Q1 2020 Earnings Call

I don't want to give a I'll give you a range, 50% to 75% or are open to treating patients.

And just really literally.

Waiting for us to get drug into the U.S., others like spoke to a physician from New York yesterday.

As well as a physician from Virginia.

July one probably a better target they've obviously got a backload of patient they're going to begin prioritizing soon but those states.

We're wont wont be June one will be closer to July and August.

Okay. Thanks, and then just one more for us.

I guess, Peter I know you guys.

So the guidance that you issue before still holds but I was wondering if there any qualitative comments you could add.

About how cold it will affect Opex for 2020, both in respect to R&D in S. DNA.

And that's it guys. Thanks for taking my questions.

It's a win with regards to our guide.

We're reiterating our guidance so I think at this moment to it so we've laid out the guidance for the street earlier as part of our fourth quarter and full year numbers back in March that was operating expenditures of 145 to 155.

Embedded in those numbers was in fact.

The settlement payment associated with the I hate, which cleared out in the first quarter.

With regards to any other guidance numbers that we provide to the street. They also Stan.

Those were around stock based compensation.

I was $32 million to $36 million for full year.

And then other operating income which was 2.5.

<unk> million dollars for the year again, we feel very comfortable relative to all those guidance numbers at this moment and there's no change relative to cope with 19.

Okay. Thanks, guys.

Thanks, Good morning.

Question comes from a line of policy only from Goldman Sachs. Your question. Please.

Great. Thank you are good morning, everyone, maybe first with a commercial question and just with regard to the feedback Youre. Your sales force has been getting in terms of virtual interactions can you maybe just comment on how procedure volumes, such as ablation and so forth.

Have have changed in that in the back in the current backdrop just to sort of gauge help us gauge what the volume change has been to help us think through the backlog of procedures that.

Physicians offices.

That is you want me to say, yes, so it depends institution to institution I can tell ya.

My words from well your first question I've had a couple of conversations that have gone.

25, 30 minutes, because physicians are certainly engaged I know reps that had the same thing that a face to face is obviously always a better a better choice, but because physicians do have.

A little bit more time.

Virtual presentations have gone extremely well and can you clarify your second question sort of I mean, I guess, depending on where you or in the country like that something I'm I'm group don't have.

Backlog at all others have a small backlog it's it depends on.

From a priority standpoint.

Third Mark talked about it beat patient that's up with them low grade you see the weight I'm not a month.

They are they're not going to wait much longer than that what we've heard I mean, there the reminded every time.

The urinate that their cancer back.

And so what we've heard is though the way about a month or two but they certainly.

I want to get treated.

Because of the.

Finally, the reminder, that any anxiety that they have with the cancer from a prior occasions in the prior to date and standpoint, I'd say is it depends on.

On the institution and some I know there.

There's not a priority there's still breeding other for example at some accounts again in the northeast they've got a few hundred basin that they've got to prioritize so hopefully that helps answer is like.

Okay sure. Thanks for that and then one for Mark has as a follow up.

Just with regard to the next update from from Optima. I guess are you looking to have you know sort of a minimum number of patients I guess chip to present.

The 12 month updates and then when could we potentially expect except the 12 month data. Thank you very much.

Oh, Thanks, Paul I.

I think probably the best in certain gives US later this year, we want to be able to give a.

Very clear view of the durability of the experiences. These patients we already know that the complete response rate is very favorable.

And mimics what we've seen.

Dealing with a strong.

So I.

I think.

Given the fact that at least Directionally information. We have currently is very positive we'd like to be able to tell a complete story and I suspect that that'll be later this year, that's probably about as specific as I should be at this point.

Does that answer your question.

Oh, yes. It does thank you very much.

Thank you. Our next question comes from the line of Matt Kaplan from Ladenburg Thalmann. Your question. Please.

Hey, guys and good morning, and thanks for taking the questions I guess, maybe first or three Chaplin wind on key can you talk about kind of the roll out reimbursement coverage you expect to see during the year.

As you add here watching the problem.

Come down, but I'm, just sort of get into the details on that but I think it you know always important to remember that whenever I dropped first gets approved yeah, you actually get reimbursement prior to any any.

Got you know particular insurance company, making a final decision, having said that and Jeff can and expand upon this is Tom let me try these patients are Medicare patients.

And you know Medicare and if they if they try to get approved by the FDIC then that Medicare reimbursed it.

So we don't really see big issues, but Jacqueline tell you I kind of where we are with our coding and perhaps a jackie just want to expand upon that.

Sure. So the patients that we have the providers that have patients right now typically the is the the way it happens or the roll out is [noise].

You do clinical presentation. The rep will the physicians want to understand the data now in Olympus and they they handle all the questions from a clinical standpoint, the second call is oftentimes we see back.

The or will be doing the coating and reimbursement, so thats, where our field reimbursement manager I will have a second call with those folks sometimes with the physician most of the time not.

Just sort of a line on the correct coding the correct reimbursement or how to build a form out.

That's normally the process from a from a and from a miscellaneous code eco decode if I could walk you through that so we will have a miscellaneous code. We believe until October 1st which that point, we'll have a unique C code the FICO to the path through those hospitals and surgery Center.

And we'll have that unique to Joe Mido, so our our pieces in promotion.

Well thought through the miscellaneous code and back you a.

Right and article that I referenced earlier.

Talked about what miscellaneous code they use.

Once we have a C code, obviously, we'll pull all of the.

Pieces. It would have we have replaced that with the C code and then we expect a J code or by the ended the year. So the permanent J code then supersedes.

The C code that sorta that transition Oh, we have a as we go out the current plan is because its buy and bill as we wait for Ah.

The c-code providers will be using and miscellaneous.

Okay. That's very helpful. Thank you and I guess for it for lives in terms of strategy for approval of gel now X U.S. and easing. They went that data do you think it will suffice actually last for pool.

Yeah, you know we've shared some of that information the passenger and to be honest with D., we sort of put on hold our work actually you asked because the entire team and all of our resources for really focused on getting our sta approval and that was the right decision to do that.

At the time and now we're we're starting to Reengage with regulatory authorities, particularly in Europe, and Japan, obviously being the biggest markets.

Biggest issue in Europe isn't really getting a proof all the biggest issue in Europe is getting a decent reimbursement because many of the country. It's well do a comparison and I want to use generic might am I cannot say compared our you know absent any other compared or isn't so what we what we plan to do is have discussion.

This would probably Germany, and France be end to end the big five.

At U.S direct competitors and see what they would like to see before they would get back east have reimbursement and I think what we did that I question might the regulatory authority. They are they had a different view on orphan drug status, but if they could get orphan drug status there that would eliminate the issues around reimbursement. So we have a couple of strategies.

Going into Europe, Japan, probably a little bit easier right. So that will we right now a scheduling our next step there has to schedule a meeting bid the Japan after today.

Actually I'm asked them the how many patients they're going to want to see a bridging study and aging population how many patients what they want it see and then probably conduct a small study to be able to get regulatory approval in Japan, So and we've had other discussions but you know other companies around the world, but I think those both well do head there.

Our first.

You know and in addition to Israel on the good news about Israel, obviously is that they accept the FDA said there there will be some work that needs to be done to gain a critical there, but it's important for us concern and we are in Israeli based company and a lot of participants in this study what from Israel. So.

So that would probably be you not be one that's a little bit easier, but we could do and then the rest of world again, well prioritized I think more likely let me get window to up and running just I mentioned before I know two will be a a global study so what that compared our and I think that plays better outside.

You asked as you can imagine, which most of them expecting and wanting unite direct competitor. So that's that's really the biggest issue again in Europe, which is our biggest opportunity for us.

Okay. Okay. Thank you and my question maybe well.

Primark can you give them some details on your thinking for the phase three design for UGI and went on to and I don't know grade intermediate risk or non muscle invasive bladder.

Got a cancer.

Thanks, Mike.

I think based or conversations with the FDA or internal discussions.

We believe the.

Study is going to be a randomized trial comparing primary ablation to free injuries were section of letter tumors, which is the contemporary standard of care.

Yeah, I think that we've seen.

[noise] positive feedback from the regulators at this time, because we're consuming and as well as from the year electric community. So I believe direction that's the.

Sort of course that the trial design will ultimately take.

Okay.

Thanks for taking my question guys and congrats products.

Thank you aren't next question comes from a line of Boris Peaker from Cowen Your question. Please.

Great. Thanks, cruising and I just want to understand from the Joe might have launched perspective, what kind of training doesn't dock need before they start using Joe Mito, but at this point, how many docs have been trained and how do you see that training increasing over time.

To Mark maybe you can just talk about what you think that position you know needs and then I'm, Jeff can talk to you about sort of our plan 10 shore the education and training of physician.

Sure first thank you the.

Luckily for us the acquisition of the skills to provide this therapy to patients.

Not complicated for urologists, because the instrumentation and the technique utilized.

Taught in all urology residency programs and this is very basic straightforward stuff. So your logic practitioners across the country already know how to do this how to use the equipment are familiar with the approach the only a fitness aspect of this therapy is learning how to inject.

He slightly discuss liquid which is what gentleman who is when it is cool prior installation.

So it's a it's a very familiar process yeah.

Our experience with the clinical trials to see participated in the Olympus trial.

Very little training to disagree roster and with the technique and I think Jeff is also spoken extensively with physicians about this year has a sense of what it would take two to ramp up of training.

Community.

So yes, do we have a team of nurses clinical nurse educators that will be there the position or want to assist assistance. What we typically heard is you know we need media there may be the for goes maybe the second but certainly after that there are good.

If for some reason offices aren't comfortable.

With the more people.

In the actual procedural room Weve also engaged with our phase three Olympus site those that administered one or Joe Mido in the in the phase three or they will act as a virtual proctors.

To the so we'll have a technology that will allow the nurse I'm just kind of have have an ipod be talking with the physician.

Through the procedure so.

We've got roughly eight or nine of those folks on call. If a physician were to want something virtually versus having or see any in the procedural room.

Gotcha Okay.

Okay. My last question, maybe on the huge in one or two phase three study.

Assuming you get it started later this year do you have kind of ballpark sense of how long. This study will take.

No we have not finalized that I haven't seen it yeah. We actually are having that meeting this week to to review now we expect it won't be several hundred patients. So it will definitely be a two to three year program, but we don't have the exact numbers yet.

Okay, great. Thank you very much for taking my question.

Thanks.

Thank you. Our next question comes on line of Leland Gershell from Oppenheimer. Your question. Please.

Good morning, Thanks for taking my questions are just one quick question for.

Okay.

As the reopenings across the country are inconsistent no variation in terms of geographies wanting to know if you're going to use that pattern to to inform where you place for her efforts. Initially as you as you want still my though versus.

Simply covering the territories irrespective of of Reopenings and.

Nucleus of a kind of normalization.

Yes, so the as the reps will be it'll just be sort of a phasing on the patients.

I know Rep had a there's a very large group in Virginia.

And the Rep recently added clinical conversation they'll just the you know they'll stay engaged or with the practice they'll follow.

In respect the procedures that the practice puts in place I'm I you know the the key for US now as Lynn mentioned I mentioned earlier is really identifying the patients in the orphan drug. So this gives them maybe a little bit more time to work with the nurse navigator and identify the pacing.

I think that the rep.

Effort will stay consistent across the U.S. they'll just have to be patient with regards to where you know where it where it what the institution policies are but yeah that we're not going to delay for example, like I said when or if it's a physician can you talk to it than the Virginia in New York, New Jersey area.

There were certainly engaging them.

Absolutely and with anything you'd have contacted with those vote, but we'll we'll just have to wait until those institutions opened their doors.

Great. Thank you very much.

Sure.

Thank you. Our next question comes on line of Chris Howerton from Jefferies. Your question. Please.

Excellent. Thank you very much and so for Jeff.

Maybe I was just are you thinking about the they came into the lawn chairs. So one of the comments you made was that you know physicians want widely adopted until they're comfortable that they will attain reimbursement so I guess.

I was just wondering how many patients typically do doctors serve and you know what is the relative effort to an acquisition costs, let's say two to convert a physician is a user of gel might have generally versus a broader adoption within their patients.

Yeah, so each account a different but if I walk into it a typical larger group, where there's 20 or 25 urologist, there's typically one or two that.

Read a significant amount of bladder cancer or upper track.

And then really a lot of that because it in that group have a few patients I think you know when I say widely adopted they're going to want you know that first patient as I've said, they're gonna wants to see.

The reimbursement from an accuracy standpoint, I do think we it it will be quick or we've had conversations with regard to.

Some of the Ceos that some of the C O lows in and around.

You know our policies that we put in place with why we have a miscellaneous code when I say it will be adopted I do think like once they treat that first patient once they start to see or the the accurate reimbursement you will start you'll you'll just start to see like every like every other drug it starts to pick up a little bit more.

Efforts to find picture.

In their system picks up a little bit more but I don't expect anything to be has slowed down a with a mess miscellaneous code there used to miscellaneous code with other drugs like growth engine to be go.

And so hopefully that answers your question.

Yeah, no debt that definitely does and I guess another one I don't know if this would be appropriate for you Jeff for potentially Peter I, just maybe if you could give us some color around what you expected gross to net to be a particularly you know given the idea that a majority of these patients are Medicare.

Okay.

Yep.

Yeah that addresses list I mean, not I'll, just make a comment about it because we really havent provided guidance around gross to net I think at best way, that's sort of think about gross to net I don't think that Medicare really Ah, yes, I mean is determining factor there, but I think you, but we won't be discounting right here.

I don't know if that was your point about Medicare patient <unk>, but even even I'll turn it definitely there aren't alternatives right you're not in a situation where many many other therapeutic areas have multiple multiple products in an area and so therefore, it can I need to and need to discount. So I think that the best way to think about it isn't that Khan.

Tax or you have well have sort of some of your traditional gross to net cost associated with you know admin fees and those types of typical I just can't be but I think thats kind of the best way to think about it but you wouldn't you wouldn't expect a heavy gross to net due to discounting went down.

And insurance company.

Okay. Okay.

And then last one I think quickly from Mark for the presentation later this month.

It is part of the virtual anyway, we'll week eight a.

Update on safety in that trial, and I guess, what other details might we learn outside of what we already know.

Chris. Thank you we will certainly.

Give you a sense.

Have a adverse events encountered so far which I can say thankfully or.

Moderate and expected.

Given the therapy.

That we're delivering.

But I think apart from some additional.

Incremental durability data.

It will be the overall complex one of the trial.

Hi, good understanding that these are interim data on the screens have not come to the state.

Okay. Okay.

Okay, well. Thank you very much I appreciate you taking your question.

Thanks Kim.

Thanks for the Q.

This does conclude the question and answer session of today's program I'd like to hand, the program back to live Spirit, President and Chief Executive Officer for any further remarks.

Thank you operator, and thanks, everyone for joining in your interest in your agenda.

Barry just a couple of weeks ago when received approval I received many messages from my peers and Collie, Yeah. Reminding me the most biotech companies never get to this day. So it's an exciting time for us I'm incredibly proud of our team and confident our ability to advance our mission for pioneer new treatment temperate patient care.

Especially cancer, then your logic diseases and on our team has been working tirelessly to provide you might have to patients you know been waiting. It goes we have probably see exciting events on the horizon. We look forward to staying in touch with you as when we deliver continue to the limitation and shareholder value. So thanks, everybody for your time and your continues to.

<unk> till operator, you may now disconnect. Thank you.

Thank you and thank you ladies and gentlemen for your participation in today's conference. This does conclude the program you may now disconnect good day.

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