Washington, D.C. 20549

Form 8-K


Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): August 11, 2020  

Shockwave Medical, Inc.
(Exact Name of Registrant as Specified in Charter)

(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification Number)


5403 Betsy Ross Drive, Santa Clara, California 95054
(Address of Principal Executive Offices) (Zip Code)

(510) 279-4262
(Registrant's telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 [   ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 [   ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 [   ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 [   ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Securities registered pursuant to Section 12(b) of the Act:


Title of each class




Name of each exchange on which registered


Common stock, par value $0.001 per shareSWAVNasdaq Global Market


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [ X ]


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ X ]



Item 2.02. Results of Operations and Financial Condition.

On August 11, 2020, the Company issued a press release (the “Press Release”) announcing its financial results for the quarter ended June 30, 2020. A copy of the Press Release is attached as Exhibit 99.1 to this current report on Form 8-K.

The information under Item 2.02 in this current report on Form 8-K and the related information in the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

       Description of Exhibit
99.1 Press release dated August 11, 2020


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 Shockwave Medical, Inc.
Date: August 11, 2020By: /s/ Dan Puckett        
  Dan Puckett
  Chief Financial Officer



Shockwave Medical Reports Second Quarter 2020 Financial Results

SANTA CLARA, Calif., Aug. 11, 2020 (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, 2020.

Recent Highlights

“The progress we made during this past quarter, despite the hurdles and challenges of COVID-19, reflects the commitment and strength of our team and the uniqueness of our proprietary IVL technology,” said Doug Godshall, President and Chief Executive Officer of Shockwave Medical. “The continued interest and demand for IVL has really demonstrated how highly valued Shockwave’s technology continues to be as a safe, effective, efficient option for our customers who treat severely calcified cardiovascular disease.  All of us at Shockwave have a great deal of gratitude and respect for our partners on the provider side of the system for their dedication to patients, particularly under such challenging conditions.  We are honored to have been given an opportunity to work with so many extraordinary healthcare professionals.” 

Second Quarter 2020 Financial Results 
Revenue for the second quarter of 2020 was $10.3 million, an increase of $0.3 million, or 3%, compared to the second quarter of 2019. The growth was primarily driven by a steady recovery as elective procedure volumes continued to increase in May and June following a significant reduction in April.  

Gross profit for the second quarter of 2020 was $6.7 million compared to $5.9 million for the second quarter of 2019. Gross margin for the second quarter of 2020 was 65%, as compared to 59% in the same period of last year.  Contributors to gross margin improvement included continued improvement in manufacturing productivity and process efficiencies as well as geographic mix and improved cost efficiencies.

Operating expenses were $24.7 million for the second quarter of 2020 compared to $17.1 million in the corresponding prior year period, a 44% increase from the same quarter in 2019, primarily driven by increases in headcount since the year ago period.

Net loss was $18.1 million in the second quarter of 2020, as compared to $10.6 million in the corresponding period of the prior year. Net loss per share was $0.56 in the second quarter of 2020.

Cash, cash equivalents and short-term investments totaled $231.4 million as of June 30, 2020. This number includes net proceeds of $83.4 million from the follow-on financing completed in June. 

2020 Financial Guidance 
Shockwave Medical withdrew its previously announced annual guidance for 2020 on April 6, 2020 due to the COVID-19 pandemic. Due to uncertainties as to the continued scope and duration of the COVID-19 pandemic, Shockwave is unable to estimate the pandemic’s impact on operations and financial results and is not issuing 2020 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 Tuesday, August 11, 2020 to discuss its second quarter 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: 8889064. 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 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 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 Shockwave’s expectations, projections, beliefs, and prospects (including statements regarding Shockwave’s product development outlook), which are “forward-looking statements” within the meaning of the federal securities laws and by their nature are uncertain. Words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plans,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements include, but are not limited to statements about: the impact of the COVID-19 pandemic on our operations, financial results, and liquidity and capital resources, including on our sales, expenses, supply chain, manufacturing, research and development activities, clinical trials and employees; our ability to design, develop, manufacture and market innovative products to treat patients with challenging medical conditions, particularly in peripheral artery disease, coronary artery disease and aortic stenosis; our expected future growth, including growth in international sales; the size and growth potential of the markets for our products, and our ability to serve those markets; the rate and degree of market acceptance of our products; coverage and reimbursement for procedures performed using our products; the performance of third parties in connection with the development of our products, including third-party suppliers; regulatory developments in the United States and foreign countries; our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines; our plans to research, develop and commercialize our products and any other approved or cleared product; our ability to scale our organizational culture of cooperative product development and commercial execution; the development, regulatory approval, efficacy and commercialization of competing products; the loss of key scientific or management personnel; our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; and our expectations regarding 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 forward-looking statements are only predictions based on our current expectations and projections about future events.  There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements.  These factors, as well as others, are discussed in greater detail 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. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.

Media Contact:
Scott Shadiow

Investor Contact:
Debbie Kaster

Balance Sheet Data
(in thousands)
  June 30,
 December 31,
Cash and cash equivalents $218,296  $139,045  
Short-term investments  13,109   56,304  
Accounts receivable, net  6,365   7,377  
Inventory  23,427   12,074  
Prepaid expenses and other current assets  3,117   1,897  
Total current assets  264,314   216,697  
Operating lease right-of-use assets  8,130   8,825  
Property and equipment, net  13,287   4,910  
Other assets  1,622   1,506  
TOTAL ASSETS $287,353  $231,938  
Accounts payable $2,562  $2,790  
Term notes, current portion     6,667  
Accrued liabilities  14,381   13,777  
Lease liability, current portion  798   774  
Total current liabilities  17,741   24,008  
Lease liability, noncurrent portion  7,903   8,125  
Term notes, noncurrent portion  16,286   7,152  
TOTAL LIABILITIES  41,930   39,285  
Preferred stock       
Common stock  34   31  
Additional paid-in capital  460,235   370,561  
Accumulated other comprehensive income  21   35  
Accumulated deficit  (214,867)  (177,974) 
TOTAL STOCKHOLDERS’ EQUITY  245,423   192,653  

Statement of Operations Data
(in thousands, except share and per share data)
  Three Months Ended
June 30,
 Six Months Ended
June 30,
   2020   2019   2020   2019 
Product revenue $10,286  $10,012  $25,483  $17,282 
Cost of revenue:        
Cost of product revenue  3,592   4,133   9,243   7,205 
Gross profit  6,694   5,879   16,240   10,077 
Operating expenses:        
Research and development  8,101   6,926   19,991   14,410 
Sales and marketing  11,206   6,961   21,617   12,831 
General and administrative  5,398   3,245   11,622   6,247 
Total operating expenses  24,705   17,132   53,230   33,488 
Loss from operations  (18,011)  (11,253)  (36,990)  (23,411)
Interest expense  (306)  (250)  (583)  (495)
Change in fair value of warrant liability           (609)
Other income, net  220   913   724   1,133 
Net loss before taxes  (18,097)  (10,590)  (36,849)  (23,382)
Income tax provision  21   18   44   25 
Net loss $(18,118) $(10,608) $(36,893) $(23,407)
Net loss per share, basic and diluted $(0.56) $(0.38) $(1.16) $(1.25)
Shares used in computing net loss per share, basic and diluted  32,156,476   28,002,887   31,900,259   18,735,307