News Release Details
Shockwave Medical Reports Third Quarter 2020 Financial Results
Recent Highlights
- Recognized revenue of
$19.6 million for the third quarter of 2020, representing a 73% increase over the third quarter of 2019 - Submitted PMA application for FDA approval of coronary IVL
- DISRUPT CAD III IDE study results of coronary IVL featured as a late breaking presentation at the TCT Connect conference
- DISRUPT PAD III peripheral trial results featured as a late breaking clinical trial presentation at VIVA20 conference
- Expanded the
U.S. Field team to over 100 members
“The successes we achieved this quarter on the clinical, financial and operational fronts speak volumes in terms of confirming the value of our proprietary IVL technology for both coronary and peripheral indications and how it uniquely addresses the challenges our customers face when treating severely calcified arteries throughout the body,” said
Third Quarter 2020 Financial Results
Revenue for the third quarter of 2020 was
Gross profit for the third quarter of 2020 was
Operating expenses were
Net loss was
Cash and cash equivalents totaled
Impact of COVID-19 Pandemic and 2020 Financial Guidance
While we have continued to see positive trends in our business, we remain mindful of the potential negative impacts due to the current increase in case volumes globally. Given what we experienced in the second quarter due to the COVID-19 pandemic, and due to the uncertain scope and duration of the pandemic, the global resurgence of cases, and uncertain timing of a global recovery and economic normalization, we still cannot reliably estimate the future impact of the pandemic. As such,
Conference Call
About
Forward-Looking Statements
This press release contains statements relating to our expectations, projections, beliefs, and prospects, including statements regarding our product development outlook, 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 | ||||||||
| (Unaudited) | ||||||||
| (in thousands) | ||||||||
2020 |
2019 |
|||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 215,256 | $ | 139,045 | ||||
| Short-term investments | — | 56,304 | ||||||
| Accounts receivable, net | 10,711 | 7,377 | ||||||
| Inventory | 28,868 | 12,074 | ||||||
| Prepaid expenses and other current assets | 3,033 | 1,897 | ||||||
| Total current assets | 257,868 | 216,697 | ||||||
| Operating lease right-of-use assets | 7,841 | 8,825 | ||||||
| Property and equipment, net | 13,282 | 4,910 | ||||||
| Other assets | 1,667 | 1,506 | ||||||
| TOTAL ASSETS | $ | 280,658 | $ | 231,938 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 1,972 | $ | 2,790 | ||||
| Term notes, current portion | 1,650 | 6,667 | ||||||
| Accrued liabilities | 16,662 | 13,777 | ||||||
| Lease liability, current portion | 841 | 774 | ||||||
| Total current liabilities | 21,125 | 24,008 | ||||||
| Lease liability, noncurrent portion | 7,685 | 8,125 | ||||||
| Term notes, noncurrent portion | 14,801 | 7,152 | ||||||
| TOTAL LIABILITIES | 43,611 | 39,285 | ||||||
| STOCKHOLDERS’ EQUITY: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 34 | 31 | ||||||
| Additional paid-in capital | 464,812 | 370,561 | ||||||
| Accumulated other comprehensive income | — | 35 | ||||||
| Accumulated deficit | (227,799 | ) | (177,974 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 237,047 | 192,653 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 280,658 | $ | 231,938 | ||||
| Statement of Operations Data | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||||
| Three Months Ended |
Nine Months Ended |
||||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||||
| Revenue: | |||||||||||||||||
| Product revenue | $ | 19,590 | $ | 11,333 | $ | 45,073 | $ | 28,615 | |||||||||
| Cost of revenue: | |||||||||||||||||
| Cost of product revenue | 5,277 | 4,401 | 14,520 | 11,606 | |||||||||||||
| Gross profit | 14,313 | 6,932 | 30,553 | 17,009 | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 7,891 | 8,368 | 27,882 | 22,778 | |||||||||||||
| Sales and marketing | 13,619 | 8,192 | 35,236 | 21,023 | |||||||||||||
| General and administrative | 5,610 | 3,437 | 17,232 | 9,684 | |||||||||||||
| Total operating expenses | 27,120 | 19,997 | 80,350 | 53,485 | |||||||||||||
| Loss from operations | (12,807 | ) | (13,065 | ) | (49,797 | ) | (36,476 | ) | |||||||||
| Interest expense | (314 | ) | (251 | ) | (897 | ) | (746 | ) | |||||||||
| Change in fair value of warrant liability | — | — | — | (609 | ) | ||||||||||||
| Other income, net | 218 | 385 | 942 | 1,518 | |||||||||||||
| Net loss before taxes | (12,903 | ) | (12,931 | ) | (49,752 | ) | (36,313 | ) | |||||||||
| Income tax provision | 29 | 26 | 73 | 51 | |||||||||||||
| Net loss | $ | (12,932 | ) | $ | (12,957 | ) | $ | (49,825 | ) | $ | (36,364 | ) | |||||
| Net loss per share, basic and diluted | $ | (0.38 | ) | $ | (0.46 | ) | $ | (1.53 | ) | $ | (1.66 | ) | |||||
| Shares used in computing net loss per share, basic and diluted | 34,078,726 | 28,085,821 | 32,631,715 | 21,886,396 | |||||||||||||
Source: Shockwave Medical, Inc.