株探米国株
日本語 英語
エドガーで原本を確認する
0001388658false00013886582022-11-012022-11-01


 
 
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): November 1, 2022
iRhythm Technologies, Inc.
(Exact name of Registrant as specified in its charter) 
Delaware 001-37918 20-8149544
(State or other jurisdiction of
incorporation or organization)
(Commission
File Number)
(I.R.S. Employer
Identification Number)
699 8th Street, Suite 600
San Francisco, California 94103
(Address of principal executive office) (Zip Code)
(415) 632-5700
(Registrant’s telephone number, including area code)
N/A
(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 Name of each exchange on which registered
Common Stock, Par Value $0.001 Per Share IRTC The 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 November 1, 2022, iRhythm Technologies, Inc. issued a press release regarding its financial results for the third quarter ended September 30, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
This information is intended to be furnished under Item 2.02 of Form 8-K and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
 
Exhibit No.   Description
99.1  
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)




SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
IRHYTHM TECHNOLOGIES, INC.
Date: November 1, 2022
By: /s/ Quentin S. Blackford
Quentin S. Blackford
Chief Executive Officer


EX-99.1 2 irtcq32022ex991pressrelease.htm EX-99.1 Document
Exhibit 99.1




iRhythm Technologies Announces Third Quarter 2022 Financial Results

SAN FRANCISCO, November 1, 2022 - iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care company focused on creating trusted solutions that detect, prevent, and predict disease, today reported financial results for the three months ended September 30, 2022.

Third Quarter 2022 Financial Results
•Revenue of $103.9 million, a 21.6% increase compared to third quarter 2021
•Gross margin of 68.3%, a 2.6 percentage point improvement compared to third quarter 2021
•Cash, cash equivalents and short-term investments of $203.5 million as of September 30, 2022
•Updating fiscal year 2022 revenue guidance to a range of approximately $407 million to $411 million
•Improving profitability profile, including updated fiscal year 2022 adjusted EBITDA guidance of negative $10 to negative $12 million

Recent Operational Highlights
•Third quarter registration growth of 22% year-over-year
•Presentations at the European Society of Cardiology (ESC) in August highlighted Zio XT increased arrhythmia detection rates by 216% and reduced time to detection as compared to traditional Holter monitors1
•Detailed refreshed vision and mission, long-term growth strategies, innovation pipeline and financial goals during analyst and investor day in September
•Upcoming data presentations at the American Heart Association (AHA) in Chicago, IL, from November 5-7, 2022

"Despite the ongoing staffing and capacity challenges, we grew registration volumes by more than 20% in the third quarter, achieving our highest daily registration volumes ever as we exited September," said iRhythm CEO and President, Quentin Blackford. "However, within the quarter, we also realized softness in returned devices - which impacted our ability to perform our services and realize revenue which muted our growth. We view this as persisting into the fourth quarter. These dynamics, as well as fourth quarter trends in account staffing and capacity challenges as well as Zio AT utilization, have led to us reducing our full year revenue guidance."

"While disappointing, we continue to be encouraged by the underlying momentum of the business as demonstrated by the accelerating daily registration growth in the third quarter. As we shared during our Investor and Analyst Day in September, we continue to believe iRhythm's innovative device with differentiated AI capabilities and clinically actionable data insights is the gold standard in the space and sets us apart in the marketplace. We remain confident in the strong fundamentals of our business and are dedicated to bringing our innovative solutions to the millions of patients who may benefit," concluded Mr. Blackford.

Third Quarter Financial Results
Revenue for the three months ended September 30, 2022 increased 21.6% to $103.9 million, from $85.4 million during the same period in 2021. The increase was primarily driven by Zio XT and AT volume growth as well as an increase in net average selling price.

Gross profit for the third quarter of 2022 was $70.9 million, up 26.4% from $56.1 million during the same period in 2021, while gross margins were 68.3%, up from 65.7% during the same period in 2021. The increase in gross profit was primarily due to increased volume and average selling price, partially offset by increases in cost per unit.

Adjusted operating expenses for the third quarter of 2022 were $89.7 million, compared to $79.4 million during the same period in 2021. This increase in adjusted operating expenses resulted primarily from increased resources to scale and higher bad debt expense as a result of incremental volumes. Operating expenses for the third quarter of 2022 were $92.0 million, compared to $79.4 million for the same period in 2021.

Adjusted net loss for the third quarter of 2022 was $19.1 million, or a loss of $0.63 per share, compared with an adjusted net loss of $23.7 million, or a loss of $0.81 per share, for the same period in 2021. Net loss for the third quarter of 2022 was $21.5 million, or a loss of $0.71 per share, compared with net loss of $23.7 million, or a loss of $0.81 per share, for the same period in 2021.

Cash, cash equivalents and short-term investments were $203.5 million as of September 30, 2022.





Exhibit 99.1




Updated 2022 Annual Guidance
Given volume trends in the third quarter and anticipated volume contributions in the fourth quarter, iRhythm is updating its fiscal year 2022 revenue guidance to range from approximately $407 to $411 million, which represents approximately 26% to 27% growth over the prior year results. This compares to prior fiscal year 2022 revenue guidance of $415 to $420 million.

Gross margin for the fiscal year 2022 is expected to range from approximately 68% to 69% and adjusted operating expenses are expected to range between approximately $360 and $365 million. Adjusted EBITDA for the full year 2022 is expected to range from negative $10 to negative $12 million. This compares to prior fiscal year 2022 adjusted operating expense guidance of $375 and $385 million and prior fiscal year 2022 adjusted EBITDA guidance of negative $12.5 to negative $17.5 million.

Webcast and Conference Call Information
iRhythm’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.

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, impairment and restructuring charges, and 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
•transformation costs to scale the organization.

Forward-Looking Statements
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These statements include statements regarding financial guidance, market opportunity, the potential impact of Medicare reimbursement rates for the CPT codes primarily relied upon for the Company’s Zio XT services, 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 filing made with the Securities and Exchange Commission, including those on the Form 10-Q expected to be filed on or about November 3, 2022. 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 Contact: Media Contact:
Stephanie Zhadkevich Morgan Mathis
(919) 452-5430 (310) 528-6306
investors@irhythmtech.com irhythm@highwirepr.com

1.Ameenathul M. Fawzy MB, Jade Edmonds, Anthony Shannon, David J. Wright MD. A Service Evaluation of Zio XT: The Liverpool Experience. In: ESC Congress 2022, August 26 - 29, 2022 Barcelona, Spain.


Exhibit 99.1




IRHYTHM TECHNOLOGIES, INC.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
September 30, December 31,
2022 2021
Assets
Current assets:
Cash and cash equivalents $ 71,222  $ 127,562 
Short-term investments 132,316  111,569 
Accounts receivable, net 60,534  46,430 
Inventory 14,452  10,268 
Prepaid expenses and other current assets 7,326  9,693 
Total current assets 285,850  305,522 
Property and equipment, net 71,515  55,944 
Operating lease right-of-use assets 62,010  84,587 
Goodwill 862  862 
Other assets 20,153  16,052 
Total assets $ 440,390  $ 462,967 
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $ 7,404  $ 10,509 
Accrued liabilities 60,264  51,486 
Deferred revenue 3,003  3,049 
Debt, current portion —  11,667 
Operating lease liabilities, current portion 12,920  11,142 
Total current liabilities 83,591  87,853 
Debt, noncurrent portion 34,931  9,690 
Other noncurrent liabilities 1,163  697 
Operating lease liabilities, noncurrent portion 81,481  85,212 
Total liabilities 201,166  183,452 
Stockholders’ equity:
Preferred Stock —  — 
Common stock 28  27 
Additional paid-in capital 741,879  685,594 
Accumulated other comprehensive loss (681) (61)
Accumulated deficit (502,002) (406,045)
Total stockholders’ equity 239,224  279,515 
Total liabilities and stockholders’ equity $ 440,390  $ 462,967 



Exhibit 99.1




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

Three Months Ended
September 30,
Nine Months Ended
September 30,
2022 2021 2022 2021
Revenue, net $ 103,875  $ 85,432  $ 298,304  $ 241,021 
Cost of revenue 32,954  29,284  95,379  78,737 
Gross profit 70,921  56,148  202,925  162,284 
Operating expenses:
Research and development 11,448  8,685  33,935  26,801 
Selling, general and administrative 80,559  70,745  235,468  203,227 
Impairment and restructuring charges —  —  26,608  — 
Total operating expenses 92,007  79,430  296,011  230,028 
Loss from operations (21,086) (23,282) (93,086) (67,744)
Interest expense (614) (279) (3,125) (921)
Other income (expense), net 365  (76) 450  103 
Loss before income taxes (21,335) (23,637) (95,761) (68,562)
Income tax provision 116  94  196  308 
Net loss $ (21,451) $ (23,731) $ (95,957) $ (68,870)
Net loss per common share, basic and diluted $ (0.71) $ (0.81) $ (3.22) $ (2.35)
Weighted-average shares, basic and diluted 30,055,166  29,397,845  29,836,601  29,294,559 



Exhibit 99.1




IRHYTHM TECHNOLOGIES, INC.
Reconciliation of GAAP to Non-GAAP Financial Information
(unaudited)
(in thousands, except per share data)
Three Months Ended
September 30,
Nine Months Ended
September 30,
Adjusted EBITDA reconciliation 2022 2021 2022 2021
Net loss $ (21,451) $ (23,731) $ (95,957) $ (68,870)
Income tax provision 116  94  196  308 
Depreciation and amortization 3,436  2,549  9,930  6,738 
Interest expense, net 15  223  2,198  717 
Stock-based compensation 12,945  12,160  41,946  42,651 
Impairment and restructuring charges —  —  26,608  — 
Transformation costs 2,315  —  2,748  — 
Adjusted EBITDA $ (2,624) $ (8,705) $ (12,331) $ (18,456)

Three Months Ended
September 30,
Nine Months Ended
September 30,
  2022 2021 2022 2021
Adjusted net loss reconciliation
Net loss, as reported $ (21,451) $ (23,731) $ (95,957) $ (68,870)
Impairment and restructuring charges —  —  26,608  — 
Transformation costs 2,315  —  2,748  — 
Adjusted net loss $ (19,136) $ (23,731) $ (66,601) $ (68,870)
Adjusted net loss per share reconciliation
Net loss per share, as reported $ (0.71) $ (0.81) $ (3.22) $ (2.35)
Impairment and restructuring charges per share —  —  0.89  — 
Transformation costs per share 0.08  —  0.09  — 
Adjusted net loss per share $ (0.63) $ (0.81) $ (2.24) $ (2.35)
Adjusted operating expense reconciliation
Operating expense, as reported $ 92,007  $ 79,430  $ 296,011  $ 230,028 
Impairment and restructuring charges —  —  (26,608) — 
Transformation costs (2,315) —  (2,748) — 
Adjusted operating expense $ 89,692  $ 79,430  $ 266,655  $ 230,028