Boston Scientific Corp 8-K, filed Jan 8, 2024
Boston Scientific Corp (BSX)
8-K
2024-01-08
For: 2024-01-08
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July 04, 2026
About this 8-K
Boston Scientific Corp filed this 8-K on January 8, 2024.
Items reported
- Item 7.01: Regulation FD disclosure
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________________________________________________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
_____________________________________________________________________
Date of Report (Date of earliest event reported): January 8, 2024
(Exact name of registrant as specified in its charter)
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(508 ) 683-4000
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 REGULATION FD
On January 8, 2024, Boston Scientific Corporation (the “Company”) issued a press release (the “Press Release”) announcing that the Company and Axonics, Inc. (“Axonics”) have executed a definitive agreement pursuant to which the Company agreed to acquire Axonics (the “Transaction”) on the terms and subject to the conditions set forth in the definitive agreement. Also, on January 8, 2024, the Company made available on its website an investor presentation (the “Investor Presentation”) regarding the Transaction. The acquisition is expected to close in the first half of 2024, subject to customary closing conditions.
A copy of the Press Release and the Investor Presentation are attached to this report as Exhibit 99.1 and Exhibit 99.2, respectively and are incorporated herein by reference; provided, however, that information on or connected to the Company’s website or the website of any third-party hyperlinked from or referenced in the Press Release or the Investor Presentation are expressly not incorporated by reference into or intended to be filed as a part of this Current Report on Form 8-K.
The information in Item 7.01 of this Current Report on Form 8-K, as well as Exhibit 99.1 and Exhibit 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements that we may make from time to time, including statements contained in this Current Report on Form 8-K and information incorporated by reference herein, constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend,” “aim,” “goal,” “target,” “continue,” “hope,” “may” 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 the financial and business impact and anticipated benefits of the transaction, the closing of the transaction and the timing thereof, business plans and strategy, product launches and product performance and impact. 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 Current Report on Form 8-K. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
The forward-looking statements in this Current Report on Form 8-K are based on certain risks and uncertainties, including the risk factors described in Part I, Item 1A. Risk Factors in our most recent Annual Report on Form 10-K and the specific risk factors discussed herein and in connection with forward-looking statements throughout this Current Report on Form 8-K, which could cause actual results to vary materially from the expectations and projections expressed or implied by our forward-looking statements. These risks and uncertainties, in some cases, have affected and in the future 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 Current Report on Form 8-K. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: 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; the impact of pandemics on our operations and financial results; disruptions caused by extreme weather or other climate change-related events; labor shortages and increases in labor costs; new product introductions and the market acceptance of those products; markets for our products; expected pricing environment; expected procedural volumes; the closing and integration of acquisitions, including our ability to achieve the anticipated benefits of the proposed transaction and successfully integrate Axonics’ operations; clinical trial results; business disruptions (including disruptions in relationships with employees, customers or suppliers) following the announcement and/or closing of the proposed transaction; the conditions to the completion of the proposed transaction, including the fact that the receipt of the required regulatory approvals and clearances, may not be satisfied at all or in a timely manner; the fact that the closing of the proposed transaction may not occur or may be delayed; demographic trends; intellectual property rights; litigation; financial market conditions; the execution and effect of our restructuring program; the execution and effect of our business strategy, including our cost-savings and growth initiatives; our ability to achieve environmental, social and governance goals and commitments; 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. 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, refer to 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 subsequent Quarterly Reports on Form 10-Q that we will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statement 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 Current Report on Form 8-K.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(d) Exhibits
Exhibit No. Description
104 Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL
document
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: | January 8, 2024 | BOSTON SCIENTIFIC CORPORATION | |||||||||
| By: | /s/ Susan Thompson | ||||||||||
| Susan Thompson | |||||||||||
| Vice President, Chief Corporate Counsel, and Assistant Secretary | |||||||||||
Exhibit 99.1
Boston Scientific Announces Agreement to Acquire Axonics, Inc.
Acquisition to expand urology portfolio with differentiated technologies to treat urinary and bowel dysfunction
MARLBOROUGH, Mass., Jan. 8, 2024 – Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Axonics, Inc. (Nasdaq: AXNX), a publicly traded medical technology company primarily focused on the development and commercialization of differentiated devices to treat urinary and bowel dysfunction. The purchase price is $71 in cash per share, reflecting an equity value of approximately $3.7 billion and an enterprise value of approximately $3.4 billion.1
In the United States, it is estimated that nearly 30 million adults ages 40 and older have bothersome symptoms of overactive bladder (OAB) and 19 million adults have fecal incontinence.2,3 These conditions can have a significant impact on quality of life, mental health, sleep, productivity and social activities.4
The Axonics product portfolio includes the Axonics R20™ and the Axonics F15™ Systems used to deliver sacral neuromodulation (SNM) therapy. SNM therapy is a minimally invasive procedure used in the treatment of OAB and fecal incontinence. It works by delivering mild electrical pulses to the sacral nerve to restore communication between the brain and the bladder. In clinical studies, Axonics Therapy has demonstrated meaningful improvement in patients’ quality of life in follow-up out to two years, with no serious device-related adverse events reported.5,6
“We are excited to add Axonics technologies to the Boston Scientific portfolio, a combination that we expect will further strengthen our ability to serve urologists who are treating patients living with these often-chronic conditions,” said Meghan Scanlon, senior vice president and president, Urology, Boston Scientific. “This acquisition also enables our entry into sacral neuromodulation, a high-growth adjacency with opportunities to expand access to care for patients.”
In January 2023, Axonics received U.S. Food and Drug Administration (FDA) approval for its fourth-generation Axonics R20 neurostimulator, a rechargeable SNM device with a battery life of 20 or more years. The company’s portfolio also includes Bulkamid® Urethral Bulking System for the treatment of female stress urinary incontinence.
Boston Scientific expects to complete the transaction in the first half of 2024, subject to customary closing conditions. Axonics expects to deliver net revenue of approximately $366 million in 2023, representing 34% growth over the prior fiscal year.7 Axonics’ revenue growth profile is anticipated to be highly accretive to the Boston Scientific Urology business in 2024. The impact to Boston Scientific adjusted earnings per share is expected to be immaterial in 2024 and accretive thereafter. The impact to GAAP earnings per share is expected to be less accretive, or more dilutive, due to amortization expense and acquisition-related net charges.
Additional information about this transaction is available on the Events and Presentations section of the Boston Scientific investor relations website.
Exhibit 99.1
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies 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. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect on Twitter and LinkedIn.
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," "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 the financial and business impact of the transaction and anticipated benefits of the transaction, the closing of the transaction and the timing thereof, business plans and strategy, product launches and product performance and impact. 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.
Factors that may cause such differences include, among other things: future 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; demographic trends; the closing and integration of acquisitions, including our ability to achieve the anticipated benefits of the proposed transaction and successfully integrate Axonics’ operations; business disruptions (including disruptions in relationships with employees, customers or suppliers) following the announcement and/or closing of the proposed transaction; intellectual property rights; litigation; financial market conditions; the execution and effect of our business strategy, including cost savings and growth initiatives; future business decisions made by us and our competitors; the conditions to the completion of the proposed transaction, including the receipt of the required regulatory approvals and clearances, may not be satisfied at all or in a timely manner; and the closing of the proposed transaction may not occur or may be delayed. 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 (“SEC”), 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.
Exhibit 99.1
Preliminary Financial Information
This press release includes expected 2023 net revenue for Axonics, Inc., which is preliminary and unaudited. Axonics, Inc.’s financial closing procedures for full year 2023 are not yet complete and, as a result, actual net revenue for full year 2023 may change as a result of its financial closing procedures.
CONTACTS:
Kirsten Lesak-Greenberg
Media Relations
(763) 300-9254
kirsten.lesak-greenberg@bsci.com
Lauren Tengler
Investor Relations
(508) 683-4479
BSXInvestorRelations@bsci.com
___________________________________
1 Equity value based on total fully diluted share count of approximately 51.7 million shares; Enterprise value is equal to Equity value minus net cash and short-term investments of approximately $0.3 billion as of September 30, 2023.
2 Coyne, et al. “National community prevalence of overactive bladder in the United States stratified by sex and age.” Urology. Volume 77, Issue 5, P1081-1087, MAY 2011. DOI:https://doi.org/10.1016/j.urology.2010.08.039
3 Ditah, Ivo et al. “Prevalence, trends, and risk factors for fecal incontinence in United States adults.” Clin Gastroenterol Hepatol. 2014 Apr.
4 Reynolds, et al. “The Burden of Overactive Bladder on US Public Health.” Curr Bladder Dysfunct Rep, Mar 2016.
5 Pezzella A, McCrery R, Lane F, Benson K, Taylor C, Padron O, Blok B, de Wachter S, Gruenenfelder J, Pakzad M, Perrouin-Verbe MA, van Kerrebroeck P, Mangel J, Peters K, Kennelly M, Shapiro A, Lee U, Comiter C, Mueller M, Goldman HB. Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system. Neurourol Urodyn. 2021 Feb;40(2):714-721. doi: 10.1002/nau.24615. Epub 2021 Jan 28. PMID: 33508155; PMCID: PMC7986436.
6 Blok B, Van Kerrebroeck P, de Wachter S, et al. Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system. Neurourology and Urodynamics. 2020; 39: 1108–1114. https://doi.org/10.1002/nau.24317.
7 Axonics, Inc. (2024). Axonics Reports Preliminary 4Q23 and Fiscal Year 2023 Revenue. https://ir.axonics.com/news-releases.
Boston Scientific Acquisition of Axonics, Inc. January 8, 2024 Exhibit 99.2
2 Certain statements that we may make from time to time, including statements contained in this presentation and information incorporated by reference herein, constitute 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," "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 the financial and business impact of the transaction and anticipated benefits of the transaction, the closing of the transaction and the timing thereof, business plans and strategy, product launches and product performance and impact. 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 presentation. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Factors that may cause such differences include, among other things: future 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; demographic trends; the closing and integration of acquisitions, including our ability to achieve the anticipated benefits of the proposed transaction and successfully integrate Axonics' operations; business disruptions (including disruptions in relationships with employees, customers or suppliers) following the announcement and/or closing of the proposed transaction; intellectual property rights; litigation; financial market conditions; the execution and effect of our business strategy, including cost savings and growth initiatives; future business decisions made by us and our competitors; the conditions to the completion of the proposed transaction, including the receipt of the required regulatory approvals and clearances, may not be satisfied at all or in a timely manner; and the closing of the proposed transaction may not occur or may be delayed. 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 (“SEC”), 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 they 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 presentation. Safe harbor for forward-looking statements
Summary Boston Scientific has entered into a definitive agreement to acquire Axonics, Inc., a rapidly growing medical technology company that offers innovative devices to treat urinary and bowel dysfunction, in a transaction that values the company at $3.4B. The Axonics product portfolio, which is highly complementary to our Urology business, includes sacral neuromodulation (SNM) therapies for overactive bladder (OAB) and incontinence. We believe this transaction is strategic and financially compelling for Boston Scientific, delivering clinically differentiated solutions to physicians and their patients.
•Founded in 20121, Axonics, Inc. is a medical technology company primarily focused on the development and commercialization of differentiated devices to treat urinary and bowel dysfunction •Headquartered in Irvine, CA with ~800 employees; products available in more than 20 countries •Launched first rechargeable SNM device for OAB in November 2019; treated ~100,000 incontinence patients globally in 2023 • Financial profile: 2023E2 net revenue of ~$366M, growing ~34% over 2022 with attractive gross margins Company Overview •Transaction expected to expand company’s ability to offer clinically differentiated treatment options with well-established therapies in a high-growth adjacency •Global reach and capabilities of Boston Scientific can help accelerate awareness and adoption of Axonics technologies •Underpenetrated SNM opportunity in the U.S. estimated to be $800M in 2022 and expected to grow to $1.6B in the next 5 years3 Strategic Rationale •Agreement consists of a purchase price of $71 per share, reflecting an equity value of ~$3.7B and an enterprise value of ~$3.4B4 •Transaction expected to close in H1:24, subject to customary closing conditions •Transaction anticipated to be immaterial to adjusted earnings per share in 2024 and accretive thereafter* •Boston Scientific expects the transaction to have an immaterial impact to total company adjusted operating margin in first two years and achieve total company adjusted operating margin in year 3 Transaction Terms Transaction Overview Strategic and financially compelling *The impact to GAAP earnings per share is expected to be less accretive, or more dilutive, due to amortization expense and acquisition-related net charges.
In a retrospective study, SUI bulking hydrogel demonstrated clinical efficacy up to seven years post treatment5 Axonics Overview Innovative devices to treat urinary and bowel dysfunction Annual Revenue YTD 20236 Gross Margin: ~75% Axonics technologies well-positioned in a large, underpenetrated incontinence market 2018 2019 2020 2021 2022 2023 $1M $14M $112M $180M $274M ~$366M Y/Y Growth +62% +52% ~+34% 6 Technology SNM therapy uses an implant to deliver mild electrical pulses targeting the sacral nerve to restore communication between the brain and the bladder. Rechargeable and recharge-free offerings for overactive bladder and fecal incontinence SUI is the unintentional passing of urine during activity or exertion, such as during coughing, laughing or exercise. Sacral Neuromodulation (SNM) Stress Urinary Incontinence (SUI)
Boston Scientific + Axonics Highlights ➢ Leaders in urology with broad and deep portfolio of industry leading technologies for treating urological conditions ➢ Ability to utilize capabilities and reach to accelerate growth ➢ Proven track record of expanding Urology portfolio for physicians and patients through internal innovation & strategic, tuck-in M&A ➢ Portfolio of differentiated incontinence solutions backed by clinical evidence ➢ History of meaningful innovation; launched the Axonics R20™ neurostimulator, its 4th generation rechargeable SNM device, in January 2023 ➢ Scaled commercial team with significant experience in urology field BSX + AXNX: Complementary portfolios expanding access to innovative technologies for physicians and patients
Appendix
Sources Slide 4 1 Founded in March 2012 under the name “American Restorative Medicine, Inc.” In August 2013, the Company’s name was changed to Axonics Modulation Technologies, Inc. and operations commenced in late 2013. 2 2023 guidance and reported YTD 2023 actuals: • Jan 8, 2024 Preliminary Net Revenue Results: https://ir.axonics.com/news-releases • November 2023 Investor Presentation: https://ir.axonics.com/static-files/26965f2c-c211-4e9d-a40e-3e6104a15731 • SEC Filing: https://ir.axonics.com/node/9781/html This presentation includes expected 2023 net revenue for Axonics, Inc., which is preliminary and unaudited. Axonics, Inc.’s financial closing procedures for full year 2023 are not yet complete and, as a result, actual net revenue for full year 2023 may change as a result of its financial closing procedures. 3 Expected market growth and size reflects Axonics internal estimates: https://ir.axonics.com/static-files/26965f2c-c211-4e9d-a40e-3e6104a15731 - Definitive Healthcare claims data 4 Equity value based on total fully diluted share count of approximately 51.7 million shares; Enterprise value is equal to Equity value minus net cash and short-term investments of approximately $0.3 billion as on September 30, 2023. *The impact to GAAP earnings per share is expected to be less accretive, or more dilutive, due to amortization expense and acquisition-related net charges. Slide 5 5 Brosche, Torsten et al. “Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence.” Neurourology and Urodynamics. 2020 Jan. 6 2023 guidance and reported YTD 2023 actuals: • Jan 8, 2024 Preliminary Net Revenue Results: https://ir.axonics.com/news-releases • November 2023 Investor Presentation: https://ir.axonics.com/static-files/26965f2c-c211-4e9d-a40e-3e6104a15731 • SEC Filing: https://ir.axonics.com/node/9781/html This presentation includes expected 2023 net revenue for Axonics, Inc., which is preliminary and unaudited. Axonics, Inc.’s financial closing procedures for full year 2023 are not yet complete and, as a result, actual net revenue for full year 2023 may change as a result of its financial closing procedures.