News Release Details
Shockwave Medical Reports Fourth Quarter and Full Year 2020 Financial Results
Recent Highlights
- Recognized revenue of
$22.7 million for the fourth quarter of 2020 and$67.8 million for the full year of 2020, representing increases of 59% and 58%, respectively, from the same periods in 2019 - Received FDA approval of IVL for severely calcified coronary artery disease
- Presented data for two large trials at late breaking sessions in the fourth quarter
- Granted four new codes by CMS that established specific payment for IVL procedures performed in an outpatient setting in arteries below the knee
- Granted eight codes by CMS for IVL performed in Ambulatory Surgery Centers
- Ended the year with over 100 issued patents
“The successes we achieved despite the myriad COVID challenges of 2020 are a testament to the team at Shockwave and to the clinical value of our proprietary IVL technology,” said
Fourth Quarter 2020 Financial Results
Revenue for the fourth quarter of 2020 was
Gross profit for the fourth quarter of 2020 was
Operating expenses were
Net loss was
Full Year 2020 Financial Results
Revenue for full year 2020 was
Gross profit for the full year 2020 was
Operating expenses were
Net loss was
Cash, cash equivalents and short-term investments totaled
Impact of COVID-19 Pandemic and 2021 Financial Guidance
The COVID-19 pandemic continues to create significant uncertainty globally, including in relation to (i) the scope and duration of the current global resurgence of COVID-19 cases, (ii) the impact of new mutations of the virus, (iii) the timing and efficacy of COVID-19 vaccines, and (iv) the timing and extent of a global recovery and economic normalization. Given this continued uncertainty, we cannot provide reasonable guidance as to Shockwave Medical’s future results of operations and financial performance. As such, Shockwave is not issuing 2021 financial guidance at this time.
Conference Call
About
Forward-Looking Statements
This press release contains statements relating to our expectations, projections, beliefs, and prospects, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue,” and similar expressions, and the negative of these terms. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware.
Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others: the impact of the COVID-19 pandemic on our operations, financial results, and liquidity and capital resources, including the impact on our sales, expenses, supply chain, manufacturing, research and development activities, clinical trials, and employees; our ability to develop, manufacture, obtain and maintain regulatory approvals for, market and sell, our products; our expected future growth, including the size and growth potential of the markets for our products; our ability to obtain coverage and reimbursement for procedures performed using our products; our ability to scale our organizational culture; the impact of the development, regulatory approval, efficacy and commercialization of competing products; the loss of key scientific or management personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; and our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others. These factors, as well as others, are discussed in our filings with the
Media Contact:
+1.317.432.9210
sshadiow@shockwavemedical.com
Investor Contact:
dkaster@shockwavemedical.com
| Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
2020 (Unaudited) |
2019 |
|||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 50,423 | $ | 139,045 | ||||
| Short-term investments | 151,931 | 56,304 | ||||||
| Accounts receivable, net | 11,689 | 7,377 | ||||||
| Inventory | 29,859 | 12,074 | ||||||
| Prepaid expenses and other current assets | 2,398 | 1,897 | ||||||
| Total current assets | 246,300 | 216,697 | ||||||
| Operating lease right-of-use assets | 7,568 | 8,825 | ||||||
| Property and equipment, net | 16,362 | 4,910 | ||||||
| Other assets | 1,812 | 1,506 | ||||||
| TOTAL ASSETS | $ | 272,042 | $ | 231,938 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 1,466 | $ | 2,790 | ||||
| Term notes, current portion | 3,300 | 6,667 | ||||||
| Accrued liabilities | 19,942 | 13,777 | ||||||
| Lease liability, current portion | 873 | 774 | ||||||
| Total current liabilities | 25,581 | 24,008 | ||||||
| Lease liability, noncurrent | 7,488 | 8,125 | ||||||
| Term notes, noncurrent portion | 13,319 | 7,152 | ||||||
| TOTAL LIABILITIES | 46,388 | 39,285 | ||||||
| STOCKHOLDERS’ EQUITY: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 35 | 31 | ||||||
| Additional paid-in capital | 469,283 | 370,561 | ||||||
| Accumulated other comprehensive loss | 9 | 35 | ||||||
| Accumulated deficit | (243,673 | ) | (177,974 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 225,654 | 192,653 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 272,042 | $ | 231,938 | ||||
| Statement of Operations Data | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| (in thousands, except share and per share data) |
||||||||||||||||
| Three Months Ended |
Year Ended |
|||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue | $ | 22,716 | $ | 14,312 | $ | 67,789 | $ | 42,927 | ||||||||
| Cost of revenue: | ||||||||||||||||
| Cost of product revenue | 6,471 | 5,553 | 20,991 | 17,159 | ||||||||||||
| Gross profit | 16,245 | 8,759 | 46,798 | 25,768 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 9,044 | 10,075 | 36,926 | 32,853 | ||||||||||||
| Sales and marketing | 16,436 | 9,597 | 51,672 | 30,620 | ||||||||||||
| General and administrative | 6,631 | 4,450 | 23,863 | 14,134 | ||||||||||||
| Total operating expenses | 32,111 | 24,122 | 112,461 | 77,607 | ||||||||||||
| Loss from operations | (15,866 | ) | (15,363 | ) | (65,663 | ) | (51,839 | ) | ||||||||
| Interest expense | (315 | ) | (198 | ) | (1,212 | ) | (944 | ) | ||||||||
| Change in fair value of warrant liability | — | — | — | (609 | ) | |||||||||||
| Other income, net | 314 | 827 | 1,256 | 2,345 | ||||||||||||
| Net loss before taxes | (15,867 | ) | (14,734 | ) | (65,619 | ) | (51,047 | ) | ||||||||
| Income tax provision | 7 | 11 | 80 | 62 | ||||||||||||
| Net loss | $ | (15,874 | ) | $ | (14,745 | ) | $ | (65,699 | ) | $ | (51,109 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.46 | ) | $ | (0.49 | ) | $ | (1.99 | ) | $ | (2.14 | ) | ||||
| Shares used in computing net loss per share, basic and diluted | 34,447,314 | 29,894,306 | 33,088,095 | 23,904,828 | ||||||||||||
Source: Shockwave Medical, Inc.