On July 25, 2024 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") and The University of Texas MD Anderson Cancer Center (MD Anderson) reported a strategic five-year collaboration agreement for the purpose of accelerating the development of ivonescimab (Press release, Summit Therapeutics, JUL 25, 2024, View Source [SID1234645099]).

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Leveraging MD Anderson’s clinical infrastructure and research expertise together with Summit’s innovative, investigational, potential first-in-class PD-1 / VEGF bispecific antibody, the collaboration is designed to quickly discover additional opportunities for ivonescimab, including several tumors outside of its current development plan. MD Anderson will lead multiple clinical trials in several tumor types to evaluate the safety and potential clinical benefit of ivonescimab, including the possibility of identifying biomarkers through additional research activities.

"We are excited to collaborate with MD Anderson to provide unique insights and expertise to further broaden the development of ivonescimab," stated Allen S. Yang, MD, PhD, Chief Medical Officer of Summit. "This collaboration will help accelerate the growing clinical development efforts for ivonescimab and help bring this innovative advancement on immunotherapy and anti-angiogenic standards to as many patients who may benefit as possible."

Early work may include certain types of renal cell carcinoma, colorectal cancer, skin cancer, and breast cancer and glioblastoma, which has the potential to rapidly expand the breadth and depth of the ivonescimab development program. The bispecific antibody has shown significant promise in recent read-outs from the randomized Phase III non-small cell lung cancer clinical trials, HARMONi-A and HARMONi-2, conducted by Summit’s partner, Akeso, in addition to promising Phase II data in other solid tumors.

"Through our extensive clinical research efforts, we are committed to bringing impactful new medicines to patients in need as rapidly as possible," said Christopher Flowers, M.D., Division Head of Cancer Medicine at MD Anderson. "We are pleased to be collaborating with Summit to broaden the clinical development efforts of ivonescimab and its unique mechanism of action to support our mutual goal to improve the therapeutic options for patients with cancer."

MD Anderson and Summit will collaborate on the design and conduct of preclinical and clinical studies with oversight from a joint steering committee. This research is expected to begin later this year.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days (Zhong, et. al., SITC (Free SITC Whitepaper), 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,800 patients have been treated with ivonescimab in clinical studies globally.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC.

In addition, Akeso has recently had positive read-outs in two single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC, HARMONi-A and HARMONi-2.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression (PD-L1 TPS >1%).

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024.

On July 24, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the publication of new pre-clinical data concerning the company’s drug Ampligen as part of a combinational therapy in the treatment of melanoma, showing that combination dendritic cell-based vaccines including anti-PD-L1 checkpoint inhibitors and Ampligen-containing chemokine modulation helped slow tumor cell growth and improved survival in a mouse model (Press release, AIM ImmunoTech, JUL 24, 2024, View Source [SID1234645033]).

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"Therapeutic Anti-Tumor Efficacy of DC-Based Vaccines Targeting TME-Associated Antigens is Improved When Combined with a Chemokine-Modulating Regimen and/or Anti-PD-L1" was published in the peer-reviewed journal Vaccines.

AIM Medical Officer David Strayer, MD, stated: "This new pre-clinical data further demonstrates Ampligen’s therapeutic potential when used with dendritic-cell vaccines, with anti-PD-L1 checkpoint inhibitors, or in combination with both. The data supports AIM’s belief that we are on the right path in our ongoing development of Ampligen as an anti-tumor therapy."

On July 24, 2024 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics targeting EGFR and LGR5, compared to investigator’s choice of single agent chemotherapy or cetuximab in previously treated (2/3L) patients with recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) referred to as the LiGeR-HN2 trial (Press release, Merus, JUL 24, 2024, View Source [SID1234645067]).

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Merus has confirmed through feedback with the U.S. Food and Drug Administration (FDA) that petosemtamab 1500 mg every two weeks is appropriate for further development in HNSCC as monotherapy, and in combination with pembrolizumab.

"With petosemtamab’s strong clinical data in HNSCC and alignment with the FDA on dose, we are excited to have treated our first patient in the 2/3L phase 3 trial," said Fabian Zohren, M.D., Ph.D., Chief Medical Officer of Merus. "We believe petosemtamab has the potential to become the new standard of care across r/m HNSCC."

More details of the trial can be found at clinicaltrials.gov.

About LiGeR-HN2
LiGeR-HN2, a phase 3 trial, will evaluate the safety and efficacy of petosemtamab compared to investigator’s choice of methotrexate, docetaxel, or cetuximab in 2/3L r/m HNSCC patients. The trial is open to adult patients that have progressed on or after anti-PD-1 therapy and platinum-containing therapy. The primary endpoints are overall response rate as assessed by BICR based on RECIST v1.1 and overall survival. Secondary endpoints are duration of response and progression free survival. Merus plans to enroll approximately 500 patients in the trial.

About Petosemtamab
Petosemtamab, or MCLA-158, is a Biclonics low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.

About Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) describes a group of cancers that develop in the squamous cells that line the mucosal surfaces of the mouth, throat, and larynx. These cancers begin when healthy cells change and grow in an unchecked manner, ultimately forming tumors. HNSCC is generally associated with tobacco consumption, alcohol use and/or HPV infections, depending on where they develop geographically. HNSCC is the sixth most common cancer worldwide and it is estimated that there were more than 930,000 new cases and over 465,000 deaths from HNSCC globally in 2020.1 The incidence of HNSCC continues to rise and is anticipated to increase by 30% to more than 1 million new cases annually by 2030.2 HNSCC is a serious and life-threatening disease with poor prognosis despite currently available standard of care therapies.

On July 24, 2024 Alkermes plc (Nasdaq: ALKS) reported financial results for the second quarter of 2024 (Press release, Alkermes, JUL 24, 2024, View Source [SID1234645034]).

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"Our second quarter results reflect solid execution across our business, delivering double-digit, year-over-year growth for our proprietary commercial product portfolio and robust profitability. We enter the second half of the year in a strong financial position with clear operational priorities to drive the performance of our commercial portfolio and advance our neuroscience development pipeline, including the phase 2 program for ALKS 2680 in narcolepsy type 1 and type 2," said Richard Pops, Chief Executive Officer of Alkermes. "As a profitable, smid-cap biotech growth company with multiple commercial products and a development pipeline with significant value potential, we are executing our plan to become a leader in the field of neuroscience."

Key Financial Highlights

Revenues

(In millions)

Three Months Ended
June 30,

Six Months Ended
June 30,

2024

2023

2024

2023

Total Revenues

$

399.1

$

617.4*

$

749.5

$

905.0*

Total Proprietary Net Sales

$

269.3

$

231.5

$

502.8

$

446.2

VIVITROL

$

111.9

$

102.1

$

209.5

$

198.7

ARISTADAi

$

86.0

$

82.4

$

164.9

$

162.5

LYBALVI

$

71.4

$

47.0

$

128.4

$

85.0

Profitability

(In millions)

Three Months Ended
June 30,

Six Months Ended
June 30,

2024

2023

2024

2023

GAAP Net Income From Continuing Operations

$

94.7

$

279.1

$

133.6

$

267.1

GAAP Net Loss From Discontinued Operations

$

(3.3)

$

(42.0)

$

(5.4)

$

(71.8)

GAAP Net Income

$

91.4

$

237.1*

$

128.2

$

195.2*

Non-GAAP Net Income From Continuing Operations

$

123.4

$

134.3

$

199.6

$

164.4

Non-GAAP Net Loss From Discontinued Operations

$

(3.3)

$

(40.0)

$

(5.4)

$

(67.7)

Non-GAAP Net Income

$

120.1

$

94.3

$

194.2

$

96.7

EBITDA From Continuing Operations

$

118.6

$

299.1

$

170.1

$

306.2

EBITDA From Discontinued Operations

$

(3.9)

$

(41.4)

$

(6.4)

$

(77.4)

EBITDA

$

114.7

$

257.7*

$

163.7

$

228.9*

*As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the three months ended June 30, 2023 included approximately $245.5 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA products (consisting of $195.4 million for 2022 and $50.1 million for the first quarter of 2023) that would ordinarily have been recognized in prior periods.

Revenue Highlights

LYBALVI

Revenues for the quarter were $71.4 million.
Revenues and total prescriptions for the quarter grew 52% and 44%, respectively, compared to the second quarter of 2023.
ARISTADAi

Revenues for the quarter were $86.0 million.
New to brand prescriptions for the quarter grew 6% sequentially compared to the first quarter of 2024.
VIVITROL

Revenues for the quarter were $111.9 million.
Revenues for the quarter grew 10% compared to the second quarter of 2023, driven by the alcohol dependence indication.
Manufacturing & Royalty Revenues

Royalty revenues from INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the quarter were $78.7 million.
VUMERITY manufacturing and royalty revenues for the quarter were $35.2 million.
Key Operating Expenses

Please see Note 1 below for details regarding discontinued operations.

(In millions)

Three Months Ended
June 30,

Six Months Ended
June 30,

2024

2023

2024

2023

R&D Expense – Continuing Operations

$

59.6

$

68.2

$

127.3

$

132.0

R&D Expense – Discontinued Operations

$

3.9

$

32.6

$

6.4

$

62.4

SG&A Expense – Continuing Operations

$

168.1

$

195.8

$

347.9

$

363.6

SG&A Expense – Discontinued Operations

$

–

$

9.5

$

–

$

16.1

Balance Sheet

At June 30, 2024, the company recorded cash, cash equivalents and total investments of $962.5 million, compared to $807.8 million at March 31, 2024. The company’s total debt outstanding as of June 30, 2024 was $289.5 million.

Share Repurchase Program
During the second quarter of 2024, the company repurchased approximately 3.5 million of the company’s ordinary shares under the share repurchase program authorized in February 2024, at a total purchase price of $84.7 million. As of June 30, 2024, the company had $315.3 million (exclusive of any fees, commissions or other expenses related to such repurchases) remaining under the program.

Financial Expectations for 2024
Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024.

Recent Events

In April 2024, the company announced positive topline results from the narcolepsy type 2 and idiopathic hypersomnia cohorts in its phase 1b proof-of-concept study evaluating ALKS 2680, the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy.
In April 2024, the company announced initiation of its Vibrance-1 phase 2 study of ALKS 2680 in patients with narcolepsy type 1.
In May 2024, the company completed the sale of its development and manufacturing facility in Athlone, Ireland to Novo Nordisk. Alkermes received a cash payment for the facility and certain related assets of approximately $91 million.
In May and June 2024, the company presented research related to its psychiatry franchise products—LYBALVI (olanzapine and samidorphan) and ARISTADA (aripiprazole lauroxil)—at several scientific conferences. The conferences included: American Psychiatric Association (APA) Annual Meeting, American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, and Psych Congress Elevate.
In June 2024, the company presented new research related to ALKS 2680 and narcolepsy, including new data from the full narcolepsy type 1 cohort in its phase 1b, proof-of-concept study evaluating ALKS 2680, at SLEEP 2024, the 38th annual meeting of the Associated Professional Sleep Societies (APSS).
Notes and Explanations

1. The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and six months ended June 30, 2023.

Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 24, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

On July 24, 2024 Boston Scientific Corporation (NYSE: BSX) reported net sales of $4.120 billion during the second quarter of 2024, growing 14.5 percent on a reported basis, 16.1 percent on an operational1 basis and 14.7 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, JUL 24, 2024, View Source [SID1234645035]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $324 million or $0.22 per share (EPS), compared to $261 million or $0.18 per share a year ago, and achieved adjusted3 EPS of $0.62 for the period, compared to $0.53 a year ago.

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"We delivered a quarter marked by exceptional performance, reflecting our global team’s relentless pursuit of innovation that is supported by strong clinical evidence and investments aligned with our strategy of category leadership," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We remain excited about our plans for the future, and I am incredibly grateful for the commitment and winning spirit of our employees around the world."

Second quarter financial results and recent developments:

Reported net sales of $4.120 billion, representing an increase of 14.5 percent on a reported basis, compared to the company’s guidance range of 10.5 to 12.5 percent; 16.1 percent on an operational basis; and 14.7 percent on an organic basis, compared to the company’s guidance range of 10 to 12 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.22 per share, compared to the company’s guidance range of $0.35 to $0.37 per share, and achieved adjusted EPS of $0.62 per share, compared to the guidance range of $0.57 to $0.59 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 9.0 percent reported, 10.1 percent operational and 7.6 percent organic
Cardiovascular: 17.8 percent reported, 19.7 percent operational and 19.0 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 16.9 percent reported and operational
Europe, Middle East and Africa (EMEA): 13.7 percent reported and 16.1 percent operational
Asia-Pacific (APAC): 7.0 percent reported and 13.2 percent operational
Latin America and Canada (LACA): 15.3 percent reported and 15.7 percent operational
Emerging Markets4: 14.8 percent reported and 19.3 percent operational

Received National Medical Products Administration (NMPA) approval in China for the FARAPULSE Pulsed Field Ablation (PFA) System.

Presented the following clinical data at Heart Rhythm 2024:
Outcomes from a sub-analysis of the pivotal ADVENT clinical trial of the FARAPULSE PFA System, which demonstrated that treatment with the system resulted in an atrial arrhythmia burden (i.e., the total arrhythmia duration experienced by a patient) of less than 0.1% – a clinically meaningful threshold – in significantly more patients compared to thermal ablation.
Acute outcomes from the global FARADISE registry, which demonstrated favorable 30-day outcomes in more than 1,100 patients treated with the FARAPULSE PFA System, with no deaths or reports of coronary spasm, persistent phrenic nerve palsy, atrioesophageal fistula or pulmonary vein stenosis.
Positive results from the ongoing pivotal MODULAR ATP clinical trial of the Modular CRM (mCRM) System5 which met all pre-specified six-month safety and effectiveness endpoints. This is the first modular cardiac rhythm management (mCRM) system that consists of the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System and the EMPOWER Leadless Pacemaker.

Initiated the U.S. launch of the AGENT Drug-Coated Balloon, indicated to treat in-stent restenosis in patients with coronary artery disease, and received NMPA approval for the device in China.

Announced agreement to acquire Silk Road Medical, Inc., (Nasdaq: SILK) a publicly traded medical technology company that commercialized a platform of products to prevent stroke in patients with carotid artery disease, subject to customary closing conditions.

Presented outcomes at the 2024 American Society of Pain & Neuroscience meeting from three follow-up studies of patients treated with the Intracept Intraosseous Nerve Ablation System, which demonstrated significant improvements in vertebrogenic pain with nearly one-third of patients 100% pain free after five years.

Elected to the company’s board of directors Dr. Cheryl Pegus, former partner at Morgan Health and former executive vice president of Health & Wellness at Walmart.

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 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 Medical Device Regulation (EU MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain 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.
5. The EMPOWER Leadless Pacemaker is an investigational device and limited by U.S. law to investigational use only. It is not available for sale. Some device references are for informational purposes only and are pending CE Mark. Not available in the European Economic Area.

Net sales for the second quarter by business and region:

View News Release Full Screen

Increase/(Decrease)

Three Months Ended

June 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

Impact of
Recent
Acquisitions/
Divestitures

Organic
Basis

(in millions)

2024

2023

Endoscopy

$ 676

$ 631

7.1 %

1.3 %

8.4 %

(0.5) %

7.9 %

Urology

525

485

8.2 %

0.9 %

9.1 %

— %

9.1 %

Neuromodulation

282

244

15.5 %

0.7 %

16.2 %

(12.5) %

3.7 %

MedSurg

1,483

1,360

9.0 %

1.0 %

10.1 %

(2.5) %

7.6 %

Cardiology

2,047

1,704

20.1 %

1.9 %

22.0 %

— %

22.0 %

Peripheral Interventions

590

535

10.2 %

2.1 %

12.3 %

(2.8) %

9.4 %

Cardiovascular

2,637

2,239

17.8 %

1.9 %

19.7 %

(0.7) %

19.0 %

Net Sales

$ 4,120

$ 3,599

14.5 %

1.6 %

16.1 %

(1.4) %

14.7 %

View News Release Full Screen

Increase/(Decrease)

Three Months Ended June 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2024

2023

U.S.

$ 2,466

$ 2,110

16.9 %

— %

16.9 %

EMEA

822

723

13.7 %

2.5 %

16.1 %

APAC

670

626

7.0 %

6.2 %

13.2 %

LACA

162

140

15.3 %

0.4 %

15.7 %

Net Sales

$ 4,120

$ 3,599

14.5 %

1.6 %

16.1 %

Emerging Markets4

$ 680

$ 592

14.8 %

4.6 %

19.3 %

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 acquisitions/divestitures are not prepared
in accordance with U.S. GAAP.

Guidance for Full Year and Third Quarter 2024

The company estimates net sales growth for the full year 2024, versus the prior year period, to be in range of approximately 13.5 to 14.5 percent on a reported basis, and 13 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 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 $1.34 to $1.38 and estimates adjusted EPS, excluding certain charges (credits), of $2.38 to $2.42.

The company estimates net sales growth for the third quarter of 2024, versus the prior year period, to be in a range of approximately 13 to 15 percent on both a reported basis and organic basis. Third 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 $0.36 to $0.38 and adjusted EPS, excluding certain charges (credits), of $0.57 to $0.59.

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.