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Treace Medical Concepts Reports First Quarter 2024 Financial Results

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Treace Medical Concepts, Inc. reported $51.1 million in revenue for Q1 2024, a 21% increase from the same period in 2023. Despite a net loss and revised guidance for 2024, the company achieved milestones, expanded its patent portfolio, and introduced new technologies. The CEO remains optimistic about navigating competitive challenges and delivering shareholder value.

Positive
  • Revenue growth of 21% in Q1 2024

  • Expansion of patent portfolio to 63 U.S. patents

  • Introduction of innovative technologies such as Micro-Lapiplasty™ and SpeedPlate™

  • Reaching 100,000+ Lapiplasty® 3D Bunion Correction® patient milestone

Negative
  • Net loss of ($18.7) million in Q1 2024

  • Revised full-year 2024 guidance due to market challenges and competition from knockoffs

  • Adjust EBITDA loss of ($8.3) million in Q1 2024

  • Operating expenses increased to $59.9 million in Q1 2024

Insights

Reviewing the financial results from Treace Medical Concepts, the reported 21% revenue growth is a notable year-over-year increase, which indicates a strong market demand for their surgical products. The gross margin remains high at 80.2%, which is reflective of the company's ability to maintain profitability on their products despite a slight decrease from the previous year's 80.9%. This slight dip could be attributed to the product mix shift towards newer technologies which may have higher cost inputs initially.

However, the increase in operating expenses, which have surpassed revenue growth, can raise concerns about the company's spending efficiency. It is essential to consider whether these investments in sales, product innovation and corporate initiatives will lead to sustainable long-term growth or if they are signs of cost management challenges. The reported improvement in Adjusted EBITDA loss by 18% does provide some positive outlook on the company's ability to manage its earnings before interest, taxes, depreciation and amortization.

The revision of the full-year revenue guidance downwards could be interpreted as a prudent move in light of increased market competition and the adoption of alternative surgical solutions. While this does temper expectations, it also reflects a realistic appraisal of market conditions. For an investor, this may suggest a period of caution is warranted until the company demonstrates it can successfully navigate these competitive pressures and maintain its market position.

The medical technology industry is characterized by rapid innovation and competition, particularly when it comes to minimally invasive surgical (MIS) solutions. Treace Medical Concepts' mention of the evolving market environment and the introduction of competitive products indicates a highly dynamic industry. For an investor, understanding the competitive landscape is essential and the company's plan to introduce two 3D MIS Osteotomy solutions could be pivotal in maintaining its competitive edge.

Another point to consider is the company's strategic decisions to rightsize the P&L and reduce costs. These measures could improve operational efficiency and financial performance in the long run, but it also suggests there might be a period of transition and potential cost constraints impacting the company's operations. For investors, the effectiveness of these measures will be a key development to watch.

Setting the financials aside, reaching the 100,000+ Lapiplasty patient milestone demonstrates significant market penetration and may serve as an indicator of strong brand recognition and customer satisfaction within the industry. The expansion of the patent portfolio to 63 U.S. patents also suggests a robust commitment to R&D and intellectual property protection, which is important in the medical device sector for maintaining a competitive advantage.

However, the mention of increased competition from knockoffs is troubling as it highlights the challenges companies face in protecting their innovations. This can impact long-term profitability and market share if not managed effectively. Investors should watch closely how Treace Medical Concepts enforces its intellectual property rights and how it innovates to stay ahead of the competition, as these factors will be critical in sustaining its market leadership.

PONTE VEDRA, Fla., May 07, 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 first quarter ended March 31, 2024.

Recent Highlights

  • Revenue of $51.1 million in first quarter 2024 increased 21% over same period in 2023
  • Gross margin of 80.2% in first quarter 2024
  • First quarter 2024 net loss attributable to common stockholders was ($18.7) million compared to ($13.5) million for same period in 2023
  • Adjusted EBITDA loss improved to ($8.3) million in first quarter 2024 compared to loss of ($10.0) million for same period in 2023
  • Achieved full commercial availability of Micro-Lapiplasty™, SpeedPlate™ and Hammertoe technologies in first quarter 2024
  • Celebrated 100,000+ Lapiplasty® 3D Bunion Correction® patient milestone and first-ever National Bunion Day, launched new “Future You” patient education and awareness campaign, and named First Medical Device Partner and Official Foot and Ankle Solution Partner for Professional Pickleball Association Tour
  • Patent portfolio expands to 63 granted U.S. patents, with an additional 20 granted patents worldwide and 83 pending U.S. patent applications
  • Revises guidance range for full-year 2024, expecting revenues of $201 million to $211 million from $220 million to $225 million

John T. Treace, CEO and Founder of Treace, said, “Our first quarter revenue growth rate of 21% represents a strong start to 2024. Revenue performance in the quarter was driven by increased procedure kit volume from our expanding base of surgeons as well as increased adoption of our newer technologies, all supported by our dedicated, direct sales team. In addition to strong revenue growth, we made encouraging progress on Adjusted EBITDA with the first quarter loss improving 18% over the prior year.”

Mr. Treace continued, “Despite our strong start to the year, we have revised our guidance for fiscal 2024 to reflect a quickly evolving market environment with increased use of MIS Osteotomy solutions and more competition from knockoffs of our Lapiplasty® products. We plan to introduce two innovative 3D MIS Osteotomy solutions later this year that we believe will establish Treace as the leading comprehensive bunion solution provider. We are also taking decisive action to mitigate the impact of these competitive headwinds by rightsizing our P&L and reducing costs. I am confident in our ability to effectively navigate this new operating environment as we continue to work to capture the opportunities ahead, innovate for our surgeon customer base and deliver long-term value for our shareholders.”

First Quarter 2024 Financial Results

Revenue for the first quarter of 2024 was $51.1 million, representing an increase of 21% compared to $42.2 million in the first quarter of 2023. The increase was driven by higher volume of procedure kits sold as a result of an expanded surgeon customer base and a product mix shift that resulted from increased adoption of newer technologies and increased sales of complementary products used in bunion and related midfoot procedures.

Gross profit for the first quarter of 2024 was $41.0 million, representing an increase of 20% compared to a gross profit of $34.2 million in the first quarter of 2023. Gross margin totaled 80.2% in the first quarter of 2024, compared to 80.9% in the first quarter of 2023, primarily due to a shift in product mix to newer products, partially offset by lower royalty rates.

Total operating expenses were $59.9 million in the first quarter of 2024, compared to total operating expenses of $47.9 million in the first quarter of 2023. Increased operating expenses in the first quarter of 2024, including share-based compensation expense, reflect strategic investments in the Company’s expanding direct sales channel, investments in product innovation, and support for other corporate initiatives.

First quarter 2024 net loss attributable to common stockholders was ($18.7) million, or ($0.30) per share, compared to ($13.5) million, or ($0.23) per share, for the same period in 2023. Adjusted EBITDA loss was ($8.3) million in the first quarter of 2024 compared to a loss of ($10.0) million for the same period in 2023. See below for additional information and a reconciliation of non-GAAP financial information.

Cash, cash equivalents, marketable securities and investment receivable totaled $112.1 million as of March 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 now expects full-year 2024 revenue of $201 million to $211 million, representing growth of 7% to 13%, compared to full-year 2023. This compares to previous guidance of $220 million to $225 million.

The Company continues to expect to make significant improvement in Adjusted EBITDA for full-year 2024 and anticipates Adjusted EBITDA to improve 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.

An investor presentation for the Company’s first quarter 2024 financial results is available in the "Investors" section of Treace's website at investors.treace.com.

Webcast and Conference Call Details

Treace will host a conference call today, May 7, 2024, at 4:30 p.m. ET to discuss its first 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 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 our 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: revised revenue guidance and estimated revenue growth rates for full-year 2024; estimated quarterly revenue growth rates; 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; ability to effectively reduce costs and right size the Company’s P&L; anticipated future product launches and the timing of such product launches, including our planned 3D MIS osteotomy platforms; our ability to protect and enforce our intellectual property rights; our success in defending against infringement of our intellectual property by third parties, including our competitors; expected seasonality; anticipated pace of growth in the foot and ankle market; sufficient balance sheet strength and flexibility to continue effectively executing on its strategic investments and growth initiatives for the foreseeable future; and expectation of progress in Adjusted EBITDA for full-year 2024 and expected rate of Adjusted EBITDA improvement. 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 March 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 patients, Treace has introduced its Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of the midfoot as well as its Hammertoe PEEK Fixation System designed to address hammertoe, claw toe and mallet toe 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 LinkedIn, Twitter, Facebook and Instagram.

Contacts:

Treace Medical Concepts, Inc.
Julie Dewey, IRC
Chief Communications & Investor Relations Officer
jddewey@treace.com | 209-613-6945


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

 Three Months Ended
March 31,
 
 2024  2023 
Revenue$51,108  $42,195 
Cost of goods sold 10,127   8,039 
Gross profit 40,981   34,156 
Operating expenses     
Sales and marketing 40,328   33,655 
Research and development 5,259   3,412 
General and administrative 14,362   10,865 
Total operating expenses 59,949   47,932 
Loss from operations (18,968)  (13,776)
Interest income 1,535   1,479 
Interest expense (1,317)  (1,285)
Other income, net 74   128 
Other non-operating income (expense), net 292   322 
Net loss$(18,676) $(13,454)
      
Other comprehensive income (loss)     
Unrealized gain (loss) on marketable securities$(94) $(29)
Comprehensive loss$(18,770) $(13,483)
      
Net loss per share attributable to common stockholders, basic and diluted$(0.30) $(0.23)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 61,792,788   58,723,760 
 

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

  March 31,  December 31, 
  2024  2023 
Assets      
Current assets      
Cash and cash equivalents $9,334  $12,982 
Marketable securities, short-term  100,672   110,216 
Accounts receivable, net of allowance for doubtful accounts of $1,076 and $980 as of March 31, 2024 and December 31, 2023, respectively  30,083   38,063 
Inventories  35,860   29,245 
Prepaid expenses and other current assets  11,448   7,853 
Total current assets  187,397   198,359 
Property and equipment, net  24,517   22,298 
Intangible assets, net of accumulated amortization of $713 and $475 as of March 31, 2024 and December 31, 2023, respectively  8,787   9,025 
Goodwill  12,815   12,815 
Operating lease right-of-use assets  9,064   9,264 
Other non-current assets  146   146 
Total assets $242,726  $251,907 
Liabilities and Stockholders’ Equity      
Current liabilities      
Accounts payable $21,149  $11,835 
Accrued liabilities  15,155   10,458 
Accrued commissions  5,527   10,759 
Accrued compensation  4,196   7,549 
Other liabilities  1,022   4,432 
Total current liabilities  47,049   45,033 
Long-term debt, net of discount of $917 and $992 as of March 31, 2024 and December 31, 2023, respectively  53,083   53,008 
Operating lease liabilities, net of current portion  16,166   15,891 
Other long-term liabilities  37   37 
Total liabilities  116,335   113,969 
Commitments and contingencies (Note 7)      
Stockholders’ equity      
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023      
Common stock, $0.001 par value, 300,000,000 shares authorized; 61,948,776 and 61,749,654 issued, and 61,929,172 and 61,749,654 outstanding as of March 31, 2024 and December 31, 2023, respectively  62  62 
Additional paid-in capital  279,433   271,973 
Accumulated deficit  (152,923)  (134,247)
Accumulated other comprehensive (loss) income  69   163 
Treasury stock, at cost; 19,604 and 1,218 shares as of March 31, 2024 and December 31, 2023, respectively  (250)  (13)
Total stockholders’ equity  126,391   137,938 
Total liabilities and stockholders’ equity $242,726  $251,907 
 

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

  Three Months Ended March 31, 
  2024  2023 
Cash flows from operating activities      
Net loss $(18,676) $(13,454)
Adjustments to reconcile net loss to net cash used in operating
activities
      
Depreciation and amortization expense  1,909   924 
Provision for allowance for doubtful accounts  159   38 
Share-based compensation expense  7,408   2,692 
Non-cash lease expense  592   626 
Amortization of debt issuance costs  75   74 
Recovery of loss reserve for surgical instruments     (23)
Accretion (amortization) of discount (premium) on marketable securities, net  (335)  (297)
Other, net  90    
Net changes in operating assets and liabilities, net of acquisitions      
Accounts receivable  7,821   3,793 
Inventory  (6,615)  (3,189)
Prepaid expenses and other assets  (1,495)  (963)
Other non-current assets     (69)
Payable to broker for unsettled marketable security purchases     710 
Operating lease liabilities  (657)  (478)
Accounts payable  9,314   (3,592)
Accrued liabilities  (6,918)  (4,076)
Other, net  107   25 
Net cash used in operating activities  (7,221)  (17,259)
       
Cash flows from investing activities      
Purchases of available-for-sale marketable securities  (28,711)  (99,550)
Sales and maturities of available-for-sale marketable securities  36,396   20,548 
Purchases of property and equipment  (3,927)  (1,478)
Net cash provided by (used in) investing activities  3,758   (80,480)
       
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 and $10.6 million     107,527 
Proceeds from exercise of employee stock options  52   352 
Taxes from withheld shares  (237)   
Net cash provided by (used in) financing activities  (185)  107,879 
Net increase (decrease) in cash and cash equivalents  (3,648)  10,140 
Cash and cash equivalents at beginning of period  12,982   19,473 
Cash and cash equivalents at end of period $9,334  $29,613 
       
Supplemental disclosure of cash flow information      
Cash paid for interest $1,317  $1,285 
Operating lease right-of-use asset and lease liability adjustment due to lease incentive $  $(35)
Noncash investing activities      
Unrealized (gains) losses, net on marketable securities $94  $29 
Unsettled matured marketable security and receivable from broker $2,100  $ 
         

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

 Three Months Ended
March 31,
 
 2024  2023 
Net loss$(18,676) $(13,454)
Adjustments:     
Interest income (1,535)  (1,479)
Interest expense 1,317   1,285 
Taxes     
Depreciation & Amortization 1,909   924 
EBITDA$(16,985) $(12,724)
Share-based compensation expense 7,408   2,692 
Acquisition-related costs 1,317    
Adjusted EBITDA$(8,260) $(10,032)


FAQ

What was Treace Medical Concepts' revenue in Q1 2024?

Treace Medical Concepts reported $51.1 million in revenue for the first quarter of 2024.

What is the stock symbol for Treace Medical Concepts?

The stock symbol for Treace Medical Concepts is TMCI.

How many U.S. patents does Treace Medical Concepts have in its portfolio?

Treace Medical Concepts has 63 granted U.S. patents in its portfolio.

What is the full-year 2024 revenue guidance for Treace Medical Concepts?

Treace Medical Concepts expects full-year 2024 revenue of $201 million to $211 million.

Treace Medical Concepts, Inc.

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