Item 1. Financial Statements
Item 1. Financial Statements (Unaudited)
TRANSMEDICS GROUP, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share amounts)
(Unaudited)
March 31,
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
17,897
$
25,580
Marketable securities
54,104
66,872
Accounts receivable
11,724
5,934
Inventory
16,714
14,859
Prepaid expenses and other current assets
5,356
5,460
Total current assets
105,795
118,705
Property and equipment, net
12,044
9,841
Restricted cash
500
500
Operating lease right-of-use assets
5,669
5,847
Total assets
$
124,008
$
134,893
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$
2,934
$
6,651
Accrued expenses and other current liabilities
15,738
16,337
Deferred revenue
247
250
Operating lease liabilities
1,337
—
Total current liabilities
20,256
23,238
Long-term debt, net of discount and current portion
35,334
35,197
Operating lease liabilities, net of current portion
8,508
8,604
Total liabilities
64,098
67,039
Commitments and contingencies (Note 9)
Stockholders' equity:
Preferred stock, no par value; 25,000,000 shares authorized; no shares
issued or outstanding
—
—
Common stock, no par value; 150,000,000 shares authorized; 27,968,583
shares and 27,791,615 shares issued and outstanding at March 31, 2022
and December 31, 2021, respectively
513,203
510,488
Accumulated other comprehensive loss
( 285
)
( 188
)
Accumulated deficit
( 453,008
)
( 442,446
)
Total stockholders' equity
59,910
67,854
Total liabilities and stockholders' equity
$
124,008
$
134,893
The accompanying notes are an integral part of these consolidated financial statements.
1
TRANSMEDICS GROUP, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended March 31,
2022
2021
Net revenue
$
15,880
$
7,053
Cost of revenue
3,776
2,242
Gross profit
12,104
4,811
Operating expenses:
Research, development and clinical trials
7,534
4,532
Selling, general and administrative
13,939
6,786
Total operating expenses
21,473
11,318
Loss from operations
( 9,369
)
( 6,507
)
Other income (expense):
Interest expense
( 960
)
( 952
)
Other expense, net
( 227
)
( 454
)
Total other expense, net
( 1,187
)
( 1,406
)
Loss before income taxes
( 10,556
)
( 7,913
)
Provision for income taxes
( 6
)
( 4
)
Net loss
$
( 10,562
)
$
( 7,917
)
Net loss per share attributable to common stockholders,
basic and diluted
$
( 0.38
)
$
( 0.29
)
Weighted average common shares outstanding,
basic and diluted
27,950,330
27,368,090
The accompanying notes are an integral part of these consolidated financial statements.
2
TRANSMEDICS GROUP, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands)
(Unaudited)
Three Months Ended March 31,
2022
2021
Net loss
$
( 10,562
)
$
( 7,917
)
Other comprehensive income (loss):
Foreign currency translation adjustment
( 24
)
( 2
)
Unrealized gains (losses) on marketable securities,
net of tax of $ 0
( 73
)
8
Total other comprehensive income (loss)
( 97
)
6
Comprehensive loss
$
( 10,659
)
$
( 7,911
)
The accompanying notes are an integral part of these consolidated financial statements.
3
TRANSMEDICS GROUP, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
(Unaudited)
Accumulated
Other
Total
Common Stock
Comprehen-
Accumulated
Stockholders'
Shares
Amount
sive Loss
Deficit
Equity
Balances at December 31, 2021
27,791,615
$
510,488
$
( 188
)
$
( 442,446
)
$
67,854
Issuance of common stock upon the
exercise of common stock options
164,503
202
—
—
202
Issuance of common stock in
connection with employee stock
purchase plan
12,465
203
—
—
203
Stock-based compensation expense
—
2,310
—
—
2,310
Foreign currency translation
adjustment
—
—
( 24
)
—
( 24
)
Unrealized losses on marketable
securities
—
—
( 73
)
—
( 73
)
Net loss
—
—
—
( 10,562
)
( 10,562
)
Balances at March 31, 2022
27,968,583
$
513,203
$
( 285
)
$
( 453,008
)
$
59,910
Accumulated
Other
Total
Common Stock
Comprehen-
Accumulated
Stockholders'
Shares
Amount
sive Loss
Deficit
Equity
Balances at December 31, 2020
27,175,305
$
502,217
$
( 95
)
$
( 398,231
)
$
103,891
Issuance of common stock upon the
exercise of common stock options
287,705
372
—
—
372
Issuance of common stock in
connection with employee stock
purchase plan
14,951
211
—
—
211
Stock-based compensation expense
—
1,112
—
—
1,112
Foreign currency translation
adjustment
—
—
( 2
)
—
( 2
)
Unrealized gains on marketable
securities
—
—
8
—
8
Net loss
—
—
—
( 7,917
)
( 7,917
)
Balances at March 31, 2021
27,477,961
$
503,912
$
( 89
)
$
( 406,148
)
$
97,675
The accompanying notes are an integral part of these consolidated financial statements.
4
TRANSMEDICS GROUP, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
Three Months Ended March 31,
2022
2021
Cash flows from operating activities:
Net loss
$
( 10,562
)
$
( 7,917
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
507
445
Stock-based compensation expense
2,310
1,112
Non-cash interest expense and end of term accretion expense
137
130
Non-cash lease expense
178
—
Net amortization of premiums on marketable securities
228
391
Unrealized foreign currency transaction losses
214
484
Changes in operating assets and liabilities:
Accounts receivable
( 5,804
)
( 583
)
Inventory
( 2,926
)
( 381
)
Prepaid expenses and other current assets
88
( 908
)
Accounts payable
( 4,013
)
( 82
)
Accrued expenses and other current liabilities
( 4
)
( 180
)
Deferred revenue
—
182
Operating lease liabilities
1,241
—
Deferred rent
—
( 23
)
Net cash used in operating activities
( 18,406
)
( 7,330
)
Cash flows from investing activities:
Purchases of property and equipment
( 1,953
)
( 20
)
Purchases of marketable securities
( 2,033
)
( 11,708
)
Proceeds from sales and maturities of marketable securities
14,500
21,000
Net cash provided by investing activities
10,514
9,272
Cash flows from financing activities:
Proceeds from issuance of common stock upon exercise of stock options
202
372
Proceeds from issuance of common stock in connection with employee stock
purchase plan
203
211
Net cash provided by financing activities
405
583
Effect of exchange rate changes on cash, cash equivalents and restricted cash
( 196
)
( 379
)
Net increase (decrease) in cash, cash equivalents and restricted cash
( 7,683
)
2,146
Cash, cash equivalents and restricted cash, beginning of period
26,080
25,081
Cash, cash equivalents and restricted cash, end of period
$
18,397
$
27,227
Supplemental disclosure of non-cash investing and financing activities:
Transfers of inventory to property and equipment
$
1,030
$
429
Purchases of property and equipment included in accounts payable and accrued expenses
$
939
$
7
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents
$
17,897
$
26,727
Restricted cash
500
500
Total cash, cash equivalents and restricted cash shown in the statement of cash flows
$
18,397
$
27,227
The accompanying notes are an integral part of these consolidated financial statements.
5
TRANSMEDICS GROUP, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Nature of the Business and Basis of Presentation
TransMedics Group, Inc. (“TransMedics Group” and, together with its consolidated subsidiaries, the “Company”) was incorporated in the Commonwealth of Massachusetts in October 2018. TransMedics, Inc. (“TransMedics”), an operating company and wholly owned subsidiary of TransMedics Group, was incorporated in the State of Delaware in August 1998. The Company is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. The Company developed the Organ Care System (“OCS”) to replace a decades-old standard of care. The OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. The Company’s OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body.
The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has incurred recurring losses since inception, including net losses of $ 10.6 million for the three months ended March 31, 2022 and $ 44.2 million for the year ended December 31, 2021. As of March 31, 2022, the Company had an accumulated deficit of $ 453.0 million. The Company expects to continue to generate operating losses in the foreseeable future.
The Company believes that its existing cash, cash equivalents, and marketable securities of $ 72.0 million as of March 31, 2022 will be sufficient to fund its operations, capital expenditures, and debt service payments for at least the next 12 months following the filing of this Quarterly Report on Form 10-Q. The Company may need to seek additional funding through equity financings, debt financings or strategic alliances. The Company may not be able to obtain financing on acceptable terms, or at all, and the terms of any financing may adversely affect the holdings or the rights of the Company’s shareholders. If the Company is unable to obtain funding, the Company will be required to delay, reduce or eliminate some or all of its research and development programs, product expansion or commercialization efforts, or the Company may be unable to continue operations.
The Company is subject to risks and uncertainties common to companies in the medical device industry and of similar size, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, uncertainty of market acceptance of products, and the need to obtain additional financing to fund operations. Potential risks and uncertainties also include, without limitation, uncertainties regarding the duration and magnitude of the impact of the COVID-19 pandemic on the Company’s business and the economy generally. Products currently under development will require additional research and development efforts, including additional clinical testing and regulatory approval, prior to commercialization. These efforts require additional capital, adequate personnel, infrastructure and extensive compliance-reporting capabilities. The Company’s research and development may not be successfully completed, adequate protection for the Company’s technology may not be obtained, the Company may not obtain necessary government regulatory approval on its expected timeline or at all, and approved products may not prove commercially viable. The Company operates in an environment of rapid change in technology and competition.
The impact of the COVID-19 pandemic has been and may continue to be extensive in many aspects of society, which has resulted in and may continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world. Impacts to the Company’s business as a result of COVID-19 have included the temporary disruption of transplant procedures at many of the organ transplant centers that purchase OCS products; customer delays or reductions in customer capital expenditures and operating budgets and the related impact on its product sales; disruptions to the Company’s manufacturing operations and supply chain caused by facility closures, reductions in operating hours, staggered shifts and other social distancing efforts; labor shortages; decreased productivity and unavailability of materials or components; delays of reviews and approvals by the Food and Drug Administration (“FDA”) and other health authorities; delays in the Company’s clinical trial enrollment; limitations on its employees’ and customers’ ability to travel, and delays in product installations, trainings or shipments to and from other affected countries and within the United States.
6
In response to the pandemic, healthcare providers have, and may need to further, reallocate resources, such as physicians, staff, hospital beds and intensive care unit facilities, and these actions significantly delay the provision of other medical care such as organ transplantation and reduce the number of transplant procedures that are performed, which negatively impacts the Company’s revenue and cash flows. While the Company maintains an inventory of finished products and raw materials used in its OCS products, a prolonged pandemic could lead to shortages in the raw materials necessary to manufacture its products. The COVID-19 pandemic also has impacted operations at the FDA and other health authorities, resulting in delays of reviews and approvals, and may affect other potential Pre-Market Approval (“PMA”) applications.
The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
2. Summary of Significant Accounting Policies
Unaudited Interim Financial Information
The accompanying unaudited interim financial statements and related notes have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of March 31, 2022 and results of operations for the three months ended March 31, 2022 and 2021 and cash flows for the three months ended March 31, 2022 and 2021 have been made. The Company’s results of operations for the three months ended March 31, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, revenue recognition, the valuation of inventory and the valuation of stock-based awards. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets. The Company has made estimates of the impact of COVID-19 within its financial statements and there may be changes to those estimates in future periods. As of the date of issuance of these unaudited consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update estimates, judgments or revise the carrying value of any assets or liabilities. Actual results may differ from those estimates or assumptions.
Risk of Concentrations of Credit, Significant Customers and Significant Suppliers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents, marketable securities, and accounts receivable. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. As of March 31, 2022 and December 31, 2021, the Company had no allowance for credit losses.
Significant customers are those that accounted for 10 % or more of the Company’s net revenue or accounts receivable. For the three months ended March 31, 2022, three customers accounted for 16 %, 15 % and 12 % of net revenue, respectively.
7
For the three months ended March 3 1 , 202 1 , two customer s each accounted for 12 % of net revenue. As of March 31, 2022 , four customer s accounted for 14 % , 12 %, 12 % and 10 % of accounts receivable , respectively . As of December 31 , 20 2 1 , two customer s accounted for 21 % and 15 % of accounts receivable , respectively .
Certain of the components and subassemblies included in the Company’s products are obtained from a sole source, a single source or a limited group of suppliers. Although the Company seeks to reduce dependence on those limited sources of suppliers and manufacturers, the partial or complete loss of certain of these sources could have a material adverse effect on the Company’s operating results, financial condition and cash flows and damage its customer relationships.
Fair Value Measurements
Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
•
Level 1—Quoted prices in active markets for identical assets or liabilities.
•
Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
•
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
The Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy described above (see Note 4). The carrying values of the Company’s accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. The carrying value of the Company’s long-term debt approximates its fair value (a level 2 measurement) at each balance sheet date due to its variable interest rate, which approximates a market interest rate.
Segment Information
The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is developing and commercializing a proprietary system to preserve human organs for transplant in a near-physiologic condition to address the limitations of cold storage organ preservation. Operating segments are defined as components of an enterprise for which separate financial information is regularly evaluated by the Company’s chief operating decision maker, or decision-making group, in deciding how to allocate resources and assess performance. The Company has determined that its chief operating decision maker is its Chief Executive Officer. The Company’s chief operating decision maker reviews the Company’s financial information on a consolidated basis for purposes of allocating resources and assessing financial performance.
Net Income (Loss) per Share
Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares assuming the dilutive effect of outstanding stock awards. For periods in which the Company reports a net loss, diluted net loss per common share is the same as basic net loss per common share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders for each of the three months ended March 31, 2022 and 2021.
8
The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated above because including them would have had an anti-dilutive effect:
As of March 31,
2022
2021
Warrants to purchase common stock
64,440
64,440
Options to purchase common stock
3,484,914
2,764,876
Employee stock purchase plan
5,794
5,882
3,555,148
2,835,198
3. Marketable Securities
Marketable securities by security type consisted of the following (in thousands):
March 31, 2022
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair Value
U.S. Treasury securities (due within one year)
$
51,212
$
—
$
( 102
)
$
51,110
U.S. government agency bonds (due within one year)
3,001
—
( 7
)
2,994
$
54,213
$
—
$
( 109
)
$
54,104
December 31, 2021
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair Value
U.S. Treasury securities (due within one year)
$
63,907
$
—
$
( 33
)
$
63,874
U.S. government agency bonds (due within one year)
3,001
—
( 3
)
2,998
$
66,908
$
—
$
( 36
)
$
66,872
4. Fair Value of Financial Assets and Liabilities
The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands):
Fair Value Measurements at March 31, 2022 Using:
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
2,847
$
—
$
—
$
2,847
Marketable securities:
U.S. Treasury securities
—
51,110
—
51,110
U.S. government agency bonds
—
2,994
—
2,994
$
2,847
$
54,104
$
—
$
56,951
9
Fair Value Measurements at December 31, 2021 Using:
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
11,169
$
—
$
—
$
11,169
Marketable securities:
U.S. Treasury securities
—
63,874
—
63,874
U.S. government agency bonds
—
2,998
—
2,998
$
11,169
$
66,872
$
—
$
78,041
Money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. U.S. Treasury securities and U.S. government agency bonds were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy.
5. Inventory
Inventory consisted of the following (in thousands):
March 31, 2022
December 31, 2021
Raw materials
$
8,322
$
7,274
Work-in-process
2,501
1,932
Finished goods
5,891
5,653
$
16,714
$
14,859
During the three months ended March 31, 2022 and 2021, the Company made non-cash transfers of OCS Consoles from inventory to property and equipment (OCS Consoles loaned to customers) of $ 1.0 million and $ 0.4 million, respectively.
6. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
March 31, 2022
December 31, 2021
Accrued research, development and clinical trials expenses
$
4,532
$
4,567
Accrued payroll and related expenses
5,819
5,173
Accrued professional fees
857
1,973
Accrued other
4,530
4,624
$
15,738
$
16,337
10
7. Long-Term Debt
TransMedics has a credit agreement (the “Credit Agreement”) with OrbiMed Royalty Opportunities II, LP (“OrbiMed”), entered into in June 2018, pursuant to which TransMedics borrowed $ 35.0 million. Long-term debt consisted of the following (in thousands):
March 31, 2022
December 31, 2021
Principal amount of long-term debt
$
35,000
$
35,000
Less: Current portion of long-term debt
—
—
Long-term debt, net of current portion
35,000
35,000
Debt discount, net of accretion
( 428
)
( 511
)
Accrued end-of-term payment
762
708
Long-term debt, net of discount and current portion
$
35,334
$
35,197
Borrowings under the Credit Agreement bear interest at an annual rate equal to the London Interbank Offered Rate (“LIBOR”), subject to a minimum of 1.0 % and a maximum of 4.0 % , plus 8.5 % (the “Applicable Margin”), subject in the aggregate to a maximum interest rate of 11.5 %. In addition, borrowings under the Credit Agreement bear paid-in-kind (“PIK”) interest at an annual rate equal to the amount by which LIBOR plus the Applicable Margin exceeds 11.5 %, but not to exceed 12.5 %. The PIK interest is added to the principal amount of the borrowings outstanding at the end of each quarter until the maturity date of the Credit Agreement in June 2023 . Borrowings under the Credit Agreement are repayable in quarterly interest-only payments until the maturity date, at which time all principal and accrued interest is due and payable. At its option, the company may prepay outstanding borrowings under the Credit Agreement. The Company is required to make a final payment in an amount equal to 3.0 % of the principal amount of any prepayment or repayment. The final payment and debt discount amounts are being accreted to interest expense over the term of the Credit Agreement using the effective interest method.
All obligations under the Credit Agreement are guaranteed by the Company and each of its material subsidiaries. All obligations of the Company and each guarantor are secured by substantially all of the Company’s and each guarantor’s assets, including their intellectual property, subject to certain exceptions, including a perfected security interest in substantially all tangible and intangible assets of the Company and each guarantor. Under the Credit Agreement, the Company has agreed to certain affirmative and negative covenants to which it will remain subject until maturity. The financial covenants include maintaining a minimum liquidity amount of $ 3.0 million; the requirement, on an annual basis, to deliver to OrbiMed annual audited financial statements with an unqualified audit opinion from the Company’s independent registered public accounting firm; and restrictions on the Company’s activities, including limitations on dispositions, mergers or acquisitions; encumbering its intellectual property; incurring indebtedness or liens; paying dividends; making certain investments; and engaging in certain other business transactions. As of March 31, 2022, the Company was in compliance with the financial covenants under the Credit Agreement.
The obligations under the Credit Agreement are subject to acceleration upon the occurrence of specified events of default, including payment default, change in control, bankruptcy, insolvency, certain defaults under other material debt, certain events with respect to governmental approvals (if such events could cause a material adverse change in the Company’s business), failure to comply with certain covenants, including the minimum liquidity and unqualified audit opinion covenants, and a material adverse change in the Company’s business, operations or other financial condition.
Upon the occurrence of an event of default and until such event of default is no longer continuing, the Applicable Margin will increase by 4.0 % per annum. If an event of default (other than certain events of bankruptcy or insolvency) occurs and is continuing, OrbiMed may declare all or any portion of the outstanding principal amount of the borrowings plus accrued and unpaid interest to be due and payable. Upon the occurrence of certain events of bankruptcy or insolvency, all of the outstanding principal amount of the borrowings plus accrued and unpaid interest will automatically become due and payable. In addition, the Company may be required to prepay outstanding borrowings, subject to certain exceptions, with portions of net cash proceeds of certain asset sales and certain casualty and condemnation events.
As of March 31, 2022, the interest rate applicable to borrowings under the Credit Agreement was 9.5 %. During the three months ended March 31, 2022, the weighted average effective interest rate on outstanding borrowings under the Credit Agreement was approximately 11.2 %.
11
8. Stock-Based Compensation
2019 Stock Incentive Plan
The Company’s 2019 Stock Incentive Plan (the “2019 Plan”) provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, unrestricted stock units, and other stock-based awards to employees, directors, and consultants of the Company and its subsidiaries. The number of shares of common stock of TransMedics Group initially available for issuance under the 2019 Plan was 3,428,571 shares, plus the number of shares underlying awards under the previously outstanding 2014 Stock Incentive Plan (the “2014 Plan”), not to exceed 1,595,189 shares, that expire or are terminated, surrendered, or cancelled without the delivery of shares, are forfeited to or repurchased by TransMedics Group or otherwise become available again for grant. Since the effectiveness of the Company’s 2019 Plan in April 2019, no future awards will be made under the 2014 Plan.
Shares withheld in payment of the exercise or purchase price of an award or in satisfaction of tax withholding requirements, and the shares covered by a stock appreciation right for which any portion is settled in stock, will reduce the number of shares available for issuance under the 2019 Plan. In addition, the number of shares available for issuance under the 2019 Plan (i) will not be increased by any shares delivered under the 2019 Plan that are subsequently repurchased using proceeds directly attributable to stock option exercises and (ii) will not be reduced by any awards that are settled in cash or that expire, become unexercisable, terminate or are forfeited to or repurchased by TransMedics Group without the issuance of stock under the 2019 Plan. As of March 31, 2022, 890,558 shares of common stock were available for issuance under the 2019 Plan.
2019 Employee Stock Purchase Plan
Pursuant to the Company’s 2019 Employee Stock Purchase Plan (the “2019 ESPP”), certain employees of the Company are eligible to purchase common stock of the Company at a reduced price during offering periods. The 2019 ESPP permits participants to purchase common stock using funds contributed through payroll deductions, subject to the limitations set forth in the Internal Revenue Code, at a purchase price of 85 % of the lower of the closing price of the Company’s common stock on the first trading day of the offering period or the closing price on the applicable purchase date, which is the final trading day of the applicable offering period. A total of 371,142 shares of the Company’s common stock are reserved for issuance under the 2019 ESPP. During the three months ended March 31, 2022, 12,465 shares of common stock were issued under the 2019 ESPP and as of March 31, 2022, 308,131 shares of common stock remained available for issuance.
2021 Inducement Plan
In August 2021, the Company’s board of directors approved the TransMedics Group, Inc. Inducement Plan (the “Inducement Plan”). Pursuant to the terms of the Inducement Plan, the Company may grant nonstatutory stock options, stock appreciation rights, restricted stock, unrestricted stock, restricted stock unit awards and performance awards to individuals who were not previously employees or directors of the Company or individuals returning to employment after a bona fide period of non-employment with the Company. A total of 1,000,000 shares of the Company’s common stock were initially available for issuance under the Inducement Plan. As of March 31, 2022, 580,200 shares of common stock were available for issuance under the Inducement Plan.
Stock-Based Compensation
The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations (in thousands):
Three Months Ended March 31,
2022
2021
Cost of revenue
$
25
$
13
Research, development and clinical trials expenses
321
197
Selling, general and administrative expenses
1,964
902
$
2,310
$
1,112
12
During the three months ended March 31, 2022, the Company granted options to its employees and directors with service-based vesting for the purchase of an aggregate of 880,910 shares of common stock with a weighted average grant-date fair value of $ 7.11 per share. As of March 31, 2022, total unrecognized compensation cost related to unvested share-based awards was $ 24.6 million, which is expected to be recognized over a weighted average period of 3.1 years.
9. Commitments and Contingencies
Operating Leases
The Company leases office, laboratory and manufacturing space under two non-cancelable operating leases. There have been no material changes to the Company’s leases during the three months ended March 31, 2022. For additional information, please read Note 12 Leases, to the consolidated financial statements in the Company’s Form 10-K for the year ended December 31, 2021.
License Agreement with the Department of Veterans Affairs
In 2002, the Company entered into a license agreement with the Department of Veterans Affairs (the “VA”), under which the Company was granted an exclusive, worldwide license under specified patents to make, use, sell and import certain technology used in the Company’s products and a non-exclusive, worldwide license to make, use, sell and import solutions for use in or with those products. The rights under the license agreement continue until the expiration of the last to expire of the licensed patents. The majority of the licensed U.S. patents expired in 2017, and the foreign patents expired in September 2018. However, the Company has requested a patent term extension for one U.S. patent covered by the VA license agreement, U.S. Patent No. 6100082. The Company was granted an interim patent term extension for this patent until November 6, 2021. The Company has not received final approval of the patent extension beyond the interim patent term extension already granted. The maximum extension requested would be through May 2022; however, the length of the patent term extension will be determined by the United States Patent and Trademark Office (“USPTO”) based on input from the FDA. On February 8, 2021, the FDA provided to the USPTO a determined regulatory review period for the OCS Lung. Under the FDA’s analysis, the patent term extension of the ’082 patent would be until November 6, 2021 . The Company has not yet received communication from the USPTO but expects that the USPTO’s determination of patent term extension for the ’082 patent will maintain the November 6, 2021 expiration date. The final determination of the length of the patent extension is not expected to have a material impact on the Company’s financial results. The license includes the right to grant sublicenses, subject to approval by the VA and other restrictions, and is subject to the U.S. government’s right to practice the licensed patents on its own behalf without payment of a royalty and obligation to grant certain sublicenses as necessary to fulfill public health, welfare and safety needs. The license agreement also requires the Company to make its products covered by the licensed patents available to the public on reasonable terms and to provide the U.S. government such products at the lowest price.
As consideration for the licenses granted by the VA, the Company is obligated to pay tiered royalties ranging from a low single-digit to a mid single-digit percentage on net sales of each product covered by a licensed patent (subject to a minimum aggregate royalty payment of less than $ 0.1 million per year during each of the first five years after the first commercial sale, after which no minimum is required). Royalties will be paid by the Company on a licensed product-by-licensed product and country-by-country basis, beginning on the first commercial sale of such licensed product in such country until expiration of the last valid patent claim covering such licensed product in such country. The Company is also responsible for all costs related to the amendment, prosecution and maintenance of the licensed patent rights.
The VA license agreement can be terminated by the Company or the VA only if the other party fails to cure its material breach within a specified period after receiving notice of such breach.
401(k) Savings Plan
The Company has a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code. This plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. Company contributions to the plan may be made at the discretion of the board of directors. As of March 31, 2022 and December 31, 2021, the Company had no t made any contributions to the plan.
Indemnification Agreements
In the ordinary course of business, the Company has agreed to defend and indemnify its customers against third-party claims asserting infringement of certain intellectual property rights, which may include patents, copyrights, trademarks, or trade secrets. The Company’s exposure under these indemnification provisions is generally limited to the total amount paid
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by the end-customer under the agreement. However, certain agreements include indemnification provisions that could potentially expose the Company to losses in excess of the amount received under the agreement. In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or services as directors or officers.
The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not currently aware of any indemnification claims and had not accrued any liabilities related to such obligations in its consolidated financial statements as of March 31, 2022 and December 31, 2021.
Unconditional Purchase Commitment
In January 2021, the Company entered into an unconditional $ 9.5 million purchase commitment, in the ordinary course of business, for goods with specified annual minimum quantities to be purchased through December 2029 . The contract is not cancellable without penalty. The remaining purchase commitment as of March 31, 2022 was $ 8.0 million.
Legal Proceedings
The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings.
10. Segment Reporting and Geographic Data
The Company has determined that it operates in one segment (see Note 2).
See Note 11 for revenue by country. Long-lived assets by geography are summarized as follows (in thousands):
March 31, 2022
December 31, 2021
Long-lived assets by country(1):
United States
$
11,317
$
9,085
All other countries
727
756
Total long-lived assets
$
12,044
$
9,841
( 1 )
The Company’s only long-lived assets consist of property and equipment, net of depreciation, which are categorized based on their location of domicile .
11. Revenue
The Company has determined that the payments made to the customer for reimbursement of clinical trial materials and customer’s costs incurred to execute specific clinical trial protocols related to the Company’s OCS products do not provide the Company with a distinct good or service transferred by the customer, and therefore such payments are recorded as a reduction of revenue from the customer in the Company’s consolidated statements of operations. Reductions of revenue related to such payments made to customers for reimbursements are recognized when the Company recognizes the revenue for the sale of its OCS disposable sets.
The reconciliation of gross revenue to net revenue for these certain payments is shown below (in thousands):
Three Months Ended March 31,
2022
2021
Gross revenue from sales to customers
$
15,880
$
7,637
Less: clinical trial payments reducing
revenue
—
584
Total net revenue
$
15,880
$
7,053
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The Company determined that payments made to customers to obtain information related to post-approval studies or existing standard-of-care protocols (i.e., unrelated to the Company’s OCS products) meet the criteria to be classified as a cost because the Company receives a distinct good or service transferred by the customer separate from the customer’s purchase of the Company’s OCS products and the consideration paid to the customer represents the fair value of the distinct good or service received. As a result, such payments made to the customers are recorded as operating expenses. The Company recorded payments made to customers related to post-approval studies and for documentation related to existing standard-of-care protocols of $ 0.5 million for each of the three months ended March 31, 2022 and 2021, as operating expenses.
Disaggregated Revenue
The Company disaggregates revenue from contracts with customers by product type and geographical area as it believes this presentation best depicts how the nature, amount, timing and uncertainty of the Company’s revenue and cash flows are affected by economic factors, as shown below (in thousands):
Three Months Ended March 31,
2022
2021
Net revenue by OCS product:
OCS Lung net revenue
$
2,298
$
2,430
OCS Heart net revenue
5,713
4,181
OCS Liver net revenue
7,869
442
Total net revenue
$
15,880
$
7,053
Three Months Ended March 31,
2022
2021
Net revenue by country(1):
United States
$
13,561
$
5,757
All other countries
2,319
1,296
Total net revenue
$
15,880
$
7,053
(1)
Net revenue by country is categorized based on the location of the end customer.
Contract Assets and Liabilities
The Company recognizes a receivable at the point in time at which it has an unconditional right to payment. Such receivables are not contract assets. Contract assets arise from unbilled amounts in customer arrangements when revenue recognized exceeds the amount billed to the customer and the Company’s right to payment is not just subject to the passage of time. The Company had no contract assets as of March 31, 2022 and December 31, 2021.
Contract liabilities represent the Company’s obligation to transfer goods or services to a customer for which it has received consideration (or the amount is due) from the customer. The Company has determined that its only contract liabilities are deferred revenue, which consists of amounts that have been invoiced but that have not been recognized as revenue.
The Company generally satisfies performance obligations within one year of the contract inception date. As of March 31, 2022, the Company’s wholly- or partially unsatisfied performance obligations totaled $ 2.1 million and are expected to be completed within the next year.
12. Related Party Transactions
Employment of Dr. Amira Hassanein
Dr. Amira Hassanein, who serves as Product Director for the Company’s OCS Lung program, is the sister of Dr. Waleed Hassanein, the Company’s President and Chief Executive Officer and a member of the Company’s board of directors. The Company paid Dr. Amira Hassanein approximately $ 0.1 million in total compensation for each of the three months ended March 31, 2022 and 2021 for her services as an employee.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.