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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) July 15, 2024
 
EDWARDS LIFESCIENCES CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 1-15525 36-4316614
(State or other jurisdiction
of incorporation)		 (Commission
file number)		 (IRS Employer
Identification No.)

One Edwards Way
Irvine, California 92614
(Address of principal executive offices and zip code)

(949) 250-2500
(Registrant's telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
 
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:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $1.00 per shareEWNew York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).
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 Disclosure.

On July 15, 2024, Edwards Lifesciences Corporation (the “Company”) issued a press release announcing the Company has exercised its option to acquire Innovalve Bio Medical Ltd. (“Innovalve”), an early-stage transcatheter mitral valve replacement company.

A copy of the press release is attached as Exhibit 99.1 and is incorporated herein by reference. In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed 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 filing.

Item 8.01. Other Events.

In connection with the Company’s acquisition of Innovalve, the Company expects to pay consideration of approximately $300 million in cash at the closing of the acquisition, which is expected to occur by the end of 2024.

Forward-Looking Statements
This report includes forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements can sometimes be identified by the use of words such as “may,” “will,” “should,” “anticipate,” “believe,” “plan,” “project,” “estimate,” “potential,” “predict,” “expect,” “intend,” “guidance,” “outlook,” “optimistic,” “aspire,” “confident” or other forms of these words or similar expressions and include, but are not limited to, expectations regarding the completion of the Company’s acquisition of Innovalve, including the timing and price thereof. No inferences or assumptions should be made from statements of past performance, efforts, or results which may not be indicative of future performance or results. Forward-looking statements are based on estimates and assumptions made by management of the Company and are believed to be reasonable, though they are inherently uncertain, difficult to predict, may be outside of the Company’s control, and may be subject to the satisfaction of certain customary conditions. The Company’s forward-looking statements speak only as of the date on which they are made and the Company does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the Company does update or correct one or more of these statements, investors and others should not conclude that the Company will make additional updates or corrections.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include, but are not limited to: (i) the Company may be unable to close the acquisition of Innovalve in a timely manner or at all, which may materially and adversely affect the Company’s business and the price of the Company’s common stock; (ii) uncertainty as to the timing of closing of the acquisition of Innovalve; (iii) the occurrence of any event, change or other circumstance that could cause the Company to abandon the acquisition of Innovalve; (iv) risks related to disruption of management’s attention from the Company’s ongoing business operations; (v) the effect of the announcement or the pendency of the acquisition of Innovalve on the Company’s relationships with its customers, operating results and business generally; (vi) potential significant transaction costs associated with the acquisition of Innovalve; (vii) the outcome of any legal proceedings or regulatory actions to the extent initiated against the Company or others related to the acquisition of Innovalve; (viii) the ability of the Company to execute on its strategy and achieve its goals and other expectations after the closing of the acquisition of Innovalve; (ix) legal, regulatory, tax and economic developments affecting the Company’s business; (x) the unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism, outbreak of war or hostilities or current or future pandemics or epidemics, as well as the Company’s response to any of the aforementioned factors; and (xi) other risks detailed in the Company’s filings with the SEC, which may be found at edwards.com.


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Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.Description
99.1
104Cover Page Interactive Data File (embedded within the Inline XBRL document).


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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


EDWARDS LIFESCIENCES CORPORATION
By:/s/ Linda J. Park
Linda J. Park
Date: July 15, 2024Senior Vice President, Associate General Counsel and Corporate Secretary

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ew45percentblacklrga21-ewla.jpg
Edwards Lifesciences Corporation
One Edwards Way · Irvine, CA USA · 92614
Phone: 949.250.2500 · Fax: 949.250.2525
www.edwards.com

FOR IMMEDIATE RELEASE
 
Media Contact: Loree Bowen, 949-250-0554
Investor Contact: Mark Wilterding, 949-250-6826

EDWARDS LIFESCIENCES TO ACQUIRE INNOVALVE

IRVINE, CA, July 15, 2024 — Edwards Lifesciences (NYSE: EW) today announced it has exercised its option to acquire Innovalve Bio Medical Ltd., an early-stage transcatheter mitral valve replacement (TMVR) company, following its initial investment in 2017. Since that time, Innovalve has demonstrated progress in its program with promising early clinical experience.
Combined with Edwards’ existing mitral innovations, the acquisition enhances the company’s TMVR technologies to address large unmet structural heart patient needs and support sustainable long-term growth. Innovalve will join the transcatheter mitral and tricuspid therapies (TMTT) product group, led by corporate vice president, Daveen Chopra.
“Building on our learnings of the complexity of mitral disease, we know there is a need for a differentiated range of therapies for these patients,” said Chopra. “Edwards’ SAPIEN M3 remains on track to become the first approved transfemoral TMVR system in Europe by the end of 2025. We believe the Innovalve technologies, paired with Edwards’ deep mitral expertise, will enable a TMVR platform that will expand the treatable population.”
Edwards is developing a portfolio of transcatheter repair and replacement therapies designed to address mitral and tricuspid valve diseases. The company is committed to transforming the treatment of mitral and tricuspid patients, supported by a robust body of clinical evidence.
The acquisition is expected to close by the end of 2024.





About Edwards Lifesciences
Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit www.edwards.com and follow us on Facebook, Instagram, LinkedIn, X and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this Proxy Statement to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of these words and include, but are not limited to, statements made by Mr. Chopra and statements regarding expected technology performance, product and therapy benefits, patient outcomes, treatable population, probability of approval by government authorities in Europe, performance of Innovalve’s technology as a basis for or in support of a TMVR platform, synergy between Innovalve’s technology and products and Edwards’ expertise, products, and operations, Edwards' commitment to developing a portfolio of transcatheter repair and replacement therapies and to expanding or transforming patients’ treatments, other objectives and expectations, and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include, but are not limited to: (i) Edwards may be unable to close the acquisition of Innovalve in a timely manner or at all, which may materially and adversely affect Edwards' business and the price of Edwards' common stock; (ii) uncertainty as to the timing of closing of the acquisition of Innovalve; (iii) the occurrence of any event, change or other circumstance that could cause Edwards to abandon the acquisition of Innovalve; (iv) risks related to disruption of management’s attention from Edwards' ongoing business operations; (v) the effect of the announcement or the pendency of the acquisition of Innovalve on Edwards' relationships with its customers, operating results and business generally; (vi) potential significant transaction costs associated with the acquisition of Innovalve; (vii) the outcome of any legal proceedings or regulatory actions to the extent initiated against Edwards or others related to the acquisition of Innovalve; (viii) the ability of Edwards to execute on its strategy and achieve its goals and other expectations after the closing of the acquisition of Innovalve; (ix) legal, regulatory, tax and economic developments affecting Edwards' business; (x) the unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism, outbreak of war or hostilities or current or future pandemics or epidemics, as well as Edwards' response to any of the aforementioned factors; and (xi) other risks detailed in Edwards' filings with the SEC, which may be found at edwards.com.

# # #

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN M3, SAPIEN, and SAPIEN M3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.





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Cover
Jul. 15, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Jul. 15, 2024
Entity Registrant Name EDWARDS LIFESCIENCES CORPORATION
Entity Incorporation, State or Country Code DE
Entity File Number 1-15525
Entity Tax Identification Number 36-4316614
Entity Address, Address Line One One Edwards Way
Entity Address, City or Town Irvine
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92614
City Area Code 949
Local Phone Number 250-2500
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Title of 12(b) Security Common Stock, par value $1.00 per share
Trading Symbol EW
Security Exchange Name NYSE
Entity Emerging Growth Company false
Entity Central Index Key 0001099800
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