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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) October 31, 2024 (October 31, 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 October 31, 2024, regarding earnings for the third 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
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: October 31, 2024 |
By: |
/s/ Kelly E. W. Grez |
| |
|
Kelly E. W. Grez |
| |
|
Corporate Secretary |
Exhibit 99.1
 |
News Release |
| |
|
Merck Announces Third-Quarter 2024 Financial
Results
| - | Total Worldwide Sales Were $16.7 Billion, an Increase of 4% From Third Quarter 2023; Excluding the Impact of Foreign Exchange, Growth
Was 7% |
| o | KEYTRUDA Sales Grew 17% to $7.4 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 21% |
| o | WINREVAIR Sales Were $149 Million; U.S. Launch of WINREVAIR Gaining Momentum; Received Approval in the EU |
| o | Animal Health Sales Grew 6% to $1.5 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 11% |
| - | GAAP EPS Was $1.24; Non-GAAP EPS Was $1.57; GAAP and Non-GAAP EPS Include a Net Charge of $0.79 per Share Related to Certain Business
Development Transactions |
| - | Achieved Significant Milestones in Vaccine Programs |
| o | CAPVAXIVE Recommended by the CDC’s ACIP for Pneumococcal Vaccination in Adults 50 Years of Age and Older |
| o | Presented Positive Results From Clinical Studies Evaluating Clesrovimab (MK-1654), an Investigational RSV Preventative Monoclonal
Antibody for Infants Entering Their First RSV Season |
| - | Data Presented for Four Approved Medicines and Six Pipeline Candidates in More Than 20 Types of Cancer at ESMO Congress 2024, Including
Overall Survival Data From KEYNOTE-522 and KEYNOTE-A18 |
| - | Completed Acquisition of Investigational B-Cell Depletion Therapy, CN201 (MK-1045), From Curon Biopharmaceutical |
| - | Full-Year 2024 Financial Outlook |
| o | Narrows Expected Worldwide Sales Range To Be Between $63.6 Billion and $64.1 Billion |
| o | Now Expects Non-GAAP EPS To Be Between $7.72 and $7.77; Outlook Reflects a Net Negative Impact of $0.24 per Share Related to Business
Development Transactions With Curon Biopharmaceutical and Daiichi Sankyo |
RAHWAY, N.J., Oct. 31, 2024 – Merck (NYSE: MRK), known as
MSD outside the United States and Canada, today announced financial results for the third quarter of 2024.
“Our third-quarter results were strong, as
we continue to make progress heading into 2025 and beyond," said Robert M. Davis, chairman and chief executive officer, Merck. "Our
pipeline is advancing and expanding, demonstrating our success in creating a sustainable innovation engine, and positioning Merck with
a more diversified portfolio to drive growth. I continue to remain confident in the strength of our business and our ability to execute,
and I want to thank our colleagues across the globe for their focus and commitment as we work to create lasting value for patients, shareholders
and all our stakeholders.”
Financial Summary
| | |
Third Quarter | |
| $ in millions, except EPS amounts | |
2024 | | |
2023 | | |
Change | | |
Change Ex-
Exchange | |
| Sales | |
$ | 16,657 | | |
$ | 15,962 | | |
| 4 | % | |
| 7 | % |
| GAAP net income1 | |
| 3,157 | | |
| 4,745 | | |
| -33 | % | |
| -30 | % |
| Non-GAAP net income that excludes certain items1,2* | |
| 3,985 | | |
| 5,427 | | |
| -27 | % | |
| -23 | % |
| GAAP EPS | |
| 1.24 | | |
| 1.86 | | |
| -33 | % | |
| -30 | % |
| Non-GAAP EPS that excludes certain items2* | |
| 1.57 | | |
| 2.13 | | |
| -26 | % | |
| -23 | % |
*Refer to table on page 7.
In the third quarter of 2024, total worldwide sales
were $16.7 billion, an increase of 4% compared with the third quarter of 2023; excluding the impact of foreign exchange, growth was 7%.
Sales growth in the third quarter of 2024 was primarily due to increased usage of KEYTRUDA globally, contributions from new launches,
including WINREVAIR and CAPVAXIVE, and strong growth in Merck’s Animal Health business. Revenue growth in the third quarter of 2024
was partially offset by lower sales of JANUVIA and JANUMET, lower combined sales of GARDASIL/GARDASIL 9 and lower sales of LAGEVRIO. Third-quarter
GARDASIL/GARDASIL 9 sales declined year-over-year due to reduced demand in China; outside of China, the company achieved double-digit
sales growth for GARDASIL/GARDASIL 9 in almost every major region globally.
For the third quarter of 2024, Generally Accepted
Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.24 and non-GAAP EPS was $1.57. The declines in GAAP and
Non-GAAP EPS in the third quarter of 2024 versus the prior year were largely due to a net charge of $0.79 per share in the aggregate for
the acquisition of Eyebiotech Limited (EyeBio) and a related development milestone, the acquisition of CN201 (now known as MK-1045) from
Curon Biopharmaceutical (Curon), as well as a payment received from Daiichi Sankyo related to the expansion of the existing development
and commercialization agreement. There were no significant business development transaction charges in the third quarter of 2023.
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.
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.
Year-to-date results can be found in the attached
tables.
Third-Quarter Sales Performance
The following table reflects sales of the company’s
top products and significant performance drivers.
| | |
Third Quarter |
| $ in millions | |
2024 | | |
2023 | | |
Change | | |
Change
Ex-Exchange | | |
Commentary |
| Total Sales | |
$ | 16,657 | | |
$ | 15,962 | | |
| 4 | % | |
| 7 | % | |
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 | |
| 14,943 | | |
| 14,263 | | |
| 5 | % | |
| 8 | % | |
Increase driven by growth in oncology and cardiovascular, partially offset by declines in diabetes, vaccines and virology. |
| KEYTRUDA | |
| 7,429 | | |
| 6,338 | | |
| 17 | % | |
| 21 | % | |
Growth driven by increased global uptake in earlier-stage indications, including triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC), as well as continued strong global demand from metastatic indications. 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. |
| GARDASIL/GARDASIL 9 | |
| 2,306 | | |
| 2,585 | | |
| -11 | % | |
| -10 | % | |
Decline primarily due to lower demand in China compared with prior year, partially offset by higher sales in the U.S., driven by public-sector buying patterns, higher pricing and demand, as well as higher demand in most international regions. |
| PROQUAD, M-M-R II and VARIVAX | |
| 703 | | |
| 713 | | |
| -1 | % | |
| -1 | % | |
Decline primarily due to timing of shipments and lower tenders in Latin America, largely offset by higher demand in certain international markets. |
| JANUVIA/JANUMET | |
| 482 | | |
| 835 | | |
| -42 | % | |
| -38 | % | |
Decline primarily due to lower pricing in the U.S., as well as ongoing generic competition in many international markets. |
| BRIDION | |
| 420 | | |
| 424 | | |
| -1 | % | |
| 0 | % | |
Relatively flat compared with prior year due to generic competition in certain international markets, particularly in Europe and Japan, largely offset by higher demand and pricing in the U.S. |
| LAGEVRIO | |
| 383 | | |
| 640 | | |
| -40 | % | |
| -36 | % | |
Decline primarily due to lower demand in Japan, partially offset by uptake from commercial launch in the U.S. |
| Lynparza* | |
| 337 | | |
| 299 | | |
| 13 | % | |
| 13 | % | |
Growth primarily due to higher global demand. |
| Lenvima* | |
| 251 | | |
| 260 | | |
| -3 | % | |
| -4 | % | |
Decline primarily due to timing of shipments in China in the prior year, partially offset by higher demand in the U.S. |
| VAXNEUVANCE | |
| 239 | | |
| 214 | | |
| 12 | % | |
| 13 | % | |
Growth largely driven by continued uptake from launches in Europe and Japan, partially offset by lower demand in the U.S. due to competition. |
| PREVYMIS | |
| 208 | | |
| 157 | | |
| 32 | % | |
| 36 | % | |
Growth primarily due to higher global demand, particularly in the U.S. |
| ROTATEQ | |
| 193 | | |
| 156 | | |
| 24 | % | |
| 25 | % | |
Growth primarily due to public-sector buying patterns in the U.S. and timing of shipments in China. |
| WINREVAIR | |
| 149 | | |
| - | | |
| - | | |
| - | | |
Represents continued uptake since launch in the U.S. in the second quarter. |
| WELIREG | |
| 139 | | |
| 54 | | |
| 156 | % | |
| 157 | % | |
Growth primarily driven by higher demand in the U.S., largely attributable to ongoing uptake of a new indication. |
| Animal Health | |
| 1,487 | | |
| 1,400 | | |
| 6 | % | |
| 11 | % | |
Growth primarily driven by higher demand and pricing for both Companion Animal and Livestock product portfolios, as well as sales related to July 2024 acquisition of Elanco aqua business. 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. |
| Livestock | |
| 886 | | |
| 874 | | |
| 1 | % | |
| 7 | % | |
Growth primarily driven by higher pricing and higher demand for poultry and swine products, as well as sales related to acquisition of Elanco aqua business. |
| Companion Animal | |
| 601 | | |
| 526 | | |
| 14 | % | |
| 17 | % | |
Growth primarily driven by uptake from new product launches, including the injectable formulation of BRAVECTO in certain international markets, as well as higher pricing across product portfolio. Sales of BRAVECTO were $266 million and $235 million in current and prior year quarters, respectively, which represented growth of 13%, or 16% excluding impact of foreign exchange. |
| Other Revenues** | |
| 227 | | |
| 299 | | |
| -24 | % | |
| -22 | % | |
Decline primarily due to lower payments received for out-licensing arrangements and lower royalty income. |
*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.
Third-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 | |
| Third Quarter 2024 | |
| | |
| | |
| | |
| | |
| |
| Cost of sales | |
$ | 4,080 | | |
$ | 639 | | |
$ | 192 | | |
$ | - | | |
$ | 3,249 | |
| Selling, general and administrative | |
| 2,731 | | |
| 43 | | |
| 31 | | |
| - | | |
| 2,657 | |
| Research and development | |
| 5,862 | | |
| 24 | | |
| - | | |
| - | | |
| 5,838 | |
| Restructuring costs | |
| 56 | | |
| - | | |
| 56 | | |
| - | | |
| - | |
| Other (income) expense, net | |
| (162 | ) | |
| (27 | ) | |
| - | | |
| 58 | | |
| (193 | ) |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| Third Quarter 2023 | |
| | | |
| | | |
| | | |
| | | |
| | |
| Cost of sales | |
$ | 4,264 | | |
$ | 552 | | |
$ | 33 | | |
$ | - | | |
$ | 3,679 | |
| Selling, general and administrative | |
| 2,519 | | |
| 17 | | |
| 40 | | |
| - | | |
| 2,462 | |
| Research and development | |
| 3,307 | | |
| 10 | | |
| - | | |
| - | | |
| 3,297 | |
| Restructuring costs | |
| 126 | | |
| - | | |
| 126 | | |
| - | | |
| - | |
| Other (income) expense, net | |
| 126 | | |
| (24 | ) | |
| - | | |
| 17 | | |
| 133 | |
GAAP Expense, EPS and Related Information
Gross margin was 75.5% for the third quarter of
2024 compared with 73.3% for the third 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 restructuring costs (primarily reflecting
asset impairment charges), as well as higher amortization of intangible assets.
Selling, general and administrative (SG&A)
expenses were $2.7 billion in the third quarter of 2024, an increase of 8% compared with the third quarter of 2023. The increase was primarily
due to higher administrative, promotional, selling, and acquisition-related costs, partially offset by the favorable impact of foreign
exchange.
Research and development (R&D) expenses were
$5.9 billion in the third quarter of 2024, an increase of 77% compared with the third quarter of 2023. The increase was primarily due
to a charge of $1.35 billion for the acquisition of EyeBio and a $100 million charge for a related development milestone, as well as a
charge of $750 million to acquire CN201 (MK-1045) from Curon. The increase in R&D expenses was also driven by higher compensation
and benefit costs, as well as higher clinical development spending. The increase in R&D expenses was partially offset by the favorable
impact of foreign exchange.
Other (income) expense, net, was $162 million
of income in the third quarter of 2024 compared with $126 million of expense in the third quarter of 2023. The favorability was primarily
due to a $170 million payment received from Daiichi Sankyo related to the expansion of the existing development and commercialization
agreement, lower exchange losses and lower net interest expense.
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.
The effective tax rate of 22.7% for the third quarter
of 2024 includes a 7.2 percentage point combined unfavorable impact related to the EyeBio and Curon transactions.
GAAP EPS was $1.24 for the third quarter of 2024
compared with $1.86 for the third quarter of 2023. GAAP EPS in the third quarter of 2024 includes a net charge of $0.79 per share in the
aggregate for the EyeBio, Curon and Daiichi Sankyo transactions. There were no significant business development transaction charges in
the third quarter of 2023.
Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was 80.5% for the third quarter
of 2024 compared with 77.0% for the third 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 third quarter of 2024, an increase of 8% compared with the third quarter of 2023. The increase was primarily due to higher administrative,
promotional and selling costs, partially offset by the favorable impact of foreign exchange.
Non-GAAP R&D expenses were $5.8 billion in
the third quarter of 2024, an increase of 77% compared with the third quarter of 2023. The increase was primarily due to a charge of $1.35
billion for the acquisition of EyeBio and a $100 million charge for a related development milestone, as well as a charge of $750 million
to acquire CN201 (MK-1045) from Curon. The increase in R&D expenses was also driven by higher compensation and benefit costs, as well
as higher clinical development spending. The increase in R&D expenses was partially offset by the favorable impact of foreign exchange.
Non-GAAP other (income) expense, net, was $193
million of income in the third quarter of 2024 compared with $133 million of expense in the third quarter of 2023. The favorability was
primarily due to a $170 million payment received from Daiichi Sankyo related to the expansion of the existing development and commercialization
agreement, lower exchange losses and lower net interest expense.
The non-GAAP effective tax rate of 21.9% for the
third quarter of 2024 includes a 6.0 percentage point combined unfavorable impact related to the EyeBio and Curon transactions.
Non-GAAP EPS was $1.57 for the third quarter of
2024 compared with $2.13 for the third quarter of 2023. Non-GAAP EPS in the third quarter of 2024 includes a net charge of $0.79 per share
in the aggregate for the EyeBio, Curon and Daiichi Sankyo transactions. There were no significant business development transaction charges
in the third quarter of 2023.
A reconciliation of GAAP to non-GAAP net income
and EPS is provided in the table that follows.
| | |
Third Quarter | |
| $ in millions, except EPS amounts | |
2024 | | |
2023 | |
| EPS | |
| | | |
| | |
| GAAP EPS | |
$ | 1.24 | | |
$ | 1.86 | |
| Difference | |
| 0.33 | | |
| 0.27 | |
| Non-GAAP EPS that excludes items listed below2 | |
$ | 1.57 | | |
$ | 2.13 | |
| | |
| | | |
| | |
| Net Income | |
| | | |
| | |
| GAAP net income1 | |
$ | 3,157 | | |
$ | 4,745 | |
| Difference | |
| 828 | | |
| 682 | |
| Non-GAAP net income that excludes items listed below1,2 | |
$ | 3,985 | | |
$ | 5,427 | |
| | |
| | | |
| | |
| Excluded Items: | |
| | | |
| | |
| Acquisition- and divestiture-related costs3 | |
$ | 679 | | |
$ | 555 | |
| Restructuring costs | |
| 279 | | |
| 199 | |
| Loss from investments in equity securities | |
| 58 | | |
| 17 | |
| Decrease to net income | |
| 1,016 | | |
| 771 | |
| Estimated income tax (benefit) expense | |
| (188 | ) | |
| (89 | ) |
| Decrease to net income | |
$ | 828 | | |
$ | 682 | |
Pipeline and Portfolio Highlights
In the third quarter, Merck continued to develop
and augment its strong, diverse pipeline and achieve key regulatory and clinical milestones.
In cardiovascular disease, Merck continued to build
on positive momentum in its U.S. launch of WINREVAIR. As of the end of September 2024, more than 3,700 patients have been prescribed
WINREVAIR. The company also received the European Commission’s (EC) approval of WINREVAIR, in combination with other pulmonary arterial
hypertension (PAH) therapies, for the treatment of adult patients with PAH with World Health Organization (WHO) functional Class II
to III. WINREVAIR is the first activin signaling inhibitor approved for the treatment of PAH in Europe. WINREVAIR has launched in Germany
and Merck is working to obtain reimbursement for WINREVAIR in other countries in the EU, which should occur in most other major European
markets in the second half of 2025.
In oncology, Merck continued to reinforce its leadership
in women’s and earlier stages of cancers and demonstrate progress in its research pipeline. At the European Society for Medical
Oncology (ESMO) Congress 2024, three of the company’s data presentations were highlighted during Presidential Symposium sessions.
These included overall survival (OS) data from the Phase 3 KEYNOTE-522 trial in high-risk, early-stage TNBC and from the Phase 3 KEYNOTE-A18
trial (also known as ENGOT-cx11/GOG-3047) in high-risk, locally advanced cervical cancer. In addition, new positive data on investigational
candidates from Merck’s pipeline were presented, including for patritumab deruxtecan (HER3-DXd), an antibody-drug conjugate (ADC)
being developed in collaboration with Daiichi Sankyo, and for sacituzumab tirumotecan (sac-TMT), an anti-TROP2 ADC being developed in
collaboration with Kelun-Biotech.
The company also achieved several regulatory milestones,
including new approvals for KEYTRUDA-based regimens in the U.S., Europe and Japan. In addition, Merck recently announced top-line results
from the KEYNOTE-689 trial, which marks the first positive trial in two decades for patients with resected, locally advanced head and
neck squamous cell carcinoma (LA-HNSCC).
In vaccines, the CDC’s Advisory Committee
on Immunization Practices (ACIP) voted in October 2024 to recommend CAPVAXIVE for individuals 50 to 64 years of age. This decision
expanded upon the initial unanimous recommendation in June 2024 for use of CAPVAXIVE in adults age 65 and older, among other cohorts.
At IDWeek 2024, Merck presented positive results
from the Phase 2b/3 trial of clesrovimab (MK-1654), an investigational respiratory syncytial virus (RSV) preventative monoclonal antibody
for infants. These results support the potential for clesrovimab to become the first and only single-dose immunization designed to protect
infants with the same dose, regardless of weight, for the duration of their first RSV season (six months).
In immunology, long-term efficacy and safety data
for tulisokibart (MK-7240), an investigational humanized monoclonal antibody directed to a novel target, tumor necrosis factor (TNF)-like
cytokine 1A (TL1A), from the Phase 2 ARTEMIS-UC and APOLLO-CD studies in ulcerative colitis (UC) and Crohn’s disease (CD), were
presented at the United European Gastroenterology (UEG) Week 2024 Congress. Both studies showed that, at week 50, maintenance of treatment
efficacy was generally observed in 12-week induction responders. Phase 3 studies in UC and CD are ongoing.
In addition, Merck continued to expand and diversify
its pipeline by securing strategic business development opportunities. Merck completed its acquisition of CN201 (MK-1045), a next-generation
CD3xCD19 bispecific antibody with potential applications in B-cell malignancies and autoimmune diseases, from Curon. Merck also announced
the expansion of the global development and commercialization agreement with Daiichi Sankyo to include MK-6070, an investigational delta-like
ligand 3 (DLL3) targeting T-cell engager. The companies are planning to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd)
in certain patients with small cell lung cancer (SCLC), as well as other potential combinations.
Notable recent news releases on Merck’s pipeline
and portfolio are provided in the table that follows.
| Oncology |
FDA Approved KEYTRUDA Plus Pemetrexed and Platinum Chemotherapy as First-Line Treatment for Adult Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma, Based on Results From Phase 3 KEYNOTE-483/CCTG IND.227 Trial |
(Read Announcement) |
| EC Approved KEYTRUDA Plus Padcev as First-Line Treatment of Unresectable or Metastatic Urothelial Carcinoma in Adults, Based on Results From Phase 3 KEYNOTE-A39/EV-302 Trial |
(Read Announcement) |
| KEYTRUDA Received 30th Approval From EC With Two New Indications in Gynecologic Cancers, Based on Results From Phase 3 KEYNOTE-868/NRG-GY018 and KEYNOTE-A18 Trials |
(Read Announcement) |
| KEYTRUDA Received New Approvals in Japan for Certain Patients With NSCLC, Based on Results From Phase 3 KEYNOTE-671 Trial, and for Radically Unresectable Urothelial Carcinoma, Based on Results From Phase 3 KEYNOTE-A39/EV-302 and Phase 2 KEYNOTE-052 Trials |
(Read Announcement) |
| KEYTRUDA Plus Chemotherapy Before Surgery and Continued as Single Agent After Surgery Reduced Risk of Death by More Than One-Third (34%) Versus Neoadjuvant Chemotherapy in High-Risk, Early-Stage TNBC, Based on Results From Phase 3 KEYNOTE-522 |
(Read Announcement) |
| KEYTRUDA Plus Chemoradiotherapy (CRT) Reduced Risk of Death by 33% Versus CRT Alone in Patients With Newly Diagnosed, High-Risk, Locally Advanced Cervical Cancer, Based on Results From Phase 3 KEYNOTE-A18/ENGOT-cx11/GOG-3047 Trial |
(Read Announcement) |
| KEYTRUDA Ten-Year Data Demonstrated Sustained OS Benefit Versus Ipilimumab in Advanced Melanoma, Based on Results From Phase 3 KEYNOTE-006 Trial |
(Read Announcement) |
| KEYTRUDA Plus Lenvima in Combination With Transarterial Chemoembolization (TACE) Significantly Improved Progression-Free Survival Compared to TACE Alone in Patients With Unresectable, Non-Metastatic Hepatocellular Carcinoma, Based on Results From Phase 3 LEAP-012 Trial |
(Read Announcement) |
| KEYTRUDA Plus Trastuzumab and Chemotherapy Significantly Improved OS Versus Trastuzumab and Chemotherapy Alone in First-Line Treatment of Patients With HER2-Positive Advanced Gastric or GEJ Adenocarcinoma, Based on Results From Phase 3 KEYNOTE-811 Trial |
(Read Announcement) |
| KEYTRUDA Met Primary Endpoint of Event-Free Survival as Perioperative Treatment Regimen in Patients With Resected, LA-HNSCC, Based on Results From Phase 3 KEYNOTE-689 Trial |
(Read Announcement) |
| Patritumab Deruxtecan (HER3-DXd) Demonstrated Statistically Significant Improvement in Progression-Free Survival Versus Doublet Chemotherapy in Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC, Based on Results From Phase 3 HERTHENA-Lung02 Trial |
(Read Announcement) |
| Ifinatamab Deruxtecan Continued to Demonstrate Promising Objective Response Rates in Patients With Extensive-Stage SCLC, Based on Results From Phase 2 IDeate-Lung01 Trial |
(Read Announcement) |
| Merck and Moderna Initiated Phase 3 Trial Evaluating Adjuvant V940 (mRNA-4157) in Combination With KEYTRUDA After Neoadjuvant KEYTRUDA and Chemotherapy in Patients With Certain Types of NSCLC |
(Read Announcement) |
| Merck Initiated Phase 3 Shorespan-007 Trial for Bomedemstat, an Investigational Candidate for the Treatment of Certain Patients With Essential Thrombocythemia |
(Read Announcement) |
| Merck and Daiichi Sankyo Initiated Phase 3 IDeate-Lung02 Trial of Ifinatamab Deruxtecan in Patients With Relapsed SCLC |
(Read Announcement) |
| Merck and Exelixis Signed Clinical Development Collaboration To Evaluate Investigational Zanzalintinib in Combination With KEYTRUDA in Head and Neck Cancer and in Combination With WELIREG in RCC |
(Read Announcement) |
| Vaccines |
Clesrovimab (MK-1654), an Investigational RSV Preventative Monoclonal Antibody, Significantly Reduced Incidence of RSV Disease and Hospitalization in Healthy Preterm and Full-Term Infants, Based on Results From Phase 2b/3 MK-1654-004 Trial |
(Read Announcement) |
| CDC’s ACIP Recommended CAPVAXIVE for Pneumococcal Vaccination in Adults 50 Years of Age and Older |
(Read Announcement) |
| CAPVAXIVE Demonstrated Positive Immune Responses in Adults With Increased Risk for Pneumococcal Disease, Based on Results From Phase 3 STRIDE-8 Trial |
(Read Announcement) |
| Merck Announced Positive Top-line Results From Phase 3 Trial Evaluating Efficacy and Safety of GARDASIL 9 in Japanese Males |
(Read Announcement) |
| Cardiovascular |
EC Approved WINREVAIR in Combination With Other PAH Therapies for the Treatment of PAH in Adult Patients With Functional Class II-III, Based on Results From Phase 3 STELLAR Trial |
(Read Announcement) |
| Immunology |
Merck Presented New Long-Term Data for Tulisokibart (MK-7240), an Investigational Anti-TL1A Monoclonal Antibody, in Inflammatory Bowel Disease at UEG Week 2024 |
(Read Announcement) |
| Infectious Diseases |
Merck and Gilead Announced Phase 2 Data Showing a Treatment Switch to an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir (MK-8591D) Maintained Viral Suppression in Adults at Week 48 |
(Read Announcement) |
| Ophthalmology |
Merck and EyeBio Initiated Phase 2b/3 Clinical Trial for MK-3000 for the Treatment of Diabetic Macular Edema |
(Read Announcement) |
Sustainability Highlights
Merck issued its 2023/2024 Impact Report, reaffirming
its commitment to operating responsibly and enabling broad access to its products. The report noted how the company reached more than
550 million people around the world with its medicines and vaccines through commercial channels, clinical trials, voluntary licensing
and product donations.
Full-Year 2024 Financial Outlook
The following table summarizes the company’s
full-year financial outlook.
| | |
Full Year 2024 | |
| | |
Updated | | |
Prior | |
| Sales* | |
| $63.6 to $64.1 billion | | |
| $63.4 to $64.4 billion | |
| Non-GAAP Gross margin2 | |
| Approximately 81% | | |
| Approximately 81% | |
| Non-GAAP Operating expenses2** | |
| $27.8 to $28.3 billion | | |
| $26.8 to $27.6 billion | |
| Non-GAAP Other (income) expense, net2 | |
| Approximately $100 million expense | | |
| Approximately $350 million expense | |
| Non-GAAP Effective tax rate2 | |
| 16.0% to 17.0% | | |
| 15.5% to 16.5% | |
| Non-GAAP EPS2*** | |
| $7.72 to $7.77 | | |
| $7.94 to $8.04 | |
| Share count (assuming dilution) | |
| Approximately 2.54 billion | | |
| Approximately 2.54 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, $1.45 billion for EyeBio acquisition and related development milestone payment,
and $750 million for acquisition of CN201 (MK-1045) from Curon. Outlook does not assume any additional significant potential business
development transactions.
***Includes net one-time charge of $1.05 per share
in aggregate for the Harpoon, EyeBio and Curon transactions, and the cash payment received from Daiichi Sankyo.
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 growth, including
from KEYTRUDA, new product launches and Animal Health. As a result, Merck is narrowing the range of its full-year sales outlook.
Merck now expects its full-year sales to be between
$63.6 billion and $64.1 billion, including a negative impact of foreign exchange of approximately 3 percentage points, at mid-October 2024
exchange rates. Approximately 2 percentage points of the negative impact of foreign exchange is due to the devaluation of the Argentine
peso, which is being largely 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 16.0% and 17.0%, which includes an unfavorable impact related to the one-time charge associated with the
acquisition of CN201 (MK-1045) from Curon.
Merck now expects its full-year non-GAAP EPS to
be between $7.72 and $7.77. The outlook includes 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 is being largely offset by inflation-related
price increases, consistent with practice in that market. This revised non-GAAP EPS range reflects a net charge of $0.24 per share for
the following items not previously included in the outlook:
| • | The acquisition of CN201 (MK-1045) from Curon. |
| • | Payment received from Daiichi Sankyo related to the expansion of the existing
development and commercialization agreement. |
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 Thursday, October 31, 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)
369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590.
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.
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)
VERQUVO (vericiguat)
WELIREG (belzutifan)
WINREVAIR (sotatercept-csrk)
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 INCOME - GAAP |
| (AMOUNTS
IN MILLIONS, EXCEPT PER SHARE FIGURES) |
| (UNAUDITED) |
| Table
1 |
| | |
GAAP | | |
| | |
GAAP | |
| |
| | |
| | |
| | |
| | |
Sep YTD | | |
Sep YTD | |
| |
| | |
| 3Q24 | | |
| 3Q23 | | |
| %
Change | | |
| 2024 | | |
| 2023 | |
| %
Change | |
| Sales | |
$ | 16,657 | | |
$ | 15,962 | | |
| 4 | % | |
$ | 48,544 | | |
$ | 45,485 | |
| 7 | % |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| Costs, Expenses and Other | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| Cost of sales | |
| 4,080 | | |
| 4,264 | | |
| -4 | % | |
| 11,365 | | |
| 12,214 | |
| -7 | % |
| Selling, general and administrative | |
| 2,731 | | |
| 2,519 | | |
| 8 | % | |
| 7,952 | | |
| 7,700 | |
| 3 | % |
| Research and development | |
| 5,862 | | |
| 3,307 | | |
| 77 | % | |
| 13,354 | | |
| 20,904 | |
| -36 | % |
| Restructuring costs | |
| 56 | | |
| 126 | | |
| -56 | % | |
| 258 | | |
| 344 | |
| -25 | % |
| Other (income) expense, net | |
| (162 | ) | |
| 126 | | |
| * | | |
| (151 | ) | |
| 388 | |
| * | |
| Income Before Taxes | |
| 4,090 | | |
| 5,620 | | |
| -27 | % | |
| 15,766 | | |
| 3,935 | |
| * | |
| Taxes on Income | |
| 929 | | |
| 870 | | |
| | | |
| 2,377 | | |
| 2,332 | |
| | |
| Net Income | |
| 3,161 | | |
| 4,750 | | |
| -33 | % | |
| 13,389 | | |
| 1,603 | |
| * | |
| Less: Net Income Attributable to Noncontrolling Interests | |
| 4 | | |
| 5 | | |
| | | |
| 15 | | |
| 12 | |
| | |
| Net Income Attributable to Merck & Co., Inc. | |
$ | 3,157 | | |
$ | 4,745 | | |
| -33 | % | |
$ | 13,374 | | |
$ | 1,591 | |
| * | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| Earnings per Common Share Assuming Dilution | |
$ | 1.24 | | |
$ | 1.86 | | |
| -33 | % | |
$ | 5.26 | | |
$ | 0.62 | |
| * | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| Average Shares Outstanding Assuming Dilution | |
| 2,541 | | |
| 2,546 | | |
| | | |
| 2,543 | | |
| 2,549 | |
| | |
| Tax Rate | |
| 22.7 | % | |
| 15.5 | % | |
| | | |
| 15.1 | % | |
| 59.3 | % |
| | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| * 100% or greater | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| MERCK
& CO., INC. |
| THREE
AND NINE MONTHS ENDED SEPTEMBER 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 | |
| Third Quarter | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Cost of sales | |
$ | 4,080 | | |
| 639 | | |
| 192 | | |
| | | |
| | | |
| 831 | | |
$ | 3,249 | |
| Selling, general and administrative | |
| 2,731 | | |
| 43 | | |
| 31 | | |
| | | |
| | | |
| 74 | | |
| 2,657 | |
| Research and development | |
| 5,862 | | |
| 24 | | |
| | | |
| | | |
| | | |
| 24 | | |
| 5,838 | |
| Restructuring costs | |
| 56 | | |
| | | |
| 56 | | |
| | | |
| | | |
| 56 | | |
| – | |
| Other (income) expense, net | |
| (162 | ) | |
| (27 | ) | |
| | | |
| 58 | | |
| | | |
| 31 | | |
| (193 | ) |
| Income Before Taxes | |
| 4,090 | | |
| (679 | ) | |
| (279 | ) | |
| (58 | ) | |
| | | |
| (1,016 | ) | |
| 5,106 | |
| Income Tax Provision (Benefit) | |
| 929 | | |
| (129 | )(3) | |
| (46 | )(3) | |
| (13 | )(3) | |
| | | |
| (188 | ) | |
| 1,117 | |
| Net Income | |
| 3,161 | | |
| (550 | ) | |
| (233 | ) | |
| (45 | ) | |
| | | |
| (828 | ) | |
| 3,989 | |
| Net Income Attributable to Merck & Co., Inc. | |
| 3,157 | | |
| (550 | ) | |
| (233 | ) | |
| (45 | ) | |
| | | |
| (828 | ) | |
| 3,985 | |
| Earnings per Common Share Assuming Dilution | |
$ | 1.24 | | |
| (0.22 | ) | |
| (0.09 | ) | |
| (0.02 | ) | |
| | | |
| (0.33 | ) | |
$ | 1.57 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Tax Rate | |
| 22.7 | % | |
| | | |
| | | |
| | | |
| | | |
| | | |
| 21.9 | % |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Sep YTD | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Cost of sales | |
$ | 11,365 | | |
| 1,708 | | |
| 374 | | |
| | | |
| | | |
| 2,082 | | |
$ | 9,283 | |
| Selling, general and administrative | |
| 7,952 | | |
| 88 | | |
| 67 | | |
| | | |
| | | |
| 155 | | |
| 7,797 | |
| Research and development | |
| 13,354 | | |
| 60 | | |
| 2 | | |
| | | |
| | | |
| 62 | | |
| 13,292 | |
| Restructuring costs | |
| 258 | | |
| | | |
| 258 | | |
| | | |
| | | |
| 258 | | |
| – | |
| Other (income) expense, net | |
| (151 | ) | |
| (48 | ) | |
| | | |
| (107 | ) | |
| | | |
| (155 | ) | |
| 4 | |
| Income Before Taxes | |
| 15,766 | | |
| (1,808 | ) | |
| (701 | ) | |
| 107 | | |
| | | |
| (2,402 | ) | |
| 18,168 | |
| Income Tax Provision (Benefit) | |
| 2,377 | | |
| (350 | )(3) | |
| (118 | )(3) | |
| 23 | (3) | |
| (259 | )(4) | |
| (704 | ) | |
| 3,081 | |
| Net Income | |
| 13,389 | | |
| (1,458 | ) | |
| (583 | ) | |
| 84 | | |
| 259 | | |
| (1,698 | ) | |
| 15,087 | |
| Net Income Attributable to Merck & Co., Inc. | |
| 13,374 | | |
| (1,458 | ) | |
| (583 | ) | |
| 84 | | |
| 259 | | |
| (1,698 | ) | |
| 15,072 | |
| Earnings per Common Share Assuming Dilution | |
$ | 5.26 | | |
| (0.57 | ) | |
| (0.23 | ) | |
| 0.03 | | |
| 0.10 | | |
| (0.67 | ) | |
$ | 5.93 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Tax Rate | |
| 15.1 | % | |
| | | |
| | | |
| | | |
| | | |
| | | |
| 17.0 | % |
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 and Animal Health intangible
asset impairment charges. 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, accelerated depreciation and asset impairments 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 | |
| 3Q | |
| Sep
YTD |
| | |
| 1Q | | |
| 2Q | | |
| 3Q | | |
| Sep
YTD | | |
| 1Q | | |
| 2Q | | |
| 3Q | | |
| Sep
YTD | |
| Nom
% | |
| Ex-Exch
% | |
| Nom
% | |
| Ex-Exch
% |
| TOTAL SALES (1) | |
$ | 15,775 | | |
$ | 16,112 | | |
$ | 16,657 | | |
$ | 48,544 | | |
$ | 14,487 | | |
$ | 15,035 | | |
$ | 15,962 | | |
$ | 45,485 | |
| 4 | |
| 7 | |
| 7 | |
| 10 |
| PHARMACEUTICAL | |
| 14,006 | | |
| 14,408 | | |
| 14,943 | | |
| 43,358 | | |
| 12,721 | | |
| 13,457 | | |
| 14,263 | | |
| 40,442 | |
| 5 | |
| 8 | |
| 7 | |
| 10 |
| Oncology | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | |
| | |
| |
| Keytruda | |
| 6,947 | | |
| 7,270 | | |
| 7,429 | | |
| 21,646 | | |
| 5,795 | | |
| 6,271 | | |
| 6,338 | | |
| 18,403 | |
| 17 | |
| 21 | |
| 18 | |
| 22 |
| Alliance
Revenue – Lynparza (2) | |
| 292 | | |
| 317 | | |
| 337 | | |
| 947 | | |
| 275 | | |
| 310 | | |
| 299 | | |
| 884 | |
| 13 | |
| 13 | |
| 7 | |
| 8 |
| Alliance
Revenue – Lenvima (2) | |
| 255 | | |
| 249 | | |
| 251 | | |
| 755 | | |
| 232 | | |
| 242 | | |
| 260 | | |
| 734 | |
| -3 | |
| -4 | |
| 3 | |
| 3 |
| Welireg | |
| 85 | | |
| 126 | | |
| 139 | | |
| 349 | | |
| 42 | | |
| 50 | | |
| 54 | | |
| 146 | |
| 156 | |
| 157 | |
| 138 | |
| 139 |
| Alliance
Revenue – Reblozyl (3) | |
| 71 | | |
| 90 | | |
| 100 | | |
| 261 | | |
| 43 | | |
| 47 | | |
| 52 | | |
| 142 | |
| 91 | |
| 91 | |
| 84 | |
| 84 |
| Vaccines
(4) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | |
| | |
| |
| Gardasil/Gardasil 9 | |
| 2,249 | | |
| 2,478 | | |
| 2,306 | | |
| 7,032 | | |
| 1,972 | | |
| 2,458 | | |
| 2,585 | | |
| 7,015 | |
| -11 | |
| -10 | |
| - | |
| 3 |
| ProQuad/M-M-R II/Varivax | |
| 570 | | |
| 617 | | |
| 703 | | |
| 1,891 | | |
| 528 | | |
| 582 | | |
| 713 | | |
| 1,823 | |
| -1 | |
| -1 | |
| 4 | |
| 4 |
| Vaxneuvance | |
| 219 | | |
| 189 | | |
| 239 | | |
| 647 | | |
| 106 | | |
| 168 | | |
| 214 | | |
| 488 | |
| 12 | |
| 13 | |
| 33 | |
| 34 |
| RotaTeq | |
| 216 | | |
| 163 | | |
| 193 | | |
| 572 | | |
| 297 | | |
| 131 | | |
| 156 | | |
| 584 | |
| 24 | |
| 25 | |
| -2 | |
| -1 |
| Pneumovax 23 | |
| 61 | | |
| 59 | | |
| 68 | | |
| 188 | | |
| 96 | | |
| 92 | | |
| 140 | | |
| 327 | |
| -51 | |
| -51 | |
| -42 | |
| -40 |
| Hospital Acute
Care | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | |
| | |
| |
| Bridion | |
| 440 | | |
| 455 | | |
| 420 | | |
| 1,315 | | |
| 487 | | |
| 502 | | |
| 424 | | |
| 1,413 | |
| -1 | |
| - | |
| -7 | |
| -6 |
| Prevymis | |
| 174 | | |
| 188 | | |
| 208 | | |
| 570 | | |
| 129 | | |
| 143 | | |
| 157 | | |
| 430 | |
| 32 | |
| 36 | |
| 33 | |
| 36 |
| Dificid | |
| 73 | | |
| 92 | | |
| 96 | | |
| 261 | | |
| 65 | | |
| 76 | | |
| 74 | | |
| 215 | |
| 31 | |
| 31 | |
| 21 | |
| 21 |
| Zerbaxa | |
| 56 | | |
| 62 | | |
| 64 | | |
| 182 | | |
| 50 | | |
| 54 | | |
| 53 | | |
| 157 | |
| 22 | |
| 25 | |
| 16 | |
| 19 |
| Noxafil | |
| 56 | | |
| 45 | | |
| 41 | | |
| 141 | | |
| 60 | | |
| 55 | | |
| 51 | | |
| 167 | |
| -20 | |
| -13 | |
| -15 | |
| -5 |
| Cardiovascular | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | |
| | |
| |
| Alliance
Revenue - Adempas/Verquvo (5) | |
| 98 | | |
| 106 | | |
| 102 | | |
| 306 | | |
| 99 | | |
| 68 | | |
| 92 | | |
| 259 | |
| 11 | |
| 11 | |
| 18 | |
| 18 |
| Winrevair | |
| | | |
| 70 | | |
| 149 | | |
| 219 | | |
| | | |
| | | |
| | | |
| | |
| - | |
| - | |
| - | |
| - |
| Adempas
(6) | |
| 70 | | |
| 72 | | |
| 72 | | |
| 214 | | |
| 59 | | |
| 65 | | |
| 65 | | |
| 189 | |
| 11 | |
| 13 | |
| 13 | |
| 15 |
| Virology | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | |
| | |
| |
| Lagevrio | |
| 350 | | |
| 110 | | |
| 383 | | |
| 843 | | |
| 392 | | |
| 203 | | |
| 640 | | |
| 1,236 | |
| -40 | |
| -36 | |
| -32 | |
| -27 |
| Isentress/Isentress HD | |
| 111 | | |
| 89 | | |
| 102 | | |
| 302 | | |
| 123 | | |
| 136 | | |
| 119 | | |
| 377 | |
| -14 | |
| -10 | |
| -20 | |
| -16 |
| Delstrigo | |
| 56 | | |
| 60 | | |
| 65 | | |
| 180 | | |
| 44 | | |
| 50 | | |
| 54 | | |
| 148 | |
| 21 | |
| 25 | |
| 22 | |
| 26 |
| Pifeltro | |
| 42 | | |
| 39 | | |
| 42 | | |
| 123 | | |
| 34 | | |
| 38 | | |
| 37 | | |
| 109 | |
| 14 | |
| 15 | |
| 13 | |
| 14 |
| Neuroscience | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | |
| | |
| |
| Belsomra | |
| 46 | | |
| 53 | | |
| 78 | | |
| 177 | | |
| 56 | | |
| 63 | | |
| 58 | | |
| 176 | |
| 35 | |
| 40 | |
| - | |
| 7 |
| Immunology | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | |
| | |
| |
| Simponi | |
| 184 | | |
| 172 | | |
| 189 | | |
| 545 | | |
| 180 | | |
| 180 | | |
| 179 | | |
| 539 | |
| 5 | |
| 7 | |
| 1 | |
| 2 |
| Remicade | |
| 39 | | |
| 35 | | |
| 41 | | |
| 115 | | |
| 51 | | |
| 48 | | |
| 45 | | |
| 144 | |
| -9 | |
| -5 | |
| -20 | |
| -16 |
| Diabetes
(7) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | |
| | |
| |
| Januvia | |
| 419 | | |
| 405 | | |
| 278 | | |
| 1,102 | | |
| 551 | | |
| 511 | | |
| 581 | | |
| 1,642 | |
| -52 | |
| -49 | |
| -33 | |
| -30 |
| Janumet | |
| 251 | | |
| 224 | | |
| 204 | | |
| 679 | | |
| 329 | | |
| 354 | | |
| 255 | | |
| 937 | |
| -20 | |
| -13 | |
| -28 | |
| -23 |
| Other
Pharmaceutical (8) | |
| 576 | | |
| 573 | | |
| 644 | | |
| 1,796 | | |
| 626 | | |
| 560 | | |
| 568 | | |
| 1,758 | |
| 13 | |
| 15 | |
| 2 | |
| 5 |
| ANIMAL HEALTH | |
| 1,511 | | |
| 1,482 | | |
| 1,487 | | |
| 4,480 | | |
| 1,491 | | |
| 1,456 | | |
| 1,400 | | |
| 4,347 | |
| 6 | |
| 11 | |
| 3 | |
| 7 |
| Livestock | |
| 850 | | |
| 837 | | |
| 886 | | |
| 2,573 | | |
| 849 | | |
| 807 | | |
| 874 | | |
| 2,530 | |
| 1 | |
| 7 | |
| 2 | |
| 7 |
| Companion Animal | |
| 661 | | |
| 645 | | |
| 601 | | |
| 1,907 | | |
| 642 | | |
| 649 | | |
| 526 | | |
| 1,817 | |
| 14 | |
| 17 | |
| 5 | |
| 7 |
| Other
Revenues (9) | |
| 258 | | |
| 222 | | |
| 227 | | |
| 706 | | |
| 275 | | |
| 122 | | |
| 299 | | |
| 696 | |
| -24 | |
| -22 | |
| 2 | |
| 4 |
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, $3,656 million and $3,675 million in the first, second and third quarter of 2024, respectively,
and $3,133 million, $3,557 million and $4,002 million in the first, second and third 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, $715 million and $592 million in the first, second and third quarter of 2024, respectively,
and $950 million, $951 million and $924 million in the first, second and third 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, $15 million and $15 million in the first, second and third quarter of 2024, respectively, and $51 million, $3 million
and $65 million in the first, second and third quarter of 2023, respectively.
Exhibit 99.2
MERCK &
CO., INC.
CONSOLIDATED
STATEMENT OF OPERATIONS - GAAP
(AMOUNTS
IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table
1a
| | |
2024 | | |
2023 | | |
% Change | |
| | |
| 1Q | | |
| 2Q | | |
| 3Q | | |
| Sep
YTD | | |
| 1Q | | |
| 2Q | | |
| 3Q | | |
| Sep
YTD | | |
| 4Q | | |
| Full
Year | | |
| 3Q | | |
| Sep
YTD | |
| Sales | |
$ | 15,775 | | |
$ | 16,112 | | |
$ | 16,657 | | |
$ | 48,544 | | |
$ | 14,487 | | |
$ | 15,035 | | |
$ | 15,962 | | |
$ | 45,485 | | |
$ | 14,630 | | |
$ | 60,115 | | |
| 4 | % | |
| 7 | % |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Costs, Expenses and Other | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Cost of sales | |
| 3,540 | | |
| 3,745 | | |
| 4,080 | | |
| 11,365 | | |
| 3,926 | | |
| 4,024 | | |
| 4,264 | | |
| 12,214 | | |
| 3,911 | | |
| 16,126 | | |
| -4 | % | |
| -7 | % |
| Selling, general and administrative | |
| 2,483 | | |
| 2,739 | | |
| 2,731 | | |
| 7,952 | | |
| 2,479 | | |
| 2,702 | | |
| 2,519 | | |
| 7,700 | | |
| 2,804 | | |
| 10,504 | | |
| 8 | % | |
| 3 | % |
| Research and development | |
| 3,992 | | |
| 3,500 | | |
| 5,862 | | |
| 13,354 | | |
| 4,276 | | |
| 13,321 | | |
| 3,307 | | |
| 20,904 | | |
| 9,628 | | |
| 30,531 | | |
| 77 | % | |
| -36 | % |
| Restructuring costs | |
| 123 | | |
| 80 | | |
| 56 | | |
| 258 | | |
| 67 | | |
| 151 | | |
| 126 | | |
| 344 | | |
| 255 | | |
| 599 | | |
| -56 | % | |
| -25 | % |
| Other (income) expense, net | |
| (33 | ) | |
| 42 | | |
| (162 | ) | |
| (151 | ) | |
| 89 | | |
| 172 | | |
| 126 | | |
| 388 | | |
| 78 | | |
| 466 | | |
| * | | |
| * | |
| Income (Loss) Before Taxes | |
| 5,670 | | |
| 6,006 | | |
| 4,090 | | |
| 15,766 | | |
| 3,650 | | |
| (5,335 | ) | |
| 5,620 | | |
| 3,935 | | |
| (2,046 | ) | |
| 1,889 | | |
| -27 | % | |
| * | |
| Income Tax Provision (Benefit) | |
| 903 | | |
| 545 | | |
| 929 | | |
| 2,377 | | |
| 825 | | |
| 637 | | |
| 870 | | |
| 2,332 | | |
| (821 | ) | |
| 1,512 | | |
| | | |
| | |
| Net Income (Loss) | |
| 4,767 | | |
| 5,461 | | |
| 3,161 | | |
| 13,389 | | |
| 2,825 | | |
| (5,972 | ) | |
| 4,750 | | |
| 1,603 | | |
| (1,225 | ) | |
| 377 | | |
| -33 | % | |
| * | |
| Less: Net Income Attributable to Noncontrolling Interests | |
| 5 | | |
| 6 | | |
| 4 | | |
| 15 | | |
| 4 | | |
| 3 | | |
| 5 | | |
| 12 | | |
| 1 | | |
| 12 | | |
| | | |
| | |
| Net Income (Loss) Attributable to Merck & Co., Inc. | |
$ | 4,762 | | |
$ | 5,455 | | |
$ | 3,157 | | |
$ | 13,374 | | |
$ | 2,821 | | |
$ | (5,975 | ) | |
$ | 4,745 | | |
$ | 1,591 | | |
$ | (1,226 | ) | |
$ | 365 | | |
| -33 | % | |
| * | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Earnings (Loss) per Common Share Assuming Dilution (1) | |
$ | 1.87 | | |
$ | 2.14 | | |
$ | 1.24 | | |
$ | 5.26 | | |
$ | 1.11 | | |
$ | (2.35 | ) | |
$ | 1.86 | | |
$ | 0.62 | | |
$ | (0.48 | ) | |
$ | 0.14 | | |
| -33 | % | |
| * | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Average Shares Outstanding Assuming Dilution (1) | |
| 2,544 | | |
| 2,544 | | |
| 2,541 | | |
| 2,543 | | |
| 2,551 | | |
| 2,539 | | |
| 2,546 | | |
| 2,549 | | |
| 2,533 | | |
| 2,547 | | |
| | | |
| | |
| Tax Rate | |
| 15.9 | % | |
| 9.1 | % | |
| 22.7 | % | |
| 15.1 | % | |
| 22.6 | % | |
| -11.9 | % | |
| 15.5 | % | |
| 59.3 | % | |
| 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 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 NINE MONTHS ENDED SEPTEMBER 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 | |
| Third Quarter | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Cost of sales | |
$ | 4,264 | | |
| 552 | | |
| 33 | | |
| | | |
| | | |
| 585 | | |
$ | 3,679 | |
| Selling, general and administrative | |
| 2,519 | | |
| 17 | | |
| 40 | | |
| | | |
| | | |
| 57 | | |
| 2,462 | |
| Research and development | |
| 3,307 | | |
| 10 | | |
| | | |
| | | |
| | | |
| 10 | | |
| 3,297 | |
| Restructuring costs | |
| 126 | | |
| | | |
| 126 | | |
| | | |
| | | |
| 126 | | |
| – | |
| Other (income) expense, net | |
| 126 | | |
| (24 | ) | |
| | | |
| 17 | | |
| | | |
| (7 | ) | |
| 133 | |
| Income Before Taxes | |
| 5,620 | | |
| (555 | ) | |
| (199 | ) | |
| (17 | ) | |
| | | |
| (771 | ) | |
| 6,391 | |
| Income Tax Provision (Benefit) | |
| 870 | | |
| (53 | )(4) | |
| (32 | )(4) | |
| (4 | )(4) | |
| | | |
| (89 | ) | |
| 959 | |
| Net Income | |
| 4,750 | | |
| (502 | ) | |
| (167 | ) | |
| (13 | ) | |
| | | |
| (682 | ) | |
| 5,432 | |
| Net Income Attributable to Merck & Co., Inc. | |
| 4,745 | | |
| (502 | ) | |
| (167 | ) | |
| (13 | ) | |
| | | |
| (682 | ) | |
| 5,427 | |
| Earnings per Common Share Assuming Dilution | |
$ | 1.86 | | |
| (0.20 | ) | |
| (0.07 | ) | |
| – | | |
| | | |
| (0.27 | ) | |
$ | 2.13 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Tax Rate | |
| 15.5 | % | |
| | | |
| | | |
| | | |
| | | |
| | | |
| 15.0 | % |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Sep YTD | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Cost of sales | |
$ | 12,214 | | |
| 1,564 | | |
| 94 | | |
| | | |
| | | |
| 1,658 | | |
$ | 10,556 | |
| Selling, general and administrative | |
| 7,700 | | |
| 62 | | |
| 93 | | |
| | | |
| | | |
| 155 | | |
| 7,545 | |
| Research and development | |
| 20,904 | | |
| 29 | | |
| 1 | | |
| | | |
| | | |
| 30 | | |
| 20,874 | |
| Restructuring costs | |
| 344 | | |
| | | |
| 344 | | |
| | | |
| | | |
| 344 | | |
| – | |
| Other (income) expense, net | |
| 388 | | |
| (12 | ) | |
| | | |
| (218 | ) | |
| 573 | (3) | |
| 343 | | |
| 45 | |
| Income Before Taxes | |
| 3,935 | | |
| (1,643 | ) | |
| (532 | ) | |
| 218 | | |
| (573 | ) | |
| (2,530 | ) | |
| 6,465 | |
| Income Tax Provision (Benefit) | |
| 2,332 | | |
| (249 | )(4) | |
| (88 | )(4) | |
| 47 | (4) | |
| (60 | )(4) | |
| (350 | ) | |
| 2,682 | |
| Net Income | |
| 1,603 | | |
| (1,394 | ) | |
| (444 | ) | |
| 171 | | |
| (513 | ) | |
| (2,180 | ) | |
| 3,783 | |
| Net Income Attributable to Merck & Co., Inc. | |
| 1,591 | | |
| (1,394 | ) | |
| (444 | ) | |
| 171 | | |
| (513 | ) | |
| (2,180 | ) | |
| 3,771 | |
| Earnings per Common Share Assuming Dilution | |
$ | 0.62 | | |
| (0.55 | ) | |
| (0.18 | ) | |
| 0.07 | | |
| (0.20 | ) | |
| (0.86 | ) | |
$ | 1.48 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Tax Rate | |
| 59.3 | % | |
| | | |
| | | |
| | | |
| | | |
| | | |
| 41.5 | % |
Only
the line items that are affected by non-GAAP adjustments are shown.
Merck
is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on
the analysis of underlying business performance and trends. Management believes that providing non-GAAP information enhances investors’
understanding of the company’s results because management uses non-GAAP measures to assess performance. Management uses non-GAAP
measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In
addition, senior management’s annual compensation is derived in part using a non-GAAP pretax income metric. The non-GAAP information
presented should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP.
(1) Amounts
included in cost of sales primarily reflect expenses for the amortization of intangible assets. Amounts included in selling, general
and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures. Amounts
included in research and development expenses primarily reflect expenses for the amortization of intangible assets. Amounts included
in other (income) expense, net, primarily reflect royalty income, partially offset by 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. Additionally, the
nine-month period includes a $37 million loss on the sale of a business.
(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
THIRD QUARTER 2024
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3a
| | |
Global | | |
U.S. | | |
International | |
| | |
3Q
2024 | | |
3Q
2023 | | |
%
Change | | |
3Q
2024 | | |
3Q
2023 | | |
%
Change | | |
3Q
2024 | | |
3Q
2023 | | |
%
Change | |
| TOTAL
SALES (1) | |
$ | 16,657 | | |
$ | 15,962 | | |
| 4 | | |
$ | 8,736 | | |
$ | 7,715 | | |
| 13 | | |
$ | 7,922 | | |
$ | 8,247 | | |
| -4 | |
| PHARMACEUTICAL | |
| 14,943 | | |
| 14,263 | | |
| 5 | | |
| 8,227 | | |
| 7,153 | | |
| 15 | | |
| 6,717 | | |
| 7,110 | | |
| -6 | |
| Oncology | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Keytruda | |
| 7,429 | | |
| 6,338 | | |
| 17 | | |
| 4,500 | | |
| 3,795 | | |
| 19 | | |
| 2,929 | | |
| 2,543 | | |
| 15 | |
| Alliance
Revenue – Lynparza (2) | |
| 337 | | |
| 299 | | |
| 13 | | |
| 161 | | |
| 153 | | |
| 5 | | |
| 177 | | |
| 146 | | |
| 21 | |
| Alliance
Revenue – Lenvima (2) | |
| 251 | | |
| 260 | | |
| -3 | | |
| 173 | | |
| 160 | | |
| 9 | | |
| 78 | | |
| 100 | | |
| -22 | |
| Welireg | |
| 139 | | |
| 54 | | |
| 156 | | |
| 127 | | |
| 51 | | |
| 148 | | |
| 12 | | |
| 3 | | |
| * | |
| Alliance
Revenue – Reblozyl (3) | |
| 100 | | |
| 52 | | |
| 91 | | |
| 82 | | |
| 43 | | |
| 93 | | |
| 18 | | |
| 10 | | |
| 83 | |
| Vaccines
(4) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Gardasil/Gardasil 9 | |
| 2,306 | | |
| 2,585 | | |
| -11 | | |
| 1,020 | | |
| 838 | | |
| 22 | | |
| 1,285 | | |
| 1,746 | | |
| -26 | |
| ProQuad/M-M-R II/Varivax | |
| 703 | | |
| 713 | | |
| -1 | | |
| 572 | | |
| 567 | | |
| 1 | | |
| 131 | | |
| 146 | | |
| -10 | |
| Vaxneuvance | |
| 239 | | |
| 214 | | |
| 12 | | |
| 137 | | |
| 182 | | |
| -25 | | |
| 103 | | |
| 33 | | |
| * | |
| RotaTeq | |
| 193 | | |
| 156 | | |
| 24 | | |
| 131 | | |
| 108 | | |
| 21 | | |
| 62 | | |
| 48 | | |
| 28 | |
| Pneumovax 23 | |
| 68 | | |
| 140 | | |
| -51 | | |
| 19 | | |
| 42 | | |
| -54 | | |
| 49 | | |
| 98 | | |
| -50 | |
| Hospital Acute
Care | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Bridion | |
| 420 | | |
| 424 | | |
| -1 | | |
| 339 | | |
| 265 | | |
| 28 | | |
| 81 | | |
| 159 | | |
| -49 | |
| Prevymis | |
| 208 | | |
| 157 | | |
| 32 | | |
| 101 | | |
| 70 | | |
| 43 | | |
| 107 | | |
| 87 | | |
| 24 | |
| Dificid | |
| 96 | | |
| 74 | | |
| 31 | | |
| 83 | | |
| 69 | | |
| 20 | | |
| 13 | | |
| 5 | | |
| 190 | |
| Zerbaxa | |
| 64 | | |
| 53 | | |
| 22 | | |
| 39 | | |
| 29 | | |
| 34 | | |
| 26 | | |
| 24 | | |
| 6 | |
| Noxafil | |
| 41 | | |
| 51 | | |
| -20 | | |
| 1 | | |
| 4 | | |
| -85 | | |
| 40 | | |
| 47 | | |
| -15 | |
| Cardiovascular | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Winrevair | |
| 149 | | |
| | | |
| - | | |
| 147 | | |
| | | |
| - | | |
| 3 | | |
| | | |
| - | |
| Alliance
Revenue - Adempas/Verquvo (5) | |
| 102 | | |
| 92 | | |
| 11 | | |
| 96 | | |
| 96 | | |
| -1 | | |
| 7 | | |
| -4 | | |
| * | |
| Adempas
(6) | |
| 72 | | |
| 65 | | |
| 11 | | |
| | | |
| | | |
| | | |
| 72 | | |
| 65 | | |
| 11 | |
| Virology | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Lagevrio | |
| 383 | | |
| 640 | | |
| -40 | | |
| 84 | | |
| | | |
| - | | |
| 299 | | |
| 640 | | |
| -53 | |
| Isentress/Isentress HD | |
| 102 | | |
| 119 | | |
| -14 | | |
| 54 | | |
| 58 | | |
| -6 | | |
| 48 | | |
| 61 | | |
| -21 | |
| Delstrigo | |
| 65 | | |
| 54 | | |
| 21 | | |
| 15 | | |
| 13 | | |
| 15 | | |
| 50 | | |
| 40 | | |
| 23 | |
| Pifeltro | |
| 42 | | |
| 37 | | |
| 14 | | |
| 31 | | |
| 27 | | |
| 12 | | |
| 12 | | |
| 10 | | |
| 20 | |
| Neuroscience | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Belsomra | |
| 78 | | |
| 58 | | |
| 35 | | |
| 20 | | |
| 23 | | |
| -12 | | |
| 58 | | |
| 35 | | |
| 66 | |
| Immunology | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Simponi | |
| 189 | | |
| 179 | | |
| 5 | | |
| | | |
| | | |
| | | |
| 189 | | |
| 179 | | |
| 5 | |
| Remicade | |
| 41 | | |
| 45 | | |
| -9 | | |
| | | |
| | | |
| | | |
| 41 | | |
| 45 | | |
| -9 | |
| Diabetes
(7) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Januvia | |
| 278 | | |
| 581 | | |
| -52 | | |
| 67 | | |
| 328 | | |
| -80 | | |
| 211 | | |
| 252 | | |
| -16 | |
| Janumet | |
| 204 | | |
| 255 | | |
| -20 | | |
| 15 | | |
| 43 | | |
| -67 | | |
| 190 | | |
| 211 | | |
| -10 | |
| Other
Pharmaceutical (8) | |
| 644 | | |
| 568 | | |
| 13 | | |
| 213 | | |
| 189 | | |
| 13 | | |
| 426 | | |
| 381 | | |
| 12 | |
| ANIMAL HEALTH | |
| 1,487 | | |
| 1,400 | | |
| 6 | | |
| 487 | | |
| 462 | | |
| 6 | | |
| 999 | | |
| 938 | | |
| 6 | |
| Livestock | |
| 886 | | |
| 874 | | |
| 1 | | |
| 194 | | |
| 205 | | |
| -5 | | |
| 692 | | |
| 669 | | |
| 3 | |
| Companion Animal | |
| 601 | | |
| 526 | | |
| 14 | | |
| 293 | | |
| 257 | | |
| 14 | | |
| 307 | | |
| 269 | | |
| 14 | |
| Other
Revenues (9) | |
| 227 | | |
| 299 | | |
| -24 | | |
| 22 | | |
| 100 | | |
| -78 | | |
| 206 | | |
| 199 | | |
| 4 | |
*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 $3,675 million and $4,002 million on a global basis in the third quarter of 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 $592 million and $924 million on a global basis in the third quarter of 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 $15
million and $65 million on a global basis in the third quarter of 2024 and 2023, respectively.
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT
SALES
SEPTEMBER YEAR-TO-DATE
2024
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3b
| | |
Global | | |
U.S. | | |
International | |
| | |
Sep
YTD
2024 | | |
Sep
YTD
2023 | | |
%
Change | | |
Sep
YTD
2024 | | |
Sep
YTD
2023 | | |
%
Change | | |
Sep
YTD
2024 | | |
Sep
YTD
2023 | | |
%
Change | |
| TOTAL
SALES (1) | |
$ | 48,544 | | |
$ | 45,485 | | |
| 7 | | |
$ | 24,089 | | |
$ | 21,393 | | |
| 13 | | |
$ | 24,455 | | |
$ | 24,092 | | |
| 2 | |
| PHARMACEUTICAL | |
| 43,358 | | |
| 40,442 | | |
| 7 | | |
| 22,563 | | |
| 19,840 | | |
| 14 | | |
| 20,795 | | |
| 20,602 | | |
| 1 | |
| Oncology | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Keytruda | |
| 21,646 | | |
| 18,403 | | |
| 18 | | |
| 13,031 | | |
| 11,142 | | |
| 17 | | |
| 8,614 | | |
| 7,261 | | |
| 19 | |
| Alliance
Revenue – Lynparza (2) | |
| 947 | | |
| 884 | | |
| 7 | | |
| 449 | | |
| 439 | | |
| 2 | | |
| 498 | | |
| 445 | | |
| 12 | |
| Alliance
Revenue – Lenvima (2) | |
| 755 | | |
| 734 | | |
| 3 | | |
| 523 | | |
| 476 | | |
| 10 | | |
| 233 | | |
| 258 | | |
| -10 | |
| Welireg | |
| 349 | | |
| 146 | | |
| 138 | | |
| 320 | | |
| 141 | | |
| 128 | | |
| 29 | | |
| 6 | | |
| * | |
| Alliance
Revenue – Reblozyl (3) | |
| 261 | | |
| 142 | | |
| 84 | | |
| 215 | | |
| 108 | | |
| 99 | | |
| 45 | | |
| 33 | | |
| 36 | |
| Vaccines
(4) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Gardasil/Gardasil 9 | |
| 7,032 | | |
| 7,015 | | |
| - | | |
| 2,045 | | |
| 1,718 | | |
| 19 | | |
| 4,988 | | |
| 5,297 | | |
| -6 | |
| ProQuad/M-M-R II/Varivax | |
| 1,891 | | |
| 1,823 | | |
| 4 | | |
| 1,500 | | |
| 1,435 | | |
| 5 | | |
| 391 | | |
| 388 | | |
| 1 | |
| Vaxneuvance | |
| 647 | | |
| 488 | | |
| 33 | | |
| 397 | | |
| 423 | | |
| -6 | | |
| 251 | | |
| 65 | | |
| * | |
| RotaTeq | |
| 572 | | |
| 584 | | |
| -2 | | |
| 388 | | |
| 381 | | |
| 2 | | |
| 185 | | |
| 203 | | |
| -9 | |
| Pneumovax 23 | |
| 188 | | |
| 327 | | |
| -42 | | |
| 36 | | |
| 105 | | |
| -66 | | |
| 152 | | |
| 223 | | |
| -32 | |
| Hospital Acute
Care | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Bridion | |
| 1,315 | | |
| 1,413 | | |
| -7 | | |
| 1,020 | | |
| 841 | | |
| 21 | | |
| 296 | | |
| 572 | | |
| -48 | |
| Prevymis | |
| 570 | | |
| 430 | | |
| 33 | | |
| 265 | | |
| 186 | | |
| 43 | | |
| 305 | | |
| 244 | | |
| 25 | |
| Dificid | |
| 261 | | |
| 215 | | |
| 21 | | |
| 231 | | |
| 199 | | |
| 16 | | |
| 30 | | |
| 16 | | |
| 93 | |
| Zerbaxa | |
| 182 | | |
| 157 | | |
| 16 | | |
| 106 | | |
| 86 | | |
| 23 | | |
| 77 | | |
| 71 | | |
| 8 | |
| Noxafil | |
| 141 | | |
| 167 | | |
| -15 | | |
| 9 | | |
| 29 | | |
| -69 | | |
| 132 | | |
| 138 | | |
| -4 | |
| Cardiovascular | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Alliance
Revenue - Adempas/Verquvo (5) | |
| 306 | | |
| 259 | | |
| 18 | | |
| 283 | | |
| 249 | | |
| 14 | | |
| 22 | | |
| 10 | | |
| 123 | |
| Winrevair | |
| 219 | | |
| | | |
| - | | |
| 216 | | |
| | | |
| - | | |
| 3 | | |
| | | |
| - | |
| Adempas
(6) | |
| 214 | | |
| 189 | | |
| 13 | | |
| | | |
| | | |
| | | |
| 214 | | |
| 189 | | |
| 13 | |
| Virology | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Lagevrio | |
| 843 | | |
| 1,236 | | |
| -32 | | |
| 144 | | |
| | | |
| - | | |
| 699 | | |
| 1,236 | | |
| -43 | |
| Isentress/Isentress HD | |
| 302 | | |
| 377 | | |
| -20 | | |
| 147 | | |
| 165 | | |
| -11 | | |
| 155 | | |
| 212 | | |
| -27 | |
| Delstrigo | |
| 180 | | |
| 148 | | |
| 22 | | |
| 42 | | |
| 37 | | |
| 13 | | |
| 139 | | |
| 110 | | |
| 26 | |
| Pifeltro | |
| 123 | | |
| 109 | | |
| 13 | | |
| 86 | | |
| 78 | | |
| 10 | | |
| 37 | | |
| 31 | | |
| 20 | |
| Neuroscience | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Belsomra | |
| 177 | | |
| 176 | | |
| - | | |
| 53 | | |
| 60 | | |
| -11 | | |
| 124 | | |
| 117 | | |
| 6 | |
| Immunology | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Simponi | |
| 545 | | |
| 539 | | |
| 1 | | |
| | | |
| | | |
| | | |
| 545 | | |
| 539 | | |
| 1 | |
| Remicade | |
| 115 | | |
| 144 | | |
| -20 | | |
| | | |
| | | |
| | | |
| 115 | | |
| 144 | | |
| -20 | |
| Diabetes
(7) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Januvia | |
| 1,102 | | |
| 1,642 | | |
| -33 | | |
| 428 | | |
| 842 | | |
| -49 | | |
| 674 | | |
| 800 | | |
| -16 | |
| Janumet | |
| 679 | | |
| 937 | | |
| -28 | | |
| 70 | | |
| 182 | | |
| -62 | | |
| 610 | | |
| 755 | | |
| -19 | |
| Other
Pharmaceutical (8) | |
| 1,796 | | |
| 1,758 | | |
| 2 | | |
| 559 | | |
| 518 | | |
| 8 | | |
| 1,232 | | |
| 1,239 | | |
| -1 | |
| ANIMAL HEALTH | |
| 4,480 | | |
| 4,347 | | |
| 3 | | |
| 1,417 | | |
| 1,418 | | |
| - | | |
| 3,063 | | |
| 2,929 | | |
| 5 | |
| Livestock | |
| 2,573 | | |
| 2,530 | | |
| 2 | | |
| 529 | | |
| 543 | | |
| -3 | | |
| 2,044 | | |
| 1,987 | | |
| 3 | |
| Companion Animal | |
| 1,907 | | |
| 1,817 | | |
| 5 | | |
| 888 | | |
| 875 | | |
| 1 | | |
| 1,019 | | |
| 942 | | |
| 8 | |
| Other
Revenues (9) | |
| 706 | | |
| 696 | | |
| 2 | | |
| 109 | | |
| 135 | | |
| -19 | | |
| 597 | | |
| 561 | | |
| 6 | |
*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 $10,755 million and $10,692 million on a global basis for September 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 $2,053 million and $2,826 million on a global basis for September 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 $91
million and $118 million on a global basis for September YTD 2024 and 2023, respectively.
MERCK & CO., INC.
PHARMACEUTICAL GEOGRAPHIC SALES
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3c
| | |
2024 | | |
2023 | | |
%
Change | |
| | |
1Q | | |
2Q | | |
3Q | | |
Sep
YTD | | |
1Q | | |
2Q | | |
3Q | | |
Sep
YTD | | |
4Q | | |
Full
Year | | |
3Q | | |
Sep
YTD | |
| TOTAL
PHARMACEUTICAL | |
$ | 14,006 | | |
$ | 14,408 | | |
$ | 14,943 | | |
$ | 43,358 | | |
$ | 12,721 | | |
$ | 13,457 | | |
$ | 14,263 | | |
$ | 40,442 | | |
$ | 13,141 | | |
$ | 53,583 | | |
| 5 | | |
| 7 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |