Form 8-K
8-K — Merck & Co., Inc.
Accession: 0001104659-26-119825
Filed: 2026-10-29
Period: 2026-10-29
CIK: 0000310158
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — tm2628203d1_8k.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (tm2628203d1_ex99-1.htm)
EX-99.2 — EXHIBIT 99.2 (tm2628203d1_ex99-2.htm)
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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 29, 2026 (October 29, 2026)
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
New
Jersey 07065
(Address of principal executive offices) (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))
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
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
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. ¨
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 29, 2026, regarding earnings for the third quarter of 2026, attached as Exhibit 99.1. Also incorporated by reference
is certain supplemental information not included in the press release, attached as Exhibit 99.2.
This information shall not be deemed to be “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to
the liabilities of that Section, and is not incorporated by reference in any filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit 99.1
Press release issued
October 29, 2026, regarding earnings for the third quarter of 2026
Exhibit 99.2
Certain supplemental information
not included in the press release
Exhibit 104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
Merck & Co., Inc.
Date: October 29, 2026
By:
/s/
Kelly E. W. Grez
Kelly
E. W. Grez
Corporate Secretary
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: tm2628203d1_ex99-1.htm · Sequence: 2
Exhibit 99.1
- 1 -
News Release
Merck & Co., Inc., Rahway, N.J.,
USA Announces Third-Quarter 2026 Financial Results; Highlights Multiple Milestones Advancing Broad, Diverse Pipeline
Sales Growth Reflects Continued Strength in
Oncology and Animal Health, Plus Contributions From Other Products in Broader Portfolio, Including WINREVAIR
Financial Highlights
- Total Worldwide Sales Were $18.1 Billion (5% Growth; 4% Growth ex-FX)
o KEYTRUDA/KEYTRUDA QLEX1 Sales Were $8.6 Billion (6% Growth;
6% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $830 Million
o WINREVAIR Sales Were $694 Million (93% Growth; 94% Growth ex-FX)
o Animal Health Sales Were $1.7 Billion (4% Growth; 3% Growth ex-FX)
- GAAP EPS Was $2.04; Non-GAAP EPS Was $2.49; GAAP and Non-GAAP EPS
Include a One-Time Charge of $0.12 per Share Related to a Global License Agreement With
SciBrunch
Pipeline & Portfolio Highlights
- Presented First-Time Pivotal Data From Phase 3 Trials Across Robust
Oncology Pipeline at ESMO Congress 2026, Including:
o TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (sac-TMT) in
Certain Patients With Advanced or Recurrent Endometrial Cancer; U.S. FDA Accepted for Priority
Review a Biologics License Application Based on These Data
o INTerpath-001 Trial Evaluating Intismeran Autogene Plus KEYTRUDA as
Adjuvant Treatment for Patients With Resected Stage IIB-IV Melanoma, in Collaboration With
Moderna
- Announced Positive Phase 2b Results in Moderate to Severe Hidradenitis
Suppurativa From Clinical Study of Investigational Immunology Candidate Tulisokibart
- Presented One-Year Results From Phase 2b/3 BRUNELLO Trial Evaluating
Remigromig in Adults With Diabetic Macular Edema
Full-Year 2026 Financial Outlook
- Narrows and Raises the Midpoint of Worldwide Sales Range; Now Expects
Sales To Be Between $66.8 Billion and $67.3 Billion
1
Available in some markets as KEYTRUDA SC.
- 2 -
- Narrows and Raises Expected Non-GAAP EPS Range To Be Between $2.77
and $2.82; Outlook Now Includes One-Time Charge of $0.12 per Share Related to the Global
License Agreement With SciBrunch
RAHWAY, N.J., Oct. 29, 2026 – Merck & Co., Inc.,
Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter
of 2026.
“Our science-led strategy is transforming
our business,” said Robert M. Davis, chairman and chief executive officer. “The potentially practice-changing advances in
oncology presented at last weekend’s ESMO meeting, including new data for our antibody-drug conjugate sac-TMT and the first Phase
3 validation of a therapeutic cancer vaccine, further clinically de-risk the substantial long-term opportunity of our late-phase pipeline.
With positive momentum across multiple therapeutic areas, I’m increasingly confident in our ability to deliver long-term value
for patients and shareholders.”
Financial Summary
Third Quarter
$ in millions, except EPS amounts
2026
2025
Change
Change Ex-
Exchange
Sales
$ 18,085
$ 17,276
5 %
4 %
GAAP net income2
5,065
5,785
-12 %
-14 %
Non-GAAP net income that
excludes certain items2,3*
6,159
6,448
-4 %
-5 %
GAAP EPS
2.04
2.32
-12 %
-13 %
Non-GAAP EPS that excludes certain
items3*
2.49
2.58
-3 %
-5 %
*Refer to table on page 7.
For the third quarter of 2026, Generally Accepted
Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $2.04 and non-GAAP EPS was $2.49. Both GAAP and non-GAAP
EPS in the third quarter of 2026 include a one-time charge of $0.12 per share related to a global license agreement with SciBrunch Therapeutics
Co., Ltd. (SciBrunch). Both GAAP and non-GAAP EPS in the third quarter of 2025 include a charge of $0.10 per share for a milestone
payment to LaNova Medicines Ltd. (LaNova, acquired by Sino Biopharmaceutical Limited) associated with the technology transfer for MK-2010.
Non-GAAP EPS excludes acquisition- and divestiture-related
costs and costs related to restructuring programs, as well as income and losses from investments in equity securities. Non-GAAP EPS in
the third quarter of 2025 also excludes tax expense relating to audit reserve adjustments.
2
Net income attributable to the Company.
3
The Company is providing certain 2026 and 2025 non-GAAP information that excludes certain items because of the nature of these items
and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information
enhances investors’ understanding of the Company’s results because management uses non-GAAP results to assess performance.
Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along
with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using
a non-GAAP pretax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information
prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release.
- 3 -
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
2026
2025
Change
Change Ex-
Exchange
Commentary
Total Sales
$ 18,085
$ 17,276
5 %
4 %
Pharmaceutical
16,268
15,611
4 %
4 %
Increase primarily driven by growth in
KEYTRUDA/KEYTRUDA QLEX, WINREVAIR, GARDASIL/GARDASIL 9, WELIREG, ENFLONSIA and the inclusion of OHTUVAYRE sales. Growth benefited
from the timing of purchases by approximately $550 million. Growth was partially offset by declines in BRIDION, JANUVIA/JANUMET
and LAGEVRIO, as well as lower alliance revenue related to Koselugo.
KEYTRUDA/
KEYTRUDA QLEX
8,601
8,147
6 %
6 %
Growth primarily driven by strong global
uptake in earlier-stage indications including triple-negative breast cancer, cervical cancer, head and neck cancer and bladder cancer,
as well as higher global demand in metastatic indications, including urothelial cancer. Timing of wholesaler purchases unfavorably
affected sales in the U.S. but was largely offset by a benefit from increased inventory in the channel. Sales of KEYTRUDA QLEX were
$830 million.
GARDASIL/GARDASIL 9
1,995
1,749
14 %
14 %
Increase primarily due to higher sales
in the U.S. reflecting favorable public-sector purchasing patterns and higher net pricing.
PROQUAD, M-M-R II and VARIVAX
730
684
7 %
7 %
Increase primarily due to higher demand
in certain European markets.
WINREVAIR
694
360
93 %
94 %
Growth primarily reflects higher demand
and favorable wholesaler and specialty pharmacy purchasing patterns in the U.S., as well as launch uptake in certain international
markets, particularly in Europe and Japan.
JANUVIA/JANUMET
380
624
-39 %
-39 %
Decline primarily driven by lower demand
due to generic competition following loss of market exclusivity in the U.S.
Lynparza*
352
379
-7 %
-7 %
Decline primarily due to lower net pricing
in the U.S. and lower demand and pricing in China.
PREVYMIS
347
266
30 %
31 %
Increase primarily due to higher demand
globally.
- 4 -
Third Quarter
$ in millions
2026
2025
Change
Change Ex-
Exchange
Commentary
WELIREG
307
196
56 %
58 %
Growth
primarily driven by higher demand in the U.S. and continued launch uptake in international markets, particularly in Japan.
Lenvima*
287
258
11 %
11 %
Growth primarily
due to higher demand in the U.S.
CAPVAXIVE
263
244
8 %
7 %
Increase primarily
driven by launch uptake in several international markets, particularly in Asia Pacific and Europe, partially offset by lower sales
in the U.S. reflecting lower adult pneumococcal vaccination rates and lower net pricing.
ENFLONSIA
187
79
138 %
136 %
Increase primarily
driven by seasonal demand and associated inventory build in the U.S. and certain international markets.
OHTUVAYRE
184
-
-
-
Product obtained
as part of the Company's October 2025 acquisition of Verona Pharma plc.
BRIDION
144
439
-67 %
-67 %
Decline primarily
driven by lower demand in the U.S. due to generic competition following loss of market exclusivity.
LAGEVRIO
17
138
-88 %
-88 %
Decline largely
due to lower demand in Japan.
Animal Health
1,676
1,615
4 %
3 %
Growth attributable
to both Livestock and Companion Animal product portfolios.
Livestock
1,048
1,023
2 %
2 %
Growth primarily
driven by higher demand for poultry products.
Companion Animal
628
592
6 %
6 %
Growth largely driven
by new product launches. Sales of BRAVECTO line of products were $264 million and $262 million in the current and prior-year quarters,
respectively, which represents an increase of 1%, or flat excluding impact of foreign exchange.
Other Revenues**
141
50
185 %
-25 %
Increase primarily
due to favorable impact of revenue-hedging activities, partially offset by lower revenue from third-party manufacturing arrangements.
*Alliance revenue for this product represents the
Company’s share of profits, which are product sales net of cost of sales and commercialization costs.
**Other revenues are comprised primarily of revenues
from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.
In addition, Koselugo alliance revenue was $13
million in the third quarter of 2026 compared with $214 million in the third quarter of 2025. The decrease was due to an amendment to
the collaboration agreement with AstraZeneca in 2025, which discontinued the provisions whereby the Company shared revenue and costs
with AstraZeneca, and revised the payment structure, resulting in the Company’s recognition of a $150 million upfront payment and
a $50 million regulatory milestone in the third quarter of 2025.
- 5 -
Third-Quarter Expense and Related Information
The table below presents selected expense information.
$ in millions
GAAP
Acquisition-
and
Divestiture-
Related
Costs4
Restructuring
Costs
(Income)
Loss From
Investments
in Equity
Securities
Non-
GAAP3
Third Quarter 2026
Cost of sales
$ 4,892
$ 1,140
$ 396
$ -
$ 3,356
Selling, general and administrative
2,886
24
-
-
2,862
Research and development
4,537
3
1
-
4,533
Restructuring costs
184
-
184
-
-
Other (income) expense, net
27
-
-
(393 )
420
Third Quarter 2025
Cost of sales
$ 3,855
$ 621
$ 110
$ -
$ 3,124
Selling, general and administrative
2,633
34
-
-
2,599
Research and development
4,234
4
233
-
3,997
Restructuring costs
47
-
47
-
-
Other (income) expense, net
(238 )
-
-
(344 )
106
GAAP Expense, EPS and Related Information
Gross margin was 72.9% for the third quarter of
2026 compared with 77.7% for the third quarter of 2025. The decrease was primarily due to higher amortization of intangible assets, restructuring
costs and production costs.
Selling, general and administrative (SG&A)
expenses were $2.9 billion in the third quarter of 2026, an increase of 10% compared with the third quarter of 2025. The increase was
primarily due to higher administrative costs, as well as higher promotional costs in support of product launches.
Research and development (R&D) expenses were
$4.5 billion in the third quarter of 2026, an increase of 7% compared with the third quarter of 2025. The increase was primarily due
to a $400 million charge related to a global license agreement with SciBrunch and higher clinical development spending, partially offset
by lower restructuring costs and a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone Life Sciences
(Blackstone). R&D expenses in the third quarter of 2025 include a $300 million charge for a milestone payment to LaNova for the completion
of the technology transfer for MK-2010.
Other (income) expense, net, was $27 million of
expense in the third quarter of 2026 compared with $238 million of income in the third quarter of 2025. The unfavorability was primarily
due to higher net interest expense.
4
Reflects expenses related to business combinations, 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, licensing arrangements and asset acquisitions, and recognition of fair value step-up to inventories
for asset acquisitions.
- 6 -
The effective income tax rate for the third quarter
of 2026 was 8.9%, reflecting the favorable impacts of certain discrete items, as well as jurisdictional mix of income and expense.
GAAP EPS was $2.04 for the third quarter of 2026
compared with $2.32 for the third quarter of 2025. The decrease was primarily driven by higher operating expenses, reflecting increased
investments to advance the R&D pipeline and support product launches, higher amortization of intangible assets, higher net interest
expense and increased restructuring costs, partially offset by operational strength in the business and a lower effective income tax
rate.
Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was 81.4% for the third
quarter of 2026 compared with 81.9% for the third quarter of 2025. The decrease was primarily due to higher production costs.
Non-GAAP SG&A expenses were $2.9 billion in
the third quarter of 2026, an increase of 10% compared with the third quarter of 2025. The increase was primarily due to higher administrative
costs, as well as higher promotional costs in support of product launches.
Non-GAAP R&D expenses were $4.5 billion in
the third quarter of 2026, an increase of 13% compared with the third quarter of 2025. The increase was primarily due to a $400 million
charge related to a global license agreement with SciBrunch and higher clinical development spending, partially offset by a $200 million
reduction in R&D expenses as part of a funding agreement with Blackstone. R&D expenses in the third quarter of 2025 include a
$300 million charge for a milestone payment to LaNova for the completion of the technology transfer for MK-2010.
Non-GAAP other (income) expense, net, was $420
million of expense in the third quarter of 2026 compared with $106 million of expense in the third quarter of 2025. The unfavorability
was primarily due to higher net interest expense.
The non-GAAP effective income tax rate for the
third quarter of 2026 was 10.9%, reflecting the favorable impacts of certain discrete items, as well as jurisdictional mix of income
and expense.
Non-GAAP EPS was $2.49 for the third quarter of
2026 compared with $2.58 for the third quarter of 2025. The decrease was primarily driven by higher operating expenses, reflecting increased
investments to advance the R&D pipeline and support product launches, and higher net interest expense, partially offset by operational
strength in the business and a lower effective income tax rate.
- 7 -
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
2026
2025
EPS
GAAP EPS
$ 2.04
$ 2.32
Difference
0.45
0.26
Non-GAAP
EPS that excludes items listed below3
$ 2.49
$ 2.58
Net Income
GAAP
net income2
$ 5,065
$ 5,785
Difference
1,094
663
Non-GAAP
net income that excludes items listed below2,3
$ 6,159
$ 6,448
Excluded Items:
Acquisition-
and divestiture-related costs4
$ 1,167
$ 659
Restructuring costs
581
390
Income from investments in equity securities
(393 )
(344 )
Decrease to net income before taxes
1,355
705
Estimated
income tax (benefit) expense5
(261 )
(42 )
Decrease to net income
$ 1,094
$ 663
Pipeline and Portfolio Highlights
In the third quarter, the Company achieved key
regulatory and clinical milestones to meaningfully advance its broad and diverse pipeline.
· Oncology:
o U.S. Food and Drug Administration (U.S. FDA) approved WELIREG plus
Lenvima, in collaboration with Eisai, for certain previously treated adult patients with
advanced renal cell carcinoma with a clear cell component (ccRCC), based on Phase 3 LITESPARK-011
trial.
§ Approval
represents first approved combination of an oral hypoxia-inducible factor-2 alpha inhibitor
and a multi-targeted vascular endothelial growth factor tyrosine kinase inhibitor (TKI) for
these patients.
o In October, U.S. FDA accepted a Biologics License Application (BLA)
seeking approval of sac-TMT for the treatment of adult patients with endometrial cancer who
have previously received platinum containing chemotherapy and a programmed death receptor
1 or programmed death ligand 1 inhibitor, separately or in combination, based on Phase 3
TroFuse-005 trial.
§ U.S.
FDA set Prescription Drug User Fee Act (PDUFA) date of June 15, 2027. The Company is
in discussions with the U.S. FDA and is hopeful for an earlier approval.
o In October, European Commission (EC) approved KEYTRUDA plus Padcev
as perioperative treatment for adults with resectable muscle-invasive bladder cancer (MIBC),
based on Phase 3 KEYNOTE-B15 trial.
5 Includes
the estimated income tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP
adjustments for all periods presented. Amount in the third quarter of 2025 also includes $86 million of tax expense relating to audit
reserve adjustments.
- 8 -
o Ministry of Health, Labor and Welfare in Japan approved subcutaneous
pembrolizumab and berahyaluronidase alfa injection under the trademark KEYJECT (marketed
as KEYTRUDA QLEX in the U.S.) for all KEYTRUDA indications approved in Japan, based on Phase
3 MK-3475A-D77 trial.
o At the European Society for Medical Oncology (ESMO) Congress 2026
in October, positive new data were presented during three late-breaking Presidential Symposia
across three Phase 3 trials from the Company’s robust oncology pipeline and portfolio,
including:
§ Results
from Phase 3 TroFuse-005 trial evaluating sac-TMT for patients with advanced or recurrent
endometrial cancer previously treated with chemotherapy and anti-PD-1/L1 immunotherapy.
§ Results
from Phase 3 INTerpath-001 trial, in collaboration with Moderna, Inc. (Moderna), evaluating
adjuvant treatment with intismeran autogene (intismeran; V940 or mRNA-4157) in combination
with KEYTRUDA.
§ Results
from Phase 3 KEYNOTE-C93 trial evaluating KEYTRUDA monotherapy versus platinum doublet chemotherapy
as a first-line treatment for certain patients with mismatch repair deficient (dMMR) advanced
or recurrent endometrial cancer who had not previously received systemic chemotherapy or
who experienced recurrence more than six months after completing prior adjuvant therapy.
§ In
addition, data were presented from Phase 3 OptiTROP studies in China, led by Kelun-Biotech,
evaluating sac-TMT in non-small cell lung cancer (NSCLC), including:
· Results
from the OptiTROP-Lung06 study as first-line treatment for PD-L1-negative advanced non-squamous
NSCLC.
· Final
overall survival data from the OptiTROP-Lung04 study in epidermal growth factor receptor
(EGFR)-mutated NSCLC following progression on EGFR TKIs.
o Ifinatamab deruxtecan (I-DXd) Biologics License Application (BLA),
in collaboration with Daiichi Sankyo, for certain patients with previously treated extensive-stage
small cell lung cancer (ES-SCLC) was voluntarily withdrawn.
· Vaccines
and Infectious Diseases:
o U.S. FDA accepted a supplemental BLA (sBLA) for ENFLONSIA to expand
its indication to include prevention of respiratory syncytial virus (RSV) lower respiratory
tract disease (LRTD) in children under 2 years of age at increased risk for severe RSV disease
through their second RSV season, based on Phase 3 SMART trial.
§ U.S.
FDA set PDUFA date of March 22, 2027.
§ Applications
to expand marketing authorization for ENFLONSIA for same population in Europe and Japan,
based on Phase 3 SMART trial, have also been accepted.
- 9 -
o U.S. FDA accepted a supplemental New Drug Application (sNDA) for IDVYNSO
for the treatment of certain adults with HIV-1 infection who had not previously received
antiretroviral treatment, based on Phase 3 P053 trial. U.S. FDA also accepted an sNDA to
include 96-week data for IDVYNSO in certain virologically suppressed adults, based on the
Phase 3 P051 and P052 trials.
§ U.S.
FDA set a PDUFA date for both sNDAs of April 22, 2027.
· Cardiometabolic,
Respiratory and Specialty:
o U.S. FDA approved an update to U.S. product label for WINREVAIR to
include efficacy and safety data from the Phase 3 HYPERION trial evaluating adults recently
diagnosed with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group
1 pulmonary hypertension).
§ In
HYPERION, in patients diagnosed with PAH in the last 12 months, adding WINREVAIR on top of
background therapy reduced the risk of clinical worsening events compared to placebo.
· Immunology:
o Presented results from Phase 2b study of tulisokibart in adults with
moderate to severe hidradenitis suppurativa (HS).
· Ophthalmology:
o At the American Academy of Ophthalmology (AAO) 2026 Annual Meeting
in October, presented for the first time one-year results from Phase 2b/3 BRUNELLO trial
evaluating remigromig, an investigational, tetravalent, tri-specific antibody designed to
agonize the Wingless-related integration site (Wnt) pathway, in adults with diabetic macular
edema (DME).
· Business
Development:
o Announced an exclusive global license agreement with SciBrunch for
MK-2690 (SPR2015), an investigational preclinical oral KRAS G12D (ON) inhibitor.
Notable recent news releases on the Company’s
pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read
the releases.*
Oncology
Sac-TMT
Reduced Risk of Death by 32% and Risk of Disease Progression or Death by 41% Compared to Chemotherapy in Certain Patients With Advanced
or Recurrent Endometrial Cancer; Results From Phase 3 TroFuse-005 Trial
The
Company and Moderna Presented Results From Landmark Phase 3 INTerpath-001 Trial for Intismeran Plus KEYTRUDA at ESMO 2026 Presidential
Symposium; Intismeran Plus KEYTRUDA Significantly Reduced Risk of Recurrence or Death by 42% (HR=0.58 [95% CI, 0.45–0.75];
Two-Sided p<0.001) Compared to KEYTRUDA Alone for Patients With Completely Resected Stage IIB-IV Melanoma
KEYTRUDA
as Monotherapy Reduced Risk of Disease Progression or Death by 43% for Certain Patients With Advanced or Recurrent Endometrial Cancer
With dMMR Tumors Compared to Chemotherapy; Results From Phase 3 KEYNOTE-C93 Trial
U.S.
FDA Approved WELIREG Plus Lenvima for Certain Previously Treated Adult Patients With ccRCC; Based on Results From Phase 3 LITESPARK-011
Trial, Presented at ESMO
- 10 -
KEYTRUDA
QLEX Approved in Japan for Subcutaneous Administration for All KEYTRUDA Indications Approved in Japan; Based on Results From Phase
3 MK-3475A-D77 Trial
EC
Approved KEYTRUDA Plus Padcev as Perioperative Treatment for Adults With Resectable MIBC; Based on Results From Phase 3 KEYNOTE-B15
Trial
I-DXd
BLA for Certain Patients With ES-SCLC Voluntarily Withdrawn
The
Company Entered Into Exclusive Global License Agreement With SciBrunch for SPR2015, an Investigational Oral KRAS G12D (ON) Inhibitor
Vaccines
and Infectious Diseases
U.S.
FDA Accepted sBLA for ENFLONSIA to Update Its RSV LRTD Indication to Include Children Under 2 Years at Increased Risk for Severe
RSV for Their Second Season; Based on Results From Phase 3 SMART Trial; FDA Set PDUFA Date of March 22, 2027
Cardiometabolic,
Respiratory and Specialty
U.S.
FDA Approved Update to the Label for WINREVAIR to Include Data From the Phase 3 HYPERION Trial Evaluating Adults Recently Diagnosed
With PAH (PAH, WHO Group 1 Pulmonary Hypertension)
Immunology
Tulisokibart
Met Primary and Key Secondary Endpoints in Phase 2b Study in Patients With Moderate to Severe HS
Ophthalmology
The
Company Presented One-Year Results From Pivotal Phase 2b/3 BRUNELLO Study Evaluating Remigromig, a Tri-Specific Agonist of the Wnt
Pathway, in Adults With DME, at AAO 2026
*References in the above news release titles have been modified for
the purpose of this announcement.
Sustainability Highlights
The Company’s 2025/2026 Purpose for Progress
Impact Report provided a comprehensive view of the Company’s measurable progress across its sustainability priorities, including
achieving all goals targeted for completion by 2025. The Company also introduced new targets for 2030, including a goal to reach
100 million people with access solutions that close gaps in care by 2030.
Full-Year 2026 Financial Outlook
The following table summarizes the Company’s
full-year financial outlook.
Full
Year 2026
Updated
Prior
Sales*
$66.8 billion to $67.3 billion
$66.3 billion to $67.3 billion
Non-GAAP
Gross margin3
Approximately 81%
Approximately 81%
Non-GAAP
Operating expenses3**
$42.4 billion to $42.9 billion
$42.0 billion to $42.7 billion
Non-GAAP
Other (income) expense, net3
Approximately $1.4 billion expense
Approximately $1.4 billion expense
Non-GAAP
Effective income tax rate3
32.0% to 33.0%
35.0% to 36.0%
Non-GAAP
EPS3***
$2.77 to $2.82
$2.66 to $2.76
Share count (assuming dilution)
Approximately 2.48 billion
Approximately 2.48 billion
*The Company does not have any non-GAAP adjustments
to sales.
**Includes one-time R&D charges of $9.0 billion
for the acquisition of Cidara Therapeutics, Inc. (Cidara), $5.7 billion for the acquisition of Terns Pharmaceuticals, Inc.
(Terns), and $400 million related to the global license agreement with SciBrunch. Outlook does not assume any additional significant
potential business development transactions.
***Includes one-time charges of $3.62 per share
for the acquisition of Cidara, $2.31 per share for the acquisition of Terns, and $0.12 per share related to the global license agreement
with SciBrunch.
The Company 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 income
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 income 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.
- 11 -
The Company now anticipates full-year 2026 sales
to be between $66.8 billion and $67.3 billion, including a positive impact from foreign exchange of approximately 1% at mid-October 2026
exchange rates.
The Company now expects the full-year non-GAAP
effective income tax rate to be between 32.0% and 33.0%, including the impact of the non-tax-deductible one-time charges for the acquisitions
of Cidara and Terns.
The Company now expects full-year 2026 non-GAAP
EPS to be between $2.77 and $2.82, including a positive impact from foreign exchange of approximately $0.15 per share at mid-October 2026
exchange rates. This range includes one-time charges of $9.0 billion, or $3.62 per share, related to the acquisition of Cidara; $5.7
billion, or $2.31 per share, related to the acquisition of Terns; and $400 million, or $0.12 per share, related to the global license
agreement with SciBrunch. The charge related to SciBrunch was not previously included in the outlook. In 2025, non-GAAP EPS of $8.98
was negatively impacted by one-time charges of $0.20 per share in the aggregate related to certain business development transactions.
Consistent with past practice, the financial outlook
does not assume additional significant potential business development transactions.
Earnings Conference Call
Investors, journalists and the general public
may access a live audio webcast of the call on Thursday, Oct. 29, at 9 a.m. EDT 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
on the Company’s website.
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 Our Company
At Merck & Co., Inc., Rahway, N.J.,
USA, 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.
- 12 -
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, 2025 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)
ENFLONSIA (clesrovimab-cfor)
GARDASIL (Human Papillomavirus Quadrivalent [Types
6, 11, 16 and 18] Vaccine, Recombinant)
GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
IDVYNSO (doravirine/islatravir)
JANUMET (sitagliptin and metformin HCl)
JANUVIA (sitagliptin)
KEYTRUDA (pembrolizumab)
KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph)
- 13 -
LAGEVRIO (molnupiravir)
Lenvima (lenvatinib)
Lynparza (olaparib)
M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live)
OHTUVAYRE (ensifentrine)
PREVYMIS (letermovir)
PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)
VARIVAX (Varicella Virus Vaccine Live)
WELIREG (belzutifan)
WINREVAIR (sotatercept-csrk)
Animal Health
BRAVECTO (fluralaner)
###
Media Contacts:
Investor Contacts:
Michael Levey
michael.levey@msd.com
John Cummins
john.cummins2@msd.com
Peter Dannenbaum
(732) 594-1579
Steven Graziano
(732) 594-1583
MERCK
& CO., INC., RAHWAY, N.J., USA
CONSOLIDATED
STATEMENT OF OPERATIONS - GAAP
(AMOUNTS
IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table
1
GAAP
GAAP
3Q26
3Q25
%
Change
Sep
YTD
2026
Sep
YTD
2025
%
Change
Sales
$ 18,085
$ 17,276
5 %
$ 50,978
$ 48,611
5 %
Costs, Expenses and Other
Cost of sales
4,892
3,855
27 %
13,482
10,831
24 %
Selling, general and administrative
2,886
2,633
10 %
8,491
7,835
8 %
Research and development
4,537
4,234
7 %
26,871
11,903
*
Restructuring costs
184
47
*
530
676
-22 %
Other (income) expense, net
27
(238 )
*
262
(281 )
*
Income Before Taxes
5,559
6,745
-18 %
1,342
17,647
-92 %
Income Tax Provision
492
958
1,855
2,346
Net Income (Loss)
5,067
5,787
-12 %
(513 )
15,301
*
Less: Net Income (Loss) Attributable to Noncontrolling Interests
2
2
(3 )
10
Net Income (Loss) Attributable to Merck & Co., Inc., Rahway, N.J., USA
$ 5,065
$ 5,785
-12 %
$ (510 )
$ 15,291
*
Earnings (Loss) per Common Share Assuming Dilution (1)
$ 2.04
$ 2.32
-12 %
$ (0.21 )
$ 6.08
*
Average Shares Outstanding Assuming Dilution (1)
2,478
2,498
2,471
2,514
Effective Income Tax Rate
8.9 %
14.2 %
138.2 %
13.3 %
* 100% or greater
(1)
Because the Company recorded a net loss in the first nine months of 2026, 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., RAHWAY, N.J., USA
THREE
AND NINE MONTHS ENDED SEPTEMBER 30, 2026 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
Third
Quarter
Cost
of sales
$ 4,892
1,140
396
1,536
$ 3,356
Selling,
general and administrative
2,886
24
24
2,862
Research
and development
4,537
3
1
4
4,533
Restructuring
costs
184
184
184
–
Other
(income) expense, net
27
(393 )
(393 )
420
Income
Before Taxes
5,559
(1,167 )
(581 )
393
(1,355 )
6,914
Income
Tax Provision (Benefit)
492
(239 )(3)
(105 )(3)
83 (3)
(261 )
753
Net
Income
5,067
(928 )
(476 )
310
(1,094 )
6,161
Net
Income Attributable to Merck & Co., Inc., Rahway, N.J., USA
5,065
(928 )
(476 )
310
(1,094 )
6,159
Earnings
per Common Share Assuming Dilution
$ 2.04
(0.38 )
(0.19 )
0.12
(0.45 )
$ 2.49
Effective
Income Tax Rate
8.9 %
10.9 %
September
YTD
Cost
of sales
$ 13,482
3,221
817
4,038
$ 9,444
Selling,
general and administrative
8,491
73
73
8,418
Research
and development
26,871
9
34
43
26,828
Restructuring
costs
530
530
530
–
Other
(income) expense, net
262
(764 )
(764 )
1,026
Income
Before Taxes
1,342
(3,303 )
(1,381 )
764
(3,920 )
5,262
Income
Tax Provision (Benefit)
1,855
(660 )(3)
(240 )(3)
163 (3)
(737 )
2,592
Net
(Loss) Income
(513 )
(2,643 )
(1,141 )
601
(3,183 )
2,670
Net
(Loss) Income Attributable to Merck & Co., Inc., Rahway, N.J., USA
(510 )
(2,643 )
(1,141 )
601
(3,183 )
2,673
(Loss)
Earnings per Common Share Assuming Dilution (4)
$ (0.21 )
(1.07 )
(0.46 )
0.24
(1.29 )
$ 1.08
Effective
Income Tax Rate
138.2 %
49.3 %
Only the line items that are affected by non-GAAP adjustments
are shown.
The Company 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 reflect expenses for the amortization of intangible assets, as well as the recognition of fair
value step-up of inventories related to the 2025 Verona Pharma plc acquisition. Amounts included in selling, general and administrative
expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures.
(2)
Amounts primarily include employee separation costs, accelerated depreciation and asset impairment charges associated with facilities
to be closed or divested, as well as contractual termination costs, 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)
Because the Company recorded a net loss in the first nine months of 2026, 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.,
RAHWAY, N.J., USA
FRANCHISE / KEY PRODUCT SALES
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3
2026
2025
3Q
Sep
YTD
1Q
2Q
3Q
Sep
YTD
1Q
2Q
3Q
Sep
YTD
4Q
Full
Year
Nom
%
Ex-Exch
%
Nom
%
Ex-Exch
%
TOTAL
SALES (1)
$ 16,286
$ 16,607
$ 18,085
$ 50,978
$ 15,529
$ 15,806
$ 17,276
$ 48,611
$ 16,400
$ 65,011
5
4
5
4
PHARMACEUTICAL
14,349
14,760
16,268
45,377
13,638
14,050
15,611
43,299
14,843
58,142
4
4
5
4
Oncology
Keytruda
7,906
7,904
7,771
23,581
7,205
7,956
8,142
23,303
8,337
31,641
-5
-4
1
0
Keytruda
Qlex
128
463
830
1,420
5
5
35
40
*
*
*
*
Alliance
Revenue – Lynparza (2)
341
365
352
1,059
312
370
379
1,061
389
1,450
-7
-7
0
-2
Alliance
Revenue – Lenvima (2)
256
283
287
826
258
265
258
781
272
1,053
11
11
6
5
Welireg
199
271
307
776
137
162
196
496
220
716
56
58
57
57
Alliance
Revenue – Reblozyl (3)
148
122
177
448
119
107
136
361
164
525
31
31
24
24
Vaccines
& Infectious Diseases
Gardasil/Gardasil
9
1,069
1,169
1,995
4,232
1,327
1,126
1,749
4,202
1,031
5,233
14
14
1
0
ProQuad/M-M-R
II/Varivax
538
592
730
1,860
539
609
684
1,832
619
2,451
7
7
2
1
Bridion
472
497
144
1,113
441
461
439
1,341
499
1,841
-67
-67
-17
-17
Prevymis
272
295
347
915
208
228
266
702
275
978
30
31
30
29
Capvaxive
142
184
263
588
107
129
244
480
279
759
8
7
22
22
Vaxneuvance
202
148
195
545
230
229
226
685
140
825
-14
-13
-20
-22
RotaTeq
206
134
196
536
228
121
204
554
119
673
-4
-4
-3
-4
Zerbaxa
82
77
90
249
70
74
81
225
87
312
11
11
11
9
Delstrigo
75
101
67
243
67
83
77
228
79
306
-13
-12
7
3
Enflonsia
1
2
187
190
79
79
21
100
138
136
142
140
Isentress/Isentress
HD
59
60
52
171
90
86
82
258
67
325
-36
-36
-34
-34
Dificid
34
22
14
70
83
96
43
222
25
247
-68
-68
-68
-68
Lagevrio
28
5
17
49
102
83
138
323
57
380
-88
-88
-85
-85
Cardiometabolic,
Respiratory, & Specialty
Winrevair
525
588
694
1,808
280
336
360
976
467
1,443
93
94
85
85
Januvia
367
258
186
811
549
372
382
1,302
302
1,604
-51
-50
-38
-37
Janumet
207
171
194
572
247
251
243
741
199
940
-20
-20
-23
-24
Ohtuvayre
131
204
184
519
178
178
-
-
-
-
Alliance
Revenue - Adempas/Verquvo (4)
109
126
118
353
106
123
112
340
129
470
5
5
4
4
Adempas
(5)
78
78
78
234
68
80
82
229
83
312
-5
-3
2
-1
Other
Pharmaceutical (6)
774
641
793
2,209
865
703
1,004
2,573
770
3,340
-21
-21
-14
-15
ANIMAL
HEALTH
1,791
1,775
1,676
5,243
1,588
1,646
1,615
4,849
1,505
6,354
4
3
8
5
Livestock
1,064
1,041
1,048
3,154
924
961
1,023
2,909
987
3,896
2
2
8
5
Companion
Animal
727
734
628
2,089
664
685
592
1,940
518
2,458
6
6
8
5
Other
Revenues (7)
146
72
141
358
303
110
50
463
52
515
185
-25
-23
-8
*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 the Company's share of profits, which are product sales net of cost of sales and commercialization
costs.
(3) Alliance Revenue represents royalties.
(4) Alliance Revenue represents the Company's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs.
(5) Net product sales in the Company's marketing territories.
(6) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $161 million, $10 million and $13 million in the first, second and third quarter of 2026, respectively, and $44 million, $43 million and $214 million in the first, second and third quarter of 2025, respectively.
(7) 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 milestone payments for out-licensed products were $132 million, $0 million and $2 million in the first, second and third quarter of 2026, respectively, and $95 million, $5 million and $11 million in the first, second and third quarter of 2025, respectively.
EX-99.2 — EXHIBIT 99.2
EX-99.2
Filename: tm2628203d1_ex99-2.htm · Sequence: 3
Exhibit 99.2
MERCK
& CO., INC., RAHWAY, N.J., USA
CONSOLIDATED
STATEMENT OF OPERATIONS - GAAP
(AMOUNTS
IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table
1a
2026
2025
% Change
1Q
2Q
3Q
Sep YTD
1Q
2Q
3Q
Sep YTD
4Q
Full Year
3Q
Sep YTD
Sales
$ 16,286
$ 16,607
$ 18,085
$ 50,978
$ 15,529
$ 15,806
$ 17,276
$ 48,611
$ 16,400
$ 65,011
5 %
5 %
Costs, Expenses and Other
Cost of sales
4,195
4,395
4,892
13,482
3,419
3,557
3,855
10,831
5,551
16,382
27 %
24 %
Selling, general and administrative
2,700
2,904
2,886
8,491
2,552
2,649
2,633
7,835
2,898
10,733
10 %
8 %
Research and development
12,592
9,741
4,537
26,871
3,621
4,048
4,234
11,903
3,886
15,789
7 %
*
Restructuring costs
195
151
184
530
69
560
47
676
213
889
*
-22 %
Other (income) expense, net
138
99
27
262
(35 )
(7 )
(238 )
(281 )
432
151
*
*
(Loss) Income Before Taxes
(3,534 )
(683 )
5,559
1,342
5,903
4,999
6,745
17,647
3,420
21,067
-18 %
-92 %
Income Tax Provision
709
654
492
1,855
818
571
958
2,346
458
2,804
Net (Loss) Income
(4,243 )
(1,337 )
5,067
(513 )
5,085
4,428
5,787
15,301
2,962
18,263
-12 %
*
Less: Net (Loss) Income Attributable to Noncontrolling Interests
(3 )
(2 )
2
(3 )
6
1
2
10
(1 )
9
Net (Loss) Income Attributable to Merck & Co., Inc., Rahway, N.J., USA
$ (4,240 )
$ (1,335 )
$ 5,065
$ (510 )
$ 5,079
$ 4,427
$ 5,785
$ 15,291
$ 2,963
$ 18,254
-12 %
*
(Loss) Earnings per Common Share Assuming Dilution (1)
$ (1.72 )
$ (0.54 )
$ 2.04
$ (0.21 )
$ 2.01
$ 1.76
$ 2.32
$ 6.08
$ 1.19
$ 7.28
-12 %
*
Average Shares Outstanding Assuming Dilution (1)
2,472
2,470
2,478
2,471
2,531
2,513
2,498
2,514
2,488
2,507
Effective Income Tax Rate
-20.1 %
-95.9 %
8.9 %
138.2 %
13.9 %
11.4 %
14.2 %
13.3 %
13.4 %
13.3 %
* 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 first and second quarters of 2026, as well as the first nine months of 2026, no potential
dilutive common shares were used in the computations of loss per common share assuming dilution as the effects would have been anti-dilutive.
MERCK & CO., INC.,
RAHWAY, N.J., USA
THREE AND NINE MONTHS
ENDED SEPTEMBER 30, 2025 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
$ 3,855
621
110
731
$ 3,124
Selling, general and administrative
2,633
34
34
2,599
Research and development
4,234
4
233
237
3,997
Restructuring costs
47
47
47
–
Other (income) expense, net
(238 )
(344 )
(344 )
106
Income Before Taxes
6,745
(659 )
(390 )
344
(705 )
7,450
Income Tax Provision (Benefit)
958
(119 )(3)
(82 )(3)
73 (3)
86 (4)
(42 )
1,000
Net Income
5,787
(540 )
(308 )
271
(86 )
(663 )
6,450
Net Income Attributable to Merck
& Co., Inc., Rahway, N.J., USA
5,785
(540 )
(308 )
271
(86 )
(663 )
6,448
Earnings
per Common Share Assuming Dilution
$ 2.32
(0.22 )
(0.12 )
0.11
(0.03 )
(0.26 )
$ 2.58
Effective
Income Tax Rate
14.2 %
13.4 %
September YTD
Cost of sales
$ 10,831
1,817
311
2,128
$ 8,703
Selling, general and administrative
7,835
72
1
73
7,762
Research and development
11,903
14
286
300
11,603
Restructuring costs
676
676
676
–
Other (income) expense, net
(281 )
(3 )
(512 )
(515 )
234
Income Before Taxes
17,647
(1,900 )
(1,274 )
512
(2,662 )
20,309
Income Tax Provision (Benefit)
2,346
(338 )(3)
(239 )(3)
109 (3)
(60 )(4)
(528 )
2,874
Net Income
15,301
(1,562 )
(1,035 )
403
60
(2,134 )
17,435
Net Income Attributable to Merck
& Co., Inc., Rahway, N.J., USA
15,291
(1,562 )
(1,035 )
403
60
(2,134 )
17,425
Earnings
per Common Share Assuming Dilution
$ 6.08
(0.62 )
(0.41 )
0.16
0.02
(0.85 )
$ 6.93
Effective
Income Tax Rate
13.3 %
14.2 %
Only
the line items that are affected by non-GAAP adjustments are shown.
The Company 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 for the third quarter reflect expenses for the amortization of intangible assets. Amounts included in cost of sales for the nine-month period include the amortization of intangible assets and intangible asset impairment charges, partially offset by a decrease in the estimated fair value measurement of liabilities for contingent consideration. 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 reflect the amortization of intangible assets.
(2) Amounts primarily include employee separation costs, accelerated depreciation and asset impairment charges associated with facilities to be closed or divested, as well as contractual termination costs, 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) Amount in the third quarter represents tax expense relating to audit reserve adjustments. Amount in the nine-month period represents a tax benefit, including a net benefit related to favorable audit reserve adjustments.
MERCK & CO., INC.,
RAHWAY, N.J., USA
FRANCHISE / KEY PRODUCT SALES
THIRD QUARTER 2026
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3a
Global
U.S.
International
3Q
2026
3Q
2025
%
Change
3Q
2026
3Q
2025
%
Change
3Q
2026
3Q
2025
%
Change
TOTAL
SALES (1)
$ 18,085
$ 17,276
5
$ 10,615
$ 10,012
6
$ 7,471
$ 7,264
3
PHARMACEUTICAL
16,268
15,611
4
10,119
9,493
7
6,149
6,118
1
Oncology
Keytruda
7,771
8,142
-5
4,520
4,879
-7
3,251
3,263
0
Keytruda
Qlex
830
5
*
693
5
*
136
-
Alliance
Revenue – Lynparza (2)
352
379
-7
171
184
-7
182
195
-7
Welireg
307
196
56
237
161
47
69
35
96
Alliance
Revenue – Lenvima (2)
287
258
11
204
177
15
83
81
3
Alliance
Revenue – Reblozyl (3)
177
136
31
145
111
31
33
25
31
Vaccines
& Infectious Diseases
Gardasil/Gardasil
9
1,995
1,749
14
1,366
1,154
18
629
595
6
ProQuad/M-M-R
II/Varivax
730
684
7
561
554
1
169
130
30
Prevymis
347
266
30
189
128
48
158
138
14
Capvaxive
263
244
8
207
238
-13
55
7
*
RotaTeq
196
204
-4
150
141
6
46
63
-28
Vaxneuvance
195
226
-14
111
134
-18
85
91
-7
Enflonsia
187
79
138
141
78
80
45
-
Bridion
144
439
-67
108
392
-72
36
47
-24
Zerbaxa
90
81
11
56
49
15
34
32
6
Delstrigo
67
77
-13
13
13
-3
54
64
-15
Isentress/Isentress
HD
52
82
-36
31
44
-31
21
37
-43
Lagevrio
17
138
-88
7
24
-71
10
114
-91
Dificid
14
43
-68
7
30
-78
7
13
-44
Cardiometabolic,
Respiratory, & Specialty
Winrevair
694
360
93
610
335
82
84
25
*
Janumet
194
243
-20
61
78
-22
133
165
-19
Januvia
186
382
-51
78
258
-70
108
124
-12
Ohtuvayre
184
-
184
-
Alliance
Revenue - Adempas/Verquvo (4)
118
112
5
108
103
4
10
8
20
Adempas
(5)
78
82
-5
78
82
-5
Other
Pharmaceutical (6)
793
1,004
-21
161
223
-28
633
784
-19
ANIMAL
HEALTH
1,676
1,615
4
493
504
-2
1,184
1,112
6
Livestock
1,048
1,023
2
199
213
-7
850
811
5
Companion
Animal
628
592
6
294
291
1
334
301
11
Other
Revenues (7)
141
50
185
3
15
-80
138
34
*
*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 the Company's share of profits, which are product sales net of cost of sales and commercialization costs.
(3) Alliance Revenue represents royalties.
(4) Alliance Revenue represents the Company's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs.
(5) Net product sales in the Company's marketing territories.
(6) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $13 million and $214 million on a global basis in the third quarter of 2026 and 2025, respectively.
(7) 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 milestone payments for out-licensed products were $2 million and $11 million on a global basis in the third quarter of 2026 and 2025, respectively.
MERCK & CO., INC.,
RAHWAY, N.J., USA
FRANCHISE / KEY PRODUCT SALES
SEPTEMBER YEAR-TO-DATE 2026
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3b
Global
U.S.
International
Sep
YTD
2026
Sep
YTD
2025
%
Change
Sep
YTD
2026
Sep
YTD
2025
%
Change
Sep
YTD
2026
Sep
YTD
2025
%
Change
TOTAL
SALES (1)
$ 50,978
$ 48,611
5
$ 29,146
$ 27,371
6
$ 21,832
$ 21,240
3
PHARMACEUTICAL
45,377
43,299
5
27,457
25,747
7
17,920
17,552
2
Oncology
Keytruda
23,581
23,303
1
13,731
13,936
-1
9,851
9,367
5
Keytruda
Qlex
1,420
5
*
1,195
5
*
225
-
Alliance
Revenue – Lynparza (2)
1,059
1,061
0
486
503
-3
573
558
3
Alliance
Revenue – Lenvima (2)
826
781
6
573
545
5
253
236
7
Welireg
776
496
57
603
422
43
173
74
133
Alliance
Revenue – Reblozyl (3)
448
361
24
370
299
24
78
62
25
Vaccines
& Infectious Diseases
Gardasil/Gardasil
9
4,232
4,202
1
2,392
2,235
7
1,840
1,967
-6
ProQuad/M-M-R
II/Varivax
1,860
1,832
2
1,409
1,457
-3
452
374
21
Bridion
1,113
1,341
-17
995
1,181
-16
118
161
-26
Prevymis
915
702
30
472
345
37
443
357
24
Capvaxive
588
480
22
464
473
-2
124
8
*
Vaxneuvance
545
685
-20
303
409
-26
243
276
-12
RotaTeq
536
554
-3
399
366
9
137
187
-27
Zerbaxa
249
225
11
151
136
11
98
89
10
Delstrigo
243
228
7
36
42
-15
208
185
12
Enflonsia
190
79
142
140
78
79
50
-
Isentress/Isentress
HD
171
258
-34
101
144
-29
70
114
-39
Dificid
70
222
-68
42
185
-78
29
37
-22
Lagevrio
49
323
-85
25
90
-73
25
233
-89
Cardiometabolic,
Respiratory, & Specialty
Winrevair
1,808
976
85
1,609
926
74
198
49
*
Januvia
811
1,302
-38
479
819
-42
333
483
-31
Janumet
572
741
-23
156
210
-26
416
530
-22
Ohtuvayre
519
-
518
-
Alliance
Revenue - Adempas/Verquvo (4)
353
340
4
329
308
7
24
32
-24
Adempas
(5)
234
229
2
234
229
2
Other
Pharmaceutical (6)
2,209
2,573
-14
479
633
-24
1,725
1,944
-11
ANIMAL
HEALTH
5,243
4,849
8
1,547
1,505
3
3,696
3,345
10
Livestock
3,154
2,909
8
613
598
3
2,541
2,312
10
Companion
Animal
2,089
1,940
8
934
907
3
1,155
1,033
12
Other
Revenues (7)
358
463
-23
142
119
19
216
343
-37
*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 the Company's share of profits, which are product sales net of cost of sales and commercialization costs.
(3) Alliance Revenue represents royalties.
(4) Alliance Revenue represents the Company's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs.
(5) Net product sales in the Company's marketing territories.
(6) Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $183 million and $301 million on a global basis for September YTD 2026 and 2025, respectively.
(7) 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 milestone payments for out-licensed products were $133 million and $111 million on a global basis for September YTD 2026 and 2025, respectively.
MERCK & CO., INC.,
RAHWAY, N.J., USA
PHARMACEUTICAL GEOGRAPHIC SALES
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3c
2026
2025
%
Change
1Q
2Q
3Q
Sep
YTD
1Q
2Q
3Q
Sep
YTD
4Q
Full
Year
3Q
Sep
YTD
TOTAL
PHARMACEUTICAL
$ 14,349
$ 14,760
$ 16,268
$ 45,377
$ 13,638
$ 14,050
$ 15,611
$ 43,299
$ 14,843
$ 58,142
4
5
United
States
8,512
8,827
10,119
27,457
7,927
8,328
9,493
25,747
8,662
34,409
7
7
% Pharmaceutical
Sales
59.3 %
59.8 %
62.2 %
60.5 %
58.1 %
59.3 %
60.8 %
59.5 %
58.4 %
59.2 %
Europe
(1)
2,725
2,801
2,837
8,363
2,384
2,551
2,675
7,610
2,839
10,449
6
10
% Pharmaceutical
Sales
19.0 %
19.0 %
17.4 %
18.4 %
17.5 %
18.2 %
17.1 %
17.6 %
19.1 %
18.0 %
Latin
America
624
636
730
1,990
589
654
691
1,933
644
2,578
6
3
% Pharmaceutical
Sales
4.3 %
4.3 %
4.5 %
4.4 %
4.3 %
4.7 %
4.4 %
4.5 %
4.3 %
4.4 %
Asia
Pacific (other than China and Japan)
569
636
596
1,800
535
609
593
1,736
586
2,323
1
4
% Pharmaceutical
Sales
4.0 %
4.3 %
3.7 %
4.0 %
3.9 %
4.3 %
3.8 %
4.0 %
4.0 %
4.0 %
Japan
535
558
569
1,662
651
604
693
1,948
684
2,632
-18
-15
% Pharmaceutical
Sales
3.7 %
3.8 %
3.5 %
3.7 %
4.8 %
4.3 %
4.4 %
4.5 %
4.6 %
4.5 %
Eastern
Europe/Middle East/Africa
413
408
399
1,220
435
451
365
1,250
348
1,598
10
-2
% Pharmaceutical
Sales
2.9 %
2.8 %
2.5 %
2.7 %
3.2 %
3.2 %
2.3 %
2.9 %
2.3 %
2.7 %
China
353
368
429
1,151
668
407
377
1,452
364
1,816
14
-21
% Pharmaceutical
Sales
2.5 %
2.5 %
2.6 %
2.5 %
4.9 %
2.9 %
2.4 %
3.4 %
2.5 %
3.1 %
Canada
137
154
152
443
125
135
134
394
153
547
13
12
% Pharmaceutical
Sales
1.0 %
1.0 %
0.9 %
1.0 %
0.9 %
1.0 %
0.9 %
0.9 %
1.0 %
0.9 %
Other
481
372
437
1,291
324
311
590
1,229
563
1,790
-26
5
%
Pharmaceutical Sales
3.3 %
2.5 %
2.7 %
2.8 %
2.4 %
2.1 %
3.9 %
2.7 %
3.8 %
3.2 %
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., RAHWAY, N.J., USA
OTHER
(INCOME) EXPENSE, NET - GAAP
(AMOUNTS
IN MILLIONS)
(UNAUDITED)
Table
4
3Q26
3Q25
Sep YTD
2026
Sep YTD
2025
Interest income
$ (52 )
$ (96 )
$ (122 )
$ (274 )
Interest expense
546
327
1,550
946
Exchange losses
63
56
138
224
Income from investments in equity securities, net (1)
(401 )
(373 )
(811 )
(563 )
Net periodic defined benefit plan (credit) cost other than service cost
(120 )
(152 )
(382 )
(452 )
Other, net
(9 )
-
(111 )
(162 )
Total
$ 27
$ (238 )
$ 262
$ (281 )
(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.
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v3.26.3
Cover
Oct. 29, 2026
Document Information [Line Items]
Document Type
8-K
Amendment Flag
false
Document Period End Date
Oct. 29, 2026
Entity File Number
1-6571
Entity Registrant Name
Merck & Co., Inc.
Entity Central Index Key
0000310158
Entity Tax Identification Number
22-1918501
Entity Incorporation, State or Country Code
NJ
Entity Address, Address Line One
126
East Lincoln Avenue
Entity Address, City or Town
Rahway
Entity Address, State or Province
NJ
Entity Address, Postal Zip Code
07065
City Area Code
908
Local Phone Number
740-4000
Written Communications
false
Soliciting Material
false
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Pre-commencement Issuer Tender Offer
false
Entity Emerging Growth Company
false
Common Stock
Document Information [Line Items]
Title of 12(b) Security
Common
Stock ($0.50 par value)
Trading Symbol
MRK
Security Exchange Name
NYSE
3.250% Notes due 2032
Document Information [Line Items]
Title of 12(b) Security
3.250% Notes due 2032
Trading Symbol
MRK/32
Security Exchange Name
NYSE
2.500% Notes due 2034
Document Information [Line Items]
Title of 12(b) Security
2.500% Notes due 2034
Trading Symbol
MRK/34
Security Exchange Name
NYSE
1.375% Notes due 2036
Document Information [Line Items]
Title of 12(b) Security
1.375% Notes due 2036
Trading Symbol
MRK 36A
Security Exchange Name
NYSE
3.500% Notes due 2037
Document Information [Line Items]
Title of 12(b) Security
3.500% Notes due 2037
Trading Symbol
MRK/37
Security Exchange Name
NYSE
3.700% Notes due 2044
Document Information [Line Items]
Title of 12(b) Security
3.700% Notes due 2044
Trading Symbol
MRK/44
Security Exchange Name
NYSE
3.750% Notes due 2054
Document Information [Line Items]
Title of 12(b) Security
3.750% Notes due 2054
Trading Symbol
MRK/54
Security Exchange Name
NYSE
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- Definition
Code for the postal or zip code
+ References
No definition available.
+ Details
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- Definition
Name of the state or province.
+ References
No definition available.
+ Details
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dei_EntityAddressStateOrProvince
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- Definition
A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
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- Definition
Indicate if registrant meets the emerging growth company criteria.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
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- Definition
Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
No definition available.
+ Details
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dei_EntityFileNumber
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Data Type:
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Balance Type:
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Period Type:
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- Definition
Two-character EDGAR code representing the state or country of incorporation.
+ References
No definition available.
+ Details
Name:
dei_EntityIncorporationStateCountryCode
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- Definition
The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
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dei_EntityRegistrantName
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- Definition
The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
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- Definition
Local phone number for entity.
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No definition available.
+ Details
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
+ Details
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
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- Definition
Title of a 12(b) registered security.
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Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
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- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
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- Definition
Trading symbol of an instrument as listed on an exchange.
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No definition available.
+ Details
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
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