Urovant Sciences Reports Second Quarter Fiscal Year 2020 Results
During the second quarter of fiscal year 2020, the Company achieved a number of significant operational and commercial planning milestones in preparation for the
“We are pleased to have the key elements of our commercial strategy in place, including the Sunovion agreement, as we continue to prepare for the anticipated launch of vibegron in the first quarter of calendar year 2021. The Sunovion agreement and the completion of our sales and market access leadership teams are essential components to support the successful launch of vibegron,” said
Urovant Recent Business Highlights
- Initiated the hiring process for the Company’s front-line sales force that will be focused on urologists, long-term care, and high-prescribing PCPs.
- Entered into a five-year co-promotion agreement with
Sunovion Pharmaceuticals that will supplement the Company’s targeted sales and market access efforts in the launch of vibegron by expanding the outreach to primary care physicians. - Engaged key payors on the clinical value of vibegron though pre-approval information exchange discussions.
Expected Upcoming Events
- The Company will be presenting at the upcoming
International Continence Society (ICS) Annual meeting inNovember 2020 . - Topline results from vibegron trial in IBS-associated pain expected in late
November 2020 . - The FDA PDUFA goal date for vibegron in OAB is
December 26, 2020 . - URO-902 Data and Safety Monitoring Board data review and decision to move from cohort 1 to cohort 2 in Phase 2a trial expected in early 2021.
Second Quarter Fiscal Year 2020 Financial Summary
For the quarter ended
As of
Conference Call
As previously announced, Urovant will hold a conference call at
A replay of the call will be available approximately four hours after the call and accessible for seven days at (855) 859-2056, conference ID: 8054049. A webcast will be archived on the Investor Relations page of the
About
About
Sumitovant is a global biopharmaceutical company with offices in
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in
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; including expectations regarding the clinical development of vibegron in patients with overactive bladder (OAB), the clinical development of URO-902 in patients with OAB, the clinical development of vibegron in patients with OAB+BPH and IBS-pain, the related status of FDA approval, and Urovant’s planned commercial footprint for vibegron and Urovant’s expectations regarding access to the market, including to primary care providers. 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 impact on the Company’s business, financial results, results of operations and ongoing clinical trials from the effects of the COVID-19 pandemic; the Company’s ability to satisfy future funding needs on commercially reasonable terms and conditions if at all; the Company’s dependence on Sumitomo Dainippon Pharma and its affiliates to provide loan funding under the Company’s loan agreement and commercial and operational support for the Company’s product candidates and the significant control Sumitomo Dainippon Pharma Co., Ltd., through its wholly owned subsidiary,
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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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Unless otherwise noted, the three and six months comparisons are to the prior fiscal year comparable period ended |
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Three Months Ended |
|
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Six Months Ended |
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|||||||||||
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
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Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development(1) |
|
$ |
14,536 |
|
|
$ |
17,796 |
|
|
$ |
30,890 |
|
|
$ |
39,810 |
|
|
General and administrative(2) |
|
|
18,933 |
|
|
|
7,435 |
|
|
|
31,422 |
|
|
|
12,900 |
|
|
Total operating expenses |
|
|
33,469 |
|
|
|
25,231 |
|
|
|
62,312 |
|
|
|
52,710 |
|
|
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(1,464 |
) |
|
|
(581 |
) |
|
|
(2,907 |
) |
|
|
(1,094 |
) |
|
Loss on disposal of property and equipment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(236 |
) |
|
Other (expense) income, net |
|
|
(308 |
) |
|
|
79 |
|
|
|
(426 |
) |
|
|
(111 |
) |
|
Loss before (benefit from) provision for income taxes |
|
|
(35,241 |
) |
|
|
(25,733 |
) |
|
|
(65,645 |
) |
|
|
(54,151 |
) |
|
(Benefit from) provision for income taxes |
|
|
(85 |
) |
|
|
8 |
|
|
|
5 |
|
|
|
75 |
|
|
Net loss |
|
$ |
(35,156 |
) |
|
$ |
(25,741 |
) |
|
$ |
(65,650 |
) |
|
$ |
(54,226 |
) |
|
Net loss per common share—basic and diluted |
|
$ |
(1.12 |
) |
|
$ |
(0.85 |
) |
|
$ |
(2.12 |
) |
|
$ |
(1.79 |
) |
|
Weighted average common shares outstanding—basic and diluted |
|
|
31,251,351 |
|
|
|
30,355,874 |
|
|
|
30,979,833 |
|
|
|
30,340,603 |
|
|
(1) |
Includes |
|
(2) |
Includes |
Condensed Consolidated Balance Sheets |
||||||||
(unaudited; in thousands) |
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Unless otherwise noted, the three months comparisons are to the prior fiscal year comparable period ended |
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|
|
2020 |
|
|
2020 |
|
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Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
74,401 |
|
|
$ |
51,414 |
|
Restricted cash |
|
|
250 |
|
|
|
243 |
|
Due from |
|
|
— |
|
|
|
172 |
|
Prepaid expenses and other current assets |
|
|
9,195 |
|
|
|
6,489 |
|
Total current assets |
|
|
83,846 |
|
|
|
58,318 |
|
Property and equipment, net |
|
|
1,492 |
|
|
|
1,210 |
|
Operating lease right-of-use assets |
|
|
3,823 |
|
|
|
3,135 |
|
Restricted cash, net of current portion |
|
|
2,198 |
|
|
|
623 |
|
Other assets |
|
|
98 |
|
|
|
9 |
|
Total assets |
|
$ |
91,457 |
|
|
$ |
63,295 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders' Deficit |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
493 |
|
|
$ |
1,589 |
|
Accrued expenses |
|
|
23,747 |
|
|
|
21,756 |
|
Due to |
|
|
— |
|
|
|
31 |
|
Due to |
|
|
173 |
|
|
|
— |
|
Current portion of share-based compensation liabilities |
|
|
3,934 |
|
|
|
7,204 |
|
Current portion of operating lease liabilities |
|
|
497 |
|
|
|
351 |
|
Total current liabilities |
|
|
28,844 |
|
|
|
30,931 |
|
Share-based compensation liabilities, net of current portion |
|
|
658 |
|
|
|
32 |
|
Related-party long-term debt |
|
|
171,278 |
|
|
|
87,252 |
|
Operating lease liabilities, net of current portion |
|
|
3,727 |
|
|
|
3,086 |
|
Total liabilities |
|
|
204,507 |
|
|
|
121,301 |
|
Total shareholders' deficit |
|
|
(113,050 |
) |
|
|
(58,006 |
) |
Total liabilities and shareholders' deficit |
|
$ |
91,457 |
|
|
$ |
63,295 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20201102005164/en/
Investor and Media inquiries:
949.769.2706
ryan.kubota@urovant.com
Source: