Abbott Reports First-Quarter 2025 Results and Reaffirms Full-Year Guidance

On April 16, 2025 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2025 (Press release, Abbott, APR 16, 2025, View Source [SID1234651954]).

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First-quarter sales increased 4.0 percent on a reported basis, 6.9 percent on an organic basis, or 8.3 percent when excluding COVID-19 testing-related sales.
First-quarter GAAP diluted EPS of $0.76 and adjusted diluted EPS of $1.09, which excludes specified items and reflects double-digit growth compared to the prior year.
Abbott reaffirms all previously provided full-year 2025 financial guidance.
In March, Abbott obtained CE Mark for its Volt PFA System to treat patients battling atrial fibrillation (AFib). With the earlier-than-expected CE Mark, Abbott has begun commercial PFA cases in the EU with physicians who have already gained experience with the Volt PFA System through participation in Abbott’s PFA clinical studies. The company will further expand the use of Volt in EU markets throughout the second half of the year.
In March, Abbott announced the initiation of its U.S. pivotal trial, TECTONIC, to evaluate its investigational Coronary Intravascular Lithotripsy (IVL) System in treating severe calcification in coronary arteries prior to implanting a stent.
In March, Abbott presented new two-year data from its TRILUMINATE pivotal trial that showed Abbott’s TriClip device significantly reduced the rate of heart failure-related hospitalizations, while continuing to provide a sustained reduction of tricuspid regurgitation and significant improvements in quality of life.
Abbott’s two new manufacturing and R&D investments in Illinois and Texas, totaling $0.5 billion, are projected to go live by the end of 2025.
"Once again, Abbott’s diversified business model delivered top-tier sales and EPS growth," said Robert B. Ford, chairman and chief executive officer, Abbott. "It is this diversification and execution that allows Abbott to navigate through periods of uncertainty and continually deliver sustainable growth."

FIRST-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect product line in the Nutrition business, is an appropriate way for investors to best understand the core underlying performance of the business.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

First Quarter 2025 Results (1Q25)

Sales 1Q25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

4,168

955

871

2,339

International

6,190

1,191

1,183

1,260

2,556

Total reported

10,358

2,146

2,054

1,260

4,895

% Change vs. 1Q24

U.S.

8.4

8.8

(6.4)

n/a

15.0

International

1.2

0.1

(7.8)

2.7

5.7

Total reported

4.0

3.8

(7.2)

2.7

9.9

Impact of foreign exchange

(2.8)

(2.4)

(2.3)

(5.1)

(2.7)

Impact of business exit*

(0.1)

(0.6)

Organic

6.9

6.8

(4.9)

7.8

12.6

U.S.

8.8

10.4

(6.4)

n/a

15.0

International

5.7

4.2

(3.8)

7.8

10.5

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

*Quarter to date March 31, 2025, reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Total company sales increased 4.0 percent on a reported basis, 6.9 percent on an organic basis, or 8.3 percent when excluding COVID-19 testing-related sales1.

Nutrition

First Quarter 2025 Results (1Q25)

Sales 1Q25 ($ in millions)

Total

Pediatric

Adult

U.S.

955

588

367

International

1,191

453

738

Total reported

2,146

1,041

1,105

% Change vs. 1Q24

U.S.

8.8

14.2

1.1

International

0.1

(8.4)

6.1

Total reported

3.8

3.2

4.4

Impact of foreign exchange

(2.4)

(1.7)

(2.9)

Impact of business exit*

(0.6)

(1.4)

Organic

6.8

4.9

8.7

U.S.

10.4

14.2

4.8

International

4.2

(4.8)

10.6

*Reflects the impact of discontinuing the ZonePerfect product line. This action was initiated in March 2024.

Worldwide Nutrition sales increased 3.8 percent on a reported basis and 6.8 percent on an organic basis in the first quarter.

In Pediatric Nutrition, global sales increased 3.2 percent on a reported basis and 4.9 percent on an organic basis. Sales growth in the U.S. was driven by growth across Abbott’s comprehensive portfolio of products designed to meet the unique nutrition needs of infants and children.

In Adult Nutrition, global sales increased 4.4 percent on a reported basis and 8.7 percent on an organic basis, which was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading brand of products designed to meet the nutritional requirements for people with diabetes.

Diagnostics

First Quarter 2025 Results (1Q25)

Sales 1Q25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

871

332

40

100

399

International

1,183

845

82

42

214

Total reported

2,054

1,177

122

142

613

% Change vs. 1Q24

U.S.

(6.4)

7.1

(4.4)

1.5

(16.9)

International

(7.8)

(5.6)

(6.7)

4.4

(17.9)

Total reported

(7.2)

(2.3)

(5.9)

2.4

(17.3)

Impact of foreign exchange

(2.3)

(3.2)

(2.4)

(0.8)

(1.2)

Organic

(4.9)

0.9

(3.5)

3.2

(16.1)

U.S.

(6.4)

7.1

(4.4)

1.5

(16.9)

International

(3.8)

(1.3)

(3.1)

7.3

(14.6)

Global Diagnostics sales decreased 7.2 percent on a reported basis, decreased 4.9 percent on an organic basis, or increased 0.5 percent when excluding COVID-19 testing-related sales1.

Diagnostics sales growth was impacted by the year-over-year decline in COVID-19 testing-related sales and volume-based procurement programs in China.

COVID-19 testing-related sales were $84 million in the quarter, compared to $204 million in the first quarter of the prior year.

Global Core Laboratory Diagnostics sales decreased 2.3 percent on a reported basis and increased 0.9 percent on an organic basis. Growth in the quarter was impacted by volume-based procurement programs in China.

Established Pharmaceuticals

First Quarter 2025 Results (1Q25)

Sales 1Q25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

International

1,260

965

295

Total reported

1,260

965

295

% Change vs. 1Q24

U.S.

n/a

n/a

n/a

International

2.7

4.0

(1.2)

Total reported

2.7

4.0

(1.2)

Impact of foreign exchange

(5.1)

(5.3)

(4.3)

Organic

7.8

9.3

3.1

U.S.

n/a

n/a

n/a

International

7.8

9.3

3.1

Established Pharmaceuticals sales increased 2.7 percent on a reported basis and 7.8 percent on an organic basis in the first quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 4.0 percent on a reported basis and 9.3 percent on an organic basis, led by double-digit growth in several countries across Asia, Latin America and the Middle East.

Medical Devices

First Quarter 2025 Results (1Q25)

Sales 1Q25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,339

304

299

262

268

282

176

748

International

2,556

281

330

77

442

295

52

1,079

Total reported

4,895

585

629

339

710

577

228

1,827

% Change vs. 1Q24

U.S.

15.0

12.3

11.1

10.6

5.5

20.9

(2.8)

27.1

International

5.7

(3.7)

4.0

14.3

1.6

4.6

16.3

10.1

Total reported

9.9

4.0

7.3

11.4

3.0

11.9

1.0

16.5

Impact of foreign exchange

(2.7)

(2.1)

(2.6)

(1.0)

(2.7)

(2.8)

(1.2)

(3.3)

Organic

12.6

6.1

9.9

12.4

5.7

14.7

2.2

19.8

U.S.

15.0

12.3

11.1

10.6

5.5

20.9

(2.8)

27.1

International

10.5

0.3

8.8

19.1

5.8

9.6

22.7

15.4

Worldwide Medical Devices sales increased 9.9 percent on a reported basis and 12.6 percent on an organic basis in the first quarter.

Sales growth in the quarter was led by Diabetes Care, Structural Heart, Heart Failure and Electrophysiology.

Several products contributed to the strong performance, including FreeStyle Libre, Navitor, TriClip, Amplatzer Amulet, and AVEIR.

In Diabetes Care, sales of continuous glucose monitors were $1.7 billion and grew 18.3 percent on a reported basis and 21.6 percent on an organic basis.

ABBOTT’S FINANCIAL GUIDANCE
Abbott projects full-year 2025 organic sales growth to be in the range of 7.5% to 8.5%.

Abbott projects full-year 2025 adjusted operating margin to be 23.5% to 24.0% of sales.

Abbott projects full-year 2025 adjusted diluted earnings per share of $5.05 to $5.25 and second-quarter 2025 adjusted diluted earnings per share of $1.23 to $1.27.

Abbott has not provided the related GAAP financial measures on a forward-looking basis for these forward-looking non-GAAP financial measures because the company is unable to predict with reasonable certainty and without unreasonable effort the timing and impact of certain items such as restructuring and cost reduction initiatives, charges for intangible asset impairments, acquisition-related expenses, and foreign exchange, which could significantly impact Abbott’s results in accordance with GAAP.

ABBOTT DECLARES 405th CONSECUTIVE QUARTERLY DIVIDEND
On Feb. 21, 2025, the board of directors of Abbott declared the company’s quarterly dividend of $0.59 per share. Abbott’s cash dividend is payable May 15, 2025, to shareholders of record at the close of business on April 15, 2025.

Abbott has increased its dividend payout for 53 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for First Quarter of 2025

On April 15, 2025 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 3,237 million in the first quarter of 2025 (Press release, Genmab, APR 15, 2025, View Source [SID1234651941]). Net trade sales were USD 1,829 million in the U.S. and USD 1,409 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.

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Hoth Therapeutics Announces Positive Initial Data in Phase 2a Clinical Trial Reports 50% Reduction in Pruritus (Mean Score Dropped from 1.6 to 0.8) by Day 21 in
Open-Label Portion of CLEER HT-001 Phase 2a clinical Trial for Cancer EGFR Inhibitor-Induced Skin Toxicities

On April 15, 2025 Hoth Therapeutics, Inc.(NASDAQ: HOTH), a biopharmaceutical company focused on developing innovative therapies for patients with high unmet medical needs, reported positive interim data from the open-label portion of its Phase 2a clinical trial, CLEER-001, evaluating HT-001 for the treatment of pruritus associated with skin toxicities caused by Epidermal Growth Factor Receptor (EGFR) inhibitors (Press release, Hoth Therapeutics, APR 15, 2025, View Source [SID1234651942]).

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EGFR inhibitors, widely used in oncology, are often associated with skin-related adverse effects, including intense itching, which can impair quality of life and reduce treatment compliance. HT-001 is designed to address this significant unmet need.

Key Interim Results (Day 1–21):

● Patients experienced a 50% reduction in pruritus severity, with mean scores dropping from 1.6 on Day 1 to 0.8 by Day 21.

● Rapid symptom relief was observed, with mean scores improving to 1.0 by Day 7.

● Some patients achieved complete resolution of pruritus within the 21-day period.

● HT-001 was well tolerated, with no treatment-related serious adverse events reported.

"These findings support the potential of HT-001 to deliver meaningful relief for cancer patients experiencing EGFR-related pruritus," said Robb Knie Chief Executive Officer of Hoth Therapeutics. "Cutaneous toxicities can significantly impact quality of life and may interfere with treatment. Our goal is to provide a safe and effective therapy that enhances patient comfort and continuity of care. This data along with our initial results released in January give us further belief in the promise of HT-001."

The CLEER-001 study is ongoing, with both cohorts in effect including the randomized, double-blind portion of the trial.

Hoth would like to thank Mr. Graig Springer who will be leaving our board as his professional position and family life both expand. Mr. Springer has not only been a superb board member, but he has been a great sounding board for the company and we wish Graig much success in all his endeavors.

ImmunityBio Announces FDA Submissions of Supplemental BLA for NMIBC Papillary Disease and for Expanded Access of ANKTIVA® to Treat Lymphopenia

On April 15, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported that it has completed multiple submissions to the FDA including an sBLA for BCG-unresponsive NMIBC in papillary disease and an EAP for ANKTIVA (nogapendekin alfa inbakicept-pmln) for the treatment of lymphopenia (Press release, ImmunityBio, APR 15, 2025, View Source [SID1234651934]).

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Supplemental Biologics License Application (sBLA):

In Q1, ImmunityBio completed the submission to the FDA of an sBLA for the use of ANKTIVA plus BCG in BCG-unresponsive NMIBC in the papillary indication. Subject to regulatory approvals, the addition of the papillary indication expands the patient population benefiting from this therapy beyond the currently approved indication of bladder carcinoma in situ (CIS) with or without papillary disease and allows more patients to avoid the high morbidity and mortality associated with radical cystectomy. The data submitted to the FDA included efficacy results demonstrating durable complete remissions in patients with BCG unresponsive NMIBC papillary disease. In 88% and 82% of subjects, the probability of avoiding surgical removal of the bladder was achieved for as long as 2 and 3 years respectively, following treatment with ANKTIVA plus BCG. The mortality and morbidity associated with a radical total cystectomy is high and this long-term bladder sparing therapy has the potential to provide a significant benefit and quality of life to patients suffering from BCG unresponsive papillary disease.

In a pivotal study published in NEJM Evidence, BCG plus ANKTIVA resulted in a disease-free survival (DFS) rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months in participants with papillary NMIBC. In addition, patients receiving the novel treatment achieved a 93% avoidance of cystectomy (surgical removal of the bladder) with a median follow up of 20.7 months. This combination immunotherapy wherein ANKTIVA rescues BCG efficacy, currently approved in the BCG-unresponsive carcinoma in situ (CIS) indication, may provide an effective therapeutic option for papillary patients who did not respond to BCG alone and face the prospect of a radical cystectomy. Papillary disease is estimated to be approximately 6-10 times more common than bladder cancer CIS, representing a large patient population that may benefit from ANKTIVA plus BCG.

Expanded Access Protocol for ANKTIVA in the Treatment of Lymphopenia:

The company also announced it has submitted to the FDA an EAP to make available ANKTIVA for the treatment of lymphopenia. Lymphopenia is the loss of natural killer cells and T cells, the very cells necessary to fight cancer. To date, no treatment exists to overcome lymphopenia which is induced by the cancer itself and by the standards of care including chemotherapy, radiation, steroids and checkpoint inhibitors. ImmunityBio received designation from the Agency for Regenerative Medicine Advanced Therapy (RMAT) for the indication of ANKTIVA to treat lymphopenia. The EAP, subject to authorization, would provide early access to patients and physicians desiring ANKTIVA in combination with standards of care.

Update of Product Revenue, Net Preliminary Results of Operations:

With the issuance of the permanent J-code (J9028) in January 2025, ImmunityBio has seen increased sales momentum supporting a trend of increases month-over-month as well as quarter-over-quarter, with March unit sales volume increasing 69% over February, and Q1 2025 unit sales exceeding unit sales achieved for all of FY 2024. ImmunityBio earned net product revenue of approximately $16.5 million during the three-month period ended March 31, 2025, which represented an increase of 129% over the $7.2 million of net revenue earned during the fourth quarter of 2024.

The amounts reported in this press release reflect the company’s preliminary estimates based solely upon information available to it as of the date of this press release, and the amounts reported are not a comprehensive statement of its financial results or position as of March 31, 2025. Any actual amounts that the company reports in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, will be subject to its financial closing procedures and any final adjustments that may be made prior to the time its financial results for the period ended March 31, 2025 are finalized. As a result, these preliminary estimates may differ materially from the actual results that will be reflected in the company’s consolidated financial statements for the quarter when they are completed and publicly disclosed.

Update on ImmunityBio Platforms

Fireside chats with Dr. Patrick Soon-Shiong and the following Key Opinion Leaders (KOLs) discussing the science and current status of ImmunityBio platforms are expected to take place during the Investor Day program:

Dr. Christopher Pieczonka – Chief Executive Officer, Associated Medical Professionals of New York & Corporate Director of Clinical Research of US Urology Partners
Dr. Steven Finkelstein – National Director of Radiation Oncology, US Urology Partners. Director of the Center of Advanced Radiation Excellence (CARE) and Director Radiation Oncology Research
Dr. Mark Lanasa – Senior Vice President, Chief Medical Officer, Solid Tumors, BeiGene
Dr. Jennifer Buell – President & Chief Executive Officer, MiNK Therapeutics
Dr. Krishnansu Tewari – Gynecologic Oncology, Obstetrics & Gynecology at UC Irvine Health
Dr. David Kerr – Professor of Cancer Medicine Genetics and Genomics, University of Oxford
Dr. Timothy Henrich – Professor, School of Medicine UC San Francisco
Dr. Carlos Cordon-Cardo – Chairman for the Mount Sinai Health System Dept. of Pathology
The live stream can be found at:

View Source;tp_key=40dc7065b5

Participant Listening (Listen Only)

1-844-539-3703 or 1-412-652-1273

Johnson & Johnson reports Q1 2025 results

On April 15, 2025 Johnson & Johnson (NYSE: JNJ) reported results for first-quarter 2025 (Press release, Johnson & Johnson, APR 15, 2025, View Source [SID1234651935]). "The power of Johnson & Johnson’s uniquely diversified portfolio was on full display this quarter, with strong operational sales growth reinforcing our confidence in 2025 guidance," said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. "During the quarter, we fortified our position as an innovation powerhouse with major advancements across our pipeline, including TREMFYA in IBD, RYBREVANT plus LAZCLUZE in non-small-cell lung cancer, and OTTAVA, our soft tissue surgical robotic system, and further enhanced our leading neuroscience portfolio with the completion of the Intra-Cellular Therapies acquisition."

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Overall financial results
Q1
($ in Millions, expect EPS)
2025
2024
% Change
Reported Sales

$21,893
$ 21,383
2.4%
Net Earnings
$10,999
$3,255
237.9%
EPS (diluted)
$4.54
$1.34
238.8%

Q1
Non-GAAP* ($ in Millions, except EPS)
2025
2024
% Change
Operational Sales1,2

4.2%
Adjusted Operational Sales1,3

3.3%
Adjusted Net Earnings1,4
$6,706
$6,580
1.9%
Adjusted EPS (diluted)1,4
$2.77
$2.71
2.2%
Free Cash Flow6,7
~$3,400
$2,850

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
4Excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
6Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings.
7First-quarter 2025 is estimated as of April 15, 2025
Note: values may have been rounded

Regional sales results
Q1

% Change

($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S.
$12,305
$11,620
5.9%
5.9

4.4
International
9,588
9,763
(1.8)
2.1
(3.9)
1.9
Worldwide
$21,893
$21,383
2.4%
4.2
(1.8)
3.3

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Segment sales results
Q1

% Change

($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine
$13,873
$13,562
2.3%
4.2
(1.9)
4.4
MedTech
8,020
7,821
2.5
4.1
(1.6)
1.3
Worldwide
$21,893
$21,383
2.4%
4.2
(1.8)
3.3

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

First-Quarter 2025 segment commentary:
Operational sales* reflected below excludes the impact of translational currency.
Innovative Medicine
Innovative Medicine worldwide operational sales grew 4.2%* driven primarily by DARZALEX, CARVYKTI, ERLEADA, and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, SPRAVATO in Neuroscience, and XARELTO in Cardiovascular/Metabolism/Other. Growth was partially offset by an approximate (810) basis points impact from STELARA in Immunology.

MedTech
MedTech worldwide operational sales grew 4.1%*, with net acquisitions and divestitures positively impacting growth by 2.8%. Growth was driven primarily by Abiomed in Cardiovascular and wound closure products in General Surgery. Growth was partially offset by Spine, Sports & Other in Orthopaedics.

Full-year 2025 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 2025
January 2025
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
2.0% – 3.0% / 2.5%
2.0% – 3.0% / 2.5%
Operational Sales2,5 / Mid-point
Change vs. Prior Year / Mid-point
$91.6B – $92.4B / $92.0B
3.3% – 4.3% / 3.8%
$90.9B – $91.7B / $91.3B
2.5% – 3.5% / 3.0%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$91.0B – $91.8B / $91.4B
2.6% – 3.6% / 3.1%
$89.2B – $90.0B / $89.6B
0.5% – 1.5% / 1.0%
Adjusted Operational EPS (Diluted)2,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
$10.75 – $10.95 / $10.85
7.7% – 9.7% / 8.7%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%

1Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2Non-GAAP financial measure; excludes the impact of translational currency
3Calculated using Euro Average Rate: April 2025 = $1.10 and January 2025 = $1.04 (Illustrative purposes only)
4Non-GAAP financial measure; excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
Note: percentages may have been rounded
Other modeling considerations will be provided on the webcast
Notable announcements in the quarter:
The information contained in this section should be read together 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 Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com.

Regulatory
European Commission approves subcutaneous RYBREVANT (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer1
Press Release
European Commission approves Johnson & Johnson’s subcutaneous DARZALEX (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility1
Press Release

U.S. FDA approves TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn’s disease
Press Release
Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren’s disease, has now received Fast Track designation
Press Release
Data Releases
Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA Robotic Surgical System1
Press Release
Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill1
Press Release
Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG)1
Press Release
TREMFYA (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis1
Press Release
Johnson & Johnson MedTech to Highlight Latest Advancements in Heart Disease Treatment with Impella at ACC.25
Press Release
RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer
Press Release
New nipocalimab data and real-world research at AAN 2025 highlight positive Phase 3 results and commitment to people living with generalized myasthenia gravis (gMG)
Press Release
RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025
Press Release
Johnson & Johnson MedTech Showcases New Era of Digital Orthopaedics at AAOS 2025
Press Release
Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients
Press Release
Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis
Press Release
TREMFYA (guselkumab) subcutaneous (SC) induction data support potential to be the first and only in its class to offer the option of both intravenous and SC induction therapy in ulcerative colitis
Press Release
New nipocalimab data published in mAbs journal details differentiated molecular design, clinical profile and potential of nipocalimab to treat IgG-driven alloantibody and autoantibody diseases
Press Release
Findings from pivotal nipocalimab Phase 3 study in a broad antibody positive population of people living with generalized myasthenia gravis (gMG) published in The Lancet Neurology
Press Release

Product Launch
Shockwave Medical Launches Novel Forward Intravascular Lithotripsy Platform in U.S. to Transform Treatment of Difficult-to-Cross Calcified Lesions

Other
Johnson & Johnson Closes Landmark Intra-Cellular Therapies, Inc. Acquisition to Solidify Neuroscience Leadership1
Press Release
Johnson & Johnson to Return to Tort System to Defeat Meritless Talc Claims1
Press Release
Johnson & Johnson Increases U.S. Investment to More than $55 Billion Over the Next Four Years
Press Release
Johnson & Johnson Announces Darren Snellgrove as Vice President, Investor Relations
Press Release

1Subsequent to the quarter

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 Investor Relations section of the company’s website at events-and-presentations.