Urovant Sciences Reports Financial Results for the Third Fiscal Quarter Ended December 31, 2018

BASEL, Switzerland & IRVINE, Calif.–(BUSINESS WIRE)–Urovant Sciences Ltd. (Nasdaq: UROV), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for urologic conditions, today reported financial
results for the three months ended December 31, 2018.

Recent Business Highlights

  • Announced plans to report topline data from international Phase 3
    trial for vibegron in adults with symptoms of overactive bladder (OAB)
    by the end of March 2019.
  • Initiated U.S. clinical program for vibegron for abdominal pain
    associated with irritable bowel syndrome (IBS) in women.
  • Gained alignment with U.S. Food and Drug Administration (FDA) on
    clinical trial protocol for pivotal Phase 3 trial for vibegron in men
    with OAB who have benign prostatic hyperplasia (BPH).

“Urovant Sciences continued to make progress on several clinical
programs for vibegron, an investigational beta-3 adrenergic agonist,
demonstrating our commitment to urology,” said Keith A. Katkin, chief
executive officer of Urovant. “We remain on schedule to report topline
data from EMPOWUR, our robust international Phase 3 trial evaluating the
safety and efficacy of vibegron as a treatment for adults with symptoms
of overactive bladder by the end of March 2019.”

Mr. Katkin continued, “Furthermore, we initiated a Phase 2a study of
vibegron in women with IBS-associated abdominal pain in December 2018.
And we recently received a response from the FDA to our proposed
protocol for our pivotal Phase 3 study of vibegron in men with
overactive bladder and benign prostatic hyperplasia. This is an
important supplemental program for vibegron as there is currently no
treatment for men with concomitant OAB and BPH.”

Third Quarter Financial Summary

For the quarter ended December 31, 2018, research and development
expenses were $21.3 million and general and administrative expenses were
$4.9 million. Cash used in operations increased by $17.2 million to
$40.7 million for the quarter ended December 31, 2018 as compared to the
prior quarter. The increase in cash used is attributed to a decrease of
$8.0 million in amounts due to Roivant Sciences, an increase of $3.4
million in prepaid expenses associated with our ongoing clinical
studies, a decrease of $4.0 million in accounts payable and accrued
expenses, and an increase of $1.8 million in operating expenses. Net
loss for the quarter ended December 31, 2018 was $26.4 million, or $0.87
per share. As of December 31, 2018, total cash balance was $95.6 million.

Note to Investors

As previously announced, Urovant will hold a conference call to discuss
fiscal 2018 third quarter financial results today, February 13, 2019,
beginning at 1:30 p.m. Pacific Time. You can listen to this call by
dialing (866) 470-1049 for domestic callers or (409) 217-8245 for
international callers and entering passcode 3197868. A replay of the
call will be available approximately four hours after the call and
accessible for 7 days at (855) 859-2056, conference ID 3197868. A
webcast will be archived on the Investor Relations page of the Urovant
Sciences website immediately after the call and available for at least
30 days.

About Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused
on developing and commercializing innovative therapies for urologic
conditions. Urovant’s lead product candidate, vibegron, is an oral,
once-daily, small molecule beta-3 agonist being evaluated for the
treatment of OAB with symptoms of urge urinary incontinence, urgency,
and urinary frequency; for OAB in men with benign prostatic hyperplasia;
and for abdominal pain associated with irritable bowel syndrome. Urovant
has licensed global rights, excluding Japan and certain Asian
territories, for the development and commercialization of vibegron.
Urovant’s second product candidate, URO-902, is a novel gene therapy
being developed for patients with OAB who have failed oral
pharmacological therapy. Urovant intends to develop treatments for
additional urologic diseases. For more information, please visit www.urovant.com.

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
trial for vibegron in adults with symptoms of OAB by the end of March
2019; the Company’s expectations regarding its Phase 2a trial for
vibegron in women with IBS-associated abdominal pain; and the Company’s
expectations regarding its Phase 3 trial for vibegron for the treatment
of OAB in men with BPH.

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 Merck Sharp & Dohme Corp.
and Ion Channel Innovations, LLC to have accurately reported results and
collected and interpreted data related to vibegron and URO-902 prior to
the Company’s acquisition of the rights related to these product
candidates; reliance on third parties to conduct, supervise and monitor
the Company’s clinical trials; reliance on a single supplier for the
enzyme used to manufacture vibegron; the ability to obtain, maintain and
enforce intellectual property protection for the Company’s technology
and products; risks related to significant competition from other
biotechnology and pharmaceutical companies; the failure to achieve the
market acceptance necessary for commercial success for a product
candidate; the Company’s ability to satisfy future funding needs on
commercially reasonable terms and conditions if at all; and other risks
and uncertainties listed in the Company’s filings with the United States
Securities and Exchange Commission (SEC), including under the heading
“Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2018 filed with the SEC on November 13,
2018, as such risk factors may be amended, supplemented or superseded
from time to time by other reports the Company files with the SEC. You
should not place undue reliance on the forward-looking statements in
this press release, which speak only as of the date hereof, and, except
as required by law, the Company undertakes no obligation to update these
forward-looking statements to reflect events or circumstances after the
date of such statements.

           

UROVANT SCIENCES LTD.

Condensed Consolidated Statements of Operations

(unaudited; in thousands, except share and per share data)

 
Three Months Ended

December 31,

Nine Months Ended

December 31,

2018       2017 2018       2017
 
Operating expenses:
Research and development(1) $ 21,299 $ 8,046 $ 69,308 $ 15,929
General and administrative(2)   4,862     1,389     12,650     1,942  
Total operating expenses   26,161     9,435     81,958     17,871  
Other income (expense):
Other income (expense)   (219 )   6     (299 )   (82 )
Loss before provision for income taxes (26,380 ) (9,429 ) (82,257 ) (17,953 )
Provision for income taxes   61     22     121     26  
Net loss $ (26,441 ) $ (9,451 ) $ (82,378 ) $ (17,979 )
Net loss per common share—basic and diluted $ (0.87 ) $ (0.47 ) $ (3.51 ) $ (1.11 )
Weighted average common shares outstanding—basic and diluted   30,264,643     20,025,098     23,450,692     16,175,425  
 
(1)     Includes $322 and $417 of share-based compensation during the three
months ended December 31, 2018 and 2017, respectively, and $887 and
$2,110 of share-based compensation during the nine months ended
December 31, 2018 and 2017.
(2) Includes $511 and $246 of share-based compensation during the three
months ended December 31, 2018 and 2017, respectively, and $1,741
and $324 of share-based compensation during the nine months ended
December 31, 2018 and 2017.
 
 
                         

UROVANT SCIENCES LTD.

Condensed Consolidated Balance Sheets

(unaudited; in thousands, except share and per share data)

 
December 31, 2018 March 31, 2018
Assets
Current assets:
Cash $ 95,613 $ 7,194
Restricted cash 244
Prepaid expenses and other current assets   15,140   5,196
Total current assets   110,997   12,390
Furniture and equipment, net 571 510
Restricted cash, net of current portion 600
Other assets   84   84
Total assets $ 112,252 $ 12,984
 
Liabilities and Shareholders’ Equity
Current liabilities:
Accounts payable $ 3,696 $ 833
Accrued expenses 6,365 3,595
Due to Roivant Sciences Ltd.   33   1,482
Total liabilities   10,094   5,910
Total shareholders’ equity   102,158   7,074
Total liabilities and shareholders’ equity $ 112,252 $ 12,984
 

Contacts

Investor inquiries: [email protected]
Media
inquiries: [email protected]

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