UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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:
UROGEN PHARMA LTD.
(Exact Name of Registrant as Specified in its Charter)
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Israel |
98-1460746 |
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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
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol |
Name of exchange on which registered |
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Ordinary Shares, par value NIS 0.01 per share |
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The Nasdaq Global Market |
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). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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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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 ☐ No ☒
As of August 5, 2019, the registrant had
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UROGEN PHARMA, LTD.
INDEX
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Page |
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PART I. |
1 |
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Item 1. |
1 |
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1 |
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2 |
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3 |
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5 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
6 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
19 |
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Item 3. |
27 |
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Item 4. |
28 |
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PART II. |
29 |
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Item 1. |
29 |
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Item 1A. |
29 |
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Item 2. |
71 |
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Item 3. |
71 |
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Item 4. |
71 |
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Item 5. |
71 |
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Item 6. |
72 |
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73 |
Trademarks and Trade Names
Unless the context requires otherwise, references in this Quarterly Report to the “Company”, “we,” “us” and “our” refer to UroGen Pharma Ltd. and its subsidiary, Urogen Pharma, Inc. The Company has trademarks for UroGen and RTGel. This Quarterly Report on Form 10-Q, or this Quarterly Report, contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Quarterly Report, including logos, artwork and other visual displays, may appear without the ® or TM 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 companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
i
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
UROGEN PHARMA, LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited; in thousands, except share amounts)
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June 30, 2019 |
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December 31, 2018 |
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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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— |
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Restricted deposit |
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Prepaid expenses and other current assets |
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TOTAL CURRENT ASSETS |
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NON-CURRENT ASSETS |
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Property and equipment, net |
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Restricted deposit |
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Marketable securities |
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— |
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Other non-current assets |
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TOTAL ASSETS |
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$ |
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$ |
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Liabilities and Shareholder's equity |
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CURRENT LIABILITIES: |
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Accounts payable and accrued expenses |
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$ |
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$ |
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Employee related accrued expenses |
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Other current liabilities |
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— |
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TOTAL CURRENT LIABILITIES |
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NON-CURRENT LIABILITIES: |
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Long-term lease liability |
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— |
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TOTAL NON-CURRENT LIABILITIES |
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— |
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TOTAL LIABILITIES |
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COMMITMENTS AND CONTINGENCIES (Note 14) |
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SHAREHOLDERS’ EQUITY: |
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Ordinary shares, NIS authorized at June 30, 2019 and December 31, 2018; and of June 30, 2019 and December 31, 2018, respectively |
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Additional paid-in capital |
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Accumulated deficit |
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( |
) |
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( |
) |
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Accumulated other comprehensive income |
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— |
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TOTAL SHAREHOLDERS’ EQUITY |
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TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
UROGEN PHARMA, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited; in thousands, except share and per share amounts)
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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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2019 |
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2018 |
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2019 |
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2018 |
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REVENUES |
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$ |
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$ |
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$ |
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$ |
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COST OF REVENUES |
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$ |
— |
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— |
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GROSS PROFIT |
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OPERATING EXPENSES: |
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RESEARCH AND DEVELOPMENT EXPENSES |
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$ |
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GENERAL AND ADMINISTRATIVE EXPENSES |
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$ |
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OPERATING LOSS |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
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INTEREST AND OTHER INCOME (EXPENSES), NET |
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$ |
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REALIZED LOSS ON SALE OF SHORT-TERM INVESTMENT |
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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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NET LOSS PER ORDINARY SHARE BASIC AND DILUTED |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER ORDINARY SHARE |
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STATEMENTS OF COMPREHENSIVE LOSS |
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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 MARKETABLE SECURITIES |
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$ |
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— |
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— |
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COMPREHENSIVE LOSS |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
UROGEN PHARMA, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(unaudited; in thousands, except share amounts)
|
|
|
Ordinary Shares |
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Preferred Shares |
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Additional paid-in |
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Accumulated |
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Other comprehensive |
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|||||||||||||
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Number of |
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Number of |
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capital |
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Deficit |
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income |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Amounts |
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|||||||||||||||||
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BALANCE AS OF 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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$ |
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CHANGES DURING THE THREE MONTHS ENDED JUNE 30, 2019 |
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Exercise of options into ordinary shares |
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Share-based compensation |
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Other comprehensive income |
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Net loss |
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( |
) |
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( |
) |
|
BALANCE AS OF 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 AS OF MARCH 31, 2018 |
|
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|
$ |
|
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|
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— |
|
|
$ |
— |
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
|
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|
CHANGES DURING THE THREE MONTHS ENDED JUNE 30, 2018 |
|
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Exercise of options into ordinary shares |
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|
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( |
) |
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— |
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Share-based compensation |
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Other comprehensive income |
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— |
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— |
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Net loss |
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( |
) |
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( |
) |
|
BALANCE AS OF JUNE 30, 2018 |
|
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|
$ |
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|
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— |
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|
$ |
— |
|
|
$ |
|
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|
$ |
( |
) |
|
$ |
— |
|
|
$ |
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
UROGEN PHARMA, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(unaudited; in thousands, except share amounts)
|
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Ordinary Shares |
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Preferred Shares |
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Additional paid-in |
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Accumulated |
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Other comprehensive |
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|
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Number of |
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Number of |
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capital |
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Deficit |
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income |
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Total |
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||||||
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Shares |
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Amount |
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Shares |
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Amount |
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Amounts |
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BALANCE AS OF JANUARY 1, 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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$ |
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CHANGES DURING THE SIX MONTHS ENDED JUNE 30, 2019 |
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Exercise of options into ordinary shares |
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Share-based compensation |
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Issuance of ordinary shares in public offering, net of issuance expenses |
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Other comprehensive income |
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Net loss |
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|
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( |
) |
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( |
) |
|
BALANCE AS OF 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 AS OF JANUARY 1, 2018 |
|
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|
$ |
|
|
|
|
— |
|
|
$ |
— |
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
|
|
|
CHANGES DURING THE SIX MONTHS ENDED JUNE 30, 2018 |
|
|
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Exercise of options into ordinary shares |
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|
|
|
|
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( |
) |
|
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|
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|
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— |
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|
Share-based compensation |
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|
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Issuance of ordinary shares in public offering, net of issuance expenses |
|
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Net loss |
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|
|
|
|
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( |
) |
|
|
|
|
|
|
( |
) |
|
BALANCE AS OF JUNE 30, 2018 |
|
|
|
|
|
$ |
|
|
|
|
— |
|
|
$ |
— |
|
|
$ |
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|
$ |
( |
) |
|
$ |
— |
|
|
$ |
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
UROGEN PHARMA, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
(unaudited; in thousands)
|
|
|
Six Months Ended June 30, |
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2019 |
|
|
2018 |
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|
CASH FLOWS FROM OPERATING ACTIVITIES: |
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|
|
|
|
|
|
|
|
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
Adjustment to reconcile net loss to net cash from operating activities: |
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|
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Depreciation and amortization |
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|
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|
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|
Amortization/Accretion on marketable securities |
|
|
( |
) |
|
|
— |
|
|
Stock-based compensation |
|
|
|
|
|
|
|
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|
Exchange rate differences |
|
|
— |
|
|
|
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|
Realized loss on sale of short-term investment |
|
|
— |
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|
|
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|
Right of use asset |
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|
|
|
|
|
— |
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|
Lease liability |
|
|
( |
) |
|
|
— |
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|
Changes in operating assets and liabilities: |
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|
Decrease in inventory |
|
|
— |
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|
|
|
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|
Increase in accounts receivable |
|
|
— |
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|
|
( |
) |
|
Increase in prepaid expenses and other current assets |
|
|
( |
) |
|
|
( |
) |
|
(Decrease) increase in accounts payable and accrued expenses |
|
|
( |
) |
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|
Decrease in deferred revenues |
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|
— |
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( |
) |
|
(Decrease) increase in employee related accrued expenses |
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|
( |
) |
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|
Net cash used in operating activities |
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|
( |
) |
|
|
( |
) |
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
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|
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|
Change in restricted deposit |
|
|
( |
) |
|
|
( |
) |
|
Purchases of marketable securities |
|
|
( |
) |
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|
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|
Purchases of property and equipment |
|
|
( |
) |
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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 options into ordinary shares |
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