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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| | | | | |
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2021
OR
| | | | | |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ____________ to______________
Commission file number: 001-36046
Axogen, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Minnesota
(State or other jurisdiction of
incorporation or organization)
13631 Progress Blvd., Suite 400 Alachua, FL
(Address of principal executive offices)
41-1301878
(I.R.S. Employer
Identification No.)
32615
(Zip Code)
386-462-6800
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)
| | | | | | | | |
Securities registered pursuant to Section 12(b) of the Act: |
Title of each class | Trading Symbol | Name of each exchange on which registered |
Common Stock, $0.01 par value | AXGN | The Nasdaq Stock Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer | ☐ | Accelerated filer | ☒ |
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Non-accelerated filer | ☐ | Smaller reporting company | ☐ |
| | | |
| | Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
As of July 30, 2021, the registrant had 41,397,053 shares of common stock outstanding.
Table of Contents
Forward-Looking Statements
From time to time, in reports filed with the U.S. Securities and Exchange Commission (the “SEC”) (including this Quarterly Report on Form 10-Q), in press releases, and in other communications to shareholders or the investment community, Axogen, Inc. (including Axogen, Inc.’s wholly owned subsidiaries, Axogen Corporation, Axogen Processing Corporation and Axogen Europe GmbH, the “Company,” “Axogen,” “we,” “our,” or “us”) may provide forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, concerning possible or anticipated future results of operations or business developments. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” variations of such words and similar expressions are intended to identify such forward-looking statements. The forward-looking statements may include, without limitation, statements regarding our assessment of our internal controls over financial reporting, our growth, the impact of COVID-19, product development, product potential, regulatory process and approvals, APC renovation timing and expense, financial performance, sales growth, product adoption, market awareness of our products, data validation, and our visibility at and sponsorship of, conferences and educational events. The forward-looking statements are and will be subject to risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in such forward-looking statements. Forward-looking statements contained in this Quarterly Report on Form 10-Q should be evaluated together with the many uncertainties that affect the our business and our market, particularly those discussed in the risk factors and cautionary statements set forth in the our filings with the SEC, including as described in “Risk Factors” included in Item 1A and “Risk Factor Summary” included in our 2020 Annual Report on Form 10-K. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those projected. Forward-looking statements are representative only as of the date they are made, and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or otherwise.
PART 1 — FINANCIAL INFORMATION
ITEM 1 — FINANCIAL STATEMENTS
Axogen, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(In Thousands, Except Share and Per Share Amounts)
| | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 53,078 | | | $ | 48,767 | |
Restricted cash | 6,333 | | | 6,842 | |
Investments | 46,839 | | | 55,199 | |
Accounts receivable, net of allowance for doubtful accounts of $258 and $416, respectively | 18,182 | | | 17,618 | |
Inventory | 13,415 | | | 12,529 | |
Prepaid expenses and other | 3,948 | | | 4,296 | |
Total current assets | 141,795 | | | 145,251 | |
Property and equipment, net | 50,952 | | | 38,398 | |
Operating lease right-of-use assets | 15,272 | | | 15,614 | |
Finance lease right-of-use assets | 53 | | | 64 | |
Intangible assets | 2,460 | | | 2,054 | |
Total assets | $ | 210,532 | | | $ | 201,381 | |
| | | |
Liabilities and Shareholders’ Equity | | | |
Current liabilities: | | | |
Accounts payable and accrued expenses | $ | 19,839 | | | $ | 21,968 | |
Current maturities of long-term lease obligations | 1,789 | | | 863 | |
Total current liabilities | 21,628 | | | 22,831 | |
| | | |
Long-term debt, net of financing fees | 46,081 | | | 32,027 | |
Long-term lease obligations | 20,344 | | | 20,874 | |
Debt derivative liability | 3,776 | | | 2,497 | |
Other long-term liabilities | — | | | 3 | |
Total liabilities | 91,829 | | | 78,232 | |
| | | |
Commitments and contingencies - see Note 13 | | | |
| | | |
Shareholders’ equity: | | | |
Common stock, $0.01 par value per share; 100,000,000 shares authorized; 41,337,108 and 40,618,766 shares issued and outstanding | 413 | | | 406 | |
Additional paid-in capital | 336,495 | | | 326,390 | |
Accumulated deficit | (218,205) | | | (203,647) | |
Total shareholders’ equity | 118,703 | | | 123,149 | |
Total liabilities and shareholders’ equity | $ | 210,532 | | | $ | 201,381 | |
See notes to condensed consolidated financial statements.
Axogen, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(In Thousands, Except Share and Per Share Amounts)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
| June 30, 2021 | | June 30, 2020 | | June 30, 2021 | | June 30, 2020 |
| | | | | | | |
Revenues | $ | 33,580 | | | $ | 22,116 | | | $ | 64,617 | | | $ | 46,377 | |
Cost of goods sold | 7,092 | | | 5,605 | | | 12,264 | | | 10,421 | |
Gross profit | 26,488 | | | 16,511 | | | 52,353 | | | 35,956 | |
Costs and expenses: | | | | | | | |
Sales and marketing | 19,250 | | | 14,290 | | | 37,224 | | | 32,128 | |
Research and development | 5,723 | | | 4,071 | | | 11,471 | | | 8,685 | |
General and administrative | 8,669 | | | 6,404 | | | 17,032 | | | 11,906 | |
Total costs and expenses | 33,642 | | | 24,765 | | | 65,727 | | | 52,719 | |
Loss from operations | (7,154) | | | (8,254) | | | (13,374) | | | (16,763) | |
Other (expense) income: | | | | | | | |
Investment income | 29 | | | 237 | | | 63 | | | 548 | |
Interest expense | (565) | | | (31) | | | (1,010) | | | (62) | |
Change in fair value of derivatives | (84) | | | — | | | (105) | | | — | |
Other expense | (124) | | | (57) | | | (132) | | | (20) | |
Total other (expense) income, net | (744) | | | 149 | | | (1,184) | | | 466 | |
Net Loss | $ | (7,898) | | | $ | (8,105) | | | $ | (14,558) | | | $ | (16,297) | |
Weighted average common shares outstanding — basic and diluted | 41,080,898 | | | 39,823,414 | | | 40,894,405 | | | 39,760,602 | |
Loss per common share — basic and diluted | $ | (0.19) | | | $ | (0.20) | | | $ | (0.36) | | | $ | (0.41) | |
See notes to condensed consolidated financial statements.
Axogen, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(In Thousands)
| | | | | | | | | | | |
| Six Months Ended |
| June 30, 2021 | | June 30, 2020 |
Cash flows from operating activities: | | | |
Net loss | $ | (14,558) | | | $ | (16,297) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Depreciation | 1,405 | | | 618 | |
Amortization of right-of-use assets | 960 | | | 802 | |
Amortization of intangible assets | 96 | | | 72 | |
Amortization of deferred financing fees | 227 | | | — | |
Provision for bad debt | (65) | | | (115) | |
Provision for inventory write-down | 2,455 | | | 1,624 | |
Changes in fair value of derivatives | 105 | | | — | |
Changes in investment gains and losses | 31 | | | (141) | |
Share-based compensation | 6,499 | | | 2,778 | |
Change in operating assets and liabilities: | | | |
Accounts receivable | (498) | | | 3,010 | |
Inventory | (3,341) | | | (600) | |
Prepaid expenses and other | 199 | | | (1,699) | |
Accounts payable and accrued expenses | (5,061) | | | (4,212) | |
Operating lease obligations | 35 | | | (915) | |
Cash paid for interest portion of finance leases | (1) | | | — | |
Contract and other liabilities | (3) | | | (6) | |
Net cash used in operating activities | (11,515) | | | (15,081) | |
| | | |
Cash flows from investing activities: | | | |
Purchase of property and equipment | (10,924) | | | (13,183) | |
Purchase of investments | (23,966) | | | (22,965) | |
Proceeds from sale of investments | 32,295 | | | 59,883 | |
Cash payments for intangible assets | (692) | | | (216) | |
Net cash (used in) provided by investing activities | (3,287) | | | 23,519 | |
| | | |
Cash flows from financing activities: | | | |
Proceeds from the issuance of long-term debt | 15,000 | | | 35,000 | |
Proceeds from the paycheck protection program | — | | | 7,820 | |
Repayment of paycheck protection program | — | | | (7,820) | |
Payments for debt issuance costs | — | | | (350) | |
Payments of employee tax withholding in exchange of common stock awards | — | | | (658) | |
Cash paid for debt portion of finance leases | (8) | | | (8) | |
Proceeds from exercise of stock options | 3,612 | | | 1,784 | |
Net cash provided by financing activities | 18,604 | | | 35,768 | |
Net increase in cash, cash equivalents, and restricted cash | 3,802 | | | 44,206 | |
Cash, cash equivalents, and restricted cash, beginning of period | 55,609 | | | 41,724 | |
Cash, cash equivalents and restricted cash, end of period | $ | 59,411 | | | $ | 85,930 | |
| | | |
Supplemental disclosures of cash flow activity: | | | |
Cash paid for interest | $ | 739 | | | $ | 23 | |
Supplemental disclosure of non-cash investing and financing activities: | | | |
Acquisition of fixed assets in accounts payable and accrued expenses | $ | 3,035 | | | $ | 617 | |
Obtaining a right-of-use asset in exchange for a lease liability | $ | 371 | | | $ | 796 | |
Embedded derivative associated with the long-term debt | $ | 1,173 | | | $ | 2,563 | |
Acquisition of intangible assets in accounts payable and accrued expenses | $ | 190 | | | $ | — | |
See notes to condensed consolidated financial statements.
Axogen, Inc.
Condensed Consolidated Statements of Changes in Shareholders’ Equity
(unaudited)
(In Thousands, Except Share Amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Paid-in Capital | | Accumulated Deficit | | Shareholders' Equity/(Deficit) |
| Shares | | Amount | | | |
Three Months Ended June 30, 2021 | | | | | | | | | |
Balance at March 31, 2021 | 40,842,717 | | | $ | 408 | | | $ | 329,603 | | | $ | (210,307) | | | $ | 119,704 | |
Net Loss | — | | | — | | | — | | | (7,898) | | | (7,898) | |
Stock-based compensation | — | | | — | | | 3,804 | | | — | | | 3,804 | |
Issuance of restricted and performance stock units | 44,411 | | | — | | | — | | | — | | | — | |
Exercise of stock options and employee stock purchase plan | 449,980 | | | 5 | | | 3,088 | | | — | | | 3,093 | |
Balance at June 30, 2021 | 41,337,108 | | | $ | 413 | | | $ | 336,495 | | | $ | (218,205) | | | $ | 118,703 | |
| | | | | | | | | |
Six Months Ended June 30, 2021 | | | | | | | | | |
Balance at December 31, 2020 | 40,618,766 | | | $ | 406 | | | $ | 326,390 | | | $ | (203,647) | | | $ | 123,149 | |
Net Loss | — | | | — | | | — | | | (14,558) | | | (14,558) | |
Stock-based compensation | — | | | — | | | 6,499 | | | — | | | 6,499 | |
Issuance of restricted and performance stock units | 138,944 | | | 1 | | | (1) | | | — | | | — | |
Shares surrendered by employees to pay tax withholdings | — | | | — | | | — | | | — | | | — | |
Exercise of stock options and employee stock purchase plan | 579,398 | | | 6 | | | 3,607 | | | — | | | 3,613 | |
Balance at June 30, 2021 | 41,337,108 | | | $ | 413 | | | $ | 336,495 | | | $ | (218,205) | | | $ | 118,703 | |
| | | | | | | | | |
Three Months Ended June 30, 2020 | | | | | | | | | |
Balance at March 31, 2020 | 39,738,767 | | | $ | 397 | | | $ | 311,850 | | | $ | (188,053) | | | $ | 124,194 | |
Net Loss | — | | | — | | | — | | | (8,105) | | | (8,105) | |
Stock-based compensation | — | | | — | | | 2,222 | | | — | | | 2,222 | |
Issuance of restricted and performance stock units | 10,021 | | | — | | | — | | | — | | | — | |
Shares surrendered by employees to pay tax withholdings | (1,766) | | | — | | | (17) | | | — | | | (17) | |
Exercise of stock options and employee stock purchase plan | 273,758 | | | 3 | | | 1,463 | | | — | | | 1,466 | |
Balance at June 30, 2020 | 40,020,780 | | | $ | 400 | | | $ | 315,518 | | | $ | (196,158) | | | $ | 119,760 | |
| | | | | | | | | |
Six Months Ended June 30, 2020 | | | | | | | | | |
Balance at December 31, 2019 | 39,589,755 | | | $ | 396 | | | $ | 311,618 | | | $ | (179,861) | | | $ | 132,153 | |
Net Loss | — | | | — | | | — | | | (16,297) | | | (16,297) | |
Stock-based compensation | — | | | — | | | 2,778 | | | — | | | 2,778 | |
Issuance of restricted and performance stock units | 145,943 | | | 1 | | | (1) | | | — | | | — | |
Shares surrendered by employees to pay tax withholdings | (38,736) | | | (1) | | | (657) | | | — | | | (658) | |
Exercise of stock options and employee stock purchase plan | 323,818 | | | 4 | | | 1,780 | | | — | | | 1,784 | |
Balance at June 30, 2020 | 40,020,780 | | | $ | 400 | | | $ | 315,518 | | | $ | (196,158) | | | $ | 119,760 | |
See notes to condensed consolidated financial statements.
Axogen, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
(In Thousands, Except Per Share Amounts)
Unless the context otherwise requires, all references in these Notes to “Axogen,” the “Company”, “we,” “us” and “our” refer to Axogen, Inc. and its wholly owned subsidiaries Axogen Corporation (“AC”), Axogen Processing Corporation, and Axogen Europe GmbH.
1.Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include the accounts of the Company as of June 30, 2021 and December 31, 2020 and for the three and six-month periods ended June 30, 2021 and 2020. The Company’s condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X, and therefore, do not include all information and footnotes necessary for a fair presentation of consolidated financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America (“US GAAP”) and should be read in conjunction with the audited financial statements of the Company for the year ended December 31, 2020, which are included in the Company’s Annual Report on Form 10-K as of and for the year ended December 31, 2020. The interim condensed consolidated financial statements are unaudited and in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of results for the periods presented. Results for interim periods are not necessarily indicative of results for the full year. All intercompany accounts and transactions have been eliminated in consolidation.
The results of operations for the three and six-months ended June 30, 2021 are not necessarily indicative of the results to be expected for the full fiscal year due primarily to the impact of the continued uncertainty of general economic conditions that may impact our markets for the remainder of fiscal year 2021. Specifically, there can be no assurances that resurgences of coronavirus (“COVID-19”) will not affect future results.
2.Summary of Significant Accounting Policies
Cash and Cash Equivalents and Concentration
The Company considers highly liquid investments with maturities of three months or less at the date of acquisition as cash equivalents in the accompanying condensed consolidated financial statements. The Company has not experienced any losses related to these balances; however, as of June 30, 2021, $52,578 of the cash and cash equivalents balance was in excess of Federal Deposit Insurance Corporation limits. As of June 30, 2021 and December 31, 2020, the Company had restricted cash balances of $6,333 and $6,842, respectively. The June 30, 2021 and December 31, 2020 balances both include $6,000, which represents collateral for an irrevocable standby letter of credit. The June 30, 2021 and December 31, 2020 balances include $83 and $842, respectively, which is the balance of the Heights Union Escrow Account (see Note 13 - Commitments and Contingencies). Additionally, the June 30, 2021 balance includes an additional irrevocable standby letter of credit in the amount of $250 (See Note 10 - Long Term Debt).
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheet that sum to the total of the same amounts shown in the statement of cash flows:
| | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
Cash and cash equivalents | $ | 53,078 | | | $ | 48,767 | |
Restricted cash | 6,333 | | | 6,842 | |
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $ | 59,411 | | | $ | 55,609 | |
Revenue Recognition
The Company enters into contracts to sell and distribute products and services to hospitals and surgical facilities for use in caring for patients with peripheral nerve damage or transection. Revenue is recognized when the Company has met its performance obligations pursuant to its contracts with its customers in an amount that the Company expects to be entitled to in exchange for the transfer of control of the products and services to the Company’s customers.
In the case of products or services sold to a customer under a distribution or purchase agreement, the customers are granted exclusive distribution rights to sell the implants internationally in a territory defined by the contract. These international distributor agreements contain provisions that allow the Company to terminate the distribution agreement with the distributor, and upon termination, the right to repurchase inventory from the distributor at the distributor’s cost. The Company has determined that its contractual rights to repurchase distributor inventory upon termination of the distributor agreement are not substantive and do not impact the timing of when control transfers; and, therefore, the Company has determined it is appropriate to recognize revenue when: i) the product is shipped via common carrier; or ii) the product is delivered to the customer or distributor, depending on the terms of the agreement. Determining the timing of revenue recognition for such contracts is subject to judgment, because an evaluation must be made regarding the distributor’s ability to direct the use of, and obtain substantially all of the remaining benefits from, the implants received from the Company. Changes in these assessments could have an impact on the timing of revenue recognition from sales to distributors.
A portion of the Company’s product revenue is generated from consigned inventory maintained at hospitals and independent sales agencies, and also from inventory physically held by field sales representatives. For these types of products sales, the Company retains control until the product has been used or implanted, at which time revenue is recognized.
The Company accounts for shipping and handling activities as a fulfillment cost rather than a separate performance obligation. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of the underlying products is transferred to the customer. The related shipping and freight charges incurred by the Company are included in cost of sales.
The Company operates in a single reportable segment of peripheral nerve repair, offers similar products to its customers, and enters into consistently structured arrangements with similar types of customers. As such, the Company does not disaggregate revenue from contracts with customers as the nature, amount, timing and uncertainty of revenue and cash flows does not materially differ within and among the contracts with customers.
The contract with the customer states the final terms of the sale, including the description, quantity, and price of each implant distributed. The payment terms and conditions in the Company’s contracts vary; however, as a common business practice, payment terms are typically due in full within thirty to sixty days of delivery. Since the customer agrees to a stated price in the contract that does not vary over the contract term, the contracts do not contain any material types of variable consideration, and contractual rights of return are not material. The Company has several contracts with distributors in international markets which include consideration paid to the customer in exchange for distinct marketing and other services. The Company records such consideration paid to the customer as a reduction to revenue from the contracts with those distributor customers.
In connection with the Acroval Neurosensory and Motor Testing System, the Company sold extended warranty and service packages to some of its customers who purchased this evaluation and measurement tool, and the prepayment of these extended warranties represent contract liabilities until the performance obligations are satisfied ratably over the term of the contract. The sale of the aforementioned extended warranty represents the only performance obligation the Company satisfies over time and creates the contract liability disclosed below. The opening and closing balances of the Company’s contract receivables and liabilities are as follows:
| | | | | | | | | | | |
Contract Balances |
| Net Receivables | Contract Liabilities, Current | Contract Liabilities, Long-Term |
Opening, January 1, 2020 | $ | 16,944 | | $ | 14 | | $ | 15 | |
Closing, June 30, 2020 | 14,049 | | 14 | | 9 | |
Increase (decrease) | (2,895) | | — | | (6) | |
| | | |
Opening, January 1, 2021 | $ | 17,618 | | $ | 14 | | $ | 3 | |
Closing, June 30, 2021 | 18,182 | | 14 | | — | |
Increase (decrease) | 564 | | — | | (3) | |
Allowance for Doubtful Accounts Receivable and Concentration of Credit Risk
The Company evaluates the collectability of accounts receivable to determine the appropriate allowance for doubtful accounts. In determining the amount of the allowance, the Company considers aging of account balances, historical credit losses, customer-specific information, the current economic environment, supportable forecasts and other relevant factors. An increase to the allowance for doubtful accounts results in a corresponding increase in general and administrative expense. The Company reviews accounts receivable and adjusts the allowance based on current circumstances and charges off uncollectible receivables against the allowance when all attempts to collect the receivable have failed. The Company’s history of write-offs has not been significant. The allowance for doubtful accounts balance was approximately $258 and $416 at June 30, 2021 and December 31, 2020, respectively.
Concentrations of credit risk with respect to accounts receivable are limited because a large number of geographically diverse customers make up the Company’s customer base, thus spreading the credit risk. The Company also controls credit risk through credit approvals and monitoring procedures.
Derivative Instruments
The Company analyzes all financial instruments with features under Accounting Standards Codification ("ASC") 480, “Distinguishing Liabilities from Equity” and ASC 815, “Derivatives and Hedging”. The Company also reviews debt agreements for embedded features. If these features are not clearly and closely related to the debt host, they meet the definition of a derivative and require bifurcation from the host. All derivative instruments are recorded on the balance sheet at their respective fair values. The Company will adjust the carrying value of the derivative liability to fair value at each subsequent reporting date. The changes in the value of the derivatives are recorded in the consolidated statement of operations in the period in which they occur.
Net Loss Per Share
Basic net loss per share is computed by dividing reported net loss by the weighted average number of common shares outstanding for the reported period. Diluted net loss per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock of the Company during the reporting period. Diluted net loss per share is computed by dividing net loss by the sum of the weighted average number of common shares and the number of potential dilutive common share equivalents outstanding during the period. Potential dilutive common share equivalents consist of the incremental common shares issuable upon the exercise of vested share options and the incremental shares issuable upon conversion of the convertible notes. Potential dilutive common share equivalents consist of stock options, restricted stock units (“RSUs”), and performance stock units (“PSUs”).
Due to net losses for the three and six months ended June 30, 2021 and 2020, basic and diluted net loss per share were the same as the effect of potentially dilutive securities and would have been anti-dilutive.
3.Recently Issued Standards to be Adopted
The Company’s management has reviewed and considered all other recent accounting pronouncements and believe there are none that could potentially have a material impact on the Company’s consolidated financial condition, results of operations, or disclosures.
4.Inventory
Inventory is comprised of unprocessed tissue, work-in-process, Avance® Nerve Graft, Axoguard® Nerve Connector, Axoguard® Nerve Protector, Axoguard® Nerve Cap, Acroval® Neurosensory and Motor Testing System, Axotouch® Two-Point Discriminator and supplies and is valued at the lower of cost (first-in, first-out) or net realizable value and consist of the following:
| | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
Finished goods | $ | 9,288 | | | $ | 8,876 | |
Work in process | 482 | | | 751 | |
Raw materials | 3,645 | | | 2,902 | |
Inventory | $ | 13,415 | | | $ | 12,529 | |
Included within Inventory is Avive® Soft Tissue Membrane ("Avive"). On May 17, 2021 the Company announced that it would suspend market availability of Avive effective June 1, 2021 pending ongoing discussions with the U.S. Food and Drug Administration (FDA) regarding the regulatory classification of Avive. The Company recorded a write-down of Avive inventory for an amount of $1,251 recorded in cost of goods sold in the condensed consolidated statement of operations related to this announcement.
The Company monitors the shelf life of its products and historical expiration and spoilage trends and writes-down inventory based on the estimated amount of inventory that may not be distributed before expiration or spoilage. For the six months ended June 30, 2021 and 2020, the Company had adjustments to the provision for inventory write downs of $2,455 (including the reserve for Avive of $1,251), and $1,624 respectively.
5.Fair Value Considerations
Fair value is defined as the price that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for classification and disclosure of fair value measurements as follows:
Level 1 – Quoted prices in active markets for identical assets or liabilities.
Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The Company classifies cash equivalents and investments according to the hierarchy of techniques used to determine fair value based on the types of inputs. The Company has elected the Fair Value Option for all investments in debt securities.
On June 30, 2020, the Company entered into the Oberland Facility (See Note - 10 Long-Term Debt), and concluded that the term debt instrument included certain embedded features that required separate accounting (the “Debt Derivative Liability”) and that the equity contract entered into concurrently was required to be classified as a liability and recorded at its fair value. These instruments were determined to be financial liabilities requiring Level 3 fair value measurements.
The following table represents the Company’s fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis as of June 30, 2021:
| | | | | | | | | | | | | | | | | | | | | | | |
| (Level 1) | | (Level 2) | | (Level 3) | | Total |
June 30, 2021 | | | | | | | |
Assets: | | | | | | | |
Money market funds | $ | 31,496 | | | $ | — | | | $ | — | | | $ | 31,496 | |
U.S. government securities | 12,059 | | | — | | | — | | | 12,059 | |
Commercial paper | — | | | 34,780 | | | — | | | 34,780 | |
Total assets | $ | 43,555 | | | $ | 34,780 | | | $ | — | | | $ | 78,335 | |
| | | | | | | |
Liabilities | | | | | | | |
Oberland facility | $ | — | | | — | | $ | 50,663 | | | $ | 50,663 | |
Debt derivative liabilities | — | | | — | | 3,776 | | | 3,776 | |
Total liabilities | $ | — | | | $ | — | | | $ | 54,439 | | | $ | 54,439 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| (Level 1) | | (Level 2) | | (Level 3) | | Total |
December 31, 2020 | | | | | | | |
Assets: | | | | | | | |
Money market funds | $ | 23,044 | | | $ | — | | | $ | — | | | $ | 23,044 | |
U.S. government securities | 12,123 | | | — | | | — | | | 12,123 | |
Corporate bonds | — | | | 6,408 | | | — | | | 6,408 | |
Commercial paper | — | | | 36,668 | | | — | | | 36,668 | |
| | | | | | | |
Total assets | $ | 35,167 | | | $ | 43,076 | | | $ | — | | | $ | 78,243 | |
| | | | | | | |
Liabilities | | | | | | | |
Oberland facility | — | | | — | | 36,855 | | | 36,855 | |
Debt derivative liabilities | — | | | — | | 2,497 | | 2,497 |
Total liabilities | $ | — | | | $ | — | | | $ | 39,352 | | | $ | 39,352 | |
Oberland Facility
The Company estimates the fair value of long-term debt under the Oberland Facility using a discounted cash flow analysis and rates being offered for similar loans to borrowers with similar credit ratings. The discounted cash flow model uses unobservable inputs, including estimates of discount rates and loan prepayments. Both tranches of the Oberland Facility are classified as Level 3. The estimated fair value of the Company’s long-term debt under the Oberland Facility was $50,663 and $36,855, at June 30, 2021 and December 31, 2020, respectively (See Note 10 - Long-Term Debt).
Debt Derivative Liabilities
The Debt Derivative Liabilities are measured using a ‘with and without’ valuation model to compare the fair value of the Oberland Facility including the identified embedded derivative features and the fair value of a plain vanilla note with the same terms. The fair value of the Oberland Facility including the embedded derivative features was determined using a probability-weighted expected return model based on four potential settlement scenarios for the Oberland Facility due to a mandatory prepayment event between January 1, 2024 and the respective maturity dates of June 30, 2027 and June 30, 2028 for the first and second tranche, respectively; (a) the prepayment of the Oberland Facility at the Company’s option; and (b) the repayment of the Oberland Facility at its maturity in accordance with the terms of the debt agreement. The estimated settlement value of each scenario, which would include any required make-whole payment (See Note 10 - Long-Term Debt) is then discounted to present value using a discount rate that is derived based on the initial terms of the Oberland Facility at issuance and corroborated utilizing a synthetic credit rating analysis.
The significant inputs that are included in the valuation of the Debt Derivative Liability - first tranche include:
| | | | | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 | |
Input | | | | |
Remaining term (years) | 6 | | 6.50 | |
Maturity date | June 30, 2027 | | June 30, 2027 | |
Coupon rate | 9.50 | % | | 9.50 | % | |
Revenue participation payments | Maximum each year | | Maximum each year | |
Discount rate | 8.65 | % | (1) | 8.70 | % | (1) |
Probability of mandatory prepayment before 2024 | 5.0 | % | (1) | 5.0 | % | (1) |
Estimated timing of mandatory prepayment event before 2024 | December 31, 2023 | (1) | December 31, 2023 | (1) |
Probability of mandatory prepayment 2024 or after | 15.0 | % | (1) | 15.0 | % | (1) |
Estimated timing of mandatory prepayment event 2024 or after | March 31, 2026 | (1) | March 31, 2026 | (1) |
Probability of optional prepayment event | 5.0 | % | (1) | 5.0 | % | (1) |
Estimated timing of optional prepayment event | December 31, 2025 | (1) | December 31, 2025 | (1) |
(1)Represents a significant unobservable input
The significant inputs that are included in the valuation of the Debt Derivative Liability - second tranche include:
| | | | | | | | |
| June 30, 2021 | |
Input | | |
Remaining term (years) | 7 | |
Maturity date | June 30, 2028 | |
Coupon rate | 9.50 | % | |
Revenue participation payments | Maximum each year | |
Discount rate | 11.21 | % | (1) |
Probability of mandatory prepayment before 2024 | 5.0 | % | (1) |
Estimated timing of mandatory prepayment event before 2024 | December 31, 2023 | (1) |
Probability of mandatory prepayment 2024 or after | 15.0 | % | (1) |
Estimated timing of mandatory prepayment event 2024 or after | March 31, 2026 | (1) |
Probability of optional prepayment event | 5.0 | % | (1) |
Estimated timing of optional prepayment event | December 31, 2025 | (1) |
(1)Represents a significant unobservable input
There were no changes in the levels or methodology of the measurement of financial assets or liabilities during the three and six months ended June 30, 2021. The maturity dates of the Company’s investments are less than one year.
The following represents the rollforward of the fair value of instruments classified as Level 3 measurements for the three and six months ended June 30, 2021:
| | | | | |
Quarter Ending June 30, 2021 | |
Beginning Balance, April 1, 2021 | $ | 39,205 | |
Addition of Oberland Facility - second tranche | 13,827 | |
Addition of debt derivative - second tranche | 1,173 | |
Change in fair value of Oberland Facility | 150 | |
Change in fair value of debt derivative | 84 | |
Ending Balance, June 30, 2021 | $ | 54,439 | |
| |
Six Months Ending June 30, 2021 | |
Beginning Balance, January 1, 2021 | $ | 39,352 | |
Addition of Oberland Facility - second tranche | 13,827 | |
Addition of debt derivative - second tranche | 1,173 | |
Change in fair value of Oberland Facility | (18) | |
Change in fair value of debt derivative | 105 | |
Ending Balance, June 30, 2021 | $ | 54,439 | |
6.Prepaid Expense and Other
Prepaid and other assets consist of the following:
| | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
| | | |
Prepaid insurance | $ | 1,389 | | | $ | 2,596 | |
Stock option receivable | 421 | | | 2 | |
Litigation receivable | 23 | | | 23 | |
Prepaid events | 318 | | | 203 | |
Prepaid marketing | 270 | | | 587 | |
Prepaid software license | 312 | | | 220 | |
Prepaid professional fees | 380 | | | 251 | |
Other prepaid items | 835 | | | 414 | |
Prepaid and Other Assets | $ | 3,948 | | | $ | 4,296 | |
Our policy year for our insurance runs on a calendar year and as such a significant portion of the policy payment is made on or about the beginning of the new year and amortized to expense throughout the remaining year.
7.Property and Equipment
Property and equipment consist of the following:
| | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
| | | |
Furniture and equipment | $ | 4,166 | | | $ | 2,334 | |
Leasehold improvements | 14,469 | | | 12,983 | |
Processing equipment | 3,580 | | | 2,634 | |
Land | 731 | | | 731 | |
Projects in process | 34,236 | | | 24,540 | |
Property and equipment, at cost | 57,182 | | | 43,223 | |
Less: accumulated depreciation and amortization | (6,230) | | | (4,825) | |
Property and equipment, net | $ | 50,952 | | | $ | 38,398 | |
Depreciation expense for the three months ended June 30, 2021 and 2020 was $633 and $311, respectively. Depreciation expense for the six months ended June 30, 2021 and 2020 was $1,405 and $618, respectively. The significant increase in projects in process is related to our Axogen Processing Center (“APC”) facility (See Note 13 - Commitments and Contingencies).
On September 20, 2018, the Company entered into an agreement (the “Heights Agreement”) with Heights Union, LLC, a Florida limited liability company (“Heights Union”), for the lease of seventy-five thousand square feet of office space in Tampa, Florida (See Note 13 - Commitments and Contingencies). In May 2020, the Company entered into a construction escrow agreement with Heights Union and Commonwealth Land Title Insurance Company (“Escrow Agent”), which provided for the establishment of a federally insured escrow bank account (the “Escrow Account”) to hold Company funds to be used for tenant improvements in excess of the tenant allowance as provided in the Heights Agreement. The Company deposited $6,289 into the Escrow Account for use in completing construction of the tenant improvements. The Escrow Agent will disburse the funds upon joint written instructions from Heights Union and the Company. During both the three month and six months ended June 30, 2021, $759 was disbursed from the Escrow Account and recorded in property and equipment account on the balance sheet. As of June 30, 2021, $83 remained in the Escrow Account and is recorded as restricted cash in the condensed consolidated balance sheet.
8.Intangible Assets
The Company’s intangible assets consist of the following:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
| Gross Carrying Amount | | Accumulated Amortization | | Net Carrying Amount | | Gross Carrying Amount | | Accumulated Amortization | | Net Carrying Amount |
Amortized intangible assets | | | | | | | | | | | |
Patents | $ | 1,987 | | | $ | (180) | | | $ | 1,807 | | | $ | 1,496 | | | $ | (139) | | | $ | 1,357 | |
License agreements | 1,101 | | | (800) | | | 301 | | | 1,093 | | | (745) | | | 348 | |
Total amortizable intangible assets | $ | 3,088 | | | $ | (980) | | | $ | 2,108 | | | $ | 2,589 | | | $ | (884) | | | $ | 1,705 | |
| | | | | | | | | | | |
Unamortized intangible assets | | | | | | | | | | | |
Trademarks | $ | 352 | | | $ | — | | | $ | 352 | | | $ | 349 | | | $ | — | | | $ | 349 | |
Total intangible asset, net | $ | 3,440 | | | $ | (980) | | | $ | 2,460 | | | $ | 2,938 | | | $ | (884) | | | $ | 2,054 | |
License agreements are being amortized over periods ranging from 17-20 years. Patent costs are being amortized over periods of up to 20 years. Amortization expense was approximately $49 and $36 for the three months ended June 30, 2021 and
2020, respectively. Amortization expense was approximately $96 and $72 for the six months ended June 30, 2021 and 2020, respectively. As of June 30, 2021, future amortization of license agreements and patents is as follows:
| | | | | |
Year Ending December 31, | |
2021 (excluding the six months ended June 30, 2021) | $ | 104 | |
2022 | 208 | |
2023 | 183 | |
2024 | 106 | |
2025 | 106 | |
Thereafter | 1,401 | |
Total | $ | 2,108 | |
License Agreements
The Company has entered into multiple license agreements (together, the “License Agreements”) with the University of Florida Research Foundation and the University of Texas at Austin. Under the terms of the License Agreements, the Company acquired exclusive worldwide licenses for underlying technology used in repairing and regenerating nerves. The licensed technologies include the rights to issued patents and patents pending in the United States and international markets. The effective term of the License Agreements extends through the term of the related patents and the agreements may be terminated by the Company with 60 days’ prior written notice. Additionally, in the event of default, licensors may terminate an agreement if the Company fails to cure a breach after written notice. The License Agreements contain the key terms listed below:
•The Company pays royalty fees ranging from 1% to 3% under the License Agreements based on net sales of licensed products. One of the agreements also contains a minimum royalty of $13 per quarter, which may include a credit in future quarters in the same calendar year for the amount the minimum royalty exceeds the royalty fees. Also, when the Company pays royalties to more than one licensor for sales of the same product, a royalty stack cap applies, capping total royalties at 3.75%;
•If the Company sublicenses technologies covered by the License Agreements to third parties, the Company would pay a percentage of sublicense fees received from the third party to the licensor. Currently, the Company does not sublicense any technologies covered by License Agreements. The Company is not considered a sub-licensee under the License Agreements and does not owe any sub-licensee fees for its own use of the technologies;
•The Company reimburses the licensors for certain legal expenses incurred for patent prosecution and defense of the technologies covered by the License Agreements; and
•Currently, under the University of Texas at Austin’s agreement, the Company would owe a milestone fee of $15 upon receiving a Phase II Small Business Innovation Research or Phase II Small Business Technology Transfer grant involving the licensed technology. The Company has not received either grant and does not owe such a milestone fee. A milestone fee to the University of Florida Research Foundation of $2 is due if the Company receives FDA approval of its Avance Nerve Graft, a milestone fee of $25 is due upon the first commercial use of certain licensed technology to provide services to manufacture products for third parties and a milestone fee of $10 is due upon the first use to manufacture products that utilize certain technology that is not currently incorporated into the Company's products.
Royalty fees were approximately $709 and $436 during the three months ended June 30, 2021 and 2020, respectively, and approximately $1,350 and $929 during the six months ended June 30, 2021 and 2020, respectively, and are included in sales and marketing expense on the accompanying condensed consolidated statements of operations.
9.Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consist of the following:
| | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
| | | |
Accounts payable | $ | 6,721 | | | $ | 4,597 | |
Accrued expenses | 5,480 | | | 3,778 | |
Accrued compensation | 7,638 | | | 13,593 | |
Accounts Payable and Accrued Expenses | $ | 19,839 | | | $ | 21,968 | |
10.Long-Term Debt
The carrying value of the Company’s outstanding debt consists of the following:
| | | | | | | | | | | | | | |
| | June 30, 2021 | | December 31, 2020 |
Oberland Facility - first tranche | | $ | 35,000 | | | $ | 35,000 | |
Oberland Facility - second tranche | | 15,000 | | | — | |
Less - unamortized debt discount and deferred financing fees | | (3,919) | | | (2,973) | |
Total long-term debt | | $ | 46,081 | | | $ | 32,027 | |
Oberland Facility
On June 30, 2020, the Company entered into a seven-year financing agreement with Oberland Capital (the “Oberland Facility”) and obtained the first tranche of $35,000 at closing. The Oberland Facility provides for a total of $75,000 through two additional tranches that can be drawn by December 31, 2021 and requires interest-only payments for the duration of the term. A second tranche of $15,000 may be drawn at the Company’s option upon achieving two consecutive quarters with revenue of at least $20,000. Such second tranche may also be put to the Company at any time by Oberland Capital. A third tranche of $25,000 may be drawn at the Company’s option upon achieving two consecutive quarters with revenue of $28,000. The financing costs for this facility are approximately $642 and were recorded as a contra liability to the debt facility. As of June 30, 2021, the Company has paid all of the financing costs. On June 30, 2021, the second tranche of $15,000 was drawn down by the Company. The second tranche of the Oberland Facility matures on June 30, 2028.
The Oberland Facility requires quarterly interest payments for seven years. Interest is calculated as 7.5% plus the greater of LIBOR or 2.0% (9.5% as of June 30, 2021). Each tranche of the Oberland Facility, if and when issued, will have a term of seven years from the date of issuance (with the first tranche issued on June 30, 2020 maturing on June 30, 2027). In connection with the Oberland Facility, the Company entered into a revenue participation agreement with Oberland Capital, which provides that, among other things, a quarterly royalty payment as a percentage of the Company’s net revenues, up to $70 million in any given fiscal year, subject to certain limitations set forth therein, during the period commencing on the later of (i) April 1, 2021 and (ii) the date of funding of a tranche of the loan, and ending on the date upon which all amounts owed under the Oberland Facility have been paid in full (the “Revenue Participation Agreement”). Payments will commence on September 30, 2021. This royalty structure results in approximately 1.0% per year of additional interest payments on the outstanding loan amount. The Company recorded $260 as interest expense for this revenue participation agreement for both the three and six months periods ended June 30, 2021. The Company pays the quarterly debt interest on the last day of the quarter, and for the three and six months ended June 30, 2021 paid $840 and $1,672, respectively, to Oberland Capital. The Company capitalized approximately $1,187 of the interest towards the costs to construct and retrofit its Axogen Processing Center in Vandalia, OH (See Note 13 - Commitments and Contingencies). The capitalized interest is recorded as part of property and equipment in the condensed consolidated balance sheet.
Additionally, Oberland Capital had the right to purchase up to $3,500 worth of the Company's common stock from the Company in one transaction at any time after closing of the Oberland Facility until the later of (i) the date all amounts due under the Oberland Facility are repaid and (ii) June 30, 2027 (the “Oberland Option”). The purchase price of the common stock will
be calculated based on the 45-day moving average of the closing stock price on the day prior to the purchase. On December 10, 2020, Oberland Capital exercised in full its option under the Option Agreement. The exercise price was determined to be $14.13, resulting in gross proceeds to the Company of approximately $3,500 and the issuance of 247,699 shares to TPC Investments II LP, a wholly owned subsidiary of Oberland Capital. In conjunction with the issuance, Oberland Capital received certain protective rights (including protection from down-round stock issuances) for a period of one year subsequent to the issuance.
The amounts outstanding under the Oberland Facility may be accelerated upon certain events, including: (a) required mandatory prepayments upon an asset sale; (b) in the event the Company is subject to (i) any litigation brought by a Governmental Authority (as defined in the Oberland Facility) including intervention after litigation is commenced by a Person (as defined in the Oberland Facility ), or (ii) any final administrative action by a Governmental Authority, in each case arising out of or in connection with any of the Company’s registry studies, payments made to doctors or training activities with respect to healthcare professionals (excluding certain final administrative action that have been fully and finally resolved by the parties pursuant to a settlement agreement) or (c) upon the occurrence of an event of default (either automatically or at the option of Oberland Capital depending on the nature of the event). In addition, the Company has the right to prepay any amounts outstanding under the Oberland Facility. Upon maturity or upon such earlier repayment of the Oberland Facility, the Company will repay the principal balance and provide a make-whole payment calculated to generate an internal rate of return to Oberland Capital of at least 11.5%, less the total of all quarterly interest and royalty payments previously paid to Oberland Capital.
Upon the occurrence of an event of default, the interest rate incurred on amounts outstanding under the Oberland Facility will be increased by 4%. The Oberland Facility includes a financial covenant requiring the Company to achieve revenue targets of $8,750 for the third and four quarters of 2020, $17,500 for the first and second quarter of 2021 and $20,000 for each quarter thereafter. In the event of a failure to meet such covenant the Company may avoid a default by electing to be subject to a liquidity covenant and meeting all of the obligations required by such covenant. Specifically, the liquidity covenant provides that the Company must maintain on deposit in a cash collateral account an amount not less than 1.1 times the aggregate outstanding principal balance of all outstanding loan amounts. The borrowings under the Oberland Facility are secured by substantially all of the assets of the Company. As of June 30, 2021, the Company was in compliance with all covenants.
Accounting Considerations
The Company assessed the accounting impact of the Oberland Facility and the related agreements entered into with Oberland Capital. The Company concluded that the Oberland Facility and the Revenue Participation Agreement should be assessed on a combined unit of account basis (with the Revenue Participation Agreement being considered as an embedded feature with the Oberland Facility), and that the Oberland Option should be considered as a separate freestanding instrument for analysis purposes.
In relation to the Oberland Facility and Revenue Participation Agreement, the Company assessed the identified embedded features to determine if they would require separate accounting. In performing this assessment, the Company concluded the following embedded features met the definition of a derivative and would not be considered clearly and closely related to the debt instrument, requiring separate accounting as bifurcated derivatives:
•Mandatory prepayments upon an asset sale or litigation involving the government, including the make-whole payment (put rights)
•Optional or automatic prepayment upon an event of default (put rights)
•Payments under the Revenue Participation Agreement (contingent interest feature)
•Additional interest upon events of default (contingent interest feature)
The Company considered these separable embedded features on a combined basis as a single derivative feature. The Company estimated the fair value of these features as $2,387 as of the date of issuance of the Oberland Facility and recorded this value as a deduction to the carrying value of the Oberland Facility. As a result of the second tranche draw, the Company recorded an additional derivative and estimated the fair value to be $1,173.
Other credit facilities
The Company maintains restricted cash of $6,333 and $6,842 at June 30, 2021 and December 31, 2020, respectively. In both years, the balance includes $6,000, which represents collateral for an irrevocable standby letter of credit. In March 2021, the Company entered in an agreement which required an additional irrevocable standby letter of credit in the amount of $250.
The remaining activity in the account relates to the Heights Union Escrow Account (see Note 13 - Commitments and Contingencies).
11.Stock Incentive Plan
The Company maintains two share-based incentive plans: the Axogen 2017 Stock Incentive Plan, as amended (“2017 Plan”), and the Axogen 2017 Employee Stock Purchase Plan (“2017 ESPP”).
Overview of Equity Incentive Plans
At the 2019 Annual Meeting of Shareholders held on August 14, 2019, the shareholders approved the Axogen 2019 Long-Term Incentive Plan (the “New Axogen Plan”), which allows for issuance of incentive stock options, non-qualified stock options, PSUs and RSUs to employees, directors and consultants at exercise prices not less than the fair market value at the date of grant. The number of shares of common stock authorized for issuance under the New Axogen Plan is (A) 3,385,482 shares, comprised of (i) 3,000,000 new authorized shares and (ii) 385,482 unallocated shares of common stock available for issuance as of August 14, 2019 pursuant to the Company’s 2010 Stock Incentive Plan, as amended and restated (the “Prior Axogen Plan”), that were not then subject to outstanding awards; plus (B) shares under the Prior Axogen Plan and the New Axogen Plan that are cancelled, forfeited, expired, unearned or settled in cash, in any such case that does not result in the issuance of common stock. Following shareholder approval of the New Axogen Plan, no future awards will be made under the Prior Axogen Plan. At the 2021 Annual Meeting of Shareholders held May 10, 2021, the shareholders approved an additional 2,500,000 shares to be allocated for issuance under the New Axogen Plan. As of June 30, 2021, 2,832,712 shares of common stock were available for issuance under the New Axogen Plan.
The Company recognized stock-based compensation expense, which consisted of compensation expense related to employee stock options, PSUs, RSUs and the 2017 ESPP based on the value of share-based payment awards that are ultimately expected to vest during the period, of approximately $3,805 and $2,222 for the three months ended June 30, 2021 and 2020, respectively and approximately $6,499 and $2,778 for the six months ended June 30, 2021 and 2020, respectively.
Stock Options
The options granted to employees prior to July 1, 2017 typically vest 25% 1 year after the grant date and 12.5% every six months thereafter for the remaining three-year period until fully vested after four years. The options granted to employees after July 1, 2017 typically vest 50% two years after the grant date and 12.5% every six months thereafter for the remaining two-year period until fully vested after four years. The options granted to directors and certain options granted from time to time to certain executive officers have vested ratably over three years, 25% per quarter over one year or had no vesting period. Options typically have terms ranging from seven to ten years.
The Company estimates the fair value of each option award issued under such plans on the date of grant using a Multiple Point Black-Scholes option-pricing model which uses a weighted average of historical volatility and peer company volatility. The Company determines the expected life of each award giving consideration to the contractual terms, vesting schedules and post-vesting forfeitures. The Company uses the risk-free interest rate on the implied yield currently available on U.S. Treasury issues with an equivalent remaining term approximately equal to the expected life of the award.
A summary of the stock option activity is as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Options | | Weighted Average Exercise Price | | Weighted Average Remaining Contractual Life | | Aggregate Intrinsic Value (in thousands) |
Outstanding, December 31, 2020 | 3,516,484 | | | $12.79 | | | 5.93 | | $ | 25,718 | |
| | | | | | | |
Granted | 556,160 | | | $20.23 | | | | | |
Exercised | (545,912) | | | $5.86 | | | | | |
Cancelled | (126,171) | | | $16.81 | | | | | |
| | | | | | | |
Outstanding, June 30, 2021 | 3,400,561 | | | $14.97 | | | 6.59 | | $ | 27,868 | |
Exercisable, June 30, 2021 | 1,978,225 | | | $13.57 | | | 4.97 | | $ | 19,749 | |
The Company used the following weighted-average assumptions for options granted during the periods indicated:
| | | | | | | | | | | | |
| | June 30, 2021 | | |
| | |
Expected term (in years) | | 5.93 | | |
Expected volatility | | 58.91 | % | | |
Risk free rate | | 1.03 | % | | |
Expected dividends | | — | % | | |
Restricted and Performance Stock Units
RSUs granted to employees have a requisite service period of four years. The RSUs granted to directors and certain RSUs granted from time to time to certain executive officers have vested ratably over three years, over one year or had no vesting period. The Company expenses the fair value of restricted stock awards on a straight-line basis over the requisite service period. PSUs generally have a requisite service period of three years and are subject to graded vesting conditions based on revenue goals of the Company. The Company expenses their fair value over the requisite service period.
A summary of the status of non-vested RSUs/PSUs as of June 30, 2021 and the changes during the six months then ended are presented below:
| | | | | | | | | | | | | | | | | | | | | | | |
| Outstanding Stock Units |
| Stock Units | | Weighted-Average Fair Value at Date of Grant per Share | | Weighted Average Remaining Vesting Life | | Aggregate Intrinsic Value (in thousands) |
Unvested December 31, 2020 | 1,782,905 | | | $ | |