On February 1, 2019 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported financial results for the fourth quarter and full year of 2018 (Press release, Merck & Co, FEB 1, 2019, View Source [SID1234533011]).
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"Last year was a strong one for Merck marked by substantial progress on scientific and commercial fronts," said Kenneth C. Frazier, chairman and chief executive officer, Merck. "The fourth-quarter and full-year results further bolster our confidence in Merck’s innovation-based strategy in which our key pillars – oncology, vaccines, animal health, and select hospital and specialty care products – are expected to drive sustainable growth over the long-term. We enter 2019 with good momentum, anticipating the many opportunities afforded by our broad and differentiated portfolio and pipeline."
Worldwide sales were $11.0 billion for the fourth quarter of 2018, an increase of 5 percent compared with the fourth quarter of 2017, including a 3 percent negative impact from foreign exchange. Full-year 2018 worldwide sales were $42.3 billion, an increase of 5 percent compared with the full year of 2017.
Sales for the full year of 2018 include approximately $125 million for the replenishment of doses of GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), a vaccine to prevent certain cancers and other diseases caused by Human Papillomavirus (HPV), that were borrowed from the U.S. Centers for Disease Control and Prevention Pediatric Vaccine Stockpile in 2017. The borrowing reduced sales in 2017 by approximately $125 million.
Lost sales due to the cyber-attack that occurred in June 2017 unfavorably affected revenue in the fourth quarter of 2017 by $125 million, and for the full year of 2018 and 2017 by $150 million and $260 million, respectively.
GAAP (generally accepted accounting principles) earnings (loss) per share assuming dilution (EPS) were $0.69 for the fourth quarter and $2.32 for the full year of 2018. GAAP EPS for the full year of 2018 reflects a $1.4 billion charge related to the formation of a strategic oncology collaboration with Eisai Co., Ltd. (Eisai). Non-GAAP EPS of $1.04 for the fourth quarter and $4.34 for the full year of 2018 exclude acquisition- and divestiture-related costs, restructuring costs and certain other items. Non-GAAP EPS for the full year of 2018 also excludes the charge related to the formation of the collaboration with Eisai.
GAAP EPS were $(0.39) for the fourth quarter and $0.87 for the full year of 2017, which reflect a $2.6 billion provisional charge related to the enactment of U.S. tax legislation and for the full year also reflect a $2.35 billion charge related to the formation of a strategic oncology collaboration with AstraZeneca.
Oncology Pipeline Highlights
Merck continued to advance 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.
KEYTRUDA
Merck will present data from the pivotal Phase 3 KEYNOTE-426 trial, studying KEYTRUDA in combination with axitinib in patients with advanced or metastatic renal cell carcinoma at the annual American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium in San Francisco in an oral session on February 16, 2019.
Merck announced that the U.S. Food and Drug Administration (FDA) approved KEYTRUDA for the following indications:
In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC), making it the first anti-PD-1 approved for first-line treatment of squamous NSCLC regardless of PD-L1 expression. The approval is based on results from the KEYNOTE-407 trial.
For the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.
For the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
Merck announced that five new approvals, including three expanded uses in advanced NSCLC, one in adjuvant melanoma, as well as a new indication in advanced microsatellite instability-high (MSI-H) tumors were granted in Japan.
Merck announced that the European Commission (EC) approved KEYTRUDA for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection based on data from the pivotal Phase 3 EORTC1325/KEYNOTE-054 trial.
Merck announced results from KEYNOTE-181, a Phase 3 trial investigating KEYTRUDA as monotherapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma, which demonstrated a 31 percent reduction in the risk of death compared to chemotherapy in previously treated patients with advanced esophageal or esophagogastric junction carcinoma whose tumors expressed PD-L1 (combined positive score [CPS] ≥10). Merck presented the data in January at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium.
Merck announced that the FDA extended the action date for the supplemental Biologics License Application (sBLA) for KEYTRUDA as monotherapy for the first-line treatment of locally advanced or metastatic NSCLC in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor aberrations. The sBLA is based on results of the Phase 3 KEYNOTE-042 trial. The company submitted additional data and analyses to the FDA, which extends the PDUFA date by three months to April 11, 2019.
Lynparza
Merck and AstraZeneca announced that the FDA approved Lynparza for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. This is the first regulatory approval for a PARP inhibitor in the first-line maintenance setting for BRCAm advanced ovarian cancer and approval was based on positive results from the pivotal Phase 3 SOLO-1 trial.
Merck and AstraZeneca announced positive results from the Phase 3 SOLO-3 trial of Lynparza in patients with relapsed ovarian cancer after two or more lines of treatment.
Lenvima
Merck and Eisai announced results of new data and analyses of Lenvima in combination with KEYTRUDA in three different tumor types, including metastatic NSCLC, metastatic melanoma and metastatic urothelial carcinoma. These were presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2018.
Other Oncology Pipeline Highlights
Clinical data from Merck’s Phase 1 trials for anti-LAG3 (MK-4280) and anti-TIGIT (MK-7684) along with preclinical data for ILT4 (MK-4830) were presented at SITC (Free SITC Whitepaper). These are each being studied as monotherapy and in combination with KEYTRUDA for the treatment of advanced solid tumors.
Other Pipeline Highlights
Merck and NGM Biopharmaceuticals, Inc. announced that Merck exercised its option to license NGM313, renamed MK-3655, an investigational monoclonal antibody agonist of the β-Klotho/FGFR1c receptor complex that is currently being evaluated for the treatment of nonalcoholic steatohepatitis (NASH) and type 2 diabetes.
Merck announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. V114 is also under development for the prevention of IPD in adults.
Merck and Instituto Butantan, a non-profit producer of immunobiologic products for Brazil, announced a collaboration to develop vaccines to protect against dengue virus disease, a mosquito-borne infection.
Merck announced that it started the submission of a rolling Biologics License Application to the FDA for V920 (rVSV∆G-ZEBOV-GP, live attenuated), the company’s investigational vaccine for Ebola Zaire disease. This rolling submission was made pursuant to the FDA’s Breakthrough Therapy Designation for V920.
Merck announced that the EC approved DELSTRIGO (doravirine / lamivudine / tenofovir disoproxil fumarate) and PIFELTRO (doravirine) for the treatment of HIV-1 infection.
Merck announced that the FDA accepted for review supplemental New Drug Applications (sNDAs) seeking approval for PIFELTRO (in combination with other antiretroviral medicines) and DELSTRIGO for use in people living with HIV-1 who are switching from a stable antiretroviral regimen and whose virus is suppressed (HIV-1 RNA <50 copies/mL). The PDUFA date for the sNDAs is September 20, 2019.
Fourth-Quarter and Full-Year Revenue Performance
Fourth-quarter pharmaceutical sales increased 6 percent to $9.8 billion, including a 2 percent negative impact from foreign exchange. The increase was driven primarily by growth in oncology and vaccines, 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 strong momentum for the treatment of patients with NSCLC and the company’s continued launches with new indications globally. Additionally, oncology sales reflect alliance revenue of $71 million related to Lenvima and $62 million related to Lynparza, representing Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.
Growth in vaccines was driven by an increase in 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, primarily due to the ongoing commercial launch in China as well as growth in the United States and Europe. The increase in U.S. sales reflects the timing of public sector purchases in 2017. Growth in vaccines was partially offset by a significant decrease in sales of ZOSTAVAX (zoster vaccine live), a vaccine for the prevention of herpes zoster, primarily due to a competing 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.
Performance 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 the ongoing launch of PREVYMIS (letermovir), a medicine for the prevention of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.
Pharmaceutical sales growth was partially offset by lower sales in virology largely reflecting a significant decline in sales of 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 impacts from the loss of market exclusivity for ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering LDL cholesterol; INVANZ (ertapenem sodium), an antibiotic; CANCIDAS (caspofungin acetate for injection), an antifungal; as well as biosimilar competition for REMICADE (infliximab), a treatment for inflammatory diseases, in the company’s marketing territories in Europe.
Full-year 2018 pharmaceutical sales increased 6 percent to $37.7 billion, reflecting growth in oncology, vaccines and hospital acute care, partially offset by declines in virology and the loss of market exclusivity for several products.
Animal Health Revenue
Animal Health sales totaled $1.0 billion for the fourth quarter of 2018, an increase of 6 percent compared with the fourth quarter of 2017, including a 5 percent negative impact from foreign exchange. Growth for the quarter was driven by both inline and newly launched products reflecting sales increases in companion animal products, primarily companion animal vaccines, and higher sales of livestock products, particularly swine and poultry products.
Worldwide sales for the full year of 2018 were $4.2 billion, an increase of 9 percent. Full-year sales growth was driven by sales increases in companion animal products, primarily the BRAVECTO (fluralaner) line of products that kill fleas and ticks in dogs and cats for up to 12 weeks, and companion animal vaccines. Full-year sales growth was also driven by higher sales of livestock products, including ruminants, poultry and swine products.
Animal Health segment profits were $387 million in the fourth quarter of 2018, an increase of 10 percent compared with $350 million in the fourth quarter of 2017, and were $1.7 billion for the full year of 2018, an increase of 7 percent compared with $1.6 billion in 2017.3
In December 2018, Merck announced it will acquire privately held Antelliq Group, which will establish Merck Animal Health as a leader in digital animal identification, traceability and monitoring solutions, one of the fastest growing parts of the animal health industry. The transaction is expected to close in the second quarter of 2019.
Gross margin was 70.1 percent for the fourth quarter of 2018 compared to 67.0 percent for the fourth quarter of 2017. The gross margin was 68.1 percent for the full year of 2018 compared to 67.8 percent for the full year of 2017. The increase in gross margin for both periods was driven in part by lower acquisition- and divestiture-related costs and restructuring costs, which negatively affected gross margin by 4.9 percentage points and 6.3 percentage points in the fourth quarter and full year of 2018, respectively, compared with 7.3 and 8.3 percentage points for the fourth quarter and full year of 2017, respectively. In addition, the gross margin improvements in 2018 reflect the favorable effects of product mix and costs recorded in 2017 related to the cyber-attack, partially offset by the unfavorable effects of pricing pressure and the amortization of amounts capitalized for potential future milestone payments related to collaborations. For the full year of 2018, the gross margin improvement was also partially offset by a charge related to the termination of a collaboration agreement with Samsung Bioepis Co., Ltd. for insulin glargine.
Selling, general and administrative expenses were $2.6 billion in the fourth quarter of 2018, the same as in the fourth quarter of 2017. Full-year 2018 selling, general and administrative expenses were $10.1 billion, comparable to the full year of 2017, reflecting higher administrative costs and the unfavorable effects of foreign exchange, offset by lower selling and promotion costs.
Research and development (R&D) expenses were $2.2 billion in the fourth quarter of 2018, a decline of 4 percent compared with the fourth quarter of 2017, driven primarily by lower expenses relating to business development activities and lower in-process research and development (IPR&D) impairment charges, partially offset by higher clinical development spending, in particular from oncology collaborations, and investment in discovery and early drug development. R&D expenses were $9.8 billion for the full year of 2018, a 6 percent decrease compared to the full year of 2017. The decline primarily reflects a charge recorded in 2017 related to the formation of a collaboration with AstraZeneca and lower IPR&D impairment charges, partially offset by a charge in 2018 related to the formation of an oncology collaboration with Eisai, higher clinical development spending and investment in discovery and early drug development, as well as higher expenses related to business development transactions.
Other (income) expense, net, was $110 million of expense in the fourth quarter of 2018 compared to $149 million of income in the fourth quarter of 2017. Other (income) expense, net, in the fourth quarter of 2018 reflects goodwill impairment charges, as well as the recognition of unrealized losses on securities as a result of the adoption of a new accounting standard for investments in equity securities. Other (income) expense, net, in the fourth quarter of 2017 reflects gains on sales of securities, partially offset by a loss on the extinguishment of debt. Other (income) expense, net, was $402 million of income for the full year of 2018 compared to $500 million of income for the full year of 2017.
The effective income tax rates of 31.7 percent for the fourth quarter and 28.8 percent for full year of 2018 include adjustments to the provisional amounts recorded in 2017 related to the enactment of U.S. tax legislation. In addition, the effective income tax rate for the full year of 2018 reflects the unfavorable impact of a $1.4 billion charge related to the formation of the collaboration with Eisai for which no tax benefit has been recognized.
GAAP EPS was $0.69 for the fourth quarter of 2018 compared with $(0.39) for the fourth quarter of 2017. GAAP EPS was $2.32 for the full year of 2018 compared with $0.87 for the full year of 2017.
Non-GAAP Expense, EPS and Related Information
The non-GAAP gross margin was 75.0 percent for the fourth quarter of 2018, compared to 74.3 percent for the fourth quarter of 2017. The increase in the fourth-quarter gross margin reflects the favorable effects of product mix and costs recorded in 2017 related to the cyber-attack, partially offset by the unfavorable effects of pricing pressure and the amortization of amounts capitalized for potential future milestone payments related to collaborations.
The non-GAAP gross margin was 75.4 percent for the full year of 2018 compared to 76.1 percent for the full year of 2017. The decrease in non-GAAP gross margin for the full year of 2018 reflects the unfavorable effects of amortization of amounts capitalized for potential future milestone payments related to collaborations and pricing pressure, partially offset by the favorable effects of product mix and costs recorded in 2017 related to the cyber-attack.
Non-GAAP selling, general and administrative expenses were $2.6 billion in the fourth quarter of 2018, comparable to the fourth quarter of 2017. Non-GAAP selling, general and administrative expenses were $10.1 billion for the full year of 2018, comparable to the full year of 2017, reflecting higher administrative costs and the unfavorable effects of foreign exchange, offset by lower selling and promotion costs.
Non-GAAP R&D expenses were $2.1 billion in the fourth quarter of 2018, a 1 percent increase compared to the fourth quarter of 2017. Non-GAAP R&D expenses were $7.9 billion for the full year of 2018, a 6 percent increase compared to the full year of 2017. The increases reflect higher clinical development spending and investment in discovery and early drug development, partially offset by lower business development costs.
Non-GAAP other (income) expense, net, was $66 million of income in the fourth quarter of 2018 compared to $143 million of income in the fourth quarter of 2017. Non-GAAP other (income) expense, net, in the fourth quarter of 2018 reflects the recognition of unrealized losses on securities as a result of the adoption of a new accounting standard for investments in equity securities. Non-GAAP other (income) expense, net, in the fourth quarter of 2017 reflects realized gains on sales of equity securities, partially offset by a loss on extinguishment of debt. Non-GAAP other (income) expense, net, for the full year of 2018 was $609 million of income compared to $503 million of income for the full year of 2017.
The non-GAAP effective income tax rate was 22.5 percent for the fourth quarter of 2018 compared with 15.3 percent for the fourth quarter of 2017 and was 19.8 percent for the full year of 2018 compared with 19.1 percent for the full year of 2017.
Non-GAAP EPS was $1.04 for the fourth quarter of 2018 compared with $0.98 for the fourth quarter of 2017. Non-GAAP EPS was $4.34 for the full year of 2018 compared with $3.98 for the full year of 2017.
At mid-January 2019 exchange rates, Merck anticipates full-year 2019 revenue to be between $43.2 billion and $44.7 billion, including an approximately 1 percent negative impact from foreign exchange.
Merck expects its full-year 2019 GAAP EPS to be between $3.97 and $4.12. Merck expects its full-year 2019 non-GAAP EPS to be between $4.57 and $4.72, including an approximately 1 percent positive impact from foreign exchange. The non-GAAP range excludes acquisition- and divestiture-related costs.
Investor Event
Merck will hold an Investor Event on Thursday, June 20, 2019, at which senior management will provide a review of the company’s key business priorities, current pillars of growth, future opportunities and research pipeline. Further details regarding logistics will be announced at a later date.
Earnings Conference Call
Investors, journalists and the general public may access a live audio webcast of the call today at 8:00 a.m. EST 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 9872199. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 9872199. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.