# EDGAR Filing Document

**Accession Number:** 0001642545
**File Stem:** 0001171843-23-001027
**Filing Date:** 2023-2
**Character Count:** 18653
**Document Hash:** 27961aea08e01d90bfc120ba62f515d0
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001171843-23-001027.hdr.sgml**: 20230216

**ACCESSION NUMBER**: 0001171843-23-001027

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230216

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230216

**DATE AS OF CHANGE**: 20230216

**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:** 23638468

**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

?xml version="1.0" encoding="utf-8"?Form 8-K

### 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 16, 2023
_______________________________

#### Shockwave Medical, Inc.
(Exact name of registrant as specified in its charter)

_______________________________

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-38829** | **27-0494101** |
| (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 class | Trading Symbol(s) | Name of each exchange on which registered |
| Common stock, par value $0.001 per share | SWAV | The 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 February 16, 2023, the Company issued a press release (the "Press Release") announcing its financial results for the three months and full year ended December 31, 2022. 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

---

| | |
|:---|:---|
| **<u>Exhibit Number</u>** | **<u>Description</u>** |
| [99.1](exh_991.htm) | [Press Release dated February 16, 2023](exh_991.htm) |
| 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.** | **Shockwave Medical, Inc.** |
| Date: February 16, 2023 | By: | <u>/s/ Daniel K. Puckett&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</u> |
|  |  | Daniel K. Puckett |
|  |  | Chief Financial Officer |

---

## Exhibit 99.1

**EXHIBIT 99.1**

**Shockwave Medical Reports Fourth Quarter and Full Year 2022 Financial Results**

SANTA CLARA, Calif., Feb. 16, 2023 (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, 2022.

**Recent Highlights**

* Recognized revenue of $144.0 million for the fourth quarter of 2022 and $489.7 million for the full year 2022, representing increases of 71% and 107%, respectively, from the same periods in 2021

* Received FDA approval for the Shockwave C<sup>2</sup><sup>+</sup> Coronary IVL Catheter in the United States

* Granted increased reimbursement for the Shockwave C<sup>2</sup> Coronary IVL Catheter by the German INEK institute

* Entered into a definitive agreement to acquire Neovasc Inc.

"We had a busy and successful fourth quarter, achieving record results across geographies and product lines. The team outperformed both operationally and strategically as we continue to advance our technology and our platform," said Doug Godshall, President and Chief Executive Officer of Shockwave Medical. "2022 was another record year filled with significant accomplishments for Shockwave. We remain focused on improving outcomes for the large population of patients with calcified cardiovascular disease with our IVL products and are also excited to be on the verge of adding another novel technology to Shockwave with the planned acquisition of Neovasc and their Reducer System. We believe this technology will give us the opportunity to strategically expand our franchise and mission and to leverage our success and capabilities to address another underserved patient population; those suffering from debilitating refractory angina."

**Fourth Quarter 2022 Financial Results**

Revenue for the fourth quarter of 2022 was $144.0 million, an increase of $59.8 million, or 71%, compared to the corresponding prior year period. Revenue growth was primarily driven by an increase in the purchase volume of our C<sup>2</sup> catheters in the United States and increased adoption of our products internationally.

Gross profit for the fourth quarter of 2022 was $126.5 million compared to $71.5 million for the corresponding prior year period. Gross margin for the fourth quarter of 2022 was 88%, as compared to 85% in the corresponding prior year period. Contributors to the increased gross margin included product mix in addition to continued improvement in manufacturing productivity and process efficiencies.

Operating expenses for the fourth quarter of 2022 were $84.1 million, compared to $57.5 million for the corresponding prior year period, representing a 46% increase, primarily driven by sales force expansion in the United States and higher headcount to support the growth of the business.

Net income was $140.9 million in the fourth quarter of 2022, as compared to a net income of $12.9 million in the corresponding prior year period. Basic net income per share was $3.89 in the fourth quarter of 2022. Diluted net income per share was $3.71 in the fourth quarter of 2022.

**Full Year 2022 Financial Results**

Revenue for the full year 2022 was $489.7 million, an increase of $252.6 million, or 107%, compared to the full year 2021. The growth was primarily driven by an increase in the purchase volume of our C<sup>2</sup> catheters in the United States and increased adoption of our products internationally.

Gross profit for the full year 2022 was $424.7 million compared to $195.7 million for the full year 2021. The gross margin percentage for the full year 2022 increased to 87% compared to 83% in the full year 2021, 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 $300.6 million for the full year 2022, compared to $196.6 million for the full year 2021, an increase of 53% primarily driven by increases in headcount to support growth in the business.

Net income was $216.0 million for the full year 2022, as compared to a net loss of $9.1 million for the full year 2021. Basic net income per share was $6.02 for the full year 2022. Diluted net income per share was $5.70 for the full year 2022.

Cash, cash equivalents and short-term investments totaled $304.5 million as of December 31, 2022.

**2023 Financial Guidance**

Shockwave Medical projects revenue for the full year 2023 to range from $660 million to $680 million, which represents 35% to 39% growth over the full year 2022 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 16, 2023, to discuss its fourth quarter and full year 2022 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: 13734496. A live and archived webcast of the event will be available at <u>https://ir.shockwavemedical.com/</u>.

**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 macroeconomic conditions, including inflation, rising interest rates, volatile market conditions, and global events, including the COVID-19 pandemic, on our operations, financial results, and liquidity, capital resources, 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; whether the acquisition of Neovasc is completed; 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 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.** | **SHOCKWAVE MEDICAL, INC.** | **SHOCKWAVE MEDICAL, INC.** |
| **Balance Sheet Data** | **Balance Sheet Data** | **Balance Sheet Data** |
| **(in thousands)** | **(in thousands)** | **(in thousands)** |
|  | **December 31,**<br>**2022** | **December 31,**<br>**2021** |
|  | **(Unaudited)** | |
| **ASSETS** |  |  |
| CURRENT ASSETS: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $156586 | $89209 |
| &nbsp;&nbsp;&nbsp;&nbsp;Short-term investments | 147907 | 111772 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts receivable, net | 71366 | 37435 |
| &nbsp;&nbsp;&nbsp;&nbsp;Inventory | 75112 | 42978 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 8292 | 4508 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 459263 | 285902 |
| Operating lease right-of-use assets | 32365 | 27496 |
| Property and equipment, net | 48152 | 24361 |
| Equity method investment | 3512 | 5987 |
| Deferred tax assets | 97568 |  |
| Other assets | 5229 | 1936 |
| TOTAL ASSETS | $646089 | $345682 |
| **LIABILITIES AND STOCKHOLDERS' EQUITY** |  |  |
| CURRENT LIABILITIES: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | $6721 | $3520 |
| &nbsp;&nbsp;&nbsp;&nbsp;Debt, current portion |  | 5500 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accrued liabilities | 55375 | 40870 |
| &nbsp;&nbsp;&nbsp;&nbsp;Lease liability, current portion | 1278 | 1738 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 63374 | 51628 |
| Lease liability, noncurrent portion | 34928 | 28321 |
| Debt, noncurrent portion | 24198 | 11630 |
| Related party contract liability, noncurrent portion | 12273 | 12273 |
| TOTAL LIABILITIES | 134773 | 103852 |
| STOCKHOLDERS' EQUITY: |  |  |
| Preferred stock |  |  |
| Common stock | 36 | 35 |
| Additional paid-in capital | 548960 | 494806 |
| Accumulated other comprehensive loss | (867) | (202) |
| Accumulated deficit | (36813) | (252809) |
| TOTAL STOCKHOLDERS' EQUITY | 511316 | 241830 |
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $646089 | $345682 |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
| **SHOCKWAVE MEDICAL, INC.** | **SHOCKWAVE MEDICAL, INC.** | **SHOCKWAVE MEDICAL, INC.** | **SHOCKWAVE MEDICAL, INC.** | **SHOCKWAVE MEDICAL, INC.** |
| **Statement of Operations Data** | **Statement of Operations Data** | **Statement of Operations Data** | **Statement of Operations Data** | **Statement of Operations Data** |
| **(Unaudited)** | **(Unaudited)** | **(Unaudited)** | **(Unaudited)** | **(Unaudited)** |
| **(in thousands, except share and per share data)** | **(in thousands, except share and per share data)** | **(in thousands, except share and per share data)** | **(in thousands, except share and per share data)** | **(in thousands, except share and per share data)** |
|  | **Three Months Ended** | **Three Months Ended** | **Year Ended** | **Year Ended** |
|  | **December 31,** | **December 31,** | **December 31,** | **December 31,** |
|  | **2022** | **2021** | **2022** | **2021** |
| Revenue: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Product revenue | $144026 | $84183 | $489733 | $237146 |
| Cost of revenue: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cost of product revenue | 17502 | 12663 | 64996 | 41438 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Gross profit | 126524 | 71520 | 424737 | 195708 |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 23723 | 14717 | 81679 | 50544 |
| &nbsp;&nbsp;&nbsp;&nbsp;Sales and marketing | 43437 | 33190 | 161995 | 111288 |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 16941 | 9630 | 56929 | 34747 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 84101 | 57537 | 300603 | 196579 |
| Income (loss) from operations | 42423 | 13983 | 124134 | (871) |
| Loss from equity method investment | (1061) | (421) | (2475) | (6286) |
| Interest expense | (969) | (301) | (1886) | (1096) |
| Other income (expense), net | 4261 | (213) | 1055 | (582) |
| Net income (loss) before taxes | 44654 | 13048 | 120828 | (8835) |
| Income tax (benefit) provision | (96257) | 106 | (95168) | 301 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net income (loss) | $140911 | $12942 | $215996 | $(9136) |
| Net income (loss) per share, basic | $3.89 | $0.37 | $6.02 | $(0.26) |
| Net income (loss) per share, diluted | $3.71 | $0.34 | $5.70 | $(0.26) |
| Shares used in computing net income (loss) per share, basic | 36178112 | 35350529 | 35900738 | 35098130 |
| Shares used in computing net income (loss) per share, diluted | 37994698 | 37614385 | 37881590 | 35098130 |

---