TMCI Treace Medical Concepts Inc

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): February 27, 2025

TREACE MEDICAL CONCEPTS, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware		001-40355		47-1052611
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification Number)

 

100 Palmetto Park Place

Ponte Vedra, Florida 32081

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (904) 373-5940

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 class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value per share		TMCI		The Nasdaq Global Select Market

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. ☐

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Item 2.02 Results of Operations and Financial Condition.

 

On February 27, 2025, Treace Medical Concepts, Inc. (the “Company”) issued a press release regarding its financial results for the year ended December 31, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

This information furnished under this Item 2.02, including Exhibit 99.1, shall not be deemed “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 deemed incorporated by reference into 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 filing.

Item 9.01	Financial Statements and Exhibits.
Exhibit No.		Description
99.1		Press Release of Treace Medical Concepts, Inc. issued on February 27, 2025
104		Cover 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, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

				TREACE MEDICAL CONCEPTS, INC.
Date: February 27, 2025				By:		/s/ Mark L. Hair
						Mark L. Hair
						Chief Financial Officer

 

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Exhibit 99.1

 

Treace Medical Concepts Reports Fourth Quarter and Full-Year 2024 Financial Results

 

PONTE VEDRA, Fla. – February 27, 2025 – Treace Medical Concepts, Inc. ("Treace" or the "Company") (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty® and Adductoplasty® Procedures, today reported financial results for the fourth quarter and full year ended December 31, 2024.

Recent Highlights

“We continued to execute on our strategic plan, launching multiple new technologies while improving profitability, positioning us well for continued growth in 2025 and beyond,” said John T. Treace, CEO, Founder and Board Member of Treace. “We are excited to enter 2025 with our expanded bunion portfolio and look forward to delivering additional innovations to address the evolving needs of our surgeon customers, positioning us to drive further penetration in the bunion market.”

Fourth Quarter 2024 Financial Results

Revenue for the fourth quarter of 2024 was $68.7 million, representing an increase of 10% compared to $62.2 million in the fourth quarter of 2023. The increase was driven by product mix shift, increased adoption of newer technologies, an increase in bunion procedure kits sold and an increase in active surgeons.

 

Gross profit for the fourth quarter of 2024 was $55.5 million compared to a gross profit of $50.7 million in the fourth quarter of 2023. Gross margin totaled 80.7% in the fourth quarter of 2024, compared to 81.6% in the fourth quarter of 2023.

 

Total operating expenses were $55.7 million in the fourth quarter of 2024, compared to total operating expenses of $57.5 million in the fourth quarter of 2023. Decreased operating expenses in the fourth quarter of 2024 reflect improved leverage in Sales & Marketing, offset by increased share-based compensation expense, investments in product innovation, and support for other corporate initiatives.

 

Fourth quarter 2024 net loss was ($0.5) million, or ($0.01) per share, compared to ($6.3) million, or ($0.10) per share, for the same period in 2023. Adjusted EBITDA was $11.1 million in the fourth quarter of 2024 compared to $2.6 million for the same period in 2023. See below for additional information and a reconciliation of non-GAAP financial information.

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Full-Year 2024 Financial Results

Revenue for the full-year 2024 was $209.4 million, representing an increase of 12% compared to $187.1 million in 2023. The increase was driven by product mix shift, increased adoption of newer technologies, an increase in bunion procedure kits sold and active surgeons.

 

Gross profit for the full-year 2024 was $168.3 million compared to a gross profit of $151.9 million in 2023. Gross margin totaled 80.4% in 2024, compared to 81.2% in 2023.

 

Total operating expenses were $224.0 million in 2024, compared to total operating expenses of $203.4 million in 2023. Increased operating expenses in 2024 reflect increased share-based compensation expense, investments in product innovation, and support for other corporate initiatives.

 

Full-year 2024 net loss was ($55.7) million, or ($0.90) per share, compared to ($49.5) million, or ($0.81) per share, for the same period in 2023. Adjusted EBITDA was a loss of ($11.0) million in 2024, compared to a loss of ($24.4) million in 2023. See below for additional information and a reconciliation of non-GAAP financial information.

 

Cash, cash equivalents, and marketable securities totaled $75.7 million as of December 31, 2024. Including access to an additional $26M of cash through our existing revolver, the balance of cash, cash equivalents and marketable securities would be approximately $102 million as of December 31, 2024.The Company believes it has sufficient balance sheet strength and flexibility to continue effectively executing on its strategic investments and growth initiatives for the foreseeable future.

Financial Outlook

The Company is providing full-year 2025 revenue guidance of $224 million to $230 million, representing growth of 7% to 10%, compared to full-year 2024.

 

The Company continues to expect breakeven Adjusted EBITDA for the full-year 2025.*

Webcast and Conference Call Details

Treace will host a conference call today, February 27, 2025, at 4:30 p.m. ET to discuss its fourth quarter and full year 2024 financial results. Investors interested in listening to the conference call may do so by registering. Once registered, participants will receive dial-in numbers and a unique pin to join the call and ask questions. The live webcast of the conference call will be available on the Investor Relations section of the Company’s website at investors.treace.com. The webcast will be archived on the website following the completion of the call.

Use of Non-GAAP Financial Measures

To supplement the financial results presented in accordance with GAAP, this earnings release presents Adjusted EBITDA, which the Company defines as net loss before depreciation and amortization expense, interest income, interest expense, taxes, share-based compensation expense, acquisition-related costs, restructuring costs, customer credit loss, litigation costs, and debt extinguishment loss. Non-GAAP financial measures such as Adjusted EBITDA are presented in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Management uses non-GAAP financial measures to evaluate the Company’s operating performance and trends, as well as for making planning decisions. The Company believes that Adjusted EBITDA helps to identify underlying trends in the Company’s business that may otherwise be masked by the effect of the income and expenses and other items that it excludes in its calculation of Adjusted EBITDA. Accordingly, the Company believes this non-GAAP financial measure provides useful information to investors and others in understanding and evaluating the Company’s operating results, enhancing the overall understanding of its past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by the Company’s management in their financial and operational decision-making. The Company also presents this non-GAAP financial measure because it believes investors, analysts and rating agencies consider it to be a useful metric in measuring the Company’s performance against other companies and its ability to meet its debt service obligations.

There are limitations related to the use of non-GAAP financial measures such as Adjusted EBITDA because they are not prepared in accordance with GAAP, may exclude significant income and expenses required

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by GAAP to be recognized in the Company’s financial statements, and may not be comparable to non-GAAP financial measures used by other companies. The Company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. A reconciliation between GAAP and non-GAAP results is presented below.

 

*A reconciliation of Adjusted EBITDA to GAAP net loss on a forward-looking basis is not available without unreasonable efforts due to the high variability, complexity and low visibility with respect to the items excluded from this non-GAAP measure.

Forward-Looking Statements

This press release and statements made during the Company’s earnings call contain 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. All statements other than statements of historical fact are forward-looking statements, including, but not limited to, the Company’s: revenue guidance and estimated revenue growth rates for full-year 2025; estimated quarterly revenue growth rates; sufficient balance sheet strength and flexibility to continue effectively executing on its strategic investments and growth initiatives for the foreseeable future; anticipated liquidity; Adjusted EBITDA guidance; ability to effectively respond to and mitigate the impact of challenges in the current market environment, including in response to increased competition and accelerating adoption of MIS osteotomy solutions; anticipated future product launches and the timing of such product launches, including the timing for full commercial availability of the Nanoplasty™ and Percuplasty™ Systems and the number and pace of new product innovations through 2025; ability to increase its procedure volumes, expand its surgeon customer base, provide a suite of technologies to address the evolving needs of bunion surgeons, and increase penetration into the bunion market; strategic investments supporting its market position and long-term outlook; ability to protect and enforce its intellectual property rights, including through its recently filed patent infringement and unfair competition suit; success in defending against infringement of its intellectual property by third parties, including its competitors; expected seasonality; and anticipated pace of growth in the foot and ankle market. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results or other events to differ materially from those contemplated in this press release can be found in the Risk Factors section of Treace’s public filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 27, 2025. 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. These forward-looking statements speak only as of their date and, except to the extent required by law, the Company undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. The Company’s results for the quarter and year ended December 31, 2024 are not necessarily indicative of its operating results for any future periods.

Internet Posting of Information

Treace routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.treace.com. The Company encourages investors and potential investors to consult the Treace website regularly for important information about Treace.

About Treace Medical Concepts

Treace Medical Concepts, Inc. is a medical technology company with the goal of advancing the standard of care for the surgical management of bunion and related midfoot deformities. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot and affect approximately 67 million Americans, of which Treace estimates 1.1 million are annual surgical candidates. Treace has pioneered and patented the Lapiplasty® 3D Bunion Correction® System – a combination of instruments, implants, and surgical methods designed to surgically correct all three planes of the bunion deformity and secure the unstable joint, addressing the root cause of the bunion and helping patients get back to their active lifestyles. To further support the needs of bunion surgeons and address the four classes of bunions, Treace has introduced its Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of midfoot deformities, the SpeedMTP™ Rapid Compression Implant for addressing

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bunions through big toe joint fusions, and two systems for minimally invasive osteotomy surgeries: the Nanoplasty™ 3D Minimally Invasive Bunion Correction System and the Percuplasty™ Percutaneous 3D Bunion Correction System. The Company continues to expand its footprint in the foot and ankle market with the introduction of its SpeedPlate™ Rapid Compression Implants, an innovative fixation platform with broad versatility across Lapiplasty® and Adductoplasty® procedures, as well as other common bone fusion procedures of the foot. For more information, please visit www.treace.com.

To learn more about Treace, connect with us on LinkedIn, X, Facebook and Instagram.

Contacts:

Treace Medical Concepts
Mark L. Hair
Chief Financial Officer

mhair@treace.net

(904) 373-5940

Investors:

Gilmartin Group

Vivian Cervantes

IR@treace.net

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Treace Medical Concepts, Inc.

Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

 

		Three Months Ended December 31,								Twelve Months Ended December 31,
		2024				2023				2024				2023
Revenue		$	68,708			$	62,212			$	209,357			$	187,118
Cost of goods sold			13,231				11,469				41,093				35,181
Gross profit			55,477				50,743				168,264				151,937
Operating expenses
Sales and marketing			36,859				39,924				147,643				140,894
Research and development			5,210				4,152				20,589				15,440
General and administrative			13,612				13,449				55,720				47,031
Total operating expenses			55,681				57,525				223,952				203,365
Loss from operations			(204	)			(6,782	)			(55,688	)			(51,428	)
Interest income			899				1,709				4,877				6,726
Interest expense			(1,314	)			(1,304	)			(5,256	)			(5,167	)
Other income, net			118				96				324				342
Other non-operating income (expense), net			(297	)			501				(55	)			1,901
Net loss		$	(501	)		$	(6,281	)		$	(55,743	)		$	(49,527	)
Other comprehensive income (loss)
Unrealized gain (loss) on marketable securities		$	(94	)		$	311			$	(66	)		$	190
Comprehensive loss		$	(595	)		$	(5,970	)		$	(55,809	)		$	(49,337	)
Net loss per share, basic and diluted		$	(0.01	)		$	(0.10	)		$	(0.90	)		$	(0.81	)
Weighted-average shares used in computing net loss per share, basic and diluted			62,340,603				61,699,336				62,112,037				60,852,153

 

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Treace Medical Concepts, Inc.

Balance Sheets

(in thousands, except share and per share amounts)

 

		December 31,				December 31,
		2024				2023
Assets
Current assets
Cash and cash equivalents		$	11,350			$	12,982
Marketable securities, short-term			64,327				110,216
Accounts receivable, net of allowance for credit losses of $1,326 and $980 as of December 31, 2024 and December 31, 2023, respectively			40,803				38,063
Inventories			39,255				29,245
Prepaid expenses and other current assets			5,667				7,853
Total current assets			161,402				198,359
Property and equipment, net			25,953				22,298
Intangible assets, net of accumulated amortization of $1,425 and $475 as of December 31, 2024 and December 31, 2023, respectively			8,075				9,025
Goodwill			12,815				12,815
Operating lease right-of-use assets			8,442				9,264
Other non-current assets			407				146
Total assets		$	217,094			$	251,907
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable		$	10,522			$	11,835
Accrued liabilities			7,197				10,458
Accrued commissions			10,121				10,759
Accrued compensation			6,575				7,549
Other liabilities			510				4,432
Total current liabilities			34,925				45,033
Long-term debt			53,306				53,008
Operating lease liabilities, net of current portion			15,934				15,891
Other long-term liabilities			37				37
Total liabilities			104,202				113,969
Commitments and contingencies (Note 8)
Stockholders’ equity
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of December 31, 2024 and December 31, 2023; 0 shares issued as of December 31, 2024 and December 31, 2023			—				—
Common stock, $0.001 par value, 300,000,000 shares authorized; 62,385,101 and 61,749,654 shares issued as of December 31, 2024 and December 31, 2023, respectively			62			62
Additional paid-in capital			303,004				271,973
Accumulated deficit			(189,990	)			(134,247	)
Accumulated other comprehensive income (loss)			97				163
Treasury stock, at cost; 23,391 and 1,218 shares as of December 31, 2024 and December 31, 2023, respectively			(281	)			(13	)
Total stockholders’ equity			112,892				137,938
Total liabilities and stockholders’ equity		$	217,094			$	251,907

 

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Treace Medical Concepts, Inc.

Statements of Cash Flows

(in thousands)

 

		Year Ended December 31,
		2024				2023
Cash flows from operating activities
Net loss		$	(55,743	)		$	(49,527	)
Adjustments to reconcile net loss to net cash used in operating    activities
Depreciation and amortization expense			8,419				5,352
Provision for allowance for credit losses			2,947				434
Share-based compensation expense			30,603				17,352
Non-cash lease expense			2,349				2,461
Amortization of debt issuance costs			298				297
Amortization (accretion) of premium (discount) on marketable securities, net			(1,145	)			(1,406	)
Other, net			538				205
Net changes in operating assets and liabilities, net of acquisitions
Accounts receivable			(5,687	)			(9,301	)
Inventory			(10,010	)			(9,848	)
Prepaid expenses and other assets			2,186				(1,210	)
Other non-current assets			(330	)			—
Operating lease liabilities			(2,473	)			(119	)
Accounts payable			(1,313	)			3,167
Accrued liabilities			(7,903	)			7,528
Other, net			97				40
Net cash provided by (used in) operating activities			(37,167	)			(34,575	)
Cash flows from investing activities
Purchases of available-for-sale marketable securities			(71,579	)			(169,865	)
Sales and maturities of available-for-sale marketable securities			118,547				120,024
Purchases of property and equipment			(11,593	)			(11,458	)
Acquisition, net of cash acquired			—				(20,000	)
Net cash provided by (used in) investing activities			35,375				(81,299	)
Cash flows from financing activities
Proceeds from issuance of common stock from public offering, net of issuance costs and underwriting discount of $7.5 million			—				107,527
Proceeds from exercise of employee stock options			428				1,869
Taxes from withheld shares			(268	)			(13	)
Net cash provided by (used in) financing activities			160				109,383
Net increase (decrease) in cash and cash equivalents			(1,632	)			(6,491	)
Cash and cash equivalents at beginning of period			12,982				19,473
Cash and cash equivalents at end of period		$	11,350			$	12,982
Supplemental disclosure of cash flow information
Cash paid for interest		$	4,955			$	5,167
Operating lease right-of-use asset and lease liability adjustment due to lease incentive		$	8			$	(22	)
Noncash investing activities
Unrealized (gains) losses, net on marketable securities		$	66			$	(190	)
Unsettled matured marketable security and receivable from broker		$	—			$	3,000
Noncash portion of internally developed software		$	—			$	(11	)

 

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Treace Medical Concepts, Inc.

Reconciliation of GAAP Net Loss to EBITDA & Adjusted EBITDA

(in thousands)

 

	Three Months Ended December 31,								Twelve Months Ended December 31,
	2024				2023				2024				2023
Net loss	$	(501	)		$	(6,281	)		$	(55,743	)		$	(49,527	)
Adjustments:
Interest income		(899	)			(1,709	)			(4,877	)			(6,726	)
Interest expense		1,314				1,304				5,256				5,167
Taxes		—				—				—				—
Depreciation & Amortization		2,237				1,769				8,419				5,352
EBITDA	$	2,151			$	(4,917	)		$	(46,945	)		$	(45,734	)
Share-based compensation expense		8,555				5,872				30,603				17,352
Acquisition-related costs		—				1,674				1,873				3,996
Restructuring costs1		—				—				964				—
Customer credit loss2		—				—				2,147				—
Litigation costs3		399				—				399				—
Adjusted EBITDA	$	11,105			$	2,629			$	(10,959	)		$	(24,386	)

1 Restructuring charges primarily relate to severance payments and other post-employment benefits from a restructuring in June 2024.

2 Customer credit loss consists of the write-off of accounts receivable due from a customer that filed for bankruptcy during the second quarter of 2024.

3 Litigation costs related to the lawsuit the Company filed against Stryker Corporate and its subsidiary Wright Medical Technology, Inc. on October 14, 2024.

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v3.25.0.1

Document and Entity Information	Feb. 27, 2025
Cover [Abstract]
Entity Tax Identification Number	47-1052611
Amendment Flag	false
Entity Central Index Key	0001630627
Document Type	8-K
Document Period End Date	Feb. 27, 2025
Entity Registrant Name	TREACE MEDICAL CONCEPTS, Inc.
Entity Incorporation, State or Country Code	DE
Securities Act File Number	001-40355
Entity Address, Address Line One	100 Palmetto Park Place
Entity Address, City or Town	Ponte Vedra
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	32081
City Area Code	904
Local Phone Number	373-5940
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, $0.001 par value per share
Trading Symbol	TMCI
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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