8-K

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): May 8, 2023

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. ☐

Item 2.02. Results of Operations and Financial Condition.

On May 8, 2023, Treace Medical Concepts, Inc. issued a press release regarding its financial results for the quarter ended March 31, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

This information is intended to be furnished under Item 2.02 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01	Financial Statements and Exhibits.
Exhibit No.		Description
99.1		Press Release of Treace Medical Concepts, Inc. issued on May 8, 2023
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: May 8, 2023	By:	/s/ Mark L. Hair
		Mark L. Hair
		Chief Financial Officer

EX-99

Exhibit 99.1

 

Treace Medical Concepts Reports First Quarter 2023 Financial Results

PONTE VEDRA, Fla. – May 8, 2023 — Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of hallux valgus (commonly known as bunions), today reported financial results for the first quarter ended March 31, 2023.

Recent Highlights:

•Revenue of $42.2 million in the first quarter of 2023, a 45% increase over the same period last year.

•Blended average revenue per Lapiplasty® procedure kit sold was $6,244, a 13% increase over the same period last year and a 6% increase sequentially.

•Gross margin of 80.9% in the first quarter 2023.

•First quarter revenue contribution from direct sales channel, the industry’s only direct bunion-focused salesforce, increased to 79% of sales compared to 63% during the first quarter 2022.

•New interim data1 from ALIGN3D™ clinical study highlighted at the 2023 American College of Foot and Ankle Surgeons (ACFAS) Annual Scientific Conference demonstrating 97.3% patient satisfaction rating at 36 months (n=37), with 92% and 90% improvement in walking/standing and social interaction scores, respectively, through 36 months (n=41); an 80.8% decrease in pain at 24 months (n=128); and a low recurrence rate of 0.9% (1 out of 114 patients) observed at 24 months post-surgery2.

•Granted seven additional U.S. patents year-to-date on innovative systems, devices, and methods for performing instrumented surgery for bunions and related deformities. Patent portfolio expands to 47 granted U.S. patents and 51 pending U.S. patent applications.

“First quarter revenue grew 45% with steady execution of our growth strategies and gains across our key operating metrics,” said John T. Treace, CEO, Founder and Board Member of Treace. “With increasing strategic investments into our direct sales channel, R&D initiatives, and direct-to-consumer programs, we continue to drive strong revenue growth and expand our market penetration. These proven commercial programs coupled with our differentiated technologies well-position us to advance our mission to improve surgical outcomes for bunion patients.”

First Quarter 2023 Financial Results

Revenue for the first quarter of 2023 was $42.2 million, representing an increase of 45% compared to $29.0 million in the first quarter of 2022. The increase was driven by an increased number of Lapiplasty® procedure kits sold as a result of an expanded surgeon customer base and increased blended average selling prices due to increased adoption of our newer technologies and expanding product line.

Gross profit for the first quarter of 2023 was $34.2 million, representing an increase of 43% compared to a gross profit of $23.9 million in the first quarter of 2022. Gross margin totaled 80.9% in the first quarter of 2023, compared to 82.3% in the first quarter of 2022. The decrease was primarily due to an increase in payroll costs and an increase in inventory and obsolescence provisions.

___________________

1 The ACFAS Scientific Poster, which includes additional details such as patient demographics, inclusion/exclusion criteria, and complications reported in the study, will be accessible on Treace’s website at: https://www.lapiplasty.com/surgeons/journal-publications/.

20.9% of patients (1 out of 114 patients) demonstrated radiographic recurrence at the 24 month follow up timepoint. 1.4% of patients (2 out of 144 patients) demonstrated radiographic recurrence at the 12 month follow up timepoint.

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Total operating expenses were $47.9 million in the first quarter of 2023, including sales and marketing (S&M) expenses of $33.7 million, research and development (R&D) expenses of $3.4 million, and general and administrative (G&A) expenses of $10.9 million. This compared to total operating expenses of $32.0 million, including S&M expenses of $22.3 million, R&D expenses of $3.1 million, and G&A expenses of $6.7 million in the first quarter of 2022. Increased operating expenses in the first quarter of 2023 reflect increased investments in our commercial initiatives as well as other G&A investments supporting our growing business.

First quarter net loss attributable to common stockholders was ($13.5) million, or ($0.23) per share, compared to a net loss of ($9.0) million, or ($0.16) per share, for the same period of 2022. Adjusted EBITDA was a loss of ($10.0) million in the first quarter, compared to a loss of ($6.4) million for the same period in 2022. See below for additional information and a reconciliation of non-GAAP financial information.

Financial Outlook

Treace is raising its full year 2023 revenue guidance to $190 million to $196 million, which represents approximately 34% to 38% growth over the Company’s 2022 revenue. This compares to the prior revenue guidance of $187 million to $193 million.

Webcast and Conference Call Details

Treace will host a conference call today, May 8, 2023, at 4:30 p.m. ET to discuss its first quarter 2023 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 https://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, share-based compensation expense, interest income, interest expense, and taxes. As of March 31, 2023, in its calculation of Adjusted EBITDA, the Company is subtracting interest income from net loss as interest income is more significant this quarter and is expected to be significant for the full year 2023. Prior period results for Adjusted EBITDA have been updated to be consistent with the current quarter’s presentation. 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 these 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 these non-GAAP financial measures provide 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 these non-GAAP financial measures because it believes investors, analysts and rating agencies consider them to be a useful metrics 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 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. Reconciliations between GAAP and non‐GAAP results are presented below.

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. All statements other than statements of historical fact are forward-looking statements, including, but not limited to the Company’s expectations that it is well positioned to advance its mission to improve surgical outcomes for bunion patients; and the Company’s expected revenue and revenue growth rates for full year 2023. 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

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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, 2022, which was filed with the SEC on March 8, 2023 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, expected to be filed with the SEC on May 9, 2023. 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 ended March 31, 2023 are not necessarily indicative of our operating results for any future periods.

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 65 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 3 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. Treace expanded its offering with the Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of the midfoot to provide further support to hallux valgus patients. For more information, please visit www.treace.com.

Contacts:

Treace Medical Concepts

Mark L. Hair

Chief Financial Officer

mhair@treace.net

(904) 373-5940

Investors:

Gilmartin Group

Lynn Lewis or 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)

(unaudited)

	Three Months Ended March 31,
	2023			2022
Revenue	$	42,195		$	29,047
Cost of goods sold		8,039			5,130
Gross profit		34,156			23,917
Operating expenses
Sales and marketing		33,655			22,299
Research and development		3,412			3,052
General and administrative		10,865			6,662
Total operating expenses		47,932			32,013
Income (loss) from operations		(13,776	)		(8,096	)
Interest income		1,479			9
Interest expense		(1,285	)		(951	)
Other income, net		128			2
Other non-operating income (expense), net		322			(940	)
Net loss	$	(13,454	)	$	(9,036	)
Other comprehensive income (loss):
Unrealized loss on marketable securities	$	(29	)	$	—
Comprehensive income (loss)	$	(13,483	)	$	(9,036	)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.23	)	$	(0.16	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted		58,723,760			54,827,665

Note: A change in presentation has been made within the Statement of Operations and Comprehensive Loss for the three months ended March 31, 2022, reclassifying $0.4 million of surgical instrument expense from cost of goods sold to sales and marketing expense to conform with the current year’s presentation. Please refer to supplemental materials related to quarterly 2022 results available on our investor relations website.

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Treace Medical Concepts, Inc.

Balance Sheets

(in thousands, except share and per share amounts)

(unaudited)

	March 31,			December 31,
	2023			2022
Assets
Current assets
Cash and cash equivalents	$	29,613		$	19,473
Marketable securities, short-term		141,049			61,779
Accounts receivable, net of allowance for doubtful accounts of $677 and $735 as of March 31, 2023 and December 31, 2022, respectively		25,365			29,196
Inventories		22,519			19,330
Prepaid expenses and other current assets		4,587			3,624
Total current assets		223,133			133,402
Property and equipment, net		15,915			15,338
Operating lease right-of-use assets		9,907			10,138
Other non-current assets		215			146
Total assets	$	249,170		$	159,024
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$	5,076		$	8,668
Accrued liabilities		7,971			6,216
Accrued commissions		5,891			7,356
Accrued compensation		3,300			7,666
Operating lease and other liabilities		1,058			339
Total current liabilities		23,296			30,245
Long-term debt, net of discount of $1,215 and $1,289 as of March 31, 2023 and December 31, 2022, respectively		52,785			52,711
Operating lease liabilities, net of current portion		15,447			15,539
Other long-term liabilities		25			—
Total liabilities		91,553			98,495
Commitments and contingencies (Note 7)
Stockholders’ equity
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 0 shares issued and outstanding as of March 31, 2023 and December 31, 2022		—			—
Common stock, $0.001 par value, 300,000,000 shares authorized; 61,280,703 issued and outstanding as of March 31, 2023; 300,000,000 shares authorized; 55,628,208 issued and outstanding as of December 31, 2022		61		55
Additional paid-in capital		255,786			145,221
Accumulated deficit		(98,174	)		(84,720	)
Accumulated other comprehensive (loss) income		(56	)		(27	)
Total stockholders’ equity		157,617			60,529
Total liabilities and stockholders’ equity	$	249,170		$	159,024

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Treace Medical Concepts, Inc.

Statements of Cash Flows

(in thousands)

(unaudited)

	Three Months Ended March 31,
	2023			2022
Cash flows from operating activities
Net loss	$	(13,454	)	$	(9,036	)
Adjustments to reconcile net loss to net cash used in operating    activities
Depreciation and amortization expense		924			334
Provision for allowance for doubtful accounts		38			30
Share-based compensation expense		2,692			1,409
Non-cash lease expense		626			336
Amortization of debt issuance costs		74			45
Recovery of loss reserve for surgical instruments		(23	)		—
Gain on fair value adjustment to derivative liability		—			(90	)
Accretion (amortization) of discount (premium) on marketable securities, net		(297	)		—
Net changes in operating assets and liabilities:
Accounts Receivable		3,793			2,542
Inventory		(3,189	)		(551	)
Prepaid expenses and other assets		(963	)		1,233
Other non-current assets		(69	)		(134	)
Payable to broker for unsettled marketable security purchases		710			—
Operating lease liabilities		(478	)		(133	)
Accounts payable		(3,592	)		(607	)
Accrued liabilities		(4,076	)		(2,619	)
Other, net		25			—
Net cash used in operating activities		(17,259	)		(7,241	)
Cash flows from investing activities
Purchases of available-for-sale marketable securities		(99,550	)		—
Maturities of available-for-sale marketable securities		20,548			—
Purchases of property and equipment		(1,478	)		(1,481	)
Net cash used in investing activities		(80,480	)		(1,481	)
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		352			1,372
Net cash provided by financing activities		107,879			1,372
Net increase (decrease) in cash and cash equivalents		10,140			(7,350	)
Cash and cash equivalents at beginning of period		19,473			105,833
Cash and cash equivalents at end of period	$	29,613		$	98,483
Supplemental disclosure of cash flow information:
Cash paid for interest	$	1,285		$	951
Operating lease right-of-use assets obtained in exchange for new lease liabilities	$	—		$	15,300
Operating lease right-of-use asset and lease liability adjustment due to lease incentive	$	(35	)	$	—
Unrealized losses on marketable securities	$	29		$	—

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Treace Medical Concepts, Inc.

Reconciliation of GAAP Net Loss to EBITDA & Adjusted EBITDA

(in thousands)

	Three Months Ended March 31,
	2023			2022
Net loss	$	(13,454	)	$	(9,036	)
Adjustments:
Interest income		(1,479	)		(9	)
Interest expense		1,285			951
Taxes		—			—
Depreciation & Amortization		924			334
EBITDA	$	(12,724	)	$	(7,760	)
Share-based compensation expense		2,692			1,409
Adjusted EBITDA	$	(10,032	)	$	(6,351	)

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XML

Document and Entity Information	May 08, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 08, 2023
Entity Registrant Name	TREACE MEDICAL CONCEPTS, Inc.
Entity Central Index Key	0001630627
Entity Tax Identification Number	47-1052611
Entity Incorporation, State or Country Code	DE
Entity 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	true
Entity Ex Transition Period	false