Form 8-K
8-K — Merck & Co., Inc.
Accession: 0001104659-26-052081
Filed: 2026-04-30
Period: 2026-04-30
CIK: 0000310158
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — tm2612241d1_8k.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (tm2612241d1_ex99-1.htm)
EX-99.2 — EXHIBIT 99.2 (tm2612241d1_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) April 30, 2026 (April 30, 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, NJ
(Address of principal executive offices)
07065
(Zip Code)
Registrant’s telephone number, including area code (908) 740-4000
Not Applicable
(Former name or former address, 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
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
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 April 30, 2026, regarding earnings for the first 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 April 30, 2026, regarding earnings for the first 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:
April 30, 2026
By:
/s/
Kelly E. W. Grez
Kelly
E. W. Grez
Corporate Secretary
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: tm2612241d1_ex99-1.htm · Sequence: 2
Exhibit
99.1
News
Release
Merck &
Co., Inc., Rahway, N.J., USA Announces First-Quarter 2026 Financial Results; Highlights Significant Regulatory Approvals and Clinical
Milestones
Sales
Growth Driven by Continued Strength in Oncology and Animal Health, Plus Increasing Contributions From Launches
- Total
Worldwide Sales Were $16.3 Billion (5% Growth; 3% Growth ex-FX)
o KEYTRUDA/KEYTRUDA
QLEX1 Sales Were $8.0 Billion (12% Growth; 8% Growth ex-FX); Includes KEYTRUDA
QLEX Sales of $128 Million
o WINREVAIR
Sales Were $525 Million (88% Growth; 87% Growth ex-FX)
o Animal
Health Sales Were $1.8 Billion (13% Growth; 6% Growth ex-FX)
- GAAP
Loss per Share Was $1.72; Non-GAAP Loss per Share Was $1.28; GAAP and Non-GAAP Loss per Share
Include a Charge of $3.62 per Share for the Acquisition of Cidara
- Presented
New Data From Cardio-Pulmonary Pipeline at ACC.26, Including Positive Results From Phase
3 CORALreef AddOn Trial
- Received
U.S. FDA Approval for IDVYNSO, a Once-Daily, Oral Treatment for Certain Adults With Virologically
Suppressed HIV-1
- Achieved
Multiple Significant Regulatory and Clinical Milestones Across Oncology Pipeline
- Announced
Agreement To Acquire Terns Pharmaceuticals, Inc. and Expand Hematology Pipeline With
TERN-701, a Novel Candidate for Chronic Myeloid Leukemia; Transaction Expected To Close in
May
- Full-Year
2026 Financial Outlook
o Narrows
and Raises the Midpoint of Worldwide Sales Range; Now Expects Sales To Be Between $65.8 Billion
and $67.0 Billion
o Narrows
and Raises Expected Non-GAAP EPS Range To Be Between $5.04 and $5.16
o Outlook
Does Not Reflect Any Impact From Proposed Acquisition of Terns Pharmaceuticals, Inc.,
Which Is Expected To Close in May and Result in a One-Time Charge of Approximately $5.8
Billion or Approximately $2.35 per Share
RAHWAY,
N.J., April 30, 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 first quarter of 2026.
1
Available in some markets as KEYTRUDA SC.
- 2 -
“We
are moving with speed to transform our portfolio to one with a diversified set of growth drivers across a broad set of therapeutic areas,”
said Robert M. Davis, chairman and chief executive officer. “During the first quarter, we continued to strengthen our pipeline
with science-led business development, including our planned acquisition of Terns. We also achieved several important milestones, such
as the FDA approval of IDVYNSO – which marks a new chapter in our longstanding commitment to people living with HIV. I am pleased
with our progress and excited for what’s ahead, as we enter a particularly robust period of Phase 3 data readouts and deliver on
the promise of our pipeline for patients.”
Financial
Summary
First Quarter
$ in millions, except EPS amounts
2026
2025
Change
Change Ex-
Exchange
Sales
$ 16,286
$ 15,529
5 %
3 %
GAAP net (loss) income2
(4,240 )
5,079
N/M
N/M
Non-GAAP net (loss) income that excludes certain items2,3*
(3,156 )
5,611
N/M
N/M
GAAP EPS
(1.72 )
2.01
N/M
N/M
Non-GAAP EPS that excludes certain items3*
(1.28 )
2.22
N/M
N/M
*Refer
to table on page 7.
N/M
- Not meaningful.
For
the first quarter of 2026, Generally Accepted Accounting Principles (GAAP) loss / earnings per share (EPS) assuming dilution was a loss
per share of $1.72 and non-GAAP loss per share was $1.28. Both the GAAP and non-GAAP loss per share were due to a charge for the acquisition
of Cidara Therapeutics, Inc. (Cidara) of $3.62 per share.
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.
2
Net (loss) 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 -
First-Quarter
Sales Performance
The
following table reflects sales of the Company’s top products and significant performance drivers.
First Quarter
$ in millions
2026
2025
Change
Change Ex-
Exchange
Commentary
Total Sales
$ 16,286
$ 15,529
5 %
3 %
Pharmaceutical
14,349
13,638
5 %
2 %
Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by declines in vaccines, diabetes and infectious diseases.
KEYTRUDA/KEYTRUDA QLEX
8,034
7,205
12 %
8 %
Growth primarily driven by higher global demand in metastatic indications including urothelial cancer, as well as strong global uptake in earlier-stage indications, including triple-negative breast cancer, cervical cancer and renal cell carcinoma (RCC). Sales growth benefited from the timing of wholesaler purchases in the U.S. Sales of KEYTRUDA QLEX were $128 million.
GARDASIL/GARDASIL 9
1,069
1,327
-19 %
-22 %
Decline primarily due to lower demand in China as well as lower sales in Japan following the national catch-up immunization program. Decline also reflects lower sales in the U.S. primarily due to unfavorable public-sector purchasing patterns, partially offset by higher net pricing.
JANUVIA/JANUMET
574
796
-28 %
-29 %
Decline primarily due to lower demand and net pricing in the U.S., as well as lower demand in China and most other international markets due to generic competition.
PROQUAD, M-M-R II and VARIVAX
538
539
0 %
-2 %
Sales were flat, primarily driven by unfavorable private sector purchasing patterns for M-M-R II and lower demand for M-M-R II and VARIVAX in the U.S., offset by higher PROQUAD sales in the U.S. due to borrowing of doses in 2025 from a U.S. government stockpile, which lowered sales in that period.
WINREVAIR
525
280
88 %
87 %
Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe.
BRIDION
472
441
7 %
7 %
Growth primarily due to higher demand in the U.S., partially offset by lower demand in most international markets due to ongoing generic competition.
Lynparza*
341
312
9 %
6 %
Growth primarily due to higher demand in the U.S. and many international markets.
PREVYMIS
272
208
31 %
26 %
Increase primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications.
Lenvima*
256
258
-1 %
-2 %
Relatively flat compared with prior year.
- 4 -
First Quarter
$ in millions
2026
2025
Change
Change Ex-
Exchange
Commentary
ROTATEQ
206
228
-10 %
-11 %
Decrease primarily driven by lower demand in China.
VAXNEUVANCE
202
230
-12 %
-16 %
Decrease primarily driven by lower demand in the U.S. and most international markets due to competitive pressure.
WELIREG
199
137
45 %
43 %
Growth primarily driven by higher demand in the U.S. and continued launch uptake in several international markets, particularly in Japan and certain European markets.
CAPVAXIVE
142
107
33 %
31 %
Increase primarily driven by launch uptake in certain European markets and continued uptake in the U.S. U.S. sales growth was partially offset by a reduction in wholesaler inventory.
OHTUVAYRE
131
-
-
-
Product obtained as part of the Company’s October 2025 acquisition of Verona Pharma plc (Verona Pharma).
LAGEVRIO
28
102
-73 %
-73 %
Decline largely due to lower demand in Japan and the U.S.
Animal Health
1,791
1,588
13 %
6 %
Growth attributable to performance in both Livestock and Companion Animal product portfolios.
Livestock
1,064
924
15 %
8 %
Growth primarily driven by higher demand for ruminant and poultry products as well as price.
Companion Animal
727
664
9 %
4 %
Growth from new product launches and price was partially offset by lower demand for other products in portfolio, reflecting a reduction in veterinary visits. Sales of BRAVECTO line of products were $379 million and $327 million in current and prior-year quarters, respectively, which represents an increase of 16%, or 9% excluding impact of foreign exchange.
Other Revenues**
146
303
-52 %
4 %
Decline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements, partially offset by higher milestones received for out-licensing arrangements and higher royalty income.
*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 $161 million for the first quarter of 2026 compared with $44 million for the first quarter of
2025. The increase was due to a $150 million payment received in the first quarter of 2026 in connection with an amendment to the collaboration
agreement with AstraZeneca in 2025, which (subject to an annual election by AstraZeneca) discontinued the provisions whereby the Company
shared revenue and costs with AstraZeneca, and revised the payment structure.
- 5 -
First-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
First Quarter 2026
Cost of sales
$ 4,195
$ 1,014
$ 237
$ -
$ 2,944
Selling, general and administrative
2,700
32
-
-
2,668
Research and development
12,592
-
34
-
12,558
Restructuring costs
195
-
195
-
-
Other (income) expense, net
138
-
-
(180 )
318
First Quarter 2025
Cost of sales
$ 3,419
$ 620
$ 36
$ -
$ 2,763
Selling, general and administrative
2,552
23
-
-
2,529
Research and development
3,621
7
-
-
3,614
Restructuring costs
69
-
69
-
-
Other (income) expense, net
(35 )
(3 )
-
(107 )
75
GAAP
Expense, EPS and Related Information
Gross
margin was 74.2% for the first quarter of 2026 compared with 78.0% for the first quarter of 2025. The decrease was primarily due to higher
amortization of intangible assets, higher restructuring costs, the recognition of inventory fair value step-up related to the 2025 Verona
Pharma acquisition and the unfavorable impact of foreign exchange, partially offset by favorable product mix.
Selling,
general and administrative (SG&A) expenses were $2.7 billion in the first quarter of 2026, an increase of 6% compared with the first
quarter of 2025. The increase was primarily due to higher administrative costs and the unfavorable impact of foreign exchange.
Research
and development (R&D) expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of
2025. The increase was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending, the
unfavorable impact of foreign exchange and restructuring costs, partially offset by a $200 million reduction in R&D expenses as part
of the funding agreement with Blackstone Life Sciences (Blackstone) and a $100 million charge in the first quarter of 2025 for the achievement
of a developmental milestone related to the 2024 acquisition of EyeBiotech Limited (EyeBio).
Other
(income) expense, net, was $138 million of expense in the first quarter of 2026 compared with $35 million of income in the first quarter
of 2025. The unfavorability was primarily due to higher net interest expense, partially offset by higher net income from investments
in equity securities.
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
income tax provision for the first quarter of 2026 was $709 million on a pretax loss of $3.5 billion, resulting in an effective income
tax rate of (20.1)%. This effective income tax rate includes a 33.1 percentage point unfavorable impact of the charge for the acquisition
of Cidara, for which no tax benefit was recorded.
GAAP
loss per share was $1.72 for the first quarter of 2026 compared with earnings per share of $2.01 for the first quarter of 2025, primarily
driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara.
Non-GAAP
Expense, EPS and Related Information
Non-GAAP
gross margin was 81.9% for the first quarter of 2026 compared with 82.2% for the first quarter of 2025. The decrease was primarily due
to the unfavorable impact of foreign exchange, partially offset by favorable product mix.
Non-GAAP
SG&A expenses were $2.7 billion in the first quarter of 2026, an increase of 5% compared with the first quarter of 2025. The increase
was primarily due to higher administrative costs and the unfavorable impact of foreign exchange.
Non-GAAP
R&D expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of 2025. The increase
was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending and the unfavorable impact
of foreign exchange, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone
and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 acquisition
of EyeBio.
Non-GAAP
other (income) expense, net, was $318 million of expense in the first quarter of 2026 compared with $75 million of expense in the first
quarter of 2025. The unfavorability was primarily due to higher net interest expense.
The
non-GAAP income tax provision for the first quarter of 2026 was $957 million on a pretax loss of $2.2 billion, resulting in a non-GAAP
effective income tax rate of (43.5)%. This effective income tax rate includes a 57.6 percentage point unfavorable impact of the charge
for the acquisition of Cidara, for which no tax benefit was recorded.
Non-GAAP
loss per share was $1.28 for the first quarter of 2026 compared with earnings per share of $2.22 for the first quarter of 2025, primarily
driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara.
- 7 -
A
reconciliation of GAAP to non-GAAP net (loss) income and EPS is provided in the table that follows.
First Quarter
$ in millions, except EPS amounts
2026
2025
EPS
GAAP EPS
$ (1.72 )
$ 2.01
Difference
0.44
0.21
Non-GAAP EPS that excludes items listed below3
$ (1.28 )
$ 2.22
Net (Loss) Income
GAAP net (loss) income2
$ (4,240 )
$ 5,079
Difference
1,084
532
Non-GAAP net (loss) income that excludes items listed below2,3
$ (3,156 )
$ 5,611
Excluded Items:
Acquisition- and divestiture-related costs4
$ 1,046
$ 647
Restructuring costs
466
105
Income from investments in equity securities
(180 )
(107 )
Increase to net loss / decrease to net income before taxes
1,332
645
Estimated income tax benefit5
(248 )
(113 )
Increase to net loss / decrease to net income
$ 1,084
$ 532
Pipeline
and Portfolio Highlights
In
the first quarter, the Company continued to advance its pipeline, achieving significant regulatory and clinical milestones across a broad
range of therapeutic areas.
· Oncology:
o U.S.
Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX plus paclitaxel, with
or without bevacizumab, for the treatment of certain adults with PD-L1+ (combined positive
score [CPS] ≥1) platinum-resistant ovarian cancer, based on Phase 3 KEYNOTE-B96 trial.
§ The
European Commission (EC) also approved this KEYTRUDA regimen for this population.
o In
April, FDA approved a label update for KEYTRUDA QLEX based on results from Phase 2 MK-3475A-F11
trial, which evaluated patient-reported preference for subcutaneous administration of KEYTRUDA
QLEX over intravenous administration of KEYTRUDA in participants with multiple tumor types.
o In
April, FDA granted priority review for ifinatamab deruxtecan (I-DXd) for certain adults with
previously treated extensive-stage small cell lung cancer, based on Phase 2 Ideate-Lung01
trial. I-DXd is part of the Company’s collaboration with Daiichi Sankyo.
§ FDA
set Prescription Drug User Fee Act (PDUFA) date of Oct. 10, 2026.
o FDA
accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA
or KEYTRUDA QLEX for the adjuvant treatment of certain patients with RCC, based on the Phase
3 LITESPARK-022 trial.
§ FDA
set PDUFA date of June 19, 2026.
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.
- 8 -
o FDA
accepted supplemental applications for WELIREG plus Lenvima in certain previously treated
patients with advanced RCC, based on the Phase 3 LITESPARK-011 trial. Lenvima is being developed
as part of a collaboration with Eisai Co., Ltd (Eisai).
§ FDA
set PDUFA date of Oct. 4, 2026.
o Announced
positive results from Phase 3 KEYNOTE-B15 trial (also known as EV-304) demonstrating KEYTRUDA
plus Padcev reduced the risk of event-free survival (EFS) events by 47% and reduced the risk
of death by 35% in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC)
when given before and after surgery.
§ KEYNOTE-B15
is the sixth study demonstrating overall survival (OS) with a KEYTRUDA-based regimen in an
earlier-stage cancer.
o In
April, FDA granted priority review for KEYTRUDA and KEYTRUDA QLEX, each with Padcev, for
cisplatin-eligible patients with MIBC, based on the Phase 3 KEYNOTE-B15 trial.
§ FDA
set PDUFA date of Aug. 17, 2026.
o In
a pre-specified interim analysis of the Phase 3 LITESPARK-012 study, compared to KEYTRUDA
plus Lenvima, the triplet combination therapy of KEYTRUDA plus Lenvima plus WELIREG, as well
as the combination of MK-1308A (an investigational fixed dose coformulation of KEYTRUDA and
the anti-CTLA-4 antibody quavonlimab) plus Lenvima, did not show a statistically significant
improvement in the primary endpoints of progression-free survival and OS in patients with
advanced clear cell RCC.
o In
the Phase 3 KEYNOTE-975 study, compared to placebo plus definitive chemoradiotherapy (dCRT),
KEYTRUDA plus dCRT did not show a statistically significant improvement in the primary endpoint
of EFS in certain patients with locally advanced unresectable esophageal carcinoma.
o In
a prespecified interim analysis of the Phase 3 KEYNOTE-866 study, compared to perioperative
placebo plus neoadjuvant chemotherapy, perioperative KEYTRUDA plus neoadjuvant chemotherapy
did not show a statistically significant improvement in the primary endpoint of EFS in patients
with cisplatin-eligible MIBC who underwent radical cystectomy and pelvic lymph node dissection.
· Vaccines
and Infectious Diseases:
o In
April, FDA approved once-daily IDVYNSO, an oral, two-drug, single-tablet regimen of doravirine/islatravir
(DOR/ISL) for the treatment of certain adults with virologically suppressed HIV-1, based
on Phase 3 MK-8591A-051 and MK-8591A-052 trials. IDVYNSO was also approved in Japan for these
patients in March.
o Presented
data from three Phase 3 trials evaluating DOR/ISL at the 33rd Conference on Retroviruses
and Opportunistic Infections (CROI), including:
§ Results
from Phase 3 MK-8591A-053 trial demonstrated that DOR/ISL is the first two-drug regimen that
does not include an integrase strand transfer inhibitor to demonstrate non-inferiority and
similar safety profile at Week 48 versus bictegravir/emtricitabine/tenofovir alafenamide6 [(50
mg/200 mg/25 mg) (BIC/FTC/TAF)] in adults living with HIV-1 who had not previously received
antiretroviral treatment.
6
Bictegravir/emtricitabine/tenofovir alafenamide (BIKTARVY) is a registered trademark of Gilead Sciences, Inc.
- 9 -
§ Results
from the Phase 3 MK-8591A-052 and MK-8591A-051 trials demonstrated that DOR/ISL maintained
virologic suppression at Week 96 in adults with virologically suppressed HIV-1 who switched
from other antiretroviral therapies, including BIC/FTC/TAF.
o In
April, EC approved ENFLONSIA for the prevention of respiratory syncytial virus (RSV) lower
respiratory tract disease in newborns and infants during their first RSV season, based on
Phase 2b/3 CLEVER and Phase 3 SMART trials.
o Announced
positive second RSV season results from Phase 3 SMART trial evaluating the safety, efficacy
and pharmacokinetics of ENFLONSIA in infants and children at increased risk for severe RSV
disease over two RSV seasons.
o European
Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive
opinion for an expanded indication for CAPVAXIVE for active immunization against invasive
pneumococcal disease and pneumococcal pneumonia in certain children and adolescents
at increased risk of pneumococcal disease.
· Cardiometabolic
and Respiratory:
o Presented
new data at the American College of Cardiology’s Annual Scientific Session and Expo (ACC.26)
including:
§ Positive
results from Phase 3 CORALreef AddOn trial demonstrated significantly greater LDL-C reductions
at eight weeks compared to guideline-recommended oral non-statin therapies when added to
background statins. This is the third positive Phase 3 study of enlicitide.
§ Positive
data from Phase 2 CADENCE trial provided definitive proof-of-concept for WINREVAIR in adults
with the syndrome of combined post- and precapillary pulmonary hypertension and heart failure
with preserved ejection fraction (CpcPH-HFpEF). Totality of evidence supports advancing development
of WINREVAIR for this distinct patient population into a registrational Phase 3 study.
· Animal
Health:
o FDA
approved NUMELVI for dogs, the first and only second-generation Janus kinase (JAK) inhibitor
indicated for the control of pruritus associated with allergic dermatitis in dogs 6 months
of age and older.
· Business
Development:
o Announced
an agreement to acquire Terns Pharmaceuticals, Inc. (Terns) through a subsidiary.
- 10 -
§ Expands
hematology pipeline with the addition of TERN-701, an investigational oral allosteric BCR::ABL1
tyrosine kinase inhibitor currently in Phase 1/2 development for certain patients with chronic
myeloid leukemia (CML).
§ Transaction
expected to close in May.
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
KEYTRUDA
and KEYTRUDA QLEX, Plus Paclitaxel ± Bevacizumab, FDA Approved for Certain Adults With PD-L1+ (CPS ≥1) Platinum-Resistant
Ovarian Carcinoma as Second- or Third-Line Treatment; Based on Results From Phase 3 KEYNOTE-B96 Trial
EC
Approved KEYTRUDA Plus Paclitaxel ± Bevacizumab for Treatment of Adults With PD-L1 (CPS ≥1) Platinum-Resistant Recurrent
Ovarian Carcinoma Who Have Received One or Two Prior Systemic Treatment Regimens; Based on Results From Phase 3 KEYNOTE-B96 Trial
I-DXd
Granted Priority Review in U.S. for Adult Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer Who Experienced
Disease Progression on or After Platinum-Based Chemotherapy; Based on Results From Phase 2 Ideate-Lung01 Trial; FDA Set PDUFA Date
of Oct. 10, 2026
FDA
Granted Priority Review for KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, for Cisplatin-Eligible Patients With MIBC; Based on Results
From Phase 3 KEYNOTE-B15 Trial; FDA Set PDUFA Date of Aug. 17, 2026
KEYTRUDA
Plus Padcev Reduced Risk of EFS Events by 47% and Risk of Death by 35% for Cisplatin-Eligible Patients With MIBC When Given Before
and After Surgery; Results From Phase 3 KEYNOTE-B15 Trial
KEYTRUDA
Plus Paclitaxel With or Without Bevacizumab Significantly Improved Key Secondary Endpoint of OS Versus Paclitaxel With or Without
Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer; Results From Phase 3 KEYNOTE-B96 Trial
KEYTRUDA
Plus WELIREG Given as Adjuvant Therapy Reduced Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain
Patients With Earlier-Stage RCC; Results From Phase 3 LITESPARK-022 Trial; FDA Set PDUFA Date of June 19, 2026 for WELIREG in
combination with KEYTRUDA or KEYTRUDA QLEX
WELIREG
Plus Lenvima Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients
With RCC; Results From Phase 3 LITESPARK-011 Trial; FDA Set PDUFA Date of Oct. 4, 2026
The
Company and Eisai Provided Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients
With Advanced RCC
Vaccines
and Infectious Diseases
FDA
Approved the Company’s Once-Daily IDVYNSO for Adults With Virologically Suppressed
HIV-1; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052
Trials
The
Company Announced Late-Breaking Data From Three Phase 3 Trials Evaluating DOR/ISL, an Investigational, Once-Daily, Two-Drug Regimen
for the Treatment of Adults Living With HIV-1, at CROI 2026
EC
Approved ENFLONSIA for the Prevention of RSV Lower Respiratory Tract Disease in Infants During Their First RSV Season; Based on Results
From Phase 2b/3 CLEVER and Phase 3 SMART Trials
The
Company Announced Positive New Data for ENFLONSIA for Infants and Children Under 2 Years of Age at Increased Risk for Severe RSV
Disease Over Two RSV Seasons; Results From Phase 3 SMART Trial
The
Company Presented New Data Reinforcing Long-Term Efficacy of GARDASIL 9 and GARDASIL at the EUROGIN International Multidisciplinary
HPV Congress 2026
- 11 -
Cardiometabolic
and Respiratory
Enlicitide
Decanoate, an Investigational Oral PCSK9 Inhibitor, Demonstrated Significantly Greater LDL-C Reductions at Eight Weeks Compared to
Guideline-Recommended Oral Non-Statin Therapies When Added to Background Statins; Results From Phase 3 CORALreef AddOn Trial
Positive
Data From Phase 2 CADENCE Trial Provided Definitive Proof-of-Concept for WINREVAIR in Adults With the Syndrome of CpcPH-HFpEF
Ophthalmology
The
Company Initiated Pivotal Phase 2b/3 Trial Evaluating MK-8748, an Investigational Bispecific Tie2 Agonist/VEGF Inhibitor, for the
Treatment of Neovascular Age-Related Macular Degeneration
Animal
Health
FDA
Approved NUMELVI for Dogs – First and Only Second-Generation JAK Inhibitor for the Control of Pruritus Associated With Allergic
Dermatitis
Research
The
Company and Mayo Clinic Announced New Research and Development Collaboration to Support AI-Enabled Drug Discovery and Precision Medicine
The
Company and Google Cloud Partnered To Accelerate Agentic AI Enterprise Transformation
*References
to the Company’s name in the above news release titles have been modified for the purpose of this announcement.
Upcoming
Investor Event
The
Company will hold an Oncology Investor Event to coincide with the 2026 American Society of Clinical Oncology Annual Meeting on Monday,
June 1, 2026, 6 p.m. CT, during which senior management will provide an update on the Company’s oncology strategy and
program. The event will take place in Chicago and will be accessible via live audio webcast at this weblink.
Full-Year
2026 Financial Outlook
The
following table summarizes the Company’s full-year financial outlook.
Full Year 2026
Updated
Prior
Sales*
$65.8 billion to $67.0 billion
$65.5 billion to $67.0 billion
Non-GAAP Gross margin3
Approximately 82%
Approximately 82%
Non-GAAP Operating expenses3**
$36.0 billion to $36.8 billion
$35.9 billion to $36.9 billion
Non-GAAP Other (income) expense, net3
Approximately $1.3 billion expense
Approximately $1.3 billion expense
Non-GAAP Effective income tax rate3
23.5% to 24.5%
23.5% to 24.5%
Non-GAAP EPS3***
$5.04 to $5.16
$5.00 to $5.15
Share count (assuming dilution)
Approximately 2.48 billion
Approximately 2.48 billion
*The
Company does not have any non-GAAP adjustments to sales.
**Includes
a one-time charge of $9.0 billion for the acquisition of Cidara. Outlook does not reflect the proposed acquisition of Terns or assume
any additional significant potential business development transactions.
***Includes
a one-time charge of $3.62 per share for the acquisition of Cidara.
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.
- 12 -
The
Company now anticipates full-year 2026 sales to be between $65.8 billion and $67.0 billion, including a positive impact from foreign
exchange of approximately 1% at mid-April 2026 exchange rates.
The
Company continues to expect the full-year non-GAAP effective income tax rate to be between 23.5% and 24.5% including the impact of the
non-tax-deductible one-time charge for the acquisition of Cidara.
The
Company now expects full-year 2026 non-GAAP EPS to be between $5.04 and $5.16, including a positive impact from foreign exchange of approximately
$0.10 per share at mid-April 2026 exchange rates. This range includes a one-time charge of $9.0 billion, or $3.62 per share, related
to the acquisition of Cidara. 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.
In
April 2026, the Company announced a tender offer to acquire Terns. The Company’s financial outlook does not reflect this transaction,
which is expected to be accounted for as an asset acquisition and result in a one-time charge of approximately $5.8 billion, or approximately
$2.35 per share. In addition, taking into consideration operational investment to advance TERN-701, as well as the cost of financing
the transaction, the Company also anticipates EPS will be negatively impacted by approximately $0.12 over the remainder of 2026 following
the close, which is expected in May.
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, April 30, at 9 a.m. ET via this weblink.
A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting
the results, will be available 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.
- 13 -
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)
- 14 -
JANUVIA (sitagliptin)
KEYTRUDA (pembrolizumab)
KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph)
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)
ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent)
WELIREG (belzutifan)
WINREVAIR (sotatercept-csrk)
Animal
Health
BRAVECTO (fluralaner)
NUMELVI
(atinvicitinib tablets)
###
- 15 -
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
- 16 -
MERCK
& CO., INC., RAHWAY, N.J., USA
CONSOLIDATED
STATEMENT OF OPERATIONS - GAAP
(AMOUNTS
IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table
1
GAAP
1Q26
1Q25
%
Change
Sales
$ 16,286
$ 15,529
5 %
Costs, Expenses and Other
Cost of sales
4,195
3,419
23 %
Selling, general and administrative
2,700
2,552
6 %
Research and development
12,592
3,621
*
Restructuring costs
195
69
*
Other (income) expense, net
138
(35 )
*
(Loss) Income Before Taxes
(3,534 )
5,903
*
Income Tax Provision
709
818
Net (Loss) Income
(4,243 )
5,085
*
Less: Net (Loss) Income Attributable to Noncontrolling Interests
(3 )
6
Net (Loss) Income Attributable to Merck & Co., Inc., Rahway, N.J., USA
$ (4,240 )
$ 5,079
*
(Loss) Earnings per Common Share Assuming Dilution (1)
$ (1.72 )
$ 2.01
*
Average Shares Outstanding Assuming Dilution (1)
2,472
2,531
Tax Rate
-20.1 %
13.9 %
*
100% or greater
(1)
Because the Company recorded a net loss in the first quarter 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
FIRST QUARTER 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
First Quarter
Cost of sales
$ 4,195
1,014
237
1,251
$ 2,944
Selling, general and administrative
2,700
32
32
2,668
Research and development
12,592
34
34
12,558
Restructuring costs
195
195
195
–
Other (income) expense, net
138
(180 )
(180 )
318
Loss Before Taxes
(3,534 )
(1,046 )
(466 )
180
(1,332 )
(2,202 )
Income Tax Provision (Benefit)
709
(202 )(3)
(85 )(3)
39 (3)
(248 )
957
Net Loss
(4,243 )
(844 )
(381 )
141
(1,084 )
(3,159 )
Net Loss Attributable to Merck
& Co., Inc., Rahway, N.J., USA
(4,240 )
(844 )
(381 )
141
(1,084 )
(3,156 )
Loss
per Common Share Assuming Dilution (4)
$ (1.72 )
(0.34 )
(0.16 )
0.06
(0.44 )
$ (1.28 )
Tax Rate
-20.1 %
-43.5 %
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, associated with 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 quarter 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
1Q
1Q
1Q
2Q
3Q
4Q
Full
Year
Nom
%
Ex-Exch
%
TOTAL
SALES (1)
$ 16,286
$ 15,529
$ 15,806
$ 17,276
$ 16,400
$ 65,011
5
3
PHARMACEUTICAL
14,349
13,638
14,050
15,611
14,843
58,142
5
2
Oncology
Keytruda
7,906
7,205
7,956
8,142
8,337
31,641
10
6
Keytruda
Qlex
128
5
35
40
-
-
Alliance
Revenue – Lynparza (2)
341
312
370
379
389
1,450
9
6
Alliance
Revenue – Lenvima (2)
256
258
265
258
272
1,053
-1
-2
Welireg
199
137
162
196
220
716
45
43
Alliance
Revenue – Reblozyl (3)
148
119
107
136
164
525
25
25
Vaccines
(4)
Gardasil/Gardasil
9
1,069
1,327
1,126
1,749
1,031
5,233
-19
-22
ProQuad/M-M-R
II/Varivax
538
539
609
684
619
2,451
-
-2
RotaTeq
206
228
121
204
119
673
-10
-11
Vaxneuvance
202
230
229
226
140
825
-12
-16
Capvaxive
142
107
129
244
279
759
33
31
Enflonsia
1
79
21
100
-
-
Cardiometabolic
& Respiratory
Winrevair
525
280
336
360
467
1,443
88
87
Ohtuvayre
131
178
178
-
-
Alliance
Revenue - Adempas/Verquvo (5)
109
106
123
112
129
470
3
3
Adempas
(6)
78
68
80
82
83
312
15
5
Infectious
Diseases
Bridion
472
441
461
439
499
1,841
7
7
Prevymis
272
208
228
266
275
978
31
26
Zerbaxa
82
70
74
81
87
312
17
14
Delstrigo
75
67
83
77
79
306
12
1
Isentress/Isentress
HD
59
90
86
82
67
325
-34
-36
Dificid
34
83
96
43
25
247
-59
-59
Lagevrio
28
102
83
138
57
380
-73
-73
Diabetes
Januvia
367
549
372
382
302
1,604
-33
-33
Janumet
207
247
251
243
199
940
-16
-18
Other
Pharmaceutical (7)
774
865
703
1,004
770
3,340
-11
-12
ANIMAL
HEALTH
1,791
1,588
1,646
1,615
1,505
6,354
13
6
Livestock
1,064
924
961
1,023
987
3,896
15
8
Companion
Animal
727
664
685
592
518
2,458
9
4
Other
Revenues (8)
146
303
110
50
52
515
-52
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 the Company'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 $2,314 million and $2,607 million in the first quarter of 2026 and 2025, respectively.
(5)
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.
(6)
Net product sales in the Company's marketing territories.
(7)
Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $161 million and
$44 million in the first quarter of 2026 and 2025, respectively.
(8)
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 and $95 million in the first quarter of 2026 and 2025, respectively.
EX-99.2 — EXHIBIT 99.2
EX-99.2
Filename: tm2612241d1_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
1Q
2Q
3Q
4Q
Full Year
1Q
Sales
$ 16,286
$ 15,529
$ 15,806
$ 17,276
$ 16,400
$ 65,011
5 %
Costs, Expenses and Other
Cost of sales
4,195
3,419
3,557
3,855
5,551
16,382
23 %
Selling, general and administrative
2,700
2,552
2,649
2,633
2,898
10,733
6 %
Research and development
12,592
3,621
4,048
4,234
3,886
15,789
*
Restructuring costs
195
69
560
47
213
889
*
Other (income) expense, net
138
(35 )
(7 )
(238 )
432
151
*
(Loss) Income Before Taxes
(3,534 )
5,903
4,999
6,745
3,420
21,067
*
Income Tax Provision
709
818
571
958
458
2,804
Net (Loss) Income
(4,243 )
5,085
4,428
5,787
2,962
18,263
*
Less: Net (Loss) Income Attributable to Noncontrolling Interests
(3 )
6
1
2
(1 )
9
Net (Loss) Income Attributable to Merck & Co., Inc., Rahway, N.J., USA
$ (4,240 )
$ 5,079
$ 4,427
$ 5,785
$ 2,963
$ 18,254
*
(Loss) Earnings per Common Share Assuming Dilution (1)
$ (1.72 )
$ 2.01
$ 1.76
$ 2.32
$ 1.19
$ 7.28
*
Average Shares Outstanding Assuming Dilution (1)
2,472
2,531
2,513
2,498
2,488
2,507
Tax Rate
-20.1 %
13.9 %
11.4 %
14.2 %
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 quarter 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
FIRST QUARTER
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
Adjustment
Subtotal
Non-GAAP
First Quarter
Cost of sales
$ 3,419
620
36
656
$ 2,763
Selling,
general and administrative
2,552
23
23
2,529
Research
and development
3,621
7
7
3,614
Restructuring
costs
69
69
69
–
Other (income)
expense, net
(35 )
(3 )
(107 )
(110 )
75
Income
Before Taxes
5,903
(647 )
(105 )
107
(645 )
6,548
Income
Tax Provision (Benefit)
818
(117 )(3)
(18 )(3)
22 (3)
(113 )
931
Net Income
5,085
(530 )
(87 )
85
(532 )
5,617
Net Income
Attributable to Merck & Co., Inc., Rahway, N.J., USA
5,079
(530 )
(87 )
85
(532 )
5,611
Earnings
per Common Share Assuming Dilution
$ 2.01
(0.21 )
(0.03 )
0.03
(0.21 )
$ 2.22
Tax
Rate
13.9 %
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 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 reflect the amortization of intangible assets.
(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.
MERCK & CO., INC.,
RAHWAY, N.J., USA
FRANCHISE / KEY PRODUCT
SALES
FIRST QUARTER 2026
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3a
Global
U.S.
International
1Q 2026
1Q 2025
% Change
1Q 2026
1Q 2025
% Change
1Q 2026
1Q 2025
% Change
TOTAL SALES (1)
$ 16,286
$ 15,529
5
$ 9,164
$ 8,522
8
$ 7,122
$ 7,007
2
PHARMACEUTICAL
14,349
13,638
5
8,512
7,927
7
5,837
5,711
2
Oncology
Keytruda
7,906
7,205
10
4,599
4,308
7
3,307
2,897
14
Keytruda Qlex
128
-
106
-
21
-
Alliance Revenue – Lynparza (2)
341
312
9
149
145
3
192
168
15
Alliance Revenue – Lenvima (2)
256
258
-1
176
186
-5
80
72
11
Welireg
199
137
45
152
123
24
47
15
*
Alliance Revenue – Reblozyl (3)
148
119
25
128
101
27
20
18
11
Vaccines (4)
Gardasil/Gardasil 9
1,069
1,327
-19
485
536
-10
585
790
-26
ProQuad/M-M-R II/Varivax
538
539
0
409
423
-3
129
116
11
RotaTeq
206
228
-10
165
164
0
42
64
-35
Vaxneuvance
202
230
-12
123
139
-11
78
92
-15
Capvaxive
142
107
33
118
106
11
23
1
*
Enflonsia
1
-
-1
-
3
-
Cardiometabolic & Respiratory
Winrevair
525
280
88
477
268
78
48
12
*
Ohtuvayre
131
-
131
-
Alliance Revenue - Adempas/Verquvo (5)
109
106
3
109
97
12
9
-100
Adempas (6)
78
68
15
78
68
15
Infectious Diseases
Bridion
472
441
7
427
378
13
45
63
-29
Prevymis
272
208
31
135
102
32
138
106
30
Zerbaxa
82
70
17
52
42
22
30
28
9
Delstrigo
75
67
12
10
15
-34
65
52
26
Isentress/Isentress HD
59
90
-34
35
51
-31
24
39
-38
Dificid
34
83
-59
24
72
-67
10
11
-10
Lagevrio
28
102
-73
16
35
-54
12
67
-83
Diabetes
Januvia
367
549
-33
252
344
-27
116
204
-43
Janumet
207
247
-16
68
65
5
139
182
-23
Other Pharmaceutical (7)
774
865
-11
167
227
-26
605
637
-5
ANIMAL HEALTH
1,791
1,588
13
519
502
3
1,272
1,086
17
Livestock
1,064
924
15
211
194
9
853
730
17
Companion Animal
727
664
9
308
308
0
419
356
18
Other Revenues (8)
146
303
-52
133
93
43
13
210
-94
*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)
Total Vaccines sales were $2,314 million and $2,607 million on a global basis in the first quarter of 2026 and 2025, respectively.
(5)
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.
(6)
Net product sales in the Company's marketing territories.
(7)
Includes Pharmaceutical products not individually shown above. Also reflects total alliance revenue for Koselugo of $161 million and
$44 million on a global basis in the first quarter of 2026 and 2025, respectively.
(8)
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 and $95 million in the first quarter of 2026 and 2025, respectively.
MERCK & CO., INC., RAHWAY, N.J., USA
PHARMACEUTICAL GEOGRAPHIC SALES
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3b
2026
2025
% Change
1Q
1Q
2Q
3Q
4Q
Full
Year
1Q
TOTAL PHARMACEUTICAL
$ 14,349
$ 13,638
$ 14,050
$ 15,611
$ 14,843
$ 58,142
5
United States
8,512
7,927
8,328
9,493
8,662
34,409
7
% Pharmaceutical Sales
59.3 %
58.1 %
59.3 %
60.8 %
58.4 %
59.2 %
Europe (1)
2,725
2,384
2,551
2,675
2,839
10,449
14
% Pharmaceutical Sales
19.0 %
17.5 %
18.2 %
17.1 %
19.1 %
18.0 %
Latin America
624
589
654
691
644
2,578
6
% Pharmaceutical Sales
4.3 %
4.3 %
4.7 %
4.4 %
4.3 %
4.4 %
Asia Pacific (other than China and Japan)
569
535
609
593
586
2,323
6
% Pharmaceutical Sales
4.0 %
3.9 %
4.3 %
3.8 %
4.0 %
4.0 %
Japan
535
651
604
693
684
2,632
-18
% Pharmaceutical Sales
3.7 %
4.8 %
4.3 %
4.4 %
4.6 %
4.5 %
Eastern Europe/Middle East/Africa
413
435
451
365
348
1,598
-5
% Pharmaceutical Sales
2.9 %
3.2 %
3.2 %
2.3 %
2.3 %
2.7 %
China (2)
353
668
407
377
364
1,816
-47
% Pharmaceutical Sales
2.5 %
4.9 %
2.9 %
2.4 %
2.5 %
3.1 %
Canada
137
125
135
134
153
547
9
% Pharmaceutical Sales
1.0 %
0.9 %
1.0 %
0.9 %
1.0 %
0.9 %
Other
481
324
311
590
563
1,790
48
% Pharmaceutical Sales
3.3 %
2.4 %
2.1 %
3.9 %
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.
(2)
Gardasil/Gardasil 9 sales in China were $0 million and $193 million in the first quarter of 2026 and 2025, respectively.
MERCK
& CO., INC., RAHWAY, N.J., USA
OTHER
(INCOME) EXPENSE, NET - GAAP
(AMOUNTS
IN MILLIONS)
(UNAUDITED)
Table
4
OTHER (INCOME) EXPENSE, NET
1Q26
1Q25
Interest income
$ (35 )
$ (109 )
Interest expense
479
313
Exchange losses
38
90
Income from investments in equity securities,
net (1)
(168 )
(90 )
Net periodic defined benefit plan (credit) cost other than service cost
(134 )
(148 )
Other, net
(42 )
(91 )
Total
$ 138
$ (35 )
(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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