On April 18, 2023 Johnson & Johnson (NYSE: JNJ) reported results for first-quarter 2023 (Press release, Johnson & Johnson, APR 18, 2023, View Source [SID1234630244]). "Our first quarter results demonstrate strong performance across all three segments of our business and reflect the dedication of Johnson & Johnson colleagues around the world," said Joaquin Duato, Chairman of the Board and Chief Executive Officer. "With this momentum, I look forward to the remainder of the year, one filled with exciting catalysts that will create both near- and long-term value for patients and all of our stakeholders."

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OVERALL FINANCIAL RESULTS:
overallresultsupdatedformat.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
5 Basic shares are used to calculate loss per share as use of diluted shares when in a loss position would be anti-dilutive
Note: values may have been rounded

REGIONAL SALES RESULTS:
updatedregionalsales.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:
updatedsegmentsales.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

FIRST QUARTER 2023 SEGMENT COMMENTARY:
Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Consumer Health
Consumer Health worldwide adjusted operational sales increased 11.3%* largely driven by over-the-counter (OTC) products. Major contributors to growth in OTC were TYLENOL and MOTRIN analgesics, upper respiratory products, IMODIUM in digestive health products and international smoking cessation products. Additional contributors to growth were NEUTROGENA and AVEENO in Skin Health/Beauty products and JOHNSON’s in Baby Care products.

Pharmaceutical
Pharmaceutical worldwide adjusted operational sales grew 7.2%*, driven by DARZALEX (daratumumab), a biologic for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, CARVYKTI (ciltacabtagene autoleucel), a BCMA-directed CAR-T immunotherapy for the treatment of patients with relapsed or refractory multiple myeloma, and XARELTO (rivaroxaban), a direct oral anticoagulant. Also contributing to growth were sales of the Janssen COVID-19 Vaccine (Ad26.COV2.S) for the prevention of the SARS-CoV-2 Virus. This growth was partially offset by declines in sales of REMICADE (infliximab), a biologic approved for the treatment of several immune-mediated inflammatory diseases, IMBRUVICA (ibrutinib), an oral, once daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, and ZYTIGA (abiraterone acetate), an oral, once daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.

MedTech
MedTech worldwide adjusted operational sales grew 6.4%*, driven primarily by electrophysiology products in Interventional Solutions, contact lenses in Vision, wound closure products in General Surgery, and knees in Orthopaedics. MedTech worldwide operational sales grew 11.0%*, with the acquisition of Abiomed contributing 4.6%.

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 and information available in the Investors section of the company’s website at news releases, as well as www.factsabouttalc.com, www.factsaboutourprescriptionopioids.com, and www.LTLManagementInformation.com.

Regulatory
Janssen Receives Positive CHMP Opinion for AKEEGA (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer
Press Release
Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations
Press Release
Data Release
Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI (cilta-cel) as Primary Endpoint Met in Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Press Release
Late Breaking Data on Pulmonary Vein Isolation with HELIOSTAR Balloon Ablation Catheter Presented at AF Symposium 2023
Press Release
First Look at Data on Biosense Webster’s Investigational Pulsed Field Ablation Platform Presented at AF Symposium 2023
Press Release
Janssen Reports Positive Topline Phase 2 Results for Nipocalimab in Pregnant Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Press Release
Janssen Data at ASCO (Free ASCO Whitepaper) GU Support Ambition to Transform Treatment of Prostate and Bladder Cancer Through Precision Medicine and Early Intervention
Press Release
TREMFYA (guselkumab) Demonstrates a Differentiated Binding Mechanism from Risankizumab in In Vitro Studies
Press Release
New STELARA (ustekinumab) Long-Term Data Support its Established Safety Profile in Inflammatory Bowel Disease and Durable Efficacy in Ulcerative Colitis
Press Release
Late-Breaking Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil Significantly Improves Pulmonary Hemodynamics versus Monotherapy in Patients with Pulmonary Arterial Hypertension (PAH)
Press Release
TREMFYA (guselkumab) Real-World Data Analyses Show Greater Treatment Persistence Than IL-17s in Both Bio-naïve and Bio-experienced Patients Living With Moderate to Severe Plaque Psoriasis
Press Release
New RYBREVANT (amivantamab-vmjw) Data Showed Long-Term Clinical Response and Safety in Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations Who Have Failed Prior Platinum-Based Chemotherapy
Press Release
Other
Johnson & Johnson Subsidiary LTL Management LLC ("LTL") Re-Files for Voluntary Chapter 11 to Equitably Resolve All Current and Future Talc Claims1
Press Release
Johnson & Johnson Appoints Dr. John Reed as Executive Vice President, Pharmaceuticals, R&D
Press Release
Johnson & Johnson Names Dr. Paula A. Johnson, President of Wellesley College, to its Board of Directors
Press Release
Johnson & Johnson Announces Pricing of $7.75 Billion of Senior Notes Issued by Kenvue Inc.
Press Release
Janssen Provides Portfolio Update
Press Release
ERLEADA (apalutamide), First-and-Only Next-Generation Androgen Receptor Inhibitor with Once-Daily, Single-Tablet Option, Now Available in the U.S.1
Press Release

1 Subsequent to the quarter

FULL-YEAR 2023 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.

($ in Billions, except EPS)
April 2023
January 2023
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
4.5% – 5.5% / 5.0%
3.5% – 4.5% / 4.0%
Operational Sales2,5/ Mid-point2,5
Change vs. Prior Year / Mid-point
$97.9B – $98.9B / $98.4B
5.5% – 6.5% / 6.0%
$96.9B – $97.9B / $97.4B
4.5% – 5.5% / 5.0%
Estimated Reported Sales3,5/ Mid-point3,5
Change vs. Prior Year / Mid-point
$97.9B – $98.9B / $98.4B
5.5% – 6.5% / 6.0%
$96.9B – $97.9B / $97.4B
4.5% – 5.5% / 5.0%
Adjusted Operational EPS (Diluted)2,4/ Mid-point2,4
Change vs. Prior Year / Mid-point
$10.50 – $10.60 / $10.55
3.5% – 4.5% / 4.0%
$10.40 – $10.60 / $10.50
2.5% – 4.5% / 3.5%
Adjusted EPS (Diluted)3,4 / Mid-point3,4
Change vs. Prior Year / Mid-point
$10.60 – $10.70 / $10.65
4.5% – 5.5% / 5.0%
$10.45 – $10.65 / $10.55
3.0% – 5.0% / 4.0%

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: January 2023 = $1.08 and April 2023 = $1.10 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items
5 Excludes COVID-19 Vaccine
Note: percentages may have been rounded

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 8:30 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.