On October 18, 2016 Johnson & Johnson (NYSE: JNJ) reported sales of $17.8 billion for the third quarter of 2016, an increase of 4.2% as compared to the third quarter of 2015 (Press release, Johnson & Johnson, OCT 18, 2016, View Source [SID1234515896]). Schedule your 30 min Free 1stOncology Demo! Operational sales results increased 4.3% and the negative impact of currency was 0.1%. Domestic sales increased 6.7%. International sales increased 1.5%, reflecting operational growth of 1.7% and a negative currency impact of 0.2%. Excluding the net impact of acquisitions, divestitures and hepatitis C sales, on an operational basis, worldwide sales increased 5.9%, domestic sales increased 7.3% and international sales increased 4.2%.* Operations in Venezuela negatively impacted worldwide operational sales growth by 30 basis points, and international sales growth by 70 basis points.
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Net earnings and diluted earnings per share for the third quarter of 2016 were $4.3 billion and $1.53, respectively. Third quarter 2016 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.2 billion. Third quarter 2015 net earnings included after-tax intangible amortization expense of approximately $0.4 billion and a charge for after-tax special items of approximately $0.4 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $4.7 billion and adjusted diluted earnings per share were $1.68, representing increases of 12.2% and 12.8%, respectively, as compared to the same period in 2015. * On an operational basis, adjusted diluted earnings per share also increased 12.8%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.
"Our third-quarter results reflect the success of our new product launches and the strength of our core businesses, driven by strong growth in our Pharmaceuticals business. With a number of regulatory approvals, several new drug application submissions and new breakthrough therapy designations from the FDA, we are increasingly confident in our pipeline expectation of filing 10 new pharmaceutical products between 2015 and 2019, each with revenue potential over $1 billion," said Alex Gorsky, Chairman and Chief Executive Officer. "Our broad-based business model, strategic investments and talented colleagues position us well for continued leadership in health care."
The Company maintained its sales guidance for the full-year 2016 of $71.5 billion to $72.2 billion. Additionally, the Company increased its adjusted earnings guidance for full-year 2016 to $6.68 – $6.73 per share.*
Worldwide Consumer sales of $3.3 billion for the third quarter 2016 represented a decrease of 1.6% versus the prior year, consisting of an operational increase of 0.1% and a negative impact from currency of 1.7%. Domestic sales increased 1.1%; international sales decreased 3.3%, which reflected an operational decrease of 0.6% and a negative currency impact of 2.7%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales decreased 0.4%, domestic sales decreased 1.5% and international sales increased 0.3%*. Operations in Venezuela negatively impacted worldwide Consumer operational sales growth by 110 basis points and international sales growth by 180 basis points.
Worldwide operational results, excluding the net impact of acquisitions and divestitures, were negatively impacted by lower trade inventory levels, primarily in the U.S. Positive contributors to Consumer operational sales results included LISTERINE oral care products; AVEENO skin care products and digestive health products and international smoking aids in over-the-counter products.
Worldwide Pharmaceutical sales of $8.4 billion for the third quarter 2016 represented an increase of 9.2% versus the prior year with an operational increase of 9.0% and a positive impact from currency of 0.2%. Domestic sales increased 11.8%; international sales increased 5.4%, which reflected an operational increase of 5.0% and a positive currency impact of 0.4%. Excluding the net impact of acquisitions, divestitures and hepatitis C sales, on an operational basis, worldwide sales increased 10.7%, domestic sales increased 13.0% and international sales increased 7.0%.*
Worldwide operational results, excluding the net impact of acquisitions, divestitures and hepatitis C sales, were driven by new products and the strength of core products. Strong growth in new products include IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer; DARZALEX (daratumumab), for the treatment of patients with multiple myeloma; and XARELTO (rivaroxaban), an oral anticoagulant.
Additional contributors to operational sales growth included STELARA (ustekinumab), REMICADE (infliximab) and SIMPONI/SIMPONI ARIA (golimumab), biologics approved for the treatment of a number of immune-mediated inflammatory diseases; and INVEGA SUSTENNA/XEPLION/TRINZA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults.
During the quarter, the U.S. Food and Drug Administration (FDA) approved INVOKAMET XR (canagliflozin/metformin HCl extended-release) for first-line treatment of adults with type 2 diabetes, and STELARA (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease. The Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of STELARA for the treatment of adults with moderately to severely active Crohn’s disease.
Additionally, regulatory applications for approval were submitted to the FDA and European Medicines Agency (EMA) for DARZALEX in combination with standard-of-care regimens for patients with multiple myeloma who have received at least one prior therapy. DARZALEX also received Breakthrough Therapy Designation from the FDA for this pending indication. The FDA also granted Breakthrough Therapy Designation to esketamine for major depressive disorder with imminent risk for suicide. Regulatory applications for approval were also submitted to the FDA for sirukumab in rheumatoid arthritis, and to EMA for a darunavir-based single tablet regimen for the treatment of HIV-1.
Worldwide Medical Devices sales of $6.2 billion for the third quarter 2016 represented an increase of 1.1% versus the prior year consisting of an operational increase of 0.7% and a positive currency impact of 0.4%. Domestic sales increased 1.4%; international sales increased 0.7%, which reflected an operational decline of 0.2% and a positive currency impact of 0.9%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 3.1%, domestic sales increased 2.3% and international sales increased 3.9%.*
Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by electrophysiology products in the Cardiovascular business; endocutters and energy in the Advanced Surgery business; ACUVUE contact lenses in the Vision Care business; and joint reconstruction and trauma products in the Orthopaedics business.
During the quarter, a definitive agreement was announced to acquire Abbott Medical Optics, a wholly-owned subsidiary of Abbott Laboratories, for $4.325 billion in cash. Acclarent announced the U.S. launch of ACCLARENT AERA, the first balloon dilation intervention approved by the FDA for Eustachian Tube Dysfunction.