Q1 2021 Urovant Sciences Ltd Earnings Call
Ladies and gentlemen, today's conference is scheduled to begin shortly please continue standby. Thank you for your patience.
[music].
Ladies and gentlemen, thank you for standing by welcome to the Euro Vince Sciences fiscal 2019 fourth quarter financial results Conference call.
As time, all participants are in listen only mode.
And management's prepared remarks, we will hold a question and answer session.
At that time, you can ask a question by pressing star followed by one on your Touchtone phone.
Anyone has difficulty hearing the conference. Please press star zero for operators system.
As a reminder, todays conference is being recorded.
I'd now like to turn the call over to write Kubota Executive director of Investor Relations. Please go ahead mr.
Thank you operator.
Afternoon, and thank you all for joining your events is called 2021st quarter financial results Conference call.
With me today, our key members of our leadership team.
Tim Robinson, President and Chief Executive Officer.
Hi, Jay Bullock Chief.
Chief Financial Officer.
And Dr. Cornelia Harden Taylor Chief Medical Officer.
Christine Ocampo, our Chief Accounting Officer, There's also present will join us for the Q and a portion of the call.
Good day after market close we should your press release containing detailed information on our quarterly results.
You may access to really solar company website <unk> dot com.
We use or website as a channel to distribute important time critical company information.
You should look to the Investor Relations page on our website <unk>.
[laughter] during our call, we'll be making forward looking statements.
I think statements regarding their plans and strategies the clinical development on Monday growth.
Other treatments for your logic Tunisia.
Listeners are cautioned that all of our forward looking statements.
Based on current expectations and assumptions.
You are subject to numerous factors could cause <unk> actual results to differ materially.
Accordingly, we advise listeners to review the forward looking statements disclosure at today's press release, the risk factor section of our form 10-K, as well as our form 10-Q.
We'll be faster.
But that said I will now turn the call or to our president and CEO Tim Robbins.
Jim.
Thank you Ryan and thanks to all of you for joining the call today.
The first fiscal quarter of Twentytwenty, you're going to continue to make strong progress.
More important operational milestones.
Gotcha clinical programs and preparing for the anticipated approval and launch a buyback Ron.
[music] before I discuss recent accomplishments.
Let me give you a brief update now we're continuing to navigate to covert 19 situation.
Hotchpotch game changing around the country.
First our employees continue to work remotely.
Relatively small size, our workforce has enabled us to remain nimble and productive.
We leveraged technology to manage hard day to day activities.
Second working remotely has not impacted our preparations for a buyback Ross expect him to do but in December for if approved the drugs the anticipated launch in the first quarter 2021.
[music] announced last quarter.
Following additional wall Johnson, and Ken Stewart, you're continuing to build out for commercial and market access capabilities. We've made several key hires under both of these respective battles.
Pedigree experience will be individuals were hiring are essential to long term and short term success of our launch, particularly in the current environment.
We say they were bringing on high quality individuals with deep expertise and strong relationships in urology.
Over the last eight weeks, we acquired a number of key people in our commercial organization.
During the majority of a regional sales managers.
His team that significant urology and overactive bladder experience.
We've also made strong progress building out our market access capability.
And our hiring of this team is now largely complete.
This month, well begin to engage with key national regional and long term care payers.
As we prepare for our anticipated launch.
In July we initiated our unbranded campaigned all the power can form and support women with overactive bladder.
A key element of that unbranded campaign is a launch of our boy Defocus community website called flatter chatter dotcom.
The purpose in bladder chatter dot com, that's helped change the dialogue around overactive bladder is often misunderstood stigmatised.
And too often accepted as normal.
Flatter chair Dot Com provides a safe and private environment people can learn from each other and the Skosh overactive bladder.
[music] listen to preparing for the potential approval and launch of my background. We also continue to drive for a number of programs designed to maximize the value the molecule.
We've recently completed enrollment in our phase two study if I back on irritable bowel syndrome pain and continue to enroll patients in our other ongoing studies.
So now let me turn the call blow our Chief Medical Officer, Dr., Cornelia Peg smoking teller can give you more detail our clinical programs.
Thank you Jim [noise].
As a reminder, if we submitted our new drug application so by being gone for the treatment of maybe to the FDA in December 2019, and turned much games. This year the equity notified us that they've accepted or indeed for video from that or could do for Golden age has been assigned for December 26, 2020 [noise].
Last month review cycle at the F.D. is ongoing and we continue to respond to XT requests.
Sorry, just a regular review cycle.
Let me now provide updates on further data presentation, so that'd be great beef.
Our ongoing clinical development programs [noise].
Quality of life responder data from the phase three empower extension studies have been accepted for presentation at the upcoming international content and society or I see is meeting scheduled for November 2020 [noise].
This meeting will be virtual [noise].
As you May remember this was the double blind extension study of the placebo controlled empowered pivotal study [noise].
Patients in this study received seven you guys Moneygrams I think on for Phil milligram extended release told charity.
This study demonstrates that fiber on was able to sustain its efficacy over 52 weeks of observations with very favorable long term. If you can see vehicles, including on the key sentiments up here in their frequency urgency urge urinary incontinence told me incontinence and a good long term safety and Tolerability profile [noise].
Patients response on the quality of life scores in this study corresponded well with improvements in a way. These symptoms again, demonstrating the sustained efficacy of safety track moneygram by background overtime [noise].
Regarding one it's the most important way be symptoms, it's only be.
Urge urinary incontinence, 71% of patients experienced a 50 Christian production of the baseline incontinence episodes at week 52 in conscious to Oneq, 61.9% industrial charity, Andrew and once you quite 8% of all patients as I think people go became dry.
Meaning that they did not have any incontinence episodes anymore. In contrast, Johnny 34.2% into told charging group at week 52.
[noise] I will now kind of ongoing clinical trials.
Given the Kobe time team condemn a clear temporarily halted the enrollment of new patients into ongoing clinical trials mid March 2020 at the end of April we began to we opened our trial sites with the screening with new patients in all up her trials in the stepwise manner.
For phase three courage development programs of I.B. Braun in men with B and benign Trustatlantic hyperplasia BPH. We're now in part you have this large trials, which over 1000 patients will be enrolling the trial is running in North America and this study sites in Europe has been initiated in most countries [noise].
Hard to have this phase three trial will assess those efficacy and safety if I break ground and men, which may be in B P. H.
Oh primary endpoints are reduction and be curious you frequency and urgency episodes for 24 hours key secondary endpoints every junction enough Turia episodes would you say wait coming at night, you Boyd prostate symptom scores and safety [noise].
Additionally, the first patients old Gen rolling into long term extension trial, which will follow patients for a total exposure at 52 weeks.
As a reminder, there's currently no sta approved products, specifically indicated for overactive bladder in men with TPH.
Regarding our phase two clinical programs of I'd make on and I'd be associated abdominal pain. Following the slight delay due to cope with 19, we have completed enrollment of 222 female patients with I.B.S. associated that Domino pain at the end of June Twentytwenty.
Patients were randomized trial, there shouldn't be that money there my background or placebo. The primary endpoint is a 30% reduction abdominal pain intensity unlocking point rating scale going from zero to 10 over 12 weeks try BSD, which the idea switched area.
Responders defined as the subject with at least it 30% decrease the worst abdominal pain compared to the we see baseline average.
Secondary endpoints include a global rating scale and safety incur teaches the lack of negative symptoms, all stool frequency or consistency.
We now plan to report topline data from this study towards the end of November 2020.
[noise] regarding further pipeline projects I will now continue with your own I know to our novel Injectable Gene therapy project could you come to go Abbey.
We're studying growing I know to interface to eight trial and Onboarding patients with maybe that's field oral tropical logic therapy.
This is a randomized double blind placebo controlled trial that will evaluate the efficacy safety and tolerability to have a single administration appear on I know to running in the U.S.
This therapy is administered by direct interest you choose injection into the bladder Walt under local anesthesia.
The trial is expected to enroll approximately 80 female patients in the U.S. into cohorts.
The first quarter Vcpe single administration of 24, Moneygram up here and I know true for matching placebo and the second the core tool BC 48 milligram appear in I know two or matching placebo.
The primary outcome measure is the change in the average daily number of Scourge urinary incontinence episodes from baseline at week 12, as well, let's just went up 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 quarter, one to core to will you made on the recommendation from the independent data safety monitoring board for de SMB.
Which is now planning to meet in December 2020.
Depending on the development of the Cobiz 19 situation do you guys. This meeting May also occurred early Twentytwenty one.
I'm very pleased with the progress you've made and I'm looking forward to providing you with further updates in the future.
Now I'll pass on to our Chief financial update.
Thank you caught neely.
In addition to the financial results summarized in our press release, you can find additional information in upcoming form 10-Q.
R&D expenses was $16.3 million for the first quarter fiscal 2020.
Compared with 22 million dollar to the same Peter in the prior year.
The decrease in R&D expenses is primarily due to lower clinical study cause of $10.2 million.
We see Mpower sturdy was completed in fiscal 2019.
This decrease was partially offset by an increase of $4.1 million for the manufacturing of our initial validation batches and purchase of drug substance and other starting material cost of future manufacturing campaign, So why the gone.
DNA expenses were $12.5 million for the first fiscal quarter 2020, compared with $5.5 million for the same period in the ideas.
The increase in G. any expenses is primarily due to an increase of $3.1 million and commercial readiness caused.
And he pieces in place matter related costs and other general and corporate expenses as we continue to prepare for the commercial launch if approved by the gone.
Total operating expenses or $28.8 million for the first quarter of 2020.
We need to $27.5 million are the same p. here in the ideas.
Net loss was $30.5 million or 99 cents per share for the first quarter Tony Tony.
It was a net loss of $28.5 billion, a 94 cents per share for the CMP here in the Guy.
Cash used in operations were $30.8 million for the quarter ended June Thirtyth 2020, as compared to $31.6 million. The immediate prior quarter ended March 31st 2020.
At June 30, 2020, total cash was $62 million.
In July we added to this cash position by drawing down $43 million from a low interest Fivea a film loan facility would DSP.
We now have $128.5 million in many under this facility.
Looking ahead.
The second quarter fiscal 2020, we expect that actually learned to be the range of $35 million to $40 million.
For the full fiscal year 2020, we now project the kashagan between $195 million to $205 million.
With that financial update I'd like to turn the call back over to Jim.
Thank you Roger.
As you've heard all your questions I'd like to summarize how we're thinking about what we've accomplished to date and our focus for the future.
Please on the progress we've made so far we continue to make strides across all aspects of our business.
We have several important milestones in the back half of the year, including topline safety data from a phase two eight study of I beg on for treatment of IB associated pain in November.
We expect to completion of Ctwon enrollment in our phase two way of our novel on Jack will gene therapy for way be your own I don't too and.
The potential approval of I beg Ron in late December.
Anticipation of the approval of I Beg run we're focused on building our commercial team and executing on our launch plan.
In summary, we believe we're well positioned to.
To be a strong leading competitor in this market and are excited about the future.
With that operator, we finish our prepared remarks, we'll now go to questions operator.
Thank you.
Ladies and gentlemen, if you wish to register for a question for today's question and answer session. You will need a press the star followed by the one key on your touched on telephone.
If your question has been answered you wish to withdraw your pulling request you may do so by pressing the pound key.
If you are using a speakerphone. Please pick up your handset before entering your request one moment. Please for our first question.
Our first question comes from Ron Self Mirage with H.C. Wainwright. Your line is now open.
Hi, This is Blair going on for Rob just a couple of questions for me first have you started label discussions about buybacks.
Not when do you expect this conversation start.
Whenever you want to handle that.
Yeah. So the label discussion. Thank you for your questions. The label discussion started later in the review cycle. So we could do.
I do for gold they did December we'd expect them in the fall so no responding to ft record label.
Discussions we expect to start in the fall.
Okay, Great and then as far as drug drug interaction in particular do you consider the most problematic for my background.
You know I expect to see with buybacks and what commercial applications do you think this gap.
So Blair Oh, Thanks again for your question I'll have Cornelius start and I'll add on the commercial aspect.
On the second part of your question.
Okay first of all by background.
The drug drug interaction that this took to de CIX level.
As you know this for example is called out.
The other backed up.
This is the first on the first page. So we do not trying to drive talk injection to de CIX level, which we think its clinically very important logic cardiovascular drugs and a lot of psychotropic drug and also paid drugs are meant to belied by a two to DC. So I think it like this.
Actually it's very important of course, we need to see the final labels from the ft, but we do not expected to Dr. action.
Looking back.
Patrick on people 60, and welcome to Jim for the commercial side.
Yes, thanks Clay and.
As part of that just said Blair.
In fact, the label reflects the lack of ship to do six interactions.
Commercial application for that would be for patients, especially if you think about the elderly population or long term care.
Those drug drug interactions on a pretty.
Important and have been important can monitor and the lack of that interactions in the important, especially when you think about the number of medications that patients and long term care facilities off and on including antidepressants.
That's was.
At times, So we do think there's a clear.
Message about the value if I back around what providing patients that are on those types of medications.
Okay, Great and then last one for me could you just comment on how it it's proceeding for the courage study with current a virus and have you adjusted the protocol at all.
Threed and.
Things like that.
Yeah. Thanks, Blair I'll have kornya handle that one as well.
So the courage studies running in the U.S. and Europe and as you know their regional differences with you Corona virus, we have restarted the study in most centers also in the U.S., but of course, depending on geographic location and happy documented Cobiz 19 measures in place we are actually content with the current enrollment in the courage.
I'd also because we have Europe additional content the study but of course, we have to closely monitor and Armani.
The development of Cobiz 19 globally. So at the moment, we're content that's of course, we have to money towards the situation.
Okay. Thank you.
Thank you.
Thank you and our next question comes from Eric Joseph with JP Morgan. Your line is now open.
Hi, Thanks for taking my question.
What I was related to the Kurds trial the opportunity in men with TPH can you talk a little bit about how.
The LNG.
May differ in this population compared to.
Yes.
And then.
Understanding Theres no approved medication currently for this population.
No what your senses on the extensive which.
Limit.
We manage with your Bachelor akin to what extent that maybe perspective apart.
Hey, heres.
We're positioned but because like for the efficient currently thanks.
Thanks, Eric I'll have corner you start with.
Answering your question and I'll follow up.
Okay, Hi, Eric.
As you know the real.
No. It has to do with aging of the bladder certainly is one of the main factors maybe with a stretch yourself just how I would like to originate it's not know.
Men with BP age have an additional extra factor, which women don't have to go for prostate.
And your interest longer sorry to go into an ACMI now and there are lot of outlet is different from that in women women have a very short your troubled.
Prostate and.
There isn't that larchmont obstruction of the outlet basically the overactive bladder.
Work again outlet obstruction until it is actually Patsy physiologically slightly different from the way be the general way the country women, that's why the FDA agreed.
Except for its developing programs.
In men with BPH. There is no approved therapy, there occasional published studies.
That's there's really no good developing.
To fully characterize the efficacy and safety of an opioid medications, including the a better three agonist in men with BP age and maybe.
Yeah, Eric if I just build on the question related to the label clearly, it's a differentiated label with my background. If we're successful with achieving that indication I think my pair receptivity perspective, where do you positive given the fact that it has the ability to treat overactive bladder and overactive bladder and many BPH three Buda obviously.
Strong positive from a differentiation perspective, including a pair differentiation perspective.
Got it.
As a follow up.
So just thinking about.
Commercial pepper preparedness, and and I'm just kind of.
Anticipating.
Kind of competition in this space you have a sense currently no.
The footprint that's styles currently has with.
That's correct.
Level, what's there still supporting that ran and do you anticipate much of the latest sort of cavity feeling.
Watch.
You know I can't comment specifically on their sales for size restructure what I can tell you is that with the size of structure. There were putting in place we feel very comfortable that we'll be able to cover over 50% of the market as it exists today because weve spoken previously we will have.
Roughly 115 220.
Our urology specially reps, which will cover the universe that we want to cover in addition to that we'll have 30 to 40 long term care sales reps, which will cover the long term care facilities and provides us we believe in advantage in terms of that space.
So with just 160 sales reps will be able to cover well over 50% in the market closer to 55% of the market.
We also expect with our urology specially team to be able to cover the top decile.
Primary care physicians, which are prescribed basically at the level of urologist. So we feel very good about that as we've talked about previously we continue to evaluate primary care partnerships, which will also be an important part of our go to market strategy and that's something that we're continuing to work on and evaluate as we speak.
Great. Thanks for taking the questions.
Thank you.
Thank you as a reminder, ladies and gentlemen that Star then one to ask the question.
Our next question comes from Biren Amin with Jefferies. Your line is now open.
Yeah, Hi, guys. Thanks for taking my questions, maybe also to start encourage.
The first portion of the BPH trial looked at I think 80 patients I think you looked at safety at week, four but have you evaluated any efficacy components in that phase one portion of courage in terms of daily Macquarie Center urgency at week four and.
Can you comment on if there's any read through that you've seen in that first portion to the week 12 primary endpoint for the part two portion.
Thanks, Aaron its Jim Thanks for your question I'm going to have corneal I handle that the start.
Well the of the review by the state.
If you're monitoring board would be safety and not if he could see.
They reviewed the safety data.
So.
Basically is what they reviewed and they come to get that we can continue to the larger.
To the larger patient population.
As.
Oh.
With that carefully there typically not being you know not.
Difference between four and week 12 regarding <unk>.
And you if you look at the body.
Maybe if you could.
Two over placebo and then certainly at week four.
So I don't think.
BPH weight per week 12, However, we will of course look at week 12. It is however on a double blind.
Yes. This was the decline of the if the but the primary endpoint is weak 12.
Got it and then maybe if you just comment on launch and any feedback we receive from payers regarding your discussions with the upcoming launch in terms of.
Hi thing or you know regarding step edits prior authorization that you think you might face any I guess.
Dose would be helpful.
Yeah. So.
Sure. Thanks for the question. So we have just completed our hiring of our market access team. So the entire long term care regional accounted national accounts team is complete.
That team is engaging and pre approval information exchange meetings, starting next week, so we'll be able to engage with key national payers and regional pairs the clinical review a buyback.
We do expect we'll get some indications and feedback at that point about buyback, Ron and we'll be able to take that into consideration as we move forward with our go to market strategy. As you would have gas we've done extensive market research with payers today on pricing what the expectations would be we still have yet to make a determination on pricing both at.
A whack basis, as well that hey, contracting basis, but we will expect to have that pretty much locked in and that ever go to market approach.
Finished in December expecting approval, and then engage with negotiations starting literally January 1st or second southern weekend.
Accelerate the review and potential for Laurie addition of by background as soon as possible.
And then on the long term care side of things that seems to be considerable component of patients that drives prescriptions and though he be market. What are your thoughts Jim in terms of.
Is this.
An area that would be an early adopter or.
And I guess, what challenges you face in gaining adoption and in this market.
So I do think it's going to be an early adopter. If you think of it the profile by bag one of the key differentiators versus any other beta three in the space.
Is that buyback runs crushable.
And so.
The stats basically indicate up to 40% of patients and long term care facilities, either cancer all have trouble swallowing. So having the ability to have a crushable tablet is going to be very important in that space and provide the differentiation for us and as was mentioned earlier by Cornelia the lack of the 36 drug drug interaction is also going to important difference.
Peter So I do think they have the potential to be an early adopter to buyback wrong.
In terms of challenges I think the obvious challenges for us will be.
Access from the standpoint of what the access to long term care facilities could look like if we're still dealing with the pandemic uncovered 19, but even that being said we have plans in place that will allow us access at the corporate level as well that consultant pharmacy level. So we can engage with the right people that are making.
Formulary decisions to create order saps for access of my background. So we feel good about long term care as as you asked is an earlier adopter for sure and we believe that's an opportunity for differentiation for us.
Great. Thanks for taking my questions.
<unk>.
Thank you I'm not showing any further questions at this time I would now like to turn the call back over to Jim Robinson for any closing remarks.
Well, thank you Daniel and thank you for those that attended our earnings call. Today. We appreciate your attendance and absolutely appreciate your questions and we look forward to providing future updates in the coming quarters.
I have a good afternoon.
Ladies and gentlemen. This concludes today's conference call you may now disconnect.
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