iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today reported financial results for the three and six months ended June 30, 2023.

Second Quarter 2023 Financial Results

  • Revenue of $124.1 million, a 21.6% increase compared to second quarter 2022
  • Gross margin of 69.5%, a 70-basis point improvement compared to second quarter 2022
  • Cash, cash equivalents and marketable securities of $164.7 million as of June 30, 2023
  • Updated fiscal year 2023 revenue guidance in a range of approximately $485 million to $490 million

Recent Operational Highlights

  • Second-highest quarter ever of Zio XT new account openings and continued volume growth across both Zio XT and Zio AT with balanced growth across multiple channels
  • Zio granted high medical needs designation by Japanese Ministry of Health, Labour, and Welfare ("MHLW") and the Company submitted a Shonin pre-market application to the Pharmaceuticals and Medical Devices Agency ("PMDA") for regulatory review
  • Upcoming data presentations at the European Society of Cardiology ("ESC") Congress in Amsterdam, the Netherlands, from August 25-28, 2023

"We delivered another strong performance during the second quarter as we realized continued balanced growth across both Zio XT and Zio AT and across multiple channels, building on the solid momentum we achieved earlier this year," said Quentin Blackford, iRhythm’s President and CEO. "Revenue growth of 21.6% year-over-year was driven by increasing demand for Zio services as we continue to redefine the standard of cardiac care and demonstrate our unique value proposition to customers, patients, and payers. This past quarter was the first in which our commercial teams were able to speak to the CAMELOT study of real-world evidence for Zio XT as we continued to increase penetration within our existing accounts and gained traction within the primary care space."

"As we've moved into the third quarter, we have also hit several milestones that we believe are important to building our international presence. In Japan, we are thrilled that the Zio Monitor System has been granted high medical needs designation by the MHLW at the recommendation of the Japanese Heart Rhythm Society (JHRS), and we look forward to continuing our collaboration with the JHRS and the PMDA during their review of our regulatory dossier. In Switzerland, we have initiated our first engagement with one of the country's five university hospitals. With continued momentum in our core U.S. business, progress with market access exploration and operational efforts in certain international markets, an improving financial profile, and the broader Zio Monitor commercial launch in the United States later this year, we are encouraged by the significant opportunities ahead of us that we believe will allow us to capture growth for years to come," concluded Mr. Blackford.

Second Quarter Financial ResultsRevenue for the second quarter of 2023 was $124.1 million, up 21.6% from $102.1 million during the same period in 2022. The increase was driven by growth in volume of Zio services, partially offset by a decline in net average selling price.

Gross profit for the second quarter of 2023 was $86.2 million, up 22.7% from $70.2 million during the same period in 2022, while gross margin was 69.5%, up from 68.8% during the same period in 2022. The increase in gross profit was primarily due to increased volume and a reduction in cost per unit.

Operating expenses for the second quarter of 2023 were $105.1 million, compared to $93.7 million for the same period in 2022. Adjusted operating expenses for the second quarter of 2023 were $99.7 million, compared to $93.5 million during the same period in 2022. This increase in adjusted operating expenses resulted primarily from increased payroll-related costs to support growth in operations.

Net loss for the second quarter of 2023 was $18.5 million, or a diluted loss of $0.61 per share, compared with net loss of $23.9 million, or a diluted loss of $0.80 per share, for the same period in 2022. Adjusted net loss for the second quarter of 2023 was $13.1 million, or a diluted loss of $0.43 per share, compared with an adjusted net loss of $23.7 million, or a diluted loss of $0.79 per share, for the same period in 2022.

Cash, cash equivalents, and marketable securities were $164.7 million as of June 30, 2023.

2023 Annual Guidance iRhythm projects revenue for the full year 2023 to grow approximately 18% to 19% compared to prior year results, ranging from approximately $485 million to $490 million. Gross margin for the full year 2023 is expected to range from 69% to 70% and adjusted operating expenses are expected to range between $417 million and $427 million. Adjusted EBITDA margin for the full year 2023 is expected to range from approximately 0% to 0.5% of revenues.

Webcast and Conference Call InformationiRhythm’s management team will host a conference call today beginning at 1:30 p.m. PT/4:30 p.m. ET. Investors interested in listening to the conference call may do so by accessing the live and archived webcast of the event, which will be available on the investors section of the Company’s website at investors.irhythmtech.com.

About iRhythm Technologies, Inc.iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Use of Non-GAAP Financial Measures We refer to certain financial measures that are not recognized under U.S. generally accepted accounting principles (GAAP) in this press release, including adjusted EBITDA, adjusted net loss, adjusted net loss per share, and adjusted operating expenses. We use these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. See the schedules attached to this press release for additional information and reconciliations of such non-GAAP financial measures to their most directly comparable GAAP measures. We have not reconciled our adjusted operating expenses and adjusted EBITDA estimates for full year 2023 because certain items that impact these figures are uncertain or out of our control and cannot be reasonably predicted. Accordingly, a reconciliation of adjusted operating expenses and adjusted EBITDA estimates is not available without unreasonable effort.

Adjusted EBITDA excludes non-cash operating charges for stock-based compensation, depreciation and amortization as well as non-operating items such as interest income, interest expense, income tax provision, impairment and restructuring charges, and business transformation costs.

We exclude the following items from non-GAAP financial measures for adjusted net loss, adjusted net loss per share and adjusted operating expenses:

  • impairment and restructuring charges, and
  • business transformation costs, which include one-time professional services and severance costs to augment and restructure the organization to use both outsourced and offshore resources.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These statements include statements regarding financial guidance, market opportunity, ability to penetrate the market, anticipated productivity improvements and expectations for growth. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled “Risk Factors” and elsewhere in our filings made with the Securities and Exchange Commission, including those on the Form 10-Q expected to be filed on or about August 3, 2023. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. iRhythm disclaims any obligation to update these forward-looking statements.

Investor Relations ContactStephanie Zhadkevich(919) 452-5430investors@irhythmtech.com

iRhythm Media ContactSaige Smith(262) 289-7065irhythm@highwirepr.com

IRHYTHM TECHNOLOGIES, INC.Condensed Consolidated Balance Sheets(unaudited)(in thousands)

  June 30, 2023   December 31, 2022
       
Assets      
Current assets:      
Cash and cash equivalents $ 61,578     $ 78,832  
Marketable securities   103,161       134,312  
Accounts receivable, net   51,108       49,918  
Inventory   14,478       15,155  
Prepaid expenses and other current assets   11,816       10,555  
Total current assets   242,141       288,772  
Property and equipment, net   89,845       75,670  
Operating lease right-of-use assets   57,917       60,666  
Goodwill   862       862  
Other assets   38,723       22,252  
Total assets $ 429,488     $ 448,222  
Liabilities and Stockholders’ Equity      
Current liabilities:      
Accounts payable $ 7,150     $ 7,517  
Accrued liabilities   64,469       65,497  
Deferred revenue   3,695       3,051  
Operating lease liabilities, current portion   14,099       13,031  
Total current liabilities   89,413       89,096  
Debt, noncurrent portion   34,942       34,935  
Other noncurrent liabilities   1,012       1,307  
Operating lease liabilities, noncurrent portion   80,242       83,072  
Total liabilities   205,609       208,410  
Stockholders’ equity:      
Preferred stock          
Common stock   30       28  
Additional paid-in capital   803,792       762,380  
Accumulated other comprehensive loss   (152 )     (396 )
Accumulated deficit   (579,791 )     (522,200 )
Total stockholders’ equity   223,879       239,812  
Total liabilities and stockholders’ equity $ 429,488     $ 448,222  
       

IRHYTHM TECHNOLOGIES, INC.Condensed Consolidated Statements of Operations(unaudited)(in thousands, except per share data)

    Three Months Ended June 30,   Six Months Ended June 30,
      2023       2022       2023       2022  
Revenue, net   $ 124,130     $ 102,051     $ 235,566     $ 194,429  
Cost of revenue     37,905       31,806       73,660       62,425  
Gross profit     86,225       70,245       161,906       132,004  
Operating expenses:                
Research and development     13,677       11,945       28,519       22,487  
Selling, general and administrative     91,420       81,751       191,763       154,909  
Impairment and restructuring charges                       26,608  
Total operating expenses     105,097       93,696       220,282       204,004  
Loss from operations     (18,872 )     (23,451 )     (58,376 )     (72,000 )
Interest expense     (832 )     (482 )     (1,782 )     (2,511 )
Interest and other income, net     1,435       69       2,867       85  
Loss before income taxes     (18,269 )     (23,864 )     (57,291 )     (74,426 )
Income tax provision     213       33       300       80  
Net loss   $ (18,482 )   $ (23,897 )   $ (57,591 )   $ (74,506 )
Net loss per common share, basic and diluted   $ (0.61 )   $ (0.80 )   $ (1.89 )   $ (2.51 )
Weighted-average shares, basic and diluted     30,502       29,843       30,400       29,720  
                 

IRHYTHM TECHNOLOGIES, INC.Reconciliation of GAAP to Non-GAAP Financial Information(unaudited)(in thousands, except per share data)

    Three Months Ended June 30,   Six Months Ended June 30,
      2023       2022       2023       2022  
Adjusted EBITDA reconciliation                
Net loss   $ (18,482 )   $ (23,897 )   $ (57,591 )   $ (74,506 )
Interest expense     832       482       1,782       2,511  
Interest income     (1,468 )     (196 )     (2,902 )     (328 )
Income tax provision     213       33       300       80  
Depreciation and amortization     3,791       3,351       7,367       6,494  
Stock-based compensation     14,099       15,098       32,350       29,001  
Impairment and restructuring charges                       26,608  
Business transformation costs     5,409       175       11,095       433  
Adjusted EBITDA   $ 4,394     $ (4,954 )   $ (7,599 )   $ (9,707 )
    Three Months Ended June 30,   Six Months Ended June 30,
      2023       2022       2023       2022  
Adjusted net loss reconciliation                
Net loss, as reported   $ (18,482 )   $ (23,897 )   $ (57,591 )   $ (74,506 )
Impairment and restructuring charges                       26,608  
Business transformation costs     5,409       175       11,095       433  
Adjusted net loss   $ (13,073 )   $ (23,722 )   $ (46,496 )   $ (47,465 )
                 
Adjusted net loss per share reconciliation                
Net loss per share, as reported   $ (0.61 )   $ (0.80 )   $ (1.89 )   $ (2.51 )
Impairment and restructuring charges per share                       0.90  
Business transformation costs per share     0.18       0.01       0.36       0.01  
Adjusted net loss per share   $ (0.43 )   $ (0.79 )   $ (1.53 )   $ (1.60 )
Weighted-average shares, basic and diluted     30,502       29,843       30,400       29,720  
                 
Adjusted operating expense reconciliation                
Operating expense, as reported   $ 105,097     $ 93,696     $ 220,282     $ 204,004  
Impairment and restructuring charges                       (26,608 )
Business transformation costs     (5,409 )     (175 )     (11,095 )     (433 )
Adjusted operating expense   $ 99,688     $ 93,521     $ 209,187     $ 176,963  
                 

 

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