Exhibit 99.1 iRhythm Technologies Announces Fourth Quarter and Full Year 2023 Financial Results SAN FRANCISCO, February 22, 2024 (GLOBE NEWSWIRE) -- 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 months and full year ended December 31, 2023. Fourth Quarter 2023 Financial Highlights Full Year 2023 Financial Highlights Recent Operational Highlights " ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________________________________________________________ Form 10-Q _______________________________________________________________________ (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-37918 _______ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________________________________________________________ Form 10-Q _______________________________________________________________________ (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-37918 ____________ ...

iRhythm Technologies, Inc. (NASDAQ:IRTC) Q2 2023 Earnings Conference Call August 3, 2023 4:30 PM ET Company Participants Stephanie Zhadkevich - Director of Investor Relations Quentin Blackford - President and Chief Executive Officer Brice Bobzien - Chief Financial Officer Daniel Wilson - Executive Vice President of Corporate Development and Investor Relations Conference Call Participants Margaret Kaczor - William Blair Lily Lozada - JPMorgan Kallum Titchmarsh - Morgan Stanley Marie Thibault - BTIG LLC Samue ...

iRhythm Technologies Second Quarter 2023 Results This presentation and the accompanying oral presentation include forward-looking statements. All statements other than statements of historical facts, including statements regarding our future results of operations and financial position, clinical results, strategy and plans, market size and opportunity, competitive position, industry environment, potential growth opportunities, business model, reimbursement rates and coverage, and our expectations for future ...

iRhythm Technologies, Inc. (NASDAQ:IRTC) Q1 2023 Earnings Conference Call May 4, 2023 4:30 PM ET Company Participants Stephanie Zhadkevich - Director of Investor Relations Quentin Blackford - President & Chief Executive Officer Brice Bobzien - Chief Financial Officer Dan Wilson - EVP of Corporate Development and Investor Relations Conference Call Participants Allen Gong - JPMorgan Marie Thibault - BTIG Nathan Treybeck - Wells Fargo Cecilia Furlong - Morgan Stanley Richard Newitter - Truist Securities Bill P ...

```markdown PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Q1 2023, showing **revenue growth of 21% to $111.4 million** and a **net loss improvement to $39.1 million** Condensed Consolidated Statements of Operations (Q1 2023 vs Q1 2022) | Financial Metric | Q1 2023 (in thousands) | Q1 2022 (in thousands) | Change (%) | | :--- | :--- | :--- | :--- | | **Revenue, net** | $111,436 | $92,378 | 20.6% | | **Gross Profit** | $75,681 | $61,759 | 22.5% | | **Loss from Operations** | $(39,504) | $(48,549) | -18.6% | | **Net Loss** | $(39,109) | $(50,609) | -22.7% | | **Net Loss per Share** | $(1.29) | $(1.71) | -24.6% | Condensed Consolidated Balance Sheets | Asset/Liability | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $52,804 | $78,832 | | Total current assets | $253,890 | $288,772 | | **Total Assets** | **$421,701** | **$448,222** | | Total current liabilities | $81,903 | $89,096 | | **Total Liabilities** | **$199,867** | **$208,410** | | **Total Stockholders' Equity** | **$221,834** | **$239,812** | Condensed Consolidated Statements of Cash Flows (Q1 2023 vs Q1 2022) | Cash Flow Activity | Q1 2023 (in thousands) | Q1 2022 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(30,753) | $(38,885) | | Net cash provided by (used in) investing activities | $3,820 | $(8,527) | | Net cash provided by financing activities | $905 | $14,636 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section details the company's business, accounting policies, revenue disaggregation, legal proceedings, debt, and stock-based compensation - The company's principal business is the design, development, and commercialization of device-based technology for remote cardiac monitoring services, primarily the **Zio Services**[26](index=26&type=chunk) Revenue by Payor Type (Q1 2023 vs Q1 2022) | Payor Type | Q1 2023 Revenue (in thousands) | % of Revenue | Q1 2022 Revenue (in thousands) | % of Revenue | | :--- | :--- | :--- | :--- | :--- | | Contracted third-party payors | $61,907 | 56% | $51,751 | 56% | | Centers for Medicare and Medicaid | $26,491 | 24% | $20,062 | 22% | | Healthcare institutions | $15,781 | 14% | $15,078 | 16% | | Non-contracted third-party payors | $7,257 | 6% | $5,487 | 6% | | **Total** | **$111,436** | **100%** | **$92,378** | **100%** | - The company is involved in a **securities class action lawsuit** and has received **subpoenas from the U.S. Attorney's Office and the Department of Justice**[86](index=86&type=chunk)[87](index=87&type=chunk) - The company has a development agreement with Verily Life Sciences to develop next-generation atrial fibrillation screening products, with **$11.0 million paid in milestone payments** as of March 31, 2023[88](index=88&type=chunk)[89](index=89&type=chunk) - The company has a loan agreement with SVB (now First-Citizens Bank) for a **$75.0 million term loan facility**, with **$35.0 million drawn** and a **$25.0 million revolving credit line**[94](index=94&type=chunk)[95](index=95&type=chunk)[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2023 financial performance, noting **21% revenue growth to $111.4 million** and a **narrowed net loss to $39.1 million** Results of Operations Comparison (Q1 2023 vs Q1 2022) | Metric (in thousands) | Q1 2023 | Q1 2022 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Revenue** | $111,436 | $92,378 | $19,058 | 21% | | **Gross Profit** | $75,681 | $61,759 | $13,922 | 23% | | **Gross Margin** | 68% | 67% | - | - | | **R&D Expenses** | $14,842 | $10,542 | $4,300 | 41% | | **SG&A Expenses** | $100,343 | $73,158 | $27,185 | 37% | | **Loss from Operations** | $(39,504) | $(48,549) | $9,045 | (19)% | | **Net Loss** | $(39,109) | $(50,609) | $11,500 | (23)% | - Revenue growth was primarily driven by **increased volume of Zio Services** and **improved CMS reimbursement rates**[140](index=140&type=chunk) - The **37% increase in SG&A expenses** was primarily due to a **$13.3 million increase in payroll-related costs** and **$5.7 million in transformation costs**[144](index=144&type=chunk) Reconciliation of Net Loss to Adjusted EBITDA (Non-GAAP) | Metric (in thousands) | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Net loss | $(39,109) | $(50,609) | | Stock-based compensation | $18,251 | $13,903 | | Impairment and restructuring charges | $— | $26,608 | | Transformation costs | $5,686 | $258 | | **Adjusted EBITDA** | **$(11,993)** | **$(4,753)** | - As of March 31, 2023, the company had **$52.8 million in cash and cash equivalents** and **$123.5 million in short-term investments**, with management believing current liquidity is sufficient[148](index=148&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks primarily from **interest rate sensitivity** and **foreign currency exchange fluctuations**, neither considered material - The company's primary market risks are **interest rate sensitivity** and **foreign currency exchange rate sensitivity**[165](index=165&type=chunk) - A hypothetical **10% change in interest rates** would have had a **$0.4 million impact on interest income** for Q1 2023[167](index=167&type=chunk)[168](index=168&type=chunk) - Foreign currency exchange risk, primarily from the **British Pound Sterling**, is not considered material[169](index=169&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's **disclosure controls and procedures were effective** as of March 31, 2023, with no material changes - The CEO and CFO concluded that the company's **disclosure controls and procedures are effective** at the reasonable assurance level as of March 31, 2023[171](index=171&type=chunk) - There were **no material changes in internal control over financial reporting** during Q1 2023[172](index=172&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in a **securities class action lawsuit** and **government investigations** by the DOJ, with full cooperation - A **putative securities class action lawsuit** filed in February 2021 is on appeal, which the company believes is without merit[176](index=176&type=chunk) - The company received **grand jury subpoenas** from the U.S. Attorney's Office and a **subpoena from the U.S. Department of Justice** regarding its products and services, with full cooperation[177](index=177&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section details numerous risks, including **reimbursement dependency, intense competition, regulatory compliance, supply chain, legal, and cybersecurity threats** - **Reimbursement Risk:** The company's revenue is highly dependent on **Medicare (24% of Q1 2023 revenue)** and commercial payors; policy changes could significantly harm the business[182](index=182&type=chunk)[183](index=183&type=chunk)[186](index=186&type=chunk) - **Regulatory & Compliance Risk:** The company is subject to extensive **FDA regulations**, **healthcare fraud and abuse laws**, and **data privacy laws**; non-compliance could lead to substantial penalties[204](index=204&type=chunk)[206](index=206&type=chunk)[240](index=240&type=chunk) - **Competitive Risk:** The market is highly competitive, with competition from **large medical device companies** and **potential new entrants like Apple** potentially reducing commercial opportunities[194](index=194&type=chunk)[195](index=195&type=chunk) - **Supply Chain Risk:** The company relies on **single-source vendors for critical Zio patch components**; supply disruptions could impair demand fulfillment[213](index=213&type=chunk)[214](index=214&type=chunk)[215](index=215&type=chunk) - **Legal & Investigation Risk:** The company faces a **securities class action lawsuit** and **ongoing government investigations** by the Department of Justice, risking significant liabilities and reputational harm[266](index=266&type=chunk)[268](index=268&type=chunk) - **Cybersecurity Risk:** Handling sensitive patient health information makes the company a target for **cyber-attacks**, risking significant liability and reputational damage[284](index=284&type=chunk)[285](index=285&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=69&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported **no unregistered sales of equity securities** during the period covered by this report - No unregistered sales of equity securities were reported[309](index=309&type=chunk) [Other Information](index=70&type=section&id=Item%205.%20Other%20Information) This section provides the company's **principal executive office address** and details on **material financial information dissemination** - The company's principal executive offices are located at **699 8th Street, Suite 600, San Francisco, CA 94103**[312](index=312&type=chunk) [Exhibits](index=70&type=section&id=Item%206.%20Exhibits) This section lists the **exhibits filed with the Quarterly Report on Form 10-Q**, including CEO/CFO certifications - Exhibits filed include **CEO and CFO certifications** and a **Resignation, Release and Consulting Agreement with former COO Douglas Devine**[313](index=313&type=chunk)[316](index=316&type=chunk) ```

Financial Data and Key Metrics Changes - The company reported revenues of $112.6 million for Q4 2022, reflecting a 38% year-over-year growth and a sequential growth of 8% [69] - Adjusted net loss for Q4 2022 was $17.9 million, or a loss of $0.59 per share, compared to a loss of $19.1 million in Q3 2022 [51] - Full year 2022 revenues reached $410.9 million, representing a 27% growth compared to 2021 [77] - Gross margin for Q4 was 69.9%, with a full year gross margin of 68.5% [50][77] - Adjusted EBITDA for Q4 was positive at $1.1 million, showing significant improvement year-over-year [79] Business Line Data and Key Metrics Changes - The Zio XT service saw strong demand, with new account openings reaching record levels [69] - Home enrollment accounted for about 20% of volume in Q4 2022 [77] - The Zio AT service continued to grow, although at a slower pace compared to the first nine months of 2022 [69] Market Data and Key Metrics Changes - The company anticipates full year revenue growth of approximately 16% to 18% for 2023, amounting to $475 million to $485 million [53] - Approximately 75% of Medicare and commercial patients eligible for coverage now have a $50 co-pay or less [43] Company Strategy and Development Direction - The company is focusing on expanding into primary care, targeting over 14 million patients with cardiac-related issues annually [42] - A nationwide agreement with One Medical has been established to enhance technology-powered solutions [36] - The company plans to launch the next-generation Zio Monitor in the back half of 2023, which is expected to improve patient experience [74] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating operational challenges and expects to see improvements in return device rates and AT business performance [58] - The company is optimistic about the early signs of improvement in healthcare staffing challenges experienced in 2022 [73] - Management highlighted the importance of EHR integration for creating stickiness with accounts and driving growth [30] Other Important Information - The company has cleared material weaknesses in its internal control environment, enhancing operational efficiency [52][80] - The anticipated launch of the Zio Watch is expected to provide complementary monitoring solutions [75] Q&A Session Summary Question: Update on 16% to 18% guidance range and challenges faced - Management feels confident about business progress and expects to navigate through growth headwinds effectively [58] Question: Insights on the new sensor's limited launch - Early indicators from the limited launch of the new sensor are positive, with expectations for a broader launch later in the year [61] Question: Status of AT volumes and growth expectations - The AT business is expected to grow around 30%, with confidence in returning to previous growth levels as operational issues are resolved [92]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________________________________________________________________________________ FORM 10-K ________________________________________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHA ...

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for the period ended September 30, 2022, detail the company's financial position, operational results, and cash flows, reflecting revenue growth, continued net losses, and significant cash usage [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2022, the company's total assets were **$440.4 million**, a decrease from **$463.0 million** at the end of 2021, primarily due to a reduction in cash and cash equivalents. Total liabilities increased to **$201.2 million** from **$183.5 million**, driven by an increase in noncurrent debt. Consequently, total stockholders' equity declined to **$239.2 million** from **$279.5 million** | Balance Sheet Items (In thousands) | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $71,222 | $127,562 | | Accounts receivable, net | $60,534 | $46,430 | | Total current assets | $285,850 | $305,522 | | Total assets | $440,390 | $462,967 | | **Liabilities & Equity** | | | | Total current liabilities | $83,591 | $87,853 | | Debt, noncurrent portion | $34,931 | $9,690 | | Total liabilities | $201,166 | $183,452 | | Total stockholders' equity | $239,224 | $279,515 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the third quarter of 2022, revenue grew to **$103.9 million** from **$85.4 million** in Q3 2021, with gross profit increasing to **$70.9 million**. However, the company reported a net loss of **$21.5 million** for the quarter. For the nine months ended September 30, 2022, revenue was **$298.3 million**, up from **$241.0 million** year-over-year, but the net loss widened to **$96.0 million** from **$68.9 million**, partly due to **$26.6 million** in impairment and restructuring charges | Metric (In thousands) | Q3 2022 | Q3 2021 | | :--- | :--- | :--- | | Revenue, net | $103,875 | $85,432 | | Gross profit | $70,921 | $56,148 | | Loss from operations | $(21,086) | $(23,282) | | Net loss | $(21,451) | $(23,731) | | Net loss per share | $(0.71) | $(0.81) | | Metric (In thousands) | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | | Revenue, net | $298,304 | $241,021 | | Gross profit | $202,925 | $162,284 | | Impairment and restructuring charges | $26,608 | $0 | | Loss from operations | $(93,086) | $(67,744) | | Net loss | $(95,957) | $(68,870) | | Net loss per share | $(3.22) | $(2.35) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2022, net cash used in operating activities was **$35.6 million**, an increase from **$24.7 million** in the prior year period. Net cash used in investing activities was **$44.3 million**, a significant shift from **$132.4 million** provided by investing activities in 2021. Net cash provided by financing activities was **$23.6 million**, primarily from new debt proceeds, compared to a **$28.9 million** use of cash in the prior year. This resulted in a net decrease in cash and cash equivalents of **$56.3 million** | Cash Flow Activity (In thousands) | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(35,588) | $(24,708) | | Net cash (used in) provided by investing activities | $(44,320) | $132,397 | | Net cash provided by (used in) financing activities | $23,568 | $(28,946) | | **Net (decrease) increase in cash** | **$(56,340)** | **$78,743** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies, highlighting risks from macroeconomic factors, Medicare reimbursement uncertainty, and the impact of CPT code transitions, alongside details on impairment charges and new debt agreements - The company faces significant uncertainty regarding Medicare reimbursement. CMS did not establish national pricing for key CPT codes for 2022, leaving it to regional MACs. On November 2, 2022, CMS released its 2023 final rule, which the company interprets as reflecting national reimbursement rates of **$224** for CPT code 93247 and **$213** for CPT code 93243[40](index=40&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk) - Revenue from CMS accounted for **26%** of total revenue in Q3 2022 and **24%** for the first nine months of 2022, a significant increase from **15%** and **14%** in the respective periods of 2021[61](index=61&type=chunk) - In February 2022, the company initiated a restructuring plan, resulting in **$3.4 million** in severance costs and a **$23.2 million** impairment charge on its San Francisco headquarters' right-of-use asset and related property[94](index=94&type=chunk) - On March 28, 2022, the company amended its loan agreement with SVB, securing a new term loan facility of up to **$75.0 million**. It borrowed **$35.0 million** at closing, using part of the proceeds to repay an existing **$18.5 million** balance[112](index=112&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's performance, noting revenue growth driven by Zio service volume and CMS rates, but a widening net loss due to increased expenses and one-time charges, alongside details on liquidity and debt facilities [Results of Operations](index=36&type=section&id=Results%20of%20Operations) Revenue for Q3 2022 increased **22%** year-over-year to **$103.9 million**, driven by higher Zio service volume and better CMS rates. Gross margin improved to **68%** from **66%**. Operating expenses rose **16%**, with R&D up **32%** and SG&A up **14%**. For the nine-month period, revenue grew **24%** to **$298.3 million**, but total operating expenses increased **29%**, including **$26.6 million** in impairment and restructuring charges, leading to a wider loss from operations | Metric (In thousands) | Q3 2022 | Q3 2021 | % Change | | :--- | :--- | :--- | :--- | | Revenue | $103,875 | $85,432 | 22% | | Gross Profit | $70,921 | $56,148 | 26% | | Gross Margin | 68% | 66% | - | | R&D Expenses | $11,448 | $8,685 | 32% | | SG&A Expenses | $80,559 | $70,745 | 14% | | Loss from Operations | $(21,086) | $(23,282) | 9% | - The nine-month results included **$23.2 million** in impairment charges related to the San Francisco headquarters and **$3.4 million** in severance costs from a restructuring plan, which were not present in the prior year[180](index=180&type=chunk) [Liquidity and Capital Expenditures](index=38&type=section&id=Liquidity%20and%20Capital%20Expenditures) As of September 30, 2022, the company had **$71.2 million** in cash and cash equivalents and **$132.3 million** in short-term investments. Management believes it has adequate liquidity for the next 12 months, supported by available term loan facilities of **$40.0 million** and a **$25.0 million** revolving credit line. Net cash used in operations for the first nine months of 2022 was **$35.6 million**, primarily due to a net loss of **$96.0 million**, offset by non-cash charges, and an increase in accounts receivable - The company's cash and cash equivalents decreased by **$56.3 million** during the first nine months of 2022[188](index=188&type=chunk) - Cash used in operating activities increased to **$35.6 million** for the nine months ended Sep 30, 2022, from **$24.7 million** in the same period of 2021, largely due to an increase in accounts receivable[189](index=189&type=chunk)[191](index=191&type=chunk) - The company secured a new term loan facility of up to **$75.0 million** and an extended **$25.0 million** revolving credit line through March 2027, enhancing its liquidity position[198](index=198&type=chunk)[199](index=199&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are related to interest rate and foreign currency exchange rate sensitivity. Interest rate risk stems from its cash equivalents, investments, and variable-rate debt. Foreign currency risk arises from transactions in British Pound Sterling. Management does not consider these risks to be material and states that a hypothetical **10%** change in interest rates would not have had a material impact on the financial statements - The company holds **$203.5 million** in cash, cash equivalents, and investments, which are subject to interest rate risk, though historical fluctuations have not been significant[204](index=204&type=chunk) - The outstanding debt of **$34.9 million** carries a variable interest rate tied to the Prime Rate, exposing the company to interest rate fluctuations[206](index=206&type=chunk) - Foreign exchange risk is primarily from transactions in British Pound Sterling but is not considered material as of September 30, 2022[207](index=207&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of September 30, 2022, due to a material weakness in the control environment, with remediation efforts underway including key personnel hires - The CEO and CFO concluded that disclosure controls and procedures were not effective as of September 30, 2022, due to a continuing material weakness in internal controls over financial reporting[210](index=210&type=chunk) - The material weakness stems from not maintaining an effective control environment, specifically a failure to maintain a sufficient number of professionals with appropriate accounting and internal control expertise[211](index=211&type=chunk) - Remediation efforts include hiring an IT Compliance Director (Jan 2022), a Chief Risk Officer (May 2022), a Senior Director of Internal Audit (June 2022), and a new Chief Financial Officer (Aug 2022) to strengthen the control environment[212](index=212&type=chunk)[218](index=218&type=chunk) [PART II. OTHER INFORMATION](index=44&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in a putative securities class action lawsuit filed in February 2021, which was dismissed by the court in March 2022 but is currently under appeal by the plaintiff. Additionally, the company received grand jury subpoenas from the U.S. Attorney's Office in March and October 2021 related to communications with the FDA and its products, and is cooperating with the request - A securities class action lawsuit alleging violations of the Exchange Act was dismissed on March 31, 2022, but the plaintiff filed a notice of appeal on April 29, 2022. The company believes the action is without merit[220](index=220&type=chunk) - The company received grand jury subpoenas from the U.S. Attorney's Office for the Northern District of California in March and October 2021 requesting information related to FDA communications and products. The company is cooperating fully[221](index=221&type=chunk)[105](index=105&type=chunk) [Item 1A. Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant risks including reimbursement uncertainty, macroeconomic impacts, a history of net losses, market competition, intellectual property litigation, regulatory changes, and recent management turnover - **Reimbursement Risk:** Changes in CMS and MAC reimbursement rates, such as the lower-than-historical rates from Novitas Solutions, could negatively impact profitability and influence commercial payors to reduce their rates[223](index=223&type=chunk)[244](index=244&type=chunk)[247](index=247&type=chunk) - **Operational & Financial Risk:** The company has a history of net losses which are expected to continue. The business is also adversely impacted by the COVID-19 pandemic and macroeconomic factors affecting supply chains, costs, and patient/hospital demand[223](index=223&type=chunk)[225](index=225&type=chunk)[231](index=231&type=chunk) - **Market & Competitive Risk:** The business depends on broad physician adoption of the Zio service. The ambulatory cardiac monitoring market is highly competitive, with large, well-resourced competitors that could develop more effective or accepted products[223](index=223&type=chunk)[232](index=232&type=chunk)[281](index=281&type=chunk) - **Management & Control Risk:** The company has recently experienced significant management turnover, including a new CEO, CFO, and CCO, which creates uncertainty. A material weakness in internal control over financial reporting also persists[296](index=296&type=chunk)[297](index=297&type=chunk)[327](index=327&type=chunk) - **Regulatory Risk:** The company must comply with extensive regulations from the FDA and CMS. Failure to maintain regulatory clearances, such as for the Zio AT monitor, or comply with IDTF rules could harm commercial operations[352](index=352&type=chunk)[356](index=356&type=chunk)[278](index=278&type=chunk) [Item 2-6. Other Information](index=83&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Under these items, the company reports no unregistered sales of equity securities, no defaults upon senior securities, and no mine safety disclosures. Item 5 provides general corporate information, including the company's website and social media channels for investor communication. Item 6 refers to the exhibit index filed with the report - The company reported no unregistered sales of equity securities or use of proceeds for the period[387](index=387&type=chunk) - The company notes that it uses its investor relations website, press releases, SEC filings, and social media channels like Facebook and Twitter to communicate material financial information[390](index=390&type=chunk)