Urovant Sciences Reports Financial Results for the Second Fiscal Quarter Ended September 30, 2018 and Provides Corporate Update
Recent Business Highlights
- Completed enrollment in international Phase 3 trial for vibegron in adults with symptoms of overactive bladder (OAB) as defined by urge urinary incontinence, urgency, and urinary frequency
- Positive results from the international Phase 2b study for vibegron in adults with OAB recently published in European Urology, the peer-reviewed medical journal of the
European Association of Urology - Expect to initiate U.S. clinical program for vibegron for pain associated with irritable bowel syndrome (IBS) in women before year end
- Submitted draft clinical trial protocol to the
FDA to study vibegron in men with overactive bladder who have benign prostatic hyperplasia (BPH) - Licensed hMaxi-K, a novel gene therapy for overactive bladder
- Completed initial public offering in
October 2018 raising total gross proceeds of approximately$144.2 million
“Urovant Sciences advanced several clinical programs for vibegron, an investigational beta-3 adrenergic agonist, demonstrating our commitment to urology,” said
“I am immensely proud of my team’s momentum with vibegron,” added Katkin. “We also continue to assess business development opportunities that support our longer-term vision of becoming a leading urology company. We were pleased to have recently added the gene therapy hMaxi-K to our clinical development portfolio.”
Second Quarter Financial Summary
For the quarter ended
Six Months Financial Summary
For the six months ended
Note to Investors
As previously announced, Urovant will hold a conference call to discuss fiscal 2018 second 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 study of 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 vibergron and hMaxi-K 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 |
Six Months Ended |
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2018 | 2017 | 2018 | 2017 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development(1) | $ | 20,664 | $ | 4,751 | $ | 48,009 | $ | 7,883 | ||||||||
General and administrative(2) | 3,664 | 219 | 7,788 | 553 | ||||||||||||
Total operating expenses | 24,328 | 4,970 | 55,797 | 8,436 | ||||||||||||
Other income (expense): | ||||||||||||||||
Other income (expense) | (309 | ) | 59 | (80 | ) | (88 | ) | |||||||||
Loss before provision for income taxes | (24,637 | ) | (4,911 | ) | (55,877 | ) | (8,524 | ) | ||||||||
Provision for income taxes | 5 | 2 | 60 | 4 | ||||||||||||
Net loss | $ | (24,642 | ) | $ | (4,913 | ) | $ | (55,937 | ) | $ | (8,528 | ) | ||||
Net loss per common share—basic and diluted | $ | (1.23 | ) | $ | (0.25 | ) | $ | (2.79 | ) | $ | (0.60 | ) | ||||
Weighted average common shares outstanding—basic and diluted | 20,025,098 | 20,025,098 | 20,025,098 | 14,240,070 | ||||||||||||
(1) | Includes $293 and $854 of share-based compensation during the three months ended September 30, 2018 and 2017, respectively, and $565 and $1,693 of share-based compensation expense during the six months ended September 30, 2018 and 2017, respectively. | |
(2) | Includes $696 and $33 of share-based compensation during the three months ended September 30, 2018 and 2017, respectively, and $1,230 and $78 of share-based compensation expense during the six months ended September 30, 2018 and 2017, respectively. |
UROVANT SCIENCES LTD. | |||||||
Condensed Consolidated Balance Sheets | |||||||
(unaudited; in thousands, except share and per share data) |
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September 30, 2018 | March 31, 2018 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash | $ | 1,659 | $ | 7,194 | |||
Prepaid expenses and other current assets | 11,757 | 5,196 | |||||
Deferred initial public offering costs | 2,201 | — | |||||
Total current assets | 15,617 | 12,390 | |||||
Property and equipment, net | 587 | 510 | |||||
Other assets | 84 | 84 | |||||
Total assets | $ | 16,288 | $ | 12,984 | |||
Liabilities and Shareholder’s Equity (Deficit) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 5,084 | $ | 833 | |||
Accrued expenses | 9,875 | 3,595 | |||||
Due to Roivant Sciences Ltd. | 8,056 | 1,482 | |||||
Total liabilities | 23,015 | 5,910 | |||||
Total shareholder’s equity (deficit) | (6,727 | ) | 7,074 | ||||
Total liabilities and shareholder’s equity (deficit) | $ | 16,288 | $ | 12,984 | |||
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Source:
Urovant Sciences Ltd.
Investor inquiries: Investors@Urovant.com
Media inquiries: Media@Urovant.com