Urovant Sciences Reports Fiscal Year and Fourth Quarter 2019 Results
The fiscal fourth quarter of 2019 marked achievement of key milestones for
“The 2019 fiscal year and fourth quarter have been transformational for our company,” said
Urovant Fiscal 2019 and Recent Business Highlights
Clinical
- Reported positive long-term data from the double-blind extension of the Phase 3 EMPOWUR study of vibegron in patients with OAB.
- Initiated Part 2 of Phase 3 COURAGE study of vibegron for OAB in men with benign prostatic hyperplasia (BPH).
- Initiated enrollment in a Phase 2a study evaluating the efficacy and safety of URO-902, a novel gene therapy product, in patients with OAB suffering with urge urinary incontinence (UUI) not adequately managed with oral pharmacological therapy.
- Submitted NDA for vibegron for the treatment of OAB to the FDA.
- Received acceptance of NDA for vibegron for the treatment of patients with OAB by the FDA.
Financing
- Entered into a
$300 million low interest, interest-only, five-year term loan facility with Sumitomo Dainippon Pharma. - Fully repaid Hercules Capital debt facility.
Organization
- Named
James Robinson as President and CEO.Mr. Robinson has deep experience in the urology and overactive bladder markets. - Appointed
James Hindman , former CFO of Allergan, to Urovant Board of Directors. - Appointed
Walt Johnston as Senior Vice President of Commercial,Kenton Stewart as Senior Vice President of Market Access.Mr. Johnston andMr. Stewart , both seasoned industry veterans, have significant experience launching products in urology and OAB.
Operations
- Entered into an exclusive three-year agreement with
Sunovion Pharmaceuticals for services related to wholesale trade and retail distribution, contract operations, and select account management activities.
Expected Upcoming Events
- Vibegron trial in IBS-associated pain top line results 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 in 4Q 2020.
- Vibegron for OAB Prescription Drug User Fee Act (PDUFA) date –
December 26, 2020 .
Fourth Fiscal Quarter 2019 Financial Summary
For the quarter ended
Fiscal Year 2019 Financial Summary
For the fiscal year 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; Urovant’s plans to advance the clinical development of vibegron in patients with overactive bladder (OAB) and obtain
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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 and fiscal year comparisons are to the prior fiscal year comparable period ended |
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Three Months Ended |
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Year Ended |
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2020 |
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2019 |
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2020 |
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2019 |
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Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development(1) |
|
$ |
29,528 |
|
|
$ |
22,890 |
|
|
$ |
92,437 |
|
|
$ |
92,198 |
|
|
General and administrative(2) |
|
|
16,712 |
|
|
|
5,935 |
|
|
|
46,299 |
|
|
|
18,585 |
|
|
Total operating expenses |
|
|
46,240 |
|
|
|
28,825 |
|
|
|
138,736 |
|
|
|
110,783 |
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Interest expense, net |
|
|
(1,086 |
) |
|
|
(259 |
) |
|
|
(3,581 |
) |
|
|
(259 |
) |
|
Loss on extinguishment of long-term debt |
|
|
(4,093 |
) |
|
|
— |
|
|
|
(4,093 |
) |
|
|
— |
|
|
Loss on disposal of property and equipment |
|
|
— |
|
|
|
— |
|
|
|
(236 |
) |
|
|
— |
|
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Other income (expense), net |
|
|
111 |
|
|
|
42 |
|
|
|
(34 |
) |
|
|
(257 |
) |
|
Loss before provision for (benefit from) income taxes |
|
|
(51,308 |
) |
|
|
(29,042 |
) |
|
|
(146,680 |
) |
|
|
(111,299 |
) |
|
Provision for (benefit from) income taxes |
|
|
(48 |
) |
|
|
(74 |
) |
|
|
65 |
|
|
|
47 |
|
|
Net loss |
|
$ |
(51,260 |
) |
|
$ |
(28,968 |
) |
|
$ |
(146,745 |
) |
|
$ |
(111,346 |
) |
|
Net loss per common share—basic and diluted |
|
$ |
(1.68 |
) |
|
$ |
(0.96 |
) |
|
$ |
(4.82 |
) |
|
$ |
(4.43 |
) |
|
Weighted average common shares outstanding—basic and diluted |
|
|
30,572,272 |
|
|
|
30,322,911 |
|
|
|
30,416,641 |
|
|
|
25,145,211 |
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(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 and fiscal year comparisons are to the prior fiscal year comparable period ended |
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2020 |
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2019 |
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Assets |
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Current assets: |
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Cash |
|
$ |
51,414 |
|
|
$ |
85,353 |
|
Restricted cash |
|
|
243 |
|
|
|
243 |
|
Due from |
|
|
172 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
6,489 |
|
|
|
12,914 |
|
Total current assets |
|
|
58,318 |
|
|
|
98,510 |
|
Property and equipment, net |
|
|
1,210 |
|
|
|
923 |
|
Operating lease right-of-use assets |
|
|
3,135 |
|
|
|
— |
|
Restricted cash, net of current portion |
|
|
623 |
|
|
|
600 |
|
Other assets |
|
|
9 |
|
|
|
88 |
|
Total assets |
|
$ |
63,295 |
|
|
$ |
100,121 |
|
|
|
|
|
|
|
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Liabilities and Shareholders' (Deficit) Equity |
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Current liabilities: |
|
|
|
|
|
|
|
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Accounts payable |
|
$ |
1,589 |
|
|
$ |
1,925 |
|
Accrued expenses |
|
|
21,756 |
|
|
|
9,877 |
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Due to |
|
|
31 |
|
|
|
15 |
|
Current portion of share-based compensation liabilities |
|
|
7,204 |
|
|
|
— |
|
Current portion of operating lease liabilities. |
|
|
351 |
|
|
|
— |
|
Total current liabilities |
|
|
30,931 |
|
|
|
11,817 |
|
Share-based compensation liabilities, net of current portion |
|
|
32 |
|
|
|
— |
|
Related-party long-term debt |
|
|
87,252 |
|
|
|
— |
|
Long-term debt |
|
|
— |
|
|
|
13,534 |
|
Operating lease liabilities, net of current portion |
|
|
3,086 |
|
|
|
— |
|
Total liabilities |
|
|
121,301 |
|
|
|
25,351 |
|
Total shareholders' (deficit) equity |
|
|
(58,006 |
) |
|
|
74,770 |
|
Total liabilities and shareholders' (deficit) equity |
|
$ |
63,295 |
|
|
$ |
100,121 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200618005101/en/
Investor and Media inquiries:
949.769.2706
ryan.kubota@urovant.com
Source: