Q2 2020 Urovant Sciences Ltd Earnings Call
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Fiscal year second quarter 2020 earnings conference call at this time, all participants I know listen only mode.
After the speaker presentation, there will be a question and answer session Ashley.
Ask a question during the session you'll need to press star one on your telephone.
Please be advised that this conference is being recorded if you acquire anybody. This is Ben Please press star Zero I would now like to hand, the conference just because today right Kubota Investor Relations. Please go ahead Sir.
[music]. Thank you operator good.
Good afternoon. Thank you all for joining your that's fiscal 2022nd quarter financial results Conference call.
With me today are key members of our leadership team.
Jim Robinson, President and Chief Executive Officer.
Hi, Jay Boncel, Chief Financial Officer.
And Dr. Cornelia had woken teller, Chief Medical Officer, Chris.
Yes, you know Campbell, our Chief Accounting Officer is also president will join us on the Q and a portion of the call.
Today after market close you should a press release containing detailed information on our quarterly results.
You may access the release on our company website.
Event Dot com.
We use our website as a channel to distribute important and time critical company information.
And you should look to the Investor Relations page of our website for this information.
During our call, we'll be making forward looking statements.
Greetings Davis regarding our plans and strategies the clinical development of Ivig and.
Other treatments for allergic diseases.
Listeners are cautioned that all of our forward looking statements are based on our current expectations and assumptions, which are subject to numerous risk factors that could cause our actual results to differ materially.
Accordingly.
Listeners to review the forward looking statements disclosures in today's press release, the risk factor section of our form 10-K, as well as our form 10-Q should be filed soon.
With that said I will now turn the call over to our president and CEO.
Tim Robinson.
Tim.
Thank you Ryan and thanks to all of you for joining the call today.
Our second fiscal quarter of 2020, Europe and continued to make strong progress preparing for the anticipated approval and commercial launch of my background as well as advancing our clinical programs.
I'll start today's call discussing the status of our regulatory and commercial activities.
My background in overactive bladder.
In regards to our new drug application, we continue to be engaged with the FDA.
Our interactions with the agency remain on track as we continue to work towards our upcoming PDUFA date of December 20 section.
With just over a month until reaching this pivotal period in the company's history. We're actively preparing for the expected commercial launch of buyback one late in the first quarter of 2021.
Now let me provide you with an update on the hiring of our sales force.
Our Copromotion agreement snowmobile.
Our market access activities and our marketing plans.
In terms of our sales force our sales leadership team has been hired and its onboard.
I'm pleased to say that this team of 20 individuals brings a significant amount of knowledge and proficiency to your event with combined experience of nearly 260 years in the pharmaceutical industry and an average of 10 years of experience in the urology space.
We're now in the process of recruiting approximately 120 represented as far urology sales force.
Additionally, 35 representatives far long term care sales force I'm.
I'm very pleased with the significant level of interest that we received from these highly qualified applicants.
With the sales effort at launch will have a higher share of voice from the combined urology specialty.
And long term care segments of the overactive bladder market.
Our urology specialty sales force also calling the top prescribing primary care providers at.
That augment our efforts in the primary care space, We recently signed a co promotion agreement with Sanofi and.
Tobey its multi specialty sales force will enable us to further expand into medium and high prescribing primary care physicians.
This is an important factor when you consider that our primary care providers represent approximately 40% of all prescriptions no rock to bladder.
Under this agreement Sonobi and will invest more than $60 million in sales marketing activities from the launch of buyback run through March 30, Onest of 2023.
We expect this agreement to create significant value by amplifying our reach within this critical segment of the market.
Without the need for us to deploy additional capital.
Now let me provide you an update on our efforts and market access since.
Since August our market access teams have been meeting with key payers to introduce and educate them on by background through preapproval information exchange meetings.
Meetings have given us the opportunity to discuss with payers the safety and efficacy data and fight back on as demonstrated in our pivotal MPOWERED trial as well as the clinical value proposition.
We believe that will provide if approved.
These meetings have been beneficial as we prepare for launch.
Shifting to our marketing efforts our sales teams will be supported by an extensive multi channel marketing campaign.
We've launched Nonbranded health care provider and consumer communications through various digital partnerships.
This platform will engage health care providers patients and payers alike, all of whom played an important role in our launch efforts.
Additionally, our sales leaders have engaged key stakeholders to further educate them on our company.
And pipeline.
And the response has been very positive.
As we shared with you on our last call we've launched on branded virtual community bladder chatter dot com over the summer.
The purpose of this communities to help change the dialogue around overactive bladder, which is often misunderstood stigmatised and too often accepted as normal.
<unk> Dot Com provides a forum where people can learn from each other and discuss their overactive bladder issues and concerns.
With more than 170000 sites visits and approximately 12000 individual registrations, we've learned a lot.
Through this virtual community, it's very clear that people suffering from overactive bladder are seeking a better alternative to what's available today.
Some key insights include that 86% are bothered or very bothered by overactive bladder.
73% of discuss their symptoms with their doctor and 68% are not currently on treatment.
I bring to market a potentially best in class treatment, we hope to make a significant contribution to alleviate the symptoms of overactive bladder for many of these patients in summary, we believe that we're well prepared to successfully commercialize buyback Ron pending FDA approval.
Now, let me briefly transition over to our development pipeline, which Cornelia will then get into more detail on in a moment.
Please with the ongoing progress we've made a number of programs designed to maximize the value of my background be on its initial indication for overactive bladder.
Our lead clinical program. The phase three current study that's developing by background to treatment with overactive bladder and B P. H.
Continuing to enroll patients into the study and expect topline results in the second half of 2021.
Our second clinical program for buyback Ron is the treatment of irritable bowel syndrome pain. We currently expect to have topline results for our phase two study for this program in the coming weeks.
Regarding our second development program your own I know two a novel injectable gene therapy for the treatment of overactive bladder, we are continuing to enroll patients who have failed oral pharmacological therapy for a we'd be.
Into our phase two trial.
The decision to move from court one the core to what we made on the recommendation from the independent data safety monitoring board or de SMB and is expected to occur in early 2021.
This concludes my opening remarks, and let me now turn the call over to our Chief Medical Officer, Dr. Cornelia Hog broken teller.
Thank you Jim that's.
As previously announced and Jim just discussed we submitted our new drug application for buybacks.
For the treatment of all he beat to the FDA in December of 29 cheap.
March if the FDA notified us that they accepted the N.D. for video set or PDUFA date is December 26 2020.
We continue to respond to ft requests as part of the regular review cycle and we remain confident that data and indeed, we submitted for Viacom.
Let me take a minute to provide some detail on the upcoming data presentations that we have planned for Bobby <unk> as.
As well as four ongoing clinical development programs.
The International Continent Society I see its meeting is taking place from November 19 to 26, 2020 and is scheduled as a virtual meeting.
The quality of life responder data from the phase we empower extension study have been accepted for presentation and will be available on November 19th.
As you May remember this was a double blind extension study of the placebo controlled power pivotal study pace.
Patients in this study received either 75 milligram I think Oh, sorry milligram extended release told clarity.
Bobby Grant was able to sustain its efficacy for over 52 weeks of observation with very favorable long term efficacy results.
It would be the key symptoms of urinary frequency urgency urge urinary incontinence.
Total incontinence and it also demonstrated a good long term safety and Tolerability profile.
The patients respond on the quality of life scores as on the disease specific questionnaire only be Q in this study correspond well with the improvements in the way. These symptoms again, demonstrating the sustained efficacy of 75 million by big overtime.
Urinary incontinence is one of the leading symptoms of away be that cause patients to seek treatment.
Our data showed that 71% of patients treated with five big experienced a 50% reduction of the baseline incontinence episodes at week 52. In contrast, only 61.9% of the total territory group and 40.8% of all patients the five equal treatment group became dry.
Meaning that they did not have any incontinence episodes in contrast to only 34.2% in the toll Cherokee group at week 52.
I will now come into an ongoing clinical trials.
Given the COVID-19 comes I mean, we have temporarily halted the enrollment of new patients and two ongoing clinical trials beat March Twentytwenty at the end of April we began to be open trial sites for the screening new patients although for trials in a stepwise manner.
For phase three courage development programs.
In men with maybe benign prostatic hyperplasia BPH. We're now in part two of this large trial, which over 1000 patients will be involved.
The trial is taking place in North America, and Europe with study sites initiated in Europe.
Our chew up this phase three trial will assess the efficacy and safety of Bobby.
And BPH the.
The co primary endpoints I reduction mytrition frequency in urgency episodes for 24 hours.
Key secondary endpoints reduction in nocturia episodes, which is the awakening to Boyd plastic symptom scores and safety dish.
Additionally, the first patients also had rolling into a long term extension trial, which will follow patients for a total exposure 52 weeks.
Due to the ongoing COVID-19 situation and increase the number of cases reported in the U.S. in many European countries, we're continuing to monitor the situation closely with respect to enrollment.
As a reminder, there's currently no ft aipu products, specifically indicated overactive bladder with TPH.
Regarding our phase two eight clinical program for five because I'd be associated abdominal pain, we completed the enrollment of 222 female patients with ideas associated abdominal pain at the end of June Twentytwenty pace.
Patients were randomized to either 75 money to buy back on placebo.
The primary endpoint is a 30% reduction in abdominal pain intensity on an 11 point rating scale ranging from zero to 10 over 12 weeks for ideas D, which CMBS with diarrhea.
It was bombed is defined as the subject with at least a 30% decrease in worst abdominal pain compared to that we see baseline average.
Secondary endpoints include the clinical rating scale and safety in particular lack of negative effect on stool frequency or consistency.
We now plan to report topline data from this study at the end of this month.
Regarding the development program for a year or two our novel injectable gene therapy for the treatment deployed beat.
We're studying your own I know to interface to a child and are holding patients or maybe the field oral pharmacologic therapy.
This is a randomized double blind placebo controlled trial that will evaluate the efficacy safety and Tolerability of a single administration of Euro I know to running of the U.S.
This therapy is administered by a direct into twos, just do the bladder wall under local anesthesia.
The trial is expected to enroll approximately 80 female patients in the U.S. two cohorts. The first cohort will receive a single administration of 24 milligram of your own I know two or matching placebo and the stakes in the courts will receive 40 milligram you our own I know to some matching placebo.
The primary outcome measure is the change in the average daily number urge urinary incontinence episodes from baseline at week 12, as well as assistant of the safety and Tolerability of this new potential therapy.
Patients will then be followed for up to 48 weeks after one injection.
The decision to move from cohort one to core two will be made the recommendation of the independent data safety monitoring board or do yes, it would be.
This trial is only running of the U.S. and based on the enrollment levels due to cope with that team situation. The DS it'd be meeting will be held in early 2020 one.
I'm pleased with the progress we've made despite the enrollment challenges presented by cope with that team and I look forward to providing you with further updates in the future.
I'll now pass on to our Chief financial update.
Thank you Claudio.
And thank you everyone for joining us on today's call. During this exciting time in the company's history.
Please note that in addition to the results summarized in our press release, you can find additional information in our upcoming form 10-Q.
R&D expenses were $14.5 million for the second quarter of fiscal 2020, compared with 17.8 million for the same period in the prior year.
The year over year decrease is primarily due to a 6.8 million reduction in our Seattle costs stemming from the completion of the double Blind extension study I'll put MPOWERED study in the prior year.
And the completion of enrollment in our phase two week trials for the treatment of abdominal pain due to I.B.S. in June this year.
This decrease was partially offset by an overall increase of $2 million with CMC cost.
Resulting from them in a faction of finishing validation batches.
Purchase of drug substance and other starting materials for future manufacturing campaigns I'd be gone.
As well as the manufacturing of drug substance for future clinical supplies of you don't I know too.
DNA expenses, what he didn't point $9 billion for the second fiscal quarter of 2020, compared with 7.4 million for the same period in the prior year.
DNA expenses have gone up due to an increase of $5.4 million in commercial readiness costs and an increase of 4.9 million and personnel related costs as we continue to prepare for the commercial launch of why the gone if approved.
Total operating expenses were 32.5 million for the second quarter was 2020 compared to 25.2 million for the same period in the prior year.
Net loss was $35.2 million or $1.10 and 12 cents per share for the second quarter was 2020.
Paired with a net loss of 25.7 million or 85 cents per share for the same period in the prior year.
Cash used in operations was $32.6 million for the quarter ended September 30, or 2020 as compared to 30.8 million in the immediate prior quarter ended June towards gets 2020.
As of September 32020, total cash on hand was $74.4 million.
At the end of the quarter, we still had a $128.5 million available for drawdown under our low interest five year term loan facility would DSP.
Looking ahead.
For the third quarter fiscal 2020, we expect that cash burn to be approximately $45 million.
For the full fiscal year 2020, we now project the cash burn between a 185 million and $190 million.
With that financial update I would like to turn the call back over to Jim.
Thank you Roger.
As we prepare to go to your questions I'd like to summarize how we're thinking about what we've accomplished to date and our focus for the future.
We're pleased with the progress we've made thus far and we continue to make strides across all aspects of our business.
We have several upcoming important milestones during the remainder of our fiscal year, including topline efficacy and safety data from the phase two study of my background for the treatment of I guess associated pain later this month.
The potential approval of my background late next month.
Back to completion of cohort one enrollment in the phase two way of our novel injectable gene therapy for overactive bladder Euro dyno too yeah.
In the commercial launch of my background, if approved in the first quarter of calendar year 2021.
In anticipation of why backgrounds approval, we're focused on building our commercial team and executing on our launch plan.
In summary, we believe we are well positioned to be a strong leading competitor in this market and are excited about the future.
And with that we finished our prepared remarks, and we'll now go to questions operator.
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Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key piece and I will be compiled the candy roster.
Our first question comes from Ram Selvaraju with H.C. Wainwright. Your line is now open.
Hi, Thanks for taking my questions first they wouldn't be possible for you to comment on the nature of the sales force that the S.P. is likely to be using in support of my background as part of the co promotion arrangements and in particular, how large this group.
Elected to be and what other products. They are currently promoting and how much of their time, they're expected to be devoting through detailing by background.
Hey, Ron it's Jeff Thanks for your question.
So let me give you a sense of the criteria in terms of what was important to us when we were evaluating partners in this area.
First we wanted to make sure we had in market successful XP.
Experienced primary care team that was very important to us having the relationships with the primary care providers have being in market and having a demonstrated track record of success. As you would expect was very important for us.
Sonobi and we'll be dedicating 90 sales professionals to buyback Ron or.
The other key component for us as we wanted someone that was willing to invest along with US part of the investment is effort. So sonobi and the representatives that we will be working on behalf of buyback Ron it'll be their primary detail and it has to be at least 60% of their overall incentive compensation waiting so it's a big part of their effort.
And it's going to be the first line detail for that sales team.
We also wanted someone that was going to invest along with us and as you saw.
As a willingness of sanofi into invest $60 million over the first two years and not only people, but also programs marketing expenses.
Samples et cetera, so in terms of the criteria that we laid out for the right partner they met all the criteria for us so they are going to be.
Very important for us.
Renting our primary care approach from that mid Def file to the high decile prescribers.
Okay, Great and then with respect to the applicability of my background I've, yes associated pain.
Just wanted to get some clarity on what you folks expect to be the most critical secondary endpoints in the study from the vantage point, though.
Competitive positioning of the drug in this indication and also if you could elaborate on the halfway through formal approval in this indication assuming that the study is positive as well as how hypothetically my background would be position from a commercial standpoint visa. The for example, the way you out.
Okay.
Sales effort, the commercial infrastructure with regard to different indication relative to the oil <unk>.
Sure. So I'll, let cornioley add some color to that but as you know we've announced at the end of November we expect to have the phase two way topline results at that point, we'll evaluate the phase two b slash three or should play phase to be slashed, three and and combined develop.
And program requirements.
For our next step in terms of utilizing the organization. There's two answers to that without question, we would utilize the existing sales and commercial infrastructure that we have we find it to be extremely efficient, we would add potentially a little effort in the Gi space as well, which would argue.
Augment our already sizable sales organization.
In terms of.
The other component if it allows for a differentiated label so not only do we have a chance to differentiate blame on the U.S., but also abroad and would provide an opportunity to show that beyond the only indication my background is effective in let's say I'd be less pain. If successful. It also goes to speak to the development program. We're doing an hour we'd be in men with BPH, so either one or.
Those indications provide for a significantly differentiated label in the U.S. and abroad in terms of endpoints in terms of primary and secondary I'll, let cornelia handle that maybe provide a little more color on the development programs pending the outcome of the phase two a study that well get to read out at the end of November Cornelius.
Yeah. Hello. This is Cornell yes. So again it is like an all IP as studies. It is the reduction in the worst abdominal pain over the 12 week period. It's a 12 week study double blind placebo controlled and again as Jim said businesses 75 milligram dose the currency and the phase two a week.
I've studied one dose. If this continues this program we will probably have to study at least two doses. We will also be looking at no negative effect stool consistency for ideas.
Okay Perfect and then just one very quick one regarding DTC advertising that you couldn't right I said that you expect my background to be long, that's probably likely to be no significant or a cooling all significant.
I wondered if you could ever.
Rather than other oil products and the buyback drawn class.
Oh, I don't know if I could make a definitive statement on what another company will do.
With their DTC program, what I can tell you is that we will have a multichannel marketing campaign as we've talked about previously we expect to leverage digital and social channels the evolution.
The ability to reach peak.
People that are interested about learning more about overactive bladder has been significant the ability to provide curated content on demand to people that are interested in learning more about.
How to talk to their doctor about it as well as the potential products that are available it's significantly changed in the last five to 10 years. So we expect to be able to have a very successful and a very targeted.
Direct to patient campaign launched sometime in 2021, so in terms of what other companies will do I mean, I think you can only speculate.
Thank you.
Thank you.
Thank you Ashley I might add that to ask a question you will need to press star one on your telephone.
Our next question comes from Byron Amendment Jefferies. Your line is now open.
Hi, guys. Thanks for taking my questions.
Maybe just on the buyback Ron potential approval, if you're approved.
Later this month.
And with with launch shortly thereafter, how should we think about the trajectory of the law should we be looking at the my back Ryan.
Trx script count and it's in the first few months of its launch and tracking to that.
Hey, Ben it's Jim that's a good question Oh in terms of timing again. The PDUFA date is December 26, well onboard our sales team over the course of January and February were interviewing them now making contingent offers now the offer would be effective upon the approval of by background.
And so again, we do the Onboarding and launching in the you know January February time frame that sales force with an expected launch in March like.
Like we said late 2021.
So late in the first quarter excuse me of 2021 in terms of trajectory as you probably know the pair aspect is really important for us to be able to get access.
Launch you know if I were to say you could.
Could you overlay the two launches I think you're going to see that by backgrounds launch is going to be a right from a standpoint of trajectory similar I would say tamir back Ron probably slightly below until we have formulary access, but we do expect formulary access in the important plans both in part D and commercial end 2021 and early two.
22.
Obviously, when we have formulary access at a critical mass we expect that our launch trajectory will.
Reflect that access and grow accordingly.
And so you talked about part D. I guess is that component is going to come through and 2022, Jim because that seems to take a little bit more time than the commercial pairs.
Yeah.
Generally as you said 2021 bid cycles would have been in and reviewed at this point. So you know for US without question 2022 is an area of.
Intense focus for Medicare part D access, but beyond that we still expect to get some access in part D. We expect some access in commercial and as we've talked about previously long term care. We believe represents a significant opportunity for us to be well provide access early in 2021 and be able to grow by background on that important segment of the market.
Great. Thanks for taking my questions.
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Thank you I'm not showing any further questions at this time I would like to turn the call back over to Jim Robinson for closing remarks.
Thank you very much operator, and again I want to thank all of those that have attended todays call and also want to thank those for the questions and we look forward to providing you an update on our next call. Thanks very much.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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