false 0001531978 0001531978 2024-02-29 2024-02-29

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 29, 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) 912-1332

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 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 


Item 2.02

Results of Operations and Financial Condition.

On February 29, 2024, Paragon 28, Inc. (the “Company”) issued a press release announcing certain financial results for the fourth quarter and full year ended December 31, 2023. A copy of the Company’s press release is furnished as Exhibit 99.1 hereto.

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, 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.

 

Item 7.01

Regulation FD Disclosure.

On February 29, 2024, the Company posted a presentation to its website relating to the Company’s quarterly and full year 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 Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. 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.

 

Item 9.01

Financial Statements and Exhibits.

 

Exhibit
Number

  

Description of Exhibit

99.1    Press Release, dated February 29, 2024, titled “Paragon 28 Reports Fourth Quarter and Full Year 2023 Financial Results and Provides 2024 Net Revenue Guidance”
99.2    Company Presentation dated February 29, 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: February 29, 2024     By:  

/s/ Robert S. McCormack

      General Counsel & Corporate Secretary

Exhibit 99.1

Paragon 28 Reports Fourth Quarter and Full Year 2023 Financial Results

and Provides 2024 Net Revenue Guidance

ENGLEWOOD, CO., February 29, 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 reported financial results for the quarter and year ended December 31, 2023 and provided 2024 Net Revenue guidance.

Fourth Quarter and Full Year 2023 Financial Results

 

   

Consolidated net revenue for the fourth quarter of 2023 was $60.6 million, representing 17.6% and 17.3% reported and constant currency growth, respectively, compared to the fourth quarter of 2022. Consolidated net revenue for the full year 2023 was $216.4 million, representing 19.3% and 19.7% reported and constant currency growth, respectively, compared to the full year 2022.

 

   

U.S. net revenue for the fourth quarter and full year 2023 was $51.7 million and $183.5 million, respectively, representing 14.1% and 16.1% reported growth, respectively, compared to the prior year periods.

 

   

International net revenue for the fourth quarter and full year 2023 was $8.9 million and $32.9 million, respectively, representing 43.1% and 41.3% reported growth, respectively, and 40.7% and 44.1% constant currency growth, respectively, compared to the prior year periods.

 

   

Gross profit margin was 74.5% for the fourth quarter of 2023 compared to 81.5% in the fourth quarter of 2022. Gross profit margin was 79.9% for the full year 2023, compared to 82.1% for the full year 2022. Related to the recent inventory stockpiling, during the fourth quarter of 2023 the Company recorded inventory write-downs totaling $4.0 million which reduced fourth quarter and full year 2023 gross profit margins by 6.6 and 1.8 percentage points, respectively.

 

   

Research and development expenses and selling, general, and administrative expenses increased by 10.5% to $56.4 million for the fourth quarter of 2023, compared to $51.0 million for the fourth quarter of 2022. The increase was driven by additional investments in new product development and selling and marketing initiatives. Research and development expenses and selling, general, and administrative expenses increased by 14.2% to $210.1 million for the full year 2023, compared to $184.0 million for the fourth quarter of 2022. The increase was driven by further investments in new product development, selling and marketing initiatives, as well as investments in corporate and operations infrastructure.

 

   

Net loss was $19.6 million for the fourth quarter of 2023, compared to a net loss of $38.8 million for the fourth quarter of 2022. Net loss was $47.8 million for the full year 2023, compared to a net loss of $67.3 million for the full year 2022.

 

   

Adjusted EBITDA for the fourth quarter of 2023, negatively impacted by the $4.0 million of inventory write downs, was a $4.4 million loss compared to a $1.5 million loss in the fourth quarter of 2022. Adjusted EBITDA for the full year 2023, negatively impacted by the $4.0 million of inventory write downs during the fourth quarter 2023, was a $9.7 million loss compared to a $10.7 million loss for the full year 2022.

“Our team ended the year with solid performances across each foot and ankle segment both in the U.S. and International markets.” said Albert DaCosta, Chairman and Chief Executive Officer. “Turning to 2024, we are incredibly excited to launch several new and high-impact solutions to start the year. Our continued growth is proof of our ability to address unmet needs in the foot and ankle market by committing to innovation and improving patient outcomes.”


2024 Net Revenue Guidance

The Company expects 2024 net revenue to be $249 million to $259 million, representing 15.1% and 19.7% 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.

Webcast and Conference Call Information

Paragon 28 will host a conference call to discuss fourth quarter and full year 2023 financial results on Thursday, February 29, 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: 593140. 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, Colo., 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 and its estimated net revenue for full year 2024. 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. 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. These risks and uncertainties are described more fully in the section titled “Risk Factors” in Paragon 28’s filings with the Securities and Exchange Commission (the “SEC”), including Paragon 28’s annual report on Form 10-K filed with the SEC on February 29, 2024. Paragon 28 does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing Paragon 28’s views as of any date subsequent to the date of this press release. Paragon 28’s results for the quarter ended December 31, 2023 are not necessarily indicative of our operating results for any future periods.

 

2


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

 

3


PARAGON 28, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(in thousands)

 

     December 31, 2023     December 31, 2022  

ASSETS

    

Current assets:

    

Cash

   $ 75,639     $ 38,468  

Trade receivables

     37,323       37,687  

Inventories, net

     98,062       60,948  

Income taxes receivable

     794       615  

Other current assets

     3,997       4,658  
  

 

 

   

 

 

 

Total current assets

     215,815       142,376  

Property and equipment, net

     74,122       61,938  

Intangible assets, net

     21,674       22,387  

Goodwill

     25,465       25,465  

Deferred income taxes

     705       148  

Other assets

     2,918       1,795  
  

 

 

   

 

 

 

Total assets

   $ 340,699     $ 254,109  
  

 

 

   

 

 

 

LIABILITIES & STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 21,696     $ 14,939  

Accrued expenses

     27,781       26,807  

Accrued legal settlement

     —        22,000  

Other current liabilities

     883       3,844  

Current maturities of long-term debt

     640       728  

Income taxes payable

     243       184  
  

 

 

   

 

 

 

Total current liabilities

     51,243       68,502  

Long-term liabilities:

    

Long-term debt net, less current maturities

     109,799       42,182  

Other long-term liabilities

     1,048       1,628  

Deferred income taxes

     233       342  

Income taxes payable

     635       527  
  

 

 

   

 

 

 

Total liabilities

     162,958       113,181  
  

 

 

   

 

 

 

Stockholders’ equity:

    

Common stock, $0.01 par value, 300,000,000 shares authorized;
83,738,974 and 78,684,107 shares issued, and 82,825,455 and 77,770,588
shares outstanding as of December 31, 2023 and December 31, 2022,
respectively

     827       776  

Additional paid in capital

     298,394       213,956  

Accumulated deficit

     (115,630     (67,789

Accumulated other comprehensive income (loss)

     132       (33

Treasury stock, at cost; 913,519 shares as of December 31, 2023 and December 31, 2022

     (5,982     (5,982
  

 

 

   

 

 

 

Total stockholders’ equity

     177,741       140,928  
  

 

 

   

 

 

 

Total liabilities & stockholders’ equity

   $ 340,699     $ 254,109  
  

 

 

   

 

 

 

 

4


PARAGON 28, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands)

 

     Three Months Ended     Year Ended  
     December 31,     December 31,  
     2023     2022     2023     2022  

Net revenue

   $ 60,561     $ 51,508     $ 216,389     $ 181,383  

Cost of goods sold

     15,440       9,537       43,598       32,457  
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     45,121       41,971       172,791       148,926  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

Research and development costs

     8,102       6,550       30,078       24,650  

Selling, general, and administrative

     48,249       44,466       180,022       159,323  

Legal settlement

     —        27,000       —        27,000  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     56,351       78,016       210,100       210,973  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (11,230     (36,045     (37,309     (62,047
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense):

        

Other (expense) income

     (860     (1,824     154       (1,214

Loss on early extinguishment of debt

     (5,308     —        (5,308     —   

Interest expense, net

     (2,038     (1,264     (5,165     (4,129
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other expense

     (8,206     (3,088     (10,319     (5,343
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (19,436     (39,133     (47,628     (67,390

Income tax expense (benefit)

     123       (370     213       (64
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (19,559   $ (38,763   $ (47,841   $ (67,326
  

 

 

   

 

 

   

 

 

   

 

 

 

 

5


PARAGON 28, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

 

     Year Ended December 31,  
     2023     2022  

Cash flows from operating activities

    

Net loss

   $ (47,841   $ (67,326

Adjustments to reconcile net loss to net cash used in operating activities:

    

Depreciation and amortization

     15,542       13,728  

Allowance for doubtful accounts

     614       155  

Excess and obsolete inventories

     (352     485  

Loss on early extinguishment of debt

     1,881       —   

Stock-based compensation

     12,364       10,365  

Change in fair value

     (791     1,280  

Other

     984       704  

Changes in other assets and liabilities, net of acquisitions:

    

Accounts receivable

     (161     (12,013

Inventories

     (36,595     (21,512

Accounts payable

     6,742       1,895  

Accrued expenses

     6,428       2,317  

Accrued legal settlement

     (22,000     22,000  

Income tax receivable/payable

     (50     391  

Other assets and liabilities

     (655     (1,650
  

 

 

   

 

 

 

Net cash used in operating activities

     (63,890     (49,181
  

 

 

   

 

 

 

Cash flows from investing activities

    

Purchase of office building

     —        (18,300

Purchases of property and equipment

     (26,716     (22,813

Proceeds from sale of property and equipment

     1,043       897  

Purchases of intangible assets

     (1,314     (1,973

Acquisitions, net of cash received

           (18,504
  

 

 

   

 

 

 

Net cash used in investing activities

     (26,987     (60,693
  

 

 

   

 

 

 

Cash flows from financing activities

    

Proceeds from draw on term loan

     —        20,000  

Proceeds from issuance of long-term debt

     100,000       16,000  

Payments on long-term debt

     (30,727     (570

Payments of debt issuance costs

     (4,423     (732

Proceeds from issuance of common stock, net of issuance costs

     68,453       —   

Proceeds from exercise of stock options

     2,406       5,271  

Proceeds from employee stock purchase plan

     944       518  

Payments on earnout liability

     (8,000     (1,000
  

 

 

   

 

 

 

Net cash provided by financing activities

     128,653       39,487  
  

 

 

   

 

 

 

Effect of exchange rate changes on cash

     (605     (497
  

 

 

   

 

 

 

Net increase (decrease) in cash

     37,171       (70,884

Cash at beginning of period

     38,468       109,352  
  

 

 

   

 

 

 

Cash at end of period

   $ 75,639     $ 38,468  
  

 

 

   

 

 

 

 

6


PARAGON 28, INC. AND SUBSIDIARIES

RECONCILIATION OF NET LOSS TO NON-GAAP ADJUSTED EBITDA

(in thousands, unaudited)

 

     Three Months Ended     Year Ended  
     December 31,     December 31,  
     2023     2022     2023     2022  
     (in thousands)  

Net loss

   $ (19,559   $ (38,763   $ (47,841   $ (67,326

Interest expense, net

     2,038       1,264       5,165       4,129  

Income tax expense (benefit)

     123       (370     213       (64

Depreciation and amortization expense

     4,940       4,104       15,542       13,728  

Stock based compensation expense

     2,070       3,313       12,364       10,365  

Employee stock purchase plan expense

     54       113       322       213  

Loss on early extinguishment of debt (1)

     5,308       —        5,308       —   

Change in fair value (2)

     603       1,855       (791     1,280  

Legal Settlement (3)

     —        27,000       —        27,000  
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ (4,423   $ (1,484   $ (9,718   $ (10,675
  

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)

Represents non-recurring expenses related to the write-off of unamortized debt issuance costs and fees incurred to exit the MidCap Credit Agreements early

(2)

Represents a non-cash change in the fair value of earnout liabilities for all periods presented and interest rate swap contract for the three months and year ended December 31, 2023

(3)

Represents non-recurring expenses in connection with the Wright Medical litigation settlement

 

7


PARAGON 28, INC. AND SUBSIDIARIES

Constant-Currency Revenue Growth

(in thousands, unaudited)

 

     Three Months Ended     Year Ended  
     December 31,      Change     December 31,      Change  
     2023     2022      %     2023      2022      %  

Total Consolidated Revenues

               

As Reported

   $ 60,561     $ 51,508        17.6   $ 216,389      $ 181,383        19.3

Impact of foreign currency exchange rates

     (151     —             652        —        
  

 

 

   

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Constant-currency net revenues

   $ 60,410     $ 51,508        17.3   $ 217,041      $ 181,383        19.7
  

 

 

   

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Total International Revenues

               

As Reported

   $ 8,849     $ 6,184        43.1   $ 32,884      $ 23,278        41.3

Impact of foreign currency exchange rates

     (151     —             652        —        
  

 

 

   

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Constant-currency net revenues

   $ 8,698     $ 6,184        40.7   $ 33,536      $ 23,278        44.1
  

 

 

   

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

 

*

Not Meaningful

 

8

Slide 1

4Q and Full Year 2023 Update February 29, 2024 Exhibit 99.2


Slide 2

Forward Looking Statements Except for the historical information contained herein, the matters set forth in this presentation 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 and its estimated net revenue for full year 2024. 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. 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. These risks and uncertainties are described more fully in the section titled “Risk Factors” in Paragon 28’s filings with the Securities and Exchange Commission (the “SEC”), including Paragon 28’s annual report on Form 10-K filed with the SEC on February 29, 2024. Paragon 28 does not undertake any obligation to update forward‐looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward‐looking statements contained herein. These forward-looking statements should not be relied upon as representing Paragon 28’s views as of any date subsequent to the date of this presentation. Paragon 28’s results for the quarter and fiscal year ended December 31, 2023 are not necessarily indicative of our operating results for any future periods. 2


Slide 3

Non-GAAP Financial Measures 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 the 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.


Slide 4

4Q and Full Year 2023 Update – Table of Contents 4Q and FY 2023 Highlights 5 4Q and FY 2023 Net Revenue 6 FY 2024 Net Revenue Guidance 7 2020 – 2023 Operating Cash Flow Trends and Implications for 2024 8 The Global Foot & Ankle Market 9 Continued Strong Product Launch Cadence & Pipeline 10


Slide 5

4Q and FY 2023 Highlights Above Market Revenue Growth Continued in 4Q 2023; Providing 2024 Net Revenue Guidance Net Revenue Performance & Guidance Key Operational and Financial Details Strategic Highlights Global Net Revenue (YoY Growth): 4Q: $60.6M (+17.6% reported; +17.3% CC) | FY 2023: $216.4M (+19.3% reported; +19.7% CC) U.S. Net Revenue (YoY Growth): 4Q: $51.7M (+14.1% reported) | FY 2023: $183.5M (+16.1% reported) International Net Revenue (YoY Growth): 4Q: $8.9M (+43.1% reported; +40.7% CC) | FY 2023: $32.9M (+41.3% reported; +44.1% CC) 2024 Net Revenue Guidance: Full-year 2024 guidance of $249M to $259M (+15.1% to +19.7% YoY) Strong growth across all 5 foot and ankle subsegments U.S. producing sales representatives increased 13.7% YoY to 266 U.S. surgeon customers increased 8.8% YoY to a record 2,215 4Q 2023 aEBITDA declined from ($1.5M) to ($4.5M); FY2023 aEBITDA improved by $1.0M to ($9.7M); both negatively impacted by $4.0M of inventory write-downs recorded in the fourth quarter Expect positive aEBITDA for Full-year 2024 2 full product launches in 4Q2023: JAWS Great White Nitinol Staple System and BEAST Cortical Fiber Bone Graft 5 full product launches in 2024 YTD in high growth forefoot, minimally invasive and soft tissue markets: Grappler® Knotless Anchor System, Bridgeline™ Adaptive Tape, Mister Tendon™ Harvester System, FJ200™ Power Console and Burr System, PRECISION® MIS Bunion System Limited market release and first cases completed using Bun-Yo-Matic™ Lapidus clamp system


Slide 6

4Q and FY 2023 Net Revenue 4Q Net Revenue Sustained performance through 4Q 2023 with significant momentum across key leading indicators to drive future growth FY 2023 Net Revenue Consolidated Growth: + 17.6% Reported + 17.3% Constant Currency Int’l: + 43.1% Rep. + 40.7% CC U.S.: + 14.1% Rep. Consolidated Growth: + 19.3% Reported + 19.7% Constant Currency Int’l: + 41.3% Rep. + 44.1% CC U.S.: + 16.1% Rep.


Slide 7

FY 2024 Net Revenue Guidance 2024 Quarterly Growth Rate Expectations Normalized seasonality to continue 1Q 2024 is expected to be the lowest quarterly year-over-year growth percentage as 1Q 2023 was the highest growth quarter of 2024 (27% constant currency) and 1Q 2024 has one less billing day We expect quarterly growth rates for the rest of the year to be higher than 1Q 2024, given dynamics of year-over-year growth rate comparisons and timing of 2024 new product launches Normalizing Supply Chain Environment 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., Australia, and South Africa, with increasing momentum in other markets FY 2024 Net Revenue Guidance Range 2024 Net Revenue Growth Commentary Low-End Mid-Point High-End Global Net Revenue $249M $254M $259M Implied YoY Growth 15.1% 17.4% 19.7%


Slide 8

Solid foundation of investments in place to drive P28 towards future profitability and positive cash flow. 2022 – 2023 Cumulative Operating Cash Use Normalized operating cash use of $23.0M from 1/1/22 through 12/31/23. Significant improvements in operating cash flow expected for 2024 and beyond. Key drivers: expected annual revenue growth at multiples of F&A market, reductions in inventory stockpile, completion of legal settlement, and annual positive adjusted EBITDA P28 2020 – 2023 Operating Cash Flow Trends Increase in operating cash use compared to 2020 and 2021 driven by temporal and non-recurring drivers. See detailed waterfall à Approximately break-even operating cash flow in both 2020 and 2021 (1) FY 2023 DIOH 786 days (excludes write-down adjustment of $4.0M included in 4Q23 COGS) compared to 4Q 2021 at 463 days. Inventory stockpile in 2022 and 2023 is calculated based on FY 2023 DIOH in excess of 4Q 2021 DIOH. 2020 – 2023 Operating Cash Flow Trends


Slide 9

The Global Foot & Ankle Market Global Foot & Ankle Market(1) Market Sub-segments(1) Estimated 2023 Global Market(2) CAGR: 7.1% Source: iData Research and Company estimates. Source: Company filings, SmartTrak, and management estimates. Fast Growing Market with Several Key Differentiators Paragon 28 Market Highlights Highly complex anatomy Generally active and younger patient populations Significant opportunity for innovation to drive improved outcomes Well over 100 indications with wide variety of causes (activity-based, trauma, genetic predisposition, etc.) Well balanced portfolio spanning each sub-segment effectively YTD growth across all sub-segments Substantial opportunity to expand footprint in U.S. and International Long runway for growth in existing and new international markets


Slide 10

Continued Strong Product Launch Cadence & Pipeline 2 Product Launches in Q4 2023 and 6 Product Launches in 2024 YTD(1) Robust Pipeline 25+ Active Projects in Development Balanced Across Portfolio 5-10 Annual Launches Expected In Next Three Years 1st Smart28 Module Planned for Mid-2024(3) January 5, 2024: Grappler® Knotless Anchor System January 17, 2024 (LMR)(2): Bun-Yo-Matic™ Lapidus Clamp System January 30, 2024: FJ2000™ Power Console and Burr System February 1, 2024: PRECISION® MIS Bunion System Q4 2023 2024 YTD January 5, 2024: Bridgeline™ Adaptive Tape January 26, 2024: Mister Tendon™ Harvester System November 2023: JAWS Great White Nitinol Staple System November 2023: BEAST Cortical Fiber Bone Graft Excludes simple line extensions. Includes products launched and on limited market release as of 12/31/2023. Some products span multiple segments. “Limited market release”. Subject to regulatory clearance.

v3.24.0.1
Document and Entity Information
Feb. 29, 2024
Cover [Abstract]  
Amendment Flag false
Entity Central Index Key 0001531978
Document Type 8-K
Document Period End Date Feb. 29, 2024
Entity Registrant Name Paragon 28, Inc.
Entity Incorporation State Country Code DE
Entity File Number 001-40902
Entity Tax Identification Number 27-3170186
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 912-1332
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, $0.01 par value
Trading Symbol FNA
Security Exchange Name NYSE
Entity Emerging Growth Company false

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