Q3 2019 Earnings Call
Excuse me everyone. Please continue to standby and wait patiently. That's just conference calls won't begin and approximately two minutes again, if you would please continue to standby and wait patiently. After this conference will begin in approximately two minutes.
Good day and welcome to the streamline earnings Conference call. Today's conference is being recorded at this time I would like to turn the conference over to Mr., Ken Hoberman. Please go ahead Sir.
Good morning, welcome to the to todays conference call to discuss our accordance with Nike financial results with me on todays call on that list them once executive management team, including our membership in our Chief Executive Officer, David Young Cole, our Chief Accounting Officer, alongside our senior Vice President Global head of commercial.
Well prepared remarks, well open the call to take any questions. As a reminder, 1 million, making forward looking statements I look forward looking statements are subject to a number of registered uncertainties that could cause our actual results could differ materially.
I guess, a detailed description of these risk.
Any forward looking statements with respect to sexual desire I moved.
Jason year ended December 31st 22, and our quarterly reports on Form 10-Q for the quarter ended September Thirtyth 20 range [laughter] I'm trying to pull the unfortunate arm C. O I live in the floor is yours. Thank you Karen and good morning, everyone.
We remain very pleased with the pace of deals on this launch.
And in particular, the uptake of new patient starts we are seeing across the country.
Additionally, and importantly, we believe there were two factors this quarter, which when adjusted for lead toward notably higher net revenue sales increase quarter over quarter.
Meaningfully narrowing the gap between the net revenue and new patient starts and I will let Robert Saccomano provide more detail on that in a minute.
In parallel we've made substantial progress to expand I was on this its potential utility and indications within and beyond BBCN as well is advancing all overall pipeline. So now I'd like to highlight the CLL opportunity, which we believe is our next indication. We're on track to open a third stage of our clinical trial in CML and the next few more.
Which is intended to ultimately to support registration the rationale for Els honest in Seattle now is clear we have presented encouraging clinical data in stages, one or two of the trial at ASKO and you had this year. The mechanistic rationale was talking to see want twice to make sense. Since you know and there remains an unmet medical need not only in real.
That's the factory patients, but potentially also on certain first line patients as well opening the door to a focused in targeted development strategy and this aggressive difficult to treat malignancy later in the call I will review our clinical efforts in more detail with that I will now turn the call over the longer cycle model, a global head of commercial who will provide further detail.
On the launch Robert.
Thank you items.
In a third quarter net sales of Elds Henri speech, new high of $13.3 million represented continued quarter over quarter growth.
As we analyze the business and launch trajectory and as I've been already alluded to we believe there were two major contributors that obscured the inherent revenue gross [laughter] first and most quantify them was a onetime 406000 dollar expense related to threeforty be hospital charge backs.
Onetime anomaly was recorded during the third quarter and was due to what transaction processing delay from one of our specialty distributors.
$350000 was related to the second quarter sales and the balance attributed to the first quarter.
Combined this represents a 756000 dollar swinging revenue between the second and third quarters.
The second factor was seasonality related to the timing of treatments and particular during the last week of June we observed a significant number of treatments pull forward into the second quarter ahead of the July 4th holiday.
While difficult to quantify we estimate this impact was similar if not greater to the magnitude of the threeforty be chargebacks factor.
Once again this would lead to a higher net revenue sales increase quarter over quarter.
Do you have continued growth moving forward and quite notably our data suggests there was a greater than 20% increase a new patient starts in the third quarter. We believe that new patient starts as a key metric that not only contributed to third quarter revenue, but sets us up for success through 2020, I suppose very well for the future of the brand.
With this in mind, we remain very pleased the pay somebody else Henri Swatch as it relates to brand uptake in new patient starts seeing across the country.
As mentioned last quarter, we don't stop here, how should we see this launch has a marathon not a sprint.
Our efforts.
It's consistently combat Miss diagnosis and grow the size of our new patient funnel.
More specifically as we seek to build out on our base. We have instituted a number of strategies designed to increase the speed and accuracy other BDC and diagnosis not only in hematology in a matter pathology, but also with ended dermatology and dramatic pathology segments, where our data indicates the preponderance of misdiagnosed.
As a curse.
In the third quarter, we significantly increased our efforts on the German geron Petside, we have implemented a two pronged approach consisting of non personal promotion via prints and electronic media, coupled with face to face personal interactions and medical Congresses and speaker programs, all designed to ways awareness and change the diagnosed.
This behavior at the regional and local level.
Additional developments delevering environment favorable for both patient.
And reimbursement includes the we recently a warning of and tap and the assignment I've been Elds AMR specific J code.
Both of which went into effect on October 1st.
As a reminder, CMS has awarding of and tap offer is up to $125000 of additional reimbursement over and above the DRG rate for inpatient infusions of else. Andreas. This reimbursement is granted to therapies that are doing to deliver substantial clinical improvement over existing therapies.
Turning to the outpatient setting the unique goes on its Jay call. It makes spelling for treatment easier and speeds up the claims processing time.
On the private payer side published policies on Els Onrush now cover more than 170 million U.S. lives and include key national organizations, such as that no anthem, Humana, Cigna and United Health care just to name a few.
We believe that creating a positive reimbursement environment for both patients and the Brad will further enhance the value proposition Osama still diverse and generate more patient starts for the foreseeable future.
Before shifting to Europe .
I'd like to take a minute to address question that we're often asked.
Given that BBCN as an emerging market and in alignment with several similar large analogs. The organization had made a strategic decision prelaunch to keep it sales data proprietary however sales reporting by our specialty distributors occurred without our authorization, sending mismatches is to the external environment.
We have reminded our valued specialty distributors obvious prelaunch agreement and they have systematically started to shutdown reporting.
We expect to have all proprietary jail data releases to and fully at some point before years end as you would suspect this would render these data to be non reliable.
Beyond the U.S., we are looking forward to potential commercialization in Europe , we continue to build a corporate infrastructure and our readying for a possible approval in mid 2020.
Overall, we're very pleased with the pace of Els honest uptake in the marketplace, but note that much work remains to be done and our commercial and medical affairs teams are well positioned to continue their strong execution.
We are committed to helping patients with BBCN received the correct diagnosis and ultimately obtained the best treatment for their disease.
Again, we see ourselves in a marathon, but one that we believe we are all well equipped to win [laughter] I would like I'll now like to turn the call over to David Johnson, Our Chief Accounting Officer, David Thank you Robert.
Third quarter results can be found in the press released we issued last night, which I will summarize.
Then one ended the third quarter was 174.5 million in cash cash equivalents and short term investments, reflecting 11.8 million of net cash expenditures during the quarter.
For the third quarter 2019, we had a net loss of $14.9 billion.
Research and development expenses were 12.3 million for the third quarter 29.
Which reflects an increase of $500000 compared with 11.8 million for the third quarter of 28 T.
The higher costs were primarily due to increased investment as we continue to explore new indications for El violence.
Selling general and administrative expenses were $15.4 million for the third quarter 2019, which reflects an increase of 5.8 million compared with 99.6 million for the third quarter of 28 Keith.
The increase in costs were primarily attributable to ongoing commercial launch expenses for loved ones.
The company ended the third quarter of 29 team with 50 million shares outstanding.
I will now turn the call over to heighten Bernstein Osteo.
Moving remarks I. Thank you David again, we remain very pleased with the continued progress Stemline is making both in the market and with our ongoing efforts to expand Amazon versus potential utility both within and beyond D.D.C.N. as wells with progress we've made with our overall pipeline.
It was honors is currently being evaluated in clinical trials of patients would seem to know M.F., the mylofibrosis and am acute myeloid leukemia as well as other CD 1.3 positive diseases and novel regulatory pathways related to this target are also being considered.
We expect to report substantial clinical trial data and regulatory updates around these programs by the end of 2020 and possibly before.
Regarding seem to know this program is on track to begin enrollment rolling patients and stage three a within the next few months as a reminder, we met with the FDA mid year regarding the path forward in CLL and to finalize the protocol. We are opening a new cohorts stage three within a and B portion of the current study wherein we will.
Mobile relapsed refractory and first line patients who are likely not benefit from available therapies.
The rationale for girls honestly see anything that was clear we have generated what we view as encouraging clinical data in stages wanting to the trial, including an acceptable safety profile and evidence of clinical activity in the form of Bono spleen response.
Notably, we see several parallels between CML and Bbc's yet on the scientific and medical side Simonelli BBCN share certain features including genetic alterations and may share a common cuomo origin. CML is believed to be able to transform into BBCN. Some cases, and then our trials we have enrolled.
BBCN patients, who had a fire diagnosis of CML CML can present with skin lesions, a hallmark of BBCN. Finally, our targets CD 123 is present on seem a blast and minus sites as well as on malignant plasma side to dendritic cells. The cell of origin of BBCN found.
I didn't see even though micro environment.
We anticipate being able to blood clinical data both in relapsed refractory in first line patients, but unlikely to benefit from available therapies as well as regulatory updates by the end of 2020.
Regarding myelofibrosis and math, we're very happy to announce that data from the ongoing phase one two trial were selected for oral presentation at the upcoming Ash conference and we were currently expanding the trial for additional enrollment at the add more sites. The goal here is the further elucidate the activity in relapsed refractory patients and other patient subset.
In order to inform our regulatory strategy and weeks expected provide update by the end of next year regarding and now we are implementing a multi pronged approach. We have one I S. T that is currently investigating the combination of as honest with other agents and patients with relapsed refractory and no first line a location on fit for chemo.
In patients with high risk Myelodysplastic syndrome.
Also we are finalizing protocols in patients with subsets of and know that enriched for CD wants 23 expression or have D.C.N. like features and expect to revise [laughter] data updates around these programs by the end of next year and possibly before.
In summary, we were very pleased with the continued momentum we are building with Alzheimer's. Moreover, we are excited about the clinical potential those on us and where you're looking to build upon us success and be the DCF in the years to come with that I would like to open the call to questions.
[noise], thank him and he would like to ask a question. Please signal by pressing star one on your telephone keypad, if you're using a speakerphone. Please make sure your mute function. It's turned off to allow your signaled to reach our equipment.
Again press Star one to ask a question.
Well pause for just a moment hello, everyone and opportunity to signal for question.
Our first question comes from Jessica five with JP Morgan.
Hey, guys. Good morning, Thanks for taking my question and thanks for providing that additional detail on the.
Quarter over quarter revenue in one timers.
When I kind of a apply the numbers that you were talking about I think I can get to sort of like a 15% delta between the two quarters.
Can you help us think about either how over all patients are trending core trended quarter over quarter or are there any other patient metrics that you can give us besides the 20%.
New patient growth in the corner that might help us better understand that kind of revenue trajectory.
Yeah, Thanks, Jess the.
Okay.
Yeah, it's it it's tough to give more insight into those patients. You know we continually are trying to look at our data and find out what is available to us to deliver for pod time viewing.
At this point, that's probably the where we're going to stop today is but that 20% growth quarter over quarter quarter. There's rather metrics that we are looking at a that we hope to be able to provide at some point down the line, but it's still not it's still not mature enough. So I think the 20 over 20% is a pretty pretty.
Good metric and we really hanging our hat on that a lot.
Okay got it maybe maybe a little more easy data for you to get then the I'm kind of patient level data I think last quarter, you talked about some metrics about reorders and new institutions ordering is there any color that you can give on that for the third quarter.
Yeah, you know when the in that effort to try to give everybody more details. So you know we instituted some of that last quarter and it was the best we had at the time.
With that type of data was a little bit de prioritize for us for today, because we were able to come up at the 20% number which we feel trumps all so.
Those numbers that we have reporting about you know unique accounts most trend still exist I'm not prepared to give you those numbers I would tell you that that the positive trends we saw in the second quarter would be somewhat consistent in the third quarter. So those messages would still be there were very very happy with with the growth of the product the diversity of of sites that are taking.
Beyond that the product to be infusion [noise].
It's it's really quite remarkable to see how this product has been broadly adopted and those metrics once again, while I'm not I.
I don't have those numbers handy they would probably confirmed its fairly similar success as we did in the second quarter.
Okay got it last one maybe just a quickie can you remind us of the payer mix that you're seeing withheld on Earth is it still 75% Medicare how much is Medicaid commercial on cash.
Yeah, it's still roughly 75% Medicare and the and the remainder in private payer.
Medicaid is if it's a very small negligible population it could be one that gross down the line. If we see you know brought about taking utilization that we we're we've experienced over the past year, but its Medicaid as it is a is really a small piece of the pie.
Got it thank you.
You're welcome.
Our next question comes from Boris Peaker with Cowen.
Well I'd just like they are probably a little further on the 340 be rebate can you comment exactly kind of how works how it was calculator more importantly, going forward would you do get just take provisions on a quarterly basis or is there going to be another quarter and the future where rebates from several quarters are going to be rolled.
Into.
Sure Hi, Boris David.
We do estimate 340 be reserves on a quarterly basis.
And there's a significant effort that goes into analyzing.
That reserve.
For example, we look at factors such as historical charge back data, we looked at the mix of Threeforty be versus non 340 be hospitals are we look at similar product benchmarks as well as industry benchmarks. So there's a significant effort in estimate.
King of reserves for Threeforty be charged that that's going to take place and that's our that's all normal process and Oh, we had a situation here where.
A a new commercial company here and Oh, we don't have a lot of historical data. So there's always good to be some potential estimation variability to deal with.
But in terms of trumps, that's what I just want to understand is they're gonna be again, we wait maybe a few quarters on there is gonna be big true up where are you gonna be no truing up on a quarterly basis, so to end up being smoothed out.
We're not expecting any further true ups. We believe this is a one time item.
Great and my next question in terms of just focusing on I was on a risk patients can you comment at this point kind of what fraction of patients end up getting the drug and then going onto a transplant versus those that just stay on drug and non transparent as well as the duration of treatment or vials per patient in either one of those scenarios.
Yeah at this point, we we are tracking some some patients that we have an intimate knowledge of because of our fields efforts, but good both the territory managers and our and medical science liaison.
You know it's difficult to to talk with any certainty about what that is pointing to as it relates to percentage of patients moving off the stem cell transplant or even treatment durations for that matter, we're not getting that level of granular data at this point, so what we've been telling.
Everybody over the past several months is that right now there would be no reason to believe that the.
Percentage of patients moving onto stem cell transplant or treatment durations would be anything different than what we saw in the alone one for trial.
Great and my last question or maybe on C.M.L. in a pivotal study where do you think you need to show clinically for approval.
[laughter] Yeah. So you know the study has has two stages threea in three d. and it's very very reminiscent of our BBCN study, which is why I mean, we feel very comfortable with great relationship with the FDA. We feel this is kind of no regulatory path to point out for us with the FDA.
Met in the first in in BBCN as I mean is and maybe refresh everyone's memory. The gold standard endpoint for approval. According to the FDA. The time for for aggressive leukemia types of diseases like BBCN was complete response, but they were open to additional endpoints. If we could demonstrate that they would try to clinical benefit prospectively.
Ah So and then they allowed us to do this kind of without missing a step in the context of our ongoing study, we're able to confirm a clinical complete response.
While generating additional data they agreed they allowed us to then formally formally introduce it as the primary endpoint and the confirmatory stage and we were successful there.
Similar type.
Process here in that.
New endpoints are being introduced into seem as though by US only this time, we have the advantage of of major thought leader major consortia in paper, all basically saying that CML is no longer is considered a myelodysplastic syndrome. So it's really a mild its plastic slash myeloproliferative.
And really suggesting that the other endpoints are then ones other than that historically you sold friends, yes should be used and see enough. So we've been able to the leverage. This again it would be D.C.N., we were kind of charting territory really in this case, we're relying on major papers and consortium to make the case they were very with.
Sept of two to introducing additional endpoints above and beyond a whole lot into the stage three eight which would allow us to continue to make forward progress rather than go off and and do a study on the side and come back. This allows us forward progress in the three I looked at some of these novel endpoints.
Typically tied to proliferative type cases, like like spleen reduction size or bone marrow response with partial them out of political recovery symptom scores or things like this and in the context of the three eight really collect this data and hopefully at the end to that show that that's one or more of these element.
Doing the tie to clinical benefit clinical benefit is not explicitly define but it's something that that when you see it you know what it is and then no. The idea would be to go to the FDA and say look a these additional endpoints that we were interested in doing the tied to some elements of clinical benefit and here's why similar to what we did a BBB.
Yeah, and hopefully that would allow us to formally introduce not just oh RR, but some of these others into the confirmatory part of stage, three which would be three b and hopefully lead to registration now the primary focus is relapse refractory see even though these are very very sick patients really no no no therapies available for.
These patients that are particularly active the median overall survival. These patients is six to seven months. So if it doesn't situation the bars very very low we've already shown what we believe is very encouraging signs of activity in the in the form a bone marrow responses and spleen response in these patients.
And we'll also be enrolling first line patients as well because there's a crop of first line patients who really are not thought to benefit from available therapies and these are patients who have more of the proliferative type, but you never know so it'll give us our first experience with first line patients and I want to remind you and BBCN.
Relapse refractory data what were good but these are very very sick patients and then well we started to treat first line patients our response, which shot up dramatically.
And we really saw the drug perform in first line treatment naive patients in CML I, just I always have to try to remind people when they say well how did you see him another to compare to the BBCN data, it's apples and oranges, CML or relapsed refractory sick patients and the data we talked about mostly be you stand as first line. So it's apples and oranges, but now we're going to have an up.
Terry to treat first line CML patients in parallel and we're not we're gonna look forward to and expect some some exciting data coming out of that as well.
Thank you very much like the detailed response.
Thanks.
Our next question.
<unk>.
Burke.
[laughter].
Hi, Good morning, guys and congrats on a quarterly results I guess, a question or Robert I'm, just wanted to dig in a little bit in terms of your programs with respect to.
Making sure patients far correctly diagnosed and at whether it's it's at the derm level Durham, setting or or a mock setting and and helping you to identify these patients and and Oh, yeah get them into treatment.
Yeah, Matt the there quite a bit of a of tactics that we have pushed out over the past several months to address this so our data do you quite some time ago revealed and I mentioned this earlier today on the call is that you we aren't data shows that most of the misdiagnosis comes from that patients that.
Presents to the dermatologist with skin lesions and doesn't get the proper diagnosis and maybe not even a biopsy, but when they do get biopsy done that tissue sample gets to the dramatic colleges and not really looking at sea do you want 23, the way they need to swallow the programs that we do both in medical affairs and in marketing with the selling.
Teams with the reimbursement teams really as a company focused on bringing about the awareness of CD 123, the importance of it not only in BBCN, but we also remind people that CD money 20, threes and prolifically expressed marker and so we want it will elevate the importance of that some people think a bit more top of mind. So everything we do.
Do there is in interactivity with with with with Lance with with dramatic pathologists with reference with reference labs, and so it's it's pretty encompassing a and every faction of the commercial and medical effort is focused on that right now.
That's the key to our success down the line is and that's where we can make the biggest impact is right. There at the signs of diagnosis. Some when agents as well is the fact that we have exceeded went 23 directed therapeutic in Amazon risk that alone spawns more interest in assessing proceeding not 23, so we're really still at the early stages.
There's some you know when and to go more specific reach one of the point you made is how do we interact with the margin how do we get alerts and how do we proactively find a patient that may have BBD C. N because perhaps we get an alert that PD 123 to 156 I'm sure you know positive in an alert system and we can mobile.
As a team to go there to help with the diagnosis. These are things that we're doing now the team has done in Asia, and quite honestly exquisitely job and putting a comprehensive programs together to answer this need so they went into place this quarter I just want to remind everybody that it's going to take some time to change the diagnostic b.
Maybe or misdiagnosis has been going on for many many years and and we're doing our best to enact.
Tactics in approaches that will change. This this behavior quickly, but it will take some time.
Okay, that's helpful and and I got a question for Ivan Thank you for the detail than CNL study can you give us some more detail with respect to the dosing regimen or NCM ml and how we should think about that as an indication is that indication similar to <unk>.
And well patients or drive driven to transplant or is this a an indication where patients will stay on nonres potentially longer periods. It's not.
Yeah sure. So [laughter] the the regimen is slightly less dose intensity. It's the same dose that being 12, Mike events, but kilogram per day.
But rather than five days in a row that we use in BBCN its three days.
And the the cycle frequency is a little bit lighter than it isn't BBB CMBS sends a very very aggressive disease, where skin lesions kind of can kind of growth in front of your eyes from day to day, it and it seems a bit more influence. So we yeah, we've decided to give it a slightly less dose intense regimen and actually we believe the.
Safety profile has been has been stellar and see even though they may be benefiting from that but it doesn't appear to be detracting from the activity. So we think we have the optimal regimen there.
Terms of getting patients the transplant historically, it's been it's very very difficult to get CML patients to transplant that is that has been a therapeutic goal, but the problem is many CML patients or middle age. The elderly have lot of co morbidities corn meal mobility to situations and it's just been very very difficult to get those types of patients.
The transplant, we obviously, we've had a one which was bridged transplant and that was a great outcome and certainly that would be an outcome, we'd be very very happy with or Alternatively, you know this therapy can be given a long term as you know we had [laughter] one or two patients in the clinical trial going out faster.
A half I think it was one patient out three years, there's certainly no.
<unk> either outcome as possible I think it will largely be patient depending on how old is the patient how sick as the patient performance status are they a transplant Canada's et cetera, but though you know time will tell and if their first line versus relapse refractory, obviously, there's a major factor as well.
Okay, great. Thank you and then.
One more question C.M.L. do you think this study could also suffice for approval in in in Europe , and then secondly.
Can you give us an updated your plans for modeling purposes.
Yes sure Yeah. Our plan in female [laughter] is to is to add we're adding sites now there's a lot of interest from the last conference and now you know we've met with a lot of seem as though okay, well no virtually all of them lot of interest internationally. So yes, we expect to add a couple of European.
Sites, and we would look to to file both for the U.S. and Europe .
Myelofibrosis.
Folks continue to dig into the data they get more excited well first of all it's not it's not another JAK inhibitor, it's completely novel mechanism of action.
CD 123 again its people begin to the data and you kind of did did have a bit deep data die for ash.
Filing and and Lo and Behold It was accepted for an old presentation as a lot of stiff competition, there and Robert hasn't had an experience in myelofibrosis, a as well so it. So we feel that is it is still well within our comfort zone in this disease, what we like about as we're seeing activity in the spleen, which is kind of the gold standard endpoint.
If the FDA makes decisions around so we're seeing activity, where it where you want to see activity, we feel like there's a lot of optionality here, there's the relapse refractory.
Population as a whole, but as we're expanding the studying spanning the sites. We're also starting to look at certain subsets of interest such as patients with thrombocytopenia as you may know some of the Jack and neighbors often have to be a dose reduce the reason with held in the setting a thrombocytopenic, which has a potential entry point for us because we have had some good success with patients.
Who are thrombocytopenic, and we have not had to a dose well this whole doses or or lower our dose. So I think that's that's one area of interest we're going to pursue a over the next year. The other is you know we're learning that there's a subset of myelofibrosis patients that have elevated monocytes. This is very interesting because CML is a disease of high.
Monocytes. So we know our drug this is very active and see in the no.
Here, we have a a kind of a subset of M.S. that looks a lot like CML with these high monocytes monocytes and see him another cdone hundred 23 positive.
The other thing is is that this is those patients appear to have a particularly poor prognosis in MF and other drugs and we don't seem to work, particularly well so that opens up a potential novel regulatory path.
Coupled with scientific rationale so that when were you have arise on and then we've seen a interesting activity in that subpopulation want to continue to double down and look at at how the drug fares and that population because that might open a novel pathway as well we're also in our.
And that study moving forward and see a male and am though all of US studies, we plan to introduce a is validated CD went 23 assay that we're working on with vendors.
Which would be very helpful to kind of nailed down you know it wouldn't see want 23 enrichment be another a pathway and we'll look at that really all of our disease moving forward.
There may be subsets of MF patients were seeing another and now that are high Cdone hundred 23 that are particularly sensitive to drug and that would be great would open up a pathway there and all these studies really have a dual purpose. It there indication specific but also the more data we can gather for the drug being active in CD went 23, hi patients for multiple indications.
The more case for a target base label is there. So these studies all have that dual purpose.
Right. Okay. Thanks, a lot Ivan and that's on the progress yeah. Thanks.
Once again, if he would like to ask a question you may signal by pressing star one on your telephone keypad.
Our next question comes from Joe.
Yeah.
Piper Jaffray.
Hi, [laughter] Charles on for Joe. Thank you for taking my question.
Just wanted to ask if you could provide any commentary on the waiting or patient starts throughout the quarter given that some patients were drawn into Q2.
Two because of the July 4th holiday.
Patient starts there for more weighted towards the ended the quarter.
And my second question about.
Commercialization and but you are and whether you could provide to give more detail there.
Filing status with the M&A.
What the next steps are and whether or not you would be prepared to commercialize on your own Andy. Thank you.
Yeah, I think it's fair to say that the patient starts where we're more initiated in the second half of the corridor.
As it relates to the European Union commercialization, where you know we're poised to to commercialize there we have the Oh, we fully haven't capability and knowledge of to go there and do this we have a small came on the ground right now that has been working tirelessly to up to prepare the market and pre.
Launch initiatives to ensure that if they have been approval does come in May 2020 that we are we're ready to capitalize on the only on the approval that said a lot of the work is preparing a million alone medical marketing.
And payer aspects to the or to the launch.
What is critically important to us of course is losing those key markets and the he you for and who you. Five is is you know substantially securing a good price points and and good reimbursement. So I would tell you that you know from where I sit right now we I'm very happy with the progress I see for the European market [laughter]. So.
At this point of things are on track from there. We said we remain very confident what that opportunity is remind you that Ah you know, we feel the opportunity and the totality of Europe is just as good as the opportunity we have in the United States and we would [laughter] our data shows that Theres, probably a similar you know inside.
Great BBCN per hundred thousand patient patient so more people so.
Yes, so those activities continue to go where we're judicious in how we go there.
But we are poised for success.
Our next question comes from Yi, Chen with H.C. Wainwright.
Good morning. This is Ed remarks on for you I. Appreciate you taking the questions. Just two quick clarifying ones for me I'm sort of elaborating on that previous question I, just wondering if <unk> Paul it as if I missed this earlier what do you expect to start generating revenues in the you would that then being the second half of next year.
And then also around the treatment cycles. I know you mentioned that you don't have that granularity yet, but [noise] excuse me I'm wondering if in the future you'd be able to have that data available and if you would be willing to talk about that on potentially future earnings calls.
Yeah. So from a revenue perspective, I'll, just remind everybody that obviously there's.
Many different markets within the European markets. So if we were to get 'em. If we were to get up an approval sometime in the made up 2020 reimbursement.
For commercialized products takes place at varying rates or do you know traditionally now speaking just very generalities and in general that generalities here as is typically you'd see Germany come on the you know come on first with the quicker reimbursement mechanisms, then maybe France, Italy, Spain, and we have a very.
Any specific launch sequence that we are and hearing to which maintains pricing integrity of the asset as well as as I'm going into markets that have very friendly reimbursement environment. So.
So when the revenue comes I will tell you well, you know automatically U.S., France, and Germany or free free.
Pricing markets that that generally you'll start to see no revenue sooner rather than later so.
At this point I think when our launch would would demonstrate was that we probably take on a traditional launch sequence in the European Union.
You know likely with with France, Germany coming on first probably France sack and that's pretty typical for that for the space. So once again I'm what I'd like to caveat. There is that if we were to get approval. Then say June 2020 that doesn't mean that we have immediate reimbursement throughout the throughout the land there it's going to come on country.
My country, so that hopefully answers your your first question as far as a treatment cycles. Yeah. You know one I think we want to be able to give as much direction to all of you folks as as we can standby and so.
If there's anything we've seen over the last nine or 10 months is that we aren't getting more and more information we are.
Able to implement more analytics.
That allows us to offer information to you folks with greater precision and confidence and that's the path I think wave I'll have to try to stay on whole heartedly, we'd like to be able to give you more so that you can.
Execute your here jobs, the way you need to do that so.
As it becomes more reliable, we'll we'll certainly take the decision to see what we can release.
That would certainly be appreciated all right. That's all from me. Thank you for taking the questions.
Thanks.
Thank you and that concludes today's question and answer session that one now I'll turn the conference back over to Mr. Ivan Bergstein.
Thank you operator [laughter] here at stem line, we are driven by mission to help improve the lives of patients with cancer I would like to take this opportunity to thank all the patients physicians health care professionals and all the outstanding employs stemline for their dedication and passion and making a difference in patients lives.
Thank you all for joining us on the call. This morning.
[noise]. Thank you everyone. That's concludes todays teleconference. You may now disconnect.
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