Anika Therapeutics, Inc.
For the period ended Jun 30, 2025. Filed Jul 30, 2025.
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Jun 30, 2025 · Filed Jul 30, 2025
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Notes to Condensed Consolidated Financial Statements
(amounts in thousands, except share and per share amounts or as otherwise noted)
| 1. | Nature of Business |
Anika Therapeutics, Inc. (the “Company”) is a global joint preservation company in osteoarthritis (“OA”) pain management and regenerative solutions, focusing on early intervention orthopedics. The Company offers hyaluronic acid-based advancements in its OA Pain Management and Regenerative Solutions businesses, designed to restore active living, empower surgeon choice, and enhance patient outcomes worldwide.
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. These acquisitions broadened the Company's product portfolio, developed over its 30 years of expertise in hyaluronic acid technology, into joint preservation and restoration, increased its commercial capabilities, diversified its revenue base, and expanded its product pipeline and research and development expertise.
In October 2024, the Company announced a strategic shift to focus on its OA Pain Management and Regenerative Solutions businesses. This strategic decision resulted in the sale of Arthrosurface on October 31, 2024 and the sale of Parcus Medical on March 7, 2025.
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, 2024 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, 2024. The results of operations for the three and six-month periods ended June 30, 2025 are not indicative of the results to be expected for the year ending December 31, 2025.
As noted above, the Company made a strategic decision in October 2024 that resulted in the sales of Arthrosurface and Parcus Medical. See Note 3,*Discontinued Operations,*for further information. The condensed consolidated financial statements reflect Arthrosurface and Parcus Medical’s results of operations as discontinued operations for all periods presented, and the related assets and liabilities as held-for-sale as of December 31, 2024.
Recent Accounting Pronouncements
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.
In November 2024, the FASB issued ASU No. 2024-03,Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40):Disaggregation of Income Statement Expenses, and in January 2025, the FASB issued ASU No. 2025-01,Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. ASU 2024-03 requires additional disclosure of the nature of expenses included in the income statement as well as disclosures about specific types of expenses included in the expense captions presented in the income statement. ASU 2024-03, as clarified by ASU 2025-01, is effective for public companies for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is evaluating the impact of ASU 2024-03 on its disclosures in future years as a result of the adoption of ASU 2024-03.
| 3. | Discontinued Operations |
In October 2024, the Company announced a strategic shift to focus on its OA Pain Management and Regenerative Solutions businesses. This strategic decision resulted in the sale of Arthrosurface on October 31, 2024 and the sale of Parcus Medical on March 7, 2025.
Arthrosurface
On October 31, 2024 (the “Closing Date”), the Company completed the sale of all of the outstanding equity interests of Arthrosurface, a Delaware corporation and former wholly-owned subsidiary of the Company, which held the Company’s Arthrosurface business, to Phoenix Brio, Incorporated, a Delaware corporation (the “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 “Arthrosurface Transaction”).
As consideration for the Arthrosurface Transaction, at the closing, the 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. The Company determined the fair value of the consideration with the sale of the Arthrosurface asset group to be $5.9 million and recorded as Notes Receivable on its balance sheet at the time of divestiture. The carrying value of the Notes Receivable was $6.0 million and $5.9 million, as of June 30, 2025 and December 31, 2024, respectively.
Parcus Medical
On March 7, 2025, the Company completed the sale of all outstanding equity interests of Parcus Medical, to Medacta Americas Manufacturing, Inc. (“Medacta”), pursuant to the terms and conditions of a Membership Interest Purchase Agreement (the “Parcus Transaction”). As consideration for the Parcus Transaction, at closing, Medacta paid $4.5 million in cash. Pursuant to the terms of the agreement, the aggregate consideration is subject to customary post-closing adjustments.
The components of loss from discontinued operations for the three and six months ended June 30, 2025 and 2024, consist of the following (in thousands):
| Three Months Ended June 30, · Six Months Ended June 30, | |||||
|---|---|---|---|---|---|
| 2025 · 2024 · 2025 · 2024 | |||||
| Revenue | $ | - | $11,197 | $2,710 | $22,699 |
| Costs and expenses | (14) | 9,225 | 3,611 | 23,285 | |
| Income (loss) from discontinued operations before income taxes | 14 | 1,972 | (901) | (586) | |
| Benefit from income taxes | (663) | (481) | (663) | (481) | |
| Net income (loss) from discontinued operations | $677 | $2,453 | $(238) | $(105) | |
The assets and liabilities reported as held-for-sale consist of the following (in thousands):
| As of December 31, | |
|---|---|
| Assets | |
| Cash and cash equivalents | $1,531 |
| Accounts receivable, net | 3,285 |
| Inventories | 221 |
| Prepaid expenses and other current assets | 89 |
| Property and equipment, net | 1,134 |
| Right-of-use assets | 892 |
| Total assets held-for-sale | $7,152 |
| Liabilities | |
| Accounts payable | $797 |
| Accrued expenses and other current liabilities | 3,324 |
| Lease liabilities | 660 |
| Total liabilities held-for-sale | $4,781 |
There are no assets and liabilities reported as held-for-sale as of June 30, 2025, as the Company completed the divestitures of the Arthrosurface and Parcus Medical asset groups prior to June 30, 2025.
Selected financial information related to significant operating and investing cash flow items from discontinued operations (excluding working capital impacts) are as follows (in thousands):
| Six Months Ended June 30, | |||
|---|---|---|---|
| 2025 · 2024 | |||
| Depreciation | $149 | $1,006 | |
| Amortization of acquisition related intangible assets | $ | - | $339 |
| Non-cash operating lease cost | $55 | $45 | |
| Stock-based compensation expense | $132 | $692 | |
| Provision for inventory | $ | - | $1,534 |
| Purchases of property and equipment | $19 | $466 | |
| 4. | 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 | |
|---|---|---|
| June 30, | December 31, | |
| 2025 | 2024 | |
| Accounts Receivable | $24,754 | $24,324 |
| Less: Allowance for credit losses | 799 | 730 |
| Net balance, end of period | $23,955 | $23,594 |
A summary of activity in the allowance for credit losses is as follows:
| As of June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Balance, beginning of the period | $730 | $666 |
| Amounts provided | 258 | 76 |
| Amounts recovered | (118) | (38) |
| Amounts written off | (138) | (36) |
| Translation adjustments | 67 | (15) |
| Balance, end of period | $799 | $653 |
| 5. | 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 six-month periods ended June 30, 2025 and 2024, respectively.
The classification of the Company’s cash equivalents within the fair value hierarchy was as follows:
| June 30, · Active Markets for Identical Assets · Significant Other Observable Inputs · Significant Unobservable Inputs · Amortized | |||||||
|---|---|---|---|---|---|---|---|
| 2025 · (Level 1) · (Level 2) · (Level 3) · Cost | |||||||
| Cash equivalents: | |||||||
| Money Market Funds | $39,892 | $39,892 | $ | - | $ | - | $39,892 |
| December 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 | $46,061 | $46,061 | $ | - | $ | - | $46,061 |
| 6. | Inventories |
Inventories consist of the following:
| June 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Raw materials | $9,965 | $13,180 |
| Work-in-process | 7,536 | 7,001 |
| Finished goods | 4,527 | 8,761 |
| Total | $22,028 | $28,942 |
| Inventories | $16,922 | $23,809 |
| Other long-term assets | 5,106 | 5,133 |
| Total | $22,028 | $28,942 |
Inventories are stated net of inventory reserves of approximately $6.2 million and $3.9 million, as of June 30, 2025 and December 31, 2024, respectively.
| 7. | Property and Equipment |
Property and equipment is stated at cost and consists of the following:
| June 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Equipment and software | $45,401 | $41,390 |
| Furniture and fixtures | 1,596 | 1,509 |
| Leasehold improvements | 37,318 | 36,340 |
| Construction in progress | 5,973 | 6,039 |
| Subtotal | 90,288 | 85,278 |
| Less accumulated depreciation | (49,205) | (46,284) |
| Total | $41,083 | $38,994 |
Depreciation expense was $1.3 million and $1.2 million for the three-month periods ended June 30, 2025 and 2024, respectively. Depreciation was $2.5 million for each of the six-month periods ended June 30, 2025 and 2024, respectively.
| 8. | Intangible Assets |
Intangible assets as of June 30, 2025 and December 31, 2024 consisted of the following:
| December 31, | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Six Months ended June 30, 2025 · 2024 | |||||||||
| Gross Value · Less: Disposals · Less: Accumulated Currency Translation Adjustment · Less: Accumulated Amortization · Net Book Value · Net Book Value · Weighted Average Useful Life | |||||||||
| Developed technology | $12,080 | $(600) | $(1,608) | $(9,872) | $ | - | $805 | $15 | |
| In-process research & development | 2,656 | - | (1,006) | - | 1,650 | 1,650 | Indefinite | ||
| Patents | 1,000 | - | (189) | (800) | 11 | 35 | 16 | ||
| Total | $15,736 | $(600) | $(2,803) | $(10,672) | $1,661 | $2,490 | 13 | ||
The aggregate amortization expense related to intangible assets was $0.2 million for each of the three-month periods ended June 30, 2025 and 2024, respectively and $0.4 million and $0.3 million for the six-month periods ended June 30, 2025 and 2024, respectively. During the three-month period ended June 30, 2025, the Company sold a developed technology intangible asset for $0.6 million which resulted in a gain of $0.1 million.
As of June 30, 2025 scheduled amortization of intangible assets is as follows:
| Remainder of 2025 | $11 |
|---|---|
| Total | $11 |
| 9. | 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 six-months ended June 30, 2025 were as follows:
| Six Months Ended June 30, | |
|---|---|
| Balance, beginning of period | $7,125 |
| Effect of foreign currency adjustments | 931 |
| Balance, ending of period | $8,056 |
| 10. | Accrued Expenses and Other Current Liabilities |
Accrued expenses and other current liabilities consist of the following:
| June 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Compensation and related expenses | $5,959 | $6,828 |
| Operating lease liability – current | 1,815 | 1,918 |
| Professional fees | 1,434 | 2,485 |
| Stock-based compensation | 1,100 | 1,213 |
| Clinical trial costs | 361 | 295 |
| Income taxes payable | - | 63 |
| Other | 641 | 765 |
| Total | $11,310 | $13,567 |
| 11. | 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 hadno accrued warranties as of June 30, 2025 or December 31, 2024 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.
| 12. | Revenue and Geographic Information |
Revenue by product classification is as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Original Equipment Manufacturer (“OEM”) Channel | $16,340 | $18,887 | $31,249 | $38,337 |
| Commercial Channel | 11,879 | 11,837 | 23,138 | 21,409 |
| $28,219 | $30,724 | $54,387 | $59,746 | |
Revenue from the Company’s sole significant customer, Johnson & Johnson MedTech (“J&J MedTech”), part of the Johnson & Johnson Medical Companies, as a percentage of the Company’s total revenue was 50% and 56% for the three-months ended June 30, 2025 and 2024, respectively, and 50% and 57% for the six-months ended June 30, 2025 and 2024, 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 June 30, | ||||
|---|---|---|---|---|
| 2025 · 2024 | ||||
| Percentage of | Percentage of | |||
| Revenue | Revenue | Revenue | Revenue | |
| Geographic Location: | ||||
| United States | $17,924 | 63% | $20,090 | 65% |
| Europe | 4,752 | 17% | 5,713 | 19% |
| Other | 5,543 | 20% | 4,921 | 16% |
| Total | $28,219 | 100% | $30,724 | 100% |
| Six Months Ended June 30, | ||||
|---|---|---|---|---|
| 2025 · 2024 | ||||
| Percentage of | Percentage of | |||
| Revenue | Revenue | Revenue | Revenue | |
| Geographic Location: | ||||
| United States | $34,287 | 63% | $40,462 | 68% |
| Europe | 10,550 | 19% | 10,278 | 17% |
| Other | 9,550 | 18% | 9,006 | 15% |
| Total | $54,387 | 100% | $59,746 | 100% |
| 13. | Equity Incentive Plans |
Equity Incentive Plans
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, June 14, 2023 and June 20, 2025. On June 20, 2025, the Company’s stockholders approved an amendment to the 2017 Plan increasing the number of shares by 475,000 shares from 5,285,000 shares to 5,760,000 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 bytwo shares. Subject to adjustment for specified types of changes in the Company’s capitalization, no more than 5.8 million shares of common stock may be issued under the 2017 Plan. There were 1.3 million shares available for future grant at June 30, 2025 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). Subject to adjustment for specified types of changes in the Company’s capitalization, no more than 350,000 shares of common stock may be issued under the Inducement Plan. There were 0.1 million shares available for future grant at June 30, 2025 under the Inducement Plan.
The Company may satisfy share-settled 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 maximum contractual term often 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 June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Cost of revenue | $56 | $173 | $162 | $299 |
| Research & development | 183 | 572 | 625 | 1,102 |
| Selling, general & administrative | 2,309 | 3,146 | 4,756 | 6,080 |
| Total stock-based compensation expense | $2,548 | $3,891 | $5,543 | $7,481 |
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 ofthree 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 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, 2024 | 2,089,040 | $32.07 | $ | - | ||
| Granted | 11,300 | $13.99 | ||||
| Exercised | - | $ | - | $ | - | |
| Forfeited and canceled | (272,468) | $34.03 | $ | - | ||
| Outstanding as of June 30, 2025 | 1,827,872 | $31.65 | 6.6 | $ | - | |
| Vested, June 30, 2025 | 1,394,669 | $32.93 | 6.0 | $ | - | |
| Vested or expected to vest, June 30, 2025 | 1,827,872 | $31.65 | 6.6 | $ | - | |
There were no options exercised for the six-month period ended June 30, 2025.
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 six months June 30, 2025 and 2024, along with the weighted-average grant-date fair values, were as follows:
| Six Months Ended | ||||||
|---|---|---|---|---|---|---|
| June 30, | ||||||
| 2025 · 2024 | ||||||
| Risk free interest rate | 3.8% | - | 4.0% | 3.9% | - | 4.6% |
| Expected volatility | 41.6% | - | 42.9% | 44.5% | - | 48.2% |
| Expected life (years) | 4.5 | 4.5 | ||||
| Expected dividend yield | 0.0% | 0.0% | ||||
| Fair value per option | $5.60 | $10.52 | ||||
As of June 30, 2025, there was $3.7 million of unrecognized compensation related to unvested stock options. This expense is expected to be recognized over a weighted average period of 1.6 years.
Restricted Stock Units (“RSUs”)
RSUs generally vest in equal annual installments over athree-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 six-month period ended June 30, 2025 was as follows:
| Weighted Average | ||
|---|---|---|
| Number of | Grant Date | |
| Shares | Fair Value | |
| Outstanding as of December 31, 2024 | 836,562 | $26.70 |
| Granted | 569,042 | $14.15 |
| Vested | (311,335) | $22.67 |
| Forfeited and cancelled | (123,808) | $19.26 |
| Outstanding as of June 30, 2025 | 970,461 | $21.58 |
The weighted-average grant-date fair value per share of RSUs granted was $14.15 and $26.68 for the six-month periods ended June 30, 2025 and 2024, respectively. The total fair value of RSUs vested was $6.7 million and $9.3 million for the six-month periods ended June 30, 2025 and 2024, respectively. As of June 30, 2025, there was $3.3 million of unrecognized compensation cost related to time-based RSUs, which was expected to be recognized over a weighted-average period of 1.1 years.
The Company’s annual grants of RSU awards in March 2024 and 2025 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 these 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. The first tranche of the March 2024 RSU awards,106,550 shares, vested in March 2025 and were settled in shares. As of June 30, 2025, the Company had 620,195 RSU shares outstanding for which a liability of $0.7 million was recorded in Accrued Expenses and Other Liabilities and there is unrecorded compensation cost of $5.8 million which is to be recognized over a weighted-average period of 2.4 years.
Performance Stock Units (“PSUs”)
PSU activity for the six-month period ended June 30, 2025 was as follows:
| Weighted Average | |||
|---|---|---|---|
| Number of · Grant Date | |||
| Shares · Fair Value | |||
| Outstanding as of December 31, 2024 | - | $ | - |
| Granted | 290,792 | $15.36 | |
| Vested | - | $ | - |
| Forfeited and cancelled | (11,038) | $10.50 | |
| Outstanding as of June 30, 2025 | 279,754 | $15.55 | |
The weighted-average grant-date fair value per share of PSUs granted was $15.36 for the six-month period ended June 30, 2025. There wereno PSUs granted in the six-month period ended June 30, 2024.
On March 14, 2025, the Company granted 290,792 PSUs to certain senior management employees. The Company granted two different PSU awards to each PSU award recipient. One form of PSU award is a 3-year cliff vest subject to achievement of certain market-based metrics in which 50-200% of target shares granted may vest based on achievement of the specified market price targets during the performance period from March 14, 2025 through March 1, 2028. No shares will vest if these market price targets are not achieved. The Company estimated the fair value of these market-based PSUs using a Monte Carlo simulation model at the grant date and will continue to use the Monte- Carlo simulation model to update the fair value at the end of each reporting period. The second form of PSU awards is vesting in equal annual installments of target on each anniversary date of grant over three years, subject to annual achievement of the specified strategic performance objectives each year based upon certain regulatory milestones and financial targets. Subject to achievement of each milestone, these awards will vest annually on each anniversary date of the grant date over three years. The Company recognizes stock-based compensation based on the probability outcomes of achieving these milestones.
The Company’s annual grants of PSU awards in March 2025 can be settled at vesting in cash or shares at the Company’s election. The Company has recorded these PSUs as a liability due to the expectation that the Company will settle the vesting of these PSU awards in cash due to a potential shortage of shares in the 2017 Plan at the time of vesting. As a result, these PSUs will be subject to change in value at the time of each reporting period. As of June 30, 2025, the Company had 279,754 shares outstanding for which a liability of $0.4 million was recorded in Accrued Expenses and Other Liabilities and there is unrecorded compensation cost of $1.9 million associated with these PSUs which is to be recognized over a weighted-average period of 2.8 years.
| 14. | Income Taxes |
The income tax expense was $0.7 million and $0.8 million for the three- and six-month periods ended June 30, 2025, resulting in effective tax rates of (17.2)% and (9.8)%, respectively. The income tax expense was $1.3 million and $1.4 million for the three- and six-month periods ended June 30, 2024, resulting in an effective tax rate of (109.2)% and (43.8)%, respectively.
The net change in the effective tax rate for the three- and six-month periods ended June 30, 2025, compared to the same periods in 2024, was primarily driven by the impact of a higher year-to-date pre-tax loss in the current year and higher U.S. current tax expense in the prior year. The higher tax expense in the prior year was due to greater projected U.S. taxable income, despite the continued presence of a full valuation allowance. The Company’s effective tax rate for the three-month and six-month periods ended June 30, 2025 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 current tax expense in 2025.
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, 2025 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 income tax provision for the six-month period ended June 30, 2025 includes an adjustment for the valuation allowance required against the U.S. deferred tax assets. As of June 30, 2025, 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 they remain under review.
On July 4, 2025, new U.S. tax legislation was enacted, including updates to provisions related to research and development expensing for income tax purposes, bonus depreciation, and international tax regimes. Since the enactment occurred after the quarter ended June 30, 2025, the effects are not reflected in these financial statements. The Company is evaluating the impact, which will be recognized in the third quarter of 2025. Other provisions of the legislation are not expected to have a material effect.
| 15. | 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 following table provides share information used in the calculation of the Company's basic and diluted EPS (in thousands):
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Shares used in the calculation of basic EPS | 14,364 | 14,839 | 14,331 | 14,769 |
| Effect of dilutive securities: | ||||
| Share based awards | 153 | 17 | - | - |
| Diluted shares used in the calculation of EPS | 14,517 | 14,856 | 14,331 | 14,769 |
The Company had a net loss during the six-month periods ended June 30, 2025 and 2024, 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 1.8 million shares and 2.3 million shares were outstanding at June 30, 2025 and 2024, respectively. Restricted and performance stock units totaling 1.3 million and 0.9 million were outstanding at June 30, 2025 and 2024, respectively. Of these securities outstanding, 0.1 million and a nominal amount of securities for the three-month periods ended June 30, 2025 and 2024, respectively, were considered to be dilutive in the computation of diluted EPS.
| 16. | 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. 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.
On May 28, 2024, the Company entered into a share repurchase agreement under a Rule 10b5-1 Plan with Bank of America. As of June 30, 2025, the Company completed the first part of the share repurchase program in which it purchased 746,431 shares at an average cost of $20.10 per share for a total cost of $15.0 million. The Company currently does not have an active share repurchase agreement in place.
| 17. | Segment Information |
Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision-maker (“CODM”) in deciding how to allocate resources and assess performance. The Company operates inone business segment. The Company’s CODM is its President and Chief Executive Officer, who reviews financial information presented on a consolidated basis. The CODM’s financial review is focused on the consolidated financial results of the Company which is used as the basis for financial performance assessment and allocation of resources.
The following table presents financial information with respect to the Company’s single operating segment for the three and six months ended June 30, 2025 and 2024 (in thousands):
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Revenue | $28,219 | $30,724 | $54,387 | $59,746 |
| Cost of product revenue | 13,856 | 10,235 | 25,343 | 20,282 |
| Gross Profit | 14,363 | 20,489 | 29,044 | 39,464 |
| Operating expenses: | ||||
| Research & development | 6,313 | 6,682 | 12,372 | 13,091 |
| Selling, general & administrative | 12,230 | 15,617 | 25,136 | 30,688 |
| Total operating expenses | 18,543 | 22,299 | 37,508 | 43,779 |
| Loss from operations | (4,180) | (1,810) | (8,464) | (4,315) |
| Interest and other income, net | 214 | 595 | 629 | 1,187 |
| Loss before income taxes | (3,966) | (1,215) | (7,835) | (3,128) |
| Provision for income taxes | 681 | 1,326 | 770 | 1,369 |
| Loss from continuing operations | (4,647) | (2,541) | (8,605) | (4,497) |
| Loss from discontinued operations, net of tax | 677 | 2,453 | (238) | (105) |
| Net loss | $(3,970) | $(88) | $(8,843) | $(4,602) |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.