8-K
Merck & Co., Inc. (MRK)
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) April 25, 2024 (April 25,2024)
Merck & Co., Inc.
(Exact name of registrant as specified in its charter)
| New Jersey<br> <br>(State or other jurisdiction<br> <br>of incorporation) | 1-6571<br> <br>(Commission<br> <br>File Number) | 22-1918501<br> <br>(I.R.S. Employer<br> <br>Identification No.) |
|---|
| 126 East Lincoln Avenue, Rahway, NJ<br> <br>(Address of principal executive offices) | 07065<br> <br>(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<br> 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 |
| 2.500% Notes due 2034 | MRK/34 | New York Stock Exchange |
| 1.375% Notes due 2036 | MRK 36A | 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 April 25, 2024, regarding earnings for the first 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<br>release issued April 25, 2024, regarding earnings for the first quarter of 2024 |
|---|---|
| Exhibit 99.2 | Certain supplemental<br> information not included in the press release |
| Exhibit 104 | Cover Page Interactive Data File (embedded<br> 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: April 25, 2024 | By: | /s/<br> Kelly E. W. Grez |
| Kelly<br> E. W. Grez<br><br> <br>Corporate<br> Secretary |
Exhibit 99.1
| News Release |
|---|
Merck Announces First-Quarter 2024 FinancialResults
| - | Sales Reflect Continued Strong Growth in Oncology and Vaccines |
|---|---|
| - | Total Worldwide Sales Were $15.8 Billion, an Increase of 9% From First Quarter 2023; Excluding the Impact of Foreign Exchange, Growth<br>Was 12% |
| --- | --- |
| o | KEYTRUDA Sales Grew 20% to $6.9 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 24% |
| --- | --- |
| o | GARDASIL/GARDASIL 9 Sales Grew 14% to $2.2 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 17% |
| --- | --- |
| - | GAAP EPS Was $1.87; Non-GAAP EPS Was $2.07; GAAP and Non-GAAP EPS Include a Charge of $0.26 per Share for Acquisition of Harpoon |
| --- | --- |
| - | Received FDA Approval of WINREVAIR, a First-in-Class Treatment for Adults With Pulmonary Arterial Hypertension (WHO Group 1) |
| --- | --- |
| - | Made Meaningful Regulatory and Clinical Progress Across Other Therapeutic Areas, Including Oncology, Vaccines and Infectious Diseases |
| --- | --- |
| - | Expanded Pipeline and Portfolio Through Business Development, Including Completed Acquisition of Harpoon and Proposed Acquisition<br>of Elanco’s Aqua Business |
| --- | --- |
| - | Full-Year 2024 Financial Outlook |
| --- | --- |
| o | Raises and Narrows Expected Worldwide Sales Range To Be Between $63.1 Billion and $64.3 Billion |
| --- | --- |
| o | Raises and Narrows Expected Non-GAAP EPS Range To Be Between $8.53 and $8.65 |
| --- | --- |
RAHWAY, N.J., April 25, 2024 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2024.
“Merck has begun 2024 with continuing momentum in our business. We are harnessing the power of innovation to advance our deep pipeline and are maximizing the impact of our broad commercial portfolio for the benefit of patients,” said Robert M. Davis, chairman and chief executive officer, Merck. “We drove strong growth across key therapeutic areas, executed strategic business development, and in the U.S., we are now launching WINREVAIR, a significant new product in the cardiometabolic space for adults with pulmonary arterial hypertension, a progressive and debilitating disease. We have important opportunities ahead of us across all areas of our business, and we are highly focused on realizing them.”
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Financial Summary
| First Quarter | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| $ in millions, except<br> EPS amounts | 2024 | 2023 | Change | Change Ex- Exchange | ||||||
| Sales | $ | 15,775 | $ | 14,487 | 9 | % | 12 | % | ||
| GAAP<br>net income^1^ | 4,762 | 2,821 | 69 | % | 76 | % | ||||
| Non-GAAP net income that excludes certain items^1,2*^ | 5,279 | 3,564 | 48 | % | 54 | % | ||||
| GAAP EPS | 1.87 | 1.11 | 68 | % | 76 | % | ||||
| Non-GAAP EPS that excludes certain items^2*^ | 2.07 | 1.40 | 48 | % | 54 | % |
*Refer to table on page 6.
Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.87 for the first quarter of 2024. Non-GAAP EPS was $2.07 for the first quarter of 2024. GAAP and non-GAAP EPS in the first quarter of 2024 include a charge of $0.26 per share for the acquisition of Harpoon Therapeutics, Inc. (Harpoon). GAAP and non-GAAP EPS in the first quarter of 2023 include charges of $0.52 per share related to the acquisition of Imago BioSciences, Inc. (Imago) and a collaboration and licensing agreement with Kelun-Biotech.
Non-GAAP EPS 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 for the first quarter of 2023 also excludes a charge related to settlements with certain plaintiffs in the Zetia antitrust litigation.
^1^ Net income 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.
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First-Quarter Sales Performance
The following table reflects sales of the company’s top products and significant performance drivers.
| First Quarter | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| $ in millions | 2024 | 2023 | Change | Change<br><br> Ex-<br><br>Exchange | Commentary | ||||||
| Total Sales | $ | 15,775 | $ | 14,487 | 9 | % | 12 | % | Approximately 2% 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 | 14,006 | 12,721 | 10 | % | 13 | % | Increase driven by growth in oncology and vaccines, partially offset by a decline in diabetes. | ||||
| KEYTRUDA | 6,947 | 5,795 | 20 | % | 24 | % | Growth driven by increased global uptake in earlier-stage indications, including triple-negative breast cancer and renal cell carcinoma, as well as non-small cell lung cancer (NSCLC) in the U.S., and continued strong global demand from metastatic indications. Substantially all of the 4% negative impact of foreign exchange was due to devaluation of Argentine peso, which was largely offset by inflation-related price increases. | ||||
| GARDASIL/ GARDASIL 9 | 2,249 | 1,972 | 14 | % | 17 | % | Growth due to strong demand, particularly in China, which also benefited from timing of shipments, as well as public-sector buying patterns in the U.S., and higher pricing. | ||||
| JANUVIA/JANUMET | 670 | 880 | -24 | % | -21 | % | 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, Canada and the Asia Pacific region. | ||||
| PROQUAD, M-M-R II and VARIVAX | 570 | 528 | 8 | % | 8 | % | Growth largely from higher pricing in the U.S., as well as higher sales in Latin America, due in part to timing of government tenders. | ||||
| BRIDION | 440 | 487 | -10 | % | -8 | % | Decline primarily due to generic competition in certain ex-U.S. markets, particularly in Europe, partially offset by higher demand in the U.S. | ||||
| LAGEVRIO | 350 | 392 | -11 | % | -5 | % | Decline due to lower demand in certain markets in the Asia Pacific region, partially offset by higher demand in Japan and the U.S. | ||||
| Lynparza* | 292 | 275 | 6 | % | 7 | % | Growth driven primarily by higher demand in certain international markets, particularly in Latin America. | ||||
| Lenvima* | 255 | 232 | 10 | % | 10 | % | Growth primarily from higher demand in the U.S. | ||||
| VAXNEUVANCE | 219 | 106 | 106 | % | 106 | % | Growth largely driven by continued uptake for pediatric indication in the U.S. and launches in Europe. Sales growth in the U.S. also benefited from public-sector buying patterns. | ||||
| ROTATEQ | 216 | 297 | -27 | % | -27 | % | Decline primarily due to timing of shipments in China and public-sector buying patterns in the U.S. |
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| Animal Health | 1,511 | 1,491 | 1 | % | 4 | % | Growth primarily driven by higher pricing in both Livestock and Companion Animal product portfolios, partially offset by lower volumes. Approximately 2% of the negative impact of foreign exchange was due to devaluation of Argentine peso, which was largely offset by inflation-related price increases. |
|---|---|---|---|---|---|---|---|
| Livestock | 850 | 849 | 0 | % | 4 | % | Sales were flat reflecting higher pricing across product portfolio, as well as higher demand for swine and poultry products, partially offset by lower demand for ruminant products. |
| Companion Animal | 661 | 642 | 3 | % | 4 | % | Growth due to higher pricing across product portfolio. Sales of BRAVECTO were $332 million and $314 million in current and prior-year quarters, respectively, which represented growth of 6%, or 7% excluding impact of foreign exchange. |
| Other Revenues** | 258 | 275 | -6 | % | 11 | % | Decline due to 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.
First-Quarter Expense, EPS and Related Information
The table below presents selected expense information.
| $ in millions | GAAP | Acquisition- and Divestiture- Related Costs^3^ | Restructuring<br> Costs | (Income)<br> Loss From<br> Investments<br> in Equity<br> Securities | <br><br><br><br>Certain Other Items | Non- GAAP^2^ | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Quarter 2024 | ||||||||||||||||
| Cost of sales | $ | 3,540 | $ | 463 | $ | 116 | $ | - | $ | - | $ | 2,961 | ||||
| Selling, general and administrative | 2,483 | 21 | 5 | - | - | 2,457 | ||||||||||
| Research and development | 3,992 | 16 | 2 | - | - | 3,974 | ||||||||||
| Restructuring costs | 123 | - | 123 | - | - | - | ||||||||||
| Other (income) expense, net | (33 | ) | (4 | ) | - | (116 | ) | - | 87 | |||||||
| First Quarter 2023 | ||||||||||||||||
| Cost of sales | $ | 3,926 | $ | 545 | $ | 29 | $ | - | $ | - | $ | 3,352 | ||||
| Selling, general and administrative | 2,479 | 20 | 1 | - | - | 2,458 | ||||||||||
| Research and development | 4,276 | 10 | - | - | - | 4,266 | ||||||||||
| Restructuring costs | 67 | - | 67 | - | - | - | ||||||||||
| Other (income) expense, net | 89 | 15 | - | (429 | ) | 573 | (70 | ) |
^3^ Includes expenses for the amortization of intangible assets recognized as a result of acquisitions of businesses, 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.
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GAAP Expense, EPS and Related Information
Gross margin was 77.6% for the first quarter of 2024 compared with 72.9% for the first quarter of 2023. The increase was primarily due to the favorable impacts of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9), foreign exchange and lower amortization of intangible assets, partially offset by higher restructuring costs and inventory write-offs.
Selling, general and administrative (SG&A) expenses were $2.5 billion in both the first quarters of 2024 and 2023, primarily due to higher administrative costs, offset by lower promotional costs, reflecting the prioritization of spending on key growth products, and the favorable impact of foreign exchange.
Research and development (R&D) expenses were $4.0 billion in the first quarter of 2024 compared with $4.3 billion in the first quarter of 2023. The decrease was primarily due to lower charges for business development activity, which included a $656 million charge for the acquisition of Harpoon in the first quarter of 2024, compared with charges of $1.2 billion for the acquisition of Imago and $175 million for a license and collaboration agreement with Kelun-Biotech in the first quarter of 2023. The decline was partially offset by increased compensation and benefit costs, higher clinical development spending, as well as higher investments in discovery research and early drug development in the first quarter of 2024.
Other (income) expense, net, was $33 million of income in the first quarter of 2024 compared with $89 million of expense in the first quarter of 2023. The favorability primarily reflects a $572.5 million charge in 2023 related to settlements with certain plaintiffs in the Zetia antitrust litigation, largely offset by lower income from investments in equity securities and higher net interest expense in 2024.
The effective tax rate was 15.9% for the first quarter of 2024 (which includes a 1.6 percentage point unfavorable impact for the acquisition of Harpoon), compared with 22.6% in the first quarter of 2023 (which includes a 5.5 percentage point unfavorable impact for the acquisition of Imago).
GAAP EPS was $1.87 for the first quarter of 2024 compared with $1.11 for the first quarter of 2023.
Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was 81.2% for the first quarter of 2024 compared with 76.9% for the first quarter of 2023. The increase was primarily due to the favorable impacts of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9) and foreign exchange, partially offset by higher inventory write-offs.
Non-GAAP SG&A expenses were $2.5 billion for both the first quarters of 2024 and 2023, primarily due to higher administrative costs, offset by lower promotional costs, reflecting the prioritization of spending on key growth products, and the favorable impact of foreign exchange.
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Non-GAAP R&D expenses were $4.0 billion in the first quarter of 2024 compared with $4.3 billion in the first quarter of 2023. The decrease was primarily due to lower charges for business development activity, which included a $656 million charge for the acquisition of Harpoon in the first quarter of 2024, compared with charges of $1.2 billion for the acquisition of Imago and $175 million for a license and collaboration agreement with Kelun-Biotech in the first quarter of 2023. The decline was partially offset by increased compensation and benefit costs, higher clinical development spending, as well as higher investments in discovery research and early drug development in the first quarter of 2024.
Non-GAAP other (income) expense, net, was $87 million of expense in the first quarter of 2024 compared with $70 million of income in the first quarter of 2023, primarily due to higher net interest expense.
The non-GAAP effective tax rate was 16.1% for the first quarter of 2024 (which includes a 1.5 percentage point unfavorable impact for the acquisition of Harpoon), compared with 20.4% in the first quarter of 2023 (which includes a 4.3 percentage point unfavorable impact for the acquisition of Imago).
Non-GAAP EPS was $2.07 for the first quarter of 2024 compared with $1.40 for the first quarter of 2023.
A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.
| First Quarter | |||||
|---|---|---|---|---|---|
| in millions, except EPS amounts | 2024 | 2023 | |||
| EPS | |||||
| GAAP EPS | 1.87 | $ | 1.11 | ||
| Difference | 0.20 | 0.29 | |||
| Non-GAAP EPS that excludes items listed below2 | 2.07 | $ | 1.40 | ||
| Net Income | |||||
| GAAP net income1 | 4,762 | $ | 2,821 | ||
| Difference | 517 | 743 | |||
| Non-GAAP net income that excludes items listed below1,2 | 5,279 | $ | 3,564 | ||
| Excluded Items: | |||||
| Acquisition- and divestiture-related costs3 | 496 | $ | 590 | ||
| Restructuring costs | 246 | 97 | |||
| Income from investments in equity securities | (116 | ) | (429 | ) | |
| Charge for Zetia antitrust litigation settlements | - | 573 | |||
| Net decrease in income before taxes | 626 | 831 | |||
| Estimated income tax (benefit) expense | (109 | ) | (88 | ) | |
| Decrease in net income | 517 | $ | 743 |
All values are in US Dollars.
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Pipeline and Portfolio Highlights
Merck continued to achieve key regulatory and clinical milestones across therapeutic areas in the first quarter.
In cardiometabolic disease, Merck received approval from the U.S. Food and Drug Administration (FDA) for WINREVAIR (sotatercept-csrk) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events. WINREVAIR is a breakthrough biologic and the first FDA-approved activin signaling inhibitor therapy for PAH, a rare, progressive disease. WINREVAIR is currently under review in the European Union and is being evaluated in ongoing Phase 3 trials in additional PAH patient populations.
In oncology, KEYTRUDA continued to demonstrate its role as a foundational therapy for certain types of cancers, receiving the first approval in Europe for an anti-PD-1/L1 therapy as part of a treatment regimen for adult patients with resectable NSCLC at high risk of recurrence. In addition, the FDA granted Priority Review to a new supplemental Biologics License Application (sBLA) that would establish KEYTRUDA as the first immunotherapy indicated for the frontline treatment of advanced endometrial cancer regardless of DNA mismatch repair status. Merck also made meaningful progress in its clinical development programs, including initiating a Phase 3 trial for MK-1084, its investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic NSCLC. And, in collaboration with Daiichi Sankyo, the company initiated the REJOICE-OVARIAN01 Phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer.
In vaccines, Merck shared positive data from multiple Phase 3 studies evaluating V116, the company’s investigational, 21-valent pneumococcal conjugate vaccine designed for adults. If approved, V116 would be the first pneumococcal conjugate vaccine designed to address the serotypes responsible for approximately 83% of invasive pneumococcal disease in adults 65 and older. Merck also announced plans to initiate clinical development of a new investigational, multi-valent HPV vaccine designed to provide broader protection against certain cancers and diseases caused by additional HPV types, as well as plans to conduct clinical trials in both females and males (16-26 years old) to evaluate the efficacy and safety of a single-dose regimen of GARDASIL 9.
In infectious diseases, Merck presented new data from its HIV development programs at the 31^st^ Conference on Retroviruses and Opportunistic Infections in March, demonstrating significant momentum within the HIV pipeline. These data included the Phase 2 study evaluating a once-weekly oral combination regimen of islatravir, the company’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), and Gilead Sciences, Inc.’s lenacapavir, a first-in-class capsid inhibitor, for the treatment of adults living with HIV. And, for the first time, Merck presented data for MK-8527, the company's novel NRTTI that is being developed as an oral once-monthly agent for HIV-1 pre-exposure prophylaxis (PrEP), which recently entered Phase 2 development.
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Merck has the following three Prescription Drug User Fee Act (PDUFA), or target action, dates set by the FDA in the second quarter of 2024: V116 (June 17), KEYTRUDA plus chemotherapy as treatment for primary advanced or recurrent endometrial carcinoma (June 21) and, in collaboration with Daiichi Sankyo, patritumab deruxtecan (HER3-DXd) for the treatment of certain patients with previously treated locally advanced or metastatic EGFR-mutated NSCLC (June 26).
Merck continued to expand and complement its pipeline and product portfolio through business development. Merck completed the acquisition of Harpoon, expanding its oncology pipeline with novel T-cell engagers, including MK-6070, an investigational delta-like ligand 3 targeting T-cell engager. The company also entered into a definitive agreement to acquire the aqua business of Elanco Animal Health Incorporated (Elanco), which will broaden its aqua portfolio with new products.
Notable recent news releases on Merck’s pipeline and portfolio are provided in the table that follows.
| Cardiometabolic | FDA Approved Merck’s WINREVAIR, a First-in-Class Treatment for Adults With PAH, Based on Results From Phase 3 STELLAR Trial | (Read Announcement) |
|---|---|---|
| Oncology | European Commission Approved Merck’s KEYTRUDA Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for Resectable NSCLC at High Risk of Recurrence in Adults, Based on Results From Phase 3 KEYNOTE-671 Trial | (Read Announcement) |
| FDA Granted Priority Review to Merck’s Application for KEYTRUDA Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma, Based on Results From Phase 3 NRG-GY018 Trial | (Read Announcement) | |
| KEYTRUDA Plus Chemoradiotherapy (CRT) Significantly Improved Overall Survival Versus CRT Alone in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer, Based on Results From Phase 3 KEYNOTE-A18 Trial | (Read Announcement) | |
| Merck and Daiichi Sankyo Initiated REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan in Patients With Platinum-Resistant Ovarian Cancer | (Read Announcement) | |
| Merck Initiated Phase 3 Clinical Trial of MK-1084, an Investigational Oral KRAS G12C Inhibitor, in Combination With KEYTRUDA for First-Line Treatment of Certain Patients With Metastatic NSCLC | (Read Announcement) | |
| Vaccines | Merck Announced Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults, Based on Results From Multiple Phase 3 Trials | (Read Announcement) |
| Merck Announced Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent HPV and Single-Dose Regimen for GARDASIL 9 | (Read Announcement) | |
| Infectious Diseases | Merck and Gilead Announced Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24 | (Read Announcement) |
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Upcoming Investor Event
Merck will host an Oncology Investor Event to coincide with the American Society for Clinical Oncology Annual Meeting on Monday, June 3, 2024, 6 p.m. CT, at which senior management will provide an update on the company’s oncology strategy and program. The event will take place in Chicago, Ill., and will be accessible via live audio webcast at this weblink.
Full-Year 2024 Financial Outlook
The following table summarizes the company’s full-year financial outlook.
| Full Year 2024 | ||
|---|---|---|
| Updated | Prior | |
| Sales^*^ | $63.1 to $64.3 billion | $62.7 to $64.2 billion |
| Non-GAAP Gross margin^2^ | Approximately 81% | Approximately 80.5% |
| Non-GAAP Operating expenses^2**^ | $25.2 to $26.1 billion | $25.1 to $26.1 billion |
| Non-GAAP Other (income) expense, net^2^ | Approximately $250 million expense | Approximately $200 million expense |
| Non-GAAP Effective tax rate^2^ | 14.5% to 15.5% | 14.5% to 15.5% |
| Non-GAAP EPS^2***^ | $8.53 to $8.65 | $8.44 to $8.59 |
| Share count (assuming dilution) | Approximately 2.55 billion | Approximately 2.54 billion |
*The company does not have any non-GAAP adjustments to sales.
**Includes a one-time R&D charge of $656 million related to the Harpoon acquisition. Outlook does not assume any additional significant potential business development transactions.
***Includes a one-time charge of $0.26 per share related to the Harpoon acquisition.
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 in oncology and vaccines. Consequently, Merck is raising and narrowing its full-year outlook ranges for sales and non-GAAP EPS.
Merck now expects its full-year 2024 sales to be between $63.1 billion and $64.3 billion, including a negative impact of foreign exchange of approximately 3% at mid-April 2024 exchange rates. Approximately 2% 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 continues to expect its full-year non-GAAP effective income tax rate to be between 14.5% and 15.5%.
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Merck now expects its full-year non-GAAP EPS to be between $8.53 and $8.65, including a charge of $0.26 per share for the acquisition of Harpoon that closed in the first quarter of 2024 and a negative impact of foreign exchange of approximately $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.
Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions.
Full-year 2023 non-GAAP EPS of $1.51 was negatively impacted by charges of $6.21 per share related to certain acquisitions and collaboration agreements.
Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, income and losses from investments in equity securities, and a previously disclosed charge related to settlements with certain plaintiffs in the Zetia antitrust litigation.
Earnings Conference Call
Investors, journalists and the general public may access a live audio webcast of the earnings conference call on Thursday, April 25, 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 (888) 847-9708 (U.S. and Canada Toll-Free) or (630) 395-0358 and using the access code 4164932.
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.
- 11 -
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)
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)
PROQUAD (Measles, Mumps, Rubella and Varicella Virus VaccineLive)
ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent)
VARIVAX (Varicella Virus Vaccine Live)
VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)
WINREVAIR*(sotatercept-csrk)*
- 12 -
Animal Health
BRAVECTO (fluralaner)
| Media Contacts: | Investor Contacts: |
|---|---|
| Robert Josephson<br><br> <br>(203) 914-2372<br><br> <br>robert.josephson@merck.com<br><br> <br><br><br> <br>Michael Levey<br><br> <br>(215) 872-1462<br><br> <br>michael.levey@merck.com | Peter Dannenbaum<br><br> <br>(732) 594-1579<br><br> <br>peter.dannenbaum@merck.com<br><br> <br><br><br> <br>Steven Graziano<br><br> <br>(732) 594-1583<br><br> <br>steven.graziano@merck.com |
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF INCOME - GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1
| GAAP | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 1Q24 | 1Q23 | % Change | |||||||
| Sales | $ | 15,775 | $ | 14,487 | 9 | % | |||
| Costs, Expenses and Other | |||||||||
| Cost of sales | 3,540 | 3,926 | -10 | % | |||||
| Selling, general and administrative | 2,483 | 2,479 | 0 | % | |||||
| Research and development | 3,992 | 4,276 | -7 | % | |||||
| Restructuring costs | 123 | 67 | 84 | % | |||||
| Other (income) expense, net | (33 | ) | 89 | * | |||||
| Income Before Taxes | 5,670 | 3,650 | 55 | % | |||||
| Income Tax Provision | 903 | 825 | |||||||
| Net Income | 4,767 | 2,825 | 69 | % | |||||
| Less: Net Income Attributable to Noncontrolling Interests | 5 | 4 | |||||||
| Net Income Attributable to Merck & Co., Inc. | $ | 4,762 | $ | 2,821 | 69 | % | |||
| Earnings per Common Share Assuming Dilution | $ | 1.87 | $ | 1.11 | 68 | % | |||
| Average Shares Outstanding Assuming Dilution | 2,544 | 2,551 | |||||||
| Tax Rate | 15.9 | % | 22.6 | % |
* 100% or greater
MERCK & CO.,INC.
FIRST QUARTER2024 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 | **** | Adjustment Subtotal | **** | Non-GAAP | **** | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Quarter | **** | **** | **** | **** | **** | **** | **** | **** | **** | **** | **** | **** | **** | **** | **** | **** | **** | **** |
| Cost of sales | $ | 3,540 | **** | 463 | 116 | 579 | $ | 2,961 | ||||||||||
| Selling, general and administrative | **** | 2,483 | **** | 21 | 5 | 26 | 2,457 | |||||||||||
| Research and development | **** | 3,992 | **** | 16 | 2 | 18 | 3,974 | |||||||||||
| Restructuring costs | **** | 123 | **** | 123 | 123 | – | ||||||||||||
| Other (income) expense, net | **** | (33 | ) | (4 | ) | (116 | ) | (120 | ) | 87 | ||||||||
| Income Before Taxes | **** | 5,670 | **** | (496 | ) | (246 | ) | 116 | (626 | ) | 6,296 | |||||||
| Income Tax Provision (Benefit) | **** | 903 | **** | (92 | )^(3)^ | (42 | )^(3)^ | 25 | ^(3)^ | (109 | ) | 1,012 | ||||||
| Net Income | **** | 4,767 | **** | (404 | ) | (204 | ) | 91 | (517 | ) | 5,284 | |||||||
| Net Income Attributable to Merck &<br> Co., Inc. | **** | 4,762 | **** | (404 | ) | (204 | ) | 91 | (517 | ) | 5,279 | |||||||
| Earnings per Common<br> Share Assuming Dilution | $ | 1.87 | **** | (0.16 | ) | (0.08 | ) | 0.04 | (0.20 | ) | $ | 2.07 | ||||||
| Tax Rate | **** | 15.9 | % | 16.1 | % |
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.
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3
| **** | **** | 2024 | **** | 2023 | **** | 1Q | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| **** | **** | 1Q | **** | 1Q | **** | 2Q | **** | 3Q | **** | 4Q | **** | Full Year | Nom % | Ex-Exch % |
| TOTAL SALES ^(1)^ | $ | 15,775 | $ | 14,487 | $ | 15,035 | $ | 15,962 | $ | 14,630 | $ | 60,115 | 9 | 12 |
| PHARMACEUTICAL | **** | 14,006 | **** | 12,721 | **** | 13,457 | **** | 14,263 | **** | 13,141 | **** | 53,583 | 10 | 13 |
| Oncology | ||||||||||||||
| Keytruda | 6,947 | 5,795 | 6,271 | 6,338 | 6,608 | 25,011 | 20 | 24 | ||||||
| Alliance<br> Revenue – Lynparza ^(2)^ | 292 | 275 | 310 | 299 | 315 | 1,199 | 6 | 7 | ||||||
| Alliance<br> Revenue – Lenvima ^(2)^ | 255 | 232 | 242 | 260 | 226 | 960 | 10 | 10 | ||||||
| Welireg | 85 | 42 | 50 | 54 | 72 | 218 | 102 | 102 | ||||||
| Alliance<br> Revenue – Reblozyl ^(3)^ | 71 | 43 | 47 | 52 | 70 | 212 | 66 | 66 | ||||||
| Vaccines ^(4)^ | ||||||||||||||
| Gardasil/Gardasil 9 | 2,249 | 1,972 | 2,458 | 2,585 | 1,871 | 8,886 | 14 | 17 | ||||||
| ProQuad/M-M-R<br> II/Varivax | 570 | 528 | 582 | 713 | 545 | 2,368 | 8 | 8 | ||||||
| Vaxneuvance | 219 | 106 | 168 | 214 | 176 | 665 | 106 | 106 | ||||||
| RotaTeq | 216 | 297 | 131 | 156 | 185 | 769 | -27 | -27 | ||||||
| Pneumovax 23 | 61 | 96 | 92 | 140 | 85 | 412 | -36 | -33 | ||||||
| Hospital Acute Care | ||||||||||||||
| Bridion | 440 | 487 | 502 | 424 | 429 | 1,842 | -10 | -8 | ||||||
| Prevymis | 174 | 129 | 143 | 157 | 175 | 605 | 35 | 39 | ||||||
| Dificid | 73 | 65 | 76 | 74 | 87 | 302 | 12 | 12 | ||||||
| Zerbaxa | 56 | 50 | 54 | 53 | 61 | 218 | 13 | 15 | ||||||
| Noxafil | 56 | 60 | 55 | 51 | 46 | 213 | -7 | 4 | ||||||
| Cardiovascular | ||||||||||||||
| Alliance<br> Revenue - Adempas/Verquvo ^(5)^ | 98 | 99 | 68 | 92 | 108 | 367 | -1 | -1 | ||||||
| Adempas<br> ^(6)^ | 70 | 59 | 65 | 65 | 66 | 255 | 18 | 18 | ||||||
| Virology | ||||||||||||||
| Lagevrio | 350 | 392 | 203 | 640 | 193 | 1,428 | -11 | -5 | ||||||
| Isentress/Isentress<br> HD | 111 | 123 | 136 | 119 | 105 | 483 | -10 | -7 | ||||||
| Delstrigo | 56 | 44 | 50 | 54 | 54 | 201 | 28 | 30 | ||||||
| Pifeltro | 42 | 34 | 38 | 37 | 33 | 142 | 23 | 23 | ||||||
| Neuroscience | ||||||||||||||
| Belsomra | 46 | 56 | 63 | 58 | 54 | 231 | -17 | -11 | ||||||
| Immunology | ||||||||||||||
| Simponi | 184 | 180 | 180 | 179 | 171 | 710 | 2 | 1 | ||||||
| Remicade | 39 | 51 | 48 | 45 | 43 | 187 | -24 | -21 | ||||||
| Diabetes ^(7)^ | ||||||||||||||
| Januvia | 419 | 551 | 511 | 581 | 547 | 2,189 | -24 | -21 | ||||||
| Janumet | 251 | 329 | 354 | 255 | 240 | 1,177 | -24 | -20 | ||||||
| Other Pharmaceutical ^(8)^ | 576 | 626 | 560 | 568 | 576 | 2,333 | -8 | -6 | ||||||
| ANIMAL HEALTH | **** | 1,511 | **** | 1,491 | **** | 1,456 | **** | 1,400 | **** | 1,278 | **** | 5,625 | 1 | 4 |
| Livestock | 850 | 849 | 807 | 874 | 808 | 3,337 | - | 4 | ||||||
| Companion<br> Animal | 661 | 642 | 649 | 526 | 470 | 2,288 | 3 | 4 | ||||||
| Other Revenues ^(9)^ | **** | 258 | **** | 275 | **** | 122 | **** | 299 | **** | 211 | **** | 907 | -6 | 11 |
*200% or greater
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 in the first quarter of 2024 and $3,133 million in the first quarter 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 $745 million in the first quarter of 2024 and $950 million in the first 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 $61 million in the first quarter of 2024 and $51 million in the first quarter of 2023.
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 | **** | 1Q | **** | 2Q | **** | 3Q | **** | 4Q | **** | Full Year | **** | 1Q | **** | |||||||
| Sales | $ | 15,775 | $ | 14,487 | $ | 15,035 | $ | 15,962 | $ | 14,630 | $ | 60,115 | 9 | % | |||||||
| Costs, Expenses<br> and Other | |||||||||||||||||||||
| Cost of sales | 3,540 | 3,926 | 4,024 | 4,264 | 3,911 | 16,126 | -10 | % | |||||||||||||
| Selling, general and administrative | 2,483 | 2,479 | 2,702 | 2,519 | 2,804 | 10,504 | 0 | % | |||||||||||||
| Research and development | 3,992 | 4,276 | 13,321 | 3,307 | 9,628 | 30,531 | -7 | % | |||||||||||||
| Restructuring costs | 123 | 67 | 151 | 126 | 255 | 599 | 84 | % | |||||||||||||
| Other (income) expense, net | (33 | ) | 89 | 172 | 126 | 78 | 466 | * | |||||||||||||
| Income (Loss) Before Taxes | 5,670 | 3,650 | (5,335 | ) | 5,620 | (2,046 | ) | 1,889 | 55 | % | |||||||||||
| Income Tax Provision (Benefit) | 903 | 825 | 637 | 870 | (821 | ) | 1,512 | ||||||||||||||
| Net Income (Loss) | 4,767 | 2,825 | (5,972 | ) | 4,750 | (1,225 | ) | 377 | 69 | % | |||||||||||
| Less: Net Income Attributable<br> to Noncontrolling Interests | 5 | 4 | 3 | 5 | 1 | 12 | |||||||||||||||
| Net Income (Loss) Attributable<br> to Merck & Co., Inc. | $ | 4,762 | $ | 2,821 | $ | (5,975 | ) | $ | 4,745 | $ | (1,226 | ) | $ | 365 | 69 | % | |||||
| Earnings<br> (Loss) per Common Share Assuming Dilution ^(1)^ | $ | 1.87 | $ | 1.11 | $ | (2.35 | ) | $ | 1.86 | $ | (0.48 | ) | $ | 0.14 | 68 | % | |||||
| Average<br> Shares Outstanding Assuming Dilution ^(1)^ | 2,544 | 2,551 | 2,539 | 2,546 | 2,533 | 2,547 | |||||||||||||||
| Tax Rate | 15.9 | % | 22.6 | % | -11.9 | % | 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 and fourth quarters 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.
FIRST QUARTER 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)<br><br> Loss from<br><br> Investments<br><br> in Equity<br><br> Securities | Certain<br><br> Other<br><br> Items | Adjustment<br><br> Subtotal | Non-GAAP | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Quarter | ||||||||||||||||
| Cost of sales | $ | 3,926 | 545 | 29 | 574 | $ | 3,352 | |||||||||
| Selling, general and administrative | 2,479 | 20 | 1 | 21 | 2,458 | |||||||||||
| Research and development | 4,276 | 10 | 10 | 4,266 | ||||||||||||
| Restructuring costs | 67 | 67 | 67 | - | ||||||||||||
| Other (income) expense, net | 89 | 15 | (429 | ) | 573 | ^(3)^ | 159 | (70 | ) | |||||||
| Income Before Taxes | 3,650 | (590 | ) | (97 | ) | 429 | (573 | ) | (831 | ) | 4,481 | |||||
| Income Tax Provision (Benefit) | 825 | (105 | )^(4)^ | (18 | )^(4)^ | 95 | ^(4)^ | (60 | )^(4)^ | (88 | ) | 913 | ||||
| Net Income | 2,825 | (485 | ) | (79 | ) | 334 | (513 | ) | (743 | ) | 3,568 | |||||
| Net Income Attributable to Merck &<br> Co., Inc. | 2,821 | (485 | ) | (79 | ) | 334 | (513 | ) | (743 | ) | 3,564 | |||||
| Earnings<br> per Common Share Assuming Dilution | $ | 1.11 | (0.19 | ) | (0.03 | ) | 0.13 | (0.20 | ) | (0.29 | ) | $ | 1.40 | |||
| Tax Rate | 22.6 | % | 20.4 | % |
Only the line items that are affected by non-GAAP adjustments are shown.
Merck is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing non-GAAP information enhances investors’ understanding of the company’s results because management uses non-GAAP measures to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, 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, reflect a $37 million loss on the sale of a business and an increase in the estimated fair value measurement of liabilities for contingent consideration related to the prior termination of the Sanofi-Pasteur MSD joint venture, partially offset by royalty income.
^(2)^Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to activities under the company's formal restructuring programs.
^(3)^ Reflects a charge related to settlements with certain plaintiffs in the Zetia antitrust litigation.
^(4)^ Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
FIRST QUARTER 2024
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3a
| Global | U.S. | International | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1Q 2024 | 1Q 2023 | % Change | 1Q 2024 | 1Q 2023 | % Change | 1Q 2024 | 1Q 2023 | % Change | ||||||||||
| TOTAL SALES ^(1)^ | $ | 15,775 | $ | 14,487 | 9 | $ | 7,478 | $ | 6,659 | 12 | $ | 8,297 | $ | 7,828 | 6 | |||
| PHARMACEUTICAL | 14,006 | 12,721 | 10 | 6,936 | 6,117 | 13 | 7,070 | 6,604 | 7 | |||||||||
| Oncology | ||||||||||||||||||
| Keytruda | 6,947 | 5,795 | 20 | 4,119 | 3,485 | 18 | 2,828 | 2,310 | 22 | |||||||||
| Alliance Revenue – Lynparza ^(2)^ | 292 | 275 | 6 | 135 | 142 | -4 | 157 | 133 | 18 | |||||||||
| Alliance Revenue – Lenvima ^(2)^ | 255 | 232 | 10 | 173 | 153 | 13 | 82 | 79 | 3 | |||||||||
| Welireg | 85 | 42 | 102 | 77 | 41 | 89 | 7 | 1 | * | |||||||||
| Alliance Revenue – Reblozyl ^(3)^ | 71 | 43 | 66 | 58 | 30 | 93 | 12 | 12 | - | |||||||||
| Vaccines ^(4)^ | ||||||||||||||||||
| Gardasil/Gardasil 9 | 2,249 | 1,972 | 14 | 488 | 416 | 17 | 1,761 | 1,556 | 13 | |||||||||
| ProQuad/M-M-R II/Varivax | 570 | 528 | 8 | 438 | 421 | 4 | 133 | 107 | 24 | |||||||||
| Vaxneuvance | 219 | 106 | 106 | 161 | 94 | 72 | 58 | 13 | * | |||||||||
| RotaTeq | 216 | 297 | -27 | 149 | 180 | -17 | 67 | 117 | -43 | |||||||||
| Pneumovax 23 | 61 | 96 | -36 | 6 | 40 | -85 | 55 | 56 | -1 | |||||||||
| Hospital Acute Care | ||||||||||||||||||
| Bridion | 440 | 487 | -10 | 329 | 276 | 19 | 111 | 210 | -47 | |||||||||
| Prevymis | 174 | 129 | 35 | 74 | 54 | 37 | 100 | 75 | 33 | |||||||||
| Dificid | 73 | 65 | 12 | 68 | 62 | 10 | 5 | 3 | 49 | |||||||||
| Zerbaxa | 56 | 50 | 13 | 33 | 27 | 23 | 23 | 23 | 1 | |||||||||
| Noxafil | 56 | 60 | -7 | 8 | 14 | -43 | 48 | 46 | 4 | |||||||||
| Cardiovascular | ||||||||||||||||||
| Alliance Revenue - Adempas/Verquvo ^(5)^ | 98 | 99 | -1 | 90 | 83 | 8 | 8 | 16 | -51 | |||||||||
| Adempas ^(6)^ | 70 | 59 | 18 | 70 | 59 | 18 | ||||||||||||
| Virology | ||||||||||||||||||
| Lagevrio | 350 | 392 | -11 | 45 | -2 | * | 305 | 394 | -23 | |||||||||
| Isentress/Isentress HD | 111 | 123 | -10 | 50 | 52 | -3 | 61 | 71 | -14 | |||||||||
| Delstrigo | 56 | 44 | 28 | 12 | 11 | 9 | 44 | 33 | 34 | |||||||||
| Pifeltro | 42 | 34 | 23 | 29 | 24 | 22 | 13 | 10 | 25 | |||||||||
| Neuroscience | ||||||||||||||||||
| Belsomra | 46 | 56 | -17 | 15 | 16 | -9 | 32 | 40 | -21 | |||||||||
| Immunology | ||||||||||||||||||
| Simponi | 184 | 180 | 2 | 184 | 180 | 2 | ||||||||||||
| Remicade | 39 | 51 | -24 | 39 | 51 | -24 | ||||||||||||
| Diabetes ^(7)^ | ||||||||||||||||||
| Januvia | 419 | 551 | -24 | 183 | 271 | -32 | 236 | 280 | -16 | |||||||||
| Janumet | 251 | 329 | -24 | 39 | 56 | -32 | 212 | 272 | -22 | |||||||||
| Other Pharmaceutical ^(8)^ | 576 | 626 | -8 | 157 | 171 | -8 | 419 | 457 | -8 | |||||||||
| ANIMAL HEALTH | 1,511 | 1,491 | 1 | 474 | 482 | -2 | 1,037 | 1,010 | 3 | |||||||||
| Livestock | 850 | 849 | - | 166 | 174 | -5 | 683 | 676 | 1 | |||||||||
| Companion Animal | 661 | 642 | 3 | 308 | 308 | - | 354 | 334 | 6 | |||||||||
| Other Revenues ^(9)^ | 258 | 275 | -6 | 68 | 60 | 13 | 190 | 214 | -11 |
*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 $3,424 million in the first quarter of 2024 and $3,133 million in the first quarter 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 $745 million in the first quarter of 2024 and $950 million in the first 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 $61 million in the first quarter of 2024 and $51 million in the first quarter of 2023.
MERCK & CO., INC.
PHARMACEUTICAL GEOGRAPHIC SALES
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3b
| 2024 | 2023 | % Change | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1Q | 1Q | 2Q | 3Q | 4Q | Full Year | 1Q | ||||||||||||||
| TOTAL PHARMACEUTICAL | $ | 14,006 | $ | 12,721 | $ | 13,457 | $ | 14,263 | $ | 13,141 | $ | 53,583 | 10 | |||||||
| United States | 6,936 | 6,117 | 6,570 | 7,153 | 6,698 | 26,539 | 13 | |||||||||||||
| % Pharmaceutical Sales | 49.5 | % | 48.1 | % | 48.8 | % | 50.1 | % | 51.0 | % | 49.5 | % | ||||||||
| Europe ^(1)^ | 2,555 | 2,326 | 2,401 | 2,497 | 2,491 | 9,715 | 10 | |||||||||||||
| % Pharmaceutical Sales | 18.2 | % | 18.3 | % | 17.8 | % | 17.5 | % | 19.0 | % | 18.1 | % | ||||||||
| China | 1,744 | 1,694 | 1,887 | 1,674 | 1,456 | 6,710 | 3 | |||||||||||||
| % Pharmaceutical Sales | 12.5 | % | 13.3 | % | 14.0 | % | 11.7 | % | 11.1 | % | 12.5 | % | ||||||||
| Japan | 802 | 737 | 652 | 1,062 | 629 | 3,081 | 9 | |||||||||||||
| % Pharmaceutical Sales | 5.7 | % | 5.8 | % | 4.8 | % | 7.4 | % | 4.8 | % | 5.7 | % | ||||||||
| Latin America | 601 | 470 | 566 | 696 | 596 | 2,328 | 28 | |||||||||||||
| % Pharmaceutical Sales | 4.3 | % | 3.7 | % | 4.2 | % | 4.9 | % | 4.5 | % | 4.3 | % | ||||||||
| Asia Pacific (other than China and Japan) | 580 | 703 | 705 | 636 | 616 | 2,661 | -18 | |||||||||||||
| % Pharmaceutical Sales | 4.1 | % | 5.5 | % | 5.2 | % | 4.5 | % | 4.7 | % | 5.0 | % | ||||||||
| Eastern Europe/Middle East/Africa | 395 | 381 | 370 | 301 | 299 | 1,351 | 3 | |||||||||||||
| % Pharmaceutical Sales | 2.8 | % | 3.0 | % | 2.7 | % | 2.1 | % | 2.3 | % | 2.5 | % | ||||||||
| Canada | 138 | 141 | 127 | 133 | 138 | 540 | -2 | |||||||||||||
| % Pharmaceutical Sales | 1.0 | % | 1.1 | % | 0.9 | % | 0.9 | % | 1.1 | % | 1.0 | % | ||||||||
| Other | 255 | 152 | 179 | 111 | 218 | 658 | 68 | |||||||||||||
| % Pharmaceutical Sales | 1.9 | % | 1.2 | % | 1.6 | % | 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)
Table4
OTHER(INCOME) EXPENSE, NET
| 1Q24 | 1Q23 | |||||
|---|---|---|---|---|---|---|
| Interest income | $ | (73 | ) | $ | (112 | ) |
| Interest expense | 303 | 242 | ||||
| Exchange losses | 83 | 61 | ||||
| Income from investments in equity securities, net ^(1)^ | (143 | ) | (450 | ) | ||
| Net periodic defined benefit plan (credit) cost other than service cost | (160 | ) | (115 | ) | ||
| Other, net | (43 | ) | 463 | |||
| Total | $ | (33 | ) | $ | 89 |
^(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.