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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

 

 

 

EX-99.1 2 tm2420272d1_ex99-1.htm EXHIBIT 99.1

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
o Following FDA Approval, CAPVAXIVE Unanimously Recommended by the CDC’s ACIP for Pneumococcal Vaccination for Certain Adults
o Announced 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
o Raises and Narrows Expected Worldwide Sales Range To Be Between $63.4 Billion and $64.4 Billion
o Now 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.

 

 

3 Reflects 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.

 

 

 

EX-99.2 3 tm2420272d1_ex99-2.htm EXHIBIT 99.2

 

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.