On July 23, 2025 Boston Scientific Corporation (NYSE: BSX) reported net sales of $5.061 billion during the second quarter of 2025, growing 22.8 percent on a reported basis, 21.6 percent on an operational1 basis and 17.4 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, JUL 23, 2025, View Source [SID1234654479]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $797 million or $0.53 per share (EPS), compared to $324 million or $0.22 per share a year ago, and achieved adjusted3 EPS of $0.75 for the period, compared to $0.62 a year ago.

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"This was another excellent quarter — marked by exceptional top-line performance — that delivered margin expansion and prioritized investment for future growth," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I am incredibly grateful to our dedicated global team for demonstrating clinical and commercial excellence across the company and positioning us for differentiated long-term performance."

Second quarter financial results and recent developments:

Reported net sales of $5.061 billion, representing an increase of 22.8 percent on a reported basis, compared to the company’s guidance range of 17.5 to 19.5 percent; 21.6 percent on an operational basis; and 17.4 percent on an organic basis, compared to the company’s guidance range of 13 to 15 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.53 per share, compared to the company’s guidance range of $0.45 to $0.47 per share, and achieved adjusted EPS of $0.75 per share, compared to the guidance range of $0.71 to $0.73 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 15.7 percent reported, 14.7 percent operational and 7.0 percent organic
Cardiovascular: 26.8 percent reported, 25.5 percent operational and 23.2 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): 6.8 percent reported and 1.8 percent operational
Asia-Pacific (APAC): 18.0 percent reported and 15.4 percent operational
Latin America and Canada (LACA): 4.0 percent reported and 8.9 percent operational
Emerging Markets4: 11.6 percent reported and 12.1 percent operational

Received U.S. Food and Drug Administration approval to expand instructions for use labeling to include the treatment of drug refractory, symptomatic persistent atrial fibrillation (AF) with the FARAPULSE Pulsed Field Ablation (PFA) System.

Commenced enrollment in the ReMATCH IDE clinical trial to evaluate the safety and effectiveness of the FARAWAVE and FARAPOINT PFA Catheters in patients with persistent AF who previously received a cardiac ablation and experienced a recurrence of the condition.5

Received CE mark for the WATCHMAN FLX Pro Left Atrial Appendage Closure Device, which is optimized for healing and designed to improve visualization during device placement and treat a broader range of patient anatomies.

Completed the acquisition of Intera Oncology Inc., a medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine, a chemotherapy drug.

Completed the acquisition of SoniVie Ltd., the developer of the TIVUS Intravascular Ultrasound System, an investigational renal nerve denervation technology designed to treat hypertension.5
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 certain 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 (EU) Medical Device Regulation (MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.

4. Our Emerging Markets countries include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.

5. The FARAPOINT PFA Catheter and the TIVUS Intravascular Ultrasound System are investigational devices. Restricted by Federal law to investigational use only. Not available for sale in the U.S.

Net sales for the second quarter by business and region:

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Increase/(Decrease)

Three Months Ended
June 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

Impact of
Certain
Acquisitions/
Divestitures

Organic
Basis

(in millions)

2025

2024

Endoscopy

$ 737

$ 676

9.1 %

(1.3) %

7.8 %

— %

7.8 %

Urology

676

525

28.9 %

(0.8) %

28.0 %

(21.7) %

6.3 %

Neuromodulation

303

282

7.2 %

(0.6) %

6.6 %

— %

6.6 %

MedSurg

1,716

1,483

15.7 %

(1.0) %

14.7 %

(7.7) %

7.0 %

Cardiology

2,647

2,047

29.3 %

(1.4) %

27.9 %

— %

27.9 %

Peripheral Interventions

698

590

18.3 %

(1.1) %

17.1 %

(10.2) %

7.0 %

Cardiovascular

3,345

2,637

26.8 %

(1.3) %

25.5 %

(2.3) %

23.2 %

Net Sales

$ 5,061

$ 4,120

22.8 %

(1.2) %

21.6 %

(4.2) %

17.4 %

Increase/(Decrease)

Three Months Ended

June 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2025

2024

U.S.

$ 3,224

$ 2,466

30.7 %

— %

30.7 %

EMEA

878

822

6.8 %

(5.0) %

1.8 %

APAC

790

670

18.0 %

(2.6) %

15.4 %

LACA

169

162

4.0 %

4.9 %

8.9 %

Net Sales

$ 5,061

$ 4,120

22.8 %

(1.2) %

21.6 %

‌

Emerging Markets4

$ 758

$ 680

11.6 %

0.5 %

12.1 %

Amounts may not add 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 certain acquisitions/divestitures are not prepared in accordance with U.S. GAAP.

Guidance for Full Year and Third Quarter 2025

The company estimates net sales growth for the full year 2025, versus the prior year period, to be approximately 18 to 19 percent on a reported basis and 14 to 15 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to certain 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 $1.89 to $1.93 and estimates adjusted EPS, excluding certain charges (credits), of $2.95 to $2.99.

The company estimates net sales growth for the third quarter of 2025, versus the prior year period, to be in a range of approximately 17 to 19 percent on a reported basis, and 12 to 14 percent on an organic basis. Third quarter organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to certain 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 $0.44 to $0.46 and estimates adjusted EPS, excluding certain charges (credits), of $0.70 to $0.72.

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.

On July 22, 2025 SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory and infectious diseases, reported detailed results from a Danish validation study, published in the Journal of Surgical Oncology (Press release, SkylineDx, JUL 22, 2025, View Source [SID1234654477]). The study demonstrates that SkylineDx’s Merlin Assay (CP-GEP) can identify cutaneous melanoma patients, in particular pT1 and pT2 patients, that have a low risk for nodal metastasis and therefore may forgo Sentinel lymph node biopsy (SLNB) surgery. Merlin is a genomic test to guide treatment decisions in early-stage melanoma.

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In the independent blinded multicenter study, primary cutaneous melanoma tissue from a cohort of 536 newly diagnosed pT1-pT3 melanoma patients who had undergone SLNB between 2010 and 2015 was collected and analyzed with CP-GEP. Merlin’s outcome labels were compared to patients’ sentinel lymph node status and a nomogram that is widely used on an international basis for SLN metastasis risk.

Key findings of the study include:

The potential SLNB reduction rate was highest for the pT1-subgroup at 72.7% (NPV 94.5%) In pT1-pT3 melanoma, 41% of patients were classified as CP-GEP Low-Risk and could have forgone SLNB surgery, which is in line with previous validation studies.
Comparison with an internationally recognized nomogram showed that CP-GEP would result in a notably larger SLNB reduction rate compared to the internationally recognized nomogram (44.2% vs. 7.8%) particularly for T1- T3 patients.
"The Merlin test is a promising and well-validated non-invasive tool for refining SLNB selection, with consistent findings across several independent cohorts," said First Author Dr. Marie B.-M. Weitemeyer from Copenhagen University Hospital-Herlev and Gentofte. "In our Danish cohort, Merlin demonstrated the potential to reduce unnecessary SLNB procedures by more than 40%."

"Merlin performance is consistent with previous study cohorts," said SkylineDx Chief Scientific Officer, Jvalini Dwarkasing, PhD. "Compared to the internationally recognized nomogram, CP-GEP demonstrated a significantly higher SLNB reduction rate while maintaining a high NPV, underscoring its potential for greater clinical benefit."

SLNB is the gold standard in staging primary melanoma patients. According to current guidelines, patients with pT1b melanoma and higher may be eligible for SLNB surgery. However, approximately 85% of these patients will not show SLN metastasis while undergoing this invasive procedure, under general anesthesia, with the risk of potential surgical complications. Also, SLNB poses a substantial burden on healthcare resources. Therefore, tools are warranted beyond clinical guidelines to stratify patients based on their risk of nodal metastasis. SkylineDx’s CP-GEP is currently the only GEP-based prediction tool specifically developed to identify melanoma patients at low risk of SLN metastasis.

About the Merlin Assay (CP-GEP)

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assign them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention and screening guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. The test has been launched in the United States and Europe as Merlin. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com.

On July 22, 2025 Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., reported the presentation of new data from zipalertinib REZILIENT1 and REZILIENT2 trials at the International Association of the Study of Lung Cancer’s (IASLC) 2025 World Conference on Lung Cancer (WCLC), to be held September 6-9, 2025, in Barcelona, Spain (Press release, Taiho, JUL 22, 2025, View Source [SID1234654476]).

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The abstracts accepted for mini oral presentations include updated efficacy and safety data from the Phase 2b REZILIENT1 trial, focusing on patients with EGFR ex20ins NSCLC previously treated with amivantamab, as well as the preliminary efficacy and safety results from the Phase 2 parallel cohort REZILIENT2 trial in patients with advanced or metastatic NSCLC harboring uncommon non-ex20ins EGFR mutations.

"Previously, zipalertinib has demonstrated clinical activity against ex20ins and preclinical activity against uncommon, non-ex20ins EGFR-mutant NSCLC," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We look forward to sharing updated data from the REZILIENT1 and REZILIENT2 trials at the upcoming 2025 World Conference on Lung Cancer, suggesting the potential for zipalertinib to make a meaningful difference in the lives of patients with certain types of NSCLC."

"Despite advances in the treatment landscape, there remains significant unmet need for NSCLC patients with EGFR exon 20 insertion mutations and for those with uncommon non-ex20ins EGFR mutations," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "Taken together, the updated results from REZILIENT1 and new data from the REZILIENT2 study highlight the potential of zipalertinib to play an important role in the evolving treatment landscape for patients with NSCLC harboring less common EGFR mutations."

Session titles and information for the two abstracts are listed below. Full abstract details will be available via the conference website at 1 p.m. EDT August 13, 2025.

Title: Zipalertinib in NSCLC Patients (Pts) With EGFR Exon 20 Insertion (Ex20Ins) Mutations Who Received Prior Amivantamab
Session Name: MA08 – Common and Uncommon EGFR Mutations, New Treatments in the Horizon
Session Type: Mini Oral Presentation
Session Date: Tuesday, September 9, 2025
Session Time: 11:30 a.m. – 12:45 p.m. CEST
Presenter: Zofia Piotrowska, MD

Title: Phase 2 Interim Results of Zipalertinib in Patients With NSCLC Harboring Uncommon Non-Exon 20 Insertion EGFR Mutations
Session Name: MA08 – Common and Uncommon EGFR Mutations, New Treatments in the Horizon
Session Type: Mini Oral Presentation
Session Date: Tuesday, September 9, 2025
Session Time: 11:30 a.m. – 12:45 p.m. CEST
Presenter: Hibiki Udagawa, MD, PhD

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

On July 22, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved ADC cancer treatments, reported that the Company’s management will participate in the BTIG Virtual Biotechnology Conference being held on July 29-30, 2025 (Press release, Whitehawk Therapeutics, JUL 22, 2025, View Source [SID1234654475]).

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On July 22, 2025 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported that the first patient has been dosed in its Phase 2 clinical trial evaluating DOC1021, an investigational patient-derived double-loaded dendritic cell therapy for glioblastoma (GBM), a highly aggressive primary brain tumor (Press release, Diakonos Oncology, JUL 22, 2025, View Source [SID1234654474]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The first patient was dosed at City of Hope’s main campus in Los Angeles, California. City of Hope is one of the largest and most advanced cancer research and treatment organizations in the U.S. with its National Medical Center named top 5 in the nation for cancer by U.S. News & World Report.

"City of Hope leads groundbreaking clinical research that has resulted in therapies like CAR T cell immunotherapy and novel drug discoveries – new treatments that are addressing even the most challenging cancers. Glioblastoma is an aggressive tumor that is difficult to treat because the tumors often are resistant to existing treatments. We need to create more effective therapies for this deadly disease," said Jana Portnow, M.D., City of Hope medical oncologist and co-director of its Brain Tumor Program.

This study (ClinicalTrials.gov Identifier: NCT06805305) is designed to evaluate the safety, tolerability, and efficacy of DOC1021 in combination with standard-of-care (SOC) treatment versus SOC alone in adult patients newly diagnosed with glioblastoma (IDH-wildtype). The trial is expected to open at approximately 20 centers in the United States, including Atlantic Health System and UTHealth Houston, that opened recently.

"We are tremendously proud to announce the dosing of the first patient in this critical Phase 2 study, marking an important milestone in our mission to develop a much-needed treatment for patients with glioblastoma, a disease that, despite significant advances in neuro-oncology, remains one of the most challenging cancers to treat, with patient outcomes still falling short of expectations," said Dr. Laura Aguilar, Chief Medical Officer of Diakonos Oncology. "This Phase 2 trial represents an important step in evaluating DOC1021’s potential to enhance the immune response and work alongside standard therapies. We are optimistic that this approach could lead to meaningful improvements in survival and quality of life for patients facing this aggressive disease."

The trial’s primary outcome measure is overall survival (OS), with 1-, 2- and 3-year survival as secondary outcome measures, along with progression-free survival (PFS), number of adverse events, health-related quality of life, and neuro-cognitive function.

"As Diakonos’ CDMO partner, we’re thrilled to see this next phase of clinical development take shape," said Darren Head, CEO of Cellipont Bioservices. "Manufacturing patient-specific cell therapies like DOC1021 requires precision, flexibility, and deep scientific collaboration. We are proud to support Diakonos in advancing this novel immunotherapy and look forward to continuing our partnership as the trial progresses."

About Glioblastoma

Glioblastoma Multiforme (GBM) is the most common and aggressive primary malignant brain tumor in adults. There are about 15,000 new GBM patients diagnosed annually in the US. Standard treatment includes surgery, radiation, and chemotherapy, but the prognosis remains poor, with a median survival of approximately 15 months. There is a significant unmet need for new and effective treatments.

About DOC1021

DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that uniquely combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double loading approach, which mimics a viral infection, unlocks a synergistic and exponentially more powerful tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient’s immune cells for manufacturing, and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 allows for a simple administration in the outpatient setting and broad reach via community cancer centers.

In addition to the recently opened Phase 2 GBM study, a clinical trial of Diakonos’ DOC1021 is ongoing for the treatment of pancreatic cancer. Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs, in October 2023 and May 2024, respectively. The company has also received Orphan Drug Designation for the GBM program in January 2024.