f
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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Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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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.
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).
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.
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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 April 29, 2021, the registrant had
Table of Contents
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PART I. |
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Item 1. |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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Condensed Consolidated Statements of Changes in Stockholders’ Equity |
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Notes to Unaudited Condensed Consolidated Financial Statements |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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PART II. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 5. |
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Item 6. |
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27 |
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 initiation, timing, progress and results of our current and future clinical trials of ARV-110, ARV-471 and ARV-766, including statements regarding 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 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
We use Arvinas, the Arvinas logo, and other marks as trademarks in the United States and other countries. This Quarterly Report on Form 10-Q contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Quarterly Report on Form 10-Q, including logos, artwork and other visual displays, may appear without the ® or ™ symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other entities’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity.
iii
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
Arvinas, INC. and Subsidiaries
Condensed Consolidated Balance Sheets (unaudited)
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March 31, 2021 |
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December 31, 2020 |
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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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Account receivable |
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— |
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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 March 31, 2021 and December 31, 2020, respectively |
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Accumulated deficit |
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Additional paid-in capital |
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Accumulated other comprehensive income (loss) |
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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 |
For the Three Months Ended March 31, |
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2021 |
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2020 |
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Revenue |
$ |
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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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Loss from operations |
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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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Total other income |
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Net loss |
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( |
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Net loss per common share, basic and diluted |
$ |
( |
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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 |
For the Three Months Ended March 31, |
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2021 |
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2020 |
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Net loss |
$ |
( |
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$ |
( |
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Other comprehensive income (loss): |
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Unrealized loss on available-for-sale securities |
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( |
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( |
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Comprehensive loss |
$ |
( |
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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 December 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 loss 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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( |
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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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Balance at December 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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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 loss 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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( |
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( |
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Balance at March 31, 2021 |
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$ |
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$ |
( |
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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 Three Months Ended March 31, |
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2021 |
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2020 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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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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( |
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Accounts payable |
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( |
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Accrued expenses |
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( |
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( |
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Deferred revenue |
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( |
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( |
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Operating lease liabilities |
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( |
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( |
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Net cash used in operating activities |
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( |
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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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Purchase of property, equipment and leasehold improvements |
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( |
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( |
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Net cash (used in) provided by investing activities |
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( |
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Cash flows from financing activities: |
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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 (decrease) increase in cash and cash equivalents |
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( |
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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 and Basis of Presentation
Arvinas, Inc. and subsidiaries (“Arvinas” or “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.
The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries. The financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X under the Securities Exchange Act of 1934, as amended (“Exchange Act”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to Securities and Exchange Commission (“SEC”) rules. In the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation have been included. The condensed consolidated balance sheet at December 31, 2020 has been derived from Arvinas’ audited consolidated financial statements at that date. Operating results for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021. The financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2020, forming part of Arvinas’ 2020 Annual Report on Form 10-K filed with the SEC on March 1, 2021.
Impact of the coronavirus (“COVID-19”) pandemic
As a result of the COVID-19 pandemic, many companies have experienced disruptions in their operations and in markets served. 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 March 31, 2021. 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. Accounting Pronouncements and Significant Accounting Policies
The Company reviews new accounting standards as issued. As of March 31, 2021 the Company has not identified any new standards that it believes will have a significant impact on the Company’s financial statements.
There were no changes to the Company’s significant accounting policies during the three months ended March 31, 2021.
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. 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. 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 November 2017, the Company entered into an Amended and Restated Option, License, and Collaboration Agreement with Genentech, Inc. and F. Hoffman-La Roche Ltd. (the Genentech Modification), amending a previous Genentech agreement. Under the Genentech Modification, the Company received additional upfront non-refundable payments of $
Information about contract liabilities included as deferred revenue in the condensed consolidated balance sheets, is as follows:
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March 31, |
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December 31, |
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2021 |
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2020 |
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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 as of March 31, 2021 from December 31, 2020 were due to additions to deferred revenue of $
The aggregate amount of the transaction price allocated to performance obligations that are unsatisfied as of March 31, 2021 was $
Remainder of 2021 |
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$ |
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2022 |
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2023 |
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Total |
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$ |
42.5 |
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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 (unadjusted) for identical instruments traded in active markets.
7
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 March 31, 2021 and December 31, 2020:
|
|
March 31, 2021 |
|
|||||||||||||||
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
||
Description |
|
Effective Maturity |
|
Amortized Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
||||
Corporate bonds |
|
2021-2022 |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
Corporate bonds |
|
|
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
|
|
Total |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
|
December 31, 2020 |
|
|||||||||||||||
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
||
Description |
|
Effective Maturity |
|
Amortized Cost |
|
|
Unrealized Gains |
|
|
Unrealized Losses |
|
|
Fair Value |
|
||||
Corporate bonds |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
— |
|
|
$ |
|
|
Total |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
— |
|
|
$ |
|
|
The following table sets forth, by level, the Company’s assets that were accounted for at fair value on a recurring basis.
|
|
March 31, 2021 |
|
|||||||||||||
Description |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate bonds |
|
$ |
— |
|
|
$ |
|
|
|
$ |
— |
|
|
$ |
|
|
|
|
December 31, 2020 |
|
|||||||||||||
Description |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate bonds |
|
$ |
— |
|
|
$ |
|
|
|
$ |
— |
|
|
$ |
|
|
8
5. Property, Equipment and Leasehold Improvements
Property, equipment and leasehold improvements consist of the following at:
|
|
March 31, 2021 |
|
|
December 31, 2020 |
|
||
Laboratory equipment |
|
$ |
|
|
|
$ |
|
|
Office equipment |
|
|
|
|
|
|
|
|
Leasehold improvements |
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
Less: accumulated depreciation and amortization |
|
|
( |
) |
|
|
( |
) |
Property, equipment and leasehold improvements, net |
|
$ |
|
|
|
$ |
|
|
Depreciation and amortization expense totaled $
6. Right to Use Assets and Liabilities
The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (ROU) assets and operating lease liabilities in the condensed consolidated balance sheets.
ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The incremental borrowing rate ranges from
The Company has operating leases for its corporate office and certain equipment, which expire no later than
The components of lease expense were as follows:
|
|
Three Months Ended |
|
||||
|
|
March 31, |
|
||||
|
|
2021 |
|
2020 |
|
||
Operating lease cost |
|
$ |
|
|
$ |
|
|
Supplemental cash flow information related to leases was as follows:
|
|
Three Months Ended |
|
||||
|
|
March 31, |
|
||||
|
|
2021 |
|
2020 |
|
||
Cash paid for amounts included in the measurement of lease liabilities: |
|
|
|
|
|
|
|
Operating cash flows from operating leases |
|
$ |
|
|
$ |
|
|
Supplemental non-cash information: |
|
|
|
|
|
|
|
Right-of-use assets obtained in exchange for new lease obligations |
|
$ |
|
|
$ |
|
|
9
Maturities of lease liabilities for operating leases as of March 31, 2021, are as follows:
Remainder of 2021 |
|
$ |
|
|
2022 |
|
|
|
|
2023 |
|
|
|
|
2024 |
|
|
|
|
Total lease payments |
|
|
|
|
Less: imputed interest |
|
|
( |
) |
Total |
|
$ |
|
|
7. Accrued Expenses
Accrued expenses consisted of the following:
|
|
March 31, 2021 |
|
|
December 31, 2020 |
|
||
Employee expenses |
|
$ |
|
|
|
$ |
|
|
Research and development expenses |
|
|
|
|
|
|
|
|
Professional fees and other |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
8. Long-Term Debt
In connection with an Assistance Agreement with the State of Connecticut entered into in 2014 (2014 Assistant Agreement) under which all the borrowings by the Company were forgiven in accordance with the 2014 Assistance Agreement, the Company is required to be located in the State of Connecticut through
In June 2018, the Company entered into an Assistance Agreement with the State of Connecticut (2018 Assistance Agreement) to provide funding for the expansion and renovation of laboratory and office space (Project). Under the terms of the 2018 Assistance Agreement, the Company was entitled to borrow from the State of Connecticut a maximum of $
Anticipated future minimum payments on long-term debt for the years ending December 31 are:
2023 |
|
$ |
|
|
2024 |
|
|
|
|
Beyond |
|
|
|
|
Total |
|
$ |
|
|
During each of the three months ended March 31, 2021 and 2020, interest expense was $
9. Equity
Common Stock
10
During December 2020, the Company completed a public offering in which the Company issued and sold
In October 2019, the Company entered into an Equity Distribution Agreement (Distribution Agreement) with Piper Sandler Companies, formerly Piper Jaffray & Co. (Piper Sandler), pursuant to which the Company may offer and sell from time-to-time in an “at-the-market offering,” at its option, up to an aggregate of $
Share-based Compensation
In September 2018, the Company adopted the 2018 Employee Stock Purchase Plan (the 2018 ESPP) initially providing participating employees with the opportunity to purchase an aggregate of
All of the Company’s employees are eligible to participate in the 2018 ESPP, provided they meet certain employment requirements. On each offering commencement date, each participant will be granted the right to purchase, on the last business day of the offering period, a number of shares of the Company’s common stock determined by multiplying $
In the Fourth Amendment to the Company’s Incentive Share Plan (the Incentive Plan) adopted in March 2018, the Company was authorized to issue up to an aggregate of
11
During the three months ended March 31, 2021, the Company recognized compensation expense of $
The fair value of the stock options granted during the three months ended March 31, 2021 was determined using the Black-Scholes option pricing model with the following assumptions:
|
March 31, 2021 |
|
March 31, 2020 |
Expected volatility |
|
|
|
Expected term (years) |
|
|
|
Risk free interest rate |
|
|
|
Expected dividend yield |
|
|
|
Exercise price |
|
|
|
Given the Company’s common stock has not been trading for a sufficient period of time, the Company utilizes a collection of volatilities of peer companies to estimate the expected volatility of its common stock. The expected term is calculated utilizing the simplified method.
The following table provides a summary of the stock option activity under the 2018 Plan during the three months ended March 31, 2021. These amounts include stock options granted to employees, directors and consultants.
Stock options |
|
Options |