Q3 2020 Urogen Pharma Ltd Earnings Call

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Good morning, ladies and gentlemen, thank you for standing by and welcome to your Genpharm. Its third quarter 2020 financial results and business update conference call. It is now my pleasure to turn the call over to Sarah Sherman.

Head of Investor Relations for your Gen Pharma. Please go ahead.

Thank you Jonathan Good morning, everyone and welcome to European Pharma third quarter, 2020 financial results and business update conference call earlier.

Earlier today, we issued a press release, providing an overview of our recent corporate highlights and financial results for the quarter ended September Thirtyth 2020.

The press release can be accessed on the investor portion of our website at investors tight your agenda.

Joining me on the call today are list Barrett, President and Chief Executive Officer, Dr., Mark Schoenebaum, Chief Medical Officer, Jeff Silva, Chief Commercial Officer, and Molly Henderson, Chief Financial Officer. Please note that we continue to conduct our calls from different locations. So we appreciate your patience and understanding should we have any technical difficulties.

On today's call Liz will provide a summary of our recent corporate developments Mark will share clinical development and regulatory updates and Jeff will discuss our recent launch of shell Mito and commercial updates.

I will then provide an overview of our financial highlights for the third quarter before we open the call for questions.

As a reminder, during today's call, we'll be making certain forward looking statements various remarks that we make during this call about the company's future expectations plans and prospects constitute forward looking statements for purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1985.

Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factor section of your Gen. Farmers quarterly report on form 10-Q filed with the FCC This morning and.

And other filings at your age and pharma make SEC from time to time.

As well as any negative effects on your origins business and commercialization and product development plans cause by are associated with the COVID-19 pandemic to the extent not disclosed previously.

We encourage all investors to read the company's quarterly report on form 10-Q, and the Companys other SEC filings. These.

These documents are available under the SEC filings section of the investors page the origins website at investors that your agenda.

In addition, all information we provide on this conference call represents our views only as of today and should not be relied upon as representing our views as of any subsequent date while.

We may elect to update these forward looking statements at some point in the future. We undertake no obligation to update any forward looking statements. We may make on this call on account of new information future events or otherwise.

With that ill now turn the call over to Liz.

Thank you Sarah and thank you all for joining us on our third quarter conference call. Since our last earnings call. Your Gen has gained important traction in bringing jump mido to patients in need and has continued to execute on our near term business objectives and growth strategies.

We are encouraged by the positive progress we've made to date in our commercial launch of jump Mido, which was officially launched on June 1st, bringing the first of its kind therapy to patients with low grade upper track Helio carcinoma.

And our first full quarter of launch we have exceeded our internal expectations and reported $3.5 million in net product sales.

I think this is a testament to the efforts of our commercial team as well as a positive reception we've received from position.

Despite the unprecedented environment, we are continuing to operate in.

Jeff will provide a more detailed update on our progress shortly but we are excited about where we are and the outlook for this important medicine.

As we previously communicated we submitted a label update with the final results from the pivotal phase three Olympus trial, a jump Mito and we believe the FDA will approve the updated label for Jim Mido, an early 2021.

Expect the updated label will be similar to the current label given the final results are consistent with previously shared resolve and we anticipate presenting the final Olympic data at a medical meeting by the end of this year.

We also continue to progress our Euro and college you pipeline. Our most advanced pipeline program is Eugene and why no two for the treatment of patients with low grade intermediate risk non muscle invasive bladder cancer, we see important synergies in a way in which low grade upper tract real failure carcinoma and low grade.

Eight intermediate risk non muscle invasive bladder cancer present, as well as the way in which our novel technology may provide a solution in a new way of treating these diseases and vulnerable population.

The type of bladder cancer, we're focusing on the UGI and want to go too it's very difficult to treat and there are no drugs currently approved by the FDA for this indication in.

And is characterized by high rates of recurrent and the need for repetitive surgical intervention. The addressable patient population is approximately 80000 patients annually in the U.S. alone.

This includes newly diagnosed patients and patients who have a recurrence after surgery we.

We believe UGI and one or two has the potential to provide a durable non surgical treatment alternative to this patient population.

On our last call, we provided update durability estimates from our phase to be Optima, two trial at UGI and window too and we remain on track to share a final data by year end. We also remain committed to initiating our pivotal phase three clinical study by the end of this year.

It's exciting for us to be able to demonstrate the potential of our novel technology and upper tract, you'll feel you'll carcinoma would jump Mito and then low grade intermediate risk non muscle invasive bladder cancer expected would want to go too.

As we look beyond low grade disease, we have an exciting earlier stage pipeline programs UGI and threeo to a combination of UGI into a one our TLR seven eight agonists and UGI in 301, the entice you to lay for antibody that we license from a genus to be combined with our gel technology.

We are initially studying Eugene threeo two in high grade non muscle invasive bladder cancer and believe it has the potential to change the treatment paradigm for this hard to treat disease.

Phase one studies are expected to start in the first half of 2021.

I want to now take a moment to introduced three new members of our executive team that joined US this past quarter.

Colleen Henderson, our new Chief Financial Officer, who you will be hearing from in a few minutes has over 15 years of experience as a public company life Science CFO and.

Joins us from Advaxis, a clinical stage biotechnology company focused on the development and commercialization of immunotherapy products, where she served as executive Vice President and Chief Financial Officer.

Jason Smith has been named General Counsel and Chief compliance Officer enjoys this from Pfizer, where he spent the last 11 years.

Jason joined Pfizer is cheap countermeasure vaccine and was most recently chief counsel oncology.

And last but not least poly Murphy has been named Chief business Officer and joins us from Pfizer, where she most recently served as the vice President of early commercial development in the oncology business unit.

These three executives bring a breath of experience, which will support the acceleration of our pipeline development or our T gel platform expansion and access to external innovation as well as great financial performance.

Although the Botox study did not meet the primary endpoint, we learned a great deal regarding our proprietary Archie gel technology that helps inform how we can best develop important new medicine through the use of this technology. We continue to actively explore a business development opportunities with and without the use of our T gel.

We are building academic collaborations that fit within our mission of improving the lives of patients with your logic diseases and specialty cancers in.

In addition, a platform expansion, we continue to investigate the potential geographic expansion of jump Mito and our pipeline.

Reflecting on the progress we've made I believe the company is uniquely positioned with a strong management team. Our first approved therapy in a pipeline that could potentially change the way. These cancers are treated.

We remain unwavering in our commitment to develop new approaches and treatment option for patients as we build a long term sustainable growth business.

We are confident that our current portfolio will provide us with a strong foundation on which to grow our organization and build a leading euro when college it company.

With that I'll turn the call over to Mark to discuss our recent clinical update mark.

Thank you Liz.

This is certainly an exciting time for your origin with increased uptake of Joe Mito across neurologic community as well as key advancements of our programs.

As a practicing urologist I have seen firsthand impacts that you all might always having as my colleagues begin to prescribe this new therapy for adult patients with low grade upper tract Urothelial cancer.

As we look to our pipeline Xian, Joe Mito, we continue to follow the fees to be often the two trial of Eugene in one or two and anticipate final data by the end of the year.

In August we communicated estimated durability of 72.4% based on interim data in this study patients are followed from Georgia facility up to 12 months post treatment initiation.

Regarding the timeline for Atlas, which is our UGI and one of the two pivotal phase three trial, we have finalized the design of the study with the FDA, we remain on track to initiate the study by year end.

Site identification is well underway in the United States Europe, and Israel for this important global study.

A reminder, Atlas will be a randomized controlled trial in approximately 600 patients assessing UGI and want to go too with or without trends, who with resection of bladder tumor were t. or b T versus t. RVP alone in patients with low grade non muscle invasive bladder cancer and it will be.

The at risk for recurrence this.

The study is designed to evaluate each year in one or two versus standard of care in patients will be randomized one to one to either UGI and one or two or Q RBC.

At the three month time point patients will be assessed response.

Patients who have demonstrated a complete response to either UGI on one or two or three you RVP will continue for long term follow up revenue super occurrence patients and demonstrate a recurrence either or will undergo a few RVP and then we'll also continue for long term follow up for evidence of recurrence the.

Primary endpoint of the study is disease free survival or recurrence free survival in this disease.

While it's a time to event analysis and is designed to evaluate non inferiority first and then superiority.

We expect the trial will take approximately one year to roll in to be completed within approximately three years.

The trial will also have interim analyses embedded throughout.

It is important to emphasize that you June one of two is designed to be primary therapy not attribute therapy.

Providing a potential alternative to surgery.

To that point today. These patients are managed by repeated trends refill procedures under general anesthesia to treat this disease.

We have seen recently published literature from a Danish national cohort study.

But this practice appears to be associated with an increased risk of overall death. It's.

It's also important to note that in the Danish studies patients with a greater number of procedures at a greater risk.

Patients who had received only one procedure.

We believe that the Atlas trial design will allow us to effectively demonstrate UGI and one or two has the potential to change the treatment paradigm and offer an alternative treatment to surgical intervention and all of the potential co morbidities and complications that come from repeated surgeries in this patient population.

We look forward to providing updates on the initiation of Atlas in the near future.

One of our most exciting pipeline programs and MGM Threeo. Two this is an immuno oncology program, which we are initially developing for patients with high grade non muscle invasive bladder cancer.

Mm 302 is a combination of UGI into a one our TLR seven eight agonist and Eugene three on one horizontal drilling ahead and anti CTLA four antibody that we have combined with our gel technology.

Hi, Great disease is very different biologically and clinically from a low grade upper tract urothelial cancer intermediate risk non muscle invasive bladder cancer populations, we have focused on international Mito, and UGI and one or two programs, respectively high grade non muscle invasive bladder cancer is an aggressive.

Potentially life threatening malignancy characterized by both a significant risk of rapid recurrence and a genuine risk of disease progression from muscle invasive cancer. The standard of care for patients with high grade non muscle invasive bladder cancer is t. or B T.

Followed by injury vessel immunotherapy with BCG, a mainstay of neurologic practice now in short supply due to production challenges.

At best this approach achieves a 50% recurrence free survival rates in patients who do not respond rapidly relapse. Following treatment are typically offered bladder removal as a means of achieving local cancer control lateral.

Bladder removals surgery is complex life, changing and characterized by high rates of your and long term complications that range from census, and bowel obstruction urinary incontinence in sexual dysfunction.

There is clearly an unmet medical need to provide patients with high grade non muscle invasive bladder cancer with an alternative to blatter removal, particularly in the face of the BCG shortage.

UGI and Threeo two program has produced encouraging non clinical data, which suggest that the combination of UGI and two a one and then you see truly for antibody resulted in improved survival and decreased tumor size or murine model.

We also observed changes in immunological more truth markers, such as decreased T regulatory cells and a trend toward increased CD eight T Reg ratios.

We believe that combinatorial immuno therapy could be meaningful when applied locally and that delivering the combination introduces we mainly gates systemic side effects in adverse events associated with systemic immunotherapy.

We believe the data generated to date may represent an innovative approach to managing high grade disease and look forward to advancing this program with a phase one trial in the first half of 2021.

And with that I would like to turn the call over to Jeff to provide a commercial update Jeff.

Thank you Mark I'm pleased to be providing you with an update today on the progress of our commercial launch until model, which has been underway since June onest, we've seen significant interest in growing demand for John Idol.

As Lynn mentioned, we received positive feedback from physicians, who have used Joe Mito and we're hearing from these positions on a daily basis.

The early success stories in calls have position provide us a first hand account of how we are making a difference in the lives of patients.

These calls are often centered around how pleased physicians are that their patient was able to avoid surgery and we're hearing from some physicians at their first patient achieved a complete response after finishing treatment gentlemen.

Mito is definitely making them.

I would like to highlight a few points that help illustrate the success of the launch today.

As of November Onest, we have increased our activated site to over 165 site up from 100 sites at our last earnings call on August 10th.

These are sites, so it's either treated patients or ready to treat patients. We expect this number to keep growing as our sales force of 48 reps continues to target hospital and community account, where most of the patients are treated.

And we are relentless in this effort just this past weekend at the virtual larger quality Group practice Association annual meeting we were the only partner who presented there.

This meeting alone provided us with the opportunity to engage approximately 500 physicians nurses and business managers from larger allergy practices.

The other number that is important to mention is repeat accounts or accounts that have treated more than one patient as it suggests that physicians are seeing clinical looks the other drug the reimbursement is working and all the other components of the process has gone well.

As of November Onest, we increased that number to 13 accounts from two accounts as of our last earnings call. This.

This is a critical success factor showing us that the processes and support in place are working and clinicians are identifying additional patients and gaining comfort and using this treatment.

I'd like to briefly provide some color on where these patients are being treated as it demonstrates another benefit of gel murdo about.

About 40% of the patients are being treated in the hospital outpatient setting about 40% in the surgery center and the remaining about 20% in the clinic.

The number of patients treated in the clinic is slightly higher than we expected likely driven by cold weather and the desire to avoid the hospital and more complex surgeries for you can you see.

Much like we are adapting to a new way of living working and utilizing technology. These physicians and patients are able to embrace a new way of treating this disease.

So that has also impacted the type of patients who were the early adopters with Joe might have.

The majority of the patients being treated with film either today or the recurrent patients those who have experienced the challenges with surgery and now are embracing a new option.

As more accounts begin to reopen we've seen an uptick in the newly diagnosed patients or treatment naive patients. We believe these newly diagnosed patients will be anxious to be treat therefore, we expect both recurring and newly diagnosed patients to continue to increase and this mix to balance out in the coming months as more because.

I'm familiar with it there.

As uptick continues reimbursement also continues to go well, we've seen positive policies from commercial payer, resulting an accurate and timely reimbursement for the clinicians we.

We believe that the payers understand the value proposition of gel Mito and that this product can prevent or delay a major surgery or Oregon loss, which is obviously expensive, but more importantly can present complications, especially for elderly patients.

As expected beginning October Onest, our unique C code was put in place and will facilitate faster and accurate reimbursement in the surgery Center and hospital outpatient setting where gel mito, mostly used well.

While we expect more timely payment and a slight uptick with this code. We have had great success with a miscellaneous code and the team has worked hard with accounts to make sure reimbursement goes smoothly.

We continue to expect the permanent J code in January which will replace the C code.

While we don't expect a significant change in trajectory with the implementation of the J code. It does eliminate potential concern by some offices.

Before turning over to Molly I would like to take a moment to acknowledge income and the efforts of our team our partners and the health care providers, they've worked with through the course of the year to help ensure that patients in need of gel mido are able to get treatment.

Although we continue to navigate unchartered territory with the current pandemic our team has proven over and over again that they are up to the task of overcoming every challenge presented to them.

And I believe Thats, a testament to the quality of people in our organization and their commitment to providing patients with our novel effective and potentially kidney sparing treatment option.

We believe that the commercial infrastructure that our team has worked so diligently to establish over the course of this year will be invaluable for gel Mito.

And potentially for the future success of UGI in one or two.

And our earlier stage pipeline programs.

And with that I would like to turn the call over to Molly who will discuss our financials.

Thanks, Jess and Hello to everyone on todays call Im delighted to join your engine such an exciting time and look forward to helping the company achieve its near and long term financial objectives.

Yeah again recorded net product sales of dramatic for the third quarter 2020 of approximately 2.5 million associated cost of revenues were approximately 309000, including certain one time start up costs.

The periods prior to receiving FDA approval in tomato and under accounting rules, we recognize inventory and related costs associated with the manufacturing termite as research and development expenses.

We expect this to continue to have a favorable impact on possible revenue during the first quarter of 2022.

Pretty similar costs, reflecting the full cost of manufacturing and as we deplete inventory that we get expense prior to receiving FDA approval.

As a result gross margins would have been 86.7% versus the reported 91.1% in the quarter ended September 32020.

Research and development expenses for the third quarter and nine months ended September Thirtyth, 2024, $10.2 million and $34.9 million, respectively, compared to 9.5 million and $29.2 million for the same periods in 2018.

Research and development expenses also include 1.5 million and $5 million non cash share based compensation expense for the third quarter and nine months ended September thirtyth 2020, as compared to $2.1 million and $6.4 million for the same periods in 2018.

Selling and marketing expenses for the third quarter and nine months ended September 32020 for $11 million and $34.4 million, respectively, compared to $30.9 million and $9.7 million for the same period in 2018.

The increase in selling and marketing expenses resulted from increased cost and activities related to the commercial launch of Jim item in June 2020, including headcount and related costs associated with building or sales force.

Selling and marketing expenses included 1.2 million and $3.5 million in non cash share based compensation expenses for the third quarter and nine months ended September Thirtyth 2020, as compared to 617000 and $1.6 million for the same period in 2019.

General and administrative expenses for the third quarter and nine months ended September Thirtyth, 2020 were $11.1 million and 33.7, respectively as compared to $10 million and $30.8 million for the same period in 2018.

General and administrative expenses included 4 million and 12.9 million of noncash share based compensation expense for the third quarter and nine months ended September 32020, as compared to $4.6 million and $13.9 million for the same periods in 2019.

Third quarter nine months ended September 32020, we reported a loss of $28.8 million or $1.31 cents per share.

And $98 million or $4.52 per share respectively.

This compares to net losses of approximately 22.3 million or a dollar six per share.

66.2 million or $3.25 per share for the same period in 2019.

Net loss for the third quarter and nine months ended September Thirtyth, 2000, $26.8 million, and 21.5 million, respectively, and noncash share based compensation expense.

The company has provided an update to previously issued guidance for 2020.

The urgent now expects 2020 total operating expense in the range of 138 million 243 million, including noncash share based compensation expense of 25 million to 29 million subject to market conditions.

Other non operating income for 2020 is anticipated to be approximately 2 million.

And lastly, we closed the third quarter 2020, with approximately 126 million cash cash equivalents.

Gary.

Yes, again continues to be well capitalized on based on this plus cost position, we expect our current run rates and brings with him 2020.

We continue to assess our capital requirements. As we look example, clinical development of UGI and one of the key as well as other clinical programs already in the pipeline for 2021 and the one point.

With that Jonathan I'd like to turn it back over to you for questions.

Certainly ladies and gentlemen, if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered maybe you'd like to remove yourself from the queue. Please press the pound key our first question comes from the line of Ram Selvaraju from H.C. Wainwright. Your question. Please.

Thank you very much for taking my question. Most of these are regarding gel mito and the metrics that you have been providing regarding the launch firstly I wanted to know whether you intend on providing these same types of metrics going forward or if that's potentially going to change as we get further and further into the launch.

Secondly, I also wanted to ask about the kinetics with which you expect to see more and more centers administered more than one treatment is the fact that 13 centers of administered more than one treatment really a factor of when they came online and you're seeing a steady increase in the number of centers that have administered more than one treatment or is that.

Number of centers that have administered more than one treatment growing substantially at a slower rate than the total number of centers that have actually utilized on micro watts.

Hi, I'm that Glen Thanks for the question I'll, just comment and then turn it over to Jeff.

What will be providing from a patient perspective is more is our revenue we won't be providing patient specific data or information on number of patients or number of Pat patient.

Warmest enrollment forms.

We should continued on the same the things that Jeff talked about this morning, so with that I'll turn it over to Jeff to add some comments and answer your question more specifically Jeff.

Sure. Thanks, Yes, so it's actually the first.

Example, you gave we're seeing a steady increase in.

In offices and account finding another patients if we I think we had one or two accounts that had two patients out of the gate, but for the most part you will see one patients.

You will see the training take place you'll see hopefully.

A CR and then you they go combed through their electronic medical records.

And find another patient that could benefit from gel mito. So if the steady increase in accounts that have treated more than one patient.

Okay.

But with Westwood relative to the J code.

Did you already start to see a change in the ease of uptake for Joe Mito in the wake of the receipt of the C code or do you expect the bulk of the impact to occur when you have the J code as well and then the last question I have is relating to the pipeline program. The phase one combination of two a one.

Valid for Allomap.

Can you give us a sense maybe of what you're looking to see from a drug activity standpoint, with this combo regimen, what you would consider potentially promising indications of therapeutic activity within the context of the phase one study. Thank you.

So Jeff why don't you take that first part and then Mark can you answered the question around our combination trials.

Drugs.

Sure. So we did see a slight uptick I always talk about this play because I really don't.

I don't think it's going to have a major impact once we have the C code and I was correct. We did have some offices that certainly appreciate having the C code.

Specific to gel mido.

That they may have moved forward with the patient.

Expected same with the J code the Jayco will replace the C code. Once this out I'm sure there are some offices that.

Have a little bit of anxiety around the miscellaneous code, but I don't I never talk I always talk about it being a slight uptick in patients and I would think that would apply here.

Yes.

Mark.

Yes.

Ron Thanks for the question in reference to.

Activity are we you know for example from previous work that.

There is it.

Anti cancer activity when you come into a one is applied intra basically as solitary agent, but because of the nature of phase one studies, which were largely directed on.

Lucidity toxicity related to dose he would be premature to provide very specific information about therapeutic signal from a from that experience. Obviously, what we're looking for primarily the safety of the combination but to put this in context.

I will refer you to recent data published about other agents used in this context and I'm sure you're familiar with the fact that in this very hard to treat population recurrence free survival hovering in the range of 15% to 20%.

A year is considered encouraging.

From a clinical perspective, so that should give you some sales long term what the current borrower looks like but obviously, we would be aspiring to something higher than that although I can't comment further I don't listen we want to provide initial comment about this as well.

No no additional comments thanks.

Very helpful. Thank you very much.

Thank you. Our next question comes from the line of attacked our Chiller from Stifel. Your question. Please.

Great. Thanks for taking the questions and congrats on the progress here just a couple from us. So I guess of the 165 sites that have been activated do you have a sense of how many you Tc patients are treated at these sites on an average on average on an annual basis. So that's question number one and then offer Liz maybe you could talk about the.

Ex us opportunities for gel Mito, and if you're looking for potential partnerships and is this something we should get some color on in the next 12 months and I have one follow up.

Yeah, I'll talk about ex US and then Jeff can answer the question I. We definitely are very engaged in both Europe, and Japan and we've got people that we have engaged with that are experts in those areas people. We know we've worked with in the past and so we absolutely are looking at two avenues and.

Europe, continuing to sort of engage with the regulatory agencies and then secondly engage with the payers the government to understand or try to help them understand the benefit of gel mido and so we absolutely will have on know within the next 12 months, but it does take time and it will be a few months.

Four we are able to give you anything specific in addition, we're very engaged also with Japan.

We've gotten some initial feedback back from them as to what we think they might one m. Our next step is actually to have a meeting with them. So we've had some work done and we think we know what would need to get done and the next step there is to really have a meeting so you're right. Once we have that information and really know specifically about what it would take them we may incur.

Age partners and though we have some that have been potentially interested and those.

Geography that we wait we would further engage in conversations once we really have a path and understand what the path forward is in those markets branch out Mito, So with that Jeff you want to answer that question.

Sure with regards to the accounts most of the accounts that have treated a patient or ready to treat a patient or.

Obviously your your cancer referral center sits at MD Anderson.

Mayo those those referral centers as well as large community practices, so where we've seen.

An increasing number of patients are the larger community groups. The referral centers. It varies as you know as you know Derek the orphan drug so its the number of patients certainly Barry, but yes, if you're looking for a number that they treat anywhere between eight and 12 patients a year, one or two positions may treat.

The bulk of those or it could be a little bit more dispersed you may have a.

A handful physicians that treat two or three a year, but those are those are the main as we expected.

Most of this is in the community the large groups with their own surgery Center, that's where we were seeing a lot of patients.

Got it thanks, Jeff and then maybe I'll throw one in to Mark here I know, it's early but I was wondering if you've gotten any sense from physicians utilizing gel might already whether they would look to incorporate maintenance dosing beyond the initial set of installations.

Oh, you know I think I think that that is the answer is it's probably a little bit too early for us to know the answer to that.

We do know that the urology community is very familiar with the concept of maintenance within the context of treating urothelial cancer. So it wouldn't be surprising to me. If we were more about that as more physicians treat more patients.

But I cant answer right now.

All right that's fair all right, thanks, guys and again congrats on the progress.

Thank you.

Thank you. Our next question comes from the line of Leland Gershell from Oppenheimer. Your question. Please.

Hey, good morning, Congratulations and thanks for taking my question.

But my words and actually has to do with any color you can provide.

On kind.

Kind of trends of patients coming into their urologist in Q3 versus Q2 in any way you could characterize as part of the resumption in awfully good seeing after where we probably have only.

Believed right Q2 into Q3, and how that May have impacted if you go to a bolus effect potentially on John I do update thanks.

Yeah, I think let Jeff comment on it it's a fluid situation right. It's it's been interesting to see.

Areas of the country open and those areas close the other areas that were close to open. So I think it's really hard for us to know what the actual impact of co bid. It I think as you've heard Jeff and Mark both talk in the past patients can't wait so long before before getting in to get treated.

So even in the Q2 and into Q3 time frame. We don't think that there was a huge delay, but Jeff why don't you sort of give some color on what we're seeing in the marketplace, specifically around physician offices and hospital seeing patients.

Sure. So we've seen a steady increase so what else sales, depending on where you are in the country and how quickly things are opening up.

It's really dependent on just prioritizing those patients so we know that the patients.

You know that that suffer from this or only going away.

A month to month that Beth.

So urology offices are being beginning to open up being to prioritize patients.

But I wouldn't say, there's any sort of the I think you mentioned bolus. It's a it's a stay steady increase our nurses continue to get access.

To all of the practices that that need their assistance, depending on where you are in that country base that they did open back up and if not we continue that virtual interaction with the physician in the physician office.

Great. That's very helpful. And then just a question to drill into.

Well, you know willingness to want to buy into July, though we could buy and bill let's say after an initial purchase by group practice I mean do you see the trend we're going to get some hesitation and then one one patient treated and then following positive reimbursement you see multiple orders because you know that practice and several urologist is now.

Comfortable with the with the buying bill thanks.

No great question. So that we know there are a handful of accounts that will treat a patient.

And our our waiting for accurate timely reimbursement, but.

But most are moving forward they really do understand that.

The value that Joe my toes, bringing and they though they may have a little as I always say undue anxiety around the miscellaneous code are now let's see code.

They are moving forward and treating patients, but do we have a handful of account.

That probably have a patient or two waiting I'm sure.

And then once they get reimbursed.

Currently and finally they'll move forward.

All right great. Thanks very much.

Thank you. Our next question comes from the line of Eric Joseph from JP Morgan Your question. Please.

Hi, good morning, Thanks for taking the questions.

I guess I'm curious to know what you are seeing currently in terms of.

CRB the procedure rates and what if any impact there is from companies like data and to what extent does your.

Expectation of one year enrollment or less.

Hey sensitivity from the ongoing pandemic.

I guess Uh huh.

Given that I talked to a global study are you able to take Jeff.

The mix of regional enrollment along the way.

And then I have a follow up.

Yeah I'll answer.

Talk a little bit about what we've done and sure that the Cove it doesn't impact our enrollment and what we what we did early on was.

But to move toward like Eastern Europe, frankly, and so we've.

We are.

Already in the works and have already have centers ready to go and we increased the number of centers of that yeah. You know in the eastern Europe area, because they don't seem to be having the same issue with co bed and we felt like they and their enrollment and the work that we did that the team did early on.

To ensure that we guide centers that could enroll they've been very bullish about their ability to enroll the study. So we know that even if we had there are some some reduction in the U.S. that out that we can offset that with our European sites. So would that Mark do you want to comment on T. RBC.

Is that what you're seeing in the hospital, obviously since you're on the on the front lines.

Sure.

It's a good question the answer is that at least in the U.S. and I suspect. This is probably as was pointed out very similar in Europe.

We're back to full swing because there was a backlog because of the delay related to the spring.

In fact in spring of the paint them become little like the surgery. So right now it's a very busy time in most operating rooms, and I think patients who are getting this surgery, which as you know is often performed.

In a surgery center hospital with the expectation that patients would either go home after surgery. The following day.

Is getting done.

Regular or maybe even slightly enhanced where you work to catch up so I don't think I don't think that there's going to be a problem.

Rolling patients in this trial based on that specific concern.

Good that's helpful.

Our.

Our lives I'm wondering if you could if I could get you to elaborate a little bit on some of.

The learnings from the Botox formulation study that you've noted.

In your prepared remarks.

I guess.

What were some of the shortcomings.

Where they seem to be efficacy or that the safety side.

Does the experience there changed at all your thinking about sort of the right yes.

But he.

You know co formulated are delivered to the specialty with artsy Joe.

Yeah, I think it's a great question and reality of it is it's never going to know exactly what happened the hypothesis that we have and I think abbvie and agree is that the botox molecule was just not able to penetrate that you're healthy and we believe it's likely because of the size of the molecule.

I don't know if you're familiar with that botox molecule, but.

It's it's a large very large large molecule. So it's about six times the size.

The example that detailing for that we're putting into it to our teach out. So that gives you. An example, sort of example of what we would be doing so I think what we learned is that we're not likely to try another large large molecule. So we think that most most of the large molecules.

More the size of our again, our own satellite where you can kind of look across some molecules, but other toxins. There are other toxins that and I think botox is well known have you know that there you know the properties of Botox, specifically are very different and sometimes challenging you know think about a promote when that the trying.

Trying to use that topically, where there are other toxins that are smaller so I think the plan forward.

And we you know they are not.

As we talked about before I think it was very clear that they want to take keep our arrangement in place and our agreement in place we were very well [laughter] frankly to to get out of the agreement because we felt like that would give us more freedom to operate but they believe in the jail. They were very happy with the way that it worked.

To deliver the botox and so they want to look at it with other toxins in their portfolio as well as potentially other products in their portfolio outside of toxin and so they kind of next steps for them is now that they are going through their integration theyre doing their prioritization and their strategy work and why.

Once they come out of that we'll know whether they are going to move forward with it or not and you know if you know we we have talked to them about us being more active in that partnership and if they choose not to and then we would have the ability to go out and find another potential partner in this space. So we feel like we learned a lot.

Got you know Mark hates it when I say that it was it was a failed study so I try not to say that what I say because.

Reason is because they have the RTL delivered when it was supposed to deliver the botox into the latter it had sustained release to celebrate over time. It was boarded appropriately. So it did when it was supposed to do unfortunately, the botox just did not get into the MLP.

Okay.

Great. Thanks for taking the question.

Thank you. Our next question comes from the line of Matt Kaplan from Ladenburg Thalmann. Your question. Please.

Matt Kaplan you might have your phone on mute.

We're still not hearing you.

All right well move onto the next question. Our next question comes from the line of Paul Choi from Goldman Sachs. Your question. Please.

Hi, This is Chris Jenkins on for Paul I was hoping you could talk a little bit about what factors you'd expect to play a driving role and a potential inflection in sales in 2021 and beyond.

Yeah, and I think what we've said and I think we still really believe this is that you'll see a steady increase in scripts as you would a typical any other typical adoption curve, we don't think theres going to be a an inflection point all of a sudden tomorrow.

As Jeff has mentioned this earlier J code comes and all of a sudden you see an inflection point, we think we'll see steady growth.

You know month over month and quarter over quarter, and that's what we would expect and weak comp.

Commented that yeah, we believe that we will stay sort of a normal traditional adoption curve that you play, but the other oncology products.

So Jeff I don't have anything to add to that.

No that but so that's it that's exactly what we expect.

Okay, and then I was hoping you could talk a little bit more about the interim analyses that are built into the outlets study and whether we should expect to get updates from those or how you're going to think about I just thought I should say.

Yeah because of the.

Because they are a bit event driven studies, we don't want to sort of hypothesize a project win when they might happen I think that you would you know you'll hear about them you probably are you only hear about them. If we are in a situation, where we would stop the study stop the study for efficacy and.

So I think that's you know that's the way I would think about it so I wouldn't expect there to be but typically any read out we might share with you that after an analysis that is continuing.

But we wouldn't be providing any any updates or projection that for when that might be.

Okay. That's helpful. And then last question for me just curious is this quarter a pretty good proxy for cash burn over the next several quarters or how are you thinking about that.

Okay.

I'm not sure what the question is obviously, our revenue impacts that as well, but when you get we do think that that from a if you're talking about from a spending perspective, you know obviously I think it is a good proxy, but you have to think about you know the things that we have upcoming I.E.R. phase.

Three study.

Thank you.

Thank you and as a reminder, ladies and gentlemen, if you do have a question at this time. Please press Star then one our next question comes from the line of Roger song from Jefferies. Your question. Please.

Great. Thank you for taking my question. So maybe two from me. So the first one is just to drill down a little bit around the gel mido kinetics.

Maybe just a quick comment on it or Jeff can comment a little bit on the tonnage from the sales.

How does the petition to the worst John Malone news and how did that compare to the time to the second person prescription and then do you see an acceleration from the first two years to the second prescription.

Yeah, Jeff.

Yeah, No I think it it really depends on if they have a patient.

Our well given the orphan drug of the disease, we've seen accounts tree. So yes to answer your first question. It usually takes two to four weeks depending on the institution it.

They they diagnosed or the pacing is recurrent that's usually a standard time, depending on again, the the sort of the bureaucracy that the institution may have to go through to get sell Mido. It's.

As far as the time the second patient you know, it's working with the nurse navigators any account to identify these folks if there you know what they've been out there. They were occurred they're now they now have another treatment option. Other accounts that may have been a couple of months.

They treated someone in July.

It's just again a matter of finding the patients given the orphan drug nature and really working with the nurse.

Folks that can look at the more the medical records and see who might benefit from Zelman <unk>. So that that second question. It varies that can be within days of after treating a patient or a couple of months.

Does that answer your question.

Oh, sorry, I have to tell me they have you know.

Yes, we can hear you now.

Great. Thank you.

My second question for Mark So can comment a little bit on the statistical assumptions or less how.

How confident and comfortable confident are you about the 600 patients sufficient to meet both superiority and a nice gherardi endpoints and we noticed you basically have two additional data point can support or change that assumption back the full phase two data read out.

Read outs and I remembered you say, you're well do some come a retrospective trying to do for them.

The natural history could you comment a little bit on the statistical assumptions.

Oh.

Sure. So we haven't shared.

The statistical model.

At a granular level and I.

I would imagine that we probably aren't going to do that today I guess, what I can tell you is that we first of all discussed all this with the FDA agreed upon both the design of the trial as well as the size.

And the and the size of the trial is.

I'm going to provide us with the power we need in order to.

Demonstrate what we believe will be both non inferiority and superiority.

The.

The interim analyses as was pointed out are improving so we don't know when they will occur and they are obviously designed in order to assess superiority noninferiority. His arm is is a turning point that would occur at the final analysis, we are without exclusivities.

So.

With respect to the database is we've been reviewing.

Some of the some of the analyses actually we're in the process of being submitted as abstracts and papers Republic can.

Consumption and presentation and I would anticipate that actually some of those presentations remake.

Later this year or early next year, although we're waiting to hear about exactly so it's probably premature to talk about the actual data in the job search. So we do however have in.

Information from those projects, we're going to share and just generically I will tell you that the information we glean from that that those exercises is supportive of what weve used to design the trial interest to put a finer point on this remember that in the hard to treat population we're focused on the intermediate risk group.

Group.

The standard of care, which is trades resource section produces recurrence free survival.

At about 12 months in about 50% of patients so.

That is sort of a general ballpark number to keep in mind when you start thinking about our trial and the context in which we're using a huge in one or two to treat this group of patients and remember that in the face to the.

The complete response rate.

65%, so I realize that's not a complete answer to your question, but that's probably about as much as a feel comfortable sharing right now.

No that does that help us think remark. Okay. That's all my question Congrats again for the color.

Okay.

Great. Thank you.

Thank you and we have a question from Matt Kaplan from Lautenberg them. Your question. Please.

Hi, Good morning, guys. Thanks for taking the question.

Just wanted to zero in a little bit.

On reimbursement and what you're seeing there and have there been any issues of reimbursement that youve had to address along the way and when and where are you with respect to that.

For Chatham lodging.

Yep.

Sure. So as with anything you know, we provided better dating to our providers because the miscellaneous code as I've always said, it's a manual process. So its a manual submission where we've seen issues that simply because the form wasn't filled up correctly. Originally so they've had to.

That's a re submit.

Certainly the carrier the Mac carriers need to be educated have been educated.

But again because its a manual process with the miscellaneous code now it is only a month and with the C code.

But yes, we have been offices that have been reimbursed and it's getting more timely now that we see it with the C code will keep obviously those accounts were treated early in October utilize the C code.

And hopefully we'll start to see some of those accurately reimburse here shortly.

Okay. That's helpful. And then in terms of you mentioned a dramatic increase in the number sites that can that are better prepared to use gel mitel I guess now you're up to 165 sites.

Can you help us think about kind of the rollout of additional sites and apps and and kind of the uptake at those sites and how we should think about that.

Sure. So I've always said, we were going to call on around four or 5000 urologists with the field force that's anywhere between.

1300 to 1500 accounts my.

My expectation is that obviously, if things open up as physicians get more use.

That that number is always going to be increasing we obviously.

We're targeting the key accounts in the community as well as the hospital.

Those that have come up and running sooner as opposed to others or maybe quicker to start seeing patients depending on where you are in the country, but yeah, I'm I'm I'm happy to see that significant growth I would expect to see that.

Throughout 2021.

And to be key because it is it is important you know not not not one or two accounts aren't going to have a handful of patients we need to make sure and were structured to get to all those accounts to make sure that every physician is aware of gel mido is an option for their patients with low grade your Tc.

All right. Thanks for taking the questions and congrats on the progress.

Thank you. This does conclude the question and answer session of today's program I'd like to hand, the program back to Liz Barrett for any further remarks.

Great. Thank you. Thank you operator and weights as we've sort of demonstrated and shared with you. We've made some important progress as a company in 2020, we are very excited about the results that we shared for Q3 and we look forward to our continued positive momentum throughout the remainder of this year and that means like really successfully trends.

Turning to commercial stage organization and our underlying fundamentals of our business are really strong. So our team continues to work relentlessly to make sure that we can provide jump hydro to all patients and practitioners and need and we're pleased with the progress them on one or two and our early pipeline. So as we start to turn our our view onto 2020.

Juan it's shaping up to be another busy year for us and we look forward to providing you further updates. So thanks to all as always for your continued interest in our company and operator, you may now disconnect everybody have a great week.

Thank you and thank you ladies and gentlemen for your participation in today's conference. This does conclude the program you may now disconnect good day.

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