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 third quarter ended September 30, 2024.

Third Quarter Financial and Recent Business Highlights

  • Generated revenue of $153 million in Q3 of 2024, up 21% over the same quarter of last year.
  • GAAP operating loss was $13.6 million in Q3 of 2024, compared to a $2.1 million operating income in the same quarter of last year.
  • Non-GAAP operating loss was $0.4 million in Q3 of 2024, compared to a $4.8 million non-GAAP operating income in the same quarter of last year.
  • Cash, cash equivalents and short-term investments were $112 million as of Q3 of 2024.
  • Received acceptance for the PEERLESS study to be presented as a late-breaking clinical trial at the 2024 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium on October 29th.

“We continue to drive strong performance across the entire Inari portfolio as we advance our leading position in large, underserved vascular markets,” said Drew Hykes, CEO of Inari Medical. “Our products are performing well, and looking ahead, we have several important catalysts on the horizon. On that note, we look forward to the presentation of our PEERLESS data at the Transcatheter Cardiovascular Therapeutics (TCT) Symposium tomorrow, our upcoming full market release of Artix following FDA clearance earlier this month, and our plans to offer Inari solutions in Japan and China. We’ve never been more committed to our mission of addressing unmet patient needs with purpose-built solutions.”

Third Quarter 2024 Financial ResultsRevenue was $153.4 million for the third quarter of 2024, up 21.4% compared to $126.4 million for the third quarter of 2023. The increase over the prior year quarter was driven primarily by an expansion in our sales territories, opening of new accounts, increase in adoption of our procedures, global commercial expansion, and introduction of new products.

Gross profit was $133.5 million for the third quarter of 2024, compared to $111.9 million for the third quarter of 2023. Gross margin was 87.1% for the third quarter of 2024, compared to 88.5% for the third quarter of 2023. The year-over-year change was primarily due to product mix, the ramp up costs associated with new products, and increasing internationalization of the business.

Operating expenses for the third quarter of 2024 were $147.1 million, compared to $109.8 million for the third quarter of 2023. The increase was mainly driven by personnel-related expenses, including commissions and share-based compensation associated with increased headcount to fund the expansion of the commercial, research and development, clinical, and support organizations; change in fair value of the contingent consideration liability; capitalized software impairment and related costs; professional fees including legal expenses; amortization expense related to an intangible asset acquired in the LimFlow acquisition, and travel related costs.

GAAP operating loss was $13.6 million in the third quarter of 2024, compared to a $2.1 million GAAP operating income for the third quarter of 2023. Sequentially, GAAP operating loss improved by $8.8 million.

Non-GAAP operating loss was $0.4 million in the third quarter of 2024. Non-GAAP operating income was $4.8 million in the third quarter of 2023. Sequentially, non-GAAP operating loss improved by $12.8 million. The following items were excluded from the non-GAAP operating loss in the third quarter of 2024: change in fair value of contingent consideration liability of $6.6 million, capitalized software impairment and related costs of $3.8 million, acquired intangible asset amortization of $2.5 million, and acquisition-related expenses of $0.3 million. The following items were excluded from the non-GAAP operating income in the third quarter of 2023: acquisition-related expenses of $2.7 million.

Net loss was $18.4 million for the third quarter of 2024 and net loss per share was $0.31 on a weighted-average basic and diluted share count of 58.4 million, compared to net income of $3.2 million and net income per share of $0.06 on a weighted-average basic share count of 57.4 million and $0.05 on a weighted-average diluted share count of 58.6 million, respectively, in the same period of the prior year.

Full Year 2024 Revenue Guidance and Operating Income Outlook

  • Inari raises full year 2024 revenue guidance to $601.5 million to $604.5 million, an increase of $3.5 million at the midpoint from our prior guidance range of $594.5 million to $604.5 million, reflecting growth of approximately 21.9% to 22.5% over 2023.
  • The company continues to expect to reach sustained operating profitability in the first half of 2025.

Webcast and Conference Call InformationInari Medical will host a conference call to discuss the third quarter 2024 financial results after market close on October 28, 2024 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. The live webinar and presentation may be accessed by visiting the Events Section of the Inari investor relations website at ir.inarimedical.com.

Use of Non-GAAP Financial MeasuresThis press release contains references to non-GAAP operating income (loss), which is considered a non-GAAP financial measure. This means that non-GAAP operating income (loss) is determined by methods other than in accordance with accounting principles generally accepted in the United States (GAAP). As used by Inari, non-GAAP operating income (loss) excludes from GAAP operating income (loss) the following items: amortization of acquired intangible assets, acquisition-related costs, fair value adjustment to our contingent consideration liability and capitalized software impairment and related costs. We present the non-GAAP operating income (loss) to exclude these charges because we believe these charges are significantly impacted by the timing and valuation of acquisitions, such as our LimFlow acquisition completed in the fourth quarter of 2023, as well as other non-recurring factors such as wind down of certain projects. Our management believes the presentation of non-GAAP operating income (loss) is useful because it provides meaningful comparisons to prior periods and provides visibility to our underlying operating performance and an additional means to evaluate the cost and expense trends excluding the impact of these acquisition-related items and other non-recurring transactions, which are not related to our core business operations.

Our definition of non-GAAP operating income (loss) may differ from similarly titled measures used by others. Non-GAAP operating income (loss) should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP. We encourage investors to review the reconciliation of non-GAAP operating income (loss) to GAAP operating income (loss), which has been provided in the financial statement tables included in this press release.

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 underserved health needs. In addition to our purpose-built solutions, 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 four other targeted disease states. We are just getting started. Learn more at www.inarimedical.com and connect with us on LinkedIn, X (Twitter), and Instagram.

Forward Looking StatementsStatements 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 expectations regarding Inari’s core business, plans for its current and future products, anticipated product launches, its ability to integrate and related expectations for the LimFlow acquisition, expectations regarding future growth, Inari's ability to meet customers' needs, and timing for achieving sustained operating profitability, and are based on Inari’s current expectations, forecasts, and assumptions. Forward-looking statements 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, 2023, and in Inari’s 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:Marissa BychGilmartin Group LLCIR@inarimedical.com

INARI MEDICAL, INC.Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)(in thousands, except share and per share data)(unaudited)
 
  Three Months Ended September 30,   Nine Months Ended September 30,
    2024       2023       2024       2023  
Revenue $ 153,390     $ 126,366     $ 442,404     $ 361,538  
Cost of goods sold   19,846       14,477       58,732       42,062  
Gross profit   133,544       111,889       383,672       319,476  
Operating expenses              
Research and development   29,431       21,492       81,216       64,641  
Selling, general and administrative   108,271       85,603       325,479       256,889  
Change in fair value of contingent consideration   6,578             18,609        
Amortization of intangible asset   2,504             7,414        
Acquisition-related expenses   328       2,681       4,143       2,681  
Total operating expenses   147,112       109,776       436,861       324,211  
(Loss) income from operations   (13,568 )     2,113       (53,189 )     (4,735 )
Other income (expense)              
Interest income   1,104       4,202       3,371       12,899  
Interest expense   (78 )     (43 )     (233 )     (127 )
Other expense   (130 )     (682 )     (130 )     (617 )
Total other income   896       3,477       3,008       12,155  
(Loss) income before income taxes   (12,672 )     5,590       (50,181 )     7,420  
Provision for income taxes   5,695       2,428       23,736       4,391  
Net (loss) income $ (18,367 )   $ 3,162     $ (73,917 )   $ 3,029  
Other comprehensive income (loss)              
Foreign currency translation adjustments   13,918       (68 )     4,200       (138 )
Unrealized gain (loss) on available-for-sale debt securities   64       91       60       (1,869 )
Total other comprehensive income (loss)   13,982       23       4,260       (2,007 )
Comprehensive income (loss) $ (4,385 )   $ 3,185     $ (69,657 )   $ 1,022  
Net (loss) income per share              
Basic $ (0.31 )   $ 0.06     $ (1.27 )   $ 0.05  
Diluted $ (0.31 )   $ 0.05     $ (1.27 )   $ 0.05  
Weighted average common shares used to compute net (loss) income per share              
Basic   58,366,364       57,384,884       58,149,296       56,478,317  
Diluted   58,366,364       58,588,452       58,149,296       58,495,921  

INARI MEDICAL, INC.Condensed Consolidated Balance Sheets(in thousands, except share data and par value)(unaudited)
 
  September 30,2024   December 31,2023
Assets      
Current assets      
Cash and cash equivalents $ 41,141     $ 38,597  
Restricted cash   67       611  
Short-term investments in debt securities   70,397       76,855  
Accounts receivable, net   84,403       70,119  
Inventories, net   55,210       42,900  
Prepaid expenses and other current assets   12,168       6,481  
Total current assets   263,386       235,563  
Property and equipment, net   24,098       20,929  
Operating lease right-of-use assets   48,301       48,407  
Goodwill   213,345       214,335  
Intangible assets   143,808       150,884  
Deposits and other assets   4,301       4,117  
Total assets $ 697,239     $ 674,235  
Liabilities and Stockholders' Equity      
Current liabilities      
Accounts payable $ 15,523     $ 10,577  
Payroll-related accruals   54,797       48,706  
Accrued expenses and other current liabilities   76,881       15,364  
Operating lease liabilities, current portion   1,579       1,692  
Total current liabilities   148,780       76,339  
Operating lease liabilities, noncurrent portion   31,145       30,355  
Deferred tax liability   36,748       36,231  
Other long-term liability   45,805       66,400  
Total liabilities $ 262,478     $ 209,325  
Commitments and contingencies (Note 9)      
Stockholders' equity      
Preferred stock, $0.001 par value, 10,000,000 shares authorized, no shares issued and outstanding as of September 30, 2024 and December 31, 2023          
Common stock, $0.001 par value, 300,000,000 shares authorized as of September 30, 2024, and December 31, 2023; 58,435,576 and 57,762,414 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively   58       58  
Additional paid in capital   543,961       504,453  
Accumulated other comprehensive income   13,145       8,885  
Accumulated deficit   (122,403 )     (48,486 )
Total stockholders' equity   434,761       464,910  
Total liabilities and stockholders' equity $ 697,239     $ 674,235  

INARI MEDICAL, INC.Reconciliation of GAAP Operating Income (Loss) to Non-GAAP Operating Income (Loss)(in thousands)(Unaudited)
 
Reconciliation of GAAP Operating (Loss) Income to Non-GAAP Operating (Loss) Income:
 
  Three Months Ended September 30,   Nine Months Ended September 30,
    2024       2023       2024       2023  
GAAP Operating (loss) income $ (13,568 )   $ 2,113     $ (53,189 )   $ (4,735 )
Non-GAAP Adjustments:              
Change in fair value of contingent consideration   6,578             18,609        
Amortization of acquired intangible asset   2,504             7,412        
Acquisition-related expenses(a)   328       2,681       4,142       2,681  
Capitalized software impairment and related costs(b)   3,789             3,789        
Non-GAAP Operating (loss) income $ (369 )   $ 4,794     $ (19,237 )   $ (2,054 )

________________(a) The acquisition-related expenses primarily include integration, severance and retention related expenses.(b) The capitalized software impairment and related costs primarily include the write-off of capitalized software and related wind down costs, which were recorded within the research and development expense within the condensed consolidated statements of operations.

Revenue Disaggregation

The following tables present the amount of revenue in VTE and Emerging Therapies recognized for the periods presented (in thousands, unaudited):

  Three Months Ended September 30,    
    2024       2023     % Growth
VTE $ 145,346     $ 121,460       19.7 %
Emerging Therapies   8,044       4,906       64.0 %
Total Revenue $ 153,390     $ 126,366       21.4 %
  Nine Months Ended September 30,    
    2024       2023     % Growth
VTE $ 420,213     $ 349,604       20.2 %
Emerging Therapies   22,191       11,934       85.9 %
Total Revenue $ 442,404     $ 361,538       22.4 %
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