Results Demonstrate Strong Momentum Across Business Third-Quarter 2021 Worldwide Sales Were $13.2 Billion, 20% Above Third-Quarter 2020; Excluding the Impact from Foreign Exchange, Sales Grew 19% Reflecting Strong Demand for the Company’s Robust Portfolio: KEYTRUDA Sales Grew 22% to $4.5 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 21% GARDASILGARDASIL 9 Sales Grew 68% to $2.0 Billion; Excluding ...
  • Results Demonstrate Strong Momentum Across Business
  • Third-Quarter 2021 Worldwide Sales Were $13.2 Billion, 20% Above Third-Quarter 2020; Excluding the Impact from Foreign Exchange, Sales Grew 19% Reflecting Strong Demand for the Company's Robust Portfolio:
    • KEYTRUDA Sales Grew 22% to $4.5 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 21%
    • GARDASIL/GARDASIL 9 Sales Grew 68% to $2.0 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 63%
    • Animal Health Sales Grew 16% to $1.4 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 14%
  • Third-Quarter 2021 GAAP EPS from Continuing Operations Was $1.80; Third-Quarter 2021 Non-GAAP EPS from Continuing Operations Was $1.75
  • Bolstered Innovation with Agreement to Acquire Acceleron Pharma, Complementing and Expanding Merck's Cardiovascular Pipeline
  • Progressed Regulatory Applications, Secured Multiple Regulatory Approvals, and Saw Advancement of Key Government Recommendations, Including:
    • Submission of Emergency Use Authorization Application to FDA for Molnupiravir, an Investigational Oral Antiviral Medicine for the Treatment of At-Risk Patients with Mild-to-Moderate COVID-19
    • FDA Approval of WELIREG for the Treatment of Adult Patients with Certain Types of Von Hippel-Lindau Disease-Associated Tumors
    • FDA Approval of KEYTRUDA in Combination with Lenvima for the First-Line Treatment of Adult Patients with Advanced Renal Cell Carcinoma
    • FDA Approval of KEYTRUDA in Combination with Chemotherapy, with or Without Bevacizumab, for the Treatment of Certain Patients with Persistent, Recurrent or Metastatic Cervical Cancer
    • U.S. CDC's Advisory Committee on Immunization Practices Vote to Provisionally Recommend Vaccination with a Sequential Regimen of VAXNEUVANCE Followed by PNEUMOVAX 23 as an Option both for Adults 65 Years and Older and for Adults Ages 19 to 64 with Certain Underlying Medical Conditions
  • 2021 Financial Outlook:
    • Raises and Narrows Estimated Full-Year 2021 Revenue Range to Be Between $47.4 Billion and $47.9 Billion, Including a Positive Impact from Foreign Exchange of Approximately 1.5%; Now Expects Full-Year 2021 Sales Growth of 14% to 15%
    • Raises and Narrows Full-Year 2021 GAAP EPS to be Between $4.71 and $4.76; Raises and Narrows Full-Year 2021 Non-GAAP EPS to be Between $5.65 and $5.70, Including a Positive Impact from Foreign Exchange of Approximately 2%

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2021.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211028005322/en/

"Merck delivered another strong quarter with positive momentum across our business and meaningful progress across our pipeline. Our teams continued to excel as we focus on evolving our operations, while driving innovations in our labs that exemplify the best of Merck science," said Robert M. Davis, chief executive officer and president, Merck. "We achieved notable clinical milestones in the key areas of oncology and COVID-19, including positive Phase 3 results for molnupiravir. We recently announced our proposed acquisition of Acceleron, which will strengthen our cardiovascular portfolio with complementary, cutting-edge science and an exciting late-stage candidate. Looking ahead, we remain focused on building more momentum, delivering on our mission of saving and improving lives and continuing to expand our portfolio and pipeline for long-term success and sustainable value creation."

Financial Summary Continuing Operations

Financial information presented in this release reflects Merck's results on a continuing operations basis, which excludes Organon & Co., that was spun-off on June 2, 2021.

$ in millions, except EPS amounts

Third Quarter

2021

2020

Change

Change
Ex-
Exchange

Sales

$13,154

$10,929

20%

19%

GAAP net income from continuing operations 1

4,567

2,324

97%

94%

Non-GAAP net income that excludes certain items 1,2 *

4,439

3,486

27%

26%

GAAP EPS from continuing operations

1.80

0.92

96%

93%

Non-GAAP EPS that excludes certain items 2 *

1.75

1.37

28%

26%

*Refer to table on page 13.

GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) was $1.80 for the third quarter of 2021. Non-GAAP EPS of $1.75 for the third quarter of 2021 excludes acquisition- and divestiture-related costs, restructuring costs, income and losses from investments in equity securities and certain other items. Year-to-date results can be found in the attached tables.

Strong Performance Across the Business

Merck achieved strong performance across its key pillars of Oncology, Vaccines, and Animal Health, led by highly innovative products, including KEYTRUDA (pembrolizumab), Lynparza (olaparib), Lenvima (lenvatinib), GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) and the BRAVECTO (fluralaner) line of products. In addition, BRIDION (sugammadex) injection 100 mg/mL saw strong growth in the quarter. The company continues to benefit from strong underlying demand for its products, as well as broad commercial scale and improved patient access to its innovative medicines across the globe.

Merck Reported Positive Phase 3 Results for Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment

Merck and Ridgeback Biotherapeutics announced positive results from the interim analysis of the Phase 3 MOVe-OUT trial of investigational oral antiviral therapeutic molnupiravir (MK-4482/EIDD-2801) in at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19. The company announced on Oct. 11, 2021, the submission of an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) based on these findings and plans to submit marketing applications to other regulatory bodies worldwide. If authorized or approved, Merck anticipates that molnupiravir can become an important treatment as part of the global effort to fight the COVID-19 pandemic. On Oct. 14, 2021, the FDA announced a Nov. 30, 2021, meeting of its Antimicrobial Drugs Advisory Committee to discuss the available data supporting the use of molnupiravir to treat at-risk adults with mild-to-moderate COVID-19. On Oct. 25, 2021, the European Medicines Agency (EMA) initiated a rolling review for molnupiravir for the treatment of COVID-19 in adults. Merck plans to work with the EMA's Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application.

Merck is committed to providing timely access to molnupiravir globally, if it is authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries' relative ability to finance their pandemic response and health systems. Merck has entered into non-exclusive voluntary licensing agreements with established generic manufacturers in India for molnupiravir. Additionally, Merck and the Medicines Patent Pool (MPP) jointly announced the signing of a voluntary licensing agreement to facilitate access to generic molnupiravir, upon local regulatory authorization. These agreements will help expand access to molnupiravir in more than 100 low- and middle-income countries.

Merck has entered into supply and purchase commitments for molnupiravir with several governments worldwide, including Australia, New Zealand, South Korea, the U.K. and the U.S., pending regulatory authorization, and is currently in discussions with other governments. The company expects to produce 10 million courses of treatment by the end of 2021, with at least 20 million additional courses expected to be produced in 2022.

Planned Acquisition of Acceleron Bolsters Innovation and Broadens Cardiovascular Pipeline

Merck announced a definitive agreement and tender offer to acquire Acceleron Pharma Inc. (Acceleron). The planned acquisition complements and strengthens Merck's cardiovascular pipeline with Acceleron's lead therapeutic candidate, sotatercept, a potentially first-in-class therapy in Phase 3 clinical trials for the treatment of pulmonary arterial hypertension. Merck commenced a tender offer on Oct. 12, 2021, and upon successful completion of the tender offer and receipt of necessary regulatory approvals, Merck, through a subsidiary, will acquire Acceleron for $180 per share in cash for an approximate total equity value of $11.5 billion. The transaction is expected to close in the fourth quarter of 2021.

Oncology Program Highlights

Merck continued to advance development programs across its oncology portfolio, anticipating more than 90 potential new indications by 2028, including notable progress for KEYTRUDA, the company's anti-PD-1 therapy; Lynparza, an oral poly (ADP-ribose) polymerase (PARP) inhibitor being co-developed and co-commercialized with AstraZeneca; Lenvima, an orally available tyrosine kinase inhibitor (TKI) being co-developed and co-commercialized with Eisai Co., Ltd. (Eisai); and WELIREG (belzutifan), an oral hypoxia-inducible factor-2 alpha inhibitor (HIF-2α).

  • Merck announced the following regulatory milestones:
    • FDA approval of WELIREG for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma (RCC), central nervous hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery based on the open label Study 004 trial. WELIREG is the first HIF-2α inhibitor therapy approved in the U.S. and is currently being evaluated in three Phase 3 studies as monotherapy and in combination with other novel therapies.
    • FDA approval of KEYTRUDA in combination with Lenvima for the first-line treatment of adult patients with advanced RCC. The approval was based on results from the pivotal Phase 3 CLEAR study (KEYNOTE-581/Study 307).
    • FDA approval of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test, based on results from the Phase 3 KEYNOTE-826 trial.
    • FDA priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney), or following nephrectomy and resection of metastatic lesions. This sBLA was based on data that demonstrated a statistically significant and clinically meaningful improvement in disease-free survival compared to placebo from the pivotal Phase 3 KEYNOTE-564 trial. The Prescription Drug User Fee Act (PDUFA) date is Dec. 10, 2021.
    • FDA priority review for a new sBLA for KEYTRUDA for the adjuvant treatment of adult and pediatric patients (12 years and older) with STAGE IIB or IIC melanoma following complete resection, based on results from the Phase 3 KEYNOTE-716 trial that showed a statistically significant and clinically meaningful improvement in recurrence-free survival compared to placebo. The PDUFA date is Dec. 4, 2021.
    • FDA review of a new sBLA seeking approval for KEYTRUDA as a single agent for the treatment of patients with advanced endometrial carcinoma (EC) that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. The application is based on overall response data from Cohorts D and K of the KEYNOTE-158 trial. The PDUFA date is March 28, 2022.
    • Positive opinion from the CHMP of the EMA for KEYTRUDA in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (CPS ≥10) and who have not received prior chemotherapy for metastatic disease. The positive opinion is based on progression-free survival and overall survival (OS) results from the Phase 3 KEYNOTE-355 trial.
    • European Commission approval of KEYTRUDA, in combination with chemotherapy, for the first-line treatment of locally recurrent unresectable or metastatic TNBC in adults whose tumors express PD-L1 (CPS ≥10) and who have not received prior chemotherapy for metastatic disease.
    • Positive opinions from the CHMP of the EMA recommending approval of the combination of KEYTRUDA plus Lenvima for two different indications: advanced RCC and advanced or recurrent EC. The positive opinions are based on data from two pivotal Phase 3 trials: CLEAR (KEYNOTE-581/Study 307) evaluating the combination in adult patients with advanced RCC and KEYNOTE-775/Study 309 evaluating the combination in certain patients with advanced or recurrent EC.
    • National Medical Products Administration approval in China of KEYTRUDA in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or gastroesophageal junction. This new indication was granted approval based on OS findings from the pivotal Phase 3 KEYNOTE-590 trial. KEYTRUDA is now approved for eight indications across five different types of cancer in China.
    • Pharmaceuticals and Medical Devices Agency approval in Japan of two KEYTRUDA indications. KEYTRUDA was approved for the treatment of patients with PD-L1-positive, hormone receptor-negative and human epidermal growth factor receptor 2-negative, inoperable or recurrent breast cancer based on the results of the Phase 3 KEYNOTE-355 trial and for the treatment of patients with unresectable, advanced or recurrent MSI-H colorectal cancer, based on the results of the Phase 3 KEYNOTE-177 trial. With these approvals, KEYTRUDA has 15 authorized uses in Japan, including indications in nine tumor types as well as MSI-H tumors.
  • Merck provided additional data presentations and updates including:
    • Final OS results from the pivotal Phase 3 KEYNOTE-355 trial were presented at the European Society for Medical Oncology (ESMO) Congress 2021 demonstrating a 27% reduction in risk of death for patients with metastatic TNBC whose tumors expressed PD-L1 (CPS ≥10) using first-line treatment of KEYTRUDA in combination with chemotherapy (paclitaxel, nab-paclitaxel or gemcitabine/carboplatin) as compared to chemotherapy alone.
    • Positive results from the Phase 3 PROpel trial demonstrating superior radiographic progression-free survival with Lynparza in combination with abiraterone and prednisone versus abiraterone plus prednisone as a first-line treatment for men with metastatic castration-resistant prostate cancer with or without homologous recombination repair gene mutations.

Other Highlights

Vaccines

  • Merck announced positive topline results from the pivotal Phase 3 PNEU-PED (V114-029) study evaluating the immunogenicity, safety and tolerability of VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) in healthy infants enrolled between 42-90 days of age.
  • Merck announced that the CHMP of the EMA has recommended the approval of VAXNEUVANCE for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The CHMP recommendation will now be reviewed by the European Commission for marketing authorization in the EU, and a final decision is expected by the end of the year.
  • Merck announced the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) voted to provisionally recommend vaccination either with a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent), or with a single dose of 20-valent pneumococcal conjugate vaccine, for both adults 65 years and older and for adults ages 19 to 64 with certain underlying medical conditions or other risk factors. Final recommendations are subject to review by the director of the CDC and the Department of Health and Human Services, and will become official when published in the CDC's Morbidity and Mortality Weekly Report (MMWR).

Infectious Diseases

  • Merck announced top-line results from two pivotal Phase 3 trials of the investigational, once-daily oral fixed dose combination pill of doravirine/islatravir in adults with HIV-1 infection who are virologically suppressed on different antiretroviral therapy regimens (ILLUMINATE SWITCH A) or bictegravir/emtricitabine/tenofovir (ILLUMINATE SWITCH B).
  • Merck anticipates the initiation of a phased resupply of ZERBAXA (ceftolozane and tazobactam) for injection beginning with the U.S. in the fourth quarter of 2021 following a voluntary recall in 2020. Additionally, the FDA has accepted for review two supplemental New Drug Applications for ZERBAXA in pediatric complicated urinary tract infections and complicated intra-abdominal infections with PDUFA dates of April 21, 2022, and May 2, 2022, respectively.

Third-Quarter Revenue Performance

The following table reflects sales of the company's top pharmaceutical products, as well as sales of Animal Health products.

$ in millions

Third Quarter

2021

2020

Change

Change Ex-
Exchange

Total Sales

$13,154

$10,929

20%

19%

Pharmaceutical

11,496

9,714

18%

17%

KEYTRUDA

4,534

3,715

22%

21%

GARDASIL / GARDASIL 9

1,993

1,187

68%

63%

JANUVIA / JANUMET

1,339

1,327

1%

0%

PROQUAD, M-M-R II and

VARIVAX

661

576

15%

14%

BRIDION

369

320

16%

15%

PNEUMOVAX 23

277

375

-26%

-26%

Lynparza*

ROTATEQ

246

227

196

210

25%

8%

25%

7%

SIMPONI

203

209

-3%

-5%

ISENTRESS / ISENTRESS HD

Lenvima*

189

188

205

142

-8%

32%

-7%

30%

Animal Health

1,417

1,220

16%

14%

Livestock

864

758

14%

12%

Companion Animals

553

462

20%

18%

Other Revenues**

241

(5)

>100%

>100%

*Alliance revenue for this product represents Merck's share of profits, which are product sales net of cost of sales and commercialization costs.

**Other revenues are comprised primarily of third-party manufacturing sales and miscellaneous corporate revenues,
including revenue-hedging activities. Other revenues in the third quarter of 2021 include $135 million
related to the receipt of a milestone payment for an out-licensed product.

Pharmaceutical Revenue

Third-quarter pharmaceutical sales increased 18% to $11.5 billion, compared to the third quarter of 2020. Excluding the favorable effect of foreign exchange, sales grew by 17%, reflecting strength in the company's oncology and vaccine businesses.

Growth in oncology was largely driven by higher sales of KEYTRUDA, which rose 22% to $4.5 billion in the quarter. Global sales growth of KEYTRUDA reflects continued strong momentum from the non-small-cell lung cancer indications as well as uptake in other indications, including RCC, head and neck squamous cell carcinoma, TNBC and MSI-H cancers. Also contributing to higher sales in oncology was a 25% increase in Lynparza alliance revenue, primarily reflecting continued uptake in the United States and Europe, as well as a 32% increase in Lenvima alliance revenue, driven primarily by higher demand in the United States and China.

Growth in vaccines for the third quarter was primarily driven by higher combined sales of GARDASIL and GARDASIL 9, vaccines to prevent certain cancers and other diseases caused by HPV. Third-quarter 2021 GARDASIL/GARDASIL 9 sales grew 68% to $2.0 billion, primarily driven by strong global demand, particularly in China, which also benefitted from increased supply, as well as in the United States, which also benefitted from the timing of public sector purchases.

Combined sales of pediatric vaccines VARIVAX (Varicella Virus Vaccine Live), a vaccine to help prevent chickenpox; PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), a combination vaccine to help protect against measles, mumps, rubella and varicella; and M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live), a vaccine to help prevent measles, mumps and rubella, also contributed to higher sales in vaccines, increasing by 15% to $661 million primarily driven by the ongoing recovery of wellness visits in the United States.

Vaccine performance was negatively affected by lower sales of PNEUMOVAX 23, a vaccine to help prevent pneumococcal disease, which declined 26% to $277 million primarily driven by lower demand in the United States reflecting prioritization of the COVID-19 vaccine.

Performance in hospital acute care reflects the suspension of sales of ZERBAXA for injection, a combination cephalosporin antibacterial and beta-lactamase inhibitor for the treatment of adults with certain bacterial infections, following a product recall in the fourth quarter of 2020. This unfavorability was partially offset by higher demand globally for BRIDION injection 100 mg/mL, a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery, which increased 16% to $369 million due in part to the ongoing COVID-19 pandemic recovery, and growth in DIFICID (fidaxomicin), a macrolide antibacterial drug for treatment of Clostridioides difficile -associated diarrhea in adults and pediatric patients aged 6 months and older, in the United States.

Animal Health Revenue

Animal Health sales totaled $1.4 billion for the third quarter of 2021, an increase of 16% compared with the third quarter of 2020. Excluding the favorable effect from foreign exchange, Animal Health sales increased 14%, reflecting growth across geographies and species, including the biopharmaceutical portfolio and the Animal Health Intelligence portfolio. Sales growth in livestock was primarily driven by higher demand globally for ruminant products, including Animal Health Intelligence products. Sales growth in companion animal was primarily driven by the BRAVECTO parasiticide line of products, as well as vaccines.

Third-Quarter Expense, EPS and Related Information

The tables below present selected expense information.

$ in millions

Third-Quarter 2021

GAAP

Acquisition-
and
Divestiture-
Related
Costs
3

Restructuring
Costs

(Income)
Loss from
Investments
in Equity
Securities

Certain
Other
Items

Non-
GAAP
2

Cost of sales

$3,450

$346

$48

$-

$-

$3,056

Selling, general and
administrative

2,336

61

5

-

-

2,270

Research and
development

2,445

48

8

-

(87)

2,476

Restructuring costs

107

-

107

-

-

-

Other (income)
expense, net

(450)

(10)

-

(684)

-

244

Third-Quarter 2020

Cost of sales

$3,013

$403

$38

$-

$-

$2,572

Selling, general and
administrative

2,060

25

15

-

-

2,020

Research and
development

3,349

19

19

-

1,082

2,229

Restructuring costs

113

-

113

-

-

-

Other (income)
expense, net

(312)

-

-

(346)

(1)

35

GAAP Expense, EPS and Related Information

Gross margin was 73.8% for the third quarter of 2021 compared to 72.4% for the third quarter of 2020. The increase primarily reflects the favorable effects of product mix and lower acquisition- and divestiture-related costs, partially offset by higher manufacturing costs.

Selling, general and administrative expenses were $2.3 billion in the third quarter of 2021, an increase of 13% compared to the third quarter of 2020. The increase primarily reflects higher administrative costs, increased promotional expenses in support of the company's growth pillars, higher acquisition- and divestiture-related costs, as well as the unfavorable effects of foreign exchange.

Research and development expenses were $2.4 billion in the third quarter of 2021 compared with $3.3 billion in the third quarter of 2020. The decrease was primarily driven by lower upfront payments related to collaborations and license agreements, partially offset by higher oncology and COVID-19 clinical development spending, as well as increased investment in discovery research and early drug development.

Other (income) expense, net, was $450 million of income in the third quarter of 2021 compared to $312 million of income in the third quarter of 2020, primarily reflecting higher income from investments in equity securities, net, partially offset by higher pension settlement costs.

The effective income tax rate was 13.2% for the third quarter of 2021, reflecting the beneficial impact of the settlement of a foreign tax matter.

GAAP EPS was $1.80 for the third quarter of 2021 compared with $0.92 for the third quarter of 2020.

Non-GAAP Expense, EPS and Related Information

Non-GAAP gross margin was 76.8% for the third quarter of 2021 compared to 76.5% for the third quarter of 2020. The increase in non-GAAP gross margin primarily reflects the favorable effect of product mix, partially offset by higher manufacturing costs.

Non-GAAP selling, general and administrative expenses were $2.3 billion in the third quarter of 2021, an increase of 12% compared to the third quarter of 2020. The increase primarily reflects higher administrative costs, increased promotional expenses in support of the company's growth pillars, as well as the unfavorable effects of foreign exchange.

Non-GAAP R&D expenses were $2.5 billion in the third quarter of 2021, an 11% increase compared to the third quarter of 2020. The increase primarily reflects higher oncology and COVID-19 clinical development spending, as well as increased investment in discovery research and early drug development.

Non-GAAP other (income) expense, net, was $244 million of expense in the third quarter of 2021 compared to $35 million of expense in the third quarter of 2020, primarily reflecting higher pension settlement costs.

The non-GAAP effective income tax rate was 13.0% for the third quarter of 2021, reflecting the beneficial impact of the settlement of a foreign tax matter.

Non-GAAP EPS was $1.75 for the third quarter of 2021 compared with $1.37 for the third quarter of 2020.

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.


$ in millions, except EPS amounts

Third Quarter

2021

2020

EPS

GAAP EPS

$1.80

$0.92

Difference

(0.05)

0.45

Non-GAAP EPS that excludes items listed below 2

$1.75

$1.37

Net Income

GAAP net income 1

$4,567

$2,324

Difference

(128)

1,162

Non-GAAP net income that excludes items listed below 1,2

$4,439

$3,486

Decrease (Increase) in Net Income Due to Excluded Items:

Acquisition- and divestiture-related costs 3

$445

$447

Restructuring costs

168

185

(Income) loss from investments in equity securities

(684)

(346)

Charges for acquisitions and collaborations 4

-

1,082

Other

(87)

(1)

Net decrease (increase) in income before taxes

(158)

1,367

Income tax (benefit) expense 5

30

(205)

Decrease (increase) in net income

$(128)

$1,162

Financial Outlook

Merck continues to experience strong global underlying demand across its business. Consequently, Merck is raising and narrowing its full-year estimated ranges for revenue and EPS. At mid-October 2021 exchange ranges, Merck now expects sales growth of 14% to 15% in 2021, with full-year 2021 revenue estimated to be between $47.4 billion and $47.9 billion, including a positive impact from foreign exchange of approximately 1.5%.

Merck continues to believe that the global health systems and patients have largely adapted to the impacts of the COVID-19 pandemic, and, that while certain negative effects will persist, the trend will continue to improve. Merck continues to estimate that the pandemic will have a net unfavorable impact to 2021 revenues of less than 3%, all of which relates to the pharmaceutical segment.

Merck is raising and narrowing its full-year 2021 GAAP EPS range to be between $4.71 and $4.76.

Merck is raising and narrowing its non-GAAP EPS range and now expects full-year 2021 to be between $5.65 and $5.70, including a positive impact from foreign exchange of approximately 2%. The non-GAAP range excludes acquisition- and divestiture-related costs, costs related to restructuring programs, income and losses from investments in equity securities, and certain other items. Neither the sales nor the EPS ranges provided above include the impact of the potential launch of Merck's COVID-19 antiviral drug candidate, molnupiravir.

The following table summarizes the company's full-year 2021 financial guidance.

GAAP

Non-GAAP 2

Revenue

$47.4 to $47.9 billion

$47.4 to $47.9 billion*

Operating
expenses

Lower than 2020 by a

mid-single digit rate

Higher than 2020 by a

high-single digit rate

Effective tax rate

14.5% to 15.0%

14.0% to 14.5%

EPS**

$4.71 to $4.76

$5.65 to $5.70

*The company does not have any non-GAAP adjustments to revenue.

**EPS guidance for 2021 assumes a share count (assuming dilution) of approximately 2.54 billion shares.

A reconciliation of anticipated 2021 GAAP EPS to non-GAAP EPS and the items excluded from non-GAAP EPS are provided in the table below.


$ in millions, except EPS amounts

Full-Year 2021

GAAP EPS

$4.71 to $4.76

Difference

$0.94

Non-GAAP EPS that excludes items listed below 2

$5.65 to $5.70

Acquisition- and divestiture-related costs

Restructuring costs

(Income) loss from investments in equity securities

$2,100

700

(2,000)

Charge for the discontinuation of COVID-19 development programs

225

Charge for the acquisition of Pandion Therapeutics

1,704

Other

(29)

Net decrease (increase) in income before taxes

2,700

Income tax (benefit) expense 6

(310)

Decrease (increase) in net income

$2,390

Earnings Conference Call

Investors, journalists and the general public may access a live audio webcast of the call today at 8:00 a.m. EDT on Merck's website at https://investors.merck.com/events-and-presentations/default.aspx . Institutional investors and analysts can participate in the call by dialing (833) 353-0277 or (469) 886-1947 and using ID code number 6768456. Members of the media are invited to monitor the call by dialing (833) 353-0277 or (469) 886-1947 and using ID code number 6768456. Journalists who wish to ask questions are requested to contact a member of Merck's Media Relations team at the conclusion of the call.

About Merck

For over 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, 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 products, including if the Acceleron acquisition is consummated, Acceleron's pipeline products, that the products 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; uncertainties as to the timing of the offer and subsequent merger with Acceleron; uncertainties as to how many of Acceleron's stockholders will tender their shares in the offer; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the merger and the offer contemplated thereby may not be satisfied or waived; the effects of disruption from the transactions contemplated by the merger agreement and the impact of the announcement and pendency of the transactions on Acceleron's business; the risk that stockholder litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); 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 2020 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).

_________________________________

1

Net income from continuing operations attributable to Merck & Co., Inc.

2

Merck is providing certain 2021 and 2020 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 and permits investors to understand how management assesses performance. Management uses these measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, senior management's annual compensation is derived in part using non-GAAP pretax income. 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

Includes expenses for the amortization of intangible assets and purchase accounting adjustments to inventories, 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 related to acquisitions and divestitures.

4

2020 includes $832 million related to the Seagen collaborations.

5

Includes the estimated tax impact on the reconciling items. In addition, the amount for 2020 includes a tax cost of $67 million, representing an adjustment to the tax benefits recorded in conjunction with the 2015 acquisition of Cubist Pharmaceuticals, Inc.

6

Includes the estimated tax impact on the reconciling items, as well as a $207 million net tax benefit related to the settlement of certain federal income tax matters.
MERCK & CO., INC.
CONSOLIDATED STATEMENT OF INCOME - GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1
On June 2, 2021, Merck completed the spinoff of products from its women's health, biosimilars and established brands businesses into a new, independent, publicly traded company named Organon & Co. (Organon) through a distribution of Organon's publicly traded stock to company shareholders. The historical results of the women's health, biosimilars and established brands businesses that were contributed to Organon in the spin-off are excluded from sales and expenses below and reflected as discontinued operations in the company's Consolidated Statements of Income provided below.
GAAP % Change GAAP % Change

3Q21

3Q20

Sep YTD 2021 Sep YTD 2020
Sales

$

13,154

$

10,929

20%

$

35,183

$

30,570

15%

Costs, Expenses and Other

Cost of sales

3,450

3,013

15%

9,752

8,589

14%

Selling, general and administrative

2,336

2,060

13%

6,804

6,336

7%

Research and development

2,445

3,349

-27%

9,177

7,609

21%

Restructuring costs (1)

107

113

-5%

487

265

84%

Other (income) expense, net

(450

)

(312

)

44%

(1,007

)

(637

)

58%

Income from Continuing Operations Before Taxes

5,266

2,706

95%

9,970

8,408

19%

Income Tax Provision

695

380

1,436

1,271

Net Income from Continuing Operations

4,571

2,326

97%

8,534

7,137

20%

Less: Net Income Attributable to Noncontrolling Interests

4

2

9

1

Net Income from Continuing Operations Attributable to Merck & Co., Inc.

$

4,567

$

2,324

97%

$

8,525

$

7,136

19%

Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests

$

-

$

617

*

$

766

$

2,025

-62%

Net Income Attributable to Merck & Co., Inc.

$

4,567

$

2,941

55%

$

9,291

$

9,161

1%

Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders:

Income from Continuing Operations

$

1.81

$

0.92

97%

$

3.37

$

2.82

20%

Income from Discontinued Operations

$

-

$

0.24

*

$

0.30

$

0.80

-63%

Net Income

$

1.81

$

1.16

56%

$

3.67

$

3.62

1%

Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders:

Income from Continuing Operations

$

1.80

$

0.92

96%

$

3.36

$

2.81

20%

Income from Discontinued Operations

$

-

$

0.24

*

$

0.30

$

0.80

-63%

Net Income

$

1.80

$

1.16

55%

$

3.66

$

3.61

1%

Average Shares Outstanding

2,530

2,529

2,531

2,530

Average Shares Outstanding Assuming Dilution

2,536

2,538

2,539

2,541

Tax Rate from Continuing Operations (2)

13.2

%

14.0

%

14.4

%

15.1

%

* 100% or greater
(1) Represents separation and other related costs associated with restructuring activities under the company's formal restructuring programs.
(2) The effective income tax rate for the first nine months of 2021 reflects the unfavorable impact of a charge for the acquisition of Pandion Therapeutics, Inc. for which no tax benefit was recognized and a net tax benefit of $207 million related to the settlement of certain federal income tax matters.
MERCK & CO., INC.
THIRD QUARTER AND NINE MONTHS ENDED SEPTEMBER 30, 2021 GAAP TO NON-GAAP RECONCILIATION - CONTINUING OPERATIONS
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2a
The table below reflects a reconciliation of GAAP to non-GAAP financial information on a continuing operations basis.  As Organon results are reflected within discontinued operations, they are excluded from the financial information provided below.
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

$

3,450

346

48

394

$

3,056

Selling, general and administrative

2,336

61

5

66

2,270

Research and development

2,445

48

8

(87)

(4)

(31)

2,476

Restructuring costs

107

107

107

-

Other (income) expense, net

(450)

(10)

(684)

(694)

244

Income From Continuing Operations Before Taxes

5,266

(445)

(168)

684

87

158

5,108

Income Tax Provision (Benefit)

695

(96)

(5)

(26)

(5)

151

(5)

1

(5)

30

665

Net Income from Continuing Operations

4,571

(349)

(142)

533

86

128

4,443

Net Income from Continuing Operations Attributable to Merck & Co., Inc.

4,567

(349)

(142)

533

86

128

4,439

Earnings per Common Share Assuming Dilution from Continuing Operations

$

1.80

(0.14)

(0.06)

0.21

0.04

0.05

$

1.75

Tax Rate

13.2%

13.0%

Sep YTD
Cost of sales

$

9,752

1,188

113

225

(3)

1,526

$

8,226

Selling, general and administrative

6,804

96

9

105

6,699

Research and development

9,177

82

21

1,678

(4)

1,781

7,396

Restructuring costs

487

487

487

-

Other (income) expense, net

(1,007)

79

(1,503)

(1,424)

417

Income From Continuing Operations Before Taxes

9,970

(1,445)

(630)

1,503

(1,903)

(2,475)

12,445

Income Tax Provision (Benefit)

1,436

(283)

(5)

(82)

(5)

331

(5)

(259)

(5)

(293)

1,729

Net Income from Continuing Operations

8,534

(1,162)

(548)

1,172

(1,644)

(2,182)

10,716

Net Income from Continuing Operations Attributable to Merck & Co., Inc.

8,525

(1,162)

(548)

1,172

(1,644)

(2,182)

10,707

Earnings per Common Share Assuming Dilution from Continuing Operations

$

3.36

(0.46)

(0.22)

0.46

(0.65)

(0.86)

$

4.22

Tax Rate

14.4%

13.9%

Only the line items that are affected by non-GAAP adjustments are shown.
Merck is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors' understanding of the company's results as it permits investors to understand how management assesses performance. Management uses these measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, senior management's annual compensation is derived in part using non-GAAP pretax income. This information 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 acquisition and divestiture-related costs.  Amounts included in research and development expenses primarily reflect expenses for the amortization of intangible assets.  Amounts included in other (income) expense, net, for the third quarter and nine months period primarily reflect an increase in the estimated fair value measurement of liabilities for contingent consideration related to the termination of the Sanofi-Pasteur MSD joint venture.  Additionally, the first nine months also includes a loss on a forward exchange contract entered into in conjunction with the Organon spinoff.  Amount included in other (income) expense, net, for the nine month period is partially offset by royalty income related to the termination of the Sanofi-Pasteur MSD joint venture.
(2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to activities under the company's formal restructuring programs.
(3) Represents charges for the discontinuation of COVID-19 development programs.
(4) Amounts included in the third quarter and first nine months reflect a $90 million adjustment to deferred tax assets identified in conjunction with the VelosBio Inc. acquisition.  Additionally, the first nine months includes a $1.7 billion charge for the acquisition of Pandion Therapeutics, Inc.
(5) Represent the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.  Certain other items for the nine month period also includes a $207 million net tax benefit related to the settlement of certain federal income tax matters.
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES - CONTINUING OPERATIONS
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3

2021

2020

3Q September YTD
1Q 2Q 3Q Sep YTD 1Q 2Q 3Q Sep  YTD 4Q Full Year Nom % Ex-Exch % Nom % Ex-Exch %
TOTAL SALES (1)

$10,627

$11,402

$13,154

$35,183

$10,288

$9,353

$10,929

$30,570

$10,948

$41,518

20

19

15

13

PHARMACEUTICAL

9,238

9,980

11,496

30,714

8,905

8,178

9,714

26,797

9,813

36,610

18

17

15

12

Oncology
Keytruda

3,899

4,176

4,534

12,609

3,284

3,388

3,715

10,387

3,993

14,380

22

21

21

19

Alliance Revenue – Lynparza (2)

228

248

246

721

145

178

196

519

206

725

25

25

39

35

Alliance Revenue – Lenvima (2)

130

181

188

498

128

151

142

421

158

580

32

30

18

15

Vaccines (3)
Gardasil / Gardasil 9

917

1,234

1,993

4,144

1,097

656

1,187

2,941

998

3,938

68

63

41

35

ProQuad / M-M-R II / Varivax

449

516

661

1,626

435

378

576

1,390

488

1,878

15

14

17

16

Pneumovax 23

171

152

277

600

256

117

375

748

339

1,087

-26

-26

-20

-21

RotaTeq

158

208

227

593

222

168

210

601

196

797

8

7

-1

-3

Vaqta

34

56

48

138

60

28

51

139

31

170

-6

-6

-1

-2

Hospital Acute Care
Bridion

340

387

369

1,096

299

224

320

843

355

1,198

16

15

30

27

Prevymis

82

93

96

270

60

63

77

200

80

281

23

22

35

31

Noxafil

67

66

64

197

94

73

79

247

82

329

-19

-20

-20

-23

Primaxin

65

60

70

194

51

64

74

189

62

251

-6

-12

3

-4

Cancidas

57

54

56

168

55

43

50

148

65

213

13

9

13

8

Invanz

57

48

53

157

64

43

51

159

53

211

5

0

-1

-4

Zerbaxa

(8)

(1)

(2)

(11)

37

32

43

112

19

130

-105

-105

-110

-110

Immunology
Simponi

214

202

203

619

215

191

209

615

223

838

-3

-5

1

-5

Remicade

85

75

73

233

88

73

82

242

88

330

-11

-11

-4

-8

Neuroscience
Belsomra

79

78

81

238

79

84

81

244

83

327

0

3

-2

-2

Virology
Isentress / Isentress HD

209

192

189

590

245

196

205

646

211

857

-8

-7

-9

-9

Cardiovascular
Alliance Revenue - Adempas/Verquvo (4)

74

74

100

248

53

79

83

216

65

281

20

20

15

15

Adempas (5)

55

74

59

188

56

57

55

167

53

220

7

8

13

7

Diabetes (6)
Januvia

809

784

852

2,445

774

854

821

2,449

857

3,306

4

3

0

-3

Janumet

486

477

487

1,449

503

490

506

1,499

472

1,971

-4

-6

-3

-7

Other Pharmaceutical (7)

581

546

572

1,704

605

548

526

1,675

636

2,312

9

8

2

1

ANIMAL HEALTH

1,418

1,472

1,417

4,307

1,214

1,101

1,220

3,535

1,168

4,703

16

14

22

19

Livestock

819

821

864

2,503

739

648

758

2,145

794

2,939

14

12

17

14

Companion Animals

599

651

553

1,804

475

453

462

1,390

374

1,764

20

18

30

26

Other Revenues (8)

(29)

(50)

241

162

169

74

(5)

238

(33)

205

* *

-32

88

* 200% or greater
Sum of quarterly amounts may not equal year-to-date amounts due to rounding.
(1) Only select products are shown.
(2) Alliance Revenue represents Merck's share of profits, which are product sales net of cost of sales and commercialization costs.
(3) Total Vaccines sales were $1,809 million, $2,293 million, and $3,315 million in the first, second, and third quarter of 2021, respectively, and $2,155 million, $1,418 million, $2,521 million and $2,163 million in the first, second, third and fourth quarters of 2020, respectively.
(4) Alliance Revenue represents Merck's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs.
(5) Net product sales in Merck's marketing territories.
(6) Total Diabetes sales were $1,363 million, $1,330 million, and $1,417 million in the first, second, and third quarter of 2021, respectively, and $1,353 million, $1,418 million, $1,405 million and $1,412 million in the first, second, third and fourth quarters of 2020, respectively.
(7) Includes Pharmaceutical products not individually shown above.
(8) Other Revenues are comprised primarily of third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.  Other Revenues in the third quarter and September year-to-date period of 2021 include $135 million related to the receipt of a milestone payment for an out-licensed product.

Media Contact:
Patrick Ryan
(973) 275-7075

Melissa Moody
(215) 407-3536

Investor Contacts:
Peter Dannenbaum
(908) 740-1037

Raychel Kruper
(908) 740-2107

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