On April 23, 2025 Boston Scientific Corporation (NYSE: BSX) reported net sales of $4.663 billion during the first quarter of 2025, growing 20.9 percent on a reported basis, 22.2 percent on an operational1 basis and 18.2 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, APR 23, 2025, View Source [SID1234652050]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $674 million or $0.45 per share (EPS), compared to $495 million or $0.33 per share a year ago, and achieved adjusted3 EPS of $0.75 for the period, compared to $0.56 a year ago.

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"We delivered an exceptional quarter to start the year, reflecting the effectiveness of our highly engaged global team and the strength of our product portfolio," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We remain well-positioned for the future as we continue to focus on meaningful innovation, clinical science and the execution of our category leadership strategy to drive differentiated growth and performance for the long-term."

First quarter financial results and recent developments:

Reported net sales of $4.663 billion, representing an increase of 20.9 percent on a reported basis, compared to the company’s guidance range of 17 to 19 percent; 22.2 percent on an operational basis; and 18.2 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 $0.45 per share, compared to the company’s guidance range of $0.43 to $0.45 per share, and achieved adjusted EPS of $0.75 per share, compared to the guidance range of $0.66 to $0.68 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 11.7 percent reported, 12.8 percent operational and 5.3 percent organic
Cardiovascular: 26.2 percent reported, 27.6 percent operational and 25.6 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 31.1 percent reported and operational
Europe, Middle East and Africa (EMEA): 5.5 percent reported and 7.9 percent operational
Asia-Pacific (APAC): 8.2 percent reported and 10.6 percent operational
Latin America and Canada (LACA): 4.4 percent reported and 14.1 percent operational
Emerging Markets4: 6.5 percent reported and 9.8 percent operational

Commenced enrollment in the ELEVATE-PF clinical trial to evaluate the safety and effectiveness of the FARAFLEX Mapping and Pulsed Field Ablation (PFA) Catheter for treatment of persistent atrial fibrillation (AF).

Began the OPTION-A clinical trial in the Asia-Pacific region to evaluate the safety and effectiveness of catheter ablation with the FARAPULSE PFA System and subsequent implant of the WATCHMAN Left Atrial Appendage Closure Device in a concomitant procedure.

Published in The New England Journal of Medicine and presented as late-breaking science at the 2025 European Heart Rhythm Association annual meeting were results from the investigator-sponsored SINGLE SHOT CHAMPION clinical trial which demonstrated the FARAPULSE PFA System achieved superior effectiveness for the treatment of symptomatic paroxysmal AF versus the Arctic Front Advance cardiac cryoablation catheter (Medtronic).

Presented late-breaking findings from the VITALYST Early Feasibility Study at the Technology and Heart Failure Therapeutics conference which demonstrated successful early experience with the investigational VITALYST Temporary Percutaneous Transvalvular Circulatory Support System in patients undergoing elective high-risk percutaneous coronary intervention.

Published in JAMA Network Open real-world data demonstrating that patients with prostate cancer treated with SpaceOAR Hydrogel showed a 25% reduction in bowel disorder risk and a 46% decrease in procedures like colonoscopies four years post-radiation therapy.

Completed the acquisition of Bolt Medical, Inc., the developer of an intravascular lithotripsy advanced laser-based platform for the treatment of coronary and peripheral artery disease.

Announced agreement to acquire SoniVie Ltd., the developer of the TIVUS Intravascular Ultrasound System, an investigational nerve denervation technology designed to treat hypertension — such as renal artery denervation in the kidneys — subject to customary closing conditions.
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.

Net sales for the first quarter by business and region:

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Increase/(Decrease)

Three Months Ended

March 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

Impact of
Certain
Acquisitions/Divestitures

Organic
Basis

(in millions)

2025

2024

Endoscopy

$ 673

$ 642

4.7 %

1.2 %

5.9 %

(0.4) %

5.5 %

Urology

633

513

23.5 %

1.0 %

24.5 %

(20.1) %

4.4 %

Neuromodulation

271

256

5.8 %

0.9 %

6.8 %

— %

6.8 %

MedSurg

1,577

1,412

11.7 %

1.1 %

12.8 %

(7.5) %

5.3 %

Cardiology

2,429

1,872

29.8 %

1.4 %

31.2 %

— %

31.2 %

Peripheral Interventions

656

573

14.4 %

1.4 %

15.8 %

(8.4) %

7.4 %

Cardiovascular

3,085

2,445

26.2 %

1.4 %

27.6 %

(2.0) %

25.6 %

Net Sales

$ 4,663

$ 3,856

20.9 %

1.3 %

22.2 %

(4.0) %

18.2 %

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Increase/(Decrease)

Three Months Ended
March 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2025

2024

U.S.

$ 2,960

$ 2,258

31.1 %

— %

31.1 %

EMEA

846

803

5.5 %

2.4 %

7.9 %

APAC

701

647

8.2 %

2.4 %

10.6 %

LACA

155

149

4.4 %

9.6 %

14.1 %

Net Sales

$ 4,663

$ 3,856

20.9 %

1.3 %

22.2 %

Emerging Markets4

$ 690

$ 648

6.5 %

3.3 %

9.8 %

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 Second Quarter 2025

The company estimates net sales growth for the full year 2025, versus the prior year period, to be approximately 15 to 17 percent on a reported basis and 12 to 14 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 $1.86 to $1.93 and estimates adjusted EPS, excluding certain charges (credits), of $2.87 to $2.94.

The company estimates net sales growth for the second quarter of 2025, versus the prior year period, to be in a range of approximately 17.5 to 19.5 percent on a reported basis, and 13 to 15 percent on an organic basis. Second 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 $0.45 to $0.47 and estimates adjusted EPS, excluding certain charges (credits), of $0.71 to $0.73.

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 April 23, 2025 Arvinas, Inc. (Nasdaq: ARVN) reported that data from the global Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant versus fulvestrant in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer will be presented as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 – June 3 in Chicago, IL (Press release, Arvinas, APR 23, 2025, View Source [SID1234652048]). The presentation includes the first pivotal data for vepdegestrant, a potential first-in-class investigational oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader.

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Vepdegestrant is being jointly developed by Arvinas and Pfizer for the treatment of patients with advanced or metastatic ER+/HER2- breast cancer.

Presentation details are as follows:

Title: Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs. fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC): results of the global, randomized, phase 3 VERITAC-2 study
Presenting Author: Erika P. Hamilton, MD, Breast Cancer Research Program, Sarah Cannon Research Institute
Abstract Number: LBA1000
Session Date, Time and Location: Saturday, May 31, 2025, 1:15 PM-4:15 PM CT in Hall B1
Session Type and Title: Oral Abstract Session – Breast Cancer—Metastatic

Late-breaking abstracts will be released at 7:00 am CT / 8:00 am ET on the day of the scientific presentation. Additional information can be found at www.asco.org.

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC (PROteolysis TArgeting Chimera) protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits.

The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy.

On April 23, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it will present updated data from the completed Phase 1 TRAVERSE trial of ALLO-316 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29-June 2 in Chicago, Illinois (Press release, Allogene, APR 23, 2025, View Source [SID1234652047]). The trial evaluated ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who had progressed following immune checkpoint inhibitor and VEGF-targeted therapies. In addition, a trial-in-progress poster is also being presented to highlight the ongoing pivotal Phase 2 ALPHA3 trial, which is evaluating cemacabtagene ansegedleucel (cema-cel) as part of first-line (1L) treatment for patients with large B-cell lymphoma (LBCL).

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ALLO-316 is an allogeneic, "off-the-shelf" CAR T product targeting CD70 and is the only allogeneic CAR T product to demonstrate potential in solid tumors. Data from the Phase 1 TRAVERSE trial previously showed a manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients with advanced or metastatic CD70+ RCC. Enrollment is now complete in the Phase 1b expansion cohort, which evaluated the safety and efficacy of ALLO-316 at dose level 2 (80M CAR T cells) following a standard lymphodepletion regimen of cyclophosphamide and fludarabine.

The ALPHA3 trial is the first pivotal study to evaluate an allogeneic CAR T product as a consolidation strategy aimed at eradicating minimal residual disease (MRD) following 1L treatment in LBCL. It is assessing cema-cel in patients with MRD after standard 1L chemoimmunotherapy, such as R-CHOP, with the goal of improving 1L cure rates. The trial identifies patients at high risk for relapse after 1L treatment by utilizing Foresight CLARITY, powered by PhasED-Seq, a novel Investigational Use Only (IUO) test for MRD. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation).

Allogene Presentations at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting:

ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study.
Presenter: Samer A. Srour, M.D., The University of Texas MD Anderson Cancer Center
Session Title: Oral Abstract Session – Genitourinary Cancer – Kidney and Bladder
Abstract: #4508
Location: Hall D2
Presentation Date and Time: Sunday, June 1, 9:45AM – 12:45PM CT

ALPHA3: A pivotal phase 2 study of first-line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients (pts) with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy.

Presenter: Jason Westin, MD, MS, FACP, The University of Texas MD Anderson Cancer Center
Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Abstract: TPS7085
Poster Board: #267a
Location: Hall A
Poster Session Display Date and Time: Sunday, June 1, 9:00AM – 12:00PM CT

About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.

About ALLO-316 (TRAVERSE)
ALLO-316 is an AlloCAR T investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic CD70+ RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced a $15 million award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.

About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to "watch and wait" to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, "off-the-shelf" treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD.

On April 23, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Shanghai Henlius Biotech, Inc. ("Henlius") has initiated a Phase 2 clinical trial with HLX22, an anti-HER2 monoclonal antibody originally developed by Alligator’s subsidiary, Atlas Therapeutics (Press release, Alligator Bioscience, APR 23, 2025, View Source [SID1234652046]). HLX22 is being developed by Henlius under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

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The Phase 2 study is being conducted in mainland China and is designed to evaluate HLX22 in combination with trastuzumab deruxtecan for the treatment of patients with locally advanced or metastatic breast cancer. The study aims to assess the efficacy and safety of the combination therapy.

Søren Bregenholt, CEO of Alligator, commented:
"Henlius’ progress with HLX22 underscores the continued clinical momentum behind this antibody. While Alligator is not directly involved in its development, we continue to monitor its progress with interest, as HLX22 may represent a potential future revenue stream for Alligator."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius.

On April 23, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported it will present the first clinical data for ADRX-0706 at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 30 – June 3, 2025) in Chicago, IL (Press release, Adcentrx Therapeutics, APR 23, 2025, View Source [SID1234652045]).

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Adcentrx will deliver a poster presentation on ADRX-0706, a clinical-stage Nectin-4 ADC. The presentation will include interim clinical data from the Phase 1a portion of the ongoing trial (NCT06036121), demonstrating the best-in-class potential for ADRX-0706. The findings indicate a differentiated safety and pharmacokinetic profile, including a significantly lower incidence of critically meaningful adverse events such as peripheral neuropathy. Additionally, preliminary efficacy signals across different dose levels and tumor types provide strong clinical validation of Adcentrx’s ADC platform, including the i-Conjugation technology and novel auristatin payload AP052.

The first-in-human Phase 1a/b study is an open-label, two-part trial being conducted at sites in the U.S. and China. The completed Phase 1a portion consisted of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in Phase 1b. This ongoing second portion of the study aims to further evaluate ADRX-0706’s safety and tolerability, preliminary efficacy, and optimal dose in urothelial, triple-negative breast and cervical cancers.

Details of the poster presentation at the ASCO (Free ASCO Whitepaper) Meeting are as follows:

Title: Preliminary results from a first-in-human phase 1 dose escalation trial of ADRX-0706, a next generation Nectin-4 ADC, in subjects with advanced solid tumors
Abstract Number: 3018
Session Date & Time: Monday, June 2, 1:30 p.m. – 4:30 p.m. CST
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

The full abstract will be published by ASCO (Free ASCO Whitepaper) in conjunction with the Meeting.

About i-Conjugation Technology

Adcentrx’s proprietary i-Conjugation technology platform is a core component in the design of the company’s ADCs. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with the desired linker-payload.

About ADRX-0706

ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumors and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs.

The ADRX-0706 antibody is linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx’s innovative i-Conjugation technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies.

ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial.
For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.