Q3 2023 UroGen Pharma Ltd Earnings Call
Good morning, ladies and gentlemen, and thank you for standing by and welcome to the Euro Gen. Pharma Q3, 2023 earnings call. Please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today had been some brown head of Investor Relations you may begin.
Thank you operator.
Good morning, everyone and welcome to Euro again farmers third quarter 2023 financial results and business update conference call.
Earlier. This morning, we issued our third quarter press release and filed our 10-Q, where you can find details for our financial and operating results.
Both documents can be accessed on the investors portion of our website at investors thought Euro John Dot com.
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 Tom <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 related to Joe <unk>, our ongoing and planned clinical trials commercial and clinical milestones market and revenue opportunities, our commercial strategy and expectation as well as potential.
Future commercialization activities for <unk>, one or two if approved anticipated data regulatory filings and decisions, including <unk> potentially receiving priority review UGI and one or two being the growth driver for you again, if approved future research and development efforts, our corporate goals and <unk>.
Thousand 23 financial guidance among other things.
These forward looking statements are based on current information assumptions and expectations that are subject to change.
Description of potential risks can be found in our earnings press release of the latest SEC disclosure documents.
You are cautioned not to place undue reliance on these forward looking statements and European disclaims any obligation to update these statements.
I'll now turn the call over to Liz Liz.
Thank you Vincent and welcome to everyone joining us today before we remark on the quarter I must mention the October 7th attack on Israel and its impact on our Israeli colleagues partners and investors. The safety of our employees is and will continue to be top of mind with regard to any potential.
<unk> impact to our business operations I want to assure our shareholders that while we have a portion of our workforce based in Israel, we have robust contingency plans and international partnerships in place to ensure the continued smooth operation of our business.
As a result, we do not anticipate any significant impact on our business our operations.
Finally, we hope and pray for peace to return to the region as soon as possible I'll now turn to the quarter.
Q3, 2023 was one of the most important quarters in <unk> history. During the third quarter, we shared extraordinary topline results from our phase three clinical trials evaluating the use of UGI and why no two to treat patients with low grade intermediate risk non muscle invasive bladder cancer.
Both the Atlas and envision trials met their primary endpoints, demonstrating meaningful and compelling results overall and compared to the current standard of care can you RPT. This is particularly notable because Eugene and one or two is being developed as the first nonsurgical therapy for this type of bladder cancer.
Sir.
Mark will talk more about this but it's important to delineate the various types of bladder cancer and understand that our products are being studied and patient segments that are not being studied by other medicines.
Following this announcement, we held a pre NDA meeting with the FDA to align on the regulatory path forward for <unk> 102 as expected. The FDA confirmed that the current clinical development plan for Eugene Mono tube, which includes evaluation of duration of response at 12 months following HCR.
At three months and the pivotal envision trial will support submission of an NDA. The FDA also agreed that our NDA can utilize a rolling review, allowing for early submission of CMC sections of the NDA, which is planned for January 2024.
Looking ahead, we anticipate sharing data from the duration of response endpoint in the second quarter of 2024.
Pending favorable results, we expect to submit the NDA to the FDA a few months later.
If granted priority review, we anticipate approval and launch in early 2025.
If approved we believe that <unk> would represent a groundbreaking nonsurgical option for approximately 82000 annual patients suffering from low grade intermediate risk non muscle invasive bladder cancer.
Currently face frequent recurrences no status necessitating the need for multiple surgery.
This potential milestones stands to becoming major growth driver for your gen with a substantial market in the U S exceeding $3 billion.
Q3, 2023 was also the second strongest revenue quarter for <unk> and low grade upper tract <unk> carcinoma, we're pleased with the pace of growth for <unk>, especially when considering this is a rare disease treated in both community and academic centers, we will continue to drive growth and meaningful adoption through.
Increasing sites of care and leveraging the growing body of real world data, highlighting <unk> meaningful value and as part of a multimodal kidney sparing approach to disease management for.
For the third quarter, we reported $29 million and Joe <unk> net revenues, an increase of 30% year over year. We believe there remains significant growth opportunity for <unk> is the first medicine ever approved for low grade <unk>.
Bringing a differentiated chemo ablative approach to patients.
The closing of our $120 million private placement during the third quarter was an important milestone that significantly strengthened our balance sheet given our fortified financial position, we are committed to deploying capital to maximize shareholder value and plan to utilize proceeds from the raise to develop and execute a car.
Per handset pre commercialization and launch strategy for UGI, and one or two while continuing to grow <unk> sells.
Importantly, and based on our latest financial forecast, we believe our current cash position will support our commercial organization through the prospective launch of <unk> 102.
Q3, 2023 and was a transformative quarter for your origin. Following strong topline data from Atlas and envision in our pre NDA meeting with the FDA, we have a clear path forward towards an approval for <unk> 102, and low grade intermediate risk non muscle invasive bladder cancer.
While <unk> continues to grow its footprint in low grade <unk> I'm very proud of the dedication and commitment across our organization as we remained focused on pioneering a new era, and urologic and specialty cancer care.
<unk> is at its strongest and most encouraging point in our company's history I will now pass the call to Mark who will provide a clinical update mark.
Thank you Liz and Hello, everyone I'd like to take a moment to briefly summarize topline results from the Atlas and envision trials before commenting on our recent pre NDA meeting with the FDA.
As a reminder, Atlas was an open label randomized controlled phase III study designed to evaluate <unk> in one or two.
With or without <unk> versus <unk> alone.
While enrolled 282, new and recurrent low grade intermediate risk and it might be C patients.
Atmos met its primary endpoint of disease free survival with <unk> in one or two demonstrating superiority to <unk> with 55% reduction of risk for recurrence progression or death in patients who received <unk> had one or two.
Eugene I wanted to also showed a 65% complete response rate at three months for patients who only received Eugene what are two compared to a 64% complete response rate at three months for patients who only received <unk>.
When we evaluate the subgroup of patients with recurrent disease and a history of at least one prior <unk> you observe duration of response in the Jan one or two treatment group was a resounding 66, 3% 12 months after achieving a complete response or 15 months post randomization.
This is in comparison to 40% duration of response observed in the <unk> at the same time point.
Results offer compelling insight into the effective Jan one or two and recurrent patients which is the population studied in our pivotal trial envision during.
During a recent pre NDA meeting FDA reaffirmed.
That envision will serve as the pivotal trial for <unk> 102, NDA envision, which is a single arm study of <unk> in one or two enrolled 242 recurrent low grade intermediate risk and it might be C patients with a history of at least one prior <unk>. The study met its primary endpoint demonstrating that patients treated with you Jim.
Two experienced an impressive 79% complete response rate at three months following initiation of treatment with.
When looking at the totality of clinical data, thus far Eugene one or two has demonstrated consistency in the three month complete response endpoints across all three trials.
<unk> and durability of response endpoints in outlets in optima, demonstrating a compelling therapeutic and safety profile throughout for envision we maintain our view that a rate of duration of response of 50% or greater as a clinically meaningful outcome in this patient population given the consistency and the durability and.
Points from Atlas in Optima, we anticipate potentials potentially similar outcomes for envision, which we believe would position <unk> 102 for approval in low grade intermediate risk and it might be seen.
Before turning the call over to Jeff for a commercial update I'd like to briefly comment on the recently reported clinical data in bladder cancer from several several of our peers as a company <unk> mission is to build novel solutions to treat <unk> and specialty cancers, because patients deserve better.
Recognize the need for innovation and the development of new therapies in our space. Thus we are encouraged that there are programs in development that may offer patients potentially better options than the current standard of care. However, as we near the final stages of clinical development for you Jan one or two and with the prospect of commercialization on the horizon, we are discovering how.
The significant distinctions between low grade and high grade and it might be see an EBIT metastatic bladder cancer may not be widely recognized.
Low grade <unk> high grade and it might be <unk> in metastatic bladder cancer are distinct types of bladder cancer with significant differences low grade and it might be seen as characterized by less aggressive tumors limited to the lining of the bladder and typically carries a better prognosis high grade disease on the other hand consists of more aggressive cancer cells.
Within the bladder lining, which may have a higher risk of recurrence and progression. In contrast, metastatic bladder cancer represents the most advanced stage, where cancer has spread statistics Oregon's carry a poor prognosis and necessitating systemic treatments.
The key distinctions lie in tumor aggressiveness location treatment approaches prognosis and the stage of disease.
It is important to understand that <unk> is focused on low grade intermediate risk and it might be seen where the competitive landscape is much less densely populated than in high grade disease or metastatic disease.
For these recent data releases do not impact our current development, nor commercial plans nor are expected to encroach on what we believe is a significant market opportunity for this program. We are hopeful that Eugene 102 may potentially serve as the first non surgical therapy for this indication which represents a <unk>.
So as a proportion of bladder cancer cases, each year and is also characterized by a high rate of recurrence if approved Aegean one or two has the potential to shift the standard of care away from repetitive surgical care and may improve the quality of life for tens of thousands of individuals battling this highly recurrent disease with that I'd like.
Turning the call over to Jeff for a commercial update Jeff.
Thanks, Mark Q3 was another strong quarter for gel motto, we had the second strongest quarter in our history with continued momentum in our underlying business. We saw a small decrease from the prior quarter due to typical summer seasonality and continue to see strong double digit year over year growth and Joe motto sales and what is <unk>.
Now our third full year of commercialization.
<unk> net sales for the third quarter were $20 9 million, which represents 30% growth from the same period last year.
This growth in our topline reinforces our long term belief in the low grade UTC opportunity.
During the third quarter further strengthening of the <unk> ramp and expansion of the <unk> user base was the result of several key factors, including continued commercial execution.
Joe motto offers clinical utility alone or following endoscopic management as part of a kidney sparing treatment regime.
The meaningful differentiated treatment profile of <unk> and its unique feature of being the only FDA approved nonsurgical treatments indicated for low grade <unk> continues to resonate with both patients and physicians.
In addition, the growing body of data from real World evidence studies continues to strengthen and reinforce <unk> value proposition.
Supporting its multimodal use across various practice patterns and diverse presentations.
Our experience with Yamato has given US a foundation with urologists by establishing the use of <unk> and our T gel.
Consistent growth in adoption for this product reinforces our optimism for the significant opportunity in low grade intermediate risk non muscle invasive bladder cancer with <unk>, one or two.
However, Eugene and wanted to offer several distinct advantages over Joe model.
Including simpler administration and a much lighter operational lift.
Delivery of <unk> 102, if approved is expected to be easier for urologists given that it does not require the use of specialized equipment scheduling time in the or.
We will be delivered pre mixed with an anticipated one week shelf life and can be given by a doctor or support staff in clinic is an outpatient procedure.
Importantly, we believe that the reimbursement economics for UGI, and one or two relative to <unk> will not be a barrier to adoption.
Following the positive Atlas and envision data, we began executing our pre commercialization plan in preparation for our perspective, Eugene one or two launch.
With approximately 95% overlap in prescriber base and well established practice patterns, we expect a seamless integration of <unk> into our commercial organization in an expedient launch upon approval.
If approved we anticipate that <unk> will be the first ever non surgical treatment option for disease afflicting approximately 82000 patients in the U S. Each year with a total market of more than $3 billion in the U S.
With that I'll turn the call over to Don to discuss our financials.
Sure.
Thank you, Jeff and thank you to everyone for joining today's call I'm pleased to review our financial results for the third quarter ended September 32023, we are pleased to report another strong quarter of year over year revenue growth for.
For the third quarter of 2023 reported a J model net product revenues of <unk> eight points to $9 million.
An increase of approximately 30% compared to 16 point to $1 million.
Same to you at the last year.
For the third quarter of 2023 research and development expenses.
10 2 million.
As compared to $13 1 million for the same period in 2022.
The decrease is primarily due to lower expenses related to the conclusion of the Atlas Trier and lower cost of envision trial will use general no tools offset by higher R&D expenses related to phase one study for <unk> 301, and ingredient scale up and production for <unk>.
<unk> will not tool.
Selling general and administrative expenses for the third quarter of 2023 or 'twenty.
$21.8 million.
Compared to 19 point to $1 million for the same period in 2022.
The increase in SG&A is primarily due to higher marketing commercial operations professional services and training.
Offset by lower commercial back office services and support expenses.
<unk> reported a non cash financing expense related to the prepaid forward obligation to TWD investment of $5 5 million for the third quarter of 2023 compared to $4 $8 million for the same period in 2022.
Interest expense related to the $100 million term loan facility with funds managed by pharma advisors was three $8 million.
Third quarter of 2023 compared to $2 7 million for the same period last year.
Eurozone reported a net loss of 21 point to $9 million.
Or a basic and diluted net loss per ordinary share of $6 <unk>.
For the third quarter of 2023.
As compared to a $25 million to $8 million or a basic and diluted net loss per ordinary shares over $1 13.
For the same period in 2022.
Turning to forward guidance, we reiterate our anticipated full year 2023, net product revenues from <unk> to be in the range of $76 million to $86 million.
We reiterate our full year 2023 operating expenses to be in the range of $135 million to $145 million.
The company anticipates.
Anticipated full year 2023, non cash financing expenses related to the prepaid forward obligation to TWD investments in the range of $21 million to $26 million.
Of this amount approximately nine nine to 11 $2 million is expected to be in cash.
We ended the quarter with $153 9 million.
And cash and cash equivalence and marketable securities.
Which includes proceeds from from the $120 million private placement, which closed during the third quarter.
With that I'd like to turn the call over to the operator for questions operator.
Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby will be compile the Q&A roster.
And one moment for our first question.
And our first question comes from Leland <unk> from Oppenheimer. Your line is now open.
Hi, Good morning, Thank you for taking my questions.
Just a few from me.
Want to ask Martin and the FDA meeting.
Hopefully discussion.
Around what what range of durability from envision the agency would like to see.
When you have those data.
Leland Thanks for the question.
We have discussed previously our interactions with the FDA has indicated that they are interested in and we are going to provide a totality of the data regarding our data sets.
And so no specific numerical bar has been discussed as a bar for approval, but it will but.
The agency has indicated that it will be the the entirety of in a clinical meeting of the outcome of these trials that will inform their decision regarding <unk>.
Approval.
Okay and with respect to the asthma data. So we have a view on whether those will be part of.
One is we want to make.
At this point how much of this as a service.
Thanks.
Let me, let me defer to Liz on that Matt.
Leland Hi, nice to talk to you absolutely the Atlas data will be in the label and so yes, we believe that the agency in the meeting talked about that data is supportive of our filing. So yes, we expect that to be in the end.
And.
In the filing and we expect it to be able to use that data externally.
Okay, great. Thank you.
One last question for me is as we have talked in the past about work you.
<unk> been doing with respect to lengthening New Orleans.
The property.
<unk> wondering if you might have any update on.
Injections.
For Wilmington.
Yeah, no update specifically, except to tell you that youll hear more in the very near future and we are on track.
<unk>.
But to do that and as we've stated before is minimally 2035, but we actually believe it will be 2041. So we're working through final details but no.
No show Stoppers looks really great and we hope to provide an update very shortly.
Okay, great. Thanks, so much for the update and taking my question.
Absolutely. Thank you.
And thank you.
And one moment for our next question.
And our next question comes from <unk> Silva Ju from HC Wainwright <unk> Company. Your line is now open.
Hi, Thanks, very much for taking my question and congrats on all the progress recently I just wanted to get an update on where you folks think you are operationally in terms of.
Identifying any potential.
<unk> fees or cost reductions and if you think that in particular on the G&A line, we might see some additional evidence of that being realized over the course of the coming quarters or if you think at this juncture you kind of reach optimum operating efficiency.
Yeah look it's a great question to be honest with you got to remember we're about to prepare for a launch.
Revenue Madison and one that is projected to be a blockbuster. So so we are not looking at reducing expenses at this point, obviously, we're very efficient as matter of fact, we're right now going through all of our operating plans, we remain very efficient and I think the most important thing. We're looking at is how much do we actually have to grow.
For UGI, and one or two and leveraging the organization that we have and obviously shifting of some of the focus from John <unk> in one or two being.
Broader opportunity for us from a patient perspective.
I don't really see us.
Reducing expenses in some areas absolutely like an example is <unk> and R&D as the as we as we look at.
The envision study and the Atlas study coming to a close youll see some reductions there, but as we've talked about before to extend the patent life will be looking at adding.
Study, but it won't it won't be at the same rates that we will definitely see some decreases and we will see some efficiencies across the board.
But we're not looking at significant cost reduction in total.
But we are being as efficient and trust me Chad.
Challenging the team internally for particularly on infrastructure and shorten that.
We're only adding what we need and we are.
Shifting where we're at.
We can and even looking things like inventory and you know how much inventory do we need.
Other thing to just to sort of I'd note in Opex is that we have we also are ensuring our supply. So we're doing a lot around supply and secondary suppliers to ensure that there is no <unk>.
<unk> and and Thats, obviously, some incremental expense, although not significant but it is something that we want to make sure that we don't have an issue with them with supply.
Okay, and then just a bifurcated question regarding the earlier stage pipeline and potential additions to the portfolio. If you look at 2024 can you give us a sense of what you expect to be the most important earlier stage pipeline developments that you're anticipating over the course of next year, particularly.
These pertain to volatile I Mab and also any other potential pipeline programs that you anticipate would likely see notable advancement over the course of 2024.
With the exception of course of UGI on one or two which I think is very much at the forefront of People's mind, and if you could also give us a sense of whether you are looking to add anything to broaden the portfolio within oncology via strategic licensing or M&A. Thank you.
Great question, and I'm going to ask Mark to talk to answer the first one and I'll come back and answer the second question. Marc. Thanks. So we are advancing the <unk>.
Phase one monotherapy program for Zeller <unk> anti <unk> four antibody for intramuscular treatments high grade disease.
As we've discussed previously this is part of a master protocol that will permit us to study combinations with the antibody and we are already in the process of.
Creating those those components of the trial. So we would expect next year to be able to talk about our monotherapy experience and update you on how our combination work is going particularly with our telos seven agonist as well as potentially with other drugs of interest such as Jim said we've.
Yeah, and I think even from that standpoint to answer the second question, but part of that as well as we also are looking at other products that are in the market.
That we would like to combine with <unk> and our technology and so we are having active discussions with external companies nothing obviously to report right now, but it is a priority for us to your second question sure. We would love to bring in something in this space. It's a very active space as you know right now.
<unk>.
With large pharma, but also in the biotech area I think not likely in 2024 that we will be doing that but as we get into 2025 absolutely.
One thing that's really important about this business to know is this is this business is a highly leverage above business. When we think about going in and being in euro oncology you can add multiple products to your portfolio and not have to add meaningfully to the infrastructure. So when you start to get down to one.
Two years, posting a jan one or two it's a very very significant.
Improvement on our bottom line, which will give us.
The resources that we need to continue to build this company over the long the long haul and the only other thing I'll mention is.
We also are interested in taking <unk> to high grade disease. We're interested in taking huge am 102 to unwilling unable in the broader low grade space. So there is a lot of things that will start to look at down the road and I think one of the other things.
I introduce Mike Louis is here without <unk>, our new Vice President of Medical Affairs, and clinical development is the lead on <unk> 102.
It's also looking at.
Registry for you Jan one or two I'm, just like we're doing which are <unk> and we're seeing a lot of great data coming out of <unk>.
Out of that registry that will start to to publicize and Youll see more publications in 2024 around that.
Yes.
Thank you.
And thank you.
And one moment our next question.
And our next question comes from Boris Becker from TD Cowen. Your line is now open.
Alright, Thanks, several questions from me first.
From the FDA discussion you've had debates specifically say why they wouldn't accept Atlas as a pivotal trial to support approval just given the very strong hazard ratio efficacy data.
But he has reported.
Yes, Mark do you want to answer you want me to.
I'll start out and Liz will undoubtedly comment I think we had originally planned to enroll a larger number of patients and the Atlas trial substantially larger than we than we ultimately enrolled.
Data are very strong, but I think the fact that we halted enrollment would continue the trial with a smaller number of patients than originally anticipated in the original statistical analysis plan, probably inform some of the fda's position on the aggregate value of the Atlas data as a standalone submission, but listen I want to comment as well no I think that's right look we tried.
The data is very compelling.
Yes.
Their initial stance on the data is exploratory we've made very clear that it is not exploratory data. It is significant day to day did they did come around to that way of thinking but given that the if you think about it from a prospective statistical analysis plan. We didn't we didn't reach the end points that we would have.
To reach.
Two for that to be the pivotal study. So they just came back to I will say in marketing.
Let's say this as well.
If there was a very positive satisfy them that way.
Madame It was the most positive they have ever been they.
They were very impressed with the data there is no pushback on the envision only we want to see durability was frankly, not only have they said to us I've said it to everybody else in this space. So I wanted to see durability and you hear that every time you hear is about somebody in bladder cancer. So it was really more a matter of prospective.
Analysis plan and not being able to have that.
That data in hand.
But again very very positive interaction, but they've been very clear all along that.
They want to see durability and durability as it is as important to them.
CR, but that was it I mean, we did <unk> I mean, it was obviously, we felt like compelling enough.
Data, but but we understood and we knew that it was that it was a probability that they would say you've got.
We wanted to see the envision durability day, which is exactly what they said so if we felt like renter.
Very very strong position with them and and knowing exactly what they want to see when they want to see it and we're marching towards that.
Great and my last question here, you mentioned reimbursement economics.
102 is more favorable than CRV T. Can you just talk about what those reimbursement economics are in various settings and academic centers versus Yale.
Rivet practices or however, you wanted to buy it.
Yes, sure Jeff will take you through that Hey, Boris yes, so depending on the size of the tumor <unk> there isn't a significant amount.
It's reimbursed to the physician.
Do you think there's maybe a perception.
That it's larger than what it is but if you would if you were to look at the reimbursement economics.
And you couple in installation of an anti carcinogenic, which would be <unk> 102 times six.
As well as the buy and bill portion of the drug which will be given in the clinic predominantly so the physician would see that buy and build versus a hospital.
The economics look look look very good when compared to <unk>.
People need to understand that.
Surgeries or reimbursement for surgeries has gone down and we see that as evidence of <unk>, obviously depends on the size of the tumor but overall the reimbursement we expect for one or two to be to be better than <unk>. Yes look the only thing I'll comment about is we are not.
Going out with a profitability message right that's not our method.
We do that we won't do that but it will be very ripe or it will be very important to them that they don't feel like they're losing money thats not a detriment to them, even though we know it's better medicine for the patient which level focus on but we do have field reimbursement managers, we will make sure that our reps are also armed enabled.
<unk> to share the information that we can appropriately share because it is an important piece as you know unfortunately decisions get made that way.
This is bill.
B Frac.
Frankly, a net positive if they use it from a financial standpoint, but keep in mind, obviously our goal.
How we discuss that to the marketplace.
Great. Thank you very much for taking my question.
And thank you.
And one moment our next question.
And our next question comes from Paul Choi from Goldman Sachs. Your line is now open.
Hi, Thank you and good morning, congrats on the good quarter.
I was just wondering mark if you could maybe share any additional feedback you've had from the physician community since the spin.
Investor Day, specifically since the society of Urologic oncology is coming up here any additional feedback you've gotten on envision an atlas. Thank you.
Paul Thanks for the question and I may actually.
Jeff as well to talk about this but.
I think people are excited about the possibility of the approval of one or two I think everybody, specifically folks who work in Urologic oncology understand.
The need and specifically the unmet need in this population so what I'm hearing from colleagues is anticipation.
It's positive, but it Jeff I don't know if you have additional you want to talk about what some of the feedback you got at <unk> sure. So we just got back Hi, Paul from <unk> annual meeting the larger larger groups, we had an advisory board there.
Dr Prasad presented some of the data that.
We saw about a day and I think.
The initial reaction was overwhelmingly positive.
It was designed to sort of get their feedback and in around the data. We workshopped a couple of different patient types, but they are eager to have a different option if you're on the conservative side of things. They certainly have a number of patients that they do not want to put under general again and have a surgery. So there's that.
And then many of them reiterated that essentially it looks like at least in Atlas.
It's the same for <unk> and its a much longer duration of response.
Which is obviously a key attribute.
If approved <unk> 102, so.
It was 12 to 13 advisors very.
Influential in the community that gave us really strong feedback we'll continue to obviously engage as we need that feedback, but I was just an initial reaction.
Okay, great. Thanks for that color and then as a follow up also for you Jeff just regarding your comments on the buy and Bill.
Process can you maybe just give us some sense of what you think the runway will be before reimbursement.
J codes and so forth are established for 102 and just how you think the early mechanics might look like.
With a launch in 2025, thank you.
Sure as with any part B drug you will have but we will have a miscellaneous code for a period of time, we did with <unk>, we expect that.
With 102 as well as with any miscellaneous code is a manual process, we have to really make sure that we're buttoned up on making sure that we support the office on how they fill everything out correctly with that miscellaneous code I will say this it will be clearer than Joe myself, because with Jim I know you had.
Bill for both drug and waste. So you had a miscellaneous miscellaneous drug code you had a miscellaneous waste code here you won't have as many line items. So it will be much more straightforward.
We will put things in place.
Sort of help with the anxiety in and around a miscellaneous code. We do expect if approved in the timeline that we think we're going to get.
The nice thing is CMS is reviewing miscellaneous codes more than once a year now so we expect the J code hopefully sooner because of that review process, but we will put those.
Great things in place to get past that but.
I always say, it's a miscellaneous code that takes a little bit more time on the physician to physician practice Youll have your early adopters that.
That will come out and use it and hopefully be reimburse accurately.
We can then share that they'll talk to their peers and then hopefully by then we have a permanent J code.
Great. Thank you.
And thank you.
And I am showing no further questions I would now like to turn the call back over to Liz Barrett for closing remarks.
Thank you and thanks, everybody for your continued interest in your agenda I think it's been a tough market. The last few weeks, but as everybody has seen that we've made significant progress we continue to make significant progress both on <unk> and then importantly on <unk> 102. So appreciate we have a lot of key catalysts coming up in the next.
Six months. So I appreciate your interest and we'll keep everybody posted thanks a lot. Appreciate it operator you can now disconnect. This concludes today's conference call. Thank you for participating you may now disconnect.
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No.
Yes.
[music].
Yes.
Yes.
Okay.
Yes.
Okay.
[music].
Yes.
Okay.
Okay.
Yes.
Okay.
Yes.
[music].
Okay.
Okay.
Okay.
[music].
Okay.
[music].
Yes.
Yes.
[music].
Okay.
Okay.
[music].
Okay.
Okay.
Thank you.
[music].
Okay.
Okay.
Sure.
[music].
Okay.
Okay.
Yes.
Yes.
Great.
Okay.
[music].
Hum.
Sure.
[music].
Okay.
[music].
Yes.
[music].
Okay.
[music].
Yes.
[music].
Yes.
<unk>.
Sure.
Okay.
Yes.
[music].
Okay.
Okay.
[music].
Okay.
Yes.
Okay.
Yes.
[music].
Okay.
Okay.
Okay.
[music].
Yes.
[music].
Okay.
[music].
Yes.
Okay.
Okay.
Okay.
[music].
Okay.
Okay.
Okay.
Okay.
Yes.
Okay.
Yes.
Yes.
Okay.
Okay.
Okay.
[music].
Yes.
Okay.
Okay.
Okay.
Okay.
Sure.
Great.
Uh huh.
[music].
Okay.
Okay.
[music].
Okay.
[music].
Okay.
Okay.
Okay.
Yes.
Okay.
Yes.
Yes.
Okay.
Yes.
Sure.
Yes.
Yes.
Okay.
Sure.
Okay.
Okay.
Yes.
Okay.
Thank you.
Sure.
Yes.
Yes.
Okay.
Yes.
Sure.
Sure.
Yes.
Yes.
Yes.
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Yes.
Sure.
Yes.
Yes.
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Okay.
Okay.
Yes.
Yes.
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Okay.
Yes.
Yes.
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Okay.
Okay.
Thanks.
Okay.
Thank you.
Sure.
Thank you.
Okay.
Yes.
Okay.
Okay.
Yes.
Okay.
[music].
Sure.
Okay.
Okay.
Okay.
Okay.
Thank you.
[music].
Sure.
[music].
Thanks.
Sure.
[music].
Yes.
Okay.
Yes.
Thank you.
Okay.
Yes.
Okay.
Okay.
Okay.
Yes.
Yes.
Okay.
Okay.
Yes.
Okay.
Okay.
Sure.
Okay.
Yes.
Yes.
Okay.
Okay.
Okay.
Thanks.
Okay.
Yes.
Thanks.
Yes.
Yes.
Okay.
Yes.
[music].
Okay.
[music].
Yes.
Okay.
[music].
Okay.
Yes.
Yes.
Okay.
[music].
Yes.
Okay.
[music].