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Dova Pharmaceuticals, Inc. (DOVA)
Q4Â 2018 Earnings Conference Call
March 05, 2019, 9:00 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
See all our earnings call transcripts.
Prepared Remarks:
Operator
Good afternoon and welcome to Dova Pharmaceutical's Fourth Quarter and Full Year 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 question-and-answer session.
Before we 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 factors -- in the Risk Factors section of the Company's Annual Report on Form 10-K for the year ended December 31, 2018, which can be accessed on the EDGAR database at www.sec.gov, and other filings that 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 date subsequent to today. Please be advised that today's conference call is being recorded and webcast.
I would now like to turn the call over to Dr. David Zaccardelli, Dova's President and CEO. David, you may begin your call.
David Zaccardelli -- President and Chief Executive Officer
Thank you, operator, and good morning, everyone. Thank you for joining us on the call today. Joining me this morning are Mark Hahn, our Chief Financial Officer; Dr. Lee Allen, our Chief Medical Officer; Dr. Kevin Laliberte, our Senior Vice President of Product Development; and Jason Hoitt, our Chief Commercial Officer.
Since I joined in mid-December, we have spent a considerable time doing an in-depth analysis of our commercial strategy for DOPTELET. First, I want to highlight that this analysis has only increased our confidence in DOPTELET its significant market opportunity across multiple indications and, more importantly, the value it provides to patients. While this analysis had less -- has led us to make some changes to our commercial operation, it also has reinforced my belief that Dova has the people, products and resources necessary to provide important treatments for patients.
In terms of today's call, I'll begin by providing an update to our commercial efforts for DOPTELET starting with some detail on recent changes that are intended to improve the trajectory of sales in the chronic liver disease or CLD market, then I'll discuss several key launch metrics for the fourth quarter. Finally, I'll provide an update on our development programs with potential additional indications for DOPTELET, most notably our chronic immune thrombocytopenia or ITP program for which our supplemental new drug application is currently under review by the FDA, and our chemotherapy-induced thrombocytopenia or CIT program, which continues to progress in its ongoing Phase 3 clinical study. I will then turn the call over to Mark to review the Company's quarterly financial performance, and after that we'll open the call up for questions. With that introduction now complete, let's get started.
As I mentioned, since December, we have focused on reevaluating our commercial operations, including sales, marketing and market access. As a reminder, Jason Hoitt joined over as Chief Commercial Officer at the same time I joined, and Jason has been instrumental in this analysis. While the analysis increased our confidence in DOPTELET and its commercial potential, the evaluation did lead us to make some significant changes to our DOPTELET commercial plan for our initial indication in CLD. First, in early January, we restructured our US sales team primarily to minimize redundancy in call points, and better align with our co-promotion partner Salix. The Dova sales team was reduced to 44 sales representatives and five regional directors. We have passed the steam to be accountable for driving DOPTELET adoption in the key market segments of hepatology, including some GI that treat primarily liver disease, hematology and interventional radiology.
Our co-promotion partner Salix has responsibility for growing DOPTELET in the GI, colorectal surgery and proctology practices. And as a reminder, under our co-promotion agreement, which was established in late Q3 2018, Salix is deploying approximately 100 sales specialists who are promoting DOPTELET as one of two products in the(ph)call point . In return, we take Salix a quarterly fee based on net sales related to prescriptions written by their target positions. While this redeployment has only been in place for a relatively short time, we are pleased with the progress and initial results.
In parallel to these changes to the sales force, we have also initiated new marketing efforts for DOPTELET based on our learnings in the field since launch and customer insights, in addition to a new campaign which we will be modifying our product positioning in the market and the associated messaging. This work is actively in market research testing and we expect to roll it out early in the second quarter. We will share more details on our Q1 earnings call. In addition to Jason Hoitt, we have recently added critical hires to the commercial team. Jason Levine joined as Vice President of Marketing. He has over 25 years of industry experience across multiple therapeutic areas and comes to us from Gilead Sciences where he spent the last 13 years in a variety of commercial leadership roles. There he built out and led the HCV marketing function and was a key driver of the successful US launches of SOVALDI, HARVONI, and EPCLUSA.
Additional -- additionally, we are pleased(ph)Elia Glachar joined Dova as Head of US Sales. Elia comes to us from Gilead where he too held a variety of commercial leadership roles in sales and marketing. Elia was responsible for the promotional launch of Vemlidy in chronic hepatitis B and most recently was leading commercialization efforts for their NASH program in the US. We expect the results of these changes in sales force structure, the new marketing campaign and message and recent commercial leadership hires, along with our co-promote partners at Salix to continue to gain momentum in 2019.
I'll now move to our key metrics for DOPTELET launch in the fourth quarter, which includes total prescribers, sales engagement of healthcare providers, payer metrics and channel inventory. Through December 31st, DOPTELET has been promoted for nearly seven months. Over those seven months, a total of 694 healthcare professionals prescribed DOPTELET to their patients with an increasing number using DOPTELET both for multiple patients within their practice and repeat courses for the same patient undergoing multiple procedures. We are also pleased that prescribers more than doubled in the fourth quarter compared to the third quarter.
We have modified our assessment of sales engagement with healthcare providers and therefore going forward we'll provide metrics related to calls on unique providers as this represents the volume of educational impact that the team is having in the market and the breadth of their reach within the space. Regardless of any change in healthcare provider call list. In the fourth quarter, we conducted more than 21,000 calls with greater than 8,700 unique healthcare providers. For 2018 as a whole, we conducted approximately 39,000 calls with more than 12,000 unique healthcare providers. For prescriptions in the fourth quarter that have gone through the adjudication process with payers, 83% of those prescriptions have been approved, which is comparable to the third quarter, with a reduction in average time to payer decision to 6.3 business days. And lastly, for metrics, inventory held by specialty pharmacies decreased 34% during the fourth quarter, primarily driven by doubling of patient shipments in the fourth quarter compared to the third quarter of 2018.
Beyond our metrics, I would also like to highlight some key aspects of our commercial activities. First, in the fourth quarter, we executed a robust commercially driven HCP education efforts that included over 125 speaker programs with KOL presenters that reached more than 1,150 unique attendees. We will continue to expand our educational activities throughout 2019, including this critical element of peer-to-peer education. Our medical affairs team will continue to actively engage healthcare professionals and provide medical information via multiple venues, including one-on-one meeting, peer-reviewed publications, and presentations at key national and international congresses.
To summarize, we have made specific clear and measurable changes to our commercial team, sales plan, and marketing strategy to support Dova as we work to expand DOPTELET across multiple indications in 2019. Now, I'll move on to providing an update on our development programs for DOPTELET.
In terms of expanding DOPTELET into new markets, we have filed a marketing authorization application with the European Medicines Agency or EMA, for DOPTELET in the currently approved indication of CLD. The EMA has granted a standard review assessment for this application with an expected decision date in quarter three of 2019. We have received the 180-day question and continue to work toward resolution of outstanding questions to allow for a positive opinion by the EMA.
In terms of our product development efforts for additional indications of DOPTELET, as we have previously disclosed, the FDA has accepted our sNDA for review in the treatment of chronic immune thrombocytopenia or ITP, in patients who have had insufficient response to a previous treatment. This has a target PDUFA date of June 30th, 2018. As a reminder, ITP is an autoimmune bleeding disorder characterized by thrombocytopenia, an abnormally low platelet count. Chronic ITP affects approximately 60,000 adults in the United States and despite currently available therapies, which includes two other TPO receptor agonist that remains an important unmet for patients with ITP. Our sNDA for ITP is primarily supported by a pivotal randomized, placebo-controlled Phase 3 trial that met its primary and secondary efficacy endpoint with high statistical significance as well as safety and efficacy data from additional clinical trials. In aggregate, 128 patients with ITP received DOPTELET across all clinical trials. We continue to work collaboratively with the FDA as they progress the review of this sNDA.
Now moving on to the chemotherapy-induced thrombocytopenia indication, or CIT, we continue to make significant progress in our Phase 3 randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of DOPTELET in subjects with non-hematologic tumors -- chemotherapy who developed CIT. As a quick reminder, CIT is a known complication of cancer patients undergoing cytotoxic chemotherapy for the treatment of various solid tumors.
Interestingly, a recent publication from the peer-reviewed CMC cancer journal assessed the risks and consequences of CIT in clinical practice using healthcare claims databases. The publication indicated that patients experienced CIT during multiple cycles of chemotherapy with high incidents of CIT associated with gemcitabine and carboplatin-based regimen. With no approved drug therapies for CIT, current treatment includes administration of platelet transfusion, which approximately 125,000 transfusions administered every year or chemotherapy dose reduction or chemotherapy cycle delay, all of which may affect clinical outcome of the patient's cancer treatment.
As a result, we believe DOPTELET has the potential to fulfill an important unmet medical need for patients experiencing CIT and represents a significant market expansion opportunity for DOPTELET. The ongoing Phase 3 clinical trial with over 50 active international trial sites continues to enroll patients and we expect to complete enrollment and announce results for the primary and select secondary endpoints in the first half of 2020.
And finally, as part of our overall assessment of build a strategy and allocation of resources, we have made the decision to discontinue the presurgery thrombocytopenia or PST trial as well as the CLD registry trial as we remain focused on the broader development of DOPTELET for ITP and CIT indications.
With that overall review of DOPTELET commercial and product development status in Q4, I'll turn the call over to Mark, who will present the financial overview for the quarter. Mark?
Mark Hahn -- Chief Financial Officer
Thank you, Dave, and good morning, everyone. For the fourth quarter of 2018, Dova reported net product sales of $2.8 million. Net product sales for 2018 since launch were $7.7 million. As a reminder, we recognized revenue using the sell-in methodology when products are delivered to our specialty pharmacy partners. Cost of sales for the fourth quarter were $0.3 million, which consists of the cost of inventory, royalty payments to Astellas and certain distribution and overhead costs. R&D expenses were $5.5 million in the fourth quarter of 2018 compared with $2.7 million for the fourth quarter of 2017. The increase was primarily due to the initiation of clinical trials to evaluate DOPTELET for the treatment of PST and CIT in 2018.
SG&A expenses were $16.1 million in the fourth quarter of 2018 compared to $6.5 million for the same period in 2017. The increase was primarily driven by the increased level of headcount in sales and marketing activities as well as the increased corporate infrastructure to support the commercial launch of DOPTELET. We had a net loss of $19.3 million for the fourth quarter compared with a net loss of $9.3 million for the fourth quarter of 2017. As of December 31, 2018, Dova had $104.6 million in cash and equivalents compared to $94.8 million as of December 31st, 2017.
We remain focused on ensuring that Dova maintains a healthy cash position. As Dave mentioned earlier, we have reduced our sales force headcount and discontinued enrollment in the PST and registry studies, which have reduced our burn rate. Those changes, along with even modest increases in sales, should allow us to maintain substantial cash reserves. We expect to begin to see the impact of these efforts in Q2 of 2019. Finally, we are actively working to extend the interest-only period on our $20 million debt facility with Silicon Valley Bank, which would provide additional cash runway.
And now, I'll turn the call back to Dave.
David Zaccardelli -- President and Chief Executive Officer
Thanks, Mark. Before we open the line to questions, I just want to conclude by highlighting our key priorities. In 2019, we are focused on the buy and the buy following goals. Improving the sales trajectory of DOPTELET in the CLD indication, gaining FDA approval for DOPTELET in the ITP indication and executing a successful launch, progressing enrollment in the CIT trial to allow for top-line data in the first half of 2020, obtaining EMA approval of DOPTELET for the CLD indication, and controlling costs to maintain a strong balance sheet and spending focused on our key objectives.
With that, I'd like to open the line for questions. Operator?
Questions and Answers:
Operator
Thank you. (Operator Instructions) Our first question comes from the line of Eun Yang with Jefferies. Your line is open. Please go ahead.
Eun Yang -- Jefferies -- Analyst
Thank you. So, you today -- do you see further inventory drawdown or inventory has been stabilized? And also, do you see the end user demand remain the same as in the fourth quarter?
Mark Hahn -- Chief Financial Officer
So, maybe -- this is Mark. I'll take the first half of the question talking about inventory, and I'll let Dave or Jason talk about end user demand. So, with respect to the channel inventory, I think you saw and we saw that in Q3, there was a kind of a buildup in inventory in the channel. And in Q4, if you do the math, you'll come out to see that. They got back down almost at the same level they were at Q2 of 2018. And I think, going forward, we're probably at a stabilized level, barring any changes in anticipated demand. So, once we get through ITP and assuming a positive approval there, I can see them picking up inventory again, but I think for the CLD indication at least we should be fairly stable going forward.
Eun Yang -- Jefferies -- Analyst
Thank you.
Jason Hoitt -- Chief Commercial Officer
Hey Eun, this is Jason Hoitt. To address your second question, I would say that over the fourth quarter, we saw really nice growth in unique prescribers. And I think we're seeing a continuation of prescribing going into Q1. We'll get into more of those details when we get to the Q1 earnings Call. But I think we would expect to see the results of some of the changes that we've made in terms of the focus of our team, in terms of the roll out of our revised marketing strategy, the recent critical commercial hires and the enhanced collaboration with our Salix partnership start to take shape over -- over the coming quarters.
Eun Yang -- Jefferies -- Analyst
Okay. And then, in the past, so you kind of mentioned that the revised commercial strategy would make an impact probably in two or three quarters now from the initiation. So, for this year, do you expect a more measured growth that we've seen in fourth quarter?
Mark Hahn -- Chief Financial Officer
Yeah, I would expect -- Eun, I would expect that we would see the impact of these changes over the subsequent couple of quarters and that we would see growth once we're able to roll those out and deploy those in front of physicians.
Eun Yang -- Jefferies -- Analyst
Okay. And then, I have a last question. So, I think you've mentioned that you're addressing a 180-day question. And I think in the past, Dova mentioned the potential EU approval in third quarter. So, is that still on track? And then, also with your focus on ITP and CIT, how do you think about European marketing strategy for CLD? Thank you.
Kevin Laliberte -- Senior Vice President, Product Development
May be just -- Eun, this is Kevin to address the first question. As you mentioned, we did receive the day 180 questions, which puts us on track to receive an opinion from the EMA in the third quarter. So we're actively working on responding to those questions, so we can maintain that timeline of the Q3 decision, but we're on -- we're on track for that decision date at this point. And then I'll turn it back over to Dave for the other question.
David Zaccardelli -- President and Chief Executive Officer
Yes, thanks. We -- with regard to CLD and Europe, we have significant interest from partners in Europe and have progressed those conversations. At the same time, we are interested in our ITP approval in the US as well as understanding our approach for ITP in Europe. And so, we are taking a measured approach to CLD in Europe during that period while we assess ITP both in the US and in Europe.
Eun Yang -- Jefferies -- Analyst
Thank you for taking the questions.
Operator
Thank you. And our next question comes from the line of Jonathan Miller with Evercore. Your line is open. Please go ahead.
Jonathan Miller -- Evercore -- Analyst
Hi, guys. Thanks for taking the questions and congrats to the new team on their first full quarter. I have a couple of questions on the CLD launch in the discontinued trials. I guess, let's start with what you have said about the total number of new prescribers, and obviously it's great news that they've jumped so much in this quarter. But backing out from the sales numbers, it looks like repeat prescriptions haven't been growing in line with the new prescriber growth. So, can you speak a little bit to the rate -- not the total number of repeat prescribers but the rate at which your prescribers are repeat customer?
Jason Hoitt -- Chief Commercial Officer
Yeah, I think that's a great question. So -- this is Jason. So we have seen nice growth in new and unique prescribers over the course of Q3 into Q4. We've also seen growth in repeat prescriptions. And one of the interesting trends that we see, as physicians gain more experience with the products, so as they get to their second and third prescriptions, they become increasingly likely to write that for prescription. And so, I think, as we're working with offices to get -- to get into scheduling protocols and the interdisciplinary connection between multiple groups, between hepatology, and some of the specialists that are performing procedures on the CLD patients, and these multiple groups are getting experience with DOPTELET. We're starting to see an increase in their subsequent prescriptions. So, I think that's a nice trend to see that their experience is yielding a positive result and that -- as they start to grow, they continue to write more productively overtime from one prescription to the next.
Jonathan Miller -- Evercore -- Analyst
Great. And I noticed that the 83% payer approval rate this quarter is pretty flat with last quarter's rate. How do you expect that to change over the next several quarters? Are we going to see continued acceptance from payers of the regimen?
Jason Hoitt -- Chief Commercial Officer
I would say, at this point, we don't have any reason to say that we would expect to see it -- to see it decline in anyway. I think we're pretty happy with that 83% approval rate that we're seeing to-date, but obviously it's something that we continue to monitor and we're also happy with the fact that the days to decision is starting to decrease. So, we're starting to see increased efficiency, I think, by opening up the(ph)direct-to-SP referral pathway as well as efficiencies in the hub in triaging those referrals to the SPs in a much quicker -- in a much quicker time-frame.
Jonathan Miller -- Evercore -- Analyst
Great. That makes sense. Thank you for the color. One final one, on the discontinued trials, I understand that focus on ITP and CIT that makes good sense. But what was that post-marketing CLD study's purpose, and what's the upshot of of having to withdraw? What are you missing out on by not continuing to study CLD into those market setting?
Kevin Laliberte -- Senior Vice President, Product Development
Hi, Jon, this is Kevin. So, the CLD post marketing registry was a voluntary study. It wasn't anything required by the FDA. And we felt at the time when we were initially evaluating the program that it would be nice -- nice to have to conduct a post-marketing study where we could collect additional data on patients with chronic liver disease receiving the product. I will say, we did decide to discontinue the trial. But we did enroll a decent number of patients that we still will analyze the data and have subsequent publications to summarize exposure data, some platelet response data, adverse event data so that we can provide additional color on the use of (inaudible) commercially. So it's certainly not -- not a fruitless initiative that we conducted that particular study. So we'll have some good publications that have come out from a post-marketing perspective.
Jonathan Miller -- Evercore -- Analyst
Great. Thank you very much for taking my question.
Operator
Thank you. And our next question comes from the line of Anupam Rama with JPMorgan. Your line is open. Please go ahead.
Analyst -- -- Analyst
Yeah. Hey, guys. Thanks for taking our questions. This is Matt on for Anupam. Just on those discontinued trials, can you talk about the discontinuation of the broader surgical population in the context of partnering discussions? It seems like since it was such a broad population, and it might be an important piece of the puzzle for any potential partners. Thanks very much.
Jason Hoitt -- Chief Commercial Officer
Yes, thanks for the -- thanks for the question. I think we -- when we looked at it and look at the valuation of our efforts in 2019 and going forward, the opportunity and the investment both in ITP as well as CIT, we felt that it was a proper use of resources to focus in those areas. That does not mean we would not come back to that in -- at some other point in time, but in an effort to balance how to utilize and manage our resources as well as creating and delivering medication to patients in the most effective way. We are focusing now in those two areas of ITP and CIT.
Analyst -- -- Analyst
Okay, thank you very much.
Operator
Thank you. And our next question comes from the line of Geoffrey Porges with SVB Leerink. Your line is open. Please go ahead.
Analyst -- -- Analyst
Hi. This is Brad coming on for Geoff. Thanks for taking our questions. I'd like to get a sense of the impact in Q4 of the Salix collaboration. So could you estimate what proportion of the doubling in volume was due to Salix promotional activities?
David Zaccardelli -- President and Chief Executive Officer
Yeah. I think it's premature for us to get into the specifics of exactly what was generated by Salix versus the Dova team. I think part of why you saw us restructure the team at the beginning of the year is because there was some redundancy in terms of call point. But also keep in mind that the Salix team had really hadn't even been deployed for a full quarter in the fourth quarter. They only deployed in the middle of October. So, as was guided previously, I think, for the -- for the full effect of the collaboration to take hold, it will take a couple of quarters. And as a result of the changes that we made at the beginning of this year, we are starting to see some nice results coming from the team and we're also starting to see and hear of really enhanced local collaboration among the two teams to drive business in the local markets, which is where I think we're going to have the most sizable impact from the -- from the joint venture with Salix.
Analyst -- -- Analyst
Okay, great, thanks. Now that Shionogi is out selling lusutrombopag, do you have an estimate of the total size of the thrombocytopenia CLD market in Q4.
Jason Hoitt -- Chief Commercial Officer
So we don't have visibility into the lusutrombopag prescription volume for Q4. I think -- I think that's the question for Shionogi in terms of what they've done in terms of volume of sales so we could really only speak to the Dova -- to the Dova side of things, but we're obviously happy with the growth that we're seeing in the market, and haven't really heard much in terms of the level of competition coming out of Shionogi in our interactions with key customers.
Unidentified Participant -- -- Analyst
Okay, great. Thanks for the commentary.
Operator
Thank you. And our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Your line is open. Please go ahead.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Hi, good morning. Thanks for taking the questions. Can you talk a little bit about the -- the plan for your revised messaging, and what that revised messaging will look like for the product?
David Zaccardelli -- President and Chief Executive Officer
Yeah, thanks for the question, Matt. I think -- to just take a step back, I think, one thing that we observed in our diagnostic over the first couple of months since -- since joining Dova is that, the campaign, the positioning, the messaging that we're out in the market, I don't think we're really resonating in the way that we would want them to with target customers. And so, we've taken a real hard work based on what we've heard from our field force over the first seven months of them being in the field, interacting with customers. Based on our own interactions with key opinion leaders in the space as well as market research that's been going on, to try to reposition the product in a manner that both resonates with physicians, but also clearly communicate the risk of bleeding associated with thrombocytopenia and the chronic liver disease patients as well as talking about the safety and efficacy of DOPTELET.
Now, the specifics around positioning and messaging and the new campaign, for commercial reasons, obviously I wouldn't want to get into those details just yet. Those are still in active market research testing as we speak, and we anticipate rolling those out at the beginning of Q2, at which point obviously we'll communicate with you guys exactly what the strategy is, and just rest assure that the strategy itself will both be -- will be well tested to ensure that it resonates with the target community in chronic liver disease space.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Great. Thanks for the detail. And then, in line with that, can you give us some more detail in terms of feedback you're hearing from customers, from physicians currently with -- from the product, and I guess specifically from prescribers that are using the product multiple times. And then -- and what that feedback is and why they're using it?
Jason Hoitt -- Chief Commercial Officer
Yeah, it's a great question. I can tell you just from my own firsthand experience over the last couple of weeks meeting with three or four different KLOs around the country that have experience using the product, I've heard overwhelmingly positive feedback on the experience that they've had with the product. I think what we've seen in terms of, I guess, the slower acceleration has to do with the scheduling lead time necessary for using the product and just the interdisciplinary approach that needs to be taken. And I feel like over the course of the seven months that the team has been in the field, significant inroads have been made and in practices where we see substantial uptake and multiple repeat prescriptions for multiple patients and to our repeat prescriptions for the same patient undergoing multiple procedures, we've seen a very dedicated infrastructure committed to following those patients within those health systems. Oftentimes a scheduler will take accountability for any CLD patient with thrombocytopenia and makes sure that they're really taking point in ensuring that that patient is on product and has enough lead time before our scheduled procedure.
So I think working through the new launches of the interplay between the multiple sub-specialty groups that can touch and perform procedures on chronic liver disease patients is one where we're starting to see a sizable impact and we see robust infrastructure in those practices where we see sizable -- a sizable uptick in repeat prescribers.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Okay, that's helpful. Thank you. And then, last question, a question for Kevin with -- I guess, with the cancellation that the two studies, PST and the follow-up study, is there a chance for you to potentially accelerate the CIT study now that you're focused on that study more with the other ones out of the way.
Jason Hoitt -- Chief Commercial Officer
Certainly, there is an opportunity for us to put essentially the entire clinical development team on point for that CIT trials to try to accelerate the enrollment and execution of that trial as quickly as possible. And I'm going to assure you that we're putting all of our efforts toward accelerating that as quickly as possible as we progress through the year 2019 with the ultimate goal of having top line results in the first half of 2020. But definitely we're certainly trying -- trying our best to accelerate that as quickly as possible.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
All right. Thanks for taking questions and congrats on the progress.
David Zaccardelli -- President and Chief Executive Officer
Thanks.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Thank you. And our last question comes from the line of Joe Pantginis with HC Wainwright. Your line is open. Please go ahead.
Joe Pantginis -- HC Wainwright -- Analyst
Hi, guys. Good morning. Thanks for taking the questions. Wanted to focus my question on ITP if you don't mind. Assuming approval of the drug which we think it will be later this year, it certainly looks like you're going to get a favorable label with regard to the breadth of targeted patients. So with that said, since the population in ITP is very heterogeneous across the treatments, across all different lines, what do you think, and I know this is real forward-looking, what do you -- what do you see as the initial potential traction for the drug? Could it be in the post steroid market? Do you think physicians would want to get experience in the drug following the failure of another TPO or do you see initial broad traction to start with?
David Zaccardelli -- President and Chief Executive Officer
This is Dave Zaccardelli, (inaudible) and thanks for the question. It clearly -- we are undergoing right now extensive planning in preparation for the launch of DOPTELET in ITP. We're quite excited about that opportunity. As you know, we believe strongly that it's a differentiated TPO receptor agonist that would work well in ITP. We are expecting that physicians who have extensive experience with TPO receptor agonist to welcome the other opportunity to use DOPTELET. And while they are familiar with these other agents, we think we offer a differentiated product that should be used in a similar fashion as they are currently. As you pointed out, the use of products is somewhat variable but we expect it to be inserted into practices in a similar fashion considering they are very familiar with the class of drug.
Joe Pantginis -- HC Wainwright -- Analyst
Got it. Thank you very much.
Operator
Thank you. And this does close today's Q&A session, and I would like to turn the conference back over to Dr. Zaccardelli for any further remarks.
David Zaccardelli -- President and Chief Executive Officer
Great. Thanks, everybody, for joining us this morning and we look forward to seeing you at future conferences and updating you on our quarterly calls. So thank you very much and have a great day.
Operator
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone, have a great day.
Duration: 40 minutes
Call participants:
David Zaccardelli -- President and Chief Executive Officer
Mark Hahn -- Chief Financial Officer
Eun Yang -- Jefferies -- Analyst
Jason Hoitt -- Chief Commercial Officer
Kevin Laliberte -- Senior Vice President, Product Development
Jonathan Miller -- Evercore -- Analyst
Analyst -- -- Analyst
Unidentified Participant -- -- Analyst
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Joe Pantginis -- HC Wainwright -- Analyst
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