8-K
false000153104800015310482022-02-232022-02-23

 

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 23, 2022

 

 

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 23, 2022, Inari Medical, Inc. (the “Company”) issued a press release announcing financial results for its fourth quarter and year ended December 31, 2021. 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 23, 2022

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 23, 2022

By:

/s/ William Hoffman

 

 

 

William Hoffman
President and Chief Executive Officer

 


EX-99.1

 

Exhibit 99.1

https://cdn.kscope.io/be2d74ea140b09b02c47b45d950c118c-img169044987_0.jpg 

 

Inari Medical Reports Fourth Quarter and Full Year 2021 Financial Results

 

IRVINE, CALIFORNIA – February 23, 2022 (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, 2021.

 

Fourth Quarter Revenue and Business Highlights:

Treated 7,700 patients, an increase of 15% over the third quarter. Over 90% of overall procedures and sequential procedural growth came from non-COVID patients.
Generated revenue of $83.2 million in the fourth quarter of 2021, up 14% sequentially and 71% over the same quarter last year, and finished full year 2021 with revenue of $277 million, a 98% increase over full year 2020.
Enrolled the first patient into our PEERLESS randomized controlled trial in PE, enrolled the 800th and final patient into the U.S. arm of the FLASH PE registry and enrolled the 500th and final patient into the CLOUT DVT registry.
Ended 2021 with over 200 U.S. sales territories.
Ended the quarter with $180.1 million in cash, cash equivalents and investments.

 

“Our fourth quarter was again successful and productive. We treated 1,000 more patients than in the third quarter and made significant progress on all of our growth drivers,” said Bill Hoffman CEO of Inari Medical. “We are especially pleased with the milestones we achieved on several clinical studies. Most notably, we enrolled our first patient into our PEERLESS randomized controlled trial. In addition, we completed enrollment in both the CLOUT registry and the U.S. arm of our FLASH registry, the largest prospective thrombectomy trials ever conducted in DVT and PE. We love every second of this work and we remain thankful for the opportunity to serve our patients and our mission."

 

Fourth Quarter 2021 Financial Results

Revenue was $83.2 million for the fourth quarter of 2021, compared to $72.9 million for the prior quarter and $48.6 million for the fourth quarter of 2020. The increase over prior quarter was driven by continued U.S. commercial expansion and new product introductions.

Gross profit was $74.9 million for the fourth quarter of 2021, compared to $44.9 million for the same period of 2020. Gross margin was 90.1% for the fourth quarter of 2021, compared to 92.4% for the same period in the prior year, modestly lower primarily due to the move to our larger production facility in the fourth quarter of 2021.

 

 


 

Operating expenses for the fourth quarter of 2021 were $73.2 million, compared to $37.9 million for the fourth quarter of 2020. The increase was mainly driven by an increase in personnel-related expenses as we increased headcount to fund the expansion of the commercial, research and development, and clinical and support organizations.

Net income was $1.1 million for the fourth quarter of 2021 and net income per share was $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, compared to a net income of $7.0 million and a net income per share of $0.14 and $0.13 on a weighted-average basic share count of 48.7 million and diluted share count of 55.2 million, respectively, in the same period of the prior year.

 

Full Year 2021 Financial Results

Revenue was $277.0 million for the year ended December 31, 2021, compared to $139.7 million in the prior year. The increase over prior year was driven by our continued U.S. commercial expansion and new product introductions.

Gross profit was $252.2 million for the full year of 2021, compared to $126.6 million for the same period of 2020. Gross margin increased slightly to 91.1% for the full year of 2021, compared to 90.6% for the prior year.

Operating expenses for the full year of 2021 were $241.4 million, compared to $108.1 million for the full year 2020.

Net income was $9.8 million for the full year of 2021 and net income per share was $0.20 and 0.18 on a weighted-average basic share count of 49.8 million and 55.6 million, respectively, compared to a net income of $13.8 million and net income per share of $0.43 and $0.27 on a weighted-average basic share count of 32.0 million and diluted share count of 51.6 million, respectively, in the prior year.

 

Full-Year 2022 Revenue Guidance

Inari Medical is providing financial guidance as follows:

For the full year 2022, revenue of $350 million to $360 million, reflecting growth of approximately 26% to 30% over 2021.

 

Webcast and Conference Call Information

Inari Medical will host a conference call to discuss the fourth quarter and full year 2021 financial results after market close on Wednesday, February 23, 2022 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (833) 519-1265 for U.S. callers or (914) 800-3838 for international callers, using conference ID: 3126888. The live webinar can be accessed at https://ir.inarimedical.com.

 

 

 


 

About Inari Medical, Inc.

Inari Medical, Inc. is a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases. Our current product offering consists of two minimally invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purpose-built its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE: deep vein thrombosis and pulmonary embolism. The ClotTriever system is 510(k)-cleared by FDA and CE marked for the non-surgical removal of clot from peripheral blood vessels, including for the use in the treatment of deep vein thrombosis. The FlowTriever system is 510(k)-cleared by FDA and CE marked for the non-surgical removal of clot from peripheral blood vessels, including for the use in the treatment of pulmonary embolism and clot in transit in the right atrium.

 

Forward Looking Statements

Statements in this press release may contain “forward-looking statements” 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 2022 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, 2021, 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)

(unaudited)

 

 

 

Three Months Ended December 31,

 

 

Years Ended December 31,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue

 

$

83,218

 

 

$

48,610

 

 

$

276,984

 

 

$

139,670

 

Cost of goods sold

 

 

8,280

 

 

 

3,685

 

 

 

24,757

 

 

 

13,106

 

Gross profit

 

 

74,938

 

 

 

44,925

 

 

 

252,227

 

 

 

126,564

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

18,726

 

 

 

6,536

 

 

 

51,018

 

 

 

18,399

 

Selling, general and administrative

 

 

54,466

 

 

 

31,393

 

 

 

190,365

 

 

 

89,746

 

Total operating expenses

 

 

73,192

 

 

 

37,929

 

 

 

241,383

 

 

 

108,145

 

Income from operations

 

 

1,746

 

 

 

6,996

 

 

 

10,844

 

 

 

18,419

 

Other income (expense)

 

 

 

 

0

 

 

 

 

 

 

 

Interest income

 

 

24

 

 

 

75

 

 

 

154

 

 

 

484

 

Interest expense

 

 

(75

)

 

 

(75

)

 

 

(295

)

 

 

(1,135

)

Change in fair value of warrant liabilities

 

 

 

 

 

 

 

 

 

 

 

(3,317

)

Other expense, net

 

 

(14

)

 

 

(11

)

 

 

(18

)

 

 

(662

)

Total other expenses

 

 

(65

)

 

 

(11

)

 

 

(159

)

 

 

(4,630

)

Income before income taxes

 

 

1,681

 

 

 

6,985

 

 

 

10,685

 

 

 

13,789

 

Provision for income taxes

 

 

574

 

 

 

 

 

 

845

 

 

 

 

Net income

 

$

1,107

 

 

$

6,985

 

 

$

9,840

 

 

$

13,789

 

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(110

)

 

 

 

 

 

(379

)

 

 

 

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

 

 

(46

)

 

 

4

 

 

 

(27

)

 

 

4

 

Total other comprehensive income (loss)

 

 

(156

)

 

 

4

 

 

 

(406

)

 

 

4

 

Comprehensive income

 

$

951

 

 

$

6,989

 

 

$

9,434

 

 

$

13,793

 

Net income per share

 

 

 

 

$

-

 

 

 

 

 

 

 

Basic

 

$

0.02

 

 

$

0.14

 

 

$

0.20

 

 

$

0.43

 

Diluted

 

$

0.02

 

 

$

0.13

 

 

$

0.18

 

 

$

0.27

 

Weighted average common shares used to
     compute net income per share

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

50,229,356

 

 

 

48,742,302

 

 

 

49,815,914

 

 

 

32,033,827

 

Diluted

 

 

55,627,807

 

 

 

55,221,012

 

 

 

55,594,159

 

 

 

51,554,996

 

 

 

 


 

INARI MEDICAL, INC.

Consolidated Balance Sheets

(in thousands, except share data and par value)

(unaudited)

 

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

92,752

 

 

$

114,229

 

Short-term investments

 

 

83,348

 

 

 

49,981

 

Accounts receivable, net

 

 

42,351

 

 

 

28,008

 

Inventories, net

 

 

21,053

 

 

 

10,597

 

Prepaid expenses and other current assets

 

 

5,694

 

 

 

2,808

 

Restricted cash

 

 

 

 

 

50

 

Total current assets

 

 

245,198

 

 

 

205,673

 

Property and equipment, net

 

 

16,471

 

 

 

7,498

 

Operating lease right-of-use assets

 

 

44,909

 

 

 

 

Long-term investments

 

 

3,983

 

 

 

 

Deposits and other assets

 

 

981

 

 

 

583

 

Restricted cash

 

 

 

 

 

338

 

Total assets

 

$

311,542

 

 

$

214,092

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

 

6,541

 

 

 

3,047

 

Payroll-related accruals

 

 

24,433

 

 

 

8,198

 

Accrued expenses and other current liabilities

 

 

10,737

 

 

 

2,593

 

Operating lease liabilities, current portion

 

 

802

 

 

 

 

Total current liabilities

 

 

42,513

 

 

 

13,838

 

Operating lease liabilities, noncurrent portion

 

 

28,404

 

 

 

 

Other long-term liability

 

 

1,416

 

 

 

 

Total liabilities

 

 

72,333

 

 

 

13,838

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders' equity

 

 

 

 

 

 

Preferred stock, $0.001 par value, 10,000,000 shares authorized, no shares
   issued and outstanding as of December 31, 2021 and December 31, 2020

 

 

 

 

 

 

Common stock, $0.001 par value, 300,000,000 shares authorized
   as of December 31, 2021 and December 31, 2020;
   50,313,452 and 49,251,614 shares issued and outstanding
   as of December 31, 2021 and December 31, 2020, respectively

 

 

50

 

 

 

49

 

Additional paid in capital

 

 

257,144

 

 

 

227,624

 

Accumulated other comprehensive (loss) income

 

 

(402

)

 

 

4

 

Accumulated deficit

 

 

(17,583

)

 

 

(27,423

)

Total stockholders' equity

 

 

239,209

 

 

 

200,254

 

Total liabilities and stockholders' equity

 

$

311,542

 

 

$

214,092