urov-8k_20200602.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 2, 2020

 

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 7.01. Regulation FD Disclosure

 

Urovant Sciences Ltd. (the “Company”) intends to present the materials attached as Exhibit 99.1 to this Current Report on Form 8-K (the “Investor Presentation”) from time to time in presentations to investors and other stakeholders. The Investor Presentation will also be available on the investor page of the Company’s website at http://ir.urovant.com.

 

The information furnished pursuant to this Item 7.01 (including Exhibit 99.1 hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or the Exchange Act, 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

 

Investor Presentation dated June 2020.

 

 

 

 

 


 

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 2, 2020

 

 

 

 

 

 

By:

 

/s/ Christine G. Ocampo

 

 

 

 

Christine G. Ocampo

 

 

 

 

Principal Accounting Officer

 

 

urov-ex991_7.pptx.htm

Slide 1

UROVANT SCIENCES Jefferies Virtual Health Care Conference June 2, 2020 Exhibit 99.1

Slide 2

Forward-Looking Statements This presentation contains forward-looking statements, including without limitation, statements related to: our plans to file for approval of vibegron with the FDA, and the timing of such filing and the likelihood of FDA approval; our ability to successfully develop Vibegron in the United States and other major markets, including meeting clinical endpoints and adequacy of clinical trial results; our ability to commence and complete new clinical trials, including for URO-902, as planned and on expected timelines; the commercial potential for Vibegron, including market size, reimbursement status, potential expanded indications and product differentiation relative to competitors; and the expected duration of patent protection. Forward-looking statements can be identified by "anticipate," "believe," "can," "continue," "could," "estimate," "expect," "intend," "likely," "may," "might," "objective," "ongoing," "plan," "potential," "predict," "project," "should," "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. Urovant cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Urovant believes it has a reasonable basis for the statements contained in this document, which are based on information available to Urovant as of the date hereof, however, such information may be inaccurate or complete.  In preparing these materials, including the models and projections contained herein, Urovant has relied upon and assumed, without independent verification, the accuracy and completeness of information available from public sources. Without limiting the generality of the foregoing, no audit or review has been undertaken by an independent third party of the financial assumptions, data, results, calculations and forecasts contained, presented or referred to in this document. Any assumptions, analyses, projections or predictions are Urovant’s and Urovant’s alone. You should conduct your own independent investigation and assessment as to the validity of the information contained in this document and the economic, financial, regulatory, legal, taxation, stamp duty and accounting implications of that information. These risks and uncertainties include, but are not limited to, those identified herein, and other risks and uncertainties in the section titled “Risk Factors” set forth in Urovant's Form 10-Q, which was filed with the Securities and Exchange Commission (“SEC”) on February 13, 2020, as well as any other future filings with the SEC available at www.sec.gov. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Except as required by law, Urovant undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. This presentation may not be reproduced, forwarded to any person or published, in whole or in part.

Slide 3

1. Subject to the approval by the FDA, including FDA approval of the inclusion of urgency data, rapid onset of action data and a single convenient once-daily dose in the label Investment Highlights UROVANT Vibegron: NDA accepted March 2020 Positive EMPOWUR Phase 3 results announced in March 2019 PDUFA date December 26, 2020 Vision: Become A Leading Urology Specialty Company Blockbuster potential for vibegron OAB category has created multiple blockbuster products U.S. FY2019 β3 agonist sales were $821 million (estimated 13% y/y) Vibegron has the potential to become a highly differentiated β3 agonist with opportunity for significant market share across OAB therapies1 Multiple large-market clinical programs under development Potential for vibegron to be the first product approved for OAB in men with benign prostatic hyperplasia: 2 million U.S. patient opportunity Potential for vibegron to address significant unmet need in the 7+ million U.S. patients with pain associated with irritable bowel syndrome (IBS) Potential for URO-902 to be first gene therapy approved for OAB Management team with demonstrated track record of success Deep category experience

Slide 4

Urovant Pipeline Development and Acquisition of Differentiated Treatments Supports Vision of Becoming a Leading Urology Company DRUG CANDIDATE INDICATION PHASE 1 PHASE 2 PHASE 3 UPCOMING MILESTONE vibegron Overactive Bladder (OAB) PDUFA date December 26, 2020 OAB in Men with BPH Phase 3 top-line data 2H 2021 IBS-Associated Pain Phase 2a top-line data 4Q 2020 URO-902 OAB Complete phase 2a cohort 1 enrollment 2H 2020

Slide 5

VIBEGRON CLINICAL DATA AND DEVELOPMENT

Slide 6

Extensive Clinical Development Program Three successful, placebo-controlled studies completed in over 4,000 patients achieving all primary and secondary endpoints Robust clinical pharmacology package (21 studies complete) Long-term toxicity and carcinogenicity studies complete In-licensed from Merck in February 2017 1. Subject to approval by the FDA, including FDA approval of the inclusion of urgency data, rapid onset of action data and a single convenient once-daily dose in the label Potential to address the limitations of current treatments and become a highly differentiated β3 agonist1

Slide 7

EMPOWUR Results: Vibegron Demonstrated Strong Efficacy Across All OAB Endpoints Week 12 LS Mean Change from Baseline (Placebo-Adjusted) Endpoint Vibegron n p-value UUI Episodes2 -0.6 383 <0.0001 Micturitions2 -0.5 492 <0.001 Urgency Episodes3 -0.7 492 0.0020 Total Incontinence Episodes3 -0.7 383 <0.0001 Volume Voided (ml)3 21.2 490 <0.0001 OAB-q Coping Score3 3.6 512 0.0038 Tolterodine1 n p-value -0.4 286 0.0123 -0.3 378 0.0988 -0.4 378 0.0648 -0.5 286 0.0074 13.3 375 <0.001 3.1 401 0.0212 1. Tolterodine was an active control, comparisons vs placebo 2. Co-primary endpoint 3. Key Secondary Endpoint LS=Least Squares

Slide 8

Rapid Onset and Sustained Benefit in Phase 3 Trial Table 14.2.2.1.2, Full Analysis Set for Incontinence, CFB Least squares mean Covariates included in the mixed model for repeated measures are study visit, sex, region, baseline number of UUI, and treatment by study visit interaction Change in Average Daily UUI Episodes 3003 Study LS Mean Change from Baseline LS Mean Change from Baseline Extension Study (3003 + 3004 Study) Durable results out to 52 weeks Onset of action in two weeks *** *** *** *** P-value is vibegron vs placebo P-value: ***<0.001 P-value is vibegron vs tolterodine P-value: ** <0.01 For extension study (3003+3004 study) , a post-hoc analysis was performed to compare the change from baseline to week 52 results between Vibegron and Tolterodine.

Slide 9

>50% of Patients Achieved ≥75% Reduction in UUI Episodes at Week 12 P-value is active vs placebo NS1 P < 0.001 P < 0.05 P < 0.05 1. P-values for the difference in proportions between active and placebo were calculated using the Cochran-Mantel-Haenszel risk difference estimate stratified by OAB Type (Wet vs Dry) and Sex (Female vs Male), with weights proposed by Greenland and Robins. MI has been used to impute values missing for any reason at the weeks analyzed. Adjusted proportions are presented. Table 14.2.4.1.1 Full Analysis Set for Incontinence. 75% Reduction in UUI from Baseline at Week 12 Table 14.2.5.1.1 Full Analysis Set for Incontinence 100% Reduction in UUI from Baseline at Week 12 Table 14.2.6.1.1 Full Analysis Set 50% Reduction in Urgency from Baseline at Week 12 Responder Analysis Percent of Patients at Target

Slide 10

Vibegron was Well Tolerated Table 14.3.1.15, Safety Analysis Set. Represents number of patients. Vibegron has not demonstrated a QTc signal at any dose, including 400 mg (highest tested dose) Completed ambulatory blood pressure study with no statistically significant increase in daytime ambulatory systolic blood pressure, including no increase above the pre-specified limit of 3.5 mmHg Most Common Adverse Events in Range of Placebo (>2% and >Placebo) AE term n (%) Placebo N=540 Vibegron N=545 Tolterodine N=430 Headache 13 (2.4) 22 (4.0) 11 (2.6) Nasopharyngitis 9 (1.7) 15 (2.8) 11 (2.6) Diarrhea 6 (1.1) 12 (2.2) 9 (2.1) Nausea 6 (1.1) 12 (2.2) 5 (1.2) Hypertension 9 (1.7) 9 (1.7) 11 (2.6) Blood pressure increased 5 (0.9) 4 (0.7) 8 (1.9)

Slide 11

Vibegron: Significant Potential For Category-Defining Differentiation1 in OAB vibegron2 ACh mirabegron Rapid onset of efficacy (2 weeks) Potential efficacy claim for urgency3 Potential broader efficacy claims No CYP2D6 drug-drug interactions Some Single convenient crushable dose4 No known dementia risk5 1. Based on product labels, publicly available literature, and data on file 2. Based on clinical trials to date. Vibegron is in Phase 3 clinical development for OAB and has not been approved by the FDA or any other regulatory authority. All potential points of differentiation are subject to verification through further clinical development of vibegron and the review of the FDA 3. Subject to approval by the FDA, including FDA approval of the inclusion of urgency data 4. Assuming successful result in planned relative bioavailability study or FDA acceptance of in vitro data 5. Gray et al. JAMA Intern Med. 2015 No QTc signal

Slide 12

OAB MARKET AND VIBEGRON COMMERCIAL STRATEGY

Slide 13

Large Market ~14 million patients discuss symptoms with a physician2 ~3.3 million patients on prescription therapy3 More than 30 million Americans over 40 years old suffer from bothersome symptoms of OAB1 1. Coyne et al., EpiLUTS 2007 2. Benner et al., J Urol, 2009 3. BIQVIA (IMS) New to Brand Data 2016-2017 4. IQVIA (IMS) NPA MAT 12-month Rx data ending Dec 2018 ~18 million prescriptions written per year in the US4 New Patients Current Patients Lapsed Patients Rx Patients Per Year

Slide 14

β3 Agonist (Mirabegron) Is Gaining U.S. OAB Market Share 1. IQVIA Launch Edition October 2012 through March 2020 2. Astellas reported projected net sales of mirabegron in the Americas of $821M for FY 2019 , ended March 31, 2020 (vs. $728M FY 2018) 3. Urovant analysis and estimate based on mirabegron’s 2019 net sales and 21% market share 4. Numbers may not add due to rounding β3 share ~21%1 of 18.6M total FY2019 Prescriptions β3 in FY 2019 ~19%+ TRx growth vs. 2%1 total market growth Net sales $821M, +13% y/y2 β3 share should continue to grow Only promoted category Anticholinergic dementia concerns

Slide 15

Goal: Establish Vibegron as the OAB Brand of Choice Start with a targeted effort with high prescribing PCPs Ensure broad payor coverage Activate patients to request vibegron Deploy a fully scaled, best-in-class sales force in Urology and Long-Term Care Key Elements of Commercial Strategy Explore co-promote options for broader PCP effort at launch

Slide 16

Urologists, LTC, High Prescribing PCPs Write >50% of OAB Prescriptions Other 13% Long-Term Care 17% Urologist 20% NPPA 16% OB/GYN 5% PCP 29% OAB Rx 2018 Volume by Specialty1 Urologists, LTC, and High Prescribing PCPs account for >50% of all OAB prescriptions Urologists prescribe 30% of all β3s Urologists, other specialties, and high prescribing PCPs can be managed with approximately 100 – 120 FTEs LTC segment can be managed with approximately 30 – 50 FTEs Urologists most productive OAB writers and more likely to prescribe branded drugs 1. IQVIA (IMS) NPA data ending Dec 2018.

Slide 17

Formulary Acceptance will be Key to Vibegron Success β3 category enjoys wide payor coverage under Medicare Part D and commercial plans Establishing market access team with deep experience in Urology to obtain formulary coverage 1. IMS PayerTrak Dec 2018 2. IQVIA (IMS) NPA data ending Dec 2018. TRx by Payor Type1 Other 11% Commercial/Cash 37% Medicare D 52% LTC Appropriate payor engagement will begin in the summer of 2020 Our market research suggests positive payor feedback on vibegron profile

Slide 18

Vibegron Could Potentially Lower Overall Costs of Care Annual Direct Medical Costs for OAB Patients are >2.5X HIGHER Than Non-OAB Patients1 Admission to a nursing facility: 2.0x greater for incontinent women2 3.2x greater for incontinent men2 19%-50% of OAB patients experienced a fall over a 1-year period3,4 23% decrease in nonpharmacy costs for treated OAB vs untreated OAB5,6 $3003 (±$12) $1123 (±$5) 1. Durden E et al. J Occup Environ Med. 2018;60(9):847-852. 2. Thom DH et al. Age Ageing. 1997;26:367-374. 3. Szabo SM et al. Adv Ther. 2018;35(11):1831-1841. 4. Sytemic literature review of 15 studies.5 Six studies from US (1), Japan (3), UK (1), Korea (1), Australia (1) reported the incidence of any fall or fracture. 5. Retrospective cohort analysis of 159,785 OAB patients and matched controls was conducted using claims from IQVIA’s LTC pharmacy data linked to IQVIA’s integrated data warehouse from the time period of May 1, 2012, to May 31, 2019. 6. Yeaw J et al. Presented at International Society for Pharmacoeconomics and Outcomes Annual Meeting 2020. May 18-20, 2020. Abstract PUK500

Slide 19

GROWTH OPPORTUNITIES

Slide 20

IBS-Associated Pain and OAB in Men with BPH Represent Lifecycle Opportunities with Significant Market Potential 40 million Men aged 50 – 80 years old with BPH >4 million Treated BPH patients in the U.S. OAB in Men with BPH > 2 million U.S. BPH patients with co-morbid OAB IBS population based upon: 1. Rosen et al., Eur Urol 2003. BPH prevalence applied to 2016 population; 2. IMS Health NPA Market Dynamics (2014); 3. Eapen et al., Res Rep Urol. 2016; 4. IQVIA (IMS) NDTI projected BPH patient visits by specialty; 5. Gallegos et al. Pharmacotherapy 2008. IBS-Associated pain population based upon: 1. IQVIA (IMS) NSP 12-month braded sales ending December 2018; 2. Cellek et al. Gastroenterology 2007; 3. Kelleher et al. Neurogastroenterol Motil 2008; 4. Lovell and Ford. Clin Gastroenterol Hepatol 2012; 5. Canavan. Clinical Epidemiology 2014; 6. Drossman. J Clin Gastroenterol 2009. IBS-Associated Pain 30-40 million Patients with IBS 9-10 million Patients consult with MD > 7-9 million Addressable US patient market

Slide 21

Gene Therapy Overview: URO-902 Market Overview Potential to address an unmet need for OAB patients who have failed oral pharmacological therapies and are concerned with potential urinary retention after BOTOX or any “toxin” effect or surgical intervention Currently, there are no FDA-approved gene therapy treatments for OAB Third-line OAB treatments (e.g. BOTOX and neuromodulation) generate >$700M in US annually1 Clinical Summary Studied in two Phase 1 clinical trials in the US in a total of 22 women with OAB Phase 1b clinical trial (n=13) showed dose-dependent reductions in micturitions, urgency episodes and UUI episodes, achieving statistical significance (p<0.05) in the high dose cohort (24,000μg) DNA gene therapy using a plasmid vector 1. Urovant estimates based on third-party market research and Cogentix and Allergan filing

Slide 22

Urovant Sciences Milestones 2020FDA acceptance of vibegron NDA Preparing for the successful launch of vibegron Further build out commercial leadership team Top-line results of vibegron trial in IBS-associated pain URO-902 complete phase 2a cohort 1 enrollment 2H 2020 PDUFA for vibegron in OAB ü 2021Potential Commercial launch of vibegron Start pediatric clinical program of vibegron for OAB Top-line results of vibegron trial in OAB and BPH Top-line results of URO-902 trial 2019Top-line results of the Phase 3 vibegron trial in OAB (March) Vibegron long-term extension study results Begin enrollment of Part 2 of the Phase 3 vibegron trial in OAB & BPH Begin enrollment of Phase 2 URO-902 trial Submit NDA for vibegron in OAB ü ü ü ü ü ü ü

Slide 23

1. Subject to the approval by the FDA, including FDA approval of the inclusion of urgency data, rapid onset of action data and a single convenient once-daily dose in the label Investment Highlights UROVANT Vision: Become A Leading Urology Specialty Company Vibegron: NDA accepted March 2020 Positive EMPOWUR Phase 3 results announced in March 2019 PDUFA date December 26, 2020 Blockbuster potential for vibegron OAB category has created multiple blockbuster products U.S. FY2019 β3 agonist sales were $821 million (estimated 13% y/y) Vibegron has the potential to become a highly differentiated β3 agonist with opportunity for significant market share across OAB therapies1 Multiple large-market clinical programs under development Potential for vibegron to be the first product approved for OAB in men with benign prostatic hyperplasia: 2 million U.S. patient opportunity Potential for vibegron to address significant unmet need in the 7+ million U.S. patients with pain associated with irritable bowel syndrome (IBS) Potential for URO-902 to be first gene therapy approved for OAB Management team with demonstrated track record of success Deep category experience

Slide 24

APPENDIX

Slide 25

OAB+BPH: URO-901-3005 Phase 3 POPULATION Men with OAB and BPH DURATION 12-week primary efficacy treatment period; 24-week efficacy and safety period plus 6-month extension KEY ENDPOINTS Co-primary endpoints: Change from baseline in daily micturitions (urination) and urgency Key secondary endpoint: Nocturia (excessive nighttime urination) W0 W12 Primary Endpoint W24 W52 2-week PBO run-in Vibegron 75 mg N = 40 Placebo N = 40 Vibegron 75 mg N = +500 Placebo N = +500 28-Week Open Label Extension1 Part 1 DSMB Review 12-week Efficacy Assessment1 24-week Safety Assessment Vibegron 75 mg N = ~200 W4 Part 2 1. Numbers of patients reflect planned enrollment Initiated March 2019; P3 Top Line Data 2H 2021

Slide 26

IBS Associated Pain: URO-901-2001 Phase 2a POPULATION Women with IBS with predominantly diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M) DURATION 12-week primary efficacy treatment period; total observation period 14 weeks (includes 2-week safety follow-up) KEY ENDPOINTS Primary endpoint: Proportion achieving ≥30% decrease in worst abdominal pain compared to the weekly baseline average Key secondary endpoints: Global improvement scale, safety, and a lack of negative effects of stool frequency or consistency Initiated December 2018; P2 Top Line Data 4Q 2020 W0 W12 Primary Endpoint 2-week PBO run-in Vibegron 75 mg N = 100 Placebo N = 100 12-week Efficacy Assessment1 DSMB safety reviews occur after ≥25%, ≥50%, and ≥75% of subjects are randomized and reach Week 4 1. Numbers of patients reflect planned enrollment

Slide 27

Gene Therapy OAB: URO-902-2001 Exploratory Phase 2a Proof-of-Concept Study POPULATION Women 40-79 years old with OAB and urge urinary incontinence (non-childbearing potential) DURATION 12-week primary efficacy treatment period; total observation period of 48 weeks KEY ENDPOINTS Change at week 12 in daily: Urge urinary incontinence episodes Micturitions Urgency episodes Complete phase 2a Cohort 1 Enrollment 2H 2020 W0 W48 URO-902 24 mg N = 26 Placebo N = 13 W6 URO-902 48 mg N = 26 Placebo N = 13 Final Assessment W12 Primary Endpoint 12-week Efficacy Assessment 1. Numbers of patients reflect planned enrollment DSMB Review COHORT 11 5-week Screening and Randomization