Item 7.01 Regulation FD Disclosure
On October 15, 2025, Merit Medical Systems, Inc. (“Merit”) issued a press release (the “Acquisition Press Release”) announcing it has signed a definitive asset purchase agreement with Pentax of America, Inc., a subsidiary of PENTAX® Medical, Inc., to acquire the C2 CryoBalloon™ device and related technology. The closing of the proposed transaction is expected to occur during the fourth quarter of 2025, subject to the satisfaction or waiver (in accordance with the provisions of the asset purchase agreement) of certain customary closing conditions.
Merit proposes to acquire the C2 CryoBalloon assets from Pentax of America, Inc. for total purchase consideration of $22 million, consisting of a $19 million cash payment at closing and potential contingent payments of up to $3 million payable upon meeting certain milestones.
A copy of the Acquisition Press Release is included as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Merit is making reference to non-GAAP information in the Acquisition Press Release. A quantitative reconciliation of such non-GAAP financial information to comparable GAAP financial information is not available without unreasonable effort.
The information contained in this Item 7.01 of this Current Report and in the attached Exhibit 99.1 is furnished pursuant to General Instruction B.2. of Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing made by Merit under the Securities Act of 1933, as amended (the “Securities Act”), or the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
The information included in this Current Report contains forward-looking statements about Merit that involve substantial risks and uncertainties. Merit intends such statements, and all subsequent forward-looking statements attributable to Merit, to be expressly qualified in their entirety by these cautionary statements and covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and Section 27A of the Securities Act. In some cases, forward-looking statements can be identified by the use of terminology such as “anticipate,” “believe,” “continue,” “estimate,” “expect,” “forecast,” “intend,” “may,” “might,” “plan,” “potential,” “project,” “will,” “would,” “seek,” “should,” “could,” “can,” “predict,” “potential,” “continue,” “objective” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology. However, not all forward-looking statements contain such identifying words. All statements included in this Current Report, other than statements of historical fact, are forward-looking statements for purposes of the Exchange Act and the Securities Act, including any projections of earnings, revenues or other financial items, any statements of the plans and objectives for future operations, any statements concerning proposed new products or services, any statements regarding the integration, development or commercialization of the business or any assets acquired from other parties, any statements regarding future economic conditions or performance, and any statements of assumptions underlying any of the foregoing. Additionally, forward-looking statements include, among other things, inherent risks and uncertainties associated with Merit’s proposed acquisition of the C2 CryoBalloon device and related technology, Merit’s integration of the assets and operations proposed to be acquired from PENTAX Medical and its ability to achieve projected financial results, product development and other anticipated benefits of the proposed acquisition, and uncertainties as to whether Merit will achieve sales, gross and operating margin, net income and earnings per share performance consistent with its forecasts projected for the assets and operations proposed to be acquired from PENTAX Medical.
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Merit’s actual results, levels of activity, performance or achievement to be materially different from those expressed or implied by these forward-looking statements, including those risks, uncertainties and other factors described in Merit’s Annual Report on Form 10-K for the year ended December 31, 2024 and Merit’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, and subsequent filings with the SEC.