Boston Scientific Announces Results For Second Quarter 2023

On July 27, 2023 Boston Scientific Corporation reported net sales of $3.599 billion during the second quarter of 2023, growing 11.0 percent on a reported basis, 12.0 percent on an operational1 basis and 11.6 percent on an organic basis, all compared to the prior year period (Press release, Boston Scientific, JUL 27, 2023, View Source;_gl=1*3kubsm*_ga*NzE2MTY5ODI1LjE2OTM4ODk2ODg.*_ga_759NN7RMMK*MTY5Mzg4OTY4Ny4xLjEuMTY5Mzg5MDUwMC4wLjAuMA.. [SID1234634864]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $261 million or $0.18 per share (EPS), compared to $246 million or $0.17 per share a year ago, and achieved adjusted3 EPS of $0.53 for the period, compared to $0.44 a year ago.

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"We had another quarter of excellent results fueled by our innovative portfolio, strong commercial execution and the high performance of our global team," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We are excited about our long-term outlook and robust pipeline of unique innovations to address unmet patient needs."

Second quarter financial results and recent developments:

Reported net sales of $3.599 billion, representing an increase of 11.0 percent on a reported basis, compared to the company’s guidance range of 6.5 to 8.5 percent; 12.0 percent on an operational basis; and 11.6 percent on an organic basis, compared to the company’s guidance range of 7 to 9 percent, all compared to the prior year period.
Reported GAAP net income attributable to Boston Scientific common stockholders of $0.18 per share, compared to the company’s guidance range of $0.23 to $0.27 per share, and achieved adjusted EPS of $0.53 per share, compared to the guidance range of $0.48 to $0.50 per share.
Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 9.0 percent reported, 9.6 percent operational and 8.8 percent organic
Cardiovascular: 12.2 percent reported, 13.4 percent operational and organic
Achieved the following net sales growth in each region, compared to the prior year period:
U.S.: 9.1 percent reported and operational
EMEA (Europe, Middle East and Africa): 9.6 percent reported and 9.3 percent operational
APAC (Asia-Pacific): 18.0 percent reported and 24.5 percent operational
LACA (Latin America and Canada): 16.9 percent reported and 17.4 percent operational
Emerging Markets4: 18.8 percent reported and 24.2 percent operational
Late-breaking clinical science based on real-world outcomes from the EU-PORIA registry of the FARAPULSE Pulsed Field Ablation (PFA) System was presented at Heart Rhythm 2023, which demonstrated strong safety outcomes and high rates of freedom from recurrence of atrial fibrillation and atrial tachycardia at a median follow-up of one year.
Presented results from the FROZEN-AF IDE study of the POLARx Cryoablation System at Heart Rhythm 2023, which met the safety and effectiveness endpoints of the trial.
Completed enrollment in the WATCHMAN FLX Pro CT pilot study, a single-center study using multiple imaging modalities to assess post-procedural healing in the investigational WATCHMAN FLX Pro Left Atrial Appendage Closure Device for patients with non-valvular atrial fibrillation.
Received U.S. FDA 510(k) clearance for the EMBOLD Soft and Packing Coils, which, along with the EMBOLD Fibered Coil, complete the EMBOLD Detachable Coil System, a peripheral embolization platform for vessel occlusion designed to simplify operator workflow and streamline inventory for hospitals.
Received U.S. FDA 510(k) clearance for the OverStitch NXT System, a next-generation endoscopic suturing system that enables suture placement and soft tissue approximation during advanced endoscopic procedures.
Received U.S. FDA approval for the Vercise Neural Navigator 5 Software, which when used with the Vercise Genus deep brain stimulation systems can help provide clinicians with simple and actionable data for efficient programming in the treatment of people living with Parkinson’s disease or essential tremor.
Completed the purchase of a minority stake (9.9%) of M.I.Tech Co., Ltd, a publicly traded, Korea-based medical device manufacturer and distributor. M.I.Tech is the creator of HANAROSTENT technology, a family of conformable, non-vascular, self-expanding metal stents, which Boston Scientific has distributed in Japan since 2015.
Elected to the company’s board of directors Dr. Jessica L. Mega, co-founder of Verily Life Sciences LLC, and Susan E. Morano, former vice president of Business Development and Strategic Operations at Johnson & Johnson MedTech.
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.

Roche’s Second Quarter Results 2023

On July 27, 2023 Hoffmann-La Roche reported its Second Quarter Results 2023 (Press release, Hoffmann-La Roche, JUL 27, 2023, View Source [SID1234634853]).

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Plus Therapeutics to Present at the 2023 SNO/ASCO CNS Cancer Conference

On July 27, 2023 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, reported that the Company will share three poster presentations at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Central Nervous System (CNS) Cancer Conference taking place August 10-12, 2023 in San Francisco, California (Press release, PLUS THERAPEUTICS, JUL 27, 2023, View Source;_hsmi=268960175&_hsenc=p2ANqtz-_UQltHa80HfRzuqnEFvoEiUlO3Egf9vH3ofTVlzYS29NZp6gryOfKKpdz4wcB0zCHyJsikLDvUsRlp-JLRJzPsyN62mw&utm_content=268960175&utm_source=hs_email [SID1234633793]).

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The presentations will describe new data from the ReSPECT-LM and ReSPECT-GBM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of leptomeningeal metastases (LM) and recurrent glioblastoma (rGBM), respectively, as well as details around the planned ReSPECT-PBC trial to evaluate rhenium (186Re) obisbemeda for the treatment of recurrent, refractory, or progressive childhood ependymoma and high-grade glioma (HGG).

All presentations will be showcased during the Poster Reception on Thursday, August 10, 2023, beginning at 5:30 p.m. PT/8:30 p.m. ET.

Details of presentations:

Title [LMAP-21] Preliminary Clinical Data in the Phase 1/2a Dose Escalation Trial of Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases (LM): The ReSPECT-LM Trial

Title [TIPS-23] Safety and Feasibility Results from a Phase 1/2 Clinical Trial of Rhenium (186Re) Obisbemeda (186RNL) in Recurrent Glioma: The ReSPECT-GBM Trial

Title [TIPS-22] A two-part, Phase 1 study of Rhenium (186Re) Obisbemeda (186RNL) delivered by convection enhanced delivery (CED) for recurrent, refractory, or progressive childhood ependymoma and high-grade glioma (HGG)

A copy of the presentations will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at View Source

Takeda Quarterly Financial Report for the Quarter Ended June 30, 2023

On July 27, 2023 Takeda reported its Quarterly Financial Report for the Quarter Ended June 30, 2023 (Presentation, Takeda, JUL 27, 2023, View Source [SID1234633580]).

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Ayala Pharmaceuticals and Biosight Enter into Definitive Merger Agreement

On July 27, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a publicly-traded clinical-stage oncology company, and Biosight Ltd., a privately-held pharmaceutical company developing innovative therapeutics for hematological malignancies and disorders, reported that they have entered into a definitive merger agreement pursuant to which Ayala will combine with Biosight in an all-stock transaction (Press release, Ayala Pharmaceuticals, JUL 27, 2023, View Source [SID1234633574]). Upon completion of the merger, the combined company will operate under the name Ayala Pharmaceuticals, Inc., and will continue to trade on the OTCQX under Ayala’s current ticker symbol ("ADXS"). Certain of the current Biosight shareholders have agreed to support the proposed transaction.

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The combined company will work to advance a portfolio of oncology assets, with a primary focus on Ayala’s AL102, a once-daily, potent, selective, oral gamma-secretase inhibitor (GSI) and Biosight’s Aspacytarabine (BST-236). AL102 is currently being evaluated in the registrational RINGSIDE study in desmoid tumors. There are currently no FDA-approved therapies for the treatment of unresectable, recurrent or progressive desmoid tumors. Data from the Phase 2 portion of RINGSIDE were presented at the recent American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating AL102’s activity against progressing desmoid tumors. These data showed 50% partial response and 100% disease control rates in evaluable desmoid tumor patients treated with AL102 in the 1.2 mg once daily arm, the dosing regimen being tested in the ongoing Phase 3 study. The majority of the patients from Phase 2 have continued on study and are now in the open label extension of the Phase 3 portion of RINGSIDE. Ayala expects to present updated data on these patients at a medical conference later this year.

"The addition of Biosight’s lead asset aspacytarabine (BST-236) fits with our strategic vision and core competencies and provides us with additional avenues towards key clinical catalysts," said Ken Berlin, President and CEO of Ayala. "Along with the merger, we have plans to strengthen our balance sheet and execute our clinical plans, with the goal of creating sustainable value for patients and shareholders."

Pini Orbach, PhD, Chairman of Biosight, commented, "The Ayala team shares our commitment to bringing innovative treatments to cancer patients in need and we are excited to enter into this merger. Leveraging the combined capabilities and resources of both organizations will provide a truly unique opportunity to build a leading, publicly-traded oncology company with advanced and diverse clinical stage assets. I would like to express my deepest appreciation to the entire Biosight team, and I am proud of their excellent work and dedication in advancing aspacytarabine and our pipeline."

About the Merger

Under the terms of the merger agreement, upon completion of the merger, ownership of the combined company will be split, with 55% ownership going to Biosight stockholders and 45% going to Ayala stockholders. The merger agreement has been unanimously approved by the Board of Directors of each company, by all directors entitled to vote. The transaction is expected to close prior to the end of the third quarter of 2023, subject to regulatory and other conditions including approval of Biosight stockholders.

Management and Organization

Effective as of the closing of the merger, the combined company will be led by Ayala’s existing senior management team, with Ken Berlin serving as President and CEO. Additionally, the Board of Directors is expected to consist of nine members, including four designated by Ayala and four designated by Biosight, as well as Mr. Berlin.

Advisors

Morgan, Lewis & Bockius LLP and Meitar are serving as legal counsel to Ayala. Goodwin Procter LLP and Horn & Co. Law Offices are serving as legal counsel to Biosight.