Urovant Sciences Reports Financial Results for the Third Fiscal Quarter Ended December 31, 2018
Recent Business Highlights
- Announced plans to report topline data from international Phase 3 trial for vibegron in adults with symptoms of overactive bladder (OAB) by the end of
March 2019 . - Initiated U.S. clinical program for vibegron for abdominal pain associated with irritable bowel syndrome (IBS) in women.
- Gained alignment with
U.S. Food and Drug Administration (FDA ) on clinical trial protocol for pivotal Phase 3 trial for vibegron in men with OAB who have benign prostatic hyperplasia (BPH).
“Urovant Sciences continued to make progress on several clinical programs for vibegron, an investigational beta-3 adrenergic agonist, demonstrating our commitment to urology,” said
Mr. Katkin continued, “Furthermore, we initiated a Phase 2a study of vibegron in women with IBS-associated abdominal pain in
Third Quarter Financial Summary
For the quarter ended
Note to Investors
As previously announced, Urovant will hold a conference call to discuss fiscal 2018 third quarter financial results today,
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 reporting of top-line data from its Phase 3 trial for vibegron in adults with symptoms of OAB by the end of
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. Condensed Consolidated Statements of Operations (unaudited; in thousands, except share and per share data) |
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Three Months Ended
December 31, |
Nine Months Ended
December 31, |
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2018 | 2017 | 2018 | 2017 | |||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development(1) | $ | 21,299 | $ | 8,046 | $ | 69,308 | $ | 15,929 | ||||||||||||||||
General and administrative(2) | 4,862 | 1,389 | 12,650 | 1,942 | ||||||||||||||||||||
Total operating expenses | 26,161 | 9,435 | 81,958 | 17,871 | ||||||||||||||||||||
Other income (expense): | ||||||||||||||||||||||||
Other income (expense) | (219 | ) | 6 | (299 | ) | (82 | ) | |||||||||||||||||
Loss before provision for income taxes | (26,380 | ) | (9,429 | ) | (82,257 | ) | (17,953 | ) | ||||||||||||||||
Provision for income taxes | 61 | 22 | 121 | 26 | ||||||||||||||||||||
Net loss | $ | (26,441 | ) | $ | (9,451 | ) | $ | (82,378 | ) | $ | (17,979 | ) | ||||||||||||
Net loss per common share—basic and diluted | $ | (0.87 | ) | $ | (0.47 | ) | $ | (3.51 | ) | $ | (1.11 | ) | ||||||||||||
Weighted average common shares outstanding—basic and diluted | 30,264,643 | 20,025,098 | 23,450,692 | 16,175,425 | ||||||||||||||||||||
(1) | Includes $322 and $417 of share-based compensation during the three months ended December 31, 2018 and 2017, respectively, and $887 and $2,110 of share-based compensation during the nine months ended December 31, 2018 and 2017. | ||
(2) | Includes $511 and $246 of share-based compensation during the three months ended December 31, 2018 and 2017, respectively, and $1,741 and $324 of share-based compensation during the nine months ended December 31, 2018 and 2017. | ||
UROVANT SCIENCES LTD. Condensed Consolidated Balance Sheets (unaudited; in thousands, except share and per share data) |
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December 31, 2018 | March 31, 2018 | ||||||||||||||||
Assets | |||||||||||||||||
Current assets: | |||||||||||||||||
Cash | $ | 95,613 | $ | 7,194 | |||||||||||||
Restricted cash | 244 | — | |||||||||||||||
Prepaid expenses and other current assets | 15,140 | 5,196 | |||||||||||||||
Total current assets | 110,997 | 12,390 | |||||||||||||||
Furniture and equipment, net | 571 | 510 | |||||||||||||||
Restricted cash, net of current portion | 600 | — | |||||||||||||||
Other assets | 84 | 84 | |||||||||||||||
Total assets | $ | 112,252 | $ | 12,984 | |||||||||||||
Liabilities and Shareholders' Equity | |||||||||||||||||
Current liabilities: | |||||||||||||||||
Accounts payable | $ | 3,696 | $ | 833 | |||||||||||||
Accrued expenses | 6,365 | 3,595 | |||||||||||||||
Due to Roivant Sciences Ltd. | 33 | 1,482 | |||||||||||||||
Total liabilities | 10,094 | 5,910 | |||||||||||||||
Total shareholders' equity | 102,158 | 7,074 | |||||||||||||||
Total liabilities and shareholders' equity | $ | 112,252 | $ | 12,984 | |||||||||||||
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Source:
Investor inquiries: Investors@Urovant.com
Media inquiries: Media@Urovant.com