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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                     to

Commission File Number: 001-40902

Paragon 28, Inc.

(Exact name of registrant as specified in its charter)

Delaware

27-3170186

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

14445 Grasslands Drive

Englewood, CO

80112

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (720) 912-1332

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

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 per share

FNA

The New York Stock Exchange

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

    

Accelerated filer

Non-accelerated filer

Smaller reporting company

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.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes      No  

As of November 8, 2024, there were 83,720,346 shares of the registrant’s common stock, $0.01 par value per share, outstanding.

EXPLANATORY NOTE

As previously disclosed in Amendment No. 1 to our Annual Report on Form 10-K/A for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (the “SEC”) on August 8, 2024 (the “Amended 2023 Annual Report”) and Amendment No. 1 to our Quarterly Report on Form 10-Q/A for the three months ended March 31, 2024, filed with the SEC on August 8, 2024 (the “Amended 2024 Quarterly Report”), we restated our audited consolidated financial statements for the fiscal year ended December 31, 2023, and the unaudited interim condensed consolidated financial statements for the periods ended March 31, 2023, June 30, 2023, September 30, 2023 and March 31, 2024. Accordingly, the audited consolidated financial statements as of December 31, 2023, and the unaudited interim condensed consolidated financial statements for the three and nine months ended September 30, 2023, included in this Quarterly Report on Form 10-Q  (the “Quarterly Report”) have been restated to reflect the restatement as described in the Amended 2023 Annual Report and the Amended 2024 Quarterly Report.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report, including statements regarding our strategy, future financial condition, future operations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical fact contained in this Quarterly Report, including without limitation statements regarding our business model and strategic plans for our products, technologies and business, including our implementation thereof, the impact on our business, financial condition and results of operations from macroeconomic conditions, the timing of and our ability to obtain and maintain regulatory approvals, our commercialization efforts, our acquisitions, including resulting synergies and future milestone payouts, marketing and manufacturing capabilities and strategy, our expectations about the commercial success and market acceptance of our products, the sufficiency of our cash, cash equivalents and marketable securities, and the plans and objectives of management for future operations and capital expenditures are forward-looking statements.

The forward-looking statements in this Quarterly Report are only predictions and are based largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of known and unknown risks, uncertainties, and assumptions, including those described under the sections in this Quarterly Report entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties, and assumptions, the future events and trends discussed in this Quarterly Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely upon these forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance, or achievements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. We intend the forward-looking statements contained in this Quarterly Report to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

Table of Contents

    

Page

PART I.

FINANCIAL INFORMATION

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

Condensed Consolidated Statements of Stockholders’ Equity

3

Condensed Consolidated Statements of Cash Flows

4

Notes to Unaudited Interim Condensed Consolidated Financial Statements

5

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

16

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

24

Item 4.

Controls and Procedures

25

PART II.

OTHER INFORMATION

27

Item 1.

Legal Proceedings

27

Item 1A.

Risk Factors

27

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

27

Item 3.

Defaults Upon Senior Securities

27

Item 4.

Mine Safety Disclosures

27

Item 5.

Other Information

28

Item 6.

Exhibits

28

Signatures

29

i

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

PARAGON 28, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

(unaudited)

    

    

September 30, 2024

December 31, 2023

ASSETS

Current assets:

Cash and cash equivalents

$

39,145

$

75,639

Trade receivables, net of allowance for doubtful accounts of $793 and $1,339, respectively

35,823

37,323

Inventories, net

96,449

90,046

Income taxes receivable

1,461

794

Other current assets

4,732

3,997

Total current assets

177,610

207,799

Property and equipment, net

74,016

74,122

Intangible assets, net

20,937

21,674

Goodwill

25,465

25,465

Deferred income taxes

714

705

Other assets

3,266

2,918

Total assets

$

302,008

$

332,683

LIABILITIES & STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable

$

20,693

$

21,696

Accrued expenses

27,424

27,781

Other current liabilities

1,336

883

Current maturities of long-term debt

640

640

Income taxes payable

626

243

Total current liabilities

50,719

51,243

Long-term liabilities:

Long-term debt net, less current maturities

109,979

109,799

Other long-term liabilities

994

1,048

Deferred income taxes

245

233

Income taxes payable

638

635

Total liabilities

162,575

162,958

Commitments and contingencies (Note 10)

Stockholders' equity:

Common stock, $0.01 par value, 300,000,000 shares authorized; 84,510,066 and 83,738,974 shares issued, and 83,596,547 and 82,825,455 shares outstanding as of September 30, 2024 and December 31, 2023, respectively

834

827

Additional paid in capital

311,342

298,394

Accumulated deficit

(167,165)

(123,646)

Accumulated other comprehensive income

404

132

Treasury stock, at cost; 913,519 shares as of September 30, 2024 and December 31, 2023

(5,982)

(5,982)

Total stockholders' equity

139,433

169,725

Total liabilities & stockholders' equity

$

302,008

$

332,683

The accompanying notes are an integral part of these condensed consolidated financial statements.

1

PARAGON 28, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share data)

(unaudited)

    

Three Months Ended September 30, 

    

Nine Months Ended September 30, 

2024

    

2023

2024

    

2023

Net revenue

$

62,336

$

52,783

$

184,434

$

155,828

Cost of goods sold

16,159

11,922

45,262

33,750

Gross profit

46,177

40,861

139,172

122,078

Operating expenses:

Research and development

5,661

7,244

20,328

21,976

Selling, general, and administrative

48,967

44,126

153,188

131,773

Total operating expenses

54,628

51,370

173,516

153,749

Operating loss

(8,451)

(10,509)

(34,344)

(31,671)

Other income (expense):

Other income (expense), net

(651)

369

(4)

(323)

Interest expense, net

(3,031)

(1,119)

(8,570)

(3,127)

Total other expense, net

(3,682)

(750)

(8,574)

(3,450)

Loss before income taxes

(12,133)

(11,259)

(42,918)

(35,121)

Income tax expense (benefit)

205

(108)

601

90

Net loss

$

(12,338)

$

(11,151)

$

(43,519)

$

(35,211)

Foreign currency translation adjustment

1,117

(630)

272

(1,012)

Comprehensive loss

$

(11,221)

$

(11,781)

$

(43,247)

$

(36,223)

Weighted average number of shares of common stock outstanding:

Basic

83,560,337

82,548,892

83,178,600

81,878,814

Diluted

83,560,337

82,548,892

83,178,600

81,878,814

Net loss per share attributable to common stockholders:

Basic

$

(0.15)

$

(0.14)

$

(0.52)

$

(0.43)

Diluted

$

(0.15)

$

(0.14)

$

(0.52)

$

(0.43)

The accompanying notes are an integral part of these condensed consolidated financial statements.

2

PARAGON 28, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(in thousands, except for number of shares)

(unaudited)

Accumulated

Additional

Other

Total

For the Three Months Ended

Common Stock

Paid-in-

Accumulated

Comprehensive

Treasury

Stockholders'

September 30, 2024

    

Shares

    

Amount

    

Capital

    

Deficit

    

Loss

    

Stock

    

Equity

Balance, June 30, 2024

83,504,206

$

833

$

307,524

$

(154,827)

$

(713)

$

(5,982)

$

146,835

Net Loss

(12,338)

(12,338)

Options exercised

79,251

1

351

352

Restricted stock vested, net of shares withheld for taxes

13,090

(42)

(42)

Foreign currency translation

1,117

1,117

Employee stock purchase plan

84

84

Stock-based compensation

3,425

3,425

Balance, September 30, 2024

83,596,547

$

834

$

311,342

$

(167,165)

$

404

$

(5,982)

$

139,433

For the Nine Months Ended September 30, 2024

Balance, December 31, 2023

82,825,455

$

827

$

298,394

$

(123,646)

$

132

$

(5,982)

$

169,725

Net Loss

(43,519)

(43,519)

Options exercised

553,000

6

3,224

3,230

Restricted stock vested, net of shares withheld for taxes

148,773

1

(467)

(466)

Foreign currency translation

272

272

Employee stock purchase plan

69,319

654

654

Stock-based compensation

9,537

9,537

Balance, September 30, 2024

83,596,547

$

834

$

311,342

$

(167,165)

$

404

$

(5,982)

$

139,433

Accumulated

Additional

Other

Total

For the Three Months Ended

Common Stock

Paid-in-

Accumulated

Comprehensive

Treasury

Stockholders'

September 30, 2023

    

Shares

    

Amount

    

Capital

    

Deficit

    

Loss

    

Stock

    

Equity

Balance, June 30, 2023

82,536,046

$

824

$

292,350

$

(90,172)

$

(415)

$

(5,982)

$

196,605

Net loss

(11,151)

(11,151)

Offering costs associated with public offering

Options exercised

19,861

70

70

Foreign currency translation

(630)

(630)

Employee stock purchase plan

86

86

Stock-based compensation

3,512

3,512

Balance, September 30, 2023

82,555,907

$

824

$

296,018

$

(101,323)

$

(1,045)

$

(5,982)

$

188,492

For the Nine Months Ended

September 30, 2023

Balance, December 31, 2022

77,770,588

$

776

$

213,956

$

(66,112)

$

(33)

$

(5,982)

$

142,605

Net loss

(35,211)

(35,211)

Issuance of common stock, net of issuance costs of $827

4,312,500

43

68,410

68,453

Options exercised

435,673

5

2,530

2,535

Foreign currency translation

(1,012)

(1,012)

Employee stock purchase plan

37,146

828

828

Stock-based compensation

10,294

10,294

Balance, September 30, 2023

82,555,907

$

824

$

296,018

$

(101,323)

$

(1,045)

$

(5,982)

$

188,492

The accompanying notes are an integral part of these condensed consolidated financial statements.

3

PARAGON 28, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

    

Nine Months Ended September 30, 

2024

    

2023

Cash flows from operating activities

Net loss

$

(43,519)

$

(35,211)

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

Depreciation and amortization

13,573

10,602

Allowance for doubtful accounts

721

147

Provision for excess and obsolete inventories

8,753

3,204

Stock-based compensation

9,537

10,294

Change in fair value of financial instruments

(267)

(57)

Other

910

(34)

Changes in other assets and liabilities, net of acquisitions:

Accounts receivable

1,156

3,706

Inventories

(14,586)

(31,117)

Accounts payable

(1,013)

12,468

Accrued expenses

1,522

3,718

Accrued legal settlement

(22,000)

Income tax receivable/payable

(215)

(533)

Other assets and liabilities

(441)

(2,704)

Net cash used in operating activities

(23,869)

(47,517)

Cash flows from investing activities

Purchases of property and equipment

(13,119)

(21,893)

Proceeds from sale of property and equipment

926

795

Purchases of intangible assets

(881)

(933)

Net cash used in investing activities

(13,074)

(22,031)

Cash flows from financing activities

Payments on long-term debt

(480)

(568)

Payments of debt issuance costs

(18)

Proceeds from issuance of common stock, net of issuance costs

68,453

Proceeds from exercise of options

3,188

2,535

RSU vesting, taxes paid

(423)

Proceeds from employee stock purchase plan

403

560

Payments on earnout liability

(2,000)

(5,500)

Net cash provided by financing activities

670

65,480

Effect of exchange rate changes on cash and cash equivalents

(221)

549

Net decrease in cash and cash equivalents

(36,494)

(3,519)

Cash and cash equivalents at beginning of period

75,639

38,468

Cash and cash equivalents at end of period

$

39,145

$

34,949

Supplemental disclosures of cash flow information:

Restricted cash

1,000

Cash paid for income taxes

1,190

610

Cash paid for interest

8,717

3,342

Purchase of property and equipment included in accounts payable

3,152

4,842

The accompanying notes are an integral part of these condensed consolidated financial statements.

4

Table of Contents

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except share and per share data)

(unaudited)

NOTE 1. BUSINESS AND BASIS OF PRESENTATION

Business

Paragon 28, Inc. (collectively with its subsidiaries, “we,” “us,” “our,” “P28” or the “Company”) develops, distributes, and sells medical devices in the foot and ankle segment of the orthopedic implant marketplace. Our approach to product development is procedurally focused, resulting in a full range of procedure-specific foot and ankle products designed specifically for foot and ankle anatomy. Our products and product families include plates and plating systems, screws, staples, and nails aimed to address all major foot and ankle procedures including fracture fixation, forefoot or hallux valgus - which includes bunion and hammertoe, ankle, flatfoot or progressive collapsing foot deformity, charcot foot and orthobiologics. P28 is a United States (“U.S.”) based company incorporated in the State of Delaware, with headquarters in Englewood, Colorado. Our sales representatives and distributors are located globally with the majority concentrated in the U.S., Australia, South Africa, and the United Kingdom.

Basis of Presentation and Consolidation

The accompanying Condensed Consolidated Financial Statements include the accounts of Paragon 28, Inc. and its subsidiaries, all of which are wholly-owned. The accompanying Condensed Consolidated Financial Statements have been prepared in conformity with accounting principles generally accepted in the U.S. (“U.S. GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information required by U.S. GAAP for complete financial statements. The interim Condensed Consolidated Financial Statements reflect all adjustments that are of a normal recurring nature and that are considered necessary for a fair representation of the results for the periods presented and should be read in conjunction with the audited Consolidated Financial Statements and notes thereto for the year ended December 31, 2023, which include a complete set of footnote disclosures, including our significant accounting policies. The audited Consolidated Financial Statements and notes thereto for the year ended December 31, 2023, are included in the Amended 2023 Annual Report. The results for interim periods are not necessarily indicative of the results that may be expected for a full fiscal year or for any other future period. All intercompany balances and transactions have been eliminated in consolidation.

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

The preparation of the financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Because future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. Any changes in these estimates will be reflected in the Company’s Condensed Consolidated Financial Statements. Significant items subject to such estimates and assumptions include the determination of the credit loss reserves for trade receivables, inventory obsolescence, impairment of long-lived assets, recoverability of goodwill and intangible assets, contingent earnout liabilities, interest rate swap valuation, income taxes and stock-based compensation. On January 1, 2024, the Company revised the inputs used in estimating the reserve on obsolete and slow-moving inventory to include forecasted sales, in addition to current inventory levels and historical sales. The effect of this change in estimate was a decrease of $248 to the Company’s reserve for obsolete and slow-moving inventory during the nine months ended September 30, 2024.

Foreign Currency Translation

The Condensed Consolidated Financial Statements are presented in U.S. dollars. The Company’s non-U.S. subsidiaries have a functional currency (i.e., the currency in which operational activities are primarily conducted) that is other than the U.S. dollar, generally the currency of the country in which such subsidiaries are domiciled. Such subsidiaries’ assets and liabilities are translated into U.S. dollars at quarter-end exchange rates, while revenue and expenses are translated at average exchange rates during the quarter based on the daily closing exchange rates. Adjustments that result from translating amounts from a subsidiary’s functional currency to U.S. dollars are reported in Accumulated other comprehensive income (loss), a separate component of stockholders’ equity.

Table of Contents

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(in thousands, except share and per share data)

(unaudited)

Transactions made in a currency other than the functional currency are remeasured to the functional currency at the exchange rates on the dates of the transactions. Foreign exchange gains and losses are recorded within Other income (expense), net on the consolidated statements of operations and comprehensive loss.

Significant Accounting Policies

There have been no changes in the Company’s significant accounting policies as disclosed in Note 2 to our audited Consolidated Financial Statements included in our Amended 2023 Annual Report on Form 10-K/A.

Recently Issued Accounting Pronouncements

In October 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. The amendments in ASU 2023-06 modify the disclosure or presentation requirements of a variety of Topics in the Codification. Certain of the amendments represent clarifications to or technical corrections of the current requirements. ASU 2023-06 is applicable to all entities subject to the SEC’s existing disclosure requirements. The effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. The Company is currently evaluating the amendments in ASU 2023-06 and does not expect the adoption to have a significant impact on the Company’s Consolidated Financial Statements and related disclosures.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ("ASU 2023-07"), which provides amendments to improve reportable segment disclosures requirements. The amendments in ASU 2023-07 are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the amendments to determine the impact it will have on the Company’s Consolidated Financial Statements and related disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), to enhance the transparency and decision usefulness of income tax disclosures. The main provisions in ASU 2023-09 enhance the disclosure requirements of rate reconciliations and income taxes paid. For public business entities, the amendments in ASU 2023-09 are effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The amendments in this update should be applied on a prospective basis, retrospective application is permitted. The Company is currently evaluating the amendments in this guidance to determine the impact it will have on the Company’s Consolidated Financial Statements and related disclosures.  

6

Table of Contents

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(in thousands, except share and per share data)

(unaudited)

NOTE 3. INTANGIBLE ASSETS

Intangibles

Intangible assets as of September 30, 2024, were as follows:

    

Gross
Carrying
Amount

    

Accumulated
Amortization

    

Net Carrying
Amount

Trademarks and tradenames, indefinite-lived

$

607

$

$

607

Patents, trademarks and tradenames, definite-lived

9,159

3,095

6,064

Customer relationships

1,733

758

975

Developed technology

17,690

4,399

13,291

Other intangibles

30

30

Total intangible assets, net

$

29,219

$

8,282

$

20,937

Intangible assets as of December 31, 2023, were as follows:

    

Gross
Carrying
Amount

    

Accumulated
Amortization

    

Net Carrying
Amount

Trademarks and tradenames, indefinite-lived

$

987

$

$

987

Patents, definite-lived

7,900

2,649

5,251

Customer relationships

1,733

567

1,166

Developed technology

17,690

3,424

14,266

Other intangibles

30

26

4

Total intangible assets, net

$

28,340

$

6,666

$

21,674

Amortization expense is included in Selling, general, and administrative expenses, on the Condensed Consolidated Statements of Operations and Comprehensive Loss, and was $479 and $509 for the three months ended September 30, 2024 and 2023, respectively. Amortization expense for the nine months ended September 30, 2024 and 2023 totaled $1,617 and $1,519, respectively. During the second quarter of 2024, the Company recategorized one of its intangible assets from Trademarks and tradenames, indefinite-lived to Patents, trademarks and tradenames, definite-lived and recorded the related amortization expense.

Expected future amortization expense is as follows:

2024 (Remaining)

    

$

515

2025

2,055

2026

2,055

2027

1,975

2028

1,975

Thereafter

11,755

Total future amortization expense

$

20,330

No impairment charges related to intangibles were recorded for the three and nine months ended September 30, 2024 and 2023.

7

Table of Contents

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(in thousands, except share and per share data)

(unaudited)

NOTE 4. FAIR VALUE OF FINANCIAL INSTRUMENTS

The Company measures certain financial assets and liabilities at fair value. There is a fair value hierarchy which prioritizes inputs used in measuring fair value into three broad levels:

Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.

Level 2 - Includes other inputs that are directly or indirectly observable in the marketplace, such as quoted market prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data.

Level 3 - Unobservable inputs which are supported by little or no market activity.

The level in the fair value hierarchy within which a fair value measurement in its entirety falls is based on the lowest-level input that is significant to the fair value measurement in its entirety.

The Company’s significant financial assets and liabilities measured at fair value as of September 30, 2024, were as follows:

    

Level 1

    

Level 2

    

Level 3

    

Total

Financial Assets:

Interest rate swap

$

917

$

917

The Company's significant financial assets and liabilities measured at fair value as of December 31, 2023, were as follows:

    

Level 1

    

Level 2

    

Level 3

    

Total

Financial Assets:

Interest rate swap

$

991

$

991

Financial Liabilities:

Contingent consideration

$

340

$

340

The Company’s Level 2 asset pertains to an interest rate swap associated with the Zions Facility (as defined below), used to manage interest rate risk related to variable rate borrowings and manage exposure to the variability of cash flows. The interest rate swap is not designated for hedge accounting and is measured utilizing inputs observable in active markets. For the three and nine months ended September 30, 2024, we reassessed the fair value of our swap which resulted in an increase of $674 a decrease of $74, respectively to the swap asset. The swap asset is recorded in Other assets on the Condensed Consolidated Balance Sheet and the change in fair value is recorded in Other income (expense), net within the Condensed Consolidated Statement of Operations and Comprehensive Loss.

The Company reassessed its Level 3 contingent earnout liability as of September 30, 2024, and determined it was not probable that the remaining two milestones associated with the acquisition of Additive Orthopaedics, LLC (“Additive Orthopaedics”) would be achieved. The Company wrote off the remaining earnout liability and recorded non-cash income of $340 in Other income (expense), net within the Consolidated Statement of Operations and Comprehensive Loss for the three and nine months ended September 30, 2024.

As of December 31, 2023, one project milestone associated with the acquisition of Disior LTD. (“Disior”) and one project milestone associated with the Additive Orthopaedics acquisition was included in Accrued expenses on the Consolidated Balance Sheet totaling $2,000. During the first quarter of 2024, $1,000 was paid in cash related to the Additive Orthopaedics milestone and the remaining $1,000 related to the Disior acquisition was paid during the second

8

Table of Contents

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(in thousands, except share and per share data)

(unaudited)

quarter of 2024. For additional information on the Disior and Additive Orthopaedics acquisitions refer to Note 4 to our Consolidated Financial Statements included in the Amended 2023 Annual Report on Form 10-K/A for the year ended December 31, 2023.

NOTE 5. DEBT

Long-term debt as of September 30, 2024 and December 31, 2023 consists of the following:

    

September 30, 2024

    

December 31, 2023

Ares Revolving Loan

$

25,000

$

25,000

Ares Term Loan

75,000

75,000

Zions Term Loan

14,453

14,933

114,453

114,933

Less: deferred issuance costs

(3,834)

(4,494)

Total debt, net of issuance costs

110,619

110,439

Less: current portion

(640)

(640)

Long-term debt, net, less current maturities

$

109,979

$

109,799

Ares Credit Agreement

On November 2, 2023, the Company and its wholly-owned subsidiary, Paragon Advanced Technologies, Inc. (“Paragon Advanced Technologies” and, together with the Company, the “Borrowers”) entered into a new credit agreement (the “Ares Credit Agreement”) with Ares Capital Corporation (“Ares”) to provide a total of $150,000, inclusive of a revolving credit facility of up to $50,000 (the “Ares Revolving Loan”) and a term loan facility of up to $100,000 (the “Ares Term Loan”). The obligations under the Ares Credit Agreement are guaranteed by each of the Borrowers’ current and future domestic subsidiaries and secured by liens on substantially all of the Borrowers’ and guarantors’ present and after-acquired assets, in each case, subject to certain customary exceptions. In connection with the closing of the Ares Credit Agreement, the Company drew down $25,000 and $75,000 on the Ares Revolving Loan and Ares Term Loan, respectively. The Ares Revolving Loan and Ares Term Loan bear interest at variable rates of Term Secured Overnight Financing Rate (“Term SOFR”) plus 4% and Term SOFR plus 6.75%, respectively, subject in the case of the Ares Term Loan to certain step-downs and adjustments as set forth in the Ares Credit Agreement, and mature on the earlier of (i) November 2, 2028, and (ii) with respect to the Ares Revolving Loan, 6 months prior to the maturity date of any other indebtedness in a principal or stated amount in excess of $12,500. The Ares Credit Agreement contains a financial covenant requiring the Company to maintain certain minimum revenue levels. As of September 30, 2024, the Company was in compliance with all financial covenants under the Ares Credit Agreement. Total debt issuance costs associated with the Ares Credit Agreement were $3,627 as of September 30, 2024. Amortization expense associated with such debt issuance costs totaled $222 and $648 for the three and nine months ended September 30, 2024, respectively and are included in Interest expense, net on the Condensed Consolidated Statements of Operations and Comprehensive Loss. There were no debt issuance costs associated with the Ares Credit Agreement during the three and nine months ended September 30, 2023.

Vectra Bank Colorado Loan Agreements

On March 24, 2022, the Company entered into a secured term loan facility (the “Zions Facility”) with Zions Bancorporation, N.A. dba Vectra Bank Colorado in the principal amount of $16,000. The loans under the Zions Facility (i) bear interest at a variable rate per annum equal to the sum of (a) a one-month Term SOFR based rate, plus (b) 1.75%, adjusted on a monthly basis and (ii) mature on March 24, 2037. Principal and interest payments are payable monthly, with optional prepayments allowed without premium or penalty.

Effective as of November 10, 2022, the Company entered into the First Amendment to the Zions Facility. The amendment to the Zions Facility amends the financial covenants to require the Company to maintain (i) the Liquidity

9

Table of Contents

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(in thousands, except share and per share data)

(unaudited)

Ratio, if the Cash Flow as of the last day of any quarter measured on a trailing three month basis is less than or equal to $0, and (ii) the Fixed Charge Coverage Ratio which will be calculated as of the last day of each quarter on a trailing four quarter basis, as well as a certain level of Liquidity, if the Cash Flow is greater than $0. In addition, a Net Revenue Growth covenant was added which will be calculated as of the last day of each quarter on a year-over-year basis.

Effective as of November 2, 2023, the Company entered into the Second Amendment to the Zions Facility (the “Second Amendment”). The Second Amendment replaces references to MidCap Financial Trust and MidCap Credit Agreements with references to Ares and the Ares Credit Agreement. As of September 30, 2024, the Company was in compliance with all financial covenants under the Second Amendment. Total debt issuance costs associated with the Zions Facility were $207 as of September 30, 2024. Amortization expense associated with such debt issuance costs was $4 and $12 for the three and nine months ended September 30, 2024, and is included in Interest expense, net on the Condensed Consolidated Statements of Operations and Comprehensive Loss, respectively and totaled $4 and $12 for the three and nine months ended September 30, 2023, respectively.

NOTE 6. STOCKHOLDERS’ EQUITY

Under its Amended and Restated Certificate of Incorporation, the Company has a total of 310,000,000 shares of capital stock authorized for issuance, consisting of 300,000,000 shares of common stock, par value of $0.01 per share, and 10,000,000 shares of convertible preferred stock, par value of $0.01 per share.

Common Stock

On January 30, 2023, the Company completed an underwritten public offering (“the Offering”) of 6,500,000 shares of its common stock at an offering price of $17.00 per share, which consisted of 3,750,000 shares of common stock issued and sold by the Company and 2,750,000 shares of common stock sold by certain selling securityholders. On February 17, 2023, the underwriters exercised in full their option to purchase an additional 562,500 shares and 412,500 shares of common stock from the Company and the selling securityholders, respectively.‌

The Company received aggregate net proceeds from the Offering of approximately $68,453 after deducting underwriting discounts and commissions and offering expenses payable by the Company. The selling securityholders received aggregate net proceeds from the Offering of approximately $50,700 after deducting underwriting discounts and commissions. The Company did not receive any of the proceeds from the sale of shares of common stock by the selling securityholders.

Treasury Stock

The Company did not purchase any of its common stock during the nine months ended September 30, 2024 and 2023. All previously repurchased shares were recorded in Treasury stock, at cost.

10

Table of Contents

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(in thousands, except share and per share data)

(unaudited)

NOTE 7. LOSS PER SHARE

Basic net loss per share is computed by dividing net loss attributable to common stockholders (the numerator) by the weighted average number of common stock outstanding for the period (the denominator). Diluted net income per share of common stock attributable to common stockholders is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period adjusted for the dilutive effects of common stock equivalents using the treasury stock method or the method based on the nature of such securities. In periods when losses from operations are reported, the weighted-average number of shares of common stock outstanding excludes common stock equivalents because their inclusion would be anti-dilutive. The computation of net loss per share for the three and nine months ended September 30, 2024 and 2023 was as follows:

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

    

2023

    

2024

    

2023

Net loss

$

(12,338)

$

(11,151)

$

(43,519)

$

(35,211)

Weighted-average common stock outstanding:

Basic

83,560,337

82,548,892

83,178,600

81,878,814

Diluted

83,560,337

82,548,892

83,178,600

81,878,814

Loss per share:

Basic

$

(0.15)

$

(0.14)

$

(0.52)

$

(0.43)

Diluted

$

(0.15)

$

(0.14)

$

(0.52)

$

(0.43)

The following outstanding potentially dilutive securities were excluded from the calculation of diluted net loss per share attributable to common stockholders because their impact would have been antidilutive for the period presented:

As of September 30, 

    

2024

    

2023

Stock options

4,878,717

6,119,477

Restricted stock units

2,983,311

1,392,087

NOTE 8. STOCK-BASED COMPENSATION

Employee Stock Purchase Plan

The Company’s Employee Stock Purchase Plan (“ESPP”) provides participating employees with the opportunity to purchase the Company’s common stock at 85% of the market price at the lesser of the date the purchase right is granted or exercisable. Eligible employees can contribute up to 15% of their gross base earnings for purchases under the ESPP through regular payroll deductions, limited to $25 worth of the Company’s shares of common stock for each calendar year in which the purchase right is outstanding. The Company currently holds offerings consisting of six-month periods commencing on January 1st and July 1st of each calendar year, with a single purchase date at the end of the purchase period on June 30th and December 31st of each calendar year.

The Company issued 69,319 shares upon exercise of purchase rights during the three and nine months ended September 30, 2024, and 37,146 shares during the three and nine months ended September 30, 2023. The Company recognizes compensation expense on a straight-line basis over the service period. During the three and nine months ended September 30, 2024, the Company recognized $84 and $252, respectively, of compensation expense related to the ESPP. During the three and nine months ended September 30, 2023, the Company recognized $86 and $268, respectively of compensation expense related to the ESPP. Stock-based compensation expenses are recorded in Selling, general and administrative expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

11

Table of Contents

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(in thousands, except share and per share data)

(unaudited)

Stock Options

The following summarizes the Company’s stock option plan and the activity for the nine months ended September 30, 2024.

    

Shares

    

Weighted-Average
Exercise Price

    

Weighted-Average
Remaining Contractual
Term (Years)

Outstanding, December 31, 2023

5,943,898

$

10.28

6.53

Granted

Exercised or released

(553,000)

5.84

Forfeited or expired

(512,181)

13.16

Outstanding, September 30, 2024

4,878,717

$

10.48

5.72

Exercisable, September 30, 2024

4,110,563

$

9.41

5.42

Vested and expected to vest at September 30, 2024

4,875,485

$

10.47

5.72

During the three months ended September 30, 2024 and 2023, the Company recognized $546 and $1,724, respectively, of compensation expense related to stock options. During the nine months ended September 30, 2024 and 2023, the Company recognized $1,585 and $5,320, respectively of compensation expense related to stock options. Stock-based compensation expenses are recorded in Selling, general and administrative expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

Restricted Stock Units

The following table summarizes the Company’s restricted stock units activity for the nine months ended September 30, 2024:

    

Restricted
Stock Units

    

Weighted-Average
Fair Value

Outstanding, December 31, 2023

1,317,402

$

17.06

Granted

1,831,985

11.55

Vested

(190,210)

17.80

Forfeited or expired

(320,944)

15.02

Outstanding, September 30, 2024

2,638,233

$

13.43

Vested and expected to vest at September 30, 2024

2,565,347

$

13.43

During the three months ended September 30, 2024 and 2023, the Company recognized $2,482 and $1,788, respectively of compensation expense related to Restricted Stock Units (“RSUs”). During the nine months ended September 30, 2024 and 2023, the Company recognized $7,119 and $4,974, respectively of compensation expense related to RSUs. Stock-based compensation expenses are recorded in Selling, general and administrative expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

Performance Share Units

On March 8, 2024, the Company granted 241,881 performance share units (“PSUs”) with a weighted-average fair value of $11.69 to certain executives, of which 21,638 were forfeited with a weighted-average fair value of $11.00 during the six months ended June 30, 2024. The grant date fair value of PSUs granted to the Chief Executive Officer was calculated using a Monte Carlo simulation and was based on assumptions, including expected volatility of 59.7%, expected dividends of 0%, and a 4.21% risk-free rate. Other granted PSUs’ fair value were based on the Company’s share price on the date of grant, or $11.00 per share. The PSUs will vest based on the Company’s achievement level relative to Adjusted

12

Table of Contents

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(in thousands, except share and per share data)

(unaudited)

Free Cash Flow (“aFCF”) for the trailing twelve months ending December 31, 2026, or the consummation of a change in control if earlier (“Performance Period”). aFCF is defined as Total Operating Cash Flow plus Investing Cash Flow adjusted for certain nonrecurring items. Upon achievement of the minimum threshold performance metric, the executive may earn a pro rata portion of their respective target shares and up to 200% of their target shares upon maximum achievement. The Chief Executive Officer was granted 166,924 of the 241,881 PSUs which may be further increased or decreased by up to 25%, based on the achievement of Relative Total Stockholder Return, as defined as the stockholder return of the Company relative to certain of its peer companies within the Healthcare Equipment Select Industry Index. The PSUs additionally require the executive to provide service over the performance period. Termination of service prior to completion of the Performance Period, except by reason of death or disability, will result in automatic forfeiture of the performance share units. If the executive’s termination of service occurs by reason of death or disability on or after January 1, 2025, a pro-rata number of the PSUs shall vest at the level based on actual performance through the end of the Performance Period, multiplied by a fraction equal to (x) the number of days elapsed between the beginning of the Performance Period and the date of executive’s termination of service, divided by (y) the total number of days in the Performance Period.

On August 7, 2024, the Company granted 124,835 PSUs with a weighted-average fair value of $8.45 to the Company’s Chief Financial Officer (“CFO”) and EVP of Supply Chain Operations. The grant date fair value of PSUs granted to the CFO and EVP of Supply Chain Operations was calculated using a Monte Carlo simulation and was based on assumptions, including expected volatility of 60.8%, expected dividends of 0%, and a 3.88% risk-free rate. The PSUs will vest based on the Company’s achievement level relative to Adjusted Free Cash Flow for the trailing twelve months ending December 31, 2026, or the consummation of a change in control if earlier.

Stock-based compensation expense is recognized on a straight-line basis over the vesting period, beginning at the point in time that the performance condition is considered probable of achievement. The probability of achieving the performance condition is assessed at each reporting period. If it is deemed probable that the performance condition will be met, compensation cost will be recognized based on the grant date fair value of the award expected to be earned. If it is deemed that it is not probable that the performance condition will be met, the Company will discontinue the recognition of compensation cost and any compensation cost previously recorded will be reversed. At September 30, 2024, achievement of the performance condition for the performance share units was deemed probable with 330,469 PSUs expected to vest, and the expense recorded for the three and nine months ended September 30, 2024, was $397 and $833, respectively. Stock-based compensation expenses are recorded in Selling, general and administrative expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

NOTE 9. INCOME TAXES

The effective tax rates for the nine months ended September 30, 2024 and 2023 are as follows:

Nine Months Ended September 30, 

    

2024

    

2023

Effective tax rate

(1.400)

%  

(0.256)

%

For the three months ended September 30, 2024 and 2023, the Company recorded tax expense of $205 and benefit of $108, respectively. For the nine months ended September 30, 2024 and 2023, the Company recorded tax expense of $601 and $90, respectively.

The Company’s fiscal year 2024 and 2023 income tax expense and rates differed from the amount of income tax determined by applying the U.S. Federal income tax rate to pre-tax income primarily due to the U.S., Finland, Germany and Italy jurisdictions that have a full valuation allowance recorded on deferred tax assets. In addition, the tax rate is lower than the U.S. statutory federal tax rate as a result of foreign earnings that are taxed at lower tax rates.

The Company continues to monitor the realization of its deferred tax assets and assesses the need for a valuation allowance. The Company analyzes available positive and negative evidence to determine if a valuation allowance is needed based on the weight of the evidence. This objectively verifiable evidence includes the current and prior two years’ profit

13

Table of Contents

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(in thousands, except share and per share data)

(unaudited)

and loss positions after considering pre-tax book income plus or minus permanent adjustments as well as other positive and negative evidence available. This process requires management to make estimates, assumptions, and judgments that are uncertain in nature. The Company has established a valuation allowance with respect to deferred tax assets in the U.S., Finland, Germany, and Italy and continues to monitor and assess potential valuation allowances in all its jurisdictions.

NOTE 10. COMMITMENTS AND CONTINGENCIES

Legal Proceedings

The Company is involved in various lawsuits, claims, inquiries, and other regulatory and compliance matters, most of which are routine to the nature of our business. When it is probable that a loss will be incurred and where a range of the loss can be reasonably estimated, the best estimate within the range is accrued. When the best estimate within the range cannot be determined, the low end of the range is accrued. The ultimate resolution of these claims could affect future results of operations should the exposure be materially different from the estimates or should liabilities be incurred that were not previously accrued. Potential insurance reimbursements are not offset against potential liabilities.

Class Action Litigation

On September 30, 2024, and October 18, 2024, respectively, two putative class action complaints were filed in the U.S. District Court for the District of Colorado.  These complaints allege that the Company and certain current and former officers violated federal securities laws.  The cases are captioned Ellington v. Paragon 28, Inc., et al., and Tiedt v. Paragon 28, Inc., et al.  We believe the allegations in the complaint are without merit and intend to vigorously defend the litigation.

Given the early stage of the litigation matters described above, we are unable at this time to reasonably estimate possible losses or form a judgment that an unfavorable outcome is either probable or remote. However, litigation is subject to inherent uncertainties, and one or more unfavorable outcomes in any claim or litigation against us could have a material adverse effect for the period in which they are resolved, and on our business generally. In addition, regardless of their merits or their ultimate outcomes, lawsuits and legal proceedings are costly, divert management attention, and may adversely affect our reputation, even if they are resolved in our favor.

NOTE 11. RELATED PARTY TRANSACTIONS

The Company has a license agreement dated July 1, 2017 for certain intellectual property with an entity that is affiliated with one of the directors of the Company, under which the Company pays a royalty of four percent (4%) of net revenue related to the licensed intellectual property for the 15 years following the date of first sale, including a minimum annual payment of $250. The term of the agreement is 20 years and it automatically renews for five-year periods thereafter. Payments to the entity under this license agreement totaled $50 and $32 for the three months ended September 30, 2024 and 2023, respectively. Payments to the entity under this license agreement totaled $249 and $233 for the nine months ended September 30, 2024 and 2023, respectively. Amounts payable to this entity as of September 30, 2024 and December 31, 2023 were $82 and $155, respectively.

The Company paid professional services fees to a related party totaling $9 and $123 for the three months ended September 30, 2024 and 2023, respectively, and $27 and $238 for the nine months ended September 30, 2024 and 2023, respectively, and are included in Selling, general, and administrative expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Amounts payable as of September 30, 2024 and December 31, 2023 to this related party were $0 and $16, respectively.

14

Table of Contents

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (continued)

(in thousands, except share and per share data)

(unaudited)

NOTE 12. SEGMENT AND GEOGRAPHIC INFORMATION

Operating segments are defined as components of an enterprise for which separate financial information is available and evaluated regularly by the chief operating decision maker, which is our Chief Executive Officer, in deciding how to allocate resources and in assessing performance. We manage our business globally within one operating segment in accordance with ASC Topic 280, Segment Reporting. Segment information is consistent with how management reviews the business, makes investing and resource allocation decisions and assesses operating performance.

The following table represents total net revenue by geographic area, based on the location of the customer for the three and nine months ended September 30, 2024 and 2023, respectively.

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

    

2023

    

2024

    

2023

United States

$

51,160

$

44,548

$

151,913

$

131,793

International

11,176

8,235

32,521

24,035

Total net revenue

$

62,336

$

52,783

$

184,434

$

155,828

No individual country with net revenue originating outside of the United States accounted for more than 10% of consolidated net revenue for the three and nine months ended September 30, 2024 and 2023.

The following table represents total non-current assets, excluding deferred taxes, by geographic area as of September 30, 2024 and December 31, 2023, respectively.

    

September 30, 2024

    

December 31, 2023

United States

$

88,902

$

89,531

Finland

24,890

25,032

Other International

9,892

9,616

Total assets

$

123,684

$

124,179

NOTE 13. EMPLOYEE BENEFIT PLAN

The Company sponsors a defined contribution plan for eligible employees who are 21 years of age with three months of service. Eligible employees can voluntarily contribute up to 100% of their eligible compensation. The Company has elected a safe harbor plan in which the Company must contribute 3% of eligible compensation. In addition, the Company may make discretionary contributions which are determined and authorized by the Board of Directors each plan year. The Company made contributions to its employee benefit plan of $356 and $315 and $1,054 and $904 for three and nine months ended September 30, 2024 and 2023, respectively.

15

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our Unaudited Interim Condensed Consolidated Financial Statements and related notes thereto included in Part I - Item 1 of this Quarterly Report. As discussed in the "Explanatory Note", amounts throughout this discussion and analysis for our unaudited interim condensed consolidated statements for the three and nine months ended September 30, 2023 have been restated to reflect the impact of the restatement as described in the Amended 2024 Quarterly Report. In addition to historical information, the following discussion contains forward-looking statements, including, but not limited to, statements regarding the Company's expectation for future performance, liquidity and capital resources, that involve risks, uncertainties and assumptions that could cause actual results to differ materially from the Company's expectations. The Company’s actual results may differ materially from those contained in or implied by any forward-looking statements. Factors that could cause such differences include those identified below and those described in “Special Note Regarding Forward-Looking Statements”. The Company assumes no obligation to update any of these forward-looking statements.

Overview

We are a leading medical device company exclusively focused on the foot and ankle orthopedic market and are dedicated to improving patient lives. Our innovative orthopedic solutions, procedural approaches and instrumentation cover a wide range of foot and ankle ailments including fracture fixation, forefoot, ankle, flatfoot or progressive collapsing foot deformity, charcot foot and orthobiologics. To treat these painful, debilitating or even life-threatening conditions, we provide a comprehensive portfolio of solutions that includes surgical implants and disposables, as well as surgical instrumentation. We design each of our 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. We believe our passion, expertise, and exclusive focus in the foot and ankle market has allowed us to better understand the needs of our patients and physicians, which has enabled us to create innovations and enhanced solutions that disrupt and transform the foot and ankle market. As a result, we have experienced significant growth and momentum in our business.

During the three and nine months ended September 30, 2024, our sales increased as a result of increased surgical volume driven primarily by U.S sales force expansion, growth in focused international markets and key product launches in the ankle, forefoot and fracture fixation segments. As a result, we reported net revenue growth of 18%, during the three and nine months ended September 30, 2024, as compared to the corresponding prior year periods.

Our gross profit margin was 74.1% and 75.5% for the three and nine months ended September 30, 2024, respectively, compared to 77.4% and 78.3% during the three and nine months ended September 30, 2023, representing decreases from the corresponding prior year periods driven primarily by higher non-cash charges for excess and obsolete inventory, partially offset by lower freight expense, as a percent of revenue.

Adjusted EBITDA was positive $0.4 million and negative $2.8 million for the three months ended September 30, 2024 and 2023, respectively. The improvement in Adjusted EBITDA for the three months ended September 30, 2024 is primarily attributable to an increase in gross profit from higher revenue and a change in the fair value of financial instruments, partially offset by an increase in operating expenses. Adjusted EBITDA was negative $10.3 million and negative $10.9 million for the nine months ended September 30, 2024 and 2023, respectively. The improvement in Adjusted EBITDA for the nine months ended September 30, 2024 is primarily attributable to an increase in gross profit from higher revenue, partially offset by an increase in operating expenses.

Non-GAAP Financial Measures

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, 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.

16

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 believe that Adjusted EBITDA, together with a reconciliation to net loss, 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.

Free Cash Flow is an additional key performance measure that our management uses to assess our financial performance and liquidity. Additionally, management believes Free Cash Flow is helpful to assessing our operational efficiency and the effectiveness of our capital expenditures, and that monitoring Free Cash Flow can help us manage financial risk. In addition, management believes Free Cash Flow provides meaningful incremental information to investors to consider when evaluating the performance of the Company.

Because of these and other limitations, you should consider our non-GAAP measures only as supplemental to other GAAP-based financial measures. For reconciliations of Adjusted EBITDA and Free Cash Flow to their most comparable GAAP financial measure, see “GAAP to Non-GAAP Reconciliations”.

17

GAAP to Non-GAAP Reconciliations

Adjusted EBITDA

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. For a full reconciliation of Adjusted EBITDA for the three and nine months ended September 30, 2024 and 2023, to the most comparable GAAP financial measure, refer to the presentation below.

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

    

2023

    

2024

    

2023

(in thousands)

Net loss

$

(12,338)

$

(11,151)

$

(43,519)

$

(35,211)

Interest expense, net

3,031

1,119

8,570

3,127

Income tax expense

205

(108)

601

90

Depreciation and amortization expense

4,705

4,188

13,573

10,602

Stock based compensation expense

3,425

3,512

9,537

10,294

Employee stock purchase plan expense

84

86

252

268

Change in fair value of financial instruments(1)

334

(423)

(267)

(57)

Workforce optimization - severance(2)

986

986

Adjusted EBITDA

$

432

$

(2,777)

$

(10,267)

$

(10,887)

(1)Represents the non-cash change in fair value of our interest rate swap contract and earnout liability for all periods presented.
(2)Represents severance costs incurred pursuant to an ongoing operational efficiency strategy.

Free Cash Flow

We define Free Cash Flow as net cash provided by operating activities less capital expenditures. For a reconciliation of Free Cash Flow for the three and nine months ended September 30, 2024 and 2023, to the most comparable GAAP financial measure, refer to the presentation below.

Three Months Ended September 30, 

Nine Months Ended September 30, 

2024

    

2023

    

2024

2023

(in thousands)

Net cash used in operating activities

$

(2,665)

$

(14,114)

$

(23,869)

$

(47,517)

Purchases of property and equipment

(3,628)

(6,539)

(13,119)

(21,893)

Free cash flow

$

(6,293)

$

(20,653)

$

(36,988)

$

(69,410)

Components of Our Results of Operations

Net Revenue

We derive our revenue from the sale of our foot and ankle orthopedic solutions, primarily implants. We also record as revenue any amounts billed to customers for shipping costs and record as cost of goods sold the actual shipping costs. We have elected to exclude from the measurement of the transaction price all taxes, such as sales, use, value-added, assessed by government authorities and collected from a customer. Therefore, revenue is recognized net of such taxes. In addition, we record revenue net of estimated discounts and other price concessions. No single customer accounted for 10% or more of our net revenue in the three and nine months ended September 30, 2024 and 2023. We expect our net revenue to increase in the foreseeable future as we expand our sales territories, add new customers and increase the utilization of our products by our existing customers, though net revenue may fluctuate from quarter to quarter due to a variety of factors, including availability of reimbursement, the size and success of our sales force, the number of hospitals and physicians who are aware of and use our products and seasonality.

18

Cost of Goods Sold, Gross Profit and Gross Margin

Cost of goods sold consists primarily of finished products purchased from third-party suppliers, shipping costs, excess and obsolete inventory adjustments and royalties. Implants are manufactured to our specifications primarily by third-party suppliers in the United States. Cost of goods sold is recognized at the time the implant is used in surgery and the related revenue is recognized. Prior to use in surgery, the cost of our implants is recorded as inventories, net in our condensed consolidated balance sheets. Cost of goods sold is expected to increase due primarily to increased sales volume.

We calculate gross profit as net revenue less cost of goods sold, and gross margin as gross profit divided by net revenue. We expect our gross profit to increase in the foreseeable future as our net revenue grows, though our gross profit and gross margin have been and will continue to be affected by a variety of factors, primarily average selling prices, third-party manufacturing costs, change in mix of customers, excess and obsolete inventory adjustments, royalties and seasonality of our business. Our gross margin is higher for products we sell in the United States versus internationally due to higher average selling prices. We expect our gross margin to fluctuate from period to period, however, based upon the factors described above and seasonality.

Operating Expenses

Research and Development

Research and development expenses is comprised of engineering costs and research programs related to new product and sustaining product development activities, clinical studies and trial expenses, quality and regulatory expenses, and salaries and benefits related to research and development functions. We maintain a procedurally focused approach to product development and have projects underway to add new systems across multiple foot and ankle indications and to add additional functionality to our existing systems. We expect our research and development expenses to increase as we hire additional personnel to develop new product offerings and product enhancements.

Selling, General, and Administrative

Selling, general, and administrative expenses consist primarily of commissions paid to U.S. sales representatives, salaries, bonuses, and benefits related to selling, marketing, and general and administrative functions, and stock-based compensation. In addition, selling, general, and administrative expenses consist of the costs associated with marketing initiatives, physician and sales force medical education programs, surgical instrument depreciation, travel expenses, professional service fees (including legal, finance, audit and tax fees), insurance costs, facility expenses and other general corporate expenses.

We expect selling, general, and administrative expenses to continue to increase in the foreseeable future as we continue to grow our business. We also expect our administrative expenses, including stock-based compensation expense, to increase as we increase our headcount and expand our facilities and business processes to support our operations as a public company. Our selling, general and administrative expenses may fluctuate from period to period due to the seasonality of our business and as we continue to add direct sales territory managers in new territories.

Other Income (Expense)

Other Income (Expense), net

Other income (expense), net consists primarily of changes in fair value related to contingent earn out liabilities and our interest rate swap contract.

Interest Expense, net

Interest expense, net consists of interest incurred, amortization of financing costs and interest income earned during the reported periods.

19

Results of Operations

For the Three Months Ended September 30, 2024 and 2023

The following table summarizes our results of operations for the periods presented:

Three Months Ended September 30, 

Change

    

2024

    

2023

    

Amount

    

%

(in thousands)

Net revenue

$

62,336

$

52,783

$

9,553

18%

Cost of goods sold

16,159

11,922

4,237

36%

Gross profit

46,177

40,861

5,316

13%

Operating expenses:

Research and development

5,661

7,244

(1,583)

(22)%

Selling, general, administrative

48,967

44,126

4,841

11%

Total operating expenses

54,628

51,370

3,258

6%

Operating loss

(8,451)

(10,509)

2,058

20%

Other income (expense):

Other income (expense), net

(651)

369

(1,020)

*

Interest expense, net

(3,031)

(1,119)

(1,912)

*

Total other expense, net

(3,682)

(750)

(2,932)

*

Income tax expense (benefit)

205

(108)

313

*

Net loss

$

(12,338)

$

(11,151)

$

(1,187)

(11)%

*

Not Meaningful

The following table represents total net revenue by geographic area, based on the location of the customer for the three months ended September 30, 2024 and 2023, respectively.

Three Months Ended September 30, 

    

2024

    

2023

(in thousands)

United States

$

51,160

$

44,548

International

11,176

8,235

Total net revenue

$

62,336

$

52,783

Net Revenue. Net revenue increased $9.6 million, or 18%, from $52.8 million during the three months ended September 30, 2023, to $62.3 million during the corresponding period in 2024. Weakening of the U.S. dollar increased net revenue growth for the three months ended September 30, 2024, by less than 1% as compared to the prior year. U.S. net revenue was $51.2 million for the three months ended September 30, 2024, representing growth of 15% compared to the prior year. U.S. net revenue growth was the result of increased surgical volume driven primarily by sales force expansion and new product launches in our ankle, forefoot and fracture fixation segments. International revenue for the three months ended September 30, 2024, was $11.2 million, representing growth of 36% compared to the prior year. International revenue growth was driven primarily by the United Kingdom, Australia, and South Africa.

Cost of Goods Sold and Gross Profit Margin. Cost of goods sold increased $4.2 million, or 36%, from $11.9 million during the three months ended September 30, 2023, to $16.2 million during the corresponding period in 2024, primarily due to an increase in net revenue, region mix and non-cash increases in inventory write-offs and excess and obsolete inventory. Gross profit margin for the three months ended September 30, 2024, decreased to 74.1%, compared to 77.4% in the same period of 2023. The decrease in gross profit margin was primarily due to higher non-cash charges for excess and obsolete inventory, partially offset by lower freight expense as a percentage of revenue.

20

Research and Development Expenses. Research and development expenses decreased $1.6 million, or 22%, from $7.2 million during the three months ended September 30, 2023, to $5.7 million as compared to the corresponding period in 2024. The decrease in research and development expenses is primarily due to the implementation of cost savings initiatives to lower outsourced consulting services as the Company focuses on internalizing new product development.

Selling, General, and Administrative Expenses. Selling, general and administrative expenses increased $4.8 million, or 11%, from $44.1 million during the three months ended September 30, 2023, to $49.0 million during the corresponding period in 2024. The increase in selling, general, and administrative expenses was primarily driven by increased variable sales representative commission expense related to net revenue growth and an increase in professional service fees.

Other Income (Expense), net. Other income (expense), net decreased $1.0 million, from income of $0.4 million during the three months ended September 30, 2023, to expense of $0.6 million for corresponding period in 2024. The change from other income to expense is primarily related to the changes in fair value of the Company’s contingent earnout liabilities and interest rate swap contract.

Interest Expense, net. Interest expense, net increased $1.9 million, from $1.1 million for the three months ended September 30, 2023, to $3.0 million for the corresponding period in 2024, primarily due to higher levels of outstanding debt and higher interest rates on our outstanding debt.

For the Nine Months Ended September 30, 2024 and 2023

The following table summarizes our results of operations for the periods presented:

Nine Months Ended September 30, 

Change

    

2024

    

2023

    

Amount

    

%

(in thousands)

Net revenue

$

184,434

$

155,828

$

28,606

18%

Cost of goods sold

45,262

33,750

11,512

34%

Gross profit

139,172

122,078

17,094

14%

Operating expenses:

Research and development

20,328

21,976

(1,648)

(7)%

Selling, general, administrative

153,188

131,773

21,415

16%

Total operating expenses

173,516

153,749

19,767

13%

Operating loss

(34,344)

(31,671)

(2,673)

8%

Other income (expense):

Other income (expense), net

(4)

(323)

319

(99)%

Interest expense, net

(8,570)

(3,127)

(5,443)

*

Total other expense, net

(8,574)

(3,450)

(5,124)

*

Income tax expense

601

90

511

*

Net loss

$

(43,519)

$

(35,211)

$

(8,308)

(24)%

*

Not Meaningful

21

The following table represents total net revenue by geographic area, based on the location of the customer for the nine months ended September 30, 2024 and 2023, respectively.

Nine Months Ended September 30, 

    

2024

    

2023

(in thousands)

United States

$

151,913

$

131,793

International

32,521

24,035

Total net revenue

$

184,434

$

155,828

Net Revenue. Net revenue increased $28.6 million, or 18%, from $155.8 million during the nine months ended September 30, 2023 to $184.4 million during the corresponding period in 2024. Weakening of the U.S. dollar increased net revenue growth for the nine months ended September 30, 2024, by less than 1% as compared to the prior year. U.S. net revenue was $151.9 million for the nine months ended September 30, 2024, representing growth of 15% compared to the prior year. U.S. net revenue growth was primarily the result of increased surgical volume driven primarily by sales force expansion and new product launches in our ankle, forefoot and fracture fixation segments. International revenue for the nine months ended September 30, 2024, was $32.5 million, representing growth of 35% compared to the prior year. International revenue growth was driven primarily by the United Kingdom, Australia, and South Africa.

Cost of Goods Sold and Gross Profit Margin. Cost of goods sold increased $11.5 million, or 34%, from $33.8 million during the nine months ended September 30, 2023, to $45.3 million during the corresponding period in 2024, primarily due to an increase in net revenue, region mix and non-cash increases in inventory write-offs and excess and obsolete inventory. Gross profit margin for the nine months ended September 30, 2024, decreased to 75.5%, compared to 78.3% in the same period of 2023. The decrease in gross profit margin was primarily due to an increase in non-cash charges for excess and obsolete inventory, partially offset by lower freight expense as a percentage of revenue.

Research and Development Expenses. Research and development expenses decreased $1.6 million, or 7%, from $22.0 million during the nine months ended September 30, 2023, to $20.3 million during the nine months ended September 30, 2024. The decrease in research and development expenses is primarily due to the implementation of cost savings initiatives to lower outsourced consulting services as the Company focuses on internalizing new product development.

Selling, General, and Administrative Expenses. Selling, general and administrative expenses increased $21.4 million, or 16%, from $131.8 million in the nine months ended September 30, 2023, to $153.2 million during the corresponding period in 2024. The increase in selling, general, and administrative expenses was primarily driven by increased variable sales representative commission expense related to net revenue growth, increased personnel expenses, an increase in depreciation expense and an increase in professional service and legal fees.

Other Income (Expense), net. Other expense decreased $0.3 million, from $0.3 million during the nine months ended September 30, 2023 to $0.0 million during corresponding period in 2024. The decrease in other expense is primarily related to the changes in fair value of the Company’s contingent earnout liabilities and interest rate swap contract.

Interest Expense, net. Interest expense, net increased $5.4 million, from $3.1 million for the nine months ended September 30, 2023, to $8.6 million for the corresponding period in 2024, primarily due to higher levels of outstanding debt and higher interest rates on our outstanding debt.

Liquidity and Capital Resources

Our primary sources of capital from inception through September 30, 2024, have been from ongoing operations, proceeds from public and private securities offerings and the incurrence of indebtedness. As of September 30, 2024, we had cash of $39.1 million and the principal amount of our outstanding consolidated debt aggregated to $110.6 million, of which $0.6 million is classified as current in our Condensed Consolidated Balance Sheet. As of September 30, 2024, we had available borrowing capacity of $50.0 million, comprised of $25.0 million on our Ares Term Loan and $25.0 million on our Ares Revolving Loan.

22

We believe that our existing cash, additional available borrowing capacity and expected revenues will be sufficient to meet our capital requirements and fund our operations for at least the next 12 months. Our primary short-term needs for capital for our planned operations, which are subject to change, include:

expanding our research and development initiatives to improve our existing products and develop new products and solutions; and
continued commercialization efforts and expansion of our sales and marketing infrastructure and programs to drive anticipated sales growth in the United States and elsewhere.

We have based our short-term capital needs and planned operating requirements on assumptions that may prove to be incorrect and we may use all our available capital resources sooner than we expect. Although not anticipated at this time, we may require additional financing to fund our operations and planned growth. We may also seek additional financing opportunistically. We may seek to raise any additional capital through public or private equity offerings or debt financings, credit or loan facilities or a combination of one or more of these funding sources. Additional funds may not be available to us on acceptable terms or at all. If we fail to obtain necessary capital when needed on acceptable terms, or at all, we could be forced to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations. If we raise additional funds by issuing equity securities, our stockholders will suffer dilution and the terms of any financing may adversely affect the rights of our stockholders. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders. If we raise additional capital through collaborations agreements, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product or grant licenses that may not be favorable to us. Debt financing, if available, may involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency, debt holders would be repaid before holders of our equity securities received any distribution of our corporate assets. In addition, market conditions impacting financial institutions could impact our ability to access some or all of our cash, cash equivalents and marketable securities, and we may be unable to obtain alternative funding when and as needed on acceptable terms, if at all.

Cash Flows

The following table sets forth the primary sources and uses of cash for the periods presented:

Nine Months Ended September 30, 

Change

    

2024

    

2023

    

Amount

    

%

(in thousands)

Net cash (used in) provided by:

Operating activities

$

(23,869)

$

(47,517)

$

23,648

50%

Investing activities

(13,074)

(22,031)

8,957

41%

Financing activities

670

65,480

(64,810)

(99)%

Effect of exchange rate changes on cash and cash equivalents

(221)

549

(770)

*

Net decrease in cash and cash equivalents

$

(36,494)

$

(3,519)

$

(32,975)

*

*

Not Meaningful

Net Cash Used in Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2024, was $23.9 million consisting of net loss of $43.5 million, partially offset by non-cash expenses of $33.2 million, which primarily consisted of $13.6 million of depreciation and amortization, $9.5 million of stock-based compensation expense, and $8.8 million of excess and obsolete inventory, and negative changes in working capital of $13.6 million. The changes in working capital are comprised primarily of a net inventory increase of $14.6 million, partially offset by an increase in accrued expenses of $1.5 million.

23

Net cash used in operating activities for the nine months ended September 30, 2023 was $47.5 million, consisting of net loss of $35.2 million, inventory increases of $31.1 million and final legal settlement payments of $22.0 million partially offset by non-cash expenses of $24.2 million, which primarily consisted of $10.6 million of depreciation and amortization and $10.3 million of stock-based compensation expense, and changes in working capital of $36.5 comprised primarily of a $12.5 million increase in accounts payable and $3.7 million decrease in accounts receivable.

Net Cash Used in Investing Activities

Net cash used in investing activities for the nine months ended September 30, 2024 was $13.1 million, consisting primarily of surgical instrumentation purchases.

Net cash used in investing activities for the nine months ended September 30, 2023 was $22.0 million, consisting primarily of surgical instrumentation purchases plus other purchases of property, plant and equipment.‌

Net Cash Provided by Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2024 was $0.7 million, consisting primarily of funds received from the exercise of options, partially offset by a $1.0 million payment related to the completion of a milestone associated with the Additive Orthopaedics acquisition and a $1.0 million payment related to the completion of a milestone associated with the Disior acquisition.

Net cash provided by financing activities for the nine months ended September 30, 2023, was $65.5 million, consisting of $68.5 million of proceeds from the issuance of common stock, net of issuance costs related to the Offering on January 30, 2023, and $2.5 million of proceeds from the exercise of stock options, partially offset by $5.5 million in payments related to the completion of certain milestones associated with the Disior and Additive Orthopaedics acquisitions.

Critical Accounting Estimates

Management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses and related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. During the nine months ended September 30, 2024, the Company revised the inputs used in estimating the reserve on obsolete and slow-moving inventory to include forecasted sales, in addition to current inventory levels and historical sales.

During the nine months ended September 30, 2024, there were no material changes to our critical accounting policies or in the methodology used for estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the Amended 2023 Annual Report, other than the item described above.

Recently Issued Accounting Pronouncements

See Note 2 to our condensed consolidated financial statements included in this quarterly report for recently adopted and recently issued accounting pronouncements not yet adopted and their potential impact to our financial statements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Interest Rate Risk

The primary objectives of our investment activities are to preserve principal and provide liquidity. In the normal course of business, we are exposed to market risk related to fluctuating interest rates. The Company has both fixed and variable rate debt to manage the impact of these fluctuations. The Company is the fixed rate payor on an interest rate swap

24

contract to help manage some of this risk. Based on our overall interest rate exposure as of September 30, 2024, we do not believe a hypothetical 10 percent change in interest rates on our variable rate indebtedness would have a material effect on our results of operations.

Foreign Currency Risk

Our business is primarily conducted in U.S. dollars. Any transactions that may be conducted in foreign currencies are not expected to have a material effect on our results of operations, financial position or cash flows. As we expand internationally our results of operations and cash flows may become increasingly subject to fluctuations due to changes in foreign currency exchange rates.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Quarterly Report. Based on that evaluation, our principal executive officer and principal financial officer have identified certain material weaknesses in our internal controls over financial reporting which were also disclosed in our Amended 2023 Annual Report. As a result of these material weaknesses, management has concluded that our disclosure controls and procedures were not effective as of September 30, 2024 at a reasonable assurance level in ensuring information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures.

Plan for Remediation of the Material Weaknesses

Management, with oversight by the Audit Committee of the board of directors, is devoting significant time, attention, and resources to remediate the material weaknesses and to strengthen its monitoring, control environment, and internal control over financial reporting. We have developed a remediation plan that includes:

Evaluating and updating (as appropriate) the organizational design and reporting structure of the controllership function, including evaluating the sufficiency, experience, and training of personnel within our accounting function.
Hiring, developing, and retaining accounting resources with appropriate accounting and internal controls expertise related to accounting for inventory in accordance with GAAP.
Engaging third-party resources with the appropriate technical knowledge and experience to assist with the accounting for inventory and designing and implementing related control activities.
Designing and implementing additional and/or enhancing controls relating to the valuation of inventory, including the calculation of the excess and obsolescence reserve and capitalization of purchase price variances.
Designing and implementing effective monitoring activities over the execution of business performance reviews and account analysis and enhance communication of internal control deficiencies to those parties responsible for taking corrective action in a timely manner.

We plan to continue to devote significant time and attention to remediate these material weaknesses as soon as reasonably practicable. Management believes that the measures described above and others that may be implemented will

25

remediate the identified material weaknesses and strengthen the Company’s internal control over financial reporting. Management has begun to take these actions to remediate the material weaknesses and may take additional measures to address control deficiencies or determine to modify, or in the appropriate circumstances not to complete, certain of the remediation measures identified. The material weaknesses will not be considered remediated until the remediation plan has been implemented and there has been appropriate time to conclude through testing that the controls are operating effectively.

Changes in Internal Control Over Financial Reporting

Other than as described above in connection with our material weaknesses, there were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the fiscal quarter ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Limitations on the Effectiveness of Disclosure Controls and Procedures

In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

26

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

We may in the ordinary course of business face various claims brought by third parties and we may, from time to time, make claims or take legal actions to assert our rights, including intellectual property rights as well as claims relating to employment matters and the safety or efficacy of our products. Any of these claims could cause us to incur substantial costs and, while we generally believe that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage, may be inadequately capitalized to pay on valid claims, or our policy limits may be inadequate to fully satisfy any associated costs, damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on our operations, cash flows and financial position. Additionally, any such claims, whether or not successful, could damage our reputation and business. We were not involved in any legal proceedings as of September 30, 2024, that could have a material adverse effect on our business, financial condition, or operating results.

Class Action Litigation  

On September 30, 2024, and October 18, 2024, respectively, two putative class action complaints were filed in the U.S. District Court for the District of Colorado.  These complaints allege that the Company and certain current and former officers violated federal securities laws.  The cases are captioned Ellington v. Paragon 28, Inc., et al., and Tiedt v. Paragon 28, Inc., et al.  We believe the allegations in the complaint are without merit and intend to vigorously defend the litigation.

Given the early stage of the litigation matters described above, we are unable at this time to reasonably estimate possible losses or form a judgment that an unfavorable outcome is either probable or remote. However, litigation is subject to inherent uncertainties, and one or more unfavorable outcomes in any claim or litigation against us could have a material adverse effect for the period in which they are resolved, and on our business generally. In addition, regardless of their merits or their ultimate outcomes, lawsuits and legal proceedings are costly, divert management attention, and may adversely affect our reputation, even if they are resolved in our favor.

Item 1A. Risk Factors.

As of the date of this Quarterly Report, there have been no material changes to the risk factors disclosed in our Amended 2023 Annual Report. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None

Item 3. Defaults Upon Senior Securities.

None

Item 4. Mine Safety Disclosures.

Not applicable

27

Item 5. Other Information.

During the three months ended September 30, 2024, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

Item 6. Exhibits.

The following exhibits are included within or incorporated herein by reference.

    

    

Incorporated by Reference

Exhibit
Number

Description

Form

    

Exhibit

    

Date Filed

    

File
Number

    

Filed
Herewith

3.1

Amended and Restated Certificate of Incorporation of Paragon 28, Inc.

8-K

3.1

10/19/2021

001-40902

3.1.1

Certificate of Amendment to amended and Restated Certificate of Incorporation of Paragon 28, Inc.

8-K

3.1

05/19/2023

001-40902

3.2

Second Amended and Restated Bylaws

8-K

3.2

05/19/2023

001-40902

4.1

Form of Common Stock Certificate

S-1/A

4.2

10/08/2021

333-259789

4.2

Amended and Restated Investors’ Rights Agreement, dated as of July 28, 2020, by and between Paragon 28, Inc. and the investors party thereto.

S-1

4.3

09/24/2021

333-259789

31.1

Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

X

31.2

Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

X

32.1*

Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

X

32.2*

Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

X

101.INS

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.

101.SCH

Inline XBRL Taxonomy Extension Schema Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

*

The certifications attached as Exhibit 32.1 and 32.2 that accompany this Quarterly Report are deemed furnished and not filed with the U.S. Securities and Exchange Commission and are not to be incorporated by reference into any filing of Paragon 28, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report, irrespective of any general incorporation language contained in such filing.

28

SIGNATURES

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

    

PARAGON 28, INC.

Date: November 12, 2024

By:

/s/ Albert DaCosta

Name:

Albert DaCosta

Title:

Chief Executive Officer (Principal Executive Officer)

Date: November 12, 2024

By:

/s/ Chadi Chahine

Name:

Chadi Chahine

Title:

Chief Financial Officer (Principal Financial Officer)

29

Exhibit 31.1

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Albert DaCosta, certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q of Paragon 28, Inc. (the “registrant”);

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 12, 2024

By:

/s/ Albert DaCosta

Albert DaCosta

Chief Executive Officer
(Principal Executive Officer)


Exhibit 31.2

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Chadi Chahine, certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q of Paragon 28, Inc. (the “registrant”);

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 12, 2024

By:

/s/ Chadi Chahine

Chadi Chahine

Chief Financial Officer

(Principal Financial Officer)


Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Paragon 28, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

(1)

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: November 12, 2024

By:

/s/ Albert DaCosta

Albert DaCosta

Chief Executive Officer

(Principal Executive Officer)

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.


Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Paragon 28, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

(1)

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: November 12, 2024

By:

/s/ Chadi Chahine

Chadi Chahine

Chief Financial Officer
(Principal Financial Officer)

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.


v3.24.3
Document and Entity Information - shares
9 Months Ended
Sep. 30, 2024
Nov. 08, 2024
Cover [Abstract]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Sep. 30, 2024  
Document Transition Report false  
Entity File Number 001-40902  
Entity Registrant Name Paragon 28, Inc.  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 27-3170186  
Entity Address, Postal Zip Code 80112  
Entity Address, Address Line One 14445 Grasslands Drive  
Entity Address, City or Town Englewood  
Entity Address, State or Province CO  
City Area Code 720  
Local Phone Number 912-1332  
Title of 12(b) Security Common stock, $0.01 par value per share  
Trading Symbol FNA  
Security Exchange Name NYSE  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Large Accelerated Filer  
Entity Small Business false  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   83,720,346
Entity Central Index Key 0001531978  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2024  
Document Fiscal Period Focus Q3  
Amendment Flag false  
v3.24.3
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Current assets:    
Cash and cash equivalents $ 39,145 $ 75,639
Trade receivables, net of allowance for doubtful accounts of $793 and $1,339, respectively 35,823 37,323
Inventories, net 96,449 90,046
Income taxes receivable 1,461 794
Other current assets 4,732 3,997
Total current assets 177,610 207,799
Property and equipment, net 74,016 74,122
Intangible assets, net 20,937 21,674
Goodwill 25,465 25,465
Deferred income taxes 714 705
Other assets 3,266 2,918
Total assets 302,008 332,683
Current liabilities:    
Accounts payable 20,693 21,696
Accrued expenses 27,424 27,781
Other current liabilities 1,336 883
Current maturities of long-term debt 640 640
Income taxes payable 626 243
Total current liabilities 50,719 51,243
Long-term liabilities:    
Long-term debt net, less current maturities 109,979 109,799
Other long-term liabilities 994 1,048
Deferred income taxes 245 233
Income taxes payable 638 635
Total liabilities 162,575 162,958
Commitments and contingencies (Note 10)
Stockholders' equity:    
Common stock, $0.01 par value, 300,000,000 shares authorized; 84,510,066 and 83,738,974 shares issued, and 83,596,547 and 82,825,455 shares outstanding as of September 30, 2024 and December 31, 2023, respectively 834 827
Additional paid in capital 311,342 298,394
Accumulated deficit (167,165) (123,646)
Accumulated other comprehensive income 404 132
Treasury stock, at cost; 913,519 shares as of September 30, 2024 and December 31, 2023 (5,982) (5,982)
Total stockholders' equity 139,433 169,725
Total liabilities & stockholders' equity $ 302,008 $ 332,683
v3.24.3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
CONDENSED CONSOLIDATED BALANCE SHEETS    
Allowance for doubtful accounts $ 793 $ 1,339
Common stock par value $ 0.01 $ 0.01
Common stock share authorized 300,000,000 300,000,000
Common stock share issued 84,510,066 83,738,974
Common stock shares, outstanding 83,596,547 82,825,455
Treasury stock share issued 913,519 913,519
v3.24.3
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS        
Net revenue $ 62,336 $ 52,783 $ 184,434 $ 155,828
Cost of goods sold 16,159 11,922 45,262 33,750
Gross profit 46,177 40,861 139,172 122,078
Operating expenses:        
Research and development 5,661 7,244 20,328 21,976
Selling, general, and administrative 48,967 44,126 153,188 131,773
Total operating expenses 54,628 51,370 173,516 153,749
Operating loss (8,451) (10,509) (34,344) (31,671)
Other income (expense):        
Other income (expense), net (651) 369 (4) (323)
Interest expense, net (3,031) (1,119) (8,570) (3,127)
Total other expense, net (3,682) (750) (8,574) (3,450)
Loss before income taxes (12,133) (11,259) (42,918) (35,121)
Income tax expense (benefit) 205 (108) 601 90
Net loss (12,338) (11,151) (43,519) (35,211)
Foreign currency translation adjustment 1,117 (630) 272 (1,012)
Comprehensive loss $ (11,221) $ (11,781) $ (43,247) $ (36,223)
Weighted average number of shares of common stock outstanding:        
Basic (in shares) 83,560,337 82,548,892 83,178,600 81,878,814
Diluted (in shares) 83,560,337 82,548,892 83,178,600 81,878,814
Net loss per share attributable to common stockholders:        
Basic (in dollars per share) $ (0.15) $ (0.14) $ (0.52) $ (0.43)
Diluted (in dollars per share) $ (0.15) $ (0.14) $ (0.52) $ (0.43)
v3.24.3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)
$ in Thousands
Common Stock
Additional Paid-in-Capital
Accumulated Deficit
Accumulated Other Comprehensive Loss
Treasury stock
Total
Beginning balance, shares at Dec. 31, 2022 77,770,588          
Beginning balance at Dec. 31, 2022 $ 776 $ 213,956 $ (66,112) $ (33) $ (5,982) $ 142,605
Net Loss     (35,211)     (35,211)
Issuance of common stock, net of issuance costs of $827, shares 4,312,500          
Issuance of common stock, net of issuance costs of $827 $ 43 68,410       68,453
Options exercised, shares 435,673          
Options exercised $ 5 2,530       2,535
Foreign currency translation       (1,012)   (1,012)
Employee stock purchase plan, shares 37,146          
Employee stock purchase plan   828       828
Stock-based compensation   10,294       10,294
Ending balance, shares at Sep. 30, 2023 82,555,907          
Ending balance at Sep. 30, 2023 $ 824 296,018 (101,323) (1,045) (5,982) 188,492
Beginning balance, shares at Jun. 30, 2023 82,536,046          
Beginning balance at Jun. 30, 2023 $ 824 292,350 (90,172) (415) (5,982) 196,605
Net Loss     (11,151)     (11,151)
Options exercised, shares 19,861          
Options exercised   70       70
Foreign currency translation       (630)   (630)
Employee stock purchase plan   86       86
Stock-based compensation   3,512       3,512
Ending balance, shares at Sep. 30, 2023 82,555,907          
Ending balance at Sep. 30, 2023 $ 824 296,018 (101,323) (1,045) (5,982) 188,492
Beginning balance, shares at Dec. 31, 2023 82,825,455          
Beginning balance at Dec. 31, 2023 $ 827 298,394 (123,646) 132 (5,982) 169,725
Net Loss     (43,519)     $ (43,519)
Options exercised, shares 553,000         553,000
Options exercised $ 6 3,224       $ 3,230
Restricted stock vested, net of shares withheld for taxes (in shares) 148,773          
Restricted stock vested, net of shares withheld for taxes $ 1 (467)       (466)
Foreign currency translation       272   272
Employee stock purchase plan, shares 69,319          
Employee stock purchase plan   654       654
Stock-based compensation   9,537       9,537
Ending balance, shares at Sep. 30, 2024 83,596,547          
Ending balance at Sep. 30, 2024 $ 834 311,342 (167,165) 404 (5,982) 139,433
Beginning balance, shares at Jun. 30, 2024 83,504,206          
Beginning balance at Jun. 30, 2024 $ 833 307,524 (154,827) (713) (5,982) 146,835
Net Loss     (12,338)     (12,338)
Options exercised, shares 79,251          
Options exercised $ 1 351       352
Restricted stock vested, net of shares withheld for taxes (in shares) 13,090          
Restricted stock vested, net of shares withheld for taxes   (42)       (42)
Foreign currency translation       1,117   1,117
Employee stock purchase plan   84       84
Stock-based compensation   3,425       3,425
Ending balance, shares at Sep. 30, 2024 83,596,547          
Ending balance at Sep. 30, 2024 $ 834 $ 311,342 $ (167,165) $ 404 $ (5,982) $ 139,433
v3.24.3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical)
$ in Thousands
9 Months Ended
Sep. 30, 2023
USD ($)
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY  
Issuance costs $ 827
v3.24.3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
$ in Thousands
9 Months Ended
Sep. 30, 2024
USD ($)
Sep. 30, 2023
USD ($)
Cash flows from operating activities    
Net Income (Loss) $ (43,519) $ (35,211)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 13,573 10,602
Allowance for doubtful accounts 721 147
Provision for excess and obsolete inventories 8,753 3,204
Stock-based compensation 9,537 10,294
Change in fair value of financial instruments (267) (57)
Other 910 (34)
Changes in other assets and liabilities, net of acquisitions:    
Accounts receivable 1,156 3,706
Inventories (14,586) (31,117)
Accounts payable (1,013) 12,468
Accrued expenses 1,522 3,718
Accrued legal settlement   (22,000)
Income tax receivable/payable (215) (533)
Other assets and liabilities (441) (2,704)
Net cash used in operating activities (23,869) (47,517)
Cash flows from investing activities    
Purchases of property and equipment (13,119) (21,893)
Proceeds from sale of property and equipment 926 795
Purchases of intangible assets (881) (933)
Net cash used in investing activities (13,074) (22,031)
Cash flows from financing activities    
Payments on long-term debt (480) (568)
Payments of debt issuance costs (18)  
Proceeds from issuance of common stock, net of issuance costs   68,453
Proceeds from exercise of options 3,188 2,535
RSU vesting, taxes paid (423)  
Proceeds from employee stock purchase plan 403 560
Payments on earnout liability (2,000) (5,500)
Net cash provided by financing activities 670 65,480
Effect of exchange rate changes on cash and cash equivalents (221) 549
Net decrease in cash and cash equivalents (36,494) (3,519)
Cash and cash equivalents at beginning of period 75,639 38,468
Cash and cash equivalents at end of period 39,145 34,949
Supplemental disclosures of cash flow information:    
Restricted cash   1,000
Cash paid for income taxes 1,190 610
Cash paid for interest 8,717 3,342
Purchase of property and equipment included in accounts payable $ 3,152 $ 4,842
v3.24.3
Business and Basis of Presentation
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Business and Basis of Presentation

NOTE 1. BUSINESS AND BASIS OF PRESENTATION

Business

Paragon 28, Inc. (collectively with its subsidiaries, “we,” “us,” “our,” “P28” or the “Company”) develops, distributes, and sells medical devices in the foot and ankle segment of the orthopedic implant marketplace. Our approach to product development is procedurally focused, resulting in a full range of procedure-specific foot and ankle products designed specifically for foot and ankle anatomy. Our products and product families include plates and plating systems, screws, staples, and nails aimed to address all major foot and ankle procedures including fracture fixation, forefoot or hallux valgus - which includes bunion and hammertoe, ankle, flatfoot or progressive collapsing foot deformity, charcot foot and orthobiologics. P28 is a United States (“U.S.”) based company incorporated in the State of Delaware, with headquarters in Englewood, Colorado. Our sales representatives and distributors are located globally with the majority concentrated in the U.S., Australia, South Africa, and the United Kingdom.

Basis of Presentation and Consolidation

The accompanying Condensed Consolidated Financial Statements include the accounts of Paragon 28, Inc. and its subsidiaries, all of which are wholly-owned. The accompanying Condensed Consolidated Financial Statements have been prepared in conformity with accounting principles generally accepted in the U.S. (“U.S. GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information required by U.S. GAAP for complete financial statements. The interim Condensed Consolidated Financial Statements reflect all adjustments that are of a normal recurring nature and that are considered necessary for a fair representation of the results for the periods presented and should be read in conjunction with the audited Consolidated Financial Statements and notes thereto for the year ended December 31, 2023, which include a complete set of footnote disclosures, including our significant accounting policies. The audited Consolidated Financial Statements and notes thereto for the year ended December 31, 2023, are included in the Amended 2023 Annual Report. The results for interim periods are not necessarily indicative of the results that may be expected for a full fiscal year or for any other future period. All intercompany balances and transactions have been eliminated in consolidation.

v3.24.3
Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

The preparation of the financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Because future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. Any changes in these estimates will be reflected in the Company’s Condensed Consolidated Financial Statements. Significant items subject to such estimates and assumptions include the determination of the credit loss reserves for trade receivables, inventory obsolescence, impairment of long-lived assets, recoverability of goodwill and intangible assets, contingent earnout liabilities, interest rate swap valuation, income taxes and stock-based compensation. On January 1, 2024, the Company revised the inputs used in estimating the reserve on obsolete and slow-moving inventory to include forecasted sales, in addition to current inventory levels and historical sales. The effect of this change in estimate was a decrease of $248 to the Company’s reserve for obsolete and slow-moving inventory during the nine months ended September 30, 2024.

Foreign Currency Translation

The Condensed Consolidated Financial Statements are presented in U.S. dollars. The Company’s non-U.S. subsidiaries have a functional currency (i.e., the currency in which operational activities are primarily conducted) that is other than the U.S. dollar, generally the currency of the country in which such subsidiaries are domiciled. Such subsidiaries’ assets and liabilities are translated into U.S. dollars at quarter-end exchange rates, while revenue and expenses are translated at average exchange rates during the quarter based on the daily closing exchange rates. Adjustments that result from translating amounts from a subsidiary’s functional currency to U.S. dollars are reported in Accumulated other comprehensive income (loss), a separate component of stockholders’ equity.

Transactions made in a currency other than the functional currency are remeasured to the functional currency at the exchange rates on the dates of the transactions. Foreign exchange gains and losses are recorded within Other income (expense), net on the consolidated statements of operations and comprehensive loss.

Significant Accounting Policies

There have been no changes in the Company’s significant accounting policies as disclosed in Note 2 to our audited Consolidated Financial Statements included in our Amended 2023 Annual Report on Form 10-K/A.

Recently Issued Accounting Pronouncements

In October 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. The amendments in ASU 2023-06 modify the disclosure or presentation requirements of a variety of Topics in the Codification. Certain of the amendments represent clarifications to or technical corrections of the current requirements. ASU 2023-06 is applicable to all entities subject to the SEC’s existing disclosure requirements. The effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. The Company is currently evaluating the amendments in ASU 2023-06 and does not expect the adoption to have a significant impact on the Company’s Consolidated Financial Statements and related disclosures.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ("ASU 2023-07"), which provides amendments to improve reportable segment disclosures requirements. The amendments in ASU 2023-07 are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the amendments to determine the impact it will have on the Company’s Consolidated Financial Statements and related disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), to enhance the transparency and decision usefulness of income tax disclosures. The main provisions in ASU 2023-09 enhance the disclosure requirements of rate reconciliations and income taxes paid. For public business entities, the amendments in ASU 2023-09 are effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The amendments in this update should be applied on a prospective basis, retrospective application is permitted. The Company is currently evaluating the amendments in this guidance to determine the impact it will have on the Company’s Consolidated Financial Statements and related disclosures.  

v3.24.3
Intangible Assets
9 Months Ended
Sep. 30, 2024
Goodwill and Intangible Assets Disclosure [Abstract]  
Intangible Assets

NOTE 3. INTANGIBLE ASSETS

Intangibles

Intangible assets as of September 30, 2024, were as follows:

    

Gross
Carrying
Amount

    

Accumulated
Amortization

    

Net Carrying
Amount

Trademarks and tradenames, indefinite-lived

$

607

$

$

607

Patents, trademarks and tradenames, definite-lived

9,159

3,095

6,064

Customer relationships

1,733

758

975

Developed technology

17,690

4,399

13,291

Other intangibles

30

30

Total intangible assets, net

$

29,219

$

8,282

$

20,937

Intangible assets as of December 31, 2023, were as follows:

    

Gross
Carrying
Amount

    

Accumulated
Amortization

    

Net Carrying
Amount

Trademarks and tradenames, indefinite-lived

$

987

$

$

987

Patents, definite-lived

7,900

2,649

5,251

Customer relationships

1,733

567

1,166

Developed technology

17,690

3,424

14,266

Other intangibles

30

26

4

Total intangible assets, net

$

28,340

$

6,666

$

21,674

Amortization expense is included in Selling, general, and administrative expenses, on the Condensed Consolidated Statements of Operations and Comprehensive Loss, and was $479 and $509 for the three months ended September 30, 2024 and 2023, respectively. Amortization expense for the nine months ended September 30, 2024 and 2023 totaled $1,617 and $1,519, respectively. During the second quarter of 2024, the Company recategorized one of its intangible assets from Trademarks and tradenames, indefinite-lived to Patents, trademarks and tradenames, definite-lived and recorded the related amortization expense.

Expected future amortization expense is as follows:

2024 (Remaining)

    

$

515

2025

2,055

2026

2,055

2027

1,975

2028

1,975

Thereafter

11,755

Total future amortization expense

$

20,330

No impairment charges related to intangibles were recorded for the three and nine months ended September 30, 2024 and 2023.

v3.24.3
Fair Value of Financial Instruments
9 Months Ended
Sep. 30, 2024
Fair Value Disclosures [Abstract]  
Fair Value of Financial Instruments

NOTE 4. FAIR VALUE OF FINANCIAL INSTRUMENTS

The Company measures certain financial assets and liabilities at fair value. There is a fair value hierarchy which prioritizes inputs used in measuring fair value into three broad levels:

Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.

Level 2 - Includes other inputs that are directly or indirectly observable in the marketplace, such as quoted market prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data.

Level 3 - Unobservable inputs which are supported by little or no market activity.

The level in the fair value hierarchy within which a fair value measurement in its entirety falls is based on the lowest-level input that is significant to the fair value measurement in its entirety.

The Company’s significant financial assets and liabilities measured at fair value as of September 30, 2024, were as follows:

    

Level 1

    

Level 2

    

Level 3

    

Total

Financial Assets:

Interest rate swap

$

917

$

917

The Company's significant financial assets and liabilities measured at fair value as of December 31, 2023, were as follows:

    

Level 1

    

Level 2

    

Level 3

    

Total

Financial Assets:

Interest rate swap

$

991

$

991

Financial Liabilities:

Contingent consideration

$

340

$

340

The Company’s Level 2 asset pertains to an interest rate swap associated with the Zions Facility (as defined below), used to manage interest rate risk related to variable rate borrowings and manage exposure to the variability of cash flows. The interest rate swap is not designated for hedge accounting and is measured utilizing inputs observable in active markets. For the three and nine months ended September 30, 2024, we reassessed the fair value of our swap which resulted in an increase of $674 a decrease of $74, respectively to the swap asset. The swap asset is recorded in Other assets on the Condensed Consolidated Balance Sheet and the change in fair value is recorded in Other income (expense), net within the Condensed Consolidated Statement of Operations and Comprehensive Loss.

The Company reassessed its Level 3 contingent earnout liability as of September 30, 2024, and determined it was not probable that the remaining two milestones associated with the acquisition of Additive Orthopaedics, LLC (“Additive Orthopaedics”) would be achieved. The Company wrote off the remaining earnout liability and recorded non-cash income of $340 in Other income (expense), net within the Consolidated Statement of Operations and Comprehensive Loss for the three and nine months ended September 30, 2024.

As of December 31, 2023, one project milestone associated with the acquisition of Disior LTD. (“Disior”) and one project milestone associated with the Additive Orthopaedics acquisition was included in Accrued expenses on the Consolidated Balance Sheet totaling $2,000. During the first quarter of 2024, $1,000 was paid in cash related to the Additive Orthopaedics milestone and the remaining $1,000 related to the Disior acquisition was paid during the second

quarter of 2024. For additional information on the Disior and Additive Orthopaedics acquisitions refer to Note 4 to our Consolidated Financial Statements included in the Amended 2023 Annual Report on Form 10-K/A for the year ended December 31, 2023.

v3.24.3
Debt
9 Months Ended
Sep. 30, 2024
Debt Disclosure [Abstract]  
Debt

NOTE 5. DEBT

Long-term debt as of September 30, 2024 and December 31, 2023 consists of the following:

    

September 30, 2024

    

December 31, 2023

Ares Revolving Loan

$

25,000

$

25,000

Ares Term Loan

75,000

75,000

Zions Term Loan

14,453

14,933

114,453

114,933

Less: deferred issuance costs

(3,834)

(4,494)

Total debt, net of issuance costs

110,619

110,439

Less: current portion

(640)

(640)

Long-term debt, net, less current maturities

$

109,979

$

109,799

Ares Credit Agreement

On November 2, 2023, the Company and its wholly-owned subsidiary, Paragon Advanced Technologies, Inc. (“Paragon Advanced Technologies” and, together with the Company, the “Borrowers”) entered into a new credit agreement (the “Ares Credit Agreement”) with Ares Capital Corporation (“Ares”) to provide a total of $150,000, inclusive of a revolving credit facility of up to $50,000 (the “Ares Revolving Loan”) and a term loan facility of up to $100,000 (the “Ares Term Loan”). The obligations under the Ares Credit Agreement are guaranteed by each of the Borrowers’ current and future domestic subsidiaries and secured by liens on substantially all of the Borrowers’ and guarantors’ present and after-acquired assets, in each case, subject to certain customary exceptions. In connection with the closing of the Ares Credit Agreement, the Company drew down $25,000 and $75,000 on the Ares Revolving Loan and Ares Term Loan, respectively. The Ares Revolving Loan and Ares Term Loan bear interest at variable rates of Term Secured Overnight Financing Rate (“Term SOFR”) plus 4% and Term SOFR plus 6.75%, respectively, subject in the case of the Ares Term Loan to certain step-downs and adjustments as set forth in the Ares Credit Agreement, and mature on the earlier of (i) November 2, 2028, and (ii) with respect to the Ares Revolving Loan, 6 months prior to the maturity date of any other indebtedness in a principal or stated amount in excess of $12,500. The Ares Credit Agreement contains a financial covenant requiring the Company to maintain certain minimum revenue levels. As of September 30, 2024, the Company was in compliance with all financial covenants under the Ares Credit Agreement. Total debt issuance costs associated with the Ares Credit Agreement were $3,627 as of September 30, 2024. Amortization expense associated with such debt issuance costs totaled $222 and $648 for the three and nine months ended September 30, 2024, respectively and are included in Interest expense, net on the Condensed Consolidated Statements of Operations and Comprehensive Loss. There were no debt issuance costs associated with the Ares Credit Agreement during the three and nine months ended September 30, 2023.

Vectra Bank Colorado Loan Agreements

On March 24, 2022, the Company entered into a secured term loan facility (the “Zions Facility”) with Zions Bancorporation, N.A. dba Vectra Bank Colorado in the principal amount of $16,000. The loans under the Zions Facility (i) bear interest at a variable rate per annum equal to the sum of (a) a one-month Term SOFR based rate, plus (b) 1.75%, adjusted on a monthly basis and (ii) mature on March 24, 2037. Principal and interest payments are payable monthly, with optional prepayments allowed without premium or penalty.

Effective as of November 10, 2022, the Company entered into the First Amendment to the Zions Facility. The amendment to the Zions Facility amends the financial covenants to require the Company to maintain (i) the Liquidity

Ratio, if the Cash Flow as of the last day of any quarter measured on a trailing three month basis is less than or equal to $0, and (ii) the Fixed Charge Coverage Ratio which will be calculated as of the last day of each quarter on a trailing four quarter basis, as well as a certain level of Liquidity, if the Cash Flow is greater than $0. In addition, a Net Revenue Growth covenant was added which will be calculated as of the last day of each quarter on a year-over-year basis.

Effective as of November 2, 2023, the Company entered into the Second Amendment to the Zions Facility (the “Second Amendment”). The Second Amendment replaces references to MidCap Financial Trust and MidCap Credit Agreements with references to Ares and the Ares Credit Agreement. As of September 30, 2024, the Company was in compliance with all financial covenants under the Second Amendment. Total debt issuance costs associated with the Zions Facility were $207 as of September 30, 2024. Amortization expense associated with such debt issuance costs was $4 and $12 for the three and nine months ended September 30, 2024, and is included in Interest expense, net on the Condensed Consolidated Statements of Operations and Comprehensive Loss, respectively and totaled $4 and $12 for the three and nine months ended September 30, 2023, respectively.

v3.24.3
Stockholders' Equity
9 Months Ended
Sep. 30, 2024
Stockholders' Equity Note [Abstract]  
Stockholders' Equity

NOTE 6. STOCKHOLDERS’ EQUITY

Under its Amended and Restated Certificate of Incorporation, the Company has a total of 310,000,000 shares of capital stock authorized for issuance, consisting of 300,000,000 shares of common stock, par value of $0.01 per share, and 10,000,000 shares of convertible preferred stock, par value of $0.01 per share.

Common Stock

On January 30, 2023, the Company completed an underwritten public offering (“the Offering”) of 6,500,000 shares of its common stock at an offering price of $17.00 per share, which consisted of 3,750,000 shares of common stock issued and sold by the Company and 2,750,000 shares of common stock sold by certain selling securityholders. On February 17, 2023, the underwriters exercised in full their option to purchase an additional 562,500 shares and 412,500 shares of common stock from the Company and the selling securityholders, respectively.‌

The Company received aggregate net proceeds from the Offering of approximately $68,453 after deducting underwriting discounts and commissions and offering expenses payable by the Company. The selling securityholders received aggregate net proceeds from the Offering of approximately $50,700 after deducting underwriting discounts and commissions. The Company did not receive any of the proceeds from the sale of shares of common stock by the selling securityholders.

Treasury Stock

The Company did not purchase any of its common stock during the nine months ended September 30, 2024 and 2023. All previously repurchased shares were recorded in Treasury stock, at cost.

v3.24.3
Loss Per Share
9 Months Ended
Sep. 30, 2024
Earnings Per Share [Abstract]  
Loss Per Share

NOTE 7. LOSS PER SHARE

Basic net loss per share is computed by dividing net loss attributable to common stockholders (the numerator) by the weighted average number of common stock outstanding for the period (the denominator). Diluted net income per share of common stock attributable to common stockholders is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period adjusted for the dilutive effects of common stock equivalents using the treasury stock method or the method based on the nature of such securities. In periods when losses from operations are reported, the weighted-average number of shares of common stock outstanding excludes common stock equivalents because their inclusion would be anti-dilutive. The computation of net loss per share for the three and nine months ended September 30, 2024 and 2023 was as follows:

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

    

2023

    

2024

    

2023

Net loss

$

(12,338)

$

(11,151)

$

(43,519)

$

(35,211)

Weighted-average common stock outstanding:

Basic

83,560,337

82,548,892

83,178,600

81,878,814

Diluted

83,560,337

82,548,892

83,178,600

81,878,814

Loss per share:

Basic

$

(0.15)

$

(0.14)

$

(0.52)

$

(0.43)

Diluted

$

(0.15)

$

(0.14)

$

(0.52)

$

(0.43)

The following outstanding potentially dilutive securities were excluded from the calculation of diluted net loss per share attributable to common stockholders because their impact would have been antidilutive for the period presented:

As of September 30, 

    

2024

    

2023

Stock options

4,878,717

6,119,477

Restricted stock units

2,983,311

1,392,087

v3.24.3
Stock-Based Compensation
9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Stock-Based Compensation

NOTE 8. STOCK-BASED COMPENSATION

Employee Stock Purchase Plan

The Company’s Employee Stock Purchase Plan (“ESPP”) provides participating employees with the opportunity to purchase the Company’s common stock at 85% of the market price at the lesser of the date the purchase right is granted or exercisable. Eligible employees can contribute up to 15% of their gross base earnings for purchases under the ESPP through regular payroll deductions, limited to $25 worth of the Company’s shares of common stock for each calendar year in which the purchase right is outstanding. The Company currently holds offerings consisting of six-month periods commencing on January 1st and July 1st of each calendar year, with a single purchase date at the end of the purchase period on June 30th and December 31st of each calendar year.

The Company issued 69,319 shares upon exercise of purchase rights during the three and nine months ended September 30, 2024, and 37,146 shares during the three and nine months ended September 30, 2023. The Company recognizes compensation expense on a straight-line basis over the service period. During the three and nine months ended September 30, 2024, the Company recognized $84 and $252, respectively, of compensation expense related to the ESPP. During the three and nine months ended September 30, 2023, the Company recognized $86 and $268, respectively of compensation expense related to the ESPP. Stock-based compensation expenses are recorded in Selling, general and administrative expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

Stock Options

The following summarizes the Company’s stock option plan and the activity for the nine months ended September 30, 2024.

    

Shares

    

Weighted-Average
Exercise Price

    

Weighted-Average
Remaining Contractual
Term (Years)

Outstanding, December 31, 2023

5,943,898

$

10.28

6.53

Granted

Exercised or released

(553,000)

5.84

Forfeited or expired

(512,181)

13.16

Outstanding, September 30, 2024

4,878,717

$

10.48

5.72

Exercisable, September 30, 2024

4,110,563

$

9.41

5.42

Vested and expected to vest at September 30, 2024

4,875,485

$

10.47

5.72

During the three months ended September 30, 2024 and 2023, the Company recognized $546 and $1,724, respectively, of compensation expense related to stock options. During the nine months ended September 30, 2024 and 2023, the Company recognized $1,585 and $5,320, respectively of compensation expense related to stock options. Stock-based compensation expenses are recorded in Selling, general and administrative expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

Restricted Stock Units

The following table summarizes the Company’s restricted stock units activity for the nine months ended September 30, 2024:

    

Restricted
Stock Units

    

Weighted-Average
Fair Value

Outstanding, December 31, 2023

1,317,402

$

17.06

Granted

1,831,985

11.55

Vested

(190,210)

17.80

Forfeited or expired

(320,944)

15.02

Outstanding, September 30, 2024

2,638,233

$

13.43

Vested and expected to vest at September 30, 2024

2,565,347

$

13.43

During the three months ended September 30, 2024 and 2023, the Company recognized $2,482 and $1,788, respectively of compensation expense related to Restricted Stock Units (“RSUs”). During the nine months ended September 30, 2024 and 2023, the Company recognized $7,119 and $4,974, respectively of compensation expense related to RSUs. Stock-based compensation expenses are recorded in Selling, general and administrative expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

Performance Share Units

On March 8, 2024, the Company granted 241,881 performance share units (“PSUs”) with a weighted-average fair value of $11.69 to certain executives, of which 21,638 were forfeited with a weighted-average fair value of $11.00 during the six months ended June 30, 2024. The grant date fair value of PSUs granted to the Chief Executive Officer was calculated using a Monte Carlo simulation and was based on assumptions, including expected volatility of 59.7%, expected dividends of 0%, and a 4.21% risk-free rate. Other granted PSUs’ fair value were based on the Company’s share price on the date of grant, or $11.00 per share. The PSUs will vest based on the Company’s achievement level relative to Adjusted

Free Cash Flow (“aFCF”) for the trailing twelve months ending December 31, 2026, or the consummation of a change in control if earlier (“Performance Period”). aFCF is defined as Total Operating Cash Flow plus Investing Cash Flow adjusted for certain nonrecurring items. Upon achievement of the minimum threshold performance metric, the executive may earn a pro rata portion of their respective target shares and up to 200% of their target shares upon maximum achievement. The Chief Executive Officer was granted 166,924 of the 241,881 PSUs which may be further increased or decreased by up to 25%, based on the achievement of Relative Total Stockholder Return, as defined as the stockholder return of the Company relative to certain of its peer companies within the Healthcare Equipment Select Industry Index. The PSUs additionally require the executive to provide service over the performance period. Termination of service prior to completion of the Performance Period, except by reason of death or disability, will result in automatic forfeiture of the performance share units. If the executive’s termination of service occurs by reason of death or disability on or after January 1, 2025, a pro-rata number of the PSUs shall vest at the level based on actual performance through the end of the Performance Period, multiplied by a fraction equal to (x) the number of days elapsed between the beginning of the Performance Period and the date of executive’s termination of service, divided by (y) the total number of days in the Performance Period.

On August 7, 2024, the Company granted 124,835 PSUs with a weighted-average fair value of $8.45 to the Company’s Chief Financial Officer (“CFO”) and EVP of Supply Chain Operations. The grant date fair value of PSUs granted to the CFO and EVP of Supply Chain Operations was calculated using a Monte Carlo simulation and was based on assumptions, including expected volatility of 60.8%, expected dividends of 0%, and a 3.88% risk-free rate. The PSUs will vest based on the Company’s achievement level relative to Adjusted Free Cash Flow for the trailing twelve months ending December 31, 2026, or the consummation of a change in control if earlier.

Stock-based compensation expense is recognized on a straight-line basis over the vesting period, beginning at the point in time that the performance condition is considered probable of achievement. The probability of achieving the performance condition is assessed at each reporting period. If it is deemed probable that the performance condition will be met, compensation cost will be recognized based on the grant date fair value of the award expected to be earned. If it is deemed that it is not probable that the performance condition will be met, the Company will discontinue the recognition of compensation cost and any compensation cost previously recorded will be reversed. At September 30, 2024, achievement of the performance condition for the performance share units was deemed probable with 330,469 PSUs expected to vest, and the expense recorded for the three and nine months ended September 30, 2024, was $397 and $833, respectively. Stock-based compensation expenses are recorded in Selling, general and administrative expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss.

v3.24.3
Income Taxes
9 Months Ended
Sep. 30, 2024
Income Tax Disclosure [Abstract]  
Income Taxes

NOTE 9. INCOME TAXES

The effective tax rates for the nine months ended September 30, 2024 and 2023 are as follows:

Nine Months Ended September 30, 

    

2024

    

2023

Effective tax rate

(1.400)

%  

(0.256)

%

For the three months ended September 30, 2024 and 2023, the Company recorded tax expense of $205 and benefit of $108, respectively. For the nine months ended September 30, 2024 and 2023, the Company recorded tax expense of $601 and $90, respectively.

The Company’s fiscal year 2024 and 2023 income tax expense and rates differed from the amount of income tax determined by applying the U.S. Federal income tax rate to pre-tax income primarily due to the U.S., Finland, Germany and Italy jurisdictions that have a full valuation allowance recorded on deferred tax assets. In addition, the tax rate is lower than the U.S. statutory federal tax rate as a result of foreign earnings that are taxed at lower tax rates.

The Company continues to monitor the realization of its deferred tax assets and assesses the need for a valuation allowance. The Company analyzes available positive and negative evidence to determine if a valuation allowance is needed based on the weight of the evidence. This objectively verifiable evidence includes the current and prior two years’ profit

and loss positions after considering pre-tax book income plus or minus permanent adjustments as well as other positive and negative evidence available. This process requires management to make estimates, assumptions, and judgments that are uncertain in nature. The Company has established a valuation allowance with respect to deferred tax assets in the U.S., Finland, Germany, and Italy and continues to monitor and assess potential valuation allowances in all its jurisdictions.

v3.24.3
Commitments And Contingencies
9 Months Ended
Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

NOTE 10. COMMITMENTS AND CONTINGENCIES

Legal Proceedings

The Company is involved in various lawsuits, claims, inquiries, and other regulatory and compliance matters, most of which are routine to the nature of our business. When it is probable that a loss will be incurred and where a range of the loss can be reasonably estimated, the best estimate within the range is accrued. When the best estimate within the range cannot be determined, the low end of the range is accrued. The ultimate resolution of these claims could affect future results of operations should the exposure be materially different from the estimates or should liabilities be incurred that were not previously accrued. Potential insurance reimbursements are not offset against potential liabilities.

Class Action Litigation

On September 30, 2024, and October 18, 2024, respectively, two putative class action complaints were filed in the U.S. District Court for the District of Colorado.  These complaints allege that the Company and certain current and former officers violated federal securities laws.  The cases are captioned Ellington v. Paragon 28, Inc., et al., and Tiedt v. Paragon 28, Inc., et al.  We believe the allegations in the complaint are without merit and intend to vigorously defend the litigation.

Given the early stage of the litigation matters described above, we are unable at this time to reasonably estimate possible losses or form a judgment that an unfavorable outcome is either probable or remote. However, litigation is subject to inherent uncertainties, and one or more unfavorable outcomes in any claim or litigation against us could have a material adverse effect for the period in which they are resolved, and on our business generally. In addition, regardless of their merits or their ultimate outcomes, lawsuits and legal proceedings are costly, divert management attention, and may adversely affect our reputation, even if they are resolved in our favor.

v3.24.3
Related Party Transactions
9 Months Ended
Sep. 30, 2024
Related Party Transactions [Abstract]  
Related Party Transactions

NOTE 11. RELATED PARTY TRANSACTIONS

The Company has a license agreement dated July 1, 2017 for certain intellectual property with an entity that is affiliated with one of the directors of the Company, under which the Company pays a royalty of four percent (4%) of net revenue related to the licensed intellectual property for the 15 years following the date of first sale, including a minimum annual payment of $250. The term of the agreement is 20 years and it automatically renews for five-year periods thereafter. Payments to the entity under this license agreement totaled $50 and $32 for the three months ended September 30, 2024 and 2023, respectively. Payments to the entity under this license agreement totaled $249 and $233 for the nine months ended September 30, 2024 and 2023, respectively. Amounts payable to this entity as of September 30, 2024 and December 31, 2023 were $82 and $155, respectively.

The Company paid professional services fees to a related party totaling $9 and $123 for the three months ended September 30, 2024 and 2023, respectively, and $27 and $238 for the nine months ended September 30, 2024 and 2023, respectively, and are included in Selling, general, and administrative expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Amounts payable as of September 30, 2024 and December 31, 2023 to this related party were $0 and $16, respectively.

v3.24.3
Segment and Geographic Information
9 Months Ended
Sep. 30, 2024
Segment Reporting [Abstract]  
Segment and Geographic Information

NOTE 12. SEGMENT AND GEOGRAPHIC INFORMATION

Operating segments are defined as components of an enterprise for which separate financial information is available and evaluated regularly by the chief operating decision maker, which is our Chief Executive Officer, in deciding how to allocate resources and in assessing performance. We manage our business globally within one operating segment in accordance with ASC Topic 280, Segment Reporting. Segment information is consistent with how management reviews the business, makes investing and resource allocation decisions and assesses operating performance.

The following table represents total net revenue by geographic area, based on the location of the customer for the three and nine months ended September 30, 2024 and 2023, respectively.

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

    

2023

    

2024

    

2023

United States

$

51,160

$

44,548

$

151,913

$

131,793

International

11,176

8,235

32,521

24,035

Total net revenue

$

62,336

$

52,783

$

184,434

$

155,828

No individual country with net revenue originating outside of the United States accounted for more than 10% of consolidated net revenue for the three and nine months ended September 30, 2024 and 2023.

The following table represents total non-current assets, excluding deferred taxes, by geographic area as of September 30, 2024 and December 31, 2023, respectively.

    

September 30, 2024

    

December 31, 2023

United States

$

88,902

$

89,531

Finland

24,890

25,032

Other International

9,892

9,616

Total assets

$

123,684

$

124,179

v3.24.3
Employee Benefit Plan
9 Months Ended
Sep. 30, 2024
Employee Benefit Plan  
Employee Benefit Plan

NOTE 13. EMPLOYEE BENEFIT PLAN

The Company sponsors a defined contribution plan for eligible employees who are 21 years of age with three months of service. Eligible employees can voluntarily contribute up to 100% of their eligible compensation. The Company has elected a safe harbor plan in which the Company must contribute 3% of eligible compensation. In addition, the Company may make discretionary contributions which are determined and authorized by the Board of Directors each plan year. The Company made contributions to its employee benefit plan of $356 and $315 and $1,054 and $904 for three and nine months ended September 30, 2024 and 2023, respectively.

v3.24.3
Pay vs Performance Disclosure - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Pay vs Performance Disclosure        
Net Income (Loss) $ (12,338) $ (11,151) $ (43,519) $ (35,211)
v3.24.3
Insider Trading Arrangements
3 Months Ended
Sep. 30, 2024
Trading Arrangements, by Individual  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.24.3
Summary of Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Basis of Presentation and Consolidation

Basis of Presentation and Consolidation

The accompanying Condensed Consolidated Financial Statements include the accounts of Paragon 28, Inc. and its subsidiaries, all of which are wholly-owned. The accompanying Condensed Consolidated Financial Statements have been prepared in conformity with accounting principles generally accepted in the U.S. (“U.S. GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information required by U.S. GAAP for complete financial statements. The interim Condensed Consolidated Financial Statements reflect all adjustments that are of a normal recurring nature and that are considered necessary for a fair representation of the results for the periods presented and should be read in conjunction with the audited Consolidated Financial Statements and notes thereto for the year ended December 31, 2023, which include a complete set of footnote disclosures, including our significant accounting policies. The audited Consolidated Financial Statements and notes thereto for the year ended December 31, 2023, are included in the Amended 2023 Annual Report. The results for interim periods are not necessarily indicative of the results that may be expected for a full fiscal year or for any other future period. All intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates

Use of Estimates

The preparation of the financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Because future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. Any changes in these estimates will be reflected in the Company’s Condensed Consolidated Financial Statements. Significant items subject to such estimates and assumptions include the determination of the credit loss reserves for trade receivables, inventory obsolescence, impairment of long-lived assets, recoverability of goodwill and intangible assets, contingent earnout liabilities, interest rate swap valuation, income taxes and stock-based compensation. On January 1, 2024, the Company revised the inputs used in estimating the reserve on obsolete and slow-moving inventory to include forecasted sales, in addition to current inventory levels and historical sales. The effect of this change in estimate was a decrease of $248 to the Company’s reserve for obsolete and slow-moving inventory during the nine months ended September 30, 2024.

Foreign Currency Translation

Foreign Currency Translation

The Condensed Consolidated Financial Statements are presented in U.S. dollars. The Company’s non-U.S. subsidiaries have a functional currency (i.e., the currency in which operational activities are primarily conducted) that is other than the U.S. dollar, generally the currency of the country in which such subsidiaries are domiciled. Such subsidiaries’ assets and liabilities are translated into U.S. dollars at quarter-end exchange rates, while revenue and expenses are translated at average exchange rates during the quarter based on the daily closing exchange rates. Adjustments that result from translating amounts from a subsidiary’s functional currency to U.S. dollars are reported in Accumulated other comprehensive income (loss), a separate component of stockholders’ equity.

Transactions made in a currency other than the functional currency are remeasured to the functional currency at the exchange rates on the dates of the transactions. Foreign exchange gains and losses are recorded within Other income (expense), net on the consolidated statements of operations and comprehensive loss.

Significant Accounting Policies

Significant Accounting Policies

There have been no changes in the Company’s significant accounting policies as disclosed in Note 2 to our audited Consolidated Financial Statements included in our Amended 2023 Annual Report on Form 10-K/A.

Recently Issued Accounting Pronouncements

Recently Issued Accounting Pronouncements

In October 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. The amendments in ASU 2023-06 modify the disclosure or presentation requirements of a variety of Topics in the Codification. Certain of the amendments represent clarifications to or technical corrections of the current requirements. ASU 2023-06 is applicable to all entities subject to the SEC’s existing disclosure requirements. The effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. The Company is currently evaluating the amendments in ASU 2023-06 and does not expect the adoption to have a significant impact on the Company’s Consolidated Financial Statements and related disclosures.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ("ASU 2023-07"), which provides amendments to improve reportable segment disclosures requirements. The amendments in ASU 2023-07 are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the amendments to determine the impact it will have on the Company’s Consolidated Financial Statements and related disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), to enhance the transparency and decision usefulness of income tax disclosures. The main provisions in ASU 2023-09 enhance the disclosure requirements of rate reconciliations and income taxes paid. For public business entities, the amendments in ASU 2023-09 are effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The amendments in this update should be applied on a prospective basis, retrospective application is permitted. The Company is currently evaluating the amendments in this guidance to determine the impact it will have on the Company’s Consolidated Financial Statements and related disclosures.  

v3.24.3
Intangible Assets (Tables)
9 Months Ended
Sep. 30, 2024
Goodwill and Intangible Assets Disclosure [Abstract]  
Intangible Assets

Intangible assets as of September 30, 2024, were as follows:

    

Gross
Carrying
Amount

    

Accumulated
Amortization

    

Net Carrying
Amount

Trademarks and tradenames, indefinite-lived

$

607

$

$

607

Patents, trademarks and tradenames, definite-lived

9,159

3,095

6,064

Customer relationships

1,733

758

975

Developed technology

17,690

4,399

13,291

Other intangibles

30

30

Total intangible assets, net

$

29,219

$

8,282

$

20,937

Intangible assets as of December 31, 2023, were as follows:

    

Gross
Carrying
Amount

    

Accumulated
Amortization

    

Net Carrying
Amount

Trademarks and tradenames, indefinite-lived

$

987

$

$

987

Patents, definite-lived

7,900

2,649

5,251

Customer relationships

1,733

567

1,166

Developed technology

17,690

3,424

14,266

Other intangibles

30

26

4

Total intangible assets, net

$

28,340

$

6,666

$

21,674

Schedule of expected future amortization expense

2024 (Remaining)

    

$

515

2025

2,055

2026

2,055

2027

1,975

2028

1,975

Thereafter

11,755

Total future amortization expense

$

20,330

v3.24.3
Fair Value of Financial Instruments (Tables)
9 Months Ended
Sep. 30, 2024
Fair Value Disclosures [Abstract]  
Summary of Significant Financial Assets and Liabilities Measured at Fair Value

The Company’s significant financial assets and liabilities measured at fair value as of September 30, 2024, were as follows:

    

Level 1

    

Level 2

    

Level 3

    

Total

Financial Assets:

Interest rate swap

$

917

$

917

The Company's significant financial assets and liabilities measured at fair value as of December 31, 2023, were as follows:

    

Level 1

    

Level 2

    

Level 3

    

Total

Financial Assets:

Interest rate swap

$

991

$

991

Financial Liabilities:

Contingent consideration

$

340

$

340

v3.24.3
Debt (Tables)
9 Months Ended
Sep. 30, 2024
Debt Disclosure [Abstract]  
Schedule of Long-term Debt Instruments

    

September 30, 2024

    

December 31, 2023

Ares Revolving Loan

$

25,000

$

25,000

Ares Term Loan

75,000

75,000

Zions Term Loan

14,453

14,933

114,453

114,933

Less: deferred issuance costs

(3,834)

(4,494)

Total debt, net of issuance costs

110,619

110,439

Less: current portion

(640)

(640)

Long-term debt, net, less current maturities

$

109,979

$

109,799

v3.24.3
Loss Per Share (Tables)
9 Months Ended
Sep. 30, 2024
Earnings Per Share [Abstract]  
Summary of Computation of Net Loss Per Share

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

    

2023

    

2024

    

2023

Net loss

$

(12,338)

$

(11,151)

$

(43,519)

$

(35,211)

Weighted-average common stock outstanding:

Basic

83,560,337

82,548,892

83,178,600

81,878,814

Diluted

83,560,337

82,548,892

83,178,600

81,878,814

Loss per share:

Basic

$

(0.15)

$

(0.14)

$

(0.52)

$

(0.43)

Diluted

$

(0.15)

$

(0.14)

$

(0.52)

$

(0.43)

Summary of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share Attributable to Common Stockholders

As of September 30, 

    

2024

    

2023

Stock options

4,878,717

6,119,477

Restricted stock units

2,983,311

1,392,087

v3.24.3
Stock-Based Compensation (Tables)
9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Summary of Stock Option Activity

    

Shares

    

Weighted-Average
Exercise Price

    

Weighted-Average
Remaining Contractual
Term (Years)

Outstanding, December 31, 2023

5,943,898

$

10.28

6.53

Granted

Exercised or released

(553,000)

5.84

Forfeited or expired

(512,181)

13.16

Outstanding, September 30, 2024

4,878,717

$

10.48

5.72

Exercisable, September 30, 2024

4,110,563

$

9.41

5.42

Vested and expected to vest at September 30, 2024

4,875,485

$

10.47

5.72

Summary of Restricted Stock Units Activity

    

Restricted
Stock Units

    

Weighted-Average
Fair Value

Outstanding, December 31, 2023

1,317,402

$

17.06

Granted

1,831,985

11.55

Vested

(190,210)

17.80

Forfeited or expired

(320,944)

15.02

Outstanding, September 30, 2024

2,638,233

$

13.43

Vested and expected to vest at September 30, 2024

2,565,347

$

13.43

v3.24.3
Income Taxes (Tables)
9 Months Ended
Sep. 30, 2024
Income Tax Disclosure [Abstract]  
Schedule of Reconciliation of Provision for Income Taxes at Federal Statutory Rate

Nine Months Ended September 30, 

    

2024

    

2023

Effective tax rate

(1.400)

%  

(0.256)

%

v3.24.3
Segment and Geographic Information (Tables)
9 Months Ended
Sep. 30, 2024
Segment Reporting [Abstract]  
Schedule of Total Net Revenue by Geographic Area

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2024

    

2023

    

2024

    

2023

United States

$

51,160

$

44,548

$

151,913

$

131,793

International

11,176

8,235

32,521

24,035

Total net revenue

$

62,336

$

52,783

$

184,434

$

155,828

Schedule of Total Non-current Assets, Excluding Deferred Taxes, by Geographic Area

    

September 30, 2024

    

December 31, 2023

United States

$

88,902

$

89,531

Finland

24,890

25,032

Other International

9,892

9,616

Total assets

$

123,684

$

124,179

v3.24.3
Summary of Significant Accounting Policies - Additional Information (Details)
$ in Thousands
9 Months Ended
Sep. 30, 2024
USD ($)
Accounting Policies [Abstract]  
Decrease in inventory reserve $ 248
v3.24.3
Intangible Assets - Intangible Assets (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Indefinite Lived Intangible Assets By Major Class [Line Items]    
Gross Carrying Amount $ 29,219 $ 28,340
Accumulated Amortization 8,282 6,666
Net Carrying Amount, definite-lived 20,330  
Net Carrying Amount 20,937 21,674
Trademarks and tradenames, indefinite-lived    
Indefinite Lived Intangible Assets By Major Class [Line Items]    
Indefinite-Lived Intangible Assets (Excluding Goodwill) 607 987
Patents, trademarks and tradenames, definite-lived    
Indefinite Lived Intangible Assets By Major Class [Line Items]    
Gross Carrying Amount, definite-lived 9,159  
Accumulated Amortization 3,095  
Net Carrying Amount, definite-lived 6,064  
Patents, definite-lived    
Indefinite Lived Intangible Assets By Major Class [Line Items]    
Gross Carrying Amount, definite-lived   7,900
Accumulated Amortization   2,649
Net Carrying Amount, definite-lived   5,251
Customer relationships    
Indefinite Lived Intangible Assets By Major Class [Line Items]    
Gross Carrying Amount, definite-lived 1,733 1,733
Accumulated Amortization 758 567
Net Carrying Amount, definite-lived 975 1,166
Developed technology    
Indefinite Lived Intangible Assets By Major Class [Line Items]    
Gross Carrying Amount, definite-lived 17,690 17,690
Accumulated Amortization 4,399 3,424
Net Carrying Amount, definite-lived 13,291 14,266
Other intangibles    
Indefinite Lived Intangible Assets By Major Class [Line Items]    
Gross Carrying Amount, definite-lived 30 30
Accumulated Amortization $ 30 26
Net Carrying Amount, definite-lived   $ 4
v3.24.3
Intangible Assets - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Finite-Lived Intangible Assets [Line Items]        
Impairment charges related to intangible assets $ 0 $ 0 $ 0 $ 0
Selling, General, and Administrative Expenses        
Finite-Lived Intangible Assets [Line Items]        
Amortization expense $ 479 $ 509 $ 1,617 $ 1,519
v3.24.3
Intangible Assets - Schedule of Expected Future Amortization Expense (Details)
$ in Thousands
Sep. 30, 2024
USD ($)
Goodwill and Intangible Assets Disclosure [Abstract]  
2024 (Remaining) $ 515
2025 2,055
2026 2,055
2027 1,975
2028 1,975
Thereafter 11,755
Net Carrying Amount, definite-lived $ 20,330
v3.24.3
Fair Value of Financial Instruments - Summary of Significant Financial Assets and Liabilities Measured at Fair Value (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Financial Assets:    
Interest rate swap $ 917 $ 991
Financial Liabilities:    
Contingent consideration   340
Level 2    
Financial Assets:    
Interest rate swap $ 917 991
Level 3    
Financial Liabilities:    
Contingent consideration   $ 340
v3.24.3
Fair Value of Financial Instruments - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Jun. 30, 2024
Mar. 31, 2024
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]            
Change in fair value of interest rate swap       $ 267 $ 57  
Derivative, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] Other Nonoperating Income (Expense)     Other Nonoperating Income (Expense)    
Payments on earnout liability in cash       $ 2,000 $ 5,500  
Additive Orthopaedics, LLC            
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]            
Payments on earnout liability in cash     $ 1,000      
Disior LTD.            
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]            
Payments on earnout liability in cash   $ 1,000        
Accrued Expenses | Additive Orthopaedics, LLC            
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]            
Achieved milestones reclassified to accrued expenses           $ 2,000
Level 2            
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]            
Change in fair value of interest rate swap $ 674     (74)    
Level 3            
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]            
Non-cash income       $ 340    
v3.24.3
Debt - Schedule of Long-term Debt Instruments (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Debt Instrument [Line Items]    
Debt, gross amount $ 114,453 $ 114,933
Less: deferred issuance costs (3,834) (4,494)
Total debt, net of issuance costs 110,619 110,439
Less: current portion (640) (640)
Long-term debt net, less current maturities 109,979 109,799
Ares Revolving Loan    
Debt Instrument [Line Items]    
Debt, gross amount 25,000 25,000
Ares Term Loan    
Debt Instrument [Line Items]    
Debt, gross amount 75,000 75,000
Zions Term Loan    
Debt Instrument [Line Items]    
Debt, gross amount $ 14,453 $ 14,933
v3.24.3
Debt - Ares Credit Agreement - Additional Information (Details) - Ares Credit Agreements - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Nov. 02, 2023
Sep. 30, 2024
Sep. 30, 2024
Sep. 30, 2023
Debt Instrument [Line Items]        
Expiration date Nov. 02, 2028      
Indebtedness principal or stated amount $ 12,500      
Debt issuance cost before amortization   $ 3,627 $ 3,627 $ 0
Interest Expense        
Debt Instrument [Line Items]        
Amortization expense   $ 222 $ 648  
Ares Term Loan        
Debt Instrument [Line Items]        
Total borrowing capacity 100,000      
Drew down value $ 75,000      
Variable interest rate 6.75%      
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration] us-gaap:SecuredOvernightFinancingRateSofrOvernightIndexSwapRateMember      
Ares Revolving Loan        
Debt Instrument [Line Items]        
Total borrowing capacity $ 50,000      
Drew down value $ 25,000      
Variable interest rate 4.00%      
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration] us-gaap:SecuredOvernightFinancingRateSofrOvernightIndexSwapRateMember      
Revolving Loan | Secured Debt        
Debt Instrument [Line Items]        
Total borrowing capacity $ 150,000      
v3.24.3
Debt - Vectra Bank Colorado Loan Agreements - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Nov. 10, 2022
Mar. 24, 2022
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Line Of Credit Facility [Line Items]              
Total debt issuance costs     $ 3,834   $ 3,834   $ 4,494
Secured Term Loan Facility              
Line Of Credit Facility [Line Items]              
Principal amount   $ 16,000          
Variable interest rate   1.75%          
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration]   us-gaap:SecuredOvernightFinancingRateSofrOvernightIndexSwapRateMember          
Maturity date   Mar. 24, 2037          
Debt, frequency of payment   monthly          
Threshold amount of operating cash flow to calculate liquidity ratio $ 0            
Threshold Amount of Operating Cash Flow to Calculate Fixed Charge Coverage Ratio $ 0            
Amortization of debt issuance costs     4 $ 4 12 $ 12  
Zions Facility              
Line Of Credit Facility [Line Items]              
Total debt issuance costs     $ 207   $ 207    
v3.24.3
Stockholders' Equity - Additional Information (Details) - USD ($)
$ / shares in Units, $ in Thousands
9 Months Ended
Jan. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Oct. 08, 2021
Class of Stock [Line Items]          
Number of shares of common stock reserved for issuance         310,000,000
Common stock share authorized   300,000,000   300,000,000 300,000,000
Common stock par value   $ 0.01   $ 0.01 $ 0.01
Convertible preferred stock, authorized         10,000,000
Convertible preferred stock, par value         $ 0.01
Net proceeds after deducting underwriting discounts and commissions $ 68,453   $ 68,453    
Treasury stock repurchase shares   0 0    
Common Stock          
Class of Stock [Line Items]          
Number of aggregate issued 6,500,000   4,312,500    
Price per share $ 17.00        
Shares sold by Company | Common Stock          
Class of Stock [Line Items]          
Number of shares issued and sold 3,750,000        
Selling securityholders          
Class of Stock [Line Items]          
Net proceeds after deducting underwriting discounts and commissions $ 50,700        
Selling securityholders | Common Stock          
Class of Stock [Line Items]          
Number of shares issued and sold 2,750,000        
Underwriters Option to Purchase Additional Shares | Maximum          
Class of Stock [Line Items]          
Number of shares issued and sold 562,500        
Underwriters Option to Purchase Additional Shares | Common Stock          
Class of Stock [Line Items]          
Number of shares issued and sold 412,500        
v3.24.3
Loss Per Share - Summary of Computation of Net Loss Per Share (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Net loss attributable to common stockholders        
Net Loss $ (12,338) $ (11,151) $ (43,519) $ (35,211)
Weighted-average common stock outstanding:        
Basic (in shares) 83,560,337 82,548,892 83,178,600 81,878,814
Diluted (in shares) 83,560,337 82,548,892 83,178,600 81,878,814
Loss per share, Basic:        
Basic (in dollars per share) $ (0.15) $ (0.14) $ (0.52) $ (0.43)
Loss per share, Diluted:        
Diluted (in dollars per share) $ (0.15) $ (0.14) $ (0.52) $ (0.43)
v3.24.3
Loss Per Share - Summary of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - shares
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Employee Stock Option    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Potentially dilutive securities excluded from computation of dilutive net loss per share 4,878,717 6,119,477
Restricted stock units    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Potentially dilutive securities excluded from computation of dilutive net loss per share 2,983,311 1,392,087
v3.24.3
Stock-Based Compensation - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Employee contribution percentage     100.00%  
Employee Stock Option        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Compensation expense $ 546 $ 1,724 $ 1,585 $ 5,320
Restricted stock units        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Compensation expense $ 2,482 $ 1,788 $ 7,119 $ 4,974
Employee Stock Purchase Plan        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Shares issued 69,319 37,146 69,319 37,146
Compensation expense $ 84 $ 86 $ 252 $ 268
Employee contribution percentage     15.00%  
Market price of shares authorized percentage 85.00%   85.00%  
Maximum purchase value of shares available for each employee     $ 25  
v3.24.3
Stock-Based Compensation - Summary of Stock Option Activity (Details)
9 Months Ended 12 Months Ended
Sep. 30, 2024
$ / shares
shares
Dec. 31, 2023
$ / shares
shares
Share-Based Payment Arrangement [Abstract]    
Shares, Outstanding, Beginning Balance | shares 5,943,898  
Shares, Exercised or Released | shares (553,000)  
Shares, Forfeited or Expired | shares (512,181)  
Shares Outstanding, Ending Balance | shares 4,878,717 5,943,898
Shares, Exercisable | shares 4,110,563  
Shares, Vested and Expected To Vest | shares 4,875,485  
Weighted-Average Exercise Price, Beginning Balance | $ / shares $ 10.28  
Weighted-Average Exercise Price, Exercised or Released | $ / shares 5.84  
Weighted-Average Exercise Price, Forfeited or Expired | $ / shares 13.16  
Weighted-Average Exercise Price, Ending Balance | $ / shares 10.48 $ 10.28
Weighted-Average Exercise Price, Exercisable | $ / shares 9.41  
Weighted-Average Exercise Price, Vested and Expected To Vest | $ / shares $ 10.47  
Weighted-Average Remaining Contractual Term (Years) 5 years 8 months 19 days 6 years 6 months 10 days
Weighted-Average Remaining Contractual Term (Years), Exercisable 5 years 5 months 1 day  
Weighted-Average Remaining Contractual Term (Years), Vested and expected to vest 5 years 8 months 19 days  
v3.24.3
Stock-Based Compensation - Schedule of RSU Activity (Details) - Restricted stock units
9 Months Ended
Sep. 30, 2024
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Outstanding, Beginning balance | shares 1,317,402
Number of shares granted | shares 1,831,985
Vested | shares (190,210)
Forfeited or expired | shares (320,944)
Outstanding, Ending balance | shares 2,638,233
Vested and expected to vest | shares 2,565,347
Weighted Average Fair Value, Beginning balance | $ / shares $ 17.06
Weighted Average Fair Value, Granted | $ / shares 11.55
Weighted Average Fair Value, Vested | $ / shares 17.80
Weighted Average Fair Value, Forfeited or expired | $ / shares 15.02
Weighted Average Fair Value, Ending balance | $ / shares 13.43
Weighted Average Fair Value, Vested and expected to vest | $ / shares $ 13.43
v3.24.3
Stock-Based Compensation - Performance Share Units (Details) - Performance Share Units - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 6 Months Ended 9 Months Ended
Aug. 07, 2024
Mar. 08, 2024
Sep. 30, 2024
Jun. 30, 2024
Sep. 30, 2024
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]          
Granted 124,835 241,881      
Weighted Average Fair Value, Granted $ 8.45 $ 11.69      
Forfeited or expired       21,638  
Weighted Average Fair Value, Forfeited or expired       $ 11.00  
Expected volatility 60.80% 59.70%      
Expected dividends 0.00% 0.00%      
Risk-free rate 3.88% 4.21%      
Share price   $ 11.00      
Maximum percentage of increase decrease on additional shares issuable   25      
Share-Based Payment Arrangement, Grantee Status [Extensible Enumeration]   us-gaap:ShareBasedPaymentArrangementEmployeeMember      
Units expected to vest     330,469   330,469
Compensation expense     $ 397   $ 833
Chief Executive Officer          
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]          
Granted   166,924      
Share-Based Payment Arrangement, Grantee Status [Extensible Enumeration]   us-gaap:ShareBasedPaymentArrangementEmployeeMember      
Maximum          
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]          
Percentage Of Targeted Shares   200.00%      
v3.24.3
Income Taxes - Schedule of Effective Tax Rates (Details)
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Income Tax Disclosure [Abstract]    
Effective tax rate (1.40%) (0.256%)
v3.24.3
Income Taxes - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Income Tax Disclosure [Abstract]        
Income tax expense (benefit) $ 205 $ (108) $ 601 $ 90
v3.24.3
Related Party Transactions - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Related Party Transaction [Line Items]          
Payments to related party $ 16,159 $ 11,922 $ 45,262 $ 33,750  
Other current liabilities 1,336   1,336   $ 883
Selling, general and administrative expenses from transactions with related party $ 48,967 44,126 $ 153,188 131,773  
Director | License Agreement          
Related Party Transaction [Line Items]          
Percentage of revenue paid as royalty     4.00%    
Royalty estimated useful life 15 years   15 years    
Related party transaction term of agreement     20 years    
Related party transaction, agreement renewal term     5 years    
Director | Related Party [Member] | License Agreement          
Related Party Transaction [Line Items]          
Due to related parties $ 0   $ 0   16
Payments to related party 50 32 249 233  
Other current liabilities 82   82   $ 155
Selling, general and administrative expenses from transactions with related party 9 $ 123 27 $ 238  
Annual Payment Threshold | Minimum | Director | Related Party [Member] | License Agreement          
Related Party Transaction [Line Items]          
Due to related parties $ 250   $ 250    
v3.24.3
Segment and Geographic Information - Schedule of Total Net Revenue by Geographic Area (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Segment Reporting Information [Line Items]        
Total net revenue $ 62,336 $ 52,783 $ 184,434 $ 155,828
United States        
Segment Reporting Information [Line Items]        
Total net revenue 51,160 44,548 151,913 131,793
International        
Segment Reporting Information [Line Items]        
Total net revenue $ 11,176 $ 8,235 $ 32,521 $ 24,035
v3.24.3
Segment and Geographic Information - Additional Information (Details)
3 Months Ended 9 Months Ended
Sep. 30, 2024
country
Sep. 30, 2023
country
Sep. 30, 2024
country
segment
Sep. 30, 2023
country
Segment Reporting Information [Line Items]        
Number of operating segments | segment     1  
International        
Segment Reporting Information [Line Items]        
Number of countries accounted more than ten percent of net revenue | country 0 0 0 0
v3.24.3
Segment and Geographic Information - Schedule of Total Non-current Assets, Excluding Deferred Taxes, by Geographic Area (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Segment Reporting Information [Line Items]    
Total assets $ 123,684 $ 124,179
United States    
Segment Reporting Information [Line Items]    
Total assets 88,902 89,531
Finland    
Segment Reporting Information [Line Items]    
Total assets 24,890 25,032
Other International    
Segment Reporting Information [Line Items]    
Total assets $ 9,892 $ 9,616
v3.24.3
Employee Benefit Plan - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Employee Benefit Plan        
Defined contribution plan, maximum percentage of eligible compensation for voluntary contribution     100.00%  
Defined Contribution Plan, Plan Name [Extensible Enumeration]     fna:SafeHaborPlanMember  
Defined contribution plan minimum annual contributions per employee percent     3.00%  
Defined benefit plan, plan assets, contributions by employer $ 356 $ 315 $ 1,054 $ 904

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