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 March 31, 2017
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 |
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20-8149544 |
(State or Other Jurisdiction of Incorporation or Organization) |
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(I.R.S. Employer Identification No.) |
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650 Townsend Street, Suite 500, San Francisco, California |
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94103 |
(Address of Principal Executive Offices) |
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(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 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 |
☐ |
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Accelerated filer |
☐ |
Non-accelerated filer |
☒ |
(Do not check if a smaller reporting company) |
Smaller reporting company |
☐ |
Emerging growth company |
☒ |
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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 April 30, 2017, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 22,228,349.
TABLE OF CONTENTS
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Page No. |
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1 |
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1 |
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2 |
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3 |
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4 |
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5 |
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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23 |
Item 3. Quantitative and Qualitative Disclosures About Market Risk |
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29 |
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29 |
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30 |
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30 |
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30 |
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
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56 |
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56 |
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56 |
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56 |
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56 |
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57 |
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58 |
i
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:
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plans to conduct further clinical studies |
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our plans to modify our current products, or develop new products, to address additional indications |
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the expected growth of our business and our organization |
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our expectations regarding government and third party payor coverage and reimbursement |
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our expectations regarding the size of our sales organization and expansion of our sales and marketing efforts in international geographies |
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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 |
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our ability to retain and recruit key personnel, including the continued development of a sales and marketing infrastructure |
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our ability to obtain and maintain intellectual property protection for our products |
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our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for, or ability to obtain, additional financing |
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our expectations regarding the time during which we will be an emerging growth company under the JOBS Act |
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our ability to identify and develop new and planned products and acquire new products |
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our financial performance |
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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.
ii
IRHYTHM TECHNOLOGIES, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands, except share and per share data)
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March 31, 2017 |
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December 31, 2016 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
15,583 |
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$ |
51,643 |
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Investments, short-term |
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77,397 |
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54,407 |
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Accounts receivable, net |
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10,982 |
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9,406 |
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Inventory |
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1,156 |
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1,390 |
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Prepaid expenses and other current assets |
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1,388 |
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1,671 |
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Restricted cash |
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91 |
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91 |
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Total current assets |
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106,597 |
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118,608 |
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Investments, long-term |
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16,429 |
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10,981 |
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Property and equipment, net |
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5,529 |
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4,653 |
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Goodwill |
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862 |
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862 |
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Other assets |
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3,384 |
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3,052 |
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Total assets |
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$ |
132,801 |
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$ |
138,156 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
1,413 |
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$ |
2,103 |
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Accrued liabilities |
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8,284 |
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10,165 |
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Deferred revenue |
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980 |
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947 |
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Total current liabilities |
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10,677 |
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13,215 |
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Debt |
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32,652 |
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32,227 |
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Deferred rent, noncurrent portion |
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26 |
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26 |
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Accrued interest, net of current portion |
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134 |
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126 |
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Total liabilities |
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43,489 |
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45,594 |
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Commitments and contingencies (Note 7) |
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Stockholders’ deficit: |
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Preferred stock, $0.001 par value – 5,000,000 authorized at March 31, 2017 and December 31, 2016, respectively; and none issued and outstanding at March 31, 2017 and December 31, 2016, respectively |
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— |
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— |
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Common stock, $0.001 par value – 100,000,000 shares authorized at March 31, 2017 and December 31, 2016, respectively; 22,153,146 and 22,139,346 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively |
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27 |
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22 |
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Additional paid-in capital |
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221,776 |
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219,718 |
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Accumulated other comprehensive loss |
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(19 |
) |
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(9 |
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Accumulated deficit |
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(132,472 |
) |
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(127,169 |
) |
Total stockholders’ equity |
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89,312 |
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92,562 |
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Total liabilities, stockholders’ equity |
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$ |
132,801 |
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$ |
138,156 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share data)
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Three Months Ended March 31, |
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2017 |
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2016 |
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Revenue |
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$ |
21,437 |
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$ |
12,854 |
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Cost of revenue |
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6,337 |
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4,659 |
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Gross profit |
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15,100 |
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8,195 |
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Operating expenses: |
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Research and development |
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2,621 |
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1,545 |
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Selling, general and administrative |
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17,224 |
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11,521 |
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Total operating expenses |
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19,845 |
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13,066 |
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Loss from operations |
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(4,745 |
) |
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(4,871 |
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Interest expense |
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(822 |
) |
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(795 |
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Other income (expense), net |
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264 |
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(460 |
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Net loss |
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$ |
(5,303 |
) |
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$ |
(6,126 |
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Net loss per common share, basic and diluted |
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$ |
(0.24 |
) |
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$ |
(4.34 |
) |
Weighted-average shares used to compute net loss per common share, basic and diluted |
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22,151,926 |
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1,413,052 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited)
(In thousands)
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Three Months Ended March 31, |
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2017 |
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2016 |
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Net Loss |
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$ |
(5,303 |
) |
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$ |
(6,126 |
) |
Other comprehensive loss: |
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Unrealized loss on available-for-sale securities |
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(19 |
) |
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— |
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Comprehensive loss |
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$ |
(5,322 |
) |
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$ |
(6,126 |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
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Three Months Ended March 31, |
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2017 |
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2016 |
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Cash flows from operating activities |
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Net loss |
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$ |
(5,303 |
) |
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$ |
(6,126 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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298 |
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227 |
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Stock-based compensation |
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2,028 |
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408 |
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Amortization of debt discount and issuance costs |
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64 |
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62 |
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Amortization of premiums (accretion of discounts) on investments, net |
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(46 |
) |
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— |
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Non-cash interest expense |
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375 |
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361 |
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Change in allowance for doubtful accounts and contractual allowance |
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1,772 |
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1,038 |
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Change in fair value of preferred stock warrant liabilities |
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— |
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462 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(3,348 |
) |
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(3,134 |
) |
Inventory |
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234 |
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(236 |
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Prepaid expenses and other current assets |
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403 |
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42 |
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Other assets |
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(346 |
) |
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(230 |
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Accounts payable |
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(690 |
) |
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1,009 |
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Accrued liabilities |
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(1,873 |
) |
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(3,239 |
) |
Deferred revenue |
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33 |
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(132 |
) |
Net cash used in operating activities |
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(6,399 |
) |
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(9,488 |
) |
Cash flows from investing activities |
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Purchases of property and equipment |
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(1,174 |
) |
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(659 |
) |
Purchases of available-for-sale investments |
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(31,822 |
) |
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— |
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Maturities of available-for-sale investments |
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3,300 |
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— |
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Net cash used in investing activities |
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(29,696 |
) |
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(659 |
) |
Cash flows from financing activities |
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Proceeds from issuance of common stock upon exercise of stock options, net of repurchases |
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35 |
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6 |
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Payments of deferred issuance costs |
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— |
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(822 |
) |
Net cash provided by (used in) financing activities |
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35 |
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(816 |
) |
Net decrease in cash and cash equivalents |
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(36,060 |
) |
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(10,963 |
) |
Cash and cash equivalents, beginning of period |
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51,643 |
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25,208 |
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Cash and cash equivalents, end of period |
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$ |
15,583 |
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$ |
14,245 |
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Supplemental disclosures of cash flow information |
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Interest paid |
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$ |
375 |
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$ |
472 |
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Non-cash investing and financing activities |
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Series E Preferred Stock Issuance costs included in accrued liabilities |
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$ |
— |
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$ |
52 |
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Deferred offering costs included in accounts payables and accrued liabilities |
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$ |
— |
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$ |
923 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
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 machine-learning capabilities. The Company commenced commercial introduction of its products in the United States in 2009 following clearance by the U.S. Food and Drug Administration.
The Company’s headquarters are based in San Francisco, California, and the Company has manufacturing facilities in Cypress, California, and clinical centers in Lincolnshire, Illinois and Houston, Texas. In March 2016, the Company formed a wholly-owned subsidiary in the United Kingdom. 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, based upon the billing address of the customer.
Reverse Stock Split
On October 4, 2016, the Company’s board of directors approved an amendment to the Company’s amended and restated certificate of incorporation to effect a reverse split of the Company’s issued and outstanding common stock at a 1-for-5.882698 ratio, which was effected on October 5, 2016. The par value and authorized shares of common stock and convertible preferred stock were not adjusted as a result of the reverse split. All issued and outstanding common stock, options to purchase common stock and per share amounts contained in these condensed consolidated financial statements have been retroactively adjusted to reflect the reverse stock split for all periods presented.
Initial Public Offering
The Company’s initial public offering (“IPO”) of 7,238,235 shares of common stock was effected through a registration statement on Form S-1 (Registration Nos. 333-213773 and 333-214179), which was declared effective on October 19, 2016. The initial public offering closed on October 25, 2016 and resulted in net proceeds of approximately $110.7 million, after deducting underwriting discounts and commissions of $8.6 million and other expenses of $3.7 million.
In October 2016, immediately upon the Company’s sale of its common stock in the initial public offering, all outstanding shares of convertible preferred stock converted into 13,375,333 shares of common stock with the related carrying value of $97.6 million reclassified to common stock and additional paid-in capital. In addition, all convertible preferred stock warrants were also thereby converted into common stock warrants.
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, or U.S. GAAP, and applicable rules and regulations of the Securities and Exchange Commission, or 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, 2016 has been derived from the audited consolidated financial statements at that date but does 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 months ended March 31, 2017 are not necessarily indicative of the results to be expected for the year ending December 31, 2017 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, 2016 included in the Company’s Form 10-K, filed with the SEC on March 31, 2017, pursuant to Rule 424(b) under the Securities Act of 1934.
5
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The accompanying interim unaudited condensed consolidated financial statements are consolidated for the three months ended March 31, 2017 and 2016 and include the accounts of iRhythm Technologies, Inc. and its wholly-owned subsidiary, iRhythm Technologies Ltd., established in March 2016. The financial statements of iRhythm Technologies Ltd. use the U.S. dollar as the functional currency. For all non-functional currency balances, the remeasurement of such balances to functional currency results in a foreign exchange transaction gain or loss, which is recorded in the consolidated statements of operations.
Use of Estimates
The preparation of the condensed 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 for revenue, 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 valuation of deferred tax assets, the fair value of the Company’s preferred and common stock and stock-based compensation. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to future events. Actual results may differ from those estimates.
Fair Value of Financial Instruments
The carrying amounts of certain of the Company’s financial instruments, which includes cash equivalents, accounts receivable, accounts payable and accrued liabilities, approximate fair value due to their short maturities.
Cash Equivalents
Cash equivalents consist of short-term, highly liquid investments with original maturities of three months or less from the date of purchase.
Investments
Short-term investments consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than 365 days from the date of acquisition. Long-term investments have maturities greater than 365 days as of the balance sheet date. All investments are carried at fair value based upon quoted market prices. Unrealized gains and losses on available-for-sale securities are excluded from earnings and are reported as a component of accumulated other comprehensive loss. The cost of available-for-sale securities sold is based on the specific-identification method. Realized gains and losses are included in earnings, and are derived for specific-identification method for determining the costs of investments sold.
Restricted Cash
Restricted cash consists of certificates of deposit held with a financial institution as security deposits for building leases and is included in short-term assets on the Company's balance sheets.
Accounts Receivable, Allowance for Doubtful Accounts and Contractual Allowance
Accounts receivable consists of amounts due to the Company from institutions, government payors and commercial insurance payors as a result of the Company's normal business activities. Accounts receivable is reported on the balance sheet net of an estimated allowance for doubtful accounts and contractual allowance.
The Company establishes an allowance for doubtful accounts for estimated uncollectible receivables based on its historical experience as a component of selling, general and administrative expenses. The Company establishes a contractual allowance, which is a reduction in revenue, for estimated uncollectible amounts from Centers for Medicare & Medicaid Services (“CMS”), and contracted third-party commercial payors.
6
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The following table presents the changes in the allowance for doubtful accounts:
|
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March 31, |
|
|
December 31, |
|
||
|
|
2017 |
|
|
2016 |
|
||
Balance, beginning of period |
|
$ |
1,792 |
|
|
$ |
1,125 |
|
Add: provision for doubtful accounts |
|
|
561 |
|
|
|
1,960 |
|
Less: write-offs, net of recoveries and other adjustments |
|
|
(132 |
) |
|
|
(1,293 |
) |
Balance, end of period |
|
$ |
2,221 |
|
|
$ |
1,792 |
|
The following table presents the changes in the contractual allowance:
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2017 |
|
|
2016 |
|
||
Balance, beginning of period |
|
$ |
2,340 |
|
|
$ |
338 |
|
Add: contractual allowances |
|
|
1,211 |
|
|
|
2,726 |
|
Less: write-offs, net of recoveries and other adjustments |
|
|
(86 |
) |
|
|
(724 |
) |
Balance, end of period |
|
$ |
3,465 |
|
|
$ |
2,340 |
|
Management reviews and updates its estimates for the allowances for doubtful accounts and contractual allowance periodically to reflect its experience regarding historical collections. If management were to make different judgments or utilize different estimates in the allowances for doubtful accounts and contractual allowance, differences in the amount of reported selling, general and administrative expenses and revenue could result, respectively.
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 and cash equivalents and investments are deposited with one financial institution in the United States of America. At times, such deposits 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, United States 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 when it becomes probable that a receivable will not be collected. Government agencies, including CMS and the Veterans Administration, accounted for approximately 37% and 42% of the Company’s revenue for the three months ended March 31, 2017 and 2016 respectively. Accounts receivable related to government agencies accounted for 24% and 27% at March 31, 2017 and December 31, 2016, respectively.
Supply Risk
While the company has not experienced manufacturing supply disruptions to date, the Company relies on single-source vendors for the supply of its reusable printed circuit board assemblies, disposable housings, instruments and other materials used to manufacture the ZIO Patch and the adhesive that binds the ZIO Patch to a patient’s body. These components and materials are critical, and there could be a considerable delay in finding alternative sources of supply.
7
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Inventory is stated at the lower of cost or market, cost being determined on a standard cost basis for material costs and on actual cost basis for labor and overhead, which approximates actual cost on a first in, first out (“FIFO)” basis, and market being determined as the lower of cost or net realizable value. The Company records write-downs of inventory that is obsolete or in excess of anticipated demand or market value based on consideration of product lifecycle stage, technology trends, product development plans and assumptions about future demand and market conditions. Actual demand may differ from forecasted demand and such differences may have a material effect on recorded inventory values. Inventory write-downs are charged to cost of revenue and establish a new cost basis for the inventory.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the assets, ranging from three to five years. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful lives of the assets. Maintenance and repairs are charged to expense as incurred and improvements and betterments are capitalized.
Internal-Use Software
The Company capitalizes costs related to internal-use software during the application development stage. Costs related to planning and post implementation activities are expensed as incurred. Capitalized internal-use software is amortized, and recognized as cost of revenue, on a straight-line basis over the estimated useful life, which is up to five years. The Company evaluates the useful lives of these assets on an annual basis and tests for impairment whenever events or changes in circumstances occur that could impact the recoverability of these assets. Capitalized internal-use software costs are classified as a component of property and equipment.
Goodwill
Goodwill represents the excess of the purchase price paid over the fair value of tangible and identifiable intangible net assets acquired in business combinations. Goodwill is tested for impairment on an annual basis and at any other time if events occur or circumstances indicate that the carrying amount of goodwill may not be recoverable. Such events or circumstances may include significant adverse changes in the general business climate, among other things. The impairment test is performed by determining the enterprise fair value of the Company, which is primarily based on the Company’s market capitalization. If the Company’s carrying value, as a one reporting unit entity, is less than its fair value, then the fair value is allocated to all of its assets and liabilities (including any unrecognized intangible assets) as if the fair value was the purchase price to acquire the Company. The excess of the fair value over the amounts assigned to the Company’s assets and liabilities is the implied fair value of the goodwill. If the carrying amount of goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess. The Company performs its annual evaluation of goodwill during the fourth quarter of each fiscal year. The Company did not record any charges related to goodwill impairment in any of the periods presented in these condensed consolidated financial statements.
Impairment of Long-Lived Assets
The Company annually reviews long-lived assets for impairment or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparison of the carrying amount to the future net cash flows which the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows arising from the asset. To date there have been no such impairments of long-lived assets.
Other Assets
Included in the other assets are PCBAs totaling $3.1 million and $2.8 million as of March 31, 2017 and December 31, 2016, respectively. The Company uses a PCBA in each wearable device and it is used numerous times and has a useful life beyond one year. Each time the PCBA is used in a wearable device, a portion of the cost of the PCBA is recorded as a cost of revenue. The Company has based its estimates of how many times a PCBA can be used on testing in research and development, loss rates, product obsolescence, and the amount of time it takes the device to go through the manufacturing, shipping, customer shelf and patient wear time and upload process. The Company periodically evaluates the use estimate.
8
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Comprehensive loss represents all changes in stockholders' equity except those resulting from and distributions to stockholders. The Company’s unrealized gains and losses on available-for-sale securities represent the only component of other comprehensive loss that are excluded from the reported net loss and that are presented in the condensed consolidated statements of comprehensive loss.
Revenue Recognition
The Company’s devices, cardiac rhythm monitors, have a wear period for up to 14 days for the ZIO Patch Service or 30 days for the ZIO Event Card. The Company's services, consisting of the delivery of reports containing analysis of data captured by the physical device to the prescribing physician, are generally billable at the start of the wear period or when reports are issued to physicians, depending on the service provided. For the ZIO Event Card, the Company recognizes revenue on a straight-line basis over the applicable wear period, as the event monitoring results are delivered to physicians. For the ZIO Patch Service, the Company recognizes the revenue at the time that a report is delivered to a physician. For all services performed, the Company considers whether or not the following revenue recognition criteria are met: persuasive evidence of an arrangement exists and delivery has occurred or services have been rendered. For services performed for customers the Company invoices directly, additional revenue recognition criteria include that the price is fixed and determinable and collectability is reasonably assured; for customers in which the Company submits claims to third party commercial and governmental payors for reimbursement, it recognizes revenue only when a reasonable estimate of reimbursement can be made.
The assessment of whether a reasonable estimate of reimbursement can be made requires significant judgment by management. Where management's judgment indicates a reasonable estimate of reimbursement can be made, revenue is recognized upon delivery of the patient report for the ZIO Patch Service and straight-line for the ZIO Event Card. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with their insurance carrier and health plans. Some payors may not cover the Company's service as ordered by the prescribing physician under their reimbursement policies. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is recognized upon the earlier of notification of the payor benefits allowed or when payment is received, until the Company has the ability to make a reasonable estimate. Once a reasonable estimate can be made, revenue is recognized upon delivery of the service. During Q1 2017, the Company recognized revenue from certain non-contracted payors as a reasonable estimate was able to be made, primarily based on the consistency of historical payments.
The Company recognizes revenue related to billings for CMS and commercial payors on an accrual basis, net of contractual allowances, when a reasonable estimate of reimbursement can be made. These contractual allowances represent the difference between the list price (the billing rate) and the reimbursement rate for each payor. Upon ultimate collection from CMS and commercial payors, the amount is compared to the previous estimates and the contractual allowance is adjusted accordingly. Until a contract has been negotiated with a commercial payor, the Company’s services may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the service in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is recognized upon the earlier of notification of the payor benefits allowed or when payment is received, until the Company has the ability to make a reasonable estimate. Revenue related to these uncontracted claims was $2.9 million and $1.8 million for the three months ended March 31, 2017 and 2016, respectively. Revenue recognized on an accrual basis was $18.5 million and $11.1 million for the three months ended March 31, 2017 and 2016, respectively.
Certain of the Company’s customers pay the Company directly for the ZIO Service upon shipment of devices. Such advance payments are recorded as deferred revenue on the condensed consolidated balance sheets and revenue is recognized when reports are delivered to physicians.
Cost of Revenue
Cost of revenue is expensed as incurred and includes direct labor, material costs, equipment and infrastructure expenses, amortization of internal-use software, allocated overhead, and shipping and handling. Material costs include both the disposable costs of the device and amortization of the PCBAs. Each time the PCBA is used in a wearable device, a portion of the cost of the PCBA is recorded as a cost of revenue.
9
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The Company’s research and development costs are expensed as incurred. Research and development costs include, but are not limited to, payroll and personnel-related expenses, laboratory supplies, consulting costs and overhead charges.
Income Taxes
The Company uses the asset and liability method to account for income taxes in accordance with the authoritative guidance for income taxes. Under this method, deferred tax assets and liabilities are determined based on future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and tax loss and credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized.
The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50% likely of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest and penalties related to unrecognized tax benefits in income tax expense. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits.
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 stock options are 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 Program (“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.
Net Loss per Common Share
Basic net loss per common share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per common share is the same as basic net loss per common share for all periods presented since the effect of potentially dilutive securities are anti-dilutive.
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (“FASB”), issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). Areas of revenue recognition that will be affected include, but are not limited to, transfer of control, variable consideration, allocation of transfer pricing, licenses, time value of money, contract costs and disclosures. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of Effective Date, which defers the effective date of ASU 2014-09 by one year allowing early adoption as of the original effective date of fiscal years and interim reporting periods beginning after December 15, 2016, at which time companies may adopt the new standard update under the full retrospective method or the modified retrospective method. The deferral results in the new revenue standard being effective for the Company for fiscal years and interim reporting periods beginning after December 15, 2017. In March, April and May 2016, the FASB issued additional updates to the new revenue standard relating to reporting revenue on a gross versus net basis, identifying performance obligations and licensing arrangements, and narrow-scope improvements and practical expedients, respectively. The Company plans on adopting this standard on January 1, 2018 and has not made the decision as to which adoption method it will utilize. The Company’s final determination will depend on the significance of the impact of the new standard on the Company’s financial results. The Company is in the initial stages of its evaluation of the adoption of the new standard on its accounting policies.
10
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
In July 2015, the FASB issued ASU No. 2015-11, Inventory, Simplifying the Measurement of Inventory. Under ASU 2015-11, the measurement principle for inventory will change from lower of cost or market value to lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. The ASU is effective for fiscal years and interim periods within those years beginning after December 15, 2016. The Company adopted this guidance effective January 1, 2017, and there was no impact on the condensed consolidated financial statements.
In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes. Under ASU 2015-17, deferred tax liabilities and assets will be classified as noncurrent on the balance sheet. Previous guidance required deferred tax liabilities and assets to be separated into current and noncurrent amounts on the balance sheet. The guidance is effective for annual periods beginning after December 15, 2016 and for interim periods within those annual periods. Early adoption is permitted. The Company adopted this guidance effective January 1, 2017, and there was no impact on the condensed consolidated financial statements.
In January 2016, the FASB issued ASU No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities, which addresses certain aspects of recognition, measurement, presentation and disclosure of financial instruments. ASU 2016-01 is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. The Company has not determined the potential effects of this ASU on its consolidated financial statements.
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which requires a lessee to recognize assets and liabilities on its consolidated balance sheet for leases with accounting lease terms of more than 12 months. ASU 2016-02 will replace most existing lease accounting guidance in U.S. GAAP when it becomes effective. The new standard states that a lessee will recognize a lease liability for the obligation to make lease payments and a right-of-use asset for the right to use the underlying asset for the lease term. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the consolidated statements of operations. ASU 2016-02 will be effective for our first quarter of fiscal 2020 and requires the modified retrospective method of adoption. Early adoption is permitted. Although we are currently evaluating the effect that ASU 2016-02 will have on our consolidated financial statements and related disclosures, we expect that most of our operating lease commitments will be subject to the new standard and recognized as operating lease liabilities and right-of-use assets upon adoption.
In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718). This ASU was issued as part of the FASB’s simplification initiative and affects all entities that issue share-based payment awards to their employees. This standard covers accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. As a result of adopting ASU No. 2016‑09 on January 1, 2017, the Company has made an accounting policy election to continue to estimate forfeitures. The adoption of ASU No. 2016‑09 also requires excess tax benefits and tax deficiencies be recorded in the income statement as opposed to additional paid‑in capital when the awards vest or are settled, and has been applied on a prospective basis with no impact on the condensed consolidated financial statements as of and for the three months ended March 31, 2017. As a result of the adoption, the Company's increased its total NOLs by $0.1 million on January 1, 2017 related to deferred tax assets that arose directly from tax deductions related to equity compensation greater than compensation recognized for financial reporting purposes. This amount is fully offset by the valuation allowance.
In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (Topic 326), which is intended to provide financial statement users with more useful information about expected credit losses on financial assets held by a reporting entity at each reporting date. The new standard replaces the existing incurred loss impairment methodology with a methodology that requires consideration of a broader range of reasonable and supportable forward-looking information to estimate all expected credit losses. This ASU is effective for fiscal years and interim periods within those years beginning after December 15, 2019 and early adoption is permitted for fiscal years and interim periods within those years beginning after December 15, 2018. The Company is currently evaluating the impact of this new guidance.
In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230) – Classification of Certain Cash Receipts and Cash Payments, which clarifies the classification of certain cash receipts and cash payments in the statements of cash flow to eliminate the diversity in practice related to eight specific cash flow issues. This ASU is effective for fiscal years and interim periods within those years beginning after December 15, 2017, with early adoption permitted. The Company is currently evaluating the impact of this new guidance.
11
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230) – Restricted Cash, which requires the presentation of changes in restricted cash or restricted cash equivalents on the statement of cash flows. This ASU is effective for the fiscal years and interim periods within those years beginning after December 15, 2017, with early adoption permitted. The Company is currently evaluating the impact of this new guidance.
In January 2017, the FASB issued a new accounting standard update to simplify the measurement of goodwill by eliminating the Step 2 impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. The new guidance required an entity to compare the fair value of a reporting unit with its carrying amount and recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value. Additionally, an entity should consider income tax effects from any tax deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. The new guidance becomes effective for goodwill impairment tests in fiscal years beginning after December 15, 2019, though early adoption is permitted. The Company is currently assessing the impact of this new guidance.
3. Cash Equivalents and Investments
The fair value of securities, not including cash at March 31, 2017 and December 31, 2016, were as follows (in thousands):
|
|
March 31, 2017 |
|
|||||||||||||
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Estimated |
|
|||||||
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
||||
Money market funds |
|
$ |
14,026 |
|
|
$ |
1 |
|
|
$ |
— |
|
|
$ |
14,027 |
|
U.S. government securities |
|
|
32,921 |
|
|
|
1 |
|
|
|
(13 |
) |
|
|
32,909 |
|
Corporate notes |
|
|
27,608 |
|
|
|
5 |
|
|
|
(13 |
) |
|
|
27,600 |
|
Commercial paper |
|
|
33,317 |
|
|
|
— |
|
|
|
— |
|
|
|
33,317 |
|
Total available-for-sale securities |
|
$ |
107,872 |
|
|
$ |
7 |
|
|
$ |
(26 |
) |
|
$ |
107,853 |
|
Classified as: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
14,027 |
|
Short-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
77,397 |
|
Long-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,429 |
|
Total cash equivalents and investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
107,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2016 |
|
|||||||||||||
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Estimated |
|
|||||||
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
||||
Money market funds |
|
$ |
45,937 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
45,937 |
|
U.S. government securities |
|
|
16,479 |
|
|
|
11 |
|
|
|
— |
|
|
|
16,490 |
|
Corporate notes |
|
|
23,947 |
|
|
|
— |
|
|
|
(20 |
) |
|
|
23,927 |
|
Commercial paper |
|
|
24,971 |
|
|
|
— |
|
|
|
— |
|
|
|
24,971 |
|
Total available-for-sale securities |
|
$ |
111,334 |
|
|
$ |
11 |
|
|
$ |
(20 |
) |
|
$ |
111,325 |
|
Classified as: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
45,937 |
|
Short-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
54,407 |
|
Long-term investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,981 |
|
Total cash equivalents and investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
111,325 |
|
Available-for-sale securities held as of March 31, 2017 had a weighted average days to maturity of 174 days. There have been no material realized gains or realized losses on available-for-sale securities for the periods presented.
12
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
As the carrying value approximates the fair value for the Company’s cash equivalents, short-term and long-term investments shown in the tables above, the following table summarizes the fair value of the Company’s cash equivalents, short-term and long-term investments classified by maturity (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2017 |
|
|
2016 |
|
||
Due within one year |
|
$ |
91,424 |
|
|
$ |
100,344 |
|
Due after one year through three years |
|
|
16,429 |
|
|
|
10,981 |
|
Total available-for-sale marketable debt securities |
|
$ |
107,853 |
|
|
$ |
111,325 |
|
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 bonds 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.
Based on Level 2 inputs and the borrowing rates currently available to the Company for loans with similar terms and maturities, the carrying value of the Company’s debt approximates its fair value.
The following table presents the fair value of the Company’s financial assets and liabilities determined using the inputs defined above (amounts in thousands).
|
|
March 31, 2017 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
14,027 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
14,027 |
|
U.S. government securities |
|
|
— |
|
|
|
32,909 |
|
|
|
— |
|
|
|
32,909 |
|
Corporate notes |
|
|
— |
|
|
|
27,600 |
|
|
|
— |
|
|
|
27,600 |
|
Commercial paper |
|
|
— |
|
|
|
33,317 |
|
|
|
— |
|
|
|
33,317 |
|
Total |
|
$ |
14,027 |
|
|
$ |
93,826 |
|
|
$ |
— |
|
|
$ |
107,853 |
|
13
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
|
|
December 31, 2016 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
45,937 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
45,937 |
|
U.S. government securities |
|
|
— |
|
|
$ |
16,490 |
|
|
|
— |
|
|
|
16,490 |
|
Corporate notes |
|
|
— |
|
|
$ |
23,927 |
|
|
|
— |
|
|
|
23,927 |
|
Commercial paper |
|
|
— |
|
|
$ |
24,971 |
|
|
|
— |
|
|
|
24,971 |
|
Total |
|
$ |
45,937 |
|
|
$ |
65,388 |
|
|
$ |
— |
|
|
$ |
111,325 |
|
The following table sets forth a summary of the changes in the fair value of the preferred stock warrants which is classified as Level 3 in the fair value hierarchy. There were no transfers into or out of Level 3 during the periods (in thousands):
|
|
Three Months Ended March 31, 2017 |
|
|
Three Months Ended March 31, 2016 |
|
||
Beginning balance |
|
$ |
— |
|
|
$ |
2,949 |
|
Total change in fair value recorded as other expense, net |
|
|
— |
|
|
|
461 |
|
Ending balance |
|
$ |
— |
|
|
$ |
3,410 |
|
The valuation of the preferred stock warrant liabilities is discussed in Note 11.
5. Balance Sheet Components
Inventory and PCBAs
Inventory and PCBAs consisted of the following (in thousands):
|
|
March 31, 2017 |
|
|
December 31, 2016 |
|
||
Raw materials |
|
$ |
989 |
|
|
$ |
839 |
|
Finished goods |
|
|
3,255 |
|
|
|
3,324 |
|
Total |
|
$ |
4,244 |
|
|
$ |
4,163 |
|
Reported on the consolidated balance sheet as: |
|
|
|
|
|
|
|
|
Inventory |
|
$ |
1,156 |
|
|
$ |
1,390 |
|
Other assets |
|
|
3,088 |
|
|
|
2,773 |
|
Total |
|
$ |
4,244 |
|
|
$ |
4,163 |
|
Amounts reported as other assets are comprised of the PCBA costs that are included in both raw materials and finished goods totals above.
14
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Property and equipment, net consisted of the following (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2017 |
|
|
2016 |
|
||
Laboratory and manufacturing equipment |
|
$ |
1,889 |
|
|
$ |
1,509 |
|
Computer equipment and software |
|
|
821 |
|
|
|
736 |
|
Furniture and fixtures |
|
|
668 |
|
|
|
657 |
|
Leasehold improvements |
|
|
510 |
|
|
|
502 |
|
Internal-use software |
|
|
3,590 |
|
|
|
2,900 |
|
Total property and equipment, gross |
|
|
7,478 |
|
|
|
6,304 |
|
Less: accumulated depreciation and amortization |
|
|
(1,949 |
) |
|
|
(1,651 |
) |
Total property and equipment, net |
|
$ |
5,529 |
|
|
$ |
4,653 |
|
Depreciation and amortization expense for the three months ended March 31, 2017 and 2016 was $298,000 and $227,000, respectively.
Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2017 |
|
|
2016 |
|
||
Accrued vacation |
|
$ |
1,868 |
|
|
$ |
1,642 |
|
Accrued payroll and related expenses |
|
|
2,912 |
|
|
|
6,179 |
|
Accrued ESPP contributions |
|
|
1,100 |
|
|
|
417 |
|
Accrued professional services fees |
|
|
806 |
|
|
|
636 |
|
Other |
|
|
1,598 |
|
|
|
1,291 |
|
Total accrued liabilities |
|
$ |
8,284 |
|
|
$ |
10,165 |
|
6. Related-Party Transactions
Kaiser Permanente (“Kaiser”) is a common stockholder of the Company, representing 6.1% ownership of the total outstanding shares of the Company as of December 31, 2016. For the three months ended March 30, 2017 and 2016, the Company recognized revenue of $844,000 and $577,000 respectively, for transactions with Kaiser. The amounts receivable from transactions with Kaiser were $665,000, and $449,000 as of March 31, 2017 and December 31, 2016, respectively. Kaiser additionally performs services related to clinical trials and the Company utilizes Kaiser for employee healthcare. The total expense recorded was $111,000 and $117,000 as of March 31, 2017 and 2016, respectively. The amounts outstanding and included in accounts payable and accrued liabilities were $159,000 and $229,000 as of March 31, 2017, and December 31, 2016 respectively.
7. Commitments and Contingencies
Lease Arrangements
The Company leases office and manufacturing space under non-cancelable operating leases which expire on various dates through 2027. These leases generally contain scheduled rent increases or escalation clauses and renewal options. The Company recognizes rent expense on a straight-line basis over the lease period.
As discussed further in Note 15, in May 2017, the Company entered into a commercial building lease agreement which will expire in September 2027.
15
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The following table summarizes the Company’s future minimum lease payments as of March 31, 2017 including the lease signed in May 2017 (in thousands):
Year Ending December 31: |
|
|
|
|
2017 (remainder of year) |
|
$ |
3,690 |
|
2018 |
|
|
5,089 |
|
2019 |
|
|
5,108 |
|
2020 |
|
|
1,178 |
|
2021 and beyond |
|
|
2,948 |
|
Total |
|
$ |
18,013 |
|
The Company’s rent expense was $1.1 million and $0.4 million for the three months ended March 31, 2017 and 2016, respectively.
Legal Proceedings
From time to time, the Company may become involved in legal proceedings arising from the ordinary course of its business. Management is currently not aware of any matters that could have a material adverse effect on the financial position, results of operations or cash flows of the Company.
Indemnifications
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. 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 California corporate 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.
8. Debt
Pharmakon Loan Agreement
In December 2015, the Company entered into the Loan Agreement with Biopharma Secured Investments III Holdings Cayman LP, or Pharmakon (the “Pharmakon Loan Agreement”). The Pharmakon Loan Agreement provides for up to $55.0 million in term loans split into two tranches as follows: (i) the Tranche A Loans are $30.0 million in term loans, and (ii) the Tranche B Loans are up to $25.0 million in term loans. The Tranche A Loans were drawn on December 4, 2015. The Tranche B Loans were available to be drawn prior to December 4, 2016. No additional draw was made.
During the first full eight quarters, payments are interest only and for the first two years, 50% of the interest will be “paid-in-kind.” The Company is subject to a financial covenant related to minimum trailing revenue targets that begins in June 2017, and is tested on a semi-annual basis. The minimum net revenue covenant ranges from $44.7 million for the period ended June 30, 2017 to $102.6 million for the period ended December 31, 2021. The minimum net revenues financial covenant has a 45-day equity cure period following required delivery date of the financial statements. Pursuant to this equity cure provision, the Company may cure a revenue covenant default by raising additional funds from the sale of equity. The loan matures December 2021.
The Tranche A Loans bear interest at a fixed rate equal to 9.50% per annum that is due and payable quarterly in arrears. During the first eight calendar quarters, 50% of the interest due and payable shall be added to the then outstanding principal.
16
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The Pharmakon Loan Agreement requires the Company to maintain a minimum consolidated liquidity and minimum net revenue during the term of the loan facility and contains customary affirmative and negative covenants and event of default provisions that could result in the acceleration of the repayment obligations under the loan facility. Upon a change in control of the Company, Pharmakon has the option to demand payment in full of the outstanding loans together with any prepayment premium.
The obligations under the Pharmakon Loan Agreement are secured by a security interest in substantially all of the Company’s assets pursuant to the Pharmakon Guaranty and Security Agreement and this security interest is governed by an intercreditor agreement between Pharmakon and Silicon Valley Bank (“SVB”).
In December 2015, the Company used the proceeds from the Pharmakon Loan Agreement to repay $4.9 million of bank debt to SVB. The issuance costs and debt discount have been netted against the borrowed funds on the balance sheet. The debt balance as of March 31, 2017 and December 31, 2016 was $31.2 million and $30.8 million, respectively.
Bank Debt
In June 2014, the Company refinanced its debt with SVB by entering into the Second Amendment to the Amended and Restated Loan Security Agreement (“Second Amendment”). Under this amendment, the Company borrowed $4.9 million with an additional advance of $5.0 million available. All the borrowings under the Second Amended Loan Agreement were collateralized by all of the Company’s assets, excluding intellectual property. In connection with entering into the Amended Loan Agreement, the Company issued warrants to purchase 20,136 shares of Series D at $7.31 per share that expire in June 2024 (See Note 11).
In December 2015, the Company used the proceeds from the Pharmakon Loan Agreement to repay $4.9 million of bank debt to SVB and entered into a Second Amended and Restated Loan and Security Agreement with SVB, or the SVB Loan Agreement. Under the 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 $15.0 million, until December 4, 2018, when all outstanding principal and accrued interest becomes due and payable. Any principal amount outstanding under the SVB revolving credit line 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%, are tied to the Company’s trailing six-month revenue and subject to certain revenue targets. The Company may borrow up to 80% of its eligible accounts receivable, up to the maximum of $15.0 million.
In August 2016, the Company obtained a $3.1 million letter of credit pursuant to the SVB revolving credit facility in connection with a lease for the San Francisco office. As of March 31, 2017 and December 31, 2016, the Company was eligible to borrow up to $ 6.5 million and $2.5 million, respectively, under the SVB revolving credit line.
The SVB Loan Agreement requires the Company to maintain a minimum consolidated liquidity and minimum net sales during the term of the loan facility. In addition, the SVB Loan Agreement contains customary affirmative and negative covenants and events of default. The obligations under the SVB Loan Agreement are collaterialized by substantially all assets of the Company and this security interest is governed by an intercreditor agreement between Pharmakon and SVB.
California HealthCare Foundation Note
In November 2012, the Company entered into a Note Purchase Agreement and Promissory Note with the California HealthCare Foundation, or the CHCF Note, through which the Company borrowed $1.5 million. The CHCF Note accrues simple interest of 2.0%. The accrued interest and the principal matured in November 2016. In partial consideration for the issuance of the CHCF Note, the Company issued warrants to purchase 22,807 shares of the Company’s Series D convertible preferred stock.
In June 2015, the Company amended the CHCF Note to extend the maturity date to May 2018. In partial consideration for the amendment, the Company issued 8,552 warrants at $6.58 exercise price per share of the Company’s Series D convertible preferred stock. See Note 11 for further discussion of the warrants. The CHCF note is subordinate to other bank debt. The debt balance, net of debt discount, as of March 31, 2017 and December 31, 2016 was $1.5 million and $1.5 million, respectively.
17
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
The Company did not record a provision or benefit for income taxes during the three months ended March 31, 2017 and 2016, respectively, as it reported losses in each period which are not more likely than not to be realized. Due to the uncertainties surrounding the realization of deferred tax assets through future taxable income, the Company has provided a full valuation allowance and, therefore, no benefit has been recognized for the net operating loss carryforwards and other deferred tax assets.
At December 31, 2016, the Company had $0.6 million of unrecognized tax benefit, none of which, if recognized, would affect the effective tax rate as most of the unrecognized tax benefit is deferred tax assets currently offset by a valuation allowance.
The Company has not recognized any interest and penalties related to uncertain tax positions as part of the income tax provision.
A number of years may elapse before an uncertain tax position is audited and finally resolved. While it is often difficult to predict the final outcome or the timing of resolution of any particular uncertain tax position, the Company believes that its reserves for income taxes reflect the most likely outcome. The Company adjusts these reserves, as well as the related interest, in light of changing facts and circumstances. Settlement of any particular position could require the use of cash. As of March 31, 2017, changes to the Company’s uncertain tax positions in the next twelve months that are reasonably possible are not expected to have a material impact on the Company’s financial position or results of operations.
10. Stockholders’ Equity
Common stock
As of March 31, 2017, the Company’s amended and restated certificate of incorporation dated October 2016, authorized 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. No dividends were declared through March 31, 2017.
The Company had reserved shares of common stock for issuance as follows:
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2017 |
|
|
2016 |
|
||
Options issued and outstanding |
|
|
3,315,677 |
|
|
|
2,977,218 |
|
Unvested Restricted Stock Units |
|
|
332,592 |
|
|
|
105,529 |
|
Common stock warrants issued and outstanding |
|
|
217,051 |
|
|
|
217,245 |
|
Shares available for grant under future stock plans |
|
|
5,085,996 |
|
|
|
4,226,068 |
|
|
|
|
8,951,316 |
|
|
|
7,526,060 |
|
11. Preferred Stock Warrant Liabilities
In November 2012, in connection with borrowings under a convertible note, the Company issued warrants to purchase shares of Series C or New Preferred. The warrants were only exercisable if the Convertible Notes were converted into Series C or New Preferred. The warrants’ exercise price is $0.001 per share and they have a seven year term. On March 27, 2013 the Company closed the Series D financing. The warrants were converted into warrants to purchase 207,177 shares of Series D convertible preferred stock. The Company recognized a charge of $294,000 related to change in the fair value of the warrants for the three months ended March 31, 2016. The warrants were exercised on October 3, 2016. Upon the IPO when the Series A preferred stock warrants converted into common stock warrants and were reclassified to additional paid-in-capital in the Company's balance sheet. As a result, the warrants are no longer subject to fair value remeasurement. In January 2017, 194 warrants were exercised.
18
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
In June 2014, in connection with borrowings under the Second Amendment (Note 7), the Company issued warrants to purchase 20,136 shares of Series D Preferred Stock at $7.31 per share that expire June 2024. The fair value of the warrant was determined by using an option pricing model prepared by a third-party based on an allocation of the Company’s aggregate value to the outstanding equity instruments, applying a 30% discount to the warrant value for lack of marketability. The fair value of the warrant, $98,000, was recorded as a debt discount and is being amortized over the loan repayment period to interest expense. The Company recognized a charge of $27,000 related to change in the fair value of the warrants for the three months ended March 31, 2016. The warrants were converted into warrants to purchase common stock upon the completion of the IPO in 2016, and were reclassified to additional paid-in-capital in the Company's balance sheet. One of the warrants for 10,068 shares was exercised through a cashless exercise on October 26, 2016 resulting in the issuance of a net 7,310 shares of the Company's common stock, and the other warrant for 10,068 shares remains outstanding as of March 31, 2017.
12. Stock Incentive Plans
2006 Plan
In October 2006, the Company adopted the 2006 Equity Incentive Plan, as amended, (the “2006 Plan”). The Plan provides for the granting of stock options to employees and non-employees of the Company. Options granted under the Plan may be either incentive stock options or nonqualified stock options. Incentive stock options (“ISO”) may be granted only to employees (including officers and directors who are also employees). Nonqualified stock options (“NSO”) may be granted to employees and non-employees. The board of directors has the authority to determine to whom options will be granted, the number of options, the term and the exercise price.
Options under the Plan may be granted for periods of up to ten years and at prices no less than 85% of the estimated fair value of the shares on the date of grant as determined by the board of directors, provided, however, that (i) the exercise price of an ISO and NSO shall not be less than 100% and 85% of the estimated fair value of the shares on the date of grant, respectively, and (ii) the exercise price of an ISO and NSO granted to a 10% stockholder shall not be less than 110% of the estimated fair value of the shares on the date of grant. In general, options become exercisable at a rate of 25% after the first anniversary of the grant and then monthly vesting for an additional three years from date of grant. The term for options is no longer than five years for ISOs for which the grantee owns greater than 10% of the voting power of all classes of stock and no longer than ten years for all other options. The Company issues new shares upon the exercise of options.
2016 Plan
In October 2016, the Company adopted the 2016 Equity Incentive Plan, (the “2016 Plan”). The 2016 Plan was subsequently approved by the Company’s stockholders and became effective on October 19, 2016, immediately before the effective date of the IPO. Following the effectiveness of the 2016 Plan, no additional options will be granted under the 2006 Plan. In addition, to the extent that any awards outstanding or subject to vesting restrictions under the 2006 Plan are subsequently forfeited or terminated for any reason before being exercised or settled, the shares of common stock reserved for issuance pursuant to such awards as of the closing of the IPO will become available for issuance under the 2016 Plan. The remaining shares available for grant under the 2006 Plan became available for issuance under the 2016 Plan upon the closing of the IPO. On the first day of each year beginning with 2017, the 2016 Plan authorizes an annual increase of the least of 3,865,000 shares, 5% of outstanding shares on the last day of the immediately preceding fiscal year or an amount as determined by the Company's Board of Directors. As of March 31, 2017, the Company has reserved 4,270,875 shares of common stock for issuance under the 2016 Stock Incentive Plan.
Pursuant to the 2016 Plan, stock options, restricted shares, stock units, including restricted stock units and stock appreciation rights may be granted to employees, consultants, and outside directors of the Company. Options granted may be either ISOs or NSOs.
Stock options are governed by stock option agreements between the Company and recipients of stock options. ISOs and NSOs may be granted under the 2016 Plan at an exercise price of not less than 100% of the fair market value of the common stock on the date of grant, determined by the Compensation Committee of the Board of Directors. Options become exercisable and expire as determined by the Compensation Committee, provided that the term of ISOs may not exceed ten years from the date of grant.
19
IRHYTHM TECHNOLOGIES, INC.
Notes to Unaudited Condensed Consolidated Financial Statements (Continued)
Employee Stock Purchase Program (“ESPP”)
In October 2016, the Company’s Board of Directors and stockholders approved the Employee Stock Purchase Plan (the “ESPP”). Under the ESPP, the Company initially reserved 483,031 shares of common stock for issuance as of its effective date of October 19, 2016. On the first day of each calendar year, beginning in 2017, the number of shares in the reserve will increase by the lesser of 966,062 shares, 1.5% of the shares of the Company’s common stock outstanding on the last day of the immediately preceding fiscal year, or an amount as determined by the Company’s Board of Directors. The ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation, subject to any plan limitations. The ESPP provides for twelve-month offering periods which each contain two six-month purchase periods. At the end of each purchase period, employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the last day of the purchase period.
As of March 31, 2017, no shares of common stock have been issued to employees participating in the ESPP and 815,121 shares were available for issuance under the ESPP.
Equity Incentive Plan Activity
A summary of share-based awards available for grant is as follows:
|
|
Options Available for Grant |
|
|
Balance at December 31, 2015 |
|
|
331,938 |
|
Additional options authorized |
|
|
3,865,000 |
|
Options granted |
|
|
(466,914 |
) |
Options forfeited |
|
|
13,013 |
|
Balance at December 31, 2016 |
|
|
3,743,037 |
|
Additional options authorized |
|
|
1,106,966 |
|
Options granted |
|
|
(582,217 |
) |
Options forfeited |
|
|
3,089 |
|
Balance at March 31, 2017 |
|
|
4,270,875 |
|
The following table summarizes stock option activity under the 2006 and 2016 Plans, including grants to nonemployees:
|
|
|
|
|
|
Options Outstanding |
|
|||||||||
|
|
Options Outstanding |
|
|
Weighted- Average Exercise Price Per Share |
|
|
Weighted- Average Remaining Contractual Life (years) |
|
|
Aggregate Intrinsic Value (in thousands) |
|
||||
Balances at December 31, 2015 |
|
|
2,685,913 |
|
|
$ |
4.81 |
|
|
|
7.63 |
|
|
$ |
11,589 |
|
Options granted |
|
|
361,385 |
|
|
|
15.65 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(57,067 |
) |
|
|
2.33 |
|
|
|
|
|
|
|
|
|
Options forfeited |
|
|
(13,013 |
) |
|
|
6.92 |
|
|
|
|
|
|
|
|
|
Balances at December 31, 2016 |
|
|
2,977,218 |
|
|
$ |
6.16 |
|
|
|
6.93 |
|
|
$ |
70,979 |
|
Options granted |
|
|
355,154 |
|
|
|
|
|
|
|
|