0001171843-22-001135.txt : 20220217 0001171843-22-001135.hdr.sgml : 20220217 20220217160515 ACCESSION NUMBER: 0001171843-22-001135 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220217 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220217 DATE AS OF CHANGE: 20220217 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Shockwave Medical, Inc. CENTRAL INDEX KEY: 0001642545 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 270494101 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38829 FILM NUMBER: 22648029 BUSINESS ADDRESS: STREET 1: 5403 BETSY ROSS DRIVE CITY: SANTA CLARA STATE: CA ZIP: 95054 BUSINESS PHONE: (510) 279-4262 MAIL ADDRESS: STREET 1: 5403 BETSY ROSS DRIVE CITY: SANTA CLARA STATE: CA ZIP: 95054 FORMER COMPANY: FORMER CONFORMED NAME: ShockWave Medical, Inc. DATE OF NAME CHANGE: 20150515 8-K 1 f8k_021722.htm FORM 8-K Form 8-K
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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):  February 17, 2022

_______________________________

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 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 (§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 February 17, 2022, the Company issued a press release (the “Press Release”) announcing its financial results for the quarter and year ended December 31, 2021. 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 February 17, 2022
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: February 17, 2022By: /s/ Daniel K. Puckett        
  Daniel K. Puckett
  Chief Financial Officer
  

 

 EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFiling

EXHIBIT 99.1

Shockwave Medical Reports Fourth Quarter and Full Year 2021 Financial Results

SANTA CLARA, Calif., Feb. 17, 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 and full year ended December 31, 2021.

Recent Highlights

  • Recognized revenue of $84.2 million for the fourth quarter of 2021 and $237.1 million for the full year of 2021, representing increases of 271% and 250%, respectively, from the same periods in 2020
  • Centers for Medicare & Medicaid Services (CMS) reassigned the payment for peripheral IVL procedures performed on above the knee (ATK) arteries in the hospital outpatient setting, thereby meaningfully increasing the payments hospitals receive for these procedures
  • Enrolled the first patient in our Disrupt BTK II global post-market study that is designed to assess the long-term benefit of peripheral IVL on the most challenging calcified below the knee lesions
  • Ended the year with 125 issued and 46 pending patents

“I continue to be humbled by the exceptional performance of the entire Shockwave team, despite the unpredictable and unprecedented challenges that are constantly being put in front of us,” said Doug Godshall, President and Chief Executive Officer of Shockwave Medical. “2021 was another stellar year with significant achievements across the board - from regulatory and sales to reimbursement, marketing, and operations. I want to thank our employees for their hard work and persistence in helping us achieve these successes and our customers and investigators for supporting us as we pursue our mission to improve outcomes for patients with calcified vascular disease.”

Fourth Quarter 2021 Financial Results

Revenue for the fourth quarter of 2021 was $84.2 million, an increase of $61.5 million, or 271%, compared to the corresponding prior year period. Revenue growth was primarily driven by the launch of the coronary product, Shockwave C2, in the U.S. in February, sales force expansion in the U.S. and increased penetration in both U.S. and international markets.

Gross profit for the fourth quarter of 2021 was $71.5 million compared to $16.2 million for corresponding prior year period. Gross margin for the fourth quarter of 2021 was 85%, as compared to 72% in the corresponding prior year period. Contributors to increased gross margin included product mix in addition to continued improvement in manufacturing productivity and process efficiencies.

Operating expenses for the fourth quarter of 2021 were $57.5 million, compared to $32.1 million for the corresponding prior year period, representing a 79% increase, primarily driven by increases in headcount to support growth in the business.

Net income was $12.9 million in the fourth quarter of 2021, as compared to a net loss of $15.9 million in the corresponding prior year period. Basic net income per share was $0.37 in the fourth quarter of 2021. Diluted net income per share was $0.34 in the fourth quarter of 2021.

Full Year 2021 Financial Results

Revenue for the full year 2021 was $237.1 million, an increase of $169.4 million, or 250%, compared to the full year of 2020. The growth was primarily driven by the launch of Shockwave C2 in the U.S. in February, along with expansion of the U.S. sales force and international distributor network.

Gross profit for the full year 2021 was $195.7 million compared to $46.8 million for the full year 2020. The gross margin percentage for the full year 2021 increased to 83% compared to 69% in the full year 2020, driven primarily by product mix in addition to continued improvements in production processes and greater absorption of fixed costs by higher production.

Operating expenses were $196.6 million for the full year 2021, compared to $112.5 million in the full year 2020, an increase of 75% primarily driven by headcount increases.

Net loss was $9.1 million for the full year 2021, as compared to $65.7 million in the full year 2020. Net loss per share was $0.26 for the full year 2021.

Cash, cash equivalents and short-term investments totaled $201 million as of December 31, 2021.

2022 Financial Guidance

Shockwave Medical projects revenue for the full year 2022 to range from $405 million to $425 million, which represents 71% to 79% growth over the full year 2021 revenue.

Conference Call

Shockwave Medical will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on Thursday, February 17, 2022, to discuss its fourth quarter and full year 2021 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: 6866777. 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, uncertainties, assumptions and other 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.

Forward-looking statements contained in this press release include, but are not limited to the following, statements about: 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)
  December 31,
2021		 December 31,
2020
  (Unaudited)  
ASSETS    
CURRENT ASSETS:    
Cash and cash equivalents $89,209  $50,423 
Short-term investments  111,772   151,931 
Accounts receivable, net  37,435   11,689 
Inventory  42,978   29,859 
Prepaid expenses and other current assets  4,508   2,398 
Total current assets  285,902   246,300 
Operating lease right-of-use assets  27,496   7,568 
Property and equipment, net  24,361   16,362 
Equity method investment  5,987   — 
Other assets  1,936   1,812 
TOTAL ASSETS $345,682  $272,042 
LIABILITIES AND STOCKHOLDERS’ EQUITY    
CURRENT LIABILITIES:    
Accounts payable $3,520  $1,466 
Term notes, current portion  5,500   3,300 
Accrued liabilities  40,870   19,942 
Lease liability, current portion  1,738   873 
Total current liabilities  51,628   25,581 
Lease liability, noncurrent  28,321   7,488 
Term notes, noncurrent portion  11,630   13,319 
Related party contract liability, noncurrent portion  12,273   — 
TOTAL LIABILITIES  103,852   46,388 
STOCKHOLDERS’ EQUITY:    
Preferred stock  —   — 
Common stock  35   35 
Additional paid-in capital  494,806   469,283 
Accumulated other comprehensive income (loss)  (202)  9 
Accumulated deficit  (252,809)  (243,673)
TOTAL STOCKHOLDERS’ EQUITY  241,830   225,654 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $345,682  $272,042 


SHOCKWAVE MEDICAL, INC.
Statement of Operations Data
(Unaudited)
(in thousands, except share and per share data)
  Three Months Ended
December 31,		 Year Ended
December 31,
   2021   2020   2021   2020 
Revenue:        
Product revenue $84,183  $22,716  $237,146  $67,789 
Cost of revenue:        
Cost of product revenue 12,663  6,471  41,438  20,991 
Gross profit 71,520  16,245  195,708  46,798 
Operating expenses:        
Research and development 14,717  9,044  50,544  36,926 
Sales and marketing 33,190  16,436  111,288  51,672 
General and administrative 9,630  6,631  34,747  23,863 
Total operating expenses 57,537  32,111  196,579  112,461 
Income (loss) from operations 13,983  (15,866) (871) (65,663)
Share in net loss of equity method investment (421) —  (6,286) — 
Interest expense (301) (315) (1,096) (1,212)
Other income (expense), net (213) 314  (582) 1,256 
Net income (loss) before taxes 13,048  (15,867) (8,835) (65,619)
Income tax provision 106  7  301  80 
Net income (loss) $12,942  $(15,874) $(9,136)  $(65,699)
Net income (loss) per share        
Basic $0.37  $(0.46) $(0.26) $(1.99)
Diluted $0.34  $(0.46) $(0.26) $(1.99)
Shares used in computing net income (loss) per share        
Basic 35,350,529  34,447,314  35,098,130  33,088,095 
Diluted 37,614,385  34,447,314  35,098,130  33,088,095 

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