Genmab Updates 2023 Financial Guidance

On July 28, 2023 Genmab A/S (Nasdaq: GMAB) reported its preliminary first half 2023 financial results and its updated 2023 financial guidance (Press release, Genmab, JUL 28, 2023, View Source [SID1234633454]).

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Preliminary First Half 2023 Financial Results

In the first half of 2023, Genmab’s revenue increased by 34% and operating profit increased by 10%, compared to the first half of 2022 primarily due to higher product royalties. Operating expenses increased by 45%, reflecting continued focused investments in Genmab’s key priorities.

First Half First Half
(DKK million) 2023 2022 % Increase
Revenue 7,052 5,281 34%
Operating expenses (5,118) (3,520) 45%
Operating profit 1,934 1,761 10%

Updated 2023 Financial Guidance

Genmab expects its 2023 revenue to be in the range of DKK 15,500 – 16,500 million, an increase to the previous guidance of DKK 14,600 – 16,100 million, driven by the continued strong growth of DARZALEX net sales and higher total royalty revenues from DARZALEX and other marketed products. DARZALEX royalties are based on Genmab’s revised estimate of DARZALEX 2023 net sales of USD 9.8 – 10.0 billion compared to Genmab’s previous estimate of USD 9.4 – 10.0 billion.

Genmab anticipates its 2023 operating expenses to be in the range of DKK 10,400 – 10,900 million, an increase to the previous guidance of DKK 9,800 – 10,600 million, primarily related to increased and accelerated investment for epcoritamab clinical trials and progression of other pipeline products.

Genmab now expects its 2023 operating profit to be in the range of DKK 4,500 – 6,000 million, compared to the previous guidance of DKK 3,900 – 6,200 million, driven primarily by the items described above.


Revised Previous
(DKK million) Guidance Guidance
Revenue 15,500 – 16,500 14,600 – 16,100
Operating expenses (10,400) – (10,900) (9,800) – (10,600)
Operating profit 4,500 – 6,000* 3,900 – 6,200*
*Operating profit does not sum due to rounding

Genmab’s full financial results for the first half of 2023 will be published on August 3, 2023.

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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