On October 25, 2018 Nordic Nanovector ASA (OSE: NANO) reported that Betalutin (177Lu-satetraxetan-lilotomab) has been granted a Promising Innovative Medicine (PIM) designation by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of patients with advanced relapsed/refractory follicular lymphoma (R/R FL) (Press release, Nordic Nanovector, OCT 25, 2018, View Source [SID1234530218]). The designation was granted based on data from the first part of the Phase 1/2 LYMRIT 37-01 trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: "We are delighted by the MHRA’s decision to award PIM designation to Betalutin. This acknowledges the high unmet medical need of this patient population as well as the potential of Betalutin to offer therapeutic benefits to FL patients. Both the PIM and Fast Track designations (granted by the FDA in June) are very encouraging, as they provide opportunities for enhanced dialogue with health authorities and the potential to bring Betalutin to patients more quickly."

PIM designation constitutes Step 1 of the UK Early Access to Medicines Scheme (EAMS). EAMS aims to give patients in the UK early access to medicines that do not yet have a marketing authorisation but meet a medical need that is currently not being met. PIM designation means that a medicinal product is a promising candidate for the EAMS, for the treatment, diagnosis or prevention of life-threatening or seriously debilitating conditions with an unmet need.

On October 25, 2018 Taiho Oncology, Inc. reported that the United States Food and Drug Administration (FDA) has accepted and granted priority review for the supplemental New Drug Application (sNDA) for LONSURF (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction (Press release, Taiho, OCT 25, 2018, View Source [SID1234530219]). The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of February 24, 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We look forward to working with the FDA as they consider the application for LONSURF under priority review," said Martin Birkhofer, MD, senior vice president and Chief Medical Officer, Taiho Oncology, Inc.

The sNDA is based on data from the global, randomized, double blind pivotal Phase III (TAGS) trial evaluating LONSURF versus placebo and best supportive care in patients with heavily pretreated metastatic gastric/gastroesophageal junction (GEJ) adenocarcinoma that progressed or were intolerant to previous lines of therapy. The trial met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS), as well as continuing to demonstrate LONSURF’s consistent safety and tolerability profile. Full results from this study were recently presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich and published simultaneously in The Lancet Oncology.

LONSURF, in the United States, is indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy and, if RAS wild-type, an anti-EGFR therapy.[1]

About TAGS
TAGS (TAS-102 Gastric Study) is a Taiho-sponsored pivotal Phase III, multinational, randomized, double-blind study evaluating trifluridine/tipiracil, also known as TAS-102, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer, including gastroesophageal junction cancer, refractory to standard treatments. The primary endpoint in the TAGS trial is overall survival (OS), and the main secondary endpoint measures include progression-free survival (PFS), and safety and tolerability, as well as quality of life.

TAGS enrolled 507 adult patients with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The study was conducted in Japan, the United States, the European Union, Russia, Belarus, Israel, and Turkey.

For more information on TAGS, please visit www.ClinicalTrials.gov (View Source). The ClinicalTrials.gov Identifier is NCT02500043.

About Metastatic Gastric Cancer
Gastric cancer, also known as stomach cancer, is a disease in which malignant cells form in the lining of the stomach. It is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and liver cancer), with an estimated 723,000 deaths annually.[2] Approximately 50 percent of patients with gastric cancer have advanced disease at the time of diagnosis.[3]

Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with ramucirumab), or irinotecan. The addition of trastuzumab to chemotherapy is standard of care for patients with HER2-neu-positive advanced gastric cancer. However, after failure of first- and second-line therapies, standard third-line treatments are limited.

About Gastroesophageal Junction Cancer
Gastroesophageal junction cancer is a type of cancer that begins in cells located near the GE junction, the area where the esophagus connects to the stomach.[4] It remains a significant clinical problem that is increasing in incidence, and is associated with a poor prognosis. The majority of patients present with advanced disease, and less than 50 percent undergo curative treatment.[5]

About LONSURF
LONSURF (trifluridine/tipiracil) is an oral anticancer drug, which utilizes the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase.

In Japan, Taiho Pharmaceutical has been marketing LONSURF for the treatment of unresectable advanced or recurrent colorectal cancer since 2014. In the United States, beginning in 2015, Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical, began marketing the drug for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. In parts of Asia outside of Japan, Taiho Pharmaceutical’s business partner TYY Biopharm launched LONSURF in Taiwan in July 2018, and Jeil Pharmaceutical is preparing to bring the drug to market in South Korea.

As of October 2018, LONSURF has been approved as a treatment for advanced mCRC in 61 countries and regions worldwide.

Indications and Use1
LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

Important Safety Information1

LONSURF may cause serious side effects, including:

Low blood counts. Low blood counts are common with LONSURF and can sometimes be severe and life‑threatening. LONSURF can cause a decrease in your white blood cells, red blood cells, and platelets. Low white blood cells can make you more likely to get serious infections that could lead to death. Your healthcare provider should do blood tests before you receive LONSURF, at day 15 during treatment with LONSURF, and as needed to check your blood cell counts. Your healthcare provider may lower your dose of LONSURF or stop LONSURF if you have low white blood cell or platelet counts
Tell your healthcare provider right away if you get any of the following signs and symptoms of infection during treatment with LONSURF: fever, chills, or body aches.

Before taking LONSURF, tell your healthcare provider about all of your medical conditions, including if you:

Have kidney or liver problems
Are pregnant or plan to become pregnant. LONSURF can harm your unborn baby
Females who can become pregnant should use effective birth control during treatment with LONSURF. Tell your healthcare provider immediately if you become pregnant
Males, while on treatment and for 3 months after your last dose of LONSURF, you should use a condom during sex with female partners who are able to become pregnant. Tell your healthcare provider right away if your partner becomes pregnant while you are taking LONSURF
Are breast‑feeding or plan to breast‑feed. It is not known if LONSURF passes into your breast milk. Do not breast‑feed during treatment with LONSURF and for 1 day after your last dose of LONSURF
Tell your healthcare provider about all the prescription and over‑the‑counter medicines, vitamins, and herbal supplements you take.

The most common side effects with LONSURF include tiredness, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever.

Tell your doctor if you have nausea, vomiting, or diarrhea that is severe or that does not go away.

These are not all of the possible side effects of LONSURF. For more information, ask your healthcare provider. Call your doctor for medical advice about side effects.

On October 25, 2018 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported the enrollment of its first patient in the Company’s Phase 2 clinical trial for newly diagnosed glioblastoma (Press release, AIVITA Biomedical, OCT 25, 2018, View Source [SID1234530220]). The single-arm, open-label trial is expected to enroll approximately 55 patients to receive the Company’s ROOT OF CANCER treatment, an immunotherapy which targets the tumor-initiating cells that are responsible for cancer proliferation and metastasis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The trial’s first patient was enrolled by the University of California, Irvine (UCI) Comprehensive Brain Tumor Program and will be treated under the direction of UCI Health neuro-oncologist and Principal Investigator Daniela Bota, MD, PhD. A second clinical site in San Diego is scheduled to open in late October, with additional clinical sites expected to be added in the coming months.

The treatment, autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor cells, is administered as an adjunctive therapy following primary surgery plus concurrent chemoradiation.

"We are proud to work with Dr. Bota to provide this next-generation immunotherapy to patients in need," said Dr. Robert Dillman, AIVITA’s Chief Medical Officer. "This is the first of many sites that will participate in our Phase 2 clinical trial, permitting fast patient recruitment and return of clinical data."

AIVITA’s ROOT OF CANCER technology is also the subject of an active Phase 2 clinical trial in ovarian cancer in the USA. The Company is pursuing commercialization of the platform treatment for melanoma patients in Japan.

About Glioblastoma

Glioblastoma (GBM) is the most aggressive and most common form of malignant brain tumor. Median survival is only nine months, rising to 15–16 months for those able to receive aggressive standard of care surgery and adjuvant chemoradiation.1 The cause of most cases is unclear. The National Cancer Institute estimates there will be 23,880 new cases of brain and nervous system cancer in 2018.

[1] Bi, Wenya Linda, and Rameen Beroukhim. "Beating the Odds: Extreme Long-Term Survival with Glioblastoma." Neuro-Oncology 16.9 (2014): 1159–1160. PMC. Web. 18 June 2018.

About the ROOT OF CANCER GBM trial

AIVITA’s treatment is a platform technology applicable to any solid tumor type and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

On October 25, 2018 McKesson Corporation (NYSE:MCK) reported that revenues for the second quarter ended September 30, 2018, were $53.1 billion, up 2% compared to $52.1 billion a year ago, and also up 2% on a constant currency basis (Press release, McKesson, OCT 25, 2018, View Source [SID1234530201]). On the basis of U.S. generally accepted accounting principles ("GAAP"), second-quarter earnings per diluted share from continuing operations was $2.51, compared to earnings per diluted share of $0.01 a year ago. GAAP earnings per diluted share included a pre-tax benefit of $90 million, or $0.33 per diluted share, related to a reversal of a contractual liability associated with McKesson’s equity investment in Change Healthcare. Prior year GAAP earnings per diluted share included $2.60 per diluted share of non-cash goodwill and other long-lived asset impairment charges, and restructuring charges.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Second-quarter Adjusted Earnings per diluted share was $3.60, up 10% compared to $3.28 a year ago, primarily driven by a lower tax rate, including a discrete tax benefit of $42 million, or $0.21 per diluted share, and the aforementioned reversal of a contractual liability, partially offset by the previously announced customer losses in our U.S. Pharmaceutical business, incremental challenges in our businesses in the U.K. and France, and increased litigation expenses related to opioids.

"While our operational performance reflects anticipated challenges coming into the fiscal year, our second quarter results were primarily affected by the incremental headwinds we are facing in the U.K. and French markets, driving underperformance versus our expectations. We continue to have conversations with the U.K. government to discuss the patient-care services that pharmacies provide and how this low-cost setting of care is vital to the healthcare system, while also working to accelerate efficiency and growth opportunities across all of our businesses," said John H. Hammergren, chairman and chief executive officer.

For the first half of the fiscal year, McKesson generated cash from operations of $318 million, and invested $248 million internally, resulting in free cash flow of $70 million, which was ahead of the company’s expectations. During the first half of the fiscal year, McKesson also paid $840 million for acquisitions, repurchased $877 million of its common stock, paid $139 million in dividends and the company ended the quarter with cash and cash equivalents of $2.1 billion.

"We are pleased with the contribution of our recent acquisitions, including MSD and RxCrossroads, which aligns with our stated multi-year strategic growth initiative. And we also continue to return capital to our shareholders through share repurchases and dividends," concluded Hammergren.

Multi-Year Strategic Growth Initiative Update

As previously announced on April 25, 2018, McKesson launched a multi-year strategic growth initiative, inclusive of plans to optimize the company’s operating and cost structures. The company expects these cost actions will strengthen McKesson’s ability to focus resources, reduce complexity and improve efficiency and cost-competitiveness, enhancing and optimizing operations. McKesson expects these initiatives and actions will generate approximately $300 million to $400 million in annual pre-tax gross savings that will be substantially realized by the end of Fiscal 2021.

"We’ve prioritized growth opportunities, which include our manufacturer value proposition, services to support specialty pharmaceuticals and the future of retail pharmacy, all supported by data and analytics. Our cost reductions and operating model optimization will drive significant savings to support these priority growth areas," said Brian S. Tyler, president and chief operating officer. "And as we move forward, the savings generated will make McKesson a more streamlined and efficient operation, complementing our investments and improving operating profit growth for the organization."

Segment Results

U.S. Pharmaceutical and Specialty Solutions revenues were $41.6 billion for the quarter, up 2%, driven primarily by market growth and acquisitions, partially offset by previously announced customer losses and branded to generic conversions. Segment GAAP operating profit was $610 million and GAAP operating margin was 1.47%. Segment adjusted operating profit was $635 million and adjusted operating margin was 1.53%.

European Pharmaceutical Solutions revenues were $6.6 billion for the quarter, down 2% on a reported basis and down 1% on a constant currency basis, driven primarily by the previously disclosed reduction in owned retail pharmacies and a challenging operating environment in the U.K. and increased competition in France versus the prior year, partially offset by market growth in other countries. Segment GAAP operating profit was $10 million and GAAP operating margin was 0.15%. Segment adjusted operating profit was $53 million and adjusted operating margin was 0.80%. On a constant currency basis, adjusted operating profit was $54 million and adjusted operating margin was 0.81%.

Medical-Surgical Solutions revenues were $1.9 billion for the quarter, up 17%, driven primarily by an acquisition and market growth. Segment GAAP operating profit was $105 million and GAAP operating margin was 5.39%. Segment adjusted operating profit was $138 million and adjusted operating margin was 7.08%.

Revenues included in Other were $2.9 billion for the quarter, down 5% on a reported basis and down 1% on a constant currency basis, driven primarily by the prior year sale of the Enterprise Information Solutions business, partially offset by market growth and acquisitions. Other GAAP operating profit was $95 million and adjusted operating profit was $300 million. On a constant currency basis, adjusted operating profit was $310 million.

Fiscal Year 2019 Outlook

McKesson now expects Adjusted Earnings per diluted share of $13.20 to $13.80 for the fiscal year ending March 31, 2019, from the previous range of $13.00 to $13.80 per diluted share.

McKesson does not provide forward-looking guidance on a GAAP basis as the company is unable to provide a quantitative reconciliation of this forward-looking non-GAAP measure to the most directly comparable forward-looking GAAP measure without unreasonable effort, as items are inherently uncertain and depend on various factors, many of which are beyond the company’s control.

Dividend Declaration

The company’s Board of Directors yesterday declared a regular dividend of thirty-nine cents per share of common stock. The dividend will be payable on January 2, 2019, to stockholders of record on December 3, 2018.

Conference Call Details

The company has scheduled a conference call for today, Thursday, October 25th, at 8:00 AM ET. The dial-in number for individuals wishing to participate on the call is 323-794-2599. Craig Mercer, senior vice president, Investor Relations, is the leader of the call, and the password to join the call is ‘McKesson’. A telephonic replay of this conference call will be available for five calendar days. For individuals wishing to listen to the replay, the dial-in number is 719-457-0820 and the pass code is 5906405. An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

27th Annual Credit Suisse Healthcare Conference, November 12-15, 2018, Scottsdale, AZ;
Evercore ISI HealthCONx Conference, November 27-29, 2018, Boston, MA; and
37th Annual J.P. Morgan Healthcare Conference, January 7-10, 2019, in San Francisco, CA.
Audio webcasts will be available live and archived on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community is available on the company’s Investor Relations website.

Adjusted Earnings

McKesson separately reports financial results on the basis of Adjusted Earnings. Adjusted Earnings is a non-GAAP financial measure defined as GAAP income from continuing operations, excluding amortization of acquisition-related intangible assets, acquisition-related expenses and adjustments, LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring and asset impairment charges, and other adjustments. A reconciliation of McKesson’s GAAP financial results to Adjusted Earnings is provided in Schedules 2 and 3 of the financial statement tables included with this release.

The company does not provide forward-looking guidance on a GAAP basis prospectively as McKesson is unable to provide a quantitative reconciliation of this forward-looking non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring and asset impairment charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

Constant Currency

McKesson also presents its financial results on a constant currency basis. The company conducts business worldwide in local currencies, including the Euro, British pound and Canadian dollar. As a result, the comparability of the financial results reported in U.S. dollars can be affected by changes in foreign currency exchange rates. Constant currency information is presented to provide a framework for assessing how the company’s business performed excluding the effect of foreign currency exchange rate fluctuations. The supplemental constant currency information of the company’s GAAP financial results and Adjusted Earnings (Non-GAAP) is provided in Schedule 3 of the financial statement tables included with this release.

Free Cash Flow

McKesson also provides free cash flow, a non-GAAP measure. Free cash flow is defined as net cash provided by operating activities less property acquisitions and capitalized software expenditures, as outlined in the company’s condensed consolidated statements of cash flows.

Risk Factors

Except for historical information contained in this press release, matters discussed may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied. These statements may be identified by their use of forward-looking terminology such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "intends", "plans", "estimates" or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. It is not possible to predict or identify all such risks and uncertainties; however, the most significant of these risks and uncertainties are described in the company’s Form 10-K, Form 10-Q and Form 8-K reports filed with the Securities and Exchange Commission and include, but are not limited to: changes in the U.S. healthcare industry and regulatory environment; managing foreign expansion, including the related operating, economic, political and regulatory risks; changes in the Canadian healthcare industry and regulatory environment; exposure to European economic conditions, including recent austerity measures taken by certain European governments; changes in the European regulatory environment with respect to privacy and data protection regulations; fluctuations in foreign currency exchange rates; the company’s ability to successfully identify, consummate, finance and integrate acquisitions; the performance of the company’s investment in Change Healthcare; the company’s ability to manage and complete divestitures; material adverse resolution of pending legal proceedings; competition and industry consolidation; substantial defaults in payment or a material reduction in purchases by, or the loss of, a large customer or group purchasing organization; the loss of government contracts as a result of compliance or funding challenges; public health issues in the U.S. or abroad; cyberattack, natural disaster, or malfunction of sophisticated internal computer systems to perform as designed; the adequacy of insurance to cover property loss or liability claims; the company’s proprietary products and services may not be adequately protected, and its products and solutions may be found to infringe on the rights of others; system errors or failure of our technology products or services to conform to specifications; disaster or other event causing interruption of customer access to data residing in our service centers; changes in circumstances that could impair our goodwill or intangible assets; new or revised tax legislation or challenges to our tax positions; general economic conditions, including changes in the financial markets that may affect the availability and cost of credit to the company, its customers or suppliers; changes in accounting principles generally accepted in the United States of America; withdrawal from participation in multiemployer pension plans or if such plans are reported to have underfunded liabilities; inability to realize the expected benefits from the company’s restructuring and business process initiatives; difficulties with outsourcing and similar third party relationships; risks associated with the company’s retail expansion; and the company’s inability to keep existing retail store locations or open new retail locations in desirable places. The reader should not place undue reliance on forward-looking statements, which speak only as of the date they are first made. Except to the extent required by law, the company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

Shareholders are encouraged to review the company’s filings with the Securities and Exchange Commission.

On October 25, 2018 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported financial results for the third quarter of 2018 (Press release, Merck & Co, OCT 25, 2018, View Source [SID1234530109]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We built on our strong momentum during the quarter and believe that Merck is well-positioned to continue creating sustainable value for shareholders and patients," said Kenneth C. Frazier, Merck Chairman and CEO. "Our focused execution is driving our operational results, with KEYTRUDA making a difference to cancer patients around the world. We are also continuing to advance our broad pipeline, including in oncology, vaccines, hospital and specialty as well as animal health. With this strong performance, we are highly confident in our portfolio, strategy and pipeline as demonstrated by our announced capital return actions today."

Financial Summary

Third Quarter
$ in millions, except EPS amounts 2018 2017
Sales $ 10,794 $ 10,325
GAAP net income (loss)1

1,950 (56 )
Non-GAAP net income that excludes items listed below1,2 3,178 3,054
GAAP EPS 0.73 (0.02 )
Non-GAAP EPS that excludes items listed below2

1.19 1.11
Worldwide sales were $10.8 billion for the third quarter of 2018, an increase of 5 percent compared with the third quarter of 2017, including a 1 percent negative impact from foreign exchange. The sales increase in the third quarter of 2018 was partially attributable to a reduction in sales in the third quarter of 2017 of approximately $240 million due to a borrowing from the U.S. Centers for Disease Control and Prevention (CDC) Pediatric Vaccine Stockpile of GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), a vaccine to prevent certain HPV-related cancers and other diseases, driven in part by the temporary production shutdown resulting from the cyber-attack that occurred in June of 2017, as well as overall higher demand than originally planned. Additionally, sales in the third quarter of 2017 were unfavorably affected by approximately $135 million from lost revenue in certain markets related to the cyber-attack.

GAAP (generally accepted accounting principles) earnings (loss) per share assuming dilution (EPS) were $0.73 for the third quarter of 2018. Non-GAAP EPS of $1.19 for the third quarter of 2018 excludes acquisition- and divestiture-related costs, restructuring costs, a charge of $420 million related to the termination of a collaboration agreement with Samsung Bioepis Co., Ltd. (Samsung) for insulin glargine and certain other items. Year-to-date results can be found in the attached tables.

Oncology Pipeline Highlights

Merck continued to expand its oncology program by further advancing the development programs for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy; Lynparza (olaparib), a PARP inhibitor being co-developed and co-commercialized with AstraZeneca; and Lenvima (lenvatinib mesylate), an orally available tyrosine kinase inhibitor being co-developed and co-commercialized with Eisai Co., Ltd. (Eisai).

KEYTRUDA

Merck announced that based on the results of the KEYNOTE-189 trial, the U.S. Food and Drug Administration (FDA) and the European Commission (EC) approved KEYTRUDA in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
Merck announced that the FDA granted priority review to a new supplemental Biologics License Application seeking approval for KEYTRUDA as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous NSCLC in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor aberrations, based on the results of the pivotal Phase 3 KEYNOTE-042 trial. The FDA set a PDUFA date of Jan. 11, 2019.
Merck announced top-line results from KEYNOTE-426, a pivotal Phase 3 trial studying KEYTRUDA in combination with Pfizer’s axitinib as first-line treatment for advanced or metastatic renal cell carcinoma. KEYNOTE-426 met its primary endpoints of overall survival (OS) and progression-free survival (PFS) demonstrating that the combination made a statistically significant and clinically meaningful improvement in survival versus sunitinib.
Merck announced interim results from KEYNOTE-048, a pivotal Phase 3 trial studying KEYTRUDA as both monotherapy and in combination with chemotherapy, for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma. KEYNOTE-048 met its primary endpoint demonstrating that monotherapy and combination therapy showed significantly improved OS compared to the standard of care. These results were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress.
Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for KEYTRUDA as adjuvant therapy in the treatment of patients with melanoma based on the significant recurrence-free survival benefit demonstrated with KEYTRUDA in the pivotal Phase 3 EORTC1325/KEYNOTE-054 trial.
Merck announced the first presentation of results from KEYNOTE-057, a Phase 2 trial evaluating KEYTRUDA in previously-treated patients with high-risk non-muscle invasive bladder cancer at the ESMO (Free ESMO Whitepaper) 2018 Congress. KEYTRUDA demonstrated a complete response rate of nearly 40 percent.
Lynparza

Merck and AstraZeneca announced detailed results from the Phase 3 SOLO-1 trial testing Lynparza as a maintenance treatment for patients with newly-diagnosed advanced BRCA-mutated ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy. Results of the trial confirm the statistically-significant and clinically-meaningful improvement in PFS for Lynparza as compared to placebo, reducing the risk of disease progression or death by 70 percent. At 41 months of follow-up, the median PFS for patients treated with Lynparza was not reached compared to 13.8 months for patients treated with placebo. These results were presented at the ESMO (Free ESMO Whitepaper) 2018 Congress and published simultaneously online in the New England Journal of Medicine.
Lenvima

Merck and Eisai announced that the FDA approved Lenvima for the first-line treatment of patients with unresectable hepatocellular carcinoma. Lenvima was also approved for the same use in China by the China National Drug Administration and in Europe by the EC.
Merck and Eisai announced that the FDA granted Breakthrough Therapy Designation for Lenvima in combination with KEYTRUDA for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed following at least one prior systemic therapy. This is the third Breakthrough Therapy Designation for Lenvima and the second Breakthrough Therapy Designation for Lenvima in combination with KEYTRUDA.
Other Oncology Pipeline Highlights

Clinical data from Merck’s early pipeline was presented at the ESMO (Free ESMO Whitepaper) 2018 Congress in October and additional data on other programs will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2018 meeting in November.

At ESMO (Free ESMO Whitepaper) 2018, Merck presented a number of datasets from its early pipeline:
STING agonist (MK-1454) first-in-human data from Merck’s Phase 1 program studying it as a monotherapy and in combination with KEYTRUDA in patients with advanced solid tumors or lymphomas;
RIG-I (MK-4621) data from Merck’s Phase 1/2 trial studying it in advanced or recurrent tumors;
CAVATAK data from Merck’s Phase 1 KEYNOTE-200 trial studying it in combination with KEYTRUDA for treatment of NSCLC and bladder cancer; and
CTLA-4 (MK-1308) data from Merck’s Phase 1 trial studying it in combination with KEYTRUDA for treatment of advanced solid tumors.
At SITC (Free SITC Whitepaper) 2018, Merck will be presenting:
LAG3 (MK-4280) data from Merck’s Phase 1 trial studying it as monotherapy and in combination with KEYTRUDA for the treatment of advanced solid tumors;
TIGIT (MK-7684) data from Merck’s Phase 1 trial studying it as monotherapy and in combination with KEYTRUDA for the treatment of patients with solid tumors; and
ILT4 (MK-4830) pre-clinical data.
Other Pipeline Highlights

The company continued to advance its vaccines, antibiotics and HIV pipelines.

The FDA approved an expanded age indication for GARDASIL 9 for use in women and men ages 27 through 45.
Merck announced that the pivotal Phase 3 clinical study evaluating the company’s antibiotic ZERBAXA (ceftolozane and tazobactam) at an investigational dose for the treatment of adult patients with either ventilated hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia met the pre-specified primary endpoints, demonstrating non-inferiority to meropenem, the active comparator, in day 28 all-cause mortality and in clinical cure rate at the test-of-cure visit. Based on these results, Merck plans to submit supplemental new drug applications to the FDA and EMA seeking regulatory approval of ZERBAXA for these potential new indications.
Merck announced that the FDA approved two new HIV-1 medicines indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience: DELSTRIGO, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg); and PIFELTRO (doravirine, 100 mg), a new non-nucleoside reverse transcriptase inhibitor to be administered in combination with other antiretroviral medicines. The CHMP of the EMA adopted a positive opinion recommending granting of marketing authorization for DELSTRIGO and PIFELTRO for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the non-nucleoside reverse transcriptase class, lamivudine or tenofovir.
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
2018 2017 Change Change
Ex-Exchange

Total Sales $ 10,794 $ 10,325 5 % 6 %
Pharmaceutical 9,658 9,156 5 % 7 %
KEYTRUDA 1,889 1,047 80 % 82 %
JANUVIA / JANUMET 1,490 1,525 -2 % -1 %
GARDASIL / GARDASIL 9 1,048 675 55 % 56 %
PROQUAD,
M-M-R II and VARIVAX

525

519
1

%

2

%

ISENTRESS / ISENTRESS HD 275 310 -11 % -9 %
ZETIA / VYTORIN 257 462 -44 % -43 %
NUVARING 234 214 9 % 10 %
BRIDION 217 185 17 % 20 %
PNEUMOVAX 23 214 229 -7 % -6 %
SIMPONI 210 219 -4 % -3 %
Animal Health 1,021 1,000 2 % 6 %
Livestock 660 655 1 % 5 %
Companion Animals 361 345 5 % 7 %
Other Revenues

115 169 -32 % -21 %
Pharmaceutical Revenue

Third-quarter pharmaceutical sales increased 5 percent to $9.7 billion, including a 2 percent negative impact from foreign exchange. In addition to the factors mentioned in the Financial Summary above, the increase was primarily driven by growth in oncology and hospital acute care, partially offset by lower sales in virology and the ongoing impacts of the loss of market exclusivity for several products.

Growth in oncology was driven by a significant increase in sales of KEYTRUDA, reflecting the company’s continued launches with new indications globally and the strong momentum for the treatment of patients with NSCLC, as KEYTRUDA is the only anti-PD-1 approved in the first-line setting. Additionally, oncology sales reflect alliance revenue of $49 million related to Lynparza and $43 million related to Lenvima, representing Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.

Growth in hospital acute care reflects strong demand in the United States for BRIDION (sugammadex) Injection 100 mg/mL, a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults undergoing surgery, and strong global demand for NOXAFIL (posaconazole), a medicine for the prevention of invasive fungal infections.

Vaccines performance reflects higher 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, in the United States attributable to the CDC stockpile borrowing in the third quarter of 2017 as described previously, and growth in international markets, primarily due to higher sales in Europe and the ongoing commercial launch in China. Vaccines performance was negatively affected by a significant decrease in sales of ZOSTAVAX (zoster vaccine live), a vaccine for the prevention of herpes zoster, primarily due to the approval of a competitor product that received a preferential recommendation from the U.S. Advisory Committee on Immunization Practices in October 2017. The company anticipates that future sales of ZOSTAVAX will continue to be unfavorably affected by competition.

Pharmaceutical sales growth in the quarter was partially offset by lower sales in virology, largely reflecting a significant decline in ZEPATIER (elbasvir and grazoprevir), a medicine for the treatment of chronic hepatitis C virus genotypes 1 or 4 infection, due to increasing competition and declining patient volumes, which the company expects to continue.

Pharmaceutical sales growth for the quarter was also partially offset by the ongoing impacts from the loss of market exclusivity for ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering LDL cholesterol; and biosimilar competition for REMICADE (infliximab), a treatment for inflammatory diseases, in the company’s marketing territories in Europe.

Animal Health

Animal Health sales totaled $1.0 billion for the third quarter of 2018, an increase of 2 percent compared with the third quarter of 2017, including a 4 percent negative impact from foreign exchange. Growth was primarily driven by higher sales of companion animal products, predominantly from the BRAVECTO (fluralaner) line of products that kill fleas and ticks in dogs and cats for up to 12 weeks. Growth was also driven by higher sales of livestock products including ruminants and poultry products.

Animal Health segment profits were $409 million in the third quarter of 2018, an increase of 5 percent compared with $389 million in the third quarter of 2017.3

Third-Quarter Expense, EPS and Related Information

The table below presents selected expense information.

$ in millions
Third-Quarter 2018

GAAP

Acquisition- and
Divestiture-Related
Costs 4

Restructuring
Costs

Certain Other
Items

Non-GAAP 2

Materials and production $ 3,619 $ 680 $ 2 $ 420 $ 2,517
Marketing and administrative 2,443 2 – – 2,441
Research and development 2,068 5 (4) – 2,067
Restructuring costs 171 – 171 – –
Other (income) expense, net (172 ) (10) – – (162)

Third-Quarter 2017 5

Materials and production $ 3,307 $ 768 $ 25 $ – $ 2,514
Marketing and administrative 2,459 11 – – 2,448
Research and development 4,413 271 2 2,350 1,790
Restructuring costs 153 – 153 – –
Other (income) expense, net (207 ) (18) – – (189)
GAAP Expense, EPS and Related Information

Gross margin was 66.5 percent for the third quarter of 2018 compared to 68.0 percent for the third quarter of 2017. The decrease in gross margin for the third quarter of 2018 was primarily driven by the charge related to the termination of a collaboration agreement with Samsung. The decrease was partially offset by the favorable effects of foreign exchange, as well as costs recorded in the third quarter of 2017 related to the cyber-attack. In addition, a lower net impact of acquisition- and divestiture-related costs and restructuring costs, which reduced gross margin by 6.3 percentage points in the third quarter of 2018 compared with 7.7 percentage points in the third quarter of 2017, also partially offset the margin decline.

Marketing and administrative expenses were $2.4 billion in the third quarter of 2018, a decline of 1 percent compared to the third quarter of 2017, reflecting lower direct selling and promotion costs, as well as the favorable effects of foreign exchange, largely offset by higher administrative costs.

Research and development (R&D) expenses were $2.1 billion in the third quarter of 2018 compared with $4.4 billion in the third quarter of 2017. The decline primarily reflects a $2.35 billion charge recorded in the third quarter of 2017 related to the formation of a collaboration with AstraZeneca and lower in-process research and development (IPR&D) impairment charges, partially offset by increased clinical development spending, in particular for oncology, higher licensing costs and investment in discovery and early drug development.

GAAP EPS was $0.73 for the third quarter of 2018 compared with $(0.02) for the third quarter of 2017.

Non-GAAP Expense, EPS and Related Information

The non-GAAP gross margin was 76.7 percent for the third quarter of 2018 compared to 75.7 percent for the third quarter of 2017. The increase was predominantly due to the favorable effects of foreign exchange, as well as costs recorded in the third quarter of 2017 related to the cyber-attack.

Non-GAAP marketing and administrative expenses were $2.4 billion in the third quarter of 2018, comparable to the third quarter of 2017, reflecting lower direct selling and promotion costs, as well as the favorable effects of foreign exchange, offset by higher administrative costs.

Non-GAAP R&D expenses were $2.1 billion in the third quarter of 2018, an increase of 15 percent compared to the third quarter of 2017. The increase primarily reflects higher clinical development spending, in particular for oncology, higher licensing costs and investment in discovery and early drug development.

Non-GAAP EPS was $1.19 for the third quarter of 2018 compared with $1.11 for the third quarter of 2017.

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
2018 2017
EPS
GAAP EPS $ 0.73 $ (0.02 )
Difference6

0.46 1.13
Non-GAAP EPS that excludes items listed below2 $ 1.19 $ 1.11

Net Income
GAAP net income (loss)1 $ 1,950 $ (56 )
Difference 1,228 3,110
Non-GAAP net income that excludes items listed below1,2 $ 3,178 $ 3,054

Decrease (Increase) in Net Income Due to Excluded Items:
Acquisition- and divestiture-related costs4

$ 677 $ 1,032
Restructuring costs 169 180
Charge related to the termination of a collaboration agreement with Samsung 420 –
Charge related to the formation of a collaboration with AstraZeneca – 2,350
Net decrease (increase) in income before taxes 1,266 3,562
Income tax (benefit) expense7

(38 ) (452 )
Decrease (increase) in net income $ 1,228 $ 3,110
Financial Outlook

Merck narrowed its full-year 2018 revenue range to be between $42.1 billion and $42.7 billion, including a minimal impact from foreign exchange at current exchange rates.

Merck narrowed and lowered its full-year 2018 GAAP EPS range to be between $2.41 and $2.47. The change in the GAAP EPS range reflects the inclusion of the charge related to the termination of the collaboration agreement with Samsung. Merck narrowed and raised its full-year 2018 non-GAAP EPS range to be between $4.30 and $4.36, including an approximately 1 percent negative impact from foreign exchange at current exchange rates. The non-GAAP range excludes acquisition- and divestiture-related costs, costs related to restructuring programs, charges related to the formation of the Eisai collaboration and the Viralytics acquisition, a charge related to the termination of a collaboration agreement with Samsung and certain other items.

The following table summarizes the company’s 2018 financial guidance.

GAAP Non-GAAP 2

Revenue $42.1 to $42.7 billion $42.1 to $42.7 billion*
Operating expenses Lower than 2017 by a low- to mid-single digit rate Higher than 2017 by a low- to mid-single digit rate
Effective tax rate 26.0% to 27.0% 19.0% to 20.0%
EPS** $2.41 to $2.47 $4.30 to $4.36

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

**EPS guidance for 2018 assumes a share count (assuming dilution) of approximately 2.7 billion shares.

A reconciliation of anticipated 2018 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 2018

GAAP EPS $2.41 to $2.47
Difference6 1.89
Non-GAAP EPS that excludes items listed below2 $4.30 to $4.36

Acquisition- and divestiture-related costs4 $ 2,800
Restructuring costs 550
Charge related to the formation of a collaboration with Eisai 1,400
Charge related to the termination of a collaboration agreement with Samsung 420
Charge for Viralytics acquisition 344
Net decrease (increase) in income before taxes 5,514
Estimated income tax (benefit) expense (460)
Decrease (increase) in net income $ 5,054
The expected full-year 2018 GAAP effective tax rate of 26.0 percent to 27.0 percent reflects an unfavorable impact of approximately 7.0 percentage points from the above items.

Capital Allocation

Merck’s Board of Directors has approved a 15 percent increase to the company’s quarterly dividend, raising it to $0.55 per share from $0.48 per share of the company’s outstanding common stock. Payment will be made on Jan. 8, 2019, to shareholders of record at the close of business on Dec. 17, 2018. The Board also authorized an additional $10 billion of treasury stock purchases with no time limit for completion. The company has entered into a $5 billion accelerated share repurchase program under its expanded authorization.

In addition, the company also plans to now invest approximately $16 billion on new capital projects through 2022, up $4 billion from its prior $12 billion commitment announced in February.

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 View Source Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 2169459. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 2169459. 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 more than a century, Merck, a leading global biopharmaceutical company 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. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. 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 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; 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 2017 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 (loss) attributable to Merck & Co., Inc.

2 Merck is providing certain 2018 and 2017 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. Senior management’s annual compensation is derived in part using non-GAAP income and non-GAAP EPS. 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 items, see Table 2a attached to this release.

3 Animal Health segment profits are comprised of segment sales, less all materials and production costs, as well as marketing and administrative expenses and research and development costs directly incurred by the segment. For internal management reporting, Merck does not allocate general and administrative expenses not directly incurred by the segment, nor the cost of financing these activities. Separate divisions maintain responsibility for monitoring and managing these costs, including depreciation related to fixed assets utilized by these divisions and, therefore, they are not included in segment profits.

4 Includes expenses for the amortization of intangible assets and purchase accounting adjustments to inventories recognized as a result of acquisitions, intangible asset impairment charges and expense or income related to changes in the estimated fair value measurement of contingent consideration. Also includes integration, transaction and certain other costs related to business acquisitions and divestitures.

5 On Jan. 1, 2018, the company adopted a new accounting standard related to defined benefit plans. Upon adoption, net periodic benefit cost/credit other than service cost was reclassified to Other (income) expense, net from the previous classifications within Materials and production costs, Marketing and administrative expenses and Research and development costs. Previously reported amounts have been reclassified to conform to the new presentation.

6 Represents the difference between calculated GAAP EPS and calculated non-GAAP EPS, which may be different than the amount calculated by dividing the impact of the excluded items by the weighted-average shares for the period.

7 Includes the estimated tax impact on the reconciling items. In addition, amount for third quarter 2017 includes a $234 million net tax benefit related to the settlement of certain federal income tax issues.

MERCK & CO., INC.
CONSOLIDATED STATEMENT OF INCOME – GAAP
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 1

GAAP % Change GAAP % Change
3Q18 3Q17 Sep YTD 2018 Sep YTD 2017
Sales $ 10,794 $ 10,325 5% $ 31,296 $ 29,689 5%

Costs, Expenses and Other
Materials and production (1) (2) 3,619 3,307 9% 10,220 9,472 8%
Marketing and administrative (1) 2,443 2,459 -1% 7,459 7,432 –
Research and development (1) (3) 2,068 4,413 -53% 7,538 8,024 -6%
Restructuring costs (4) 171 153 12% 494 470 5%
Other (income) expense, net (1) (172 ) (207 ) -17% (512 ) (351 ) 46%
Income Before Taxes 2,665 200 * 6,097 4,642 31%
Taxes on Income (1) 707 251 1,682 1,186
Net Income (Loss) 1,958 (51 ) * 4,415 3,456 28%
Less: Net Income Attributable to Noncontrolling Interests 8 5 22 16
Net Income (Loss) Attributable to Merck & Co., Inc. $ 1,950 $ (56 ) * $ 4,393 $ 3,440 28%
Earnings (Loss) per Common Share Assuming Dilution (5) $ 0.73 $ (0.02 ) * $ 1.63 $ 1.25 30%

Average Shares Outstanding Assuming Dilution (5) 2,678 2,727 2,694 2,754
Tax Rate (6) 26.5 % 125.5 % 27.6 % 25.5 %

* 100% or greater
(1) Amounts include the impact of acquisition and divestiture-related costs, restructuring costs and certain other items. See accompanying tables for details.

(2) Materials and production costs in the third quarter and first nine months of 2018 include a $420 million aggregate charge related to the termination of a collaboration agreement with Samsung Bioepis Co., Ltd. (Samsung) for insulin glargine.

(3) Research and development expenses in the first nine months of 2018 include a $1.4 billion aggregate charge related to the formation of a collaboration with Eisai Co., Ltd. (Eisai), as well as a $344 million charge for the acquisition of Viralytics Limited. Research and development expenses for the third quarter and first nine months of 2017 include a $2.35 billion aggregate charge related to the formation of a collaboration with AstraZeneca PLC (AstraZeneca).

(4) Represents separation and other related costs associated with restructuring activities under the company’s formal restructuring programs.

(5) Because the company recorded a net loss in the third quarter of 2017, 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.

(6) The effective income tax rates for the third quarter and first nine months of 2018 include the unfavorable impact of a $420 million aggregate pretax charge related to the termination of a collaboration agreement with Samsung for which no tax benefit was recognized. The effective income tax rate for the first nine months of 2018 also reflects the unfavorable impact of a $1.4 billion aggregate pretax charge related to the formation of a collaboration with Eisai for which no tax benefit was recognized. The effective income tax rates for the third quarter and first nine months of 2017 reflect the unfavorable impact of a $2.35 billion aggregate pretax charge related to the formation of a collaboration with AstraZeneca for which no tax benefit was recognized, partially offset by the favorable impact of a net tax benefit of $234 million related to the settlement of certain federal income tax issues.
MERCK & CO., INC.
GAAP TO NON-GAAP RECONCILIATION
THIRD QUARTER 2018
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2a

GAAP
Acquisition and
Divestiture-Related
Costs (1)

Restructuring
Costs (2)

Certain Other
Items (3)

Adjustment
Subtotal

Non-GAAP
Materials and production $ 3,619 680 2 420 1,102 $ 2,517
Marketing and administrative 2,443 2 2 2,441
Research and development 2,068 5 (4) 1 2,067
Restructuring costs 171 171 171 -
Other (income) expense, net (172) (10) (10) (162)
Income Before Taxes 2,665 (677) (169) (420) (1,266) 3,931
Income Tax Provision (Benefit) 707 (26) (4) (20) (4) 8 (38) 745
Net Income 1,958 (651) (149) (428) (1,228) 3,186
Net Income Attributable to Merck & Co., Inc. 1,950 (651)
(149)

(428) (1,228) 3,178
Earnings per Common Share Assuming Dilution $ 0.73 (0.24) (0.06) (0.16) (0.46) $ 1.19

Tax Rate 26.5% 18.9%

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. Senior management’s annual compensation is derived in part using non-GAAP income and non-GAAP EPS. 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 materials and production costs reflect expenses for the amortization of intangible assets recognized as a result of business acquisitions. Amounts included in marketing and administrative expenses reflect integration, transaction and certain other costs related to business acquisitions and divestitures. Amounts included in research and development expenses primarily reflect an increase in the estimated fair value measurement of liabilities for contingent consideration. Amounts included in other (income) expense, net primarily reflect royalty income, partially offset by an increase in the estimated fair value measurement of liabilities for contingent consideration related to the 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) Amount included in materials and production costs represents an aggregate charge related to the termination of a collaboration agreement with Samsung Bioepis Co., Ltd. for insulin glargine.

(4) Represents the estimated tax impact on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.
MERCK & CO., INC.
GAAP TO NON-GAAP RECONCILIATION
NINE MONTHS ENDED SEPTEMBER 30, 2018
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)
(UNAUDITED)
Table 2b

GAAP
Acquisition and
Divestiture-Related
Costs (1)

Restructuring
Costs (2)

Certain Other
Items (3)

Adjustment
Subtotal

Non-GAAP
Materials and production $ 10,220 2,147 11 420 2,578 $ 7,642
Marketing and administrative 7,459 26 2 28 7,431
Research and development 7,538 7 1 1,744 1,752 5,786
Restructuring costs 494 494 494 -
Other (income) expense, net (512 ) 85 (54 ) 31 (543 )
Income Before Taxes 6,097 (2,265 ) (508 ) (2,110 ) (4,883 ) 10,980
Income Tax Provision (Benefit) 1,682 (230 )
(4

)

(69 )
(4

)

(101

)
(4

)

(400

) 2,082
Net Income 4,415 (2,035 ) (439 ) (2,009 ) (4,483 ) 8,898
Net Income Attributable to Merck & Co., Inc. 4,393 (2,035 ) (439 ) (2,009 ) (4,483 ) 8,876
Earnings per Common Share Assuming Dilution $ 1.63 (0.75 ) (0.16 ) (0.75 ) (1.66 ) $ 3.29

Tax Rate 27.6 % 19.0 %

Only the line items that are affected by non-GAAP adjustments are shown.
Merck is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing 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. Senior management’s annual compensation is derived in part using non-GAAP income and non-GAAP EPS. 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 materials and production costs reflect expenses for the amortization of intangible assets recognized as a result of business acquisitions. Amounts included in marketing and administrative expenses reflect integration, transaction and certain other costs related to business acquisitions and divestitures. Amounts included in research and development expenses primarily reflect an increase in the estimated fair value measurement of liabilities for contingent consideration. Amounts included in other (income) expense, net primarily reflect an increase in the estimated fair value measurement of liabilities for contingent consideration, 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) Amount included in materials and production costs represents an aggregate charge related to the termination of a collaboration agreement with Samsung Bioepis Co., Ltd. for insulin glargine. Amounts included in research and development expenses represent a $1.4 billion aggregate charge related to the formation of a collaboration with Eisai Co., Ltd., as well as a $344 million charge for the acquisition of Viralytics Limited.

(4) Represents the estimated tax impact on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.
MERCK & CO., INC.
FRANCHISE / KEY PRODUCT SALES
(AMOUNTS IN MILLIONS)
(UNAUDITED)
Table 3


2018

2017

3Q

Sep YTD
1Q 2Q 3Q Sep YTD 1Q 2Q 3Q Sep YTD 4Q Full Year Nom % Ex-Exch % Nom % Ex-Exch %
TOTAL SALES (1) $10,037 $10,465 $10,794 $31,296 $9,434 $9,930 $10,325 $29,689 $10,433 $40,122 5 6 5 5
PHARMACEUTICAL 8,919 9,282 9,658 27,859 8,185 8,759 9,156 26,101 9,290 35,390 5 7 7 5
Oncology
Keytruda 1,464 1,667 1,889 5,020 584 881 1,047 2,512 1,297 3,809 80 82 100 97
Emend 125 148 123 396 133 143 137 413 143 556 -10 -10 -4 -6
Temodar 57 56 46 159 66 65 68 198 73 271 -32 -30 -20 -21
Alliance Revenue – Lynparza 33 44 49 125 5 5 16 20 * * * *
Alliance Revenue – Lenvima 35 43 78 * 100 * 100
Vaccines (2)
Gardasil / Gardasil 9 660 608 1,048 2,317 532 469 675 1,675 633 2,308 55 56 38 36
ProQuad / M-M-R II / Varivax 392 426 525 1,343 355 399 519 1,273 403 1,676 1 2 5 5
Pneumovax 23 179 193 214 586 163 166 229 558 263 821 -7 -6 5 4
RotaTeq 193 156 191 540 224 123 179 525 160 686 7 8 3 2
Zostavax 65 44 54 163 154 160 234 547 121 668 -77 -77 -70 -71
Hospital Acute Care
Bridion 204 240 217 661 148 163 185 495 209 704 17 20 33 31
Noxafil 176 188 188 551 141 155 162 458 179 636 16 18 21 18
Invanz 151 149 137 437 136 150 159 445 157 602 -14 -12 -2 -2
Cubicin 98 94 95 287 96 103 91 290 92 382 4 6 -1 -3
Cancidas 91 87 79 257 121 112 94 327 95 422 -16 -14 -22 -25
Primaxin 72 68 72 212 62 71 73 206 74 280 -1 0 3 -1
Immunology
Simponi 231 233 210 673 184 199 219 602 217 819 -4 -3 12 5
Remicade 167 157 135 459 229 208 214 651 186 837 -37 -35 -29 -33
Neuroscience
Belsomra 54 71 66 191 42 52 56 150 60 210 17 17 27 25
Virology
Isentress / Isentress HD 281 305 275 860 305 282 310 896 308 1,204 -11 -9 -4 -5
Zepatier 131 113 104 347 378 517 468 1,363 296 1,660 -78 -77 -75 -76
Cardiovascular
Zetia 305 226 165 696 334 367 320 1,021 323 1,344 -48 -48 -32 -36
Vytorin 167 155 92 414 241 182 142 565 186 751 -35 -34 -27 -31
Atozet 73 101 84 258 49 63 59 171 54 225 42 44 51 42
Adempas 68 75 94 238 84 67 70 221 79 300 35 35 7 4
Diabetes (3)
Januvia 880 949 927 2,756 839 948 1,012 2,799 938 3,737 -8 -8 -2 -3
Janumet 544 585 563 1,693 496 563 513 1,572 586 2,158 10 12 8 6
Women’s Health
NuvaRing 216 236 234 686 160 199 214 573 188 761 9 10 20 19
Implanon / Nexplanon 174 174 186 535 170 178 155 503 183 686 20 22 6 6
Diversified Brands
Singulair 175 185 161 521 186 203 161 550 182 732 0 1 -5 -9
Cozaar / Hyzaar 120 125 103 348 112 119 128 360 125 484 -20 -18 -3 -6
Nasonex 122 81 71 274 139 85 42 266 120 387 67 73 3 0
Arcoxia 83 84 83 249 103 89 80 272 91 363 3 7 -8 -10
Follistim AQ 67 70 60 198 81 79 72 232 66 298 -16 -15 -15 -17
Fosamax 55 59 45 159 61 66 53 180 62 241 -16 -14 -12 -15
Dulera 57 42 50 149 82 69 59 210 77 287 -15 -14 -29 -29
Other Pharmaceutical (4) 989 1,053 980 3,023 995 1,064 952 3,017 1,048 4,065 3 6 0 -1
*
ANIMAL HEALTH 1,065 1,090 1,021 3,176 939 955 1,000 2,894 981 3,875 2 6 10 8
Livestock 652 633 660 1,946 578 582 655 1,816 668 2,484 1 5 7 6
Companion Animals 413 457 361 1,230 361 373 345 1,078 313 1,391 5 7 14 12

Other Revenues (5) 53 93 115 261 310 216 169 694 162 857 -32 -21 -62 -16

* 200% or greater

Sum of quarterly amounts may not equal year-to-date amounts due to rounding.

(1) Only select products are shown.

(2) Total Vaccines sales were $1,561 million, $1,533 million and $2,159 million in the first, second and third quarters of 2018, respectively, and $1,516 million, $1,404 million, $1,924 million and $1,704 million for the first, second, third and fourth quarters of 2017, respectively.

(3) Total Diabetes sales were $1,433 million, $1,571 million and $1,506 million in the first, second and third quarters of 2018, respectively, and $1,338 million, $1,520 million, $1,531 million and $1,533 million for the first, second, third and fourth quarters of 2017, respectively.
(4) Includes Pharmaceutical products not individually shown above.
(5) Other Revenues are comprised primarily of Healthcare Services segment revenues, third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.