tmdx-8k_20210331.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): May 4, 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 May 4, 2021, TransMedics Group, Inc. (the “Company) issued a press release announcing the Company’s financial results for the quarter ended March 31, 2021. 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 filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit
No.

 

Description

 

 

99.1

 

Press release issued by TransMedics Group, Inc. on May 4, 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: May 4, 2021

 

By:

 

/s/ Stephen Gordon

 

 

 

 

Name: Stephen Gordon

 

 

 

 

Title: Chief Financial Officer, Treasurer and Secretary

 

 

tmdx-ex991_6.htm

Exhibit 99.1

TransMedics Reports First Quarter 2021 Financial Results

 

Andover, Mass. – May 4, 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 ended March 31, 2021.

 

Recent Highlights

 

Net revenue of $7.1 million in the first quarter of 2021, representing a 6% decrease compared to the first quarter of 2020

 

Reported U.S. net revenue growth of 11% year-over-year

 

Announced positive FDA advisory committee vote for OCS Heart System

 

Appointed Stephanie Lovell to Board of Directors

 

Announced expectation for mid-July 2021 OCS Liver FDA advisory committee meeting

 

“We are pleased with our progress as we advance quickly toward several near term regulatory and commercial catalysts expected in 2021,” said Waleed Hassanein, MD, President and Chief Executive Officer. “Following the favorable FDA advisory panel vote for OCS Heart, we are working with the FDA to map out the process to a decision on our PMA. In addition, we are making significant progress towards our key 2021 catalysts and strategic initiatives, which gives us confidence in our long-term outlook.”

 

First Quarter 2021 Financial Results

Net revenue for the first quarter of 2021 was $7.1 million, a 6% decrease compared to $7.5 million in the first quarter of 2020. U.S. net revenue was $5.8 million in the first quarter of 2021, an 11% increase from $5.2 million in the first quarter of 2020. The increase in U.S. net revenue was driven by strong OCS Lung and OCS Heart sales, was offset by the completion of the OCS Liver PROTECT CAP and lower transplant activity outside of the U.S.

 

Gross margin for the first quarter of 2021 was 68% as compared to 65% in the first quarter of 2020.

 

Operating expenses for the first quarter of 2021 were $11.3 million compared to $12.9 million in the first quarter of 2020. The decrease in operating expense was driven by limited travel and other spending due to COVID, which more than offset the increased investment in the National OCS Program.

 

Net loss for the first quarter of 2021 was $7.9 million compared to $8.9 million in the first quarter of 2020.

 

Cash, cash equivalents and marketable securities were $118.1 million as of March 31, 2021.

 

 


 

 

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, May 4, 2021. Investors interested in listening to the conference call may do so by dialing (866) 393-4306 for domestic callers or (763) 488-9145 for international callers, followed by Conference ID: 1172894. 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 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 31, 2020, our quarterly reports on Form 10-Q, 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

TransMedics Group, Inc.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2021

 

 

2020

 

Net revenue

 

$

7,053

 

 

$

7,530

 

Cost of revenue

 

 

2,242

 

 

 

2,670

 

Gross profit

 

 

4,811

 

 

 

4,860

 

Gross Margin

 

 

68

%

 

 

65

%

Operating expenses:

 

 

 

 

 

 

 

 

Research, development and clinical trials

 

 

4,532

 

 

 

6,225

 

Selling, general and administrative

 

 

6,786

 

 

 

6,652

 

Total operating expenses

 

 

11,318

 

 

 

12,877

 

Loss from operations

 

 

(6,507

)

 

 

(8,017

)

Other income (expense):

 

 

 

 

 

 

 

 

Interest expense

 

 

(952

)

 

 

(1,042

)

Other income (expense), net

 

 

(454

)

 

 

217

 

Total other expense, net

 

 

(1,406

)

 

 

(825

)

Loss before income taxes

 

 

(7,913

)

 

 

(8,842

)

Provision for income taxes

 

 

(4

)

 

 

(10

)

Net loss

 

$

(7,917

)

 

$

(8,852

)

Net loss per share attributable to common stockholders, basic

   and diluted

 

$

(0.29

)

 

$

(0.42

)

Weighted average common shares outstanding, basic and diluted

 

 

27,368,090

 

 

 

21,221,385

 

 

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

 

 

 

Three Months Ended March 31,

 

 

 

2021

 

 

2020

 

Gross revenue from sales to customers

 

$

7,637

 

 

$

8,243

 

Less: clinical trial payments reducing revenue

 

 

584

 

 

 

713

 

Total net revenue

 

$

7,053

 

 

$

7,530

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 


 

 

TransMedics Group, Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

 

 

 

March 31, 2021

 

 

December 31, 2020

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

26,727

 

 

$

24,581

 

Marketable securities

 

 

91,386

 

 

 

101,061

 

Accounts receivable

 

 

7,395

 

 

 

6,864

 

Inventory

 

 

11,820

 

 

 

11,934

 

Prepaid expenses and other current assets

 

 

3,215

 

 

 

2,326

 

Total current assets

 

 

140,543

 

 

 

146,766

 

Property and equipment, net

 

 

4,734

 

 

 

4,754

 

Restricted cash and other long-term assets

 

 

506

 

 

 

506

 

Total assets

 

$

145,783

 

 

$

152,026

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,289

 

 

$

1,206

 

Accrued expenses and other current liabilities

 

 

9,931

 

 

 

10,317

 

Deferred revenue

 

 

432

 

 

 

263

 

Current portion of deferred rent

 

 

105

 

 

 

93

 

Total current liabilities

 

 

11,757

 

 

 

11,879

 

Long-term debt, net of discount

 

 

34,787

 

 

 

34,657

 

Deferred rent, net of current portion

 

 

1,564

 

 

 

1,599

 

Total liabilities

 

 

48,108

 

 

 

48,135

 

Total stockholders' equity

 

 

97,675

 

 

 

103,891

 

Total liabilities and stockholders' equity

 

$

145,783

 

 

$

152,026