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Alkermes Announces Recipients of 2022 Alkermes Inspiration Grants® Program

On October 27, 2022 Alkermes plc (Nasdaq: ALKS) reported the 2022 recipients of the Alkermes Inspiration Grants program. Grants were awarded to nine nonprofit organizations working to address the needs of people living with alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and cancer (Press release, Alkermes, OCT 27, 2022, View Source [SID1234622450]). The selected programs also have a focus on addressing unmet needs in historically under-resourced or underrepresented communities with longstanding and widespread health disparities.

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"This year’s Alkermes Inspiration Grants recipients inspire us with their innovative approaches to providing critical support for people living with addiction, serious mental illness or cancer, as well as their caregivers and family members. These organizations have the potential to positively impact people across the U.S. and offer an opportunity to engage diverse communities in new ways," said Richard Pops, Chief Executive Officer of Alkermes.

Nearly 250 applications were submitted for this highly competitive program. Submissions were evaluated based on a set of criteria outlined in the request for proposals, including clearly defined needs, objectives, activity format, mode of delivery and intended audience, and relevance to historically under-resourced or underrepresented communities. Grant recipients were selected by a committee that included senior leaders from Alkermes and individuals from outside the organization chosen to represent the perspectives of people with lived experience, caregivers and patient advocates.

"Alkermes’ desire to support high-impact programs that can help those affected by addiction, cancer and serious mental illness came through clearly throughout the review process. I was impressed with the purposeful and collaborative effort, and the particular focus on supporting underserved communities and regions across the country," commented committee member Sharon Slade, Chief Marketing Officer, Cancer Research Institute.

Since 2016, the Alkermes Inspiration Grants program has awarded more than $4.5 million in funding to innovative programs that support the needs of those impacted by serious diseases in our areas of focus. For more information on the Alkermes Inspiration Grants program, please visit View Source

2022 Grant Recipient Organizations and Programs:

The American Psychiatric Association Foundation’s Building Bridges to Care: APAF Mental Health and Faith Community Partnership aims to foster dialogue to improve the understanding of mental health and substance use disorders, reduce stigma and increase connections to care with local community organizations, including faith-based organizations. The group will develop and disseminate culturally appropriate mental health information and resources for people with mental health and substance use disorders, including schizophrenia and bipolar disorder and/or caregivers for people living with these illnesses.

Community Anti-Drug Coalitions of America (CADCA) will create an alcohol use disorder (AUD) awareness video and fact sheet to further support CADCA’s training of local grassroots groups, known as community coalitions, with the goal of developing effective community problem-solving strategies related to substance use disorders. Groups are taught how to assess their local alcohol, tobacco and other drug-related problems and develop a comprehensive plan to address them. The video and fact sheet will be used to increase awareness and reduce stigma of AUD and seeking treatment.

Depression and Bipolar Support Alliance’s (DBSA) Addressing Mental Health Disparities Through Peer Support program will train Asian American/Pacific Islander, Black and rural peers with lived experience as support group facilitators and create 10 peer-led support groups. The goal is for participants to address and overcome systemic barriers, increase their access to mental health support and achieve positive mental health outcomes along their recovery journeys.

Foundation for Women’s Cancer’s (FWC) Move The Message campaign is designed to motivate high-risk and historically marginalized communities to take preventive action by increasing awareness of gynecologic cancers through dissemination of vital FWC resources. Gynecological cancer mortality rates are increasing among women of color and rural women, with late-stage diagnoses more prevalent due to lack of education and awareness. FWC will take its message directly to communities across the country to drive awareness and enhance education and support of early diagnoses by motivating people to help #MoveTheMessage.

The National Association for Children of Addiction’s (NACoA) Children Deserve Recovery, Too! program seeks to deliver NACoA’s Children Program Kit training on-demand via a Learning Management System to 40 community-based youth-serving nonprofits in historically under-resourced and underrepresented communities with high rates of alcohol or opioid use disorder. Children living with a parent or caregiver who has alcohol or opioid use disorder are at high risk for experiencing adverse childhood experiences (ACEs), making them vulnerable to lifelong negative mental and physical health consequences. Early prevention and intervention are key for addressing this systemic issue, and this program will provide proven, trauma-sensitive, culturally informed educational support programs to mitigate the impact of ACEs.

Ovarcome’s Lifecycle of OVARCOMING program seeks to eradicate disparities in equity of care and information to Ovarcomers that are in an underrepresented part of the population. Ovarcome will educate, inform, engage and empower ovarian cancer survivors, caregivers, friends, family members and the general population with information on screening, genetics, detection, diagnosis, and treatment; a book of inspiration with real life stories for newly diagnosed patients; a video and resource packet to make Ovarcomers feel cared for; and a Clinical Trials Finder in both English and Spanish, among other resources. This information will help people take ownership of their treatment process and the journey of OVARCOMING.

Parents of Addicted Loved Ones’ Healing Families of Substance Use Disorder in the Nation’s Largest Cities program will start free weekly meeting groups utilizing Parents of Addicted Loved Ones’ evidence-based education in the nation’s 15 largest cities. The lessons used in the meetings will give parents whose adult children suffer from substance use disorder (SUD) the tools needed to encourage their loved one’s recovery and provide peer-to-peer support to face the challenges of SUD.

Sound Mind Live’s "Released" Mental Health Docuseries on bipolar disorder will be a five-part docuseries that will take us inside the lives and work of five influential musicians living with bipolar disorder. Each episode will focus on one artist living with bipolar disorder and how their journey with the condition and making music helped them break free from stigma to find support, healing and, ultimately, themselves to share their creations with the world. This will further the work Sound Mind Live does to bring together a coalition of mental health and music organizations with musicians and music lovers to build a supportive community and open dialogue around mental illness.

Young People in Recovery’s (YPR) Native American Youth Substance Use Disorder Recovery Support Services Pilot will be a community-based chapter and redesign of one of their existing life-skills curriculum programs to be linguistically and culturally appropriate for Native American youths who struggle with substance misuse or who are in recovery from substance use disorder. YPR will partner with one tribe to launch a new chapter to serve tribal constituents under age 30. The program will be staffed by Native Americans and create a youth advisory board to inform the program with the values, language, and traditions of the specific tribe.

Acorda Therapeutics Provides Long-Term Business Plan and Financial Guidance

On October 27, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported a detailed, long-term business plan to drive shareholder value and also provided long-term financial guidance (Press release, Acorda Therapeutics, OCT 27, 2022, View Source [SID1234622449]).

Acorda has developed a long-term business plan to increase the value of the Company, focused on growing INBRIJA (levodopa inhalation powder), maximizing AMPYRA (dalfampridine), and implementing additional operational and manufacturing efficiencies. Due to the recent Alkermes arbitration award, along with continued fiscal discipline, Acorda has substantial liquidity, which the Company expects will allow it to execute on its business plan. Acorda expects to be cash-flow positive in 2023. The outcome of the reverse stock split proposal at the upcoming Special Meeting of Stockholders, scheduled for November 4, 2022, will be a key determinant of Acorda’s strategic alternatives and ability to execute its business plan.

Key Assumptions Underlying Business Plan and Guidance

INBRIJA will continue to grow in the U.S.
INBRIJA will expand into additional ex-U.S. markets
AMPYRA will continue to lose market share, but at a stabilizing rate
Acorda’s expectation is to be cash-flow positive in 2023
Shareholder approval of reverse stock split proposal; continued Nasdaq listing
INBRIJA

The Company believes that INBRIJA has a significant opportunity to expand the market for on-demand treatments
INBRIJA currently enjoys a 67% market share within the on-demand treatment class1
Healthcare professionals report they are generally more comfortable with INBRIJA than apomorphine-based on-demand treatments2
< 2% of the 380,000 people with Parkinson’s who experience OFF periods are actively on any on-demand treatment3
Acorda is implementing high-potential initiatives to grow the INBRIJA business
Launching new brand campaigns for physicians and people with Parkinson’s
Expanding usage of recently launched E-prescribing platform, which removes barriers to prescribing and has increased fulfillment rates
Introducing cash-pay option to improve patient access
Focusing sales team with a hyper-targeted call strategy
Ex-U.S. revenue expected to increase in 2023 and 2024 as Germany launch progresses and additional launches commence in Spain and Latin America
Partner discussions are in progress for Asia and additional EU markets
AMPYRA

Alkermes arbitration ruling significantly improves operating margins
$16.5M cash received October 2022
No further royalty payments and ability to find lower-cost supply, which has already been secured
$10-$12M savings in 2023 annual cost of goods (based on volume)
AMPYRA net sales currently at ~13% of peak sales
AMPYRA currently holds ~15% of dalfampridine market4
Long-term value of the brand expected at ~10% of peak sales through 2027
Field team continues to promote the brand
~200 health care professionals resumed prescribing AMPYRA in 2022
Tenacity of prescribers and patients has resulted in fewer payer restrictions5
~70% of all covered lives have access to AMPYRA6
Financial Guidance

Acorda provided the following long-term financial guidance ranges, assuming successful implementation of the business plan and its key assumptions:

CEO Video Q&A Friday, October 28 at 1:00pm ET / 10:00am PT

Acorda will hold a video Q&A with its CEO, Ron Cohen, M.D., on Friday, October 28 at 1:00pm ET / 10:00am PT. The call will review Acorda’s long-term business plan and the items on the ballot for Acorda’s Special Meeting of Shareholders on November 4, 2022. Participants will be able to submit questions to Dr. Cohen, which he will address live.

Video Q&A Participation Instructions

To participate in the video event:

Click the link below from a laptop or mobile device. (Mobile device users will be prompted to download the BlueJeans app.) View Source
If prompted, enter the following case-sensitive Event ID: rraraavy

Sporos BioDiscovery Presents Preclinical Data on Differentiated TEAD Inhibitor Program, SPR1, at the 34th EORTC-NCI-AACR Symposium

On October 26, 2022 Sporos BioDiscovery, Inc. (a wholly owned affiliate of Sporos Bioventures, "Sporos" or the "Company"), a precision oncology company developing a diversified pipeline of small molecule therapeutic programs targeting cancer vulnerabilities in the tumor and tumor microenvironment, reported its poster presentation highlighting preclinical data on the Company’s lead program, SPR1, a differentiated, novel TEAD inhibitor at 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place October 26-28, 2022, in Barcelona, Spain.

"We were excited to present preclinical data from SPR1, a next-generation, finely tuned TEAD inhibitor program, with a unique TEAD isoform selectivity that we believe sets it apart from other TEAD inhibitors and offers a potential best-in-class profile. These preclinical data sets demonstrate compound safety and superior in vivo single-agent activity in large-volume tumor models and in combination with KRAS, MEK, and RTK inhibitors," said Dr. Stephen Rubino, Chief Executive Officer of Sporos. "Our data supports our initiative to move SPR1 into clinical development with a goal of filing an IND before the end of 2023."

The Hippo pathway (effected by the YAP/TAZ-TEAD transcriptional complex) is a major oncogenic pathway and hyperactivation of YAP/TAZ-TEAD transcription has been demonstrated as a key mechanism of resistance to MAPK pathway inhibition, as well as inhibition of its upstream inputs, such as EGFR and other receptor tyrosine kinases. The poster presents the first disclosure of SPR1, Sporos TEAD inhibitor program. Highlights of the poster, titled "A Family of Novel TEAD Palmitoylation Site Inhibitors with Exceptional Pre-clinical Anti-neoplastic Activity as a Monotherapy and in Combination with MAPK Inhibitors," include:

The synthesis of a series of small molecule inhibitors of TEAD transcription factors with nM activity in a broad range of cancer cell lines, coupled with favorable pharmacokinetic and safety profiles.
Fine-tuning of TEAD isoform specificity yielded exceptional TEAD inhibitors with low toxicity (MTD >300 mg/kg, >20X efficacious dose) coupled with high anti-tumor efficacy.
Sporos’ TEAD inhibitors yield rapid regression even in very large pre-clinical tumors, a first in the TEAD-inhibitor space.
Sporos’ TEAD inhibitors show strong synergy with precision oncology drugs targeting the MAPK pathway and its upstream inputs, including Sotorasib, Trametinib, and Osimertinib.
Differentiated activity profile of SPR1 TEAD inhibitors may derive from favorable TEAD isoform inhibitory specificity.

(Press release, Sporos BioDiscovery, OCT 26, 2022, View Source [SID1234662124])

Boston Scientific Announces Results for Third Quarter 2022

On October 26, 2022 Boston Scientific reported that it generated net sales of $3.170 billion during the third quarter of 2022, growing 8.1 percent on a reported basis, 13.7 percent on an operational1 basis and 11.5 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, OCT 26, 2022, View Source;_gl=1*lnrr96*_ga*MTE5OTI0MTk5Mi4xNjcyNDYzODY2*_ga_759NN7RMMK*MTY3MjQ2Mzg2NS4xLjEuMTY3MjQ2NDEwNS4wLjAuMA.. [SID1234625690]). The company reported GAAP net income available to common stockholders of $174 million or $0.12 per share (EPS), compared to $405 million or $0.28 per share a year ago, and achieved adjusted3 EPS of $0.43 for the period, compared to $0.41 a year ago.

"I’m pleased with our team’s ongoing commitment to executing our strategy, and the double-digit organic revenue growth we delivered across nearly every business," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "Despite ongoing challenges in the macro environment, we remain focused on enhancing our portfolio and delivering strong global performance."

Third quarter financial results and recent developments:

Reported net sales of $3.170 billion, representing an increase of 8.1 percent on a reported basis, compared to the company’s guidance range of 6 to 8 percent; 13.7 percent on an operational basis; and 11.5 percent on an organic basis, compared to the company’s guidance range of 8 to 10 percent, all compared to the prior year period.
Reported GAAP net income available to common stockholders of $0.12 per share, compared to the company’s guidance range of $0.20 to $0.24 per share, and achieved adjusted EPS of $0.43 per share, compared to the guidance range of $0.43 to $0.45 per share.
Achieved net sales growth in each reportable segment4, compared to the prior year period:
MedSurg: 6.5 percent reported, 11.0 percent operational and 9.8 percent organic
Cardiovascular: 9.1 percent reported, 15.3 percent operational and 12.6 percent organic
Achieved net sales growth/(declines) in each region, compared to the prior year period:
U.S.: 12.0 percent reported and operational
EMEA (Europe, Middle East and Africa): (0.8) percent reported and 15.2 percent operational
APAC (Asia-Pacific): 2.8 percent reported and 15.3 percent operational
LACA (Latin America and Canada): 20.4 percent reported and 24.2 percent operational
Emerging Markets5: 28.1 percent reported and 40.0 percent operational
Received CE Mark for the LUX-Dx Insertable Cardiac Monitor System, a long-term diagnostic device inserted under the skin in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope.
Received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use labeling for the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device to include a 45-day dual anti-platelet therapy (DAPT) option as an alternative to 45-day oral anticoagulation plus aspirin for post-procedural treatment of patients with non-valvular atrial fibrillation.
Launched Rezūm Water Vapor Therapy, a non-surgical treatment for benign prostatic hyperplasia (BPH), in Japan following regulatory approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) and approval of a new reimbursement category from Japan’s Central Social Insurance Medical Counsel (Chuikyo) for both the device and procedure.
Launched a line extension of the ELUVIA Drug-Eluting Stent (DES), introducing the longest-length DES (150 mm) available for treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA).
Presented late-breaking clinical data for the PROTECTED TAVR randomized trial evaluating the use of the SENTINEL Cerebral Protection System to reduce the risk of peri-procedural stroke in patients with aortic valve stenosis who are indicated for transcatheter aortic valve replacement (TAVR). The primary endpoint was not met, as data demonstrated a non-significant 21% relative risk reduction in all-stroke through 72 hours or time of hospital discharge in patients treated with the device vs. TAVR alone, while a secondary non-powered analysis demonstrated a significant 63% relative risk reduction in disabling stroke.
Completed enrollment in the AGENT IDE trial, a prospective, multi-center, randomized study evaluating the safety and effectiveness of the AGENT Drug Coated Balloon for the treatment of patients with coronary artery disease who experience in-stent restenosis.
Completed the acquisition of Obsidio, Inc., a privately-held company that developed a gel embolic material technology used for embolization of blood vessels in the peripheral vasculature.

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. In the first quarter of 2022, we reorganized our operational structure and have aggregated our core businesses, each of which generate revenues from the sale of medical devices (Medical Devices), into two reportable segments comprised of MedSurg and Cardiovascular. Within the Cardiovascular segment, the newly formed Cardiology division represents the combined former Rhythm Management and Interventional Cardiology businesses. We have revised prior period amounts to conform to the current year presentation.

5. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities.

Net sales for the third quarter by business and region:

Increase/(Decrease)

Three Months Ended

September 30,

Reported
Basis

Less: Impact
of Foreign
Currency
Fluctuations

Operational

Basis

Less:

Impact of
Recent
Acquisitions
/ Divestitures

Organic
Basis

(in millions)

2022

2021

Endoscopy

$ 559

$ 533

4.9 %

(5.6) %

10.4 %

— %

10.4 %

Urology and Pelvic Health

433

384

12.6 %

(3.6) %

16.2 %

3.6 %

12.6 %

Neuromodulation

221

(0.1) %

(3.2) %

3.2 %

— %

3.2 %

MedSurg4

1,213

1,138

6.5 %

(4.4) %

11.0 %

1.2 %

9.8 %

Cardiology

1,479

1,342

10.2 %

(6.3) %

16.5 %

3.7 %

12.8 %

Peripheral Interventions

479

452

5.9 %

(6.0) %

12.0 %

— %

12.0 %

Cardiovascular4

1,958

1,794

9.1 %

(6.2) %

15.3 %

2.8 %

12.6 %

Net Sales

$ 3,170

$ 2,932

8.1 %

(5.5) %

13.7 %

2.2 %

11.5 %

Increase/(Decrease)

Three Months Ended
September 30,

Reported
Basis

Less: Impact
of Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2022

2021

U.S.

$ 1,934

$ 1,726

12.0 %

— %

12.0 %

EMEA

585

590

(0.8) %

(16.0) %

15.2 %

APAC

532

517

2.8 %

(12.5) %

15.3 %

LACA

119

20.4 %

(3.8) %

24.2 %

Net Sales

$ 3,170

$ 2,932

8.1 %

(5.5) %

13.7 %

Emerging Markets5

$ 454

$ 354

28.1 %

(11.9) %

40.0 %

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 Fourth Quarter 2022

The company now estimates net sales growth for the full year 2022, versus the prior year period, to be approximately 6.5 percent on a reported basis, and approximately 9 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 $0.57 to $0.63 and estimates adjusted EPS, excluding certain charges (credits), of $1.71 to $1.74.

The company estimates net sales growth for the fourth quarter of 2022, versus the prior year period, to be in a range of approximately 2 to 4 percent on a reported basis, and approximately 7 to 9 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 $0.23 to $0.28 and adjusted EPS, excluding certain charges (credits), of $0.45 to $0.48.

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.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "may," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our expected net sales; reported, operational and organic revenue growth rates; reported and adjusted EPS for the fourth quarter and full year 2022; our financial performance; our business plans and product performance, and new and anticipated product approvals and launches. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Risks and uncertainties that may cause such differences include, among other things: the impact of the ongoing COVID-19 pandemic on our operations and financial results; the impact of foreign currency fluctuations; future U.S. and global economic, political, competitive, reimbursement and regulatory conditions; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by extreme weather or other climate change-related events; labor shortages and increases in labor costs; new product introductions; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property rights; litigation; financial market conditions; the execution and effect of our business strategy, including our cost-savings and growth initiatives; and future business decisions made by us and our competitors. New risks and uncertainties may arise from time to time and are difficult to predict, including those that have emerged or have increased in significance or likelihood as a result of the COVID-19 pandemic. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this press release.

Note: Amounts reported in millions within this press release are computed based on the amounts in thousands. As a result, the sum of the components reported in millions may not equal the total amount reported in millions due to rounding. Certain columns and rows within tables may not add due to the use of rounded numbers. Percentages presented are calculated from the underlying numbers in dollars.

Use of Non-GAAP Financial Information
A reconciliation of the company’s non-GAAP financial measures to the corresponding GAAP measures, and an explanation of the company’s use of these non-GAAP financial measures, is included in the exhibits attached to this press release.

CONTACT:

Media:

Kate Haranis

Investors:

Lauren Tengler

508-683-6585 (office)

508-683-4479 (office)

Media Relations

Investor Relations

Boston Scientific Corporation

[email protected]

BOSTON SCIENTIFIC CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Three Months Ended

September 30,

Nine Months Ended

September 30,

in millions, except per share data

2022

2021

2022

2021

Net sales

$ 3,170

$ 2,932

$ 9,440

$ 8,761

Cost of products sold

979

900

2,945

2,739

Gross profit

2,191

2,032

6,495

6,022

Operating expenses:

Selling, general and administrative expenses

1,132

1,066

3,357

3,206

Research and development expenses

339

310

993

884

Royalty expense

Amortization expense

202

184

604

549

Intangible asset impairment charges

125

128

132

173

Contingent consideration net expense (benefit)

(26)

(117)

Restructuring net charges (credits)

Litigation-related net charges (credits)

—

302

Gain on disposal of businesses and assets

—

(40)

—

(48)

1,833

1,645

5,248

5,003

Operating income (loss)

358

387

1,247

1,019

Other income (expense):

Interest expense

(63)

(86)

(406)

(254)

Other, net

(51)

181

(96)

192

Income (loss) before income taxes

245

483

745

957

Income tax expense (benefit)

188

Net income (loss)

$ 188

$ 419

$ 558

$ 946

Preferred stock dividends

(14)

(42)

Net income (loss) available to common stockholders

$ 174

$ 405

$ 516

$ 905

Net income (loss) per common share – basic

$ 0.12

$ 0.28

$ 0.36

$ 0.64

Net income (loss) per common share – assuming
dilution

$ 0.12

$ 0.28

$ 0.36

$ 0.63

Weighted-average shares outstanding

Basic

1,431.6

1,423.8

1,429.7

1,421.3

Assuming dilution

1,440.0

1,435.6

1,438.7

1,433.0

View News Release Full Screen
BOSTON SCIENTIFIC CORPORATION

NON-GAAP NET INCOME AND NET INCOME PER SHARE RECONCILIATIONS

(Unaudited)

Three Months Ended September 30, 2022

(in millions, except per share data)

Gross
Profit

Operating
Expenses

Operating
Income
(Loss)

Other
Income
(Expense)

Income
(Loss)
Before
Income
Taxes

Net
Income
(Loss)

Preferred
Stock
Dividends

Net Income
(Loss)
Available to
Common
Stockholders

Impact
per
Share (1)

Reported

$ 2,191

$ 1,833

$ 358

$ (114)

$ 245

$ 188

$ (14)

$ 174

$ 0.12

Non-GAAP adjustments:

Amortization expense

—

(202)

202

—

202

174

—

174

0.12

Intangible asset impairment charges

—

(125)

125

—

125

—

0.07

Acquisition / divestiture-related net
charges (credits)

(65)

113

112

—

112

0.08

Restructuring and restructuring-related
net charges (credits)

(4)

—

0.01

Litigation-related net charges (credits)

—

(0)

—

(0)

(0.00)

Investment portfolio net losses (gains)

—

(3)

—

(3)

(0.00)

EU MDR implementation costs

(7)

—

0.01

Debt extinguishment charges

—

(0)

—

(0)

(0.00)

Deferred tax expenses (benefits)

—

0.02

Adjusted

$ 2,240

$ 1,430

$ 810

$ (91)

$ 719

$ 634

$ (14)

$ 620

$ 0.43

Three Months Ended September 30, 2021

(in millions, except per share data)

Gross
Profit

Operating
Expenses

Operating
Income
(Loss)

Other
Income
(Expense)

Income
(Loss)
Before
Income
Taxes

Net
Income
(Loss)

Preferred
Stock
Dividends

Net Income
(Loss)
Available to
Common
Stockholders

Impact
per
Share (1)

Reported

$ 2,032

$ 1,645

$ 387

$ 95

$ 483

$ 419

$ (14)

$ 405

$ 0.28

Non-GAAP adjustments:

Amortization expense

—

(184)

184

—

184

168

—

168

0.12

Intangible asset impairment charges

—

(128)

128

—

128

109

—

109

0.08

Acquisition / divestiture-related net
charges (credits)

(7)

(225)

(232)

(230)

—

(230)

(0.16)

Restructuring and restructuring-related
net charges (credits)

(26)

—

0.03

Litigation-related net charges (credits)

—

(0)

—

(0)

(0.00)

Investment portfolio net losses (gains)

—

0.01

EU MDR implementation costs

(4)

—

0.01

Deferred tax expenses (benefits)

—

0.03

Discrete tax items

—

0.01

Adjusted

$ 2,071

$ 1,322

$ 750

$ (104)

$ 646

$ 595

$ (14)

$ 581

$ 0.41

(1) For the three months ended September 30, 2022 and 2021, the effect of assuming the conversion of Mandatory Convertible Preferred Stock (MCPS) into shares of common stock was anti-dilutive, and therefore excluded from the calculation of EPS. Accordingly, GAAP net income and adjusted net income were reduced by cumulative Preferred stock dividends, as presented in our unaudited consolidated statements of operations, for purposes of calculating net income available to common stockholders.

An explanation of the company’s use of these non-GAAP financial measures is provided at the end of this document.

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BOSTON SCIENTIFIC CORPORATION

NON-GAAP NET INCOME AND NET INCOME PER SHARE RECONCILIATIONS

(Unaudited)

Nine Months Ended September 30, 2022

in millions, except per share data

Gross
Profit

Operating
Expenses

Operating
Income
(Loss)

Other
Income
(Expense)

Income
(Loss)
Before
Income
Taxes

Net
Income
(Loss)

Preferred
Stock
Dividends

Net Income
(Loss)
Available to
Common
Stockholders

Impact
per
Share (2)

Reported

$ 6,495

$ 5,248

$ 1,247

$ (502)

$ 745

$ 558

$ (42)

$ 516

$ 0.36

Non-GAAP adjustments:

Amortization expense

—

(604)

604

—

604

519

—

519

0.36

Intangible asset impairment charges

—

(132)

132

—

132

103

—

103

0.07

Acquisition / divestiture-related net
charges (credits)

(177)

250

276

279

—

279

0.19

Restructuring and restructuring-related
net charges (credits)

(33)

—

0.05

Litigation-related net charges (credits)

—

(42)

—

0.02

Investment portfolio net losses (gains)

—

0.00

EU MDR implementation costs

(19)

—

0.03

Debt extinguishment charges

—

194

149

—

149

0.10

Deferred tax expenses (benefits)

—

0.07

Discrete tax items

—

(0)

—

(0)

(0.00)

Adjusted

$ 6,651

$ 4,242

$ 2,409

$ (274)

$ 2,135

$ 1,858

$ (42)

$ 1,816

$ 1.26

Nine Months Ended September 30, 2021

in millions, except per share data

Gross
Profit

Operating
Expenses

Operating
Income
(Loss)

Other
Income
(Expense)

Income
(Loss)
Before
Income
Taxes

Net
Income
(Loss)

Preferred
Stock
Dividends

Net Income
(Loss)
Available to
Common
Stockholders

Impact
per
Share (2)

Reported

$ 6,022

$ 5,003

$ 1,019

$ (62)

$ 957

$ 946

$ (42)

$ 905

$ 0.63

Non-GAAP adjustments:

Amortization expense

—

(549)

549

—

549

496

—

496

0.35

Intangible asset impairment charges

—

(173)

173

—

173

148

—

148

0.10

Acquisition / divestiture-related net
charges (credits)

(19)

(425)

(444)

(449)

—

(449)

(0.31)

Restructuring and restructuring-related
net charges (credits)

(74)

133

—

133

118

—

118

0.08

Litigation-related net charges (credits)

—

(302)

302

—

302

233

—

233

0.16

Investment portfolio net losses (gains)

—

178

136

—

136

0.09

EU MDR implementation costs

(12)

—

0.02

Deferred tax expenses (benefits)

—

0.06

Discrete tax items

—

(21)

—

(21)

(0.01)

Adjusted

$ 6,138

$ 3,946

$ 2,191

$ (308)

$ 1,883

$ 1,725

$ (42)

$ 1,683

$ 1.17

(2) For the nine months ended September 30, 2022 and 2021, the effect of assuming the conversion of MCPS into shares of common stock was anti-dilutive, and therefore excluded from the calculation of EPS. Accordingly, GAAP net income and adjusted net income were reduced by cumulative Preferred stock dividends, as presented in our unaudited consolidated statements of operations, for purposes of calculating net income available to common stockholders.

An explanation of the company’s use of these non-GAAP financial measures is provided at the end of this document.

BOSTON SCIENTIFIC CORPORATION
Q4 and FY 2022 GUIDANCE RECONCILIATIONS
(Unaudited)

Net Sales

Q4 2022 Estimate

Full Year 2022
Estimate

(Low)

(High)

Reported growth

2.0 %

4.0 %

~6.5%

Less: Impact of foreign currency fluctuations

(6.5) %

~(5.0)%

Operational growth

8.5 %

10.5 %

~11.5%

Less: Impact of certain acquisitions / divestitures

1.5 %

~2.5%

Organic growth

7.0 %

9.0 %

~9.0%

Earnings per Share

Q4 2022 Estimate

Full Year 2022 Estimate

(Low)

(High)

(Low)

(High)

GAAP results

$ 0.23

$ 0.28

$ 0.57

$ 0.63

Amortization expense

0.12

0.48

Intangible asset impairment charges

—

0.07

Acquisition / divestiture-related net charges (credits)

0.04

0.03

0.23

0.22

Restructuring and restructuring-related net charges (credits)

0.03

0.02

0.08

0.07

Litigation-related net charges (credits)

—

0.02

Debt extinguishment charges

—

0.10

Other adjustments

0.04

0.15

0.14

Adjusted results

$ 0.45

$ 0.48

$ 1.71

$ 1.74

Use of Non-GAAP Financial Measures

To supplement our unaudited consolidated financial statements presented on a GAAP basis, we disclose certain non-GAAP financial measures, including adjusted net income (loss), adjusted net income (loss) available to common stockholders and adjusted net income (loss) per share (EPS) that exclude certain charges (credits); operational net sales, which exclude the impact of foreign currency fluctuations; and organic net sales, which exclude the impact of foreign currency fluctuations as well as the impact of certain acquisitions and divestitures with less than a full period of comparable net sales. These non-GAAP financial measures are not in accordance with generally accepted accounting principles in the United States and should not be considered in isolation from or as a replacement for the most directly comparable GAAP financial measures. Further, other companies may calculate these non-GAAP financial measures differently than we do, which may limit the usefulness of those measures for comparative purposes.

To calculate adjusted net income (loss), adjusted net income (loss) available to common stockholders and adjusted net income (loss) per share we exclude certain charges (credits), which 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); and certain litigation-related net charges (credits), EU MDR implementation costs, debt extinguishment charges, deferred tax expenses (benefits) and discrete tax items. Amounts are presented after-tax at the company’s effective tax rate, unless the amount is a significant unusual or infrequently occurring item in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 740-270-30, "General Methodology and Use of Estimated Annual Effective Tax Rate." Please refer to Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our most recent Annual Report filed on Form 10-K filed with the Securities and Exchange Commission or any Quarterly Report on Form 10-Q that we file thereafter for an explanation of each of these adjustments and the reasons for excluding each item.

The GAAP financial measures most directly comparable to adjusted net income (loss), adjusted net income (loss) available to common stockholders and adjusted net income (loss) per share are GAAP net income (loss), GAAP net income (loss) available to common stockholders and GAAP net income (loss) per common share – assuming dilution, respectively.

To calculate operational net sales growth rates, which exclude the impact of foreign currency fluctuations, we convert actual net sales from local currency to U.S. dollars using constant foreign currency exchange rates in the current and prior periods. To calculate organic net sales growth rates, we also remove the impact of acquisitions and divestitures with less than a full period of comparable net sales. The GAAP financial measure most directly comparable to operational net sales and organic net sales is net sales on a GAAP basis.

Reconciliations of each of these non-GAAP financial measures to the corresponding GAAP financial measure are included in the accompanying schedules.

Management uses these supplemental non-GAAP financial measures to evaluate performance period over period, to analyze the underlying trends in our business, to assess our performance relative to our competitors and to establish operational goals and forecasts that are used in allocating resources. In addition, management uses these non-GAAP financial measures to further its understanding of the performance of our operating segments. The adjustments excluded from our non-GAAP financial measures are consistent with those excluded from our operating segments’ measures of net sales and profit or loss. These adjustments are excluded from the segment measures reported to our chief operating decision maker that are used to make operating decisions and assess performance.

We believe that presenting adjusted net income (loss), adjusted net income (loss) available to common stockholders, adjusted net income (loss) per share, operational net sales growth rates and organic net sales growth rates, in addition to the corresponding GAAP financial measures, provides investors greater transparency to the information used by management for its operational decision-making and allows investors to see our results "through the eyes" of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.

Papyrus Therapeutics Research Presentation at the 34th EORTC-NCI-AACR meeting in Barcelona, Spain, on 27th October

On October 26, 2022 Papyrus Therapeutics Inc reported that Data will be presented by R Yang and colleagues from the Guangxi Medical University Cancer Hospital and H Gabra demonstrating that intravenously administered rOPCML-Fc has excellent tumor targeting affinity forhuman ovarian cancer patient derived xenografts (PDX) and produces strong dose dependent monotherapy efficacy both in-vitro and in-vivo (Press release, Papyrus Therapeutics, OCT 26, 2022, View Source;utm_medium=rss&utm_campaign=papyrus-therapeutics-research-presentation-at-the-34th-eortc-nci-aacr-meeting-in-barcelona-spain-on-27th-october%25ef%25bf%25bc [SID1234623197]). Intravenous treatment at 10mg/kg over 4 weeks showed a 93% reduction in tumor volume without any obvious toxicities as judged by lack of differences in animals’ activities and weight in treated animals, as compared with control vehicle treated animals.

Chief Scientific Officer Professor Hani Gabra commented "We are excited to present these data which confirm that our approach to the intravenous restoration of tumor suppression function is indeed feasible, efficacious and safe using our recombinant engineered Fc fusion Opioid Binding/Cell Adhesion Molecule-like [rOPCML]. These encouraging results are consistent with data generated by Papyrus and support the company’s effort to develop novel extracellular tumor suppressor therapies."