SANTA CLARA, Calif., Aug. 08, 2022 (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 ended June 30, 2022.

Recent Highlights

  • Recognized revenue of $120.7 million for the second quarter of 2022, representing an increase of 116% from the same period in 2021
  • Shared two-year data from the Disrupt PAD III trial, which found that Shockwave IVL maintains superiority to angioplasty in calcified peripheral disease and preserves future treatment options
  • Received regulatory approval in China to market and sell the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheters and the Shockwave M5 and S4 Peripheral IVL

“Our results in the second quarter were encouraging once again and demonstrated the strength throughout the entire Shockwave organization. Our teams continue to deliver due to their ability to work effectively together and with our customers to overcome the obstacles that continue to be put in front of us,” said Doug Godshall, President and Chief Executive Officer of Shockwave Medical. “The progress of our business across categories and geographies demonstrates the global impact of IVL as a safe, effective technology to address calcified arterial disease and we look forward to continuing to improve outcomes for patients across the globe.”  

Second Quarter 2022 Financial Results

Revenue for the second quarter ended June 30, 2022, was $120.7 million, a 116% increase from $55.9 million in the same period of 2021. The growth was primarily driven by the launch of the coronary product, Shockwave C2, in the U.S. in February 2021, continued recovery from the pandemic impact and increased adoption of Shockwave products.

Gross profit for the second quarter of 2022 was $104.0 million compared to $46.0 million for the second quarter of 2021. Gross margin for the second quarter of 2022 was 86%, as compared to 82% in the second quarter of 2021. The increase in gross margin was primarily driven by product mix along with continued improvement in manufacturing productivity and process efficiencies.

Total operating expenses for the second quarter of 2022 were $74.4 million, a 61% increase from $46.2 million in the second quarter of 2021. The increase was primarily driven by sales force expansion in the U.S. and higher headcount to support the growth of the business.

Net income for the second quarter of 2022 was $25.6 million, compared to a net loss of $0.4 million in the same period of 2021. Basic and diluted net income per share for the second quarter of 2022 was $0.71 and $0.68, respectively.  

Cash, cash equivalents and short-term investments totaled $224.9 million as of June 30, 2022.

2022 Financial Guidance

Shockwave Medical projects revenue for the full year 2022 to range from $465 million to $475 million, which represents 96% to 100% growth over the Company’s prior year revenue. This compares to previous revenue guidance of $435 million to $455 million.

Conference Call

Shockwave Medical will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on Monday, August 8, 2022, to discuss its second quarter 2022 financial results. To access the earnings call via telephone, please register in advance using the link here. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call. 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
+1.317.432.9210
sshadiow@shockwavemedical.com

Investor Contact:
Debbie Kaster
dkaster@shockwavemedical.com


SHOCKWAVE MEDICAL, INC.
Balance Sheet Data
(in thousands)
     
  June 30,
2022		 December 31,
2021
  (Unaudited)  
ASSETS    
CURRENT ASSETS:    
Cash and cash equivalents $99,913  $89,209 
Short-term investments 124,993  111,772 
Accounts receivable, net 59,797  37,435 
Inventory 60,028  42,978 
Prepaid expenses and other current assets 7,275  4,508 
Total current assets 352,006  285,902 
Operating lease right-of-use assets 26,045  27,496 
Property and equipment, net 32,253  24,361 
Equity method investment 4,476  5,987 
Other assets 2,365  1,936 
TOTAL ASSETS $417,145  $345,682 
LIABILITIES AND STOCKHOLDERS’ EQUITY    
CURRENT LIABILITIES:    
Accounts payable $5,266  $3,520 
Term notes, current portion 11,000  5,500 
Accrued liabilities 47,253  40,870 
Lease liability, current portion 2,688  1,738 
Total current liabilities 66,207  51,628 
Lease liability, noncurrent 27,157  28,321 
Term notes, noncurrent portion 6,440  11,630 
Related party contract liability, noncurrent portion 12,273  12,273 
TOTAL LIABILITIES 112,077  103,852 
STOCKHOLDERS’ EQUITY:    
Preferred stock —  — 
Common stock 36  35 
Additional paid-in capital 519,096  494,806 
Accumulated other comprehensive loss (1,337)  (202) 
Accumulated deficit (212,727)  (252,809) 
TOTAL STOCKHOLDERS’ EQUITY 305,068  241,830 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $417,145  $345,682 


SHOCKWAVE MEDICAL, INC.
Statement of Operations Data
(Unaudited)
(in thousands, except share and per share data)
         
  Three Months Ended Six Months Ended
  June 30, June 30,
  2022 2021 2022 2021
Revenue:        
Product revenue $120,746  $55,908  $214,377  $87,808 
Cost of revenue:        
Cost of product revenue 16,730  9,934  29,620  17,826 
Gross profit 104,016  45,974  184,757  69,982 
Operating expenses:        
Research and development 20,760  11,815  37,779  22,092 
Sales and marketing 40,515  25,713  76,476  49,705 
General and administrative 13,165  8,626  25,554  15,852 
Total operating expenses 74,440  46,154  139,809  87,649 
Income (Loss) from operations 29,576  (180)  44,948  (17,667) 
Loss from equity method investment (1,464)  —  (1,511)  (5,523) 
Interest expense (304)  (318)  (601)  (630) 
Other income (expense), net (1,473)  146  (1,783)  (89) 
Net income (loss) before taxes 26,335  (352)  41,053  (23,909) 
Income tax provision 774  73  971  117 
Net income (loss) $25,561  $(425)  $40,082  $(24,026) 
Net income (loss) per share, basic $0.71  $(0.01)  $1.12  $(0.69) 
Net income (loss) per share, diluted $0.68  $(0.01)  $1.06  $(0.69) 
Shares used in computing net income (loss) per share, basic 35,825,947  35,030,036  35,707,301  34,914,361 
Shares used in computing net income (loss) per share, diluted 37,690,094  35,030,036  37,690,320  34,914,361