Urovant Sciences Reports Fiscal First Quarter 2020 Results
The first quarter of fiscal 2020 saw the Company achieve a number of significant operational milestones as it embarked on the build out of both its commercial and market access teams and completed enrollment in the Phase 2a study of vibegron for irritable bowel syndrome (IBS) pain.
“We continued to make important progress in the first fiscal quarter of 2020. We significantly enhanced the commercial and market access capabilities we need to successfully launch vibegron,” said
Urovant Recent Business Highlights
- Completed enrollment in the Phase 2a study of vibegron for IBS pain.
- Made significant progress in the hiring of customer-facing personnel and are nearing completion of our sales leadership, market access, and medical science liaison teams.
- Initiated an unbranded campaign to help inform and support patients with overactive bladder (OAB), which included the launch of an OAB-focused community website called bladderchatter.com.
Expected Upcoming Events
- Topline results from vibegron trial in IBS-associated pain expected in Q4 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 by early 2021.
- The
U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) date for vibegron in OAB isDecember 26, 2020 .
First Fiscal Quarter 2020 Financial Summary
For the quarter ended
Note to Investors
As previously announced, Urovant will hold a conference call today,
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, and the related status of FDA approval. 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 months comparisons are to the prior fiscal year comparable period ended |
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Three Months Ended |
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2020 |
|
2019 |
||||
Operating expenses: |
|
|
|
|
|
|
||
Research and development(1) |
|
$ |
16,354 |
|
|
$ |
22,014 |
|
General and administrative(2) |
|
|
12,489 |
|
|
|
5,465 |
|
Total operating expenses |
|
|
28,843 |
|
|
|
27,479 |
|
Other expense: |
|
|
|
|
|
|
||
Interest expense, net |
|
|
(1,443 |
) |
|
|
(513 |
) |
Loss on disposal of property and equipment |
|
|
— |
|
|
|
(236 |
) |
Other expense, net |
|
|
(118 |
) |
|
|
(190 |
) |
Loss before provision for income taxes |
|
|
(30,404 |
) |
|
|
(28,418 |
) |
Provision for income taxes |
|
|
90 |
|
|
|
67 |
|
Net loss |
|
$ |
(30,494 |
) |
|
$ |
(28,485 |
) |
Net loss per common share—basic and diluted |
|
$ |
(0.99 |
) |
|
$ |
(0.94 |
) |
Weighted average common shares outstanding—basic and diluted |
|
|
30,705,334 |
|
|
|
30,325,169 |
|
(1) |
Includes |
|
(2) |
Includes |
Condensed Consolidated Balance Sheets |
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(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 |
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2020 |
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Assets |
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|
|
|
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Current assets: |
|
|
|
|
|
|
||
Cash |
|
$ |
63,039 |
|
|
$ |
51,414 |
|
Restricted cash |
|
|
250 |
|
|
|
243 |
|
Due from |
|
|
— |
|
|
|
172 |
|
Prepaid expenses and other current assets |
|
|
8,980 |
|
|
|
6,489 |
|
Total current assets |
|
|
72,269 |
|
|
|
58,318 |
|
Property and equipment, net |
|
|
1,237 |
|
|
|
1,210 |
|
Operating lease right-of-use assets |
|
|
3,939 |
|
|
|
3,135 |
|
Restricted cash, net of current portion |
|
|
623 |
|
|
|
623 |
|
Other assets |
|
|
69 |
|
|
|
9 |
|
Total assets |
|
$ |
78,137 |
|
|
$ |
63,295 |
|
|
|
|
|
|
|
|
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Liabilities and Shareholders' Deficit |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
130 |
|
|
$ |
1,589 |
|
Accrued expenses |
|
|
23,098 |
|
|
|
21,756 |
|
Due to |
|
|
2 |
|
|
|
31 |
|
Current portion of share-based compensation liabilities |
|
|
6,919 |
|
|
|
7,204 |
|
Current portion of operating lease liabilities. |
|
|
422 |
|
|
|
351 |
|
Total current liabilities |
|
|
30,571 |
|
|
|
30,931 |
|
Share-based compensation liabilities, net of current portion |
|
|
370 |
|
|
|
32 |
|
Related-party long-term debt |
|
|
128,270 |
|
|
|
87,252 |
|
Operating lease liabilities, net of current portion |
|
|
3,862 |
|
|
|
3,086 |
|
Total liabilities |
|
|
163,073 |
|
|
|
121,301 |
|
Total shareholders' deficit |
|
|
(84,936 |
) |
|
|
(58,006 |
) |
Total liabilities and shareholders' deficit |
|
$ |
78,137 |
|
|
$ |
63,295 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200813005140/en/
Investor and Media inquiries:
949.769.2706
ryan.kubota@urovant.com
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