Q2 2021 Urogen Pharma Ltd Earnings Call
Good morning, ladies and gentlemen, and thank you for standing by and welcome to the Euro Gen Pharma second quarter 2021 financial results and business update conference call. It is now my pleasure to turn the call over there with Sherman head of Investor Relations for your Gen. Pharma. Please go ahead.
Thank you operator, and welcome everyone to European Pharma second quarter, 2021 financial results and business update conference call earlier. This morning, we issued a press release, providing an overview of our recent corporate highlights and financial results for the quarter.
And at June 32021, the press release can be accessed on the investors portion of our website at investors day at your Gen Satcom.
And 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 patience and understanding should we have any technical difficulties during 2.
Days called and really making certain forward looking statements. These may include statements regarding the success and timing of our ongoing commercialization of Joe Midol planned clinical trials data presentations and regulatory filings future research and development efforts manufacturing capabilities 2021 financial guidance among other things.
These forward looking statements are based on current information assumptions and expectations that are subject to change and description of potential risks can be found on our earnings press release and latest SEC disclosure documents you are cautioned not to place undue reliance on these forward looking statements and your origins disclaims any obligation to update these statements I will now turn the call over to Lee.
Yes.
Thank you Sarah and thank you all for joining us today, as we provide and update on our progress and recent corporate development.
At year origin, we believe patients deserve better options and we're steadfast in our approach to fundamentally change the way Euro oncology is treated today.
As we move into the second half of 2021 and 1 of our key priorities remains the increased adoption of Jamba items. The first approved therapy for my novel reverse thermal hydrogel technology platform and.
As we announced in July we recorded $13 million and Yamato net product sales for the second quarter of 'twenty, 'twenty, 1 and $25 million for the first half of 'twenty 'twenty 1.
We believe this early success with you on Mato provides proof of concept, but the broader platform both in low grade disease with U G and 1 O 2 as long as our expansion into high grade disease and other tumor type.
We are focused on changing the way you all feel you'll cancers are treated and area, where there had been no significant advances in recent years and we see Yamato as our first opportunity to make a positive impact for patients.
It's critical for patients to have alternatives to invasive and our repetitive surgeries, which have a well defined associated morbidity and.
<unk> negative outcome from the use of general anesthesia.
Our novel Technology has enabled us to deliver job murdo and expand with our second euro oncology investigational product candidates Eugene and 1 O 2 which is being studied and low grade intermediate risk non muscle invasive bladder cancer and large patient population, where there are no non surgical primary treatment option.
Our Archie gel platform enables us to develop these novel therapeutic approaches and we are enthusiastic about their potential.
Mark will provide and more detailed update on the U G and 1 O 2 phase III Atlas study, but we are pleased with our progress and interest to date from 10 carriers around the world.
While we focus on expanding our pipeline and we have also made progress and our commitment to expand job job meadows geographic presence.
And we announced our first collaboration which involves a license and supply agreement with me are for them to pursue regulatory approval and commercialization for job motto and Israel Your.
Your agenda Ms founded in Israel, and they played a key role and our pivotal trial, we look forward to the possibility of patients and Israel have and access to this innovative treatment as quickly as possible.
The 2 other priority regions for near term expansion, our Japan and Europe based on the work we have done to date. We believe we have a plan for them might of regulatory and reimbursement pathways and look forward to providing more detail on our ex U S strategy and the coming months.
As we have communicated our goal remains to establish our first 2 medicines as standard of care changing the way these patients with low grade disease are treated.
We believe by doing so these 2 lead products set a strong foundation for our company and assuming regulatory approval of Eugene and 1 O..2 our goal is to deliver peak revenues of over $1 billion by the end of 2020.7.
Given the total market size of low grade you to you see is over $700 million and low grade intermediate risk non Muslim based on bladder cancer over $3 billion. We believe this goal is attainable and positions your origin as a leader and euro and collagen.
Beyond Yamato and Eugene and 1 O..2 we continued to expand and progress our early stage pipeline, both internally as well as with academic collaborations and Mark will talk more about these programs.
We are actively seeking opportunities to expand our portfolio with innovative medicines and areas for which there are no adequate treatments and where new technologies and innovation can make a difference for patients and we will share updates as available and.
With that I'd like to turn the call over to Jeff to provide a commercial update Jeff.
Thank you Liz I'm pleased to provide you with an update on our commercial launch of gel model.
And second quarter, we saw some return to a sense of normalcy with respect to the commercialization of <unk> and access to physicians and they've been able to benefit from a higher level of in person and physician interaction.
Challenges do remain with 30% to 40% of your offices close to representative as we monitor the evolving COVID-19 situation and the potential further impacts of the pandemic may have on the business physicians and patients.
As we enter the fall conference season, and we look forward to having a major presence at the key urology conferences, including the American Urological Association or <unk>.
Which will be held from September 10th through the 13th in Las Vegas, and is the largest medical conference and the relative strength.
Anyway, it will be a hybrid virtual and in person meeting this year and will allow euros and the opportunity to meet with physicians and provide educational and Joe and myself.
We will have both a virtual and in person and boots, including and interactive patient builder and demonstrations on how our innovative hydrogel technology makes chemo ablation possible well.
We'll also have a product theater with Doctor Katie Murray focus on how <unk> is transforming the treatment paradigm and low grade <unk>.
Moving away from previous surgical treatments to the first drug therapy of just crime.
Influence physician response, and Joe might who has been positive and we've been able to leverage the growing enthusiasm to increase the number of sites treating patients as well as the number of patients treated and each site.
We expect this growth to continue alongside the total number of active sites as we expand field engagement.
As of August 1st we have increased the number of activated sites to 407 up from 316 as of May Force. These are sites that have either treated patients or have completed all of the internal processes required to allow them to treat patients.
For repeat accounts, we've increased the number of repeat accounts to 63 as of August 1.
And from 40 as of May Force. This suggests that physicians are seeing clinical efficacy of the therapy and benefit to patients that reimbursement is working and all of the components of the process are running smoothly.
We also hear from physicians that the education and support received from the urge and stuff and nurse educators, along the treatment continuum is critical to seamless integration of <unk> and their practices and net practices are receiving timely and accurate reimbursement across Medicare and commercial covered lives we can see.
And really watch this number to ensure that physicians are identifying additional patients and gaining more and more comfort using our therapy.
Reflecting on our strong second quarter, we do believe that there was some impact on patients who decided to wait for their vaccinations and the first quarter, who are then treated and the second quarter and we're pleased that patients who are returning to their physicians and seeking treatment.
And personal engagement with the physician and office is critical given the administration of the therapy as well as the orphan drug nature of the disease and this remains an important focus for our field team.
As we look to the second half of the year, we see the importance of depth and each accounts, we will focus on expanding the physicians and patients and our current accounts and leveraging the positive experienced peers have with our treatment to increase the number of physicians utilizing our therapy.
With that I'll turn the call over to Mark to discuss our recent clinical updates.
Art.
Thank you, Jeff I'll now touch upon the progress we have made on our clinical and non clinical programs this quarter.
And with Joe and myself, we are paving the way to do something different in neuro oncology.
As we explore ways to optimize the treatments and think through lifecycle management it.
It is incumbent on us to ensure physicians and patients are utilizing Joe Milo and the most optimal and appropriate manner for patients' success and we are committed to generating the data to support our key stakeholders.
And we plan to start a registry and are also working with clinicians to better understand the use of administering Joe and myself and the Frost me too and clinical practice, we expect to see data from the prompts me to abuse in the community. Starting later this year.
As Liz mentioned are leading late stage clinical programs, Eugene and 1 or 2 for the treatment of low grade intermediate risk non muscle invasive bladder cancer.
And we are actively enrolling patients and the ongoing outlooks trial studying Aegean and 1 or 2 plus or minus to U R E T compared to <unk> alone.
And it's an event driven and phase III trial, we expect it will take approximately 1 year to enroll and an additional 2 years to complete targeting and approval potentially by the end of 2020.4.
It's a very important patient population, where the current standard of care is repeated surgery and we are.
Seeing that there is significant demand with nearly 100 sites activated and the U S Europe, and Israel and the momentum and enrollment is picking up we look forward to providing updates for Atlas later this year.
We've talked about the trial design for this study and how.
We relied on our phase <unk> Optima II study to help inform the design and assumptions for the trial.
And we anticipate presenting the final on the 2 data and at a medical meeting this year as well as publishing the results and the peer review Journal and.
In addition to the Optima 2 publication, we have sponsored research and a variety of areas and special relevance to our programs.
Putting work on patient preference for non surgical options and non muscle invasive bladder cancer and the natural treated history of non muscle invasive bladder cancer and in U S. HMO population.
We have worked with her colleagues and academia to examine the financial impacts and medical complication rates associated with current standards of care for N and M IDC and the U S. We expect data from these studies to be presented at a medical meeting later this year.
And in parallel to the Atlas trial. We're also on track to begin on a home installation feasibility study and the second half of this year. The trial will be a small 10 patient study with a goal to demonstrate that Eugene and 1 or 2 can be safely administered by a health care professional and the home setting we expect to enroll and approximately.
5 centers in the U S.
I'd like to touch upon the progress we've made and our early stage immuno oncology pipeline, namely with UGG and 301, our <unk> 4 antibody.
And Eugene and 2 or 1 or 2 or 7 agonist.
We see Eugene and 301 is a foundational checkpoint inhibitor and intend to study this agent as monotherapy and in combination therapy, including in combination with Eugene and 2 O..1 as well as other agents, we refer to the combination of Eugene and 2 or 1 and Eugene and 301 is Eugene and mm 302.
And our initially studying this combination in patients with high grade non muscle invasive bladder cancer.
In June we started and the non human primate toxicity study for EG and 301, which is on the critical path as we move towards submitting an IND for this asset.
We expect to have the results of the toxicity study by the end of the year and assuming and acceptable toxicity profile, we'll submit and IMD for UGI and 301 and the first half of 2022.
We are actively working with MD Anderson further progress on our understanding of the synergy between <unk> and 201, and Eugene and 301 and are on track to start a study in humans later this year with UGG and 201 to assess the immune module and tour activity in the bladder we expect to see additional non clinical data throughout 2002.
2 from both monotherapy and combination therapy.
Last quarter, we announced a sponsored research agreement with the Johns Hopkins University aiming to understand how local administration of checkpoint inhibition may be useful and the treatment of glioblastoma.
Continued nearing work at Johns Hopkins and are exploring the possibility to expand to other molecules and other tumor types.
Our team is also actively working both on our own labs and with other academic centers to explore our pipeline and other solid tumors and with that I'd like to turn the call over to Molly who will discuss financials.
Thank you Mark and thank each and everyone for joining today's call as mentioned by Liz and Jess we recorded net product sales and to a minor for the second quarter 2021 of approximately $13 million and $20.5 million for the first half of 2020.1.
Cost of revenues for the second quarter 2021 were approximately $1.4 million, resulting and the gross margin of $89.1 per cent.
And as we mentioned on previous calls and periods prior to receiving FDA approval for Jim items, we recognized inventory and related to costs associated with and manufacturer of drum items as research and development expenses.
We expect this to continue to impact cost of revenues through the second quarter of 2022, as we deplete inventories that we had expense prior to receiving FDA approval.
As a result on a gross margin would've been approximately 87, 7% versus the $89.1 per cent for the 3 months ended June 30 of 2021, if we had not sold them idle units that were expense prior to regulatory approval.
Research and development expense for the second quarter ended June 32021 for $12.1 million compared to $8.1 million and the same period of time and 23.
Research and development expense also includes $1 million and noncash share based compensation expense for the second quarter ended June 32021, as compared to 1.6 million per the phone carried in 2020.
The overall increase in R&D expense related to the initiation of our phase III Atlas study for UGI and 1 or 2 at the end of 2020.
Selling general and administrative expenses for the second quarter ended June 30, and 'twenty, 'twenty, 1 or $22.3 million as compared to $24 million and the same period and 2020, the decrease and the annual selling general and administrative expenses resulted primarily from the higher brand marketing expenses in the second quarter of 2020 and preparation for the launch of <unk>.
As well as a decrease and share based compensation expenses.
Selling general and administrative expenses included $5 million and noncash share based compensation expenses for the second quarter ended June 32021, as compared to $5.5 million for the same period and 2020.
For the second quarter on June 32021, we've reported financing expenses related to the prepaid forward obligation to RTW investments of $3.1 million as previously reported.
And in accordance with U S. Generally accepted accounting principles, we expect to accrue approximately $12 million to $15 million and non operating financing expenses related to the RTW transaction, which is reported below the operating income or loss line.
Cash payments in 2021 will equal $9.5 per cent of much of motto sales recognized subsequent to the May 2021 closing.
And the second quarter ended June 32021, we reported a loss of $26.2 million or $1.17 per share. This compares to a net loss of approximately $31.3 million or a dollar and 44 cents per share for the same period and 2020. The net loss for the second quarter ended June 32021 includes $6 million and non cash share base.
Compensation expense.
For the first 6 months of 2021 net loss was $52.2 million as compared to $69.1 million for the same period and the prior year.
This improvement and operating loss over the period was driven by our Joe might have revenue of $20.5 million as compared to $4 million and the prior year.
Total operating expenses decreased slightly to $67.1 million as compared to $70.7 million and the prior year.
Our guidance for 2020, 1 operating expense remains unchanged and is and the range of 155 to 165 million and this includes estimated noncash share based compensation expense of $24 million to $28 million subject to market conditions.
Lastly, we closed the second quarter with $129.3 million and cash cash equivalents in marketable securities.
This includes the.
The $75 million and funding from Archie W, which we announced earlier in the year and was closed and that base.
Based on our current operating plan and cash position. We believe we will have sufficient capital to fund operations into 2023 and.
As a biotech company and as Mark indicated we are always evaluating opportunities to expand the use of our platform technology as such we will continue to evaluate our cash needs to ensure we are investing and our future.
With that operator, I'd like to turn the call over for questions.
Certainly ladies and gentlemen, if you have a question at this time. Please press Star then 1 on your Touchtone telephone. If your question has been answered and he'd like to remove yourself from the queue. Please press the pound key our first question comes from the line of Leland <unk> from Oppenheimer. Your question. Please.
Hi, Good morning. Thank you for taking my question and congratulations on on the nice commercial performance.
Couple of questions first on Orange on Idaho and had.
You mentioned that Youre seeing increased repeat rates it.
And an increasing number of centers, maybe wanted to see if you could share more color on kind of what what's.
Sort of the kinds of.
The feedback youre getting from physicians at the centers in terms of their interest and using <unk> again, and the types of patients and which they may be using Jo Mira with respect to a degree of pathology and.
Location of the tumors and so forth and I have a follow up thank you.
Hey, Hi, Thanks, Leland, Jeff why don't you take that and Mark if you have any additional comments on Jeff has done and then let's see what's ligands and follow up so Jeff.
Sure Thanks and.
And that's as far as the number of accounts that are treating more than 1 patient.
Couple of things that you've obviously got peer to peer influence within that practice, so position and build out their peers.
Did it go on a certain patient.
Clinically obviously, what we here are positive from a field perspective and.
And there.
Pairing that with their colleagues obviously as we said earlier representatives are really motivated to go in and expand the depth and that accounts. So the reps between the representatives doing a good job expanding the depth and physicians talking to physicians, that's really why we've seen and increase and the number of accounts trading multiple patient we have to.
There's still a lot of potential within given accounts given the some of these accounts are 10, 15, 20, plus urologists and the accounts. So we'll continue to do that as far as the patients treated because we have so.
So many that have been treated has I'll say, it's been across the indication.
We've had recurrent patients that have been treated you're seeing more I'm seeing more newly diagnosed or hearing more newly diagnosed that may be the resection is going to be challenging.
And as I expected launch and I expect it to get more of the recurrent pool and it'll evolve into probably about 50.50 half coming from the current pool half coming from the newly diagnosed.
Good day, Thank you Sir.
Good.
And thank you that's very helpful and and then a question for Mark and you know in terms of these collab.
Collaborations, obviously, MD Anderson, and then Johns Hopkins and Glioblastoma.
Maybe if you could just give us a sense of.
How much further and we should see additional potential academic type.
Collaborations materialize as we go forward.
With the potential application of the <unk>.
The artichoke platform. Thanks.
Uh huh.
Thanks Leland.
Great question, and it's actually I think you've heard from lives and per Molly and we are.
Very interested in exploring.
Other opportunities for the platform.
And we know that.
Joe that the gel we're using can deliver a lot of different types of molecules through a lot of different types of <unk>.
And then use within the body. So so the answer is I think you would expect to see more and time.
Actively pursuing this and lives and we want to comment further but I think there was more on the horizon.
Yeah. My only comment is is that is correct. We do see a lot of interest in them and and with different academic centers and and using it and so anytime we get and inbound interest we absolutely.
Yeah, absolutely the follow up on that and we've got a couple and it works right now that hopefully we can talk about on the next few months.
In addition to that we haven't actively gone out to other companies and and we will we continuously look to say to think about whether we believe there's opportunity and then we'll proactively per se that was as well. So definitely we believe that we have an opportunity to.
<unk> continued to expand the usage of our you know you're very very unique technology and the Archie channel. So thanks Leland.
Great. Thanks, very much I'll hop back in the queue.
Okay.
Thank you. Our next question comes from the line of Chris Howerton from Jefferies. Your question. Please.
Fantastic good morning, and thanks for taking the questions.
First I guess, Jeff I just wanted to ask.
What is the current status of utilization of gel NATO in the different center types.
I think that there was some discussion of trends that you were seeing of additional equipment that physicians could augment there.
Offices with to be able to instill Joe motto and in their locations as opposed to going to and ambulatory surgical centers, So just kind of touch and basins with.
And the trends that youre seeing there in terms of the different types of centers.
And then the second question that I had is frankly, I'm just intrigued with the <unk>.
<unk> mentioned that you had at the age of the interactive patient build there for you to use C and I guess I was just kind of curious what were the important and kind of variables or features that you found important or most intriguing or most educational and to physicians.
You know heading into that experience.
And then the third question I had was if I may is for Mark.
Didn't share and you mentioned of any presentations at this time. So just kind of wanted to see if there was still on any kind of presence from either.
Either clinical or preclinical.
Preclinical work that you had been describing thank you.
So Jack why don't you take the first 2 and Mark can definitely share with you what he can around and we won't be able to share specifics, but we definitely have a lot happening and so Jeff.
Sure. Thanks.
Yes, so some of the trends that we're seeing recently as you know.
And gives us and outpatient hospital and ASC and surgery center or are they as you said they make arrangements to give it and the clinic, either via and Nephrostomy tube or <unk>.
They bring fluoro into the clinic as expected we still have most of our administration is taking place and the hospital what I've seen a good trend and is that we're starting to get diagnosis more in the community setting. So that's starting to balance out and you're starting to see a diagnosis and the community setting you're starting to see more administrations.
And their surgery center, which they may own or they have a strong affiliation with.
And so those are some of the trends, we've seen and I expected to see.
If it's diagnosed and the community and they go to the hospital to administer it.
That's fine as well.
But I do think you're starting to see and uptake both in diagnosis and administration and the community and whether they do it and their surgery center or the clinic.
Yes, it's entirely obviously up to them.
Still a very small portion of the administrations via nephrostomy too, but it is growing.
We get a lot of questions around it and we are hoping to collect a lot of data when we start the registry.
That was your first and second the patient builder, yes. So we're excited for this the field actually has this right now.
Patient builders and designed to capture as I was talking to Leland and the entire indication so.
And the representatives able to build a patient whether that's in newly diagnose whether that's recurrent number of tumor size of tumors and then what it does and extrapolate out what the data tells us and Olympus and so it allows the field to really talk to the entire indication to make sure that every 1.
1 of those 6% to 7000 patients that we see every year Joe might have considered so we'll expand upon that we're excited for alive.
But yes, the reps have that patient builder is right now.
Chris Thanks for asking about the U N.
The organization has very specific rules embargo related to accept and research that will be presented during the meeting items.
Or is it too.
We have a bunch of things coming.
Up for presentation.
At the meeting this year, but unfortunately, the embargo and non reportable. It lifted so all I can tell you at this point is that we're going to be very busy we have a lot of exciting stuff per cent and we can't talk about it yet although we expect net the embargo will be lifted in the next couple of days and hopefully.
And that point, and we'll be able to be more transparent about the specific research.
Okay.
That's very clear.
Thank you very much for taking the questions and I'll hop back in the queue.
Great. Thanks, Chris.
Thank you. Our next question comes from the line of grams, silver and <unk> from H C. Wainwright Your question. Please.
Yes, and if you could first of all maybe give us some background on the relationship with Neil Farm and.
And what might be some perspectives regarding the local Israeli market and neo farms capabilities in that region.
Sure Hi, Ram they they are 1 of the top I don't Wanna say distributors, but commercial.
Partners for many companies in Israel. So they have a very I mean, we as you can imagine there was a lot of interest from multiple companies and Israel to be our commercial arm. We actually also considered do we do it ourselves, but we felt like near form has the capabilities they already have.
Infrastructure and they fit very nicely into where they work what they're already doing so we've worked very closely with them free.
Israel and look we yeah.
It's not a huge market right, let's be.
Realistic about that but it's a very very price fall for US right. As we are an Israeli company, we started and Israel. They were a big part of what we've done but near farm, we looked like I said it all of the different options and felt like both from a financial and a capability standpoint and made the most sense to do our part.
And our share and near farm of all the companies rose to the top because of their capabilities and them and they've been really great to work with so we felt very good about that decision and and we'll be looking for similar type of partners frankly, you know as we as we expand globally.
And want partners that day, if we're not going to do it ourselves that can bring that added.
Extra capability, and we believe that near form does that and Israel.
Has Neil farm expressed any interest and commercializing the product in countries outside.
Outside of Israel or would you need to seek partners.
Strength from Neo farm for those territories and if so give us on.
And update on how the discussions are progressing.
Sure that day, they were interested and other countries, but we as we've talked about before we think it's really important for us to be very thoughtful about who we partner with them, which geographies right and we wanted to make sure that the partners. We have are the top partners in those geographies and.
I think what we also want to make sure. We don't do is have so many partners that 1 it dilutes the effort both our internal resources, but also the potential to have a bigger partner.
Worldwide. So we have not started even though we have had inbound interest and different regions and I would say pretty much every region and the world We've had inbound interest.
But we want and be careful that we don't just again had 10 different partners and 10 different regions around the world that'd be a little bit more thoughtful so what we've actually been focused on is let us develop that is really understand what does it take to get approval and reimbursement and Europe, what does it take to get approval and re.
Membership and in Japan, and we are very close to having a full plan set in place.
And we've started to have conversations with those companies that have expressed interest and then at the time, where we felt like we have the knowledge and the path forward.
Laid out then we will also be and make make some proactive con contacts with companies and those regions. So.
I'll just say, we we are looking at potentially.
Company that has both Europe, and Japan, and China, and you know where it's at.
1 ex U S partner outside of Israel, obviously, so that would be ideal I think and a lot of ways and we want to make sure that it's a partner that will be successful on those market if that doesn't work out that and would probably look at and potentially.
Europe, Japan, and maybe China, because obviously, China is very unique and and again, while we have had some preliminary conversations we just are finishing up.
And what will it take to be successful and those markets. We can negotiate the best deal for our company and for our shareholders with other partners and let until we know exactly what it would take and that's kind of what we've been focused on so and <unk>.
Had we been gauged experts in this area.
Obviously run global businesses, we have other people and the company and have a lot of experience and and areas on chief business Officer.
Lived in China for several years and she has personal relationships and so we've really leveraged and the knowledge and the knowhow that we have to make sure that when we do start to have those conversations would be.
And that we're putting ourselves and the best situation possible. So those will start and the fall and I think that we'll be able to give an update over the next.
I'd say you know 2 months on exactly what that looks like like like you know what what is it going to take and I've said this before and Japan, you always have to do a bridging study they want to see the the medicine and and their patients and it said, it's more of a safety and efficacy, but we know that we can get reimbursement there Europe. It was about under.
Or standing what are the possibilities of us getting a decent reimbursement and not being compared to generic.
And my friend and we think we have a path forward. There. So now that we felt like we have more of a and understanding exactly what it takes we will start those conversations.
Sorry that was a long a long winded answer to your question Ram.
So just as a follow on to that.
Are you seeing any evidence that specifically within the context of Europe potential partners to assist with the commercialization of gel and <unk>.
And I want to actually see not only regulatory approval, but also reimbursement discussions completed before they would be interested in getting involved or do you think that potential partnership could be consummated before all of that is set in stone.
But what we've been doing over the last few months is actually having those conversations with some of the payers that we have some experts that we've been working with so that was our decision that we felt like we wanted to understand right. So some of the partners have said you know they have their perspective on what you know what that would look like and you want somebody who has that capability.
And Europe, that's probably the number 1 and capability you need is as market access can they get in there Ken and negotiate a good deal with the you know with the government. So that we'll be looking for that capability, but I think where we were in a position now where we have enough information and enough knowledge that that we'll be able to to start those discussions.
Gotcha.
Okay, and then just very quickly you know given the rise of the Delta there and are you seeing any evidence that you now yes.
Further restrictions on new restrictions are placed on face to face promotional activities and door clinical site recruiting activities that either the continued rollout of gel mito or for enrollment and the Atlas trial would be affected and if so and what way or do you think debt. This is something that you.
And feel confident you can manage through on both of those fronts.
Well you know look I would be remiss, if I said there. It was would have no impact I mean, I think that we've seen just a you know things change and the last couple of weeks. They are changing daily you know, Jeff can comment, but you know accounts that where maybe we're going to open access or know shutting down access.
I had my own personal experience with the health care system, where a family member couldn't even get a good couldnt get hospital bed because.
Because of because of Covid and so to say that it won't have any impact and we don't have that right. We are we continue to see good access we do see we still see restrictions right and.
And so we said, it's a day by day week by week thing as.
As far as Atlas is concerned we you know we.
We felt like because we have a lot of site up and running and different areas around the world that if we need to pivot and get more patients and 1 area versus others that we can actually do that which is 1 of the reasons that we actually wanted to have more sites and as you heard and we've got almost 100 sites and activate.
And so you know to be in that position I think will help us from and Atlas standpoint, I don't think that the delta variant or Covid at this point would shut down our business if that makes sense. So I don't think we're in a position where we were.
We're not going to be able to continue to be successful. So it might impact the ramp, but I don't think it's going to impact some patients are still going to be need to and I think patients are more comfortable now, especially those had been vaccinated and more comfortable I'm going out there and you know Jeff talked about the Nephrostomy tube I personally.
And very excited about that administration and think that if things continue to shut down and the hospitals aren't able to do elective surgeries are elective procedures and you may see an increase in approximately 2 and we'll make sure that we are in a position to be able to support physician offices to be able to do that route of administration.
Okay, and then lastly did you actually provide a timeline for completion of the non human Primate study with Eugene on 301 on.
Sure if I missed that.
No. That's okay. Mark do you just want to comment on that I don't remember, if we said anything about timing.
We actually have and we're moving along we're expecting data at the end of the year, So I suspect that zone.
And we'll decide to talk about that.
And so I guess, that's probably on.
And next year, Yeah, yeah, great. Thank you.
Thanks Ram.
Thank you and as a reminder, ladies and gentlemen, if you have a.
And at this time. Please press Star then 1 our next question comes from the line go back Cohen from Ladenburg Thalmann. Your question. Please.
Hey, guys congrats on the.
Good quarter.
I wanted to follow up in terms of.
And digging a little bit more to the prior question in terms of how how have I guess third quarter sales and new starts and shaping up versus second quarter and have you been able to maintain the momentum that you saw on the second quarter and the third quarter, given the changing dynamics here and now with the Delta variant and and.
And then and.
Another question with respect to the nephropathy to.
Ah study data.
I guess, maybe most of them are on how will this do you think impact to use and uptake of <unk> kind of going forward and.
And not only in the context of the pandemic, but also kind of further out after work kind of out of that that range.
Yeah, Matt I'm, Liz and I were you know, we're not really providing month over month on month to month or.
Data around patients I would say we continue to see.
Patient enrollment forms command and we continue to see new patients being dosed. So we we continue to see growth and the numbers that Jeff talked about so we expect that and we will continue to see adoption increase over.
Over the next over the next few months and you know and beyond and so you know where we're we remain.
We remain bullish about that but Jeff maybe you can just comment on what you're seeing out in the field around positions and and around the reps and the representatives and what Theyre able to do I think that would be very helpful and for how it how things are going and then turn it over to Mark to answer the question on the on.
Yeah.
The study.
Yep. Thanks.
Exactly what you said so reps are going deeper into accounts. So we're continuing to see growth.
And we'll continue to see that and so as I said earlier, they've got a tool now to help you and expanding into.
On the full indication.
I'm excited to have that and.
So I think you'll.
And you'll be good timing to finish the year strong as well for slide meeting so.
Mark.
And.
And just to make sure on answering my question.
Breast meat cube.
The issue I think is what you're asking about and it's a very interesting.
Byproduct of the launch because as you and others know.
The pivotal study was done entirely and a retrograde manner, meaning that the drug was and still into the kidney through a catheter placed through the.
And of the bladder and then up into the kidney.
Fisher's have started placing and approximately 2 which as many know is the place.
<unk> directly to the skin on the back end of the kidney, which provides direct access without the need for lower urinary tract instrumentation in order to deliver Joe and myself and what we're hearing anecdotally is that it is a very acceptable.
Method for delivering the drug both from a practitioner and also from a patient perspective, I think there was initial worry.
The approximately 2 would be viewed by patients' lives and incumbents and.
And convenience as it turns out and it actually is both convenient well tolerated and very significantly simplifies the office workflow imagine a patient coming into the office pulling up there sure.
And the the port and effectively the tube access into the kidney the practitioner and still.
And if the drug and the patient goes on so we're hearing anecdotally that there on a lot of advantages both from a patient acceptance as well as a workflow perspective, using the price youtube's, we know that they're on our investigators and the field now studying this and we are expecting ex what you see some presentations and <unk>.
Papers in the coming year about this so I expect.
And then if what we're hearing anecdotally continues.
And will be a significant uptake of this mode of delivery.
And he has a lot of advantages both in terms of again and office workflow as well as patient acceptability.
Okay got it.
That's very helpful. Thanks, and the added detail and and 1 last question I guess, given the success that you've been having any plans to change your commercial footprint at this point.
No not really the way we may we're adding a couple of clinical nurse educators, because we wanted to make sure that we 1 of the things that's been very helpful. As a debt the success and the support that we provided the debt physician offices. So other than a couple of clinical nurse educators, who need to be there that far.
First or second.
Time, they do the installation.
On the footprint should stay the same.
Okay very good.
Thanks for taking the questions.
Thank you Matt.
Thank you. Our next question comes from the line of Paul Choi from Goldman Sachs. Your question. Please.
Hi, Thank you good morning, everyone and congrats on lives and team on on on the strong quarter, just a couple from us.
Starting with your comments on the on the community setting could you maybe just elaborate a little more if this is just more sort of early on.
Early trialing by.
Practitioners on the community or is this more reflective of Jeff and team.
They are sort of next wave of of cheering and target account penetration here.
Jeff.
Yes.
And so I would say its the next wave I think youre starting to see community.
Obviously, you're looking to bring back revenue.
There's been a big push to bring back revenue and the surgery Center.
And so you're starting to see and and.
I've said this.
Well they they liked the J code.
I like having the permanent code.
And they're just a little more level of comfort and so those doctors that were diagnosing and there and the community and going to the hospital are now, saying, okay, I'm going to diagnose and community and do this and my surgery Center, so and.
To your point, we expected out of the gate and the hospital and <unk>.
As we grow we're going to continue to grow and will continue to grow and the hospital, but you're going to start to see more of that into the community.
Okay. Thanks for that color and then 1 on the on the pipeline side for US just with regard to the 3 O. On I know you mentioned that the earlier that to an earlier question about the non human primate work would be completed around year end or <unk> or so but your comments on Europe that you see it as a.
Combinatorial asset for additional solid tumor types and have you.
Have you identified I guess at this point based on sort.
Sort of analogs on the market, where Directionally you would go and then would you pursue this additional combination development as.
And as either investigator sponsored trials or would this would these be primarily a company directed.
Company sponsored excuse me.
Yeah, Great question I think that we are just starting to look to see other areas and I think it would be both right. We have we have investigators that are interested and potentially seeing it.
Used in certain ways, and we would do that and we also when we when we see other assets out in the marketplace that are being studied or we think oh wow that might be a good opportunity for us to do a combination and we may do some partnerships with other companies. So I think we're looking at it and then.
Continuum on a different areas, but we don't have anything specific yet.
And that's just as we started to work with and the feedback that we're getting so far with with 301 anti.
Anti <unk> 4 is well known.
The efficacy is well known and so our ability to deliver it locally we believe has the it that has advantages both from an efficacy and safety standpoint, and so if we're able to do that and combination we think there's a lot of opportunity there.
Okay. Thank you very much I'll hop back in queue. Thanks.
Great. Thank you.
Thank you and this does conclude the question and answer session of today's program I'd like to hand, the program back to Liz Barrett for any further remarks.
Great. Thank you operator, and thanks to everybody for joining us today and as we look forward to the remainder of the year, we're really poised to continue to advance our efforts both on commercial efforts and our pipeline priorities will contain and provide updates as we always do as we leverage the proprietary technology, we have deliver on our promise to bring patient.
These novel therapies and areas, where there really has been little innovation. So while we do recognize the COVID-19 landscape as I mentioned before is evolving daily we keep a close eye on it and the potential impact that it has to both patients and the health care system, we still feel very very positive and optimistic about patients' ability to that.
To come in and get our Madison and so it remains fluid we can't predict the impact, but we consistently like I said work and we know now that we can't and we have the flexibility and adaptability to adapt to whatever situation. There is because we are committed to ensuring that patients have access to jump items. So again, thanks for your interest and the and our company.
And we look forward to more dialogue and the operator you can now disconnect.
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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