Q4 2020 Urogen Pharma Ltd Earnings Call
Yeah.
Good morning, ladies and gentlemen, and thank you for standing by and welcome to the Euro Gen Pharma fourth quarter and full year 2020 financial results and business update conference call. It is now my pleasure to turn the call over to Sara Sherman had been.
Bester relations at European Pharma. Please go ahead.
Thank you Jonathan Good morning, everyone and welcome to European Pharma fourth quarter, and full year, 2020 financial results and business update conference call earlier. This morning, we issued a press release, providing an overview of our recent corporate highlights and financial results for the quarter and year ended December 31st 2020 per.
So I used to be accessed on the investors portion of our website at investors that yard and 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 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.
And this will provide a summary of our recent corporate developments and Mark will share clinical development updates and Jeff will provide a commercial update and I will then provide an overview of our financial highlights for the fourth quarter and full year before we open the call for questions.
During today's call, we will be making certain forward looking statements. These may include statements regarding the timing of our ongoing and planned clinical trials, John Lytle commercialization data presentations potential regulatory filings future research and clinical development efforts and our ability to change treatment paradigm manufacturing capability.
And with future expectations plans and prospects in 2020, one financial guidance among other things.
Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed and the risk factors section of European Farmers Annual report on form 10-K filed with the SEC. This morning, and other filings that European pharma and makes with the SEC from time to time as well as any negative.
A tax on the origins business its all its commercialization and product development plans caused by or associated with the COVID-19 pandemic to the extent not disclosed previously.
We encourage all investors to read the company's annual report on form 10-K, and the company's other SEC filings. These documents are available under the SEC filings section of the investors page of the origins website at investors thought yards and dotcom.
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 and 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 and I'll now turn the call over to Liz.
Thank you Sarah and thank you to everyone. Joining us today, it's not an understatement to say that 2020 was memorable for everyone. Despite the challenges we face collectively it's been inspiring to see how innovation and the pharma and biotech industries per.
For severe to the benefit of society.
Although this is what our industry does day in and day out I am grateful to see that heroic efforts being universally applauded.
While that work has rightfully been on the forefront of many diseases don't become front page news, but they do take center stage for the individuals who've been diagnosed.
Your agenda is focused on developing treatments focused on your logic and specialty cancers last year. Our first approved therapy Yamato became the first and only FDA approved non surgical treatment option for adult patients with low grade upper tract, you'll feel you'll cancer.
Although launching gem, Idaho in the midst of the COVID-19 pandemic certainly presented challenges we are incredibly pleased with the way. Our team has responded to those challenges and the first two full quarters of launch we recorded $8 million and net product sales for the fourth quarter of two months of 'twenty and 11.8 million since June.
And one 2020 launch.
We continue to be mindful of the environment, we're operating in including the vaccine rollout and its impact on the health care system and the patient populations. We serve we have seen these trends have an impact on patient procedures, including job might've uptake and the first two months of 2021 we continue to closely monitor and.
GAAP and Molly will provide more details on our progress shortly but we remain confident and the outlook for continued and accelerated adoption as the year progresses.
And the demonstration of what's possible and makes us even more enthusiastic for what's to come and we've made important progress in advancing our pipeline and executing on our near and long term growth strategy.
Most recently, we initiated the Atlas trial, our phase III clinical study of our lead product candidate Eugene and one O two for patients diagnosed with low grade intermediate risk non muscle invasive bladder cancer.
We're very excited about the U G and one O two program for many reasons, but mainly for this significant unmet need and this patient population with no FDA approved primary treatment option.
We believe that there are important similarities are crossed the therapeutic indications for both John Mito, and Eugene and one O two and we hope to leverage our learnings and experience from job Murdo and apply those to Eugene and one O two and its potential for these approximately 80000 patients annually and the U S alone.
The low grade intermediate risk patient is this day is a unique patient population identified and at high risk for recurrent and current standard and it's just not good enough and our phase II B study 57 per cent of patients had received three or more T. R. B T surgeries prior treated and rolling in the trial.
All these patients deserve better options and if Eugene and one O. Two as approved these patients may benefit from the first primary non surgical treatment option.
We were very encouraged by the data we share from the Optima II trial, showing a strong complete and importantly, durable response and believe it supports one Eugene and 102 has potential as an outpatient treatment option for these patients.
We intend to present these data at an upcoming medical meeting and published and a peer review journal.
Our work extends beyond low grade disease to high grade disease, our early stage programs, most notably Eugene and three a true is initially being studied and high grade non muscle invasive bladder cancer, a life threatening disease with risk of progression.
We believe that Eugene and three O two which is a combination of Eugene and two I want our T. L are seven and eight agonists and Eugene and 301, the anti Cta life for antibody that we license from a genus combined with our gel technology has the potential to transform this disease and provide and advanced are currently available.
Treatment option.
And the recently announced three year research collaboration with the University of Texas MD Anderson Cancer Center is aimed at advancing this common editorial intramuscular and no therapy for the treatment of high grade non muscle invasive bladder cancer and the initial focus on Eugene and three O. Two we're particularly excited to leverage their collective experience.
A doctor James Allison and Dr. Pam Sharma, who have both been instrumental in developing breakthrough therapies with immuno oncology.
We continued to expand our focus and immunotherapy research utilizing our proprietary technology with checkpoint inhibitors as reflected in this week's announcement of the non clinical response and research agreement with the Johns Hopkins University to explore this combination and Glioblastoma Multiforme RGB.
And an aggressive and difficult to treat brain cancer.
These two important programs with world renowned academic institutions are part of our ongoing efforts to expand our pipeline and realize the full potential of our proprietary our T gel platform.
As we look ahead, we are pleased to announce that we completed a strategic transaction with our T W providing funding of $75 million.
We believe this will serve to fuel our mission to advance and bring life altering therapies to patients.
Bollywood provide additional detail on this important transaction shortly but this finding and shore has a solid financial outlook for our company.
As we look ahead, we are building a company to transform how we treat specialty cancers and urologic diseases.
We have and continue to deliver on all of our commitments and I am proud of the work. We're doing we faced challenges every day and our colleagues rise to overcome barriers because we share a vision to have an impact on patients that need our medicines.
We have a strong foundation to ensure a long term growth business and realized leadership by delivering new approaches to patient that had been left behind.
With that I'll turn the call over to Mark to discuss our recent clinical update mark.
Thank you Liz.
Exciting to see the impact Joe and Mike I was having on real world practice, and an exciting time for patients as we continue to expand our pipeline and important areas Euro oncology.
During the fourth quarter of 2020, doctors Serena math and from MD Anderson presented the final durability data for more phase III Olympus pivotal trial.
And Joe might owe and low grade upper tract residual cancer and a virtual podium presentation.
The 20 <unk> annual meeting on the society of Urologic oncology.
We were pleased to see that and both the Olympics intent to treat population.
And then the subpopulation of patients who are deemed to have unresectable disease. At study entry 58 per cent of patients achieved a complete response with durability of response and a 12 months estimated to be 81 eight per cent by Kaplan Meier analysis.
Median time to recurrence was not reached.
Safety profile and the Olympus data was consistent with previously reported results.
This was previously a disease where options for patients included multiple endoscopic procedures for the removal of the kidney and Europe, both of which have consequences and packing patient health and quality of life.
And final durability data from Olympics were in line with our expectations.
Support the use of <unk> as a less invasive kidney preserving durable treatment for low grade upper tract <unk>.
Youll carcinoma, which may reduce the need for multiple endoscopic procedures, where law for the kidney.
We also had several updates to provide for our UGI and went on to program since our last quarterly call for.
First of which is the final top line data from the Optima two phase two b trial evaluating Eugene and one on two primary therapy and <unk>.
Patients with low grade.
And at risk non muscle invasive bladder cancer that we announced in November.
This study showed a 65 per cent of patients 41, and 63 received and Eugene and one or two and achieved a complete response three months after the start of therapy.
And this subset of patients duration of response for 12 months from start of therapy was estimated by Kaplan Meier analysis to be $72 five per cent.
The median duration of response was not reached.
Treatment with Eugene and one or two was generally well tolerated and.
Safety profile was consistent with previously reported results.
And with mostly mild to moderate adverse events that resolved over time.
And the trial, we observed typical symptoms and explosion in line, a bunch and and no treatment related serious adverse events were reported.
As Liz mentioned, we initiated the Atlas trial, our phase III study of EG and on one or two in December and are actively enrolling patients.
Atlas is a randomized controlled global study and will enroll approximately 630 patients and compare Eugene and one or two plus or minus treasuries for sexual bladder tumors, where T or b T. T. RPT alone, which is standard of care and patients diagnosed with low grade intermediate risk non muscle invasive bladder cancer.
We were following the same enrollment criteria used in our phase <unk> Optima II trial and <unk>.
Specs to enroll a similar population.
Patients will be randomized one to one to either upfront Eugene and one or two treatment, where T or b T and.
And at the three months time point patients will be assessed for response.
Patients who have demonstrated a complete response to you here in Eugene on one or two where T or b T will be monitored quarterly for evidence for curves.
Issuance, who have tumor presence on evaluation for three months in either arm will undergo to RPT and then and are identical monitoring for courage and the primary endpoint for this study is disease free survival or recurrence free survival in this disease and.
And the trial is a time to event analysis designed to evaluate non inferiority and superiority and we expect the trial will take approximately one year to enroll and to be completed women approximately three years.
There are no non surgical primary therapies approved in this patient population and to do.
Day patients are managed by repeated trend to reach will procedures under general anesthesia with a minority of patients receiving management water based chemotherapy.
Per published literature, two thirds of patients kind of two or more recurrences and approximately one fourth for five or more where currency throughout the course of their disease ICB.
I see these patients and my practice and with each recurrence comes into digital surgery.
Although the risk of death for diseases relatively modest the risk of repetitive surgery is real and these risks include unintended hospitalization for bleeding and infection as well and so recently reported risk of increased mortality following multiple surgeries for non muscle invasive bladder cancer.
It is our belief that the Atlas trial is designed to effectively demonstrate Eugene and one or two has potential to change the treatment paradigm by providing a useful non surgical therapeutic alternative to patients. So they can avoid the potential co morbidities and complications that come from repeat it to you our beauty Wheeler.
And we look forward to providing enrollment updates on this trial later this year.
While there are many similarities with Joe and myself and Eugene and one or two.
And both represent important advances and patient care one important differentiation is the additional ease of administration that we believe UGC on one or two may offer patients.
Given the feedback we've received for more clinical trials, including the potential for a nurse to administer Eugene and one on too.
We are planning a small feasibility study to assess the potential for at home installation.
We're currently and the final planning stages for this study and expect to start sometime this year.
We will provide more details as we progress, but believe the potential ease and flexibility of administration could be an important differentiator for patients with this disease.
We are also focused on expanding our immuno oncology pipeline, specifically Eugene and three O two which is a combinatorial approach initially being developed for patients with high grade non muscle invasive bladder cancer.
As Liz mentioned Eugene and three O. Two was a combination of Eugene and two a one hour telos, seven and eight agonists and Eugene and 301.
Or sell the thrill of Mad and Mtc GLA for antibody that we have combined with our T gel technology.
There are significant differences between high grade disease, and the low grade disease that we focus on with Joe Mundo and Eugene on one or two.
High grade non muscle invasive bladder cancer is an aggressive and potentially life threatening malignancy characterized by both a significant risk of recurrence and disease progression for muscle invasive cancer.
And we know that some patients with high grade non muscle invasive bladder cancer respond to immunotherapy using the Philips come and go around for BCG. So there is a strong predicate rationale for exploring potentially better immunotherapies for the treatment of this patient population.
As we've shared before.
For non clinical data with the Eugene and 302 program has generated today.
And very encouraging and it's the combination of Eugene on 201, and and anti <unk> four antibody resulted in improved survival and decreased tumor size and our marine model.
Additionally, we absorbed changes and immunological markers, such as decreased T regulatory cells and a trend towards increased CD eight T Reg ratios.
It is our belief that the data generated to date and support the potential of a locally applied combinatorial immunotherapy.
We are thrilled to be collaborating with M. D. Anderson on this novel program, given their expertise and innovative clinical trials and infrastructure.
We expect to progress the Eugene and 302 program. This year, which includes potential non clinical studies for <unk> and three a one and a combination of Eugene and two on one and Eugene and 301 as well as clinical studies for <unk> and 201.
We are working closely with M. D. Anderson on next steps and trial designs and we will continue to share details as they are available.
The second immuno oncology program to highlight is.
And interesting new sponsored research agreement with the Johns Hopkins University, where we intend to explore and a preclinical setting the potential of checkpoint inhibitors combined with our T gel and Glioblastoma multi for me where G. P M.
This program stems from our focus on expanding our novel or T gel technology in combination with other medicines to provide treatment options for patients and diseases with significant unmet need and where local immune modulation may make a difference on our focus with this program is G. P M and aggressive malignant brain tumor.
And with a five year survival rate of less than 5% G. B on its difficult to treat and treatment options. Today are limited and typically include surgery, followed by radiation and chemotherapy.
It is the most common primary brain tumor with around 12000 cases diagnosed per year.
With this research we will examine combining our novel RTG on technology with anti PD, one and you know and PC purely for antibodies, respectively to assess the impact on survival and it.
Mouse model of GBM.
While early we continue to investigate the potential of our T gel platform and immuno oncology.
Uh huh and explore local applications and immunotherapy, both with and oral laboratory and and working with key academic centers, who may leverage our technology and exploring therapeutic options and with that I'd like to turn the call over to Jeff to provide a commercial update Chuck.
Thank you Mark I'm pleased to provide you with an update on our commercial launch of gel Mitel as Liz mentioned, we achieved $8 million and net product sales and the fourth quarter of 2020, and $11 8 million from startup <unk> launch on June one.
And a 2020 this represents a great early start for the launch and is a testament to the important work. The team is doing and the value that Joe might oak and bring two adult patients with low grade <unk>.
The feedback that our team continues to receive from physicians treating their patients with Joe and Idaho remains extremely positive and we are seeing firsthand the tremendous impact that Yamato is making the lives of patients the.
And most consistent and recurring themes. We here include patients avoiding surgery and achieving a complete response post treatment consistent with what we've observed in our clinical trial.
Heard from a number of physicians, who have treated their first patient with <unk> received a promising response and are now working on identifying additional patients.
In November of 2020, we announced the CMS established a permanent and product specific J code for <unk>, which took effect on January 1st of this year for Jay.
The code replaces the previously issued and temporary C code and Standardizes and facilitate reimbursement and the hospital outpatient and ambulatory surgery Center and physician office settings of care. This day.
The code is helpful and simplifying and streamlining reimbursement for physicians and we believe that will translate into improved access to Joe Murdo throughout 2021.
There are couple of data points I've been sharing on our calls for help illustrate the success of the launch to date and the growth that we've seen early on.
The first is activated site.
As of March 1st we have increased our activated sites over 250 sites up from 210 site at the year end and 165 sites as of November one 2020.
These are sites, who are treated patients or are ready to treat patients. We expect this number to continue to grow as our sales force of 48 reps continue to target hospital and community accounts, where most of the patients are treated.
The other data point that is important to note is repeat accounts or accounts that have treated more than one patient as it suggested for physicians are seeing clinical efficacy and the drug that reimbursements working and all of the other components of the process have gone.
As of March 1st we have increased that number to 31 accounts up from 24 accounts at year end and 13 as of November for.
This is a critical factor demonstrating that the processes and support in place are working and clinicians are identifying additional patients and gaining comfort and using this treatment.
As we continue to expand and usage of <unk> and reach additional target providers and accounts. We expect this number to become less relevant but believe it's valuable and the early stages of launch.
We have also received compelling market research results showing the increased level of Yamato awareness a testament to the team's efforts as of November 2020, aided awareness increased to 94% up from approximately 70% prelaunch. We also see a slight shift towards physicians viewing radical net flow.
Redirecting me at less favorable than prior to gel mitosis approval and we expect to see that increase.
I'd like to take a moment to highlight what we're seeing and the industry today and the impact of COVID-19.
We saw them in 2020 cancer diagnoses were down about 40% and formal market research. It's evident that at least one third of the patients are delaying treatment due to the pandemic.
And these phenomena are industry wide and in January 2021, based on the IQ via data elected procedures were down 25 per cent.
We are not immune to these trends and are also seeing patients with low grade tumors deferring treatment.
While we're optimistic for the future January was the harshest months as it relates to Covid deaths and the U S and we wanted to share two potential trends that are important to note as the pandemic continues to evolve.
Given the patient population with low grade <unk> to UC is generally and they're 70 and makeup the majority of patients being vaccinated and the early rollout. These patients have prioritized and we expect near term, we'll continue to prioritize and receiving the vaccine before seeking treatment.
Additionally, at the hospital level, we are aware that some formulary reviews are being delayed because of the vaccine rollout as the hospitals are focused on prioritizing vaccine <unk>.
These trends are resulting in a softer first quarter of 2021 than previously anticipated.
That being said, we are seeing leading indicators and potentially new patient starts in the coming months and all metrics reflect five physician and patient interest and adopting <unk> into their practice.
And just on the recent interactions I've had and the field with physicians I continue to hear that physicians are supportive of zelle, murdo and its potential benefit to patients.
We are closely monitoring this environment as the pandemic and vaccination rollout continues but anticipate improvement and patient access to treatment providers and Suzhou motto in the coming months as patients and physicians are vaccinated.
And we will continue to monitor and adapt to ensure patients have access to jump on it.
Although we are navigating the unchartered territory of this pandemic our team continues to deliver and I would be remiss if I didn't thank our team as well as the many external parties involved including our partners and our health care providers for their continued efforts and commitment to patients.
Our team's commitment to providing patients with our novel effective and potentially kidney sparing treatment option remains unwavering and we believe our experience would tell midol bodes well for potential commercialization of Eugene and one or two if approved and with that I would like to turn the call over to Molly who will discuss financials.
Thank you, Jeff and thank each and everyone who joined today's call before I discuss our fourth quarter and year end 2020 financials I'd like to touch upon the strategic transaction announced this morning with RTW and provide some details.
We're pleased to partner with RTW, and and influential and healthcare Investor, whose mission is to invest and innovative companies looking to bring important new products to patients.
And Debbie use research driven and we believe this investment reflects their confidence and the European team and the important impact that you might have on patients as well as the excitement surrounding the potential opportunity for UGI and went on to and non muscle invasive bladder cancer.
The $75 million and funding from RTW puts us and a solid financial position to support the continued launch of Mitre and the development of easy and went up to and return arch and Debbie will receive tiered future cash payments based upon global annual net sales of tomato equal to nine 5% of annual net sales up to 200 million three person.
On a annual net sales between $200 million and $300 million and 1% and annual net sales above $300 million.
And if certain annual revenue thresholds for Jim Might've aggregate worldwide net sales are not met the future payments with respect for the first share of net sales will increase by three five per cent and that subsequently decrease depending on meeting certain annual net sales thresholds.
In addition, our T. W will received tier and future payments based on global annual net sales of Eugene and one O two subject to FDA approval equal to two 5% of annual net sales up to $200 million, 1% of annual net sales between 200 million and 300 million and <unk> <unk> five per cent of annual net sales above $300 million.
Payments based on net sales and boats Yamato and Eugene one or two will terminate terminate upon the day that our T. W has received an aggregate amount equal to $300 million.
We are excited to partner with RTW and industry leader, providing ear agenda solid balance sheet to execute on our mission.
I will now take a moment to review the fourth quarter and year end 2020 financials.
Carriage and recorded net product sales, which are minor for the fourth quarter 2020 of approximately 8 million full year, 2020 net product sales of tomato, which launched on June 1st 2020 were $11 8 million.
Before turning to cost of revenues I'd like to mention a few external trends that we're watching as we start 2021 first as lives and Jeff mentioned, we continue to be mindful of the evolving pandemic landscape and expect the vaccine rollout to have an impact on our first quarter 2021 results.
And we are cognizant of the severe weather and the U S. Throughout the first quarter of this year and the impact that and it has had on shipments of <unk> to patients.
Lastly, given the concerns over potential shipment delays around the year and holidays last year. We received several bulk orders at the end of 2020 that were recognized in 2020 revenue of approximately 500 to 800000.
And don't anticipate similar bulk purchases are stocking patterns and the first quarter of 2021 based on these three impacts we are carefully monitoring our Q1 revenues for 2021.
Turning to cost of revenue for the fourth quarter of 2020 and the year ended December 31, 2020 cost of revenues were approximately 652000 and $1 million, respectively and included certain one time start up costs.
And periods prior to receiving FDA approval of <unk> and pursuant to accounting rules, we recognized inventory and related costs associated with the manufacturer for myself as research and development expenses.
We expect a favorable impact on cost of revenues through the first quarter of 2022, as we deplete inventories that we had expenses prior to receiving FDA approval.
Research and development expenses for the fourth quarter and year ended December 31, 2020 were $12 4 million and $47 3 million, respectively, compared to $20 1 million and $49 3 million respectively for the same periods in 2019.
Research and development expenses for 2019 included $10 million milestone payment related to our license agreement that Gina.
Setting aside that expense research and development expenses increased by $8 million year over year.
The increase of $8 million, resulting primarily from a one time payment of $6 6 million to unwind the company's obligation to the Israeli innovation authority. During the first quarter of 2020 and increased expenses related to EOG and one or two clinical trial and UV and 201 studies, partially offset by the completion of the Milo phase III clinical trial.
And reduce regulatory activity.
Research and development expenses also includes $1 4 million and $6 4 million of noncash share based compensation expense for the fourth quarter and year ended December 31, 2020, respectively, as compared to $1 9 million and $8 $3 million, respectively for the same periods in 2019.
Selling general and administrative expenses for the fourth quarter and year ended December 31, 2020, or $22 2 million and $90 2 million, respectively, as compared to $19 7 million and $60 2 million respectively for the same periods in 2019 being.
The increase in annual selling general and administrative expenses resulted primarily from increased costs and activities related to the commercial launch until Mito and June of 2020, including head count and related costs associated with building, our sales force and administrative costs.
Selling general and administrative expenses included $5 1 million and $21 6 million of noncash share based compensation expense for the fourth quarter and year ended December 31 2020, respectively.
Per the $6 2 million and $21 7 million respectively for the same periods in 2019.
The fourth quarter and year end December 31, 'twenty, 'twenty and reported a loss of 35 million or a dollar and 38 cents per share and $128 5 million for $5.90 per share respectively.
This compares to net losses of approximately 39 million or a dollar and 86 cents per share and $105 1 million or $5.12 per share respectively for the same periods in 2019.
The loss for the fourth quarter and year ended December 31 2026.
$6 5 million and $28 million, respectively of noncash share based compensation expense.
Our guidance for 2020, one operating expenses and the range of 155 million and $270 million. This is largely driven by the initiation of our phase III Atlas study late last year.
This includes estimated noncash share based compensation expenses of 24 million to $28 million subject to market conditions.
Lastly, we closed the fourth quarter and year end and year with approximately 103 9 million and cash and cash cash equivalents and marketable securities with no debt.
And this was supplemented post here and by the $75 million and funding we announced this morning from RTW.
We believe we are and are solid and sound position to execute on our strategy.
With that operator, I would like to turn over the call for questions.
Certainly ladies and gentlemen, if you have a question at this time. Please press Star then one on your touch on telephone if for your question has been answered and you'd like to remove yourself from the queue. Please press the pound key our first question comes from the line of Chris Howerton from Jefferies. Your question. Please.
Excellent and good morning, and thanks for taking the questions and really appreciate all the progress through a pretty.
Difficult year last year.
Great. So I guess, maybe is to start things off in terms of <unk>.
Jeff.
For the the repeat customers that you saw in terms of the accounts and I guess I'm just wondering if there's any trends that you see there categorically use that more tend to be academic centers community centers and as you know what's your expectations there.
And we're kind of what youre seeing for.
First of all and then secondly.
With respect to the first quarter revenue numbers I guess I just wanted to fully understand the expected dynamics to the net revenues.
I think Molly you said that there were some weather related shipment delays and then there was also perhaps some larger orders in the fourth quarter.
And then perhaps there's also something to be understood with respect to.
On the payer environment payment plan resets or anything like that I guess, just maybe help us better understand the expected dynamics.
For the first quarter.
Revenue numbers.
And I think maybe that's it for now and I might have a follow up.
Hey, Chris. Thanks, It's labs, how are you I'll turn it over to Jeff to answer. Your first question and then Molly you can talk a little bit more about Q4 and Q1 suggests.
Hi, Chris and Tim.
Address your first question.
The multiple or the patients or the physicians are multiple patients, it's primarily probably 60% to 70% are those and the hospital, but we do have community accounts that have multiple physicians.
Writing Joe might opt for their patients.
Or single positions that are identified.
More than one patient as well so my expectations I can.
As I said and the path to continue to expect this will translate more into the community. Some more community practices will begin to adopt and treat multiple patients but for the time being the predominant number of.
Multiple patients are coming out of the hospital setting.
Great Okay.
And hi, Chris to answer your question on the Q1 revenue so as Jeff and I, both alluded to we started to see some softness as we went into January and February of this year and a lot of the reasons and we discussed them.
And our narrative around the vaccine rollout and some other impacts as it relates to the weather.
To that effect, we're starting to see the rebound of that and I think when we look at the patient population that we serve it was the same patient population that was getting the vaccination or in the queue to get vaccinated.
And so that really trends in line with kind of the rebound and worsening and March we're still in the first quarter. So we're not going to provide any more.
Clarity as far as where we expect and because we still have a few more couple of more weeks to go and there'll be certain wanted to flag that the market because those are some of the dynamics that we're watching.
And then maybe lastly, as it relates to some of the stocking charges. We saw last year I referenced about a 500 to 800000 dollar.
Estimate based upon some indication we got from certain practices that they were looking to stock and ore and get ahead of any shipment concerns I remember last year's holiday season, and there was a lot of delays and shipments. So we saw some of that and advance line last year and we're not gonna see a similar pattern they wanted to queue the market into some.
And with that dynamic as well.
Okay.
Great and and maybe just as one clarifying question with respect to that in terms of the day shipment delays and the first quarter did that impact any kind of treatment schedule or any effect in terms of the payment patients or just maybe like initiation of treatment just a clarification there and then.
Another question for Mark would be what do you expect the impact could be of in home installation and and as that.
Primarily in the context of the Covid environment may be very impactful and not so much outside of that or.
Or maybe just how youre seeing that would be helpful to understand snakes.
Jeff do you want to take the impact to patient treatment.
So it did impact we had a few that needed to be rescheduled.
And Fortunately the Olympus trial was designed that though it's once weekly and not everyone was got a dose every seven days and so they were able to.
Miss It a day or two and the Olympus trial, there for physicians felt comfortable.
And obviously given the weather that we had shipments were delayed by a day or two they just simply reschedule those patients.
Got it.
Chris Mark.
Chris Thanks for the question about home installation.
I think this is an example of something that was really fostered and the company, which which has been I think accelerated by Covid, which is thinking innovative.
Lee and.
Out of the box the concept of home care for patients with recurrent disease. It was really a very innovative one but its comfortable with this therapy.
And so we want to explore that because we think it represents a very positive step.
And in the right direction for this population and obviously, we have to do the study.
To examine whether it makes sense, but it is a really interesting and I think and innovative way.
Thinking about the next generation of treating patients and Covid I think has made us think about this and then accelerated fashion. So I think it has had a little bit to do with Covid, but I also think it's completely consistent with our larger corporate goals.
For those articulate the many times.
Yes, Okay, alright, well.
Great. Thanks, so much for all the answers and again and I appreciate all the progress.
Thanks, Chris.
Our next question comes from the line of Derek or channel from Stifel. Your question. Please.
Hey, good morning, everyone and congrats on the news and the updates here. So just two questions from us.
The first one is for Jeff I, just wanted to get an understanding as how you think the sales ramp and the.
Trajectory for Xiaomi.
May be impacted with the J code now that you have it maybe you can kind of talk to some of the things that have happened.
For some of the trends thus far in the first quarter and.
And then maybe the second for for Liz and Mali.
Now with the RTW investment I guess.
Do you think this is enough runway to get yourself to profitability and just kind of curious how youre thinking about that thanks.
And to answer.
So with regards to date, what we've seen particularly and a community to community.
You know, whether it's warranted or not.
Tends to be a little bit.
And have a little bit more anxiety and around miscellaneous code and so they they they.
And they like having the J code the product specific code, they're being trained with the CMS CMS and giving guidance on.
How to bill correctly for the drug. So it certainly has helped with regards to uptake and keeping the urologists I expect it to continue as well, having a permanent J code.
Molly you want to give you a perspective on the financing and then I'll try and minutes as well.
Sure Hi, Derek Yes, we were excited to announce that financing. This morning, we haven't provided any specific guidance on when we anticipate the breakeven, but it's safe to say this additional funding gets us into 2023 and it certainly allows us the ability to continue the launch efforts that we have on Yamato and and the Atlas trial.
And relating to one on too.
Yes, I think Derek they either on the other comment I'll make is we you know we've had a lot of questions and comments from you know from investors and around needing to raise money, obviously and people wondering where we're going to go back out to the market and this is non dilutive financing and so we just you know I think this whole.
And the answers that question and and you know, we don't have and need to go out to the market right now and I think you know.
And we're well funded to do the things that we need to do right now I think theres always the question of business development right and that's something we get we find something we're excited about where constant constantly looking for new opportunities, but and.
So if we find something we're excited about that might might change things, but at this point and time I think you know as as you I'm sure can tell where we're funded where we need to be and you know and don't expect to be doing any dilutive financing and anytime soon.
Thanks for the question.
Yes, thanks, and congrats again.
And thank you Derrick.
Thank you. Our next question comes on the line of Eric Joseph from Jpmorgan. Your question. Please.
And good morning, and his Hannah on for Eric. Thanks for taking the question just a few from us and so now that you're further into the launch are you able to speak a little true the frequency of them on maintenance therapy is and the commercial setting you mentioned earlier that the number of patients have seen a complete response, but have you been able to determine what proportion of patients on <unk>.
And let's see are and how that would compare for the Olympus trial.
And then I have a follow up on that.
Yeah, Jeff why don't you take those.
Yeah, as I said it.
System with what we saw on the Olympics.
Olympus trial.
Whereas the physician if they choose to tell us how the patient is doing.
Yeah, that's information that we have.
We haven't really maintenance has been something that is and the debt.
Physician discretion and I will say this we have a more patients.
More physicians, considering on maintenance and putting patients on maintenance, but it hit.
The bulk of the majority of.
For the patients are getting the treatment the six doses with no maintenance.
Yeah, and the only comment about see are and what we're seeing is you know as Jeff comment that's anecdotal right we don't capture.
For all World, we're not capture and real world CR, but yeah from.
What anecdotally.
And I would say at least as good or better and we're happy for you.
And it's well tolerated and and we do capture obviously any aes that have to come in you know to the.
And so we felt really good about not only the efficacy, but the safety as well. So you said you had a follow up question on Hana.
Yes, and you had mentioned a little while ago interest and pursuing a re treatment trial and just wondering if that was still adventurous and if there's any particular time lines, where you might see that come to fruition.
Yeah, we're definitely interested and that and we will start that study as soon as its feasible. The reason I say that is because pace.
Patients have to recur right. So they have to do well on the treatment and then have a recurrence. So we would not see to start that study obviously patients are just starting on the on the treatment and the last six months so and.
And we wouldn't expect to start that till the end of this year or really into probably in 2020 two.
Having said that just you know we do know that there were patients that were in the study that have gotten retreated and it is and our label today, but we would like to generate additional data on re treatment its not stopping pay a physician from re trading patience as I said, it's part of our label.
We'd like to capture data, but it will be a quite.
Quite a few months before we'll actually be able to even start that study.
Okay, great very helpful. Thanks for taking the question alright. Thank you.
Thank you. Our next question comes from the line and Matt Kaplan from Ladenburg Thalmann and your question. Please.
Hi, good morning, and and let me and my congratulations for the progress.
Just wanted to dig in a little bit to kind of the dynamics of patients receiving treatment that youre seeing I guess, given the pandemic and patience.
Not seeing the doctors as you and and diagnoses going down are you seeing some sort of a backlog of patients given this.
This backdrop on our end.
And do you think for these patients have been aidid by practices and are just awaiting therapy that youll start to see them roll in to receive and the treatment.
And this year.
Yeah, Hi, Matt and sleds and thanks for the question I'm going to ask Jeff to comment, but before he does I think I think we would speculate right that even and.
You know even in the beginning of our launch and there were some patients that had not come in as you saw Covid cases go down somewhat and we did our adjusted and some nice work on understanding the dynamics of a COVID-19 vs versus our patients and you can clearly see that when you know diagnosis of Covid went.
Down patients went up so we do think that even in the first six months of the launch and we're likely patients that had been kind of waiting.
And so I think that dynamic exists, it's hard to quantify them, but you know Jeff.
But I'd love for you to share with Matt Your perspective.
Sure, Thanks, Matt and I guess, the easily answered it quite it depends on me.
Where in the country you are and how about the cases have been when did they put into place that they've put in a delay and elective procedures and I will say majority.
And you know electric procedures are on hold on.
Now open elective procedures up and to your point and that they they they do begin and then to prioritize these patients and so as we see as we've seen with Covid going down Covid cases going down.
We've seen an increase and patient enrollments.
Okay. That's helpful and you mentioned in your prepared remarks that you have now I guess over 250 sites activated.
Can you give us a sense in terms of the number of those sites that have have treated a patient so far.
And we haven't provided naphtha and fee.
Back on.
Okay, and then I guess, maybe a question for Mark on the the Atlas study can you give us a sense in terms of just remind us of the kind of the endpoint and the powering of that study.
For for.
For the low grade intermediate risk non muscle invasive bladder.
Catherine.
Sure. Thanks, Matt.
So as you probably remember and in our discussions.
The primary endpoint and recurrence free or disease free survival.
And it's an event driven trial.
So the objective here is to look for curve separation between the group receiving primary Eugene on one or two versus those who are treated primarily with surgery.
And interim analyses that are event driven so we can't tell you when those will occur.
And I think that's probably about what we have shared along with the fact that we know that and the control arm.
Recurrence rates to be approximately 50%.
And we're higher at a year, we've been pretty conservative about our design.
So.
And I hope that's helpful in terms of thinking about the trial.
The primary endpoint is recurrence free survival and and listening and want to comment further on this as well.
No I think that's right I think that powering to your point to your question, Matt as Mark said, we used around 50% knowing that.
And the literature anywhere from 50 to 80 per cent of those patients will recur if they only have a T. R. B T.
And are you now meet the criteria for intermediate risk and obviously you know we used our own phase two data for the assumptions, but but on a conservative side for for us as well. So you know put ourselves in a position where we can.
Can be successful from a technical standpoint.
Alright.
Thanks for you on the detail and thanks for the questions.
Thanks, Matt.
Thank you. Our next question comes on the line of Paul Choi from Goldman Sachs. Your question. Please.
Hi, Good morning team and let me add my congratulations on the progress as well.
And so maybe just revisit Atlas if we could and just with regards to your comments.
And with regard to patients being treated at home I.
I guess my question is twofold here first do.
Do you see this and potentially for for this low grade intermediate risk population as.
And a potential real world treatment paradigm vs.
Versus being treated into clinic or and the hospital and then secondly, if there is potential for us.
And on treatment model here, how does that potentially affect the economics of <unk> and why don't you.
For instance, just more like a function of the environment. We're in currently.
Yeah Yeah.
Thanks, Paul how are you D. I think from our perspective, well you know, we want and make things as easy as possible on patients you start to think about T. R. B T. I think one of the missed information on misunderstanding is that people think on T. R between no big deal.
We share and 57% of the patients and our study had three or more T RPT and that patient population, we're talking about and as they have more and more we know what's and independent factor of on mortality. So yeah, we're saying how one can we differentiate our therapy from what's there today.
And frankly, it doesn't work and we do know that more and more you know this is an elderly patient population and so it was just one additional way.
And we still think that frankly, the majority of the patients will go in to.
To the clinic to get treated.
But having an opportunity to treat these patients at home I think will be a benefit to some of those patients who are unwilling or unable to get to the doctor and make it make it easier on them.
And I don't think it will impact the financials.
And you know at all because obviously you know you would get treated at home.
It would be for home health company.
Company, So I guess the differences for physicians and obviously they would make more money if the patient comes into the office, but again, our ability to offer that to patients and had that as an option. We think is important so the financials for us don't won't really change the financials for the.
For the office.
Obviously would if if the patient came into their office. They would they would they would see the revenue associated with that.
Okay. Thank you for that contract was and then maybe as a follow up either for you or for Jeff just with regards to your comments on the.
Total trends youre seeing so far and in the first quarter share can you, maybe just help us contextualize and.
And your view is this more just specific to this quarter given the various factors such as Covid does that you mentioned share or with regard to historical practice and in this population on the commercial side.
Is this more reflective if you think of typical seasonality and the Medicare population and doughnut holes and put those kinds of factors any clarity on that point.
Great.
Yeah, Jeff do you want to comment and maybe I'll add something on Africa.
Sure.
On a very small number.
Since that Medicare that don't have supplemental.
I don't think that Thats, a great impact.
As much so as we've seen with sort of prioritizing the vaccine both from a patient standpoint.
And a hospital or a provider standpoint.
The good thing and the majority of accounts that were there.
We had out there or the accounts that we're pushing on formulary review are now reviewing.
Things are starting to get back to normal within the provider.
But there's a very minimal impact with regards to.
Pocket because majority of our patients have supplemental insurance.
Yeah, and just a comment about the trend.
And we we don't think that it will continue that way as a matter of fact, as Mollie mentioned and we've already seen seen it start rebounding and and March so.
It made sense that these patients and the physicians one now that the vaccines available wait a few weeks you know get to get the vaccine. There's there's tons of publications out there and.
Literature out there that says that across the board our hospitals around the country institutions around the country are doing that.
And you know not just obviously and its instance, but across the board and so we don't see I expect to see that trend continue and as you know as Jeff said.
And we'll be we'll be on a good position so far for us the outlook on the year hasn't changed at all right. It's just more it's just more timing thing.
Okay. Thanks for the color line and congratulations again.
Alright, thank you.
Thank you and ask for a reminder, ladies and gentlemen, if you have a question at this time. Please press Star then one.
Our next question comes from line of Gram Silver and <unk> from H C. Wainwright Your question. Please.
Good morning. This is months speaking on behalf of from thanks for taking.
No questions I have a couple of Covid impact question and then.
Hello.
Hum.
That's for Jeremy to sales and.
Conducted and the context of COVID-19.
Do you anticipate being able to conduct the voting for.
A motion that's and teach in the coming months that you won.
On previously.
Because the COVID-19 pandemic.
And that's coming down on them.
And in terms of the Atlas trial enrollment.
You.
You mentioned you expect to provide enrollment.
And yet.
Are you seeing any logistical challenge and excuse.
And if the trial due to COVID-19.
And if so what are they use and how you're mitigating.
And.
Yes.
Yeah, I'll comment about the study.
And I would say not really we anticipated that there would likely be delayed so our expectations for enrolment.
From a from an amount on a roll and then obviously it starts flow anyway.
We did make sure that we sort of are around the world doing doing the study, but you know there were a couple of countries that you know that delay started the study, but then there are other countries that didn't and.
And we will continue to work through that but we felt like we have enough.
Fight and it's one of the reasons and we actually increased the number of sites versus our initial expectation because we wanted to make sure that with Covid.
On a country or area shut down that we would be able to sort of make up that enrollment elsewhere.
And so and then.
Jack you want to comment on and promotion.
Promotion.
Sure. So what we've seen is an increase and face to face interactions I was.
Fortunate to get out.
And with some accounts last week, a couple of weeks ago and the face to face is improving so theyre opening.
Up to the face to face and interactions and more importantly, I'll open up to have representatives come in and.
Do presentations over lunch, so a lot of places that have limited.
Lunches or face to face interaction are slowly beginning to open those interactions up where that's still limited we continue.
Does an excellent job of continuing to have virtual reminders virtual presentations with the physicians being mindful and respectful of what the office.
For us at this time, but.
And I am happy to say that yes, there's more face to face that are taking place heightened I see that continuing.
Covid cases go down.
Okay excellent.
And do you expect the difference between the number of sites activated and number of.
Slide.
Treated more than one patient with xiaomi until tomorrow substantially over the course for the next several quarters.
And if not why do you think that went on.
Yes.
Yes.
No I expect both to grow and I mean, and I think.
Someone asked a question to the we want all of our sites.
Sites activated and treating more than one patient and we wanted to get to the point where.
Physicians are opening it up.
And we've had that too you have initially you obviously have a champion and the office, but the you're asking the gold the reps representatives or to go in and open it up to the other physicians. So you hope so and I expect both numbers to continue to grow.
As we've got.
A large number of accounts that either are putting it on formulary habit on formulary looking for a patient and then once they experience using Joe Munda with the patient either finding more patients or certainly that peer to peer influence that I talk about discussing it with other physicians during there on.
All of these accounts have.
Tumor boards or medical meetings with their urologists make.
Making sure that we're part of that agenda.
As a key goal for us to get the majority of the urologists within an account considering Joe might owe for their patients.
Okay, Great and then just.
The final financial housekeeping question. So are there any timeframes friction on the funding received from R. W investment. So in other words growth I'll keep up the right to impose.
Additional commissions on our clients' bushnell configuration of growth.
300 million amount non bulk within a specific period of time.
And will these additional commissions on me.
So and then for.
Sure.
On any of the regions.
Bob.
Molly I guess, maybe you should answer that Theres no timeframe commitment and.
And the event that.
And that $300 million achieved over a certain period of time, so that there's no to answer that question Theres no time commitment as far as collateral and certainly they have for security and the and interest on the strip and of of them idle.
And then that's carved out within the IP interest as well, but certainly nothing that we believe would prohibit us to look at ex U S or other and BB type activities and these products.
Okay makes sense, thanks for taking my questions.
Alright, thank Kim.
Thank you and this does conclude the question and answer session of today's program I'd like to hand, the program back to Liz Barrett for any further remarks.
Great. Thank you operator.
Yeah, we look back into 2020, we're really pleased with what we were able to accomplish with our first approved medicine as well as significant progress made on our pipeline, it's an exciting time and our company and we're committed to ensuring that patients that need our medicines have access to them.
We look to the other side of the pipe and pandemic hopefully we look forward to continuing dialogue with you and as we advance our long term growth strategy in 2020, one and beyond as always we appreciate your support and interest and our company and thanks for taking the time today. Operator, you can disconnect the call at this time. Thank you.
Thank you and thank you, ladies and gentlemen, and for your participation in today's conference. This does conclude the program you may now disconnect good day.
Okay.
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