Company Announcements

Treace Medical Concepts Reports Third Quarter 2024 Financial Results

Source: GlobeNewswire
Treace Medical Concepts Reports Third Quarter 2024 Financial Results

PONTE VEDRA, Fla., Nov. 05, 2024 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2024.

Recent Highlights

  • Revenue of $45.1 million in third quarter 2024 increased 11% over same period in 2023
  • Third quarter 2024 net loss was ($15.4) million compared to ($17.5) million for same period in 2023. Adjusted EBITDA loss improved 45% to ($5.1) million in the third quarter 2024 compared to ($9.2) million for the same period in 2023
  • Announces first entry into high volume osteotomy market with Nanoplasty™ 3D Minimally Invasive Bunion Correction™ Procedure and reaffirms plan to release second minimally invasive technology platform later in the fourth quarter
  • Focused R&D innovation pipeline is now poised to significantly expand technology and procedure offerings through 2025 and beyond
  • Files patent infringement and unfair competition suit to protect Lapiplasty® bunion technology. Expanded patent portfolio now includes 67 granted U.S. patents, 24 granted patents outside of the U.S. and 85 pending U.S. patent applications

“Our third quarter results reflect our focused execution to drive growth in the business while steadily improving our operating leverage. In addition, we are excited to announce the market release of Nanoplasty™ 3D MIS System, our first entry into the osteotomy market,” said John T. Treace, CEO and Founder of Treace. “We believe this innovative new system, combined with our market leading Lapiplasty®, Adductoplasty® and robust pipeline of future technology and procedure offerings, will further drive penetration into the overall bunion market and continue to expand our surgeon customer base through 2025 and beyond.”

Third Quarter 2024 Financial Results

Revenue for the third quarter of 2024 was $45.1 million, representing an increase of 11% compared to $40.8 million in the third quarter of 2023. The increase was driven by product mix shift that resulted from increased adoption of newer technologies and increased sales of ancillary products used in bunion cases and an increase in active surgeons.

Gross profit for the third quarter of 2024 was $36.1 million compared to a gross profit of $32.8 million in the third quarter of 2023. Gross margin totaled 80.1% in the third quarter of 2024, compared to 80.4% in the third quarter of 2023, primarily due to an increase in inventory provisions and a shift in product mix, partially offset by lower royalty rates.

Total operating expenses were $51.3 million in the third quarter of 2024, compared to total operating expenses of $50.6 million in the third quarter of 2023. Increased operating expenses in the third quarter of 2024 reflect increased share-based compensation expense, investments in product innovation, and support for other corporate initiatives.

Third quarter 2024 net loss was ($15.4) million, or ($0.25) per share, compared to ($17.5) million, or ($0.28) per share, for the same period in 2023. Adjusted EBITDA loss was ($5.1) million in the third quarter of 2024 compared to a loss of ($9.2) million for the same period in 2023. See below for additional information and a reconciliation of non-GAAP financial information.

Cash, cash equivalents, and marketable securities totaled $82.8 million as of September 30, 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 revising full-year 2024 revenue guidance to $204 million to $211 million, representing growth of 9% to 13%, compared to full-year 2023. This compares to previous guidance of $201 million to $211 million.

The Company continues to expect our Adjusted EBITDA loss to decrease by approximately 50% compared to full-year 2023.*

* 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.

Webcast and Conference Call Details

Treace will host a conference call today, November 5, 2024, at 4:30 p.m. ET to discuss its third quarter 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, 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 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.

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 2024; 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; expected rate of Adjusted EBITDA improvement; 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 its planned 3D MIS osteotomy platforms 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 patients, and increase penetration into the overall 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, 2023, which was filed with the SEC on February 27, 2024, and its subsequent SEC filings. 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 September 30, 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 patients, Treace has introduced its Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of midfoot deformities. 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 LinkedInXFacebook 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

Treace Medical Concepts, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)

  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
  2024  2023  2024  2023 
Revenue $45,086  $40,758  $140,649  $124,906 
Cost of goods sold  8,954   7,998   27,862   23,712 
Gross profit  36,132   32,760   112,787   101,194 
Operating expenses            
Sales and marketing  32,775   33,542   110,784   100,970 
Research and development  4,963   4,350   15,379   11,288 
General and administrative  13,528   12,686   42,108   33,582 
Total operating expenses  51,266   50,578   168,271   145,840 
Loss from operations  (15,134)  (17,818)  (55,484)  (44,646)
Interest income  1,067   1,570   3,978   5,017 
Interest expense  (1,313)  (1,296)  (3,942)  (3,863)
Other income, net  20   23   206   246 
Other non-operating income (expense), net  (226)  297   242   1,400 
Net loss $(15,360) $(17,521) $(55,242) $(43,246)
             
Other comprehensive income (loss)            
Unrealized gain (loss) on marketable securities $217  $71  $28  $(121)
Comprehensive loss $(15,143) $(17,450) $(55,214) $(43,367)
             
Net loss per share, basic and diluted $(0.25) $(0.28) $(0.89) $(0.71)
Weighted-average shares used in computing net loss per share, basic and diluted  62,229,463   61,562,494   62,035,293   60,566,655 
                 

Treace Medical Concepts, Inc.
Balance Sheets
(in thousands, except share and per share amounts)
(unaudited)

  September 30,  December 31, 
  2024  2023 
Assets      
Current assets      
Cash and cash equivalents $12,110  $12,982 
Marketable securities, short-term  70,689   110,216 
Accounts receivable, net of allowance for credit losses of $743 and $980 as of September 30, 2024 and December 31, 2023, respectively  24,177   38,063 
Inventories  43,611   29,245 
Prepaid expenses and other current assets  7,015   7,853 
Total current assets  157,602   198,359 
Property and equipment, net  25,168   22,298 
Intangible assets, net of accumulated amortization of $1,188 and $475 as of September 30, 2024 and December 31, 2023, respectively  8,312   9,025 
Goodwill  12,815   12,815 
Operating lease right-of-use assets  8,569   9,264 
Other non-current assets  458   146 
Total assets $212,924  $251,907 
Liabilities and Stockholders’ Equity      
Current liabilities      
Accounts payable $18,649  $11,835 
Accrued liabilities  8,098   10,458 
Accrued commissions  5,347   10,759 
Accrued compensation  5,598   7,549 
Other liabilities  571   4,432 
Total current liabilities  38,263   45,033 
Long-term debt, net of discount of $769 and $992 as of September 30, 2024 and December 31, 2023, respectively  53,231   53,008 
Operating lease liabilities, net of current portion  16,487   15,891 
Other long-term liabilities  37   37 
Total liabilities  108,018   113,969 
Commitments and contingencies (Note 7)      
Stockholders’ equity      
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023      
Common stock, $0.001 par value, 300,000,000 shares authorized; 62,294,975 and 61,749,654 issued, and 62,275,371 and 61,749,654 outstanding as of September 30, 2024 and December 31, 2023, respectively  62  62 
Additional paid-in capital  294,392   271,973 
Accumulated deficit  (189,489)  (134,247)
Accumulated other comprehensive (loss) income  191   163 
Treasury stock, at cost; 19,604 and 1,218 shares as of September 30, 2024 and December 31, 2023, respectively  (250)  (13)
Total stockholders’ equity  104,906   137,938 
Total liabilities and stockholders’ equity $212,924  $251,907 
         

Treace Medical Concepts, Inc.
Statements of Cash Flows
(in thousands)
(unaudited)

  Nine Months Ended September 30, 
  2024  2023 
Cash flows from operating activities      
Net loss $(55,242) $(43,246)
Adjustments to reconcile net loss to net cash used in operating
activities
      
Depreciation and amortization expense  6,182   3,583 
Provision for allowance for credit losses  2,381   79 
Share-based compensation expense  22,048   11,480 
Non-cash lease expense  607   1,868 
Amortization of debt issuance costs  223   223 
Accretion (amortization) of discount (premium) on marketable securities, net  (918)  (1,031)
Other, net  180   164 
Net changes in operating assets and liabilities, net of acquisitions      
Accounts receivable  11,505   4,121 
Inventory  (14,366)  (9,915)
Prepaid expenses and other assets  838   (1,028)
Other non-current assets  (312)   
Operating lease liabilities  (147)  497 
Accounts payable  6,814   12 
Accrued liabilities  (12,753)  (1,954)
Other, net     40 
Net cash provided by (used in) operating activities  (32,960)  (35,107)
       
Cash flows from investing activities      
Purchases of available-for-sale marketable securities  (52,890)  (140,075)
Sales and maturities of available-for-sale marketable securities  93,363   82,979 
Purchases of property and equipment  (8,519)  (9,210)
Acquisition, net of cash acquired     (20,000)
Net cash provided by (used in) investing activities  31,954   (86,306)
       
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  371   1,691 
Taxes from withheld shares  (237)   
Net cash provided by (used in) financing activities  134   109,218 
Net increase (decrease) in cash and cash equivalents  (872)  (12,195)
Cash and cash equivalents at beginning of period  12,982   19,473 
Cash and cash equivalents at end of period $12,110  $7,278 
       
Supplemental disclosure of cash flow information      
Cash paid for interest $3,732  $3,863 
Operating lease right-of-use asset and lease liability adjustment due to lease incentive $88  $(22)
Noncash investing activities      
Unrealized (gains) losses, net on marketable securities $(28) $121 
Unsettled marketable security purchase and payable to broker $  $(1,100)
Unsettled matured marketable security and receivable from broker $  $6,000 
         

Treace Medical Concepts, Inc.
Reconciliation of GAAP Net Loss to EBITDA & Adjusted EBITDA
(in thousands)
(unaudited)

 Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
 2024  2023  2024  2023 
Net loss$(15,360) $(17,521) $(55,242) $(43,246)
Adjustments:           
Interest income (1,067)  (1,570)  (3,978)  (5,017)
Interest expense 1,313   1,296   3,942   3,863 
Taxes           
Depreciation & Amortization 2,157   1,564   6,182   3,583 
EBITDA$(12,957) $(16,231) $(49,096) $(40,817)
Share-based compensation expense 7,900   5,192   22,048   11,480 
Acquisition-related costs    1,802   1,873   2,322 
Restructuring costs1       964    
Customer credit loss2       2,147    
Adjusted EBITDA$(5,057) $(9,237) $(22,064) $(27,015)
            

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.