Urovant Sciences Limited (UROV) 首席执行官 Keith Katkin 在 2018年 第四季度业绩 - 收益电话会议记录

Urovant Sciences Limited (NASDAQ:UROV) Q4 2018 Earnings Conference Call June 13, 2019 4:30 PM ET

Urovant Sciences Limited(纳斯达克股票代码:[UROV])2018年第四季度收益电话会议2019年6月13日美国东部时间下午4:30


Christine Ocampo - Senior Vice President and Chief Accounting Officer
Keith Katkin - Chief Executive Officer
Cornelia Haag-Molkenteller - Chief Medical Officer
Michael McFadden - Chief Commercial Officer

  • Christine Ocampo - 高级副总裁兼首席会计官
  • Keith Katkin - 首席执行官
  • Cornelia Haag-Molkenteller - 首席医疗官
  • Michael McFadden - 首席商务官


Jeet Mukherjee - Jefferies LLC
Ritu Baral - Cowen and Company
Eric Joseph - JPMorgan
Raghuram Selvaraju - H.C. Wainwright & Co, LLC

  • Jeet Mukherjee - Jefferies LLC
  • Ritu Baral - Cowen and Company
  • Eric Joseph - 摩根大通
  • Raghuram Selvaraju - H.C. Wainwright&Co,LLC


Ladies and gentlemen, thank you for standing by. Welcome to the Urovant Sciences Fiscal 2018 Fourth Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following managements prepared remarks, we will odd a question-and-answer session. [Operator Instructions] As a reminder, today’s conference is being recorded.
I’d now like to turn the call over to Christine Ocampo, Chief Accounting Officer. Please go ahead, Ms. Ocampo.

女士们,先生们,谢谢你们的支持。 欢迎来到Urovant Sciences 2018财年第四季度财务业绩电话会议。 此时,所有参与者都处于只听模式。 在管理层准备好评论之后,我们将奇怪的是一个问答环节。 [操作员说明]提醒一下,今天的会议正在录制中。

我现在想把这个电话转给首席会计官Christine Ocampo。 请继续,奥坎波女士。

Christine Ocampo

Thank you. It is my pleasure to welcome you to our conference call to discuss our financial and operating results for the fiscal 2018 fourth quarter. I am joined today by several members of our leadership team; including Keith Katkin, our Chief Executive Officer; Dr. Cornelia Haag-Molkenteller, our Chief Medical Officer, and Michael McFadden, our Chief Commercial Officer.
After the close of market today, Urovant issued a press release containing detailed information on results. You may access this release on our Company website, urovant.com.
Today's remarks contain forward-looking statements, including statements regarding our plans and strategies for the clinical development of vibegron and another treatment for urologic diseases. I direct your attention to the forward-looking statements disclosure in today's press release and the Risk Factor section of the quarterly report on Form 10-Q, which was filed with the SEC in February 2019 as well as the Form 10-K, which will be filed with the SEC in the near-term for a review of the various risks and uncertainties that could cause actual results to differ materially from projections.
And with that said, I'll turn the call over to our CEO, Keith Katkin.

谢谢。我很高兴欢迎您参加我们的电话会议,讨论我们在2018财年第四季度的财务和经营业绩。我今天加入了我们领导团队的几位成员;包括我们的首席执行官Keith Katkin;我们的首席医疗官Cornelia Haag-Molkenteller博士和我们的首席商务官Michael McFadden。



有了这个,我会把电话转给我们的首席执行官Keith Katkin。


Thank you, Christine and my thanks to all of you for joining us today. The fourth fiscal quarter marked a pivotal time for Urovant with the achievement of key milestones across our business, moving us closer to developing Urovant into a leading specialty urology company. In March, we announced positive topline data results from our pivotal Phase III EMPOWUR study of vibegron in patients with overactive bladder, in which vibegron met both co-primary endpoints, as well as all seven key secondary endpoints.
We believe the EMPOWUR Phase III study positions vibegron, if approved by the FDA, to be a best-in-class beta-3 agonist and potentially a best-in-class – a best-in-category oral OAB treatment. This belief is supported by the early launch success of vibegron in Japan.
March was also a milestone month for the COURAGE study with the first patient enrolled in the pivotal Phase III trial vibegron in men with OAB and BPH, an important supplemental program for vibegron given there is currently no approved treatment for the concomitant OAB and BPH. Additionally, the Phase IIa trial for vibegron for IBS-related abdominal pain which was initiated in December 2018 also continues to enroll well with topline results expected in 2020.
Furthermore, during the past quarter, we gained alignment with the FDA on the proposed Phase IIa protocol for our novel gene therapy product for OAB, URO-902. And finally to further our cash runway, we secured a debt finance agreement with Hercules Capital for up to $100 million.
With that, I'll now turn the call over to our Chief Medical Officer, Dr. Cornelia Haag-Molkenteller who will provide a more detailed update on our clinical programs. Cornelia?


我们相信EMPOWUR III期研究表明,如果获得FDA的批准,vibegron将成为同类最佳的β-3激动剂,并且可能是同类产品中最佳的一种口服OAB治疗方法。 vibegron在日本的早期发布成功支持了这一信念。

3月也是COURAGE研究的一个里程碑月,第一名患者参加了OAB和BPH男性关键的III期试验vibegron,这是一项重要的vibegron补充计划,因为目前没有经过批准的OAB和BPH治疗方案。此外,2018年12月开始的针对IBS相关腹痛的vibegron IIa期试验也继续很好地进行,预计将在2020年获得最终结果。

此外,在过去的一个季度中,我们与FDA就我们用于OAB的新型基因治疗产品URO-902的IIa方案提出了一致意见。最后为了进一步推进我们的现金跑道,我们与Hercules Capital达成了高达1亿美元的债务融资协议。

有了这个,我现在将电话转交给我们的首席医疗官Cornelia Haag-Molkenteller博士,他将提供有关我们临床计划的更详细的更新。科妮莉亚?

Cornelia Haag-Molkenteller

Thank you, Keith. We continue to make excellent progress across all four of our clinical development program. First, I would like to talk about our international EMPOWUR Phase III trial for vibegron adults with overactive bladder. The EMPOWUR study, our pivotal Phase III study in OAB completed in early 2019 and we announced positive topline results in March.
The primary efficacy analysis, once-daily vibegron 75 milligram met the co-primary endpoints at week 12, achieving statistical significance compared to placebo on both reduction in daily urinary urge incontinence episodes, a key symptoms for patient seeking OAB treatment and daily micturitions.
The difference from placebo for both daily UUI episodes, which are the Urge Urinary Incontinence episodes and micturitions was highly statistically significant by week 2, which was the first timepoint measured and efficacy for both primary endpoints was maintained at all timepoint measured throughout week 12.
Moreover, the subgroup analyses for both co-primary variables showed efficacy in patients above 65 years of age, patients with prior anticholinergics and patients with prior mirabegron. All seven pre-specified secondary endpoints were also met, including statistically significant reduction in daily urgency episodes, the most important secondary measure.
Also vibegron significantly increased the volume voided per micturition over placebo, which is an important and objective pharmacologic parameter for OAB drugs. Vibegron was also well tolerated in the Phase III. The most common adverse events were at or below 4% included headache, nasopharyngitis, diarrhea and nausea. The frequency of serious adverse events was similar across treatment arms. Also the incidence of the reported adverse events of hypertension was equal to placebo, which is 1.7% in vibegron and 1.7% in placebo.
The EMPOWUR study was recently presented at the American Urological Association meeting by Dr. David Staskin from Boston, as a breaking news in the plenary session. Further presentation and full publication of the study are planned. The long-term extension study is still ongoing and results expected towards the end of the third quarter.
New Drug Application also called NDA, preparations are continuing well with the targets submission in the first quarter of 2020. Of note, we are also exploring all options to accelerate this timelines to the end of the fourth quarter of 2019.
Second, we have our OAB program for men with Benign Prostatic Hyperplasia or BPH. This is an important supplemental development program for vibegron, because there is currently no FDA approved product specifically indicated for overactive bladder in men with BPH.
The co-primary endpoints are reduction micturition frequency and urgency episodes for 24 hours. Key secondary endpoints are reduction in nocturia episodes, which is the awakening at night devoid, prostate symptom scores and safety.
Given the limited clinical data available in men with OAB and BPH, we aligned under two-part trial with the FDA. In Part 1, we will assess initial safety in 80 patients via an Independent Data Safety Monitoring Boards. In Part 2, we will assess safety and efficacy in all patients. Part 1 started enrolling in March 2019 and is expected to complete in the fall of 2019.

谢谢,基思。我们在所有四个临床开发计划中继续取得良好进展。首先,我想谈谈我们针对膀胱过度活动症的成年人的国际EMPOWUR III期试验。 EMPOWUR研究是我们在OAB完成的关键性III期研究,于2019年初完成,我们在3月份公​​布了积极的一线结果。

主要功效分析,每日一次的vibegron 75毫克满足第12周的共同主要终点,与安慰剂相比,在减少每日尿急性尿失禁发作方面达到统计学显着性,这是寻求OAB治疗和每日排尿的患者的关键症状。



与安慰剂相比,vibegron显着增加每排尿的排尿量,这是OAB药物的重要和客观的药理学参数。 Vibegron在第三阶段也得到了很好的耐受。最常见的不良事件是4%或以下,包括头痛,鼻咽炎,腹泻和恶心。治疗组的严重不良事件发生率相似。报告的高血压不良事件的发生率也与安慰剂相当,其中vibegron为1.7%,安慰剂为1.7%。

EMPOWUR研究最近在波士顿的David Staskin博士的美国泌尿学会会议上作为全体会议的重大新闻提出。计划进一步介绍和完整发表该研究。长期推广研究仍在进行中,预计将在第三季度末完成。





Next regarding our clinical program for IBS-associated abdominal pain, we started enrollment into a Phase IIa study in December 2018. We plan to enroll 200 female patients with IBS-associated pain due to IBS with diarrhea or mixed IBS. Patients will be randomized to either 75 milligram of vibegron or placebo.
The primary endpoint is a 30% reduction of abdominal pain intensity on an 11-point rating scale at week 12 for the IBS-D. The responder is defined as a subject with at least a 30% decrease in worst abdominal pain compared to the weekly baseline average.
Secondary endpoints include the global rating scale and safety in particular also negative – lack of negative effects on the stool frequency or consistency. Enrollment continues to go well and we expect it to report topline data in 2020.
Lastly, in the first quarter of 2019, we received feedback from the FDA on development and proposed Phase IIa protocol for a novel gene therapy product for OAB, called URO-902. The FDA was generally aligned with our plan and we expect to start patient enrollment towards the end of the first quarter 2019.
With that, I'll turn the call over to our Chief Commercial Officer, Michael McFadden.



次要终点包括全球评定量表和安全性,尤其是负面因素 - 对大便频率或一致性没有负面影响。入学率继续良好,我们预计它将在2020年报告收入数据。

最后,在2019年第一季度,我们收到了FDA关于开发的反馈,并提出了一种新的OAB基因治疗产品IIA方案,称为URO-902。 FDA总体上与我们的计划保持一致,我们期望在2019年第一季度末开始患者入组。

有了这个,我会把电话交给我们的首席商务官Michael McFadden。

Michael McFadden

Thanks, Cornelia. We continue to be excited about the commercial opportunities for vibegron. Beta-3 agonist market share continues to increase and new patients consistently enter pharmacologic treatment in a large OAB category.
Also we continue to observe this high patient turn with existing treatments in the OAB class, further adding to the great opportunity, a potential new treatment like vibegron, which if approved will be the first new oral OAB product in eight years.
Post the EMPOWUR study topline data release, we conducted an in-depth qualitative market research study across 42 physicians including both OAB thought leaders and prescribing physicians to ascertain their opinions about the vibegron data.
The market research results support our belief that vibegron, if approved, will represent a highly differentiated options for physicians treating OAB. Specifically, the interviewed physicians believe vibegron, if approved, would represent a clear choice over the Myrbetriq based on vibegron's rapid 2-week onset versus Myrbetriq’s 8-week onset.
In addition, the interviewed doctors rated UUI episodes volume voided data, urgency and responder secondary endpoints as top differentiators versus Myrbetriq. Vibegron's single dose and lack of titration will also viewed positively by interviewed physicians as simple dosing is always preferred. And vibegron's safety profile was rated highly by the interviewed physicians and is expected to be a significant decision-making factor on its own.
The results of this market research confirm our thinking about the strength of the pivotal trial results and our commercial team's ability to differentiate vibegron from the currently available OAB medications. Our plan is to commercialize vibegron in the United States with urology and long-term care specialty sales forces that will focus on physicians who treat high numbers of OAB patients.
We believe we can deliver this footprint with approximately 150 sales personnel, which will provide a significant reach in the both segments. And both segments combined represent a potential market in excess of $3 billion. We plan to demonstrate success in these segments first and then either bolt-on or partner our primary care and internal management sales force.
Now I'd like to address the top three commercial questions typically raised about the launch of vibegron. First, how are we going to successfully launch vibegron? The market is large. We estimate over 8 million patients have failed one to two pharmacologic therapies. We will market to these patients directly and through partners to alert them of a new therapy option.
Additionally, we'll target our sales force urologists and long-term care providers that are seeing high numbers of patients with OAB. Our indicational efforts will target these practitioners to educate them on vibegron. And lastly, we will utilize our expertise and manage markets to obtain access so the patients will have access to vibegron with an affordable co-pay.

谢谢,科妮莉亚。我们继续对vibegron的商业机会感到兴奋。 β-3激动剂市场份额继续增加,新患者一直在大型OAB类别中进行药物治疗。




此外,受访医生将UUI剧集的无效数据,紧急程度和响应者次要终点评为Myrbetriq的最大差异因素。 Vibegron的单剂量和滴定不足也将受到采访医生的积极评价,因为简单的剂量总是首选。 vibegron的安全性被受访医生评为高度评价,并且有望成为一个重要的决策因素。





Second question that we receive, how can we effectively compete with Astellas? With regard to Myrbetriq, the beta-3 competitor, we plan to match Astellas share of voice among urologist as well as via new and dominant share of voice and long-term care. The share voice is important in this category, and we believe we can effectively compete with an efficiently sized sales force.
Third, how can we compete in a generic market? Although the OAB treatment market has been highly genericized for decades, several blockbuster drugs have entered this market over the years, which is further evidence that OAB continues to remain a market with a high unmet need, high patient turnover rate, high adverse events from anticholinergics medications and a very large market size of 18 million prescriptions provide a great market dynamic for new products.
Now I'll pass to Christine for financial update.

我们收到的第二个问题是,我们如何有效地与安斯泰来竞争? 关于β-3竞争对手Myrbetriq,我们计划在泌尿科医生之间以及通过新的和占主导地位的语音和长期护理来匹配安斯泰来的声音份额。 分享声音在此类别中非常重要,我们相信我们可以有效地与有效规模的销售人员竞争。

第三,我们如何在仿制药市场中竞争? 尽管OAB治疗市场几十年来一直高度普及,但多年来已有几种重磅药物进入这一市场,这进一步证明OAB仍然是一个需求高,患者更替率高,抗胆碱能药物不良反应高的市场。 药物和1800万处方药的非常大的市场规模为新产品提供了巨大的市场动态。


Christine Ocampo

Thank, Michael. In addition to the financial results summarized in the press release, you can find additional information including full-year information and our upcoming Form 10-K, which will be filed with the SEC in the near-term. Research and development expenses were $22.9 million for the fourth quarter of 2018 compared with $16.4 million for the same period in the prior year.
Research and development expenses were $92.2 million for the fiscal year 2018 compared with $32.4 million for the prior year. In the fourth fiscal quarter and the full fiscal year of 2018, research and development costs were primarily attributed to our ongoing Phase III EMPOWUR trial of vibegron in adults with OAB.
General and administrative expenses of $5.9 million for the fourth quarter of 2018 compared with $2.7 million for the same period in the prior year. General and administrative expenses were $18.6 million for the fiscal year 2018 compared with $4.6 million for the prior year. When comparing the two fiscal years, fiscal 2017 did not reflect a full-year of G&A cost associated with the establishment of our U.S. headquarters in Irvine, California and the related personnel costs as the office was not opened until the middle of the fourth quarter 2017.
Total operating expenses for the fiscal year and fourth quarter of 2018 were $110.8 million and $28.8 million respectively compared with $37 million and $19.1 million for the same period in fiscal 2017.
Cash used in operations decreased by $16.7 million to $24 million for the quarter ended March 31, 2019 as compared to the previous quarter that ended December 31, 2018. Our net loss for the fiscal fourth quarter of 2018 was $29 million, or $0.96 per share, compared with the net loss of $19.1 million or $0.95 per share for the same period in fiscal 2017.
Our net loss for the fiscal 2018 was $111.3 million or $4.43 per share compared with a net loss of $37.1 million or $2.16 per share for fiscal 2017. We closed our debt financing facility for up to $100 million for Hercules Capital in February, resulting in net proceeds of approximately $14.1 million received at closing.
Following the announcement of the positive topline results from the EMPOWUR study, we are able to draw an additional $30 million under the debt facility anytime through September 30, 2019. As of March 31, 2019, our total cash and cash equivalents balance was $85.4 million or $115.4 million with the $30 million available from Hercules.
Looking ahead to the first quarter of 2019, we currently expect our total operating expenses to remain consistent at $27 million to $29 million. As we close out our Phase III EMPOWUR trial and continue our Phase IIa trial for the treatment of abdominal pain due to IBS and Part 1 of the Phase III trial for the treatment of OAB in men with BPH, which was initiated in March. We expect our cash used in operations in the first quarter of 2019 to be approximately $23 million to $24 million.
With that summary of our financial results, I'd like to turn the call back over to Keith for closing remarks.

谢谢,迈克尔。除了新闻稿中总结的财务结果外,您还可以找到其他信息,包括全年信息和即将发布的10-K表格,该表格将在近期向美国证券交易委员会提交。 2018年第四季度的研发费用为2290万美元,而去年同期为1640万美元。


2018年第四季度的一般和行政费用为590万美元,而去年同期为270万美元。 2018财年的一般和管理费用为1,860万美元,而去年为460万美元。在比较两个财政年度时,2017财年并未反映与我们在加利福尼亚州欧文市设立美国总部相关的全年G&A成本以及相关人员成本,因为该办公室直到2017年第四季度中期才开放。



我们2018财年的净亏损为1.113亿美元或每股4.43美元,而2017财年净亏损为3710万美元或每股2.16美元。我们在2月份为Hercules Capital完成了高达1亿美元的债务融资工具,从而实现了净亏损收盘时收到约1410万美元的收益。





Thanks, Christine. To build on Christine's financial comments, I also wanted to comment on how we're thinking about our current capital plan. We're obviously very disappointed with our current stock price and do not think it reflects the true value of Urovant.
As such, we do not want to do a financing at these levels in the near-term as we think it will legitimize the stock price. We are fortunate that we have a strong financial background in our parent company Roivant and do not need to be in a rush to do a financing at the current stock price levels.
In addition, we believe that we have a number of milestones later this year and in 2020 that can meaningfully impact the stock price. We are also pleased to see that Roivant recognizes how undervalued our stock is at the current time and is demonstrating their conviction by buying stock in the open market.
Now to recap, in the fourth fiscal quarter, we achieved significant key milestones across all aspects of our business. As I mentioned before, we look forward to a number of upcoming milestones that will continue to drive us toward the goal of developing Urovant into a leading specialty urology company.
These milestones include completion of the EMPOWUE Phase III extension study in late summer, continuing enrollment in both our Phase III OAB BPH study and our Phase II IBS-associated pain study, with data from the IBS pain study expected in 2020, and filing our NDA for vibegron in OAB in the first quarter of 2020, while trying to accelerate that filing into the fourth quarter of 2019.
With that summary of milestones, I'll now open the call to questions. Operator?





这些里程碑包括在夏末完成EMPOWUE III期延伸研究,继续参加我们的III期OAB BPH研究和II期IBS相关疼痛研究,预计将于2020年进行IBS疼痛研究,并提交我们的NDA对于2020年第一季度OAB中的vibegron,同时试图将该申请加速到2019年第四季度。



Thank you. [Operator Instructions] Our first question comes from the line of Biren Amin of Jefferies. Your line is open.

谢谢。 [操作员说明]我们的第一个问题来自Jefferies的Biren Amin。 你的线是开放的。

Jeet Mukherjee

Hi, guys. This is Jeet on for Biren. Thanks for taking our question. Just wanted to know if you could provide any additional color on physician and payer feedback following the EMPOWUR readout and what data points might [have split out] in particular to them compared to mirabegron? Thanks.

嗨,大家好。 对于Biren来说,这是Jeet。 谢谢你提出我们的问题。 只是想知道你是否可以在EMPOWUR读数后提供医生和付款人反馈的任何其他颜色,以及与mirabegron相比,特别是哪些数据点可能[已经拆分]了? 谢谢。


Yes. So we conducted a qualitative market research of 42 physicians, both thought leaders and prescribing physicians and reviewed the topline data with them. They also were aware – these physicians were aware of other products in the market and what their data was in the context of that research. And the physician feedback was very clear. They felt that the product if approved will represent a clear choice versus Myrbetriq and I believe it already would represent a clear choice versus anticholinergic.
And I think the attributes that were called out by the physicians is most impactful were 2-week onset versus Myrbetriq’s 8-week onset. They also – physicians commented that the UUI data, volume voided data, urgency and responder secondary endpoints were key differentiators and were – represented really robust efficacy numbers. Additionally, the safety profile was viewed as favorable by those physicians. And last but not least, they commented that any drug that does not require titration, single dose and starting dose is preferable for their practice.

是。因此,我们对42位医生进行了定性市场调查,包括思想领袖和处方医师,并与他们一起审查了最重要的数据。他们也知道 - 这些医生了解市场上的其他产品以及他们在该研究背景下的数据。医生的反馈很清楚。他们认为,如果获得批准,该产品将代表Myrbetriq的明确选择,我相信它已经代表了与抗胆碱能药相比的明确选择。

而且我认为医生提出的最有影响的属性是2周的起病,而Myrbetriq的8周起病。他们还 - 医生评论说,UUI数据,体积无效数据,紧急性和响应者次要终点是关键的区别,并且 - 代表了非常强大的疗效数字。此外,这些医生认为安全概况是有利的。最后但并非最不重要的是,他们评论说,任何不需要滴定,单剂量和起始剂量的药物都适合他们的实践。

Jeet Mukherjee

Okay. Thank you.

好的。 谢谢。


Thank you. Our next question comes from Edward Nash of SunTrust. Your line is open.

谢谢。 我们的下一个问题来自SunTrust的Edward Nash。 你的线是开放的。


Hey. This is [indiscernible] on for Edward. Did you have any early discussion with payers with regard to how vibegron is likely going to be reimbursed?

嘿。 对于爱德华来说,这是[音频不清晰]。 您是否与付款人就振动器可能获得报销的方式进行了早期讨论?


So we completed an initial payer research last summer. We did that with two different payer research studies, both of which came back with the exact same output from the study. They represent over 160 million payer lives in the U.S. both commercial and Medicare D.
And the payers shared with – they offer that research was really threefold: One, they don't view the class as one that they highly manage or regulate, they view it as very predictable for their [auctorial models] to manage and price the class for employers and patients; and third, they manage the class with co-pay differential today and will continue to do so in the future meaning that if a patient chooses to fill a branded script, they prefer to differentiate the branded script from a generic with co-pay differential.
They don't actively manage the class with prior authorizations or stuff added, and we believe that is due to the pricing of the class and the predictability of the class. And indeed, we've quantified that the results of that research by looking at how drugs in the class are covered and they are covered with no restriction in over 90% of covered lives. And that includes Myrbetriq, it included and it includes [indiscernible]. So the payers are telling us pre-open class relative to many others that they manage. We have not done completed research with the payers post topline data, but we will do that work in the fall of this year.


与付款人分享 - 他们提供的研究实际上有三个方面:一,他们不认为班级是他们高度管理或规范的班级,他们认为这对于他们的[教师模型]管理和定价课程是非常可预测的对于雇主和患者;第三,他们今天以共付差价管理班级,并将在未来继续这样做,这意味着如果病人选择填写品牌脚本,他们更愿意将品牌脚本与具有共付差价的通用品区分开来。



That's very helpful. And then secondly, so basically you present some data of efficacy in some key subpopulations. Is there anything you would like to highlight or call out?

这非常有帮助。 其次,基本上你在一些关键的子群体中提供了一些有效性的数据。 有什么想要突出或呼唤的吗?

Michael McFadden

Yes. So I think what we were very excited to see in that or we focus particularly on three subpopulations: The first, patients that are 65 years or older. Obviously, that is a delicate patient population that we've been clear profiler of vibegron, if approved would work very well. And in that population, we're very pleased to see that a strong treatment effect in that group.
Additionally, one question that we get to ask very frequently is what about patients that have been on prior therapy either in prior anticholinergic therapy or even more importantly, prior mirabegron therapy. And so we were pleased to report that in both of those groups, we also saw a very strong treatment effect. And so we think that's a very meaningful commercially. One, obviously you would expect that anticholinergics and if even people failed anticholinergics that the beta-3 at vibegron would work, so that was good to confirm that.
And then second, we often get to ask if the patient does not successful on mirabegron, then will they be successful on vibegron? And I think that these data show a very strong treatment effect and for patients that were previously on mirabegron when treated with vibegron. So we think that positions us very well as we move forward towards launch.





Great. Thank you so much.

非常好。 非常感谢。


Thank you.



Thank you. Our next question comes from Ritu Baral of Cowen. Your line is open.

谢谢。 我们的下一个问题来自Cowen的Ritu Baral。 你的线是开放的。

Ritu Baral

Good afternoon, guys. Thanks for taking the question. I wanted to ask about a couple of things. One, what's left to do on the NDA filing? And also, you mentioned that you might be able to expedite this. What are the leverage points for potentially expediting the filing? And then I've got a follow-up.

大家下午好。 谢谢你提出这个问题。 我想问一些事情。 一,NDA备案还剩下什么? 而且,你提到你可以加快这一点。 可能加快申请的杠杆点是什么? 然后我有一个后续行动。


Sure. So in terms of left-to-do, three things that are needed in order to file the NDA: The first is completion of the open-label extension study, which we should have late in the summer. The second is the ambulatory blood pressure study that was requested by the FDA, which that too we should have late in the summer.
And then the last, which is actually the critical path item, is stability on the new 75-milligram dose. And so that is the – what would potentially allow us to accelerate into Q4 is essentially how quickly we can move the stability data once we get it into the NDA.
Obviously, we want to make certain that the NDA is perfect when it's submitted the links work and then if the highest quality document possible. So it really blows down to how long it will take us to get that stability data into the NDA as everything else will be complete just waiting on the stability data.

当然。 因此,就离职而言,提交NDA需要三件事:首先是完成开放标签扩展研究,我们应该在夏天晚些时候完成。 第二个是FDA要求的动态血压研究,我们也应该在夏天晚些时候进行。

然后,最后一个,实际上是关键路径项,是新的75毫克剂量的稳定性。 这就是 - 可能让我们加速进入第四季度的基本原则是,一旦我们将稳定性数据纳入NDA,我们可以多快地移动稳定性数据。

显然,我们希望确保NDA在提交链接工作时是完美的,然后如果最高质量的文档可能。 因此,我们需要花多长时间才能将稳定性数据纳入NDA,因为其他一切都将在等待稳定性数据时完成。

Ritu Baral

The ambulatory blood pressure study, is that open-label? Are you able to monitor that? Is it perceived?

动态血压研究,是开放标签吗? 你能监控吗? 它被察觉了吗?


It is a double-blind study. As a reminder, over 200 patients, and we'll be obviously thoroughly monitoring blood pressure at multiple timepoints and multiple visits to understand what if any impact that vibegron has on blood pressure.
And just as a reminder, our going-in assumption is that we'll see some very minimal increases much like vibegron saw in their studies, which could result in similar labeling. That said, we do think it would be a very significant upside event if no blood pressure changes were observed in the study.

这是一项双盲研究。 作为提醒,超过200名患者,我们将在多个时间点和多次访问中明显地彻底监测血压,以了解振动器对血压的影响。

而且作为一个提醒,我们的进入假设是,我们会看到一些非常小的增长,就像vibegron在他们的研究中看到的那样,这可能会导致类似的标签。 也就是说,如果在研究中没有观察到血压变化,我们认为这将是一个非常重要的上行事件。

Ritu Baral

Got it. Moving to commercial, you mentioned the – right now the estimated sales force size is about 150 reps. Can you talk about the number of potential targets that you guys have in mind? You mentioned urologists, are there any high-prescribing PCPs also targeted in the current plan? And how do you think about potentially tearing the calls of those 150 reps?

得到它了。 转向商业,你提到 - 现在估计的销售人员规模大约是150个代表。 你能谈谈你们想到的潜在目标的数量吗? 您提到了泌尿科医生,是否还有针对当前计划的高处方PCP? 您如何看待可能撕裂这150名代表的电话?


Yes. It's a great question, Ritu. There are about 7,000 urologists that treat the majority of OAB patients and write the majority of OAB prescriptions, we'll certainly call all of those urologists. And then there are about 1,000 to 3,000 primary care physicians/internal medicine physicians and their supporting Nurse Practitioner and Physician Assistant, ACPs that write a very large majority of the PCP, OAB prescriptions. And we plan to call on both of those with our urology sales force.
And then the other segment that we're going to enter is long-term care. We feel like we can do that with a 50-person in sales force and we can cover about half of the bed lives in long-term care directly. And then a substantial portion indirectly with that sales force size.

是。 这是一个很好的问题,Ritu。 大约有7,000名泌尿科医生治疗大多数OAB患者并写下大部分OAB处方,我们肯定会打电话给所有这些泌尿科医生。 然后,大约有1,000到3,000名初级保健医生/内科医生及其支持的护士执业者和医师助理,ACP写了绝大多数的PCP,OAB处方。 我们计划与泌尿科销售人员一起拜访这两个人。

然后我们要进入的另一个部分是长期护理。 我们觉得我们可以用一个50人的销售队伍做到这一点,我们可以直接覆盖大约一半的床位长期护理。 然后大部分间接与销售人员的规模。

Ritu Baral

Got it. So the 150 includes those 50 long-term care reps or is that a separate force?

得到它了。 那么150包括那50名长期护理代表或者是一支单独的部队?


It does. No, it can include.

确实如此。 不,它可以包括。

Ritu Baral

Got it, okay. And then last question, how with the additional work you've done over the last few months, how are you thinking about pricing? Or should we all still assume branded parity or are there other factors that play here now?

知道了,好的。 然后是最后一个问题,你在过去几个月里做了多少工作,你是如何考虑定价的? 或者,我们是否仍然应该假设品牌平价,或者现在还有其他因素在这里发挥作用?


Well, there's still work to be done with the payers this fall and that will certainly inform and expand potentially our thinking on pricing, as of now. I think parity pricing with Myrbetriq plus or minus or bracket of about 20% seems to make sense in this market. But we still need to see the data that is to come with the blood pressure study and have the market research this fall with the payers to solidify our thinking on that.

那么,今年秋天还有一些与付款人有关的工作,这肯定会告知并扩大我们对定价的看法,就像现在一样。 我认为Myrbetriq加上或减去或约20%的支架的平价定价似乎在这个市场中有意义。 但我们仍然需要查看血压研究所带来的数据,并在今年秋季与付款人进行市场调查,以巩固我们对此的思考。

Ritu Baral

Great. Thanks for taking all the questions.

非常好。 感谢您提出所有问题。

Michael McFadden

Thank you, Ritu.



Thank you. Our next question comes from Eric Joseph of JPMorgan. Your line is open.

谢谢。 我们的下一个问题来自摩根大通的Eric Joseph。 你的线是开放的。

Eric Joseph

Hey, guys. Thanks for taking the questions. I'm just wondering if you could speak to any incremental visibility on the Japanese vibegron launched by Kyorin and any feedback on how that product is being received clinically relative to Myrbetriq whether it's – that is while informing your commercial strategy here in the U.S.? Then I have a follow-up.

大家好。 感谢您提出问题。 我只是想知道你是否可以谈谈Kyorin推出的日本vibegron的任何增量可见性以及关于该产品如何在临床上相对于Myrbetriq获得的任何反馈,无论是否 - 这是在通知您在美国的商业策略时? 然后我有一个跟进。


Yes. Thanks for the question Eric. So we have very limited data on exactly what's going on with the launch in Japan. This is a reminder, it's co-marketed between Kyorin and Kissei Pharmaceutical in Japan. Kyorin actually announces their data and the quarterly revenues.
And so my comment earlier in terms of the success of the Japanese launches, in their first full quarter of launch, they actually posted some pretty attractive revenue numbers in that first quarter. We're just not certain if it's a combination of all the sales between Kyorin and Kissei or if there's a revenue split between the two companies.
But if you do look at Kyorin's forecast for this year, they actually have quite a substantial revenue forecast for vibegron. When you consider that the Japanese market in total is about $300 million a year, they're actually projecting that they get a very nice percent market share in their first year on the market.
Again, we don't have access to IMS or [indiscernible] data in Japan. So we don't have great visibility. But it does look like their first quarter revenue performance was strong and their projections for the full-year revenue performance are quite strong, such that if we achieved similar levels then we'd certainly have an incredibly strong launch here in the States.

是。谢谢你的问题埃里克。因此,关于日本发布的具体内容,我们的数据非常有限。这是一个提醒,它在日本的Kyorin和Kissei Pharmaceutical之间共同销售。 Kyorin实际上公布了他们的数据和季度收入。




Eric Joseph

Got it. And just a follow-up here on COURAGE and then with OAB due to BPH, just wondering to what extent the male subjects that were accrued in EMPOWUR reflect those being recruited to COURAGE? And whether subset-analysis you may have conducted on EMPOWUR. How are you thinking about – I guess expectations around the success of the co-primary endpoint that in COURAGE or micturition and urgency of that?

得到它了。 只是在COURAGE上进行了跟进,然后是因为BPH的OAB,只是想知道在EMPOWUR积累的男性受试者在多大程度上反映了被招募到COURAGE的人? 您是否可以在EMPOWUR上进行子集分析。 您是如何思考的 - 我猜这个联合主要终点在COURAGE或排尿和紧迫性方面取得成功的期望是什么?


Cornelia, would you like to answer that one?


Cornelia Haag-Molkenteller

Yes. So thank you, Eric. So first of all, the men in our current EMPOWUR study are not totally reflective because of course here in the COURAGE study, we require them to also be on an alpha blocker. They also need to have a minimum number of urgency and micturition and they also need to have nocturia, which was not a requirement from EMPOWUR, so you can't really compare them.
We looked at micturition [indiscernible] urgency as well, looks at least in the right range. However, we do know to look of course at these data more carefully. But at the moment, we're confident in our current co-primary variables that we will continue to look of course.

是。 埃里克,谢谢你。 首先,我们目前的EMPOWUR研究中的男性并非完全反思,因为当然在COURAGE研究中,我们要求他们也使用α阻滞剂。 他们还需要尽可能少的紧急和排尿,他们还需要夜尿症,这不是EMPOWUR的要求,所以你无法真正比较它们。

我们也考虑了排尿[音频不清晰]的紧迫性,至少在正确的范围内看。 但是,我们确实更清楚地了解这些数据。 但目前,我们对目前的共同主要变量充满信心,我们将继续关注这些变量。

Eric Joseph

Got it. That's it. That’s helpful. Thanks for taking the questions, guys.

得到它了。 而已。 这很有帮助。 谢谢你提出问题,伙计们。


Thanks, Eric.



[Operator Instructions] Our next question comes from the line of Ram Selvaraju of H.C. Wainwright. Your line is open.

[操作员说明]我们的下一个问题来自H.C.的Ram Selvaraju。温赖特。 你的线是开放的。

Raghuram Selvaraju

Thanks very much for taking my questions. Just three very quick one, guys. So with respect to vibegron, I wanted to know whether you could maybe quantify for us what you think the delta or the distance might be between vibegron and mirabegron, if vibegron were to obtain successfully a label for use in patients with concomitant OAB and BPH.
Secondly, if you could give us a sense of what – to what degree physicians would require prior treatment and failure or prior treatment at all with mirabegron in patients who would not be considered particularly good candidates for mirabegron therapy before starting vibegron therapy.
So for example, those patients who either are on concomitant medications would be consider candidates for concomitant medications were there are likely to be drug-drug interactions with mirabegron, whether you think there's any likelihood at all that physicians would continue, sort of, counterintuitively to insist that those patients try mirabegron first before going on vibegron.
And then lastly, a question on URO-902, if you could just give us a sense of what you expect the timing of initiation of the Phase IIa study to be and also whether you can confirm at this juncture whether the route of administration would be similar to what reduced by Ion Channel before or whether it's been changed? Thank you.


其次,如果你能够让我们了解一下 - 在开始使用vibegron治疗之前,医生需要事先治疗和治疗失败或事先治疗的程度,以及在mirabegron治疗中不被认为是特别好的mirabegron疗法的患者。




Thank you, Ram. Appreciate the question. I'll take the first one. I'll let Michael take the second and then Cornelia to take the third one on that. So first off, your first question was about quantifying potential benefit of vibegron in OAB and BPH relative to mirabegron. And there, I don't know if there's – it's not really a question of quantifying the differential.
Right now, there are no approved products for contaminant OAB and BPH. And in our discussions with the FDA, the FDA was very clear. They view that men would have OAB and BPH as a separate and distinct indication from an OAB indication. So what that means is if our study is successful, we will be able to file a sNDA and have essentially a label enhancing indication allowed on the vibegron labels.
And so given the FDA's stance, we don't think that it's – we don't believe that Astellas would promote into that marketplace, which then would make obviously, vibegron the only promoted product into that category. And we do view that as a very large category.
I think as you are aware, 75% of the men that have OAB and BPH, their OAB goes untreated. And so we think that is a very large market opportunity with over 2 million men out there that can benefit from vibegron, if approved for that additional indication.
So with that, let me turn over to Michael to talk about your question about whether or not physicians would maybe require to have or may want prior treatment with mirabegron before prescribing vibegron.

谢谢你,拉姆。感谢这个问题。我会拿第一个。我会让迈克尔拿下第二个然后科妮莉亚拿下第三个。首先,您的第一个问题是关于量化OAB和BPH中相对于mirabegron的vibegron的潜在益处。在那里,我不知道是否存在 - 这不是一个量化差异的问题。


因此,鉴于FDA的立场,我们认为不是 - 我们不相信安斯泰来会推动进入那个市场,而这显然会使vibegron成为该类别中唯一推出的产品。我们认为这是一个非常大的类别。



Michael McFadden

Yes. Let me comment on two fronts. First from the payer front, how they’ll view it? And what the physicians have told us in market research. From the payer front, they have shared with us, this is a non-managed class. They managed it with co-pay differential.
And then their [content is to let] each manufacturer, trying to differentiate their product and physician select the product, if they think is best for the patient, whether that's [indiscernible] or generic or whether that is Myrbetriq or ultimately what – if approved with vibegron.
So we believe the differentiation choice for – from a payer standpoint is that non-managed class let the physician that patient work through those issues. From the physician standpoint, when we look at the market, I'll frame the question maybe how we're thinking about it. There are about 14 million active patients that are in the process of seeking treatment has sought treatment or have sought treatment and [indiscernible] on treatment.
There are 3.3 million of those patients that are active meaning, they are taking medicine today. They're filling scripts at a pharmacy. There are about 8 million to 10 million that have failed, one, two and/or three medications.
And so as we think about the market, we will certainly pursue the active patients, the 3.3 million, because we know the medicine they own today, over 70% of them will not be taking that medicine six months from now. And they stop taking it typically for tolerability issues with the old anticholinergics and from Myrbetriq, we know they lose 40|% of our patients by month two.
And so we will actively pursue next choice for those patients as they represent the majority of the market. And then there are about 8 million to 10 million patients who failed everything, and we're actively working on ways to bring those patients back into therapy by sharing information with them, finding them first and then sharing information about a coming therapy.
And ultimately if approved, we'll talk to them about the therapy option of vibegron and ask them to engage their doctor if they want to reengage the therapy. So as we think about, there are a lot of different opportunities across the continuum for us to differentiate the product and then actively pursue different patient types.
And then last, but not the least the long-term care. There is no product in OAB today that has a better profile for the long-term care patient both from a safety and efficacy standpoint. So we believe that vibegron will be highly differentiated in that category, which we believe represents $1 billion potential.


然后他们[内容是让]每个制造商,试图区分他们的产品和医生选择产品,如果他们认为最适合患者,无论是[音频不清晰]还是通用的,或者是否是Myrbetriq或最终是什么 - 如果批准与vibegron。

因此,我们认为差异化选择 - 从付款人的角度来看,非托管类让医生让患者解决这些问题。从医生的角度来看,当我们看待市场时,我会问我们如何思考这个问题。目前正在寻求治疗的大约1400万活跃患者已经寻求治疗或寻求治疗和[音频不清晰]治疗。






Cornelia Haag-Molkenteller

Okay. So on URO-902, is that correct?

好的。 那么在URO-902上,这是正确的吗?


Yes, please. It's about – when we're planning on initiating in route of administration.

是的,请。 这是关于 - 当我们计划在管理途径中启动时。

Cornelia Haag-Molkenteller

Yes. We are planning to initiate towards the end of the year. And the route of administration will be in [particular injections] just as the last of the Ion studies and equivalent to BOTOX and essentially all of that has been established for BOTOX injections, and the local anesthesia is an in-office procedure.

是。 我们计划在年底前启动。 并且给药途径将是[特别注射],就像最后一项离子研究和BOTOX相当,并且基本上所有这些都已经建立用于BOTOX注射,并且局部麻醉是在办公室程序。

Raghuram Selvaraju

Great. Thank you very much for those nuanced answers. Much appreciated.

非常好。 非常感谢你那些微妙的答案。 非常感激。


Thanks Ram. Appreciated.



Thank you. At this time, I'd like to turn the call back over to Keith Katkin, for any closing remarks. Sir?

谢谢。 在这个时候,我想把这个电话转回Keith Katkin的任何结束语。 先生?


Thank you. Just like that, thank you everybody for joining us on our conference call today, and we look forward to seeing everyone at the JMP Conference in New York next week or on our next earnings call. Thank you, everyone.

谢谢。 就这样,感谢大家今天参加我们的电话会议,我们期待在下周的纽约JMP大会或下一次的财报电话会议上与大家见面。 谢谢大家。


And this concludes today's conference call. Thank you for your participation, and have a wonderful day. You may disconnect your lines at this time.

这就结束了今天的电话会议。 感谢您的参与,祝您度过愉快的一天。 您可以在此时断开线路。

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