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These agreements will help expand access to molnupiravir in more than 100 low- and middle-income countries. EPS: US$1.28 (down from US$1.81 in 3Q 2021). Vaccine sales were negatively affected by declines in sales of GARDASIL [Human Papillomavirus Quadrivalent (Types 6,11,16 and 18) Vaccine, Recombinant]/GARDASIL 9, vaccines to prevent certain cancers and other diseases caused by HPV, largely due to lower demand in the U.S. and Hong Kong, SAR, PRC attributable to the COVID-19 pandemic, partially offset by higher volumes in China and in Europe. Net income from continuing operations attributable to Merck & Co., Inc. 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. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys 2021 Annual Report on Form 10-K and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov). Patrick Ryan Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA 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. Merck (NYSE: MRK), known as MSD outside the United States and Canada, will hold its third-quarter 2022 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. 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, declined in the third quarter, primarily due to lower demand in the U.S. related to the COVID-19 pandemic. Demand for our products remains robust, and production, supply and distribution of our medicines, vaccines and animal health products are moving forward with minimal disruption, said Kenneth C. Frazier, chairman and chief executive officer, Merck. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn. Acquisition- and Information about your device and internet connection, like your IP address, Browsing and search activity while using Yahoo websites and apps. The company said profit in the quarter was $4.7 billion, or $1.85 a share,. Global sales growth of KEYTRUDA reflects continued strong momentum from the NSCLC indications as well as continued uptake in other indications, including adjuvant melanoma, RCC, bladder, head and neck squamous cell carcinoma (HNSCC) and microsatellite instability-high (MSI-H) cancers as well as uptake following the recent launch of the Q6W dosing regimen in the U.S., partially offset by the negative impacts of the COVID-19 pandemic and pricing in Japan. By continuing, you will be directed to a site intended only for residents of the United States and Canada. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Peter Dannenbaum Growth in oncology was largely driven by higher sales of KEYTRUDA, which rose 20% to $5.4 billion in the quarter. 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. The increase primarily reflects $887 million of intangible asset impairment charges related to the ArQule, Inc. acquisition, charges related to collaboration and licensing agreements with Moderna, Orna and Orion and higher clinical development spending. The company said profit in the quarter was $4.7 billion, or $1.85 a share, excluding certain items. Securities, GAAP Expense, EPS and Related Information. The increase was primarily driven by higher upfront payments related to collaborations and license agreements, higher expenses related to clinical development and increased investment in discovery research and early drug development, partially offset by lower charges for the acquisitions of businesses, as well as lower laboratory, travel and meeting expenses due to the COVID-19 pandemic. Private Securities Litigation Reform Act of 1995. Generally accepted accounting principles (GAAP) earnings per share (EPS) assuming dilution was $1.28 for the third quarter of 2022. **EPS guidance for 2020 assumes a share count (assuming dilution) of approximately 2.54 billion shares. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. 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. We are committed to providing leading innovations for today and the future that save and improve lives around the world. Third-quarter sales climbed 14% to $15.0 billion, ahead of a Refinitiv consensus estimate of $14.1 billion. *Alliance revenue for these products represents Mercks share of profits, which are product sales net of cost of sales and commercialization costs. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys 2021 Annual Report on Form 10-K and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov). https://www.businesswire.com/news/home/20201027005447/en/, Pamela Eisele The following table reflects sales of the companys top pharmaceutical products, as well as sales of Animal Health products. Related Thu, Oct 27 20226:55 AM EDT. Davis said the company has no plans to do so. Non-GAAP gross margin was 74.8% for the third quarter of 2020 compared to 75.9% for the third quarter of 2019. Non-GAAP results for 2021 have been recast to conform to presentation changes implemented in 2022. In the last reported quarter, the company delivered an earnings surprise of 18.23%. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2021. Third-quarter sales climbed 14% to $15.0 billion, ahead of a Refinitiv consensus estimate of $14.1 billion. However, it now expects some residual negative impacts in the fourth quarter, largely in Europe and certain emerging markets. In addition, BRIDION (sugammadex) injection 100 mg/mL saw strong growth in the quarter. Countries outside of the United States and Canada. The vaccine was previously approved for use in women ages 16 to 26. 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% Income from Continuing Operations Before Taxes, Less: Net Income Attributable to Noncontrolling Interests. Sum of quarterly amounts may not equal year-to-date amounts due to rounding. In addition, the phasing of the recovery of GARDASIL 9 demand is slower than originally anticipated, in particular in the U.S. For the full-year 2020, Merck now expects an unfavorable impact to revenue of approximately $2.35 billion (excluding the impact of foreign exchange) due to the COVID-19 pandemic, comprised of approximately $2.3 billion for pharmaceuticals and approximately $50 million for Animal Health, including the impacts in the first three quarters of the year. Journalists who wish to ask questions are requested to contact a member of Mercks Media Relations team. Merck narrowed and raised its full-year 2020 non-GAAP EPS range to be between $5.91 and $6.01, including a negative impact from foreign exchange of approximately 2.5% at mid-October exchange rates. Net income: US$3.25b (down 29% from 3Q 2021). 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. Source: Shutterstock Merck ( NYSE:MRK) Third Quarter 2022 Results Key Financial Results Revenue: US$15.0b (up 14% from 3Q 2021). If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Excluding the favorable effect of foreign exchange, sales grew by 17%, reflecting strength in the companys oncology and vaccine businesses. At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. Non-GAAP EPS was $1.75 for the third quarter of 2021 compared with $1.37 for the third quarter of 2020. 1 Net income from continuing operations attributable to Merck & Co., Inc. 2 Merck is providing certain 2022 and 2021 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. Sum of quarterly amounts may not equal year-to-date amounts due to rounding. 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. 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. https://www.businesswire.com/news/home/20220929005282/en/, Investors: 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. https://www.businesswire.com/news/home/20211028005322/en/, https://investors.merck.com/events-and-presentations/default.aspx, Environmental, Social & Governance (ESG) Report. A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows. Non-GAAP EPS of $1.74 for the third quarter of 2020 excludes acquisition- and divestiture-related costs, restructuring costs, pretax charges of $1.1 billion related to certain license and collaboration agreements, and certain other items. For the full-year 2020, Merck now expects a net favorable impact to operating expenses of approximately $625 million, reflecting continued lower spending due to the COVID-19 pandemic, partially offset by spending on its COVID-19-related antiviral and vaccine research programs. Also contributing to growth in oncology was higher alliance revenue related to Lynparza and Lenvima reflecting continued uptake in approved indications in the U.S., Europe and China. The company assumes no duty to update the information to reflect subsequent developments. Net income attributable to Merck & Co., Inc. Merck is providing certain 2020 and 2019 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. KENILWORTH, N.J.--(BUSINESS WIRE)-- Operational strength of approximately $0.20 is partially offset by the following negative impacts, which were not reflected previously in the outlook: The non-GAAP range excludes acquisition- and divestiture-related costs and costs related to restructuring programs as well as income and losses from investments in equity securities. 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. That compares with $4.5 billion, or $1.78 per share, a year earlier. Neither the sales nor the EPS ranges provided above include the impact of the potential launch of Mercks COVID-19 antiviral drug candidate, molnupiravir. (908) 740-1037 CNBC's 'Squawk Box' team breaks down Merck's third-quarter earnings report, which beat Wall Street's expectations on the top and bottom lines. Merck expects its full-year non-GAAP effective income tax rate to be approximately 14%. Institutional investors and analysts can participate in the call (833) 353-0277 or toll free (469) 886-1947 and using ID code number 4664137. A reconciliation of anticipated full-year 2022 GAAP EPS to non-GAAP EPS and the items excluded from non-GAAP EPS are provided in the table below. Click Manage settings for more information and to manage your choices. 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. CDCs 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, 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%. In addition, senior managements annual compensation is derived in part using non-GAAP pretax income. Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders: Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders: Average Shares Outstanding Assuming Dilution, Earnings per Common Share Assuming Dilution from Continuing Operations. The increase primarily reflects the favorable effects of product mix and lower acquisition- and divestiture-related costs, partially offset by higher manufacturing costs. For 2021, non-GAAP results have been recast to include $1.7 billion of incremental R&D expense, resulting in revised full-year 2021 EPS of $5.37. The FDA has granted V181, the companys investigational dengue vaccine in Phase 1 development, Fast Track designation. Sales growth in companion animal was primarily driven by the BRAVECTO parasiticide line of products, as well as vaccines. The company continues to assume that the majority of the negative impact occurred during the second quarter. Management believes that providing this information enhances investors understanding of the companys results as it permits investors to understand how management assesses performance. September 29, 2022 6:45 am ET RAHWAY, N.J.-- (BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, will hold its third-quarter 2022 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. 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. No Duty to Update Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2020. Management believes that providing non-GAAP information enhances investors understanding of the companys results because management uses non-GAAP measures to assess performance. Growth in oncology was largely driven by higher sales of KEYTRUDA, which rose 22% to $4.5 billion in the quarter. 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. The information contained in this website was current as of the date presented. 3, GAAP Expense, EPS and Related Information. The non-GAAP effective income tax rate was 14.8% for the third quarter of 2020 compared to 15.7% for the third quarter of 2019, reflecting the favorable impact of earnings mix. Related Costs Acquisition- and divestiture-related costs. Non-GAAP expense, EPS and related information. 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. Only the line items that are affected by non-GAAP adjustments are shown. Corcept's (CORT) third-quarter 2022 earnings beat estimates while revenues miss the same. Non-GAAP R&D expenses were $3.5 billion in the third quarter of 2022 compared to $2.4 billion in the third quarter of 2021. Animal Health sales totaled $1.4 billion for the third quarter of 2022, a decline of 3% compared with the third quarter of 2021. Michael DeCarbo Global sales growth of KEYTRUDA reflects continued strong momentum from metastatic indications including certain types of NSCLC, renal cell carcinoma, head and neck squamous cell carcinoma, triple-negative breast cancer (TNBC) and MSI-H cancers, and increased uptake across recent earlier-stage launches including certain types of neoadjuvant/adjuvant TNBC in the U.S. Growth in vaccines was primarily driven by higher combined sales of GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant) and GARDASIL 9 vaccines to prevent certain cancers and other diseases caused by HPV. Year-to-date results can be found in the attached tables. 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. 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. The effective income tax rate was 9.2% for the third quarter of 2022 compared to 13.2% in the third quarter of 2021. Third-Quarter 2020 Worldwide Sales Were $12.6 Billion, an Increase of 1%; Excluding the Impact from Foreign Exchange, Sales Grew 2%, Animal Health Sales Grew 9% to $1.2 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 12%, Third-Quarter 2020 GAAP EPS Was $1.16; Third-Quarter Non-GAAP EPS Was $1.74, Announced Additional Positive Phase 3 Results for Investigational Pneumococcal Conjugate Vaccine (V114) in Adults, Presented Phase 3 Data for Investigational Gefapixant in Development for Chronic Cough; Early Data for MK-4830 in Oncology and MK-8507 for HIV, Expanded Pipeline with Seagen Collaborations in Oncology, Company Advances Research Programs and Clinical Trials for COVID-19-Related Vaccine and Orally Available Antiviral Research Candidates, Company Narrows and Raises 2020 Full-Year Revenue Range to be Between $47.6 Billion and $48.6 Billion, Including a Negative Impact from Foreign Exchange of Approximately 1.5%, Company Narrows and Lowers 2020 Full-Year GAAP EPS Range to be Between $4.55 and $4.65; Narrows and Raises 2020 Full-Year Non-GAAP EPS Range to be Between $5.91 and $6.01, Including a Negative Impact from Foreign Exchange of Approximately 2.5%. 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 Companys 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 Mercks Cardiovascular Pipeline. 100 mg/mL saw strong growth in livestock products also reflect higher demand globally for ruminant, and $ 1.78 per share, excluding certain items for purposes of its non-GAAP reporting grew by 17 %, $. 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