On July 16, 2020 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2020. "Our second quarter results reflect the impact of COVID-19 and the enduring strength of our Pharmaceutical business, where we saw continued growth even in this environment," said Alex Gorsky, Chairman and Chief Executive Officer (Press release, Johnson & Johnson, JUL 16, 2020, View Source [SID1234561946]). "Thanks to the tireless work of our colleagues around the world and our broad range of capabilities, we continue to successfully navigate the external landscape, and we remain focused on advancing the development of a vaccine to help address this pandemic and save lives." Mr. Gorsky continued, "We are bringing together our best minds, our global footprint and our sophisticated supply chain technology to deliver on our commitment to provide the vaccine on a not-for-profit basis for emergency pandemic use, globally. We know the need is urgent, and every day we commit to doing our part to find a solution for the global good."
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OVERALL FINANCIAL RESULTS:
a2020q2chart111.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Excludes intangible amortization expense and special items
REGIONAL SALES RESULTS:
a2020q2chart211.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded
SEGMENT SALES RESULTS:
a2020q2chart411.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded
SEGMENT COMMENTARY:
Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined by 3.4%* as results were negatively impacted by the COVID-19 pandemic most notably reflected in skin health and beauty care products, followed by women’s health care products and international baby care products. Partially offsetting this impact was growth in over-the-counter products including TYLENOL analgesics; digestive health products and ZARBEE’S NATURALS; and LISTERINE mouthwash in oral care products. Both over-the-counter and oral care products were positively impacted by COVID-19.
Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 3.9%* driven by STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, DARZALEX (daratumumab), for the treatment of multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, UPTRAVI (selexipag), an oral prostacyclin receptor agonist used to treat pulmonary arterial hypertension and reduce hospitalization, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, and OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression. This growth was partially offset by the negative impact of COVID-19 as well as biosimilar and generic competition, with declines primarily in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, international VELCADE (bortezomib), a proteasome inhibitor for the treatment of multiple myeloma, and ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.
Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined by 32.5%* primarily driven by the negative impact of the COVID-19 pandemic and the associated deferral of medical procedures to our Surgery, Orthopaedics, Vision and Interventional Solutions businesses.
NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the Company’s website at news releases.
Regulatory
Approvals
TREMFYA (guselkumab) – U.S. Food and Drug Administration (FDA) Approves for Adult Patients with Active Psoriatic Arthritis (PsA)¹ (press release) ZABDENO (Ad26.ZEBOV) and MVABEA (MVA-BN-Filo) – European Commission Approves Janssen’s Preventive Ebola Vaccine¹ (press release) DARZALEX (daratumumab) – European Commission (EC) Grants Marketing Authorisation for Subcutaneous Formulation for all Currently Approved Intravenous Formulation Indications (press release)
SIRTURO (bedaquiline) – U.S. FDA Approves New Pediatric Formulation as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis
(press release)
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) – U.S. FDA Approves a new Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma
(press release)
IMBRUVICA (ibrutinib) – U.S.FDA Approves IMBRUVICA Plus Rituximab for Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
(press release) Regulatory
Submissions
SIMPONI ARIA (golimumab) – Submission to the U.S. Food and Drug Administration (FDA) for the Treatment of Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis
(press release) Other
STELARA (ustekinumab) Discontinuation of Phase 3 LOTUS Study in Systemic Lupus Erythematosus
(press release)
Johnson & Johnson Announces Acceleration of its COVID-19 Vaccine Candidate; Phase 1/2a Clinical Trial to Begin in Second Half of July
(press release)
Biosense Webster Unveils Late-Breaking Results from PRECEPT Study in Patients with Persistent Atrial Fibrillation
(press release)
1 Subsequent to the quarter
FULL-YEAR 2020 GUIDANCE:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the Company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
The estimated impact of the COVID-19 pandemic is included in the guidance below.
1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2 Non-GAAP financial measure; excludes the impact of translational currency
3 Calculated using Euro Average Rate: July 2020 = $1.12 Euro Average Rate: April 2020 = $1.09 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items
Other modeling considerations will be provided on the webcast.
WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:00 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the Company’s website at events-and-presentations.