News Release
TransMedics Reports First Quarter 2019 Financial Results
Recent Highlights
- Recorded net revenue of
$4.7 million in the first quarter of 2019, representing 86% growth compared to the first quarter of 2018 - Received
FDA approval for expanded indications of the Organ Care System (OCS™) Lung to include donor lungs initially deemed unacceptable for transplantation which includes unutilized donor lungs after donor brain death (DBD) and donor circulatory death (DCD) - Final results of the OCS Heart EXPAND Trial and long-term follow-up data of the OCS Lung EXPAND Trial were presented at the 39th Annual Meeting and Scientific Sessions of the
International Society for Heart and Lung Transplantation inApril 2019 - Received IDE approval for the U.S. OCS Heart DCD clinical trial, which will enable DCD heart transplant procedures to be performed in the U.S. for the first time
- Completed initial public offering of approximately 6.5 million shares, raising approximately
$97.4 million in net proceeds, after deducting underwriting discounts and commissions
“TransMedics is committed to expanding access to life-saving transplant procedures for patients suffering from end-stage organ failure across multiple disease states using our paradigm-shifting OCS platform. We are pleased with our first quarter results, which demonstrated meaningful progress in sales growth, and expansion of our body of clinical evidence for our lung and heart transplant indications. Our recent FDA PMA approval significantly expands our commercial opportunity in the U.S. by enabling the use of currently unutilized DBD and DCD donor lungs for transplantation,” said
First Quarter 2019 Financial Results
Net revenue for the first quarter of 2019 was
Gross margin for the first quarter of 2019 was 55% as compared to 37% in the first quarter of 2018. The increase in gross margin was primarily driven by the increase in net revenue from sales of OCS disposable sets, higher average selling prices, and improved efficiency in production.
Operating expenses for the first quarter of 2019 were
Net loss for the first quarter of 2019 was
Cash and cash equivalents were
2019 Financial Outlook
Webcast and Conference Call Details
The
About
Forward-Looking Statements
This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about our results of operations, commercial opportunity and the adoption and benefits of the OCS. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to our anticipation that we will continue to incur losses in the future; our potential 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, 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; 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
Investor Contact:
646-924-1769
Investors@transmedics.com
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(in thousands)
(unaudited)
Fiscal Three Months Ended | ||||||||
March 30, 2019 | March 31, 2018 | |||||||
Net revenue* | $ | 4,676 | $ | 2,519 | ||||
Cost of revenue | 2,103 | 1,595 | ||||||
Gross profit | 2,573 | 924 | ||||||
Gross Margin | 55 | % | 37 | % | ||||
Operating expenses: | ||||||||
Research, development and clinical trials | 3,882 | 3,465 | ||||||
Selling, general and administrative | 4,653 | 2,240 | ||||||
Total operating expenses | 8,535 | 5,705 | ||||||
Loss from operations | (5,962 | ) | (4,781 | ) | ||||
Other income (expense): | ||||||||
Interest expense | (1,093 | ) | (258 | ) | ||||
Change in fair value of preferred stock warrant liability | 273 | (30 | ) | |||||
Other (expense) income, net | (103 | ) | 175 | |||||
Total other expense, net | (923 | ) | (113 | ) | ||||
Loss before income taxes | (6,885 | ) | (4,894 | ) | ||||
Provision for income taxes | (10 | ) | (7 | ) | ||||
Net loss | $ | (6,895 | ) | $ | (4,901 | ) |
*Reconciliation of Gross to Net revenue for certain payments made to customers (in thousands) |
Fiscal Three Months Ended | ||||||||
March 30, 2019 | March 31, 2018 | ||||||||
Gross revenue from sales to customers | $ | 5,290 | $ | 2,756 | |||||
Less: clinical trial payments reducing revenue | (614 | ) | (237 | ) | |||||
Total Net Revenue | $ | 4,676 | $ | 2,519 |
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
March 30, | December 29, | |||||||
2019 | 2018 | |||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 12,215 | $ | 20,241 | ||||
Accounts receivable | 5,146 | 3,438 | ||||||
Inventory | 11,294 | 9,277 | ||||||
Prepaid expenses and other current assets | 1,404 | 1,838 | ||||||
Total current assets | 30,059 | 34,794 | ||||||
Property and equipment, net | 3,750 | 3,474 | ||||||
Deferred offering costs | 4,444 | 3,383 | ||||||
Restricted cash and other long-term assets | 506 | 506 | ||||||
Total Assets | $ | 38,759 | $ | 42,157 | ||||
Current liabilities: | ||||||||
Accounts payable | $ | 5,499 | $ | 4,720 | ||||
Accrued expenses and other current liabilities | 9,989 | 7,178 | ||||||
Deferred revenue | 359 | 306 | ||||||
Current portion of deferred rent | 354 | 349 | ||||||
Total current liabilities | 16,201 | 12,553 | ||||||
Preferred stock warrant liability | 625 | 898 | ||||||
Long-term debt, net of discount | 33,785 | 33,670 | ||||||
Deferred rent, net of current portion | 667 | 759 | ||||||
Total liabilities | 51,278 | 47,880 | ||||||
Total Preferred Stock and Stockholder's Equity (Deficit) | (12,519 | ) | (5,723 | ) | ||||
Total Liabilities and Equity | $ | 38,759 | $ | 42,157 |
Source: Transmedics