8-K
0001531048false00015310482023-02-272023-02-27

 

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 27, 2023

 

 

Inari Medical, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39293

45-2902923

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

6001 Oak Canyon, Suite 100

 

Irvine, California

 

92618

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (877) 923-4747

 

 

(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, $0.001 par value

 

NARI

 

NASDAQ Global Select 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 27, 2023, Inari Medical, Inc. (the “Company”) issued a press release announcing financial results for the fourth quarter and year ended December 31, 2022. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information furnished in this Current Report on Form 8-K (including Exhibit 99.1) 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 to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

No.

 

 

Description

99.1

 

Press Release of Inari Medical, Inc., dated February 27, 2023

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


SIGNATURES

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 thereunto duly authorized.

 

 

 

INARI MEDICAL, INC.

 

 

 

 

Date:

February 27, 2023

By:

/s/ Mitchell Hill

 

 

 

Mitchell Hill
Chief Financial Officer

 


EX-99

 

Exhibit 99.1

https://cdn.kscope.io/ecc0e0a3f08304f0a71a34fec80be2fc-img169044987_0.jpg 

 

Inari Medical Reports Fourth Quarter and Full Year 2022 Financial Results

 

IRVINE, CALIFORNIA – February 27, 2023 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, today reported financial results for its fourth quarter and full year ended December 31, 2022.

 

Fourth Quarter Revenue and Recent Business Highlights

Generated revenue of $107.8 million in the fourth quarter of 2022, up 12% sequentially and 30% over the same quarter last year, and finished full year 2022 with revenue of $383.5 million, a 38% increase over full year 2021.
Enrolled the first patient into our DEFIANCE randomized controlled trial (“RCT”) in Deep Vein Thrombosis, comparing the performance of ClotTriever against anticoagulation alone.
Ended the quarter with $326.4 million in cash, cash equivalents and short-term investments.

 

“Crisp execution across all five of our growth drivers generated robust revenue growth in the fourth quarter,” said Drew Hykes, CEO of Inari Medical. “We are especially pleased with the milestones we achieved across several clinical studies as well as two important new product launches. Our efforts continue to drive market expansion and uptake of our devices while further distancing Inari from both existing and future competition.”

 

Fourth Quarter 2022 Financial Results

Revenue was $107.8 million for the fourth quarter of 2022, compared to $83.2 million for the fourth quarter of 2021 and $96.2 million for the prior quarter. The increase over prior periods was driven primarily by continued U.S. commercial expansion, increased adoption of our procedures, and introduction of new products.

 

Gross profit was $94.6 million for the fourth quarter of 2022, compared to $74.9 million for the same period of 2021. Gross margin was 87.8% for the fourth quarter of 2022, compared to 90.1% for the same period in the prior year. The decrease in gross margin is primarily due to the addition of new components offered under our FlowTriever system price.

 

Operating expenses for the fourth quarter of 2022 were $100.5 million, compared to $73.2 million for the fourth quarter of 2021. The increase was mainly driven by personnel-related expenses as we increased headcount to fund the expansion of the commercial, research and development, clinical, and support organizations.

 

Net loss was $5.8 million for the fourth quarter of 2022 and net loss per share was $0.11 on a weighted-average basic and diluted share count of 53.6 million, compared to a net income of $1.1 million and a net income per share of $0.02 on a weighted-average basic share count of 50.2 million and $0.02 on a weighted average diluted share count of 55.6 million, in the same period of the prior year.

 


 

 

Full Year 2022 Financial Results

Revenue was $383.5 million for the year ended December 31, 2022, compared to $277.0 million in the prior year. The increase over prior periods was driven primarily by continued U.S. commercial expansion, increased adoption of our procedures, and introduction of new products.

 

Gross profit was $339.0 million for the full year of 2022, compared to $252.2 million for the prior year. Gross margin was 88.4% for the full year of 2022, compared to 91.1% for the prior year. The decrease in gross margin is primarily due to the addition of new components offered under our FlowTriever system price and a decrease in operating leverage due to the expanded footprint of our manufacturing operations.

 

Operating expenses for the full year of 2022 were $367.1 million, compared to $241.4 million for the prior year. The increase was mainly driven by personnel-related expenses as we increased headcount to fund the expansion of the commercial, research and development, clinical, and support organizations.

 

Net loss was $29.3 million for the full year of 2022 and net loss per share was $0.55 on a weighted-average basic and diluted share count of 52.8 million, compared to a net income of $9.8 million and net income per share of $0.20 on a weighted-average basic share count of 49.8 million and $0.18 on a weighted-average diluted share count of 55.6 million, in the prior year.

 

Full-Year 2023 Revenue Guidance

For the full year 2023, we are reaffirming our revenue guidance range of $470 million to $480 million.

 

Webcast and Conference Call Information

Inari Medical will host a conference call to discuss the fourth quarter and full year 2022 financial results after market close on Monday, February 27, 2023 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live by dialing 844-825-9789 for domestic callers or 412-317-5180 for international callers, using conference ID: 10175548. The live webinar may be accessed by visiting the Events Section of the Inari investor relations website at ir.inarimedical.com.

 

About Inari Medical, Inc.

Patients first. No small plans. Take care of each other. These are the guiding principles that form the ethos of Inari Medical. We are committed to improving lives in extraordinary ways by creating innovative solutions for both unmet and underrecognized health needs. In addition to our purpose-built products, we leverage our capabilities in education, clinical research, and program development to improve patient outcomes. We are passionate about our mission to establish our treatments as the standard of care for venous thromboembolism and beyond. We are just getting started.

 

Forward Looking Statements

Statements in this press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements include estimated full year 2023 revenue and are based on Inari’s current expectations, forecasts, and assumptions, are subject to

 


 

inherent uncertainties, risks and assumptions that are difficult to predict, and actual outcomes and results could differ materially due to a number of factors. These and other risks and uncertainties include those described more fully in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the period ended December 31, 2022, and in its other reports filed with the U.S. Securities and Exchange Commission. Forward-looking statements contained in this announcement are based on information available to Inari as of the date hereof and are made only as of the date of this release. Inari undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing Inari’s views as of any date subsequent to the date of this press release. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Inari.

 

Investor Contact:

ICR Westwicke

Caroline Corner

Phone +1-415-202-5678

caroline.corner@westwicke.com

 


 

Inari Medical, Inc.

Consolidated Statements of Operations and Comprehensive Income (Loss)

(in thousands, except share and per share data)

 

 

 

Three Months Ended December 31,

 

 

Years Ended December 31,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

107,771

 

 

$

83,218

 

 

$

383,471

 

 

$

276,984

 

Cost of goods sold

 

 

13,128

 

 

 

8,280

 

 

 

44,506

 

 

 

24,757

 

Gross profit

 

 

94,643

 

 

 

74,938

 

 

 

338,965

 

 

 

252,227

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

20,412

 

 

 

18,726

 

 

 

74,221

 

 

 

51,018

 

Selling, general and administrative

 

 

80,122

 

 

 

54,466

 

 

 

292,843

 

 

 

190,365

 

Total operating expenses

 

 

100,534

 

 

 

73,192

 

 

 

367,064

 

 

 

241,383

 

(Loss) income from operations

 

 

(5,891

)

 

 

1,746

 

 

 

(28,099

)

 

 

10,844

 

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

970

 

 

 

24

 

 

 

1,852

 

 

 

154

 

Interest expense

 

 

(74

)

 

 

(75

)

 

 

(294

)

 

 

(295

)

Change in fair value of warrant liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense)

 

 

187

 

 

 

(14

)

 

 

356

 

 

 

(18

)

Total other income (expense)

 

 

1,083

 

 

 

(65

)

 

 

1,914

 

 

 

(159

)

(Loss) income before income taxes

 

 

(4,808

)

 

 

1,681

 

 

 

(26,185

)

 

 

10,685

 

Provision for income taxes

 

 

990

 

 

 

574

 

 

 

3,082

 

 

 

845

 

Net (loss) income

 

$

(5,798

)

 

$

1,107

 

 

$

(29,267

)

 

$

9,840

 

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

222

 

 

 

(110

)

 

 

(592

)

 

 

(379

)

Unrealized gain (loss) on available-for-sale debt securities

 

 

1,572

 

 

 

(46

)

 

 

1,843

 

 

 

(27

)

Total other comprehensive income (loss)

 

 

1,794

 

 

 

(156

)

 

 

1,251

 

 

 

(406

)

Comprehensive (loss) income

 

$

(4,004

)

 

$

951

 

 

$

(28,016

)

 

$

9,434

 

Net (loss) income per share

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.11

)

 

$

0.02

 

 

$

(0.55

)

 

$

0.20

 

Diluted

 

$

(0.11

)

 

$

0.02

 

 

$

(0.55

)

 

$

0.18

 

Weighted average common shares used to compute net (loss) income per share

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

53,610,347

 

 

 

50,229,356

 

 

 

52,837,674

 

 

 

49,815,914

 

Diluted

 

 

53,610,347

 

 

 

55,627,807

 

 

 

52,837,674

 

 

 

55,594,159

 

 

 

 


 

Inari Medical, Inc.

Consolidated Balance Sheets

(in thousands, except share data)

 

 

 

December 31,
2022

 

 

December 31,
2021

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

60,222

 

 

$

92,752

 

Short-term investments in debt securities

 

 

266,179

 

 

 

83,348

 

Accounts receivable, net

 

 

58,611

 

 

 

42,351

 

Inventories, net

 

 

32,581

 

 

 

21,053

 

Prepaid expenses and other current assets

 

 

5,312

 

 

 

5,694

 

Total current assets

 

 

422,905

 

 

 

245,198

 

Property and equipment, net

 

 

21,655

 

 

 

16,471

 

Operating lease right-of-use assets

 

 

50,703

 

 

 

44,909

 

Deposits and other assets

 

 

8,889

 

 

 

981

 

Long-term investments in debt securities

 

 

 

 

 

3,983

 

Total assets

 

$

504,152

 

 

$

311,542

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

7,659

 

 

$

6,541

 

Payroll-related accruals

 

 

38,955

 

 

 

24,433

 

Accrued expenses and other current liabilities

 

 

8,249

 

 

 

10,737

 

Operating lease liabilities, current portion

 

 

1,311

 

 

 

802

 

Total current liabilities

 

 

56,174

 

 

 

42,513

 

Operating lease liabilities, noncurrent portion

 

 

30,976

 

 

 

28,404

 

Other long-term liability

 

 

 

 

 

1,416

 

Total liabilities

 

 

87,150

 

 

 

72,333

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders' equity

 

 

 

 

 

 

Preferred stock, $0.001 par value, 10,000,000 shares authorized, no shares issued and outstanding as of December 31, 2022 and 2021

 

 

 

 

 

 

Common stock, $0.001 par value, 300,000,000 shares authorized as of December 31, 2022 and 2021; 54,021,656 and 50,313,452 shares issued and outstanding as of December 31, 2022 and 2021, respectively

 

 

54

 

 

 

50

 

Additional paid in capital

 

 

462,949

 

 

 

257,144

 

Accumulated other comprehensive income (loss)

 

 

849

 

 

 

(402

)

Accumulated deficit

 

 

(46,850

)

 

 

(17,583

)

Total stockholders' equity

 

 

417,002

 

 

 

239,209

 

Total liabilities and stockholders' equity

 

$

504,152

 

 

$

311,542