Johnson & Johnson
3Q Revenues: $23.3 billion (+11%)
3Q Earnings: $3.7 billion (+3%)
YTD Revenues: $69.0 billion (+15%)
YTD Earnings: $16.1 billion (+24%)
Comments: Pharmaceutical sales were $13.0 billion in the quarter, up 14% driven by DARZALEX for the treatment of multiple myeloma, STELARA, a biologic for immune-mediated inflammatory diseases, TREMFYA, a biologic for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis, ERLEADA, a next-generation androgen receptor inhibitor for prostate cancer, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA, long-acting, injectable atypical antipsychotics for the treatment of schizophrenia, and OPSUMIT for the treatment of pulmonary arterial hypertension. Also contributing to sales growth was the not-for-profit COVID-19 Vaccine (Ad26.COV2.S) with $502 million in sales. This growth was partially offset by declines in U.S. sales of REMICADE, a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and INVOKANA for the treatment of type 2 diabetes. R&D expenses were up 21% in the quarter to $3.4 billion.
 
FDA Filings
In the quarter, the FDA approved INVEGA HAFYERA (paliperidone palmitate) the first and only twice-yearly treatment for adults with Schizophrenia.
 
XARELTO (rivaroxaban) plus aspirin was approved for expanded Peripheral Artery Disease (PAD) indication to include patients after Lower-Extremity Revascularization (LER).
 
UPTRAVI (selexipag) was approved for intravenous use in adult patients with Pulmonary Arterial Hypertension (PAH)
 
J&J submitted Emergency Use Authorization Amendment to the FDA to support a booster of its Single-Shot COVID-19 Vaccine.