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ShockWave Medical, Inc. (SWAV)

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Previous Close116.54
Open117.61
Bid106.00 x 1200
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52 Week Range22.01 - 143.79
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  • Shockwave Medical Reports Fourth Quarter and Full Year 2020 Financial Results
    GlobeNewswire

    Shockwave Medical Reports Fourth Quarter and Full Year 2020 Financial Results

    SANTA CLARA, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, today reported financial results for the three months and full year ended December 31, 2020. 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 2019Received FDA approval of IVL for severely calcified coronary artery diseasePresented data for two large trials at late breaking sessions in the fourth quarterGranted four new codes by CMS that established specific payment for IVL procedures performed in an outpatient setting in arteries below the kneeGranted eight codes by CMS for IVL performed in Ambulatory Surgery CentersEnded 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 Doug Godshall, President and Chief Executive Officer of Shockwave Medical. “With the recent FDA approval of our C2 device, we will now be able to address a significant unmet need for patients with severely calcified coronary arteries in the United States. I want to thank our employees and our investigators for their hard work and persistence as they have fought through the pandemic to put us in this fortunate position.” Fourth Quarter 2020 Financial Results Revenue for the fourth quarter of 2020 was $22.7 million, an increase of $8.4 million, or 59%, compared to the fourth quarter of 2019. The growth was primarily driven by sales force expansion in the U.S. and increased penetration in both U.S. and international markets. Gross profit for the fourth quarter of 2020 was $16.2 million compared to $8.8 million for the fourth quarter of 2019. Gross margin for the fourth quarter of 2020 was 72%, as compared to 61% in the same period of last year. Contributors to gross margin expansion included continued improvement in manufacturing productivity and process efficiencies. Operating expenses were $32.1 million for the fourth quarter of 2020 compared to $24.1 million in the corresponding prior year period, representing a 33% increase, primarily driven by increases in headcount since the year ago period. Net loss was $15.9 million in the fourth quarter of 2020, as compared to $14.7 million in the corresponding period of the prior year. Net loss per share was $0.46 in the fourth quarter of 2020. Full Year 2020 Financial Results Revenue for full year 2020 was $67.8 million, an increase of $24.9 million, or 58%, compared to the full year of 2019. The growth was primarily driven by the expansion of the U.S. sales force and international distributor network. Gross profit for the full year 2020 was $46.8 million compared to $25.8 million for the full year 2019. The gross margin percentage for the full year 2020 increased to 69% compared to 60% in the full year 2019, driven primarily by improvements in production processes and greater absorption of fixed costs by higher production. Operating expenses were $112.5 million for the full year 2020 compared to $77.6 million in the prior year, an increase of 45%, primarily driven by headcount increases. Net loss was $65.7 million for full year 2020, as compared to $51.1 million in the prior year. Net loss per share was $1.99 for full year 2020. Cash, cash equivalents and short-term investments totaled $202.4 million as of December 31, 2020. 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 Shockwave Medical will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on Wednesday, February 17, 2021 to discuss its fourth quarter and full year 2020 financial results. The call may be accessed through an operator by dialing (866) 795-9106 for domestic callers or (470) 495-9173 for international callers, using conference ID: 7854854. A live and archived webcast of the event will be available at https://ir.shockwavemedical.com/. About Shockwave Medical, Inc. Shockwave Medical is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave Medical aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which Shockwave Medical refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com. 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 Securities and Exchange Commission (SEC), including in Part I, Item IA - Risk Factors in our most recent Annual Report on Form 10-K filed with the SEC, and in our other periodic and other reports filed with the SEC. Except to the extent required by law, we do not undertake to update any of these forward-looking statements after the date hereof to conform these statements to actual results or revised expectations. Media Contact: Scott Shadiow +1.317.432.9210sshadiow@shockwavemedical.com Investor Contact:Debbie Kasterdkaster@shockwavemedical.com SHOCKWAVE MEDICAL, INC. Balance Sheet Data (in thousands) December 31,2020(Unaudited) December 31,2019ASSETS 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 SHOCKWAVE MEDICAL, INC. Statement of Operations Data(Unaudited)(in thousands, except share and per share data) Three Months EndedDecember 31, Year EndedDecember 31, 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

  • ACCESSWIRE

    Shockwave Medical, Inc. to Host Earnings Call

    NEW YORK, NY / ACCESSWIRE / February 17, 2021 / Shockwave Medical, Inc. (NASDAQ:SWAV) will be discussing their earnings results in their 2020 Fourth Quarter Earnings call to be held on February 17, 2021 at 4:30 PM Eastern Time.

  • Shockwave Intravascular Lithotripsy FDA Approved to Treat Advanced Heart Disease
    GlobeNewswire

    Shockwave Intravascular Lithotripsy FDA Approved to Treat Advanced Heart Disease

    Transformative Technology Now Available for Calcified Coronary PlaqueSANTA CLARA, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the company’s sonic pressure wave therapy received Pre-Market Approval for severely calcified coronary artery disease from the U.S. Food and Drug Administration (FDA). The innovative technology, which was granted Breakthrough Device designation by the FDA, is a novel application of lithotripsy, an approach that has been used for decades to safely break up kidney stones. With this approval, IVL is now commercially available in the United States to treat problematic calcium in the coronary arteries, which can reduce blood flow in the heart. As coronary artery disease progresses, plaque in the arterial wall often evolves into calcium deposits, which narrow the artery and restrict blood flow. These bone-like structures make the artery rigid and more difficult to reopen with conventional treatments including balloons, which attempt to crack the calcium when inflated to high pressure, and atherectomy, which drills through the calcium to open the artery. While atherectomy has been available for several decades, its use remains low, despite the high prevalence of calcium, due to its complexity of use and potential to result in adverse patient outcomes. Intravascular Lithotripsy uses sonic pressure waves, also known as shockwaves, that pass through soft arterial tissue and preferentially disrupt calcified plaque by creating a series of micro-fractures. After the calcium has been cracked, the artery can be expanded at low pressure and a stent safely implanted to improve blood flow, with minimal trauma to normal arterial tissue. The coronary technology has been widely adopted internationally and is now available in 50 countries, with more than 25,000 patients successfully treated since the initial commercial availability in early 2018. “Coronary calcification is a major challenge for physicians because it limits the success of coronary angioplasty procedures and our current tools for addressing calcium have limitations,” said Dean Kereiakes, M.D., FACC, FSCAI, President of The Christ Hospital Heart and Vascular Institute, Professor of Clinical Medicine, The Ohio State University, and the Co-Principal Investigator of the pivotal Disrupt CAD III U.S. study. “This approval represents a major advance in both the safety and simplicity of some of our most challenging procedures – and potentially promises to become a new standard of care.” The approval comes on the heels of its U.S. pivotal study recently published in the Journal of the American College of Cardiology (JACC), which confirmed that coronary IVL met both the primary safety and effectiveness endpoints with a low rate of major adverse events and a high rate of procedural success. Notably, coronary IVL was simple to use and demonstrated a low risk of rare but life-threatening complications that have been associated with the use of high-pressure balloons and atherectomy technologies, including tears in the artery, abrupt arterial closure and a sudden stop of blood flow. “Obtaining FDA approval for this transformational technology marks a significant advance in the treatment of patients with calcified coronary lesions, and is the culmination of years of technical research, rigorous clinical studies and key learnings from our real-world global experience,” said Doug Godshall, President and Chief Executive Officer of Shockwave Medical. “We are eager for U.S. cardiologists to have access to this technology and experience how a safe, efficient and predictable calcium modification strategy can positively impact their clinical outcomes.” The Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting in the United States. The technology has been cleared for the treatment of peripheral arterial disease in the United States since 2016. About Shockwave Medical, Inc.Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com. 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 Securities and Exchange Commission (SEC), including in Part I, Item IA - Risk Factors in our most recent Annual Report on Form 10-K filed with the SEC, and in our other periodic and other reports filed with the SEC. Except to the extent required by law, we do not undertake to update any of these forward-looking statements after the date hereof to conform these statements to actual results or revised expectations. Media Contact:Scott Shadiow+1.317.432.9210sshadiow@shockwavemedical.com Investor Contact:Debbie Kasterdkaster@shockwavemedical.com