Q1 2021 Urogen Pharma Ltd Earnings Call
Good morning, ladies and gentlemen, thank you for standing by and welcome to the your old Gen Pharma first quarter 2021 financial results and business update conference call.
It is now my pleasure to turn the call over to Lee Roth of Burns Mcclellan. Please go ahead.
Thank you operator, good morning, everyone and welcome to your Gen Pharma first quarter 2021 financial results and business update conference call I'm filling in for Sara Sherman and head of Investor Relations at your agenda as I'm turning to day Leafs earn.
Earlier. This morning, we issued a press release, providing an overview of our recent corporate highlights and financial results for the quarter ended March 31 2021.
Press release can be accessed on the investors portion of our website at investors debt <unk> Dot com joining.
Joining me on the call today are Liz Barrett, President and Chief Executive Officer.
Jeff BOVA, Chief Commercial officer, Dr. Mark Schoenberg, Chief Medical Officer, and Molly Henderson, Chief Financial Officer.
Please note that we continue to conduct our calls from different locations. So we appreciate your understanding should we have any technical difficulties.
During today's call, we will be making certain forward looking statements. These may include statements regarding the success and timing of our ongoing commercialization of gel NATO planned clinical trials data presentations regulatory filings future research and development efforts manufacturing capabilities and 2021 financial guidance among others.
These forward looking statements are based on current information assumptions and expectations that are subject to change.
A description of potential risks can be found in our earnings press release as well as the latest SEC disclosure documents you are cautioned not to place undue reliance on these forward looking statements and <unk> disclaims any obligation to update these statements with that it's my pleasure to turn the call over to Liz.
Thank you Lee and thank you for everyone joining us today, while it has only been eight weeks since we hosted our fourth quarter and full year 2020 earnings call. We have continued to make important progress towards our goal of becoming the leading euro oncology company.
Our ongoing priority is the successful commercialization of job might out despite facing the unique challenge of launching during a global pandemic <unk> place in the clinic continues to take shape and the only FDA approved non surgical treatment for adult patients with low grade upper tract and don't feel you'll cancer.
For the first quarter of 2021, and we recorded $7 $5 million and net product sales. This.
And this brings us to a total of $19 3 million and sales since the June one and 2020 launch and Yamato.
As mentioned during our yearend earnings call in March we experienced softness and the beginning of the quarter, which we attribute to the start of the vaccination efforts throughout the United States.
And patients specifically, but and then the age group that are most likely to suffer from U T. You see we're delaying treatment appointments until they were vaccinated and felt comfortable going to a health care facility.
And you have undoubtedly heard as numerous companies reported earnings is the impact was seen across the biotech pharma and medical device industries.
Jeff will provide some more detail and a bit but we are confident and our outlook for job might go for the remainder of 2021 and beyond do did they increase and patients treated and March and April and a record number of patient enrollment and three received over this same period.
We believe the increased demand is driven by the fact that a large percentage of our patient demographics and it's been vaccinated and COVID-19 related restrictions are relaxing and many parts of the country. While we have not provided specific financial guidance, we reiterate our position that our internal projection for 2021 is aligned with.
Analysts revenue consensus.
We also want to share that our preliminary results for April represent the highest monthly revenue since launch, making us optimistic about Q2 and the remainder of 2021.
Beyond <unk>, we are making progress without Eugene and one O two program and specifically the phase III Atlas trial, which kicked off in late 2020, we're recruiting and enrolling patients and the U S Israel and Europe and expect to provide an enrollment update later this year. We are excited about the potential of Eugene and why not.
Two has to transform the treatment landscape for patients diagnosed with low grade intermediate risk non muscle invasive bladder cancer if approved.
There are significant and similarities between the therapeutic indications for a job baidu and Eugene and window too and we expect that we'll be able to successfully leverage our learnings and experience from Joe motto as we move the Eugene and went Oh two program forward and.
Another important priority for us is to advance our earlier pipeline and build your origin and try and leader in immuno oncology. Our most advanced I O program is Eugene and three O two which we are studying as part of a research collaboration with the MD Anderson cancer Center and high grade non muscle invasive bladder cancer.
We have also begun work with the Johns Hopkins University to study and a preclinical setting the potential of checkpoint inhibitors combined with our T gel and glioblastoma multi form or G. B M and aggressive form of brain cancer, Mark will provide additional commentary on both of these programs.
I'm proud of our continued strong execution during a global pandemic and the significant progress we're making against our strategy. We believe that very few companies are and the unique position. We at your Gen. Enjoy we have an approved product that alone could be a standalone profitable business and our second therapy is in a phase III clinical.
And as Derisked, given the similarities with Yamato and impressive phase two results we.
We also have a unique medicine and preclinical that if successful has the potential to change the treatment paradigm and high grade non muscle invasive bladder cancer. These three therapies combined reflect what we consider one of the strongest pipelines and euro and collagen and can provide a long term growth business and a portfolio that can support a sustained.
Book business for many years to come we will continue to build our presence and urology and oncology and leverage our proprietary technology through partners and other areas that could benefit from a sustained release delivery and mechanism.
Before I turn things over to Jeff for additional detail on our commercialization effort I want to recognize and thank our employees for their hard work and resilience. During this challenging time about three quarters of our employees have been with the origin for less than two years. This means the majority of their tenure has been significantly impacted by.
COVID-19, but through it all and they have remained focused and committed to our mission of helping improve outcomes for patients battling urologic malignancy I cannot be prouder to lead. This team are more excited about the future of our company I'd now like to turn the call over to Jeff Jeff.
Thank you Luiz.
I'm pleased to provide you with an update on our commercial launches Joe myself as Liz mentioned, we reported $7 5 million and net product sales and the first quarter of 2021, which totaled $19 3 million from the start of Joe models launch on June one 2000 and 'twenty. Please.
Please keep in mind as we discussed in March at about 508, hundreds and thousands of sales and Q4, where stock ups that will work through and the January February timeframe.
When you take this into accounts Q1 surpassed two for it in terms of patient demand.
And as noted earlier the COVID-19 pandemic has presented challenges to our industry at the beginning of the year COVID-19 infections and hospitalizations spiked across the country.
Vaccinations were still and the very early stages of rollout and it created a situation, where we believe that patients postpone doctor and treatment appointments.
This was happening across our industry as evidenced by our recent Kaiser family Foundation study that reported 25% of American and said that day for someone in their household had delayed medical care in December due to Corona virus concerns.
Another report from the U S centers for disease control and prevention found that 41% of Americans delayed medical care, including 12%, who postponed urgent or emergency care.
And lastly, and January electric procedures were down 25% according to <unk> data.
We believe the impact of patient's postponing treatments until they are vaccinated and generally behind us given that the vast majority of people and the U S. Over the age of 65, which is our patient demographics are now back to Natus and for.
As of today, 83% of the U S population over the age of 65 have received at least one dose of a COVID-19 vaccine and close to 70% had been fully vaccinated.
With market conditions, improving we are seeing a rebound and <unk> sales and the second quarter and expect this to continue for the rest of the year.
And as Liz mentioned, we've already seen a steady increase and patient activity in fact in March and April we set new records in terms of patient enrollment forms received.
The total number of patient enrollment forms received in March and April was more than four times. The number we received in January and is.
As a reminder, patient enrollment forms of the initial step to getting a patient treated and our best leading indicator of future patient starts.
Can you itemize, the time between receiving and enrollment form and treating the patient we have been diligently working to activate sites since our launch last year.
I am proud to report that doesn't make for we have increased the activated sites to 316 up from 250, just eight weeks ago and up.
From 210 at the end of 2020.
These are sites, who have either treated patients or have completed all of the internal processes required to allow them to treat patients.
The other indicator we routinely monitor is the number of repeat accounts, meaning accounts that have treated more than one patient. We believe this suggests that physicians are potentially seeing clinical efficacy of the therapy that reimbursement is working and all the other components of the process have run smoothly.
As of May one we have increased the number of repeat accounts for 40 up from 31 accounts on March one and 24 accounts at the end of 2020.
This is a critical success factor showing us that the processes and support in place are working and clinicians are identifying additional patients and gaining comfort and using this treatment.
Access to physicians has also started to increase across the country. Our team did a great job since launch in June and engaging with doctors virtually but there is really no substitute for face to face interaction.
I've been out with members of our field team recently and I can tell you that they are excited and are looking at this as the in person phase of our launch to me. We are finally, and a fair fight and our team is taking full advantage.
To underscore this point, even further field related travel entertainment and entertainment expenses were up 15 fold from January to February and we saw another fourfold jump from February to March.
Our ability to have meetings and offices and conduct live speaker programs played an important role and our strong finish to the first quarter and the great start we had to Q2.
Before I turn things over to Mark for a clinical update I want to share results from the most recent awareness trial and usage research. We conducted these studies track physicians awareness of the product and their experience using the product.
The data for Jo Mira is extremely positive.
The following trends were noted.
Aided and unaided awareness of Joe and myself have continued to increase and are now, 94% and 68% respectively.
These percentages are almost unprecedented in our industry, especially this early into the launch.
The second point I want to share is that urologists, who abused film idle reported 88% overall satisfaction, which is an average of how they rated patient acceptance ease of administration logistics safety and efficacy.
And lastly, and most importantly, 83% of urologists in the survey suggests they would use <unk> within the next 12 months.
The leading indicators and feedback we're getting from physicians are all very positive and we remain highly optimistic that the increased activity. We've experienced in March and April will continue and that we will deliver on our full year 2021 revenue expectations.
That I will turn the call over to Mark Mark.
Thank you Jeff.
Since our last quarterly call, we've continued to make progress on our Eugene.
102 program for patients with low grade intermediate risk non muscle invasive bladder cancer.
We are enrolling patients for phase III Atlas trial with about a third of a trial sites from the U S. A handful and Israel and the remainder in Europe, primarily eastern Europe.
We look forward to providing you enrolment and updates for Atlas and the second half of this year.
And we work to bring this investigational treatment to patients.
In addition to Atlas, we are planning to initiate a small single arm at home installations study of one or two with.
And with a goal of demonstrating that and home installation is a feasible method of administration and further reinforcing its potential differentiation from <unk>.
We plan to enroll approximately 10 patients who would receive Eugene and one of the two administered by a qualified home health provider. This study is expected to initiate and the second half of 2021.
And as you know our goal with EG and one of the two program is to demonstrate that a non surgical therapeutic alternative can function as primary therapy for low grade intermediate risk non muscle invasive bladder cancer patients importantly, and non surgical option would help patients avoid the risk of potential.
Complications could come from the current treatment approach, which is repeated torb T procedures.
Dr. Gary Steinberg and I recently had the manuscript published in the journal of Urology, which highlighted the challenges associated with repeated T or b T, including the high rate of disease recurrence as well as the risks and complications for the procedure.
Manuscript, which is currently available online and will be into July and print edition of the journal and.
Dresses the desire for both patients and physicians to identify non surgical alternative to <unk> for recurrent and M. D C.
We also recently received notification that the EUA excepted multiple abstracts, we submitted for the presentation at the annual National meeting in September.
We have been conducting extensive research aimed at better understanding the unmet need and clinical course and patients living with intermediate risk and it might be see this work, which is performed and partnership with groups. Both UCLA and the University of North Carolina explores multiple aspects of the disease course.
And the contemporary patient experience.
Turning to Joe and myself, we are launching a registry program that will enable us to collect information about this drug for use in practice and <unk>.
And in a real world evidence based look and how physicians are treating patients across the U S. We believe this information will be invaluable as we look to optimize treatment with Joe and myself.
One of the things the registry program will help us better understand the prevalence of Nephrostomy tube administration and what impact. This has on the patient experience and clinical outcomes, while none of the patients sooner Olympus trial were treated via and Nephrostomy tube. It as part of our label and we know them.
Doctors, who are treating patients for this way in clinical practice.
It's too early to talk numbers or outcomes for treatment for you and the frost meat tube seems to be gaining momentum and it is intriguing to hypothesize that nephrostomy tube administration could be easier for the patient and physician practice and then.
Also mitigate some of the adverse events observed with Ureteral catheter administration more to come on this topic and the future.
Next I want to talk about our earlier pipeline.
As Liz mentioned, we continue to expand our immuno oncology pipeline and advanced programs for high grade disease R. Eugene and 302 program a combination of EG and two a one or <unk> 70 per day agonist, and Eugene and 301 or sell a thrill amount and Mtc Kelly for antibody.
We have combined with our R. A T gel technology.
<unk> initially being developed for patients with high grade non muscle invasive bladder cancer with.
We've often discussed there are significant differences between high grade and low grade disease high grade non muscle invasive bladder cancer is an aggressive and potentially life threatening malignancy characterized by both significant risk of recurrence and rapid disease progression and some patients with high grade non muscle invasive bladder cancer response.
Immunotherapy, using the silex kilometer rent or BCG.
Which explains the strong rationale for exploring immuno therapies for the treatment of this patient population.
Our 302 program has demonstrated encouraging non clinical data to date, which support the potential of locally applied combinatorial immunotherapy.
Our collaboration with MD Anderson for this program allows us to leverage their expertise and innovative clinical trials and we look forward to providing updates as we work on next steps and trial designs.
We also recently announced a sponsored research agreement with Johns Hopkins University, and which we intend to explore and a preclinical setting the potential checkpoint inhibitors combined with our T gel and Glioblastoma multiforme or GBM.
The origin of this program was our focus on expanding our novel <unk> technology in combination with other medicines to investigate potential treatment options for patients and diseases with significant unmet need and where local immune modulation may make a difference.
And in the initial area of focus for this agreement is an aggressive malignant brain tumor with a five year survival rate of less than 5%.
This is a difficult to treat disease with limited available treatment options and most of which includes surgery, followed by radiation and chemotherapy.
Is the most common primary brain tumor with around 12000 cases diagnosed each year in the U S.
We look forward to examining the combination of our T gel technology and immuno oncology.
And to pursue potential collaborations with academic centers and they leverage our technology and exploring therapeutic options and with that I'd like to turn the call over to Molly for a financial overview Molly.
Thank you Mark and thank you for everyone who joined today's call.
Mentioned, we recorded net product sales and Joe might have for the first quarter ended March 31st 2021 of approximately $7 5 million.
Although this was a slower start and 2021 and then we had initially anticipated we are optimistic with respect to revenues for the range or per year.
As Jeff mentioned, we have set new records and patient enrollment forms and March and April and April was our strongest month, yet in terms of both new patient starts and shipment.
Cost of revenues for the first quarter of 2021 were approximately 0.9 million, resulting in a gross margin of 88% and for.
<unk> prior to receiving FDA approval and became idle, we recognized inventory and related costs associated with the manufacturer and from Idaho as research and development expenses.
We expect this to continue to impact cost of revenues through the second quarter of 2022, and we produced Yamato at cost, reflecting the full cost of manufacturing and as we deplete inventories that we had expense prior to reading receiving FDA approval from.
Gross margin would have been approximately 85, 6% versus the 88% for the three months ended March 31st 2021, if we had not thought somebody and say where expenses prior to regulatory equivalents.
Research and development expenses for the first quarter ended March 31, 2021 were $10 5 million compared to $16 6 million for the same period in 2020 R&D expenses declined $6 1 million and the first quarter 2020, one compared to the first quarter and 2020 due to one.
And one time payment of $6 6 million to the Israel innovation authority to unwind our obligation and garden grants that were linked to the company between January 22000 for and September 2016.
Other than the commitment to continue at least 75 per cent of our R&D jobs in Israel for a period of at least three years all of their obligations would be I E have ended.
Also included in research and development expense was $1 1 million and non cash and share based compensation expense for the first quarter ended March 31, 2021, as compared to $1 9 million for the same period and 2020.
Selling general and administrative expenses for the first quarter ended March 31, 2021, or $22 2 million as compared to 22 million for the same day in 2020 day.
The increase and selling general and administrative expenses resulted primarily from increased costs and activities related to the commercial launch and myself.
Selling general and administrative expenses included $5 1 million of noncash share based compensation expense for the first quarter ended March 31st 2021, as compared to $5 7 million for the same period and 2020.
For the first quarter ended March 31st 2021, we reported a loss of $25 9 million or a dollar and 17 cents per share. This compares to a net loss of approximately $37 8 million or a dollar and 79 cents per share for the same period and 2020.
And net loss for the first quarter ended March 31, 2021 includes $6 2 million and noncash share based compensation expenses.
In light of the impact for the COVID-19 pandemic has had on our revenues and the early months of 2021, we continue to monitor our expenditures to ensure that we are spending wisely and investing in areas of the business that will yield a strong return on investment as a result, we are narrowing our guidance for 2020, one operating expenses to 155 to 165 million.
Which is the lower end of the range previously announced and a $155 million to $170 million. Additionally.
Additionally, and according to the U S. Generally accepted accounting principle, the company anticipates accruing approximately $12 million to $15 million and non operating funding expenses relating to the RTW transaction announced in March.
Of which cash payment for 2020, one will equal and nine 5% of tomato sales.
The financing charge it will be reported below the operating income and loss line.
Last week, we closed the first quarter with approximately $75 9 million and cash cash equivalents and marketable securities with no debt.
Supplemented following the end of the first quarter by the $75 million and funding, we announced last month from RTW, which was received and the second quarter following receipt of necessary regulatory approvals.
We anticipate that our current cash balance supports the company's initiatives into 2023, and believe we are and solid financial position to execute on our strategy.
With that operator, I would like to turn the call over for questions.
Thank you. That's a reminder to ask a question you will need to press star one and your telephone.
So let's try your question press the pound key please standby, while we compile the Q&A roster.
Our first question comes from Eric Joseph with Jpmorgan. Your line is now open.
And good morning, Thanks for taking the question. This is kinda on for Erika just to see from US first looking at the soft sales from the last quarter as things start opening back up do you anticipate that and you might be seeing any patient warehousing impacts from the pandemic and therefore any potential for a bullish for fast and.
Quarter, and third quarter that might not be reflective of the subsequent quarters.
Hi Plaza.
Debt. Thanks for the question I think what we have already seen and what we've talked about on this call as we've already seen and uptake I would not call. It a bolus and I'll ask Jeff to comment as well.
One big Bolus that you would actually see go down, but I think what we're seeing is very consistent.
Higher Ah patients coming in for Jeff do you want and add anything to that.
Sure. So we see steady growth so I would agree with lids and you just don't see it.
Significant bolus, but as offices are opening up patients are getting back donated patients are coming in to get treated we're starting to see that steady steady growth and then even the access to the representatives, obviously and an orphan drug setting patient identification is key and.
And our reps are the face of gel mito, and so having them and their help identify additional patients.
And again, not a bolus effect, but a steady increase and patients coming in Q2 Q3.
Okay. Thank you and also I'm just looking at the breakdown between treatment sites versus nearly treating sites in terms of the proportion of treated patients.
Do you see retreat and insights picking up in that respect for example, treating a larger proportion of patients.
Compared to before or is that breakdown in terms of percentages remaining more or less steady.
No I see that increasing.
And that increasing as well and youre starting to see multiple patients in one account and the other thing that we're starting to see your multiple physicians and that accounts I always talk about that peer to peer interaction being a second wave.
Of launch and we're starting to see that number of grow as well and we'll continue that.
And if I could thank you so much and if I could just one more so you've guided to ex U S regulatory update and second half of 2020, one, but while you might not be able to provide outcomes at the moment and just wondering what regulatory agencies and we've been speaking to and what those topics.
Conversations and things so far.
And we haven't had any regulatory outside of the U S. Obviously, when we I don't think we talked at all about regulatory updates what we said was that if this.
Cut by kind of mid year, we would know more about what we needed to do that and launch around the world and.
And part of that is obviously talking to regulatory agencies, but it's also understanding what clinical studies and we might need to do so theres more and more than just regulatory so we're and our ongoing dialogues and the U S and many things right where.
Had our eye and D for three O two program and.
We're always talking to them about Eugene and one O two and.
And and you know and making sure that we're covering all our bases there from a standpoint of maybe other populations that we might be able to study. So we have and ongoing dialogue with the FDA.
We do have upcoming meetings and both Europe and Japan.
And that will give us more of a button.
Understand and know exactly what it needs to for us exactly what we need to do.
And to launch and those space and those geographies, but that those are as we said it would be kind of midyear timeframe, we'll be able to get a better idea of what's happening ex U S.
Okay, great. Thanks, so much for taking the question.
Thank you and Cat and next question comes from Chris Howerton with Jefferies. Your line is now open.
Great well congratulations to your team Jeff really.
And good quarter from my perspective, and nice to see so I guess with respect to kind of the performance that we're seeing.
Overall there.
And what you know.
And I think you said in your prepared remarks, something along the lines that <unk> Q is out for outperforming patient demand I just.
If you could just walk us through those numbers relative to what you saw and fourth quarter I think that would be really helpful.
And then the second question I have is for Mark I guess I'm curious if you could just give us a little more color as to.
What do you expected presentations might be at a UA and and in particular I'm interested if you.
Have any analysis of the current rates for the <unk> procedure and the intermediate risk patient population. Thank you.
And Joe why don't you take that first and then Mark can chime in.
Sure. Thanks, Chris.
So to put some light on what happened at the end of the year. So what we had were a handful of accounts.
Because of I think everyone can relate to the shipping issues.
The demand from Amazon and Fedex and everything else, we had a handful of accounts that order to a bulk amount and so they ordered the six doses. They wanted to be sure that they have the accounts we had.
A lot of weather issues and set a fedex hub and Tennessee.
And so the the 500 to 800.
And would have been reflected in Q1, and therefore Q1 demand was actually higher than Q4. So most accounts in fact 95 per cent. The order one at a time, what we saw at the end of the year because of all the issues, we were having weather related and then package demand okay.
And once order more than one.
Hopefully that helps you.
Yes, Okay I got it.
Chris Thanks for the question and I have to apologize in advance I can tell you generally that we've been focused as you know on.
Getting a better understanding of the actual course and experience for patients with intermediate risk disease, and so a number of the abstracts will in fact address at a granular level some of that information which comes from the very good contemporary database. In addition, there will be some very specific information presented about Ah patient.
Experience and patient attitudes towards surgery and.
Unfortunately, I can't be more specific because the abstracts are actually embargoed, but I hope that's helpful at least and giving you a sense of where these presentations we will go directionally.
Yeah, Okay, Yeah that is helpful and I guess.
Yes.
Do you know.
Any more timelines in terms of when the abstracts are or whatever it would be become available and I know you said the meeting is in September.
Yeah, historically, the abstracts and it's become available I believe about three or four weeks before the meeting.
But I'm sure that we'll be able to provide more updates because it's been a bit up and unusual year in terms of scheduling of the UAE and format presentations.
It's a little hard to predict but if history is any guide it'll it'll probably be sometime in August.
Okay well.
Awesome.
And look forward to that thank you.
Thanks, Chris.
Thank you. Our next question comes from Ram <unk> with H C. Wainwright. Your line is now open.
Hi, Thanks, very much for taking my questions and congrats and all the progress can you hear me.
But yes, we can thank you.
Okay. So firstly a question for Liz on strategy I think you were talking earlier about our regulatory interactions and ex U S. Territories can you discuss a little bit and overall plan with respect to Jo Mira UGI and one on ones.
Penetration into ex U S territories, how youre viewing the most expeditious and optimal effective and efficient way of doing that whether that's gonna be via partnerships or distribution arrangements. How youre thinking has evolved over time since the Jo Mira launch and the United States.
Okay.
Yeah, It's a great question and you know.
I think we're obviously thinking about it opportunistically I think we feel like likely we would not.
Commercialize ourselves ex U S and we've looked at it but and we'll likely partner and.
We have had a lot of interest and like individual regions.
But we're considering whether it makes more sense to have one or two larger partners that can cover more and geography.
And are willing to sort of take you know more regional deals I think at this point and time, we've decided that the freedom to operate and to maintain.
Fewer partners ex U S is probably the better route for us.
Because if you start to think about that just just a distraction and the individual countries for Yamato again, being an orphan and orphan drugs and as we start to think about one or two and that could easily change but at this point in time.
Have had interest in Europe, we've had interest in Japan, we've had interest in China, we've had interest and and.
And Latin.
Latin America, we've had interest and Canada and so what were you know what we have to do first and find out exactly what it's going to take because before we could do a deal with a partner and we need to understand what has to get done and those regions and as we've talked about before you know a small company. We haven't we didn't have the resources to really spend there, but we are doing.
And that now so we have interactions upcoming as I've mentioned, both went and Europe, and Japan, and after that and then well well.
More increase the conversation that we've been having with some of our partners. After we understand that we've had a lot of interest and China as you can imagine and so that's so.
The first step interested and know exactly what the plan is and then two to discuss with potential partners and what that might look like but and I think if we have arm and.
And if I had my preference I think I'd, rather have fewer partners.
And more geography.
The one area that we may feel differently about Israel, which is not financially doesn't matter so much and it isn't significant but frankly.
And our Israeli based company and we think it's important for us and and you know Israel physicians and institutions from part of the studies since we started and so are we are looking to try to commercialize and Israel as quickly as possible and either ourselves we could do it or through a partner there so where we're at.
And working on that as we speak.
Okay, and then just a couple of quick questions I don't know whether these are more addressable by Jeff for by Mark perhaps by both.
If we could start with the at home installation and potential for UGI and 102 I was just wondering if you could provide some more color on the degree to which this might be.
Virtually are impactful.
Impactful presentation of the drug and also the extent to which you're already seeing interest in this presentation. This context from both patients and physicians and thank you.
Yeah, and I think I'll, just take that because it's just easier and the.
And what the home installation is for them one or two it's not for a job right. I think that's really important and I think there may have been some confusion around that so but we're looking at and the purpose of doing that with a couple of follow up for one.
The installation for one or two it's much easier than it is for a job might have given that its and that lower track and and we think it's really important for for patients for physicians to understand and for regulators to understand the ease of use one O two said that.
Provide to provide the flexibility of being able to have these installations done at home and that not only broaden the patient population that may be able to get one or two but it also serves to demonstrate their and ease of use of one or two so about and in fairness. We don't expect a large majority of that patients and we'd probably.
<unk> be a small majority of the small minority of the patients that would actually end up with using it at home, but we think it's important to do a home installation study and given what's happened and this past year and the pandemic and some of the challenges. We've had is to demonstrate our ability to actually have a therapy that as much.
Easier and they give them and what you've seen with T. R. B T. So those are some of the reasons and rationale for US doing this doing the studies so I hope that helps.
No that's very helpful. One last one here.
With respect to the Nephrostomy tube based application I was just wondering if you already had clarity regarding how to pursue this from a regulatory perspective or what are the implications with regard to labeling or if you think that this is likely to be more pursued or become part of the.
Treatment continuum with respect to the product.
From a commercial standpoint purely on the basis of physician discretion is at work.
The good news is its already and our label so because it was part of this trial, even though no one used it it's actually in our label today. So we don't need to do any additional regulatory work. We do think that it's an exciting area for us because it if we have found and.
Physicians are able to give it and that clinic and they're you know and their office and so it may be and ease of use but we don't need to do anything from a regulatory standpoint, we want and be able to share with physicians and other positions that the experience that that some are having with them, which is one of the reason we want to be able to to talk about it more interest.
Share experiences, but we don't need to do anything from a regulatory standpoint.
Thank you.
And thank you and.
And next question comes from Derik I Chiller with Stifel. Your line is now open.
Hey, Good morning, guys. This is Jack on for Derek.
For taking our questions just a couple from us here.
First regarding formulary approvals are there any upcoming ones that could be major drivers and.
Then.
If I could.
And the last one and hear about.
How you view spending quarter over quarter and what.
The progression might look like there.
Thanks.
And Jeff why don't you take the formulary question and Molly can follow up with the quarter over quarter spending.
Sure so.
Yes, you.
Every quarter every week, we have formulary reviews, and do you have commodity starting to meet again.
Delayed because of the vaccine for COVID-19.
So we have a significant number still and formulary review and accounts coming on every one of those.
Huge win because that you get through that internal process. The bureaucracy of the particular accounts. So and then opens it up for physicians within that practice I will say for the for the most part the major cancer institutions.
But not all habits already on formulary.
But for us to be.
Constantly working through formulary I see that continuing and opening up accounts and they will have they will have some significant impact of the remainder of the year.
Okay.
And as it relates to spending and quarter over quarter for the year. I think you saw Q1 was a little bit lower and I, usually because of COVID-19 some teeny commercial spend.
But we would expect that would continue to ramp for the rest of the year, especially as it relates to the ongoing one or two trial.
Great. Thanks, that's very helpful and congrats on all the progress.
Thank you.
Thank you. Our next question comes from Matt Kaplan with Ladenburg Thalmann and your line is now open.
Great. Thanks, and good morning, guys.
Just wanted to get a little bit more color I guess now with 316 sites open up.
Can you put that in context for us in terms of the number of sites and overall that you would expect to.
And be able to have a trained and ready to read the Ts Jo Malone.
GAAP.
Sure. So we have we target around 1300, 1500 accounts of which quartile one of our top accounts.
Five to 600, and so I'm very pleased with where we are with the major accounts that we wanted to make sure that we had access to early on that number as I stated continues to grow will continue to grow up to that 13, and a 13 to 15.
And to have to have the majority or all of those accounts onboard, but the $3 16 continues to grow and those key accounts that we were obviously targeting.
Okay. That's very helpful. Thanks, and then.
Yes for.
Or maybe for Mark.
Can you give us a little bit more color in terms of how the enrollment and Atlas is growing.
And.
And and sites opening up you mentioned kind of expectation for one third of the sites and U S and some.
And in Israel, and and another bulk of sites and Eastern Europe can you give us a sense in terms of where you are and opening.
Those sites and enrollment and.
Hi.
And Matt Thank you.
We have not released specific information and 100 bed patient numbers were sales numbers, but I can tell you that we are.
<unk> and along working hard to open up the sites that we predicted we would flow from the U S and in Europe and.
That is in fact happening.
And calls as recently as yesterday with European.
European regulators regarding the protocol, so we're moving forward and and <unk>.
And just with the way that it's growing but unless lives wants to comment further and I think that's probably about as much as I can share with you.
Yeah, I think you know daily.
And Mark's right you know its typical it's actually what I, what I'm, saying here is now that we're kind of starting to open sites and it's very typical of what you would normally see in any clinical study right now.
And we'll get to a point, where we start to see a hockey stick, we're not there yet, but we are seeing our sites are.
Now coming on.
Every week, so we'll be able to be and are positioned better positioned and give them more and more of an update later this year.
I think from at home Yeah. That's helpful. Thanks, and then last question I guess more on kind of get a sense from you.
Business development, I guess to two areas in terms of crush.
Questioning in terms of our T. R T gel technology and business development, there and how you're thinking about that and then I guess now with your commercial operations up and running fully and your oncology urology and guess what are your plans for and business development point of view to bring and potentially new products and.
Well externally.
Yeah, Great. Great question, you know on the RT Zhao.
No we absolutely talk to most of the academic centers, but we have had a couple of companies and say hey, there might be something you know.
And interesting either for us and their portfolio or for them and their portfolio and we are you know we are always looking for potential areas even outside of euro oncology that you know that others are interested in and nothing that's far enough along for us that had discussion about and we.
We are excited about one particular area that we're working with and one academic institution about and.
And at the appropriate time, we'll be able to share that information and that sort of expands day use up on you know.
That's our bar and technology as far as bring and products and we absolutely are looking for them. All the time. They we wanted to make sure we were staying within an hour or spaces, right and euro oncology and specialty oncology and are both with and without the gel. So.
And you know we constantly are doing something where and you know in the process right now of doing another screen.
You know looking and you know, they're hard to find and book, but we absolutely would like to leverage our our team our company our infrastructure. We believe we have the right infrastructure and the right people the right expertise to add to our portfolio and we also are not going and we don't need it right he touched on and situations, where we need.
Something to come in and we would like to add more to our portfolio as I mentioned before.
And it right now have three you know three different medicines at three different stages of development and of course, we'd love to add more either again and Euro and college and our specialty oncologists and we continue to look and hope that we can bring something and but we wanted to make sure. It's something that will advance standard of care and and send the right the right space for us.
But I'll always looking do you ever run across anything have any suggestions please feel free to for them along.
Great. Thanks, and thanks for taking my questions and congrats on the good results and the corner.
Thanks, Matt.
Yeah.
Thank you and your next question comes from Paul Choi with Goldman Sachs. Your line is now open.
Hi, Thank you good morning, and thank you for taking our questions.
Commercial one perhaps for Jeff to start just with regard to time getting time onto therapy.
And I was wondering if you can maybe just provide a little bit of Colorado through how over the course of the quarter.
And from patients start between the script and then actually getting the installation has progressed and.
Right now and the primary out sort of a headwind is either COVID-19 or payer approval and so forth any color there would be great and then I had a follow up.
Yeah, Great question, So I will say that that continues to get faster we.
On average, it's four to five weeks to get into accounts up and running a lot depends on that account.
There's formulary process, we need to go through it could take longer.
And I will say that when I said, it gets faster once and accounts up and running that number goes down to about two weeks, sometimes even less so once they've gotten through everything been trained on already and got through the.
Formulary process. So accounts that are onboard bring that four to five week average significantly down but.
Yes.
Phil accounts that if a formulary and meeting isn't for a couple of months.
We will take a little bit longer, but the average is coming down from a setup standpoint.
Okay, Great. That's very helpful. And then I had one pipeline question for Mark just regarding any expanded our updated thoughts and the GBM program and just how you're thinking about positioning.
Listening to drug there and.
Thoughts on and early basket trial or early trial design and in terms of patient groups I'd be thinking mostly.
Opportunity for Carryout per test population or are you thinking perhaps about and combinations with my device therapies like for like the option device.
Okay.
Hum.
Great question, and I think to be quite honest.
Although we've had.
Very intriguing conversations with our collaborators at Johns Hopkins about these very issues. It is a little premature for me to tell you about where this is going to go once it becomes a clinical project because right now and we're focusing on demonstrating.
The preclinical.
Value.
Just thinking which we think is.
And it would be very interesting, but I think we need to provide a little bit more data before we move.
And answering those questions, but we're certainly thinking about them and I think ultimately and I hope, we get where you where you want to go with this but I think it's too early to say.
Okay. Thank you Mark and thanks for taking my questions.
Thanks, Paul.
Thank you and next question comes from Leland <unk> with Oppenheimer. Your line is now open.
Hey, good morning, everyone and thanks for taking my questions wanted to ask.
And as the intermodal lunch roll scored and and has more experience and the field just wanted to ask if you are aware of.
The kinds of patients who are.
Or getting the product is it or are there certain characteristics and anatomy is it search for eligibility or is it kind of across the board and more dependent on just those centers and those providers who are.
And you know able to them to have access to get the product just wanted us for more color on kind of the population of patients and their characteristics.
I guess for anybody who can answer thank you.
Yeah, Jeff I think is probably the best person and I answer that question Jeff.
Sure so out of the at launch it was probably more of the recurrent pool.
Patients.
<unk>.
It's across the board as you stated so we're seeing positions.
Use it and and Unresectable population or even a resectable they'll go in.
Remove what they can see and then come back a week or two later with six doses the clean clean up what they can't see or can't get.
So.
Fully what I expected at launch.
The first few months, where patients were recurring they knew their cancer was back physicians wanted.
A different treatment option and.
As we evolve and we go in and we get face to face interaction and Lee.
You promote the entire indication.
And start to think about other patients.
And we're starting to see that that could benefit from them either.
Great. Thank you that's helpful. Thanks very much.
And Cleveland.
Thank you I'm not showing any further questions at this time I would now like to turn the call back over to Liz Barrett for closing remarks.
Thank you operator, and thanks to everyone and as we look for to the remainder of 2021, we're very enthusiastic and we felt like we're having a significant impact on patients and and we're seeing that as we talked about which I'm Idaho.
We have the people we have the financial strength to drive <unk> and our pipeline forward and so we'll continue to provide updates throughout the year as we execute on our long term strategy and I just wanted to say thank you to everybody for your time today your interest and support so operator, you may now disconnect.
Thank you. This concludes this concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
Okay.
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