Norgine welcomes TGA registration in Australia of IFINWIL® (eflornithine) for adults and children diagnosed with high-risk neuroblastoma (HRNB)

On April 17, 2025 Norgine reported that the Australian Therapeutic Goods Administration (TGA) has approved the registration of IFINWIL (eflornithine) for the treatment of adults and paediatric patients with high-risk neuroblastoma (HRNB), who have responded to prior multiagent, multimodality therapy (Press release, Norgine, APR 16, 2025, View Source [SID1234651964]).

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Neuroblastoma Australia welcomed the news today:

"On behalf of all families of children impacted by neuroblastoma, we welcome the TGA’s decision to approve IFINWIL. We urgently need treatments for children diagnosed with neuroblastoma and this milestone marks a step in the right direction towards a better future for children and their families. We thank the Federal Government for taking action to ensure access and we look forward to continued support for children with aggressive cancers." said Lucy Jones, CEO Neuroblastoma Australia.

High Risk Neuroblastoma is a rare but aggressive form of cancer, predominantly affecting children and most commonly presenting in the first 5 years of life2. Each year in Australia, approximately 50 children are diagnosed with neuroblastoma, with about half of these cases being classified as high risk neuroblastoma3,4. Neuroblastoma originates in the body’s nerve cells (neuroblasts) and typically presents as a primary tumour in the adrenal glands5. It is considered an aggressive tumour because it often spreads to other parts of the body (metastasizes). In most cases, it has spread by the time it is diagnosed5.

"We are committed to improving the lives of children and their families living with high-risk neuroblastoma" said Gus Rudolph, General Manager, Norgine, Australia. "This rare childhood cancer has devastating consequences for those impacted and while more needs to be done to improve treatment outcomes, we would like to recognise the TGA for their work to-date on this approval. Norgine will continue to engage with the relevant stakeholders to bring IFINWIL to patients as quickly as possible."

"This approval, as part of the Project Orbis initiative, represents a vital step forward in ensuring access to innovative cancer treatments for patients around the world," said Dr. David Gillen, Chief Medical Officer, Norgine. "By working collaboratively with international regulatory partners, we are able to help bring promising therapies to paediatric patients sooner – a goal that is especially important when time is critical. We’re proud to support Project Orbis as we strive to expedite access to high-impact oncology medicines."

Receiving the TGA approval is an important milestone on the path to realising sustainable and equitable access. IFINWIL is not currently included on the PBS.

Please refer to the IFINWIL Consumer Medicines Information (CMI) for full safety information on risks, side effects and precautions including the risk of low red blood cells (anaemia), low neutrophils (blood cells that fight infection), low platelets (clotting cells), increase in liver enzymes, and hearing loss or problems balancing.1

Notes to Editors:

About IFINWIL

IFINWIL has been investigated for use as a post maintenance treatment for high-risk neuroblastoma (HRNB) in paediatric patients with no active disease (NAD) / no evidence of disease (NED) after first line multiagent, multimodality therapy.6 IFINWIL is a therapy that blocks an enzyme called ornithine decarboxylase (ODC) responsible for producing polyamines, which are important to tumour growth and development 7.

For more information on IFINWIL, find the CMI here: IFINWIL Consumer Medicine Information (CMI) or the Therapeutic Goods Administration at View Source or speak to your healthcare practitioner.

High-Risk Neuroblastoma (HRNB) Treatment Background

Children diagnosed with HRNB undergo an intense treatment regimen that still leaves them vulnerable to relapse and death.8 Although there have been some improvements in survival, children with high risk neuroblastoma still face a 30% chance of recurrence (relapse) within the first 5 years post maintenance, and have an extremely poor prognosis and low likelihood of long term survival9 (e.g. estimates as low as 15% of patients will live for five years after relapsing).10 Avoiding relapse is key to long-term survival, and until now, there have been no approved therapies for the post maintenance treatment period in major markets outside of the United States11.

About Project Orbis

Project Orbis is an initiative (since May 2019) of the US FDA Oncology Center of Excellence (OCE) and provides a framework for concurrent submission and collaborative review of innovative oncology products among international regulatory authorities. It was created with the overarching goal to speed worldwide patient access to innovative cancer therapies. Project Orbis is coordinated by the FDA, and its partners include United Kingdom Medicines and Healthcare Products regulatory Agency (UK MHRA), Australia Therapeutic Goods Administration (TGA), Canada (Health Canada), Singapore (Health Sciences Authority (HSA), Switzerland (Swissmedic), Brazil (Agência Nacional de Vigilância Sanitária (ANVISA), Israel (Ministry of Health).

In April 2024, Norgine submitted an application for approval of eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia, Switzerland and the United Kingdom. This milestone supports Norgine’s efforts to deliver patient access to eflornithine and bring a further treatment option in the field of paediatric oncology.

Oncotelic Therapeutics Reports FY 2024 Highlights and FY 2024 Earnings Compared to FY 2023

On April 16, 2025 Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a developer of treatments for rare and orphan indications, including Parkinson’s Disease, pancreatic ductal adenocarcinoma ("PDAC"), diffuse intrinsic pontine glioma ("DIPG"), and various other cancers, reported its financial results for the fiscal year ended December 31, 2024 ("FY 2024"), as compared to the fiscal year ended December 31, 2023 ("FY 2023") (Press release, Oncotelic, APR 16, 2025, View Source [SID1234651963]). The financial results are based on the Annual Report on Form 10-K ("Form 10-K") as filed with the Securities and Exchange Commission ("SEC") on April 15, 2025.

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Highlights for FY 2024 and thereafter:

2024 has been a transformational year for us. We made great progress on multiple fronts and this momentum continues in 2025. We individually discuss each of these areas below:

San Diego Facility

Our joint venture ("JV"), GPM Biotechnology Limited, with Dragon Capital Overseas Limited has continued the development of its nanoparticle pipeline at its facility in San Diego ("Facility") since late 2023 / early 2024. In late 2024, just over a year after breaking ground, the Facility became good manufacturing practices certified and was issued a Drug Manufacturing License by the State of California Department of Public Health and Food and Drug Branch. The Facility is planned to primarily manufacture our drug product, including the clinical trial materials, for the clinical programs for each of our compounds.

Nanoparticle Platform

At the Facility, the JV initially identified 5 compounds, including OT-101, for development as nanoparticles. Subsequently, the JV identified an additional compound, bringing the total to 5 new compounds, not including OT-101. Each of the nanoparticle compounds is designed as a next-generation anticancer agents. We believe that each of these new compounds can potentially lead to significant revenue and value for the JV, which in turn could lead to significant value to the Company due to our investment in the JV. Two of the 6 compounds are in late stages of manufacturing, and the Company plans to file INDs for both before the end of the year. Our proprietary nanoparticle platform enables the development of multiple therapeutic candidates, to address various oncology indications.

Investigational New Drug Filing Platform with Shanghai Medicilon

We recently announced that we entered into an agreement to utilize the proprietary rapid investigational new drug ("IND") platform created and owned by Shanghai Medicilon Inc. ("Medicilon") to file up to 20 new INDs. We, and the JV, plan to utilize it to file the 6 compounds identified utilizing the Medicilon IND platform, among and upto 20 total filings.

OT-101 Clinical Program

The primary candidate of our JV, OT-101, which has previously completed multiple clinical trials, is currently undergoing a Phase 3 trial in pancreatic cancer. OT-101 also completed a phase 1 combination trial with IL-2. This will allow us to pursue OT-101 in combination with various checkpoint inhibitors, such as PD-1 blockers.

Artificial Intelligence Platform

Our artificial intelligence ("AI") team has played an increasingly important role in the development of the Company and the Facility. Our proprietary AI technology has been used by our scientists in writing research papers, development reports, and regulatory documents from the data gathered from our Facility and elsewhere. As announced in December 2024, we are leveraging our AI Platform, "PDAOAI", to allow third party researchers and individuals to utilize our platform in their workflow. Unlike standard AI tools, PDAOAI is specifically designed for pharmaceutical regulatory processes and research documentation, streamlining workflows and potentially accelerating development timelines.

Results of Operations

Below is a presentation of our financial results comparing FY 2024 to FY 2023, and are based on our results published in our Form 10-K filed with the SEC on April 15, 2025.

FY 2024 compared to FY 2023 Financial Results Overview

ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS

For the Year Ended December 31,
2024 2023
Service Revenue $ - $ 70,000
Total Revenue - 70,000
Operating expenses:
Research and development $ - $ 61,143
General and administrative 376,013 573,726
Goodwill impairment (See note 2 and 3) 3,200,000 6,083,146
Total operating expenses 3,576,013 6,718,015
Income/(Loss) from operations (3,576,013 ) (6,648,015 )
Other income (expense):
Interest expense, net (857,723 ) (1,044,786 )
Reimbursement for expenses – related party 22,937 72,246
Change in fair value of investment in GMP Bio - 12,706
Change in fair value of derivative on debt (280,402 ) (225,074 )
Loss on debt conversion (88,258 ) (373,142 )
Total other income (expense) (1,203,446 ) (1,558,050 )
Net income (loss) before non-controlling interests (4,779,459 ) (8,206,065 )
Net loss attributable to non-controlling interests (255,527 ) (302,972 )
Net income (loss) attributable to Oncotelic Therapeutics, Inc. $ (4,523,932 ) $ (7,903,093 )
Basic net loss per share attributable to common stock $ (0.01 ) $ (0.02 )
Basic weighted average common stock outstanding 404,396,473 384,075,369

We incurred a lower net loss per basic share of $0.01 for the year ended December 31, 2024 as compared to net loss per basic share of $0.02 for the year ended December 31, 2023. We incurred a significantly lower net loss of approximately $3.4 million between December 31, 2024 and 2023, respectively. The lower net loss was primarily due to lower impairment of goodwill by approximately $2.9 million, lower general and administrative expenses of approximately $0.2 million and lower other expenses, including interest cost, or approximately $0.3 million. All operational costs associated with OT-101 and the nanoparticle platform are substantially covered by the JV, significantly reducing our direct financial burden till such time we make a determination to commence development of our own compounds.

"Our JV is growing rapidly and is moving towards a potential initial public offering, the timing of which is under evaluation. The JV’s product portfolio has the potential to generate significant revenues and value for itself and, consequently, the Company and its shareholders due to our ownership in the JV. That has been the plan for the Company, since we entered into the JV. As reported in our Form 10-K, while we believe that the valuation of the JV has increased, we have opted to revise the fair value of our investment in the JV only upon a triggering event occurring, and justifying the revision to our fair value, such as, but not limited to, a financing, licensing, an IPO, or results of late stage clinical trials such as our Phase 3 pancreatic cancer trial", said Amit Shah, CFO for Oncotelic.

New Preclinical Data on BTX-A51 in Liposarcoma Models to be Highlighted at AACR Annual Meeting 2025

On April 16, 2025 Edgewood Oncology, a clinical-stage biotechnology company focused on delivering BTX-A51 to patients with hematologic malignancies and genetically-defined solid tumors, reported the upcoming presentation of new preclinical data from studies of BTX-A51 in human liposarcoma conducted by Dana-Farber Cancer Institute and Hebrew University-Hadassah Medical School (Press release, Edgewood Oncology, APR 16, 2025, View Source [SID1234651959]). These data will be featured in poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, taking place April 25-30, 2025 in Chicago, Illinois.

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The presentations will showcase the therapeutic potential of BTX-A51, a first-in-class dual inhibitor of casein kinase 1 alpha (CK1a) and cyclin-dependent kinases 7 and 9 (CDK7/9), in preclinical models of human liposarcoma and CIC-rearranged sarcoma—a rare and aggressive cancer that tends to affect pediatric and younger adult patients.

Presentation Details:

Poster 1:

Title: Therapeutic Potential of Combined Targeting of Casein Kinase 1 alpha (CK1 alpha) and CDK7/9 with the Inhibitor BTX-A51 in Human Liposarcomas

Session Category: Experimental and Molecular Therapeutics
Session Title: Identification of Molecular Targets 1
Date and Time: Monday, April 28, 2025 | 2:00 PM – 5:00 PM CT
Location: Poster Section 19 | Board Number: 10
Abstract Number: 2980

These data support the ongoing phase 1 study of BTX-A51 in patients with advanced MDM2-amplified liposarcoma. Additional details about the study can be found at clinicaltrials.gov under the identifier NCT06414434.

Poster 2:

Title: Preclinical efficacy of the CK1 alpha/CDK7/CDK9 inhibitor BTX-A51 in CIC-rearranged sarcoma

Session Category: Experimental and Molecular Therapeutics
Session Title: Protein Kinases and Phosphatases as Targets for Therapy
Date and Time: Wednesday, April 30, 2025 | 9:00 AM – 12:00 PM CT
Location: Poster Section 24 | Board Number: 3
Abstract Number: 6941

Akari Therapeutics Reports Full Year 2024 Financial Results and Provides Corporate Update

On April 16, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), a biotechnology company developing next-generation precision bi-functional antibody drug conjugates (ADC) for the treatment of cancer, reported its financial results for the fiscal year ended December 31, 2024 and provided a corporate update (Press release, Akari Therapeutics, APR 16, 2025, View Source [SID1234651955]).

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"2024 was a transformational year for Akari with the successful completion of our merger with Peak Bio Inc., and renewed focus on advancing our next-generation precision ADC pipeline candidates," commented Samir R. Patel, M.D., President and Chief Executive Officer of Akari Therapeutics. "Looking ahead, we have made strategic leadership appointments with key skillsets to continue setting the Company up for success. We recently announced the appointment of Abizer Gaslightwala, a seasoned oncology executive with an impressive track record, who will serve as Akari’s President and Chief Executive Officer, effective April 21, 2025. I believe with our innovative platform technology and preclinical data demonstrated to date, Akari is well-positioned to become a key player in the ADC space and capitalize on the significant deal-flow seen in early ADC development. We look forward to an exciting year ahead and remain focused on the successful execution of our capital-efficient development strategies."

Program Highlights

Following the completed merger with Peak Bio, Inc. in November 2024, Akari has focused its efforts on the discovery, research and development of novel anti-cancer payloads with mechanisms of action that differ from currently approved ADC therapies and the application of those payloads against clinically validated targets. Leveraging its platform, the Company is advancing a pipeline of potentially first-in-class, best-in-class ADC candidates that are designed to target and kill cancer cells and stimulate the immune system, or bifunctional ADCs, all while potentially overcoming the limitations inherent in existing therapies.

Lead Candidate: AKTX-101 (TROP2 PH1 ADC) – Novel Payload is a Spliceosome Inhibitor With Multiple Anti-Tumor Mechanisms


Potential to overcome shortcomings of current ADCs

Immunostimulatory effects

Reduced off-target toxicity

Overcomes resistance mechanisms

Potential for synergy with immunotherapies


Significant advantages over current TROP2 ADCs observed in multiple preclinical models:
o
Superior activity
o
Prolonged survival
o
Less resistance
o
Better tolerability
o
Prolonged survival in combination with checkpoint inhibitors (CPI)

Upcoming Expected Value-Driving Milestones

Next-Generation Precision Bi-Functional ADC Platform


Present anticipated PH1 Payload preclinical data at scientific conference

Complete additional preclinical studies for AKTX-101


Continue to advance pipeline by generating additional validating data on PH1 payload while advancing discovery work on additional novel payloads PH5 and PH6

Round out Executive Team with critical hires

Seek licensing/strategic partner for AKTX-101 (TROP2 PH1 ADC)

Legacy Pipeline Assets


Continue Business Development efforts to secure development partners and provide non-dilutive capital

Summary of Financial Results for Full Year 2024

The net loss from operations for the year ended December 31, 2024 was approximately $21.6 million compared to approximately $16.8 million for the comparable period in 2023. The increase in net loss from operations is primarily attributable to merger related costs of $3.3 million, restructuring costs of $1.7 million and an increase in research and development expenses of $1.5 million which was offset by a reduction in general and administrative expenses of $1.7 million.

The Company reported research and development expenses of $7.0 million for the year ended December 31, 2024 compared to approximately $5.5 million for the comparable period in 2023.

General and administrative expenses were approximately $9.7 million for the year ended December 31, 2024 compared to approximately $11.4 million for the year ended December 31, 2023.

As of December 31, 2024, the Company had cash of approximately $2.6 million. Management anticipates that its cash on hand as of December 31, 2024 including the net proceeds from the private placement of $6.6 million announced in March 2025, is sufficient to fund operations into September 2025.

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.