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Johnson & Johnson Reports 2018 Third-Quarter Results

Johnson & Johnson announced sales of USD 20.3 billion for the third quarter of 2018, an increase of 3.6 percent as compared to the third quarter of 2017. Operational sales results increased 5.5 percent, partially offset by the negative impact of currency of 1.9 percent. Domestic sales increased 3.6 percent. International sales increased 3.5 percent, reflecting operational growth of 7.5 percent and a negative currency impact of 4.0 percent. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 6.1 percent, domestic sales increased 3.9 percent and international sales increased 8.5 percent. Net earnings and diluted earnings per share for the third quarter of 2018 were USD 3.9 billion and USD 1.44, respectively. Third-quarter 2018 net earnings included after-tax intangible amortization expense of approximately USD 1.0 billion and a net charge for after-tax special items of approximately USD 0.7 billion, primarily consisting of a non-cash charge attributed to a partial write-down of an in-process research and development asset associated with the acquisition of Alios BioPharma Inc. Third-quarter 2017 net earnings included after-tax intangible amortization expense of approximately USD 0.9 billion and a charge for after-tax special items of approximately USD 0.5 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were USD 5.6 billion and adjusted diluted earnings per share were USD 2.05, representing increases of 7.3 percent and 7.9 percent, respectively, as compared to the same period in 2017.

On an operational basis, adjusted diluted earnings per share also increased 9.5 percent. A reconciliation of non-GAAP financial measures is included as an accompanying schedule. “We are pleased with our strong third-quarter performance, which reflects continued above-market growth in our Pharmaceutical business, accelerating sales momentum in our Consumer business and consistent progress in our Medical Devices business,” said Alex Gorsky, Chairman and Chief Executive Officer. “I’m confident that with our collaborative and inspired J&J colleagues around the world, unique broad-based business model and strategic investments in innovation, we are well positioned for success today and into the future.” The Company issued sales guidance for the full-year 2018 in a range of USD 81.0 to USD 81.4 billion. This reflects an increase in expected operational growth to a range of 5.5 percent to 6.0 percent, partially offset by the estimated lower favorable impact of currency. Additionally, the Company increased its adjusted earnings guidance for full-year 2018 to a range of USD 8.13 to USD 8.18 per share. This reflects an increase in expected operational EPS growth to a range of 9.3 percent to 10.0 percent.

Segment sales performance

Worldwide Consumer sales of USD 3.4 billion for the third quarter 2018 represented an increase of 1.8 percent versus the prior year, consisting of an operational increase of 4.9 percent and a negative impact from currency of 3.1 percent. Domestic sales increased 6.6 percent, while international sales decreased 1.3 percent, which reflected an operational increase of 3.7 percent and a negative currency impact of 5.0 percent. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 6.1 percent, with domestic sales increasing 6.4 percent and international sales increasing 5.9 percent. Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by over-the-counter products including MOTRIN and TYLENOL analgesics, ZYRTEC upper respiratory and IMODIUM digestive health products; beauty products including NEUTROGENA, OGX and DR CI LABO; as well as domestic sales of JOHNSON’s baby care products.

During the quarter, the acquisition of Zarbee’s, Inc., a leader in naturally-based healthcare products, was completed. Worldwide Pharmaceutical sales of USD 10.3 billion for the third quarter 2018 represented an increase of 6.7 percent versus the prior year with an operational increase of 8.2 percent and a negative impact from currency of 1.5 percent. Domestic sales increased 4.8 percent, international sales increased 9.5 percent, which reflected an operational increase of 13.2 percent and a negative currency impact of 3.7 percent.  Acquisitions and divestitures had a negligible impact to sales growth in the quarter. Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, STELARA (ustekinumab), a biologic for the treatment of  a number of immune-mediated inflammatory diseases, DARZALEX (daratumumab), for the treatment of multiple myeloma, TREMFYA (guselkumab), for the treatment of adults living with moderate to severe plaque psoriasis, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, SIMPONI/SIMPONI ARIA (golimumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, and UPTRAVI (selexipag), an oral prostacyclin receptor agonist used to treat pulmonary arterial hypertension and reduce hospitalization.

During the quarter, the US Food and Drug Administration (FDA) approved an additional indication for IMBRUVICA (ibrutinib) in combination with rituximab as a non-chemotherapy combination regimen for patients with Waldenström’s Macroglobulinemia, a rare blood cancer. The European Commission (EC) granted marketing authorization for DARZALEX (daratumumab) in combination with VELCADE (bortezomib), a proteasome inhibitor, melphalan, an alkylating agent, and prednisone for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant.  In addition, the FDA approved and the EC granted marketing authorization for SYMTUZA (D/C/F/TAF), a complete darunavir-based single-tablet regimen for the treatment of HIV-1 infection. A New Drug Application was submitted to the FDA for esketamine nasal spray, a rapidly acting antidepressant for treatment-resistant depression in adults and erdafitinib, a once-daily, oral pan-fibroblast growth factor receptor (FGFR) inhibitor for the treatment of locally advanced or metastatic urothelial cancer. A supplemental New Drug Application was submitted to the FDA seeking to broaden the use of IMBRUVICA (ibrutinib) in chronic lymphocytic leukemia or small lymphocytic lymphoma to include combination use with a non-chemotherapy agent, obinutuzumab, in the frontline setting.

A Type II Variation was submitted to the European Medicines Agency (EMA) seeking to expand the indication of OPSUMIT (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group 4, to improve exercise capacity and pulmonary vascular resistance. In addition, the Company also submitted a supplemental Biologics License Application to the FDA and a Type II Variation to the EMA seeking approval of a split dosing regimen for DARZALEX (daratumumab). Subsequent to the quarter, the FDA approved an additional indication for XARELTO (rivaroxaban) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction and stroke, in people with chronic coronary or peripheral artery disease. Additionally, a Marketing Authorization Application was submitted to the EMA for esketamine nasal spray, a rapidly acting antidepressant for treatment-resistant depression in adults.  The Company also entered into an exclusive worldwide license agreement with Arrowhead Pharmaceuticals, Inc. to develop and commercialize a new treatment for chronic Hepatitis B viral infection.

Worldwide Medical Devices sales of USD 6.6 billion for the third quarter 2018 represented a decrease of 0.2 percent versus the prior year consisting of an operational increase of 1.7 percent and a negative currency impact of 1.9 percent. Domestic sales increased 0.3 percent, while international sales decreased 0.6 percent, which reflected an operational increase of 3.0 percent and a negative currency impact of 3.6 percent. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 2.9 percent, domestic sales increased 1.2 percent and international sales increased 4.4 percent. Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by the growth of electrophysiology products in the Interventional Solutions business; ACUVUE contact lenses in the Vision business; endocutters and biosurgicals in the Advanced Surgery business; and wound closure products in the General Surgery business, partially offset by declines in the Diabetes Care business.

During the quarter, the Company received European CE mark approval for its BRAVO Flow Diverter for use in the treatment of patients suffering from intracranial aneurysms.  In addition, the acquisition of Emerging Implant Technologies GmbH, a privately held manufacturer of 3D-printed titanium interbody implants for spinal fusion surgery, was completed. Lastly, the Company accepted the binding offer from Fortive Corporation to acquire its Advanced Sterilization Products business for an aggregate value of approximately USD 2.8 billion, subject to customary adjustments. Subsequent to the quarter, the Company announced the completion of the divestiture of its LifeScan business to Platinum Equity for approximately USD 2.1 billion, subject to customary adjustments. – Medical Buyer Bureau

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