Form 8-K
0001642545 False 0001642545 2023-08-07 2023-08-07 iso4217:USD xbrli:shares iso4217:USD xbrli:shares
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________

FORM 8-K

_________________

CURRENT REPORT

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

Date of Report (Date of earliest event reported):  August 7, 2023

_______________________________

Shockwave Medical, Inc.

(Exact name of registrant as specified in its charter)

_______________________________

Delaware001-3882927-0494101
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification No.)

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 classTrading Symbol(s)Name of each exchange on which registered
Common stock, par value $0.001 per shareSWAVThe Nasdaq Stock Market LLC

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

Emerging growth company

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. ☐

 
 
Item 2.02. Results of Operations and Financial Condition.

On August 7, 2023, the Company issued a press release (the “Press Release”) announcing its financial results for the second quarter ended June 30, 2023. 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

Exhibit Number Description
      
99.1 Press Release dated August 7, 2023
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 

SIGNATURE

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 7, 2023By: /s/ Daniel K. Puckett        
  Daniel K. Puckett
  Chief Financial Officer
  

 

EdgarFiling

EXHIBIT 99.1

Shockwave Medical Reports Second Quarter 2023 Financial Results

SANTA CLARA, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, today reported financial results for the three months ended June 30, 2023.

Recent Highlights

“Our teams throughout the Shockwave organization continue to execute at the highest level, enabling us to offer an expanding range of products to meet the needs of our customers across the globe,” said Doug Godshall, President and Chief Executive Officer of Shockwave Medical. “The consistent growth across our business is a testament to the need for our novel products and we look forward to continuing to provide innovative solutions to improve outcomes for patients suffering from cardiovascular diseases.”

Second Quarter 2023 Financial Results

Revenue for the second quarter ended June 30, 2023, was $180.2 million, a 49% increase from $120.7 million in the same period of 2022. The growth was primarily driven by an increase in the purchase volume of our catheters in both the United States and internationally.

Gross profit for the second quarter of 2023 was $155.7 million compared to $104.0 million for the second quarter of 2022. Gross margin percentage was 86% for the three months ended June 30, 2023, which was unchanged from the gross margin percentage for the three months ended June 30, 2022.

Total operating expenses for the second quarter of 2023 were $123.3 million, a 66% increase from $74.4 million in the second quarter of 2022. The increase was primarily driven by sales force expansion, higher headcount to support the growth of the business, and acquisition-related expenses associated with the acquisition of Neovasc.

Net income for the second quarter of 2023 was $28.9 million, compared to net income of $25.6 million in the same period of 2022. Basic and diluted net income per share for the period was $0.79 and $0.76, respectively.  

Cash, cash equivalents and short-term investments totaled $258.6 million as of June 30, 2023.

2023 Financial Guidance

Shockwave Medical projects revenue for the full year 2023 to range from $725 million to $730 million, which represents 48% to 49% growth over the Company’s prior year revenue. This compares to previous revenue guidance for the full year of 2023 of $700 million to $720 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 7, 2023, to discuss its second quarter 2023 financial results. The call may be accessed by dialing 877-704-4453 for domestic callers or 201-389-0920 for international callers, using conference ID: 13737256. A live and archived webcast of the event will be available at https://ir.shockwavemedical.com/.

About Shockwave Medical, Inc.

Shockwave Medical is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Shockwave has also recently acquired the Neovasc Reducer, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom. By redistributing blood flow within the heart, the Reducer is designed to provide relief to the millions of patients worldwide suffering from refractory angina. Learn more at www.shockwavemedical.com and www.neovasc.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. Forward-looking statements in this press release include, but are not limited to, statements regarding our anticipated future operating results and financial position, including for the full year ending December 31, 2023, our business strategy and plans, our objectives for future operations and financial performance and other matters. 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 macroeconomic conditions, including inflation, rising interest rates, the federal budget, instability in the global banking system, and volatile market conditions, geopolitical factors, including the ongoing conflict between Russia and Ukraine and responses thereto, and supply chain disruptions, on our operations, financial results, liquidity, capital resources, expenses, supply chain, manufacturing, research and development activities, clinical trials, and employees; our ability to successfully execute our business and growth strategies; our ability to develop, manufacture, obtain and maintain regulatory approvals for, and 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; the success of any acquisitions that we make; 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 the sections titled “Risk Factors” in our most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in our 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,
2023
 December 31,
2022
 
  (Unaudited)   
ASSETS       
CURRENT ASSETS:     
Cash and cash equivalents $141,458  $156,586  
Short-term investments  117,131   147,907  
Accounts receivable, net  96,562   71,366  
Inventory  92,093   75,112  
Prepaid expenses and other current assets  9,118   8,292  
Total current assets  456,362   459,263  
Operating lease right-of-use assets  31,117   32,365  
Property and equipment, net  59,803   48,152  
Equity method investment  2,543   3,512  
Intangible assets, net  94,692     
Goodwill  39,789     
Deferred tax assets  94,699   97,568  
Other assets  7,599   5,229  
TOTAL ASSETS $786,604  $646,089  
LIABILITIES AND STOCKHOLDERS’ EQUITY     
CURRENT LIABILITIES:     
Accounts payable $12,869  $6,721  
Accrued liabilities  65,769   55,375  
Lease liability, current portion  1,582   1,278  
Total current liabilities  80,220   63,374  
Lease liability, noncurrent portion  33,205   34,928  
Debt, noncurrent portion  24,266   24,198  
Related party contract liability, noncurrent portion  12,273   12,273  
Deferred tax liabilities  10,421     
Other liabilities  9,307     
TOTAL LIABILITIES  169,692   134,773  
STOCKHOLDERS’ EQUITY:     
Preferred stock       
Common stock  37   36  
Additional paid-in capital  586,092   548,960  
Accumulated other comprehensive loss  (391)   (867)  
Retained earnings (accumulated deficit)  31,174   (36,813)  
TOTAL STOCKHOLDERS’ EQUITY  616,912   511,316  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $786,604  $646,089  


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,
  2023
 2022
 2023
 2022
Revenue:        
Product revenue $180,165  $120,746  $341,231  $214,377 
Cost of revenue:        
Cost of product revenue  24,493   16,730   45,559   29,620 
Gross profit  155,672   104,016   295,672   184,757 
Operating expenses:        
Research and development  36,829   20,760   63,800   37,779 
Sales and marketing  56,738   40,515   110,749   76,476 
General and administrative  29,731   13,165   48,935   25,554 
Total operating expenses  123,298   74,440   223,484   139,809 
Income from operations  32,374   29,576   72,188   44,948 
Loss from equity method investment  (146)   (1,464)   (969)   (1,511) 
Interest expense  (810)   (304)   (1,446)   (601) 
Other income (expense), net  1,586   (1,473)   3,968   (1,783) 
Net income before taxes  33,004   26,335   73,741   41,053 
Income tax provision  4,142   774   5,754   971 
Net income $28,862  $25,561  $67,987  $40,082 
Net income per share, basic $0.79  $0.71  $1.86  $1.12 
Net income per share, diluted $0.76  $0.68  $1.78  $1.06 
Shares used in computing net income per share, basic  36,663,327   35,825,947   36,545,948   35,707,301 
Shares used in computing net income per share, diluted  38,226,153   37,690,094   38,139,948   37,690,320