable impact related to the one-time charge for the acquisition of EyeBio, which is not tax deductible.

 

Merck now expects its full-year non-GAAP EPS to be between $7.94 and $8.04, including one-time charges of $0.26 and $0.51 per share for the acquisitions of Harpoon and EyeBio, respectively. The outlook includes a negative impact of foreign exchange of more than $0.30 per share. The negative impact of foreign exchange is primarily due to the devaluation of the Argentine peso, which the company expects will largely be offset by inflation-related price increases, consistent with practice in that market. This revised non-GAAP EPS range reflects the following items, which were not previously included in the outlook:

 

·A charge of $1.3 billion, or $0.51 per share, for the acquisition of EyeBio.

 

·Estimated 2024 expense of approximately $0.09 per share to be incurred to finance the EyeBio and Elanco aqua business acquisitions and to advance the acquired assets.

 

 

- 11 -

 

Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions.

 

Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, income and losses from investments in equity securities, as well as a tax benefit in 2024 due to a reduction in reserves for unrecognized income tax benefits, resulting from the expiration of the statute of limitations for assessments related to the 2019 federal tax return year.

 

Earnings Conference Call

 

Investors, journalists and the general public may access a live audio webcast of the earnings conference call on Tuesday, July 30, at 9 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com.

 

All participants may join the call by dialing (800) 779-0641 (U.S. and Canada Toll-Free) or (517) 308-9147 and using the access code 4761229.

 

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 X (formerly 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.

 

 

- 12 -

 

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 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, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

Appendix

 

Generic product names are provided below.

 

Pharmaceutical

BRIDION (sugammadex)

CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine)

GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant)

GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

JANUMET (sitagliptin and metformin HCl)

JANUVIA (sitagliptin)

KEYTRUDA (pembrolizumab)

LAGEVRIO (molnupiravir)

Lenvima (lenvatinib)

Lynparza (olaparib)

M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)

PREVYMIS (letermovir)

PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)

ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent)

VARIVAX (Varicella Virus Vaccine Live)

VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)

WELIREG (belzutifan)

WINREVAIR (sotatercept-csrk)

 

 

- 13 -

 

Animal Health

BRAVECTO (fluralaner)

 

###

 

 

 

Media Contacts: Investor Contacts:

 

Robert Josephson

(203) 914-2372

robert.josephson@merck.com

 

Michael Levey

(215) 872-1462

michael.levey@merck.com

 

Peter Dannenbaum

(732) 594-1579

peter.dannenbaum@merck.com

 

Steven Graziano

(732) 594-1583

steven.graziano@merck.com

 

 

 

 

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

 

   GAAP       GAAP     
           June YTD   June YTD     
   2Q24    2Q23    % Change   2024   2023   % Change 
Sales  $16,112   $15,035    7%  $31,887   $29,522    8%
                               
Costs, Expenses and Other                              
Cost of sales   3,745    4,024    -7%   7,285    7,951    -8%
Selling, general and administrative   2,739    2,702    1%   5,221    5,182    1%
Research and development   3,500    13,321    -74%   7,492    17,597    -57%
Restructuring costs   80    151    -47%   202    218    -7%
Other (income) expense, net   42    172    -76%   12    259    -95%
Income (Loss) Before Taxes   6,006    (5,335)   *    11,675    (1,685)   *  
Income Tax Provision   545    637         1,447    1,462      
Net Income (Loss)   5,461    (5,972)   *    10,228    (3,147)   *  
Less: Net Income Attributable to Noncontrolling Interests   6    3         11    7      
Net Income (Loss) Attributable to Merck & Co., Inc.  $5,455   $(5,975)   *   $10,217   $(3,154)   *  
                               
Earnings (Loss) per Common Share Assuming Dilution (1)  $2.14   $(2.35)   *   $4.02   $(1.24)   *  
                               
Average Shares Outstanding Assuming Dilution (1)    2,544    2,539         2,544    2,539      
Tax Rate   9.1%   -11.9%        12.4%   -86.8%     

 

* 100% or greater

         

(1) Because the company recorded a net loss in the second quarter and first six months of 2023, no potential dilutive common shares were used in the computation of loss per common share assuming dilution as the effect would have been anti-dilutive.

 

 

MERCK & CO., INC.
THREE AND SIX MONTHS ENDED JUNE 30, 2024 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  
Second Quarter                                          
Cost of sales   $ 3,745       606       66                       672     $ 3,073  
Selling, general and administrative     2,739       24       31                       55       2,684  
Research and development     3,500       20                               20       3,480  
Restructuring costs     80               80                       80        
Other (income) expense, net     42       (17 )             (49 )             (66 )     108  
Income Before Taxes     6,006       (633 )     (177 )     49               (761 )     6,767  
Income Tax Provision (Benefit)     545       (129 )(3)     (30 )(3)     11 (3)     (259 )(4)     (407 )     952  
Net Income     5,461       (504 )     (147 )     38       259       (354 )     5,815  
Net Income Attributable to Merck & Co., Inc.     5,455       (504 )     (147 )     38       259       (354 )     5,809  
Earnings per Common Share Assuming Dilution   $ 2.14       (0.20 )     (0.06 )     0.02       0.10       (0.14 )   $ 2.28  
                                                         
Tax Rate     9.1 %                                             14.1 %
                                                         
June YTD                                                        
Cost of sales   $ 7,285       1,069       182                       1,251     $ 6,034  
Selling, general and administrative     5,221       45       36                       81       5,140  
Research and development     7,492       36       2                       38       7,454  
Restructuring costs     202               202                       202        
Other (income) expense, net     12       (21 )             (165 )             (186 )     198  
Income Before Taxes     11,675       (1,129 )     (422 )     165               (1,386 )     13,061  
Income Tax Provision (Benefit)     1,447       (221 )(3)     (72 )(3)     36 (3)     (259 )(4)     (516 )     1,963  
Net Income     10,228       (908 )     (350 )     129       259       (870 )     11,098  
Net Income Attributable to Merck & Co., Inc.     10,217       (908 )     (350 )     129       259       (870 )     11,087  
Earnings per Common Share Assuming Dilution   $ 4.02       (0.35 )     (0.14 )     0.05       0.10       (0.34 )   $ 4.36  
                                                         
Tax Rate     12.4 %                                             15.0 %

 

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, annual employee compensation, including senior management’s 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, primarily reflect royalty income related to the prior termination of the Sanofi-Pasteur MSD joint venture.  
(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) Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.  
(4) Represents a benefit due to a reduction in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to the 2019 federal tax return year.  

 

 

 

MERCK & CO., INC.

FRANCHISE / KEY PRODUCT SALES

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3 

 

    2024    2023    2Q    June YTD 
   1Q    2Q   June YTD    1Q   2Q   June YTD    3Q   4Q    Full Year    Nom %    Ex-Exch %    Nom %    Ex-Exch % 
TOTAL SALES (1)   $15,775   $16,112   $31,887   $14,487   $15,035   $29,522   $15,962   $14,630   $60,115    7    11    8    11 
PHARMACEUTICAL   14,006    14,408    28,415    12,721    13,457    26,179    14,263    13,141    53,583    7    11    9    12 
Oncology                                                                 
Keytruda   6,947    7,270    14,217    5,795    6,271    12,065    6,338    6,608    25,011    16    21    18    22 
Alliance Revenue – Lynparza (2)   292    317    609    275    310    585    299    315    1,199    2    4    4    6 
Alliance Revenue – Lenvima (2)   255    249    504    232    242    474    260    226    960    3    4    6    7 
Welireg   85    126    211    42    50    92    54    72    218    150    150    128    128 
Alliance Revenue – Reblozyl (3)   71    90    161    43    47    90    52    70    212    92    92    80    80 
Vaccines (4)                                                                 
Gardasil/Gardasil 9   2,249    2,478    4,727    1,972    2,458    4,430    2,585    1,871    8,886    1    4    7    10 
ProQuad/M-M-R II/Varivax   570    617    1,187    528    582    1,109    713    545    2,368    6    7    7    7 
Vaxneuvance   219    189    408    106    168    274    214    176    665    13    16    49    51 
RotaTeq   216    163    379    297    131    428    156    185    769    25    26    -11    -10 
Pneumovax 23   61    59    120    96    92    188    140    85    412    -36    -32    -36    -32 
Hospital Acute Care                                                                 
Bridion   440    455    895    487    502    989    424    429    1,842    -9    -8    -9    -8 
Prevymis   174    188    362    129    143    273    157    175    605    31    35    33    37 
Dificid   73    92    165    65    76    141    74    87    302    20    20    16    16 
Zerbaxa   56    62    118    50    54    104    53    61    218    14    18    13    16 
Noxafil   56    45    101    60    55    116    51    46    213    -20    -9    -13    -2 
Cardiovascular                                                                 
Alliance Revenue - Adempas/Verquvo (5)   98    106    203    99    68    167    92    108    367    56    56    22    22 
Adempas (6)   70    72    142    59    65    125    65    66    255    11    15    14    17 
Winrevair        70    70                                  -    -    -    - 
Virology                                                                 
Lagevrio   350    110    460    392    203    595    640    193    1,428    -46    -42    -23    -18 
Isentress/Isentress HD   111    89    200    123    136    259    119    105    483    -35    -31    -23    -19 
Delstrigo   56    60    116    44    50    94    54    54    201    19    23    23    26 
Pifeltro   42    39    81    34    38    72    37    33    142    3    4    13    13 
Neuroscience                                                                 
Belsomra   46    53    99    56    63    119    58    54    231    -16    -8    -17    -10 
Immunology                                                                 
Simponi   184    172    356    180    180    359    179    171    710    -4    -2    -1    -1 
Remicade   39    35    74    51    48    99    45    43    187    -27    -20    -25    -21 
Diabetes (7)                                                                 
Januvia   419    405    824    551    511    1,062    581    547    2,189    -21    -16    -22    -19 
Janumet   251    224    475    329    354    683    255    240    1,177    -37    -32    -30    -26 
Other Pharmaceutical (8)   576    573    1,151    626    560    1,187    568    576    2,333    2    6    -3    -1 
ANIMAL HEALTH   1,511    1,482    2,993    1,491    1,456    2,947    1,400    1,278    5,625    2    6    2    5 
Livestock   850    837    1,686    849    807    1,656    874    808    3,337    4    11    2    7 
Companion Animal   661    645    1,307    642    649    1,291    526    470    2,288    -1    1    1    3 
Other Revenues (9)   258    222    479    275    122    396    299    211    907    82    53    21    24 

 

Sum of quarterly amounts may not equal year-to-date amounts due to rounding.

 

(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. 

(4) Total Vaccines sales were $3,424 million and $3,656 million in the first and second quarter of 2024, respectively, and $3,133 million and $3,557 million in the first and second quarter of 2023, respectively. 

(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 $745 million and $715 million in the first and second quarter of 2024, respectively, and $950 million and $951 million in the first and second quarter of 2023, respectively. 

(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 $61 million and $15 million in the first and second quarter of 2024, respectively, and $51 million and $3 million in the first and second quarter of 2023, respectively.

 

 

 

 

Exhibit 99.2 

 

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

  

   2024   2023   % Change 
   1Q   2Q   June YTD   1Q   2Q   June YTD   3Q   4Q   Full Year   2Q   June YTD 
Sales  $15,775   $16,112   $31,887   $14,487   $15,035   $29,522   $15,962   $14,630   $60,115    7%   8%
                                                        
Costs, Expenses and Other                                                       
Cost of sales   3,540    3,745    7,285    3,926    4,024    7,951    4,264    3,911    16,126    -7%   -8%
Selling, general and administrative   2,483    2,739    5,221    2,479    2,702    5,182    2,519    2,804    10,504    1%   1%
Research and development   3,992    3,500    7,492    4,276    13,321    17,597    3,307    9,628    30,531    -74%   -57%
Restructuring costs   123    80    202    67    151    218    126    255    599    -47%   -7%
Other (income) expense, net   (33)   42    12    89    172    259    126    78    466    -76%   -95%
Income (Loss) Before Taxes   5,670    6,006    11,675    3,650    (5,335)   (1,685)   5,620    (2,046)   1,889    *    * 
Income Tax Provision (Benefit)   903    545    1,447    825    637    1,462    870    (821)   1,512           
Net Income (Loss)   4,767    5,461    10,228    2,825    (5,972)   (3,147)   4,750    (1,225)   377    *    * 
Less: Net Income Attributable to Noncontrolling Interests   5    6    11    4    3    7    5    1    12           
Net Income (Loss) Attributable to Merck & Co., Inc.  $4,762   $5,455   $10,217   $2,821   $(5,975)  $(3,154)  $4,745   $(1,226)  $365    *    * 
                                                        
Earnings (Loss) per Common Share Assuming Dilution (1)   $1.87   $2.14   $4.02   $1.11   $(2.35)  $(1.24)  $1.86   $(0.48)  $0.14    *    * 
                                                        
Average Shares Outstanding Assuming Dilution (1)    2,544    2,544    2,544    2,551    2,539    2,539    2,546    2,533    2,547           
Tax Rate   15.9%   9.1%   12.4%   22.6%   -11.9%   -86.8%   15.5%   40.1%   80.0%          

 

* 100% or greater 

Sum of quarterly amounts may not equal year-to-date amounts due to rounding.  

 

(1) Because the company recorded a net loss in the second quarter and first six months of 2023, as well as the fourth quarter of 2023, no potential dilutive common shares were used in the computation of loss per common share assuming dilution as the effect would have been anti-dilutive.  

 

 

 

 

MERCK & CO., INC.

THREE AND SIX MONTHS ENDED JUNE 30, 2023 GAAP TO NON-GAAP RECONCILIATION

(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)

(UNAUDITED) 

Table 2b

 

   GAAP   Acquisition and
Divestiture-Related
Costs
(1) 
   Restructuring
Costs
(2) 
   (Income)
Loss from
Investments
in Equity
Securities
   Certain
Other
Items
   Adjustment
Subtotal
   Non-GAAP 
Second Quarter                                   
Cost of sales  $4,024    467    32              499   $3,525 
Selling, general and administrative   2,702    25    52              77    2,625 
Research and development   13,321    9    1              10    13,311 
Restructuring costs   151         151              151    - 
Other (income) expense, net   172    (3)        194         191    (19)
Loss Before Taxes   (5,335)   (498)   (236)   (194)        (928)   (4,407)
Income Tax Provision (Benefit)   637    (91)(4)    (38)(4)    (44)(4)         (173)   810 
Net Loss   (5,972)   (407)   (198)   (150)        (755)   (5,217)
Net Loss Attributable to Merck & Co., Inc.   (5,975)   (407)   (198)   (150)        (755)   (5,220)
Loss per Common Share Assuming Dilution(5)   $(2.35)   (0.16)   (0.07)   (0.06)        (0.29)  $(2.06)
                                    
Tax Rate   -11.9%                            -18.4%
                                    
June YTD                                   
Cost of sales  $7,951    1,012    61              1,073   $6,878 
Selling, general and administrative   5,182    45    53              98    5,084 
Research and development   17,597    19    1              20    17,577 
Restructuring costs   218         218              218    - 
Other (income) expense, net   259    12         (235)   573(3)    350    (91)
(Loss) Income Before Taxes   (1,685)   (1,088)   (333)   235    (573)   (1,759)   74 
Income Tax Provision (Benefit)   1,462    (196)(4)    (56)(4)    51(4)    (60)(4)    (261)   1,723 
Net Loss   (3,147)   (892)   (277)   184    (513)   (1,498)   (1,649)
Net Loss Attributable to Merck & Co., Inc.   (3,154)   (892)   (277)   184    (513)   (1,498)   (1,656)
Loss per Common Share Assuming Dilution(5)    $(1.24)   (0.35)   (0.11)   0.07    (0.20)   (0.59)  $(0.65)
                                    
Tax Rate   -86.8%                            2,328.4%

 

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, annual employee compensation, including senior management’s 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 expenses for the amortization of intangible assets.  Amounts included in other (income) expense, net, for the six-month period primarily 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.  
(5) Because the company recorded a net loss in the second quarter and first six months of 2023, no potential dilutive common shares were used in the computation of loss per common share assuming dilution as the effect would have been anti-dilutive.  

 

 

 

 

MERCK & CO., INC.

FRANCHISE / KEY PRODUCT SALES

SECOND QUARTER 2024

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3a

 

   Global   U.S.   International 
   2Q 2024   2Q 2023   % Change   2Q 2024   2Q 2023   % Change   2Q 2024   2Q 2023   % Change 
TOTAL SALES (1)   $16,112   $15,035    7   $7,876   $7,018    12   $8,236   $8,018    3 
PHARMACEUTICAL   14,408    13,457    7    7,399    6,570    13    7,009    6,887    2 
Oncology                                             
Keytruda   7,270    6,271    16    4,412    3,863    14    2,858    2,408    19 
Alliance Revenue – Lynparza (2)    317    310    2    153    144    6    165    166    -1 
Alliance Revenue – Lenvima (2)    249    242    3    177    163    8    73    79    -7 
Welireg   126    50    150    116    49    138    10    2    * 
Alliance Revenue – Reblozyl (3)    90    47    92    75    36    110    15    11    36 
Vaccines (4)                                             
Gardasil / Gardasil 9   2,478    2,458    1    536    464    16    1,941    1,994    -3 
ProQuad / M-M-R II/Varivax   617    582    6    490    447    10    127    135    -6 
Vaxneuvance   189    168    13    99    147    -33    90    20    * 
RotaTeq   163    131    25    107    93    15    56    37    50 
Pneumovax 23   59    92    -36    11    23    -54    48    69    -30 
Hospital Acute Care                                             
Bridion   455    502    -9    351    299    17    104    203    -49 
Prevymis   188    143    31    90    61    47    98    82    19 
Dificid   92    76    20    79    68    16    12    8    56 
Zerbaxa   62    54    14    33    30    12    28    24    17 
Noxafil   45    55    -20         11    N/M    44    45    -1 
Cardiovascular                                             
Alliance Revenue - Adempas/Verquvo (5)    106    68    56    98    70    41    8    -2    * 
Adempas (6)    72    65    11                   72    65    11 
Winrevair   70         -    70         -                
Virology                                             
Lagevrio   110    203    -46    15    2    *    95    201    -53 
Isentress/Isentress HD   89    136    -35    43    56    -24    46    80    -42 
Delstrigo   60    50    19    14    13    13    45    37    21 
Pifeltro   39    38    3    27    27    -1    12    11    15 
Neuroscience                                             
Belsomra   53    63    -16    19    21    -12    34    42    -18 
Immunology                                             
Simponi   172    180    -4                   172    180    -4 
Remicade   35    48    -27                   35    48    -27 
Diabetes (7)                                             
Januvia   405    511    -21    177    243    -27    227    267    -15 
Janumet   224    354    -37    17    82    -80    208    272    -24 
Other Pharmaceutical (8)   573    560    2    190    158    20    386    403    -4 
ANIMAL HEALTH   1,482    1,456    2    455    475    -4    1,027    982    5 
Livestock   837    807    4    168    165    2    669    643    4 
Companion Animal   645    649    -1    287    310    -7    358    339    6 
Other Revenues (9)   222    122    82    22    -27    -181    200    149    34 

 

*200% or greater
N/M - Not Meaningful
Sum of U.S. plus international may not equal global due to rounding.

 

(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.
(4) Total Vaccines sales were $3,656 million in the second quarter of 2024 and $3,557 million in the second quarter of 2023.
(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 $715 million in the second quarter of 2024, and $951 million in the second quarter of 2023.
(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 $15 million in the second quarter of 2024 and $3 million in the second quarter of 2023.

 

 

 

 

MERCK & CO., INC.

FRANCHISE / KEY PRODUCT SALES

JUNE YEAR-TO-DATE 2024

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3b

 

   Global   U.S.   International 
   June YTD
2024
   June YTD
2023
   % Change   June YTD
2024
   June YTD
2023
   % Change   June YTD
2024
   June YTD
2023
   % Change 
TOTAL SALES (1)   $31,887   $29,522    8   $15,354   $13,676    12   $16,533   $15,846    4 
PHARMACEUTICAL   28,415    26,179    9    14,336    12,688    13    14,079    13,491    4 
Oncology                                             
Keytruda   14,217    12,065    18    8,531    7,348    16    5,686    4,718    21 
Alliance Revenue – Lynparza (2)    609    585    4    288    286    1    321    299    7 
Alliance Revenue – Lenvima (2)    504    474    6    349    316    10    155    158    -2 
Welireg   211    92    128    194    90    116    17    3    * 
Alliance Revenue – Reblozyl (3)    161    90    80    133    66    102    28    24    17 
Vaccines (4)                                             
Gardasil/Gardasil 9   4,727    4,430    7    1,024    880    16    3,702    3,550    4 
ProQuad/M-M-R II/Varivax   1,187    1,109    7    928    868    7    259    242    7 
Vaxneuvance   408    274    49    260    241    8    148    33    * 
RotaTeq   379    428    -11    257    273    -6    123    155    -21 
Pneumovax 23   120    188    -36    17    63    -73    103    125    -17 
Hospital Acute Care                                             
Bridion   895    989    -9    680    576    18    215    413    -48 
Prevymis   362    273    33    165    116    42    197    157    26 
Dificid   165    141    16    147    130    13    17    11    54 
Zerbaxa   118    104    13    67    57    17    51    47    9 
Noxafil   101    116    -13    8    25    -67    92    91    2 
Cardiovascular                                             
Alliance Revenue - Adempas/Verquvo (5)    203    167    22    188    153    23    16    14    11 
Adempas (6)    142    125    14                   142    125    14 
Winrevair   70         -    70         -                
Virology                                             
Lagevrio   460    595    -23    60         -    400    595    -33 
Isentress/Isentress HD   200    259    -23    93    108    -14    107    151    -29 
Delstrigo   116    94    23    26    24    11    89    70    27 
Pifeltro   81    72    13    56    51    9    25    21    20 
Neuroscience                                             
Belsomra   99    119    -17    33    37    -10    66    82    -19 
Immunology                                             
Simponi   356    359    -1                   356    359    -1 
Remicade   74    99    -25                   74    99    -25 
Diabetes (7)                                             
Januvia   824    1,062    -22    361    514    -30    463    548    -15 
Janumet   475    683    -30    55    138    -60    420    544    -23 
Other Pharmaceutical (8)   1,151    1,187    -3    346    328    5    807    857    -6 
ANIMAL HEALTH   2,993    2,947    2    929    956    -3    2,064    1,991    4 
Livestock   1,686    1,656    2    334    338    -1    1,352    1,318    3 
Companion Animal   1,307    1,291    1    595    618    -4    712    673    6 
Other Revenues (9)   479    396    21    89    32    178    390    364    7 

 

*200% or greater
Sum of U.S. plus international may not equal global due to rounding.
 
(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.
(4) Total Vaccines sales were $7,080 million and $6,690 million on a global basis for June YTD 2024 and 2023, respectively.
(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 $1,461 million and $1,901 million on a global basis for June YTD 2024 and 2023, respectively.
(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 $76 million and $54 million on a global basis for June YTD 2024 and 2023, respectively.

 

 

 

 

MERCK & CO., INC.

PHARMACEUTICAL GEOGRAPHIC SALES

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 3c

                      

   2024   2023   % Change 
   1Q   2Q   June YTD   1Q   2Q   June YTD   3Q   4Q   Full Year   2Q   June YTD 
TOTAL PHARMACEUTICAL  $14,006   $14,408   $28,415   $12,721   $13,457   $26,179   $14,263   $13,141   $53,583    7    9 
                                                        
United States   6,936    7,399    14,336    6,117    6,570    12,688    7,153    6,698    26,539    13    13 
% Pharmaceutical Sales   49.5%   51.4%   50.5%   48.1%   48.8%   48.5%   50.1%   51.0%   49.5%          
Europe (1)   2,555    2,572    5,128    2,326    2,401    4,727    2,497    2,491    9,715    7    8 
% Pharmaceutical Sales   18.2%   17.9%   18.0%   18.3%   17.8%   18.1%   17.5%   19.0%   18.1%          
China   1,744    1,790    3,534    1,694    1,887    3,581    1,674    1,456    6,710    -5    -1 
% Pharmaceutical Sales   12.5%   12.4%   12.4%   13.3%   14.0%   13.7%   11.7%   11.1%   12.5%          
Japan   802    664    1,466    737    652    1,390    1,062    629    3,081    2    6 
% Pharmaceutical Sales   5.7%   4.6%   5.2%   5.8%   4.8%   5.3%   7.4%   4.8%   5.7%          
Latin America   601    661    1,262    470    566    1,036    696    596    2,328    17    22 
% Pharmaceutical Sales   4.3%   4.6%   4.4%   3.7%   4.2%   4.0%   4.9%   4.5%   4.3%          
Asia Pacific (other than China and Japan)   580    595    1,175    703    705    1,409    636    616    2,661    -16    -17 
% Pharmaceutical Sales   4.1%   4.1%   4.1%   5.5%   5.2%   5.4%   4.5%   4.7%   5.0%          
Eastern Europe/Middle East/Africa   395    353    747    381    370    751    301    299    1,351    -5    -1 
% Pharmaceutical Sales   2.8%   2.4%   2.6%   3.0%   2.7%   2.9%   2.1%   2.3%   2.5%          
Canada   138    143    281    141    127    268    133    138    540    12    5 
% Pharmaceutical Sales   1.0%   1.0%   1.0%   1.1%   0.9%   1.0%   0.9%   1.1%   1.0%          
Other   255    231    486    152    179    329    111    218    658    29    48 
% Pharmaceutical Sales   1.9%   1.6%   1.8%   1.2%   1.6%   1.1%   0.9%   1.5%   1.4%          

 

Sum of quarterly amounts may not equal year-to-date amounts due to rounding.             

 

(1) Europe represents all European Union countries, the European Union accession markets and the United Kingdom.      

 

 

 

 

MERCK & CO., INC.

OTHER (INCOME) EXPENSE, NET - GAAP

(AMOUNTS IN MILLIONS)

(UNAUDITED)

Table 4

 

OTHER (INCOME) EXPENSE, NET          

 

   2Q24   2Q23   June
 YTD 2024
   June 
YTD 2023
 
Interest income  $(69)  $(109)  $(141)  $(221)
Interest expense   310    277    613    519 
Exchange losses   60    62    144    122 
(Income) loss from investments in equity securities, net (1)    (56)   175    (200)   (274)
Net periodic defined benefit plan (credit) cost other than service cost   (159)   (111)   (319)   (226)
Other, net   (44)   (122)   (85)   339 
Total  $42   $172   $12   $259 

 

(1) Includes net realized and unrealized gains and losses from investments in equity securities either owned directly or through ownership interests in investment funds. Unrealized gains and losses from investments that are directly owned are determined at the end of the reporting period, while gains and losses from ownership interests in investment funds are accounted for on a one quarter lag.

 

 

 

v3.24.2
Cover
Jul. 30, 2024
Document Information [Line Items]  
Document Type 8-K
Amendment Flag false
Document Period End Date Jul. 30, 2024
Entity File Number 1-6571
Entity Registrant Name Merck & Co., Inc.
Entity Central Index Key 0000310158
Entity Tax Identification Number 22-1918501
Entity Incorporation, State or Country Code NJ
Entity Address, Address Line One 126 East Lincoln Avenue
Entity Address, City or Town Rahway
Entity Address, State or Province NJ
Entity Address, Postal Zip Code 07065
City Area Code 908
Local Phone Number 740-4000
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Common Stock  
Document Information [Line Items]  
Title of 12(b) Security Common Stock ($0.50 par value)
Trading Symbol MRK
Security Exchange Name NYSE
0.500% Notes due 2024  
Document Information [Line Items]  
Title of 12(b) Security 0.500% Notes due 2024
Trading Symbol MRK 24
Security Exchange Name NYSE
1.875% Notes due 2026  
Document Information [Line Items]  
Title of 12(b) Security 1.875% Notes due 2026
Trading Symbol MRK/26
Security Exchange Name NYSE
3.250% Notes due 2032  
Document Information [Line Items]  
Title of 12(b) Security 3.250% Notes due 2032
Trading Symbol MRK/32
Security Exchange Name NYSE
2.500% Notes due 2034  
Document Information [Line Items]  
Title of 12(b) Security 2.500% Notes due 2034
Trading Symbol MRK/34
Security Exchange Name NYSE
1.375% Notes due 2036  
Document Information [Line Items]  
Title of 12(b) Security 1.375% Notes due 2036
Trading Symbol MRK 36A
Security Exchange Name NYSE
3.500% Notes due 2037  
Document Information [Line Items]  
Title of 12(b) Security 3.500% Notes due 2037
Trading Symbol MRK/37
Security Exchange Name NYSE
3.700% Notes due 2044  
Document Information [Line Items]  
Title of 12(b) Security 3.700% Notes due 2044
Trading Symbol MRK/44
Security Exchange Name NYSE
3.750% Notes due 2054  
Document Information [Line Items]  
Title of 12(b) Security 3.750% Notes due 2054
Trading Symbol MRK/54
Security Exchange Name NYSE

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