Q4 2019 Earnings Call
off
good morning, ladies and gentlemen. Thank you for standing by and welcome to your origin farmers fourth-quarter and full-year 2019 Financial results in business update conference call. It is now my pleasure to turn the call over to Kate bechtold senior director of investor relations for your gen Pharma, please go ahead. Good morning everyone. Welcome to your urgent Pharmacy fourth-quarter and full-year 2019 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, 2019. The press release can be accessed on the investors portion of our website at investors birth.
Joining me.
On the call today are Liz Barrett president and chief executive officer. Dr. Mark Schellenberg chief medical officer and Peter French Chief Financial Officer joining us for the back portion of this call will be Steven. Mullenax Chief Operating Officer and Senior vice president of commercial.
Liz will provide a summary of our recent corporate developments and Mark will share clinical development and Regulatory updates Peter will then provide an overview of our financial highlights for the fourth quarter full year before we open up the call for questions.
As a reminder during today's call. We will 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 1995.
Actual results May differ materially from those indicated by these forward-looking statements as a result of various important factors including those discussed in a risk factors section of your choice Pharmacy annual report on form 10-K filed with the SEC this morning and other filings that yours in Pharma makes with the SEC from time to time.
We encourage.
All investors to read the company's annual report on form 10-K and the companies other SEC filings.
These documents are available under the SEC filing section of the investors page of your agents website and investors.
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 days 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, I will now turn the call over to live. Good morning everyone and thank you for joining us today. I help my first quarterly conference call as CEO of your agenda this time last year and they've had the opportunity to reflect on the tremendous progress. We've made in 2019 2019 was a pivotal year for the company and our team over delivered on the commission missing goals that we set out to achieve.
We believe that our accomplishments.
The 2019 has set us up for the most transformative year in the company's history. This is the culmination of many years of work and dedication by the colleagues of yours and Pharma. We are preparing to bring the first non-surgical treatment option for low-grade upper tract. You'll feel you'll cancer to patients who in critical need of a better option.
Our top priority in 2019 with the complete the submission of the Rolling new drug application or NDA to the US Food and Drug Administration for Eugene 101 for mistreatment of patience with low-grade you at the end of last year. We were pleased to announce that the FDA accepted for filing and granted priority review for our in d a m a priority review designation shortens the review time from the standard 10 months to six months from the submission of the n d a r prescription drug user fee act are producing a gold 8th of April 18th is quickly approaching as a reminder the FDA previously granted orphan drug Fast Track and breakthrough designations for Eugene 101 month for the treatment of low-grade u t you see reflecting the high unmet need in this area. We are very pleased with our discussions with the FDA and their willingness to partner with us to advance package.
Innovative therapy
We remain excited by their complete response rate and importantly the strong six and 12-month durability presented to date and we expect publication of the final ugn 1:01 a.m. And our prestigious journal the first half of the year as you can imagine, we are intensely focused on the successful launch of you GM 101 as we await our potential approval. We're well prepared for commercialization in the United States with all commercial and medical colleagues in place. We've hired an outstanding team a deep experience in oncology in your life. She led by Jeff Boba the team as well into training and in the field meeting customers and discussing the high unmet need and low-grade, you know, we employed a very efficient account based approach with a Nimble sales force of 48 Representatives who will be able to reach 90% of the patient population dead.
We believe the force will be.
To swiftly and effectively reach our Target Urology practices. In addition to the sales reps. We have a small team of seven Regional business managers seven clinical nurse Educators divide training and support around installation and seven reimbursement field reimbursement managers to ensure access and reimbursement in addition earlier in 2019. We harder team of seven msl's who have appropriately engaged with positions interested in learning more about your origin and our technology to our commercial planning process easy to three key factors for successful launch patient identification reimbursement and seamless integration into the physician practice.
First low-grade you to you see is an orphan indication with approximately 6 to 7000 eligible patients and we will work closely with the nurse Navigators in the practices to identify these patients upon diagnosis second because this is a buy and build drug positions want confidence that they will get reimbursed before they will widely adopt them. We have a comprehensive program in place to assist physicians in securing reimbursement in our field reimbursement managers will be on site to ensure that it's done correctly the first time addition to our field team. We have secured the services of an experience Hub to assist offices with all reimbursement and access questions. So patients in need of Eugene 101 may be able to access it.
notably at CMS has moved from
And you will notifications of J codes to quarterly notifications. We are optimistic that we will have a J Code by year-end more importantly Physicians can also use a Seco which we expect to secure by October of this year. Many of these procedures will be performed in a surgical center or a hospital where a c code is necessary.
And the third key element in the seat is the seamless integration into physician practices. We want to make you GM 101 preparation and administration convenient for practitioners month. We have several programs in place to support this including our recently executed agreement with a national Pharmacy partner to provide prepared admixture to Europe clinics. Our drug needs to be reconstituted with our jail prior to installation while some offices and hospitals can do this themselves with the right equipment most practised prefer to have it ready to use. Our Pharmacy partner will deliver to the surgery center are the hospital ready for installation. All Logistics will be coordinated through our support page for a seamless customer experience increasing awareness of you GM 101 in your origin is a critical component of adoption and was a key initiative over this month.
last year in 2018
Only about thirty percent of positions were even aware of your origin and u g n 101 as of a UA this past year. It was up to 70% and we expect it to be even greater by launch. We know from recent market research that 88% of urologists desire a new and differentiated treatment option for their patients the results of this life support our belief that if approved this will be a typical adoption curve and used across the treatment Continuum and newly diagnosed patients and recurrent patience as well as those with resectable and unresectable disease urologist recognize the need to delay radical surgery and we are very encouraged that there will be multiple opportunities often coorporate Eugene 101 and to their physician treatment options of low-grade you following anticipated FDA approval.
Our teams are excited and fully preparing to bring Eugene 101 to patients who have been waiting Beyond anticipated launch and we are progressing research to identify opportunities to bring Eugene 101 to patients in other parts of the world.
So continue to advance our leading pipeline of Euro and ecology candidates. We are accelerating development of our next candidate Eugene 102 for the treatment of patients with low-grade immediate risk, non muscle-invasive bladder cancer similar to you GM 101 with Yugi and 102. We are seeking to address the high unmet need and improve your standard of care for patients who deserve better options. Currently. There are no drugs approved for the first line treatment of low-grade non muscle-invasive bladder cancer and the current standard-of-care transurethral resection of bladder tumor r a t e r b t is used repeatedly to address chronic recurrence of disease the specific patient population of low-grade patients. We are targeting our patients classified as intermediate risk and have it particularly High rate of recurrence.
These patients could be considered surgical failures. We believe you GM 102 has a potential to
Provide a non-surgical alternative for the treatment of approximately eighty thousand patients in need of new treatment options. We were pleased to share a positive complete response data birth an interim analysis of over half of the patients from the phase to be Optima to study last year and intend to report durability data, including 12-month durability and took over to patients and the first half of this year. We are in ongoing discussions with the FDA and experts in the field to finalize the design of our pivotal phase 3 study off that will be compelling from a regulatory and clinical perspective and give us a quickest path to bring in this important medicines to patients. We remain on track to initiate the study this year. We believe that the peak Revenue potential of you GM 101 and Yugi and 102 could be greater than 1 billion dollars providing a strong Foundation from which to build. Yep.
long-term sustainable growth business
And 302 for high-grade non muscle-invasive bladder cancer, Mark will provide further details, but you GN 302 is a combination of Yugi and 201 RTL are off with with his lab and anti ctla-4 antibody. We licensed from a Genus. The initial indication is supported by the encouraging non-clinical work. We previously shared we continue to explore other areas for both local delivery and novel medicines in adjacent spaces further building Upon Our leadership position m e and Specialty cancers with that. I'll turn the call over to Mark to discuss our clinical development programs and progress and more detail mark. Thank you Liz this past year has been very eventful for your origin are proprietary r t gel provides an Innovative platform for developing non surgical therapies that can be applied to diseases traditionally treated wage.
Surgery such as low-grade and bladder cancer as we waited, too.
Beyond low-grade disease we're excited about advancing Eugene.
Official approval of our first medicine ugn 101. We remain encouraged by the complete response and durability data previously presented as a reminder the final analysis the primary endpoint of our pivotal phase 3 Olympus trial demonstrated a 59% complete response rate in patients with low-grade durability response was estimated by kaplan-meier to be 89% at 6 months and 84% at 12 months after primary disease evaluation. The estimated median time to recurrence was thirteen months in 34 of the 71 patients treated in the study were initially characterized by the treating physician that's having endoscopically unresectable. These are the patients who according to the current standard-of-care would be candidates for immediate kidney removal.
The most common treatment emergent Adverse Events included ureterostenosis urinary tract infection hematuria flank pain nausea, renal impairment and vomiting off. The majority of these were characterized as mild and moderate and severity and transient these Adverse Events are familiar to urologists given the disease being treated and the instruments utilized as loose stated. We are eagerly anticipating publication of the final results of the primary endpoint from the Olympics trial in the near future.
similar to
Low-grade intermediate-risk non muscle-invasive bladder cancer remains a challenge to urologist given the frequent rate of recurrence that has been difficult to control standard of care surgical intervention or turbt. The intermediate risk population is an emerging clinical entity defined by two or more of the following characteristics birth multivocality tumors greater than 3 centimeters and Rapid rates of recurrence in September. We presented complete response data from an interim analysis of the phase to be optimal to study of Eugene 102 in patients with low grade intermediate risk nmibc in this cohort of thirty-two patients twenty patients or 63% achieved a complete response in the interim analysis. There were no serious Adverse Events reported the most common treatment-emergent Adverse Events observed word assuage.
frequency of urination
Fatigue hematuria and urinary tract infection. We look forward to sharing updated complete response and durability findings from this study in the next few months these findings off with positive results from the Olympics study further support our excitement about advancing ugn 102 in patients with low grade intermediate risk non-muscle Mesa bladder cancer from both local and molecular perspective low-grade is very similar to low-grade nmibc. We are optimistic about the potential of Eugene 102 to an immediate impact and provide approximately 80,000 intermediate-risk patience with a non-surgical option for the treatment of chronic relapse.
I was losing mentioned. We are actively engaged in discussions with the FDA to finalize the design of our pivotal phase three protocol and expect to begin the study in the second half of the Year wage. We look forward to updating you on the trial design once finalized while our lead programs are focused on low-grade disease high grade and remains a significant clinical change for patients and Physicians. Even as we have seen new medicines approved recently for these patients the benefit remains limited and new options are needed patients with high rep who feel conservative therapy may require bladder removal surgery or radical cystectomy. This procedure is associated with significant morbidity in an elderly population based on encouraging non-clinical data. We share in September. We believe you GN 302 a combination of Eugene 201 with zela film lab and they provide birth
a therapeutic alternative
Acting for patients who fail standard of care treatment with agent such as BCG We are continuing formulation and non-clinical development in advance of initiating human studies laid off this year. We will provide details on the program at a later date. And with that I would like to turn the call over to Peter who will discuss financials. Thank you Mark and good morning to bring it on. Today's call. Your engine is well capitalized as we prepare for potential us approval and launch of Eugen 101 and Advance our clinical development programs including initiation of Eugene 102 phase 3 trial later this year. We close the fourth quarter of 2019 with 195.6 million cash cash equivalents and marketable securities. This excludes restricted cash.
For the fourth quarter and full-year ended December 31st, 2019. We reported net losses of $39 million or $1.86 per share and 105.1 million or $5.12 per share respectively off this compares to net losses of approximately 23.7 million or $1.46 per share wage and 75.7 million or $4.80 per share for the same period in 2018.
the net loss is
For the fourth quarter and full year ended December 31st, 2019 include 8.1 million and 30 million respectively in non-cash stock-based compensation expense.
Research and development expenses for the fourth quarter and full year ended December 31st 2019 War twenty Point 1 million and 49.3 million respectively compared to 11.5 million and 36.9 million for the same periods in 2018.
Research and development expenses include 1.9 million and 8.3 million of non-cash stock-based compensation expenses for the fourth quarter and full-year ended December 31st, 2019 respectively as compared to 3 million and 12 million for the same periods in 2018.
Setting aside non-cash stock-based compensation expense that year-on-year increase from 2018 to 2019 was mainly attributable to cost associated with birth stone payments related to our licensing agreement with a genius Inc. A purchase of API and other manufacturing activities as we prepare for em and 101 product commercial launch increased clinical activities for you Jan 102 phase to be clinical trial and an increase of home town and the related costs supporting increased clinical trial activities General and administrative expenses for the fourth quarter and full year ended December thirty first May 2019 were
19.7 million and 60.2 million respectively as compared to 12.6 million and 39.6 million off the same. In 2018.
General and administrative expenses include 6.2 million and 21.7 million of non-cash stock-based compensation expense for the fourth quarter and full-year ended December 31st, 2019 respectively as compared to 5.9 million and 18.6 million for the same periods in 2018 the increase from 2018 to 2019 was mainly attributable to the increase in headcount and related costs is part of the build-out of our company in anticipation of commercialization of our first product Commercial Services Consulting and other outside fees as well as non-cash stock-based compensation expense as of December 31st, 2019. We had approximately 21 million ordinary shares outstanding base wage.
Our current plans we are well.
All capitalized for a strong commercial launch and continued advancement of our pipeline.
The company anticipates operating expenses for 2020 in a range of $145 to $155 million. They increase in operating expenses in 2012 is largely attributable to having a full commercial organization in place for the whole year.
Non-cash stock-based compensation expense for 2020 is expected to be in a range of $32 to $36 million subject to market conditions. And other than the operating income for 2020 is anticipated to be approximately 2.5 million subject to market conditions.
With that operator, I would like to turn the call over for questions.
Thank you. We will not begin the question-and-answer session. If you have a question, please press * then 1 on your touchtone phone. If you wish to be removed from the queue, please press the pound key. If you are using a speakerphone, you may need to pick up the handset before pressing the numbers. Once again, if you have a question, please press * then 1 on your touchtone. And our first question comes from Derek from stifel, please go ahead hey, good morning guys, and thanks for taking the question just a few from us off just first on the reimbursement and you just give us a sense. So you said that you likely would have a J Code by the end of this year, even when they're doing the quarterly review. So I guess I know why couldn't we see, you know, potentially A J Code by like the end of September maybe just kind of, you know walk us through the timing on that and then the other component have you guys, you know done any additional?
In terms of the overall.
Cost of patients in terms of you know, kind of Health Care economic data and that those at the things hi Derek, it's Liz. I'll answer the question on the call should turn it over to Jeff can give you more specifics about the reason you know, why we stay you're right we could get potentially get it earlier, but they have very specific dates. But let just give you the details on that. We actually had to do a lot of work around the cost. But to be honest with you have not been very successful because the issue with these patients after kidney removal is really the cost of managing these pages over time and there's not great data about the long-term, you know management of these patients that we do have some health economic data, but not a lot of Health economic data we know and obviously more it can talk more about the sequela associated with with the kidney removal in these patients and some of the things that they that they that impact their lives all that Mark just sort of briefly talked to you more qualitatively about that dead.
And then Jeff if you could answer the question were specifically on reimbursement. That would be great to Mark. Hey, Derek, the
That sort of the short story on the downstream effects of kidney removal is that we know and there's actually recent peer-reviewed literature on this page and see who undergo kidney removal who are elderly and therefore have other comorbidities have an increased risk, not only a chronic renal insufficiency, obviously, but also the downstream effects of this wage most important of which is the exacerbation of cardiac disease. So we do know that in the elderly population and that is the population we're talking about with respect to the treatment of this disease that kidney removal is not a birthday procedure and does have Downstream effects that are costly to the system probably the most important which is exacerbation of other comorbidities. Yeah, and I think that we've talked a lot about the fact that on a per-patient basis being the most costly cancer and its associated with the fact of the kidney remove on managing these patients over time, but unfortunately the specifics around that aren't really you know, birth
Early available. So Jeff. Can you just talk more specifically about a reimbursement in our comment on J code?
Question, it all depends depends on timing from a from an approval standpoint. Yes, you're correct. CMS is moved to a quarterly approval. So it is possible that we could have bought a Jeep code October 1st, which is also mentioned the importance of a c code a c code is a unique pass-through code that CMS grand theft in as early as October as well. So in short it depends on the timing of approval once approved. We're ready to submit for both cars code.
Got it. Great. Thanks guys and congrats on the progress. Thanks. Thanks a lot, Derek.
Our next question comes from Chris Howerton from Jefferies, please go ahead. Excellent. Thanks so much for taking the questions. So I guess you know Derek obviously based on the the launch. Um is there you know how with respect to the coding and the reimbursement moving forward. How should we expect gross-to-net to evolve over? You know, at least this first year and moving forward from there with respect to those coding and then I have a follow-up question on the pipeline. Yeah, it's there's not really there's not a whole lot of need for a discounting in this space. So the the gross to net from from that perspective. It really doesn't the codes don't really impact the gross to net as much right so long, you know while we're not guiding specifically and what the gross to net is, I would say it's fairly typical but not on the high end where you would see most some of these therapies that get or hi.
Sure. Thanks, and thanks Eric.
You know have the 20% type of discount. We don't we won't really see it.
Need or have a need to be discounting with payers. That's really where you see our gross to net erosion. So again, you'll see your typical, you know percentages from Administration and those types of grass to net but that's you know, that's sort of what we can say about gross net. I don't think you'll see a very high gross-to-net considering, you know, the that we're the only non-surgical treatment so we won't be competing, you know competing against others in this space and needing to Discount. Okay? Okay, and then I guess for suppose this would be for Marco ever on the team, but with respect to 102 in the end the potential pivotal design here, uh, what are the key features that you hope to get an alignment with the regular package trial size ten point, you know, what are the kind of key sticking points? And then you know as a corollary to that discussion has there been any involvement in terms of the discussion? Yep.
Speak to chemo therapy versus and adjuvant to 2:30 cuz we're still getting questions. It's
Based on the buy side with on that point. So if you could address both those, that'd be great. Thank you. Thanks Chris. Let me take the first one the second one first. So this is not an adjective or a few. This is a primary key blade of therapy. And we're we're committed to that for reasons that I think everybody on call understands, but let me just reiterate them the value to patients and the Physicians my primary key blade of approach to this disease is that it can be performed without anesthesia in the office and that that is a great benefit to patients of the multifocal disease is who can therefore not only have the diseased address, but I have it but address without the need for anesthesia, which is an important component of the overall care of elderly patients in that respect to the design. We are working closely with the FDA the issues of trial design here revolve around size. You're right power to make sure that we are appropriately powering to show the types of birth.
This is between groups that we aspire to and I think we're in pretty good alignment. It's just a matter of deciding some very specific questions around control group.
Uh design and characterization that we're finalizing and we hope to share that with you soon. Yeah, and just to add to that on the you know, you think about the the reason why I played of versus adjuvant therapy is because we these patients are patients who actually surgery hasn't worked and we hope to that they'll avoid having to get another month or so and then you know, Mark has talked many times about you know, the reason why you really can't go in right after t u r b t and give you know, and give mitomycin, you know from the perspective of the you know, the side effects of mitomycin and an area where you've just you know, just had a you know, just had surgery so I think all those reasons the best benefit to these patients is that they'll actually avoid to your ability and then you know, is it in the data we shared we have a very high and those patients and we're waiting on durability data, but the durability data plays out and and you know the wage
since I typically go in, you know, potentially several several times a year would not have to go in and you know and have to your BT's so
But thanks for the question sure. And you know if I can sneak in just maybe one more with respect to to 1 and the high-grade obviously. I had a recent approval maybe not in this particular setting that you're going after but similar for a key truda. So just curious, you know how you think this positioning for 201 will look like if you do enter the clinic and for the eventual approval.
You know, it's a it's a great question and I think one of the things to keep in mind about the recent approval of keytruda, is that approval of a systemically administered drug for an extended period of time and we are currently approaching the formulation of 301 which is this combination therapy as an entry vesicle approach to the management of refractory or may not invasive disease. That's a format that would permit urologists to treat patients in a very familiar way in the in the office which is what's done now. So I personally believe that this would be a completely differentiated approach compared to the case router approval and I don't think it represents a a disadvantage at all. In fact, I think it represents Advantage. I think the other thing to keep in mind Chris is the response rate that they're seeing right? I'm going to look we're really happy frankly. I think it's great for patients that all of these products are being dead.
Approved but you have to look at their data. They're getting approved on you know, just a small percentage of the patients.
Actually being, you know getting a good response. So I think that there's still a very high unmet need in this post BCG, you know and post BCG and then hopefully eventually being able to replace them. So I I think it's still a high-end met need in that patient population and I think you see that by the number of of molecules out there that are that are being studied in this area.
Right. Well, yeah total point taken in terms of the intravascular delivery. And then of course also, you know those patients were ineligible for selected me or chose not to take it. So I'm a bit of a skewed results for shorter. Well so much taken the questions sure absolutely and you know, it's Mark stated the you know, being able to give local delivery versus having the side effects associated with treatments like, you know, the pd-1 Inhibitors. I think what we believe is that being able to give a seat for that has the benefit of a checkpoint inhibitor, you know without the down side effects. Oh, thanks. Thanks a lot Chris.
Our next question comes from Paul Choi from Goldman Sachs, please. Go ahead.
Thank you and good morning everyone and thanks for taking our questions. I wanted to follow up with regard to another question on one or two and just you know, maybe ask Mark and the team how you're thinking about any observations or learnings from the from the interim data that you've presented earlier with regard to refresh refining patient selection or thinking about any additional inclusion or exclusion criterias wage. Just to boost your you know, boost your probability of success here and then just higher thinking about you know, how we should come with regard to the control arm. Think about the response rates relative to what's established in the literature. And then I had a financial question as a follow-up. Thank you Paul. So I think happily the design of our on going to be trial has helped us really understand that we pick the right group at the outset of that trial. So we are focused on a group that you know, we've characterized based on both and birth.
Other Professional Organization criteria as a as importing with definition of intermediate risk.
Disease, this is the population that has chronic recurrence as Liz mentioned earlier frequent surgical intervention with all of the attendant disadvantages of that approach. So we believe that the parts are currently studying actually does represent the right population both based on definitions and also based on our current data, which we've shared with you. So I think the population is what it is, and just answer the question about the performance of the control group, which would be of course how these patients do with a contemporary standard of care which is transferring to reception of bladder tumor. We know that this population is the group of people who have recurrent disease on multiple occasions after transferring to reception. So it's lives have said many times, you know, this is the group of people you could characterize surgical failures. So we're expecting recurrence rates in that arm to be anywhere from sixty to eighty percent based on you know, what we've you know, you know understood from the pureview age.
Obviously the the trial would have to play out but I I hope that kind of level sets for you. You know what our expectations are with regard to with respect to the control.
Performance. Yeah, just to reiterate Paul. I think as Mark said we did do it. Right and I think the patient population were looking at 102 is exactly the same patient population, which is great for us because it also makes it easy when we launched the study to be able to start in those, you know, in in those hospitals and institutions where we currently are running 100 to and you said you had a financial question. Yes. Thank you Liz just as a follow-up just a quick one for Peter. Just want to double-check to see if you had with regard to the upcoming launch a m e r and d inventory that will bleed off before you transition to to a regular call logs over the course of twenty twenty good good question of fact, if you go through Thursday or script that we went through with you guys on the today's call. We did reference the fact in our Rd expense that we actually had pre bill that the API as well as other related wage.
associated with the build of inventory in advance of the commercial loss of ugn 101 so in fiscal twenty
Nineteen those costs were actually embedded in research and development expenses. We did not call out specifically how much but good question because we will believe that off and that was expensed in 2019. It also be expensed leading up to the actual approval and upon the approval will flip to capitalizing any further build of inventory and run it through our p&l appropriately. So I thought well you will see is for at least the initial period of the launch cost of goods will be skewed favorable relative to that pre-build of inventory of which actually will not run through the p&l.
Great. Thanks for that. No worries.
Our next question comes from ROM silver from HC Wainwright, please go ahead, Could you comment on the nature of the 3pl organization and maybe describe for us the process work flow from the whole point of prescription entry to the point of prescription filling and administration of the drug. And if you could give us a sense as to whether from a distribution Channel perspective is similar in concept to a specialty farm and farm and network. And then also with respect to the sales force composition and prior history and performance of our sales folks that you have on board. If you could maybe give us some background on the kinds of drugs that they've been promoting in the past kind of you know, what their performance history was.
You know with those drugs to whatever.
Sent your able to disclose that. Yeah sure and I'll just let Jeff answer that but just want to congratulate Jeff frankly on the his ability to attract some great sales representatives in colleagues to the company. I can say we had no shortage of people interested in joining and I think that that's also a testament to to where we're headed. So Jeff, can you answer more specifically asked questions around the 3pl and the distribution Channel as well as give them some some more guidance around where you know, where the sales force came from. I know it was many many different companies, but I think it would be helpful to share that Faith context.
Sure, and thanks Rob. The you're correct. The orders will go through a 3pl. The actual order itself will come in through the Hub. So if when a position boss wants to administer this to a patient, they'll be an 800 number that they call that'll go to our Hub that table woman process the script similar to other jobs that are in the space, um, like a provenge or radium-223 the 3pl then we'll ship product to the specialty distributor and the distributor will then ship product to the hospital or the surgery center. So so yeah, the three Fields where it starts we will have a specialty distributor as well, which is different than drugs that are Specialty Pharmacy. Those are particularly part Ki since we're A Part B drug, we will go through the specialty distributor with rep.
To the field for yes, we were able to get a lot of talented folks from those that are in the urologist.
Our our Field Force as an average of about ten years in the genitourinary space. They don't come from any one company in particular. They come from a variety of companies in the state that have a significant amount of experience selling drugs in anything from hormone-sensitive prostate cancer to tap dancer or some sort of Urology drug test experience. So hopefully that setting up
Absolutely, and then a couple of additional ones just wanted to clarify are you expecting to be able to start booking sales of 101 into queue 2026 or is that still kind of openness to whether that would definitely occur and then can you perhaps maybe this is a question for Peter. Give us some sense of when you might be in a position to give Revenue as well as effects guidance and whether this might occur later this year or perhaps next year and finally with regard to the clinical development plan for you g and 302 wanted to see if any combo trial. I likely to start before the end of this year or if we should expect that later and wage. Also if you could maybe comment I don't know if you're in a position to do this, but give us a sense of whether we should see any additional clinical read out information on brought to jail before the end of this year as well.
Yeah, I'll answer.
The last two and then turn over to Peter too, but you know, I would not expect that. We'll see studies in the combination this year. I think we will be in human studies this year but not be working through, you know through dose-escalation and optic dose optimization on on the botox Allergan collaboration. If you look at clinicaltrials.gov, I do see that their primary completion date is in the May time frame and so we would expect a few months after that that they'll have data. Now what they decide to disclose will obviously be up to them is their decision is from a materiality perspective, but we do expect that by the end of the year. We will have a path forward and be able to share at least some information on where we're headed with that wage, you know with that and with that I'll turn it over to Peter and he can answer your first couple of questions.
So I'll answer the revenue guidance question first and then we'll kind of back into twenty-twenty and in sales, which I know you asked about. So first off you saw through our wage earnings release Here we did provide guidance in regards to operating expense share-based compensation and non-operating income. We did not provide a Guidance with regards to read you or bottom line. Net income, you know, if you look typically speaking 8 out of 10 by tech companies out of the gate usually do not provide Revenue guidance. I think we're following that Paradigm the two or three that do, you know call it two out of ten? You see that typically speaking when they do do that. They they you know for various reasons. Get it always right. So we think the The Prudent approach is not provide Revenue guidance and obviously not to provide bottom line. Net income or cash flow guidance relative to 2020 South
You guys are smart.
Go back into those numbers if we we provide one or the other so to speak, you know, I think from our perspective, you know, we've gone around the street had a lot of discussions with yourself as well as many of your colleagues the other analysts that are on the line. I think over the course of time. We've you know, we've we've we've had those conversations I think where the consensus numbers are right now, they're relatively in line kind of, you know, with the conversations that we've had we point to various numbers that are out there. So again, we're not provide specific guidance per se for this year. I think look to the consensus number that's out there. It's kind of the guidance for Thursday with regards to booking revenue for this year. The guidance that we have provided to yourself as well as the street is that you can expect that will book Revenue age.
For Q3 and Q4 the sheet.
So we have the opportunity to book Revenue in Q2 because of earlier timing will do that. But again our Guidance the street in a resume. It's a Q3 key for event.
Thank you very much.
Our next question comes from Matt Kaplan from Lautenberg and please go ahead. Hi. Good morning guys. Thanks for taking the questions. I guess maybe a question for Liz or Jeff. Could you provide us some more color or describe in more detail the I guess initiative in terms of the solutions around the patient ID program embarrassment program to I guess really Drive uptake of one-on-one as you launch it filing approval.
Yeah, sure Jeff. Why don't you take the the question?
Sure. Thanks. Matt had mentioned earlier the the important of the relationship with the nurse Navigator in the practice. So what we've done is expired folks that have that experience that relationship cuz as you pointed out it would be important to identify those patients that are eligible for u g n 101 so long that certainly in place. The other thing that we have is there's a company that works mainly with Urology accounts that helps identify those patients Thursday. It's an EMR company that'll that'll help identify patients that are obviously eligible. So we'll work with them to help sort of have a a rapid alert off with those patients do come in and they're diagnosed either initially with you to use low-grade UTC or if they're a recurrent payment patient. So that'll help as well with regards to reimburse.
We do have a very experienced feel dream.
The team in place to help with the coding and billing that'll take place, uh upon approval the field reimbursement team will sit down with reimbursement managing practice or the hospital to make sure that the forms are being filled out correctly to ensure accurate and sign the reimbursement.
Okay, that's helpful. Thank you. And then just shifting gears in terms of your pipeline. I guess a question for Mark for 102 years. Where do you think it it will fit into the current treatment paragraph for low-grade? I guess intermediate-risk non-muslims a Civ bladder cancer. Yeah, so, you know the problem with these patients is that they get chronic surgery and that that is a tough way to treat an elderly population. I actually think that and I I know this Thursday from my own practice and I notice we're talking to my colleagues these patients are difficult to care for and it's it's debilitating both for Physicians from a psychological perspective and also for patients physical to constantly rotate through what appears to become a sort of futile exercise in managing a chronic illness. So I think that one of the two represents a different way of thinking about the disease it is from New Jersey
And any perspective more sophisticated because it treats the entire field of disease, which we do know is expressed in this popular.
Is your patients who do have multifocal recurrent Cancers and you can't really approach that surgically and and you can temper results. I think underscore that. So not only do I think back to be applicable to the Cure of the of the population but I think it's going to be applicable to the majority of these individuals because Physicians readily appreciate that. We're really not doing a good job catching these people and we need a better alternative and I think one of the two, is that better alternative.
Great. So this this in other words, this will be used in lieu of lieu of surgery because these patients really aren't eligible for it as as I I would imagine that that man again this is speculative on my part. I would have took this will this will appear to be very appealing alternative to the patients and Physicians once it's once it's available because it really is more rational in terms of how we know the disease evolved. I'm at just it's just a sort of add some more context around that when you think about the patient population the low-grade non-muslim invasive bladder patient population, you know, the the prevalent for is is a majority of the patients, right? So you have your incident full of patients that come in that you can recognize as marks talked about here the different factors that would you know, that would specify a patient to be this low-grade intermediate-risk patient. But importantly I think a Big Driver of that is what you've heard us talk and particularly marked talk a lot about
Those patients that just continue to come in their very positions are very frustrated because they don't have a way to treat those patients. And actually that's about 80% of the paid.
In population in our in our total pool about 20% of the annual patient population will be the new patients and usually diagnose patients. So I think we feel like we have a great alternative to those patients who have already seen PR BT several times and clearly doesn't work for them. And then as Physicians begin to recognize that patient when they come in, you know more likely they'll want to put up with 102 first and see if see if they can get a response with one or two before going through going to a t u r b t so, I think it's important just to understand that this the patient population is is you know, so is that patient population that lives for many many years with low-grade non-muslim invasive bladder cancer.
Okay. Yeah, that's very helpful. Thank you. And then and then last question in terms of can you give us a little bit more color in terms of the role of the national Pharmacy partner? Are they going to be preparing the the mixture of 101 for use in in all clinics or how how are they going to how is that going to work? Yeah, I mean it will actually be their choice what we but we expect that the majority of Physicians will want to use it if they have the right equipment and in some hospitals they may want to mix it themselves and they'll be able to do that. But we expect the majority of the time and even Physicians that actually have that ability to do it, you know, they they you know, it takes a nursing time to mix to mix and we expect that most you know, the majority of either even in the hospital in in the clinics where they where they have the surgery Center's wherever they are that they'll want to use, you know use our mixing partner. So you're right in the sense if that's basically what's going to happen is the pharmacy will mix and get it to the physician. Yep.
The time that they have their their their procedure scheduled in Jeff and the team have a lot of experience.
Answered his past past experience been doing just this and it really has worked extremely well. So we we're we're very confident at this is this will work in in in our advantage because it's position them said, you know, I want to make it, you know, make it easy for me and this is exactly what we're doing.
Right. Yeah makes a lot of sense. Thanks for taking questions, and thank you. Thanks, Matt.
Our next question comes from Maria Barbara from natural Securities, please go ahead.
Good morning, and thank you for taking my questions. The first question is regarding the US regulatory pathway and commercialization and I was wondering if there have been any progress in terms of the conversations with Regulators in Europe and Japan for GM 101.
We have not Advanced that to be honest with you. The regulatory team here has been knee-deep in with the FDA. So while we have had initial consultation with with some Consultants on the you know in Japan and in Europe, we actually want to we need to wait until our FDA approval in the in the US before we take those resources and start to actually have meetings. But we've we've done a lot a lot of the the, you know foundational work and we I think we understand what would need to be done. But now it's just a matter of fact having the official and formal meetings with those regulatory authorities have stated before in the past that in Europe. It's really not a regular we did have some regulatory action before it's more of a pair interaction. And so we're really working on getting in to see the German authorities and the you know, Germany France and the UK wage
the big you know, the big countries to the
Understand what they would need to see to be able to ensure we can get a decent reimbursement make it, you know make it financially viable for us to even go into Europe and that would be well. I know one as we approached 102 we want to look at it and hopefully be able to design a study. That would not only give us a a regulatory approval with us. But even in some other countries around the world as well. So we expect that to be a global study. So I hope that helps. Okay great and then staying with one one took during if you could share if any patients had been enroll in the recruitment extension study.
Unfortunately, no and actually, you know, we'll have to look at an alternative alternative as we begin to launch for. You know for another treatment study. I guess is a good news is we haven't been a lot because there haven't been a lot of recurrences so that sort of a good good news bad news story. But more of a good news than anything. We also do believe in our conversations with Physicians that there wouldn't be any reason that they wouldn't Retreat they've all said that they would retreat but we do think it's important for us to gather data. I mean assuming that they have like the type of durability that we've seen in the study that they would that they would Retreat these patients and and we believe that that would be viable and not not an off-label use of our of our medicine. So we do want to continue to get and gather data on Retreat meant but it looks like we'll have to maybe do a phase for a study post-approval.
okay, and then regarding
The Medical Science license, I think you said there are seven of them. I'm assuming one per region and I believe they had been out in the field since early 2019 and I was wondering what is the feedback you get from the MS else about interactions with the decisions and how how have those conversations change if in any way since June 2019 when they went out to the field to now early twenty Twenty-One year later. Well, I think it's really important to to keep in mind the role of an MSL. Right? The role of boss is not a promotional role. It's really an educational role and to be able to have you know, peer to peer conversations with Physicians. So, you know, we don't track it's not appropriate to track sort of, you know promotional type event with an MSL. So what I can tell you though, and I I'll turn it over to Jeff and let him talk to you about not the MSL specifically, but what time?
Progress we've made as a company.
And and Physicians their their perception and their awareness of of your origin in our products over the last year. So Jeff you just want to talk about the most recent research. That would be received.
Sure. So the MSL have been for the last year a huge help with regards to a couple of factors. We've we've attended every reality conference that really is relevant to youji 101 and they are able to have sort of a political discussion in there in around the data that's been published for 101. So there's a significant interest that we serve. So, uh an increase in 2019 just from having a a strong presence that these meeting the research that lives alluding to is is in around awareness month. So over a year ago. Our awareness was around Thirty 40% for you GM 101 is for for the company itself because of that presence that we had and the office cussing the awareness is shut up to around seventy 75% So three-quarters of the positions are aware of one-on-one. You can imagine when we have a booth at the Congress is dead.
a significant amount a
Questions interest in and around the product and then you know, the the question we have to get off is you know, are are we approved or when we approved I think positions are having a m i a specific number of patients that that they're waiting for approval. So that that awareness is something that we can capture and if we can measure and in the MSM the a great job out there raising that
okay, and then lastly in terms of pipeline, is there any update on the formulation feasibility study that you were doing with Jensen? I'm not at this time. No.
Okay. Thank you for taking their questions. Thank you.
I am showing no further questions at this time. I will now turn the call back over to your agenda president and CEO for closing remarks. Thank you operator. And you know, I am Sam and Incredibly proud of our team and all that we've accomplished in 2019, you know with we put together a mission to Pioneer new treatments to improve patient care and special to cancel or illogic diseases and we're really advancing on that mission. We're excited about the many key events on the horizon, especially the potential approval of ugn 101. And I'm confident that given what we've demonstrated today that this is just the beginning of what your your origin will be able to achieve. So we really appreciate all of your interest in time this morning and your continued support So operator you can now disconnect. Thank you God. Thank you, ladies and gentlemen, this concludes today's conference. Thank you for participating and you may now disconnect.
Yep.