Q2 2023 UroGen Pharma Ltd Earnings Call
Good morning, ladies and gentlemen, thank you for standing by and welcome to the European Farmers second quarter 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 and sort of her own head of Investor Relations you may begin.
Thank you good morning, everyone and welcome to European Pharma second quarter, 2023 financial results and business update conference call.
Earlier. This morning, we issued a press release, providing an overview of our recent corporate highlights and preliminary financial results for the quarter ended June 32023.
The press release can be accessed on the investors portion of our website at investors not euro Gen Dot com joining.
Joining me today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, Jeff BOVA, Chief Commercial Officer, and Don Kim 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 our ongoing.
And planned clinical trials commercial and clinical milestones market and revenue opportunities, our commercialization strategy and expectations as well as potential future commercialization activities for UGI and one or two if approved anticipated data regulatory filings and decisions, including UGG and one or two potentially receiving priority.
Review.
Gen, one or two being the primary growth driver for your origin, if approved future research and development efforts, our corporate goals in 2023 financial guidance among other things.
These forward looking statements are based on current information assumptions and expectations that are subject to change a description of potential risks can be found in our earnings press release and latest SEC disclosure documents.
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 thank you to everyone joining us today I'm excited to speak to you again, what I can only describe as a transformative time for Harrington you origin is committed to revolutionizing patient care by developing and commercializing novel therapies targeting euro failures and spans specialty cancers for.
Is that just are a better way.
Recently announced unprecedented results from two phase III clinical trial investigating the use of Eugene one other carrier 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 consistent results overall and relative to T. R. A T.
And the Atlas trial, Eugene <unk> met its primary endpoint of disease free survival, reducing risk of recurrence progression or death by 55%.
Disease free survival of 15 months after randomization was estimated to be 72% for patients in the U G N plus or minus tier b T arm compared to 50% for patients and the Teu RPT arm by Kaplan Meier analysis.
Jan one or two also showed a 65% complete response rate at three months for patients, who only received <unk> Jan one or two.
Compared to a 64% complete response rate at three months for patients who only received a T. R. B G.
The envision trial also met its primary endpoint by demonstrating that patients treated with new G. M Winter too had a 79, 2% rate of complete response at three months.
Following the initiation of treatment.
And one or two has now demonstrated a consistent and what we believe compelling therapeutic and safety profile across multiple clinical trials, while showcasing the limitations of <unk> in this patient population.
Looking ahead data evaluating the secondary endpoint of duration of response is expected in the first half of 2024, assuming positive findings, we anticipate submitting an NDA to the FDA in 2024, the goal would be to receive priority review, which if granted may potentially result in approval as Earl.
At the end of 2024 or early 2025.
If approved we anticipate Eugene one or two to be the primary growth driver for your gen. As the first ever non surgical treatment option for disease afflicting approximately 82000, new patients in the U S. Each year with an annual total market opportunity of more than $3 billion.
The shift away from traditional surgical care has the potential to improve the quality of life of tens of thousands of individuals battling this highly recurrent disease.
This patriot patient centric focus underscores the origins dedication to have any meaningful impact on patient care.
Turning to jump right in the second quarter net revenues were a record $21 1 million a 27% increase from the same quarter one year prior.
Pleased to see the continued and consistent growth and adoption as additional recent real world data strengthens the case for John Midas therapeutic value and safety across different practice Pat practice patterns.
We will leverage Yamato as recent success as we shape Eugene 100, two's perspective, pre Kirk commercialization strategy.
In parallel strategic steps were taken to strengthen our financial position. The recent $120 million private placement of ordinary shares provides us with the resources to support our business, including our interest anticipated pre commercialization and launch strategy for you Jim on a chip.
We're proud to partner with a group of high quality biotech investors, who believe in the opportunity of your origins portfolio to address significant unmet needs and your old failure and specialty cancers.
I am thrilled to the progress we've made in 2023 and for the road ahead as we plan for an FDA submission of Eugene went out to next year, we believe EOG in one or two and Yamato together represent over a 1 billion dollar revenue opportunity. Your gin is positioned to pioneer a new era in urology.
And specialty cancer care, while creating significant value for our patients and shareholders with that I'll pass the call over to Mark Mark.
Thank you Liz and Hello, everyone.
<unk> gone through and describe the details and strength of our recently announced phase III Atlas and envision topline data I would like to spend some time, putting this information in the context of actual clinical practice and patient care to do so I'll draw from information shared by European and key stakeholders from the presentation and panel.
A discussion at our recent new Horizons data event, which I hope you were able to attend if not I would encourage you to access the replay are available on our website. In addition, the journal of Urology earlier. This week published if your peer reviewed article highlighting results from the phase III Atlas study.
We continue to encounter a surprise when people learned that bladder cancer is actually one of the most prevalent cancers with over 700000 patients in the U S alone.
Of the 82000 patient subset with low grade intermediate risk and it might be seen recurrence is high with 68% of those having two or more recurrences.
3% with five or more recurring sources.
When we examine Eugene one of them.
<unk> for the treatment of low grade intermediate risk and it might be see we often draw parallels to Joe might owe for low grade upper tract here with William carcinoma. It.
It is well characterized that the genetic and molecular makeup of tumors are similar in both Meanwhile, the medicines are different drugs. They leverage the same argue gel technology and active with similar dosing schedules interestingly, while the similarities between <unk> and Eugene one or two work to our advantage the differences are.
Significant for wanted the patient population for you Jan one or two as you mentioned.
As an order of magnitude larger than NGL by Doe and because of the bladder is easier to access than the upper urinary tract did you had one or two it can be administered in a clinic setting by a nurse or advanced practice provider using a standard ureteral catheter.
<unk> remains the standard of care for this patient population and is one of the most common procedures performed in Urologic oncology <unk> is not without risk of 33% of patients encountered adverse events within 90 days of surgery based on data from the published literature.
Others have shown that patients who undergo two to four <unk>.
A significantly increased risk of mortality if approved <unk> 102 stands to offer an efficacious treatment alternative while also allowing this patient population to avoid the risks associated with repetitive surgery.
That I will turn the call over to Jack for a commercial update Jeff.
Thanks, Mark the second quarter represented our strongest quarter performance ever for Joe Milo during the second quarter. We saw further strengthening of the gym idle ramp and an increase in uptake in several developing territories growing awareness and adoption of gel motto remains attributable to several key factors first the benefits of our revolver.
Our sales strategy continued to deliver consistency and growth in the developing territories.
Second the extension of the stability period of the Jamba, Idaho admixture from 8% to 96 hours has limited needed several operational and logistical challenges, including allowing for gay prior delivery, enabling HCP preferred early morning installation.
Currently more than 50% of doses consist of day prior delivery.
<unk> expansion of geographic coverage of our mixing partner and optimizing our territory business managers time in the field.
And finally, the growing body of outcomes from real World evidence data continues to strengthen and reinforce Yamato efficacy and safety profile supporting its multimodal used across various practice patterns.
Joe My those traction and adoption appears to be accelerating as the product becomes increasingly proven in a real world setting easier to administer and incorporate across multiple practice patterns.
Reimbursement remains at approximately 96% across all payer types.
This reinforces our optimism and lays the foundation for the potentially much larger opportunity with <unk> 102 in low grade intermediate risk non muscle invasive bladder cancer.
On the heels of the positive Atlas and envision data, we've begun executing our pre commercialization plan in preparation for a perspective <unk> NDA.
With 95% overlap in our prescriber base and well established practice patterns, we expect a seamless integration of Eugene and 102 into our commercial organization if approved.
With that I'll turn the call over to Don to discuss our financials.
Thank you, Jeff and thank you for everyone for joining today's call I'm pleased to review our financial results for the second quarter ended June 32023.
For the second quarter of 2023, we reported J, Michael net product revenues of $21 1 million in line with consensus estimates and an increase of 27% compared to $16.6 million in the same period last year.
For the second quarter of 2023 research and development expenses were 11 $6 million as compared to $12.6 million for the same period in 2022.
The decrease is primarily due to lower expenses related to the conclusion of the Atlas trial and lower cost of envision on fire for us yet to offset by higher R&D expense related to the phase one study for <unk> 301.
Selling general and administrative expenses for the second quarter of 2023, or 22 point to $5 million. This compares to $28 million.
For the same period in 2022.
Increased SG&A is primarily due to higher marketing commercial operations professional services and trainees offset by lower market research related expenses.
Euros and reported non cash financing expense related to the prepaid forward obligation to RTW investment of $5 3 million.
The second quarter of 2023.
<unk> reported a net loss of $24 1 million or basic and diluted net loss per ordinary share of $1 three.
For the second quarter of 2023.
As compared to 26 point to $7 million or a basic and diluted net loss per ordinary share of $1 18.
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.
Including noncash share based compensation expense of $611 million.
Subject to market conditions.
The company reiterates anticipated full year 2023, non cash financing expense related to the prepaid forward obligation to RTW and investments in the range of $21 million to $26 million.
Of this amount approximately nine points to $9 million to $11 $2 million is expected to be in cash.
Ended the second quarter with $55 3 million in cash and cash equivalence and marketable securities not including the proceeds of the $120 million private placement financing announced on July 27 2023.
With that I'd like to turn the call over the operator for questions operator.
Thank you we will now conduct a question and answer session.
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, while we compile the Q&A roster.
Our first question comes from Ross Silver argue.
H C Wainwright.
Thanks, very much for taking my questions and congratulations on a very well executed quarter.
I wanted to first of all focus on <unk>, if you could give us a sense of what the key underlying trends are that you are seeing in the marketplace right now that are driving uptake to what extent for example, the use of Antero grade installation is driving adoption that would be very helpful and much appreciated and also if you could clarify.
Whether you expect to continue to revise guidance or issue revisions to guidance as necessary as we get through as we go further into 2023. Thank you.
Thanks, Rhonda <unk>, Yeah, I think for now we will not be changing guidance I think we're comfortable with the guidance and where we are.
As everyone knows Q3.
As the summer months, and so I think we want to wait and see how things go in Q3.
Before we.
Try to narrow the guidance maybe at our next call so with that I'll turn it over to Jack and he can answer your other questions there Jeff.
Yes. Thanks, Ron So we continue to have a lot of momentum from.
We're as you know they put out guidelines when mentioned in those guidelines and ablative.
<unk> they reinforce the fact that you shouldnt be pulling or if at all cost you shouldn't be pulling.
Kidneys and low grade disease.
Two presentations there we had an industry theater, we continue to talk about the real world evidence, which partners us with urologists. So they go in the endoscopic Lee Resected then they bring in six doses of <unk>. So I think it was it was a positive <unk> for us we've seen a lot of data coming out this year that answered a lot of unanswered questions.
From Olympus.
And the field has been able to get to get to get that access. We also see a convenience standpoint, when the 8% to 96 hour administer our stability time increased physicians are happy that that you can get the product the day before they can do the procedure in the morning.
So just a lot of good momentum a lot of good things that are opening doors and allowing the territory business managers.
Really talk about all of the latest data you mentioned answer grade.
Somewhere 60%, 65% or integrate administrations I never really see I will see that continue to go up but there are some physicians institutions that still prefer a retro great. Some patients actually prefer retrograde, but all of the data that we published from Dr. Rose.
Dr. Jacob.
Shows a lower stenosis rate, so I do I do see anterograde, continuing to increase probably a little bit of a slower rate, but thats.
As I said thats, mainly due to just physician preference or patient preference.
And then just with respect to one or two can you comment on whether you expect the.
Real World data analyses that are currently being reported at a steady pace for <unk> to be a useful model for us to think about in the context of a putative Eugene one O to approval would you be collecting that same kind of data on <unk> 102 real world use.
Once if and when the product a product to come through.
Yeah, absolutely we will definitely continue with the registry and expand their registry with that <unk> to not only by adding one or two but adding more sites as well, but I wanted to gets approved.
As Jeff mentioned, we're starting really to see a lot of real world data out there I think that's been a big driver and we know just from recent questions around how can you use your Jan one or two we've seen many different uses of <unk> through the registry and I'm sorry, the retrospective analysis and we expect to do the same.
It's a good way for us to get learning, it's a good way for physicians to see.
The optimal way of treating their patients so absolutely.
Thank you.
Alright. Thank you one moment for our next question.
Our next question comes from the line of Boris <unk> of TD Cohen.
Good morning, and let me add my congratulations on a commercial and clinical side of things.
First question is on the Atlas study, obviously, we're still very impressive data there I'm curious if you've had any interactions with the FDA to discuss whether or not that could be the basis of a pivotal study potentially allowing you to file earlier than waiting for envision.
We have not as of yet had conversations with the FDA, we will be requesting a meeting with them and how long the FTA take so it takes them 60 days to award us.
Meeting and so as soon as we can talk to them, we will talk to them I think that the.
Base case, and I think we should expect from the FDA based on the conversations we had with them is that they're going to want to see durability and envisioned we feel very confident given the not only the optima data, but the durability and Atlas and we feel very confident about the durability, but the FDA has been very clear all along.
Durability is very important so we will talk to them about this if there is any wiggle room from a timing standpoint, but at this point in time I think it's fair to say that we're sticking with our current timeline as far as the FDA is concerned.
My second.
Can you just outline what exactly is the formulation difference between Joe might own one or two I guess the purpose of the question is just to get a sense. If Ken 102 once approved be used in place of <unk>.
Yes, Mark can you talk a talk about that and why that can't be entertained, but the differences in them, yes sure.
Boris Thanks for the question. So there are.
Some very specific differences the first of which is one of them. He was a much larger volume.
With a lower concentration of might've mice and pursue C compared to <unk>.
So so I think.
It's important to understand that while both are efficacious.
Doses of medication are actually delivered by the different medications. They are not interchangeable and 102 would not be an acceptable.
Agent for use in the upper urinary tract based on our published data.
Great. Thanks for taking my questions.
Thank you one moment for our next question.
Our next question comes from the line of Linda <unk> of Oppenheimer.
Hey, good morning, Thank you for taking my questions.
A couple from me first.
I know, it's a little bit early but would you expect that the data section of the went out to label. Therefore to feature both the full complement of the Atlas.
And envision data.
Currently.
Think about.
Operating expense for the company going forward clearly lots of overlap here with the existing commercial infrastructure, you mentioned, 95% overlap and prescriber base.
Should we contemplate.
For modeling purposes, as we think about what additional expense the urgent need.
We need to incur as the company expands its scope too.
To be selling one or two thank you.
Well, Thanks, Leland I think we don't we don't know, but we would expect all of the data.
Be in the label Jesse.
Obviously in the clinical trial section of the label if nowhere else, but we obviously will have those discussions with the FDA to your point, it's early but I don't see any reason why that data would not be included I'm just going to ask.
Jeff to comment on expenses from a standpoint of launching <unk> in one or two and the leverage ability of across the board Yamato So Jeff.
Sure. Thanks, so yeah.
Obviously with the 95% overlap you can also say, 100% overlap with wherever we would be conference wise for <unk>, we will be there for one or two.
Obviously, what we'll build in launch expenses, but the synergies for meetings for conferences for other events for the overlap in the target I don't see a significant expansion in the field.
Because of the overlap and the targets, we will adequately prepare for a strong launch with 102.
But yes, there are significant synergies.
We can take from Jo Malone.
Yes, I think having said that though we do expect that there will be an increase.
In the field.
It's much smaller than you might expect obviously for a big opportunities like <unk>, but we would add.
Some territories, just physical geographical perspective.
And.
As Jeff mentioned, a lot of the other other leverages that we can do we absolutely will do but there'll be incremental expenses for launching new GM went up too.
And actually.
Had a quick question that comes to mind. There is now with respect to the premix thing.
Task for many community.
Urologists, that's something that's done by third parties and I know you have a number of.
Kind of agreements or you've established that facility for for various practices. How should we think about the need for increased coverage.
Across the neurological practice space.
Core pre.
Mixing.
Needs and would that have any impact on.
On your spend thank you.
Jeff Sorry, Yeah, no I'd like Joe might know, we have a mixed option for those community accounts that don't prefer to mix. We will do the same we are looking at either a gel midol like model or a all mixed.
So everyone would receive the product.
Mix, obviously, yes, there are incurred expenses, but theres also operational efficiency theres not training that's needed to mix. The stability. We believe will be long enough that we can deliver the product on Monday, they can keep at it.
Administrator anytime during that week.
And we're evaluating that decision now what we won't do is require folks to mix everyone to mix. This it'll either be very similar to Joe might owe or a 100% deliberate mix.
Great. Thanks, Thanks very much.
Okay. Okay.
Thanks Helane.
Moment for our next question.
Our next question comes from the line of Matt Kaplan of Ladenburg Thalmann.
Hi, good morning, guys and thanks for taking the questions.
I guess, just going back a little bit based on the comments had been recent.
Well day by some of the panel members how do you think.
Given the strength of the 102 data and then Susie hasnt toward how do you think it will be utilized in the treatment of.
And <unk>, especially <unk>.
Given the ongoing BCG shortage.
Yes, Mark.
And on that.
Yes sure.
Hi, Matt Thanks.
So I think.
Obviously, our data have focused on patients with intermediate risk.
Low grade technology, So my expectation would be.
After approval.
At the indication would be in patients who have newly recurrence.
Risk disease, having.
Having said that.
Obviously, we've seen in the GL might own experience I think exemplifies this that once decisions have a new tool available to them.
They can be creative and.
In their management of patients obviously that would.
In the setting of patients who are appropriate for treatment BCG and tail off label use in high grade histology, which we obviously could not and would not promote.
But my expectation is that the lion's share of use would be for the indication, namely for low grade intermediate risk disease, either de novo disease, or recurrent disease and listen I want to comment on this as well.
Yes, I guess I would just add to Mark's point, we obviously have no way would promote for high grade disease.
Thank the ongoing shortage of the BCG just under.
And every lender lines the need for more treatments and I think one of the things that we're considering is now with the data being so strong Duane study Eugene and one or two in high grade disease, where else do we studying your Jan one or two I think we have a lot of a lot of opportunity and a lot of ideas on where we can take it next.
Again, the high unmet need in this space, so, but I think from <unk> perspective, I think you'll see it really in the intermediate risk patient population in which we studied.
Okay. Thanks, that's helpful and just one quick question for Jeff, Perhaps I guess.
Learnings from gel Mitel commercialization, which you think can be applied to <unk> 102, once approved to help facilitate the ramp up that uptake.
Yes, no great question.
The convenience that one or two offers you just don't have as big of a operational lift as I said earlier, if we deliver product mix.
I believe most of this will be given in the clinic. It can be given by an extender. So you don't have to worry about setting up all our time getting this product through formulary.
At the hospital institutions. So I think we've learned that having a mixed product delivered is something that we definitely need for the community accounts.
Yes.
That level of <unk>.
<unk> with regards to being partners with the urologists their surgeons.
They do surgery, so, making sure that our messaging and positioning our strong to partner with them.
Not be reserved for someone who has six or seven <unk>. The other thing that I will caveat is that certainly the from a business standpoint that convenience for the urologists from that.
Well this will be another buy and bill drug that they can be that can be given in the clinic. So a lot of learnings are lot of learnings will be overcome just by the sheer convenience.
102, but then certainly how we message how we partner with urologists, that's going to significantly help with the launch curves of one or two.
Alright.
Thanks, Thanks, guys.
Okay. Thank you I'm showing no further questions at this time, so I would now like to turn the conference back to Liz Barrett for closing remarks.
Great. Thank you operator as always we appreciate your taking the time to join US today as I mentioned earlier, it's an unprecedented time not only for our company, but for patients with <unk> cancers.
Spire to everyday by the commitment of our colleagues that have remained steadfast in our belief in our ability to advance care for patients in need. So we look forward to the next few months and to continued dialogue with you. Thanks again for your interest and your origin and for joining US today. So operator you can disconnect now thank you.
This concludes today's conference call. Thank you for participating everyone. You may disconnect.
Okay.
Okay.
[music].
Okay.
Okay.
[music].
Okay.
[music].