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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

100

399

International

1,183

845

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

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

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

442

295

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.

Ipsen delivers strong sales in the first quarter 2025 and confirms its full-year guidance

On April 16, 2025 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported sales for the first quarter of 2025 (Press release, Ipsen, APR 16, 2025, View Source [SID1234651945]).

Q1 2025 % change % change
€m Actual CER1
Oncology 655.0 8.5% 8.0%
Neuroscience 193.5 8.0% 9.6%
Rare Disease 70.3 78.4% 74.6%
Total Sales 918.8 11.7% 11.6%

"Ipsen has delivered a strong start to 2025, building further momentum in the transformation of our company," commented David Loew, Chief Executive Officer, Ipsen. "We continued to execute on our strategy with strong top-line growth and pipeline progression. I am pleased to see the rapid build-up of our Rare Cholestatic Liver disease franchise with two innovate medicines for five indications. 2025 is set to be an important year for Ipsen, with multiple launches underway and several milestones expected across our portfolio."

Full-year guidance

Ipsen is confirming financial guidance for full-year 2025:

Total sales growth greater than 5.0%, at constant currency. Based on the average level of exchange rates in March 2025, a limited effect on total sales from currencies is expected.
Core operating margin greater than 30.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities.
Guidance includes expected negative impact on Somatuline sales due to increased generic competition in the U.S. and Europe. It excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions.

Upcoming Milestones

Ipsen anticipates several key milestones across its portfolio in 2025, including:

Cabometyx (CABINET trial) – Regulatory decision in the European Union for advanced pancreatic (pNETs) and extra-pancreatic (epNETs) neuroendocrine tumors (NETs).
fidrisertib (FALKON trial) – Readout of the pivotal Phase IIb trial in fibrodysplasia ossificans progressiva (FOP).
LANT3 (LANTIC trial) – Proof-of-concept data readout, evaluating its potential in aesthetics.
Q1 pipeline progress

The regulatory filing for tovorafenib was accepted by EMA for review in the European Union, marking an important step forward in the development of this potential treatment for pediatric low-grade glioma and reinforcing Ipsen’s commitment to innovation in rare and difficult-to-treat cancers.

Ipsen also initiated the entry in Phase I of IPN01195, a RAF inhibitor, complementing IPN01194, an ERK inhibitor, and tovorafenib, two other assets targeting the MAPK pathway.

Group refinancing

Ipsen announced on March 19th the successful completion of its inaugural Rated Public Bond of €500 million with a coupon of 3.875%, maturing in March 2032. Following the disclosure of the Investment Grade ratings from S&P and Moody’s, this transaction was very well received and largely oversubscribed by a diversified and solid institutional investor base. This transaction is an important component of Ipsen’s refinancing plan which included the successful renewal of €1,5 billion syndicated Revolving Credit Facility, extending Ipsen’s debt maturity profile.

Conference call

A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the call and its details by registering here; webcast details can be found here.

Calendar

Ipsen intends to publish its half-year results on July 31st, 2025.

Notes

All financial figures are in € millions (€m). The performance shown covers the three-month period to 31 March 2025 (Q1 2025, the quarter), compared to the three-month period to 31 March 2024 (Q1 2024), unless stated otherwise.

TJ Biopharma Announces Completion of Patient Enrollment in Phase 2 Clinical Study of Uliledlimab for NSCLC

On April 15, 2025 TJ Biopharma ("TJ Bio" or "Company"), a fully integrated biotech company focusing on discovery, development, manufacturing and commercialization of innovative biologics in the areas of autoimmune diseases, oncology and metabolic disorders, reported completion of patient enrollment in the Phase 2 stage of its ongoing Phase 2/3 clinical study evaluating uliledlimab, a differentiated CD73 antibody, in combination with toripalimab (doublet study) as first-line treatment for non-small cell lung cancer (NSCLC) (Press release, TJ Bio, APR 15, 2025, View Source [SID1234654002]). The Company anticipates topline data readout in the first half of 2025 and intends to initiate a Phase 3 registrational study of the doublet study as planned.

"Despite multiple challenges, our team successfully managed to complete the patient enrollment on track, demonstrating TJ Bio’s exceptional clinical operations capabilities," said Dr. Jingwu Zang, Founder and Chairman of TJ Bio. "The development of uliledlimab, a cornerstone of our staged pipeline, is accelerating steadily. We’re confident in the clinical value of this therapy and look forward to upcoming data analysis results as we prepare for the Phase 3 study launch, aiming to provide more effective and innovative treatment options for lung cancer patients."

Earlier this year, TJ Bio initiated and dosed the first patient in another Phase 2 clinical study evaluating uliledlimab in combination with sintilimab and chemotherapy (triplet study) as first-line treatment for NSCLC. The Company is actively advancing both studies in China as planned.

About Uliledlimab
Uliledlimab (also known as TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine, in turn, binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in the tumor microenvironment. Uliledlimab is expected to offer clinical benefits by suppressing tumor growth in concert with checkpoint therapies such as PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties, as evident in preclinical and clinical studies.

Positive results from the Phase 1b/2 clinical study (NCT04322006) of uliledlimab in combination with toripalimab as first-line treatment for advanced non-small cell lung cancer (NSCLC) were presented at ASCO (Free ASCO Whitepaper) 2023: The combination therapy showed a 31% response rate in treatment-naïve NSCLC patients; notably, in patients with high CD73 expression and PD-L1 positivity, the response rate reached 63%. Biomarker analysis revealed a strong correlation between high tumor CD73 expression and treatment response, further supporting the potential of CD73 expression as a predictive biomarker. In September 2024, TJ Bio and Sanofi entered into strategic partnership for the development, manufacturing and commercialization of uliledlimab in Greater China.

Galmed Unveils Novel Pharmacodynamic Blood Markers for Aramchol, the Most Clinically Advanced SCD1 Inhibitor

On April 15, 2025 Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company dedicated to developing novel treatments for liver, cardiometabolic, and gastrointestinal oncology indications, reported the unveiling of novel pharmacodynamic (PD) blood markers for its lead compound, Aramchol, the industry’s most clinically advanced SCD1 inhibitor (Press release, Galmed Pharmaceuticals, APR 15, 2025, View Source,-the-Most-Clinically-Advanced-SCD1-Inhibitor [SID1234652231]). These newly identified biomarkers shed fresh light on Aramchol’s potential far beyond its role in NASH (MASH) therapy—offering a deeper understanding of the drug candidate’s biochemical impact and presenting an exciting opportunity to enhance clinical decision-making and expand into additional disease areas.

In collaboration with Proteas Health, a leader in innovative protein biomarker and targeted assay development, Galmed has pinpointed plasma markers that track Aramchol’s therapeutic impact through cutting-edge proteomics and AI technologies. Specifically, a panel of 70 proteins expressed at Week 12 of Aramchol treatment (compared with baseline) was captured in the Company’s Phase 3 ARMOR MASH study. This panel forms an actionable, single blood-based pharmacodynamic signature to monitor and potentially predict patient response, encompassing both systemic and local (liver) effects.

Galmed’s analysis revealed that this signature aligns with reduced chronic systemic inflammation, oxidative stress, and atherosclerotic plaque pathogenesis—key drivers in cardiometabolic diseases. Significantly, the data also demonstrate a marked reduction in ANP (Atrial Natriuretic Peptide), widely recognized as an established clinical biomarker for heart failure and left ventricular dysfunction. Moreover, the findings indicate a stimulated expression of KDM4C, a protein known to play a role in repressing liver fibrosis. Altogether, these insights underscore Aramchol’s broad therapeutic relevance and create valuable opportunities for Galmed to expand its clinical pipeline and address additional cardiometabolic and potentially oncological indications.

Allen Baharaff, CEO of Galmed Pharmaceuticals commented: "The newly discovered markers showed significant expression in untreated patients at baseline and were reversed following treatment with Aramchol. These PD markers could serve as a liquid biopsy as an early indicator of Aramchol’s efficacy in clinical settings. Additionally, the observed significant effects on cardiometabolic biomarkers open future research avenues for Aramchol in CVD and related conditions".

The collaboration with Proteas Health aims to translate these discoveries into a streamlined, cost-efficient, high-throughput assay that directly measures Aramchol’s unique PD signature. Such an assay, once validated, could bolster Galmed’s forthcoming clinical trials by further de-risking development and allowing clinicians to evaluate drug response in real time.

"Through this collaboration, Proteas Health and Galmed aim to develop a cost-effective, high-throughput assay targeting Aramchol’s unique pharmacodynamic signature. This assay could play a pivotal role in Galmed’s future clinical trials, accelerating the efforts to bring Aramchol to market" said Dr. Antigoni Manousopoulou, MD, PhD, Co-Founder and Chief Scientific Officer at Proteas Health. "By focusing on targeted pharmacodynamic biomarkers, Proteas Health is not just enhancing drug development Proteas Health ensuring therapies are tailored to achieve maximum benefit with minimal risk."

These promising data underscore Galmed’s growing momentum: by combining innovative biomarker strategies with Aramchol’s safety and efficacy profile, the Company believes it is well-positioned to broaden its market reach and deliver significant value to patients and stakeholders alike. Given the global burden of cardiometabolic and fibro-inflammatory conditions, the ability to demonstrate and monitor Aramchol’s impact through a single blood test has the potential to transform future clinical development and create new horizons for commercialization.

Annual report [Section 13 and 15(d), not S-K Item 405]

On April 15, 2025 Vaccinex reported its annual report for the year 2024 (Filing, 3 mnth, DEC 31, Vaccinex, 2024, APR 15, 2025, View Source [SID1234652129]).