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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, 2021
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.
(Exact Name of Registrant as Specified in its Charter)
_______________________________________________________________________ | | | | | | | | | | | | | | |
| Delaware | | 20-8149544 |
| (State or Other Jurisdiction of Incorporation or Organization) | | (I.R.S. Employer Identification No.) |
| | | | |
| 699 8th Street Suite 600 | | |
| San Francisco, | California | | 94103 |
| (Address of Principal Executive Offices) | | (Zip Code) |
(415) 632-5700
(Registrant’s Telephone Number, Including Area Code)
_______________________________________________________________________
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☑ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. | | | | | | | | | | | | | | |
Large accelerated filer | ☑ | | Accelerated filer | ☐ |
Non-accelerated filer | ☐ | | Smaller reporting company | ☐ |
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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑
As of July 30, 2021, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 29,403,360.
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 $.001 Per Share | IRTC | The Nasdaq Stock Market |
IRHYTHM TECHNOLOGIES, INC.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business, operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
•the impact of the COVID-19 pandemic on our operations and financial results;
•plans to conduct further clinical studies;
•our plans to modify our current products, or develop new products, to address additional indications;
•the expected growth of our business and our organization;
•our expectations regarding government and third-party payor coverage and reimbursement;
•our expectations regarding the size of our sales organization and expansion of our sales and marketing efforts in international geographies;
•our expectations regarding revenue, cost of revenue, cost of service per device, operating expenses, including research and development expense, sales and marketing expense and general and administrative expenses;
•our ability to retain and recruit key personnel, including the continued development of a sales and marketing infrastructure;
•our ability to obtain and maintain intellectual property protection for our products;
•our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for, or ability to obtain, additional financing;
•our ability to identify and develop new and planned products and acquire new products;
•our ability to remediate our material weaknesses over financial reporting;
•our financial performance; and
•developments and projections relating to our competitors or our industry.
We believe that it is important to communicate our future expectations to our investors. However, there may be events in the future that we are not able to accurately predict or control and that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements. These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and management’s beliefs and assumptions and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this Quarterly Report on Form 10-Q may turn out to be inaccurate. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Potential investors are urged to consider these factors carefully in evaluating the forward-looking statements. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. We assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to actual results or to changes in our expectations.
You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed with the SEC as exhibits to the Quarterly Report on Form 10-Q with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
IRHYTHM TECHNOLOGIES, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands, except share and per share data) | | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 138,872 | | | $ | 88,628 | |
Short-term investments | 116,792 | | | 246,589 | |
Accounts receivable, net of allowances for doubtful accounts of $11,923 and $12,711 as of June 30, 2021 and December 31, 2020, respectively | 63,423 | | | 29,932 | |
Inventory | 9,261 | | | 5,313 | |
Prepaid expenses and other current assets | 7,219 | | | 7,363 | |
Total current assets | 335,567 | | | 377,825 | |
Property and equipment, net | 47,086 | | | 34,247 | |
Operating lease right-of-use assets | 87,533 | | | 84,714 | |
Goodwill | 862 | | | 862 | |
Other assets | 14,176 | | | 14,091 | |
Total assets | $ | 485,224 | | | $ | 511,739 | |
Liabilities and Stockholders’ Equity | | | |
Current liabilities: | | | |
Accounts payable | $ | 8,945 | | | $ | 4,365 | |
Accrued liabilities | 42,598 | | | 40,532 | |
Deferred revenue | 2,507 | | | 930 | |
Debt, current portion | 11,667 | | | 11,667 | |
Operating lease liabilities, current portion | 7,301 | | | 8,171 | |
Total current liabilities | 73,018 | | | 65,665 | |
Debt, noncurrent portion | 15,515 | | | 21,339 | |
Other noncurrent liabilities | 2,265 | | | 1,830 | |
Operating lease liabilities, noncurrent portion | 87,984 | | | 81,293 | |
Total liabilities | 178,782 | | | 170,127 | |
Commitments and contingencies (Note 6) | | | |
Stockholders’ equity: | | | |
Preferred stock, $0.001 par value – 5,000,000 shares authorized at June 30, 2021 and December 31, 2020; and none issued and outstanding at June 30, 2021 and December 31, 2020 | — | | | — | |
Common stock, $0.001 par value – 100,000,000 shares authorized at June 30, 2021 and December 31, 2020; 29,386,146 and 29,019,350 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 27 | | | 27 | |
Additional paid-in capital | 656,231 | | | 646,258 | |
Accumulated other comprehensive income | 7 | | | 11 | |
Accumulated deficit | (349,823) | | | (304,684) | |
Total stockholders’ equity | 306,442 | | | 341,612 | |
Total liabilities and stockholders’ equity | $ | 485,224 | | | $ | 511,739 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
IRHYTHM TECHNOLOGIES, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share data) | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2021 | | 2020 | | 2021 | | 2020 |
Revenue, net | $ | 81,278 | | | $ | 50,878 | | | $ | 155,589 | | | $ | 114,413 | |
Cost of revenue | 25,995 | | | 15,484 | | | 49,453 | | | 31,547 | |
Gross profit | 55,283 | | | 35,394 | | | 106,136 | | | 82,866 | |
Operating expenses: | | | | | | | |
Research and development | 9,606 | | | 12,542 | | | 18,116 | | | 20,957 | |
Selling, general and administrative | 62,669 | | | 43,014 | | | 132,482 | | | 91,244 | |
Total operating expenses | 72,275 | | | 55,556 | | | 150,598 | | | 112,201 | |
Loss from operations | (16,992) | | | (20,162) | | | (44,462) | | | (29,335) | |
Interest expense | (307) | | | (381) | | | (642) | | | (761) | |
Other income, net | 55 | | | 237 | | | 179 | | | 742 | |
Loss before income taxes | (17,244) | | | (20,306) | | | (44,925) | | | (29,354) | |
Income tax provision | 116 | | | 131 | | | 214 | | | 148 | |
Net loss | $ | (17,360) | | | $ | (20,437) | | | $ | (45,139) | | | $ | (29,502) | |
Net loss per common share, basic and diluted | $ | (0.59) | | | $ | (0.75) | | | $ | (1.54) | | | $ | (1.09) | |
Weighted-average shares, basic and diluted | 29,318,894 | | | 27,176,601 | | | 29,242,089 | | | 27,008,236 | |
| | | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
IRHYTHM TECHNOLOGIES, INC.
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited)
(In thousands) | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2021 | | 2020 | | 2021 | | 2020 |
Net loss | $ | (17,360) | | | $ | (20,437) | | | $ | (45,139) | | | $ | (29,502) | |
Other comprehensive income: | | | | | | | |
Net change in unrealized gains on available-for-sale securities | (5) | | | (183) | | | (4) | | | 99 | |
Comprehensive loss | $ | (17,365) | | | $ | (20,620) | | | $ | (45,143) | | | $ | (29,403) | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
IRHYTHM TECHNOLOGIES, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands) | | | | | | | | | | | |
| Six Months Ended June 30, |
| 2021 | | 2020 |
Cash flows from operating activities | | | |
Net loss | $ | (45,139) | | | $ | (29,502) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Depreciation and amortization | 4,189 | | | 3,220 | |
Stock-based compensation | 30,490 | | | 10,073 | |
Accretion of discounts on investments, net and other | 1,010 | | | (66) | |
Provision for doubtful accounts and contractual allowances | 14,180 | | | 13,524 | |
Amortization of operating lease right-of-use assets | 3,227 | | | 2,986 | |
Changes in operating assets and liabilities: | | | |
Accounts receivable | (47,671) | | | (12,994) | |
Inventory | (4,027) | | | (1,015) | |
Prepaid expenses and other current assets | 145 | | | 592 | |
Other assets | (29) | | | (2,728) | |
Accounts payable | 1,873 | | | (4,540) | |
Accrued liabilities | (1,985) | | | (9,689) | |
Deferred revenue | 1,577 | | | (54) | |
Operating lease liabilities | (2,576) | | | (2,326) | |
Reimbursement of tenant improvement allowance | 2,351 | | | — | |
Net cash used in operating activities | (42,385) | | | (32,519) | |
Cash flows from investing activities | | | |
Purchases of property and equipment | (10,134) | | | (5,586) | |
Purchases of available-for-sale investments | (46,429) | | | (8,009) | |
Sales of available-for-sale investments | — | | | 14,525 | |
Maturities of available-for-sale investments | 175,300 | | | 88,645 | |
Net cash provided by investing activities | 118,737 | | | 89,575 | |
Cash flows from financing activities | | | |
Payment of long term debt | (5,833) | | | — | |
Proceeds from issuance of common stock in connection with employee equity incentive plans | 5,577 | | | 9,361 | |
Tax withholding upon vesting of restricted stock awards | (25,852) | | | (5,149) | |
Net cash used in financing activities | (26,108) | | | 4,212 | |
Net increase in cash and cash equivalents | 50,244 | | | 61,268 | |
Cash and cash equivalents beginning of period | 88,628 | | | 20,462 | |
Cash and cash equivalents end of period | $ | 138,872 | | | $ | 81,730 | |
Supplemental disclosures of cash flow information | | | |
Interest paid | $ | 658 | | | $ | 796 | |
Non-cash investing and financing activities | | | |
Property and equipment costs included in accounts payable and accrued liabilities | $ | 5,319 | | | $ | 1,369 | |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ | 6,047 | | | $ | 621 | |
Capitalized stock-based compensation | $ | 1,632 | | | $ | — | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
IRHYTHM TECHNOLOGIES, INC.
Condensed Consolidated Statement of Stockholders’ Equity
(Unaudited)
(In thousands, except share data)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Common Stock | | | | | | Accumulated Other | | Total |
| | Shares | | Amount | | Additional Paid-In Capital | | Accumulated Deficit | | Comprehensive Income | | Stockholders' Equity |
Balances at March 31, 2021 | | 29,287,749 | | | $ | 27 | | | $ | 641,996 | | | $ | (332,463) | | | $ | 12 | | | $ | 309,572 | |
Issuance of common stock in connection with employee equity incentive plans, net | | 98,397 | | | — | | | 4,001 | | | — | | | — | | | 4,001 | |
Tax withholding upon vesting of restricted stock awards | | — | | | — | | | (747) | | | — | | | — | | | (747) | |
Stock-based compensation expense | | — | | | — | | | 10,981 | | | — | | | — | | | 10,981 | |
Net loss | | — | | | — | | | — | | | (17,360) | | | — | | | (17,360) | |
Net change in unrealized gain on investments | | — | | | — | | | — | | | — | | | (5) | | | (5) | |
Balances at June 30, 2021 | | 29,386,146 | | | $ | 27 | | | $ | 656,231 | | | $ | (349,823) | | | $ | 7 | | | $ | 306,442 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Common Stock | | | | | | Accumulated Other | | Total |
| | Shares | | Amount | | Additional Paid-In Capital | | Accumulated Deficit | | Comprehensive Income | | Stockholders' Equity |
Balances at December 31, 2020 | | 29,019,350 | | | $ | 27 | | | $ | 646,258 | | | $ | (304,684) | | | $ | 11 | | | $ | 341,612 | |
Issuance of common stock in connection with employee equity incentive plans, net | | 366,796 | | | — | | | 5,577 | | | — | | | — | | | 5,577 | |
Tax withholding upon vesting of restricted stock awards | | — | | | — | | | (25,852) | | | — | | | — | | | (25,852) | |
Stock-based compensation expense | | — | | | — | | | 30,248 | | | — | | | — | | | 30,248 | |
Net loss | | — | | | — | | | — | | | (45,139) | | | — | | | (45,139) | |
Net change in unrealized gain on investments | | — | | | — | | | — | | | — | | | (4) | | | (4) | |
Balances at June 30, 2021 | | 29,386,146 | | | $ | 27 | | | $ | 656,231 | | | $ | (349,823) | | | $ | 7 | | | $ | 306,442 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
IRHYTHM TECHNOLOGIES, INC.
Condensed Consolidated Statement of Stockholders’ Equity
(Unaudited)
(In thousands, except share data)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Common Stock | | | | | | Accumulated Other | | Total |
| | Shares | | Amount | | Additional Paid-In Capital | | Accumulated Deficit | | Comprehensive Income | | Stockholders' Equity |
Balances at March 31, 2020 | | 27,026,975 | | $ | 25 | | | $ | 394,507 | | | $ | (269,919) | | | $ | 364 | | | $ | 124,977 | |
Issuance of common stock in connection with employee equity incentive plans, net | | 337,176 | | — | | | 6,392 | | | — | | | — | | | 6,392 | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
Tax withholding upon vesting of restricted stock awards | | — | | | — | | | (687) | | | — | | | — | | | (687) | |
Stock-based compensation expense | | — | | | — | | | 7,884 | | | — | | | — | | | 7,884 | |
Net loss | | — | | | — | | | — | | | (20,437) | | | — | | | (20,437) | |
Net change in unrealized gain on investments | | — | | | — | | | — | | | — | | | (183) | | | (183) | |
Balances at June 30, 2020 | | 27,364,151 | | | $ | 25 | | | $ | 408,096 | | | $ | (290,356) | | | $ | 181 | | | $ | 117,946 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Common Stock | | | | | | Accumulated Other | | Total |
| | Shares | | Amount | | Additional Paid-In Capital | | Accumulated Deficit | | Comprehensive Income | | Stockholders' Equity |
Balances at December 31, 2019 | | 26,682,720 | | $ | 25 | | | $ | 395,695 | | | $ | (260,393) | | | $ | 82 | | | $ | 135,409 | |
Issuance of common stock in connection with employee equity incentive plans, net | | 681,431 | | — | | | 9,361 | | | — | | | — | | | 9,361 | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
Tax withholding upon vesting of restricted stock awards | | — | | | — | | | (5,149) | | | — | | | — | | | (5,149) | |
Stock-based compensation expense | | — | | | — | | | 8,189 | | | — | | | — | | | 8,189 | |
Accounting Standards Codification 326 cumulative effect adjustment upon adoption | | — | | | — | | | — | | | (461) | | | — | | | (461) | |
Net loss | | — | | | — | | | — | | | (29,502) | | | — | | | (29,502) | |
Net change in unrealized gain on investments | | — | | | — | | | — | | | — | | | 99 | | | 99 | |
Balances at June 30, 2020 | | 27,364,151 | | | $ | 25 | | | $ | 408,096 | | | $ | (290,356) | | | $ | 181 | | | $ | 117,946 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements
1. Organization and Description of Business
iRhythm Technologies, Inc. (the “Company”) was incorporated in the state of Delaware in September 2006. The Company is a digital healthcare company redefining the way cardiac arrhythmias are clinically diagnosed by combining wearable biosensing technology with cloud-based data analytics and deep-learning capabilities. The Company began commercial operations in the United States in 2008 following clearance by the U.S. Food and Drug Administration.
The Company is headquartered in San Francisco, California, which also serves as a clinical center. The Company has additional clinical centers in Lincolnshire, Illinois and Houston, Texas and a manufacturing facility in Cypress, California. In March 2016, the Company formed a wholly-owned subsidiary in the United Kingdom. Additionally, in June 2021, the Company formed a wholly-owned subsidiary in Singapore. The Company manages its operations as a single operating segment. Substantially all of the Company’s assets are maintained in the United States. The Company derives substantially all of its revenue from sales to customers in the United States.
On August 21, 2020, the Company issued and sold an aggregate of 1,257,142 shares (the “Shares”) of common stock, in a public offering at a price of $175.00 per share. The Shares included the full exercise of the underwriters’ option to purchase an additional 163,975 shares of common stock. Total proceeds received from the offering were $206.8 million, after deducting discounts and issuance costs.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP") and applicable rules and regulations of the Securities and Exchange Commission (the "SEC") regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted, and accordingly the balance sheet as of December 31, 2020, and related disclosures, have been derived from the audited consolidated financial statements at that date but do not include all of the information required by GAAP for complete consolidated financial statements. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for the fair statement of the Company’s condensed consolidated financial information. The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021, or for any other interim period or for any other future year.
The accompanying interim unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2020, included in the Company’s annual report on Form 10-K, filed with the SEC on February 26, 2021.
Risks and Uncertainties
COVID-19
As a result of the COVID-19 pandemic, the Company has experienced significant business disruptions, restrictions on its ability to travel, reduction in access to customers due to diverted resources at hospitals, and shortened business hours as governments institute prolonged shelter-in-place and/or self-quarantine mandates.
Governmental mandates related to the COVID-19 pandemic have impacted, and is expected to continue to impact, Company personnel and personnel at third-party manufacturing facilities in the United States and other countries, and the availability or cost of materials, which could disrupt our supply chain and reduce margins. For instance, on or about March 16, 2020, the Health Officers of the counties of San Francisco (where the Company's headquarters is located), Santa Clara, San Mateo, Marin, Contra Costa and Alameda, where many employees are located, issued mandatory shelter-in-place orders and all employees transitioned to a remote work environment. The Company is also subject to orders in Southern California that temporarily shut down its manufacturing and distribution facilities in Cypress, California. For a limited number of employees who continue to support essential operations, including those at our manufacturing facilities, the Company has instituted protective equipment policies and, to the degree practical, social distancing measures to protect the safety of its employees. While the Company has continued to deliver its Zio service by operating with remote employees and essential employees on site, an extended implementation of these governmental mandates could further impact the Company's ability to effectively
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
provide its Zio service, and could impede progress of all ongoing initiatives. Appropriate social distancing techniques and other measures at the Company's facilities have been implemented for the limited number of employees who have returned to work to support essential operations, and will not return until the risk to employee health has meaningfully diminished.
While hospital systems and healthcare facilities shift their focus and resources to treating COVID-19 patients and combating the spread of the coronavirus, the Company has adapted its service to meet the immediate needs of physicians, customers, and patients and significantly increased the utilization of its home enrollment service which allows patients to receive and wear the single-use Zio device without going to a healthcare facility.
During the second half of 2020, the Company saw recovery of patient registrations for the Zio service to pre-COVID levels of the first quarter of 2020. During the six months ended June 30, 2021, the Company experienced a further increase in the level of Zio service patient registrations. However, this may be due, in some part, to the re-opening of certain regions within the United States and may not represent sustainable levels of patient registrations in future time periods.
The Company is continuously reviewing its liquidity and anticipated capital requirements in light of the significant uncertainty created by the COVID-19 pandemic. The Company believes it will have adequate liquidity over the next 12 months to operate its business and to meet its cash requirements. As of June 30, 2021, the Company is in compliance with its financial covenants in its debt agreement.
On March 27, 2020, as a result of the COVID-19 pandemic, Congress enacted the Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act") to support businesses during the COVID-19 pandemic, including deferment of the employer portion of certain payroll taxes, refundable payroll tax credits, and technical amendments to tax depreciation methods for qualified improvement property. The primary provisions of the CARES Act which are potentially applicable to us include:
• certain amendments to the limitations on the deductibility of interest contained in Section 163(j) of the Internal Revenue Code of 1986, as amended, for taxable years beginning in 2019 and 2020; and
• an allowance of net operating loss carrybacks for taxable years beginning in 2018 and before 2021.
The Company did not qualify for the Paycheck Protection Program under the CARES Act due to the number of employees in our organization. The CARES Act did not have material impact on the Company’s overall consolidated financial statements.
The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change. This impact is having a material, adverse impact on liquidity, capital resources, supply chain, operations and business and those of the third parties on which the Company relies, and could worsen over time. The extent to which the COVID-19 pandemic impacts the Company’s results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the COVID-19 pandemic and the actions to contain the COVID-19 pandemic or treat its impact, among others. The full extent of potential delays or impacts on the business, financial condition, cash flows and results of operations remains unknown. Additionally, while the potential economic impact brought by, and the duration of, the COVID-19 pandemic is difficult to assess or predict, the COVID-19 pandemic has resulted in, and may continue to result in, significant disruption of global financial markets, reducing the Company’s ability to raise additional capital through equity, equity-linked or debt financings, which could negatively impact short-term and long-term liquidity and the ability to operate on a timely basis, or at all.
Furthermore, capital markets and economies worldwide have been negatively impacted by the COVID-19 pandemic, which may result in a period of regional, national, and global economic slowdown or regional, national, or global recessions that could curtail or delay demand for the Zio service as well as increase the risk of customer defaults or delays in payments. COVID-19 and the current financial, economic, and capital markets environment, and future developments in these and other areas present material uncertainty and risk with respect to the Company's performance, financial condition, volume of business, results of operations, and cash flows.
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
Reimbursement
Government payors may change their coverage and reimbursement policies, as well as payment amounts, in a way that would prevent or limit reimbursement for the Zio service, which would significantly harm the Company. Government and other third-party payors require the Company to report the service for which it is seeking reimbursement by using a Current Procedural Terminology (“CPT”) code-set maintained by the American Medical Association (“AMA”). For Zio XT, the Company had historically utilized temporary CPT codes (or Category III CPT codes) used for newly introduced technologies and specific to our category of diagnostic monitoring. The process to convert Category III CPT codes to Category I CPT codes is governed by the AMA and Centers for Medicare and Medicaid (“CMS”). On October 25, 2019, the AMA’s CPT Editorial Panel established two new Category I CPT codes which are applicable to the Zio service and took effect on January 1, 2021. In August 2020, CMS published the Calendar Year 2021 Medicare Physician Fee Schedule Proposed Rule which proposed reimbursement for the Category I CPT codes that were higher than their associated Category III CPT codes. Following a comment period through October 2020, CMS published its Calendar Year 2021 Medicare Physician Fee Schedule Final Rule (the “Final Rule”) in December 2020. In the Final Rule, CMS chose not to finalize national pricing for four of the eight Category I CPT codes, 93241, 93243, 93245 and 93247 which include the CPT codes that the Company primarily uses to seek reimbursement for Zio XT.
Determinations of which products or services will be reimbursed under Medicare can be developed at the national level through a national coverage determination (“NCD”) by CMS, or at the local level through a local coverage determination (“LCD”), by one or more of the regional Medicare Administrative Contractors (“MACs”) who are private contractors that process and pay claims on behalf of CMS for different regions. In the absence of a specific NCD, as is the case with Zio XT historically and for Calendar Year 2021 following the Final Rule, the MAC with jurisdiction over a specific geographic region will have the discretion to make an LCD. The Company is seeking to establish LCD pricing with one or more MACs to establish pricing for 2021 and will be subject to LCD pricing until such time CMS establishes a NCD.
On January 29, 2021, Novitas Solutions, the MAC which covers the region where the Company's Independent Diagnostic Testing Facility (“IDTF”) in Houston, Texas is located and where almost all Medicare services for Zio XT are processed, published rates for 2021 that were significantly below our historical Medicare rates for Zio XT. The Company believes that the published rates by Novitas on January 29, 2021, were based off of rates from CPT codes 93224 and 93226, which are existing CPT codes for external continuous electrocardiographic recording up to 48 hours, while the Zio service is capable of continuous monitoring for up to 14 days.
On April 10, 2021, Novitas published updated reimbursement rates for codes 93243 and 93247 at $103 and $115, respectively. The updated rates are retroactive to January 1, 2021 and replace rates initially published on January 29, 2021. While these new rates represent an increase from the rates posted on January 29, 2021, the Company believes these rates do not appropriately reflect the clinical and economic value that long-term continuous ECG monitoring offers patients, their care teams and the Medicare system. Due to the cost of providing the service relative to the updated rates published by Novitas, the Company may not be able to provide the Zio service to the Medicare fee for service segment if these rates remain unchanged. However, the Company believes there are potential paths to more equitable rates which it plans to explore before making any changes to the availability of Zio XT in the Medicare portion of its business. It is the Company's strong preference that continued access to Zio XT is available to all patients.
We submitted the majority of Zio XT claims from the first and second quarter of 2021 on a delayed basis due to the CPT code transition. Claims were being held due to a combination of negotiations with payors and administrative delays with payors. Most of the held claims were released and submitted by the end of the second quarter of 2021. Delays in reimbursements of these held claims from the payors can result in delays to our cash flows in the second half of 2021 and may impact the timing and accounting for various income statement items, particularly revenue recognition and bad debt expense. We believe we have adequate balance sheet liquidity to manage through these delays in cash flow timing.
If the published rates by Novitas remain unchanged or are not significantly improved for the CPT codes listed above, thereby allowing the Company to obtain adequate Medicare reimbursement for the Zio service in the future, the Company may be unable to provide the Zio service or would experience a significant loss of revenue, either of which would have a material adverse effect on our cash flows, results of operations and financial condition.
Further, a reduction in coverage by Medicare could cause some commercial third-party payors to implement similar reductions in their coverage or level of reimbursement of the Zio service. Given the evolving nature of the healthcare industry and on-going healthcare cost reforms, the Company will continue to be subject to changes in the level of Medicare coverage for
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
its products, and unfavorable coverage determinations at the national or local level could adversely affect its results of operations. Although a large majority of commercial customers have re-contracted the Zio XT service since the establishment of the Category I codes on January 1, 2021 matching to pre-existing rates, if the Company is unsuccessful in improving the Medicare rates before calendar year 2022, it is prudent to expect that commercial rates may begin to be more negatively impacted next year. If published rates by Novitas are not increased to above the cost of service for Zio XT, and the Company is unable to achieve a level of revenues adequate to support its cost structure, or is unable to reduce its overall cost structure, this would raise substantial doubts about the Company's ability to continue as a going concern.
Use of Estimates
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, contractual allowances, allowance for doubtful accounts, the useful lives of property and equipment, the recoverability of long-lived assets including the estimated usage of the printed circuit board assemblies (“PCBAs”), the incremental borrowing rate for operating leases, accounting for income taxes, and various inputs used in estimating stock-based compensation. Certain of these estimates are impacted by uncertainties surrounding COVID-19 such as revenue recognition, contractual allowances for revenue, allowance for doubtful accounts, and stock based compensation. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that management believes are reasonable under the circumstances, including assumptions as to future events. Actual results may differ from those estimates.
Investments
Short-term investments consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than one year as of the balance sheet date. Long-term investments have maturities greater than one year as of the balance sheet date. All investments are carried at fair value based upon quoted market prices.
The Company periodically assesses its portfolio of debt investments for impairment. For debt securities in an unrealized loss position, this assessment first takes into account the intent to sell, or whether it is more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis. If either of these criteria are met, the debt security’s amortized cost basis is written down to fair value through interest and other, net. For debt securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in fair value has resulted from credit losses or other factors.
The Company evaluates expected credit losses by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions. Expected credit losses on available-for-sale debt securities are recognized in other income, net in the condensed consolidated statements of operations, and any remaining unrealized losses, net of taxes, are reported as a component of accumulated other comprehensive loss. The Company did not recognize any credit losses on its available-for-sale securities during the three and six months ended June 30, 2021 and there were no impairment charges for unrealized losses in the periods presented.
The cost of available-for-sale securities sold is based on the specific-identification method and realized gains and losses are included in earnings. Amortization of premiums and accretion of discounts are reported as a component of other income, net.
Accounts Receivable, Allowance for Doubtful Accounts and Contractual Allowances
Accounts receivable includes amounts due to the Company from healthcare institutions, third-party payors, and government payors and their related patients, as a result of the Company's normal business activities. Accounts receivable is reported on the consolidated balance sheets net of an estimated allowance for doubtful accounts and contractual allowances.
The Company establishes an allowance for doubtful accounts for estimated uncollectible receivables based on its assessment of the collectability of customer accounts and recognizes the provision as a component of selling, general and administrative expenses.
The Company records a provision for contractual allowances based on the estimated differences between contracted amounts and expected collection rates. Such provisions are based on the Company's historical experience and are reported as a reduction of revenue.
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
The Company regularly reviews the allowances by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay.
The following table presents the changes in the allowance for doubtful accounts (in thousands):
| | | | | | | | | | | | | | | | | |
| Six Months Ended June 30, 2021 | | Year Ended December 31, 2020 | | Six Months Ended June 30, 2020 |
Balance, beginning of period | $ | 12,711 | | | $ | 9,049 | | | $ | 9,049 | |
Add: provision for doubtful accounts | 3,703 | | | 10,515 | | | 5,957 | |
Add: adoption of ASC 326 | — | | | 461 | | | 461 | |
Less: write-offs, net of recoveries and other adjustments | (4,491) | | | (7,314) | | | (4,202) | |
Balance, end of period | $ | 11,923 | | | $ | 12,711 | | | $ | 11,265 | |
The following table presents the changes in the contractual allowance (in thousands):
| | | | | | | | | | | | | | | | | |
| Six Months Ended June 30, 2021 | | Year Ended December 31, 2020 | | Six Months Ended June 30, 2020 |
Balance, beginning of period | $ | 21,281 | | | $ | 15,433 | | | $ | 15,433 | |
Add: provision for contractual allowances | 10,477 | | | 20,916 | | | 7,567 | |
Less: realized contractual adjustments | (6,450) | | | (15,068) | | | (7,245) | |
Balance, end of period | $ | 25,308 | | | $ | 21,281 | | | $ | 15,755 | |
Concentrations of Risk
Credit Risk
Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash and cash equivalents, investments and accounts receivable. Cash balances are deposited in financial institutions which, at times may be in excess of federally insured limits. Cash equivalents are invested in highly-rated money market funds. The Company invests in a variety of financial instruments, such as, but not limited to, U.S. government securities, corporate notes, commercial paper and, by policy, limits the amount of credit exposure with any one financial institution or commercial issuer. The Company has not experienced any material losses on its deposits of cash and cash equivalents or investments.
Concentrations of credit risk with respect to accounts receivable are limited due to the large number of customers comprising the Company’s customer base and their dispersion across many geographies. The Company does not require collateral. The Company records an allowance for doubtful accounts based on the assessment of the collectability of customer accounts, considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer’s ability to pay. Centers for Medicare and Medicaid Services (“CMS”), accounted for approximately 14% of the Company's revenue for each of the three and six months ended June 30, 2021, and 27% of the Company’s revenue for each of the three and six months ended June 30, 2020. CMS accounted for 7% and 20% of accounts receivable at June 30, 2021 and December 31, 2020, respectively.
Revenue Recognition
The Company’s revenue is generated primarily from the provision of its cardiac rhythm monitoring service, the Zio XT service. The Zio XT is a cardiac rhythm monitoring service that has a patient wear period of up to 14 days and is billable when the monitoring reports are delivered to the healthcare provider, which is also when the service is complete and the Company recognizes revenue. The time from when the patient has the Zio XT device applied to the time the report is posted is generally around 25 days. The Company has concluded that the Zio XT service is one performance obligation on the basis that the customer cannot benefit from each component of the service on its own or together with other resources that are readily available to the customer.
The Zio AT mobile cardiac telemetry monitor, a wearable patch-based biosensor, offers what the Zio XT offers plus the additional capability of transmissions during the wear period to assist physicians in diagnosing and treating patients that require
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
more timely action. During the wear period, physicians will receive notifications if there are significant events that meet predetermined arrhythmia detection criteria. The Zio AT service revenue is recognized ratably over the prescription period.
The Company recognizes as revenue the amount of consideration to which it expects to be entitled in exchange for performing the service. The consideration the Company is entitled to varies by portfolio, as further defined below, and includes estimates that require significant judgment by management. A unique aspect of healthcare is the involvement of multiple parties to the service transaction. In addition to the patient, often a third-party, for example a commercial or governmental payor or healthcare institution, will pay the Company for some or all of the service on the patient’s behalf. Separate contractual arrangements exist between the Company and third-party payors that establish amounts the third-party payor will pay on behalf of a patient for covered services rendered.
A small portion of the Company’s transactions are covered by third-party payors with whom there is neither a contractual agreement nor an established amount that the third-party payor will pay. In determining the collectability and transaction price for its service, the Company considers factors such as insurance claims which are adjudicated as allowable under the applicable policy and payment history from both payors and patient out-of-pocket costs, payor coverage, whether there is a contract between the payor or healthcare institution and the Company, historical amount received for the service, and any current developments or changes that could impact reimbursement and healthcare institution payments. Certain of these factors are forms of variable consideration which are only included in the transaction price to the extent it is probable that a significant reversal of cumulative revenue will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
A summary of the payment arrangements with third-party payors and healthcare institutions is as follows:
•Contracted third-party payors – The Company has contracts with negotiated prices for services provided to patients with commercial healthcare insurance coverage.
•CMS – The Company has received independent diagnostic testing facility approval from regional Medicare Administrative Contractors and will receive reimbursement per the relevant CPT code rates for the services rendered to the patient covered by CMS.
•Non-contracted third-party payors – Non-contracted commercial and government payors often reimburse out-of-network rates provided under the relevant CPT codes on a case-by-case basis. The transaction price used for determining revenue recognition is based on factors including an average of the Company’s historical collection experience for its non-contracted services. This rate is reviewed at least quarterly.
•Healthcare institutions – Healthcare institutions are typically hospitals or physician practices in which the Company has negotiated amounts for its monitoring services, including certain governmental agencies such as the Veterans Administration and Department of Defense.
The Company is utilizing the portfolio approach practical expedient under ASC 606 for revenue recognition whereby services provided under each of the above payor types form a separate portfolio. The Company accounts for the contracts within each portfolio as a collective group, rather than individual contracts. Based on history with these portfolios and the similar nature and characteristics of the patients within each portfolio, the Company has concluded that the financial statement effects are not materially different than if accounting for revenue on a contract-by-contract basis.
For contracted and CMS portfolios, the Company recognizes revenue, net of contractual allowances, and recognizes an allowance for doubtful accounts for uncollectible patient accounts receivable. The transaction price is determined based on negotiated rates, and the Company has historical experience of collecting substantially all of these contracted rates. These contracts also impose a number of obligations regarding billing and other matters, and the Company’s noncompliance with a material term of such contracts may result in a denial of the claim. The Company accounts for denied claims as a form of variable consideration that is included as a reduction to the transaction price recognized as revenue. The Company estimates the denied claims which require management judgment. The estimated denied claims are based on historical information and judgement includes the historical period utilized. The Company monitors the estimated denied claims against the latest available information, and subsequent changes to the estimated denied claims are recorded as an adjustment to revenue in the periods during which such changes occur. Historical cash collection indicates that it is probable that substantially all of the transaction price, less the estimate of denied claims, will be received. Contracted payors may require that we bill patient co-payments and deductibles and from time to time we may not be able to collect such amounts due to credit risk. The Company provides for estimates of uncollectible patient accounts receivable, based upon historical experience where judgment includes the historical period utilized, at the time revenue is recognized, with such provisions presented as bad debt expense within the
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
selling, general and administrative line item of the consolidated statement of operations. Adjustments to these estimates for actual experience are also recorded as an adjustment to bad debt expense.
For non-contracted portfolios, the Company is providing an implicit price concession due to the lack of a contracted rate with the underlying payor, the result of which requires the Company to estimate the transaction price based on historical cash collections utilizing the expected value method. All subsequent adjustments to the transaction price are recorded as an adjustment to revenue.
For healthcare institutions, the transaction price is determined based on negotiated rates, and the Company has historical experience collecting substantially all of these contracted rates. Historical cash collection indicates that it is probable that substantially all of the transaction price will be received. As such, the Company is not providing an implicit price concession but, rather, has chosen to accept the risk of default, and any subsequent uncollected amounts are recorded as bad debt expense.
Disaggregation of Revenue
The Company disaggregates revenue from contracts with customers by payor type. The Company believes these categories aggregate the payor types by nature, amount, timing and uncertainty of its revenue streams. Disaggregated revenue by payor type and major service line for three and six months ended June 30, 2021 and June 30, 2020 were as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
| 2021 | | 2020 | | 2021 | | 2020 |
Contracted third-party payors | $ | 49,633 | | | $ | 26,544 | | | $ | 96,225 | | | $ | 58,254 | |
Non-contracted third-party payors | 6,547 | | | 2,868 | | | 11,825 | | | 6,244 | |
Centers for Medicare & Medicaid | 10,989 | | | 13,718 | | | 21,166 | | | 31,034 | |
Healthcare Institutions | 14,109 | | | 7,748 | | | 26,373 | | | 18,881 | |
Total | $ | 81,278 | | | $ | 50,878 | | | $ | 155,589 | | | $ | 114,413 | |
Contract Liabilities
ASC 606 requires an entity to present a revenue contract as a contract liability when the Company has an obligation to transfer goods or services to a customer for which the Company has received consideration from the customer, or an amount of consideration from the customer is due and unconditional (whichever is earlier).
Certain of the Company’s customers pay the Company directly for the Zio XT service upon shipment of devices. Such advance payments are contract liabilities and are recorded as deferred revenue on the Condensed Balance Sheets and revenue is recognized when reports are delivered to the healthcare provider. During the six months ended June 30, 2021, $0.9 million relating to the contract liability balance at the beginning of 2021 was recognized as revenue. Total revenue recognized during the six months ended June 30, 2020 that was included in the contract liability balance at the beginning of 2020 was $1.2 million.
Contract Costs
Under ASC 340, the incremental costs of obtaining a contract with a customer are recognized as an asset. Incremental costs of obtaining a contract are those costs that an entity incurs to obtain a contract with a customer that it would not have incurred if the contract had not been obtained.
The Company’s current commission programs are considered incremental. However, as a practical expedient, ASC 340 permits the Company to immediately expense contract acquisition costs, as the asset that would have resulted from capitalizing these costs will be amortized in one year or less.
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
Stock-based Compensation
The Company measures its stock-based awards made to employees based on the estimated fair values of the awards as of the grant date. The fair value of market condition awards is determined using the Monte-Carlo option pricing model and the fair value of stock options is determined using the Black-Scholes option pricing model. Stock-based compensation expense is recognized over the requisite service period using the straight-line method and is based on the value of the portion of stock-based payment awards that is ultimately expected to vest. As such, the Company’s stock-based compensation is reduced for the estimated forfeitures at the date of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. For restricted stock, the compensation cost for these awards is based on the closing price of the Company’s common stock on the date of grant, and recognized as compensation expense on a straight-line basis over the requisite service period.
The Company recognizes compensation expense related to the Employee Stock Purchase Plan (“ESPP”) based on the estimated fair value of the options on the date of grant, net of estimated forfeitures. The Company estimates the grant date fair value, and the resulting stock-based compensation expense, using the Black-Scholes option pricing model for each purchase period. The grant date fair value is expensed on a straight-line basis over the offering period.
3. Cash Equivalents and Investments
The fair value of cash equivalents and available-for-sale investments at June 30, 2021 and December 31, 2020, were as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| June 30, 2021 |
| Amortized Cost | | Gross Unrealized | | Estimated Fair Value |
| | Gains | | Losses | |
Money market funds | $ | 104,615 | | | $ | — | | | $ | — | | | $ | 104,615 | |
U.S. government securities | 56,188 | | | 10 | | | — | | | 56,198 | |
Corporate notes | 31,622 | | | 1 | | | (4) | | | 31,619 | |
Commercial paper | 28,975 | | | — | | | — | | | 28,975 | |
Total cash equivalents and available-for-sale investments | $ | 221,400 | | | $ | 11 | | | $ | (4) | | | $ | 221,407 | |
Classified as: | | | | | | | |
Cash equivalents | | | | | | | $ | 104,615 | |
Short-term investments | | | | | | | 116,792 | |
Total cash equivalents and available-for-sale investments | | | | | | | $ | 221,407 | |
| December 31, 2020 |
| Amortized Cost | | Gross Unrealized | | Estimated Fair Value |
| | Gains | | Losses | |
Money market funds | $ | 59,823 | | | $ | — | | | $ | — | | | $ | 59,823 | |
U.S. government securities | 190,663 | | | 16 | | | (2) | | | 190,677 | |
Corporate notes | 26,426 | | | 2 | | | (5) | | | 26,423 | |
Commercial paper | 29,489 | | | — | | | — | | | 29,489 | |
Total cash equivalents and available-for-sale investments | $ | 306,401 | | | $ | 18 | | | $ | (7) | | | $ | 306,412 | |
Classified as: | | | | | | | |
Cash equivalents | | | | | | | $ | 59,823 | |
Short-term investments | | | | | | | 246,589 | |
Total cash equivalents and available-for-sale investments | | | | | | | $ | 306,412 | |
The following table summarizes the fair value of the Company’s cash equivalents, short-term and long-term marketable securities classified by maturity (in thousands):
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
| | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
Due within one year | $ | 221,407 | | | $ | 306,412 | |
Due after one year through three years | — | | | — | |
Total cash equivalents and available-for-sale investments | $ | 221,407 | | | $ | 306,412 | |
There were no available-for-sale securities that were in an unrealized loss position for more than twelve months as of June 30, 2021. Unrealized losses as of June 30, 2021, and December 31, 2020, were not material. Available-for-sale securities held as of June 30, 2021 had a weighted average maturity of 66 days. At June 30, 2021, seven investments were in an unrealized loss position and no investments have been in an unrealized loss position for more than one year.
4. Fair Value Measurements
The Company discloses and recognizes the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows:
Level 1 - Inputs are unadjusted quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2 - Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
Level 3 - Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. The corporate notes, commercial paper and government securities are classified as Level 2 as they were valued based upon quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets.
The fair value of the Company’s outstanding interest-bearing obligations is estimated using the net present value of the future payments, discounted at an interest rate that is consistent with market interest rates, which is a Level 2 input. The carrying amount and the estimated fair value of the Company’s outstanding interest-bearing obligations at June 30, 2021 were $27.2 million and $27.8 million, respectively. The carrying amount and the estimated fair value of the Company’s outstanding interest-bearing obligations at December 31, 2020 were $33.0 million and $33.9 million, respectively.
The Company had no transfers between levels of the fair value hierarchy of its assets measured at fair value.
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
The following tables present the fair value of the Company’s financial assets determined using the inputs defined above (in thousands).
| | | | | | | | | | | | | | | | | | | | | | | |
| June 30, 2021 |
| Level 1 | | Level 2 | | Level 3 | | Total |
Assets | | | | | | | |
Money market funds | $ | 104,615 | | | $ | — | | | $ | — | | | $ | 104,615 | |
U.S. government securities | — | | | 56,198 | | | — | | | 56,198 | |
Corporate notes | — | | | 31,619 | | | — | | | 31,619 | |
Commercial paper | — | | | 28,975 | | | — | | | 28,975 | |
Total | $ | 104,615 | | | $ | 116,792 | | | $ | — | | | $ | 221,407 | |
| | | | | | | | | | | | | | | | | | | | | | | |
| December 31, 2020 |
| Level 1 | | Level 2 | | Level 3 | | Total |
Assets | | | | | | | |
Money market funds | $ | 59,823 | | | $ | — | | | $ | — | | | $ | 59,823 | |
U.S. government securities | — | | | 190,677 | | | — | | | 190,677 | |
Corporate notes | — | | | 26,423 | | | — | | | 26,423 | |
Commercial paper | — | | | 29,489 | | | — | | | 29,489 | |
Total | $ | 59,823 | | | $ | 246,589 | | | $ | — | | | $ | 306,412 | |
5. Balance Sheet Components
Inventory and Other Assets
Inventory consisted of the following (in thousands):
| | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
Raw materials | $ | 4,001 | | | $ | 2,469 | |
Finished goods | 5,260 | | | 2,844 | |
Total | $ | 9,261 | | | $ | 5,313 | |
The Company uses PCBAs in each wearable Zio XT and Zio AT monitor as well as in the wireless gateway used in conjunction with the Zio AT monitor. The PCBAs are used numerous times and have useful lives beyond one year. Each time a PCBA is used in a wearable Zio XT monitor or Zio AT monitor, a portion of the cost of the PCBA is recorded as a cost of revenue. Each time a wireless gateway is used with a Zio AT monitor, a portion of the gateway is recorded as a cost of revenue. PCBAs which are recorded as other assets, were $12.5 million and $12.6 million as of June 30, 2021, and December 31, 2020, respectively.
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
| | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
Laboratory and manufacturing equipment | $ | 5,044 | | | $ | 4,667 | |
Computer equipment and software | 2,013 | | | 2,005 | |
Furniture and fixtures | 4,158 | | | 3,794 | |
Leasehold improvements | 17,399 | | | 9,215 | |
Internal-use software | 36,511 | | | 28,416 | |
Total property and equipment, gross | 65,125 | | | 48,097 | |
Less: accumulated depreciation and amortization | (18,039) | | | (13,850) | |
Total property and equipment, net | $ | 47,086 | | | $ | 34,247 | |
Depreciation and amortization expense was $2.2 million and $4.2 million for the three and six months ended June 30, 2021, respectively, and $1.6 million and $3.2 million for three and six months ended June 30, 2020, respectively.
Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
| | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
Accrued vacation | $ | 7,194 | | | $ | 6,007 | |
Accrued payroll and related expenses | 22,374 | | | 19,709 | |
Accrued ESPP contribution | 578 | | | 851 | |
Accrued professional services fees | 1,612 | | | 1,709 | |
Accrued interest | 96 | | | 121 | |
Claims payable | 4,669 | | | 4,757 | |
Other | 6,075 | | | 7,378 | |
Total accrued liabilities | $ | 42,598 | | | $ | 40,532 | |
6. Commitments and Contingencies
Legal Proceedings
From time to time, the Company is involved in claims and legal proceedings or investigations, that arise in the ordinary course of business. Such matters could have an adverse impact on its reputation, business and the financial condition and divert the attention of its management from the operation of its business. These matters are subject to many uncertainties and outcomes that are not predictable.
On February 1, 2021, a putative class action lawsuit was filed in the United States District Court for the Northern District of California alleging that the Company and our former Chief Executive Officer, Kevin M. King, violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 promulgated thereunder. On August 2, 2021, the lead plaintiff filed an amended complaint that, in addition to the Company and Mr. King, also names our former Chief Executive Officer, Michael J. Coyle, and current interim Chief Executive Officer, Douglas J. Devine, as defendants. The purported class in the amended complaint includes all persons who purchased or acquired our common stock between August 4, 2020 and July 13, 2021. The amended complaint seeks unspecified damages purportedly sustained by the class. The Company believes the class action to be without merit and plans to vigorously defend itself.
On March 26, 2021, the Company received a subpoena from the U.S. Attorney’s Office for the Northern District of California requesting information related to communications with the Food and Drug Administration and the Company’s products. We have not been informed that the Company is considered a target of the investigation or committed any violations. The Company is cooperating fully and is providing the requested information.
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
Development Agreement
On September 3, 2019, the Company entered into a Development Collaboration Agreement (the “Development Agreement”) with Verily Life Sciences LLC (“Verily”). The Development Agreement, which is over a 24 month term, involves joint development and production of intellectual property between the Company and Verily. Each participant has primary responsibility for certain aspects of development and approval, with all processes to be performed at each respective party’s own cost. Costs incurred by the Company in connection with the Development Agreement will be expensed as research and development expense in accordance with ASC 730, Research and Development.
The Company and Verily will develop certain next-generation atrial fibrillation (“AF”) screening, detection, or monitoring products pursuant to the Development Agreement, which products will involve combining Verily and the Company’s technology platforms and capabilities. Under the terms of the Development Agreement, the Company paid Verily an upfront fee of $5.0 million in 2019. In addition, the Company has agreed to make additional payments to Verily up to an aggregate of $12.75 million in milestone payments upon achievement of various development and regulatory milestones over the 24 months of the Development Agreement, which payments will be made in cash to Verily. During the year ended December 31, 2020, the Company recognized $7.0 million of research and development expense related to Verily milestones. No payment-triggering milestones were achieved during the six months ended June 30, 2021. The Company expects to incur an additional, milestone-related expense of $3.0 million for the year ended December 31, 2021.
The Development Agreement provides each party with licenses to use certain intellectual property of the other party for development activities in the field of AF screening, detection, or monitoring. Ownership of developed intellectual property will be allocated to the Company or Verily depending on the subject matter of the underlying developed intellectual property, and, for certain subject matter, shall be jointly owned.
Indemnifications
In the ordinary course of business, the Company enters into agreements pursuant to which it agrees to indemnify customers, vendors, lessors, business partners, and other parties with respect to certain matters, including losses arising out of the breach of such agreements, services to be provided by the Company, or from intellectual property infringement claims made by third parties. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by applicable law. The Company currently has directors’ and officers’ insurance. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions, and believes that the estimated fair value of these indemnification obligations is not material and it has not accrued any amounts for these obligations.
7. Debt
Bank Debt
In December 2015, the Company entered into a Second Amended and Restated Loan and Security Agreement (“Loan Agreement”) with Silicon Valley Bank (“SVB”). Under the SVB Loan Agreement, the Company could borrow, repay and reborrow under a revolving credit line, but not in excess of the maximum loan amount of $15.0 million, until December 4, 2018, when all outstanding principal and accrued interest became due and payable. Any principal amount outstanding under the SVB Loan Agreement shall bear interest at a floating rate per annum equal to the rate published by The Wall Street Journal as the “Prime Rate” plus 0.25%. The Company could borrow up to 80% of its eligible accounts receivable, up to the maximum of $15.0 million.
In October 2018, the Company entered into the Third Amended and Restated Loan and Security Agreement with SVB (“Third Amended and Restated SVB Loan Agreement”). This Agreement amends and restates the Second Amended and Restated Loan and Security Agreement between the Company and SVB dated December 4, 2015, as amended by the First Loan Modification Agreement between the Company and SVB dated August 22, 2016.
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
Pursuant to the Third Amended and Restated SVB Loan Agreement, the Company obtained a term loan (“SVB Term Loan”) for $35.0 million. Total proceeds from the SVB Term Loan were used to pay off the loan agreement with Biopharma Secured Investments III Holdings Cayman LP (“Pharmakon”), totaling $35.8 million. The Company made interest-only payments through October 31, 2020. Beginning in November 2020, the Company began monthly payments of principal plus interest, which will continue through October 31, 2024. Interest charged on the SVB Term Loan will be the greater of (a) a floating rate based on the “Prime Rate” published by The Wall Street Journal minus 0.75%, or (b) 4.25%.
Under the Third Amended and Restated SVB Loan Agreement, the Company may borrow, repay, and reborrow under a revolving credit line, but not in excess of the maximum loan amount of $25.0 million, which includes an $11.0 million standby letter of credit sublimit availability. In October 2018, a $6.9 million standby letter of credit was obtained in connection with a lease for the Company’s San Francisco headquarters. Any principal amount outstanding under the Third Amended and Restated SVB Loan Agreement revolving credit line shall bear interest at an amount that is the greater of (a) a floating rate per annum equal to the rate published by The Wall Street Journal as the “Prime Rate” or (b) 5.00%. The Company may borrow up to 75% of eligible accounts receivable, up to the maximum of $25.0 million.
The Third Amended and Restated Loan Agreement requires the Company to maintain a minimum consolidated liquidity ratio or minimum adjusted Earnings Before Interest, Tax, Depreciation, and Amortization during the term of the loan facility. In addition, the SVB Loan Agreement contains customary affirmative and negative covenants and events of default. The Company was in compliance with loan covenants as of June 30, 2021. The obligations under the Third Amended and Restated Loan Agreement are collateralized by substantially all assets of the Company.
8. Income Taxes
The Company recorded a tax provision related to its U.S. state taxes and the U.K. subsidiary during the six months ended June 30, 2021 and June 30, 2020. Due to the uncertainties surrounding the realization of the U.S. deferred tax assets through future taxable income, the Company has provided a full valuation allowance and, therefore, no benefit has been recognized for the U.S. net operating loss carryforwards and other deferred tax assets.
9. Stockholders’ Equity
Common stock
The Company’s amended and restated certificate of incorporation dated October 25, 2016, as amended, authorizes the Company to issue 100,000,000 shares of common stock with a par value of $0.001 per share and 5,000,000 shares of preferred stock with a par value of $0.001 per share. The holders of common stock are entitled to receive dividends whenever funds and assets are legally available and when declared by the board of directors, subject to the prior rights of holders of all series of convertible preferred stock outstanding. No dividends were declared through June 30, 2021.
The Company had reserved shares of common stock for issuance as follows:
| | | | | | | | | | | |
| June 30, 2021 | | December 31, 2020 |
Options issued and outstanding | 527,536 | | | 609,881 | |
Unvested restricted stock units | 1,074,814 | | | 1,114,159 | |
Shares available for grant under future stock plans | 9,670,121 | | | 8,016,517 | |
Shares available for future issuance | 11,272,471 | | | 9,740,557 | |
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
10. Equity Incentive Plans
Equity Incentive Plan Activity
A summary of share-based awards available for grant under the 2016 Equity Incentive Plan is as follows: | | | | | |
| Awards Available for Grant |
Balance at December 31, 2019 | 5,528,132 | |
Additional awards authorized | 1,333,928 | |
Awards granted | (595,915) | |
Awards forfeited | 156,623 | |
Awards withheld for tax purposes | 82,622 | |
Balance at December 31, 2020 | 6,505,390 | |
Additional awards authorized | 1,450,967 | |
Awards granted | (511,148) | |
Awards forfeited | 193,816 | |
Awards withheld for tax purposes | 135,886 | |
Balance at June 30, 2021 | 7,774,911 | |
During the six months ended June 30, 2021, 344,414 restricted stock units (“RSUs”) were granted, 235,123 RSUs vested, and 74,840 RSUs were forfeited.
The following table summarizes stock option activity under the 2006 and 2016 Equity Incentive Plans:
| | | | | | | | | | | | | | | | | | | | | | | |
| | | Options Outstanding |
| Options Outstanding | | Weighted- Average Exercise Price Per Share | | Weighted- Average Remaining Contractual Life (years) | | Aggregate Intrinsic Value (in thousands) |
Balance at December 31, 2019 | 1,503,247 | | | $ | 27.40 | | | 6.43 | | $ | 62,401 | |
| | | | | | | |
Options exercised | (868,614) | | | $ | 17.31 | | | | | |
Options forfeited | (24,752) | | | $ | 66.89 | | | | | |
Balance at December 31, 2020 | 609,881 | | | $ | 40.18 | | | 6.24 | | $ | 120,163 | |
| | | | | | | |
Options exercised | (77,228) | | | $ | 29.68 | | | | | |
Options forfeited | (5,117) | | | $ | 63.72 | | | | | |
Balances at June 30, 2021 | 527,536 | | | $ | 41.49 | | | 5.73 | | $ | 13,896 | |
Options exercisable – June 30, 2021 | 467,756 | | | $ | 37.82 | | | 5.65 | | $ | 13,792 | |
Options vested and expected to vest – June 30, 2021 | 526,235 | | | $ | 41.41 | | | 5.73 | | $ | 13,895 | |
The aggregate intrinsic values of options outstanding, exercisable, vested and expected to vest were calculated as the difference between the exercise price of the options and the closing price of the Company’s common stock.
The Company did not grant any options during the six months ended June 30, 2021, and 2020.
IRHYTHM TECHNOLOGIES, INC.
Notes to the Unaudited Condensed Consolidated Financial Statements (Continued)
11. Stock-Based Compensation
Market-based RSU Valuation
The fair value of market based RSUs was estimated at the date of grant using the Monte-Carlo option pricing model with the assumptions below. Additional details on the Company's market based RSUs are included below. | | | | | |
| Six Months Ended June 30, |
| 2021 |
Expected term (in years) | 0.74 |
Expected volatility | |