UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission File Number:
(Exact name of registrant as specified in its Charter)
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
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(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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The |
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 every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit 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 |
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Non-accelerated filer |
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Smaller reporting company |
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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
As of July 24, 2020, the registrant had
Table of Contents
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Page |
PART I. |
2 |
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Item 1. |
2 |
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2 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
3 |
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Condensed Consolidated Statements of Changes in Stockholders’ Equity |
4 |
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5 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
6 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
14 |
Item 3. |
24 |
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Item 4. |
24 |
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PART II. |
25 |
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Item 1. |
25 |
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Item 1A. |
25 |
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Item 2. |
65 |
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Item 6. |
66 |
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67 |
i
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “goals,” “will,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:
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the timing and conduct of our clinical trial programs of ARV-110 and ARV-471, including statements regarding the conduct of our ongoing Phase 1/2 clinical trials of ARV-110 and ARV-471 and the period during which the results of the clinical trials will become available; |
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the timing of, and our ability to obtain, marketing approval of ARV-110 and ARV-471, and the ability of ARV-110 and ARV-471 and our other product candidates to meet existing or future regulatory standards; |
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our plans to pursue research and development of other product candidates; |
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the potential advantages of our platform technology and our product candidates; |
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the extent to which our scientific approach and platform technology may potentially address a broad range of diseases; |
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the potential benefits of our arrangements with Yale University and Professor Crews; |
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the potential receipt of revenue from future sales of our product candidates; |
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the rate and degree of market acceptance and clinical utility of our product candidates; |
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our estimates regarding the potential market opportunity for our product candidates; |
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our sales, marketing and distribution capabilities and strategy; |
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our ability to establish and maintain arrangements for manufacture of our product candidates; |
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the potential achievement of milestones and receipt of payments under our collaborations; |
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our ability to enter into additional collaborations with third parties; |
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our intellectual property position; |
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our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; |
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the impact of COVID-19 on our business and operations; |
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the impact of government laws and regulations; and |
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our competitive position. |
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q, particularly in the “Risk Factors” section, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements except as required by applicable law.
In this Quarterly Report on Form 10-Q, unless otherwise stated or the context otherwise requires, references to the “Company,” “Arvinas,” “we,” “us,” and “our,” except where the context requires otherwise, refer to Arvinas, Inc. and its consolidated subsidiaries, or any one or more of them as the context may require, and “our board of directors” refers to the board of directors of Arvinas, Inc.
ii
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
Arvinas, INC. and Subsidiaries
Condensed Consolidated Balance Sheets (unaudited)
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June 30, 2020 |
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December 31, 2019 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Marketable securities |
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Other receivables |
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Prepaid expenses and other current assets |
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Total current assets |
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Property, equipment and leasehold improvements, net |
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Operating lease right of use assets |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders' equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Deferred revenue |
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Current portion of operating lease liability |
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Total current liabilities |
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Deferred revenue |
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Long term debt |
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Operating lease liability |
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Total liabilities |
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Commitments and Contingencies |
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Stockholders’ equity: |
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Common stock, $ issued and outstanding as of June 30, 2020 and December 31, 2019, respectively |
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Accumulated deficit |
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( |
) |
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( |
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Additional paid-in capital |
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Accumulated other comprehensive income |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes
2
Arvinas, INC. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
Condensed Consolidated Statements of Operations |
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For the Three Months Ended June 30, |
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For the Six Months Ended June 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Revenue |
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$ |
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$ |
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$ |
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$ |
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Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Income (loss) from operations |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
Other income (expenses) |
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Other income, net |
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Interest income |
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Interest expense |
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( |
) |
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( |
) |
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( |
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( |
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Total other income |
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Net loss |
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( |
) |
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( |
) |
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( |
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( |
) |
Net loss per common share, basic and diluted |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
Weighted average common shares outstanding, basic and diluted |
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Condensed Consolidated Statements of Comprehensive Loss |
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For the Three Months Ended June 30, |
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For the Six Months Ended June 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
Other comprehensive income: |
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Unrealized gain on available-for-sale securities |
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Comprehensive loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
See accompanying notes
3
Arvinas, INC. and Subsidiaries
Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited)
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Accumulated |
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Additional |
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Other |
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Total |
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Common |
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Accumulated |
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Paid-in |
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Comprehensive |
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Stockholders' |
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Shares |
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Amount |
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Deficit |
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Capital |
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Income (Loss) |
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Equity |
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Balance at March 31, 2019 |
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$ |
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$ |
( |
) |
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$ |
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$ |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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( |
) |
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— |
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— |
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( |
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Restricted stock vesting |
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— |
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( |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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Unrealized gain on available-for -sale securities |
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— |
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— |
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— |
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— |
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Balance at June 30, 2019 |
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$ |
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$ |
( |
) |
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$ |
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$ |
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$ |
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Balance at March 31, 2020 |
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$ |
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$ |
( |
) |
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$ |
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$ |
( |
) |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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|
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|
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— |
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Net loss |
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— |
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|
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— |
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|
( |
) |
|
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— |
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|
|
— |
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( |
) |
Restricted stock vesting |
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— |
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( |
) |
|
|
— |
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— |
|
Exercise of stock options |
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|
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— |
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|
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|
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— |
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Unrealized gain on available-for -sale securities |
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— |
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— |
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— |
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— |
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Balance at June 30, 2020 |
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$ |
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$ |
( |
) |
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$ |
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$ |
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$ |
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Accumulated |
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Additional |
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Other |
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Total |
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|||
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Common |
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Accumulated |
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Paid-in |
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Comprehensive |
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Stockholders' |
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Shares |
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Amount |
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Deficit |
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Capital |
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Income (Loss) |
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Equity |
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||||||
Balance at December 31, 2018 |
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$ |
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|
$ |
( |
) |
|
$ |
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|
|
$ |
( |
) |
|
$ |
|
|
Stock-based compensation |
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|
— |
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|
|
— |
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|
|
— |
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|
|
|
|
|
|
— |
|
|
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|
|
Net loss |
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|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Restricted stock vesting |
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|
|
|
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
Exercise of stock options |
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|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
Unrealized gain on available-for -sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Balance at June 30, 2019 |
|
|
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Balance at December 31, 2019 |
|
|
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Stock-based compensation |
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|
— |
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|
|
— |
|
|
|
— |
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|
|
|
|
|
|
— |
|
|
|
|
|
Net loss |
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|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
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|
|
— |
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|
( |
) |
Restricted stock vesting |
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|
|
|
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|
— |
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( |
) |
|
|
— |
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— |
|
Exercise of stock options |
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|
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|
|
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|
— |
|
|
|
|
|
|
|
— |
|
|
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|
|
Unrealized gain on available-for -sale securities |
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|
— |
|
|
|
— |
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|
|
— |
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|
— |
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|
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|
Balance at June 30, 2020 |
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$ |
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|
$ |
( |
) |
|
$ |
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|
$ |
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|
|
$ |
|
|
See accompanying notes
4
Arvinas, INC. and Subsidiaries
Condensed Consolidated Statements of Cash Flows (unaudited)
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For the Six Months Ended June 30, |
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2020 |
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2019 |
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Cash flows from operating activities: |
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Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Amortization of debt discount |
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Depreciation and amortization |
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Net accretion of bond discounts/premiums |
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( |
) |
Amortization of right to use assets |
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Stock-based compensation |
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Changes in operating assets and liabilities: |
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Account receivable |
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Other receivables |
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Prepaid expenses and other current assets |
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( |
) |
Accounts payable |
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( |
) |
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( |
) |
Accrued expenses |
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( |
) |
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( |
) |
Deferred revenue |
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( |
) |
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( |
) |
Operating lease liabilities |
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( |
) |
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( |
) |
Net cash used in operating activities |
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( |
) |
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( |
) |
Cash flows from investing activities: |
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Purchase of marketable securities |
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( |
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( |
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Maturities of marketable securities |
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Sales of marketable securities |
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Purchase of property, equipment and leasehold improvements |
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( |
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( |
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Net cash provided by investing activities |
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Cash flows from financing activities: |
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Repayments of long-term debt |
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( |
) |
Proceeds from exercise of stock options |
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Net cash provided by financing activities |
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Net increase in cash and cash equivalents |
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Cash and cash equivalents, beginning of the period |
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Cash and cash equivalents, end of the period |
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$ |
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$ |
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Supplemental disclosure of cash flow information: |
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Purchases of property, equipment and leasehold improvements unpaid at period end |
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$ |
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$ |
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Cash paid for interest |
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$ |
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$ |
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See accompanying notes
5
Arvinas, INC. and Subsidiaries
Notes to Condensed Consolidated Financial Statements (unaudited)
1. Nature of Business
Arvinas, Inc. and subsidiaries (the Company) is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development and commercialization of therapies that degrade disease-causing proteins. The Company expects to incur additional operating losses and negative operating cash flows for the foreseeable future.
A novel strain of coronavirus (COVID-19) was first identified in December 2019, and subsequently declared a global pandemic by the World Health Organization on March 11, 2020. As a result of the outbreak, many companies have experienced disruptions in their operations and in markets served. The Company has instated some and may take additional precautionary measures intended to help ensure the well-being of its employees and minimize business disruption. The Company temporarily shut down its laboratories in mid-March 2020 but has now reopened its laboratories as well as initiated work with biology contract research organizations (CROs). The Company’s office-based employees continue to work remotely. The Company considered the impact of COVID-19 on the assumptions and estimates used and determined that there were no material adverse impacts on the Company’s results of operations and financial position as of June 30, 2020. The full extent of the future impacts of COVID-19 on the Company’s operations is uncertain. A prolonged outbreak could have a material adverse impact on financial results and business operations of the Company, including the timing and ability of Company to complete certain clinical trials and other efforts required to advance its preclinical pipeline.
2. Summary of Significant Accounting Policies
Unaudited Interim Financial Statements
The accompanying condensed consolidated financial statements are unaudited and have been prepared by the Company in accordance with accounting principles generally accepted in the United States (U.S. GAAP) and pursuant to the rules and regulations of the Securities and Exchange Commission. The year-end condensed consolidated balance sheet data was derived from the Company’s audited financial statements but does not include all disclosures required by U.S. GAAP. These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements for the years ended December 31, 2019 and 2018 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on March 16, 2020 (the Annual Report). The condensed consolidated financial statements, in the opinion of management, reflect all normal and recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations.
Recently Adopted Accounting Pronouncements
In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments – Credit Losses, which provides a model for recognizing credit losses on financial instruments based on an estimate of current expected losses, requiring immediate recognition of credit losses expected over the life of a financial instrument. The Company adopted ASU 2016-13 in the first quarter of 2020. The adoption of the standard was immaterial to the accompanying condensed consolidated financial statements.
During the three months ended June 30, 2020, there were no changes to the Company’s significant accounting policies as described in Note 2 to the notes to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019.
3. Research Collaboration and License Agreements
In June 2019, the Company and Bayer AG entered into a Collaboration and License Agreement (Bayer Collaboration Agreement) setting forth the Company’s collaboration with Bayer AG to identify or optimize proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that mediate for degradation of target proteins (Targets), using the Company’s proprietary platform technology, which Targets will be selected by Bayer AG, subject to certain exclusions and limitations. The Bayer Collaboration Agreement became effective in July 2019. Under the terms of the Bayer Collaboration Agreement, the Company received an upfront non-refundable payment of $
6
The Company determined that the Bayer Collaboration Agreement and a Stock Purchase Agreement entered into with Bayer AG at the same time should be evaluated as a combined contract in accordance with ASC 606, Revenue from Contracts with Customers, given that the agreements were entered into at the same time and have the same commercial objective to provide funding to further the Company’s research utilizing its proprietary technology. The Company identified the elements under the agreements as license and research revenue and the issuance of the common stock. The Company determined the fair value of the shares sold under the Stock Purchase Agreement to be $
In December 2017, the Company entered into a Research Collaboration and License Agreement with Pfizer, Inc. (Pfizer) (the Pfizer Collaboration Agreement). Under the terms of the Pfizer Collaboration Agreement, the Company received an upfront non-refundable payment and certain additional payments totaling $
In September 2015, the Company entered into an Option and License Agreement with Genentech, Inc. and F. Hoffman-La Roche Ltd. (together, Genentech) (the Genentech Agreement). During 2015, the Company received an upfront non-refundable payment of $
Information about contract liabilities, which are recorded as deferred revenue on the condensed consolidated balance sheets, is as follows:
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June 30, |
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December 31, |
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2020 |
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2019 |
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Contract liabilities |
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$ |
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$ |
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Revenues recognized in the period from |
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Amounts included in deferred revenue in previous periods |
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$ |
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$ |
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Changes in deferred revenue from December 31, 2019 to June 30, 2020 were due to additions to deferred revenue of $
7
The aggregate amount of the transaction price allocated to performance obligations that are unsatisfied as of June 30, 2020 was $
Remainder of 2020 |
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2021 |
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2022 |
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2023 |
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$ |
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4. Fair Value Measurements
ASC Topic 820, Fair Value Measurements and Disclosures, requires disclosure of the fair value of financial instruments held by the Company. ASC 825, Financial Instruments, defines fair value and establishes a three-level valuation hierarchy for disclosures of fair value measurement that enhances disclosure requirements for fair value measures. The Company’s principal financial instruments comprise cash, marketable securities, accounts receivable, accounts payable, accrued liabilities and long-term debt. The carrying value of all financial instruments approximates fair value. The three levels of valuation hierarchy are defined as follows:
Level 1—Inputs are based upon observable or quoted prices for identical instruments traded in active markets.
Level 2—Inputs are based upon quoted 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 assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets or liabilities. The Company’s Level 2 investments consist primarily of corporate notes and bonds and U.S. government and agency securities.
Level 3—Inputs are generally unobservable and typically reflect management’s estimates of assumptions that market participants would use in pricing the asset or liability. The fair values are therefore determined using model-based techniques that include option pricing models, discounted cash flow models, and similar techniques.
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
The Company’s marketable securities consist of corporate bonds which are adjusted to fair value at each balance sheet date, based on quoted prices, which are considered Level 2 inputs.
The following is a summary of the Company’s available-for-sale securities as of June 30, 2020 and December 31, 2019:
June 30, 2020 |
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Gross |
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Gross |
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