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.

Orbital Therapeutics Secures $270 Million in Series A Financing to Unleash Full Potential of RNA Medicines

On April 26, 2023 Orbital Therapeutics, a company focused on enhancing global health by unleashing the full potential of RNA medicines to treat human disease, reported the successful closing of $270 million Series A financing. The Series A raise was led by ARCH Venture Partners, with participation from initial investors a16z Bio + Health and Newpath Partners, and new investors Abu Dhabi Growth Fund (ADG), Redmile Group, Exor N.V., Invus, Moore Strategic Ventures, iGlobe Platinum Fund Group, Casdin Capital, Agent Capital, Alexandria Venture Investments, Rellim Capital Management, Heritage Medical Systems, and other undisclosed investors (Press release, Orbital Therapeutics, APR 26, 2023, View Source [SID1234630515]).

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Orbital Therapeutics aims to expand the applicability of RNA-based medicines across a range of human diseases, including in the areas of next-generation vaccines, immunomodulation, and protein replacement. The company is building a first-in-kind RNA platform that integrates both established and emerging RNA technologies and delivery mechanisms. This platform is designed to extend the durability of Orbital’s novel RNA therapeutics, while also expanding their delivery to a wide range of cell types and tissues.

"In recent years, we have only just started to see the expansive potential RNA-based therapeutics may offer to the future of medicine and how we treat disease," said Giuseppe Ciaramella, Ph.D., Orbital co-founder and CEO. "Since our founding, we have been diligently focused on advancing our platform of RNA technologies to elucidate the most promising opportunities with our initial programs so we may reach patients as efficiently as possible. We are thrilled to have the backing of such an exceptional group of investors, whose support further enables the growth of our organization and the meaningful expansion of our platform and portfolio."

"Few companies can possess the know-how, technology and biologic insights to deliver on the full breadth of opportunity that RNA medicines could provide for patients. Orbital was founded and has been built to be that special company," said Kristina Burow, managing partner at ARCH Venture Partners, co-founder and board director of Orbital. "We are pleased to partner with Orbital’s team of industry leaders and visionaries in drug development to help them achieve a bold mission of bringing forward the next generation of RNA-based medicines."

In addition to the financing, Orbital announced the expansion of its leadership team with the appointments of Niru Subramanian as chief operating officer and Jonathan Piazza as chief financial officer, who join Gilles Besin, Ph.D., chief scientific officer, and Dr. Ciaramella on the company’s executive leadership team.

Dr. Ciaramella added, "Key to our long-term success is having a team that not only brings experience, but also passion and drive for the work we are doing. Niru has an extensive background in driving corporate strategy and portfolio development for successful biotech and pharmaceutical companies, which is complemented by Jonathan’s successful history of leading financial organizations within the industry and guiding several strategic transactions while at top investment banks. Their collective expertise and dedication to create a company that can advance important new medicines for patients makes them ideal additions to our team, and they already have made tremendous early contributions to our company’s growth and capital raise. We are thrilled to have them on board."

Niru Subramanian, Chief Operating Officer

Ms. Subramanian brings 25 years of business and corporate development experience, including building new strategies and capabilities for high-growth organizations, leading multifunctional teams, managing partnerships and M&A transactions, and directing portfolio planning, alliance management, finance and operations. She most recently served as chief operating officer at Rheos Medicines, and prior to that, was senior vice president, corporate development & business planning at Agios Pharmaceuticals, where she led several key initiatives including the $2 billion sale of Agios’ oncology business in December 2020. Earlier, she held several roles at Novartis Vaccines, including as vice president, head of Influenza Global Programs and at Novartis as vice president, Vaccines Business transition lead following the divestment of the business unit. Earlier in her career, she worked at The Boston Consulting Group in their healthcare practice area advising large and small biopharma companies on a variety of strategic and operational issues. Ms. Subramanian received a BS in computer science and engineering from the University of Pennsylvania and an MBA from the Harvard Business School.

Jonathan Piazza, Chief Financial Officer

Mr. Piazza is a seasoned biotech executive and finance professional with more than 20 years of experience in biotech, healthcare investment banking, finance, and large pharma roles. He most recently served as CFO of Silverback Therapeutics and helped orchestrate its IPO, and later its reverse merger with ARS Pharma. As a healthcare banker at Goldman Sachs, Barclays Capital, and Lehman Brothers, he has advised on approximately $100 billion in biopharma and life sciences financing and strategic transactions across both large and small companies. Previously, he was a financial advisor at Smith Barney (now Morgan Stanley Smith Barney), and prior to that, he worked in engineering, development, and international marketing disciplines at Abbott Laboratories across multiple divisions of the company. Mr. Piazza earned a BS in chemical engineering from The Ohio State University and an MBA from the Haas School of Business at the University of California at Berkeley.