Urovant Sciences Reports Financial Results for the Fourth Fiscal Quarter and Full Fiscal Year Ended March 31, 2019

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Urovant Sciences (Nasdaq: UROV), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for urologic conditions, today reported financial
results for the fourth fiscal quarter and full fiscal year ended March
31, 2019.

Recent Business Highlights

• Announced positive top-line data results from the pivotal Phase 3
  EMPOWUR study of vibegron in patients with overactive bladder
• Presented EMPOWUR study results at the American Urological Association
  annual meeting in May
• Initiated enrollment into the pivotal Phase 3 study of vibegron in men
  with OAB and benign prostatic hyperplasia (BPH), for which there is
  currently no approved treatment
• Gained general alignment with U.S. Food and Drug Administration (FDA)
  on proposed Phase 2a protocol for URO-902, our novel gene therapy
  product for OAB
• Entered into a debt financing agreement with Hercules Capital for up
  to $100 million

“Urovant Sciences achieved key milestones for several clinical programs
for vibegron, an investigational beta-3 adrenergic agonist, driving us
closer toward the goal of developing a leading specialty urology
company,” said Keith A. Katkin, chief executive officer of Urovant. “We
were pleased to announce positive topline data from EMPOWUR, our robust
Phase 3 trial of vibegron as a treatment for adults with symptoms of
overactive bladder, which demonstrated significant clinical efficacy on
both co-primary endpoints, as well as all seven key secondary endpoints.”

Mr. Katkin continued, “We achieved another important clinical milestone
with enrollment into the pivotal Phase 3 study of vibegron in men with
OAB and BPH, an important supplemental program for vibegron as there is
currently no approved treatment for concomitant OAB and BPH.
Furthermore, we gained general alignment with the FDA on the proposed
Phase 2a protocol for URO-902, our novel gene therapy product for OAB.”

Fiscal 2018 Financial Summary

For the year ended March 31, 2019, research and development expenses
were $92.2 million and general and administrative expenses were $18.6
million compared to research and development expenses of $32.4 million
and general and administrative expenses of $4.6 million in the prior
fiscal year. Cash used in operations increased by $75.0 million to
$109.0 million for the year ended March 31, 2019 as compared to the
prior fiscal year. Net loss for the year ended March 31, 2019 was $111.3
million, or $4.43 per share. As of March 31, 2019, total cash and cash
equivalents balance was $85.4 million and the financing commitment
available to be drawn down by the Company from Hercules Capital as of
March 31, 2019 was $30.0 million.

Fourth Fiscal Quarter 2018 Financial Summary

For the quarter ended March 31, 2019, research and development expenses
were $22.9 million and general and administrative expenses were $5.9
million compared to research and development expenses of $16.4 million
and general and administrative expenses of $2.7 million in the prior
quarter. Cash used in operations decreased by $16.7 million to $24.0
million for the quarter ended March 31, 2019 as compared to the prior
quarter. Net loss for the quarter ended March 31, 2019 was $29.0
million, or $0.96 per share.

Note to Investors

As previously announced, Urovant will hold a conference call to discuss
2018 fourth fiscal quarter and full fiscal year ended March 31, 2019
financial results today, June 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
conference ID 1883414. 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 1883414. 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 recently reported positive Phase 3 trial results for
its lead product candidate, vibegron, an oral, once-daily small molecule
beta-3 agonist being evaluated for overactive bladder (OAB). The
international, pivotal trial achieved co-primary endpoints and all seven
key secondary endpoints. In addition, vibegron is being evaluated in a
Phase 3 study for the treatment of OAB in men with benign prostatic
hyperplasia and in a Phase 2a study for abdominal pain associated with
irritable bowel syndrome. 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 Sciences, a subsidiary of
Roivant Sciences, Ltd., intends to develop novel treatments for
additional urologic diseases. Learn more about us at 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 Company’s expectations regarding its Phase 3
study of vibegron in men with OAB and BPH; and the Company’s
expectations regarding its proposed Phase 2a protocol for URO-902.

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 December 31, 2018 filed with the SEC on February 14, 2019,
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.

Contacts

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