ARTIVION INC
For the period ended Mar 31, 2024. Filed May 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.
Mar 31, 2024 · Filed May 7, 2024
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Notes to Condensed Consolidated Financial Statements
- Basis of Presentation and Summary of Significant Accounting Policies
The accompanying Condensed Consolidated Financial Statements include the accounts of Artivion, Inc. and its subsidiaries (“Artivion,” the “Company,” “we,” or “us”). All significant intercompany accounts and transactions have been eliminated in consolidation. The accompanying Consolidated Balance Sheet as of December 31, 2023 has been derived from audited financial statements. The accompanying unaudited Condensed Consolidated Financial Statements as of, and for the three months ended, March 31, 2024 and 2023 have been prepared in accordance with (i) accounting principles generally accepted in the United States of America (“US GAAP”) for interim financial information and (ii) the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the US Securities and Exchange Commission (the “SEC”). Accordingly, such statements do not include all the information and disclosures that are required by US GAAP for a complete presentation of financial statements. In the opinion of management, all adjustments (including those of a normal, recurring nature) considered necessary for a fair presentation have been included. Certain prior-year amounts have been reclassified to conform to the current year presentation. Operating results for the three months ended March 31, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024. These Condensed Consolidated Financial Statements should be read in conjunction with the Consolidated Financial Statements and Notes included in Artivion’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 23, 2024.
Significant Accounting Policies
A summary of our significant accounting policies is included in Note 1 of the “Notes to Consolidated Financial Statements” contained in our Form 10-K for the year ended December 31, 2023. Management believes that the consistent application of these policies enables us to provide users of the financial statements with useful and reliable information about our operating results and financial condition. The Condensed Consolidated Financial Statements are prepared in accordance with US GAAP, which require us to make estimates and assumptions. We did not experience any significant changes during the three months ended March 31, 2024 in any of our Significant Accounting Policies from those contained in our Form 10-K for the year ended December 31, 2023.
New Accounting Standards
Not Yet Effective
In December 2023 the FASB issued ASU 2023-09, Income Taxes Topic 740 - Improvements to Income Tax Disclosures. This amendment is expected to enhance the transparency and decision usefulness of income tax disclosures by requiring public business entities, on an annual basis, to disclose specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold, and certain information about income taxes paid. This revised guidance is effective for financial statements issued for fiscal years beginning after December 15, 2024. We are currently evaluating the impacts of the new standard.
In November 2023 the FASB issued ASU 2023-07, Segment Reporting Topic 280 - Improvements to Reportable Segment Disclosures. This amendment requires disclosure of incremental segment information on an annual and interim basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, and requires retrospective application to all prior periods presented in the financial statements. We are currently evaluating the impacts of the new standard.
- Financial Instruments
The following is a summary of our financial instruments measured at fair value on a recurring basis (in thousands):
| March 31, 2024 | Level 1 | Level 2 | Level 3 | Total |
|---|---|---|---|---|
| Cash equivalents: | ||||
| Money market funds | $23,958 | $— | $— | $23,958 |
| Certificates of deposit | 3,884 | — | — | 3,884 |
| Total assets | $27,842 | $— | $— | $27,842 |
| Long-term liabilities: | ||||
| Contingent consideration | — | — | (46,420) | (46,420) |
| Total liabilities | $— | $— | $(46,420) | $(46,420) |
| December 31, 2023 | Level 1 | Level 2 | Level 3 | Total |
|---|---|---|---|---|
| Cash equivalents: | ||||
| Money market funds | $22,802 | $— | $— | $22,802 |
| Certificates of deposit | 3,968 | — | — | 3,968 |
| Total assets | $26,770 | $— | $— | $26,770 |
| Long-term liabilities: | ||||
| Contingent consideration | — | — | (63,890) | (63,890) |
| Total liabilities | $— | $— | $(63,890) | $(63,890) |
We used prices quoted from our investment advisors to determine the Level 1 valuation of our investments in money market funds and certificates of deposit. The estimated market value of all cash equivalents is equal to cost basis as there wereno gross realized gains or losses on cash equivalents for the three months ended March 31, 2024 and 2023.
On September 2, 2020 we entered into a Securities Purchase Agreement to acquire 100% of the outstanding equity interests of Ascyrus Medical LLC (“Ascyrus”). Ascyrus developed the Ascyrus Medical Dissection Stent (“AMDS”) hybrid prosthesis, the world’s first aortic arch remodeling device for use in the treatment of acute Type A aortic dissections. As part of the acquisition, we may be required to pay additional consideration in cash of up to $100.0 million to the former shareholders of Ascyrus upon the achievement of certain milestones and the sales-based additional earn-out.
The contingent consideration represents the estimated fair value of future potential payments. The fair value of the contingent consideration liability was estimated by discounting to present value the contingent payments expected to be made based on a probability-weighted scenario approach. We applied a discount rate based on our unsecured credit spread and the term commensurate risk-free rate to the additional consideration to be paid, and then applied a risk-based estimate of the probability of achieving each scenario to calculate the fair value of the contingent consideration. This fair value measurement was based on unobservable inputs, including management estimates and assumptions about the future achievement of milestones and future estimate of revenues, and is, therefore, classified as Level 3 within the fair value hierarchy. We used a discount rate of approximately 17% and estimated future achievement of milestone dates between 2025 and 2026 to calculate the fair value of contingent consideration as of March 31, 2024. We will remeasure this liability at each reporting date and will record changes in the fair value of the contingent consideration in General, administrative, and marketing expenses on the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss). Increases or decreases in the fair value of the contingent consideration liability can result from changes in passage of time, discount rates, the timing and amount of our revenue estimates, and the timing and expectation of regulatory approvals.
We performed an assessment of the fair value of the contingent consideration and recorded a fair value reduction of $17.5 million for the three months ended March 31, 2024, as compared to a fair value increase of $4.8 million for the three months ended March 31, 2023, on the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss), as a result of this assessment. The reduction in the fair value for the three months ended March 31, 2024 was primarily due to an increase in the credit risk spread resulting from the change in the inputs related to the newly issued Credit Facilities further discussed in Note 7.
The fair value of the contingent consideration component of the Ascyrus acquisition was updated using Level 3 inputs. Changes in fair value of Level 3 assets and liabilities are listed in the table below (in thousands):
| Contingent Consideration | |
|---|---|
| Balance as of December 31, 2023 | $(63,890) |
| Change in valuation | 17,470 |
| Balance as of March 31, 2024 | $(46,420) |
The determination of fair value and the assessment of a measurement’s placement within the hierarchy requires judgment. Level 3 valuations often involve a higher degree of judgment and complexity. Although we believe that the recorded fair values of our financial instruments are appropriate, these fair values may not be reflective of future fair values.
The contingent consideration liability of $46.4 million and $63.9 million was included in Long-term liabilities as of March 31, 2024 and December 31, 2023, respectively, on the Condensed Consolidated Balance Sheets.
- Inventories, net and Deferred Preservation Costs
Inventories, net at March 31, 2024 and December 31, 2023 were comprised of the following (in thousands):
| March 31,2024 | December 31,2023 | |
|---|---|---|
| Raw materials and supplies | $36,567 | $36,907 |
| Work-in-process | 12,940 | 12,687 |
| Finished goods | 32,209 | 32,382 |
| Total inventories, net | $81,716 | $81,976 |
To facilitate product usage, we maintain consignment inventory of our On-X heart valves at domestic hospital locations and On-X heart valves and aortic stent grafts at international hospital locations. We retain title and control over this consignment inventory until we receive a notification of implantation, at which time we invoice the hospital and recognize revenue. As of March 31, 2024 we had $10.4 million in consignment inventory, with approximately 43% in domestic locations and 57% in international locations. As of December 31, 2023 we had $10.7 million in consignment inventory, with approximately 44% in domestic locations and 56% in international locations.
Total deferred preservation costs were $50.2 million and $49.8 million as of March 31, 2024 and December 31, 2023, respectively.
Inventory and deferred preservation costs obsolescence reserves were $3.0 million as of March 31, 2024 and December 31, 2023.
- Goodwill and Other Intangible Assets
Indefinite Lived Intangible Assets
As of March 31, 2024 and December 31, 2023 the carrying values of our indefinite lived intangible assets were as follows (in thousands):
| March 31,2024 | December 31,2023 | |
|---|---|---|
| Goodwill | $245,030 | $247,337 |
| In-process R&D | 2,108 | 2,154 |
| Procurement contracts and agreements | 2,013 | 2,013 |
We monitor the phases of development of our acquired in-process research and development projects, including the risks associated with further development and the amount and timing of benefits expected to be derived from the completed projects. Incremental costs associated with development are charged to expense as incurred. Capitalized costs are amortized over the estimated useful life of the developed asset once completed. Our in-process research and development projects are reviewed for impairment annually, or more frequently, if events or changes in circumstances indicate that the asset might be impaired. We didnot record any impairment of indefinite lived intangible assets during the three months ended March 31, 2024. In-process research and development, procurement contracts and agreements are included in Other intangibles, net on the Condensed Consolidated Balance Sheets as of March 31, 2024 and the Consolidated Balance Sheets as of December 31, 2023.
Based on our experience with similar agreements, we believe that our acquired procurement contracts and agreements have indefinite useful lives, as we expect to continue to renew these contracts for the foreseeable future.
We evaluate our goodwill and non-amortizing intangible assets for impairment on an annual basis during the fourth quarter of the year, and, if necessary, during interim periods if factors indicate that an impairment review is warranted. As of March 31, 2024 we concluded that our assessment of current factors did not indicate that goodwill or non-amortizing intangible assets are more likely than not to be impaired. We will continue to evaluate the recoverability of these non-amortizing intangible assets in future periods as necessary.
As of March 31, 2024 and December 31, 2023 the carrying value of goodwill, all of which is related to our Medical Devices segment, was as follows (in thousands):
| Medical Devices Segment | |
|---|---|
| Balance as of December 31, 2023 | $247,337 |
| Foreign currency translation | (2,307) |
| Balance as of March 31, 2024 | $245,030 |
Definite Lived Intangible Assets
The definite lived intangible assets balance includes balances related to acquired technology, customer relationships, distribution and manufacturing rights and know-how, patents, and other definite lived intangible assets. As of March 31, 2024 and December 31, 2023 the gross carrying values, accumulated amortization, and approximate amortization period of our definite lived intangible assets were as follows (in thousands, except weighted average useful life):
| March 31, 2024 | Gross CarryingValue | AccumulatedAmortization | Net Carrying Value | Weighted AverageUseful Life(Years) |
|---|---|---|---|---|
| Acquired technology | $199,733 | $61,259 | $138,474 | 18.2 |
| Other intangibles: | ||||
| Customer lists and relationships | 28,686 | 10,650 | 18,036 | 21.6 |
| Distribution and manufacturing rights and know-how | 9,400 | 8,078 | 1,322 | 5.0 |
| Patents | 4,368 | 3,235 | 1,133 | 17.0 |
| Other | 9,287 | 4,393 | 4,894 | 5.0 |
| Total other intangibles | $51,741 | $26,356 | $25,385 | 9.7 |
| December 31, 2023 | Gross CarryingValue | AccumulatedAmortization | Net Carrying Value | Weighted AverageUseful Life(Years) |
|---|---|---|---|---|
| Acquired technology | $201,897 | $59,304 | $142,593 | 18.2 |
| Other intangibles: | ||||
| Customer lists and relationships | 28,729 | 10,334 | 18,395 | 21.6 |
| Distribution and manufacturing rights and know-how | 9,608 | 7,807 | 1,801 | 5.0 |
| Patents | 4,365 | 3,225 | 1,140 | 17.0 |
| Other | 7,815 | 3,680 | 4,135 | 5.0 |
| Total other intangibles | $50,517 | $25,046 | $25,471 | 10.0 |
Amortization Expense
The following is a summary of amortization expense as recorded in General, administrative, and marketing expenses on our Condensed Consolidated Statement of Operations and Comprehensive Income (Loss) (in thousands):
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Amortization expense | $3,867 | $3,882 |
As of March 31, 2024 scheduled amortization of intangible assets for the next five years is as follows (in thousands):
| Remainderof 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | Total | |
|---|---|---|---|---|---|---|---|
| Amortization expense | $11,375 | $13,218 | $12,919 | $12,814 | $12,600 | $12,357 | $75,283 |
- Income Taxes
Income Tax Expense
Our effective income tax rate was a tax expense of 41% and 52% for the three months ended March 31, 2024 and 2023, respectively. Our income tax rate for the three months ended March 31, 2024 and 2023 was primarily impacted by changes in our valuation allowance against our net deferred tax assets, non-deductible executive compensation, the foreign derived intangible income deduction, the research and development tax credit, changes in our uncertain tax position liabilities, and tax shortfalls on stock compensation.
Deferred Income Taxes
We generate deferred tax assets primarily as a result of finance and operating leases, net operating losses, excess interest carryforward, change in contingent consideration, accrued compensation, and stock compensation. Our deferred tax liabilities are primarily comprised of intangible assets acquired in previous years, finance and operating leases, and unrealized gains and losses.
We maintained a net deferred tax liability of $21.7 million and $20.8 million as of March 31, 2024 and December 31, 2023, respectively. Our valuation allowance against our deferred tax assets was $28.2 million and $32.9 million as of March 31, 2024 and December 31, 2023, respectively, primarily related to net operating loss carryforwards, disallowed excess interest carryforwards, change in contingent consideration, and capitalized research and development expenses.
- Leases
We have operating and finance lease obligations resulting from the lease of land and buildings that comprise our corporate headquarters and various manufacturing facilities; leases related to additional manufacturing, office, and warehouse space; leases on company vehicles; and leases on a variety of office and other equipment.
Information related to leases included in the Condensed Consolidated Balance Sheets was as follows (in thousands, except lease term and discount rate):
| Operating leases: | March 31,2024 | December 31,2023 |
|---|---|---|
| Operating lease right-of-use assets, net | $42,492 | $43,822 |
| Current maturities of operating leases | $3,214 | $3,395 |
| Non-current maturities of operating leases | 42,861 | 43,977 |
| Total operating lease liabilities | $46,075 | $47,372 |
| Finance leases: | ||
| Property and equipment, at cost | $6,813 | $6,862 |
| Accumulated amortization | (3,211) | (3,136) |
| Property and equipment, net | $3,602 | $3,726 |
| Current maturities of finance leases | $590 | $582 |
| Non-current maturities of finance leases | 3,268 | 3,405 |
| Total finance lease liabilities | $3,858 | $3,987 |
| Weighted average remaining lease term (in years): | ||
| Operating leases | 10.2 | 10.4 |
| Finance leases | 6.5 | 6.8 |
| Weighted average discount rate: | ||
| Operating leases | 6.3% | 6.3% |
| Finance leases | 2.3% | 2.2% |
Current maturities of finance leases are included as a component of Other current liabilities on our Condensed Consolidated Balance Sheets. A summary of lease expenses for our finance and operating leases included in General, administrative, and marketing expenses on our Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) was as follows (in thousands):
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Amortization of property and equipment | $147 | $131 |
| Interest expense on finance leases | 22 | 21 |
| Total finance lease expense | 169 | 152 |
| Operating lease expense | 1,920 | 1,802 |
| Sublease income | (129) | — |
| Total lease expense | $1,960 | $1,954 |
A summary of our cash flow information related to leases was as follows (in thousands):
| Three Months EndedMarch 31, | ||
|---|---|---|
| Cash paid for amounts included in the measurement of lease liabilities: | 2024 | 2023 |
| Operating cash flows for operating leases | $1,889 | $1,796 |
| Financing cash flows for finance leases | 147 | 132 |
| Operating cash flows for finance leases | 22 | 21 |
Future minimum lease payments and sublease rental income are as follows (in thousands):
| FinanceLeases · OperatingLeases | ||
|---|---|---|
| Remainder of 2024 | $497 | $4,180 |
| 2025 | 656 | 7,166 |
| 2026 | 636 | 6,642 |
| 2027 | 626 | 6,087 |
| 2028 | 608 | 5,830 |
| Thereafter | 1,114 | 33,805 |
| Total minimum lease payments | 4,137 | 63,710 |
| Less amount representing interest | (279) | (17,635) |
| Present value of net minimum lease payments | 3,858 | 46,075 |
| Less current maturities | (590) | (3,214) |
| Lease liabilities, less current maturities | $3,268 | $42,861 |
- Debt
Credit Facilities
On January 18, 2024 we entered into a credit and guaranty agreement with Ares Management Credit funds for $350.0 million of senior secured, interest-only, credit facilities, consisting of a $190.0 million secured term loan facility (the “Initial Term Loan Facility”), a $100.0 million secured delayed draw term loan facility (the “Delayed Draw Term Loan Facility” and, together with the Initial Term Loan Facility, the “Term Loan Facilities”) and a $60.0 million “senior-priority” secured revolving credit facility which has a priority claim ahead of the other secured facilities (the “Revolving Credit Facility” and, together with the Term Loan Facilities, the “Credit Facilities”). The final scheduled maturity date of the Credit Facilities is January 18, 2030. There are no scheduled repayments of principal required to be made prior to the final maturity date. We have the right to prepay loans under the Ares Credit Agreement in whole or in part at any time, provided that any prepayment of loans under the Term Loan Facilities (or loans under the Revolving Credit Facility to the extent of reducing the balance of outstanding loans below $30.0 million) will be subject to a prepayment premium of 5.00% if the prepayment occurs prior to January 18, 2025 and 1.00% if the prepayment occurs thereafter and prior to January 18, 2026. Amounts repaid in respect of loans under the Initial Term Loan Facilities may not be reborrowed. The Credit Facilities are secured by a security interest in substantially all existing and after-acquired real and personal property (subject to certain exceptions and exclusions) of us and the Guarantors.
Upon closing, we borrowed $190.0 million under the Initial Term Loan Facility and $30.0 million under the Revolving Credit Facility. The remaining $30.0 million of undrawn availability under the Revolving Credit Facility may be drawn for working capital, capital expenditures, and other general corporate purposes. The Delayed Draw Term Loan Facility remained undrawn upon closing as of March 31, 2024.
We paid $6.5 million of debt issuance costs related to the Initial Term Loan Facility which are included in Long-term debt on the Condensed Consolidated Balance Sheets as of March 31, 2024 and amortized, thereafter, over the life of the Initial Term Loan Facility. We paid $3.7 million of debt issuance costs related to the Delayed Draw Term Loan Facility and Revolving Credit Facility which are included in Other long-term assets on the Condensed Consolidated Balance Sheets as of March 31, 2024.
We recognized $5.8 million of interest expense on the Credit Facilities for the three months ended March 31, 2024, of which $341,000 represents non-cash amortization of debt issuance costs. There was approximately $6.2 million of unamortized debt issuance costs related to the Initial Term Loan Facility as of March 31, 2024.
The proceeds of the initial borrowings were used along with cash on hand to pay off our previously existing credit agreement, dated as of December 1, 2017, and pay related fees and expenses. As a result of this transaction, we recorded a loss on extinguishment of our previously existing debt of $3.7 million during the three months ended March 31, 2024 on our Condensed Consolidated Statements of Operations and Comprehensive Income (Loss). The proceeds of borrowings under the Delayed Draw Term Loan Facility may be used solely to repurchase or repay our outstanding 4.25% Convertible Senior Notes due July 1, 2025 and to pay related fees and expenses. Subject to the satisfaction of a specified maximum total net leverage ratio and other customary conditions, we may borrow under the Delayed Draw Term Loan Facility at any time and from time to time on or prior to the maturity date of the convertible bonds on July 1, 2025. Loans borrowed under the Delayed Draw Term Loan Facility generally have the same terms as the loans under the Initial Term Loan Facility.
The Credit Facilities contain certain customary affirmative and negative covenants, including covenants that limit our ability and the ability of our subsidiaries to, among other things, grant liens, incur debt, dispose of assets, make loans and investments, make acquisitions, make certain restricted payments (including cash dividends), merge or consolidate, change business or accounting or reporting practices, in each case subject to customary exceptions for a credit facility of this size and type. The covenants include a financial maintenance covenant that requires the company’s total net leverage ratio, as defined in the agreement, to be not greater than 6.25 x for the test periods from the second quarter of fiscal year 2024 through the fourth quarter of fiscal year 2024 and not greater than 5.75 x from the first quarter of fiscal year 2025 and thereafter. As of March 31, 2024 the total net leverage ratio, as defined in the agreement, was 3.79 x.
The Revolving Credit Facility bears interest, at our option, at a floating annual rate equal to either the base rate plus a margin of 3.00%, or the Adjusted Term Secured Overnight Financing Rate (“Adjusted Term SOFR”) plus a margin of 4.00%. In addition, we will be required to pay fees of 0.50% per annum on the daily unused amount of the Revolving Credit Facility and 1.00% per annum on the daily unused amount of the Delayed Draw Term Loan Facility. The Term Loan Facilities initially bear interest, at our option, at a floating annual rate equal to either the base rate plus a margin of 5.50%, or the Adjusted Term SOFR plus a margin of 6.50%. If, after the second quarter of fiscal year 2025, the company reports total net leverage ratio, as defined in the Credit Facilities, of less than or equal to 3.75 x the interest margins applicable to the Term Loan Facilities will be reduced by 25 basis points, to 5.25% and 6.25%, for base rate and Adjusted Term SOFR loans, respectively. As of March 31, 2024 the aggregate interest rate was 11.80% and 9.30% per annum for the Term Loan Facilities and Revolving Credit Facility, respectively.
Convertible Senior Notes
On June 18, 2020 we issued $100.0 million aggregate principal amount of 4.25% Convertible Senior Notes with a maturity date of July 1, 2025 (the “Convertible Senior Notes”). The net proceeds from this offering, after deducting initial purchasers’ discounts and costs directly related to this offering, were approximately $96.5 million. On January 1, 2021 we adopted ASU 2020-06 and adjusted the carrying balance of the Convertible Senior Notes to notional. The Convertible Senior Notes balance was $100.0 million recorded in Long-term debt on the Condensed Consolidated Balance Sheets as of March 31, 2024 and the Consolidated Balance Sheets as of December 31, 2023. The Convertible Senior Notes may be settled in cash, stock, or a combination thereof, solely at our discretion. The initial conversion rate of the Convertible Senior Notes is 42.6203 shares per $1,000 principal amount, which is equivalent to a conversion price of approximately $23.46 per share, subject to adjustments. We use the if-converted method for assumed conversion of the Convertible Senior Notes for the diluted earnings per share calculation. The fair value and the effective interest rate of the Convertible Senior Notes as of March 31, 2024 was approximately $113.4 million and 5.05%, respectively. The fair value was based on market prices observable for similar instruments and is considered Level 2 in the fair value hierarchy.
The interest expense recognized on the Convertible Senior Notes includes $1.2 million for both thethree months ended March 31, 2024 and 2023 related to the aggregate of the contractual coupon interest and the amortization of the debt issuance costs. Interest on the Convertible Senior Notes began accruing upon issuance and is payable semi-annually. There were approximately$1.0 million and$1.1 million of unamortized debt issuance costs related to the Convertible Senior Notes as of March 31, 2024 and December 31, 2023, respectively.
Holders of the Convertible Senior Notes may convert their notes at their option at any time prior to January 1, 2025, but only under the following circumstances: (i) during any calendar quarter commencing after the calendar quarter ending on September 30, 2020 (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (ii) during thefive business day period after anyfive consecutive trading day period in which the trading price per $1,000 principal amount of notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; (iii) we give a notice of redemption with respect to any or all of the notes, at any time prior to the close of business on the second scheduled trading day immediately preceding the redemption date; or (iv) upon the occurrence of specified corporate events. On or after January 1, 2025 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert their notes at any time, regardless of the foregoing circumstances.
We became eligible to redeem the Convertible Senior Notes beginning on July 5, 2023, following the expiration of their non-redemption period. We are able to redeem the Convertible Senior Notes in whole or in part, at our option, if the last reported sale price per share of our common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption. We may redeem for cash all or part of the Convertible Senior Notes at a redemption price equal to 100% of the principal amount of the redeemable Convertible Senior Notes, plus accrued and unpaid interest to, but excluding, the redemption date. No principal payments are due on the Convertible Senior Notes prior to maturity. Other than restrictions relating to certain fundamental changes and consolidations, mergers or asset sales and customary anti-dilution adjustments, the Convertible Senior Notes do not contain any financial covenants and do not restrict us from conducting significant restructuring transactions or issuing or repurchasing any of our other securities. As of March 31, 2024 and December 31, 2023 we are not aware of any current events or market conditions that would allow holders to convert the Convertible Senior Notes.
Loan Balances
The short-term and long-term balances of our Initial Term Loan Facility, Revolving Credit Facility, and other long-term borrowings were as follows (in thousands):
| March 31,2024 | December 31,2023 | |
|---|---|---|
| Initial Term Loan Facility | $190,000 | $— |
| Revolving Credit Facility | 30,000 | — |
| Convertible Senior Notes | 100,000 | 100,000 |
| Term loan balance | — | 211,500 |
| 2.45% Sparkasse Zollernalb (KFW Loan 1) | — | 61 |
| 1.40% Sparkasse Zollernalb (KFW Loan 2) | 405 | 484 |
| Total loan balance | 320,405 | 312,045 |
| Less unamortized loan origination costs | (7,131) | (5,063) |
| Net borrowings | 313,274 | 306,982 |
| Less short-term loan balance, net | (270) | (1,451) |
| Long-term loan balance, net | $313,004 | $305,531 |
Interest Expense
Interest expense was $7.8 million and $6.1 million for the three months ended March 31, 2024 and 2023, respectively. Interest expense includes interest on debt and uncertain tax positions in both periods.
- Commitments and Contingencies
Liability Claims
In the normal course of business, we are made aware of adverse events involving our products and tissues. Future adverse events could ultimately give rise to a lawsuit against us, and liability claims may be asserted against us in the future based on past events that we are not aware of at the present time. We maintain claims-made insurance policies to mitigate our financial exposure to product and tissue processing liability claims. Claims-made insurance policies generally cover only those asserted claims and incidents that are reported to the insurance carrier while the policy is in effect. The amounts recorded in these Condensed Consolidated Financial Statements as of March 31, 2024 and the Consolidated Financial Statements as of December 31, 2023 represent our estimate of the probable losses and anticipated recoveries for incurred but not reported claims related to products sold and services performed prior to the balance sheet date.
- Revenue Recognition
Disaggregation of Revenue
Revenues are disaggregated by the following geographic regions:
North America: consists of US and Canada. We market our medical device products and preservation services (predominantly in the US), primarily to physicians through our direct sales representatives who are managed by region managers.
Europe, the Middle East, and Africa (“EMEA”): In certain countries, we market approved medical device products to physicians, hospitals, and distributors through our direct sales force. In countries where we have no direct sales forces, regional sales managers market to distributors who buy medical device products directly from us and sell to hospitals in their respective countries.
Asia Pacific (“APAC”): we market medical device products that are approved in each country to distributors in the region.
Latin America (“LATAM”): we market medical device products that are approved in each country to distributors in the region except for Brazil where we sell directly to end customers and distributors.
Net revenues by geographic location based on the location of the customer for the three months ended March 31, 2024 and 2023 were as follows (in thousands):
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2024 | 2023 | |
| North America | $50,928 | $43,244 |
| EMEA | 33,588 | 27,929 |
| APAC | 7,609 | 7,878 |
| LATAM | 5,306 | 4,178 |
| Total revenues | $97,431 | $83,229 |
Also see segment disaggregation information in Note 12 below.
Contract Balances
We may generate contract assets during the pre-delivery design and manufacturing stage of E-xtra Design Engineering product order fulfillment. We assess the balance related to any arrangements in process and determine if the enforceable right to payment creates a material contract asset requiring disclosure. No material arrangements in process existed as of March 31, 2024 and 2023.
We also incur contract obligations on general customer purchase orders that have been accepted but unfulfilled. Due to the short duration of time between order acceptance and delivery of the related product or service, we have determined that the balance related to these contract obligations is generally immaterial at any point in time. We monitor the value of orders accepted but unfulfilled at the close of each reporting period to determine if disclosure is appropriate. The value of orders accepted but unfulfilled as of March 31, 2024 and 2023 was not material.
- Stock Compensation
We have stock option and stock incentive plans for employees and non-employee directors that provide for grants of restricted stock awards (“RSAs”), restricted stock units (“RSUs”), performance stock units (“PSUs”), and options to purchase shares of our common stock at exercise prices generally equal to the fair value of such stock at the dates of grant. We also maintain a shareholder-approved Employee Stock Purchase Plan (“ESPP”) for the benefit of our employees. The ESPP allows eligible employees to purchase common stock on a regular basis at the lower of 85% of the market price at the beginning or end of each offering period.
Equity Grants
During the three months ended March 31, 2024 the Compensation Committee of our Board of Directors (the “Committee”) authorized awards from approved stock incentive plans of RSUs and PSUs to certain employees and company officers, which, assuming that performance under the PSUs will be achieved at target levels, together totaled 700,000 shares and had an aggregate grant date fair value of $14.2 million.
During the three months ended March 31, 2023 the Committee authorized awards from approved stock incentive plans of RSUs and PSUs to certain employees and company officers, which, assuming that performance under the PSUs were to be achieved at target levels, together totaled 376,000 shares and had an aggregate grant date fair value of $5.0 million.
The Committee did not authorize any grants of stock options during the three months ended March 31, 2024 and 2023.
Employees purchased common stock totaling 51,000 and 56,000 shares in the three months ended March 31, 2024 and 2023, respectively, through the ESPP.
Stock Compensation Expense
The following weighted-average assumptions were used to determine the fair value of shares purchased under the ESPP:
| Three Months EndedMarch 31, 2024 | |
|---|---|
| ESPP | |
| Expected life | 0.5 Years |
| Expected stock price volatility | 0.48 |
| Risk-free interest rate | 5.26% |
The following table summarizes total stock compensation expenses prior to the capitalization of amounts into Deferred preservation and Inventory costs (in thousands):
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2024 | 2023 | |
| RSA, RSU, and PSU expense | $2,985 | $2,641 |
| Stock option and ESPP expense | 687 | 872 |
| Total stock compensation expense | $3,672 | $3,513 |
Included in the total stock compensation expense, as applicable in each period, were expenses related to RSAs, RSUs, PSUs, and stock options issued in each respective year, as well as those issued in prior periods that continue to vest during the period, and compensation related to the ESPP. These amounts were recorded as stock compensation expense and were subject to our normal allocation of expenses to inventory costs and deferred preservation costs. We capitalized $194,000 and $172,000 for the three months ended March 31, 2024 and 2023, respectively, of the stock compensation expense into our inventory costs and deferred preservation costs.
- Income (Loss) Per Common Share
The following table sets forth the computation of basic and diluted income (loss) per common share (in thousands, except per share data):
| Three Months EndedMarch 31, | ||
|---|---|---|
| Basic income (loss) per common share | 2024 | 2023 |
| Net income (loss) | $7,533 | $(13,532) |
| Net (income) loss allocated to participating securities | (22) | 60 |
| Net income (loss) allocated to common shareholders | $7,511 | $(13,472) |
| Basic weighted-average common shares outstanding | 41,290 | 40,432 |
| Basic income (loss) per common share | $0.18 | $(0.33) |
| Three Months EndedMarch 31, | ||
|---|---|---|
| Diluted income (loss) per common share | 2024 | 2023 |
| Net income (loss) | $7,533 | $(13,532) |
| Net (income) loss allocated to participating securities | (19) | 60 |
| Net income attributable to convertible senior notes | 935 | — |
| Net income (loss) allocated to common shareholders | $8,449 | $(13,472) |
| Basic weighted-average common shares outstanding | 41,290 | 40,432 |
| Effect of dilutive stock options and awards | 889 | — |
| Effect of convertible senior notes | 5,707 | — |
| Diluted weighted-average common shares outstanding | 47,886 | 40,432 |
| Diluted income (loss) per common share | $0.18 | $(0.33) |
We excluded stock options from the calculation of diluted weighted-average common shares outstanding if the per share value, including the sum of (i) the exercise price of the options and (ii) the amount of the compensation cost attributed to future services and not yet recognized, was greater than the average market price of the shares because the inclusion of these stock options would be antidilutive to loss per common share. For the three months ended March 31, 2024 $1.3 million of potential common shares related to stock options and awards were antidilutive and excluded from the calculation of diluted weighted-average common shares outstanding. For the three months ended March 31, 2023 all stock options and awards were excluded from the calculation of diluted weighted-average common shares outstanding as these would be antidilutive due to the net loss.
- Segment Information
We havetwo reportable segments organized according to our products and services: Medical Devices and Preservation Services. The Medical Devices segment includes external revenues from product sales of aortic stent grafts, On-X, surgical sealants, and other product revenues. Aortic stent grafts include aortic arch stent grafts, abdominal stent grafts, and synthetic vascular grafts. Aortic arch stent grafts include our E-vita Open NEO, E-vita Open Plus, AMDS, NEXUS, NEXUS DUO, E-vita Thoracic 3G, and Artivex. Abdominal stent grafts include our E-xtra Design Engineering, E-nside, E-tegra, E-ventus BX, and E-liac products. Surgical sealants include BioGlue Surgical Adhesive products. The Preservation Services segment includes external services revenues from the preservation of cardiac and vascular tissues. There areno intersegment revenues.
The primary measure of segment performance, as viewed by our management, is segment gross margin or net external revenues less cost of products and preservation services. We do not segregate assets by segment; therefore, asset information is excluded from the segment disclosures below.
The following table summarizes revenues, cost of products and preservation services, and gross margins for our operating segments (in thousands):
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Revenues: | ||
| Medical devices | $71,114 | $62,291 |
| Preservation services | 26,317 | 20,938 |
| Total revenues | 97,431 | 83,229 |
| Cost of products and preservation services: | ||
| Medical devices | 23,750 | 19,533 |
| Preservation services | 10,735 | 9,969 |
| Total cost of products and preservation services | 34,485 | 29,502 |
| Gross margin: | ||
| Medical devices | 47,364 | 42,758 |
| Preservation services | 15,582 | 10,969 |
| Total gross margin | $62,946 | $53,727 |
The following table summarizes net revenues by product and service (in thousands):
| Three Months EndedMarch 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Products: | ||
| Aortic stent grafts | $32,103 | $26,150 |
| On-X | 19,681 | 17,656 |
| Surgical sealants | 16,981 | 16,703 |
| Other | 2,349 | 1,782 |
| Total products | 71,114 | 62,291 |
| Preservation services | 26,317 | 20,938 |
| Total revenues | $97,431 | $83,229 |
Forward-Looking Statements
This Form 10-Q includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). Forward-looking statements give our expectations or forecasts of future events as of the date of this Form 10-Q. In some cases, words such as “could,” “may,” “might,” “will,” “would,” “shall,” “should,” “pro forma,” “potential,” “pending,” “intend,” “believe,” “expect,” “anticipate,” “estimate,” “plan,” “future,” “assume,” and variations of these types of words or other similar expressions identify forward-looking statements. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements, which are made as of the date of this Form 10-Q.
All statements included herein, other than statements of historical facts, that address activities, events, or developments that we expect or anticipate will or may occur in the future, or that reflect our beliefs about the future and/or expectations, are forward-looking statements, including statements about the following:
Our belief that new products, new indications, global expansion, and business development are the four growth areas that will drive our business in the future;
The potential impact the wars in Ukraine and in the Gaza Strip and around Israel, may have on demand for and sales of our products and services, business operations, manufacturing operations, supply chain, cash flow, workforce, clinical and regulatory timelines, and our research and development projects;
The potential impact general global, regional, or national economic downturns and macroeconomic trends, including heightened inflation, interest rate and currency fluctuations, as well as general or localized economic slowdowns or recessions may have on demand for and sales of our products and services, including ordering trends for international distributors based on currency fluctuations against the US dollar, and our business operations, manufacturing operations, supply chain, and workforce;
Our beliefs about the robustness of our global supply chain in light of current global and macroeconomic conditions and about the potential impact of supply chain disruptions, particularly disruptions to single and sole source suppliers and third-party manufacturing partners;
Our beliefs about our R&D and product pipeline, including our beliefs about the timing of our clinical trials and product launches;
Our beliefs and anticipation regarding the favorable attributes, benefits, and clinical advantages of our products and services, the basis on which our products and services compete, the benefits of our physician education activities, and the advantages of our relationships with organ and tissue procurement organizations and tissue banks;
Our beliefs about the future regulatory status of our medical devices and processed tissues, our compliance with applicable laws and regulations, and our ability to make timely transitions to our Notified Bodies and obtain renewals for our Conformité Européenne Mark product certification impacted by Brexit and the transition to the Medical Device Regulation in Europe, and the impact these transitions, renewals, and related processes may have on our business, including any impact on our customers’ ordering patterns and our ability to supply products;
Our beliefs regarding our global expansion efforts, including the international growth opportunity that would be provided by obtaining regulatory approval for BioGlue in China;
Our beliefs regarding the impact lower INR anticoagulation therapy and transcatheter heart valve replacement may have on the number of patients choosing On-X mechanical heart valves;
Our beliefs about the advantages of our intellectual property and its significance to our segments and our business as a whole, and our beliefs about the present value and potential impairment of our intangible assets and leases;
Our beliefs about our workforce, including our ability to attract and retain talent at all levels, and about our relationship with our workforce, including our works council in Germany and union in Brazil;
Our beliefs about potential information security vulnerabilities, and the associated potential adverse effects on our business;
The dependencies affecting our ability to realize the anticipated business opportunities, growth prospects, synergies, and other benefits of the agreements with Endospan and Baxter and our acquisition of Ascyrus, and our beliefs about the costs and timelines for certain regulatory approvals and clinical trial milestones;
Our beliefs regarding the fair value of our acquisitions, divestitures, and other business development activities and the estimates and assumptions about the future achievements of milestones and future revenues and cash flows related to those business development activities, including our ability to achieve the milestones in the Ascyrus and Baxter transactions;
Our belief that revenues for preservation services, particularly revenues for certain high-demand cardiac tissues, can vary from quarter-to-quarter and year-to-year due to a variety of factors including: quantity and type of incoming tissues, yields of tissue through the preservation process, timing of receipt of donor information, staffing levels, timing of the release of tissues to an implantable status, demand for certain tissue types due to the number and type of procedures being performed, and pressures from competing products or services;
Our beliefs regarding the seasonal nature of the demand for some of our products and services and the reasons for such seasonality, if any, and regarding the impact of consignment inventory on product sales, if any;
Our belief that our cash from operations and existing cash and cash equivalents will enable us to meet our current operational liquidity needs for at least the next twelve months, our expectations regarding future cash requirements, and the impact that our cash requirements might have on our cash flows for the next twelve months;
Our expectation regarding the impact on cash flows of undertaking significant business development activities and the potential need to obtain additional debt financing or equity financing;
Our belief that we will incur expenses for research and development projects, including for clinical research projects to gain regulatory approvals for products or indications, including On-X, aortic stent grafts, and BioGlue products, and for new products and technologies which will likely require additional investment, research, and new clinical studies or data;
Our beliefs about pending and potential legal or other governmental or regulatory proceedings;
Our expectations regarding the timing and impact of clinical research work and regulatory approvals for certain products or indications, including On-X, aortic stent grafts, and BioGlue products, and the CryoValve SG pulmonary heart valve if the US Food and Drug Administration reclassifies allograft heart valves as Class III medical devices;
Our beliefs and expectations regarding the utilization of net operating loss carryforwards from our acquisitions of JOTEC, On-X Life Technologies, Inc., Hemosphere, Inc., and Cardiogenesis Corporation;
Our beliefs about our operating results which may fluctuate significantly on a periodic basis as a result of internal and external factors, including reduced demand for our products, the potential impact of GLP-1 drugs, healthcare workforce trends and labor disputes, regulatory challenges, the availability of products, materials, and supplies, strategic actions we take such as acquisitions or divestitures, unanticipated costs and expenses, market reception of our new or improved product offerings, and interest rate and currency fluctuations; and
Other statements regarding projections of future financial and business performance; anticipated growth and trends in our business and the markets relevant to our business, including how our growth relates to our competitors; the robustness and reliability of our workforce and supply chain; future production capacity and product supply; the availability and benefits of our products in the future; and the expected timing and impact of our strategic initiatives.
These and other forward-looking statements reflect the views of management at the time and such statements are originally made based on certain assumptions and analyses made by us in light of our experience and our perception of historical trends, current conditions, and expected future developments as well as other factors we believe are appropriate in the circumstances and are subject to a number of risks, uncertainties, estimates, and assumptions. Whether actual results and developments will conform with our expectations and predictions is subject to a number of risks and uncertainties which could cause actual results to differ materially and adversely from our expectations, including, without limitation, in addition to those specified in the text surrounding such statements, the risks described in Part II, Item 1A, “Risk Factors” in this Form 10-Q and elsewhere throughout this report, the risks described in our other filings with the Securities and Exchange Commission including the risks described in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 and elsewhere throughout that report, and other risks which we may not be able to identify in advance, many of which are beyond our control. Consequently, all of the forward-looking statements made in this Form 10-Q are qualified by these cautionary statements, and there can be no assurance that the actual results or developments anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us or our business or operations. We assume no obligation, and expressly disclaim any duty, to update publicly any such forward-looking statements, whether as a result of new information, future events, or otherwise.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.