tmdx-8k_20210302.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 2, 2021

TransMedics Group, Inc.

(Exact Name of Registrant as Specified in Charter)

Massachusetts

 

001-38891

 

83-2181531

(State or Other Jurisdiction of Incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification No.)

200 Minuteman Road

Andover, Massachusetts 01810

(Address of Principal Executive Offices, and Zip Code)

(978) 552-0900

Registrant’s Telephone Number, Including Area Code

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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 per share

 

TMDX

 

The Nasdaq Stock Market LLC

(The Nasdaq Global Market)

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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.

 


 


 

Item 2.02. Results of Operations and Financial Condition.

On March 2, 2021, TransMedics Group, Inc. (the “Company) issued a press release announcing the Company’s financial results for the quarter and fiscal year ended December 31, 2020. A copy of this press release is furnished as Exhibit 99.1 and is incorporated herein by reference.

The information in this Form 8-K (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company, under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filling.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit
No.

 

Description

 

 

99.1

 

Press release issued by TransMedics Group, Inc. on March 2, 2021

 


 


 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

TRANSMEDICS GROUP, INC.

 

 

 

Date: March 2, 2021

 

By:

 

/s/ Stephen Gordon

 

 

 

 

Name: Stephen Gordon

 

 

 

 

Title: Chief Financial Officer, Treasurer and Secretary

 

 

tmdx-ex991_7.htm

Exhibit 99.1

TransMedics Reports Fourth Quarter and Full Year 2020 Financial Results

Andover, Mass. – March 2, 2021 – TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today reported financial results for the quarter and year ended December 31, 2020.

 

Recent Highlights

 

Net revenue of $7.6 million in the fourth quarter of 2020, representing 26% growth compared to the fourth quarter of 2019

 

Expanded the National OCS Program to include 5 new U.S. regions

 

Initiated the OCS Heart DCD CAP program in 25 U.S. heart transplant centers

 

Completed enrollment of the OCS Liver PROTECT CAP first tranche of 74 patients

 

Appointed Merilee Raines to Board of Directors

 

Announced scheduling of OCS Heart FDA Advisory Panel Committee Meeting on April 6, 2021

 

“Fourth quarter sales exceeded expectations and were driven primarily by the recovery of U.S. OCS Lung procedure volumes as well as progress with the OCS DCD Heart and the OCS Liver CAP clinical programs,” said Waleed Hassanein, MD, President and Chief Executive Officer. “We are now focused on leveraging the progress made with our National OCS Program in 2020 and advancing our FDA initiatives in the upcoming months to accelerate our growth through 2021 and beyond.”

 

Fourth Quarter 2020 Financial Results

Net revenue for the fourth quarter of 2020 was $7.6 million, a 26% increase compared to $6.1 million in the fourth quarter of 2019. The increase in revenue was predominantly a result of the recovery of U.S. sales led by the OCS Lung activities.

 

Gross margin for the fourth quarter of 2020 was 63% as compared to 62% in the fourth quarter of 2019.

 

Operating expenses for the fourth quarter of 2020 were $10.7 million compared to $12.4 million in the fourth quarter of 2019. The decrease in operating expenses was due primarily to an overall reduction in spending associated with the COVID pandemic.

 

Net loss for the fourth quarter of 2020 was $6.3 million compared to $9.2 million in the fourth quarter of 2019.


Exhibit 99.1

Full Year 2020 Financial Results

Net revenue for the full year of 2020 was $25.6 million, a 9% increase compared to $23.6 million in the full year of 2019. The increase in revenue was predominantly a result of 18% overall growth in U.S. sales led by the OCS DCD Heart program.

 

Gross margin for the full year of 2020 was 65% as compared to 59% in the full year of 2019.

 

Operating expenses for the full year of 2020 were $43.0 million compared to $43.5 million in the full year of 2019. Operating expenses were essentially flat year over year due primarily to the impact of the COVID pandemic.

 

Net loss for the full year of 2020 was $28.7 million compared to $33.5 million in the full year of 2019.

 

Cash, cash equivalents and marketable securities were $125.6 million as of December 31, 2020.

 

Webcast and Conference Call Details

The TransMedics management team will host a conference call beginning at 4:30 p.m. ET / 1:30 p.m. PT on Tuesday, March 2, 2021. Investors interested in listening to the conference call may do so by dialing (833) 378-1026 for domestic callers or (236) 712-2500 for international callers, followed by Conference ID: 3751905. A live and archived webcast of the event will be available on the “Investors” section of the TransMedics website at www.transmedics.com.  

 

About TransMedics Group, Inc.

TransMedics is the world’s leader in portable extracorporeal warm perfusion and assessment of donor organs for transplantation. Headquartered in Andover, Massachusetts, the company was founded to address the unmet need for more and better organs for transplantation and has developed technologies to preserve organ quality, assess organ viability prior to transplant, and potentially increase the utilization of donor organs for the treatment of end-stage heart, lung and liver failure.

 

Forward-Looking Statements

This press release contains forward-looking statements with respect to, among other things, our operations and financial performance and expected timing of regulatory approvals for our OCS products. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. 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 press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Some of the key factors that could cause actual results to differ include: that we continue to incur losses; our


Exhibit 99.1

need to raise additional funding; 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 to until maturity, and our ability to obtain additional financing on favorable terms or at all; the fluctuation of our financial results from quarter to quarter; our ability to use net operating losses and research and development credit carryforwards; our dependence on the success of the OCS; the rate and degree of market acceptance of the OCS; our ability to educate patients, surgeons, transplant centers and private payors of benefits offered by the OCS; the impact of the outbreak of the novel strain of coronavirus and associated containment and remediation efforts; our ability to improve the OCS platform; our dependence on a limited number of customers for a significant portion of our net revenue; the timing of and our ability to obtain and maintain regulatory approvals or clearances for our OCS products; our ability to adequately respond to FDA follow-up inquiries in a timely manner; the performance of our third-party suppliers and manufacturers; the timing or results of 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 attract and retain key personnel; 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; our ability to obtain and maintain regulatory approvals or clearance for our OCS products; the pricing of the OCS, as well as the reimbursement coverage for the OCS in the United States and internationally; and the risks identified under the heading “Risk Factors” and elsewhere in our annual report on Form 10-K for the year ended December 28, 2019, our quarterly reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020, and September 30, 2020, and in any subsequent filings with the Securities and Exchange Commission ("SEC"). Additional information will be made available by our annual and quarterly reports and other filings that we make from time to time with the SEC. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law.

 

 

 

 

Investor Contact:

Brian Johnston

631-807-1986

Investors@transmedics.com

 

 

 

 


Exhibit 99.1

TransMedics Group, Inc.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

 

 

 

Fiscal Three Months Ended

 

 

Fiscal Year Ended

 

 

 

December 31, 2020

 

 

December 28, 2019

 

 

December 31, 2020

 

 

December 28, 2019

 

Net revenue

 

$

7,627

 

 

$

6,057

 

 

$

25,639

 

 

$

23,604

 

Cost of revenue

 

 

2,799

 

 

 

2,316

 

 

 

9,004

 

 

 

9,741

 

Gross profit

 

 

4,828

 

 

 

3,741

 

 

 

16,635

 

 

 

13,863

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross Margin

 

 

63

%

 

 

62

%

 

 

65

%

 

 

59

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research, development and clinical trials

 

 

4,548

 

 

 

6,262

 

 

 

18,831

 

 

 

19,870

 

Selling, general and administrative

 

 

6,176

 

 

 

6,173

 

 

 

24,188

 

 

 

23,596

 

Total operating expenses

 

 

10,724

 

 

 

12,435

 

 

 

43,019

 

 

 

43,466

 

Loss from operations

 

 

(5,896

)

 

 

(8,694

)

 

 

(26,384

)

 

 

(29,603

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(971

)

 

 

(1,063

)

 

 

(3,985

)

 

 

(4,353

)

Change in fair value of preferred stock warrant liability

 

 

 

 

 

 

 

 

 

 

 

(341

)

Other income

 

 

566

 

 

 

590

 

 

 

1,653

 

 

 

790

 

          Total other expense, net

 

 

(405

)

 

 

(473

)

 

 

(2,332

)

 

 

(3,904

)

Loss before income taxes

 

 

(6,301

)

 

 

(9,167

)

 

 

(28,716

)

 

 

(33,507

)

Provision for income taxes

 

 

(10

)

 

 

(10

)

 

 

(32

)

 

 

(40

)

Net loss

 

$

(6,311

)

 

$

(9,177

)

 

$

(28,748

)

 

$

(33,547

)

Net loss per share attributable to common

   stockholders, basic and diluted

 

$

(0.23

)

 

$

(0.43

)

 

$

(1.16

)

 

$

(2.36

)

Weighted average common shares outstanding,

   basic and diluted

 

 

27,163,390

 

 

 

21,170,330

 

 

 

24,702,764

 

 

 

14,204,787

 

 

 

* Reconciliation of Gross to Net revenue for certain payments made to customers (in thousands)

 

 

 

Fiscal Three Months Ended

 

 

Fiscal Year Ended

 

 

 

December 31, 2020

 

 

December 28, 2019

 

 

December 31, 2020

 

 

December 28, 2019

 

Gross revenue from sales to customers

 

$

8,217

 

 

$

6,463

 

 

$

28,356

 

 

$

25,844

 

Less: clinical trial payments reducing revenue

 

 

590

 

 

 

406

 

 

 

2,717

 

 

 

2,240

 

          Total net revenue

 

$

7,627

 

 

$

6,057

 

 

$

25,639

 

 

$

23,604

 

 

 

 

 

 

 

 

 

 

 


Exhibit 99.1

TransMedics Group, Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

 

 

 

December 31,

 

 

December 28,

 

 

 

2020

 

 

2019

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

24,581

 

 

$

20,092

 

Marketable securities

 

 

101,061

 

 

 

60,596

 

Accounts receivable

 

 

6,864

 

 

 

6,559

 

Inventory

 

 

11,934

 

 

 

11,216

 

Prepaid expenses and other current assets

 

 

2,326

 

 

 

1,538

 

         Total current assets

 

 

146,766

 

 

 

100,001

 

Property and equipment, net

 

 

4,754

 

 

 

4,792

 

Restricted cash and other long-term assets

 

 

506

 

 

 

506

 

        Total assets

 

$

152,026

 

 

$

105,299

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,206

 

 

$

7,247

 

Accrued expenses and other current liabilities

 

 

10,317

 

 

 

8,332

 

Deferred revenue

 

 

263

 

 

 

166

 

Current portion of deferred rent

 

 

93

 

 

 

370

 

               Total current liabilities

 

 

11,879

 

 

 

16,115

 

Long-term debt, net of discount

 

 

34,657

 

 

 

34,146

 

Deferred rent, net of current portion

 

 

1,599

 

 

 

389

 

  Total liabilities

 

 

48,135

 

 

 

50,650

 

  Total stockholders' equity

 

 

103,891

 

 

 

54,649

 

      Total liabilities and equity

 

$

152,026

 

 

$

105,299