Urovant Sciences Reports 2019 Second Fiscal Quarter Financial Results
Recent Business Highlights
Sumitomo Dainippon Pharma committed to provide Urovant with a$200 million , low-interest, interest-only, five-year term loan facility, access to enhanced commercial support, minority shareholder protection, and expected financial support through profitability.- Reported positive data from the long-term extension of the phase 3 EMPOWUR study of vibegron in patients with overactive bladder, in which vibegron demonstrated a favorable long-term safety and tolerability profile and further improved treatment benefit on key overactive bladder symptoms over the 40-week extension period.
- Completed pharmacokinetic study to support administration of vibegron as a crushed tablet in soft food, which has the potential to be a significant benefit for elderly patients who have trouble swallowing.
- Initiated part 2 of the phase 3 COURAGE trial, which will assess both efficacy and safety of vibegron in men with OAB and BPH, a patient population for which no product is currently approved.
“Significant progress was made this quarter towards the filing of our New Drug Application for vibegron, with positive results reported from the long-term extension of the phase 3 EMPOWUR study and pharmacokinetic results to support administration of vibegron as a crushed tablet,” said
Second Fiscal Quarter 2019 Financial Summary
For the quarter ended
Note to Investors
As previously announced, Urovant will hold a conference call to discuss 2019 second 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; the Company’s pharmacokinetic crushed vibegron tablet study and its expectations regarding the inclusion of this in the product label; and the commitments 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 September 30, |
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Six Months Ended September 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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Operating expenses: |
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|
|
|
|
|
|
|
|
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|
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Research and development(1) |
|
$ |
17,796 |
|
|
$ |
20,664 |
|
|
$ |
39,810 |
|
|
$ |
48,009 |
|
General and administrative(2) |
|
|
7,435 |
|
|
|
3,664 |
|
|
|
12,900 |
|
|
|
7,788 |
|
Total operating expenses |
|
|
25,231 |
|
|
|
24,328 |
|
|
|
52,710 |
|
|
|
55,797 |
|
Other income (expense): |
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|
|
|
|
|
|
|
|
|
|
|
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Interest expense, net |
|
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(581 |
) |
|
|
— |
|
|
|
(1,094 |
) |
|
|
— |
|
Loss on disposal of furniture and equipment |
|
|
— |
|
|
|
— |
|
|
|
(236 |
) |
|
|
— |
|
Other income (expense) |
|
|
79 |
|
|
|
(309 |
) |
|
|
(111 |
) |
|
|
(80 |
) |
Loss before provision for income taxes |
|
|
(25,733 |
) |
|
|
(24,637 |
) |
|
|
(54,151 |
) |
|
|
(55,877 |
) |
Provision for income taxes |
|
|
8 |
|
|
|
5 |
|
|
|
75 |
|
|
|
60 |
|
Net loss |
|
$ |
(25,741 |
) |
|
$ |
(24,642 |
) |
|
$ |
(54,226 |
) |
|
$ |
(55,937 |
) |
Net loss per common share—basic and diluted |
|
$ |
(0.85 |
) |
|
$ |
(1.23 |
) |
|
$ |
(1.79 |
) |
|
$ |
(2.79 |
) |
Weighted average common shares outstanding—basic and diluted |
|
|
30,355,874 |
|
|
|
20,025,098 |
|
|
|
30,340,603 |
|
|
|
20,025,098 |
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(1) |
Includes $257 and $293 of share-based compensation expense during the three months ended September 30, 2019 and 2018, respectively, and $522 and $565 of share-based compensation during the six months ended September 30, 2019 and 2018. |
(2) |
Includes $964 and $696 of share-based compensation expense during the three months ended September 30, 2019 and 2018, respectively, and $1,746 and $1,230 of share-based compensation during the six months ended September 30, 2019 and 2018. |
Condensed Consolidated Balance Sheets (unaudited; in thousands) |
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September 30, 2019 |
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March 31, 2019 |
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Assets |
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Current assets: |
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|
|
|
|
|
|
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Cash and cash equivalents |
|
$ |
67,796 |
|
|
$ |
85,353 |
|
Restricted cash |
|
|
243 |
|
|
|
243 |
|
Prepaid expenses and other current assets |
|
|
8,823 |
|
|
|
12,914 |
|
Total current assets |
|
|
76,862 |
|
|
|
98,510 |
|
Furniture and equipment, net |
|
|
1,226 |
|
|
|
923 |
|
Operating lease right-of-use assets |
|
|
3,301 |
|
|
|
— |
|
Restricted cash, net of current portion |
|
|
623 |
|
|
|
600 |
|
Other assets |
|
|
16 |
|
|
|
88 |
|
Total assets |
|
$ |
82,028 |
|
|
$ |
100,121 |
|
|
|
|
|
|
|
|
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Liabilities and Shareholders' Equity |
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Current liabilities: |
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|
|
|
|
|
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Accounts payable |
|
$ |
1,567 |
|
|
$ |
1,925 |
|
Accrued expenses |
|
|
9,590 |
|
|
|
9,877 |
|
Due to Roivant Sciences Ltd. |
|
|
133 |
|
|
|
15 |
|
Current portion of long-term debt |
|
|
10 |
|
|
|
— |
|
Current portion of operating lease liabilities. |
|
|
265 |
|
|
|
— |
|
Total current liabilities |
|
|
11,565 |
|
|
|
11,817 |
|
Long-term debt, net of current portion |
|
|
43,438 |
|
|
|
13,534 |
|
Operating lease liabilities, net of current portion |
|
|
3,269 |
|
|
|
— |
|
Total liabilities |
|
|
58,272 |
|
|
|
25,351 |
|
Total shareholders' equity |
|
|
23,756 |
|
|
|
74,770 |
|
Total liabilities and shareholders' equity |
|
$ |
82,028 |
|
|
$ |
100,121 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20191105006085/en/
Source:
Investor inquiries: Investors@Urovant.com