On October 25, 2016 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported financial results for the third quarter of 2016 (Press release, Merck & Co, OCT 25, 2016, View Source [SID1234515986]). Schedule your 30 min Free 1stOncology Demo! "The latest achievements for KEYTRUDA and other recent regulatory approvals across our portfolio show that our innovation strategy is working," said Kenneth C. Frazier, chairman and chief executive officer, Merck. "We are confident that our focus on the science, along with continued commercial execution, will drive long-term results for the company and our shareholders."
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Financial Summary
$ in millions, except EPS amounts Third Quarter
2016 2015
Sales $10,536 $10,073
GAAP EPS 0.78 0.64
Non-GAAP EPS that excludes items listed below1
1.07 0.96
GAAP net income2
2,184 1,826
Non-GAAP net income that excludes items listed below1,2
2,989 2,720
Worldwide sales were $10.5 billion for the third quarter of 2016, an increase of 5 percent compared with the third quarter of 2015, including a 1 percent negative impact from foreign exchange. Sales in the third quarter of 2016 include an estimated benefit of approximately $150 million of additional sales in Japan resulting from the timing of shipments in anticipation of a resource planning system Merck is implementing in the fourth quarter of 2016.
GAAP (generally accepted accounting principles) earnings per share (EPS) assuming dilution were $0.78 for the third quarter. Non-GAAP EPS of $1.07 for the third quarter excludes acquisition- and divestiture-related costs and restructuring costs. GAAP and non-GAAP EPS in the third quarter include an estimated benefit of approximately $0.04 from the timing of shipments in Japan noted above.
Pipeline Highlights
Merck significantly advanced the clinical development program for KEYTRUDA (pembrolizumab), an anti-PD-1 therapy. KEYTRUDA is now approved in the United States for the treatment of previously untreated metastatic NSCLC in patients whose tumors express high levels of PD-L1 (TPS of 50 percent or more) and previously treated metastatic NSCLC in patients whose tumors express PD-L1 (TPS of 1 percent or more), as well as advanced melanoma and previously treated recurrent or metastatic head and neck cancer (HNSCC). Earlier this month at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress, data were presented from 30 studies evaluating the use of KEYTRUDA as a monotherapy and in combination in 23 cancers.
Lung Cancer
Yesterday the U.S. Food and Drug Administration (FDA) approved two supplemental Biologics License Applications (sBLA) for KEYTRUDA in lung cancer.
Based on the KEYNOTE-024 study, KEYTRUDA was approved for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (TPS of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. The data from KEYNOTE-024 were published in The New England Journal of Medicine and highlighted at ESMO (Free ESMO Whitepaper).
The FDA also approved a sBLA to include data from the pivotal KEYNOTE-010 study in which KEYTRUDA showed superior overall survival compared to chemotherapy in patients with previously treated advanced NSCLC whose tumors express PD-L1 (TPS of 1 percent or more) as determined by an FDA-approved test.
Data were presented at ESMO (Free ESMO Whitepaper) from KEYNOTE-021, Cohort G, showing superior efficacy of KEYTRUDA plus chemotherapy compared to chemotherapy alone as a first-line treatment for patients with metastatic non-squamous NSCLC regardless of PD-L1 expression. These data were simultaneously published in The Lancet Oncology.
The European Commission approved KEYTRUDA for the treatment of locally advanced or metastatic NSCLC in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.
Head and Neck Cancer
The FDA approved a sBLA for KEYTRUDA for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
Bladder Cancer
On Friday the company announced that the KEYNOTE-045 trial investigating the use of KEYTRUDA in patients with previously treated advanced bladder cancer (urothelial cancer) met its primary endpoint. In the study, KEYTRUDA met the primary endpoint of overall survival and was superior compared to investigator choice chemotherapy.
Interim Phase 2 data were presented at ESMO (Free ESMO Whitepaper) for the first time investigating the use of KEYTRUDA in previously untreated patients with advanced bladder cancer.
Last week the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices voted to recommend a 2-dose vaccination regimen for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), a vaccine to prevent certain cancers and other diseases caused by HPV, in certain girls and boys 9 through 14 years of age, which followed the FDA’s approval of a 2-dose regimen in this adolescent population earlier this month.
The FDA accepted for review the New Drug Application (NDA) for MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes that is being developed in collaboration with and partially funded by Samsung Bioepis.
The FDA accepted for review a supplemental NDA for a once-daily formulation of ISENTRESS (raltegravir) in combination with other antiretroviral therapies for the treatment of HIV-1 infection in previously untreated patients or patients whose virus remains suppressed after treatment with an initial regimen of 400 mg of ISENTRESS twice-daily. The FDA granted a PDUFA action date of May 27, 2017.
Merck announced last week that the pivotal Phase 3 study of letermovir, an investigational antiviral medicine for prevention of cytomegalovirus infection in high-risk bone marrow transplant patients, met its primary endpoint; Merck will submit results from the study for presentation at a future scientific conference.
Third-Quarter Revenue Performance
The following table reflects sales of the company’s top pharmaceutical products, as well as total sales of Animal Health products.
$ in millions Third Quarter Change Change
Ex-Exchange
2016 2015
Total Sales $10,536 $10,073 5% 6%
Pharmaceutical 9,443 8,925 6% 6%
JANUVIA / JANUMET 1,554 1,576 -1% -2%
ZETIA / VYTORIN 944 936 1% –
GARDASIL / GARDASIL 9 860 625 38% 38%
PROQUAD / M-M-R II / VARIVAX 496 390 27% 28%
ISENTRESS 372 377 -1% 1%
KEYTRUDA 356 159 124% 128%
CUBICIN 320 325 -2% -2%
REMICADE 311 442 -30% -28%
Animal Health 865 827 5% 7%
Other Revenues 228 321 -29% 10%
Pharmaceutical Revenue
Third-quarter pharmaceutical sales increased 6 percent to $9.4 billion, reflecting higher sales in vaccines, oncology, the cardiovascular franchise and hospital acute care.
Growth in vaccines resulted from higher sales of GARDASIL 9 and GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], vaccines to prevent certain cancers and other diseases caused by HPV, primarily due to the timing of public sector purchases and increased pricing and demand in the United States; and higher sales of PROQUAD (Measles, Mumps, Rubella and Varicella Vaccine Live), driven by the timing of sales activity in the third quarter of 2015 related to the Pediatric Vaccine Stockpile of the U.S. CDC.
Growth in oncology was driven by KEYTRUDA as the company continues to launch the product with new indications globally.
Higher sales in the cardiovascular portfolio were driven by an increase in sales of ADEMPAS (riociguat), a medicine for treating pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, which the company is now promoting and distributing in Europe; and ZETIA (ezetimibe), a medicine for lowering LDL cholesterol, primarily driven by higher sales in Japan due to the timing of shipments. U.S. sales of ZETIA were $411 million for the third quarter of 2016; in December 2016 the company will lose market exclusivity in the United States for ZETIA and anticipates a significant decline in U.S. ZETIA sales thereafter.
Growth in hospital acute care primarily resulted from higher sales of 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, which had worldwide sales of $139 million for the quarter that were driven by the ongoing launch in the United States, higher sales in Europe and the timing of shipments in Japan.
Pharmaceutical sales growth also reflects the continued launch of ZEPATIER (elbasvir and grazoprevir), a medicine for the treatment of chronic hepatitis C virus genotypes 1 or 4 infection, which had sales of $164 million in the third quarter.
Third-quarter pharmaceutical sales reflect a decline in REMICADE (infliximab), a treatment for inflammatory diseases, due to the impact of biosimilar competition in the company’s marketing territories in Europe.
U.S. sales of CUBICIN (daptomycin for injection), an I.V. antibiotic, were $264 million in the third quarter. The company has lost U.S. patent protection for CUBICIN and anticipates a significant decline in U.S. CUBICIN sales going forward.
Animal Health Revenue
Animal Health sales totaled $865 million for the third quarter of 2016, an increase of 5 percent compared with the third quarter of 2015, including a 2 percent negative impact from foreign exchange. Sales growth was primarily driven by an increase in sales of companion animal and poultry products, particularly the BRAVECTO (fluralaner) line of products that kill fleas and ticks in dogs and cats for up to 12 weeks.
Earlier this month, the company announced that the U.S. Department of Agriculture approved a license for Nobivac Canine Flu Bivalent vaccine, the first vaccine to aid in the control of disease associated with both canine influenza virus H3N2 and canine influenza virus H3N8.
Third-Quarter Expense, EPS and Related Information
The table below presents selected expense information.
$ in millions Acquisition-
and
Divestiture- Certain
Related Restructuring Other
Non-
GAAP
Costs (3)
Costs Items
GAAP (1)
Third-Quarter 2016
Materials and production $3,409 $773 $36 $– $2,600
Marketing and administrative 2,393 36 1 – 2,356
Research and development 1,664 13 14 – 1,637
Restructuring costs 161 – 161 – –
Other (income) expense, net 22 12 – (6) 16
Third-Quarter 2015
Materials and production $3,761 $1,184 $70 $– $2,507
Marketing and administrative 2,472 26 17 – 2,429
Research and development 1,500 (71) 17 – 1,554
Restructuring costs 113 – 113 – –
Other (income) expense, net (170) 7 – (283) 106
GAAP Expense, EPS and Related Information
On a GAAP basis, the gross margin was 67.6 percent for the third quarter of 2016 compared to 62.7 percent for the third quarter of 2015. The increase in gross margin for the third quarter of 2016 was primarily driven by lower acquisition- and divestiture-related costs, which negatively affected gross margin by 7.7 percentage points in the third quarter of 2016 compared with 12.4 percentage points for the third quarter of 2015. The increase in gross margin also reflects the favorable effects of product mix.
Marketing and administrative expenses were $2.4 billion in the third quarter of 2016, a 3 percent decrease compared to the third quarter of 2015. The decline primarily reflects lower selling and promotional expenses as a result of prioritizing investments in key brands, the favorable impact of foreign exchange and lower restructuring costs, partially offset by higher acquisition- and divestiture-related costs.
Research and development (R&D) expenses were $1.7 billion in the third quarter of 2016, an 11 percent increase compared to the third quarter of 2015. The increase primarily reflects higher clinical development spending, as well as a reduction in the third quarter of 2015 of the estimated fair value of liabilities for contingent consideration.
Other (income) expense, net, was $22 million of expense in the third quarter of 2016 compared to $170 million of income in the third quarter of 2015, reflecting a gain of $250 million in the third quarter of 2015 on the divestiture of certain migraine clinical development programs, as well as lower foreign exchange losses in the third quarter of 2016.
GAAP EPS was $0.78 for the third quarter of 2016 compared with $0.64 for the third quarter of 2015.
Non-GAAP Expense, EPS and Related Information
The non-GAAP gross margin was 75.3 percent for the third quarter of 2016 compared to 75.1 percent for the third quarter of 2015. The increase in non-GAAP gross margin for the third quarter of 2016 reflects the favorable impact of product mix.
Non-GAAP marketing and administrative expenses were $2.4 billion in the third quarter of 2016, a 3 percent decline compared to the third quarter of 2015. The decline reflects lower selling costs and promotional spending as a result of prioritizing investments in key brands and the favorable impact of foreign exchange.
Non-GAAP R&D expenses were $1.6 billion in the third quarter of 2016, a 5 percent increase compared to the third quarter of 2015. The increase primarily reflects higher clinical development spending.
Non-GAAP EPS was $1.07 for the third quarter of 2016 compared with $0.96 for the third quarter of 2015.
Non-GAAP other (income) expense, net, was $16 million of expense in the third quarter of 2016 compared to $106 million of expense in the third quarter of 2015, reflecting lower foreign exchange losses.
A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows. Year-to-date results can be found in the attached tables.
$ in millions, except EPS amounts Third Quarter
2016 2015
EPS
GAAP EPS $0.78 $0.64
Difference4
0.29 0.32
Non-GAAP EPS that excludes items listed below1
$1.07 $0.96
Net Income
GAAP net income2 $2,184 $1,826
Difference 805 894
Non-GAAP net income that excludes items listed below1,2 $2,989 $2,720
Decrease (Increase) in Net Income Due to Excluded Items:
Acquisition- and divestiture-related costs3 $834 $1,146
Restructuring costs 212 217
Gain on divestiture of certain migraine clinical development programs – (250)
Other (6) (33)
Net decrease (increase) in income before taxes 1,040 1,080
Income tax (benefit) expense5
(235) (186)
Decrease (increase) in net income $805 $894
Financial Outlook
Merck has narrowed and raised its full-year 2016 GAAP EPS to be between $2.02 and $2.09. The company has narrowed and raised its full-year 2016 non-GAAP EPS to be between $3.71 to $3.78, including an approximately 1 percent negative impact from foreign exchange at mid-October exchange rates. The non-GAAP range excludes acquisition- and divestiture-related costs and costs related to restructuring programs.
Merck has narrowed and raised its full-year 2016 revenue range to be between $39.7 billion and $40.2 billion, including an approximately 2 percent negative impact from foreign exchange at mid-October exchange rates.
The following table summarizes the company’s 2016 financial guidance.
GAAP Non-GAAP 1
Revenue $39.7 to $40.2 billion $39.7 to $40.2 billion*
Marketing and administrative expenses Lower than 2015 Lower than 2015
R&D expenses Higher than 2015 Higher than 2015
Effective tax rate 26.0% to 27.0% 21.5% to 22.5%
EPS $2.02 to $2.09 $3.71 to $3.78
*The company does not have any non-GAAP adjustments to revenue.
A reconciliation of anticipated 2016 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 2016
GAAP EPS $2.02 to $2.09
Difference4 1.69
Non-GAAP EPS that excludes items listed below1 $3.71 to $3.78
Acquisition- and divestiture-related costs $4,750
Restructuring costs 900
Net decrease (increase) in income before taxes 5,650
Estimated income tax (benefit) expense (955)
Decrease (increase) in net income $4,695
The expected full-year 2016 GAAP effective tax rate of 26.0 to 27.0 percent reflects an unfavorable impact of approximately 4.5 percentage points from the above items.
Total Employees
As of Sept. 30, 2016, Merck had approximately 68,000 employees worldwide.