UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

 

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

 

For the quarterly period ended September 30, 2017March 31, 2024

 

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

 

For the transition period fromto

 

Commission File Number 000-21326001-14027

 

Anika Therapeutics, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Massachusetts

Delaware

04-3145961

(State or Other Jurisdiction of Incorporation or Organization)

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

Incorporation or Organization)
32 Wiggins Avenue, Bedford, Massachusetts01730
(Address of Principal Executive Offices)(Zip Code)

32 Wiggins Avenue, Bedford, Massachusetts 01730

(Address of Principal Executive Offices) (Zip Code)

 

(781) 457-9000

(Registrant’s Telephone Number, Including Area Code)

 

N/A

(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

Name of Each Exchange on Which Registered

Common Stock, par value $0.01 per share

ANIK

NASDAQ Global Select Market

 

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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 ☐

(Do not check if a smaller

reporting company)

Smaller reporting

Emerging growth

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 ☒

 

APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PRECEDING FIVE YEARS:

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☐ No ☐

APPLICABLE ONLY TO CORPORATE ISSUERS:

 

As of October 17, 2017April 30, 2024, there were 14,661,76914,828,456 outstanding shares of Common Stock, par value $0.01 per share.

 

 

ANIKA THERAPEUTICS, INC.

TABLE OF CONTENTS

 

Page

Part I

Financial Information

3

Item 1.

Condensed Consolidated Financial Statements (unaudited):

3

 

Condensed Consolidated Balance Sheets as of September 30, 2017March 31, 2024 and December 31, 20162023

3

 

Condensed Consolidated StatementsStatement of Operations and Comprehensive Income for the three and nine months ended September 30, 2017March 31, 2024 and 20162023

4

 

Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2024 and 2023

5

Condensed Consolidated Statements of Cash Flows for the ninethree months ended September 30, 2017March 31, 2024 and 20162023

56

 

Notes to Condensed Consolidated Financial Statements

67

Item 2.

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

1416

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

25

Item 4.

Controls and Procedures

25

Part II

Other Information

25

Item 1.

Legal Proceedings

25

Item 1A.

Risk Factors

25

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

26

Item 3.

Defaults Upon Senior Securities

1926

Item 4.

Mine Safety Disclosures

Controls and Procedures1926

Part IIItem 5.

Other Information

Other Information
Item 1.Legal Proceedings2026

Item 1A.6.

Risk FactorsExhibits

2027

Item 6.Signatures

Exhibits

2128

Signatures22

 

References in this Quarterly Report on Form 10-Q to “we,” “us,” “our,” “our company,” and other similar references refer to Anika Therapeutics, Inc. and its subsidiaries unless the context otherwise indicates.

 

ANIKA, ANIKA THERAPEUTICS, ARTHROSURFACE, CINGAL, HYAFF, HYALOFAST, HYVISC, INTEGRITY, MONOVISC, ORTHOVISC, PARCUS MEDICAL, and ORTHOVISCTACTOSET are our registered trademarks that appear in this Quarterly Report on Form 10-Q. For convenience, these trademarks appear in this Quarterly Report on Form 10-Q without ® and ™ symbols, but that practice does not mean that we will not assert, to the fullest extent under applicable law, our rights to the trademarks. This Quarterly Report on Form 10-Q also contains registered marks, trademarks and trade names that are the property of other companies and licensed to us.

 


PART I:

FINANCIAL INFORMATION

  

ITEM 1.

FINANCIAL STATEMENTS

 

Anika Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands, except per share data)

(unaudited)

 

 

March 31,

 

December 31,

 
ASSETS September 30,
2017
 December 31,
2016
 

2024

  

2023

 
Current assets:         
Cash and cash equivalents $126,960  $104,261  $68,629  $72,867 
Investments  25,750   20,500 
Accounts receivable, net of reserves of $217 and $194 at September 30, 2017 and December 31, 2016, respectively  23,804   27,598 

Accounts receivable, net

 32,077  35,961 
Inventories, net  20,252   15,983  49,408  46,386 
Prepaid expenses and other current assets  2,268   2,098   8,848   8,095 
Total current assets  199,034   170,440  158,962  163,309 
Property and equipment, net  53,973   52,296  46,057  46,198 

Right-of-use assets

 28,181  28,767 
Other long-term assets  1,283   69  17,571  18,672 

Deferred tax assets

 1,273  1,489 
Intangible assets, net  10,738   10,227  4,297  4,626 
Goodwill  8,104   7,214   7,403   7,571 
Total assets $273,132  $240,246  $263,744  $270,632 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        

LIABILITIES AND STOCKHOLDERS EQUITY

        
 
Current liabilities:         
Accounts payable $5,189  $2,303  $10,022  $9,860 
Accrued expenses and other current liabilities  6,516   6,496   18,438   21,199 
Total current liabilities  11,705   8,799   28,460   31,059 
Other long-term liabilities  545   2,126  404  404 
Deferred tax liability  7,593   6,548 
Commitments and contingencies (Note 12)        

Lease liabilities

 26,344  26,904 

Commitments and contingencies (Note 9)

   
Stockholders’ equity:         
Preferred stock, $0.01 par value; 1,250 shares authorized, no shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively  -   - 
Common stock, $0.01 par value; 60,000 shares authorized, 14,662 and 14,627 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively  146   146 

Preferred stock, $0.01 par value; 1,250 shares authorized, no shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively

 -  - 

Common stock, $0.01 par value; 90,000 shares authorized, 15,009 issued and 14,821 outstanding and 14,848 issued and 14,660 outstanding at March 31, 2024 and December 31, 2023, respectively

 148  147 
Additional paid-in-capital  66,746   61,735  91,165  90,009 
Accumulated other comprehensive loss  (5,047)  (7,317) (6,315

)

 (5,943

)

Retained earnings  191,444   168,209   123,538   128,052 
Total stockholders’ equity  253,289   222,773   208,536   212,265 
Total liabilities and stockholders’ equity $273,132  $240,246  $263,744  $270,632 

 

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

3

 

 

Anika Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(in thousands, except per share data)

(unaudited)

 

  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Product revenue $27,178  $25,783  $78,899  $74,636 
Licensing, milestone and contract revenue  6   6   5,133   17 
Total revenue  27,184   25,789   84,032   74,653 
                 
Operating expenses:                
Cost of product revenue  6,250   4,998   18,648   16,488 
Research and development  5,842   2,822   14,521   7,773 
Selling, general and administrative  4,823   4,280   14,862   12,525 
Total operating expenses  16,915   12,100   48,031   36,786 
Income from operations  10,269   13,689   36,001   37,867 
Interest income, net  261   93   335   214 
Income before income taxes  10,530   13,782   36,336   38,081 
Provision for income taxes  3,643   4,830   12,587   13,619 
Net income $6,887  $8,952  $23,749  $24,462 
                 
Basic net income per share:                
Net income $0.47  $0.61  $1.63  $1.66 
Basic weighted average common shares outstanding  14,579   14,625   14,572   14,726 
Diluted net income per share:                
Net income $0.46  $0.59  $1.58  $1.61 
Diluted weighted average common shares outstanding  15,115   15,077   15,065   15,163 
                 
Net income $6,887  $8,952  $23,749  $24,462 
Other comprehensive income:                
Foreign currency translation adjustment  690   310   2,270   548 
Comprehensive income $7,577  $9,262  $26,019  $25,010 
  

Three Months Ended March 31,

 
  

2024

  

2023

 

Revenue

 $40,523  $37,924 

Cost of revenue

  15,895   15,081 

Gross Profit

  24,628   22,843 
         

Operating expenses:

        

Research and development

  8,164   8,400 

Selling, general and administrative

  21,527   26,996 

Total operating expenses

  29,691   35,396 

Loss from operations

  (5,063

)

  (12,553

)

Interest and other income (expense), net

  592   539 

Loss before income taxes

  (4,471

)

  (12,014

)

Provision for (benefit from) income taxes

  43   (1,664)

Net loss

 $(4,514

)

 $(10,350)
         

Net loss per share:

        

Basic

 $(0.31

)

 $(0.71)

Diluted

 $(0.31

)

 $(0.71)
         

Weighted average common shares outstanding:

        

Basic

  14,698   14,653 

Diluted

  14,698   14,653 
         

Net loss

 $(4,514

)

 $(10,350)

Foreign currency translation adjustment

  (372)  272 

Comprehensive loss

 $(4,886

)

 $(10,078)

 

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


4

Anika Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash FlowsStockholders' Equity

(in thousands)thousands, except per share data)

(unaudited)

 

  Nine Months Ended September 30,
  2017 2016
Cash flows from operating activities:        
Net income $23,749  $24,462 
Adjustments to reconcile net income to net cash provided by operating activities:        
Depreciation and amortization  3,224   2,777 
Stock-based compensation expense  3,940   2,276 
Deferred income taxes  943   (571)
Provision for doubtful accounts  (1)  52 
Provision for inventory  609   259 
Changes in operating assets and liabilities:        
Accounts receivable  4,388   (104)
Inventories  (4,668)  (3,229)
Prepaid expenses, other current and long-term assets  (922)  355 
Accounts payable  2,030   (5,390)
Accrued expenses and other current liabilities  643   1,091 
Income taxes  645   (3,496)
Other long-term liabilities  (749)  (104)
Net cash provided by operating activities  33,831   18,378 
         
Cash flows from investing activities:        
Proceeds from maturity of investments  31,250   37,750 
Purchase of investments  (36,500)  (32,250)
Purchase of property and equipment  (6,506)  (12,608)
Net cash used in investing activities  (11,756)  (7,108)
         
Cash flows from financing activities:        
Repurchases of common stock  -   (25,000)
Proceeds from exercise of equity awards  310   988 
Net cash provided by (used in) financing activities  310   (24,012)
         
Exchange rate impact on cash  314   82 
         
Increase (decrease) in cash and cash equivalents  22,699   (12,660)
Cash and cash equivalents at beginning of period  104,261   110,707 
Cash and cash equivalents at end of period $126,960  $98,047 
Supplemental disclosure of cash flow information:        
Non-cash investing activities:        
Purchases of property and equipment included in accounts payable and accrued expenses $1,208  $474 
Build-to-suit lease agreement $-  $1,825 

  

Three Months Ended March 31, 2024

 
  

Common Stock

      

Accumulated

     
          

Additional

      

Other

  

Total

 
  

Number of

  

$.01 Par

  

Paid

  

Retained

  

Comprehensive

  

Stockholders'

 
  

Shares

  

Value

  

in Capital

  

Earnings

  

Loss

  

Equity

 

Balance, January 1, 2024

  14,660  $147  $90,009  $128,052  $(5,943

)

 $212,265 

Issuance of common stock for equity awards

  1   -   23   -   -   23 

Vesting of restricted stock units

  250   2   (2

)

  -   -   - 

Stock-based compensation expense

  -   -   3,430   -   -   3,430 

Retirement of common stock for minimum tax withholdings

  (90

)

  (1

)

  (2,295

)

  -   -   (2,296

)

Net loss

  -   -   -   (4,514

)

  -   (4,514

)

Other comprehensive loss

  -   -   -   -   (372)  (372)

Balance, March 31, 2024

  14,821  $148  $91,165  $123,538  $(6,315

)

 $208,536 

 

  

Three Months Ended March 31, 2023

 
  

Common Stock

      

Accumulated

     
          

Additional

      

Other

  

Total

 
  

Number of

  

$.01 Par

  

Paid

  

Retained

  

Comprehensive

  

Stockholders'

 
  

Shares

  

Value

  

in Capital

  

Earnings

  

Loss

  

Equity

 

Balance, January 1, 2023

  14,625  $146  $81,141  $210,719  $(6,443

)

 $285,563 

Issuance of common stock for equity awards

  1   -   7   -   -   7 

Vesting of restricted stock units

  177   2   (2

)

  -   -   - 

Stock-based compensation expense

  -   -   3,717   -   -   3,717 

Retirement of common stock for minimum tax withholdings

  (62

)

  (1)  (1,620)  -   -   (1,621)

Net loss

  -   -   -   (10,350

)

  -   (10,350

)

Other comprehensive income

  -   -   -   -   272   272 

Balance, March 31, 2023

  14,741  $147  $83,243  $200,369  $(6,171

)

 $277,588 

 

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


5

Anika Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash FlowsANIKA THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS(in thousands)

(unaudited)

  

Three Months Ended March 31,

 
  

2024

  

2023

 

Cash flows from operating activities:

        

Net loss

 $(4,514

)

 $(10,350

)

Adjustments to reconcile net income to net cash provided by operating activities:

        

Depreciations

  1,734   1,605 

Amortization of acquisition related intangible assets

  329   1,946 

Non-cash operating lease cost

  565   542 

Stock-based compensation expense

  3,590   3,717 

Deferred income taxes

  193   (2,373)

Provision for credit losses

  93   24 

Provision for inventory

  2,063   629 

Changes in operating assets and liabilities:

        

Accounts receivable

  3,624   4,057 

Inventories

  (4,090

)

  (3,063

)

Prepaid expenses, other current and long-term assets

  (548)  (462)

Accounts payable

  401   (713)

Operating lease liabilities

  (546

)

  (523)

Accrued expenses, other current and long-term liabilities

  (3,110

)

  665 

Income taxes

  90   681 

Net cash used in operating activities

  (126

)

  (3,618)
         

Cash flows from investing activities:

        

Purchases of property and equipment

  (1,808

)

  (1,389

)

Net cash used in investing activities

  (1,808

)

  (1,389

)

         

Cash flows from financing activities:

        

Cash paid for tax withheld on vested restricted stock awards

  (2,296

)

  (1,620

)

Proceeds from exercises of equity awards

  23   7 

Net cash used in financing activities

  (2,273)  (1,613)
         

Exchange rate impact on cash

  (31

)

  30 
         

Decrease in cash and cash equivalents

  (4,238

)

  (6,590

)

Cash and cash equivalents at beginning of period

  72,867   86,327 

Cash and cash equivalents at end of period

 $68,629  $79,737 

Supplemental disclosure of cash flow information:

        

Non-cash investing activities:

        

Purchases of property and equipment included in accounts payable and accrued expenses

 $622  $729 

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

6

Anika Therapeutics, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(amounts in thousands, except share and per share amounts or as otherwise noted)

(unaudited)(unaudited)

 

1.

Nature of Business

 

Anika Therapeutics, Inc. (the “Company”) is a global integratedjoint preservation company that creates and delivers meaningful advancements in early intervention orthopedic medicines company committed to improvingcare, including in the livesareas of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliativeosteoarthritis (“OA”) pain management, to regenerative cartilage repair. Thesolutions, sports medicine and Arthrosurface joint solutions.

In early 2020, the Company hasexpanded its overall technology platform through its strategic acquisitions of Parcus Medical, LLC (“Parcus Medical”), a sports medicine implant and instrumentation company, and Arthrosurface, Inc. (“Arthrosurface”), a company specializing in less invasive, bone preserving partial and total joint replacement solutions. These acquisitions broadened the Company's product portfolio, developed over two decadesits 30 years of global expertise developing, manufacturing,in hyaluronic acid technology, into joint preservation and commercializing products based on the Company’s proprietary Hyaluronic Acid (“HA”) technology. The Company’s orthopedic medicine portfolio includes ORTHOVISC, MONOVISC,restoration, added higher-growth revenue streams, increased its commercial capabilities, diversified its revenue base, and CINGAL, which alleviate painexpanded its product pipeline and restore joint function by replenishing depleted HA,research and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration.development expertise.

 

The Company is subject to risks common to companies in the biotechnology and medical device industrieslife sciences industry including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, commercialization of existing and new products, and compliance with U.S. Food and Drug Administration (“FDA”) and foreign regulations and approval requirements, as well as the ability to grow the Company’s business through appropriate commercial strategies.

 

2.

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements and related notes have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) and in accordance with accounting principles generally accepted in the United States (“USU.S. GAAP”). The financial statements include the accounts of Anika Therapeutics, Inc. and its subsidiaries. Inter-company transactions and balances have been eliminated. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with USU.S. GAAP have been condensed or omitted pursuant to SEC rules and regulations relating to interim financial statements. The December 31, 20162023 balances reported herein arewere derived from the audited consolidated financial statements. In the opinion of management, these unaudited condensed consolidated financial statements contain all adjustments (consisting only of normal recurring adjustments) necessary to fairly state the condensed consolidated financial position of the Company as of September 30, 2017, the results of its operations for the three- and nine-month periods ended September 30, 2017 and 2016, and cash flows for the nine-month periods ended September 30, 2017 and 2016.statements.

 

The accompanying unaudited condensed consolidated financial statements and related notes should be read in conjunction with the Company’s annual financial statements filed with its Annual Report on Form 10-K for the year ended December 31, 2016.2023. The results of operations for the nine-monththree-month period ended September 30, 2017March 31, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2017. Certain prior period amounts have been reclassified2024.

Segment Information

Operating segments are components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making group, in deciding how to conform to the current period presentation. This changeallocate resources and in classification does not materially affect previously reported cash flows from operations or from financing activities in the Condensed Consolidated Statementassessing performance. The Company’s chief operating decision maker as of Cash Flows,March 31, 2024 was its President and had no effectChief Executive Officer. Based on the previously reported Condensed Consolidated Statement of Operationscriteria established by Accounting Standards Codification 280, Segment Reporting, the Company has one operating and Comprehensive Income.

reportable segment.

 

3.Recent Accounting Pronouncements

 

Recently IssuedRecent Accounting Pronouncements

InMay 2014, November 2023, the Financial Accounting Standards Board (“FASB”("FASB") issued Accounting Standards Update (“ASU”) No. 2014-09,2023-07, Revenue from Contracts with CustomersSegment Reporting (Topic 280). ASU 2014-09 supersedes the revenue recognition:  Improvements to Reportable Segment Disclosures, are intended to improve reportable segment disclosure requirements, in Topic 605, Revenue Recognition, and requires entities to recognize revenue in a way that depictsprimarily through enhanced disclosures about significant segment expenses. In addition, the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In July 2015, the FASB issued a one-year deferral of ASU 2014-09 making it effective for annual reporting periods beginning on or after December 15, 2017, while also providing for early adoption not to occur before the original effective date. The Company currently anticipates it will adopt the new standard on a modified retrospective basis with the cumulative effect of the change reflected in retained earnings as of January 1, 2018 and to not restate prior periods. The Company has commenced work to assess the impact of the new revenue standard on its principal revenue streams. The Company has not made a determination on the impact to its consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). ASU 2016-02 amends existing lease accounting requirements. The most significant change will result in the recognition of lease assets and lease liabilities by lessees for virtually all leases. The new guidance will also require significant additional disclosures aboutenhance interim disclosure requirements, clarify circumstances in which an entity can disclose multiple segment measures of profit or loss, provide new segment disclosure requirements for entities with a single reportable segment, and contain other disclosure requirements. The purpose of the amount, timing,amendments is to enable investors to better understand an entity’s overall performance and uncertainty ofassess potential future cash flows from leases.for the entity. ASU 2016-022023-07 is effective for fiscal years and interim periods beginning after December 15, 2018. Upon adoption, entities are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. Early adoption2024. The Company is permitted, and a number of optional practical expedients may be elected to simplifyevaluating the impact of adoption. The Company is assessing ASU 2016-02 and the impact that adopting this new accounting standard will have2023-07 on its consolidated financial statements and footnote disclosures.


In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments (Topic 326) Credit Losses. ASU 2016-13 changes the impairment model for most financial assets and certain other instruments. Under the new standard, entities holding financial assets and net investment in leases that are not accounted for at fair value through net income are to be presented at the net amount expected to be collected. An allowance for credit losses will be a valuation account that will be deducted from the amortized cost basis of the financial asset to present the net carrying value at the amount expected to be collected on the financial asset. ASU 2016-13 is effective as of January 1, 2020. Early adoption is permitted. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements or footnoterelated disclosures.

 

In January 2017,December 2023, the FASBFinancial Accounting Standards Board ("FASB") issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740):  Improvements to Income Tax Disclosures, which establishes new income tax disclosure requirements in addition to modifying and eliminating certain existing requirements. Under the new guidance, entities must consistently categorize and provide greater disaggregation of information in the rate reconciliation and must also disaggregate income taxes paid. ASU No. 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment. ASU 2017-04 will simplify the subsequent measurement of goodwill by eliminating Step 2 from the goodwill impairment test. Current guidance requires that companies compute the implied fair value of goodwill under Step 2 by performing procedures to determine the fair value at the impairment testing date of its assets and liabilities (including unrecognized assets and liabilities) following the procedure that would be required in determining the fair value of assets acquired and liabilities assumed in a business combination. This standard will require companies to perform annual or interim goodwill impairment tests by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. This standard will be2023-09 is effective for annualfiscal years and interim periods beginning after December 15, 2019, including interim periods occurring after that date, and will be applied prospectively. Early adoption2024. The Company is evaluating the impact of this standard is permitted. The adoption of this standard is not expected to have a material impactASU 2023-09 on the Company’sits consolidated financial statements or footnoteand related disclosures.

3.

Accounts Receivable

The Company estimates an allowance for credit losses with its accounts receivable resulting from the inability of its customers to make required payments, which is included in selling, general and administrative expenses in the accompanying consolidated statements of operations. In determining the adequacy of the allowance, management specifically analyzes individual accounts receivable, historical bad debts, customer concentrations, customer creditworthiness, current and reasonable and supportable forecasts of future economic conditions, accounts receivable aging trends, and changes in the Company’s customer payment terms.

 

Recently Adopted

In March 2016, the FASB issued ASU No. 2016-09,Compensation(Topic 718) Stock Compensation. ASU 2016-09 identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as equity or liabilities, an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. ASU 2016-09 is effective as of January 1, 2017. Since January 1, 2017, the Company has recognized excess tax benefits and tax deficiencies related to share-based payments in the Condensed Consolidated Statements of Operations and Comprehensive Income as a component of the provision for income taxes on a prospective basis. Such excess tax benefits and tax deficiencies were previously recorded in equity. The Company also began presenting tax-related cash flows resulting from share-based payments as operating activities in the Condensed Consolidated Statements of Cash Flows, and retrospectively revised prior periods to reflect this provision. Accordingly, the Condensed Consolidated Statement of Cash Flows for the nine months ended September 30, 2016 was revised by increasing net cash provided by operating activities by $0.4 million and by decreasing net cash used in financing activities by $0.4 million. Lastly, as of January 1, 2017, the Company elected to recognize forfeitures as they occur rather than estimate forfeitures each period on a modified retrospective basis. See Notes 6 and 14 for additional information regarding the impacts on the condensed consolidated financial statements.

4.Investments

Allcomponents of the Company’s investmentsaccounts receivable are classified as available-for-sale and are carried at fair value with unrealized gains and losses recorded as a component of accumulated other comprehensive income, net of related income taxes. The Company held bank certificates of deposit of $25.8 million and $20.5 million at September 30, 2017 and December 31, 2016, respectively. There were no unrealized gains or losses on the Company’s available-for-sale securities at September 30, 2017 or December 31, 2016.

follows:

 

  

As of

  

As of

 
  

March 31,

  

December 31,

 
  

2024

  

2023

 

Accounts Receivable

 $33,735  $37,580 

Less: Allowance for credit losses

  1,658   1,619 

Net balance, end of period

 $32,077  $35,961 

A summary of activity in the allowance for credit losses is as follows:

  

As of March 31,

 
  

2024

  

2023

 

Balance, beginning of the period

 $1,619  $1,608 

Amounts provided

  185   102 

Amounts recovered

  (92

)

  (78

)

Amounts written off

  (45

)

  (106

)

Translation adjustments

  (9)  11 

Balance, end of period

 $1,658  $1,537 


5.

4.

Fair Value Measurements

 

Fair value is an exit price, representing the amountThe Company has certain cash equivalents in money market funds that would be received from the sale of an asset or paid to transfer a liability in an orderly transaction between market participants based on assumptions that market participants would use in pricing an asset or liability. As a basis for classifying the fair value measurements, a three-tier fair value hierarchy, which classifies the fair value measurements based on the inputs used in measuring fair value, was established as follows: (Level 1) observable inputs such as quoted prices in active markets for identical assets or liabilities; (Level 2) significant other observable inputs that are observable either directly or indirectly; and (Level 3) significant unobservable inputs for which there is little or no market data, which requires the Company to develop its own assumptions. This hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. On a recurring basis, the Company records its investments at fair value.


The Company’s investments are all classified within Level 2 of the fair value hierarchy. These investments classified within Level 21 of the fair value hierarchy and are valued based on matrix pricing compiled by third party pricing vendors, using observable market inputs such asquoted prices in active markets. For cash, accounts receivables, accounts payable, and accrued interest, rates, yield curves,the carrying amounts approximate fair value, because of the short maturity of these instruments, and credit risk.therefore fair value information is not included in the table below. There were no transfers between fair value levels during the three-month periods ended March 31, 2024 and 2023, respectively.

 

The fair value hierarchyclassification of the Company’s cash equivalents and investments atwithin the fair value ishierarchy was as follows:

 

  

March 31,

  

Active
Markets
for Identical
Assets

  

Significant
Other
Observable
Inputs

  

Significant
Unobservable
Inputs

  

Amortized

 
  

2024

  

(Level 1)

  

(Level 2)

  

(Level 3)

  

Cost

 

Cash equivalents:

                    

Money Market Funds

 $52,177  $52,177  $-  $-  $52,177 

    Fair Value Measurements at Reporting Date Using
  September 30, 2017 Quoted Prices in
Active Markets
for Identical Assets
(Level 1)
 Significant Other
Observable Inputs
(Level 2)
 Significant
Unobservable Inputs
(Level 3)
Cash equivalents:                
Money market funds $5,324  $-  $5,324  $- 
                 
Investments:                
Bank certificates of deposit $25,750  $-  $25,750  $- 

  

December 31,

  

Active
Markets
for Identical
Assets

  

Significant
Other
Observable
Inputs

  

Significant
Unobservable
Inputs

  

Amortized

 
  

2023

  

(Level 1)

  

(Level 2)

  

(Level 3)

  

Cost

 

Cash equivalents:

                    

Money Market Funds

 $55,485  $55,485  $-  $-  $55,485 

 

    Fair Value Measurements at Reporting Date Using
  December 31, 2016 Quoted Prices in
Active Markets
for Identical Assets
(Level 1)
 Significant Other
Observable Inputs
(Level 2)
 Significant
Unobservable Inputs
(Level 3)
Cash equivalents:                
Money market funds $68,352  $-  $68,352  $- 
Bank certificates of deposit  750   -   750   - 
Total cash equivalents $69,102  $-  $69,102  $- 
                 
Investments:                
Bank certificates of deposit $20,500  $-  $20,500  $- 

6.

5.

Equity Incentive Plan

Inventories

The Company estimates the fair value of stock options and stock appreciation rights (“SARs”) using the Black-Scholes valuation model. Fair value of restricted stock awards (“RSAs”) and restricted stock units (“RSUs”) are measured by the grant-date price of the Company’s shares. The fair value of each stock option award during the nine-month periods ended September 30, 2017 and 2016, respectively, was estimated on the grant date using the Black-Scholes option-pricing model with the following assumptions:

     
  Nine Months Ended September 30,
  2017 2016
Risk-free interest rate  1.60%-1.78%   0.94%-1.40% 
Expected volatility  41.36%-44.30%   48.84%-51.61% 
Expected life (years)   4.0     4.5  
Expected dividend yield   0.00%     0.00%  

The Company recorded $1.5 million and $0.8 million of share-based compensation expense for the three-month periods ended September 30, 2017 and 2016, respectively, for equity compensation awards. The Company recorded $3.9 million and $2.3 million of share-based compensation expense for the nine-month periods ended September 30, 2017 and 2016, respectively, for equity compensation awards. The Company presents the expenses related to share-based compensation awards in the same expense line items as cash compensation paid to each of its employees as follows:

  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Cost of product revenue $107  $40  $306  $66 
Research and development  177   156   340   300 
Selling, general and administrative  1,190   601   3,294   1,910 
Total stock-based compensation expense $1,474  $797  $3,940  $2,276 

On June 13, 2017, the Company’s shareholders approved the Anika Therapeutics, Inc. 2017 Omnibus Incentive Plan (the “2017 Plan”). The 2017 Plan replaced the Anika Therapeutics, Inc. Second Amended and Restated 2003 Stock Option and Incentive Plan, as amended, (the “2003 Plan”), as the plan under which future grants to employees, directors, officers, and consultants will be made. The 2017 Plan was originally approved by the Company’s Board of Directors on March 31, 2017. The terms of the 2017 Plan provide for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, and performance awards that may be settled in cash, stock, or other property. Subject to adjustment for specified types of changes in our capitalization, no more than 1.2 million shares of common stock may be issued under the 2017 Plan.

During the three-month period ended September 30, 2017, a total of 60,609 stock options and 14,506 RSAs were granted under the 2017 Plan. During the nine-month period ended September 30, 2017, a total of 63,109 stock options and 14,506 RSAs were granted under the 2017 Plan and a total of 407,635 stock options were granted under the 2003 Plan. The stock options granted to employees become exercisable or vest ratably over a three-year period. In addition, the Company executed its annual grant of 9,970 RSUs to non-employee directors, and these RSUs vest over a one-year period.

A portion of the stock options granted during the nine-month period ended September 30, 2017 contained certain performance criteria in addition to time-based vesting conditions. For performance-based awards with financial achievement targets, the Company recognizes expense using the graded vesting methodology based on the number of shares expected to vest. Compensation cost associated with performance grants is estimated using the Black-Scholes valuation method multiplied by the expected number of shares to be issued, which is adjusted based on the estimated probabilities of achieving the performance goals. Changes to the probability assessment and the estimated shares expected to vest will result in adjustments to the related share-based compensation expense that will be recorded in the period of the change. If the performance targets are not achieved, no compensation cost is recognized and any previously recognized compensation cost is reversed.

In connection with the adoption of ASU 2016-09, as of January 1, 2017, the Company elected to recognize forfeitures as they occur rather than estimate forfeitures each period, which was applied on a modified retrospective basis. Accordingly, the Company recognized a cumulative adjustment to retained earnings at the beginning of the nine-month period ended September 30, 2017, resulting in a reduction of $0.5 million.

7.Earnings Per Share (“EPS”)

Basic EPS is calculated by dividing net income by the weighted average number of shares outstanding during the period. Unvested restricted shares, although legally issued and outstanding, are not considered outstanding for purposes of calculating basic earnings per share. Diluted EPS is calculated by dividing net income by the weighted average number of shares outstanding plus the dilutive effect, if any, of outstanding stock options, SARs, RSAs, and RSUs using the treasury stock method.

The following table provides share information used in the calculation of the Company's basic and diluted earnings per share (in thousands):

  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Shares used in the calculation of basic earnings per share  14,579   14,625   14,572   14,726 
Effect of dilutive securities:                
Stock options, SARs, and RSAs  536   452   493   437 
Diluted shares used in the calculation of earnings per share  15,115   15,077   15,065   15,163 


Equity awards of 0.5 and 0.6 million shares were outstanding for the three- and nine-month periods ended September 30, 2017, respectively, and were not included in the computation of diluted EPS because the awards’ impact on EPS would have been anti-dilutive. Equity awards of 0.3 and 0.4 million shares were outstanding for the three- and nine-month periods ended September 30, 2016, respectively, and were not included in the computation of diluted EPS because the awards’ impact on EPS would have been anti-dilutive. 

On February 26, 2016, the Company entered into an accelerated stock repurchase agreement with Morgan Stanley & Co. LLC (“Morgan Stanley”) pursuant to a Fixed Dollar Accelerated Share Repurchase Transaction (“ASR Agreement") to purchase $25.0 million of shares of its common stock. Pursuant to the terms of the ASR Agreement, the Company paid Morgan Stanley $25.0 million in cash and received delivery of 0.4 million shares of the Company’s common stock on February 29, 2016 based on a closing market price of $46.40 per share and the applicable contractual discount.

On August 26, 2016, the Company settled the approximately $7.5 million remaining under the ASR Agreement, which was recorded as an equity forward sale contract and was included in additional paid-in capital in stockholders' equity in the condensed consolidated balance sheets as it met the criteria for equity accounting. Pursuant to the terms of the ASR Agreement, the final number of shares and the average purchase price was determined at the end of the applicable purchase period, which was August 26, 2016. Based on the volume-weighted average price since the effective date of the ASR Agreement less the applicable contractual discount, Morgan Stanley delivered 0.1 million additional shares to the Company on August 31, 2016. In total, 0.5 million shares were repurchased under the ASR Agreement at an average repurchase price of $47.08 per share. These shares are held by the Company as authorized but unissued shares pursuant to Massachusetts law. The initial and final delivery of shares resulted in immediate reductions of the outstanding shares used to calculate the weighted-average common shares outstanding for basic and diluted net income per share.

8.Inventories

 

Inventories consist of the following:

 

  

March 31,

  

December 31,

 
  

2024

  

2023

 

Raw materials

 $16,264  $15,507 

Work-in-process

  17,264   17,002 

Finished goods

  33,048   32,084 

Total

 $66,576  $64,593 
         
         

Inventories

 $49,408  $46,386 

Other long-term assets

  17,168   18,207 

Total

 $66,576  $64,593 

Inventories are stated net of inventory reserves of approximately $13.6 million and $11.7 million, as of March 31, 2024 and December 31, 2023, respectively.

  September 30,
2017
 December 31,
2016
Raw materials $7,867  $5,884 
Work-in-process  6,564   5,559 
Finished goods  5,821   4,540 
Total $20,252  $15,983 

 

9.

6.

Intangible Assets

 

Intangible assets as of September 30, 2017March 31, 2024 and December 31, 2016 consist2023 consisted of the following:

 

      September 30, 2017 December 31, 2016
  Gross Value Useful Life Accumulated
Currency
Translation
Adjustment
 Accumulated
Amortization
 Net Book
Value
 Net Book
Value
Developed technology $17,100   15  $(2,644) $(7,487) $6,969  $6,842 
In-process research & development  4,406   Indefinite   (1,061)  -   3,345   2,973 
Distributor relationships  4,700   5   (415)  (4,285)  -   - 
Patents  1,000   16   (158)  (418)  424   412 
Elevess trade name  1,000   9   -   (1,000)  -   - 
Total $28,206      $(4,278) $(13,190) $10,738  $10,227 

                  

December 31,

     
      

Three Months Ended March 31 , 2024

  

2023

     
      

Less:

                 
      

Accumulated

              

Weighted

 
      

Currency

  

Less:

  

Net

      

Average

 
  

Gross

  

Translation

  

Accumulated

  

Book

  

Net Book

  

Useful

 
  

Value

  

Adjustment

  

Amortization

  

Value

  

Value

  

Life

 

Developed technology

 $33,061  $(1,608

)

 $(29,653) $1,800  $1,973   15 

IPR&D

  2,656   (1,006

)

  -   1,650   1,650  

Indefinite

 

Customer relationships

  3,887   -   (3,542)  345   360   10 

Distributor relationships

  4,700   (415

)

  (4,285)  -   -   5 

Patents

  1,000   (189

)

  (740)  71   83   16 

Tradenames

  4,641   -   (4,210)  431   560   5 

Total

 $49,945  $(3,218

)

 

$

(42,430) $4,297  $4,626   13 

 

The aggregate amortization expense related to intangible assets was $0.2$0.3 million and $0.3$1.9 million for the three-month periods ended September 30, 2017March 31, 2024 and 2016,2023, respectively. The aggregate

As of March 31, 2024 scheduled amortization expense related toof intangible assets was $0.7 million and $0.8 million for the nine-month periods ended September 30, 2017 and 2016, respectively.next five years is as follows:

Remainder of 2024

 $1,008 

2025

  274 

2026

  160 

2027

  160 

2028

  160 

Thereafter

  886 

Total

 $2,648 


10.

7.

Goodwill

 

Through September 30, 2017, there have not been anyThe Company assesses goodwill for impairment annually, or, under certain circumstances, more frequently, such as when events or changes in circumstances that indicate that the carrying value of goodwillthere may not be recoverable. impairment.

Changes in the carrying value of goodwill for the three-months ended March 31, 2024 were as follows:

 

  Nine Months
Ended September 30,
2017
 Twelve Months
Ended December 31,
2016
Balance, beginning $7,214  $7,482 
Effect of foreign currency adjustments  890   (268)
Balance, ending $8,104  $7,214 

  

Three Months Ended
March 31,

 
  

2024

 

Balance, beginning of period

 $7,571 

Effect of foreign currency adjustments

  (168)

Balance, ending of period

 $7,403 

 

11.

8.

Accrued Expenses and Other Current Liabilities

 

Accrued expenses and other current liabilities consist of the following:

 

  September 30,
2017
 December 31,
2016
Compensation and related expenses $2,985  $3,089 
Facility construction costs  -   804 
Research grants  413   463 
Professional fees  897   802 
Clinical trial costs  2,136   227 
Deferred rent  -   231 
Other  85   880 
Total $6,516  $6,496 

  

March 31,

  

December 31,

 
  

2024

  

2023

 

Compensation and related expenses

 $8,595  $11,828 

Professional fees

  3,434   3,240 

Operating lease liability – current

  2,129   2,133 

Discontinuation of software development project

  1,904   1,904 

Income taxes payable

  1,490   1,240 

Clinical trial costs

  249   460 

Share based compensation

  160   - 

Other

  477   394 

Total

 $18,438  $21,199 

 

12.

9.

Commitments and Contingencies

 

In certain of its contracts, the Company warrants to its customers that the products it manufactures conform to the product specifications as in effect at the time of delivery of the specific product. The Company may also warrant that the products it manufactures do not infringe, violate, or breach any U.S. or international patent or intellectual property right, trade secret, or other proprietary information of any third party. On occasion, the Company contractually indemnifies its customers against any and all losses arising out of, or in any way connected with, any claim or claims of breach of its warranties or any actual or alleged defect in any product caused by the negligent acts or omissions of the Company. The Company maintains a products liability insurance policy that limits its exposure to these risks. Based on the Company’s historical activity, in combination with its liability insurance coverage, the Company believes the estimated fair value of these indemnification agreements is immaterial. The Company had no accrued warranties at September 30, 2017as of March 31, 2024 or December 31, 20162023 and has no history of claims paid.

 


The Company is also involved from time-to-time in various legal proceedings arising in the ordinarynormal course of business. Although the outcomes of these legal proceedings are inherently difficult to predict, the Company does not expect the resolution of these occasional legal proceedings to have a material adverse effect on its financial position, results of operations, or cash flow.

 

13.

10.

Leases

Revenue and Geographic Information

 

On October 9, 2015, our Italian subsidiary,Revenue by product family is as follows:

  

Three Months Ended March 31,

 
  

2024

  

2023

 

OA Pain Management

 $24,318  $22,633 

Joint Preservation and Restoration

  13,841   13,453 

Non-Orthopedic

  2,364   1,838 
Total $40,523  $37,924 

Revenue from the Company’s sole significant customer, DePuy Synthes Mitek Sports Medicine, part of the Johnson & Johnson Medical Companies, as a percentage of the Company’s total revenue was 42% and 43% for the three months ended March 31, 2024 and 2023, respectively.

Total revenue by geographic location based on the location of the customer in total and as a percentage of total revenue were as follows:

  

Three Months Ended March 31,

 
  

2024

  

2023

 
      

Percentage of

      

Percentage of

 
  

Revenue

  

Revenue

  

Revenue

  

Revenue

 

Geographic Location:

                

United States

 $29,236   72

%

 $27,288   72

%

Europe

  5,969   15

%

  5,662   15

%

Other

  5,318   13

%

  4,974   13

%

Total

 $40,523   100

%

 $37,924   100

%


11.

Equity Incentive Plan

Equity Incentive Plan

The Anika Therapeutics, S.r.l.Inc. 2017 Omnibus Incentive Plan (the “2017 Plan”) was approved by the Company’s stockholders on June 13, 2017 and subsequently amended on June 18, 2019, June 16, 2020, June 16, 2021, June 8, 2022 and June 14, 2023. On June 14, 2023, the Company’s stockholders approved an amendment to the 2017 Plan increasing the number of shares by 435,000 shares from 4,850,000 shares to 5,285,000 shares. The 2017 Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights (“Anika S.r.l.”) entered into a build-to-suit lease agreement with Consorzio Zona Industriale E Porto Fluviale di Padova (“ZIP”SARs”), as landlord,restricted stock awards, performance restricted stock units (“PSUs”), restricted stock units (“RSUs”), total shareholder return options (“TSRs”) and performance options that may be settled in cash, stock, or other property. In accordance with the 2017 Plan approved by the Company’s stockholders, including the amendments thereto, each share award other than stock options or SARs will reduce the number of total shares available for grant by two shares. Subject to adjustment for specified types of changes in the Company’s capitalization, no more than 4.6 million shares of common stock may be issued under the 2017 Plan. There were 0.7 million shares available for future grant at March 31, 2024 under the 2017 Plan.

Anika Therapeutics, Inc. 2021 Inducement Plan (the “Inducement Plan”) was adopted by the Company’s board of directors on November 4, 2021 and subsequently amended on December 22, 2023. On December 22, 2023, the Company’s board of directors approved an amendment to the Inducement Plan increasing the number of shares by 125,000 shares from 125,000 to 250,000 shares. The Inducement Plan reserves 250,000 shares of common stock for issuance pursuant to which Anika S.r.l. leasesequity-based awards granted under the Inducement Plan. Such awards may be granted only to an individual who was not previously the Company’s employee or director with the Company. The Inducement Plan provides for the grant of awards under terms substantially similar to the 2017 Plan (as amended). There were 0.1 million shares available for future grant at March 31, 2024 under the Inducement Plan.

The Company may satisfy the awards upon exercise, or upon fulfillment of the vesting requirements for other equity-based awards, with either newly issued shares or shares reacquired by the Company. Stock-based awards are granted with an exercise price equal to or greater than the market price of the Company’s stock on the date of grant. Awards contain service conditions or service and performance conditions, and they generally become exercisable ratably over three years with a new European headquarters facility, consisting of approximately 33,000 square feet of general office, research and development, training, and warehousing space located in Padova, Italy. The lease has an initialmaximum contractual term of fifteenten years.

The Company presents the expenses related to stock-based compensation awards in the same expense line items as cash compensation paid to each of its employees as follows (in thousands):

  

Three Months Ended March 31,

 
  

2024

  

2023

 
         

Cost of revenue

 

$

127

  

$

184

 

Research and development

  

531

   

517

 

Selling, general and administrative

  

2,932

   

3,016

 

Total stock-based compensation expense

 

$

3,590

  

$

3,717

 

Stock Options

Stock options are granted to purchase common shares at prices that are equal to the fair market value of the shares on the date the options are granted or, in the case of premium options, are granted with an exercise price at 110% of the market price of the Company’s common stock on the date of grant. Options generally vest in equal annual installments over a period of three years and expire 10 years after the date of grant. The grant-date fair value of options is recognized as expense on a straight-line basis over the requisite service period, which commencedis generally the vesting period.


The following summarizes the activity under the Company’s stock option plans:

          

Weighted

     
          

Average

     
      

Weighted

  

Remaining

  

Aggregate

 
      

Average

  

Contractual

  

Intrinsic

 
  

Number of

  

Exercise

  

Term

  

Value

 
  

Options

  

Price

  

(in years)

  

(in thousands)

 

Outstanding as of December 31, 2023

  1,812,729  $33.42      $127 

Granted

  426,925  $27.93         

Exercised

  (1,089

)

 $21.77      $4 

Forfeited and canceled

  (26,128

)

 $29.99      $22 

Outstanding as of March 31, 2024

  2,212,437  $32.41   7.8  $316 

Vested, March 31, 2024

  1,305,902  $35.24   6.8  $38 

Vested or expected to vest, March 31, 2024

  2,212,437  $32.41   7.8  $316 

The aggregate intrinsic value of options exercised for the three-month period ended March 31, 2024 was immaterial. The Company granted 426,925 stock options during the three-month ended March 31, 2024.

The Company uses the Black-Scholes pricing model to determine the fair value of options granted. The calculation of the fair value of stock options is affected by the stock price on the grant date, the expected volatility of the Company’s common stock over the expected term of the award, the expected life of the award, the risk-free interest rate and the dividend yield.

The assumptions used in the Black-Scholes pricing model for options granted during the three months ended March 1, 2017.31, 2024 and 2023, along with the weighted-average grant-date fair values, were as follows:

  

Three Months Ended

 
  

March 31,

 
  

2024

  

2023

 

Risk free interest rate

  3.9

%

  -   4.3

%

  3.5

%

  -   4.3

%

Expected volatility

  46.8

%

  -   48.2

%

  48.7

%

  -   49.4

%

Expected life (years)

      4.5           4.5     

Expected dividend yield

      0.0%      0.0%

Fair value per option

     $10.48          $11.71     

As of March 31, 2024, there was $9.0 million of unrecognized compensation cost related to unvested stock options. This expense is expected to be recognized over a weighted average period of 2.2 years.

Restricted Stock Units

RSUs generally vest in equal annual installments over a three-year period. The lease will automatically renewgrant-date fair value of RSUs is recognized as expense on a straight-line basis over the requisite service period, which is generally the vesting period. The Company determines the fair value of RSUs based on the closing price of its common stock on the date of grant.

RSU activity for upthe three-month period ended March 31, 2024 was as follows:

      

Weighted

 
  

Number of

  

Average

 
  

Shares

  

Fair Value

 

Outstanding as of December 31, 2023

  771,358  $27.19 

Granted

  405,917  $25.44 

Vested

  (249,716

)

 $27.82 

Forfeited and cancelled

  (28,611

)

 $27.00 

Outstanding as of March 31, 2024

  898,948  $26.89 


The weighted-average grant-date fair value per share of RSUs granted was $25.44 and $26.91 for the three-month periods ended March 31, 2024 and 2023, respectively. The total fair value of RSUs vested was $7.7 million and $5.7 million for the three-month periods ended March 31, 2024 and 2023, respectively.  As of March 31, 2024, there was $8.9 million of unrecognized compensation cost related to three additional six-year terms, subjecttime-based RSUs, which was expected to certain terms and conditions.be recognized over a weighted-average period of 1.6 years.

The Company’s annual grant of RSU awards in March 2024 can be settled at vesting in cash or shares at the Company’s election.  The Company has recorded these RSUs as a liability due to the abilityexpectation that the Company will settle the vesting of the March 2024 RSU awards in cash due to withdraw from this leasea potential shortage of shares in the 2017 Plan at the time of vesting.  As a result, these RSUs will be subject to certain financial penalties after six yearschange in value at the time of each reporting period.  As of March 31, 2024, the Company had 405,917 shares outstanding in which a liability of $0.2 million was recorded in Accrued Expenses and with no penalties after the ninth year. Beginning on the commencement date, the lease provides for an initial yearly rent of approximately $0.3 million.Other Liabilities.

 

Construction of the new facility commenced during the first quarter of 2016. During the period of construction, the Company was the deemed owner of the facility. Accordingly, the landlord's costs of constructing the facility were capitalized, as a non-cash transaction, offset by a corresponding facility lease obligation in the Company’s consolidated balance sheet. When the construction concluded on March 1, 2017, the Company removed the construction-in-process asset of $3.1 million and related liability from its condensed consolidated balance sheet. The Company commissioned ZIP for additional tenant improvements of $0.8 million, which are recorded within Other long-term assets on the condensed consolidated balance sheet and which will be amortized over the life of the lease. The lease is accounted for as an operating lease based on the Company’s assessment of the applicable accounting principles. 


14.

12.

Income Taxes

 

Provisions forThe income taxes were $3.6 million and $12.6 milliontax expense was immaterial for the three- and nine-month periodsthree-month period ended September 30, 2017, based onMarch 31, 2024, resulting in an effective tax rate of 34.6% for both periods.  Provisions for(1.0%). The income taxes were $4.8 million and $13.6tax benefit was $1.7 million for the three- and nine-month periodsthree-month period ended September 30, 2016, based onMarch 31, 2023, resulting in an effective tax ratesrate of 35.0% and 35.8%, respectively.13.9%. The decrease in income taxes for the three- and nine-month periods ended September 30, 2017 resulted from decreased income before income taxes in addition to a net decreasechange in the effective tax rate for the three-month period ended March 31, 2024, as compared to the same period in the prior year. The net decrease in the effective tax rate for the three- and nine-month periods ended September 30, 2017, as compared to the same periods in 2016, 2023, was primarily due to a full valuation allowance being recorded against domestic deferred tax assets at March 31, 2024.

The Company recognizes deferred tax assets to the increaseextent that it believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, carryback potential if permitted under the tax law, and results of recent operations. The Company has incurred operating losses in recent years. As a result, the Company anticipates that deferred tax assets originating during the year ended December 31, 2024 will exceed the availability of reversing taxable temporary differences. Due to significant negative evidence, including the Company’s prior year operating losses, the Company concluded its anticipated net deferred tax assets in the expected research and development and state investment tax credits.  In addition,U.S. are not more likely than not to be realizable. Accordingly, the Company realized windfall tax benefits related to share-based payments in connection with the adoption of ASU 2016-09 during the period. The amount of excess tax benefits recognized as a discrete period income tax benefit was $0.0 and $0.3 million for the three- and nine-month periods ended September 30, 2017, respectively, which decreased theestimated annual effective tax rate used to compute the income tax provision for the interim periods by 0.0% and 0.9%, respectively. Prior to the adoption of ASU 2016-09 excess tax benefits and deficiencies were recorded in equity. The amount of excess tax benefits recognized through additional paid-in-capital was $0.0 million and $0.4 millionthree-month period ended March 31, 2024 includes an adjustment for the three-valuation allowance required against the U.S deferred tax assets. As of March 31, 2024, the Company continues to believe its foreign deferred tax assets are realizable based upon future reversals of existing taxable temporary differences and nine-month periods ended September 30, 2016, respectively.projected future taxable income.

 

The Company files income tax returns in the United States on a federal basis, in certain U.S. states, and in Italy.certain foreign jurisdictions. The associated tax filings remain subject to examination by applicable tax authorities for a certain length of time following the tax year to which those filings relate.relate, which varies by jurisdiction.

 

In connection with the preparation of the financial statements, the Company performed an analysis to ascertain if it was more likely than not that it would be able to utilize, in future periods, the net deferred tax assets associated with its net operating loss carry-forward. The Company has concluded that the positive evidence outweighs the negative evidence and, thus, that the deferred tax assets not otherwise subject to a valuation allowance are realizable on a “more likely than not” basis. As such, the Company did not record a valuation allowance at September 30, 2017 or December 31, 2016.

15.

13.

DePuy Synthes Mitek Sports Medicine Agreements

Earnings Per Share (EPS)

 

In December 2011,Basic EPS is calculated by dividing net income (loss) by the Company entered into a fifteen-year licensing agreement with DePuy Synthes Mitek Sports Medicine, a divisionweighted average number of DePuy Orthopaedics, Inc. (“Mitek”), to exclusively market MONOVISC inshares outstanding during the U.S. The Company fully recognized revenueperiod. Unvested restricted shares, although legally issued and outstanding, are not considered outstanding for a milestone payment of $5.0 million as a result of MONOVISC achieving $100.0 million in U.S. end-user sales within a consecutive 12-month period ending in June 2017.

ORTHOVISC became available for sale in the United States on March 1, 2004, and it is marketed exclusively by Mitek under the terms of an initial ten-year licensing, distribution, supply, and marketing agreement entered into in December 2003. The agreement was extended by Mitek for additional five-year terms in 2012 and in 2017, with the current agreement to expire on December 20, 2023.

16.Segment and Geographic Information

The Company has one reportable operating segment for the purposes of assessing performance and determining the allocation of resources.

Product revenuecalculating basic EPS. Diluted EPS is calculated by product group is as follows:

  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Orthobiologics $23,990  $22,428  $68,686  $65,319 
Surgical  1,765   1,173   4,395   3,924 
Dermal  358   594   1,235   1,558 
Other  1,065   1,588   4,583   3,835 
Product Revenue $27,178  $25,783  $78,899  $74,636 


Total revenue by geographic location and as a percentage of overall total revenue for the three- and nine-month periods ended September 30, 2017 and 2016 are as follows:

  Three Months Ended September 30,
  2017 2016
  Total
Revenue
 Percentage of
Revenue
 Total
Revenue
 Percentage of
Revenue
Geographic Location:                
United States $22,227   82% $21,126   82%
Europe  2,832   10%  2,703   10%
Other  2,125   8%  1,960   8%
Total Revenue $27,184   100% $25,789   100%

  Nine Months Ended September 30,
  2017 2016
  Total
Revenue
 Percentage of
Revenue
 Total
Revenue
 Percentage of
Revenue
Geographic Location:                
United States $68,624   82% $61,032   82%
Europe  9,743   11%  8,240   11%
Other  5,665   7%  5,381   7%
Total Revenue $84,032   100% $74,653   100%

17.Subsequent Event

On October 24, 2017, the Company, as borrower, entered into a new five-year agreement with Bank of America, N.A., as administrative agent, swingline lender and issuer of letters of credit, for a $50.0 million senior revolving line of credit (the “Credit Agreement”). Subject to certain conditions, the Company may request up to an additional $50.0 million in commitments for a maximum aggregate commitment of $100.0 million, which requests must be approveddividing net income by the Revolving Lenders (as defined inweighted average number of shares outstanding plus the Credit Agreement). Loans underdilutive effect, if any, of outstanding share-based awards using the Credit Agreement generally bear interest equaltreasury stock method. Due to at the Company’s option, either: (i) LIBOR plusloss position, the Applicable Margin, as defined below, or the (ii) Base Rate, defined as the highest of: (a) the Federal Funds Rate plus 0.50%, (b) Bank of America, N.A.’s prime rate and (c) the one month LIBOR adjusted daily plus 1.0%, plus the Applicable Margin. The Applicable Margin ranges from 0.25% to 1.75% based on the Company’s consolidated leverage ratios at the time of the borrowings under the Credit Agreement. The Company has agreed to pay a commitment fee in an amount that is equal to 0.25% per annum on the actual daily unused amount of the credit facility and that is due and payable quarterly in arrears. Loan origination costs will be amortized over the five-year term of the Credit Agreement.share-based payment awards are anti-dilutive.

 

The Credit Agreement contains customary representations, warranties, affirmativeCompany had a net loss during the three-month periods ended March 31, 2024 and negative covenants, including financial covenants, events2023, respectively, and therefore all potential common shares would have been anti-dilutive and accordingly were excluded from the computation of defaultdiluted EPS. Stock options of 2.2 million shares and indemnification provisions in favor1.9 million shares were outstanding for the three-month periods ended March 31, 2024 and 2023, respectively. Restricted stock units totaling 0.9 million were outstanding for each of the Lenders (as definedthree-month periods ended March 31, 2024 and 2023. These securities were not included in the Credit Agreement). The covenants include restrictions governingcomputation of diluted EPS because the Company’s leverage ratio and interest coverage ratio, its incurrence of liens and indebtedness, and its entry into certain merger and acquisition transactions or dispositions and other matters, all subject to certain exceptions. The financial covenants require us not to exceed certain maximum leverage and interest coverage ratios. The Lendersawards’ impact on EPS would have been granted a first priority lien and security interest in substantially all of the Company’s assets, except for certain intangible assets.anti-dilutive.

 


ITEM 2.

MANAGEMENT’S

MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

You should read the following discussion in conjunction with our financial statements and related notes appearing elsewhere in this report.report and our audited consolidated financial statements and related notes contained in our Annual Report on Form 10-K for the year ended December 31, 2023, or our 2023 Form 10-K. In addition to historical information, this report contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 concerning our business, consolidated financial condition, and results of operations. The Securities and Exchange Commission, ("SEC")or the SEC, encourages companies to disclose forward-looking statements so that investors can better understand a company’scompanys future prospects and make informed investment decisions. Forward-looking statements are subject to risks and uncertainties, many of which are outside our control, which could cause actual results to differ materially from these statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements can be identified by such words as "will," "likely," "may," "believe," "expect," "anticipate," "intend," "seek," "designed," "develop," "would," "future," "can," "could," and other expressions that are predictions of or indicate future events and trends and that do not relate to historical matters. All statements other than statements of historical facts included in this report regarding our strategies, prospects, financial condition, operations, costs, plans, and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements regarding expected future operating results, expectations regarding the timing and receipt of regulatory results, anticipated levels of capital expenditures, and expectations of the effect on our financial condition of claims, litigation, and governmental and regulatory proceedings.

 

Please also refer to those factors described in Part II, Item“Item 1A. “RiskRisk Factors” of our Annual Report on2023 Form 10-K for the year ended December 31, 2016 for important factors that we believe could cause actual results to differ materially from those in our forward-looking statements. Any forward-looking statement made by us in this Quarterly Report on Form 10-Qreport is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 

Management Overview

 

We are a global integratedjoint preservation company that creates and delivers meaningful advancements in early intervention orthopedic medicines companycare. Based on our collaborations with clinicians to understand what they need most to treat their patients, we develop minimally invasive products that restore active living for people around the world. We are committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliativeleading in high opportunity spaces within orthopedics, including OA pain management, to regenerative cartilage repair. solutions, sports medicine and Arthrosurface joint solutions.

We have over two decadesthirty years of global expertise developing, manufacturing and commercializing our products based on our proprietary hyaluronic acid, (“HA”) technology. Our orthopedic medicine portfolio includes ORTHOVISC, MONOVISC, and CINGAL, which alleviate pain and restore joint function by replenishing depletedor HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration.

Our therapeutic offerings consist of products in the following areas: Orthobiologics, Dermal, Surgical, and Other, which includes our ophthalmic and veterinary products. All of our products are based ontechnology platform. HA is a naturally occurring biocompatible polymer found throughout the body. Due to its unique biophysicalbody that is vital for proper joint health and biochemical properties, HA plays an important role in a number of physiological functions such as the protection and lubrication of soft tissues and joints, the maintenance of the structural integrity of tissues, and the transport of molecules to and within cells.

tissue function. Our proprietary technologies for modifying the HA molecule allow product properties to be tailored specifically to therapeutic use. Our patented technology chemically modifies HA to allow formultiple uses, including enabling longer residence time in the body. We also offer products made from HA based on two other technologies: HYAFF, which isto support OA pain management and creating a solid form of HA and ACP gel, an autocross-linked polymer of HA. Our technologies are protected by an extensive portfolio of owned and licensed patents.called Hyaff, which is a platform utilized in our regenerative solutions portfolio.

 

SinceIn early 2020, we expanded our inception in 1992, we have utilized aoverall technology platform, product portfolio, and significantly expanded our commercial partnership model for the distribution of our products to end-users. Our strong, worldwide network of distributors has historically provided, and continues to provide, a solid foundation for our revenue growth and territorial expansion. In 2015, we made the strategic decision to commercialize our next generation viscosupplementation product, CINGAL,infrastructure, especially in the United States, ourselves, initially through the engagementour strategic acquisitions of Parcus Medical, LLC, or Parcus Medical, a contract sales organization. Ultimately,sports medicine and instrumentation solutions provider, and Arthrosurface, Inc, or Arthrosurface, a company specializing in bone preserving partial and total joint replacement solutions. These acquisitions augmented our HA-based OA pain management and regenerative products with a broad suite of products and capabilities focused on early intervention joint preservation primarily in upper and lower extremities such as shoulder, foot/ankle, knee and hand/wrist.


As we intendlook forward, our business is positioned to transition the direct sales function intocapture value within our company as parttarget market of a broader buildout of our commercial capabilities.joint preservation. We believe that the combination of the direct and distribution commercial modelsour future success will maximize the revenue potential from our current and future product portfolio.be driven by our:

Over 30 years of experience in HA-based regenerative solutions and early intervention orthopedics combined with seasoned leadership with a strong financial foundation for future investment in meaningful solutions for our customers and their patients;

Utilizing HA-based technology and manufacturing expertise to provide new and differentiated solutions in next generation OA Pain Management and regenerative solutions markets;

Introducing key HA-based products into the US market upon FDA approval/clearance, such as Cingal, Hyalofast and Integrity, our arthroscopic patch system for rotator cuff repair;

Robust network of stakeholders in our target markets to identify evolving unmet patient treatment needs;

Global commercial expertise, which we will leverage to drive growth across our product portfolio, including continued international expansion;

Opportunity to pursue strategic inorganic growth opportunities, including potential partnerships and smaller acquisitions and technology licensing, and leveraging our strong financial foundation and operational capabilities; and

Energized and experienced team focused on strong values, talent, and culture.

Products

 

We began a strategic project in 2015 to move the manufacturing of our HYAFF-based products, which were previously manufactured under an existing contract manufacturing agreement with a third party in Italy, to our Bedford, Massachusetts facility. Our main purposes behind this strategic move are to enhance our research and development capabilities with the aim of accelerating future product development and to improve the efficiency of our manufacturing process. We expect to expend approximately $25.0 million on this project. Since project inception through September 30, 2017, we have expended approximately $22.7 million on the project, and we have completed key planned project milestones to date. We expect the HYAFF manufacturing to be fully operational before the end of 2017.


Please see the section captioned “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations-Management Overview” in our Annual Report on Form 10-K for the year ended December 31, 2016, for a description of each of the above therapeutic areas, including the individual products.

Research and DevelopmentOA Pain Management

 

Our researchOA Pain Management product family consists of Monovisc and development efforts primarily consist of the development of new medical applications forOrthovisc, our injectable, HA-based, technology, the management of clinical trials for certainOA Pain Management offerings that are indicated to provide pain relief from osteoarthritis conditions; and Cingal, our novel, single-injection OA Pain Management product candidates, the preparation and processing of applications for regulatory approvals or clearances at all relevant stages of product development, and process development and scale-up manufacturing activities for our existing and new products. Our development focus includes products for tissue protection, repair, and regeneration. We anticipate that we will continue to commit significant resources to research and development, including clinical trials in the future.

Our second single-injection osteoarthritis product under development in the United States is CINGAL, which is composedconsisting of our proprietary cross-linked HA material combined with an approved steroid anda fast-acting steroid. Cingal is our next generation fast-acting, long-lasting, non-opioid, clinically proven osteoarthritis pain product which is designed to provide both short- and long-term pain relief to patients. Wethrough at least six months. It is currently sold outside the United States in approximately 40 countries. In 2022, we completed an initial CINGAL phasea third Phase III clinical trial including the associated statistical analysis for 368 enrolled patients, during the fourth quarter of 2014 with data indicating that the product met allCingal, which achieved its primary and secondary endpoints relative to placebo set forthendpoint. Cingal is not currently approved for the trial. During the first half of 2015, we completed a CINGAL retreatment study with 242 patients who had participatedcommercial use in the phase III clinical trial and reported safety data related to the retreatment study. This initial phase III clinical trial and the associated retreatment study supported the Health Canada and CE Mark approval of the product, and the commercial launch of the product in both Canada and the European Union occurred in the second quarter of 2016. In the United States, after discussionsStates. We have been actively engaging with the U.S. Food and Drug Administration, (“FDA”) related toor the FDA, on next steps for U.S. regulatory pathway for CINGAL, we conducted a formal meeting with the FDA’s Office of Combination Products (“OCP”) to presentapproval.


Joint Preservation and discuss our data in September 2015, and we submitted a formal request for designation with OCP a month later. In its response to our formal request for designation, OCP assigned the product to the FDA’s Center for Drug Evaluation and Research (“CDER”) as the lead agency center for premarket review and regulation. Since then, we have been in ongoing discussions with CDER to understand the requirements for submitting a New Drug Application (“NDA”) for CINGAL. We held a meeting with CDER in September 2016 to align on an approval framework and on submission requirements for this NDA for CINGAL, including the execution of an additional Phase III clinical trial to supplement our existing CINGAL pivotal study data. We submitted an Investigational New Drug Application (“IND”) in late 2016, and discussions with CDER indicated no objections to our clinical protocol design. As a result, we commenced work on this second Phase III clinical trial in the first quarter of 2017, and the first patient was treated in the second quarter of 2017. Enrollment in this second Phase III clinical trial was completed during October 2017. We have also initiated a nine-month extended follow-up study in conjunction with the second Phase III clinical trial to investigate the efficacy of CINGAL over this longer period. This extended follow-up study will not impact the timeline for submission of the NDA for CINGAL following the completion of the second Phase III clinical trial.Restoration

 

We have several researchOur Joint Preservation and development programs underwayRestoration product family consists of: (a) our portfolio of orthopedic regenerative solutions products utilizing HA, including Integrity, our new arthroscopic regenerative patch system for new products, including for HYALOFAST (in the United States), an innovative product for cartilage tissuerotator cuff repair and other early stage regenerativetendon procedures, Tactoset products and Hyalofast, a HA-based biodegradable support used for cartilage regeneration currently available outside the United States in over 30 countries; (b) our line of sports medicine development programs. HYALOFAST received CE Mark approval in September 2009,solutions used to repair and it is commercially available in Europereconstruct damaged ligaments and certain international countries. During the first quartertendons due to sports injuries, trauma and disease; and (c) our Arthrosurface portfolio of 2015, we submitted an Investigational Device Exemption (“IDE”) for HYALOFAST to the FDA, which was approved in July 2015. We commenced patient enrollment in a clinical trial in December 2015,bone preserving joint technologies, including partial joint replacement, jointresurfacing, and we are advancing site initiationsminimally invasive and patient enrollment activities. In the second quarter of 2016, a supplement to the HYALOFAST IDE was approved to expand the inclusion criteria for the clinical study. The purpose of this supplement is to allow us to increase enrollment rates with the ultimate goal of decreasing the time needed to complete the clinical trial. In addition, we are currently proceeding with other research and development programs, one of which utilizes our proprietary HA technologybone sparing implants, designed to treat pain associated with common repetitive overuse injuries, such as lateral epicondylitis,upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease.

Non-Orthopedic

Our Non-Orthopedic product family consists of legacy HA-based products that are marketed principally for non-orthopedic applications, including our anti-adhesion barrier product, advanced wound care products, our ear, nose and throat products, and our ophthalmic products. Our Non-Orthopedic product family also known as tennis elbow. We submitted a CE Mark application for this treatment during the first quarter of 2016 and received a CE Markincludes Hyvisc, our high molecular weight injectable HA veterinary product approved for the treatment of painjoint dysfunction in horses due to non-infectious synovitis associated with tennis elbow in December 2016. Outside of the United States, this product will be marketed under the trade name ORTHOVISC-T. In the second quarter of 2016, we submitted an IDE to the FDA to conduct a phase III clinical trial for this treatment, which was approved by the FDA in June 2016. We also have other research and development programs underway focused on expanding the indications of our current products, including one program being conducted and funded by our U.S. MONOVISC distribution partner, DePuy Synthes Mitek Sports Medicine, a division of DePuy Orthopaedics, Inc. (“Mitek”), seeking to expand MONOVISC’s indication to include the treatment of pain associated with osteoarthritis of the hip. In third quarter of 2017, we also submitted an application to the FDA for 510(k) clearance of an injectable HA-based bone repair treatment, which derived from previous research and development activities related to HYALOBONE.equine OA.

 

In June 2015, we entered into an agreement with the Institute for Applied Life Sciences at the University of Massachusetts Amherst to collaborate on research to develop a therapy for rheumatoid arthritis. The purpose of this research is to develop a novel modality for the treatment of rheumatoid arthritis and, if successful, it is expected to yield a potential product candidate that we could begin to move towards commercialization through additional pre-clinical studies.

 

15 


Results of Operations

 

Three- and Nine-MonthsThree Months Ended September 30, 2017March 31, 2024 Compared to Three- and Nine-MonthsThree Months Ended September 30, 2016

March 31, 2023

 

  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 $ Inc/(Dec) % Inc/(Dec) 2017 2016 $ Inc/(Dec) % Inc/(Dec)
  (in thousands, except percentages) (in thousands, except percentages)
Product revenue $27,178  $25,783  $1,395   5% $78,899  $74,636  $4,263   6%
Licensing, milestone and contract revenue  6   6   -   0%  5,133   17   5,116   * 
Total revenue  27,184   25,789   1,395   5%  84,032   74,653   9,379   13%
                                 
Operating expenses:                                
Cost of product revenue  6,250   4,998   1,252   25%  18,648   16,488   2,160   13%
Research and development  5,842   2,822   3,020   107%  14,521   7,773   6,748   87%
Selling, general and administrative  4,823   4,280   543   13%  14,862   12,525   2,337   19%
Total operating expenses  16,915   12,100   4,815   40%  48,031   36,786   11,245   31%
Income from operations  10,269   13,689   (3,420)  (25%)  36,001   37,867   (1,866)  (5%)
Interest income, net  261   93   168   181%  335   214   121   57%
Income before income taxes  10,530   13,782   (3,252)  (24%)  36,336   38,081   (1,745)  (5%)
Provision for income taxes  3,643   4,830   (1,187)  (25%)  12,587   13,619   (1,032)  (8%)
Net income $6,887  $8,952  $(2,065)  (23%) $23,749  $24,462  $(713)  (3%)
Product gross profit $20,928  $20,785  $143   1% $60,251  $58,148  $2,103   4%
Product gross margin  77%  81%          76%  78%        
  

Three Months Ended March 31,

 
  

2024

  

2023

  

$ Change

  

% Change

 
  

(in thousands, except percentages)

 

Revenue

 $40,523  $37,924  $2,599   7%

Cost of revenue

  15,895   15,081   814   5%

Gross profit

  24,628   22,843   1,785   8%

Gross margin

  61%  60%        

Operating expenses:

                

Research and development

  8,164   8,400   (236)  (3%)

Selling, general and administrative

  21,527   26,996   (5,469)  (20%)

Total operating expenses

  29,691   35,396   (5,705)  (16%)

Loss from operations

  (5,063)  (12,553)  7,490   (60%)

Interest and other income (expense), net

  592   539   53   10%

Loss before income taxes

  (4,471)  (12,014)  7,543   (63%)

Provision for (benefit from) for income taxes

  43   (1,664)  1,707   (103%)

Net loss

 $(4,514) $(10,350) $5,836   (56%)

 

* Percentage increase has been omitted due to magnitude.

Product Revenue

 

ProductThe following table presents revenue by product family for the three-month period ended September 30, 2017 was $27.2 million, an increase of 5%March 31, 2024 and 2023 as compared to $25.8 millionfollows:

  

Three Months Ended March 31,

 
  

2024

  

2023

  

$ Change

  

% Change

 
  

(in thousands, except percentages)

 

OA Pain Management

 $24,318  $22,633  $1,685   7%

Joint Preservation and Restoration

  13,841   13,453   388   3%

Non-Orthopedic

  2,364   1,838   526   29%
  $40,523  $37,924  $2,599   7%

Revenue from our OA Pain Management product family increased 7% for the three-month period ended September 30, 2016.Product revenue for the nine-month period ended September 30, 2017 was $78.9 million, an increase of 6% as compared to $74.6 million for the nine-month period ended September 30, 2016. For the three-month period ended September 30, 2017, the increase in product revenue was mainly driven by the growth of our orthobiologics and surgical franchises. For the nine-month period ended September 30, 2017, the increase in product revenue was mainly driven by the growth of our orthobiologics and surgical franchises and the growth of our veterinary product in the other franchise category, with such increase being partially offset by a decrease in revenue from our dermal franchise.

The following tables present product revenue by product group for the three- and nine-month periods ended September 30, 2017 and 2016:

  Three Months Ended September 30,
  2017 2016 $ Inc/(Dec) % Inc/(Dec)
  (in thousands, except percentages)
Orthobiologics $23,990  $22,428  $1,562   7%
Surgical  1,765   1,173   592   50%
Dermal  358   594   (236)  (40%)
Other  1,065   1,588   (523)  (33%)
Total $27,178  $25,783  $1,395   5%

  Nine Months Ended September 30,
  2017 2016 $ Inc/(Dec) % Inc/(Dec)
  (in thousands, except percentages)
Orthobiologics $68,686  $65,319  $3,367   5%
Surgical  4,395   3,924   471   12%
Dermal  1,235   1,558   (323)  (21%)
Other  4,583   3,835   748   20%
Total $78,899  $74,636  $4,263   6%


Orthobiologics

Our orthobiologics franchise consists of our joint health and orthopedic products. Overall, sales increased 7% and 5% for the three- and nine-month periods ended September 30, 2017, respectively,March 31, 2024, as compared to the same periodsperiod in 2016. The2023, due primarily to favorable strategic partner ordering patterns and sales growth in the three-on increasing customer demand as strategic partner and nine-month periods ended September 30, 2017 was primarily due to an increase in worldwide MONOVISC revenue. MONOVISC worldwide revenuedistributor ordering patterns can vary significantly on a quarterly basis.

Revenue from our Joint Preservation and Restoration product family increased during the three- and nine-month periods ended September 30, 2017 as a result of robust and growing end-user demand3% for the product. MONOVISC’s strong growth is further augmented as end-user demand in the market for viscosupplementation products more generally continues to shift from multi-injection products, including ORTHOVISC, to single-injection products, such as MONOVISC, both domestically and internationally. CINGAL and ORTHOVISC-T, both of which launched internationally during the second half of 2016, also contributed to the growth of orthobiologics revenue during the period. We expect orthobiologics revenue to continue to grow for the remainder of 2017, led by increased MONOVISC revenue in domestic and international markets, including in India, Australia, New Zealand, and Taiwan, where regulatory approvals were achieved in the second quarter and third quarters of 2017, the commercial availability of CINGAL in Canada and Europe, as well as overall revenue growth from our viscosupplementation products both domestically and internationally.

Surgical

Our surgical franchise consists of products used to prevent surgical adhesions and to treat ear, nose, and throat (“ENT”) disorders. Sales of our surgical products increased 50% and 12% for the three- and nine-month periodsthree-month period ended September 30, 2017 to $1.8 million and $4.4 million, respectively,March 31, 2024, as compared to the same periodsperiod in 2016. The increase in surgical product revenue for the three- and nine-month periods was2023, primarily due to an increase in sales togrowing commercial adoption of our worldwide ENT commercial partner. We expect surgical product revenue to increase modestly in 2017, as compared to 2016, primarily due to increased worldwidenewest products, which offset lower sales of our ENT products.

Dermalcertain legacy products.

 

Our dermal franchiseconsists of advanced wound care products, which are based onRevenue from our HYAFF technology, and aesthetic dermal fillers. Our advanced wound care products treat complex skin wounds ranging from burns to diabetic ulcers, with HYALOMATRIX and HYALOFILL asNon-Orthopedic product family increased 29% for the lead products. For the three- and nine-month periodsthree-month ended September 30, 2017, dermal product sales decreased 40% and 21%, respectively,March 31, 2024, as compared to the same periodsperiod in 2016. This year-to-date decrease reflects order2023, primarily due to favorable timing byof distributor ordering patterns with our distribution partners. We expect dermal revenueHyvisc veterinary product.


Gross Profit and Margin

Gross profit for the three-month period ended March 31, 2024 increased $1.8 million to increase in 2017$24.6 million, representing a 61% gross margin for the period as compared to 2016 primarily due to increased end-user demand and geographic expansion related to our advanced would care products60% in the U.S. and European markets.

Other

Other product revenue includes revenues from our ophthalmic and veterinary franchises. Product revenue from these franchises decreasedprior year. The increase in gross profit for the three-month and increased for the nine-month periodsperiod ended September 30, 2017March 31, 2024, as compared to the same periodsperiod in 2016. We expect other revenue to increase in 2017 as compared to 2016, driven2023, primarily by our veterinary product.

Licensing, milestone and contract revenue

Licensing, milestone and contract revenue for the three- and nine-month periods ended September 30, 2017 was $6 thousand and $5.1 million, as compared to $6 thousand and $17 thousand for the same periods in 2016. Revenue for the nine-month period ended September 30, 2017 included a $5.0 million milestone payment associated with our U.S. license agreement with Mitek for MONOVISC that was received and fully recognized as a result of U.S. MONOVISC 12-month end-user sales exceeding $100.0 million.

Product gross profit and margin

Product gross profit for the three- and nine-month periods ended September 30, 2017resulted from increased $143 thousand and $2.1 million to $20.9 and $60.3 million, respectively, representing 77% and 76% of product revenue. Product gross profit for the three- and nine- months ended September 30, 2016 was $20.8 million and $58.1 million,representing 81% and 78% of product revenue. The decrease in product grossGross margin for the three and nine-month periodsthree-month period ended September 30, 2017, asMarch 31, 2024 increased compared to the same periods in 2016, was primarily attributable to higher production volume in theperiod of prior year periods anddue primarily to lower acquisition related amortization expenses on intangible assets, offset by higher inventory write-offs in 2017. This current product gross margin may not be indicative of the rest of the year due to dynamics such as future revenue mix and production volume variability.reserves.

17 

Research and developmentDevelopment

 

Research and development expenses for the three- and nine-month periodsthree-month period ended September 30, 2017March 31, 2024 were $5.8$8.2 million, and $14.5a decrease of $0.2 million representing 21.5% and 17.3% of total revenue for the respective periods, an increase of $3.0 million and $6.7 million, respectively, as compared to the same periodsperiod in 2016.2023. The increase in research and development expensesdecrease was primarily duerelated to a higher level of clinicallower product development and regulatory activities, including our HYALOFAST and CINGAL phase III clinical studies. Furthermore, we also increased our pre-clinical product development activities with respect to certain product candidates in our research and development pipeline. Research and development spending is expected to increase in 2017 and thereafter, as compared to 2016, as we further develop new products and line extensions and initiate new clinical trials based on our existing technology assets, including CINGAL and HYALOFAST, as well as increase development activities for other products and line extensions in the pipeline.costs.

Selling, generalGeneral and administrativeAdministrative

 

Selling, general and administrative (“SG&A”) expenses for the three- and nine-month periodsthree-month period ended September 30, 2017March 31, 2024 were $4.8$21.5 million, and $14.9a decrease of $5.5 million, or 17.7% of total revenue for both periods, an increase of $0.5 million and $2.3 million, respectively, as compared to the same periodsperiod in 2016. SG&A expenses increased2023. This decrease for the three-three-month period ended March 31, 2024 was primarily due to $5.0 million of costs incurred during the same quarter last year related to the Parcus Medical unitholder arbitration settlement and nine-month periods ended September 30, 2017 primarily as a result of increases in personnel related costs, external professional fees, and marketing initiatives to support the CINGAL and ORTHOVISC-T international launches. We expect SG&A expenses for 2017 will increase to reflect the support, including the implementation of improved operational and financial technology platforms, required to grow our business both domestically and internationally.other non-recurring corporate costs.

Income taxesTaxes

 

Provisions forThe income taxes were $3.6 million and $12.6 milliontax expense was immaterial for the three- and nine-month periodsthree-month period ended September 30, 2017, based onMarch 31, 2024, resulting in an effective tax rate of 34.6% for both periods.  Provisions for(1.0%). The benefit from income taxes were $4.8 million and $13.6was $1.7 million for the three- and nine-month periodsthree-month period ended September 30, 2016, based on effective tax rates of 35.0% and 35.8%, respectively. The decreaseMarch 31, 2023, resulting in income taxes for the three- and nine-month periods ended September 30, 2017 resulted from decreased income before income taxes and a net decrease in thean effective tax rate as compared to the same periods in the prior year.of 13.9%. The net decreasechange in the effective tax ratefor the three- and nine-month periods ended September 30, 2017, as compared to the same periods in 2016,was primarily due to the increase in the expected research and development and state investment tax credits.

In addition, we realized windfall tax benefits related to share-based payments in connection with the adoption of ASU 2016-09 as of January 1, 2017. The amount of excess tax benefits recognized as a discrete period income tax benefit was $0.0 and $0.3 million for the three- and nine-month periods ended September 30, 2017, respectively, which decreased the effective tax rate for the interim periods by 0.0% and 0.9%, respectively. Priorthree-month period ended March 31, 2024, as compared to the adoptionsame period in 2023, was primarily due to a full valuation allowance being recorded against domestic deferred tax assets at March 31, 2024.

Net Loss

For the three-month period ended March 31, 2024, net loss was $4.5 million, or $0.31 per diluted share, compared to net loss of ASU 2016-09 excess tax benefits and deficiencies were recorded in equity. The amount of excess tax benefits recognized through additional paid-in-capital was $0.0$10.4 million, and $0.4 millionor $0.71 per diluted share, for the three-same period in prior year. The decrease in net loss and nine-month periods ended September 30, 2016, respectively.diluted net loss per share was primarily due to higher revenues in 2024 and the non-recurring expenses related to the Parcus Medical arbitration settlement and other non-recurring corporate costs that occurred in the prior year.

 

Non-GAAP Financial Measures

We present certain information with respect to adjusted gross profit and adjusted gross margin, adjusted Earnings Before Interest, Tax, Depreciation and Amortization, or EBITDA, adjusted net income, adjusted diluted earnings per share or adjusted EPS, which are financial measures not based on any standardized methodology prescribed by accounting principles generally accepted in the United States, or GAAP, and is not necessarily comparable to similarly titled measures presented by other companies.


We have presented adjusted gross profit and adjusted gross margin, adjusted EBITDA, adjusted net income, adjusted EPS, because they are key measures used by our management and board of directors to understand and evaluate our operating performance and to develop operational goals for managing our business. We believe these financial measures help identify underlying trends in our business that could otherwise be masked by the effect of the expenses that we exclude. In particular, we believe that the exclusion of these items in calculating these measures can provide a useful tool for period-to-period comparisons of our core operating performance. Accordingly, we believe that these measures provide 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 key financial metrics used by our management in their financial and operational decision-making.

Adjusted Gross Profit and Adjusted Gross Margin

We define adjusted gross profit as our gross profit excluding amortization of certain acquired intangible assets, the impact of inventory fair-value step up associated with our recent acquisitions and certain product rationalization charges. The amortized assets contribute to revenue generation, and the amortization of such assets will likely continue in future periods until such assets are fully amortized. These assets include the fair value of certain identified assets acquired in acquisitions, including developed technology and acquired tradenames. We define adjusted gross margin as adjusted gross profit divided by total revenue.

The following is a reconciliation of adjusted gross profit and gross margin, both non-GAAP metrics, to gross profit, the most directly comparable GAAP financial measure for the three-month periods ended March 31, 2024 and 2023, respectively:

  

Three-Month Periods Ended March 31,

 
  

2024

  

2023

 

Gross profit

 $24,628  $22,843 

Product rationalization charges

  472   - 

Acquisition related intangible asset amortization

  157   1,562 

Adjusted gross profit

 $25,257  $24,405 

Adjusted gross margin

  62%  64%

Adjusted gross profit for the three-month period ended March 31, 2024 increased $0.9 million to $25.3 million representing adjusted gross margin of 62%. Adjusted gross profit for the three-month period ended March 31, 2023 was $24.4 million, or adjusted gross margin of 64%. There was a decrease in adjusted gross margin for the three-month period ended March 31, 2024 as compared to 2023, due to the impact of production inefficiencies and higher inventory reserves in 2024.

Adjusted EBITDA

We present information below with respect to adjusted EBITDA, which we define as our net income (loss) excluding interest and other expense, net, income tax benefit, depreciation and amortization, stock-based compensation, and acquisition-related expenses.

Adjusted EBITDA is not prepared in accordance with GAAP, and should not be considered in isolation of, or as an alternative to, measures prepared in accordance with GAAP. There are a number of limitations related to the use of adjusted EBITDA rather than net (loss) income, which is the nearest GAAP equivalent. Some of these limitations are:

adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA;

we exclude share-based compensation expense from adjusted EBITDA although (a) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy and (b) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position;


we exclude acquisition related expenses, including, amortization and depreciation of acquired assets in recent acquisitions, and the impact of inventory fair-value step up on cost of revenue;

the expenses and other items that we exclude in our calculation of adjusted EBITDA may differ from the expenses and other items, if any, that other companies may exclude from adjusted EBITDA when they report their operating results;

The following is a reconciliation of adjusted EBITDA, a non-GAAP metric, to net loss, the most directly comparable GAAP financial measure, for the three-month periods ended March 31, 2024 and 2023, respectively:

  

Three Months Ended March 31,

 
  

2024

  

2023

 
  

(in thousands)

 

Net loss

 $(4,514) $(10,350)

Interest and other (income) expense, net

  (592)  (539)

Provision for (benefit from) income taxes

  43   (1,664)

Depreciation and amortization

  1,866   1,764 

Share-based compensation

  3,590   3,717 

Arbitration settlement

  -   3,250 

Product rationalization charges

  472   - 

Acquisition related intangible asset amortization

  197   1,787 

Severance costs

  839   - 

Costs of shareholder activism

  601   831 

Adjusted EBITDA

 $2,502  $(1,204)

Adjusted EBITDA in the three-month period ended March 31, 2024 increased $3.7 million as compared with the same period in 2023. The increase in adjusted EBITDA for the period was primarily due to an increase in revenues as well as lower spending following the successful launch of key products and addressing new regulatory requirements in the European Union in 2023.

Adjusted Net Income (Loss) and Adjusted EPS

We present information below with respect to adjusted net (loss) income and adjusted EPS. We define adjusted net (loss) income as our net (loss) income excluding amortization and depreciation of acquired assets, share-based compensation, and other non-recurring items, such as product rationalization charges, severance costs and costs of shareholder activism. We define adjusted EPS as GAAP diluted earnings per share excluding the above adjustments to net (loss) income used in calculating adjusted net (loss) income, each on a per share and tax effected basis.

The following is a reconciliation of adjusted net loss, a non-GAAP metric, to net income (loss), the most directly comparable GAAP financial measure, for the three-month periods ended March 31, 2024 and 2023, respectively:

  

Three Months Ended March 31,

 
  

2024

  

2023

 
  

(in thousands)

 

Net loss

 $(4,514) $(10,350)

Product rationalization charges, tax effected

  477   - 

Arbitration settlement, tax effected

  -   2,776 

Share-based compensation, tax effected

  3,624   3,175 

Acquisition related intangible asset amortization, tax effected

  199   1,526 

Severance costs, tax effected

  847   - 

Costs of shareholder activism, tax effected

  607   710 

Adjusted net income (loss)

 $1,240  $(2,163)


The following is a reconciliation of adjusted diluted EPS, a non-GAAP metric, to diluted EPS, the most directly comparable GAAP financial measure, for the three-month periods ended March 31, 2024 and 2023, respectively:

  

Three Months Ended March 31,

 
  

2024

  

2023

 

Diluted loss per share

 $(0.31) $(0.71)

Product rationalization charges, tax effected

  0.03   - 

Arbitration settlement, tax effected

  -   0.19 

Share-based compensation, tax effected

  0.25   0.22 

Acquisition related intangible asset amortization, tax effected

  0.02   0.11 

Severance costs, tax effected

  0.06   - 

Costs of shareholder activism, tax effected

  0.04   0.05 

Adjusted diluted earnings (loss) per share

 $0.09  $(0.14)

Adjusted net income and adjusted diluted earnings per share in the three-month period ended March 31, 2024 increased $3.4 million and $0.23, respectively, as compared with the same period in 2023. The increase for the period was primarily due to higher revenues and lower spending following the successful launch of key products and addressing new regulatory requirements in the European Union in 2023.

Liquidity and Capital Resources

 

On October 24, 2017, we entered into a five-year agreement for a $50.0 million senior revolving line of credit,We require cash to fund our operating activities and as of October 24, 2017, $50.0 million was available for borrowing underto make capital expenditures and other investments in the line of credit. See Note 17 to the condensed consolidated financial statements for additional information regarding the line of credit.

business. We expect that our requirements for cash to fund operations and capital expendituresthese uses will increase as the scope of our operations expands. Historically, we have generated positiveexpand. We continue to generate cash flow from operations, which together withoperating activities and believe that our availableoperating cash flows, cash currently on our condensed consolidated balance sheet and investments have metavailability under our credit facility will be sufficient to allow us to continue to invest in our existing business, to manage our capital structure on a short and long-term basis, and to meet our anticipated operating cash requirements.needs. Cash and cash equivalents and investments totaled approximately $152.7aggregated $68.6 million and $124.8$72.9 million, and working capital totaled $130.5 million and $132.2 million, at September 30, 2017March 31, 2024 and December 31, 2016,2023, respectively. Working capital totaled approximately $187.3 million at September 30, 2017 and $161.6 million at December 31, 2016. We believe that

On November 12, 2021, we have adequate financial resources, including amounts available under theentered into a Third Amendment to Credit Agreement with Bank of America N.A. as administrative agent, which amended our existing revolving line of credit agreement dated October 24, 2017 which provides up to support our business$75.0 million in the form of a senior revolving line of credit. Subject to certain conditions, we may request up to an additional $75.0 million for at leasta maximum aggregate commitment of $150.0 million. As of March 31, 2024, and December 31, 2023, there were no outstanding borrowings, and we are in compliance with the next twelve months beyond the releaseterms of the financial statements.credit facility.

Summary of Cash Flows (in thousands):

  

Three Months Ended March 31,

 
  

2024

  

2023

 

Cash provided by (used in)

        

Operating activities

 $(126) $(3,618)

Investing activities

  (1,808)  (1,389)

Financing activities

  (2,273)  (1,613)

Effect of exchange rate changes on cash

  (31)  30 

Net decrease in cash and cash equivalents

 $(4,238) $(6,590)

The following changes contributed to the net change in cash and cash equivalents in the three-month period ended March 31, 2024 as compared to the same period in 2023.

Operating Activities

 

Cash provided byused in operating activities was $33.8$0.1 million for the nine-monththree-month period ended September 30, 2017,March 31, 2024, as compared to cash provided byused in operating activities of$18.4 $3.6 millionfor the sameperiod in 2016. This increase2023. The decrease in cash used in operating activities in 2024 was primarily relateddue to a decrease in accounts receivable, an increase in accounts payable, and an increase in income taxes payable, due tolower net loss during the timing of payments, offset, in part, by an increase in inventories. period.


Investing Activities

 

Cash used in investing activities was $11.8$1.8 million for the nine-monththree-month period ended September 30, 2017,March 31, 2024, as compared to cash used in investing activities of $7.1$1.4 million for the same period in 2016.2023. The change was primarily due to an increase in cash used in investing activitieswas primarily the result of the purchase of investments offset by maturities of investments during the first half of 2017. Furthermore, expenditures for the buildout ofcapital expenditures to support manufacturing operations at our Bedford Massachusetts facility are declining and we expect to complete validation by the end of 2017.facility.

Financing Activities

 

Cash provided byused in financing activities was $0.3$2.3 million for the nine-monththree-month period ended September 30, 2017,March 31, 2024, as compared to cash used byin financing activities totaling$24.0of $1.6 millionfor the same period in 2016. The decrease in2023. In both periods, the cash used in financing activities for the nine-month period ended September 30, 2017 was primarily attributable to the Fixed Dollar Accelerated Share Repurchase Transaction to repurchase $25.0 millionutilization of cash for employee tax withholding in exchange for shares of our common stock in February 2016.surrendered by equity award holders.

18 

Critical Accounting Policies and Estimates

 

The preparation of our condensed consolidated financial statements in conformity with GAAP requires management to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. We believe that our accounting policies for revenue recognition, accounts receivable and allowance for credit losses, goodwill, acquired in-process research and development, inventory and contingencies are based on, among other things, judgments and assumptions made by management that include inherent risks and uncertainties. There werehave been no other significant changes to the above critical accounting policies or in the underlying accounting assumptions and estimates used in such policies from those disclosed in our critical accounting estimates during the nine months ended September 30, 2017 to augment the critical accounting estimates disclosed in Management’s Discussionannual consolidated financial statements and Analysis of Financial Condition and Results of Operationsaccompanying notes included in our Annual Report on2023 Form 10-K for the fiscal year ended December 31, 2016.2023. We monitor our estimates on an ongoing basis for changes in facts and circumstances, and material changes in these estimates could occur in the future. Changes in estimates are recorded in the period in which they become known. We base our estimates on historical experience and other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from our estimates if past experience or other assumptions do not turn out to be substantially accurate.

Recent Accounting Pronouncements

 

A discussion of Recent Accounting Pronouncements is included in our Annual Report on2023 Form 10-K for the fiscal year ended December 31, 20162023 and is updated in Note 3the Notes to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.report.

Contractual Obligations and Other Commercial Commitments

 

Our contractual obligations and other commercial commitments are summarized in the section captioned “Part II, Item 7,7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Contractual Obligations and Other Commercial Commitments” in our Annual Report on2023 Form 10-K for the year ended December 31, 2016. We had2023. There were no material changes outside the ordinary course of business to our contractual obligations reported in our 2016 Annual Report on2023 Form 10-K during the first ninethree months of 2017.ended March 31, 2024. For additional discussion, see Note 9 to the condensed consolidated financial statements included in this report.

 

To the extent that funds generated from our operations, together with our existing capital resources, are insufficient to meet future requirements, we will be required to obtain additional funds through equity or debt financings, including through the previously discussed $50.0 million senior revolving line of credit, strategic alliances with corporate partners and others, or through other sources. No assurance can be given that any additional financing will be made available to us or will be available on acceptable terms should such a need arise.

 

Off-balance Sheet Arrangements

We do not use special purpose entities or other off-balance sheet financing techniques, except for operating leases, that we believe have, or are reasonably likely to have, a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, or capital resources.


 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our market risks and the ways we manage them are summarized in the section captioned “Part II, Item 7A,7A. Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report on Form 10-K for the year ended December 31, 2016.2023. There have been no material changes in the first ninethree months of 20172024 to our market risks or to our management of such risks.

 

ITEM 4.

CONTROLS AND PROCEDURES

(a)Evaluation of disclosure controls and procedures.

 

As required by Rule 13a-15 under the Securities Exchange Act(a) Evaluation of 1934, as amended (the “Exchange Act”), we carried out an evaluation underdisclosure controls and procedures.

Under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, ofwe have evaluated the effectiveness of the design and operation of our disclosure controls and procedures as defined by Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended, as of the end of the period covered by this report. Based upon that evaluation, the chief executive officer and chief financial officer have concluded as of March 31, 2024 that our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in reports we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in SEC rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by our company in the reports it fileswe file or submitssubmit under the Exchange Act 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. On an on-going basis, we review and document our disclosure controls and procedures, and our internal control over financial reporting, and may from time to time make changes aimed at enhancing their effectiveness and to ensure that our systems evolve with our business.

 

(b)Changes in internal controls over financial reporting.

(b) Changes in internal controls over financial reporting.

 

There were no material changes in our internal control over financial reporting during the three-month periodquarter ended September 30, 2017March 31, 2024, that have materially affected, or that arewere reasonably likely to materially affect, our internal controlscontrol over financial reporting.


PART II: OTHER INFORMATION

 

ITEM 1.PART II:

OTHER INFORMATION

ITEM 1.

LEGAL PROCEEDINGS

 

We are involved from time-to-time in various legal proceedings arising in the ordinarynormal course of business. Although the outcomes of these legal proceedings are inherently difficult to predict, we do not expect the resolution of these occasional legal proceedings to have a material adverse effect on our financial position, results of operations, or cash flow. There have been no material changes to the information provided in the section captioned “Part I, Item 3,3. Legal Proceedings” in our Annual Report on Form 10-K for the year ended December 31, 2016.2023.

 

ITEM 1A.

RISK FACTORS

 

ThereExcept as set forth below, there have been no material changes to the risk factors described in the section captioned “Part I, Item 1A,1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2016.2023. In addition to the other information set forth in this report, you should carefully consider the factors discussed in the section captioned “Part I, Item 1A,1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2016,2023, which could materially affect our business, financial condition, or future results. The risks described in our Annual Report on Form 10-K are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may have a material adverse effect on our business, financial condition, and/or operating results.

 

 


ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Issuer Purchases of Equity Securities

In April 2023, we agreed to establish a share repurchase program for an aggregate purchase price of $20.0 million. The first $5.0 million was to be effected through an accelerated stock repurchase program, the second $5.0 million is to be purchased in the open market and the remaining $10.0 million is to be purchased in the open market subject to positive cash flow. On May 12, 2023, we entered into an accelerated share repurchase agreement with Bank of America, N.A. (“Bank of America”) pursuant to a Fixed Dollar Accelerated Share Repurchase Transaction (“ASR Agreement”) to purchase $5.0 million of shares of its common stock. During 2023, we repurchased 188,029 shares at an average purchase price of $26.59 per share.

Recent Sales of Unregistered Securities

None.

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4.

MINE SAFETY DISCLOSURES.

Not applicable.

ITEM 5.

OTHER INFORMATION.

Rule 10b5-1 Trading Plans

During the fiscal quarter ended March 31, 2024, none of the Company’s directors or executive officers adopted or terminated any contract, instruction or written plan for the purchase or sale of Company securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement.


ITEM 6.

EXHIBITS

 

Exhibit No.

Description
(10)

Description

  

*10.13.1

Credit Agreement, dated asCertificate of October 24, 2017, among Anika Therapeutics, Inc., certain subsidiariesIncorporation of Anika Therapeutics, Inc. as are or may from time(incorporated by reference to time become partiesExhibit 3.1 to the Credit Agreement, Bank of America, N.A., as administrative agent, swingline lender and issuer of letters of credit, andCurrent Report on Form 8-K (File No. 001-14027) filed by the lenders party thereto.Registrant on June 6, 2018)

  

*10.23.2

Security and Pledge Agreement, dated asBylaws of October 24, 2017, among Anika Therapeutics, Inc., certain subsidiarieseffective as of Anika Therapeutics, Inc. listedJune 6, 2018 (incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K (File No. 001-14027) filed by the signature pages thereto, and Bank of America, N.A., as administrative agent.Registrant on June 6, 2018)

  
10.3

(31)

Negotiated Settlement Agreement and General Release, dated July 13, 2017, by and between Stephen Mascioli, M.D., MPH and Anika Therapeutics, Inc., incorporated herein by reference to Exhibit 10.1 to Form 8-K, filed with the SEC on July 14, 2017.

Rule 13a-14(a)/15d-14(a) Certifications

  
10.4Employment Agreement, dated July 27, 2017, by and between Anika Therapeutics, Inc. and Joseph Darling, incorporated herein by reference to Exhibit 10.1 to Form 8-K, filed with the SEC on July 27, 2017.
(31)Rule 13a-14(a)/15d-14(a) Certifications.

*31.1

Certification of Charles H. Sherwood, Ph.D.,Dr. Cheryl R. Blanchard, pursuant to Rules 13a-15(e) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

  

*31.2

Certification of Sylvia CheungMichael Levitz, pursuant to Rules 13a-15(e) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

  

(32)

Section 1350 Certifications.Certifications

  

**32.1

Certification of Charles H. Sherwood, Ph.D.,Dr. Cheryl R. Blanchard, and Sylvia Cheung,Michael Levitz, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

  

(101)

XBRL

  

*101

The following materials from Anika Therapeutics, Inc.’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017,March 31, 2024 as filed with the SEC on October 27, 2017,May 8, 2024, formatted in Inline XBRL (eXtensible Business Reporting Language), as follows:

 

 

i.

Condensed Consolidated Balance Sheets as of September 30, 2017March 31, 2024 (unaudited) and December 31, 20162023 (unaudited)

 ii. 

ii.

Condensed Consolidated Statements of Operations and Comprehensive Income for the Three and Nine Months Ended September 30, 2017March 31, 2024 and September 30, 2016March 31, 2023 (unaudited)

 

iii.

Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended March 31, 2024 and March 31, 2023 (unaudited)

 

iv.

Condensed Consolidated Statements of Cash Flows for the NineThree Months Ended September 30, 2017March 31, 2024 and September 30, 2016March 31, 2023 (unaudited)

 iv. 

v.

Notes to Condensed Consolidated Financial Statements (unaudited)

104

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

*

Filed herewith.

**

Furnished herewith.

 

 

*Filed herewith.
** Furnished herewith.

 


SIGNATURESSIGNATURES

 

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

 

  

ANIKA THERAPEUTICS, INC.

 
Date: October 27, 2017By:/s/ SYLVIA CHEUNG
  Sylvia Cheung

(Registrant)

  Chief Financial Officer

Date: May 8, 2024

By:

/s/ MICHAEL LEVITZ

  

Michael Levitz

Executive Vice President, Chief Financial Officer and Treasurer

(Authorized Officer and Principal Financial Officer)

 

 

 

 


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