Galera to Present One-Year Reductions in Cisplatin-Related Chronic Kidney Disease Data from ROMAN Trial at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 26, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that a prespecified analysis from the Phase 3 ROMAN trial detailing one-year reductions in cisplatin-related chronic kidney disease in patients with head and neck cancer treated with avasopasem will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, 2023, in Chicago, IL (Press release, Galera Therapeutics, APR 26, 2023, View Source [SID1234630521]).

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Presentation Details:

Title: One-year reductions in cisplatin-related chronic kidney disease (CKD) in patients with head and neck (HNC) cancer treated with avasopasem manganese: A prespecified analysis from the phase 3 ROMAN trial
Abstract Number: 6066
Session Title: Head and Neck Cancer
Session Date and Time: Monday, June 5, 2023, 1:15 PM – 4:15 PM ET

The titles of the abstracts are currently available in the ASCO (Free ASCO Whitepaper) digital program, with the full abstracts scheduled to be published on May 25, 2023, at 5 p.m. ET. The presentation will be available on Galera’s website at the start of the poster session at View Source

G1 Therapeutics to Release First Quarter 2023 Financial Results and Provide Business Update on May 3, 2023

On April 26, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that it will host a webcast and conference call to provide a financial and corporate update for the first quarter 2023 on Wednesday May 3, 2023, at 8:30 a.m. ET (Press release, G1 Therapeutics, APR 26, 2023, View Source [SID1234630520]).

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Please note that there is a new process to access the call via telephone. To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

Deciphera Pharmaceuticals to Announce First Quarter 2023 Financial Results and Host Conference Call and Webcast on May 3, 2023

On April 26, 2023 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that it will announce its first quarter 2023 financial results on Wednesday, May 3, 2023 (Press release, Deciphera Pharmaceuticals, APR 26, 2023, View Source [SID1234630519]).

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In connection with the earnings release, Deciphera’s management team will host a live conference call and webcast at 8:00 AM ET on Wednesday, May 3, 2023, to discuss the Company’s financial results and provide a corporate update.

The conference call may be accessed via this link: https://register.vevent.com/register/BI75fb53c225a648b486e50d922b166468

A live webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

Chemomab Therapeutics to Present at 2023 Aegis Virtual Conference

On April 26, 2023 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported that the company will participate in the Aegis Virtual Conference being held May 2–May 4, 2023 (Press release, Chemomab, APR 26, 2023, View Source [SID1234630518]). Chemomab management will present a corporate overview on Wednesday, May 3, 2023.

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Aegis 2023 Virtual Investor Conference

Date:

May 3, 2023

Time:

9:00am EDT

Venue:

Virtual

Format:

Webcast — Corporate overview

Presenter:

Senior management

Webcast Link:

View Source

Information:

[email protected]

In addition, Chemomab reported that its corporate development team will be in Boston June 5-8, 2023, participating in the BIO International Convention’s One-on-One Partnering event. Registered attendees can click here to log in and schedule a meeting with Chemomab.

Boston Scientific Announces Results for First Quarter 2023

On April 26, 2023 Boston Scientific Corporation (NYSE: BSX) reported to have generated net sales of $3.389 billion during the first quarter of 2023, growing 12.0 percent on a reported basis, 14.9 percent on an operational1 basis and 14.0 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, APR 26, 2023, View Source [SID1234630516]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $300 million or $0.21 per share (EPS), compared to $97 million or $0.07 per share a year ago, and achieved adjusted3 EPS of $0.47 for the period, compared to $0.39 a year ago.

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"I’m pleased with our excellent results this quarter, which highlight our team’s strong performance across each business and region," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "With a robust pipeline in 2023 and beyond, I’m optimistic about our ability to continue to deliver differentiated financial performance and the opportunity to reach more patients with life-changing therapies."

First quarter financial results and recent developments:

Reported net sales of $3.389 billion, representing an increase of 12.0 percent on a reported basis, compared to the company’s guidance range of 3 to 5 percent; 14.9 percent on an operational basis; and 14.0 percent on an organic basis, compared to the company’s guidance range of 6 to 8 percent, all compared to the prior year period.
Reported GAAP net income attributable to Boston Scientific common stockholders of $0.21 per share, compared to the company’s guidance range of $0.23 to $0.26 per share, and achieved adjusted EPS of $0.47 per share, compared to the guidance range of $0.42 to $0.44 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 11.0 percent reported, 13.4 percent operational and organic

Cardiovascular: 12.7 percent reported, 15.9 percent operational and 14.4 percent organic
Achieved the following net sales growth in each region, compared to the prior year period:
U.S.: 12.7 percent reported and operational
EMEA (Europe, Middle East and Africa): 14.2 percent reported and 20.0 percent operational
APAC (Asia-Pacific): 5.9 percent reported and 15.4 percent operational
LACA (Latin America and Canada): 17.4 percent reported and 20.0 percent operational
Emerging Markets4: 20.2 percent reported and 26.3 percent operational

Received U.S. Food and Drug Administration (FDA) clearance and launched in the U.S. and Japan the LithoVue Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope system with a built-in sensor that enables urologists to monitor intrarenal pressure in real time during ureteroscopy procedures.

Received Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada and CE Mark approval for the POLARx FIT Cryoablation Balloon Catheter, an expandable balloon catheter capable of enabling 28 and 31mm sizes, which promotes procedural efficiency and adaptability to varying patient anatomies during the treatment of atrial fibrillation.

Announced real-world outcomes from the SURPASS one-year analysis of more than 66,000 patients with the WATCHMAN FLX Left Atrial Appendage Closure Device during a late-breaking session at the Cardiovascular Research Technologies (CRT) 2023 meeting, with data demonstrating a low 1.2% rate of ischemic stroke and 0.11% rate of systemic embolism at one year. Also exceeded 300,000 patients worldwide who have been treated with the WATCHMAN technology.

Completed enrollment in the ACURATE IDE trial, a prospective, multicenter, randomized study in the U.S. and Canada evaluating the safety and effectiveness of the ACURATE neo2 Aortic Valve System for the treatment of patients with severe, symptomatic aortic stenosis across all surgical risk levels who are indicated for transcatheter aortic valve replacement.

Commenced enrollment of the global ADVANTAGE AF clinical trial, which will evaluate the safety and effectiveness of the FARAPULSE Pulsed Field Ablation (PFA) System for the treatment of drug-resistant, symptomatic, persistent atrial fibrillation (AF). Also, presented as late-breaking science at the European Heart Rhythm Association (EHRA) annual meeting were real-world outcomes from the independent MANIFEST-PF registry, which demonstrated the real-world safety, efficacy and efficiency of the FARAPULSE PFA System. Despite a variety of workflows, procedure times remained at approximately one hour, and there was only one case of phrenic palsy and no reports of esophageal complications or pulmonary vein stenosis. One-year freedom from recurrence was 82% in patients with paroxysmal, or intermittent, AF and 72% in patients with persistent AF.

Closed the acquisition of Apollo Endosurgery, Inc., expanding the Boston Scientific endoluminal surgery portfolio and enabling entry into the endobariatric market.

Completed the acquisition of a majority stake investment in Acotec, a Chinese medical technology company that offers innovative solutions designed for several types of interventional procedures. This investment is expected to create strategic value for both companies through a variety of opportunities, including collaboration in research and development, manufacturing and commercial strategies.

Released the 2022 Performance Report, measuring progress on the ways in which the company is transforming care, investing in employees, protecting the environment and creating value responsibly.

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 intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio gains and losses, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), EU MDR implementation costs, debt extinguishment charges, deferred tax expenses (benefits) and 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. We have revised prior year amounts to conform to the current year’s presentation.

Net sales for the first quarter by business and region:

Increase/(Decrease)

Three Months Ended

March 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

Impact of
Recent
Acquisitions /
Divestitures

Organic
Basis

(in millions)

2023

2022

Endoscopy

$ 577

$ 531

8.6 %

2.9 %

11.5 %

— %

11.5 %

Urology

469

413

13.5 %

2.1 %

15.6 %

— %

15.6 %

Neuromodulation

234

209

11.9 %

1.8 %

13.7 %

— %

13.7 %

MedSurg

1,280

1,153

11.0 %

2.4 %

13.4 %

— %

13.4 %

Cardiology

1,606

1,407

14.1 %

3.1 %

17.3 %

(1.9) %

15.4 %

Peripheral Interventions

503

465

8.2 %

3.4 %

11.5 %

— %

11.5 %

Cardiovascular

2,110

1,873

12.7 %

3.2 %

15.9 %

(1.4) %

14.4 %

Net Sales

$ 3,389

$ 3,026

12.0 %

2.9 %

14.9 %

(0.9) %

14.0 %

Increase/(Decrease)

Three Months Ended
March 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2023

2022

U.S.

$ 2,003

$ 1,778

12.7 %

— %

12.7 %

EMEA

712

624

14.2 %

5.8 %

20.0 %

APAC

548

517

5.9 %

9.5 %

15.4 %

LACA

126

107

17.4 %

2.6 %

20.0 %

Net Sales

$ 3,389

$ 3,026

12.0 %

2.9 %

14.9 %

Emerging Markets4

$ 529

$ 440

20.2 %

6.0 %

26.3 %

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

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 Second Quarter 2023

The company now estimates net sales growth for the full year 2023, versus the prior year period, to be approximately 8.5 to 10.5 percent on a reported basis, and approximately 8 to 10 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 now estimates EPS on a GAAP basis in a range of $0.93 to $1.02 and estimates adjusted EPS, excluding certain charges (credits), of $1.90 to $1.96.

The company estimates net sales growth for the second quarter of 2023, versus the prior year period, to be in a range of approximately 6.5 to 8.5 percent on a reported basis, and approximately 7 to 9 percent on an organic basis. Second 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 $0.23 to $0.27 and adjusted EPS, excluding certain charges (credits), of $0.48 to $0.50.

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: www.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.