On October 27, 2023 AbbVie (NYSE:ABBV) reported financial results for the third quarter ended September 30, 2023 (Press release, AbbVie, OCT 27, 2023, View Source [SID1234636404]).

"We delivered another quarter of outstanding results driven by accelerating performance across our non-Humira growth platform, which is demonstrating double-digit growth," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Based upon the strength and momentum of our business, we are once again raising our full-year 2023 guidance as well as our floor EPS outlook for next year. We are also increasing our quarterly dividend, underscoring our confidence in AbbVie’s long-term outlook."

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Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates. 1

Third-Quarter Results

•Worldwide net revenues were $13.927 billion, a decrease of 6.0 percent on a reported basis, or 5.8 percent on an operational basis.

•Global net revenues from the immunology portfolio were $6.783 billion, a decrease of 11.3 percent.
◦Global Humira net revenues of $3.547 billion decreased 36.2 percent. U.S. Humira net revenues were $3.020 billion, a decrease of 39.1 percent. Internationally, Humira net revenues were $527 million, a decrease of 12.6 percent on a reported basis, or 12.2 percent on an operational basis.
◦Global Skyrizi net revenues were $2.126 billion, an increase of 52.1 percent on a reported basis, or 51.9 percent on an operational basis.
◦Global Rinvoq net revenues were $1.110 billion, an increase of 59.8 percent on a reported basis, or 59.6 percent on an operational basis.

•Global net revenues from the oncology portfolio were $1.512 billion, a decrease of 8.4 percent on a reported basis, or 8.6 percent on an operational basis.
◦Global Imbruvica net revenues were $908 million, a decrease of 20.0 percent, with U.S. net revenues of $678 million and international profit sharing of $230 million.
◦Global Venclexta net revenues were $590 million, an increase of 14.6 percent on a reported basis, or 14.0 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $2.043 billion, an increase of 22.1 percent on a reported basis, or 22.0 percent on an operational basis.
◦Global Botox Therapeutic net revenues were $748 million, an increase of 7.1 percent on a reported basis, or 7.4 percent on an operational basis.
◦Global Vraylar net revenues were $751 million, an increase of 35.4 percent.
◦Global Ubrelvy net revenues were $233 million, an increase of 45.6 percent.
◦Global Qulipta net revenues were $132 million.

•Global net revenues from the aesthetics portfolio were $1.239 billion, a decrease of 4.7 percent on a reported basis, or 4.0 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $620 million, a decrease of 2.7 percent on a reported basis, or 1.7 percent on an operational basis.
◦Global Juvederm net revenues were $321 million, a decrease of 8.6 percent on a reported basis, or 7.9 percent on an operational basis.

•On a GAAP basis, the gross margin ratio in the third quarter was 53.4 percent. The adjusted gross margin ratio was 83.5 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 24.2 percent of net revenues. The adjusted SG&A expense was 23.9 percent of net revenues.

•Research and development (R&D) expense on a GAAP and adjusted basis was 12.4 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.

•Acquired IPR&D and milestones expense was 0.5 percent of net revenues.

•On a GAAP basis, the operating margin in the third quarter was 16.4 percent. The adjusted operating margin was 46.7 percent.

•Net interest expense was $398 million.

•On a GAAP basis, the tax rate in the quarter was 8.8 percent. The adjusted tax rate was 15.7 percent.

•Diluted EPS in the third quarter was $1.00 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.95. These results include an unfavorable impact of $0.04 per share related to acquired IPR&D and milestones expense.
Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.
2

Recent Events

•AbbVie announced that it submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Skyrizi (risankizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). The submissions are supported by two Phase 3 clinical trials demonstrating Skyrizi achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

•AbbVie announced positive topline results from SEQUENCE, a Phase 3 study evaluating Skyrizi versus Stelara (ustekinumab) in patients with moderately to severely active Crohn’s disease (CD) who have failed one or more anti-TNF therapies. In the study, Skyrizi met both primary endpoints (non-inferiority for clinical remission per CDAI at week 24 and superiority of endoscopic remission at week 48) versus Stelara. All secondary endpoints in the trial achieved statistical significance for superiority versus Stelara. Safety results were consistent with the overall safety profile of Skyrizi, with no new safety risks identified.

•AbbVie announced that its Phase 2b study evaluating Rinvoq (upadacitinib) in adults with non-segmental vitiligo (NSV) met the primary endpoint of percent change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 with the 11 mg and 22 mg doses versus placebo. The percent reduction from baseline in F-VASI at week 52 was numerically greater than results at week 24 for all Rinvoq doses. No new safety signals were identified beyond the known safety profile for Rinvoq. Based on these data, AbbVie is advancing its clinical program of Rinvoq in vitiligo to Phase 3.

•At the United European Gastroenterology (UEG) Week 2023, AbbVie shared 23 abstracts, including 11 oral presentations and 12 poster presentations, spanning research on Skyrizi and Rinvoq in both CD and UC. Highlights included late-breaking data from the head-to-head Phase 3 SEQUENCE study evaluating Skyrizi versus Stelara in CD, primary efficacy and safety results from the Phase 3 INSPIRE induction study for Skyrizi in UC, as well as analyses on clinical and endoscopic outcomes from AbbVie’s maintenance trials for Skyrizi and Rinvoq in CD and for Rinvoq in UC.

•At the European Academy of Dermatology and Venereology (EADV) Congress, AbbVie announced new data analyses from the Measure Up 1, Measure Up 2 and AD Up Phase 3 studies that further demonstrated the long-term efficacy and safety profile of Rinvoq among adults and adolescents 12 years and older with moderate to severe atopic dermatitis (AD). Across all 3 studies, response rates for EASI 75 and vIGA-AD 0/1 (co-primary endpoints) and for EASI 90 and WP-NRS 0/1 at week 16 were sustained through week 140 among patients treated with Rinvoq. Safety results were consistent with the known safety profile of Rinvoq, with no new safety signals observed.

•AbbVie announced that the European Commission (EC) granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Tepkinly is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU). This conditional marketing authorization approval represents AbbVie’s second approved hematological cancer treatment in the EU and is supported by data from the pivotal Phase 1/2 EPCORE NHL-1 clinical trial. Tepkinly is being co-developed by AbbVie and Genmab.

•In August 2023, as part of Inflation Reduction Act (IRA) of 2022, the company’s oncology product Imbruvica, sold in the U.S., was included on the list of products selected for price negotiation by the Centers for Medicare & Medicaid Services (CMS). The selection contributed to a significant decrease in the estimated future cash flows for the product and represented a triggering event which required the company to evaluate the underlying definite lived-intangible asset for impairment. The company utilized a discounted cash flow analysis to estimate the fair value of the intangible asset resulting in a partial impairment of both the gross and net carrying amount. Based on the revised cash flows, the company recorded a pre-tax impairment charge of $2.1 billion to cost of products sold in the condensed consolidated statement of earnings for the third quarter of 2023. The remaining intangible asset carrying value related to Imbruvica in the U.S. totaled $1.8 billion as of September 30, 2023.

•AbbVie announced results from CANOVA, a Phase 3 study evaluating Venclexta (venetoclax) plus dexamethasone (VenDex) for patients with t(11;14)-positive r/r multiple myeloma (MM) who received two or more prior treatments. Data did not demonstrate that the treatment combination significantly improved progression-free survival (PFS), the primary endpoint of the trial. Patients receiving VenDex showed improvement in median PFS of 9.9 months compared to 5.8 months with the combination of study comparator pomalidomide and dexamethasone (PomDex); however, the results did not reach statistical significance. Results were presented at the International Myeloma Society (IMS) Annual Meeting and AbbVie will discuss the data with health authorities to further understand the potential of venetoclax as a biomarker-driven therapy in MM. Venclexta is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

•AbbVie announced that the (EC) approved Aquipta (atogepant) for the prophylaxis of migraine in adults who have four or more migraine days per month. The approval makes Aquipta the only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment in the EU for the preventive treatment of both chronic and episodic migraine. The approval is based on two pivotal Phase 3 studies that demonstrated statistically significant reduction in mean monthly migraine days with Aquipta compared to placebo in adult patients with both chronic and episodic migraine.

•Allergan Aesthetics announced positive topline results from the second of three Phase 3 clinical studies evaluating Botox Cosmetic (onabotulinumtoxinA) for the treatment of moderate to severe platysma prominence associated with platysma muscle activity. All primary and secondary endpoints were met for this study and results were consistent with findings from the first Phase 3 study. Results support Botox Cosmetic as a potential treatment option for moderate to severe platysma prominence and data will be included as part of an upcoming FDA regulatory submission expected near the end of the year. If approved, Botox Cosmetic will be the first and only neurotoxin for this indication.

•Allergan Aesthetics announced positive topline results from two pivotal Phase 3 clinical studies evaluating trenibotulinumtoxinE (BoNT/E) for the treatment of moderate to severe glabellar lines. All primary and secondary endpoints were met for both studies and results support trenibotulinumtoxinE as a novel botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration and short duration of effect within 2-3 weeks.

•AbbVie announced that it exercised its exclusive right to acquire of Mitokinin, a discovery-stage biotechnology company developing a potentially first-in-class disease-modifying treatment for Parkinson’s Disease (PD). Mitokinin’s lead compound, a selective PINK1 activator, is designed to address mitochondrial dysfunction that is believed to be a major contributing factor to PD pathogenesis and progression.

Full-Year 2023 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2023 from $10.86 – $11.06 to $11.19 – $11.23, which includes an unfavorable impact of $0.27 per share related to acquired IPR&D and milestones expense incurred year-to-date through the third quarter 2023. The company’s 2023 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the third quarter of 2023, as both cannot be reliably forecasted.

AbbVie Raises 2024 EPS Guidance Floor

AbbVie is raising its adjusted diluted EPS guidance floor for the full year 2024 from $10.70 to $11.00, which excludes any impact from acquired IPR&D and milestones, as both cannot be reliably forecasted. This is an update to guidance that was initially issued in February 2023 as part of AbbVie’s fourth quarter 2022 earnings call. As a result of this update, AbbVie does not expect adjusted diluted EPS for full year 2024 to be below $11.00 per share. The company will issue its formal 2024 adjusted diluted EPS guidance range in conjunction with fourth quarter 2023 results.

Company Declares Dividend Increase of 4.7 Percent

AbbVie is announcing today that its board of directors declared an increase in the company’s quarterly cash dividend from $1.48 per share to $1.55 per share beginning with the dividend payable on February 15, 2024 to shareholders of record as of January 16, 2024. This reflects an increase of approximately 4.7 percent, continuing AbbVie’s strong commitment to returning cash to shareholders through a growing dividend. Since the company’s inception in 2013, AbbVie has increased its quarterly dividend by more than 285 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On October 27, 2023 SN Bioscience Co., Ltd. (CEO Younghwan Park) reported the results of the phase 1 clinical study of SNB-101, a nanoparticle anti-cancer new drug pipeline, at ESMO (Free ESMO Whitepaper) Congress 2023 held in Madrid, Spain from October 20 to 24 (Press release, SN BioScience, OCT 27, 2023, View Source [SID1234636396]). This phase 1 clinical study was conducted to evaluate the safety and tolerability of SNB-101 administered to 21 patients with solid tumors in Korea and to determine the recommended dose for phase 2. CHA Bundang Medical Center (Professor Joo-Hang Kim), Catholic University of Korea Seoul ST. Mary’s Hospital (Professor Myung A Lee), and Severance Hospital of the Yonsei University (Professor Sun Young Rha) participated in this study.

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In this phase 1 clinical study, patients with various solid cancers, such as small cell lung cancer, non-small cell lung cancer, gastric cancer, esophageal cancer, head and neck cancer, and rectal cancer, who failed existing standard therapy were enrolled, and they had previously experienced 1st to 9th lines of treatment.

The results of the phase 1 study showed excellent safety in the dosage range (5 to 50 mg/m2 as of SN-38) and did not reach the maximum tolerable dose (MTD) even when all the cohorts were consumed. The most common adverse drug reactions were hematological, such as neutropenia, and were well manageable. In particular, diarrhea of grade 3 or higher, a major adverse drug reaction that frequently occurs with irinotecan, a drug with same active moiety, was not observed. Accordingly, it was evaluated to have excellent safety and tolerability compared to the competitive drugs.

In terms of the efficacy evaluation results, out of a total of 21 patients, partial response (PR) was 14.3% (3 patients, small cell lung cancer, non-small cell lung cancer, rectal cancer), and stable disease (SD) was 28.6% (6 patients, small cell lung cancer, non-small cell lung cancer, rectal cancer, head and neck cancer, gastric cancer), and progressive disease (PD) was 57.1% (12 patients). The disease control rate (DCR) of all patients was 42.9%, well demonstrating the characteristics of general cytotoxic anti-cancer drugs. In particular, in the high dose group (40~50mg/m2), the DCR was 83.3%, well indicating dose dependency.

SNB-101 is a polymeric nanoparticle with an average particle size of approximately 100 nm, and in the preclinical studies, its distribution to the lungs was significantly higher than that of the anti-cancer drugs in conventional delivery. That aligns well with the efficacy results in lung-related tumors such as small cell lung cancer and non-small cell lung cancer from preclinical and phase 1 clinical studies. Based on the results, SN Bioscience plans to conduct multinational phase 2 clinical study targeting the small cell lung cancer in 2024.

For small cell lung cancer, which is one of the areas with very high unmet medical needs, cisplatin + etoposide combination is currently used as the first line standard therapy. Second line therapies include lurbinectedin (product name: Zebzelca), which was recently approved as an orphan drug, and topotecan and paclitaxel, which are traditional chemotherapeutic regimen. According to the NCCN (National Comprehensive Cancer Network) guidelines, treatments are so limited that clinical studies are listed as second line treatment options. In preclinical studies, SNB-101 showed superior efficacy over the first line therapies as well as the second line therapies that are approved for small cell lung cancer. The goal of phase 2 clinical study is to show the superiority over competitive drugs as monotherapy and/or combination with immunotherapy, based on which, SN BioScience plans to enter the global market through expedited approval process after completing phase 2 clinical study.

[SNB-101]

SNB-101 is the world’s first nano-anti-cancer drug in which the active metabolite (SN-38) of Irinotecan, a commercially available anti-cancer drug, is active ingredient, and is applied with double nanomicelle technology, a core platform technology of SN Bioscience. SNB-101 is expected to secure new indications as it does not require a metabolic step for activation as well as the advantage of directly administering SN-38, an active metabolite. SNB-101 is a polymeric nanoparticle of approximately 100 nm characterized by a high accumulation rate, especially in the lung and tumor tissue, when administered intravenously, and has shown a wide range of efficacy in solid cancers such as small cell lung cancer, gastric cancer, colon cancer, and pancreatic cancer in preclinical studies. In addition, since it shows a synergistic effect even when used in combination with commercially available immune-anti-cancer drugs, targeted anti-cancer drugs, and chemical anti-cancer drugs, the possibility of its development as a combination therapy in the future is also very high. SNB-101 has secured mass production technology, which is one of the barriers to the development of nanomedicines and is being produced as a sterile product by a contract manufacturing organization (CMO) specializing in anti-cancer drugs that has received EU GMP certification. Furthermore, the US FDA has designated SNB-101 for orphan drug on SCLC based on the medical needs and its preclinical outcome.

On October 26, 2023 Medidata, a Dassault Systèmes company and leading provider of clinical trial solutions to the life sciences industry, reported a multi-year partnership expansion with Catalyst Clinical Research to support their global oncology brand, Catalyst Oncology (Press release, Catalyst Clinical Research, OCT 26, 2023, View Source [SID1234638823]). This renewal builds upon Catalyst’s existing success with the Medidata Platform and incorporates wider offerings, including Medidata Grants Manager and Medidata AI Intelligent Trials, as Catalyst has grown into a robust and global full-service clinical research organization.

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This continued commitment for Medidata Rave EDC, Medidata Rave CTMS, and Medidata Rave eTMF enables Catalyst to run complex clinical trials while simplifying its operations and management. By using these integrated capabilities, and incorporating the expansive elements of Grants Manager and Intelligent Trials, Catalyst can streamline workflows, automate document management, and improve visibility to critical trial metrics.

"Medidata remains our preferred partner because of their scalability and skill in managing complex trials," said Nik Morton, president and COO, Catalyst. "Their advanced technology will further support our growth and expansion."

Catalyst has supported over 150 oncology studies and is currently managing more than 80 next-generation cancer clinical trials today across Phases I-III. With 90% of all oncology approvals last year in the U.S. developed using Medidata software, Catalyst’s use of the Medidata Platform will be critical to their continued expansion. In addition, Catalyst is excited to leverage Medidata AI, which accesses a dataset spanning more than 20 years to engage a more diverse patient population and accelerate enrollment.

"Medidata is thrilled to serve as Catalyst’s partner since their first trial in 2019 and be part of their continued success," said Joan Shaiman, senior vice president, Partners, Medidata. "Their decision to recommit to the core elements of our Platform and adopt broader solutions demonstrates that we have the expertise and capabilities needed to support faster decision-making and accelerate trials to advance cancer research."

On October 26, 2023 Orion reported its Interim Report January to September 2023 (Presentation, Orion, OCT 26, 2023, View Source [SID1234638623]).

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On October 26, 2023 Boston Scientific Corporation (NYSE: BSX) reported net sales of $3.527 billion during the third quarter of 2023, growing 11.2 percent on a reported basis, 11.1 percent on an operational1 basis and 10.2 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, OCT 26, 2023, View Source;_gl=1*1muje07*_ga*MTgxMjY3ODM0OS4xNzAyMzU3ODg1*_ga_759NN7RMMK*MTcwMjM1Nzg4NC4xLjEuMTcwMjM1NzkxNS4wLjAuMA.. [SID1234638411]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $505 million or $0.34 per share (EPS), compared to $174 million or $0.12 per share a year ago, and achieved adjusted3 EPS of $0.50 for the period, compared to $0.43 a year ago.

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"We achieved another quarter of strong performance, thanks to the hard work of our talented global team and our differentiated medical technologies that improve the lives of patients across the globe," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "As we shared at our recent Investor Day meeting, we are well-positioned for the long term, backed by our category leadership strategy, strong pipeline of innovation and track record of strong commercial execution."

Third quarter financial results and recent developments:

Reported net sales of $3.527 billion, representing an increase of 11.2 percent on a reported basis, compared to the company’s guidance range of 8.5 to 10.5 percent; 11.1 percent on an operational basis; and 10.2 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 $0.34 per share, compared to the company’s guidance range of $0.21 to $0.25 per share, and achieved adjusted EPS of $0.50 per share, compared to the guidance range of $0.46 to $0.48 per share.
Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 10.6 percent reported, 10.0 percent operational and 9.4 percent organic
Cardiovascular: 11.6 percent reported, 11.7 percent operational and 10.6 percent organic
Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 8.5 percent reported and operational
Europe, Middle East and Africa (EMEA): 14.7 percent reported and 10.9 percent operational
Asia-Pacific (APAC): 14.8 percent reported and 19.5 percent operational
Latin America and Canada (LACA): 22.0 percent reported and 16.1 percent operational
Emerging Markets4: 14.4 percent reported and 19.0 percent operational
Announced positive 12-month results from the ADVENT pivotal clinical trial of the FARAPULSE Pulsed Field Ablation (PFA) System,5 which met the primary safety and efficacy endpoints, and demonstrated the FARAPULSE PFA System is noninferior to standard-of-care therapies.
Completed enrollment in the first phase of the ADVANTAGE AF clinical trial studying the FARAPULSE PFA System for the treatment of patients with persistent atrial fibrillation (AF) and commenced enrollment in an extension arm of the study to evaluate the safety and effectiveness of adjunctive use of the FARAPOINT PFA Catheter for cavotricuspid isthmus (CTI) ablations, a procedure used to treat atrial flutter.
Received U.S. Food and Drug Administration (FDA) approval for the POLARx Cryoablation System, which includes the POLARx FIT Cryoablation Balloon Catheter and is used to treat patients with paroxysmal AF.
Announced the U.S. FDA approval of the latest-generation WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device, which is designed to improve visualization during device placement, reduce device-related thrombus post-implant and treat a broader range of patient anatomies.
Received U.S. FDA 510(k) clearance and launched the next-generation LUX-Dx II/II+ Insertable Cardiac Monitor (ICM) System for long-term monitoring of arrhythmias.
Received CE Mark, U.S. FDA clearance and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval for the AVVIGO+ Multi-Modality Guidance System, a next-generation technology that provides high-quality intravascular ultrasound (IVUS) imaging and physiologic assessment of coronary vessels and lesions.
Announced positive data at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium demonstrating statistical superiority of the AGENT Drug Coated Balloon5 versus uncoated balloon angioplasty for the treatment of patients with in-stent restenosis, meeting the primary endpoint of target lesion failure (TLF) at 12 months (17.9% vs. 28.7%, P=0.006) for the AGENT IDE clinical trial.
Presented at TCT were study results demonstrating statistically significant lower major bleeding rates in patients with pulmonary embolism (PE) who were treated with the EKOS Endovascular System compared to the Inari FlowTriever System as analyzed in the REAL-PE study.
Received U.S. FDA De Novo classification grant and marketing authorization for an expanded indication for the AXIOS Stent and Electrocautery-Enhanced Delivery System. The new indication allows for use of the device to facilitate endoscopic drainage of the gallbladder for patients with acute cholecystitis who are at high risk for surgery.
Announced U.S. FDA approval for an expanded indication of the WaveWriter Alpha Spinal Cord Stimulator (SCS) Systems for the treatment of painful diabetic peripheral neuropathy (DPN).
Announced agreement to acquire Relievant Medsystems, Inc., a privately held medical technology company that has developed and commercialized the only U.S. FDA-cleared system, the Intracept Intraosseous Nerve Ablation System, for vertebrogenic pain, subject to customary closing conditions.
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.

5. The FARAPULSE PFA System and the AGENT DCB are investigational devices. Restricted by Federal law to investigational use only. Not available for sale in the U.S.

Net sales for the third quarter by business and region:

Increase/(Decrease)

Three Months Ended
September 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

Impact of
Recent
Acquisitions /
Divestitures

Organic
Basis

(in millions)

2023

2022

Endoscopy

$ 629

$ 559

12.6 %

(0.7) %

11.9 %

(1.4) %

10.6 %

Urology

483

433

11.5 %

(0.5) %

11.1 %

— %

11.1 %

Neuromodulation

229

221

3.7 %

(0.4) %

3.2 %

— %

3.2 %

MedSurg

1,341

1,213

10.6 %

(0.5) %

10.0 %

(0.6) %

9.4 %

Cardiology

1,647

1,479

11.4 %

(0.1) %

11.4 %

— %

11.4 %

Peripheral Interventions

538

479

12.3 %

0.6 %

12.9 %

(4.5) %

8.4 %

Cardiovascular

2,185

1,958

11.6 %

0.1 %

11.7 %

(1.1) %

10.6 %

Net Sales

$ 3,527

$ 3,170

11.2 %

(0.1) %

11.1 %

(0.9) %

10.2 %

Increase/(Decrease)

Three Months Ended
September 30,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

(in millions)

2023

2022

U.S.

$ 2,099

$ 1,934

8.5 %

— %

8.5 %

EMEA

671

585

14.7 %

(3.8) %

10.9 %

APAC

611

532

14.8 %

4.7 %

19.5 %

LACA

146

119

22.0 %

(5.9) %

16.1 %

Net Sales

$ 3,527

$ 3,170

11.2 %

(0.1) %

11.1 %

Emerging Markets4

$ 594

$ 519

14.4 %

4.6 %

19.0 %

Amounts may not add due to the use of rounded numbers. Growth rates are based on actual, unrounded 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 Fourth Quarter 2023

The company now estimates net sales growth for the full year 2023, versus the prior year period, to be approximately 11 percent on both a reported basis and 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 $1.00 to $1.04 and estimates adjusted EPS, excluding certain charges (credits), of $1.99 to $2.02.

The company estimates net sales growth for the fourth quarter of 2023, versus the prior year period, to be in a range of approximately 9 to 11 percent on a reported basis, and approximately 8 to 10 percent on an organic basis. Fourth 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 $0.26 to $0.30 and adjusted EPS, excluding certain charges (credits), of $0.49 to $0.52.

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.