Quarterly Report for Quarter Ending September 30, 2024 (Form 10-Q)

anik20240930_10q.htm

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, 2024 and December 31, 2023	3
	Condensed Consolidated Statement of Operations and Comprehensive Income (Loss) for the three and nine months ended September 30, 2024 and 2023	4
	Condensed Consolidated Statements of Stockholders' Equity for the three and nine months ended September 30, 2024 and 2023	5
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024 and 2023	7
	Notes to Condensed Consolidated Financial Statements	8
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	27
Item 4.	Controls and Procedures	27
Part II	Other Information	27
Item 1.	Legal Proceedings	27
Item 1A.	Risk Factors	27
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	28
Item 3.	Defaults Upon Senior Securities	28
Item 4.	Mine Safety Disclosures	28
Item 5.	Other Information	28
Item 6.	Exhibits	29
Signatures	30

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, CINGAL, HYAFF, HYALOFAST, HYVISC, INTEGRITY, MONOVISC, ORTHOVISC, PARCUS MEDICAL, and TACTOSET 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 trademarks and trade names that are the property of other companies and may be 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)

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

Anika Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(in thousands, except per share data)

(unaudited)

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

Anika Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders' Equity

(in thousands, except per share data)

(unaudited)

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

Anika Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

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

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)

1.	Nature of Business

Anika Therapeutics, Inc. (the "Company") is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care, including in the areas of osteoarthritis ("OA") pain management, regenerative solutions, sports medicine and Arthrosurface joint solutions. The Company has over 30 years of expertise in hyaluronic acid ("HA") technology.

In early 2020, the Company expanded its overall technology platform through its acquisitions of Parcus Medical, LLC ("Parcus Medical"), a sports medicine implant and instrumentation company, and Arthrosurface Incorporated ("Arthrosurface"), a company specializing in less invasive, bone preserving partial and total joint replacement solutions.

On October 31, 2024, the Company sold its equity interests in Arthrosurface (Note 15) and the Company announced its intention to divest of the Parcus Medical business. These decisions were a result of a strategic review to focus on the Company's core HA technology and regenerative solutions products to maximize shareholder value.

The Company is subject to risks common to companies in the life 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 ("U.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 U.S. GAAP have been omitted pursuant to SEC rules and regulations relating to interim financial statements. The December 31, 2023 balances reported herein were 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 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, 2023. The results of operations for the three and nine-month periods ended September 30, 2024 are not indicative of the results to be expected for the year ending December 31, 2024.

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 allocate resources and in assessing performance. The Company's chief operating decision maker as of September 30, 2024 was its President and Chief Executive Officer. Based on the criteria established by Accounting Standards Codification 280, Segment Reporting, the Company has oneoperating and reportable segment.

Recent Accounting Pronouncements

In November 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, are intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. In addition, the new guidance will enhance 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 amendments is to enable investors to better understand an entity's overall performance and assess potential future cash flows for the entity. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The Company is evaluating the impact of ASU 2023-07 on its consolidated financial statements and related disclosures.

In December 2023, the Financial 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 2023-09 is effective for fiscal years and interim periods beginning after December 15, 2024. The Company is evaluating the impact of ASU 2023-09 on its consolidated financial statements and 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.

The components of the Company's accounts receivable are as follows:

		As of			As of
		September 30,			December 31,
		2024			2023
Accounts receivable		$	30,927			$	37,580
Less: Allowance for credit losses			2,570				1,619
Net balance, end of period		$	28,357			$	35,961

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

		As of September 30,
		2024			2023
Balance, beginning of the period		$	1,619			$	1,608
Amounts provided			1,284				353
Amounts recovered			(261	)			(279	)
Amounts written off			(78	)			(101	)
Translation adjustments			6				(7	)
Balance, end of period		$	2,570			$	1,574

4.	Fair Value Measurements

The Company has certain cash equivalents in money market funds that are classified within Level 1 of the fair value hierarchy and are valued based on quoted prices in active markets. For cash, accounts receivables, accounts payable, and accrued interest, the carrying amounts approximate fair value, because of the short maturity of these instruments, and therefore fair value information is not included in the table below. There were no transfers between fair value levels during the nine-month periods ended September 30, 2024 and 2023, respectively.

The classification of the Company's cash equivalents within the fair value hierarchy was as follows:

		September 30,			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		$	45,538			$	45,538			$	-			$	-			$	45,538

		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

5.	Inventories

Inventories consist of the following:

		September 30,			December 31,
		2024			2023
Raw materials		$	16,401			$	15,507
Work-in-process			16,423				17,002
Finished goods			17,528				32,084
Total		$	50,352			$	64,593
Inventories		$	39,629			$	46,386
Other long-term assets			10,723				18,207
Total		$	50,352			$	64,593

Inventories are stated net of inventory reserves of approximately $6.5 million and $11.7 million, as of September 30, 2024 and December 31, 2023, respectively. As described in more detail in Note 15, the Company sold its Arthrosurface business on October 31, 2024. As a result of this transaction, the Company adjusted the carrying value of the inventories related to the Arthrosurface business to the net realizable value. Accordingly, the company recorded a write-down of inventories of $22.7 million which was charged to Cost of Goods Sold during the three-month and nine-month periods ended September 30, 2024.

6.	Acquired Intangible Assets, Net

Intangible assets as of September 30, 2024 and December 31, 2023 consisted of the following:

																										December 31,
						Nine Months ended September 30, 2024			2023
		Gross Value			Plus: Additions			Less: Accumulated Currency Translation Adjustment			Less: Current Period Impairment Charge			Less: Accumulated Amortization			Net Book Value			Net Book Value			Weighted Average Useful Life
Developed technology		$	33,061			$	600			$	(1,608	)		$	(718	)		$	(29,997	)		$	1,338			$	1,973			$	15
In-process research & development			2,656				-				(1,006	)			-				-				1,650				1,650			Indefinite
Customer relationships			3,887				-				-				(316	)			(3,571	)			-				360				10
Distributor Relationships			4,700				-				(415	)			-				(4,285	)			-				-				5
Patents			1,000				-				(189	)			-				(764	)			47				83				16
Tradenames			4,641				-				-				(126	)			(4,469	)			46				560				5
Total		$	49,945			$	600			$	(3,218	)		$	(1,160	)		$	(43,086	)		$	3,081			$	4,626				12

The aggregate amortization expense related to intangible assets was $0.3 million and $1.9 million for the three-month periods ended September 30, 2024 and 2023, respectively and $1.0 million and $5.8 million for the nine-month periods ended September 30, 2024 and 2023, respectively. During the three-month period ended September 30, 2024, the Company acquired $0.6 million new drug application ("NDA") that has regulatory approval in the U.S. that it has recorded as developed technology. The Company also recorded a $1.2 million charge to intangible assets related to its Arthrosurface asset group during the three-month period ended September 30, 2024 due to the Company not expecting to recover the value of the intangible asset from the expected net proceeds related to the sale of the Arthrosurface business (see Note 15).

As of September 30, 2024 scheduled amortization of intangible assets is as follows:

Remainder of 2024		$	252
2025			347
2026			232
2027			182
2028			32
Thereafter			386
Total		$	1,431

7.

Goodwill

The Company assesses goodwill for impairment annually, or, under certain circumstances, more frequently, such as when events or changes in circumstances indicate there may be impairment.

Changes in the carrying value of goodwill for the nine-months ended September 30, 2024 were as follows:

		Nine Months Ended September 30,
		2024
Balance, beginning of period		$	7,571
Effect of foreign currency adjustments			85
Balance, ending of period		$	7,656

8.	Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consist of the following:

		September 30,			December 31,
		2024			2023
Compensation and related expenses		$	10,500			$	11,828
Professional fees			3,449				3,240
Operating lease liability - current			2,292				2,133
Stock-based compensation			1,624				-
Clinical trial costs			363				460
Income taxes payable			82				1,240
Discontinuation of software development project			-				1,904
Other			378				394
Total		$	18,688			$	21,199

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 are immaterial. The Company had noaccrued warranties as of September 30, 2024 or December 31, 2023 and has no history of claims paid.

The Company is also involved from time-to-time in various legal proceedings arising in the normal 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.

10.	Revenue and Geographic Information

Revenue by product family is as follows:

		Three Months Ended September 30,			Nine Months Ended September 30,
		2024			2023			2024			2023
OA Pain Management		$	24,428			$	24,888			$	75,404			$	76,855
Joint Preservation and Restoration			11,950				13,470				39,345				39,583
Non-Orthopedic			2,375				3,107				6,448				7,253
		$	38,753			$	41,465			$	121,197			$	123,691

Revenue from the Company's sole significant US customer, J&J Medtech (previously known as DePuy Synthes Mitek Sports Medicine), part of the Johnson & Johnson Medical Companies, as a percentage of the Company's total revenue was 45% and 44% for the three-months ended September 30, 2024 and 2023, respectively, and 43% and 45% for the nine-months ended September 30, 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 September 30,
		2024			2023
						Percentage of							Percentage of
		Revenue			Revenue			Revenue			Revenue
Geographic Location:
United States		$	27,699				71	%		$	30,831				74	%
Europe			5,688				15	%			5,420				13	%
Other			5,366				14	%			5,214				13	%
Total		$	38,753				100	%		$	41,465				100	%

		Nine Months Ended September 30,
		2024			2023
						Percentage of							Percentage of
		Revenue			Revenue			Revenue			Revenue
Geographic Location:
United States		$	85,923				71	%		$	90,986				74	%
Europe			18,264				15	%			16,757				13	%
Other			17,010				14	%			15,948				13	%
Total		$	121,197				100	%		$	123,691				100	%

11.	Equity Incentive Plan

Equity Incentive Plan

The Anika Therapeutics, 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 ("SARs"), 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 twoshares. 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 September 30, 2024 under the 2017 Plan.

The 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 and May 2, 2024. On May 2, 2024, the Company's board of directors approved an amendment to the Inducement Plan increasing the number of shares by 100,000 shares. The Inducement Plan reserves 350,000 shares of common stock for issuance pursuant to equity-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 September 30, 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 threeyears with a maximum contractual term of tenyears.

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:

		Three Months Ended September 30,			Nine Months Ended September 30,
		2024			2023			2024			2023
Cost of revenue		$	92			$	181			$	391			$	532
Research & development			485				304				1,587				1,474
Selling, general & administrative			2,817				3,076				8,897				9,422
Total stock-based compensation expense		$	3,394			$	3,561			$	10,875			$	11,428

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 threeyears 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 is 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			541,100			$	28.13
Exercised			(3,556	)		$	21.96							$	14
Forfeited and canceled			(127,008	)		$	37.50							$	30
Outstanding as of September 30, 2024			2,223,265			$	31.92				7.5			$	248
Vested, September 30, 2024			1,276,640			$	34.57				6.5			$	102
Vested or expected to vest, September 30, 2024			2,223,265			$	31.92				7.5			$	248

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 nine months September 30, 2024 and 2023, along with the weighted-average grant-date fair values, were as follows:

		Nine Months Ended
		September 30,
		2024			2023
Risk free interest rate			3.6% - 4.6	%			3.5% - 4.4	%
Expected volatility			44.5% - 48.2	%			48.2% - 49.4	%
Expected life (years)			4.5				4.5
Expected dividend yield			0.0	%			0.0	%
Fair value per option		$	10.53			$	11.46

As of September 30, 2024, there was $7.4 million of unrecognized compensation cost related to unvested stock options. This expense is expected to be recognized over a weighted average period of 2.0 years.

Restricted Stock Units

RSUs generally vest in equal annual installments over a three-year period. The grant-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 the nine-month period ended September 30, 2024 was as follows:

						Weighted
		Number of			Average
		Shares			Fair Value
Outstanding as of December 31, 2023			771,358			$	27.19
Granted			491,541			$	26.62
Vested			(308,634	)		$	27.73
Forfeited and cancelled			(74,874	)		$	26.43
Outstanding as of September 30, 2024			879,391			$	26.74

The weighted-average grant-date fair value per share of RSUs granted was $26.62 and $26.66 for the nine-month periods ended September 30, 2024 and 2023, respectively. The total fair value of RSUs vested was $9.6 million and $6.8 million for the nine-month periods ended September 30, 2024 and 2023, respectively. As of September 30, 2024, there was $7.1 million of unrecognized compensation cost related to time-based RSUs that are expected to settle in shares, which was expected to be recognized over a weighted-average period of 1.3 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 expectation that the Company will settle the vesting of the March 2024 RSU awards in cash due to a potential shortage of shares in the 2017 Plan at the time of vesting. As a result, these RSUs will be subject to change in value at the time of each reporting period. As of September 30, 2024, the Company had 381,029 shares outstanding in which a liability of $1.6 million was recorded in Accrued Expenses and Other Liabilities. There was $7.7 million of unrecognized compensation cost for these RSUs recorded as a liability which was expected to vest over a weighted-average period of 2.4 years.

12.	Income Taxes

The income tax expense was $2.3 million and $3.2 million for the three- and nine-month periods ended September 30, 2024, resulting in effective tax rates of (8.4%) and (10.2%), respectively. The income tax benefit was $0.5 million and $2.5 million for the three- and nine-month periods ended September 30, 2023, resulting in an effective tax rate of 6.6% and 11.1%, respectively.

The net change in the effective tax rate for the three- and nine-month periods ended September 30, 2024, as compared to the same periods in 2023, was primarily due to the impact of the valuation allowance in the US in both the current and prior periods and the impact of recording of $1.5 million of discrete items during the nine-month period ended September 30, 2024. The Company's effective tax rate for the three-month and nine-month periods ended September 30, 2024 was primarily driven by the full valuation on the Company's deferred tax assets in the US and the projected taxable income for the Company resulting in expected current tax expense in 2024.

The Company recognizes deferred tax assets to the extent 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 U.S. are not more likely than not to be realizable. Accordingly, the estimated annual effective tax rate used to compute the income tax provision for the nine-month period ended September 30, 2024 includes an adjustment for the valuation allowance required against the U.S. deferred tax assets. As of September 30, 2024, the Company continues to believe its foreign deferred tax assets are realizable based upon future reversals of existing taxable temporary differences and 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 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, which varies by jurisdiction. In September 2024, the Company was notified by the Italian tax authorities that it had selected the Company's tax returns for its Italian subsidiary for 2021 for examination and remains under review.

13.	Earnings Per Share ("EPS")

Basic EPS is calculated by dividing net income (loss) 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 EPS. Diluted EPS is calculated by dividing net income by the weighted average number of shares outstanding plus the dilutive effect, if any, of outstanding share-based awards using the treasury stock method. Due to the Company's loss position, the share-based payment awards are anti-dilutive.

The Company had a net loss during the three and nine-month periods ended September 30, 2024 and 2023, respectively, and therefore all potential common shares would have been anti-dilutive and accordingly were excluded from the computation of diluted EPS. Stock options of 2.2 million shares and 1.8 million shares were outstanding at September 30, 2024 and 2023, respectively. Restricted stock units totaling 0.9 million and 0.8 million were outstanding at September 30, 2024 and 2023, respectively. These securities were not included in the computation of diluted EPS because the awards' impact on EPS would have been anti-dilutive.

14.	Share Repurchase

In May 2024, the Company agreed to implement a share repurchase program for an aggregate purchase price of $40.0 million to occur as follows: (i) first $15.0 million was effected through a Rule 10b5-1 Plan initiated prior to June 1, 2024 and to be effective through June 30, 2025, and (ii) the remaining amount to be purchased in the open market through June 2026. In the event of positive "free cash flow" as defined in the Cooperation Agreement dated May 28, 2024, with Caligan Partners LP, Caligan Partners Master Fund LP and David Johnson, for the period from July 1, 2024 through June 30, 2025, the amount under the share repurchase program shall be increased by 50% of such positive amount and in no event would we be required to make any purchases in the event that the Company's cash would be less than $45.0 million after taking into account the share repurchase and reasonably anticipated capital expenditures and restructuring costs. This new authorization replaces our share repurchase program previously announced in April 2023.

On May 28, 2024, the Company entered into a share repurchase agreement under a Rule 10b5-1 with Bank of America. As of September 30, 2024, the Company had repurchased 205,404 shares at an average cost of $25.99 per share for a total cost of $5.3 million.

15.	Subsequent Event

On October 31, 2024 (the "Closing Date"), the Company completed the sale of all of the outstanding equity interests (the "Transaction") of Arthrosurface Incorporated, a Delaware corporation and former wholly-owned subsidiary of the Company ("Arthrosurface"), which held the Company's Arthrosurface business, to Phoenix Brio, Incorporated, a Delaware corporation ("Buyer"), pursuant to the terms and conditions of a Share Purchase Agreement, dated as of the Closing Date (the "Purchase Agreement"), by and among the Company, Arthrosurface and Buyer (the "Transaction").

As consideration for the Transaction, at the closing Buyer delivered to the Company a ten-year non-interest bearing promissory note in the principal amount of $7.0 million. Under the terms of the Purchase Agreement, the Company is also eligible to receive: (i) for each calendar quarter, an amount equal to a percentage of the net sales (the "Revenue Payments") for the sale of certain commercial and pipeline products during the period commencing on the Closing Date and ending on the earlier of the fifth (5th) anniversary of the Closing Date or the date on which the Buy-Out Payment (as defined below) is paid to the Company; and (ii) a percentage of the gross proceeds with respect to the sale of certain commercial and pipeline products in a bona-fide arm's length transaction with a third party that is not an affiliate of Buyer or the Company occurring within the first twenty four (24) months following the Closing Date. The Buyer can also elect to make a payment in an amount equal to the greater of (A) $14.0 million or (B) ten (10) times the Revenue Payments ((A) and (B) together, the "Buy-Out Payment") paid to the Company during the last full calendar year prior to the consummation of a change of control transaction or Buyer's written notice to the Company that it is electing to make the Buy-Out Payment. Pursuant to the Purchase Agreement, the aggregate consideration is subject to customary post-closing adjustments.

As a result of the Transaction, the Company tested the assets associated with the Arthrosurface business to determine if the carrying value of the assets at September 30, 2024 were fully recoverable. Given that the expected proceeds from the sale of the Arthrosurface business is expected to be less than the carrying value of its net assets, the Company recorded asset impairment charges totaling $27.4 million during the three-month period ended September 30, 2024 related to a write-down of its accounts receivable, inventories, property and equipment and intangible assets related to the Arthrosurface business.

ITEM 2.

MANAGEMENT'S 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 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, or the SEC, encourages companies to disclose forward-looking statements so that investors can better understand a company's 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 "Item 1A. Risk Factors" of our 2023 Form 10-K 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 report 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 joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. 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 leading in high opportunity spaces within orthopedics, including OA pain management, regenerative solutions, sports medicine and Arthrosurface joint solutions.

We have over thirty years of global expertise developing, manufacturing and commercializing products on our hyaluronic acid, or HA, technology platform. HA is a naturally occurring polymer found throughout the body that is vital for proper joint health and tissue function. Our proprietary technologies for modifying the HA molecule allow product properties to be tailored specifically to multiple uses, including enabling longer residence time to support OA pain management and creating a solid form of HA called Hyaff, which is a platform utilized in our regenerative solutions portfolio.

In early 2020, we expanded our overall technology platform, product portfolio, and significantly expanded our commercial infrastructure, especially in the United States, through our acquisitions of Parcus Medical, LLC, or Parcus Medical, a 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 look forward, our business is positioned to capture value within our target market of joint preservation. We believe our future success will be driven by our:

●

Over 30 years of experience in HA and 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 proprietary HA technology and manufacturing expertise to provide new and differentiated solutions in next generation OA Pain Management (eg. Cingal) and regenerative (eg. Integrity Implant System and Hyalofast) markets;

●

Introducing key HA products into the US market upon FDA approval/clearance, such as Cingal, Hyalofast and Integrity, our arthroscopic patch system for rotator cuff and other tendon repairs, and additional products in development that leverage our proprietary Hyaff regenerative platform;

●

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.

On October 31, 2024 (the "Closing Date"), we completed the sale of all of the outstanding equity interests (the "Transaction") of Arthrosurface Incorporated, a Delaware corporation and former wholly-owned subsidiary of the Company ("Arthrosurface"), which held our Arthrosurface business, to Phoenix Brio, Incorporated, a Delaware corporation ("Buyer"), pursuant to the terms and conditions of a Share Purchase Agreement, dated as of the Closing Date (the "Purchase Agreement"), by and amongst us, Arthrosurface and Buyer (the "Transaction").

As consideration for the Transaction, at the closing Buyer delivered to us a ten-year non-interest bearing promissory note in the principal amount of $7.0 million. Under the terms of the Purchase Agreement, we are also eligible to receive: (i) for each calendar quarter, an amount equal to a percentage of the net sales (the "Revenue Payments") for the sale of certain commercial and pipeline products during the period commencing on the Closing Date and ending on the earlier of the fifth (5th) anniversary of the Closing Date or the date on which the Buy-Out Payment (as defined below) is paid to us; and (ii) a percentage of the gross proceeds with respect to the sale of certain commercial and pipeline products in a bona-fide arm's length transaction with a third party that is not an affiliate of Buyer or us occurring within the first twenty four (24) months following the Closing Date. The Buyer can also elect to make a payment in an amount equal to the greater of (A) $14.0 milllion or (B) ten (10) times the Revenue Payments ((A) and (B) together, the "Buy-Out Payment") paid to us during the last full calendar year prior to the consummation of a change of control transaction or Buyer's written notice to us that it is electing to make the Buy-Out Payment. Pursuant to the Purchase Agreement, the aggregate consideration is subject to customary post-closing adjustments.

We also announced on October 31, 2024 our intention to divest of the Parcus Medical business. These decisions were a result of a strategic review to focus on our core HA technology and our regenerative solutions products to maximize shareholder value.

Products

OA Pain Management

Our OA Pain Management product family consists of Monovisc and Orthovisc, our injectable, HA, OA Pain Management offerings that are indicated to provide pain relief from osteoarthritis conditions; and Cingal, our novel, next generation, single-injection OA Pain Management product consisting of our proprietary cross-linked HA material combined with a 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 through at least six months. It is currently sold outside the United States in approximately 40 countries. In 2022, we completed a third Phase III clinical trial for Cingal, which achieved its primary endpoint. Cingal is not currently approved for commercial use in the United States. We have been actively engaging with the U.S. Food and Drug Administration, or the FDA, on next steps for U.S. regulatory approval. We acquired the Aristospan NDA regulatory approval in the U.S. in September 2024 to assist with our Cingal regulatory filing with the FDA.

Joint Preservation and Restoration

Our Joint Preservation and Restoration product family consists of: (a) our portfolio of orthopedic regenerative solutions products utilizing HA, including Integrity, our new hyaluronic acid-based scaffold for rotator cuff and other tendon repairs, Tactoset, our HA-enhanced injectable bone substitute, and Hyalofast, our HA, biodegradable scaffold used for cartilage regeneration currently available outside the United States in over 35 countries; (b) our line of sports medicine solutions used to repair and reconstruct damaged ligaments and tendons due to sports injuries, trauma and disease; and (c) our Arthrosurface portfolio of bone preserving joint technologies, including partial joint replacement, joint resurfacing, and minimally invasive and bone sparing implants, designed to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease.

Non-Orthopedic

Our Non-Orthopedic product family consists of legacy HA 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 includes Hyvisc, our high molecular weight injectable HA veterinary product approved for the treatment of joint dysfunction in horses due to non-infectious synovitis associated with equine OA.

Results of Operations

Three and Nine Months Ended September 30, 2024 Compared to Three and Nine Months Ended September 30, 2023

		Three Months Ended September 30,			Nine Months Ended September 30,
		2024			2023			$ Change			% Change			2024			2023			$ Change			% Change
		(in thousands, except percentages)							(in thousands, except percentages)
Revenue		$	38,753			$	41,465			$	(2,712	)			(7	%)		$	121,197			$	123,691			$	(2,494	)			(2	%)
Cost of revenue			37,313				16,521				20,792				126	%			67,764				46,932				20,832				44	%
Gross Profit			1,440				24,944				(23,504	)			(94	%)			53,433				76,759				(23,326	)			(30	%)
Gross Margin			4	%			60	%											44	%			62	%
Operating expenses:
Research & development			7,244				7,791				(547	)			(7	%)			22,806				25,105				(2,299	)			(9	%)
Selling, general & administrative			19,112				24,827				(5,715	)			(23	%)			60,445				75,512				(15,067	)			(20	%)
Long lived asset impairment			3,101				-				3,101				100	%			3,101				-				3,101				100	%
Total operating expenses			29,457				32,618				(3,161	)			(10	%)			86,352				100,617				(14,265	)			(14	%)
Income (loss) from operations			(28,017	)			(7,674	)			(20,343	)			265	%			(32,919	)			(23,858	)			(9,061	)			38	%
Interest and other income, net			406				635				(229	)			(36	%)			1,593				1,735				(142	)			(8	%)
Income (loss) before income taxes			(27,611	)			(7,039	)			(20,572	)			292	%			(31,326	)			(22,123	)			(9,203	)			42	%
Provision for (benefit from) income taxes			2,307				(463	)			2,770				(598	%)			3,194				(2,456	)			5,650				(230	%)
Net loss		$	(29,918	)		$	(6,576	)		$	(23,342	)			355	%		$	(34,520	)		$	(19,667	)		$	(14,853	)			76	%

Revenue

The following table presents revenue by product family for the three and nine-month periods ended September 30, 2024 and 2023:

		Three Months Ended September 30,
		2024			2023			$ Change			% Change
		(in thousands, except percentages)
OA Pain Management		$	24,428			$	24,888			$	(460	)			(2	%)
Joint Preservation and Restoration			11,950				13,470				(1,520	)			(11	%)
Non-Orthopedic			2,375				3,107				(732	)			(24	%)
		$	38,753			$	41,465			$	(2,712	)			(7	%)

		Nine Months Ended September 30,
		2024			2023			$ Change			% Change
		(in thousands, except percentages)
OA Pain Management		$	75,404			$	76,855			$	(1,451	)			(2	%)
Joint Preservation and Restoration			39,345				39,583				(238	)			(1	%)
Non-Orthopedic			6,448				7,253				(805	)			(11	%)
		$	121,197			$	123,691			$	(2,494	)			(2	%)

Revenue from our OA Pain Management product family decreased 2% for each of the three- and nine-month periods ended September 30, 2024, as compared to the same periods in 2023, due primarily to unfavorable timing of strategic partner orders as distributor ordering patterns can vary significantly on a quarterly basis.

Revenue from our Joint Preservation and Restoration product family decreased 11% and 1% for the three- and nine-month periods ended September 30, 2024, respectively, as compared to the same periods in 2023, primarily due to lower sales of certain legacy Arthrosurface and sports medicine products, offset somewhat from growing commercial adoption of our newest products, particularly Integrity.

Revenue from our Non-Orthopedic product family decreased 24% and 11% for the three- and nine-month periods ended September 30, 2024, as compared to the same periods in 2023, primarily due to unfavorable timing of distributor ordering patterns as well as due to the end of life of certain legacy non-orthopedic products.

Gross Profit and Margin

Gross profit for the three-month period ended September 30, 2024 decreased by $23.5 million and decreased $23.3 million for the nine-month period ended September 30, 2024 to $1.4 million and $53.4 million, respectively. Gross profit for the three- and nine-month periods ended September 30, 2023 was $24.9 million and $76.8 million, respectively. The decrease in gross profit for the three-month and nine-month periods ended September 30, 2024 was due primarily to the write down of inventories and related raw material deposits with the Arthrosurface business in the amount of $23.4 million during the three-month period ended September 30, 2024.

Gross margin for the three- and nine-month periods ended September 30, 2024 was 4% and 44%, respectively. Gross margin for the three- and nine-month period ended September 30, 2023 was 60% and 62%, respectively. The increase in gross margin for the three- and nine-month periods ended September 30, 2024, as compared to the same periods in 2023 was primarily due to the write-down of Arthrosurface inventories.

Research and Development

Research and development expenses for the three- and nine-month periods ended September 30, 2024 were $7.2 million and $22.8 million, respectively. Research and development expenses for the three- and nine-month periods ended September 30, 2023 were $7.8 million and $25.1 million, respectively. The decrease for the three-month and nine-month periods ended September 30, 2024 was primarily related to lower product development and regulatory costs.

Selling, General and Administrative

Selling, general and administrative expenses for the three- and nine-month periods ended September 30, 2024 were $19.1 million and $60.4 million, respectively. Selling, general and administrative expenses for the three- and nine-month periods ended September 30, 2023 were $24.8 million and $75.5 million, respectively. This decrease for the three- and nine-month periods ended September 30, 2024 was primarily due to a $3.3 million payment on the Parcus Medical unitholder arbitration settlement in 2023, a $1.4 million benefit on the settlement of a contract obligation related to a discontinuation of a software project, cost savings as a result of recent headcount reductions taken in first quarter of 2024, and lower shareholder activism costs in 2024.

Impairment of Long-Lived Assets

We assess our long-lived assets for impairment under certain circumstances, such as when events or changes in circumstances indicate there may be impairment. On October 31, 2024, we sold our equity interest in Arthrosurface Incorporated. in which the expected consideration will be less than carrying value of the net assets of the Arthrosurface reporting unit at September 30, 2024. As a result, we performed an assessment of long-lived assets for impairment related to Arthrosurface reporting unit. The results of these impairment tests indicated that the estimated fair value of this reporting unit was less than its carrying value. Consequently, a non-cash impairment of long-lived assets charge of $3.1 million was recorded in the three-month period ended September 30, 2024. The decline in fair value was primarily due to expectation of lower cash flows related the Arthrosurface reporting unit.

Income Taxes

Income tax expense was $2.3 million and $3.2 million for the three- and nine-month periods ended September 30, 2024, resulting in effective tax rates of (8.4%) and (10.2%), respectively. The income tax benefit was $0.5 million and $2.5 million for the three- and nine-month periods ended September 30, 2023, resulting in an effective tax rate of 6.6% and 11.1%, respectively. The net change in the effective tax rate for the three- and nine-month periods ended September 30, 2024, as compared to the same periods in 2023, was primarily due to the impact of the valuation allowance in the U.S. in both the current and prior periods and the impact of recording of $1.5 million of discrete items during the nine-month period ended September 30, 2024. The Company's effective tax rate for the three- and nine-month periods ended September 30, 2024 was primarily driven by the full valuation on the Company's deferred tax assets in the US and the projected taxable income for the Company, and resulting current tax payable, for the three- and nine-month periods ended September 30, 2024.

Net Loss

For the three- and nine-month periods ended September 30, 2024, net loss was $29.9 million and $34.5 million, or $2.03 loss per diluted share and $2.34 loss per diluted share, respectively, compared to a net loss of $6.6 million and $19.7 million, or $0.45 loss per diluted share and $1.34 loss per diluted share, for the same periods in the prior year. The decrease in net loss and diluted net loss per share was primarily due to impairment charges and write-down of assets related to the Arthrosurface business.

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, certain writedowns of inventories to realizable value 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 and nine-month periods ended September 30, 2024 and 2023, respectively:

		For the Three Months Ended September 30,			For the Nine Months Ended September 30,
		2024			2023			2024			2023
Gross profit		$	1,440			$	24,944			$	53,433			$	76,759
Product rationalization charges			-				748				472				748
Writedown of inventories			23,438				-				23,438				-
Acquisition related intangible asset amortization			153				1,561				464				4,684
Adjusted gross profit		$	25,031			$	27,253			$	77,807			$	82,191
Adjusted gross margin			65	%			66	%			64	%			66	%

Adjusted gross profit for the three- and nine-month periods ended September 30, 2024 decreased $2.3 million and $4.4 million to $25.0 million and $77.8 million, respectively, representing adjusted gross margin of 65% and 64%, respectively. Adjusted gross profit for the three- and nine-month periods ended September 30, 2023 was $27.3 million and $82.2 million, respectively, or adjusted gross margin of 66% and 66%, respectively. The decrease in adjusted gross margin for the three- and nine-month periods ended September 30, 2024 as compared to 2023 was due to lower revenue largely due to a higher proportion of international revenues which have lower margins.

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, impairments or writedowns on acquired assets, 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 and nine-month periods ended September 30, 2024 and 2023, respectively:

		For the Three Months Ended September 30,			For the Nine Months Ended September 30,
		2024			2023			2024			2023
Net loss		$	(29,918	)		$	(6,576	)		$	(34,520	)		$	(19,667	)
Interest and other income, net			(406	)			(635	)			(1,593	)			(1,735	)
Provision for (benefit from) income taxes			2,307				(463	)			3,194				(2,456	)
Depreciation and amortization			2,045				1,755				5,800				5,282
Share-based compensation			3,394				3,561				10,875				11,428
Arbitration settlement			-				-				-				3,250
Product rationalization charges			-				748				472				748
Acquisition related intangible asset amortization			143				1,787				509				5,361
Impairment/writedown of assets			27,401				-				27,401				-
Discontinuation of software development project			-				4,473				(1,404	)			4,473
Non-recurring professional fees			465				-				465				-
Severance costs			-				-				839				-
Costs of shareholder activism			-				-				2,185				3,033
Adjusted EBITDA		$	5,431			$	4,650			$	14,223			$	9,717

Adjusted EBITDA in the three-month period ended September 30, 2024 increased $0.7 million as compared with the same period in 2023. Adjusted EBITDA for the period was primarily driven by lower operating expenses offset by the reduced volume of higher margin US OA Pain Management revenue.

Adjusted EBITDA in the nine-month period ended September 30, 2024, increased $4.5 million as compared with the same period in 2023. The increase in adjusted EBITDA for the period was due to lower operating expenses, growth in new product sales, offset partially by lower OA Pain Management revenue in the US.

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 and nine-month periods ended September 30, 2024 and 2023, respectively:

		For the Three Months Ended September 30,			For the Nine Months Ended September 30,
		2024			2023			2024			2023
Net loss		$	(29,918	)		$	(6,576	)		$	(34,520	)		$	(19,667	)
Product rationalization, tax effected			-				699				392				665
Arbitration settlement, tax effected			-				-				-				2,889
Share based compensation, tax effected			2,820				3,327				9,037				10,159
Acquisition related intangible asset amortization, tax effected			119				1,669				423				4,767
Impairment/writedown of assets, tax effected			22,770				-				22,770				-
Discontinuation of software development project, tax effected			-				4,179				(1,167	)			3,976
Non-recurring professional fees, tax effected			386				-				386				-
Severance costs, tax effected			-				-				697				-
Costs of shareholder activism, tax effected			-				-				1,816				2,696
Adjusted net (loss) income		$	(3,823	)		$	3,298			$	(166	)		$	5,485

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 and nine-month periods ended September 30, 2024 and 2023, respectively:

		For the Three Months Ended September 30,			For the Nine Months Ended September 30,
		2024			2023			2024			2023
Diluted (loss) earnings per share (EPS)		$	(2.03	)		$	(0.45	)		$	(2.34	)		$	(1.34	)
Product rationalization, tax effected			-				0.05				0.03				0.05
Arbitration settlement, tax effected			-				-				-				0.20
Share based compensation, tax effected			0.19				0.23				0.61				0.69
Acquisition related intangible asset amortization; tax effected			0.01				0.11				0.03				0.32
Impairment/writedown of assets, tax effected			1.55				-				1.55				-
Discontinuation of software development project, tax effected			-				0.29				(0.08	)			0.27
Non-recurring professional fees, tax effected			0.03				-				0.02				-
Severance costs, tax effected			-				-				0.05				-
Cost of shareholder activism, tax effected			-				-				0.12				0.18
Adjusted diluted earnings per share (EPS)		$	(0.25	)		$	0.23			$	(0.01	)		$	0.37

Adjusted net income and adjusted diluted earnings per share in the three-month period ended September 30, 2024 decreased $7.1 million and $0.48, respectively, as compared with the same period in 2023. The decrease for the period was primarily due to lower revenues due to timing of strategic ordering patterns with OA Pain Management customers that have higher margins.

Adjusted net income and adjusted diluted earnings per share in the nine-month period ended September 30, 2024 decreased $5.7 million and $0.38, respectively, as compared with the same period in 2023. The increase for the period was primarily due to lower operating expenses in 2024 partially offset by lower revenues on timing of strategic ordering patterns with higher margin OA Pain Management customers.

Liquidity and Capital Resources

We require cash to fund our operating activities and to make capital expenditures and other investments in the business. We expect that our requirements for cash to fund these uses will increase as our operations expand. We continue to generate cash from operating activities and believe that our operating cash flows, cash currently on our balance sheet and availability 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 needs. Cash and cash equivalents were $62.4 million and $72.9 million, and working capital totaled $110.6 million and $132.2 million, at September 30, 2024 and December 31, 2023, respectively.

On November 12, 2021, we entered 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 $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 a maximum aggregate commitment of $150.0 million. As of September 30, 2024, and December 31, 2023, there were no outstanding borrowings, and we are in compliance with the terms of the credit facility.

Summary of Cash Flows (in thousands):

		Nine Months Ended September 30,
		2024			2023
Cash (used in) provided by
Operating activities		$	3,821			$	(5,426	)
Investing activities			(7,027	)			(3,587	)
Financing activities			(7,375	)			(6,666	)
Effect of exchange rate changes on cash			82				3
Net decrease in cash and cash equivalents		$	(10,499	)		$	(15,676	)

The following changes contributed to the net change in cash and cash equivalents in the nine-month period ended September 30, 2024 as compared to the same period in 2023.

Operating Activities

Cash provided by operating activities was $3.8 million for the nine-month period ended September 30, 2024, as compared to cash used in operating activities of $5.4 million for the same period in 2023. The increase in cash provided by operating activities for the nine-months ended September 30, 2024, compared to the same period in prior year, was primarily due to a lower net loss during the nine-month period ended September 30, 2024 and higher non-recurring costs in 2023 for the Parcus Medical arbitration settlement and shareholder activism expenses.

Investing Activities

Cash used in investing activities was $7.0 million for the nine-month period ended September 30, 2024, as compared to cash used in investing activities of $3.6 million for the same period in 2023. The change was primarily due to an increase in capital expenditures in 2024 to support the expansion of manufacturing capacity at our Bedford facility and a purchase of developed technology for $0.6 million.

Financing Activities

Cash used in financing activities was $7.4 million for the nine-month period ended September 30, 2024, as compared to cash used in financing activities of $6.7 million for the same period in 2023. In both periods, the cash used in financing activities was primarily attributable to utilization of cash for share repurchases and employee tax withholding in exchange for shares surrendered by equity award holders. We paid $5.3 million and $5.0 million in share repurchases for the nine-month periods ended September 2024 and 2023, respectively.

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 have been no 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 annual consolidated financial statements and accompanying notes included in our 2023 Form 10-K for the year ended December 31, 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 2023 Form 10-K for the fiscal year ended December 31, 2023 and is updated in the Notes to the condensed consolidated financial statements included in this report.

Contractual Obligations and Other Commercial Commitments

Our contractual obligations and other commercial commitments are summarized in the section captioned "Part II, Item 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 2023 Form 10-K for the year ended December 31, 2023. There were no material changes to our contractual obligations reported in our 2023 Form 10-K during the nine months ended September 30, 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, 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.

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. Quantitative and Qualitative Disclosures About Market Risk" in our Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes in the first six months of 2024 to our market risks or to our management of such risks.

ITEM 4.

CONTROLS AND PROCEDURES

(a) Evaluation of disclosure controls and procedures.

Under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, we 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 September 30, 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 we file or submit 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.

There were no material changes in our internal control over financial reporting during the quarter ended September 30, 2024, that have materially affected, or were reasonably likely to materially affect, our internal control over financial reporting.

PART II:

OTHER INFORMATION

ITEM 1.

LEGAL PROCEEDINGS

We are involved from time-to-time in various legal proceedings arising in the normal 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. Legal Proceedings" in our Annual Report on Form 10-K for the year ended December 31, 2023.

ITEM 1A.

RISK FACTORS

There have been no material changes to the risk factors described in the section captioned "Part I, Item 1A. Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023 as amended and supplemented by the information in "Part II, Item 1A. Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly periods ended March 31, 2024 and June 30, 2024. 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. Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023 and in "Part II, Item 1A. Risk Factors" in our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2024 and June 30, 2024, which could materially affect our business, financial condition, or future results. The risks described in our Annual Report on Form 10-K and such subsequently filed Quarterly Report on Form 10-Q 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.

The impact of the Russian invasion of Ukraine and the conflict in the Middle East on the global economy, energy supplies and raw materials is uncertain, but may prove to negatively impact our business and operations.

The short and long-term implications of Russia's invasion of Ukraine and the conflict in the Middle East are difficult to predict at this time. We continue to monitor any adverse impact that the outbreak of war in Ukraine, the subsequent institution of sanctions against Russia by the United States and several European and Asian countries, and the conflict in the Middle East may have on the global economy in general, on our business and operations and on the businesses and operations of our suppliers and other third parties with which we conduct business. For example, a prolonged conflict in Ukraine or the Middle East may result in increased inflation, escalating energy prices and constrained availability, and thus increasing costs, of raw materials. We also have suppliers and customers in and around those areas that we periodically do business with that could be disrupted by these events. We will continue to monitor this fluid situation and develop contingency plans as necessary to address any disruptions to our business operations as they develop. To the extent these conflicts may adversely affect our business as discussed above, it may also have the effect of heightening many of the other risks described herein. Such risks include, but are not limited to, adverse effects on macroeconomic conditions, including inflation; disruptions to our global technology infrastructure, including through cyberattack, ransom attack, or cyber-intrusion; adverse changes in international trade policies and relations; disruptions in global supply chains; and constraints, volatility, or disruption in the capital markets, any of which could negatively affect our business and financial condition.

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Issuer Purchases of Equity Securities

The following is a summary of stock repurchases for the three-month period ended September 30, 2024 (in thousands, except share and per share data):

Period		(a) Total number of shares purchased (1)			(b) Average Price per Share			(c) Total number of shares purchased as part of publicly announced plans or programs			(d) Maximum number (or approximate dollar value) of shares that may yet be purchased under the plans or programs
July 1 to 31, 2024			49,245			$	27.23				49,245			$	37,289
August 1 to 31, 2024			53,605			$	25.76				53,605			$	35,908
September 1 to 30, 2024			50,002			$	24.94				50,002			$	34,661
Total			152,852								152,852

(1) In May 2024, we agreed to implement a share repurchase program for an aggregate purchase price of $40.0 million to occur as follows: (i) first $15.0 million was to be effected through a Rule 10b5-1 plan initiated prior to June 1, 2024 and to be effective through June 30, 2025, and (ii) the remaining amount to be purchased in the open market (the "2024 Share Repurchase Program"). In the event of positive "free cash flow" as defined in the Cooperation Agreement dated May 28, 2024, with Caligan Partners LP, Caligan Partners Master Fund LP and David Johnson, for the period from July 1, 2024 through June 30, 2025, the amount under the share repurchase program shall be increased by 50% of such positive amount and in no event would we be required to make any purchases in the event that our cash would be less than $45.0 million after taking into account the share repurchase and reasonably anticipated capital expenditures and restructuring costs. This new authorization replaces our share repurchase program previously announced in April 2023. On May 28, 2024, the Company entered into a share repurchase agreement under a Rule 10b5-1 with Bank of America. As of September 30, 2024, the Company had repurchased 205,404 shares at an average cost of $25.99 per share, representing 13% of the then estimated total number of shares expected to be repurchased under the 2024 Share Repurchase Program.

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 September 30, 2024, noneof 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
3.1	Certificate of Incorporation of Anika Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K (File No. 001-14027) filed by the Registrant on June 6, 2018)
3.2	Bylaws of Anika Therapeutics, Inc., effective as of June 6, 2018 (incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K (File No. 001-14027) filed by the Registrant on June 6, 2018)
(31)	Rule 13a-14(a)/15d-14(a) Certifications
*31.1	Certification of 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 Stephen Griffin, 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
**32.1	Certification of Dr. Cheryl R. Blanchard, and Stephen Griffin, 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, 2024 as filed with the SEC on October 31, 2024, formatted in Inline XBRL (eXtensible Business Reporting Language), as follows:

i.

Condensed Consolidated Balance Sheets as of September 30, 2024 (unaudited) and December 31, 2023 (unaudited)

ii.

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

iii.

Condensed Consolidated Statements of Stockholders' Equity for the Nine Months Ended September 30, 2024 and September 30, 2023 (unaudited)

iv.

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and September 30, 2023 (unaudited)

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.

SIGNATURES

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

		ANIKA THERAPEUTICS, INC.
		(Registrant)
Date: November 4, 2024	By:	/s/ STEPHEN GRIFFIN
		Stephen Griffin
		Executive Vice President, Chief Financial Officer and Treasurer
		(Authorized Officer and Principal Financial Officer)