tmdx-8k_20221103.htm
false 0001756262 0001756262 2022-11-03 2022-11-03

 

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): November 3, 2022

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 November 3, 2022, TransMedics Group, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 2022. 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 November 3, 2022

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 


 


 

 

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: November 3, 2022

 

By:

 

/s/ Stephen Gordon

 

 

 

 

Name: Stephen Gordon

 

 

 

 

Title: Chief Financial Officer, Treasurer and Secretary

 

 

tmdx-ex991_6.htm

Exhibit 99.1

TransMedics Reports Third Quarter 2022 Financial Results

 

Net revenue of $25.7 million, comprised of $24.3 million in sales revenue and $1.4 million favorable adjustment

2022 Revenue Guidance Range Raised to $80 million to $85 million

 

Andover, Mass. – November 3, 2022 - 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 September 30, 2022.

Recent Highlights

 

Net revenue of $25.7 million in the third quarter of 2022, a 378% increase compared to the third quarter of 2021 and a 25% increase compared to the second quarter of 2022.  Includes $1.4 million favorable adjustment due to updated estimate of accrued clinical trial contra revenue.

 

Revenue excluding $1.4 million adjustment in estimate was $24.3 million, a 349% increase compared to the third quarter of 2021 and an 18% increase compared to the second quarter of 2022.

 

Transplant centers’ use of the National OCS Program (NOP) drove approximately 90% of total US revenue.

 

Completed public offering of common stock for approximately $140 million in net proceeds.

 

“We are very pleased with our third quarter and year-to-date performance and the strong clinical demand for our OCS technology and NOP integrated offering,” said Waleed Hassanein, MD, President, and Chief Executive Officer. “We strongly believe that we are in the early stages of capitalizing on the significant greenfield opportunity that we have created in the transplant space.  We now plan to leverage the solid foundation that we have established in 2022 to drive TransMedics into its next growth phase in 2023.”

Third Quarter 2022 Financial Results

Net revenue for the third quarter of 2022 was $25.7 million, a 378% increase compared to $5.4 million in the third quarter of 2021. This included a favorable revenue impact of $1.4 million as a result of a change in estimate related to accrued clinical trial contra revenue, as compared to a negative impact of less than $0.1 million of clinical trial related contra revenue in the third quarter of 2021.  Revenue from sales to customers was $24.3 million, a 349% increase compared to $5.4 million in the third quarter of 2021.  The increase was due primarily to the contribution of revenue attributed to OCSTM Heart and OCSTM Liver, sales of which were driven by the company’s NOP.

Gross margin for the third quarter of 2022 was 71%, including a 2.0 percentage point favorable impact from the adjustment to clinical trial related contra revenue, as compared to 70% in the third quarter of 2021.  

Operating expenses for the third quarter of 2022 were $23.7 million, compared to $15.5 million in the third quarter of 2021 and compared to $24.1 million in the second quarter or 2022. The increase in operating expense from the prior year was driven primarily by increased investment in the company’s NOP, our next generation OCSplatform, as well as further investments in general commercial efforts and corporate infrastructure. Third quarter operating expenses in 2022 included $2.7 million of stock


compensation expense, compared to $2.0 million of stock compensation in the third quarter of 2021.

Net loss for the third quarter of 2022 was $7.4 million, compared to $13.0 million in the third quarter of 2021.

Cash and cash equivalents were $204.5 million as of September 30, 2022, which includes the net proceeds from the recent public offering and debt refinancing.

2022 Financial Outlook

TransMedics is updating full year 2022 revenue to be in the range of $80 million to $85 million, excluding the $1.4 million favorable change in estimate for contra revenue, which represents 164% to 181% growth compared to the company’s prior year revenue. TransMedics’ prior 2022 net revenue guidance was $67 million to $75 million.

 

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 Thursday, November 3, 2022. Investors interested in listening to the conference call may do so by dialing (844) 200-6205 for domestic callers or (929) 526-1599 for international callers, followed by Conference ID: 241968. 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 full year guidance, and statements about our operations, financial position, and business plans. 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; 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 OCS; our ability to expand access to OCS through the National OCS Program; 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; our ability to improve the OCS platform; our dependence on a limited number of customers for a significant portion of our net revenue; our ability to maintain regulatory approvals or clearances for our OCS products in the United States and the European Union; our ability to adequately respond to FDA follow-up inquiries in a


timely manner; the timing and our ability to commercialize and market our OCS products; the performance of our third-party suppliers and manufacturers; 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 attract and retain key personnel; the impact of the outbreak of COVID-19, including variants of the virus and associated containment, remediation and vaccination efforts; 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 that are or may become available; the impact of any product recalls or improper use of our products; our estimates regarding revenues, expenses and needs for additional financing; and other factors that may be described in our filings with the Securities and Exchange Commission (the “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 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.

Non-GAAP Financial Measures

This press release contains a non-GAAP financial measure, gross revenue from sales to customers. The Company’s management believes that the presentation of this measure provides useful information to investors. This measure may assist investors in evaluating the Company’s operations, period over period. However, this measure may exclude items that may be highly variable and of a size that could have a substantial impact on the Company’s reported results of operations for a particular period. Management uses this and other non-GAAP measures internally for evaluation of the performance of the business. Investors should consider this non-GAAP measure only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

Investor Contact:

Brian Johnston

332-895-3222

Investors@transmedics.com



 

TransMedics Group, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net revenue

 

$

25,683

 

 

$

5,370

 

 

$

62,084

 

 

$

20,594

 

Cost of revenue

 

 

7,568

 

 

 

1,597

 

 

 

17,515

 

 

 

6,421

 

Gross profit

 

 

18,115

 

 

 

3,773

 

 

 

44,569

 

 

 

14,173

 

Gross Margin

 

 

71

%

 

 

70

%

 

 

72

%

 

 

69

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research, development and clinical trials

 

 

6,808

 

 

 

5,163

 

 

 

21,056

 

 

 

15,990

 

Selling, general and administrative

 

 

16,851

 

 

 

10,335

 

 

 

48,171

 

 

 

26,283

 

Total operating expenses

 

 

23,659

 

 

 

15,498

 

 

 

69,227

 

 

 

42,273

 

Loss from operations

 

 

(5,544

)

 

 

(11,725

)

 

 

(24,658

)

 

 

(28,100

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(787

)

 

 

(979

)

 

 

(2,719

)

 

 

(2,896

)

Other expense, net

 

 

(1,076

)

 

 

(249

)

 

 

(2,087

)

 

 

(532

)

Total other expense, net

 

 

(1,863

)

 

 

(1,228

)

 

 

(4,806

)

 

 

(3,428

)

Loss before income taxes

 

 

(7,407

)

 

 

(12,953

)

 

 

(29,464

)

 

 

(31,528

)

Provision for income taxes

 

 

(19

)

 

 

(9

)

 

 

(47

)

 

 

(19

)

Net loss

 

$

(7,426

)

 

$

(12,962

)

 

$

(29,511

)

 

$

(31,547

)

Net loss per share attributable to common stockholders,

   basic and diluted

 

$

(0.25

)

 

$

(0.47

)

 

$

(1.03

)

 

$

(1.14

)

Weighted average common shares outstanding, basic and

   diluted

 

 

30,229,936

 

 

 

27,701,252

 

 

 

28,729,649

 

 

 

27,564,589

 

 

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

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Gross revenue from sales to customers

 

$

24,303

 

 

$

5,413

 

 

$

60,704

 

 

$

21,717

 

Less: clinical trial payments reducing revenue

 

 

(1,380

)

 

 

43

 

 

 

(1,380

)

 

 

1,123

 

Total net revenue

 

$

25,683

 

 

$

5,370

 

 

$

62,084

 

 

$

20,594

 

 



 

TransMedics Group, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)

 

 

September 30, 2022

 

 

December 31, 2021

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

204,462

 

 

$

25,580

 

Marketable securities

 

 

 

 

 

66,872

 

Accounts receivable

 

 

22,035

 

 

 

5,934

 

Inventory

 

 

18,575

 

 

 

14,859

 

Prepaid expenses and other current assets

 

 

5,514

 

 

 

5,460

 

Total current assets

 

 

250,586

 

 

 

118,705

 

Property and equipment, net

 

 

18,472

 

 

 

9,841

 

Operating lease right-of-use assets

 

 

5,315

 

 

 

5,847

 

Restricted cash

 

 

500

 

 

 

500

 

Total assets

 

$

274,873

 

 

$

134,893

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,080

 

 

$

6,651

 

Accrued expenses and other current liabilities

 

 

15,976

 

 

 

16,337

 

Deferred revenue

 

 

226

 

 

 

250

 

Operating lease liabilities

 

 

1,407

 

 

 

 

Total current liabilities

 

 

20,689

 

 

 

23,238

 

Long-term debt, net of discount

 

 

58,540

 

 

 

35,197

 

Operating lease liabilities, net of current portion

 

 

7,787

 

 

 

8,604

 

Total liabilities

 

 

87,016

 

 

 

67,039

 

Total stockholders' equity

 

 

187,857

 

 

 

67,854

 

Total liabilities and stockholders' equity

 

$

274,873

 

 

$

134,893