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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): August 5, 2024

 

 

 

Paragon 28, Inc.

(Exact name of Registrant as Specified in its Charter)

 

 

 

Delaware 001-40902 27-3170186

(State or Other Jurisdiction

of Incorporation)

(Commission
File Number)

(IRS Employer

Identification No.)

 

 

14445 Grasslands Drive

Englewood, Colorado

80112  
  (Address of Principal Executive Offices) (Zip Code)  

 

Registrant’s Telephone Number, Including Area Code: (720) 399-3400

 

Not Applicable
(Former name or former address, if changed since last report.)

 

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, $0.01 par value   FNA   The New York Stock Exchange

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §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 August 8, 2024, Paragon 28, Inc. (“Paragon 28” or the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

The information in this Item 2.02 of this Current Report on Form 8-K and the Exhibit 99.1 attached hereto 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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), or incorporated by reference in any filing of Paragon 28 under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

(1)Effective August 5, 2024, Chadi Chahine, age 51, has been appointed as Chief Financial Officer (“CFO”) and EVP of Supply Chain Operations of Paragon 28. Mr. Chahine will become a member of the Company’s executive leadership team, reporting directly to Albert DaCosta, Chief Executive Officer and will lead all aspects of the Company’s finance function including business planning and analysis, accounting, SEC reporting, internal audit, tax, and treasury as well as its information technology and operations teams. Kristina Wright has concurrently stepped down as Interim Chief Financial Officer and will continue as a member of the Company’s Board of Directors.

 

Mr. Chahine brings over 25 years of extensive global experience in finance and business operations, including a proven track record in the orthopedic industry. Prior to joining the Company, Mr. Chahine served as Group CFO of the Global Business Group for Zimmer Biomet Holdings Inc. (“Zimmer Biomet”), where he oversaw $7 billion in revenue and had full P&L, balance sheet, and commercial finance responsibilities, for all geographic regions. During his tenure at Zimmer Biomet, Mr. Chahine helped drive record revenue and profit in 2022 and 2023 and identified additional efficiencies in inventory and research & development investments. Prior to Zimmer Biomet, Mr. Chahine served as Chief Operating Officer and CFO of Global Stanley Security at Stanley Black & Decker prior to the business’s $4.1 billion sale. He was also previously CFO at CIRCOR International, leading takeover defense efforts and implementing significant cost-saving measures. Furthermore, he held divisional CFO roles at Smith+Nephew responsible for International Markets and the US where he led initiatives to accelerate sustainable growth. Mr. Chahine holds a Bachelor of Commerce in Accounting from Université du Québec à Montréal and a Bachelor of Science in Math and Economics from Université de Montréal.

 

Pursuant to his Employment Agreement, Mr. Chahine will receive an annual base salary of $550,000. Mr. Chahine will receive a sign-on cash bonus of $300,000, which will be paid in $60,000 increments starting with his appointment date and thereafter every six (6) months until August 5, 2026. Mr. Chahine is also eligible to participate in the Company’s Performance Based Bonus Plan. His target performance bonus is equal to 70% of his base salary. The Company will also grant equity comprising restricted stock units (“RSUs”) and performance stock units (“PSUs”) covering a number of shares of the Company’s common stock with an aggregate value of $3,800,000, based on the thirty-day closing trading average of a share of Company common stock prior to the date of grant and rounded down the nearest whole share. The equity will be granted in accordance with the Company’s 2021 Incentive Award Plan, as amended. The RSUs will vest with respect to 25% of the RSUs on each anniversary of the date of grant, subject to Mr. Chahine’s continuing service with the Company through the applicable vesting date. The PSUs are subject to service and performance-vesting conditions and will vest following the end of the defined performance period. Each RSU and PSU represents the right to receive a share of Company common stock upon vesting.

 

 

 

 

There are no arrangements or understandings between Mr. Chahine and any other persons pursuant to which he was appointed as an officer, and Mr. Chahine has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K. Mr. Chahine does not have a family relationship with any member of the Board or any executive officer of the Company.

 

(2)Effective August 6, 2024, as part of the Company’s broader operational efficiency strategy, Albert DaCosta, Chief Executive Officer, is eliminating his salary increase and forfeiting his annual bonus for 2024. Matt Jarboe, Chief Commercial Officer, Drew Hill, EVP, Research and Development, Robert McCormack, General Counsel, Matthew Millard, Chief Human Resources Officer, and Matt Brinckman, SVP, Strategy and Investor Relations are each capping their target annual bonuses to 50%. These executives described above will have the ability to earn back the remaining 50% of their target bonus upon achievement of certain revenue and adjusted cash flow measures.

 

Item 7.01 Regulation FD Disclosure.

 

On August 8, 2024, the Company announced an operational efficiency strategy targeted at optimizing the organizational structure, minimizing costs and preserving cash without compromising revenue growth opportunities. This strategy was initiated in the second quarter of 2024 and is expected to result in durable savings for the rest of 2024 and in 2025. Management has determined that this operational efficiency strategy will not result in the Company incurring material charges. This operational efficiency strategy includes:

 

An approximately 7% reduction in work force expected to take place in August of 2024, and is intended to result in up to $8 million in annualized savings offset by approximately $1 million in severance costs;

 

Detailed review and optimization of functional costs and controls;

 

An inventory burn-down plan; and

 

One-time realignment of executive compensation for 2024 (as described above).

 

On August 8, 2024, the Company posted a presentation to its website relating to the Company’s quarterly discussion of its financial profile, market strategy, products and recent developments. A copy of the presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K.

 

The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.2, shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section or Section 11 and 12(a)(2) of the Securities Act. The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.2, shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.

 

Cautionary Statement Regarding Forward-Looking Statements

 

This Current Report on Form 8-K contains certain “forward-looking” statements as that term is defined by Section 27A of the Securities Act and Section 21E of the Exchange Act. Statements that are predictive in nature, that depend on or relate to future events or conditions, or that include words such as “believes,” “anticipates,” “expects,” “may,” “will,” “would,” “should,” “estimates,” “could,” “intends,” “plans” or other similar expressions are forward-looking statements, including the Company’s preliminary financial results for the quarter ended June 30, 2024, and the Company’s operational efficiency strategy. These forward-looking statements are based on the Company’s current assumptions, expectations and beliefs and are subject to numerous risks, including, among other things, factors relating to uncertainties as to any difficulties with respect to the Company's operational efficiency strategy, including expenses associated such strategy; the effect of the announcement of the Company's operational efficiency strategy on the Company's ability to retain and hire key personnel and to maintain relationships with customers, suppliers and other business partners; risks related to the possible diversion of management’s attention as a result of the Company's operational efficiency strategy; uncertainties as to the Company's ability and the amount of time necessary to realize the expected benefits of the Company's operational efficiency strategy; and those set forth under the caption “Risk Factors” in the Company’s most recent filings with the Securities and Exchange Commission, as well as other uncertainties, assumptions and changes in circumstances that may cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied in any forward-looking statement. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this Current Report on Form 8-K.

 

 

 

 

Further information on these and other factors that could affect the Company’s financial results and the forward-looking statements in this Current Report on Form 8-K is included in the Company’s filings with the Securities and Exchange Commission, including, among others, the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2023, particularly under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

 

The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

 

Item 9.01 Financial Statements and Exhibits.

 

Exhibit
Number
  Description of Exhibit
99.1   Press Release, dated August 8, 2024
99.2   Company Presentation, dated August 8, 2024
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    PARAGON 28, INC.
   
Date: August 8, 2024 By:

/s/ Robert S. McCormack

    General Counsel & Corporate Secretary

 

 

 

 

Exhibit 99.1

 

Paragon 28 Appoints Chadi Chahine as Chief Financial Officer and Executive Vice-President of Supply Chain Operations, Reports Second Quarter 2024 Financial Results and Narrows 2024 Net Revenue Guidance

 

ENGLEWOOD, CO., August 8, 2024 -- Paragon 28, Inc. (NYSE: FNA) (“Paragon 28” or "Company”), a leading medical device company exclusively focused on the foot and ankle orthopedic market, today announced that Chadi Chahine has been appointed Chief Financial Officer and Executive Vice-President of Supply Chain Operations, effective August 5, 2024. The Company also reported financial results for the quarter ended June 30, 2024, and narrowed its 2024 net revenue guidance.

 

Recent Business Updates

 

·Strengthened executive leadership team with appointment of Chadi Chahine as CFO & EVP Supply Chain Operations, effective August 5, 2024

 

·Recorded global revenue of $61.0 million in the second quarter, representing 19.6% and 19.7% reported and constant currency growth compared to the prior year period, respectively

 

·Drove 840 basis point improvement in operating expense as a percent of revenue in the second quarter compared to the prior year period

 

·Initiated an operational efficiency strategy targeted at optimizing the organizational structure, minimizing costs and preserving cash without compromising revenue growth opportunities

 

·Narrowed 2024 net revenue guidance of $249 million to $255 million, representing 15.1% to 17.8% reported growth compared to 2023

 

·Filed an amended Form 10-K/A for the 2023 fiscal year and an amended Form 10-Q/A for the quarter ended March 31, 2024 in connection with the financial restatement detailed in the Form 8-K filed July 30, 2024

 

Appointment of Chadi Chahine as Chief Financial Officer

 

The appointment of Chadi Chahine concludes an extensive search process conducted by the Company. Mr. Chahine will succeed Kristina Wright who has been serving as Interim CFO since April 3, 2024.

 

“We are thrilled to welcome Chadi to our executive team,” said Albert DaCosta, CEO and Chairman of Paragon 28. “Chadi's extensive experience in orthopedics and finance combined with his strategic vision and proven ability to drive growth and operational efficiency will be invaluable as we continue to expand our presence in the foot and ankle market and further scale our business operations. We also extend our sincere gratitude to Krissy Wright for her exceptional leadership as interim CFO and look forward to her continued contributions on our Board.”

 

Chadi Chahine brings over 25 years of extensive global experience in finance and business operations, including a proven track record in the orthopedic industry, to Paragon 28. Before joining Paragon 28, Mr. Chahine served as Group CFO of the Global Business Group for Zimmer Biomet Holdings Inc. (“Zimmer Biomet”), where he oversaw $7 billion in revenue and had full P&L, balance sheet, and commercial finance responsibilities, across all geographic regions. During his tenure at Zimmer Biomet, Mr. Chahine helped drive record revenue and profit in 2022 and 2023 and identified additional efficiencies in inventory and research & development investments.

 

Prior to his tenure at Zimmer Biomet, Mr. Chahine served as COO and CFO of Global Stanley Security at Stanley Black & Decker prior to the business’s $4.1 billion sale. He also previously served as CFO at CIRCOR International, leading takeover defense efforts and implementing significant cost-saving measures. Earlier in his career, he held divisional CFO roles at Smith+Nephew responsible for International Markets and the US where he led initiatives to accelerate sustainable growth. Mr. Chahine holds a Bachelor of Commerce in Accounting from Université du Québec à Montréal and a Bachelor of Science in Math and Economics from Université de Montréal.

 

“Paragon 28 is a truly unique business in the world of orthopedics. The Company’s commitment to innovation and excellence in foot and ankle aligns perfectly with my professional values and goals,” said Chadi Chahine, CFO. “I am excited to join Paragon 28 at such a critical time and look forward to contributing to its continued growth and success.”

 

 

 

 

Chadi Chahine's appointment as CFO & EVP Supply Chain Operations marks a significant step forward for Paragon 28 as it strengthens its leadership team and positions the Company for continued growth and success in the foot and ankle market.

 

Second Quarter 2024 and Six Months Ended June 30, 2024 Financial Results

 

·Consolidated net revenue for the second quarter of 2024 was $61.0 million, representing 19.6% and 19.7% reported and constant currency growth, respectively, compared to the second quarter of 2023. Consolidated net revenue for the six months ended June 30, 2024 was $122.1 million, representing 18.5% reported and constant currency growth compared to the six months ended June 30, 2023.

 

oU.S. net revenue for the second quarter of 2024 and six months ended June 30, 2024 was $49.7 million and $100.8 million, respectively, representing 17.6% and 15.5% reported growth, respectively, compared to the prior year periods.

 

oInternational net revenue for the second quarter of 2024 and six months ended June 30, 2024 was $11.3 million and $21.3 million, respectively, representing 29.4% and 35.1% reported growth respectively, compared to the prior year periods.

 

·Gross margin was 75.0% for the second quarter of 2024 compared to 77.3% in the second quarter of 2023. Gross margin was 76.2% for the six months ended June 30, 2024 compared to 78.8% for the six months ended June 30, 2023.

 

·Operating expenses were $56.5 million for the second quarter of 2024, an increase of 9.7%, compared to $51.5 million for the second quarter of 2023. Operating expenses were $118.9 million for the six months ended June 30, 2024, an increase of 16.1%, compared to $102.4 million for the six months ended June 30, 2023.

 

·Net loss was $13.8 million for the second quarter of 2024, a $0.6 million increase, compared to a net loss of $13.2 million for the second quarter of 2023. Net loss was $31.2 million for the six months ended June 30, 2024, a $7.1 million increase, compared to net a loss of $24.1 million for the six months ended June 30, 2023.

 

·Adjusted EBITDA was a $3.0 million loss for the second quarter of 2024, a $2.4 million improvement, compared to a $5.4 million loss in the second quarter of 2023. Adjusted EBITDA was a $10.7 million loss for the six months ended June 30, 2024, a $2.6 million decrease compared to a $8.1 million loss for the six months ended June 30, 2023.

 

“We are pleased with our results this quarter and continue to see strong momentum in the U.S. driven in part by the energy around our recent new product launches,” said Albert DaCosta, Chairman and Chief Executive Officer. “Further, we have made significant progress on our cost optimization plans resulting in an 840 basis point year-over-year improvement to operating expenses in the quarter, with more planned in the second half of 2024 and into 2025.”

 

Operational Efficiency Strategy

 

The Company also announced an operational efficiency strategy targeted at optimizing the organizational structure, minimizing costs and preserving cash without compromising revenue growth opportunities. This strategy was initiated in the second quarter of 2024 and is expected to result in durable savings for the rest of 2024 and in 2025. Management has determined that this operational efficiency strategy will not result in the Company incurring material charges. This operational efficiency strategy includes:

 

·An approximately 7% reduction in work force expected to take place in August of 2024, and is intended to result in up to $8 million in annualized savings offset by approximately $1 million in severance costs;

 

·Detailed review and optimization of functional costs and controls;

 

·An inventory burn-down plan; and

 

·One-time realignment of executive compensation for 2024

 

 

 

 

“Our company has consistently demonstrated strong growth and we remain committed to sustaining that momentum by making thoughtful strategic adjustments,” said Albert DaCosta, Chairman and Chief Executive Officer. “Although these processes are never easy, this initiative is critical to enhance efficiency, minimize costs and preserve cash without compromising our growth initiatives or our high-quality product portfolio.”

 

2024 Net Revenue Guidance

 

The Company narrows its prior 2024 net revenue guidance and expects net revenue to be $249 million to $255 million, representing 15.1% to 17.8% reported growth compared to 2023.

 

The Company’s 2024 net revenue guidance assumes foreign currency translation rates remain consistent with current foreign currency translation rates.

 

Restatement

 

As previously announced in our Current Report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on July 30, 2024, on July 30, 2024, the Audit Committee (the “Audit Committee”) of the Board of Directors and in consultation with management, concluded that its audited consolidated financial statements for the fiscal year ended December 31, 2023 and its unaudited condensed consolidated financial statements for the periods ended March 31, 2023, June 30, 2023, September 30, 2023, and March 31, 2024 could no longer be relied upon as a result of material accounting errors identified by management. Accordingly, the consolidated financial statements as of and for the fiscal year ended December 31, 2023 have been restated in the Company’s Annual Report on Form 10-K/A filed on August 8, 2024 to reflect the correction of identified errors in the calculation of excess and obsolete inventory, as well as its accounting for inventory variances, which resulted in a net overstatement of inventory as of March 31, 2023, June 30, 2023, September 30, 2023, and December 31, 2023, and a net understatement in cost of goods sold for the respective interim periods ended on such dates and for the fiscal year ended December 31, 2023. Additionally, the unaudited interim condensed consolidated financial statements as of and for the three months ended March 31, 2024 have been restated in the Company’s Quarterly Report on Form 10-Q/A filed on August 8, 2024 to reflect the correction of identified errors in the calculation of excess and obsolete inventory, as well as its accounting for inventory variances, which resulted in a net overstatement of inventory as of March 31, 2024 and a net understatement in cost of goods sold for the three months ended March 31, 2024. In connection with the presentation of comparative prior period financial statements in the amended Form 10-K/A for the fiscal year ended December 31, 2023, the Company revised the consolidated financial statements for the year ended December 31, 2022 and the condensed consolidated financial statements for the interim periods for such year, each as presented in the amended Form 10-K/A for the fiscal year ended December 31, 2023, to correct errors identified that were determined to be immaterial both individually and in the aggregate.

 

Webcast and Conference Call Information

 

Paragon 28 will host a conference call to discuss second quarter 2024 financial results on Thursday, August 8, 2024, at 2:30 p.m. Mountain Time / 4:30 p.m. Eastern Time. Investors interested in listening to the conference call may do so by dialing (833-470-1428) for domestic callers or (404-975-4839) for international callers, using conference ID: 389675. Live audio of the webcast will be available on the “Investors” section of the company’s website at ir.paragon28.com. The webcast will be archived and available for replay for at least 90 days after the event.

 

About Paragon 28, Inc.

 

Based in Englewood, CO., Paragon 28, is a leading medical device company exclusively focused on the foot and ankle orthopedic market and is dedicated to improving patient lives. From the onset, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and instrumentation that cover a wide range of foot and ankle ailments including fracture fixation, forefoot, ankle, progressive collapsing foot deformity (PCFD) or flatfoot, Charcot foot and orthobiologics. The Company designs products with both the patient and surgeon in mind, with the goal of improving outcomes, reducing ailment recurrence and complication rates, and making the procedures simpler, consistent, and reproducible.

 

 

 

 

Forward Looking Statements

 

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Paragon 28’s potential to shape a better future for foot and ankle patients; the Company’s preliminary financial results for the quarter ended June 30, 2024; statements about the Company’s 2024 net revenue guidance; reaffirming the Company’s 2024 net revenue guidance ranges; the anticipated timing of the filing of the restated filings; the financial statements to be restated and the filings in which such restated financial statements will appear; the Company's intent to report material weaknesses in its internal control over financial reporting; and the Company’s operational efficiency strategy. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties and are subject to numerous risks, including, among other things, risks related to the timely and correct completion of the restatement and restated filings; the risk that additional information may become known prior to the expected filing with the SEC of the restated filings or that other subsequent events may occur that would require the Company to make additional adjustments to its financial statements, which could be material, or delay the filing of the corrected or future periodic reports with the SEC; risks related to the timing and results of the Company’s review of the effectiveness of internal control over financial reporting and related disclosure controls and procedures, remediation of the control deficiencies identified and our ability to implement and maintain effective internal control over financial reporting in the future, which may adversely affect the accuracy and timeliness of our financial reporting; identification of errors in our financial reporting in the future that require us to restate previously issued financial statements, which may subject us to unanticipated costs or regulatory penalties and could cause investors to lose confidence in the accuracy and completeness of our financial statements; factors relating to uncertainties as to any difficulties with respect to the Company's operational efficiency strategy, including expenses associated such strategy; the effect of the announcement of the Company's operational efficiency strategy on the Company's ability to retain and hire key personnel and to maintain relationships with customers, suppliers and other business partners; risks related to the possible diversion of management’s attention as a result of the Company's operational efficiency strategy; uncertainties as to the Company's ability and the amount of time necessary to realize the expected benefits of the Company's operational efficiency strategy; and those set forth under the caption “Risk Factors” in the Company’s most recent filings with the Securities and Exchange Commission. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Paragon 28’s business in general, see Paragon 28’s current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K/A for the fiscal year ended December 31, 2023, as updated periodically with its other filings with the SEC. These forward-looking statements are made as of the date of this press release, and Paragon 28 assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Paragon 28’s net revenue guidance for 2024 is not necessarily indicative of our operating results for any future periods.

 

Use of Non-GAAP Financial Measures and Their Limitations

 

In addition to our results and measures of performance determined in accordance with U.S. GAAP presented in this press release, we believe that certain non-GAAP financial measures are useful in evaluating and comparing our financial and operational performance over multiple periods, identifying trends affecting our business, formulating business plans, and making strategic decisions.

 

Adjusted EBITDA is a key performance measure that our management uses to assess our financial performance and is also used for internal planning and forecasting purposes. We define Adjusted EBITDA as earnings (loss) before interest expense, income tax expense (benefit), depreciation and amortization, stock-based compensation expense, employee stock purchase plan expense, non-recurring expenses, and certain other non-cash expenses.

 

 

 

 

We believe that Adjusted EBITDA, together with a reconciliation to net income, helps identify underlying trends in our business and helps investors make comparisons between our company and other companies that may have different capital structures, tax rates, or different forms of employee compensation. Accordingly, we believe that Adjusted EBITDA provides useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects, and allowing for greater transparency with respect to a key financial metric used by our management in its financial and operational decision-making. Our use of Adjusted EBITDA has limitations as an analytical tool, and you should not consider these measures in isolation or as a substitute for analysis of our financial results as reported under U.S. GAAP. Some of these potential limitations include:

 

·other companies, including companies in our industry which have similar business arrangements, may report Adjusted EBITDA, or similarly titled measures but calculate them differently, which reduces their usefulness as comparative measures;

 

·although depreciation and amortization expenses are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and Adjusted EBITDA does not reflect cash capital expenditures for such replacements or for new capital expenditure requirements;

 

·Adjusted EBITDA also does not reflect changes in, or cash requirements for, our working capital needs or the potentially dilutive impact of stock-based compensation; and

 

·Adjusted EBITDA does not reflect the interest expense, or the cash requirements necessary to service interest or principal payments on our debt that we may incur.

 

Additionally, we report revenue growth on a constant-currency basis in order to facilitate period-to-period comparisons of results without regard to the impact of fluctuating foreign currency exchange rates. The term foreign currency exchange rates refers to the exchange rates used to translate the company's operating results for all countries where the functional currency is not the U.S. dollar into U.S. dollars. Because we are a global company, foreign currency exchange rates used for translation may have a significant effect on our reported results. References to revenue growth on a constant-currency basis means without the impact of foreign currency exchange rate fluctuations.

 

The company believes disclosure of constant-currency revenue growth rates is helpful to investors because it facilitates period-to-period comparisons. However, constant-currency revenue growth rates are non-GAAP financial measures and are not meant to be considered as an alternative or substitute for comparable measures prepared in accordance with GAAP. Constant-currency growth has no standardized meaning prescribed by GAAP and should be read in conjunction with our consolidated financial statements prepared in accordance with GAAP. We calculate constant-currency growth rates by translating local currency amounts in the current period at actual foreign exchange rates for the prior period.

 

Because of these and other limitations, you should consider our non-GAAP measures only as supplemental to other GAAP-based financial measures.

 

Investor Contact:

Matt Brinckman

Senior Vice President, Strategy and Investor Relations

mbrinckman@paragon28.com

 

 

 

 

PARAGON 28, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, unaudited)

 

   June 30, 2024   December 31, 2023 
       (As Restated) 
ASSETS          
Current assets:          
Cash and cash equivalents  $46,741   $75,639 
Trade receivables, net of allowance for doubtful accounts of $931 and $1,339, respectively   36,708    37,323 
Inventories, net   96,406    90,046 
Income taxes receivable   1,018    794 
Other current assets   3,575    3,997 
Total current assets   184,448    207,799 
           
Property and equipment, net   74,904    74,122 
Intangible assets, net   20,977    21,674 
Goodwill   25,465    25,465 
Deferred income taxes   714    705 
Other assets   3,959    2,918 
Total assets  $310,467   $332,683 
           
LIABILITIES & STOCKHOLDERS' EQUITY          
Current liabilities:          
Accounts payable  $23,136   $21,696 
Accrued expenses   26,531    27,781 
Other current liabilities   962    883 
Current maturities of long-term debt   640    640 
Income taxes payable   422    243 
Total current liabilities   51,691    51,243 
           
Long-term liabilities:          
Long-term debt net, less current maturities   109,913    109,799 
Other long-term liabilities   1,159    1,048 
Deferred income taxes   231    233 
Income taxes payable   638    635 
Total liabilities   163,632    162,958 
           
Stockholders' equity:          
Common stock, $0.01 par value, 300,000,000 shares authorized; 84,417,725 and 83,738,974 shares issued, and 83,504,206 and 82,825,455 shares outstanding as of June 30, 2024 and December 31, 2023, respectively   833    827 
Additional paid in capital   307,524    298,394 
Accumulated deficit   (154,827)   (123,646)
Accumulated other comprehensive loss   (713)   132 
Treasury stock, at cost; 913,519 shares as of June 30, 2024 and December 31, 2023   (5,982)   (5,982)
Total stockholders' equity   146,835    169,725 
Total liabilities & stockholders' equity  $310,467   $332,683 

 

 

 

 

PARAGON 28, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, unaudited)

 

   Three Months Ended June 30,   Six Months Ended June 30, 
   2024   2023   2024   2023 
       (As Restated)       (As Restated) 
Net revenue  $61,016   $51,009   $122,098   $103,045 
Cost of goods sold   15,261    11,599    29,103    21,828 
Gross profit   45,755    39,410    92,995    81,217 
                     
Operating expenses:                    
Research and development costs   7,083    7,683    14,667    14,732 
Selling, general, and administrative   49,439    43,827    104,221    87,647 
Total operating expenses   56,522    51,510    118,888    102,379 
Operating loss   (10,767)   (12,100)   (25,893)   (21,162)
                     
Other income (expense):                    
Other income (expense), net   132    (76)   647    (692)
Interest expense, net   (2,917)   (803)   (5,539)   (2,008)
Total other expense, net   (2,785)   (879)   (4,892)   (2,700)
Loss before income taxes   (13,552)   (12,979)   (30,785)   (23,862)
Income tax expense   230    269    396    198 
Net loss  $(13,782)  $(13,248)  $(31,181)  $(24,060)
Foreign currency translation adjustment   252    (283)   (845)   (382)
Comprehensive loss  $(13,530)  $(13,531)  $(32,026)  $(24,442)
Weighted average number of shares of common stock outstanding:                    
Basic   83,115,861    82,373,441    82,984,878    81,536,607 
Diluted   83,115,861    82,373,441    82,984,878    81,536,607 
Net loss per share attributable to common stockholders:                    
Basic  $(0.17)  $(0.16)  $(0.38)  $(0.30)
Diluted  $(0.17)  $(0.16)  $(0.38)  $(0.30)

 

 

 

 

PARAGON 28, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands, unaudited)

 

   Six Months Ended June 30, 
   2024   2023 
       (As Restated) 
Cash flows from operating activities          
Net loss  $(31,181)  $(24,060)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   8,868    6,414 
Allowance for doubtful accounts   785    147 
Provision for excess and obsolete inventories   5,932    923 
Stock-based compensation   6,112    6,782 
Change in fair value of financial instruments   (601)   366 
Other   (581)   394 
Changes in other assets and liabilities, net of acquisitions:          
Accounts receivable   (360)   3,138 
Inventories   (12,631)   (20,959)
Accounts payable   1,456    14,745 
Accrued expenses   809    1,845 
Accrued legal settlement       (22,000)
Income tax receivable/payable   (23)   (359)
Other assets and liabilities   211    (779)
Net cash used in operating activities   (21,204)   (33,403)
           
Cash flows from investing activities          
Purchases of property and equipment   (9,491)   (15,354)
Proceeds from sale of property and equipment   724    635 
Purchases of intangible assets   (462)   (544)
Net cash used in investing activities   (9,229)   (15,263)
           
Cash flows from financing activities          
Payments on long-term debt   (320)   (396)
Payments of debt issuance costs   (18)    
Proceeds from issuance of common stock, net of issuance costs       68,453 
Options exercised   2,878    2,464 
RSU vesting, taxes paid   (424)    
Proceeds from employee stock purchase plan   403    560 
Payments on earnout liability   (2,000)   (4,250)
Net cash provided by financing activities   519    66,831 
           
Effect of exchange rate changes on cash and cash equivalents   1,016    114 
Net (decrease) increase in cash and cash equivalents   (28,898)   18,279 
Cash and cash equivalents at beginning of period   75,639    38,468 
Cash and cash equivalents at end of period  $46,741   $56,747 

 

 

 

 

PARAGON 28, INC. AND SUBSIDIARIES

RECONCILIATION OF NET LOSS TO NON-GAAP ADJUSTED EBITDA

(in thousands, unaudited)

 

   Three Months Ended June 30,   Six Months Ended June 30, 
   2024   2023   2024   2023 
       (As Restated)       (As Restated) 
Net loss  $(13,782)  $(13,248)  $(31,181)  $(24,060)
Interest expense, net   2,917    803    5,539    2,008 
Income tax expense   230    269    396    198 
Depreciation and amortization expense   4,610    3,297    8,868    6,414 
Stock based compensation expense   3,024    3,600    6,112    6,782 
Employee stock purchase plan expense   88    60    168    182 
Change in fair value of financial instruments(1)   (82)   (151)   (601)   366 
Adjusted EBITDA  $(2,995)  $(5,370)  $(10,699)  $(8,110)

 

 

(1)Represents non-cash change in the fair value of our interest rate swap contract for all periods presented and earnout liabilities for the three and six months ended June 30, 2023.

 

 

 

 

PARAGON 28, INC. AND SUBSIDIARIES

Constant-Currency Revenue Growth

(in thousands, unaudited)

 

   Three Months Ended June 30,   Change   Six Months Ended June 30,   Change 
   2024   2023   %   2024   2023   % 
Total Consolidated Revenues                              
As Reported  $61,016   $51,009    19.6%  $122,098   $103,045    18.5%
Impact of foreign currency exchange rates   24        *    47        * 
Constant-currency net revenues  $61,040   $51,009    19.7%  $122,145   $103,045    18.5%
                               
Total International Revenues                              
As Reported  $11,313   $8,745    29.4%  $21,345   $15,800    35.1%
Impact of foreign currency exchange rates   24        *    47        * 
Constant-currency net revenues  $11,337   $8,745    29.6%  $21,392   $15,800    35.4%

 

 

*Not meaningful

 

 

 

 

Exhibit 99.2

 

1 2Q 2024 Earnings Update August 8, 2024

 

2 Copyright ©2024 Paragon 28. All rights reserved. Forward Looking Statements Except for the historical information contained herein, the matters set forth in this document are forward - looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 , including, but not limited to : Paragon 28 ’s potential to shape a better future for foot and ankle patients ; the Company’s preliminary financial results for the quarter ended June 30 , 2024 ; statements about the Company’s 2024 net revenue guidance ; reaffirming the Company’s 2024 net revenue guidance ranges ; the anticipated timing of the filing of the restated filings ; the financial statements to be restated and the filings in which such restated financial statements will appear ; the Company's intent to report material weaknesses in its internal control over financial reporting ; and the Company’s operational efficiency strategy . You are cautioned not to place undue reliance on these forward - looking statements . Forward - looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware . Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved . These forward-looking statements are based on Paragon 28 ’s current expectations and inherently involve significant risks and uncertainties and are subject to numerous risks, including, among other things, risks related to the timely and correct completion of the restatement and restated filings ; the risk that additional information may become known prior to the expected filing with the SEC of the restated filings or that other subsequent events may occur that would require the Company to make additional adjustments to its financial statements, which could be material, or delay the filing of the corrected or future periodic reports with the SEC ; risks related to the timing and results of the Company’s review of the effectiveness of internal control over financial reporting and related disclosure controls and procedures, remediation of the control deficiencies identified and our ability to implement and maintain effective internal control over financial reporting in the future, which may adversely affect the accuracy and timeliness of our financial reporting ; identification of errors in our financial reporting in the future that require us to restate previously issued financial statements, which may subject us to unanticipated costs or regulatory penalties and could cause investors to lose confidence in the accuracy and completeness of our financial statements ; factors relating to uncertainties as to any difficulties with respect to the Company's operational efficiency strategy, including expenses associated such strategy ; the effect of the announcement of the Company's operational efficiency strategy on the Company's ability to retain and hire key personnel and to maintain relationships with customers, suppliers and other business partners ; risks related to the possible diversion of management’s attention as a result of the Company's operational efficiency strategy ; uncertainties as to the Company's ability and the amount of time necessary to realize the expected benefits of the Company's operational efficiency strategy ; and those set forth under the caption “Risk Factors” in the Company’s most recent filings with the Securities and Exchange Commission . Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties . For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward - looking statements, as well as risks relating to Paragon 28 ’s business in general, see Paragon 28 ’s current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10 - K/A for the fiscal year ended December 31 , 2023 , as updated periodically with its other filings with the SEC . These forward - looking statements are made as of the date of this document, and Paragon 28 assumes no obligation to update the forward - looking statements, or to update the reasons why actual results could differ from those projected in the forward - looking statements, except as required by law . Paragon 28 ’s net revenue guidance for 2024 is not necessarily indicative of our operating results for any future periods .

 

3 Copyright ©2024 Paragon 28. All rights reserved. Non - GAAP Financial Measures In addition to our results and measures of performance determined in accordance with U . S . GAAP presented in this document, we believe that certain non - GAAP financial measures are useful in evaluating and comparing our financial and operational performance over multiple periods, identifying trends affecting our business, formulating business plans and making strategic decisions . Adjusted EBITDA is a key performance measure that our management uses to assess our financial performance and is also used for internal planning and forecasting purposes . We define Adjusted EBITDA as earnings (loss) before interest expense, income tax expense (benefit), depreciation and amortization, stock - based compensation expense, employee stock purchase plan expense, non - recurring expenses and certain other non - cash expenses . We believe that Adjusted EBITDA, together with a reconciliation to net income, helps identify underlying trends in our business and helps investors make comparisons between our company and other companies that may have different capital structures, tax rates, or different forms of employee compensation . Accordingly, we believe that Adjusted EBITDA provides useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects, and allowing for greater transparency with respect to a key financial metric used by our management in its financial and operational decision - making . Our use of Adjusted EBITDA has limitations as an analytical tool, and you should not consider these measures in isolation or as a substitute for analysis of our financial results as reported under U . S . GAAP . Some of these potential limitations include : • other companies, including companies in our industry which have similar business arrangements, may report Adjusted EBITDA, or si milarly titled measures but calculate them differently, which reduces their usefulness as comparative measures; • although depreciation and amortization expenses are non - cash charges, the assets being depreciated and amortized may have to be replaced in the future, and Adjusted EBITDA does not reflect cash capital expenditures for such replacements or for new capital expenditure requirements; • Adjusted EBITDA also does not reflect changes in, or cash requirements for, our working capital needs or the potentially dilu tiv e impact of stock - based compensation; and • Adjusted EBITDA does not reflect the interest expense, or the cash requirements necessary to service interest or principal pa yme nts, on our debt that we may incur. Additionally, we report revenue growth on a constant - currency basis in order to facilitate period - to - period comparisons of results without regard to the impact of fluctuating foreign currency exchange rates . The term foreign currency exchange rates refers to the exchange rates used to translate the company's operating results for all countries where the functional currency is not the U . S . dollar into U . S . dollars . Because we are a global company, foreign currency exchange rates used for translation may have a significant effect on our reported results . References to revenue growth on a constant - currency basis means without the impact of foreign currency exchange rate fluctuations . The company believes disclosure of constant - currency revenue growth rates is helpful to investors because it facilitates period - to - period comparisons . However, constant - currency revenue growth rates are non - GAAP financial measures and are not meant to be considered as an alternative or substitute for comparable measures prepared in accordance with GAAP . Constant - currency growth has no standardized meaning prescribed by GAAP and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP . We calculate constant - currency growth rates by translating local currency amounts in the current period at actual foreign exchange rates for the prior period . Because of these and other limitations, you should consider our non - GAAP measures only as supplemental to other GAAP - based financial measures .

 

4 Copyright ©2024 Paragon 28. All rights reserved. 2Q 2024 Earnings Update – Table of Contents 2Q 2024 and YTD Highlights 5 2Q 2024 and YTD Revenue Performance 6 Operational Efficiency Strategy 7 Review of Impact Related to Recent Restatements 8 The Global Foot & Ankle Market 9 Continued Strong Product Launch Cadence & Pipeline 10 Smart Bun - Yo - Matic Case Management and Workflow 11

 

5 Copyright ©2024 Paragon 28. All rights reserved. 2Q 2024 and YTD Highlights Accelerated growth in 2Q 2024 well above broader market ; Narrowed 2024 Net Revenue guidance Net Revenue Performance & Guidance Key Operational and Financial Details Strategic Highlights Global Net Revenue (YoY Growth): • 2Q : $ 61.0M (+19.6% reported; +19.7% CC) | YTD: $ 122.1M (+18.5% reported; +18.5% CC) U.S. Net Revenue (YoY Growth): • 2Q : $ 49.7M (+17.6% reported) | YTD: $ 100.8M (+15.5% reported) International Net Revenue (YoY Growth): • 2Q : $ 11.3M (+29.4% reported; +29.6% CC) | YTD: $ 21.3M (+35.1% reported; +35.4% CC) Narrowed Full - year 2024 Net Revenue Guidance of $ 249M to $ 255M (+15.1% to +17. 8% YoY) • Balanced growth across all 5 sub - segments • U.S. p roducing sales representatives increased 13.1 % YoY to 277 • U.S. surgeon customers increased 11.1% YoY to 2,271 • Realized 840 basis point improvement to operating expense as a percent of revenue in 2Q2024 compared to the prior year period • Chadi Chahine appointed Chief Financial Officer & EVP of Supply Chain Operations, effective August 5, 2024 • Initiated operational efficiency strategy targeted at optimizing the organizational structure, minimizing costs and preservin g c ash without compromising revenue growth opportunities • Smart 28 Case Management Portal and first Smart 28 Pre - op planning module, the Smart Bun - Yo - Matic, in pilot launch • Full Market Launch of Bun - Yo - Matic Lapidus Clamp and Cut Guide System • Monkey Rings line extension with launch of BONOBO Ρ Ball Joint Strut System for diabetic limb salvage • 2 limited market releases in soft tissue and total ankle replacement: R3FLEX Ρ Stabilization System and APEX 3D Ρ Right Angle Drill

 

6 Copyright ©2024 Paragon 28. All rights reserved. 2 Q Net Revenue Performance Highest YoY U.S. Revenue growth rate since 1Q23 driven by sales force expansion and focus on new product launches YTD Net Revenue Performance Narrowed FY 2024 Net Revenue Guidance Consolidated Growth: + 19.6% Reported + 19.7% Constant Currency Int’l: + 29.6% Rep. + 29.6% CC U.S.: + 17.6% Rep. + $7.4M vs 2Q23 Consolidated Growth: + 18.5% Reported + 18.5% Constant Currency Int’l: + 35.1% Rep. + 35.4% CC U.S.: + 15.5% Rep. 2Q 2024 and YTD Revenue Performance $42.3 $49.7 $8.7 $11.3 $51.0 $61.0 2Q 2023 2Q 2024 $87.2 $100.8 $15.8 $21.3 $103.0 $122.1 2023 YTD 2024 YTD Low - End Mid - Point High - End Global Net Revenue $249M $252M $255M Implied YoY Growth 15.1% 16.5% 17.8% Key Drivers in 2H24 • United States: New product contributions, sales force expansion, sales force productivity gains. Customer expansion and penetration • International: Continued growth in top markets of the U.K. and Australia with increasing momentum in other markets

 

7 Copyright ©2024 Paragon 28. All rights reserved. Operational Efficiency Strategy We believe these initiatives will translate to durable cost savings going forward Streamline organization Manage costs and preserve cash Sustain long - term top - line growth Strategic Intent Key Elements of the Plan Reduction in work force and elimination of several open backfills and planned roles Continued focus on territory expansion and product development Deep dive reviews and optimization of functional spend categories Inventory burn - down plan resulting in reduced days inventory on hand 1 2 3 4

 

8 Copyright ©2024 Paragon 28. All rights reserved. 1Q 2023 2Q 2023 3Q 2023 4Q 2023 FY 2023 1Q 2024 Gross Profit as Previously Reported $43,130 $42,151 $42,389 $45,121 $172,791 $48,896 Gross Margin as Previously Reported 82.9% 82.6% 80.3% 74.5% 79.9% 80.0% Effect of Restatement (from COGS) ($1,323) ($2,741) ($1,528) ($2,764) ($8,356) ($1,656) Gross Profit as Restated $41,807 $39,410 $40,861 $42,357 $164,435 $47,240 Gross Margin as Restated 80.3% 77.3% 77.4% 69.9% 76.0% 77.3% Adjusted EBITDA as Previously Reported ($1,417) ($2,629) ($1,249) ($4,423) ($9,718) ($5,481) Adjusted EBITDA Margin as Previously Reported (2.7%) (5.2%) (2.4%) (7.3%) (4.5%) (9.0%) Effect of Restatement (from COGS) ($1,323) ($2,741) ($1,528) ($2,764) ($8,356) ($1,656) Effect of Restatement (from SG&A) (1) -- -- -- -- -- ($567) Adjusted EBITDA as Restated ($2,740) ($5,370) ($2,777) ($7,187) ($18,074) ($7,704) Adjusted EBITDA Margin as Restated (5.3%) (10.5%) (5.3%) (11.9%) (8.4%) (12.6%) Inventories, net as Previously Reported $69,174 $85,225 $94,380 $98,062 $98,062 $104,298 Effect of Restatement (from COGS) ($983) ($3,724) ($5,252) ($8,016) ($8,016) ($9,672) Inventories, net as Restated $68,191 $81,501 $89,128 $90,046 $90,046 $94,626 Review of Impact Related to Recent Restatements (1) Adjustment to SG&A related to timing of recognition of bad debt expense for customer bankruptcy Restatement of FY 2023 and 1Q 2024 financials resulting in non - cash adjustments to COGS and Net Inventory

 

9 Copyright ©2024 Paragon 28. All rights reserved. $5.2 Billion $6.9 Billion 2024 2028 The Global Foot & Ankle Market Global Foot & Ankle Market (1) Market Sub - segments (1) Estimated 20 24 Global Market (2) Forefoot 34% Fracture Fixation 30% Flatfoot / PCFD 8% Ankle 11% Charcot 4% Biologics 13% 5% Large Diversified Players ~ 65% Single Product / Other ~ 30% (1) Source: iData Research and Company estimates. (2) Source: Company filings, SmartTrak , and management estimates. Fast Growing Market with Several Key Differentiators Paragon 28 Market Highlights x Highly complex anatomy x Generally active and younger patient populations x Significant opportunity for innovation to drive improved outcomes x Well over 100 indications with wide variety of causes (activity - based, trauma, genetic predisposition, etc.) x Well balanced portfolio spanning each sub - segment effectively x Double digit growth across all sub - segments in 2Q 2024 x Substantial opportunity to expand footprint in U.S. and International x Long runway for growth in existing and new international markets

 

10 Copyright ©2024 Paragon 28. All rights reserved. Continued Strong Product Launch Cadence & Pipeline Nine Full Product L aunches and Three Limited Market Release in 2024 YTD (1) Robust Pipeline January 5, 2024 : Grappler® Knotless Anchor System January 30, 2024 : FJ2000 Ρ Power Console and Burr System February 1, 2024: PRECISION® MIS Bunion System January 5, 2024: Bridgeline Ρ Adaptive Tape January 26, 2024: Mister Tendon Ρ Harvester System (1) “ Excludes simple line extensions. Includes products launched and on limited market release as of 12/31/2023. Some products spa n m ultiple segments. (2) “Limited Market Release” March 28, 2024: Grappler® R3INFORCE Ρ Extraosseous Repair System 25+ Active Projects in Development Balanced Across Portfolio 5 - 10 Annual Launches Expected In Next Three Years and Q1 Q2 and Q3 to Date August 2024: SMART28℠ Case Management Portal (Live) August 2024: SMART Bun - Yo - Matic℠ Pilot (1 st Pre - op Module) August 2024: Full Launch of Bu - Yo - Matic Lapidus Clamp August 2024 (LMR) (2) : APEX 3D Ρ Right Angle Drill August 2024 (LMR) (2) : R3FLEX Ρ Stabilization System August 2024 (LMR) (2) : BONOBO Ρ Ball Joint Strut (Monkey Rings Line Extension)

 

11 Copyright ©2024 Paragon 28. All rights reserved. Smart Bun - Yo - Matic Case Management and Workflow Bringing unique patient solutions to life with powerful planning combined with precise instrumentation Surgeon accesses the Smart 28 Case Management Portal Select Smart Bun - Yo - Matic CT or X - Ray program Upload the medical images (CT or X - rays) Leveraging AI - enabled algorithms, the program rapidly characterizes anatomy and calculates a patient specific surgical plan Results are displayed for the surgeon to review and adjust as needed Surgeon precisely achieves the planned correction using the Bun - Yo - Matic guide The surgical plan is seamlessly compiled into a report for interoperative use 1 2 3 5 6 7 For more information please regarding the Smart 28 ecosystem and modules please visit: https://smart.paragon28.com/ “The ability to 3D plan your Hallux Valgus correction is crucial… Even more revolutionary is the capability to apply, control, and achieve the planned correction with the use of the Jig.” Dr. Cesar de Cesar Netto , surgeon designer and first user of the Smart Bun - Yo - Matic 4

v3.24.2.u1
Cover
Aug. 05, 2024
Cover [Abstract]  
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Document Period End Date Aug. 05, 2024
Entity File Number 001-40902
Entity Registrant Name Paragon 28, Inc.
Entity Central Index Key 0001531978
Entity Tax Identification Number 27-3170186
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 14445 Grasslands Drive
Entity Address, City or Town Englewood
Entity Address, State or Province CO
Entity Address, Postal Zip Code 80112
City Area Code 720
Local Phone Number 399-3400
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.01 par value
Trading Symbol FNA
Security Exchange Name NYSE
Entity Emerging Growth Company false

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