urov-8k_20190613.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 13, 2019

 

Urovant Sciences Ltd.

(Exact name of Registrant as Specified in Its Charter)

 

 

Bermuda

 

001-38667

 

98-1463899

(State or Other Jurisdiction

of Incorporation)

 

(Commission File Number)

 

(IRS Employer

Identification No.)

 

 

 

 

 

Suite 1, 3rd Floor

11-12 St. James’s Square

London SW1Y 4LB

United Kingdom

 

 

 

Not Applicable

(Address of Principal Executive Offices)

 

 

 

(Zip Code)

 

+44 (0) 207 400 3347

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Shares, $0.000037453 par value

UROV

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

 

 


 

Item 2.02. Results of Operations and Financial Condition.

On June 13, 2019, Urovant Sciences Ltd., or the Company, issued a press release announcing its financial results for the fourth fiscal quarter and full fiscal year ended March 31, 2019. The press release is attached as Exhibit 99.1 and is incorporated herein by reference.

The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 is furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this Current Report shall not be incorporated by reference in any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

 

Description

 

 

 

99.1

 

Press Release, dated June 13, 2019.

 

 

 

 

 


 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Urovant Sciences Ltd.

 

 

 

 

 

Dated: June 14, 2019

 

 

 

 

 

 

By:

 

/s/ Christine G. Ocampo

 

 

 

 

Christine G. Ocampo

 

 

 

 

Principal Financial and Accounting Officer

 

 

urov-ex991_6.htm

Exhibit 99.1

 

 

5281 California Avenue

Suite 100

Irvine, California 92617

urovant.com

 

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

 

IRVINE, Calif. and BASEL, Switzerland /June 13, 2019 /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 wih 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.


UROVANT SCIENCES LTD.

Condensed Consolidated Statements of Operations

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

 

 

 

Three Months Ended

March 31,

 

 

Year Ended

March 31,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development(1)

 

$

22,890

 

 

$

16,430

 

 

$

92,198

 

 

$

32,359

 

General and administrative(2)

 

 

5,935

 

 

 

2,698

 

 

 

18,585

 

 

 

4,640

 

Total operating expenses

 

 

28,825

 

 

 

19,128

 

 

 

110,783

 

 

 

36,999

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

(259

)

 

 

 

 

 

(259

)

 

 

 

Other income (expense)

 

 

42

 

 

 

44

 

 

 

(257

)

 

 

(38

)

Loss before provision for income taxes

 

 

(29,042

)

 

 

(19,084

)

 

 

(111,299

)

 

 

(37,037

)

Provision for (benefit from) income taxes

 

 

(74

)

 

 

11

 

 

 

47

 

 

 

37

 

Net loss

 

$

(28,968

)

 

$

(19,095

)

 

$

(111,346

)

 

$

(37,074

)

Net loss per common share—basic and diluted

 

$

(0.96

)

 

$

(0.95

)

 

$

(4.43

)

 

$

(2.16

)

Weighted average common shares outstanding—basic and

   diluted

 

 

30,322,911

 

 

 

20,025,098

 

 

 

25,145,211

 

 

 

17,124,659

 

 

(1)

Includes $409 and $367 of share-based compensation during the three months ended March 31, 2019 and 2018, respectively, and $1,296 and $2,477 of share-based compensation during the year ended March 31, 2019 and 2018.

(2)

Includes $941 and $370 of share-based compensation during the three months ended March 31, 2019 and 2018, respectively, and $2,682 and $694 of share-based compensation during the year ended March 31, 2019 and 2018.


UROVANT SCIENCES LTD.

Condensed Consolidated Balance Sheets

(unaudited; in thousands)

 

 

 

March 31, 2019

 

 

March 31, 2018

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

85,353

 

 

$

7,194

 

Restricted cash

 

 

243

 

 

 

 

Prepaid expenses and other current assets

 

 

12,914

 

 

 

5,196

 

Total current assets

 

 

98,510

 

 

 

12,390

 

Furniture and equipment, net

 

 

923

 

 

 

510

 

Restricted cash, net of current portion

 

 

600

 

 

 

 

Other assets

 

 

88

 

 

 

84

 

Total assets

 

$

100,121

 

 

$

12,984

 

 

 

 

 

 

 

 

 

 

Liabilities and Shareholders' Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,925

 

 

$

833

 

Accrued expenses

 

 

9,877

 

 

 

3,595

 

Due to Roivant Sciences Ltd.

 

 

15

 

 

 

1,482

 

Total current liabilities

 

 

11,817

 

 

 

5,910

 

Long-term debt

 

 

13,534

 

 

 

 

Total liabilities

 

 

25,351

 

 

 

5,910

 

Total shareholders' equity

 

 

74,770

 

 

 

7,074

 

Total liabilities and shareholders' equity

 

$

100,121

 

 

$

12,984

 

 

Contacts

Investor inquiries: Investors@Urovant.com

Media inquiries: Media@Urovant.com