Q3 2022 Urogen Pharma Ltd Earnings Call
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Good morning, ladies and gentlemen, thank you for standby and welcome to Yeargin farmers third quarter 2022 financial results and business update conference call. It is now my pleasure to turn the call over to Vincent Perrone Senior director of Investor Relations for you or Jim Farmer. Please go ahead.
Yeah.
Thank you operator, good morning, everyone and welcome to Euro Gen Pharma third quarter 2022 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 ended September 32022.
The press release can be accessed on the investors portion of our website at investors <unk> com joining.
Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, Jeff BOVA, Chief Commercial Officer, and Dan <unk>, Chief Financial Officer.
During today's call, we will be making certain forward looking statements. These may include statements regarding our ongoing commercialization activities relating to gel motto. The expected benefits of the FDA is expansion of the end use period for gel Mitel, our ongoing and planned clinical trials commercial and clinical milestones in the year ahead the growth potential for Joe.
Idaho, the desired potential benefits and commercial potential for <unk> 102, if approved the.
The design potential benefits and commercial potential of <unk> potential future commercialization activities for <unk>, one or two if approved data presentations expected regulatory filings and timing thereof, future research and development efforts and our financial and other corporate goals among other things. These.
These forward looking statements are based on current information assumptions and expectations that are subject to change our description of potential risks can be found in our earnings press release and latest SEC disclosure documents, including under the risk factors heading of our quarterly report on Form 10-Q for the quarter ended September 32020 to file today through our cost.
And not to place undue reliance on these forward looking statements and European disclaims any obligation to update these statements I will now turn the call over to list list.
Thank you Vincent and thank you everyone for joining us today looking back on this last quarter and just as importantly, looking at the quarters ahead. There is much to be encouraged and excited about although sales were slightly lower on a sequential quarter basis year over year revenue grew 41% during the third quarter compared to the same peer.
Last year, we have come to believe this is reflective of the type of summer seasonality, which in 2021, we associated with the rise of COVID-19 cases.
Last year half conversions for protracted in July before bouncing back in August .
In the third quarter of 2022 timing of conversions from patient enrollment forms to new patient starts remained longer through August before returning to baseline after labor day.
Importantly, the rate of decline in revenue was only 3% compared to a more significant decline in same period in 2021, reflecting more consistent revenue versus prior year.
Jeff will provide more on this shortly but we expect a return to growth in quarter four.
The introduction of John might have requires a bold shift in the treatment paradigm and rate of adoption varies territory to territory. One of the most important proof point to the significant opportunity and low grade <unk> is the breakout results in certain parts of the country, especially in the northeast and mid Atlantic region.
These regions show what is possible when urologists have strong clinical conviction and serve as a model for expansion in other parts of the country.
Early adopters appear to be embracing John Idaho, and our RT gel technology.
We believe that experience and familiarity is expected to spread which would positively impact.
<unk> performance and importantly, create a more receptive environment for the introduction of <unk>.
We've also learned that NPL, Joe might have more closely resembles a medical device sell accordingly, we have made several strategic and purposeful changes to our commercial approach based on this and other key learnings, which Jeff will elaborate on shortly.
Moving to <unk> 102, it's been well established that both types of low grade malignancies respond well to minimize and delivery in a gel I'm pleased to announce that we anticipate full enrollment of envision a pivotal phase III trial with <unk> in patients with low grade intermediate risk non muscle invasive bladder cancer.
Early as the end of this month.
We believe the success of this program to be partially just de risk given the similarities of the diseases, a shared API and <unk>, which has shown efficacy activity in both forms of low grade malignancies, and the comment Archie gel technology, we therefore believe efficacy activity do.
To prolonged exposure to itemize that wisdom, Idaho in the upper tract may translate to the bladder.
Assuming positive results from envision we anticipate filing an NDA with the FDA in 2024 targeting priority priority review, which if granted may potentially result in approval before the end of 2024.
If approved <unk> 102 will be the first non surgical primary therapeutic to treat low grade intermediate risk non muscle invasive bladder cancer patients and this is where our experienced and foundation with jump Idaho will prove invaluable.
After establishing the use of <unk> in our T gel with urologists, Eugene and one or two is expected to have a stronger starting point and Joe might of delivery of the AGM 102 is expected to be much easier for urologists given it does not require the use of specialized equipment scheduling of or time, and it's designed to be administered by Dr.
Our support staff and clinic as an outpatient procedure installation.
Installation of the AGM, one or two is perceived as a routine procedure in the urologist office similar to other products administered on a regular basis with.
With a simplified administration, an addressable patient population roughly tenfold that of low grade <unk>, we expect <unk>, one or two to have strong and rapid adoption in its position that the primary driver of value generation for European business over the long term.
While geopolitical and macro economic forces continue to call for financial Prudence, we remain confident in our ability to end the year with around $100 million in cash.
We continue to focus on capital preservation and investment in our core assets, specifically <unk> sales growth in <unk> in one or two development, while carefully scrutinizing capital investments elsewhere.
Finally, and before handing the call over to my colleagues I'd like to welcome two prestigious individuals to our board of directors, Mr. Dan Wildman and Dr. Lena Lena is an emergency medicine physician and has served as a professor of health policy and management at the George Washington University School of public health.
Since 2019.
She also serves on the boards of several other organizations, including Golf Coast Corporation. The bipartisan policy Center, the Baltimore Community Foundation, and the National Committee on U S. China Relations.
Dan is a seasoned executive with more than 40 years in the medical device industry. He has he was currently chairman. He is currently chairman of progenitors medical and he also serves as a strategic advisor for several medical device and pharmaceutical companies.
With Johnson <unk> Johnson, Dan led the digital surgery strategy initiatives tasked with developing an integrated strategy for robotic surgery, leading to the 2019 acquisition of Auris Health <unk>.
<unk> will benefit greatly from their insight and guidance with that I'll pass the call over to Mark to update you on our clinical development programs Mark.
Thank you Liz.
I jump into our clinical update I want to share our results from our recent retrospective analysis published in the British Journal of Urology International.
Study was conducted by Dr. Carl Rose and colleagues and evaluated 32 patients who received at least one dose of <unk>.
Study found that 17 or 59% of patients had no evidence of disease at primary disease evaluation.
That did not recur at a median follow up of 13 months post reduction importantly, the rial stenosis occurred in just 9% of patient study with <unk>.
Multi institutional retrospective analysis concluded that integrated administration of Gen. <unk> demonstrated a favorable safety profile, including a low rate of ureteral stenosis and can be administered without general anesthesia.
Additional reports of a real world data are anticipated later this year and are expected to support the use of <unk> to treat low grade <unk>.
As Liz mentioned, both of our phase III envision trial with one or two in our phase one trial <unk> 301, our ongoing envision as our single arm International Multicenter study evaluating the efficacy and safety of <unk> in one or two as primary chemo ablative therapy in patients with recurrent.
Low grade intermediate risk <unk>.
There are no approved primarily non surgical therapies for malignancy that affects approximately 80000 patients each year in the U S alone. It is also worth restating that for these patients. The current standard of care remains trends retail resection of a bladder tumors or <unk>, a surgical procedure performed by resectoscope through the <unk>.
Myers seizure lifelong surveillance and is associated with risks and complications and frequent recurrent treatment up to 61% of <unk> patients typically experience recurrence after one year and 78% experience recurrence after five years.
34% to 76% of patients show evidence of tumor over <unk> two to six weeks given the high recurrence rate of low grade intermediate risk and there might be seen there remains a high unmet medical need for alternative therapies that decrease procedure related risks and the need for repetitive intervention, we believe that.
June one or two if approved has the potential to offer convenient <unk> therapeutic option administered in an outpatient non surgical setting.
We expect the envision trial to enroll approximately 220 patients across 90 clinical sites, who will receive <unk> once weekly in traditional installation.
Two the primary endpoint will evaluate the complete response rate at three months. After the first installation and the key secondary endpoint will evaluate durability over time in patients who achieve a complete response at the three month assessment.
We remain confident about the design of the envision trial.
Clinical potential of <unk> in one or two based on similar design to our previously completed phase <unk> Optima II study, which included new and recurrent low grade intermediate risk patients.
Pleased to announce we anticipate the trial to be fully enrolled as soon as the end of this month with an NDA submission planned in 2024, assuming positive results in parallel we continue to advance a single or at home and solution feasibility study with <unk> 102.
In 2023, we intend to share a data readout from the Atlas trial, which will be included in our planned NDA submission, including complete response duration of response and safety data of patients who completed treatment with new Gen one and Q.
To further build on what Luis commented about in her opening remarks, we are likewise optimistic about the clinical potential of <unk> 102, because of its similarities to Joe might have both products utilize <unk> as their key pharmaceutical ingredient, albeit in a different ratio in both allow for local delivery and <unk>.
Sustained exposure to might've bison for up to six hours importantly, both low grade <unk> low grade <unk>.
Sure many biological and clinical similarities we are optimistic that the clinical results demonstrated by Joe <unk> in the kidney could translate similarly to the bladder.
102.
It sets itself apart from <unk> is that it.
It is designed to be instilled into the bladder urethral catheter into the outpatient setting we believe that if successful it may offer a simpler minimally invasive non surgical alternative to <unk> that can be administered in clinic by a urologist or a member of the support staff.
<unk> and Kols, we've engaged have already shown a receptiveness to this potential new treatment option with 96%, indicating they are likely to use Eugene and one or two within two years of approval.
Meanwhile, our phase one trial of <unk> 301, our in licensed anti <unk> four antibody for intramuscular administration in our T. Gel continues to enroll <unk> hundred one is in development for the use in combination with other immuno modulators, including <unk> hundred one our proprietary.
<unk> seven agonist and other potential chemotherapy and immuno therapies to treat high grade <unk> seen this.
This study is aimed at identifying the suitable dose for a subsequent phase two trial, we view Eugene in 301 is a cornerstone checkpoint inhibitor for a variety of potential combination therapies targeting targeting and it might be seen and continue to see broad applicability of intra vesicle administration therapies with RTG.
Well.
A compelling opportunity to explore novel immuno module four drug combinations for advancing care in a broad range of clinical indications and Urologic and specialty cancers, I'll now hand, the call over to Jeff to provide a commercial update Jeff.
Thank you Marc as Luke noted the third quarter saw a slight decline in <unk> sales compared to last quarter. However, on a year to date basis, Joe module sales have grown 45% compared to 2021.
We remain confident in the long term success of <unk> and its ability to address a significant unmet need in an underserved patient population.
Last year, we attributed third quarter softness to what we believe corresponded to arrive in COVID-19 cases.
We now believe that the slowdown is more likely a result of seasonality, resulting from a wider conversion rate of patient enrollment forms to new patient starts.
Specifically in 2021 half conversion slowed down in July before returning to baseline in August . This year. However, the slowdown continued through August and snapped back September right. After the labor day holiday.
While this pattern was not expected, we do feel better about the consistency, we're beginning to see quarter to quarter and expect to return to growth in Q4 based on the number of pests converted in October .
Key metrics learnings from the field and recent real world outcomes data continue to give us confidence in the low grade UTC opportunity.
<unk> metrics continue to support encouraging trends and positive long term thesis.
Activated sites on November one with 930 compared to 893 on August one and repeat accounts were 177 compared to 144 for the same periods.
Additional metrics demonstrate a steady addition of new prescribers, each quarter and steady expansion of repeat users as well.
Reimbursement remains at approximately 99% across all coverage sites importantly, several larger academic and referral institutions on our part.
Coming online, including NYU, and LSU, which has taken longer than expected to onboard.
From a field operations perspective, several territories and sales reps continue to outperform others, we dug deeper to better understand what's driving their success and came away with several important findings first.
We found that while patient identification remains a key driver.
Early adopters and these regions tend to be comfortable using Joe model for all appropriate patients.
We also learned that in the field, Joe Mandato closely resembles a medical device sale within a therapeutic.
In response, we proactively made changes to several underperforming territories and regions to better align with this type of relevant experience.
As Liz mentioned, Dan Waldmann, who led J&J med device business is a recent addition to our board of directors and we expect his extensive device experience to have a positive impact on our commercial organization.
We also continue to look for opportunities to facilitate additional logistical efficiencies and minimize operational complexities for doctors and patients during.
During the third quarter, we announced the FDA authorization of an extension of the end use period of gel midol add mixture from eight to <unk> 96 hours.
We believe this update simplifies treating <unk> and will positively impact adoption moving forward.
We're already seeing positive impact helping to solve several logistical challenges, including allowing for delivery of the admixture the day before the installation.
And enabling early morning installation, which based on the feedback from the field is preferred by nearly all of our HCP.
Feedback is overwhelmingly positive and day before delivery has proved as providing confidence and on time procedures for both patients and doctors.
Looking ahead to next year, we anticipate all doses will be delivered at least one day before scheduled installation and for 90% of procedures to take place before 90 M, allowing <unk> to fit in nicely with the HCP schedules.
Not only does this benefit current adopters, but it also allows us to reengage with prospective customers, who were reluctant or unable to adopt home Idaho as the previous and use period of eight hours was viewed as too restrictive.
This reinforces our optimism for the future of Joe Murdo to enhanced treatment of low grade UTC and lay the foundation for the potentially much larger opportunity with <unk> 102 in low grade intermediate risk non muscle invasive bladder.
As Mark mentioned the publication of outcomes from real World data. Most recently in the form of retrospective analysis evaluating administration of gel Murdo via Nephrostomy tube continues to support the use of Joe Murdo and low grade <unk>.
Growing adoption of administration via Nephrostomy tube, which represents more than 50% of <unk> installations continues to offer operational efficiencies and benefits to patients as well.
Hcp's generally recognize the benefits of an integrated administration, which avoids the need of an ore and offers more flexibility with scheduling and installation since it can be performed by a trained nurse and does not require fluoroscopy after placement of the nephrectomy too.
During the third quarter, we continued implementing our phased launch of our you track registry, which is expected to provide additional insights into the real world outcomes of <unk> patients treated with <unk>.
And evaluate its used in clinical practice in the U S.
With that I'm happy to pass the call over to Don to discuss our financials.
John .
Thank you, Jeff and thank you everyone for joining today's call I'm pleased to be with you today to review our financial reserves of the third quarter ended September 32022.
<unk> reported a net product revenue <unk> for the third quarter, 2022, or 16 point to $1 million.
Compared to $11 million to $4 million in the third quarter of 2021.
We presenting a 41% increase from the same period last year.
Cost of revenue for the third quarter over 2022 was approximately $2 million, resulting in a gross margin of 87% compared to gross margin of 89%.
Third quarter over 2020 one.
Research and development expenses for the third quarter of 2022, or 13 point to $1 million, including noncash share based compensation expense of $600000.
As compared to $11 9 million, including noncash share based compensation expense of $1 million.
The same period in 2021.
Overall increase of $1 $2 million.
Primarily attributable to the phase three envision study for use in one or two research into ingredients of scale up and production.
<unk> CFO Jim idle.
Partially offset by lower stock based compensation expense 2022.
Selling general and administrative expenses for the third quarter of 2022 were at $19 to $1 million, including noncash share based compensation expense over $1 8 million.
This compares to 21 6 million.
Including noncash share based compensation expense of $4 5 million for the same period in 2021.
Reduction in SG&A resulted primarily from lower stock based compensation expenses in 2022.
For the third quarter ended September 32022, we reported a financing expense related to the prepaid forward obligation to RTW investment of $4 8 million.
Compared to $6 8 million for the same period in 2021.
Interest expense related to the up to $100 million home loan facilities with the funds made Biopharma advisors was $2 7 million for the third quarter of 2022.
The transaction closed in March of 2022.
There was no such expense in the third quarter of 2021 for.
For the third quarter ended September 32022, we reported a net loss of $25 8 million or $1 13 per share. This compares to net loss of $32 million or $1 35 per share in the third quarter over 2021.
The net loss for the third quarter of 2022 includes two point to $4 million in noncash share based compensation expense compared to $5 5 million in noncash share based compensation expense in the third quarter over 2021 we closed the quarter with $95 9 million.
In cash cash equivalents and marketable securities.
During the third quarter, we continued to prioritize our balance sheet in support of our commercial and clinical development activities.
We remain cognizant of the challenging capital market environment and maintain a keen eye on peptide preservation.
He is on prudent and responsible management of our operating catch car continues to ensure investments in our core assets, specifically J modal commercial stage growth and clinical development of <unk>, one or two as parties.
While we acknowledge the contraction in termite nest says, we will able to offset this short floor by deferring quarters pending noncore activities ending the quarter with a solid two point of $2 million.
And operating expenses.
<unk> 7 million below consensus.
Our efforts to manage our cash flow gives us confidence in our ability to end the year with approximately $100 million in cash, which assumes the receipt of the $25 million second tranche under our $100 million home loan facility with the pharma advisors, which is expected to fund <unk>.
<unk> 16 2022.
Project to customary conditions and deliverable.
Looking ahead, we will watch revenue and expenses carefully while also managing the emperor avenues of <unk> type potentially available to us shows are needed to opportunistically strengthen our balance sheet arise.
With that I would like to turn the call back to Lisa for closing remarks.
Thank you Don as we look ahead, we are very enthusiastic about the learnings and covered several over performing territories that will allow us to capitalize on our significant market opportunity to increase adoption. For example might have we're even more bullish on the potential of low grade intermediate risk non muscle invasive bladder cancer with <unk>.
And look forward to sharing data in 2023, and leveraging our experience to prepare for its potential approval and launch in the not so distant future. We thank you for your continued support as we advance both programs in parallel I'll now turn the call over to the operator for a Q&A session operator.
Thank you if you'd like to ask a question. Please press star one one.
Our first question comes from.
<unk> Patel with H C. Wainwright your line is open.
Hi, Thank you for the update this is deepak propelled standing in for Ram <unk> I have a few questions with regards to Joe Mito and then a few others with regards to the other assets.
So beginning with gel might so what percentage of potential target physicians remains likely to switch to using Joe myself with the new installation method.
I think it's hard to measure I can tell you that that new installation method has increased last since last we spoke from around 40%, 45% to now over 50% and that was without the data from Dr. Rose we had.
Only nine patients and now we're looking at.
32 patients, which is obviously much more robust so the.
Nation.
That it will help it will grow it will make things more convenient for both the physician and the patient.
But as far as the exact number we do believe it's going to help grow <unk> sales overall, but it's a matter of obviously.
Understanding the clinical benefits first.
And this will certainly help from a convenience standpoint.
Great. Thanks, and have the utilizing physician population remarks control upon the enhanced ease of use with the in use period extension for German mines last mixture and how impactful is this.
Definitely have reacted well again at this provides an opportunity for those physicians that are used to doing surgeries in the morning.
Because we may not have been able to get them a mixed dose until the afternoon, they've had to shift a lot of things around the business territory business managers have done a phenomenal job managing that.
In some cases multiple positions would give a dose to the same patient just because of the scheduling this will allow flexibility.
So to confirm that the doses there the day before it will allow the representative if they're in they're supporting.
To do that in the morning.
Then once they support the installation in the morning, they're able to go out and sell and bring <unk> to more patients and so the response has been immediate we've already had I think the number is higher now five accounts.
That have gotten the product the day before and administered in the morning. When this wasn't possible just a month ago.
Great. That's helpful. And then have there been any new developments with respect to optimizing the value of Joe My toe in ex U S territories.
No what we've continued to do the named patient program, but we have not done any work on ex U S. Mainly as we've talked about before because of reimbursement. So the idea is to sort of get.
Understanding and appreciation for the value of Yamato and ex U S territories, and then at that point in time be able to go to payers and.
Our work with them on being able to.
Ah.
Valuable and feasible frankly price for bringing <unk> into the market I can just tell you that yesterday I received an article that was done in Australia that talked about a patient that got dose or the named patient program and how compelling it was for her personally and hoped for.
Those types of story will start to get out and then the payers and the government will be more interested in working with us on being able to provide a price.
At reasonable prices to be able to market the products outside the U S.
Great. Thank you and then just a couple of questions on some of the other asset <unk>.
Since you now expect possible completion of enrollment in the <unk> 102 phase III envision trial by the end of this month.
And might we see top line data and how quickly after that might you be able to file for regulatory approval of the drug in the U S.
Yeah, So as we've mentioned before and just.
Just so that everybody understands the good news is we've actually.
Already recruited already today recruited the number of patients we need to hit our enrollment target. So it's just a matter of shifting from from the recruitment to enrollment and Thats why we felt very confident in our ability to do that very shortly here.
Great news for us and for patients.
Remember that the peso, we all have to have we need 12 months minimum of 12 months follow up post TR for all patients before we can go to the FDA. So that obviously won't happen till after the end of 'twenty three and then it's just a matter of the timing.
The database closed and stuff so as we've talked about before our intention is to work with the FDA and.
The net in 2024, and then hopefully be able to get priority review and be able to buy to have a six month review period. So that that's the goal at this point and that's what we're working toward but.
It's important that when we do go to the FDA, it's more important to ensure that we have all of the appropriate data that will allow them to quickly review and provide approval than it is for us.
Try to try to kind of do it earlier. So again, that's the time and we need we need all of 'twenty three to get us to to get us to followed that all of the patients, which we all have 12 months and obviously has a lot of patients would have more than 12 months follow up at that point in time.
Great I appreciate the added color on that and then last question. What are the next steps are likely to be in the development of <unk> hundred one assuming positive phase one results.
Yes so.
What we will continue to do it easy in 301 is the study that we have in place.
And I apologize it really should turn this over to Mark Mark to answer, but the intention is really to combine with multiple different chemotherapies and other targeted agents and so we will cycle through.
And whatever we believe and we see in the data.
Most compelling combination and those are the ones that we would move forward with so we continue our enrollment in the <unk>.
The monotherapy and then we obviously have to get data on monotherapy for Rick and start the combinations, which should happen in 2023.
Great. Thank you so much for the update.
Our next question comes from Boris <unk> with Cowen Your line is open.
Alright, thats several questions as well maybe first let's start on Joe Midol, how should we be thinking about the expectation for <unk> sales and also do you anticipate tuition annual guidance in early 'twenty three.
I'm sorry, what was the last question do you anticipate to issue annual sales guidance in the beginning of 'twenty, maybe JP Morgan or on your <unk> results call.
Yes, so I think what where we are right now obviously, given the Q3 results.
Do expect that Q4 will return to growth in Q4, having said that that.
I can't I'm, not confident in being able to say that we won't hit guidance. This year. So I think that it's too early to speculate on what we will do as far as guidance for 2023.
So I think Q4 is an important quarter for us. The good news is is that we've seen a real bounce back is as Jeff talked about in September and October and November to date.
But again too early to speculate and given the variability I think we at this point in time, that's all we're going to say about about guidance.
Got it and then lastly, when it comes to Joel Mitre administration within the prostate you mentioned an increase.
Increasing proportion patients can you talk about the economics for the physician or traditional administration versus proximity.
Sure so.
And then approximately two if they were to go to the surgery center or to the hospital or the surgery Center or hospital buy and Bill for the drug. This gives the clinician the opportunity to go to administer it in their clinic.
Where they would buy and bill for the drug so from a professional fee, they're probably similar theres always a little bit more because they are encouraged to give it in the clinic I don't know how meaningful that is but it's really the buy and bill portion.
<unk> physicians to buy the product in their clinic administer it in their clinic versus <unk>.
Retro grade they often go to the ASC or the surgery center would buy the product or the hospital, where the hospital with buy and bill for the product.
Got it. Thank you thanks for taking my questions.
Thanks Boris.
Our next question comes from Matt Kaplan with Ladenburg. Your line is open.
Hi, Thanks for taking the questions and good morning.
Just can you talk a little bit about how you can translate your success regional I guess in the northeast to more broadly.
Across the country and what your strategy is to do that now for you all might have.
Sure. So the challenge with <unk> is that each region. Each territory is a bit unique the northeast is not like the Midwest. They may have more academic centers. The Midwest may have more larger community accounts and so what we've found is very important to look at each region.
Look at each territory and decipher the background.
The business manager, that's really going to be successful we sure. It's a great question that we share best practices every day.
And many of them.
Are implemented in the accounts that are similar to those that are successful but.
What business managers will tell you is that each each account is unique.
And they do things differently.
And it's important for them to problem solve to work through the operational logistics to work through formulary, but.
But yes, certainly we're sharing best practices and where they are applicable across the nation, we're implementing those.
It's channel it is a challenge because not every territory is similar and so we have to make sure that we get the right person in there and we have to adapt accordingly.
And you mentioned something about <unk>.
Thinking about <unk> at in certain regions as a as a device type salary drug device combo sale.
Have you implemented that aspect of it yet or do you think that that should have an impact going forward.
We have and I believe it will.
And the last year, we provided more hospital training.
We certainly look at the territory and try to get the perfect fit for that territory. It does resemble a device, but that doesn't necessarily mean that we have successful.
Territories that have device.
It's a mix it's a certainly a mix what's consistent is high.
Higher and folks that can work and navigate through the issues and more importantly are motivated by the challenge quite frankly in this as you talked to the business managers. This is.
Hard work, it's a lot of work, but it is very gratifying once they become successful and getting these accounts onboard and getting patients treated with <unk>. So yes that we recognize this and.
<unk> implemented some changes.
Well as I talked to you know, making sure that we have the right person in the territory.
Okay. Great. That's helpful. Thank you and then just a follow up to <unk> question. I guess previously you had given guidance for $70 million to $80 million revenues for this year I guess now with more than with a $46 million in the first.
Nine months.
What.
<unk>.
What are you seeing now.
In terms of ability to meet that prior guidance.
Yes, no as I stated before when <unk> asked the question I would say that we do not think that we will be able to hit guidance for this year.
Having said that I think we feel very good about where we are in.
In Q4, and where we're going just to give you seven perspective right. If you had looked at that.
Growth rates from last year second half over first half.
If that had translated we would've hit the guidance this year as well and even through where we are but we had a really really strong Q4 over Q3 last year I think the good news is what we actually are seeing is more consistency. So while we while there was a slight decline in Q3, it was nowhere near that.
Magnitude that we saw in 2021, which gives us a lot of confidence in the fact that we're getting to a more consistent.
Quarter over quarter experience and so I think that's important also just to note.
Part of what Jeff was talking about I think the other thing that we're very enthusiastic about is how successful some of our territories have been what that tells US is that the opportunity is there right. So it's not a situation where we felt like the opportunity is and what we expected we actually see and they have proven that it is.
There and we know that if we have the lower territory anywhere near the average of the better territories that that this is a significant product as we've talked about many times so.
All of those things combined with the changes that Jeff has talked about.
Really really gives us a lot of confidence in the future. It's just a slower stay really honest about it just a slower.
Growth than we expected it to be so the inflection point and we were in the middle of Covid and now we're seeing that yes. It continues to grow we continue to get very positive we continue to see.
Accounts come on.
We continue to see new doctors prescribe and then most importantly, the doctors that are using it we actually see them adopt this as their standard of care. So they are using this in most of their patients have <unk>.
All of those elements.
It gives us great confidence at the peak, where we expect to be has not been unchanged. It's just that growth rate to get there.
Okay. Okay. That's very helpful. Thank you and then maybe a question for Mark on the.
The <unk> 301 phase one study.
Can you talk about a little bit of what you're looking for.
And what would what would meet.
Designate a positive result in that phase one study as a monotherapy at before you go into the combination arms of that study.
Matt Thanks for the question so remember this stuff.
The study is designed in order to help us identify an appropriate dose for inter vesicle administration of this antibody.
Which of course is a very novel things.
Seem to be doing in this disease state.
So what we're looking for is safety and Tolerability and the identification of the dose we would obviously be interested if we saw.
On the efficacy signal, but that's really not the point of the study currently is to help us identify a dose which we can then carry into the next phase of the development program, which would be combinations.
Earlier with other agents such as our <unk> seven agonist.
Or other potential combinations with chemo or immuno modulators.
Okay. Okay. Thank you.
Thanks, guys.
Thank you Matt.
Our next question comes from Chris Howerton with Jefferies. Your line is open.
Great. Thank you so much I think probably most of the questions at this point have been answered.
Was curious what the status of <unk> hundred one was.
And Mark I guess I am always kind of bugging you about this one but.
What about doing a combination study with BCG in high grade I can appreciate the fact that there are supply issues, but BCG is already approved and would have a similar mechanism to other <unk> agonism. So maybe I'll just end with a bit of a combative question to mark. Thank you.
Thank you very much Chris.
Listen I want to come in as well just give you my my impression.
One of the interesting things about BCG is that although if you read about it there are a lot.
Other hypotheses about how it works it is still an area of active investigation and it is a bit of a history how it.
Does what it does and as you also know many people who received BCG ultimately relapse. So between the issues related to supply as you noted because BCG is in short supply and manufacturing is challenged currently having a real impact on clinical practice I think personally it would be good.
Right and I'm glad that we're doing this to identify other novel immuno modular towards combinations, which would move us away from a BCG dependent strategy for this particular population. So while I can agree with you on a theoretical level that it would be interesting to do I think practically in from a clinical proof.
<unk> it.
It will be very important for us to pursue lines of investigation like we are doing an urgent namely to seek other important immuno module, a tory and potentially other types of therapeutic combinations to address the unmet need in this patient population, which is acute and as you know these patients do face some difficult choices when BCG does not work.
Okay, that's fair.
Alright, that's fair bet and so what about for 200 women.
Well as you know and as we've previously discussed we have.
Very interesting non clinical data, suggesting that there is a sort of a synergistic interaction between 201, and 301 and that forms the basis for our.
Our current development program for the 301 molecule. So one of the combinations we are contemplating.
Tentatively planned as the combination of 201 with 301 once the phase one dose escalation study has provided us with safety and dose information about 301. So we are still actively developing that as a combination that wed like to carryforward. Once we have the.
One data on me on the antibody.
Yeah.
Okay.
Awesome. Thank you very very much I appreciate all the answers and look forward to.
102 data from Atlas soon.
Thanks, Chris I appreciate it.
Our next question comes from Paul Choi with Goldman Sachs. Your line is open.
Thank you and good morning. My first question is for Jeff and Jeff I was wondering if you can maybe just help us understand.
Market, maybe segmenting, a little more as to which proportion of potential prescribers are.
About <unk> as a device.
<unk> space approach.
Maybe relative to.
Medical Oncologists, who think about it more from a.
Therapeutic treatment perspective, and just help us understand.
<unk>.
Additionally, a portion of the prescriber base you might be additionally, able to target here.
So I think what we've what we've seen is.
Lynn device reps are sort of part of the LR team, they're in there they're assessing whether.
<unk>, our nursing team or their assisting with the installation and so I think.
It's just it's more of a mentality as a company and I think as a business manager even if the business manager has a lot of buy and bill experience.
It's adapting to the institution and the academic institution or maybe where they are familiar the clinic or the larger urology group and so.
It's more of just a yes, we look at that certainly when we're when we're hiring.
But it's also we look at it.
With the additional training that we give.
Do think that positions the accounts that we have that are looking at Joe might owe for every patient really appreciate our support they appreciate the business manager. They appreciate the nurse.
Appreciate the field reimbursement manager all of the support that we provide them is just a little bit more device oriented.
That's where you see early success and then you see consistent success.
There's a constant effort to try to find patients that will benefit from gel. Michael. So we're we're doing that you've heard me say in the past we do need to go deeper into accounts that still holds true, but we need to continue to set accounts up you heard me mentioned on the call NYU has come onboard LSU as well there are still plenty of accounts loss.
Like those that need to come on board and we need to provide them that the support and behaving more like a.
Device, which is we have so many similarities this is a procedure.
This is sometimes in the or there are many things that are similar.
Starting to see rich.
Receptiveness, we're starting to see doors open.
And it's it's.
Different type of sell then its just the pill, where you write a prescription that goes through specialty pharmacy.
It's just a different mentality and when we do that the accounts the physicians really they notice the difference.
But more importantly, we notice a difference because we have more success.
And just commentary Paul to ask.
Medical Oncologists don't treat these cancers. These are really treated by urologists.
You have your large urology group practices and then you have your institutions and what we have found to Jeffs point is its really win when you go into the institutions, where you had can have some great success.
And the large group practices tend to use more than the proximate to the administration and so that's where we're seeing some delineation, but just and just to be clear in tier and answer. Your question, it's not really about medical oncologists, it's really with urologists.
Alright, okay. Thanks for that.
My My second question.
For you Liz or maybe Mark is just your commentary on.
Thinking about getting priority review.
For one or two next year, obviously, you had success with your one on one filings can you maybe just comment on what feedback or.
Commentary from the regulators do you foresee if I.
Underpinning that.
Yes.
View that you could possibly get priority review next year, when you do some or sorry in 'twenty four and when you do something at the filing.
That's really just based off of the fact that to your point, we were able to get it for.
For <unk>, we do believe when the agency.
Agreed with us on the high unmet need and.
With this patient population and we moved to a single arm study I think that that shows that they recognize that there is a high unmet need. So when you take those things into consideration I mean, I think that's why we felt like we have an opportunity to take get priority review.
Again, using a lot of the same the same data when you think about it and approach as we gave it using an 101, which is now John might have that.
Okay, great. Thanks for that clarification.
And last one for me is just the financial.
Maybe for Don.
I think your comments have your cash.
For this year factor in the second tranche access to the second tranche are coming along but can you provide an update on.
After that.
Second tranche, what your assumed cash runway is going forward.
Yes, sure. So we already gave the notice the Carmichael and which was accepted so we are going to get funded.
December 16, this year before the year end and we then money we are going to achieve approximately $100 million at the end of the year.
And the analyst.
Go ahead.
And how long is that $100 million assume to last you through.
So the $100 million listen I'll cover 2023, and it all depending on our termite revenue and also how we invest and spend the money right. So we can pretty much cut a lot of stuff, except for our core business, depending on again, Jo Mira <unk> and financing financial market condition goes.
We are not going to touch anything about the <unk> growth and using Illinois tool.
R&D and investment.
Okay. Okay. Thank you very much thanks for taking our questions.
Sure Paul.
Our next question comes from Leland <unk> with Oppenheimer. Your line is open.
Yes. Thanks.
My apologies I joined a bit late so I missed the prepared remarks and I was wondering did.
Could you touch on the use of the Nephrostomy tube delivery method.
<unk> been trending and I think on your last quarterly call you had mentioned that was a.
A favorable aspect with respect to.
Physician uptake and convenience and so forth.
Has that been playing out it seems like with the sales.
In Q3.
<unk> been a supportive is as you'd expected could you provide some more color. Thank you.
Sure So hi Leland.
Yes, we are now over 50% I think the last time, we reported we were around 40, 40% to 45%.
Over 50% is still without the data that Mark just talked about from Dr. Rose.
32 additional patients.
That we will be able to go out there and discussed with physicians.
And I think youre going to see there.
That will start in Q4, so the effects of that will be Q4, moving onward, but its still slowly was going up even with just a small amount of patients that we had had to reference from Dr. Mary. So good that we will have additional I think those physicians that were a little reluctant.
Nine nine patients.
We're probably still doing retro great I do think with this additional data youll see youll youll see a big increase in approximately tube administration.
Okay, and just to drill a bit further I mean, it seems like there are other hurdles to growth and uptake of gel murdo could.
Could you put into perspective kind of the role that.
And approximately two.
On the <unk>.
Move to that frustrates, who.
It is offset by.
Other hurdles that still exist, whether it's reimbursement whether it's other logistical issues.
As we think about kind of how <unk> is doing here too.
Two plus years into the launch thanks.
Sure couple that with the additional eight hours stability to 96 hour, how thats going to eliminate a hurdle that was in place a month ago. So nephrostomy tube administration allowed convenience for the physician and the patient let's start with the physician if we didn't have.
<unk> as an opportunity the physicians would have to go to the or to go to the surgery center he'd have to schedule time.
They may or may not have to have another physician trained to give the dose through the same patient just because it doesn't work out from a timing standpoint.
We know that patients would prefer to come to the clinic.
More than they would the surgery center or the hospital.
It's just it's an overall convenience.
We now have more robust data to talk about with those doctors, who to your point solid as a hurdle.
Maybe not a hurdle that they could overcome but certainly was a hurdle there.
We're excited about the 8% to 96 hours.
In fact, just since I saw you answered <unk> question first question.
So that 15 accounts have now gotten the product before the day before and had been administered in the morning by the end of the week, but today, we're going to hit will have or by tomorrow. We will have up to 20 accounts that are doing that so there that's probably just as much excitement is getting that stability increase to allow for flexibility.
So if they want to administer in the or if they want to administer in the surgery center. They can now do it on their schedule because of this flexibility. So these two operational hurdles that existed.
Really no longer exist moving forward.
Okay. Thank you.
Hey, Glenn.
That concludes our question and answer session I will turn the call over to Liz Barrett for any closing remarks.
Thank you as always we appreciate your support and interest in Europe , and we continue to forge new ground in the treatment of your own theory, all cancers, as we change and very long embedded standards that we have much to look forward to over the next 24 months, we will keep our open dialogue as key initiatives play out. So I hope you guys. All have a nice day and operator you can now.
Now disconnect. Thank you.
This concludes the program you may now disconnect.
Goodbye.
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