Dova Pharmaceuticals (DOVA) CEO Alex Sapir on Q3 2018 Results - Earnings Call Transcript

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About: Dova Pharmaceuticals (DOVA)
by: SA Transcripts

Dova Pharmaceuticals (NASDAQ:DOVA) Q3 2018 Earnings Conference Call November 8, 2018 5:00 PM ET

Executives

Alex Sapir - President and CEO

Mark Hahn - CFO

Lee Allen - Chief Medical Officer

Kevin Laliberte - SVP, Product Development

Analysts

Anupam Rama - JP Morgan

Umer Raffat - Evercore

Eun Yang - Jefferies

Geoffrey Porges - Leerink

Laura Chico - Raymond James

Matthew Kaplan - Ladenburg Thalmann

Operator

Good afternoon and welcome to Dova Pharmaceutical's Third Quarter 2018 Financial Results and Operating Highlights Conference Call. All lines have been placed on mute to prevent any background noise. Following the speakers' remarks, there will be a Q&A session.

Before I begin, I would like to remind you that during today's call, statements about the company's future expectations, plans and prospects, constitute forward-looking statements for purposes of 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 the Risk Factors session of the company's quarterly report on Form 10-Q for the quarter ended September 30, 2018, which can be accessed on the EDGAR database at www.sec.gov, and the other filings that the company makes with the SEC from time-to-time.

In addition, any forward-looking statements represents the speakers views only, as of today, and should not be relied upon as representing the speakers' or the company's views as of any subsequent date.

While the company may elect to update these forward-looking statements at some future point, the company specifically disclaims any obligation to do so, even if the company's views change. These forward-looking statements should not be relied upon as representing the company's views, as of any dates subsequent to today. Please be advised that today's call is being recorded and webcasted.

I would now like to turn the call over to Alex Sapir, Dova's President and CEO. Alex, you may begin your call.

Alex Sapir

Thanks Danielle, and thanks to all of you on the line for joining us for our Q3 earnings call. Joining me on the call this afternoon are Mark Hahn, our Chief Financial Officer; Dr. Lee Allen, our Chief Medical Officer; and Kevin Laliberte, our Senior Vice President of Clinical and Product Development. I will begin with an update on our ongoing launch efforts for DOPTELET. I will then spend some time updating you on our progress to expand the indications for DOPTELET, specifically chronic immune thrombocytopenia or ITP, for which our supplemental new drug application was recently accepted for filing.

In addition, I will also discuss our Phase 3 chemotherapy induced thrombocytopenia program or CIT for short, which remains on track for a mid-2020 data readout. I will then turn the call over to Mark to review the company's quarterly financial performance and after that we’ll open up the call for questions.

So after an important second quarter highlighted by the launch of DOPTELET we continue to see our progress on both the commercial side of our business as well as our pipeline. Before I get into the DOPTELET launch metrics, I would like to briefly discuss the exclusive copromotion agreement with Salix Pharmaceuticals that we finalized at the end of September.

For many of you who know Salix, they are one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. Under this agreement, Dova and Salix will co-promote DOPTELET in the United States. DOPTELET has deployed approximately 100 sales representatives and they promote DOPTELET to gastroenterology healthcare professionals in the United States.

In return, we will pay Salix a quarterly fee based on net sales to gastroenterologists that they call on. The Salix sales force began selling DOPTELET on October 15 and we are pleased with the initial traction Salix is making in the GI community though as we previously stated it will take a couple of quarters to see the full effect of that partnership.

Mark will be providing the specifics on our five key launch metrics that we provide every quarter, but before doing so I would like to summarize some of the overarching themes and updates regarding the launch to date.

Firstly, DOPTELET is benefiting patients similar to what we saw in our Phase 3 trials. Patients receiving DOPTELET in the commercial setting are experiencing increases in platelet count, essentially a doubling, which was similar to what we saw in our Phase 3 studies. We believe this further validates DOPTELET as the new standard of care for the treatment of thrombocytopenia in adult patients with chronic liver disease scheduled to undergo a procedure.

And while changing the standard of care takes time and doesn't happen overnight we believe that transformative drugs like DOPTELET can accelerate that adoption curve. Secondarily, we are happy with the number of new and repeat prescribers and we received very positive feedback on our full array of patient assistance programs, especially our Dova [on time 30 program], which provides product when there is either a significant delay with the payer approving the drug or the payer denies coverage. And though this program impacts net revenues, it provides a positive experience for both the patient and the physician.

In addition to the number of unique prescribers that we have seen to the end of September that Mark will share with you, we are also happy with the rate at which the number of new prescribers continues to rise in the early days of Q4. Thirdly, we have modified our shipping strategy in the quarter to reduce the amount of time DOPTELET remains an inventory at the specialty pharmacy after approval by the payer.

We no longer require procedure date before shipping out drug and will now ship the drug upon approval from that payer. And finally we are pleased with the job our sales and marketing teams have done to date targeting both hepatologists and gastroenterologists. Gastroenterologists, especially those that treat a large number of chronic liver disease patients continue to be early adopters of the product and as of September 30 represent over 40% of our unique prescribers.

As I have spoken about in the past, we are finding the liver transplant centers to be a bit slower to adopt DOPTELET and to address that slower adoption that we have seen in some of these major liver transplant centers, we are starting to ship DOPTELET to the outpatient specialty pharmacies within these liver transplant centers. We believe having this type of access to the drug along with increased familiarity of DOPTELET will help this segment of the market adopt more broadly.

Now Mark will discuss launch metrics in a moment, but before we talk about that I want to share a couple of key updates with you. Beyond the launch efforts we made significant progress towards gaining approval for DOPTELET in new geographies and new indications. We filed a marketing authorization application with the European Medicines Agency in April for DOPTELET for the currently approved indication and the EMA has granted a standard review assessment for this application with a targeted recommended approval date of June 2019.

Another key regulatory milestone for Dova was the FDA accepting for review our sNDA for DOPTELET for the treatment of chronic immune thrombocytopenia, or ITP. Now for those of you who may not be familiar with ITP, is it is an autoimmune bleeding disorder characterized by thrombocytopenia, which is abnormally low platelet counts.

Chronic ITP affects approximately 60,000 adults in the United States, and despite the currently available therapies, which include two other thrombopoietin receptor agonists, it remains an important unmet need. Our ITP sNDA supported by safety and efficacy data from one pivotal, randomized placebo-controlled Phase 3 trial and two Phase 2 clinical trials in the targeted indication that met its primary and secondary endpoint with high statistical significance.

Acceptance of this NDA – sNDA filing for review is another significant milestone for Dova and an important step towards addressing this underserved and expanding the applications for DOPTELET as a treatment for thrombocytopenia. The PDUFA goal date for an FDA decision is June 30, 2019 and we look forward to working closely with FDA as they review this supplemental new drug application.

Now moving on to chemotherapy induced thrombocytopenia, or CIT, we continue to make progress in our Phase 3 randomized, double blind placebo controlled trial that will evaluate the efficacy and safety of DOPTELET in subjects with active non-hematological tumors, who develop CIT. As a quick reminder, CIT is a common complication in cancer patients undergoing chemotherapy for the treatment of various solid tumors and can occur in up to 70% of patients.

With approximately 125,000 platelet transfusions administered every year for cancer patients who develop CIT, we believe this market represents a significant market expansion opportunity for DOPTELET. We expect to unblind the Phase 3 trial and announce trial results mid-2020. So as you can see, Dova has the potential to address the large untouched global market for both CLD as well as several exciting expansion indications.

So with that overview let me now turn the call over to Mark to review the launch metrics and present a financial overview for the quarter. Mark?

Mark Hahn

Thank you, Alex and good afternoon everyone. For the third quarter of 2018, Dova reported net product sales of $2.9 million. As a reminder, we recognize revenue using the sell-in methodology when products are delivered to our specialty pharmacy partners.

Now let me spend a few minutes talking about the drivers of that revenue. Through September 30, we were in the field selling DOPTELET for nearly 4 months. We are pleased to announce that over those four months a total of 335 healthcare professionals have prescribed DOPTELET for their patients with an increasing number using DOPTELET for multiple patients within their practice.

We have seen more prescriptions come from the GI community than we initially anticipated and we expect GI adoption will continue to increase as Salix’s sales team gains traction.

In the third quarter, for the prescriptions that have gone through the adjudication process with payers, 81% of those prescriptions have been approved by the payer similar to the level we saw last quarter with an average approval rate of 7.9 days.

Moving on, our sales force continues to make progress in our outreach efforts to prescribers. At this point, they have reached approximately 67% of target prescribers from launch to September 30 and on average have contacted them 2.8 times. And lastly, since this is the second quarter of DOPTELET results we can now provide channel inventory levels quarter-over-quarter.

Those channel inventory levels increased approximately 65% from June 30 to September 30 as we saw certain specialty pharmacies adjust their inventory levels and stocking locations based on increased patient shipments.

For the other financial metrics, cost of sales for the quarter were $0.4 million, which consisted of the cost of inventory, royalty payments to Astellas and certain distribution and overhead costs.

R&D expenses were $4.8 million in the third quarter of 2018, compared with $5.4 million for the third quarter of 2017. The decrease was largely driven by the $1 million milestone payment that we became obligated to pay Astellas upon the submission of the NDA on the completion of the clinical trials in 2017, partially offset by initiation of clinical trials to evaluate DOPTELET for the treatment of a broader population of PST patients, as well as for CIT.

SG&A expenses were $17 million for the third quarter of 2018 compared to $4.2 million for the same period in 2017. The increase was primarily driven by the increased level of headcount and sales and marketing activities, as well as the increased corporate infrastructure to support the commercial launch of DOPTELET.

We had a net loss of $19.5 million for the quarter, compared with a loss of $9.7 million for the third quarter of 2017. As of September 30, 2018, Dova had $122 million in cash and equivalents compared to $94.8 million as of December 31. This increase was primarily due to the completion of our secondary offering in February, as partially offset by a net operating loss and the repayment of the Eisai note and its partial refinance.

And now, I’ll turn the call back to Alex.

Alex Sapir

Thanks Mark. So with that business and financial overview, I’d now like to open up the line for questions. Danielle, can you please open up the line please?

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] Our first question comes from Anupam Rama from JP Morgan. Your line is now open. Please go ahead.

Anupam Rama

Hi guys. Thanks for taking the question and congrats on all the progress. We know that [Ava] here is approved acute indication of CLD, but with the chronic ITP indication potentially on the horizon mid next year, just wondering how we should think about [Ava] pricing long-term? Thank you so much.

Alex Sapir

Anupam. This is Alex. Great question. I appreciate you jumping on the line. Yes, so a couple of metrics to talk about. So as everyone on the call knows, our price for the acute treatment is approximately $9,500 for the 40 mg and $14,000 for the 60 mg. As we move into chronic dosing what we will ensure the same way that we are ensuring in our current market that we are not in any way sort of disadvantaged from a payer standpoint because of our price.

We will make sure that when we move into ITP that we will be priced competitively with the other TPO receptor agonist, all of which are in kind of $100,000 to $115,000 per patient per year. So we are looking at a number of sort of mechanisms by way of doing that, primarily through some type of rebate or contracting strategy that we would provide to the payers potentially on a quarterly basis.

But I think rest assured what we will make sure is that the same way that we are not going to make sure that we are unfairly disadvantaged from a payer standpoint because of any price differential in the acute segment, we will also make sure that we are not unfairly disadvantaged in the chronic segment. So our intent is to really try to price it competitively with the other TPO receptor agonists, which are priced at about $100,000 and [indiscernible] which is priced at around $114,000 per year.

Anupam Rama

Great. Thank you so much for taking the question.

Alex Sapir

Thanks Anupam.

Operator

Thank you, and our next question comes from Umer Raffat from Evercore. Your line is now open. Please go ahead.

Umer Raffat

Hi. Thank you so much for taking my questions. I just wanted to drill down the $2.9 million reported sales, maybe in two parts if I may, so first, what I just want to understand is the inventory. So perhaps if you could give us insights into how much of the $2.9 million was inventory this quarter, and how much sort of exactly the number of the $2 million in 2Q was inventory, and I have a follow-up?

Mark Hahn

Okay. So this is Mark. I will take that one. So I think I have said on the earnings call for last quarter that because we had just launched on June 4th that the vast majority of the $2 million should be considered to be in the channel. Certainly not all of it was in there. And while we don't give detailed information on how much of our sales this quarter were for inventory build, I will say that there was a 65% increase in the inventory. So you can kind of do some basic math there, but later I should give you a little additional color on, what we saw happen with respect to a couple of the specialty pharmacies expanded the number of locations where they were stocking drug.

They had been pretty tightly controlled at the end of Q2, and as they saw their volume increase and they expanded the number of locations and then some of them also in addition to opening new locations just held more at each location as they saw their own individual volumes throughout their SP growing. But go ahead with your follow-up.

Umer Raffat

Sure. Mark, so just to be clear, if let us say one out of the 2 million last quarter was inventory, so with the 65% increase that would imply perhaps at least a quarter – something close to a quarter of this current quarter is inventory, am I on the right track?

Mark Hahn

I think that is the right math.

Umer Raffat

Okay. So the follow-up was this then, it seems like at least 187 new doctors wrote a prescription since the last update, you provided, so if each of them only wrote one prescription that seems like about something close to $1.7 million in sales those guys should have produced, and perhaps close to $0.5 million if a third of those 148 doctors as of August 8. So my point is when we add some of this up, it looks like if everyone just wrote one prescription, $2.2 million worth of sales should have come from the prescribers alone, so what I'm trying to get at is, is there free drug in the channel and/or some other dynamic that we should be aware of? We're just trying to do some basic math on the number of prescribers you guys have closed?

Mark Hahn

So let me take that and maybe Alex wants to add on a little color as well. So yes, there were some free goods in the numbers. Of course it is the early days of launch and we fully expected that. But I think also the number that you used was $9,000 per prescription, which I guess [indiscernible] I come up with a balance between the 9,000 and the 14,000 and some sort of gross to net discount. And I think your gross to net discount needs to be a little bit higher, in order to accommodate all those numbers.

I'm sorry?

Umer Raffat

About 25% or so?

Mark Hahn

So the total gross to net is more than 25%. I think we have talked about all the components of the gross to net, but if you apply that to the average price, I think the average price if you did a 50-50 split is like a 11,000 in change.

Umer Raffat

Sure. Got it. Okay. Thank you very much. Alex, unless you wanted to add something thank you very much for that Mark.

Alex Sapir

No. That was it. Thanks Umer.

Umer Raffat

You can call me Anupam.

Alex Sapir

I have been called worse.

Operator

Thank you and our next question comes from Eun Yang from Jefferies. Your line is now open. Please go ahead.

Eun Yang

Thank you. It is a follow up on the prior question, so Mark do you expect that the inventory level to continue to increase or do you think third quarter level is kind of a stabilized state?

Mark Hahn

That is a great question Eun. So I think the way I would answer that is that we have to look – if I think about it and I look at it on a SP by – or a specialty pharmacy by specialty pharmacy basis there maybe some what I would call rightsizing of inventory. And so we saw that in a couple of those SPs, where they increase the inventory. I think for the – if we see volumes dramatically increase and might continue their increase but I think if we see volume just kind of gradually increasing over time, that their inventories would be fairly flat, maybe a slight increase.

Eun Yang

Okay, and was there kind of a little bit – was there a change in gross to net discount in the third quarter versus the second quarter?

Mark Hahn

Yes, there was. It increased just very slightly.

Eun Yang

Okay. And then have you seen any activity or impact changes to the uplift from the Mulpleta launch?

Alex Sapir

Yes. Eun, this is Alex. That is a great question. So, the latest intel that we have heard is that the Mulpleta, the Shionogi sales force will not begin selling Mulpleta until December 3 of this year. So we will essentially have a six-month head start over them. So because they have not really been out yet in full force, we have not seen to date any impact of Mulpleta being available having any impact on our launch trajectory.

Eun Yang

Okay thanks, and I have a last question, so PDUFA date is set for June 30 for the ITP indication, but in the past you kind of guided that even though it is an sNDA, the review time from the submission will be about 12 months. But it is kind of a short-term, so was there some discussion with the FDA to expedite the review process?

Alex Sapir

Eun, great question. I think to answer that I will turn that over to Dr. Lee Allen, our Chief Medical Officer to address.

Lee Allen

Yes. I think we have always said it would be a standard review clock. For the supplemental NDA, they don't put in a two month window of time additionally as they do for an NDA. So an NDA although it is “a ten-month review” it actually takes 12 months. For an sNDA it takes 10 months. So this is a standard sNDA review period.

Eun Yang

Okay. Thanks very much.

Alex Sapir

Thank you.

Mark Hahn

Thank you.

Operator

Thank you and our next question comes from Geoffrey Porges from Leerink. Your line is now open. Please go ahead. Geoffrey, please check your mute button.

Geoffrey Porges

Thanks very much. Alex and Mark I think we are all triangulating to sort of 250 to 300 patients treated given your commentary about gross to net in the quarter, and I'm just wondering, if you see anything in front of you that is going to trigger a significant inflection in that treated patient number? Are there a lot of patients who are being treated with free drug in addition to that 250 to 300, or are there major changes in reimbursement access that would trigger it, or is the inflection really just adding the Salix support into the GE offices? Thanks.

Alex Sapir

Yes, Jeff this is Alex. That is a great question. So I think there is a number of demand inflection points. I think obviously the first one that you hit on is the Salix team. So they have now been out in the field for approximately three weeks. As I mentioned during the prepared remarks we are already starting to see some impact of their efforts. We are now seeing gastroenterologists that have never written before that the Dova team has never called on. We're starting to see some of those coming now.

Obviously as we mentioned before that it will take a little time to see sort of the full impact of the extra 100 people. But we are obviously starting to see some early signs of that progress.

I think the other thing that we are obviously starting to do with some of these liver transplant centers is ensuring a couple of things. Ensuring that there are sort of protocols in place so that DOPTELET is now really the new sort of standard of care, and it is really replacing platelet transfusions on those protocols, and then in addition to that for those major liver transplant centers that are interested, we are stocking the drug directly in their specialty pharmacies. I think some of those large liver transplants centers have expressed a great interest to make sure that the drug is available for them at their local liver transplant center, specialty pharmacy. So I would think those are two major areas that is driving demand.

I think and obviously the other one that is continuing to drive demand as well is obviously the 70 people that we currently have – that we currently have in the market. I think what we are also doing is we are obviously making sure that we have trying to get the number of shipments that go out and are paid, where we are trying to get that number is as high as possible. As Mark mentioned, we have had to use the DOVA ONTIME30 program so that physicians aren't encumbered by any sort of payer restrictions or payer access that results in them having to delay or even cancel a procedure.

But I think what we are starting to see as well is the number of paid shipments as a percent of total shipments is also starting to – we are also starting to see an increase in that over the last sort of five months. So Mark, I don’t know – you have anything to add to that?

Mark Hahn

I think you have covered it.

Alex Sapir

Okay.

Geoffrey Porges

Great, thanks Mark.

Operator

Thank you and our next question comes from Laura Chico from Raymond James. Your line is now open. Please go ahead.

Laura Chico

Good afternoon guys. Thanks for taking the question. I just kind of wanted to follow up on one comment you made there Alex, have you talked about what proportion of the prescribers are actually utilizing the DOVA ONTIME30 program and I guess how should we be thinking about that going forward? Would this be increasing as we get more providers writing prescriptions?

Alex Sapir

Yes, it is a great question Laura. We haven't disclosed specifically the number of shipments that have gone out that have utilized the DOVA ONTIME30 program. What I will tell you is that we have been generous with the DOVA ONTIME30 program really to ensure that physicians when they have that first experience don't get frustrated by any sort of payer delays, and so we have been overly generous with that program. Then the only other thing that I mentioned in the answer that I gave to Jeff, over time what we have seen is the number of shipments that are going out – the number of paid shipments as a percent of the total shipments have been going up and some of that has to do with the fact that we are not having to use the DOVA ONTIME30 program as readily as we had to during the couple of months of launch.

Laura Chico

Okay, got it. And then I guess, as we are trying to think about pricing and the gross to net going forward, I noticed you did take the 5% price increase heading into 4Q, so again a little bit more color if you might be able to help us in terms of how we should be thinking about what is an appropriate gross to net here at least over the next perhaps 12 months?

Alex Sapir

Sure. Maybe I will talk a little bit about your question about the price increase and then turn it over to Mark in terms of – for a little bit of color on the gross to net. So as you had mentioned we did take a price increase, and our plan obviously is to take modest price increases and what you sort of saw was the execution of that plan. In today's climate we do not intend to take aggressive price increases, but rather more modest price increases like you mentioned. I think what is also really important to understand is that the way that we priced our drug is to be similar to the total cost of a platelet transfusion, which can range anywhere from $5,000 up to a high as $13,000 depending upon the complications that are associated with that transfusion.

I think what we are most sort of pleased about is that the price for the drug has not impeded the approval on the part of the payers, and that is obviously one of the metrics that we have disclosed over the last few quarters, and we will continue to disclose in terms of the 81% of the referrals that have made their way through the payer adjudication process have been getting approved. Mark do you want to add any color on the – anything you can offer on the gross to net moving forward?

Mark Hahn

Sure. I think if we go back and think about some of the commentary we have given on gross to nets in the past, when you start adding together the channel costs and our policy of not denying low income folks access to DOPTELET, and then you lay on top of that some of the payer related cost, such as the co-pay assistance programs that we have in the standard Medicaid and Medicare rebates, which you have to give. I think most people have kind of honed in on a gross to net range of mid-30s to around 40% may be low 40%, and I would say right now, we are kind of at the higher end of that range, and the expectation should be over the next couple of quarters that should start to whittle down to the middle to low end of that range.

Laura Chico

Got it. Thanks Mark. Thanks Alex.

Alex Sapir

Thank you.

Operator

[Operator Instructions] Our next question comes from Matthew Kaplan from Ladenburg. Your line is now open. Please go ahead.

Unidentified Analyst

Thank you for taking the question. This is Maria for Matt. Can you hear me?

Alex Sapir

We can Maria.

Unidentified Analyst

Okay. So my first question is about the pre-surgery study, I was wondering if you could elaborate on the patient population for that study. I think when it was first designed you were not planning on including the CLD patients and then you said maybe, and then with the [label] I guess was not necessary, so there are two studies in clinical trials, one the Phase 3 and then Phase 4 with CLD patients, so can you elaborate a little bit on those two studies?

Alex Sapir

Absolutely Maria, and to answer that question let me turn that one over to Kevin, who is our Head of Clinical Development, who is actually leading that study. Kevin?

Kevin Laliberte

Thanks for the question. So just to provide some additional information on the pre-surgery study, we did start the study in the first quarter of this year, not including chronic liver disease patients. We subsequently amended that protocol to include chronic liver disease patients focusing in on a baseline platelet count between 50,000 and 100,000. So we are currently enrolling patients in that trial both with and without chronic liver disease. And those procedures as we have talked about previously are the more invasive surgical procedures, the neurosurgeries, the orthopedic surgeries etcetera.

We do have a separate study ongoing, a Phase 4 study, it is post-marketing registry study for the branded product DOPTELET in patients that are receiving the product commercially. In that study we are evaluating just real world use of DOPTELET and trying to gather additional safety, efficacy as well as patient information on those patients that are receiving the product commercially. So they are two separate initiatives. The pre-surgery study can include patients with and without chronic liver disease, whereas the Phase 4 registry study only includes patients with chronic liver disease that are prescribed DOPTELET as their normal course of treatment.

Unidentified Analyst

Okay. So then the Phase 4, is it CLD registry study that you mentioned in the press release?

Alex Sapir

Yes, that is correct.

Unidentified Analyst

And then I have a second question about trying to understand the 40% of gastroenterologists, so just trying to understand the number without having the sales force targeting them at this point. So do you think the reason is because of what we learnt on the Investors Day these gastroenterologists are treating mostly outpatients and they see that as an advantage treating these patients, or where they part of the ADAPT studies, why the 40% without the sales force targeting them?

Alex Sapir

Maria, it's a great question. This is Alex. I can take a stab at that. So I think that at launch our primary focus was really the hepatologists. I would say that we were not excluding the gastroenterologists, and so we were calling on gastroenterologists during the launch. I think what we were seeing was that those – that segment of the market was adopting more rapidly than what we were anticipating and that is really I think the main rationale for why we did the partnership with Salix.

We know that there is about 100 large GI group practices, an average number of gastroenterologists in those practices is probably about 50 or 60. So you have about 5000 or 6000 gastroenterologists sort of practicing in these large community gastro offices. With respect to your question about do they behave differently then maybe hepatologists at a liver transplant center, the question is absolutely. I think that these physicians are probably less inclined to use the transfusion when appropriate when compared to a hepatologist at a major liver transplant center that may have been more readily available.

I think what you need to remember is that for these large GI group practices they want to do as many procedures as possible over the course of a given day, and they obviously want to make sure that there is no complication that sort of interrupt that normal flow of those procedures throughout the day, and so I think that is really I think really the main rationale and the main impetus for why we are seeing such an interesting and an early uptake amongst those community gastros, and again really the rationale for why we decided to do the deal with Salix.

Unidentified Analyst

Thank you for taking the questions.

Alex Sapir

Thank you, Maria.

Operator

Thank you. We do have a follow-up from Eun Yang from Jefferies. Your line is now open. Please go ahead.

Eun Yang

Thank you. So, the Phase 3 trial for CIT, Alex I think I heard you saying that data is mid-2020, but previously you have guided as second-quarter 2020, so are you seeing some change difference in the patient enrollment than you previously anticipated?

Alex Sapir

Eun, it is a great question again. I think to answer that I will turn that one over to Kevin in addition to running the pre-surgery thrombocytopenia study and the registry study, Kevin is also leading our CIT study. So Kevin do you want to address that?

Kevin Laliberte

Sure. So, Eun, really nothing has changed for the chemotherapy induced thrombocytopenia study. I think we have maybe just not used the exact same terminology when we refer to when we anticipate data availability to be. But we remain on track for getting sites up and running, enrolling patients and anticipate in that second-quarter mid-2020 range that we would have a data availability. Of course, it is the end of third quarter 2018. So if anything dramatically changes both in the positive direction or in the negative direction we would obviously provide updates on further calls, but as we stand here today we haven't changed our path on that chemotherapy induced thrombocytopenia study and when data availability may occur.

Eun Yang

Okay. Thanks very much.

Operator

I'm showing no further questions in queue. I would like to turn the call back to Alex Sapir for further remarks.

Alex Sapir

Thanks Danielle, and again thanks everybody for joining us on the call today. We look forward to seeing many of you at one of the fall investor conferences that we plan to attend over the next several weeks, and we look forward to keeping you apprised of our commercial, regulatory and clinical progress. Daniel you may end the call.

Operator

Thank you. Ladies and gentlemen thank you for participating in today's conference. This does conclude the program. You may all disconnect. Everyone have a great day.