Axogen Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 7, 2024
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Notes to Unaudited Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
- Nature of Business
Axogen, Inc. (together with its wholly-owned subsidiaries, the “Company”) was incorporated in Minnesota. Our business is focused on the science, development and commercialization of the technologies used for peripheral nerve regeneration and repair. The Company's products include Avance® Nerve Graft, Axoguard Nerve Connector®, Axoguard Nerve Protector®, Axoguard HA+ Nerve Protector™, Axoguard Nerve Cap®, Avive+ Soft Tissue Matrix™, and Axotouch® Two-Point Discriminator. The Company is headquartered in Florida. The Company has processing, warehousing, and distribution facilities in Texas and Ohio.
The Company manages its operations as a single operating segment. Substantially all of the Company's assets are maintained in the United States. The Company derives substantially all of its revenues from sales to customers in the United States.
- Summary of Significant Accounting Policies
Please see Note 2 to the Company’s consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission ("SEC") on March 5, 2024, for a description of all significant accounting policies.
Reclassifications
Certain reclassifications have been made to the prior period financial information to conform to the presentation used in the condensed consolidated statement of operations for the three and nine months ended September 30, 2024.
Effective in the first quarter of 2024, the Company voluntarily changed its accounting policy for shipping and handling costs. Under the new accounting policy, these costs are included in Costs of goods sold, whereas they were previously included in Sales and marketing expenses. Including these expenses in Costs of goods sold better aligns these costs with the related revenue in the gross profit calculation. Although the prior method of accounting continues to be an accepted alternative, the new accounting policy is more widely used in the industry and provides improved comparability of the Company's financial statements to its peers. This change in accounting policy has been applied retrospectively. The consolidated statement of operations for the three and nine months ended September 30, 2023, has been reclassified to reflect this change in accounting policy. The impact of this reclassification was an increase of $1,460 and $4,204 to Cost of goods sold for the three and nine months ended September 30, 2023, respectively, and a corresponding decrease to Sales and marketing expenses in the same periods.
Effective in the first quarter of 2024, the Company also ceased allocating certain costs to and from certain departments. Previously such costs had been allocated based on the Company’s estimate of the proportionate share of total expense to Cost of goods sold, Sales and marketing, Research and development, and General and administrative. The Company determined that these changes would better reflect industry practice and would provide more meaningful information as well as increased transparency of its operations. To conform the 2023 presentation to the current quarter and year to date presentation,$1,035 and$3,019 was reclassified to General and administrative, of which$295 and$867 was previously included in Research and development,$803 and$2,209 was previously included in Sales and marketing, and$63 and $58 was previously included in Cost of goods sold for thethree and nine months ended September 30, 2023, respectively, in the condensed consolidated statement of operations.
These reclassifications had no impact on net revenue, loss from operations, net loss, or loss per common share for prior periods and do not represent a restatement of the Company's previously issued condensed consolidated financial statements.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include the accounts of the Company as of September 30, 2024, and December 31, 2023, and for the three and nine months ended September 30, 2024, and 2023. 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 ("U.S. GAAP") and should be read in conjunction with the audited financial statements of the
Company for the year ended December 31, 2023, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
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. The results of operations for the three and nine months ended September 30, 2024, are not necessarily indicative of the results to be expected for the full year due primarily to the impact of the continued uncertainty of general economic conditions that may impact the Company's markets for the remainder of fiscal year 2024. All intercompany accounts and transactions have been eliminated in consolidation.
Cash and Cash Equivalents and Concentration
Cash and cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of acquisition. Certain of the Company's cash and cash equivalents balances exceed Federal Deposit Insurance Corporation ("FDIC") insured limits or are invested in money market accounts with investment banks that are not FDIC-insured. The Company places its cash and cash equivalents in what they believe to be credit-worthy financial institutions. As of September 30, 2024, $18,162 of the cash and cash equivalents balance was in excess of FDIC limits.
Restricted Cash
Amounts included in restricted cash represent those required to be set aside to meet contractual terms of a lease agreement held by the Company. See Note 8 - Long-Term Debt, Net of Debt Discount and Financing Fees, Other Credit Facilities.
The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported in the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows:
| (in thousands) | September 30,2024 | December 31,2023 |
|---|---|---|
| Cash and cash equivalents | $18,662 | $31,024 |
| Restricted cash | 6,000 | 6,002 |
| Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $24,662 | $37,026 |
Government Assistance
As there is no authoritative guidance under U.S. GAAP for accounting for grants to for-profit business entities, the Company accounts for the grants by analogy to International Accounting Standard ("IAS") 20 Accounting for Government Grants and Disclosures of Government Assistance ("IAS 20"). Government assistance and grants are recognized when there is reasonable assurance that the Company has met the requirements of the assistance and there is reasonable assurance that the grant will be received. The Company received government grants of $378 and $— for the three months ended September 30, 2024 and 2023, respectively and $544 and $155 for the nine months ended September 30, 2024 and 2023, respectively. See Note 12 - Commitments and Contingencies.
Shipping and Handling
All shipping and handling costs, including facility and warehousing overhead, directly related to bringing the Company’s products to their final selling destination are included in cost of goods sold on the consolidated statements of operations. The Company has elected to account for shipping and handling costs for products shipped to customers as a fulfillment activity as the costs are incurred as part of the transfer of the goods to the customer in accordance with ASC 606. See Reclassifications above.
Recent Accounting Pronouncements
All other Accounting Standards Updates ("ASU's") issued and not yet effective as of September 30, 2024, and through the date of this report, were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s current or future financial position or results of operations except for the following:
In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standard Update 2023-09 —Income Taxes (Topic 740) — Improvements to Income Tax Disclosures ("ASU 2023-09"). The new guidance provides for disclosure on an annual basis of the following: (i) specific categories in the rate reconciliation, and (ii) additional information for reconciling items that meet a quantitative threshold of greater than 5% of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate. The amendment in ASU 2023-09 is effective for the annual periods beginning after December 15, 2025, early adoption is permitted. The Company expects to enhance annual income tax reporting disclosures based on the new requirements.
In November 2023, the FASB issued Accounting Standard Update 2023-07 —Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures ("ASU 2023-07"). The new guidance requires disclosure on an annual and interim basis of the following: (i) significant segment expenses regularly provided to the chief operating decision maker ("CODM") and a measure of segment profit or loss; (ii) an amount for other segment items by reportable segment and a description of its composition; (iii) all annual disclosures about a reportable segment's profit and loss and assets as currently required by Topic 280; (iv) clarify if the CODM uses more than one measure of a segment's profit or loss in assessing segment performance and deciding how to allocate resources; and (v) disclose title and position of the CODM and how the CODM uses the reported measures. Public entities with a single reportable segment are required to provide all the disclosures required by this amendment. The amendment in ASU 2023-07 is effective for the annual periods beginning after December 15, 2023, and for the quarters in the years after December 15, 2024, early adoption is permitted. The Company expects to enhance annual segment reporting disclosures based on the new requirements.
- Inventory
Inventory consists of the following:
| (in thousands) | September 30,2024 | December 31,2023 |
|---|---|---|
| Finished goods | $23,766 | $13,545 |
| Work in process | 900 | 2,120 |
| Raw materials | 4,697 | 7,355 |
| Inventory | $29,363 | $23,020 |
As of September 30, 2024, and December 31, 2023, the Company reserved $1,518 and $1,342, respectively, for potential losses relating to inventory. The reserve is included in the Inventory, net on the Condensed Consolidated Balance Sheets.
- Property and Equipment, Net
Property and equipment, net consist of the following:
| (in thousands) | September 30,2024 | December 31,2023 |
|---|---|---|
| Land | $731 | $731 |
| Building | 60,679 | 60,679 |
| Leasehold improvements | 17,889 | 15,348 |
| Processing equipment | 13,883 | 13,116 |
| Furniture and equipment | 9,516 | 8,741 |
| Projects in process | 1,072 | 3,674 |
| Finance lease right-of-use assets | 138 | 138 |
| Property and equipment, at cost | 103,908 | 102,427 |
| Less: accumulated depreciation and amortization | (18,276) | (13,697) |
| Property and equipment, net | $85,632 | $88,730 |
Depreciation expense is as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2024 | 2023 | 2024 | 2023 |
| Depreciation expense | $1,654 | $1,154 | $4,831 | $2,660 |
- Intangible Assets, Net
Intangible assets consist of the following:
| September 30, 2024 | December 31, 2023 | |||||
|---|---|---|---|---|---|---|
| (in thousands) | Gross Carrying Amount | Accumulated Amortization | Net Carrying Amount | Gross Carrying Amount | Accumulated Amortization | Net Carrying Amount |
| Amortizable intangible assets: | ||||||
| Patents | $5,691 | $(1,009) | $4,682 | $4,905 | $(820) | $4,085 |
| License agreements | — | — | — | 1,101 | (1,087) | 14 |
| Total amortizable intangible assets | 5,691 | (1,009) | 4,682 | 6,006 | (1,907) | 4,099 |
| Unamortized intangible assets: | ||||||
| Trademarks | 533 | — | 533 | 432 | — | 432 |
| Total intangible assets | $6,224 | $(1,009) | $5,215 | $6,438 | $(1,907) | $4,531 |
Amortization expense is as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2024 | 2023 | 2024 | 2023 |
| Amortization expense | $65 | $70 | $202 | $214 |
As of September 30, 2024, future amortization of patents and license agreements is as follows:
| Year Ending December 31, | (in thousands) |
|---|---|
| 2024 (excluding the nine months ended September 30, 2024) | $68 |
| 2025 | 272 |
| 2026 | 272 |
| 2027 | 272 |
| 2028 | 272 |
| Thereafter | 3,526 |
| Total | $4,682 |
License Agreements
The Company had various license agreements that required the payment of royalty fees.
Royalty fee expense included in sales and marketing expense is as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2024 | 2023 | 2024 | 2023 |
| Royalty fee expense (1) | $— | $930 | $— | $2,628 |
(1)Royalty fees are no longer being paid due to the expiration of the patents in 2023.
- Fair Value Measurement
The following tables present the Company's fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2024, and December 31, 2023:
| September 30, 2024 | ||||
|---|---|---|---|---|
| (in thousands) | (Level 1) | (Level 2) | (Level 3) | Total |
| Assets: | ||||
| Money market funds (1) | $13,233 | $— | $— | $13,233 |
| U.S. government securities | 5,868 | — | — | 5,868 |
| Total assets | $19,101 | $— | $— | $19,101 |
| Liabilities: | ||||
| Debt derivative liabilities | $— | $— | $2,445 | $2,445 |
| Total liabilities | $— | $— | $2,445 | $2,445 |
(1) Money market funds are included in Cash and cash equivalents on the Condensed Consolidated Balance Sheet.
| December 31, 2023 | ||||
|---|---|---|---|---|
| (in thousands) | (Level 1) | (Level 2) | (Level 3) | Total |
| Assets: | ||||
| Money market funds(1) | $24,977 | $— | $— | $24,977 |
| Total assets | $24,977 | $— | $— | $24,977 |
| Liabilities: | ||||
| Debt derivative liabilities | $— | $— | $2,987 | $2,987 |
| Total liabilities | $— | $— | $2,987 | $2,987 |
(1) Money market funds are included in Cash and cash equivalents on the Condensed Consolidated Balance Sheet.
The changes in Level 3 liabilities measured at fair value on a recurring basis for the three and nine months ended September 30, 2024, were as follows (in thousands):
| Beginning Balance, July 1, 2024 | $2,458 |
|---|---|
| Change in fair value included in net loss | (13) |
| Ending Balance, September 30, 2024 | $2,445 |
| Beginning Balance, January 1, 2024 | $2,987 |
|---|---|
| Change in fair value included in net loss | (542) |
| Ending Balance, September 30, 2024 | $2,445 |
The fair value of cash, restricted cash, accounts receivable, accounts payable and accrued expenses approximates the carrying values because of the short-term nature of these instruments. The carrying value and fair value of the Credit Facility were $47,272 and $51,274 at September 30, 2024, and $46,603 and $51,486 at December 31, 2023, respectively. See Note 8 - Long-Term Debt, Net of Debt Discount and Financing Fees.
The debt derivative liabilities are measured using a ‘with and without’ valuation model to compare the fair value of each tranche of the Credit 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 Credit Facility including the identified embedded derivative features was determined using a probability-weighted expected return model based onfour potential settlement scenarios, one of which ended December 31, 2023, for the financing agreement as disclosed in the table below. The estimated settlement value of each scenario, which would include any required make-whole payment, (see Note 8 - Long-Term Debt, Net of Debt Discount and Financing Fees), is then discounted to present value using a discount rate that is derived based on the initial terms of the financing agreement 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:
| September 30, 2024 · December 31, 2023 | |||||
|---|---|---|---|---|---|
| Input | |||||
| Remaining term (years) · 2.75 years · 3.5 years | |||||
| Maturity date · June 30, 2027 · June 30, 2027 | |||||
| Coupon rate | 9.5% - 13.0% | 9.5% - 13.2% | |||
| Revenue participation payments | Maximum each year | Maximum each year | |||
| Discount rate | 11.56% | (1) | 12.06% | (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) | |
| Probability of note held-to-maturity(2) | 80.0% | (1) | 80.0% | (1) | |
(1)Represents a significant unobservable input.
(2) See Maturity date in table.
The significant inputs that are included in the valuation of the debt derivative liability - second tranche include:
| September 30, 2024 · December 31, 2023 | |||||
|---|---|---|---|---|---|
| Input | |||||
| Remaining term (years) · 3.75 years · 4.5 years | |||||
| Maturity date · June 30, 2028 · June 30, 2028 | |||||
| Coupon rate | 9.5% - 13.0% | 9.5% - 13.2% | |||
| Revenue participation payments | Maximum each year | Maximum each year | |||
| Discount rate | 14.92% | (1) | 15.60% | (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) | |
| Probability of held-to-maturity(2) | 80.0% | 80.0% | |||
(1)Represents a significant unobservable input.
(2)See Maturity date in table.
- Leases
The Company leases administrative, processing, research and distribution facilities through operating leases. Several of the leases include fixed payments, including rent and non-lease components such as common area or other maintenance costs.
Operating lease expense is as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2024 | 2023 | 2024 | 2023 |
| Operating lease expense | $1,183 | $1,327 | $3,673 | $3,871 |
Supplemental balance sheet information related to the operating and financing leases is as follows:
| (in thousands, except lease term and discount rate) | September 30, 2024 | December 31, 2023 |
|---|---|---|
| Operating Leases | ||
| Right-of-use operating assets | $14,614 | $15,562 |
| Current maturities of long-term lease obligations | $1,850 | $1,541 |
| Long-term lease obligations | $19,720 | $21,123 |
| Sublease receivable | $272 | $— |
| Financing Leases | ||
| Right-of-use financing leases (1) | $19 | $28 |
| Current maturities of long-term lease obligations | $6 | $6 |
| Long-term lease obligations | $14 | $19 |
| Weighted average operating lease term (in years): | 9.0 | 9.6 |
| Weighted average financing lease term (in years): | 1.7 | 6.5 |
| Weighted average discount rate operating leases | 10.96% | 10.99% |
| Weighted average discount rate financing leases | 6.81% | 13.22% |
(1)Financing leases are included in property and equipment, net on the condensed consolidated balance sheets.
Future minimum lease payments under operating and financing leases at September 30, 2024, are as follows:
| (in thousands) | |
|---|---|
| 2024 (excluding nine months ended September 30, 2024) | $999 |
| 2025 | 4,143 |
| 2026 | 4,278 |
| 2027 | 3,115 |
| 2028 | 3,113 |
| Thereafter | 18,567 |
| Total | 34,215 |
| Less: Imputed interest | (12,625) |
| Total lease liability | 21,590 |
| Less: Current lease liability | (1,856) |
| Long-term lease liability | $19,734 |
Sublease Agreement
On May 31, 2024, the Company entered into a sublease agreement to sublease a portion of its headquarters in Tampa, FL. The sublease commenced on August 1, 2024. The Company accounts for this sublease in accordance with ASC 842, Leases.
- Long-Term Debt, Net of Debt Discount and Financing Fees
Long-term debt, net of debt discount and financing fees consists of the following:
| (in thousands) | September 30, 2024 | December 31, 2023 |
|---|---|---|
| Credit Facility - first tranche | $35,000 | $35,000 |
| Credit Facility - second tranche | 15,000 | 15,000 |
| Less - unamortized debt discount and deferred financing fees | (2,728) | (3,397) |
| Long-term debt, net of debt discount and financing fees | $47,272 | $46,603 |
Credit Facility
On June 29, 2023, the Company amended its Credit Facility with Oberland Capital and its affiliates TPC Investments II LP and Argo LLC (collectively, the "Lender"). The term loan agreement for the Credit Facility was amended to transition the base interest rate from three-month LIBOR to Adjusted SOFR. The Company obtained the first tranche of $35,000 at closing on June 30, 2020. On June 30, 2021, the second tranche of $15,000 was drawn down by the Company.
Each tranche under the Credit Facility requires quarterly interest payments forseven years. Interest is calculated as 7.5% plus thegreater of Adjusted SOFR or 2.0% (12.9% at September 30, 2024), provided that the interest rate shall never be less than 9.5%. Each tranche of the Credit Facility has a term ofseven years from the date of issuance (with the first tranche issued on June 30, 2020, maturing on June 30, 2027, and the second tranche issued on June 30, 2021, maturing on June 30, 2028). In connection with the Credit Facility, the Company entered into a revenue participation agreement (the “Revenue Participation Agreement”) with the Lender, which provided that, among other things, a quarterly royalty payment as a percentage of the Company’s net revenues, up to $70 million in any given year, after April 1, 2021, ending on the date upon which all amounts owed under the Credit Facility have been paid in full. This structure results in approximately 1.5% per year of additional interest payments on the outstanding loan amount. The Company recorded $0 as interest expense for this Revenue Participation Agreement for each of the three months ended September 30, 2024, and 2023, and $756 for each of the nine months ended September 30, 2024, and 2023, respectively. The Company pays the quarterly debt interest on the last day of the quarter and for the three months ended September 30, 2024, and 2023, paid $1,652 and $1,642, respectively, and$4,917 and $4,776 for the nine months ended September 30, 2024, and 2023, respectively, to the Lender. The Company capitalized interest of $0 and $1,043 for the three months ended September 30, 2024, and 2023, respectively, and$0 and $5,240 for the nine months ended September 30, 2024, and 2023, towards the costs to construct and retrofit the Axogen Processing Center ("APC Facility") in Vandalia, Ohio which was completed during 2023. As of September 30, 2024, the Company was in compliance with all financial covenants. The borrowings under the Credit Facility are secured by substantially all of the assets of the Company.
Embedded Derivatives
The fair values of the debt derivative liabilities were $2,445 and $2,987 at September 30, 2024, and December 31, 2023, respectively. See Note 6 - Fair Value Measurement.
Unamortized Debt Discount and Financing Fees
The unamortized debt discount consists of the remaining initial fair values of the embedded derivatives related to the Credit Facility.
The financing fees for the Credit Facility were $642 and were recorded as a contra liability to long-term debt on the consolidated balance sheet.
Amortization of debt discount and deferred financing fees for the three months ended September 30, 2024, and 2023 was $225 and $224, respectively, and for the nine months ended September 30, 2024, and 2023, was $669 and $666, respectively.
Other Credit Facilities
The Company had restricted cash of $6,000 and $6,002 at September 30, 2024, and December 31, 2023, respectively for an irrevocable standby letter of credit.
- Stock-Based Compensation
The Company's stock-based compensation plans are described in Note 11. Stock-Based Compensation to the Company’s consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
During the fiscal year 2024, the following stock compensation was awarded to officers and employees. All awards were granted under the 2019 Amended and Restated Long-Term Incentive Plan ("2019 Plan"), with the exception of the inducement shares awarded as material inducement of employment to new employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).
| Type of Award | Quarter Awarded | Target Shares or Units | Weighted Average Grant Date Fair Value |
|---|---|---|---|
| Stock Options (1) | 1st Quarter | — | $— |
| 2nd Quarter | 145,984 | $4.11 | |
| Restricted Stock Units (2) | 1st Quarter | 787,688 | $9.05 |
| 2nd Quarter | 200,108 | $7.56 | |
| 3rd Quarter | 2,875 | $14.29 | |
| Performance Stock Units (3)(4) | 1st Quarter | 911,400 | $8.92 |
| 2nd Quarter | 424,400 | $3.06 | |
| Inducement Shares (5) | |||
| Stock Options | 1st Quarter | 18,700 | $6.04 |
| Restricted Stock Units | 1st Quarter | 310,000 | $7.00 |
| Restricted Stock Units | 3rd Quarter | 20,000 | $10.43 |
| Performance Stock Units | 3rd Quarter | 600,000 | $13.38 |
(1)Options granted to the Board of Directors during the second quarter for their annual fee vest inone year from the date of grant.
(2)Restricted Stock Units ("RSUs") awarded to certain officers and employees during the first, second and third quarter vest over afour-year period. Included in the second and third quarter RSUs are 88,099 units awarded to the Board of Directors for their annual fee of which 2,875 were granted to a board member for accepting the Chairmanship of the Board of Directors in September, the units vest inone year from the date of the award. Upon vesting, the outstanding number of RSUs vested are converted into common stock.
(3)Performance Stock Units (PSUs) awarded to certain officers and employees related to their work on the BLA ("2024 BLA PSUs") totaled 487,000 shares during the first quarter of 2024. Participants with 2024 BLA PSUs will earn from 0% to 100% upon achievement of certain milestones related to the BLA submission and U.S. Food and Drug Administration ("FDA") approval. The number of shares available for grant is linked to certain milestones related to the BLA submission to and approval by the FDA. These awards will vest provided the participants remain in continuous service to the Company through the achievement of the applicable performance goal and the one-year anniversary of the grant date.
(4) PSUs were awarded to certain officers and employees with a target of 424,400 shares with performance metrics tied to the achievement of stock price goals between February 2024 through February 2027 ("TSR PSU") during the first and third quarter of 2024. Participants with TSR PSUs will earn from 0% to 200% upon achievement of specific stock price goals. The maximum number of shares that can be issued under this award is 848,800. Vesting occurs at the end of thethree-year performance period upon Compensation Committee certification of the results at the end of the performance period.
(5)Inducement shares were issued to officers and new employees as a material inducement to entering into employment with the Company during the first and third quarters of 2024 with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). Vesting for both the stock options and restricted stock units are over both athree-andfour-year periods. During the third quarter of 2024,600,000 PSUs, which included 450,000 of the TSR PSUs and 150,000 2024 BLA
PSUs, were issued to an officer as a material inducement to entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). No inducement shares were issued in the second quarter of 2024.
Total stock-based compensation expense is as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2024 | 2023 | 2024 | 2023 |
| Stock-based compensation expense | $5,004 | $4,747 | $12,830 | $13,091 |
- Net Loss Per Common Share
The following reflects the net loss attributable to common shareholders and share data used in the basic and diluted earnings per share computations using the two-class method:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (In thousands, except per share amounts) | 2024 | 2023 | 2024 | 2023 |
| Numerator: | ||||
| Net loss | $(1,858) | $(4,089) | $(10,414) | $(17,823) |
| Denominator: | ||||
| Weighted-average common shares outstanding (Basic) | 43,882,110 | 43,022,328 | 43,610,481 | 42,821,284 |
| Weighted-average common shares outstanding (Diluted) | 43,882,110 | 43,022,328 | 43,610,481 | 42,821,284 |
| Net loss per common share (Basic and Diluted) | $(0.04) | $(0.10) | $(0.24) | $(0.42) |
| Anti-dilutive shares excluded from the calculation of diluted earnings per share (1) | ||||
| Stock options | 1,678,775 | 4,552,919 | 3,077,373 | 4,321,696 |
| Restricted stock units | 319,136 | 1,391,717 | 513,975 | 373,794 |
(1) These common equivalent shares are not included in the diluted per share calculations as they would be anti-dilutive if the Company was in a net income position.
- Income Taxes
The Company has no recorded income tax expense or income tax benefit for thethree and nine months ended September 30, 2024, and 2023 due to the generation of net operating losses, the benefits of which have been fully reserved.
The Company has not recorded current income tax expense due to the generation of net operating losses. Deferred income taxes are accounted for using the balance sheet approach, which requires recognition of deferred tax assets and liabilities for the expected future consequences of temporary differences between the financial reporting basis and the tax basis of assets and liabilities. A valuation allowance is provided when it is more likely than not that a deferred tax asset will not be realized. A full valuation allowance has been established on the deferred tax asset as it is more likely than not that a future tax benefit will not be realized. In addition, future utilization of the available net operating loss carryforward may be limited under Internal Revenue Code Section 382 as a result of changes in ownership.
The Company identifies and evaluates uncertain tax positions, if any, and recognizes the impact of uncertain tax positions for which there is a less than more likely than not probability of the position being upheld when reviewed by the relevant tax authority. Such positions are deemed to be unrecognized tax benefits and a corresponding liability is established on the condensed consolidated balance sheet. The Company has not recognized a liability for uncertain tax positions. If there were an unrecognized tax benefit, the Company would recognize interest accrued related to unrecognized tax benefits in interest expense and penalties in operating expenses. The Company’s remaining open tax years subject to examination by federal tax authorities include the years ended December 31, 2019, through 2023, and we received a notice of examination from the federal tax authorities for tax year 2021 is currently under examination. For tax years 2005 through 2018, federal taxing authorities may examine and adjust loss carryforwards in the years in which those loss carryforwards are ultimately utilized.
- Commitments and Contingencies
Service Agreements
The Company pays Community Blood Center, (d/b/a Solvita), formerly d/b/a Community Tissue Service, ("Solvita") a facility fee for the use of clean rooms/manufacturing, storage, and office space and for services in support of its tissue processing including for routine sterilization of daily supplies, providing disposable supplies and microbial services, and office support. Pursuant to the Solvita Agreement, the Company recorded expensesof $233 and $600 for the three months ended September 30, 2024, and 2023, respectively, and $706 and $1,911 during the nine months ended September 30, 2024, and 2023, is included in cost of goods sold. The Solvita Agreement was amended on June 30, 2024, extending the term through December 31, 2026. The Solvita Agreement maybe terminated by either party by providing aneighteen-month written notice. The Company is continuing its use of Solvita for Avive+.
Distribution and Supply Agreements
In August 2008, the Company entered into an exclusive distribution agreement with Cook Biotech Incorporated ("Cook Biotech") to distribute the Axoguard Nerve Connector and Axoguard Nerve Protector products worldwide and the parties subsequently amended the agreement on August 4, 2023. The distribution agreement expires on December 31, 2030. The Cook Biotech agreement establishes a formula for the transfer cost of the Axoguard products and requires certain minimum purchases by the Company, although, through mutual agreement, the parties have not established such minimums; and, to date, have not enforced such provision. Under the Cook Biotech agreement, the Company provides purchase orders to Cook Biotech, and Cook Biotech fulfills the purchase orders. The agreement allows for termination provisions for both parties. The loss of the ability to sell the Axoguard products could have a material adverse effect on the Company's business until other replacement products would be available.
In June 2017, the Company entered into the Nerve End Cap Supply Agreement (the "Supply Agreement") with Cook Biotech whereby Cook Biotech is the exclusive contract manufacturer of the Axoguard Nerve Cap; the parties subsequently amended the agreement on August 4, 2023. The Supply Agreement expires on December 31, 2030. The Supply Agreement establishes the terms and conditions in which Cook Biotech will manufacture the product for the Company. Under the Supply Agreement the Company provides purchase orders to Cook Biotech and Cook Biotech fulfills the purchase orders. The Supply Agreement allows for termination provisions for both parties. The loss of the Company's ability to sell the Axoguard Nerve Cap products could have a material adverse effect on the Company's business until other replacement products would become available.
In May 2023, the Company entered into a Supply and Manufacturing Agreement ("HA+ Supply Agreement") with Cook Biotech whereby Cook Biotech is the exclusive contract manufacturer of the Axoguard HA+ Nerve Protector. The HA+ Supply Agreement expires on July 1, 2030. The HA+ Supply Agreement establishes the terms and conditions in which Cook Biotech will manufacture, package, label and deliver the product to the Company. Under the HA+ Supply Agreement, the Company provides purchase orders to Cook Biotech, and Cook Biotech fulfills the purchase orders. The HA+ Supply Agreement allows for termination provisions for both parties. The loss of the Company's ability to sell the Axoguard products could have a material adverse effect on the Company's business until other replacement products would become available. On January 31, 2024, RTI Surgical, Inc. announced the acquisition of Cook Biotech. The acquisition of Cook Biotech has not had any material impact on our relationship with Cook Biotech or our operations.
Insurance Finance Agreement
We finance certain of our commercial insurance policies ("Insurance Financing Agreement"). Outstanding payments owed under the Insurance Financing Agreement are recorded as "prepaid expenses and other" in our condensed consolidated balance sheets. The amounts owed under the Insurance Financing Agreement included in prepaid expenses and other were $465 and $0 as of September 30, 2024, and December 31, 2023, respectively.
Processing Facilities
The Company is highly dependent on the continued availability of its processing facilities at Solvita and APC in Dayton, Ohio and could be harmed if the physical infrastructure of these facilities is unavailable for any prolonged period of time.
Certain Economic Development Grants
The Company obtained certain economic development grants from state and local authorities totaling up to $2,685 including $1,250 of cash grants to offset costs to acquire and develop the APC Facility. The economic development grants are subject to certain job creation milestones through December 31, 2023, and have clawback clauses if the Company does not meet the job creation milestones The Company requested an extension from the grant authorities to extend the job creation milestones and received approval to extend the evaluation date to December 31, 2024, and the expiration date to December 31, 2026. As of September 30, 2024, the Company has received $1,188 from the cash grants.
Fair Value of the Debt Derivative Liabilities
The fair value of the debt derivative liabilities is $2,445 as of September 30, 2024. The fair value of the debt derivative liabilities is determined using a probability-weighted expected return model based upon four potential settlement scenarios, one of which ended December 31, 2023, with the Credit Facility. The estimated settlement value of each scenario, which includes any required make-whole payment, is discounted to present value using a discount rate that is derived based upon the initial terms of the Credit Facility at issuance and corroborated utilizing a synthetic rating analysis. The calculated fair values under thefour scenarios are then compared to the fair value of a plain vanilla note, with the difference reflecting the fair value of the debt derivative liabilities. The Company estimated the make-whole payments required under each scenario according to the terms of the Credit Facility to generate an internal rate of return equal to 11.5% through the scheduled maturity dates, less the total of all quarterly interest and royalty payments previously paid to the Lender. The calculation utilized the XIRR function in Microsoft Excel as required by the Credit Facility. If the debt is not prepaid but instead is held to its scheduled maturities, the Company’s estimate of the make-whole payment for the first tranche and second tranche of the Credit Facility due on June 30, 2027, and June 30, 2028, respectively, are approximately zero. The Company has consistently applied this approach since the inception of the debt agreement on June 30, 2020.
The Company is aware that the Lender may have an alternative interpretation of the calculation of the make-whole payments that the Company believes does not properly utilize the same methodology utilized by the XIRR function in Microsoft Excel as described in the Credit Facility. The Company estimates the top end of the range of the make-whole payments if the debt is held to scheduled maturity under an alternative interpretation to be approximately $9,000 for the first tranche of the Credit Facility due on June 30, 2027, and approximately $4,000 for the second tranche of the Credit Facility due on June 30, 2028. Further, if the debt is prepaid prior to the scheduled maturity dates and subject to the alternative interpretation, the make-whole payment would be larger than the amounts herein.
Legal Proceedings
The Company is and may be subject to various claims, lawsuits, and proceedings in the ordinary course of the Company's business. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. While there can be no assurances as to the ultimate outcome of any legal proceeding or other loss contingency involving the Company, in the opinion of management, such claims are either adequately covered by insurance or otherwise indemnified, or are not expected individually or in the aggregate, to result in a material, adverse effect on the Company's financial condition, results of operations or cash flows. However, it is possible that the Company's results of operations, financial position and cash flows in a particular period could be materially affected by these contingencies.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.