Boston Scientific announces results for fourth quarter and full year 2024

On February 5, 2025 Boston Scientific Corporation (NYSE: BSX) reported net sales of $4.561 billion during the fourth quarter of 2024, growing 22.4 percent on a reported basis, 23.1 percent on an operational1 basis and 19.5 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, FEB 5, 2025, View Source [SID1234650066]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $566 million or $0.38 per share (EPS), compared to $504 million or $0.34 per share a year ago and achieved adjusted3 EPS of $0.70 for the period, compared to $0.55 a year ago.

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For the full year 2024, the company generated net sales of $16.747 billion, growing 17.6 percent on a reported basis, 18.5 percent on an operational1 basis and 16.4 percent on an organic2 basis. The company reported GAAP net income attributable to Boston Scientific common stockholders of $1.853 billion or $1.25 per share, compared to $1.570 billion or $1.07 per share a year ago, and delivered full year adjusted3 EPS of $2.51, compared to $2.05 a year ago.

"2024 was one of the best years in the history of Boston Scientific, fueled by our innovative portfolio, the launch of our FARAPULSE Pulsed Field Ablation System as well as significant clinical achievements and commercial excellence across businesses and regions," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We have a strong foundation for growth, and I am incredibly grateful for our talented global team and the opportunity to continue transforming the lives of millions of patients around the world."

Fourth quarter financial results and recent developments:

Reported net sales of $4.561 billion, representing an increase of 22.4 percent on a reported basis, compared to the company’s guidance range of 16.5 to 18.5 percent; 23.1 percent on an operational basis; and 19.5 percent on an organic basis, compared to the company’s guidance range of 14 to 16 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.38 per share, compared to the company’s guidance range of $0.41 to $0.43 per share, and achieved adjusted EPS of $0.70 per share, compared to the guidance range of $0.64 to $0.66 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 12.4 percent reported, 13.0 percent operational and 7.0 percent organic
Cardiovascular: 28.8 percent reported, 29.5 percent operational and 27.4 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 30.7 percent reported and operational
Europe, Middle East and Africa (EMEA): 10.8 percent reported and 11.6 percent operational
Asia-Pacific (APAC): 11.1 percent reported and 12.4 percent operational
Latin America and Canada (LACA): 4.6 percent reported and 12.6 percent operational
Emerging Markets4: 12.4 percent reported and 15.2 percent operational

Presented positive 36-month primary endpoint findings from the OPTION clinical trial at the American Heart Association Scientific Sessions demonstrating superior bleeding risk reduction and similar efficacy with the WATCHMAN FLX Left Atrial Appendage Closure Device compared to oral anticoagulation in high-risk patients with atrial fibrillation (AF) post ablation, followed by a late-breaking sub-analysis at AF Symposium 2025 reaffirming positive outcomes with the device in both concomitant and sequential procedures.

Presented positive 12-month primary endpoint findings from phase one of the ADVANTAGE AF clinical trial at AF Symposium 2025 that achieved the safety and effectiveness endpoints for the treatment of patients with persistent AF with the FARAPULSE Pulsed Field Ablation System.

Received U.S. Centers for Medicare & Medicaid Services approval of a new transitional pass-through payment for the AGENT Drug-Coated Balloon effective Jan. 1, 2025, which offers facilities additional reimbursement for outpatient procedures.

Received both U.S. Food and Drug Administration (FDA) approval and CE mark for the Vercise Cartesia X and HX Directional Leads, the first and only 16-contact directional leads designed for more precise targeting for enhanced clinical outcomes using the Vercise Genus Deep Brain Stimulation System.

Completed the acquisition of Axonics, Inc., an innovative medical technology company focused on the development and commercialization of differentiated devices for the treatment of urinary and bowel dysfunction.

Announced and completed the acquisition of Cortex, Inc., a privately held medical technology company focused on the development of a diagnostic mapping solution which aims to identify triggers and drivers outside of the pulmonary veins that are foundational to AF.

Announced agreements to acquire the following companies, subject to customary closing conditions:
Bolt Medical, Inc., a developer of an intravascular lithotripsy advanced laser-based platform for the treatment of coronary and peripheral artery disease which is pending U.S. FDA approval.
Intera Oncology Inc., a medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine, a chemotherapy drug.
1 Operational net sales growth excludes the impact of foreign currency fluctuations.

2 Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales.

3 Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union Medical Device Regulation (EU MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.

4 Periodically, we assess our list of Emerging Markets countries, and effective January 1, 2023, modified our list to include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.

Fourth quarter net sales by business and region:

Increase/(Decrease)

Three Months Ended
December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

Impact of
Recent
Acquisitions/
Divestitures

Organic
Basis

(in millions)

2024

2023

Endoscopy

$ 690

$ 645

7.0 %

0.6 %

7.6 %

(0.7) %

7.0 %

Urology

630

527

19.5 %

0.5 %

20.1 %

(12.2) %

7.9 %

Neuromodulation

299

269

11.4 %

0.5 %

11.9 %

(6.4) %

5.5 %

MedSurg

1,619

1,441

12.4 %

0.6 %

13.0 %

(6.0) %

7.0 %

Cardiology

2,297

1,751

31.1 %

0.8 %

31.9 %

— %

31.9 %

Peripheral Interventions

645

533

21.0 %

0.8 %

21.7 %

(9.2) %

12.5 %

Cardiovascular

2,942

2,285

28.8 %

0.8 %

29.5 %

(2.2) %

27.4 %

Net Sales

$ 4,561

$ 3,725

22.4 %

0.7 %

23.1 %

(3.6) %

19.5 %

Increase/(Decrease)

Three Months Ended
December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

(in millions)

2024

2023

U.S.

$ 2,893

$ 2,213

30.7 %

— %

30.7 %

EMEA

830

749

10.8 %

0.9 %

11.6 %

APAC

684

616

11.1 %

1.2 %

12.4 %

LACA

155

148

4.6 %

8.0 %

12.6 %

Net Sales

$ 4,561

$ 3,725

22.4 %

0.7 %

23.1 %

Emerging Markets4

$ 668

$ 595

12.4 %

2.8 %

15.2 %

Amounts may not foot due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of acquisitions/divestitures are not prepared in
accordance with GAAP.

Full year net sales by business and region:

Increase/(Decrease)

Year Ended

December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

Impact of
Recent
Acquisitions /
Divestitures

Organic
Basis

(in millions)

2024

2023

Endoscopy

$ 2,687

$ 2,482

8.3 %

0.6 %

8.9 %

(1.0) %

8.0 %

Urology

2,200

1,964

12.0 %

0.5 %

12.5 %

(3.3) %

9.3 %

Neuromodulation

1,106

976

13.3 %

0.4 %

13.7 %

(11.0) %

2.7 %

MedSurg

5,993

5,422

10.5 %

0.6 %

11.1 %

(3.6) %

7.5 %

Cardiology

8,344

6,709

24.4 %

1.0 %

25.4 %

— %

25.4 %

Peripheral Interventions

2,410

2,110

14.2 %

1.2 %

15.5 %

(4.6) %

10.9 %

Cardiovascular

10,755

8,819

22.0 %

1.1 %

23.0 %

(1.1) %

21.9 %

Net Sales

$ 16,747

$ 14,240

17.6 %

0.9 %

18.5 %

(2.1) %

16.4 %

Increase/(Decrease)

Year Ended

December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

(in millions)

2024

2023

U.S.

$ 10,210

$ 8,425

21.2 %

— %

21.2 %

EMEA

3,228

2,856

13.0 %

0.8 %

13.8 %

APAC

2,686

2,400

11.9 %

3.7 %

15.7 %

LACA

624

560

11.4 %

2.6 %

14.1 %

Net Sales

$ 16,747

$ 14,240

17.6 %

0.9 %

18.5 %

Emerging Markets4

$ 2,680

$ 2,310

16.1 %

3.6 %

19.6 %

Amounts may not foot due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of acquisitions/divestitures are not prepared in
accordance with U.S. GAAP.

Guidance for Full Year and First Quarter 2025

The company estimates net sales growth for the full year 2025, versus the prior year period, to be in a range of approximately 12.5 to 14.5 percent on a reported basis, and approximately 10 to 12 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $1.86 to $1.93 and estimates adjusted EPS, excluding certain charges (credits), of $2.80 to $2.87.

The company estimates net sales growth for the first quarter of 2025, versus the prior year period, to be in a range of approximately 17 to 19 percent on a reported basis, and approximately 14 to 16 percent on an organic basis. First quarter organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $0.43 to $0.45 and estimates adjusted EPS, excluding certain charges (credits), of $0.66 to $0.68.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: investors.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

Cellectar Biosciences to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference

On February 5, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that members of its management team will present an overview of the company at the upcoming Oppenheimer 35th Annual Healthcare Life Sciences Conference being held virtually (Press release, Cellectar Biosciences, FEB 5, 2025, View Source [SID1234650051]). Details are as follows:

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Date: Wednesday, February 12, 2025
Time: 12:00 PM Eastern Time
Webcast: Click HERE

A replay of the corporate presentation will be available on the Events section of the company’s investor relations website.

Carisma Therapeutics to Participate in Oppenheimer 35th Annual Healthcare Life Sciences Conference

On February 5, 2025 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a leader in macrophage-focused therapeutics, reported that Steven Kelly, President and Chief Executive Officer, will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Tuesday, February 11 at 4:40 pm ET (Press release, Carisma Therapeutics, FEB 5, 2025, View Source [SID1234650067]).

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An audio webcast of the event will be available on the Company’s Investor Events section of the Investor Relations webpage and will be archived for a limited time following the event.

US Patent Granted Titled: Bifunctional Compositions for the Treatment of Cancer

On February 5, 2025 Armaceutica reported US patent granted titled: Bifunctional Compositions for the Treatment of Cancer (Press release, Armaceutica, FEB 5, 2025, View Source [SID1234650068]). This drug, which is often used to treat malaria, is being repurposed by Armaceutica, Inc. to treat various types of cancer.

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Renato Aguilera, Ph.D. and Biology Professor and cancer researcher at the University of Texas at El Paso, published data demonstrating that the drug (pyronaridine, or PND) kills various types of cancer cells.3

Pyronaridine was shown to preferentially kill certain types of leukemia, lymphoma, melanoma, multiple myeloma, lung, ovarian, and breast cancer cells while limiting off-target toxicities in normal, healthy cells.3 That is, pyronaridine had reduced effects on non-cancerous cells with a favorable selective cytotoxicity index (SCI), as compared with cancerous cells.3

Dr. Aguilera’s studies revealed that pyronaridine inhibits the activity of a critical enzyme (topoisomerase II) required for DNA replication and cancer cell division.4

Studies on mice with metastatic human breast cancer showed the group that received pyronaridine had smaller tumor volumes (P<0.0001) and increased longevity than control mice.4 A study on dogs with cancer showed pyronaridine reduced tumor volumes and increased longevity.1 In one case a lymphoma tumor shrunk by 70%.1 A pilot study on terminally-ill humans with late-stage cancers of the breast, lung and liver; pyronaridine appears to have increased longevity.1

The company’s CEO, Ernest Armstrong, said: "Pyronaridine represents a disruptive breakthrough relative to other cancer therapies. Pyronaridine has been proven safe and effective for malaria in at least four phase 3 studies and is an approved drug in parts of Asia and Africa." 2

Patent offices in Australia, Canada, EU, Israel, Japan, Malaysia, Mexico, Philippines, Russia, Thailand and the UK have granted patents corresponding to U S Patent No.: 12,201,626.

If you or a loved one has ever been treated with chemotherapy, you’ll understand how devastating the side effects can be.

Dr. Aguilera stated: "If the drug were available in the US and approved as an anti-cancer treatment, I would take it in an instant, if I came down with cancer."

Armaceutica, Inc. is a US-based pharmaceutical company focused on low-toxicity cancer treatments. Armaceutica is seeking a partner to develop pyronaridine into an approved drug for cancer, a process that will take several years.

References: 1US Patent No.: 12,201,626, Jan. 21, 2025. 2Croft et al., Malaria Journal 2012, 11:270. 3 Villanueva PJ, et al., PLOS One, 5 Nov 2018, 13(11):e0206467. 4 Villanueva PJ, et al., Clinical Cancer Drugs 2021, 8:50-56.

FDA Accepts Integral Molecular’s Membrane Proteome Array™ Qualification Plan, Advancing the Platform for Approval as a Drug Development Tool

On February 5, 2025 Integral Molecular, a leader in antibody discovery technologies, reported that the FDA has accepted their Membrane Proteome Array (MPA) Qualification Plan for advancement as a Drug Development Tool (DDT) to assess antibody binding specificity (Press release, Integral Molecular, FEB 5, 2025, View Source [SID1234650053]). Antibody drug developers already routinely include MPA data in regulatory packages, and qualification as a DDT will allow them to further rely on the MPA in the approval process. Integral Molecular’s MPA is the industry-leading technology for antibody specificity testing and is the only specificity platform under FDA consideration as a DDT.

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Learn more about the Membrane Proteome Array, and how it enables the precise identification of off-target binding interactions

Non-specific drug binding is a significant cause of adverse events in patients that can lead to severe complications or even death, and early specificity testing can de-risk drug development and enhance patient safety. Recent research has demonstrated that up to one-third of antibody drugs exhibit non-specific binding to unintended targets.

The MPA assesses binding across ~6,000 structurally intact membrane proteins and is the only platform of its kind that screens membrane proteins in their native conformation. The MPA has been used to screen over 2,000 preclinical antibody therapeutics for customers worldwide, and MPA specificity data has been accepted by regulatory bodies globally, including the FDA, EMA, and NMPA.

"This milestone towards MPA qualification reflects the continued dedication of our team to set a new standard in testing antibody drug specificity. Our continued improvements to the MPA—including statistical analyses, bioinformatic comparisons, and enhanced quality systems—have been critical to our qualification plan and have supported ISO 9001 certification of our processes. We thank the FDA for their confidence in our approach and commitment to advancing the safety of biologics."

-Benjamin Doranz, CEO, Integral Molecular

The MPA is progressing toward DDT qualification under the FDA’s ISTAND Pilot Program, which promotes Innovative Science and Technology Approaches for New Drugs. As part of this process, Integral Molecular has been invited to submit a Full Qualification Plan (FQP) for the MPA, which is the final step in achieving DDT status.