KIRKLAND, Wash., April 14, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS) (“Kestra”), a wearable medical device and digital healthcare company, today reported financial results for the third quarter fiscal 2025, which ended January 31, 2025. Recent Highlights Q3 FY25 revenue and gross margin were in line with the preliminary estimated financial results previously disclosed in the company’s IPO prospectus. Generated revenue of $15.1 million in Q3 FY25, an increase of 82% compared to the prior year period.Achieved gross margin of 43.4% in Q3 FY25 compared to 10.6% in the prior year period. Completed initial public offering in March 2025, raising approximately $205.2 million of net proceeds.Signed in-network contracts with additional insurers, with covered lives for the ASSURE® system now totaling more than 285 million health plan members in the United States.Appointed Mr. Al Ford as Chief Commercial Officer. “Our quarterly results reflect sustained commercial momentum as Kestra grows and penetrates the wearable defibrillator market,” said Brian Webster, President and CEO. “We continue to make progress on our key operational objectives, including expansion of our commercial organization and advancement of our revenue cycle management capabilities. Following our initial public offering in March, we remain focused on delivering strong growth and executing on our commitments to patients and their prescribers.” Q3 FY25 Financial Results Total revenue was $15.1 million, an increase of 82% compared to the prior year period. 3,459 prescriptions were written for the ASSURE® system, an increase of 51% compared to the prior year period.Revenue growth was driven by higher share of wallet at existing customers and activation of new accounts. Revenue also benefited from a higher mix of in-network patients and improvements in revenue cycle management capabilities. Gross profit was $6.5 million compared to $0.9 million in the prior year period. Gross margin improved to 43.4% compared to 10.6% in the prior year period, driven by volume leverage and a higher mix of in-network patients. Operating expenses were $27.1 million compared to $20.8 million in the prior year period. The increase was attributable to growth in commercial and revenue cycle headcount and a $1.9 million increase in professional services expenses related to the IPO. GAAP net loss and comprehensive loss was $21.8 million compared to GAAP net loss and comprehensive loss of $21.6 million in the prior year period. Adjusted EBITDA loss was $16.3 million compared to an adjusted EBITDA loss of $16.2 million in the prior year period. Cash and cash equivalents totaled $54.4 million as of January 31, 2025. Net proceeds from the initial public offering completed in March 2025 totaled $205.2 million, after deducting underwriting discounts, commissions and offering expenses. Fiscal Year 2025 Revenue Outlook Kestra expects revenue for fiscal year ending April 30, 2025 to be in the range of $58.0 million to $58.5 million, representing growth of approximately 109% to 110% compared to fiscal year 2024. Webcast and Conference CallKestra will host a conference call today, April 14, 2025, at 4:30 p.m. ET to discuss third quarter fiscal 2025 financial results. A live and archived webcast of the event will be available in the “Events” section of the investor relations website. Explanatory NoteOn March 7, 2025, Kestra completed its initial public offering of its Common Shares, par value $1.00 per share (the “Common Shares”). Kestra was formed solely for the purpose of completing the IPO and prior to the consummation of the IPO, did not engage in any business or activities other than those incidental to its formation, the organizational transactions consummated in connection with the IPO and the preparation of the prospectus and registration statement in connection with the IPO. Prior to the consummation of the IPO, the Company’s business was conducted through West Affum Intermediate Holdings Corp. In connection with the IPO, certain organizational transactions were completed, pursuant to which West Affum Intermediate Holdings Corp. became a wholly owned subsidiary of Kestra. West Affum Intermediate Holdings Corp is the predecessor to Kestra for financial reporting purposes. As such, the financial statements and the discussion of the Company’s financial results for the third quarter fiscal 2025 included in this press release represent the financial results of West Affum Intermediate Holdings Corp. and the financial statements of Kestra Medical Technologies, Ltd. are not included in this press release. Unless otherwise indicated or the context requires, “Kestra,” the “Company,” “we,” “our,” “us” and other similar terms refer collectively to West Affum Intermediate Holdings Corp. and its consolidated subsidiaries for periods prior to the consummation of the initial public offering, and to Kestra Medical Technologies, Ltd. and its consolidated subsidiaries for periods following the consummation of the initial IPO. Use of Non-GAAP Financial MeasuresThis press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles (“GAAP”), including adjusted EBITDA. The non-GAAP financial measures are provided as supplemental information to Kestra’s financial measures presented in this press release that are calculated and presented in accordance with GAAP. Adjusted EBITDA, which is calculated as net income (loss), as adjusted to exclude other income/expense (including interest), income tax expense (benefit), depreciation and amortization expense, stock-based compensation expense, and expenses related to Kestra’s initial public offering, is presented because management believes it allows investors to view the Company’s performance in a manner similar to the method used by management to evaluate the Company’s performance for both strategic and annual operating planning. Management believes that in order to properly understand short-term and long-term financial trends, it is helpful for investors to understand the impact of the items excluded from the calculation of Adjusted EBITDA, in addition to considering the Company’s GAAP financial measures. The excluded items vary in frequency and/or impact on our results of operations and management believes that the excluded items are not reflective of our ongoing core business operations and financial condition. Excluding such items allows investors and analysts to compare our operating performance to other companies in our industry and to compare our period-over-period results. The non-GAAP financial measures used by Kestra may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Kestra’s financial results prepared and reported in accordance with GAAP. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business. A reconciliation of adjusted EBITDA reported in this press release to the most comparable GAAP measure for the respective periods appears in the table captioned “Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA” later in this release. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Forward-Looking StatementsExcept where otherwise noted, the information contained in this press release is as of April 14, 2025. Statements in this press release and on the related teleconference that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; business plans, strategy, goals and prospects; and expectations for our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Kestra’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; and other risks and uncertainties, including those described under the heading “Risk Factors” in our Registration Statement on Form S-1 and other filings filed or to be filed with the U.S. Securities and Exchange Commission (“SEC”). These filings, when made, are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/. About KestraKestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com. WEST AFFUM INTERMEDIATE HOLDINGS CORP. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts)(unaudited) January 31,2025 April 30,2024 Assets Current assets Cash and cash equivalents$54,352 $8,249 Accounts receivable, net 7,929 1,998 Disposable medical equipment supplies 5,999 3,290 Prepaid expenses and other current assets 1,636 1,370 Total current assets 69,916 14,907 Right-of-use assets 1,956 2,286 Deposits 2,058 1,710 Restricted cash 334 334 Property and equipment, net 31,387 26,105 Other long-term assets 2,344 607 Total assets$107,995 $45,949 Liabilities, Redeemable Preferred Stock and Stockholder’s Deficit Current liabilities Accounts payable$25,657 $23,892 Accrued liabilities 13,036 9,079 Total current liabilities 38,693 32,971 Operating lease liabilities, net of current portion 2,862 2,633 Other long-term liabilities 76 76 Long-term debt, net 43,749 42,536 Total liabilities 85,380 78,216 Commitments and contingencies Redeemable preferred stock, $0.01 par value; 5,000,000 shares authorized; 280,510 and 177,110 shares issued and outstanding as of January 31, 2025 and April 30, 2024, respectively 280,510 177,110 Stockholder’s deficit Common stock, $0.01 par value; 5,000,000 shares authorized; 105,808 shares issued and outstanding 1 1 Additional paid-in capital 194,142 197,057 Accumulated deficit (468,196) (406,435)Total West Affum Intermediate Holdings Corp. stockholder’s deficit (274,053) (209,377)Non-controlling interest 16,158 — Total stockholder’s deficit (257,895) (209,377)Total liabilities and stockholder’s deficit$107,995 $45,949 WEST AFFUM INTERMEDIATE HOLDINGS CORP. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts)(unaudited) Three Months Ended January 31, Nine Months Ended January 31, 2025 2024 2025 2024 Revenue$15,090 $8,277 $42,582 $17,760 Costs of revenue 8,543 7,397 26,005 18,795 Gross margin 6,547 880 16,577 (1,035)Operating expenses: Research and development costs 3,353 3,735 10,266 11,669 Selling, general and administrative 23,795 17,091 64,477 52,010 Total operating expenses 27,148 20,826 74,743 63,679 Loss from operations (20,601) (19,946) (58,166) (64,714)Other expense (income): Interest expense 1,783 1,651 5,974 4,295 Interest income (628) — (1,543) — Other expense (income) (15) 8 73 2,776 Net loss before provision for income taxes (21,741) (21,605) (62,670) (71,785)Provision for income taxes 18 14 33 51 Net loss and comprehensive loss (21,759) (21,619) (62,703) (71,836)Net loss attributable to non-controlling interest (250) — (942) — Net loss and comprehensive loss attributable to West Affum Intermediate Holdings Corp. (21,509) (21,619) (61,761) (71,836)Less: Undeclared preferred stock dividends 3,324 1,812 9,030 4,727 Net loss attributable to common stockholder, basic and diluted$(24,833) $(23,431) $(70,791) $(76,563) Net loss per share attributable to common stockholder, basic and diluted$(1.25) $(1.18) $(3.56) $(3.85)Weighted-average shares of common stock outstanding, basic and diluted 19,885,382 19,885,382 19,885,382 19,885,382 RECONCILIATION OF GAAP NET LOSS AND COMPREHENSIVE LOSS TO ADJUSTED EBITDA(in thousands)(unaudited) Three Months Ended January 31, Nine Months Ended January 31, 2025 2024 2025 2024 GAAP Net loss and comprehensive loss$(21,759) $(21,619) $(62,703) $(71,836)Non-GAAP Adjustments: Interest expense 1,783 1,651 5,974 4,295 Interest income (628) — (1,543) — Other expense (income) (15) 8 73 2,776 Provision for income taxes 18 14 33 51 Depreciation expense 1,888 3,363 6,132 8,058 Stock-based compensation expense 459 372 1,958 1,099 IPO expense 1,927 — 1,927 — Adjusted EBITDA$(16,327) $(16,211) $(48,149) $(55,557) CONTACT: Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com
Financial
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Elutia Confirms No Material Impact from Global Tariffs
SILVER SPRING, Md., April 14, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today confirmed that the ongoing global tariff environment has had no material impact on its commercial or operational performance. Elutia sources, manufactures, and distributes 100% of its products within the United States, primarily from its Roswell, Georgia production facility and U.S.-based suppliers. These products include EluPro™, CanGaroo®, SimpliDerm®, and its full Cardiovascular portfolio. 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With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward Looking Statements This press release contains “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. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding any future impacts on Elutia’s performance of current or new and/or increased global tariffs, and any resulting future difficulties, delays or cost increases in securing necessary suppliers or materials for Elutia’s products. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: the risk that clinical research data may not match preclinical study data; our ability to successfully commercialize, market and sell our EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com This press release was published by a CLEAR® Verified individual.
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CVRx Reports Preliminary First Quarter 2025 Financial Results
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In addition, the first quarter of 2025 was impacted by seasonal softness, as patients and customers schedule procedures around insurance coverage and deductibles. We did not fully anticipate this impact because past first quarter events, including COVID spikes, material clinical data releases, and management changes, likely obscured the magnitude of first-quarter seasonality.” “Despite the disappointing revenue performance in the quarter, we remain confident in our ability to drive growth in Barostim adoption. We continue to believe that our strategic focus on driving deep penetration within high-potential accounts will unlock higher future growth. We look forward to providing further information on the earnings call with the release of our full first quarter results in early May.” First Quarter 2025Total revenue for the first quarter of 2025 is expected to be approximately $12.3 million, representing an increase of approximately 15% over first quarter 2024 revenue of $10.8 million. Total revenue generated in the first quarter of 2024 is expected to be comprised of approximately $11.2 million in U.S. revenue and $1.1 million in European revenue. As of March 31, 2025, the Company had a total of 227 active implanting centers in the U.S., as compared to 223 as of December 31, 2024. The number of sales territories in the U.S. decreased by 3 to a total of 45 during the three months ended March 31, 2025. As of March 31, 2025, cash and cash equivalents were $102.7 million. During the three months ended March 31, 2025, the Company issued 543,462 shares of common stock for gross proceeds of $9.5 million under its at-the-market offering. First Quarter 2025 Earnings Release Webcast and Conference Call InformationThe Company plans to release first quarter 2025 financial and operating results after market close on Thursday, May 8, 2025. The Company will host a conference call to review its results at 4:30 p.m. Eastern Time the same day. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-800-445-7795 for U.S. callers, or 1-785-424-1699 for international callers, approximately ten minutes prior to the start time. Please reference the following conference ID to access the call: CVRXQ125. About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our expected first quarter 2025 results), our anticipated growth strategies, anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Preliminary First Quarter 2025 Results This press release includes estimated financial results for the first quarter of 2025, which are preliminary, unaudited and represent the most recent current information available to Company management. The Company’s actual results may differ from these estimated financial results, including due to the completion of its financial closing procedures and final adjustments. The Company expects to issue full financial results and provide information about its outlook for fiscal year 2025 in early May. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.651-338-6204emeyers@cvrx.com
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Neil Bhalodkar
neil.bhalodkar@kestramedical.com


