10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-38891

 

TransMedics Group, Inc.

(Exact name of registrant as specified in its charter)

 

Massachusetts

83-2181531

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification Number)

200 Minuteman Road

Andover, Massachusetts

01810

(Address of principal executive offices)

(Zip code)

 

(978) 552-0900

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, No Par Value

 

TMDX

 

The Nasdaq Global Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

As of April 28, 2023, the registrant had 32,553,650 shares of common stock, no par value per share, outstanding.

 

 

 


 

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements with respect to, among other things, our operations and financial performance. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy and plans and our objectives for future operations, including our acquisitions, joint ventures or strategic investments, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “could,” “target,” “predict,” “seek” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those referenced in the section titled “Risk Factors,” which could cause actual results to differ materially. Moreover, we operate in a very competitive and rapidly changing environment and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in or implied by any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this Quarterly Report on Form 10-Q may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

The forward-looking statements included in this Quarterly Report on Form 10-Q are made only as of the date of this report. You should not rely upon forward-looking statements as predictions of future events. We cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to actual results or reflect interim developments.

Some of the key factors that could cause actual results to differ include:

that we continue to incur losses;
our ability to attract and retain key personnel;
our existing and any future indebtedness, including our ability to comply with affirmative and negative covenants under our credit agreement to which we will remain subject until maturity;
the fluctuation of our financial results from quarter to quarter;
our need to raise additional funding and our ability to obtain it on favorable terms, or at all;
our ability to use net operating losses and research and development credit carryforwards;
our dependence on the success of the Organ Care System, or OCS;
our ability to expand access to the OCS through our National OCS Program;
our ability to scale our manufacturing and sterilization capabilities to meet increasing demand for our products;
the rate and degree of market acceptance of the OCS;
our ability to educate patients, surgeons, transplant centers and private and public payors on the benefits offered by the OCS;
our ability to improve the OCS platform and develop the next generation of the OCS products;
our dependence on a limited number of customers for a significant portion of our revenue;
our ability to maintain regulatory approvals or clearances for our OCS products in the United States and European Union;
our ability to adequately respond to the Food and Drug Administration, or FDA, follow-up inquiries in a timely manner;
the performance of our third-party suppliers and manufacturers;

i


 

our dependence on third parties to transport donor organs and medical personnel for our National OCS Program and our ability to establish or acquire an aviation business or strategic relationship to reduce such dependence;
price increases of the components of our products;
the timing or results of post-approval studies and any clinical trials for the OCS;
our manufacturing, sales, marketing and clinical support capabilities and strategy;
attacks against our information technology infrastructure;
the economic, political and other risks associated with our foreign operations;
our ability to protect, defend, maintain and enforce our intellectual property rights relating to the OCS and avoid allegations that our products infringe, misappropriate or otherwise violate the intellectual property rights of third parties;
the pricing of the OCS, as well as the reimbursement coverage for the OCS in the United States and internationally;
regulatory developments in the United States, European Union and other jurisdictions;
the extent and success of competing products or procedures that are or may become available;
the impact of any product recalls or improper use of our products; and
our estimates regarding revenue, expenses and needs for additional financing.

ii


 

TransMedics Group, Inc.

Table of Contents

 

 

 

 

Page

PART I—FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Financial Statements (Unaudited)

 

1

Consolidated Balance Sheets

 

1

Consolidated Statements of Operations

 

2

Consolidated Statements of Comprehensive Loss

 

3

Consolidated Statements of Stockholders’ Equity

 

4

Consolidated Statements of Cash Flows

 

5

Notes to Unaudited Consolidated Financial Statements

 

6

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

15

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

24

Item 4.

Controls and Procedures

 

25

 

 

 

 

 

PART II—OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

26

Item 1A.

Risk Factors

 

26

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

27

Item 5.

Other Information

 

27

Item 6.

Exhibits

 

28

Signatures

 

29

 

 

 

iii


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

TRANSMEDICS GROUP, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share amounts)

(Unaudited)

 

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash

 

$

195,375

 

 

$

201,182

 

Accounts receivable

 

 

38,620

 

 

 

27,611

 

Inventory

 

 

23,961

 

 

 

20,605

 

Prepaid expenses and other current assets

 

 

3,774

 

 

 

2,896

 

Total current assets

 

 

261,730

 

 

 

252,294

 

Property and equipment, net

 

 

19,161

 

 

 

19,223

 

Restricted cash

 

 

750

 

 

 

500

 

Operating lease right-of-use assets

 

 

4,939

 

 

 

5,130

 

Other non-current assets

 

 

508

 

 

 

 

Total assets

 

$

287,088

 

 

$

277,147

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,329

 

 

$

3,341

 

Accrued expenses and other current liabilities

 

 

22,581

 

 

 

18,635

 

Deferred revenue

 

 

244

 

 

 

241

 

Operating lease liabilities

 

 

1,481

 

 

 

1,444

 

Total current liabilities

 

 

28,635

 

 

 

23,661

 

Long-term debt, net of discount and current portion

 

 

58,802

 

 

 

58,696

 

Operating lease liabilities, net of current portion

 

 

7,026

 

 

 

7,415

 

Total liabilities

 

 

94,463

 

 

 

89,772

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

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; 32,534,003
   shares and
32,141,368 shares issued and outstanding at March 31, 2023
   and December 31, 2022, respectively

 

 

674,156

 

 

 

666,277

 

Accumulated other comprehensive loss

 

 

(218

)

 

 

(225

)

Accumulated deficit

 

 

(481,313

)

 

 

(478,677

)

Total stockholders' equity

 

 

192,625

 

 

 

187,375

 

Total liabilities and stockholders' equity

 

$

287,088

 

 

$

277,147

 

 

The accompanying notes are an integral part of these unaudited 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,

 

 

 

2023

 

 

2022

 

Revenue:

 

 

 

 

 

 

Net product revenue

 

$

33,993

 

 

$

14,939

 

Service revenue

 

 

7,561

 

 

 

941

 

Total revenue

 

 

41,554

 

 

 

15,880

 

Cost of revenue:

 

 

 

 

 

 

Cost of net product revenue

 

 

7,306

 

 

 

3,378

 

Cost of service revenue

 

 

5,482

 

 

 

398

 

Total cost of revenue

 

 

12,788

 

 

 

3,776

 

Gross profit

 

 

28,766

 

 

 

12,104

 

Operating expenses:

 

 

 

 

 

 

Research, development and clinical trials

 

 

5,871

 

 

 

7,534

 

Selling, general and administrative

 

 

24,984

 

 

 

13,939

 

Total operating expenses

 

 

30,855

 

 

 

21,473

 

Loss from operations

 

 

(2,089

)

 

 

(9,369

)

Other income (expense):

 

 

 

 

 

 

Interest expense

 

 

(1,091

)

 

 

(960

)

Other income (expense), net

 

 

555

 

 

 

(227

)

Total other expense, net

 

 

(536

)

 

 

(1,187

)

Loss before income taxes

 

 

(2,625

)

 

 

(10,556

)

Provision for income taxes

 

 

(11

)

 

 

(6

)

Net loss

 

$

(2,636

)

 

$

(10,562

)

Net loss per share attributable to common stockholders,
   basic and diluted

 

$

(0.08

)

 

$

(0.38

)

Weighted average common shares outstanding,
   basic and diluted

 

 

32,260,267

 

 

 

27,950,330

 

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

2


 

TRANSMEDICS GROUP, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2023

 

 

2022

 

Net loss

 

$

(2,636

)

 

$

(10,562

)

Other comprehensive income (loss):

 

 

 

 

 

 

Foreign currency translation adjustment

 

 

7

 

 

 

(24

)

Unrealized losses on marketable securities,
   net of tax of $
0

 

 

 

 

 

(73

)

Total other comprehensive income (loss)

 

 

7

 

 

 

(97

)

Comprehensive loss

 

$

(2,629

)

 

$

(10,659

)

 

The accompanying notes are an integral part of these unaudited 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, 2022

 

 

32,141,368

 

 

$

666,277

 

 

$

(225

)

 

$

(478,677

)

 

$

187,375

 

Issuance of common stock upon the
   exercise of common stock options

 

 

378,500

 

 

 

3,574

 

 

 

 

 

 

 

 

 

3,574

 

Issuance of common stock in
   connection with employee stock
   purchase plan

 

 

14,135

 

 

 

384

 

 

 

 

 

 

 

 

 

384

 

Stock-based compensation expense

 

 

 

 

 

3,921

 

 

 

 

 

 

 

 

 

3,921

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

7

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(2,636

)

 

 

(2,636

)

Balances at March 31, 2023

 

 

32,534,003

 

 

$

674,156

 

 

$

(218

)

 

$

(481,313

)

 

$

192,625

 

 

 

 

 

 

 

 

 

 

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

 

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

4


 

TRANSMEDICS GROUP, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(2,636

)

 

$

(10,562

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization expense

 

 

1,287

 

 

 

507

 

Stock-based compensation expense

 

 

3,921

 

 

 

2,310

 

Non-cash interest expense and end of term accretion expense

 

 

106

 

 

 

137

 

Non-cash lease expense

 

 

191

 

 

 

178

 

Net amortization of premiums on marketable securities

 

 

 

 

 

228

 

Unrealized foreign currency transaction (gains) losses

 

 

(137

)

 

 

214

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(10,962

)

 

 

(5,804

)

Inventory

 

 

(3,623

)

 

 

(2,926

)

Prepaid expenses and other current assets

 

 

(884

)

 

 

88

 

Other non-current assets

 

 

(54

)

 

 

 

Accounts payable

 

 

1,028

 

 

 

(4,013

)

Accrued expenses and other current liabilities

 

 

3,454

 

 

 

(4

)

Operating lease liabilities

 

 

(352

)

 

 

1,241

 

Net cash used in operating activities

 

 

(8,661

)

 

 

(18,406

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(927

)

 

 

(1,953

)

Purchases of marketable securities

 

 

 

 

 

(2,033

)

Proceeds from sales and maturities of marketable securities

 

 

 

 

 

14,500

 

Net cash provided by (used in) investing activities

 

 

(927

)

 

 

10,514

 

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from issuance of common stock upon exercise of stock options

 

 

3,574

 

 

 

202

 

Proceeds from issuance of common stock in connection with employee stock
   purchase plan

 

 

384

 

 

 

203

 

Net cash provided by financing activities

 

 

3,958

 

 

 

405

 

Effect of exchange rate changes on cash, cash equivalents and restricted cash

 

 

73

 

 

 

(196

)

Net decrease in cash, cash equivalents and restricted cash

 

 

(5,557

)

 

 

(7,683

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

201,682

 

 

 

26,080

 

Cash, cash equivalents and restricted cash, end of period

 

$

196,125

 

 

$

18,397

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

Transfers of inventory to property and equipment

 

$

317

 

 

$

1,030

 

Purchases of property and equipment included in accounts payable and accrued
   expenses

 

$

30

 

 

$

939

 

Reconciliation of cash, cash equivalents and restricted cash:

 

 

 

 

 

 

Cash and cash equivalents

 

$

195,375

 

 

$

17,897

 

Restricted cash

 

 

750

 

 

 

500

 

Total cash, cash equivalents and restricted cash shown in the statement of cash flows

 

$

196,125

 

 

$

18,397

 

 

The accompanying notes are an integral part of these unaudited 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 Company also developed its National OCS Program (“NOP”), an innovative turnkey solution to provide outsourced organ retrieval and OCS organ management, to provide transplant programs in the United States with a more efficient process to procure donor organs with the OCS.

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 $2.6 million for the three months ended March 31, 2023 and $36.2 million for the year ended December 31, 2022. As of March 31, 2023, the Company had an accumulated deficit of $481.3 million. The Company expects to continue to generate operating losses in the foreseeable future.

The Company believes that its existing cash of $195.4 million as of March 31, 2023 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. 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. Continued impacts to the Company’s business as a result of COVID-19 may include decreased overall frequency of transplant procedures; disruptions to the Company’s manufacturing operations and supply chain; labor shortages; decreased productivity and unavailability of materials or components; 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. While the Company maintains an inventory of finished products and raw materials used in its OCS products, a further prolonged pandemic could lead to shortages in the raw materials necessary to manufacture its products.

6


 

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, 2022 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, 2023 and results of operations for the three months ended March 31, 2023 and 2022 and cash flows for the three months ended March 31, 2023 and 2022 have been made. The Company’s results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.

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 unaudited 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. 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 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, 2023 and December 31, 2022, the Company had no allowance for credit losses.

Significant customers are those that accounted for 10% or more of the Company’s revenue or accounts receivable. For the three months ended March 31, 2023, no customer accounted for more than 10% of revenue. For the three months ended March 31, 2022, three customers accounted for 16%, 15% and 12% of revenue, respectively. As of March 31, 2023 and December 31, 2022, no customer accounted for more than 10% of accounts receivable.

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, as are sterilization services. Although the Company seeks to reduce dependence on those limited sources of suppliers, manufacturers and service providers, 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.

7


 

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 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 has developed and is 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, 2023 and 2022.

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,

 

 

 

2023

 

 

2022

 

Warrants to purchase common stock

 

 

14,440

 

 

 

64,440

 

Options to purchase common stock

 

 

3,167,730

 

 

 

3,484,914

 

Employee stock purchase plan

 

 

6,511

 

 

 

5,794

 

Restricted stock units

 

 

182,911

 

 

 

 

Restricted stock awards

 

 

24,315

 

 

 

 

 

 

3,395,907

 

 

 

3,555,148

 

 

8


 

3. Marketable Securities and Fair Value Measurements

The Company did not have marketable securities as of March 31, 2023 or December 31, 2022. The Company also did not have assets or liabilities measured at fair value on a recurring basis as of March 31, 2023 or December 31, 2022.

4. Inventory

Inventory consisted of the following (in thousands):

 

 

 

March 31, 2023

 

 

December 31, 2022

 

Raw materials

 

$

12,265

 

 

$

10,939

 

Work-in-process

 

 

2,264

 

 

 

1,876

 

Finished goods

 

 

9,432

 

 

 

7,790

 

 

 

$

23,961

 

 

$

20,605

 

 

5. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

 

 

 

 

March 31, 2023

 

 

December 31, 2022

 

Accrued payroll and related expenses

 

 

$

10,991

 

 

$

9,812

 

Accrued logistics costs

 

 

 

5,415

 

 

 

2,581

 

Accrued research, development and clinical trials expenses

 

 

 

1,918

 

 

 

1,876

 

Accrued professional fees

 

 

 

1,600

 

 

 

965

 

Accrued other

 

 

 

2,657

 

 

 

3,401

 

 

 

 

$

22,581

 

 

$

18,635

 

 

6. Long-Term Debt

Long-term debt consisted of the following (in thousands):

 

 

 

March 31, 2023

 

 

December 31, 2022

 

Principal amount of long-term debt

 

$

60,000

 

 

$

60,000

 

Less: Current portion of long-term debt

 

 

 

 

 

 

Long-term debt, net of current portion