Urovant Sciences Reports 2019 First Fiscal Quarter Financial Results
Recent Business Highlights
- Announced the ambulatory blood pressure study for vibegron achieved its primary endpoint demonstrating that vibegron does not have an effect on daytime systolic ambulatory blood pressure compared to placebo (where no effect was defined as a change from baseline of less than 3.5 mm Hg compared to placebo within a 90% confidence interval).
- Presented positive topline results from the Phase 3 EMPOWUR study of 75 mg vibegron for overactive bladder at the annual AUA meeting in May.
- Completed a productive pre-NDA meeting with the
FDA in preparation for our anticipated New Drug Application (NDA) filing by early 2020. - Completed enrollment in Part 1 of the two-part OAB/BPH study in men.
- Finalized Phase 2a protocol for URO-902, our novel gene therapy product for OAB and expect to start patient enrollment by the end of fourth quarter 2019.
“During the last quarter,
First Fiscal Quarter 2019 Financial Summary
For the quarter ended
Note to Investors
As previously announced, Urovant will hold a conference call to discuss 2019 first fiscal quarter ended
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding the Company’s plans and strategies for the development and commercialization of innovative therapies for the treatment of urological conditions; the Company’s expectations regarding its anticipated NDA filing for vibegron for OAB; the Company’s expectations regarding its Phase 3 study of vibegron in men with OAB and BPH; and the Company’s expectations regarding its Phase 2a study for URO-902.
The Company’s forward-looking statements are based on management’s current expectations and beliefs, and are subject to a number of risks and uncertainties that could lead to actual results differing materially from those projected, forecasted or expected. Although the Company believes that the assumptions underlying these forward-looking statements are reasonable, they are not guarantees and the Company can give no assurance that its expectations will be attained. Factors that could materially affect the Company’s operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to: the Company’s limited operating history and the fact that it has never generated any product revenue; the Company’s ability to achieve or maintain profitability in the future; the Company’s dependence on the success of its lead product candidate, vibegron; the Company’s reliance on its key scientific, medical or management personnel and on certain affiliates to provide certain services to the Company; risks related to clinical trials, including uncertainties relating to the success of the Company’s clinical trials for vibegron and URO-902 and any future therapy or product candidates; uncertainties surrounding the regulatory landscape that governs gene therapy products; the Company’s dependence on
UROVANT SCIENCES LTD. |
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Condensed Consolidated Statements of Operations |
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(unaudited; in thousands, except share and per share data) |
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Three Months Ended June 30, |
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|
|
2019 |
|
|
2018 |
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Operating expenses: |
|
|
|
|
|
||||
Research and development(1) |
|
$ |
22,014 |
|
|
|
$ |
27,965 |
|
General and administrative(2) |
|
|
5,465 |
|
|
|
|
3,504 |
|
Total operating expenses |
|
|
27,479 |
|
|
|
|
31,469 |
|
Other income (expense): |
|
|
|
|
|
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Interest expense, net |
|
|
(513 |
) |
|
|
|
— |
|
Loss on disposal of furniture and equipment |
|
|
(236 |
) |
|
|
|
— |
|
Other income (expense) |
|
|
(190 |
) |
|
|
|
229 |
|
Loss before provision for income taxes |
|
|
(28,418 |
) |
|
|
|
(31,240 |
) |
Provision for income taxes |
|
|
67 |
|
|
|
|
55 |
|
Net loss |
|
$ |
(28,485 |
) |
|
|
$ |
(31,295 |
) |
Net loss per common share—basic and diluted |
|
$ |
(0.94 |
) |
|
|
$ |
(1.56 |
) |
Weighted average common shares outstanding—basic and diluted |
|
|
30,325,169 |
|
|
|
|
20,025,098 |
|
(1) |
Includes $265 and $452 of share-based compensation expense during the three months ended June 30, 2019 and 2018, respectively. |
|
(2) |
Includes $782 and $354 of share-based compensation expense during the three months ended June 30, 2019 and 2018, respectively. |
Condensed Consolidated Balance Sheets |
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(unaudited; in thousands) |
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June 30, |
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March 31, |
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Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
62,360 |
|
|
$ |
85,353 |
Restricted cash |
|
|
243 |
|
|
|
243 |
Prepaid expenses and other current assets |
|
|
8,416 |
|
|
|
12,914 |
Total current assets |
|
|
71,019 |
|
|
|
98,510 |
Furniture and equipment, net |
|
|
1,203 |
|
|
|
923 |
Operating lease right-of-use assets |
|
|
3,386 |
|
|
|
— |
Restricted cash, net of current portion |
|
|
623 |
|
|
|
600 |
Other assets |
|
|
21 |
|
|
|
88 |
Total assets |
|
$ |
76,252 |
|
|
$ |
100,121 |
|
|
|
|
|
|
|
|
Liabilities and Shareholders' Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,971 |
|
|
$ |
1,925 |
Accrued expenses |
|
|
8,287 |
|
|
|
9,877 |
Due to Roivant Sciences Ltd. |
|
|
97 |
|
|
|
15 |
Current portion of operating lease liabilities |
|
|
92 |
|
|
|
— |
Total current liabilities |
|
|
11,447 |
|
|
|
11,817 |
Long-term debt |
|
|
13,728 |
|
|
|
13,534 |
Operating lease liabilities, net of current portion |
|
|
3,357 |
|
|
|
— |
Total liabilities |
|
|
28,532 |
|
|
|
25,351 |
Total shareholders' equity |
|
|
47,720 |
|
|
|
74,770 |
Total liabilities and shareholders' equity |
|
$ |
76,252 |
|
|
$ |
100,121 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190813005601/en/
Source:
Investor inquiries: Investors@Urovant.com
Media inquiries: Media@Urovant.com