Urovant Sciences (Nasdaq: UROV) today reported financial results
for its fiscal quarter ended September 30, 2020.
During the second quarter of fiscal year 2020, the Company
achieved a number of significant operational and commercial
planning milestones in preparation for the U.S. Food and Drug
Administration’s (FDA) decision on the New Drug Application (NDA)
for vibegron in overactive bladder (OAB) by the assigned
Prescription Drug User Fee Act (PDUFA) goal date of December 26th.
This includes the co-promotion agreement with Sunovion
Pharmaceuticals that provides access to their multi-specialty sales
force to bring vibegron to primary care physicians (PCP). This
agreement significantly enhances the commercial reach of Urovant’s
direct sales approach that will target urology, long-term care and
high prescribing PCPs following the launch of vibegron, if
approved.
“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 James Robinson, president and chief executive officer of
Urovant Sciences.
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 in November 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 September 30, 2020, total operating
expenses were $33.5 million, comprised of research and development
expenses of $14.5 million and general and administrative expenses
of $18.9 million. Net loss for the quarter ended September 30, 2020
was $35.2 million, or $1.12 per share. Cash used in operations was
$32.6 million.
As of September 30, 2020, total cash was $74.4 million.
Conference Call
As previously announced, Urovant will hold a conference call at
1:30 p.m. Pacific (4:30 p.m. Eastern) today, November 2, 2020, to
discuss financial results from the second fiscal quarter ended
September 30, 2020. Interested participants may listen to this call
by dialing (866) 470-1049 for domestic callers or (409) 217-8245
for international callers and entering conference ID 8054049.
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 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. The
Company’s lead product candidate, vibegron, is an oral, once-daily
small molecule beta-3 agonist that is being evaluated for
overactive bladder (OAB). Urovant Sciences reported positive data
from the vibegron 12-week, Phase 3 pivotal EMPOWUR study and
demonstrated favorable longer-term efficacy, safety, and
tolerability in a 40-week extension study. The Company submitted a
New Drug Application to the U.S. Food and Drug Administration
seeking approval of vibegron for the treatment of patients with OAB
in December 2019. Vibegron is also being evaluated for treatment of
OAB in men with benign prostatic hyperplasia (OAB+BPH) and for
abdominal pain associated with irritable bowel syndrome (IBS).
Urovant’s second product candidate, URO-902, is a novel gene
therapy being developed for patients with OAB who have failed oral
pharmacologic therapy. Urovant Sciences, a subsidiary of Sumitovant
Biopharma Ltd., which is a wholly owned subsidiary of Sumitomo
Dainippon Pharma Co., Ltd., intends to develop novel treatments for
additional urologic diseases. Learn more about us at
www.urovant.com.
About Sumitovant Biopharma Ltd.
Sumitovant is a global
biopharmaceutical company with offices in New York City and London.
Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon
Pharma. Sumitovant is the majority shareholder of Myovant and
Urovant, and wholly owns Enzyvant, Spirovant, and Altavant.
Sumitovant's promising pipeline is comprised of early through
late-stage investigational medicines across a range of disease
areas targeting high unmet need. For further information about
Sumitovant, please visit
https://www.sumitovant.com.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is
among the top-ten listed pharmaceutical companies in Japan,
operating globally in major pharmaceutical markets, including
Japan, the U.S., China, and the European Union. Sumitomo Dainippon
Pharma is based on the merger in 2005 between Dainippon
Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd.
Today, Sumitomo Dainippon Pharma has more than 6,000 employees
worldwide. Additional information about Sumitomo Dainippon Pharma
is available through its corporate website at
https://www.ds-pharma.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; 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, Sumitovant
Biopharma Ltd., can assert over the Company through its ownership
of the Company’s common shares and control of the Company’s board
of directors; 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 success and
cost of Urovant’s efforts to commercialize vibegron; Urovant’s
ability to realize the anticipated benefits of the co-promotion
agreement with Sunovion in the manner or timeline expected;
Urovant’s reliance on Sunovion for the co-promotion and
distribution of vibegron and Urovant’s ability to secure
alternative access to commercial infrastructure or strategic
collaborations for the commercialization or distribution of
products if it is unable to continue the relationship with
Sunovion; 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
most recently filed Annual Report on Form 10-K and any subsequent
Quarterly Reports on Form 10-Q filed with the SEC, as such risk
factors may be amended, supplemented, or superseded from time to
time by other filings 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)
Unless otherwise noted, the three
and six months comparisons are to the prior fiscal year comparable
period ended September 30, 2019.
Three Months Ended September
30,
Six Months Ended September
30,
2020
2019
2020
2019
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 $419 and $788 and $257 and $522
of share-based compensation during the three and six months ended
September 30, 2020 and 2019, respectively.
(2)
Includes $947 and $2,616 and $964 and
$1,746 of share-based compensation during the three and six months
ended September 30, 2020 and 2019, respectively.
Condensed Consolidated Balance
Sheets
(unaudited; in thousands)
Unless otherwise noted, the three months
comparisons are to the prior fiscal year comparable period ended
March 31, 2020.
September 30,
2020
March 31,
2020
Assets
Current assets:
Cash
$
74,401
$
51,414
Restricted cash
250
243
Due from Sumitovant Biopharma Ltd.
—
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 Roivant Sciences Ltd.
—
31
Due to Sunovion Pharmaceuticals, Inc.
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: Ryan Kubota 949.769.2706
ryan.kubota@urovant.com
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