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Stemline Therapeutics Inc (STML) Q3 2019 Earnings Call Transcript

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Stemline Therapeutics Inc (NASDAQ: STML)
Q3 2019 Earnings Call
Nov 8, 2019, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day and welcome to the Stemline 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.

Ken Hoberman -- Chief Operating Officer

Good morning and welcome to today's conference call to discuss our third quarter 2019 financial results. With me on today's call are members of Stemline's executive management team, including Ivan Bergstein, our Chief Executive Officer; David Gionco, our Chief Accounting Officer; and Robert Francomano, our Senior Vice President, Global Head of Commercial.

After our prepared remarks, we will open the call to take any questions. As a reminder, we may be making forward-looking statements. Our forward-looking statements are subject to a number of risks and uncertainties, that could cause our actual results to differ materially from our forecasts. A detailed description of these risks can be found in the forward-looking statements in risk factors section of our Annual Report on Form 10-K for the year ended December 31, 2018 and in our quarterly report on Form 10-Q for the quarter ended September 30, 2019.

With that, I will now turn over the call to Ivan Bergstein, our CEO. Ivan, the floor is yours.

Ivan Bergstein -- Chief Executive Officer and President

Thank you, Ken, and good morning everyone. We remain very pleased with the pace of the ELZONRIS 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 to a notably higher net revenue sale increase quarter-over-quarter, meaningfully narrowing the gap between the net revenue and new patient starts. And I will let Robert Francomano provide more detail on that in a minute.

In parallel, we've made substantial progress to expand ELZONRIS' potential utility and indications within and beyond BPDCN as well as advancing our overall pipeline. For now, I'd like to highlight the CMML opportunity, which we believe is our next indication. We are on track to open the third stage of our clinical trial in CMML in the next few months, which is intended ultimately to support registration. The rationale for ELZONRIS in CMML is clear. We have presented encouraging clinical data in Stages I and II the trial at ASCO and EHA this year. The mechanistic rationale of targeting CD123 makes sense in CMML and there remains an unmet medical need, not only in relapsed refractory patients, but potentially also in certain first-line patients as well, opening the door to a focused and targeted development strategy in 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 to Robert Francomano, our Global Head our Commercial, who will provide further details on the launch. Robert?

Robert M. Francomano -- Senior Vice President and Global Head of Commercial

Thank you, Ivan. In the third quarter, net sales of ELZONRIS reached a new high of $13.3 million, representing continued quarter-over-quarter growth. As we analyze the business and launch trajectory, and as Ivan already alluded to, we believe there were two major contributors that obscured the inherent revenue growth. The first and most quantifiable them was a one-time $406,000 expense related to 340B hospital chargebacks. This one-time anomaly was recorded during the third quarter and was due to a transaction processing delay from one of our specialty distributors. Of this, $350,000 was related to the second quarter sales and the balance attributed to the first quarter. Combined, this represents a $756,000 swing in revenue between the second and third quarters.

The second factor was seasonality related to the timing of treatments. In particular, during the last week of June, we observed a significant number of treatments go forward into the second quarter, ahead of the July 4 holiday. While difficult to quantify, we estimate this impact was similar, if not greater to the magnitude of the 340B chargeback factor. Once again, this would lead to a higher net revenue sales increase quarter-over-quarter.

Fueling continued growth moving forward, and quite notably, our data suggests there was a greater than 20% increase in new patient starts in the third quarter. We believe that new patient starts is a key metric that not only contributed to third quarter revenue, but sets us up for success through 2020. This supports very well for the future of the brand. With this in mind, we remain very pleased with the pace of the ELZONRIS launch, as it relates to brand uptake in new patient starts seen across the country. As mentioned last quarter, we don't stop here as we see this launch is a marathon, not a sprint. Our efforts in the -- let's consistently combat misdiagnosis 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 of a BPDCN diagnosis, not only in hematology and hematopathology, but also within the dermatology and dermatopathology segments where our data indicate the preponderance of misdiagnosis occurs.

In the third quarter will be significantly increased our efforts on the dermpath side. We have implemented a two pronged approach consisting of non-personal promotion via print and electronic media coupled with face-to-face personal interactions at medical congresses and speaker programs, all designed to raise awareness and change of the diagnosis behavior at the regional and local level.

Additional developments delivering an environment favorable for both patient and reimbursement includes the recent awarding of NTAP and the assignment of an ELZONRIS specific J-Code, both of which went into effect on October 1. As a reminder, CMS has awarding of NTAP offers up to $125,000 of additional reimbursement over and above the DRG rate for inpatient infusions of ELZONRIS. This reimbursement is granted to therapies that are deemed to deliver a substantial clinical improvement over existing therapies. Shifting to the outpatient setting, the unique ELZONRIS J-Code makes billing for treatment easier and speeds up the claims processing time.

On the private payer side, published policies on ELZONRIS now cover more than 170 million US lives and include key national organizations such as Aetna, Anthem, Humana, Cigna and UnitedHealthcare, just to name a few. We believe that creating a positive reimbursement environment for both patients and the brand will further enhance the value proposition ELZONRIS delivers and generate more patient starts for the foreseeable future.

Before shifting to Europe, I would like to take a minute to address the question that we are often asked. Given that BPDCN is an emerging market and in alignment with several similar large analogs, the organization has made a strategic decision prelaunch to keep its sales data proprietary. However, sales reporting by our specialty distributors occurred without our authorization, sending missed messages to the external environment. We have reminded our valued specialty distributors of this prelaunch agreement and they have systematically started to shut down reporting. We expect to have all proprietary data release just to end fully at some point before year's end. As you would suspect, this would render these data to be non-reliable. Beyond the US, we are looking forward to potential commercialization in Europe. We continue to build the corporate infrastructure and are waiting for a possible approval in mid 2020.

Overall, we are very pleased with the pace of ELZONRIS' 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 BPDCN receive the correct diagnosis and ultimately obtain 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.

I would now like to turn the call over to David Gionco, our Chief Accounting Officer. David?

David Gionco -- Vice President of Finance and Chief Accounting Officer

Thank you, Robert. Our third quarter results can be found in the press release we issued last night, which I will summarize. Stemline ended the third quarter with $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 of 2019, we had a net loss of $14.9 million. Research and development expenses were $12.3 million for the third quarter of 2019, which reflects an increase of $500,000 compared with $11.8 million for the third quarter of 2018. The higher costs were primarily due to an increased investment, as we continue to explore new indications for ELZONRIS.

Selling, general and administrative expenses were $15.4 million for the third quarter of 2019, which reflects an increase of $5.8 million compared with $9.6 million for the third quarter of 2018. The increase in costs were primarily attributable to ongoing commercial launch expenses for ELZONRIS. The Company ended the third quarter of 2019 with 50 million shares outstanding.

I will now turn the call over to Ivan Bergstein, our CEO, for concluding remarks. Ivan?

Ivan Bergstein -- Chief Executive Officer and President

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 ELZONRIS' potential utility both within and beyond BPDCN as well as with the progress we've made with our overall pipeline. ELZONRIS is currently being evaluated in clinical trials of patients with CMML, MF, myelofibrosis and AML, acute myeloid Leukemia. As well as other CD123 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 CMML, this program is on track to begin rolling patients in Stage 3a within the next few months. As a reminder, we met with the FDA midyear regarding a path forward in CMML and have finalized the protocol.

We are opening a new cohort Stage 3 with an A and B portion of the current study, wherein we will enroll both relapsed refractory and first-line patients who are likely not benefit from available therapies. The rationale for ELZONRIS in CMML is clear. We have generated what we view as encouraging clinical data in stages 1 and 2 of the trial, including an acceptable safety profile and evidence of clinical activity in the form of bone marrow and spleen responses.

Notably, we see several parallels between CMML and BPDCN. On the scientific and medical side, CMML and BPDCN share certain features including genetic alterations and may share a common clonal origin. CMML is believed to be able to transform into BPDCN in some cases. And then our trials, we have enrolled BPDCN patients who had a prior diagnosis of CMML. CMML can present with skin lesions, a hallmark of BPDCN.

Finally, our target CD123 is present on CMML blast and monocyte, as well as on malignant plasmacytoid dendritic cells, the cell of origin of BPDCN found in the CMML micro environment. We anticipate being able to drive clinical data both in relapsed refractory and first-line patients, but unlikely to benefit from available therapies as well as regulatory updates by the end of 2020.

Regarding myelofibrosis, MF, we are very happy to announce that data from the ongoing Phase 1/2 trial were selected for oral presentation at the upcoming ASH Conference. And we are currently expanding the trial for additional enrollment at to add more sites. The goal here is to further elucidate the activity in relapsed refractory patients and other patient subsets in order to inform our regulatory strategy and we expect to provide updates by the end of next year.

Regarding AML, we are implementing a multi-pronged approach. We have one IST, that is currently investigating the combination of ELZONRIS with other agents in patients with relapsed refractory AML, first-line AML patients on fit for chemo and patients with high risk myelodysplastic syndrome. Also, we are finalizing protocols in patients with subsets of AML that are enriched with CD123 expression or have BPDCN-like features and expect to provide data updates around these programs by the end of next year and possibly before.

In summary, we are very pleased with the continued momentum we are building with ELZONRIS. Moreover, we're excited about the clinical potential of ELZONRIS and we are looking to build upon our success in BPDCN in the years to come.

With that, I would like to open the call to questions.

Questions and Answers:

Operator

Thank you. [Operator Instructions] Our first question comes from Jessica Fye with JPMorgan.

Jessica Fye -- JPMorgan -- Analyst

Hey, guys, good morning. Thanks for taking my question and thanks for providing that additional detail on the quarter-over-quarter revenue and one-timers. When I kind of 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 overall patients are trending -- trended quarter-over-quarter or are there any other patient metrics that you can give us besides the 20% new patient growth in the quarter that might help us better understand that kind of revenue trajectory?

Ivan Bergstein -- Chief Executive Officer and President

Yeah, thanks, Jess. The -- yes, it's tough to give more insight into those patients. We continually are trying to look at our data and find out what is available to us to deliver for prime-time [Phonetic] viewing. At this point, that's probably the -- where we're going to start today with that 20% growth quarter-over-quarter. There is -- there are other metrics that we are looking at that we hope to be able to provide at some point down the line, but it's still not mature enough. So I think, the 20% over -- the 20% is a pretty good metric and we're really hanging our hat on that the lot.

Jessica Fye -- JPMorgan -- Analyst

Okay, got it. Maybe a little more data for you to get than the 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?

Ivan Bergstein -- Chief Executive Officer and President

Yes. In that effort to try to give everybody more details, we instituted some of that last quarter and it was the best we had at the time. We -- that type of data was a little bit deprioritized for us for today, because we were able to come up with the 20% number, which we feel trumps all. So those numbers that we have reported about unique accounts, those trends still exist. I'm not prepared to give you those numbers. I would tell you 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. We're very, very happy with the growth of the product, the diversity of sites that are taking on the product, the infusions. It's really quite remarkable to see how this product has been broadly adopted and those metrics once again, while I'm not -- I don't have those numbers handy. They would probably confirm with similar success as we did in the second quarter.

Jessica Fye -- JPMorgan -- Analyst

Okay, got it. Last one, maybe just a quickie, can you remind us of the payer mix that you're seeing with ELZONRIS? Is it still 75% Medicare? How much is Medicaid commercial on cash?

Ivan Bergstein -- Chief Executive Officer and President

Yes, it's still roughly 75% Medicare and the remainder in private payer. Medicaid is a very small negligible population. It could be one that grows down the line, if we see broader uptake in utilization that we've experienced over the past year, but Medicaid is really a small piece of the buying.

Jessica Fye -- JPMorgan -- Analyst

Got it. Thank you.

Ivan Bergstein -- Chief Executive Officer and President

You're welcome.

Operator

Our next question comes from Boris Peaker with Cowen.

Boris Peaker -- Cowen -- Analyst

I'd just like to probe a little further on the 340B rebate. Can you comment exactly kind of how it works, how it was calculated and more importantly, going forward would you -- do you just take provisions on a quarterly basis or is it going to be another quarter in the future where rebates from several quarters are going to be rolled into?

David Gionco -- Vice President of Finance and Chief Accounting Officer

Sure. Hi, Boris, this is David. We do estimate 340B reserves on a quarterly basis and there is significant effort that goes into analyzing that reserve. Wee -- for example, we look at factors such as historical chargeback data. We looked at the mix of 340B versus non-340B hospitals. We look at similar product benchmarks as well as industry benchmarks. So there is a significant effort in estimating reserves for 340B chargeback that will take place, and that's our normal process and we had a situation here where -- look, we are a new commercial company here and we don't have a lot of historical data. So there is always going to be some potential estimation variability to deal with.

Boris Peaker -- Cowen -- Analyst

But in terms of true-ups, that's what I just want to understand. Is there going to be, again we wait maybe a few quarters, and there's going to be a big true-up or are you going to be now truing up on a quarterly basis, so its being smoothed out?

David Gionco -- Vice President of Finance and Chief Accounting Officer

We are not expecting any further true-ups. We believe this is a one-time item.

Boris Peaker -- Cowen -- Analyst

Great. And my next question, in terms of just focusing on ELZONRIS patients. Can you comment at this point, kind of what fraction of patients and getting the drug and then going on to transplant versus those that just stay on drug and non-transplant as well as the duration of treatment or vials per patient in either one of those scenarios?

Ivan Bergstein -- Chief Executive Officer and President

Yes, at this point we are tracking some patients that we have an intimate knowledge of because of our field efforts with both the territory managers in our medical science liaisons. It's difficult to talk with any certainty about what that is pointing to as it relates to percentage of patients moving on to 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 on to stem cell transplant or treatment durations would be anything different than what we saw in the 0114 trial.

Boris Peaker -- Cowen -- Analyst

Great. And my last question, may be on CMML in the pivotal study. What do you think you need to show clinically for approval?

Ivan Bergstein -- Chief Executive Officer and President

Yes. So the study has two stages, 3A and 3B and it's very, very reminiscent of our BPDCN study, which is why I think we feel very comfortable. We have a great relationship with the FDA and we feel this is kind of a regulatory path 2.0 for us with the FDA in that -- in the first -- in BPDCN, as I may refresh everyone's memory, the gold standard endpoint for approval according to the FDA at the time for aggressive leukemia types of diseases like BPDCN was complete response, but they were open two additional endpoints if we could demonstrate and that they were tied to clinical benefit prospectively.

So -- and they allowed us to do this kind of without missing a step in the context of our ongoing study. We were able to confirm clinical complete response, while generating additional data. They agreed, they allowed us to then formally introduce it as the primary endpoint in the confirmatory stage and we were successful there.

Very similar type process here in that new endpoints are being introduced into CMML by us, only this time we have the advantage of major thought leaders major consortium papers, all basically saying that CMML is no longer considered a myelodysplastic syndrome solely, it's really a myelodysplastic/myeloproliferative and really suggesting that other endpoints -- ones other than historically used solely [indecipherable], should be used in CMML. So we've been able to leverage this.

Again, with BPDCN, we were kind of charting new territory really. In this case, we're relying on major papers and consortium to make the case. They were very receptive to introducing additional end points above and beyond ORR into the Stage 3A, which would allow us to continue to make forward progress rather than go off and do a study on the side and come back. This allows us forward progress in the 3A, look at some of these novel endpoints that typically tied to proliferative type cases like spleen reduction size or bone marrow response with partial hematopoietic recovery, symptom scores and things like this. And in the context of the 3A, we'll collect this data and hopefully at the end of that, show that one or more of these elements do indeed tie to clinical benefit. Clinical benefit is not explicitly defined, but it's something that when you see it, you know what it is and then, now, the idea would be to go to the FDA and say, look, these additional endpoints that we were interested in do indeed tie to some elements of clinical benefit and here is why, similar to what we did with BPDCN and hopefully, that would allow us to formally introduce not just ORR, but some of these others into the confirmatory part of Stage III, which would be 3B and hopefully lead to registration.

Now, the primary focus is relapsed refractory CMML, which is very, very sick patients. Really no therapies available for these patients that are particularly active. The median of overall survival of these patients is six to seven months. So with a dismal situation, the bar is very, very low. We've already shown what we believe is very encouraging signs of activity in the form of bone marrow responses and spleen responses in these patients. And we'll also be enrolling first-line patients as well, because there is 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 prolific type of CMML, so it will give us our first experience with first-line patients.

And I want to remind you, in BPDCN, our relapsed refractory data were good, but these are very, very sick patients and then, when we started to treat first-line patients, our response rate shot up dramatically and we really saw the drug perform in first-line treatment-naive patients. In CMML, I just -- I always have to try to remind people when they say, well, how does your CMML data compared to your BPDCN data. Its apples and oranges. The CMML are relapsed refractory sick patients and the data we talked about mostly [Indecipherable] first-line. So, it's apples and oranges, but now we're going to have an opportunity to treat first-line CMML patients in parallel and we're going to look forward to and expect some exciting data coming out of that as well.

Boris Peaker -- Cowen -- Analyst

Thank you very much for that lengthy and detailed response. Thanks.

Operator

Our next question comes from Matt Kaplan with Ladenburg Thalmann.

Matt Kaplan -- Ladenburg Thalmann. -- Analyst

Hi, good morning guys, and congrats on the quarterly results. I guess, a question for Robert. Just wanted to dig in a little bit in terms of your programs with respect to making sure patients are correctly diagnosed and at whether at the derm level -- derm setting or EMR [Phonetic] setting and helping you to identify these patients and get them into treatment?

Robert M. Francomano -- Senior Vice President and Global Head of Commercial

Yes, Matt, there quite a bit of tactics that we have pushed out over the past several months to address this. Our data, quite some time ago revealed, and I mentioned this earlier today on the call is that, we -- our data shows that most of the misdiagnosis comes from that patient that presents to the dermatologists with skin lesions and doesn't get the proper diagnosis and maybe not even a biopsy. But when they do get biopsied and that tissue sample gets to the dermatopathologist, they are not really looking at CD123 the way they need to. So while 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 CD123 and the importance of it, not only in BPDCN, but we also remind people that CD123 is an prolifically expressed marker. And so, we want to elevate the importance of that, so people think a bit more top of mind.

So everything we do there is interactivity with labs, with dermatopathologist, with reference labs and so it's pretty encompassing and every fraction 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 side of diagnosis. So what aides us as well is the fact that we have a CD123 directed therapeutic in ELZONRIS. That alone spans more interest in assessing for CD123.

So we're really still at the early stages of this. And to go more specifically to one of the points you made is, is how do we interact with EMRs and how do we get alerts and how do we proactively find a patient that may have BPDCN because perhaps we get alert that CD123, for 156 [Phonetic] show positive in an alert system and we can mobilize a team to go there to help with the diagnosis.

These are things that we're doing now. The team has done a, quite honestly, an exquisite job in putting the comprehensive programs together and answer this need, so they went into place this quarter. I just want to remind everybody that it is going to take some time to change the diagnostic behavior. Misdiagnosis has been going on for many, many years and we're doing our best to enact tactics and approaches that will change this behavior quickly, but it will take some time.

Matt Kaplan -- Ladenburg Thalmann. -- Analyst

Okay, that's helpful. And I guess a question for, Ivan. Thank you for the detail on the CMML study. Can you give us some more detail with respect to the dosing regimen in CMML and how we should think about that as an indication? Is that indication similar to BPDCN, where patients are driven to transplant? Or is this an indication where patients will stand ELZONRIS potentially longer periods to come [Phonetic].

Ivan Bergstein -- Chief Executive Officer and President

Yes, sure. So the regimen is slightly less dose intense. Its the same dose that being 12 micrograms per kilogram per day. But rather than five days in a row that we use in the BPDCN, it's three days and the cycle frequency is a little bit lighter than it is in BPDCN. BPDCN is a very, very aggressive disease, where skin lesions can kind of grow in front of your eyes from day to day and then CMML is a little bit more indolent.

So we've decided to give it a slightly less dose intense regimen. And actually, we believe the safety profile has been stellar in CMML and 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. In terms of getting patients to transplant, historically it's been very, very difficult to get CMML patients the transplant. That is -- that has been the therapeutic goal. But the problem is many CMML patients, who are middle age to elderly have lot of comorbid situations and it's just been very, very difficult to get those types of patients to transplant.

We obviously -- we've had one which was bridge to transplant and that was a great outcome. And certainly, that would be an outcome we would be very, very happy with. Alternatively, this therapy can be given a long-term, as you know, we had one or two patients in the clinical trial going out, passed a year and a half, I think, there was one patient out three years. So, certainly, either outcome is possible. I think it will largely be patient dependent, how old is the patient, how sick is the patient, performance status, are they transplant candidate, etc, but time will tell and if they are first-line versus relapsed refractory, obviously, is a major factor as well.

Matt Kaplan -- Ladenburg Thalmann. -- Analyst

Okay, great. Thank you. And then one more question on CMML. Do you think this study could also suffice for approval in Europe? And then secondly, can you give us an update on your plans for myelofibrosis, MF?

Ivan Bergstein -- Chief Executive Officer and President

Yes, sure. Yes, our plan in CMML is to add -- we're adding sites now. There's a lot of interest from the last conference and now, we've met with a lot of CMML KOLs. We know virtually all of them. A lot of interest internationally. So, yes, we expect to add a couple of European site and we would look to file both in the US and Europe.

In myelofibrosis as folks continue to dig into the data, they get more excited. First of all, it's not another JAK inhibitor, it's completely novel mechanism of action, CD123. Again, as people dig into the data and we kind of did a deep data for ASH filing and loan behold is accepted for an oral presentation, as there are lot of stiff competition there. And Robert has an experience in myelofibrosis as well. So we feel that it is well within our comfort zone in this disease. What we like about is, we're seeing activity in the spleen, which is kind of a gold standard endpoint that the FDA makes decisions around. So we're seeing activity where you would want to see activity. We feel like there is a lot of optionality here. There's the relapsed refractory population as a whole. But as we are expanding the studying, and expanding 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 JAK inhibitors often have to be dose reduced, the reason withheld in the setting of thrombocytopenia, which is a potential entry point for us, because we have had some good success with patients who are thrombocytopenic and we have not had a dose, where we hold doses or lower our dose. So I think that's one area of interest we're going to pursue over the next year.

The other is, we're learning that there is a subset of myelofibrosis patients that have over elevated monocytes. This is very interesting, because CMML is a disease of high monocytes. So we know our drug is very active in CMML. Here we have a kind of a subset of MF that looks a lot like CMML with these high monocytes. The monocytes and CMML are CD123 positive. The other thing is that, this is -- those patients appear to have a particularly poor prognosis in MF and other drugs don't work -- don't seem to work particularly well, so that opens up the potential novel regulatory path coupled with scientific rationale.

So that one where we have our eyes on and then we've seen interesting activity in that sub population. We want to continue to double down and look at how the drug fares in that population, because that might open a novel pathway as well. We're also in our MF study moving forward, and CMML and AML, all of our studies, while we plan to introduce a validated CD123 assay that we're working on with vendors, which will be very helpful to kind of nail down -- with CD123 enrichment, the another pathway and we look at that and really all of our disease moving forward.

There may be subsets of MF patients or CMML or AML that are high CD123, that are particularly sensitive to drug and that would be great. We'd open up a pathway there. And all these studies really have a dual purposes. They're indication specific, but also the more data we can gather for the drug being active in CD123 high patients for multiple indications, the more are case for our target based label is there. So these studies all have that dual purpose.

Matt Kaplan -- Ladenburg Thalmann. -- Analyst

Great, thanks a lot, Ivan and congrats on the progress.

Ivan Bergstein -- Chief Executive Officer and President

Yes, thanks.

Operator

[Operator Instructions] Our next question comes from Joe Catanzaro from Piper Jaffray.

Charles Frantzreb -- Piper Jaffray -- Analyst

Hi. Good morning. This is Charles, on for Joe. Thank you for taking my questions. I just wanted to ask if you could provide any commentary on the weighting of patient starts throughout the quarter, given that some patients were drawn into you Q2, because of the July 4 holiday, where patient starts therefore more weighted toward the end of the quarter? And my second question was about commercialization in the EU and whether you could provide a bit more detail there on this filing status with the EMA, what the next steps are and whether or not you would be prepared to commercialize on your own in the EU. Thank you.

Ivan Bergstein -- Chief Executive Officer and President

Yes, I think, it's fair to say that the patient starts were more initiated in the second half of the quarter. As it relates to the European Union commercialization, where we are poised to commercialize that we have the -- we fully have the capability and knowledge to go there and do this. We have a small team on the ground right now, that has been working tirelessly to prepare the market and prelaunch initiatives to ensure that if an approval does come in mid 2020 that we are ready to capitalize on the approval.

That said, a lot of the work is preparing medical marketing and payer aspects to the launch. What's critically important to us of course is in those key markets, in the EU4 and EU5 is substantially securing good price points and good reimbursements. I will tell you that from where I sit right now, we -- I'm very happy with the progress I see for the European market. So at this point, things are on track from where we sit. We remain very confident what that opportunity is. And I'll remind you that 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 -- our data shows that there is probably a similar incident rate of BPDCN per 100,000 patients, so more people. So, yes, so those activities continue to go. We're judicious in how we go there, but we are poised for success.

Operator

Our next question comes from Yi Chen with H.C. Wainwright.

Edward Marks -- H.C. Wainwright -- Analyst

Good morning. This is Edward Marks on for Yi. I appreciate you taking the questions. Just two quick clarifying ones for me. It's sort of elaborating on that previous question. Just wondering if -- apologize if I missed this earlier, when do you expect to start generating revenues in the EU? Would that then be in 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 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.

Ivan Bergstein -- Chief Executive Officer and President

Yes, so from a revenue perspective, I'll just remind everybody that obviously there is many different markets within the European market. So if we were to get an approval sometime in the mid of 2020, reimbursement for commercialized products takes place at varying rates traditionally and I'll speak in just very generalities here is, typically you'd see Germany come on first with the quicker reimbursement mechanisms, then maybe, France, Italy, Spain, and we have a very specific launch sequence that we are adhering to which maintains pricing integrity of the asset as well as going into markets that have very friendly reimbursement environment. So when the revenue comes, I will tell you, automatically you have France and Germany are free pricing markets that generally you'll start to see more revenue sooner rather than later.

So at this point, I think what our launch would demonstrate was that we probably take on a traditional launch sequence in the European Union, likely with Germany coming on first, probably France second and then that's pretty typical for this space. So once again, what I would like to caveat there is that, if we were to get approval in, say, June of 2020, that doesn't mean that we have immediate reimbursement throughout the land there. It's going to come on country by country. So that hopefully answers your first question.

As far as the treatment cycles, yes, you know what, I think we want to be able to give as much direction to all of you folks as we can standby. And so, if there is anything we've seen over the last nine or 10 months is that we are 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 we're going to try to stay on wholeheartedly. I would like to be able to give you more, so that you can execute your jobs the way you need to do that. So as it becomes more reliable, we'll certainly take the decision to see what we can release.

Edward Marks -- H.C. Wainwright -- Analyst

That would certainly be appreciated. Alright, that's all from me. Thank you for taking the questions.

Ivan Bergstein -- Chief Executive Officer and President

Thanks.

Operator

Thank you. And this concludes today's question-and-answer session. I will now turn the conference back over to Mr. Ivan Bergstein.

Ivan Bergstein -- Chief Executive Officer and President

Thank you, operator. Here at Stemline, we are driven by our mission to help improve the lives of patients with cancer. I would like to take this opportunity to thank all of the patients, physicians, healthcare professionals and all of the outstanding employees at Stemline for their dedication and passion in making a difference in patient lives. Thank you all for joining us on the call this morning.

Operator

[Operator Closing Remarks]

Duration: 40 minutes

Call participants:

Ken Hoberman -- Chief Operating Officer

Ivan Bergstein -- Chief Executive Officer and President

Robert M. Francomano -- Senior Vice President and Global Head of Commercial

David Gionco -- Vice President of Finance and Chief Accounting Officer

Jessica Fye -- JPMorgan -- Analyst

Boris Peaker -- Cowen -- Analyst

Matt Kaplan -- Ladenburg Thalmann. -- Analyst

Charles Frantzreb -- Piper Jaffray -- Analyst

Edward Marks -- H.C. Wainwright -- Analyst

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