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Dova Pharmaceuticals, Inc. (NASDAQ:DOVA)
Q2 2019 Earnings Call
Aug. 6, 2017, 9:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning and welcome to Dova Pharmaceuticals Second Quarter 2019 Financial Results and Operating Highlights Conference Call. All lines have been placed on mute to prevent any background noise. Following the speaker's 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 the purposes of 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 section of the company's annual report on Form 10-K filed with the SEC on March the 5, 2019 and quarterly report on Form 10-Q for the quarter ended June 30, 2019, which can be accessed on the EDGAR database at www.sec.gov and the other filings the company makes with the SEC from time to time.

In addition, any forward-looking statement represents the speaker's views only as of today and should not be relied upon as representing the speaker's 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 subsequent to today. Please be advised that today's call is being recorded and webcast.

I would not like to turn the call over to Dr. David Zaccardelli, Dova's President and CEO. David, you may begin your conference.

David Zaccardelli -- President and Chief Executive Officer

Thank you, operator. And good morning, everyone. Joining me on the call this morning are Mark Hahn, our Chief Financial Officer; Dr. Lee Allen, our Chief Medical Officer; Kevin Laliberte, our Senior Vice President, Product Development, and Jason Hoitt, our Chief Commercial Officer. In addition, as noted in our press release, we are delighted to have Dr. James Bussel joining us today.

The past few weeks have been incredibly productive and transformative for Dova. We are pleased that in late June, the FDA approved DOPTELET for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia or ITP who have had an insufficient response to previous treatment. And on July 16, just three weeks ago, DOPTELET was launched commercially for the ITP indication in the United States.

I will discuss in more details regarding recent activity shortly, but before I do, we have a very special guest with us on the call this morning, Dr. James Bussel, Professor and Merited at Weill Cornell Medicine and a leading global expert in the treatment of ITP, joins us today to discuss his thoughts on the approval of DOPTELET and his view on how DOPTELET changes the treatment paradigm for adult patients with ITP. Dr. Bussel.

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

Thank you very much. Just to give you a brief overview of ITP, though I'm sure that the great majority of you are very sophisticated. ITP has been the classic hematologic autoimmune disease mediated by antibodies against platelets. The biggest development in our understanding in the last 20 years to 30 years has been that these antibodies also attack the cells that make platelets, megakaryocytes and cause reduced platelet production as well. Because of the strong effects of thrombopoietin on megakaryocytes that can help them to evade this damage and nonetheless, be able to make platelets, obviously a critical feature in ITP.

This hypothesis or thesis, if you will, has been well-proven over now more than 10 years by the successful use of thrombopoietic agents in ITP. And as such has opened a whole new therapeutic pathway for patients, clearly effective in well over 50%, including some of those who are the most difficult to treat. In the past, we had Romiplostim, which requires a subcutaneous injection weekly from a healthcare provider. The current status is that the FDA does not allow patients to learn to inject themselves at home.

There is also eltrombopag, which is taken once a day by mouth, but has very special dietary requirements and means that in order to successfully take that, you have to plan your whole day's eating to have a long stretch of no eating and an empty stomach for it to be absorbed. Back in 2014, I was the lead investigator and first author in the publication of the Phase 2 trial of avatrombopag, which is the name for DOPTELET. In that study, our site entered 26 of the 64 patients in a very successful Phase 2 study, because it was so obvious to us how effective it was with the idea that you could take it once a day without any need to seriously consider diet in when you took it.

We, therefore, were very excited when it was pursued further in Europe with a very successful and very strongly positive Phase 3 study and has now become available for patients. In my experience, over well over 30 years, when you give patients a choice, would you rather get a shot once a week or take a pill by mouth once a day. The overwhelming majority will choose to take a pill once a day. That choice with avatrombopag is freed from the dietary restrictions that can make that difficult for many people, and I, therefore, am very excited about the approval and the fact that avatrombopag will be available to a wide range of ITP patients.

Thanks, Mr. Zaccardelli.

David Zaccardelli -- President and Chief Executive Officer

Thank you, Dr. Bussel, very much for your insightful review of the importance of DOPTELET and how it fits into the current treatment paradigm for ITP and for participating in the call today. We really appreciate it. We are equally excited about the impact we believe DOPTELET will have on the treatment of ITP.

Now, let me outline the agenda for the rest of today's call as follows. First, I'll begin by highlighting the recent FDA approval of our SMDA for DOPTELET for the treatment of ITP and our ongoing launch efforts, including some very early achievements from the field. I'll then move to recent updates related to our first approved indication for DOPTELET the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure or CLD, including the expanded co-promotion agreement with Salix. The recent European approval for CLD and a review of commercial metrics for the second quarter of 2019.

I will then provide an update on the progress of our ongoing Phase 3 clinical program for chemotherapy-induced thrombocytopenia, or CIT, for which we expect to announce top-line results in the first half of 2020. Finally, I will quickly discuss our overall financial outlook and global partnering strategy before turning the call over to Mark to review the company's financial performance for the second quarter and our strong cash position.

After that, we will open the call up for questions.

The FDA approval in late June of DOPTELET for the treatment of ITP was a transformative moment for Dova and especially for patients with ITP. Gaining this approval from the FDA was the highlight of an eventful period for Dova as we continue to build on our significant progress toward becoming a leader in the treatment of thrombocytopenia.

As a reminder, the FDA approval of DOPTELET for ITP was supported by safety and highly statistically significant efficacy data from a pivotal Phase 3 clinical trial and two Phase 2 clinical trials for DOPTELET in patients with ITP. Phase 3 clinical data were highlighted in the British Journal of Hematology publication in September 2018, with additional ITP data presented at several scientific congresses this year. We believe there remains a significant unmet medical need for ITP patients, particularly to address the burden of treatment and we believe DOPTELET is well a differentiated alternative to current treatments available for patients with ITP.

This differentiation or the ITP indication is grounded in four unique and clinically important ways. First, DOPTELET is the only oral TPO receptor agonist approved for use in adult patients with ITP that does not have a boxed warning for hepatotoxicity, which is designed to into products with serious or life-threatening risk and as a result DOPTELET does not require routine monitoring of liver function tests.

Second, DOPTELET is the only oral TPO receptor agonist approved for use in adult patients with ITP that is conveniently taken with food and does not have any food type restrictions, including limits on calcium intake. Third, DOPTELET as an oral tablet does not require a weekly visit to a healthcare professional's office to receive a subcutaneous injection. And finally, DOPTELET has a proven efficacy profile, with 66% of patients achieving a platelet count over 50,000 by day eight of therapy and platelet counts that were maintained in the target range during the six-month treatment period in Phase 3 clinical study.

While TPO receptor agonists are commonly used to treat ITP, factors such as the need for weekly subcutaneous administration, monitoring for potential liver toxicity, and stringent dosing restrictions with regard to the timing of meals and types of food, each of which represents a significant barrier to compliant and effective TPO receptor treatment. As mentioned, DOPTELET is an oral tablet conveniently taken with food and thus we believe its lack of dietary restrictions make it well-suited to fit more easily into a patient's lifestyle rather than disrupting it.

Dietary restrictions or other oral TPO approved for use in ITP require taking the other oral TPO product one hour before or two hours after any meal and if more than 50 milligrams of calcium is consumed, then the restrictions increase to two hours before and four hours after a meal, which as you can imagine, can be incredibly inconvenient and disruptive to a patient's life. Keep in mind, 50-milligram calcium thresholds can be exceeded by a slice of American cheese, one cup of broccoli, and even many types of bottled water. As a reminder, the treatment of ITP represents a significant opportunity in a well-established market. The estimated U.S. prevalence of ITP is approximately 60,000 patients with an estimated TPO receptor agonist market size of approximately $1 billion in the US. Based on our market research, we believe there is a demand for more ITP therapies, particularly oral options with a preferred safety profile and increased dosing convenience for adult patients.

We believe physicians are interested in having a broad range of treatment options due to the impact of existing therapies on their patient's daily life. It's also important to highlight the ITP patient population is diverse. A particular treatment for one patient with ITP may work while it may not be effective for another patient. And further, over time, patients may experience treatment failure and need to move on to a different treatment option, thus leaving patients resigned to coping with the frustrations of managing the daily burden of their treatment as well as their disease. That is why it's so critical for patients and physicians to have multiple treatment options available to them.

We believe there's a sizable ITP population available for Dova to address quickly. I would highlight that currently, patients receiving TPO receptor agonists only average about eight months of use before needing to change therapies for several possible reasons. These include managing food restrictions, lack of an adequate response, frequent visits to a physician's office that may become inconvenient for the patient, and physicians pausing therapy to assess the durability of response. With these dynamics in the market, we believe there's a sizable patient population for DOPTELET to address.

Now, moving to our commercial strategy. Starting with the sales force, as we discussed previously, we have now strategically focused Dova reps exclusively on serving the ITP market and have also modestly increased the size of our sales footprint to approximately 60 territories. The newly hired members of this sales team are very experienced and bring out on average 20 years of industry experience with 10 years in the hematology-oncology space. With DOPTELET now launched for ITP, our sales reps are calling on approximately 6,000 healthcare providers, primarily hematologist oncologists in both the community and academic setting. These physician offices represent approximately 96% of the ITP patient population for DOPTELET. As such, we believe our sales force is well-sized to call on and educate the physicians caring for adult patients with ITP in the U.S.

As we indicated on our ITP approval call, the wholesale acquisition price or WAC price of DOPTELET for both ITP and CLD has been adjusted and is now similar to other TPO receptor agonists used to treat ITP. Based on extensive research and feedback from payers in both the Medicare and commercial segment, we believe at this price market access and pricing will not be a barrier to update. We will also continue to have both patient assistance and copay programs to support patients and their ability to access DOPTELET. While we launched into the ITP space just three short weeks ago, and it's still incredibly early in the launch, I wanted to give you some specifics from these initial days.

Today, greater than 2,600 sales calls have been made by our ITP team reaching and educating over 2,100 healthcare professionals on DOPTELET for the treatment of ITP. We have already seen prescriptions for ITP patients written, paid for, and shipped. Further, prescription and shipment numbers from these early days of launch have exceeded our internal expectations. We are extremely encouraged by this early uptake and believe it represents a positive first step toward our goal of making DOPTELET the preferred TPO receptor agonist for the treatment of ITP in adult patients.

With regard to payers, we have communicated with over 75 plans or PBMs since approval sharing information on DOPTELET's approval in ITP and updated pricing information. These 75 plans represent more than 90% of all covered lives. For the launch, the market access team's strategic priority is focused on the top 30 plans across commercial, Medicare, and Medicaid, representing an estimated 70% of total covered lives. They have had over 25 in-person clinical and business presentations since approval, with payers representing approximately 50% of the covered lives. Given the early stage of the launch, we are not providing any additional metrics for ITP at this time. We plan to monitor the launch to determine the most appropriate metrics that best provide real insight into our progress. Once determined, we are committed to providing these metrics on a future call.

Now, moving to CLD. As we mentioned in the IPO approval call, we strategically expanded our partnership with Salix. In addition to gastroenterology, colorectal surgery, and proctology segment, Salix now has the exclusive right to co-promote the CLD indication for DOPTELET to the hepatology and interventional radiology segment. We will continue to pay Salix a commission on a percentage of net sales in these specialties, which is expected to be in the mid-30s. In addition, the co-promotion agreement has been extended by one year until September of 2023. Salix remains a critical component of our overall commercial strategy and we believe the expansion of our partnership with Salix and the impact of our pricing change will continue to increase the use of DOPTELET in adult patients with the CLD.

Now for metrics for the second quarter for CLD. First, net product sales for DOPTELET were $3.5 million for the quarter. Inventory held by specialty pharmacies in Dova's network decreased from March 31, 2019 to June 30, 2019 by approximately 17% or $450,000 as we believe our network, especially pharmacies, may have anticipated their inventory would be exchanged at the time of ITP approval due to the CLD specific labeling as we've previously discussed.

For prescriptions in the second quarter that have gone through the adjudication process with payers, 77% of those prescriptions were approved. On average, the time to decision for a referral was 7.4 business days in the quarter. While the approval rate is down somewhat from prior quarters, it is important to note that a few large payers instituted payor restrictions in the second quarter based on DOPTELET's prior price relative to the competition.

With the new WAC price, we have begun addressing this issue with payers and anticipate the restrictions will be removed in the second half of 2019. We have already seen a few payers either remove the restrictions or not institute them since we lowered the WAC price. In summary, we were pleased that prescriptions written for CLD increased by approximately 7% in the second quarter as compared to the first quarter. However, as a result of restrictions instituted by certain payers, actual shipments to patients remained fairly constant from Q1 to Q2, while the decrease in channel inventory adversely affected our net revenue in Q2.

With the change in WAC price for DOPTELET, we believe we have removed the competitive pricing concerns and going forward we anticipate that payor restrictions for DOPTELET will be removed. Also, we were pleased the European Commission recently granted marketing authorization for DOPTELET for the treatment of severe thrombocytopenia in adult patients with CLD who are scheduled to undergo an invasive procedure. The marketing authorization applies to all 28 European Union member states plus Iceland, Norway, and Liechtenstein. European Marketing Authorization is another significant milestone for Dova.

Next, I'll discuss our continued progress in our Phase 3 randomized double-blind, placebo-controlled trial that is evaluating the efficacy and safety of DOPTELET in subjects with non-hematologic tumors receiving chemotherapy who developed CIT. We have continued to progress enrollment of the 120 required patients and are on track to announce top-line results in the first half of 2020. As a quick reminder, CIT is a serious complication in cancer patients undergoing hepatotoxic chemotherapy for the treatment of various tumors. Currently, with no approved drug therapies for CIT, treatment includes chemotherapy dose reduction or a chemotherapy cycle delay, either of which may adversely affect the clinical outcome of the patient's cancer treatment.

In some cases of CIT, administration of platelet transfusions occurs with approximately 125,000 transfusions administered every year to patients with CIT. In the US, there are approximately 765,000 patients annually that receive chemotherapy. Among those patients, roughly 93% have solid tumors, with approximately a 10% incidence of Thrombocytopenia in this patient population.

Based on these facts, we estimate that the addressable CIT market to include approximately 71,000 patients annually in the US. Assuming the use of DOPTELET in at least three courses of chemotherapy for each patient, that results in over 200,000 potential treatment uses in the U.S. The study dose of DOPTELET in CIT is 60 milligrams a day for five days before and five days after a course of chemotherapy, which is priced at the current level, equates to approximately a $2 billion market opportunity in the U.S. We believe DOPTELET has the potential to fill an important unmet medical need for patients experiencing CIT and represents a significant market expansion opportunity for DOPTELET.

Before I turn the call over to Mark, I want to quickly discuss our financial position and Ex-US partnering status. We believe that Dova has sufficient cash reserves and available access through current debt financing and the existing partnership with Fosun to fund our business through top-line results of CIT and beyond. Most importantly, we are keenly focused on achieving profitability and a sales ramp in line with our expectations, we believe we could achieve positive cash flow within the next one to two years.

As a reminder, outside of the US, we intend to partner with companies that are experts at commercialization in the respective territories to market DOPTELET. We are in ongoing discussions with numerous potential partners in multiple territories and we will provide updates as these discussions progress further. These partnerships could provide additional upfront payments, milestones, and royalties from licensing DOPTELET outside the US to increase our cash position and financial strength to fund the business, including potential additional development programs. As mentioned in previous calls, we will continue to evaluate opportunities for end licensing products and programs that may be complementary to our pipeline and corporate strategy.

With that overview, I will now turn the call over to Mark to present our financial view for the quarter. Mark?

Mark Hahn -- Chief Financial Officer

Thanks, Dave, and good morning, everyone. Let me begin today with the operating results. For the second quarter of 2019, Dova reported net product sales of $3.5 million. As a reminder, we recognize revenue using the selling methodology when products are delivered to our specialty pharmacy partners. While channel inventory decreased toward the end of the second quarter, it's important to note that all the inventory in the channel was packaged and labeled for the CLD indication. This inventory will be returned to Dova for destruction and replaced on a dollar for dollar basis with product appropriately labeled for both the CLD and ITP indications.

Cost of sales for the first quarter was $0.4 million, which consists of the cost of inventory, royalty payments, and certain distribution and overhead costs. Cost of sales has been running at approximately 13% of net sales over the last several quarters, and we expect that percentage to increase in the short-run as we work through our existing inventories.

R&D expenses were $4.5 million in the second quarter of 2019, which was consistent with R&D expenses for the second quarter of 2018. SG&A expenses were $15.5 million in the second quarter of 2019 compared to $18.6 million for the same period in 2018. This decrease was largely driven by Dova having the full complement of salesforce for most of the second quarter of 2018, while our ITP sales team largely started with the company late in June and early in July 2019.

We had a net loss of $17.1 million for the second quarter of 2019, compared with a net loss of $19.7 million for the second quarter of 2018. During the second quarter, we entered into an amended and restated loan agreement with Silicon Valley Bank in order to refinance the $20 million debt facility we entered into with SVB in April 2018. In early Q3 of 2019, we borrowed an additional $10 million under the new facility. The new facility also provides us access to additional capital. In addition to the $10 million we drew in Q3, we have the ability to draw up to an additional $20 million in the aggregate, and up to two tranches upon the achievement of certain regulatory and commercial milestones upon specified dates.

The new facility is currently in an interest-only period, which extends to August 2020 and will automatically extend to May 2021 if the additional draws are made. On June 30, 2019, we had $76.8 million in cash and equivalence. After giving effect to the $10 million draw I just mentioned on a pro forma basis our cash balance is $86.8 million. We believe this cash will support our operating activities for at least the next 12 months allowing us sufficient resources to complete the CIT study including a readout of top-line data in the first half of 2020. We believe a potential additional borrowing from the new facility will provide supplemental runway if drawn.

Additionally, within the next 12 months, we expect to receive a milestone payment upon achievement of certain regulatory milestones by our partner in China, Fosun Pharmaceuticals. Furthermore, as Dave mentioned, we are in discussions with numerous potential commercialization partners in Europe, Japan, and other territories. We believe potential upfront and milestone payments from any such ex-US partnerships could further enhance our runway.

And now, I'll turn the call back to Dave. 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. Moving forward we are focused on executing a successful launch for DOPTELET in the ITP indication, supporting the continued growth of the CLD indication, progressing in moment in the CIT trial to generate top-line data in the first half of 2020, obtaining partnerships in Europe, Japan, and other territories for DOPTELET, and maintaining a strong balance sheet. With the incredible progress we have made over the recent months, I continue to believe Dova has the people, product, and resources necessary to deliver novel therapy to patients in need and create significant for shareholders and increase our leadership in the treatment of thrombocytopenia.

With that, I'd like to open the line for questions. Operator?

Questions and Answers:

Operator

Ladies and gentlemen, if you have a question at this time, please press the * then the 1 key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, press the # key.

Our first question comes from the line of Eun Yang with Jefferies. Your line is now open.

Eun Yang -- Jefferies -- Analyst

Thank you. I have a couple of questions for Dr. Bussel as well as the company. For Dr. Bussel, in the last 12 months or so there are two new drugs approved for ITP, DOPTELET, and TAVALISSE. Can you talk about how you would utilize those drugs in your patients? And the second question is if a patient is not responding to one of the TPO medics, would you use another TPO medic with the patient? Thank you.

David Zaccardelli -- President and Chief Executive Officer

Dr. Bussel?

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

In regard to the first question, I've been very involved in the development of TAVALISSE of fostamatinib. I believe that it definitely has advantages and has a different mechanism than do the TPO agents. However, I would be surprised in the United States at least if avatrombopag or DOPTELET was not chosen before fostamatinib unless there was a very compelling reason to use one or the other.

In regard to your second question about using one TPO agent if another doesn't work. The data very much surprised me when it came out that it like yes you could use one and if it didn't work using another in the setting of two would have a 50% chance of success. Avatrombopag and eltrombopag bind apparently to the same place on the thrombopoietin receptor. So, if a patient used romiplostim and it didn't work, the published work strongly supports trying one of the other agents, in this case, we're talking about avatrombopag. If somebody had used eltrombopag and it didn't work, the data again might surprise me, but we would not expect avatrombopag to necessarily work much better. Although, it is possible given that on a milligram per milligram basis it appears to be stronger than eltrombopag. Thank you.

Eun Yang -- Jefferies -- Analyst

Thank you. And then I have a couple of questions for the company. So, David, in terms of partnership ex-China, is it likely dependent upon CIT data in the first half of next year? Also, for the CIT indication previously data is it sufficient to apply for approval in Europe as well? Thank you.

David Zaccardelli -- President and Chief Executive Officer

Thanks for your question. With regard to our partnerships outside the US, as mentioned we have very active, ongoing discussions with potential partners now. We don't believe it is necessarily impacted by having the CIT results. We think that with now the ITP approval in the US and our upcoming discussions in Europe with regard to the ITP pathway as well, of course, the CLD approval in Europe is adequate to progress that. We've had very good enthusiasm from partners not only in Europe but other parts of the world including Asia. So, we're quite enthusiastic about that. It's just a matter of making the best-informed decision and progressing those discussions, which we'll keep you definitely informed.

With regard to CIT, I guess in Europe. We will continue that conversation. We were very focused on making sure that what we were doing was satisfactory in the US. We believe that the study would be supportive in Europe, but we will have those conversations in the coming quarters with the European regulators.

Eun Yang -- Jefferies -- Analyst

Thank you very much.

Operator

Your next question comes from the line of Anupam Rama with JP Morgan. Your line is now open.

Tessa Romero -- JP Morgan-- Analyst

Hi, all. This is Tessa filling in for Anupam this morning. Thank you for taking our questions. Perhaps one for both the doctor and the team. In the early innings of the DOPTELET launch here and for a few weeks in ITP, can you please comment on what you are hearing from the field about the range of severity that DOPTELET is expected to be used in? i.e. How refractory are patients or how many prior lines of therapy have they seen? Related to this, what is your expectation on how this could trend in the next 6-18 months of the launch? Thanks so much, guys.

David Zaccardelli -- President and Chief Executive Officer

Tessa, I'll give you my perspective and then Dr. Bussel can add any color. I think that as you know we're extremely early in the launch, just three weeks. We are continuing to get information from the field. A lot of the breakout as to what types of patients and what it's being prescribed for specifically, we don't have. We think that, as I mentioned in my remarks, patients come from different sources. Maybe patients who are newly diagnosed, patients who may have already been on treatment with another TPO receptor agonist. It can come from multiple different directions. And that's what we are currently seeing very early on but have no more color on that.

With regard to the future, we're very encouraged in these early days of the uptake. But again, it's very early, just three weeks. So, we will continue to monitor that and look forward to providing you additional color in the next quarterly call. I don't know if Dr. Bussel you wanted to add anything to that with regard to the types of patients and refractory patients and what patients would be using DOPTELET?

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

Sure. One of the things ASH guidelines is strongly highlighting, the ones that are going to come out soon that have been already presented and even published through the December 2018 meeting is not to use steroids for too long. In effect, what that's going to do is going to push what we could call second-line agents to be used earlier, even in the second and third month of ITP. I think that, like anything, it will take familiarity with prescribers to want to use this. But given that it's been known for a while and given that it has advantages as I said previously over other agents, I think it will be used across a wide variety of patients from ones who maybe received steroids for one or two months all the way to people who have been refractory to other therapies. I would anticipate that many people would gradually switch over because of the appeals of how it can be tolerated.

The main thing, I think, at the moment is there's not a lot of long-term experience with it so it may take prescribers and/or patients a little while to get comfortable with using it. But I think the uptake is going to be substantial.

Tessa Romero -- JP Morgan-- Analyst

Great. Thank you for taking our questions.

Operator

Our next question comes from the line of Laura Chico with Wedbush Securities. Your line is now open.

Laura Chico -- Wedbush Securities-- Analyst

Good morning and thanks for taking the questions. I just have a couple here but first for Dr. Bussel. Among your current ITP patients, who do you see most likely being the best candidates for DOPTELET? Conversely, what patients would not be good DOPTELET candidates in your view?

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

Dave, is it OK if I answer?

David Zaccardelli -- President and Chief Executive Officer

Yeah. Sure. Please.

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

As far best candidates, I think anybody who is closer to diagnosis is likely to respond better than somebody who has had ITP for a number of years and been very difficult to treat. As I indicated, I think more and more patients will get TPO agents earlier and that will certainly include avatrombopag. Meaning, while they're still newly diagnosed in the first three months and certainly early persistent from three to six months. I think the ones who might not be as good candidates could be ones which would be true for any thrombopoietic agent who are at very high risk of thrombosis if their platelet counts go up, ones who have anti-phospholipid antibodies who have had a thrombosis in the past who have strong family history of thrombosis, something like that. People use thrombopoietic agents in those patients but are a little bit more conservative and cautious and may add aspirin as soon as the platelet count goes up.

Finally, as I mentioned previously, we don't know if people who not only don't respond to romiplostim but don't respond to eltrombopag will be able to be treated with avatrombopag. We'll have to wait for the data to see. But in reality, that's a pretty small fraction of ITP patients who would not be good candidates.

Laura Chico -- Wedbush Securities-- Analyst

Thank you. That's very helpful. And then I guess one more question on CIT and CLD. For CIT, David, I'm wondering if you can just step through a little bit more detail how you're deriving that estimate of about 70,000 CIT patients in the US market. And then on CLD, it looks like, as you mentioned, the adjudication rate dropped down versus the prior quarter. I'm also seeing if my math is correct here. It looks like the number of new prescribers in the quarter dropped versus the first quarter. Any color as to the implications of the Salix team taking over or was this purely driven by reimbursement issues? Thanks.

David Zaccardelli -- President and Chief Executive Officer

Thanks, Laura, for that excellent question. I'm going to have Jason talk to both of those points.

Jason Hoitt -- Chief Commercial Officer

Yeah. Thanks, Laura. Great questions. The way that we get to the 71,000 is from CDC data that highlighted the number of outpatient chemotherapy patients each year in the US. We get the 765,000-number based on our own market research we estimate that about 85% of chemotherapy is given in the outpatient setting. I'm sorry, that 765,000 includes 85%. 650,000 or so from CDC. So, with the 85% outpatient if you include the inpatient chemotherapy that gets you the 765,000. Roughly from the American Cancer Society, 93% of cancer patients have solid tumors. So, that gets you the solid tumor number. And then a recent publication showed that among patients with solid tumors you see a 10% or so incidence of severe thrombocytopenia in those patients which then gets you to the 71,000 annual patients in the US. That's where the math comes from. I think we have those references in our corporate slides that are on our website. We're happy to go into more detail with you at a future time if you'd like.

And then with regard to the CLD question, we did see the number of new prescribers drop in June specifically. I think it was a combination of a couple of factors. As I mentioned in our last earnings call, we continued to see the trend for prescriptions and business coming from repeat prescribers grow. So, the number of repeat prescriptions that we saw in Q2 was as a percentage of our business higher than in any previous quarter. I think the reason you did see new prescribers fall somewhat is in large part due to the operationalization of some step edits with the major plans in the second quarter.

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

Jason, could I add something?

Jason Hoitt -- Chief Commercial Officer

Sure.

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

I would just like to say something about chemotherapy-induced thrombocytopenia just to make sure everybody understands this. When you give chemotherapy, it typically will most attack rapidly dividing cells usually in the bone marrow and also in the GI tract. When it does that, your white count, your platelet counts fall and this creates an issue. You don't want to give platelet transfusions just to support giving the next round of chemotherapy. You wait until the count gets to, depending on the protocol, usually 75,000 or 100,000. If that's delayed, and that means you wait an extra week or even longer, then you lose efficacy of your chemotherapy because cancer has more time to recover as well. I think 10% of solid tumor chemotherapy is a reasonably conservative estimate and these agents have been shown by two different studies from Memorial Sloan Kettering and one from China argue that you can give these in a new way, meaning give them continuously, through chemotherapy and have a great effect on giving on-time chemotherapy and not dose reducing.

If that holds up in the clinical setting, that could translate very easily into better survival.

David Zaccardelli -- President and Chief Executive Officer

Thank you, Dr. Bussel.

Laura Chico -- Wedbush Securities-- Analyst

Thank you very much.

Operator

Your next question comes from the line of Jonathan Miller with Evercore. Your line is now open.

Jonathan Miller -- Evercore -- Analyst

Hi, guys. Thanks for taking my question. Congrats on all the progress on the ITP launch. Before we get into ITP too much, too quick, now that you have a CLD approval in EU, are ex-US deals more the focus than they've been in the past? I know you've been looking at these continuously but the opportunity to launch immediately, does that make that more of a focus?

And then secondly, I know you said that the 6,000 hematology oncologists are about 96% of the ITP market in the US. Is that the whole ITP market or just the TPO-RA prescribers? And is there a possibility that additional prescriber groups will turn out to be important like what happened with the CLD launch?

David Zaccardelli -- President and Chief Executive Officer

Thanks, Jon, for the question. Let me speak to the first on CLD and then have Jason expand on the sales in ITP. With regards to CLD, as you pointed out, we do now have approval in Europe. We had ongoing discussions prior to that approval. Clearly, with the approval, it strengthened those conversations. We also purposefully wanted to get the US readout on ITP in the approval, which as you know occurred which again strengthens the conversations and the opportunity in Europe and the possibility for approval there. As I mentioned, we're looking forward to speaking with the regulatory group in Europe in the coming couple of months. With all of that, we are strategically making sure that we have an increasing position in our conversations to optimize the potential for DOPTELET outside the US. We are very active. It is a priority for the company to progress that. As we talked about today, it's important for our continued incoming milestones increasing our cash position and our overall strategy. I think you will see continued progress in 2019 on that front, for sure. As I mentioned, we'll keep you updated as we progress.

Jason, you want to talk about the second question?

Jason Hoitt -- Chief Commercial Officer

Yeah, sure. Thanks for the question, Jon. When you look at the 6,000 HCPs that we're covering with our roughly 60 salespeople, that covers 96% of the ITP addressable patient population for DOPTELET. So, this primarily comes from an analysis of the claims database. If you look at the total ITP treating universe, it's about 8,000 HCPs. But when you remove those physicians that really only treat front-line with steroid and/or IVIG you get 6,000 physicians that treat in the second-line, which is reflective of the label for DOPTELET for those patients who have had an insufficient response to previous treatment. I would anticipate, as Dr. Bussel mentioned, we have the opportunity to gain patients in second-line and beyond regardless of what they've been treated with previously provided that they had an insufficient response. So, those 6,000 HCPs that we mentioned represent the 96% of the ITP patient potential in the second-line treatment and beyond.

Jonathan Miller -- Evercore -- Analyst

Great. That makes sense. I guess then one follow-up on ITP salesforce. You mentioned that the SG&A relative to last year appeared to be down because sales staff was hired at the end of the quarter. In the past, you had said that you were repurposing existing sales staff and so I was wondering what proportion of the ITP salesforce you've currently got is old CLD folks that are getting repurposed versus new hires and are you done building out that salesforce at this point?

David Zaccardelli -- President and Chief Executive Officer

It's a great question, Jon. Right now we have a handful of territories left to fill. Of the roughly 60 sales professionals that we've got, 17 are from the previous salesforce, many of whom have previous hematology-oncology experience. And the remainder are folks that we've recently recruited into Dova that come from a hematology-oncology background with about 10 years of experience coming from commercially successful companies like Novartis Oncology, Celgene, Amgen, etcetera.

Jonathan Miller -- Evercore -- Analyst

Okay. Great. Thank you very much.

David Zaccardelli -- President and Chief Executive Officer

Thanks, Jon.

Operator. Again, ladies and gentlemen, if you have a question at this time please press the * then the 1 key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, press the # key.

Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Your line is now open.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Hi. Good morning, guys. Thanks for taking the questions. I guess for Dr. Bussel first. With respect to DOPTELET, how are you thinking about its use in terms of switching patients that you currently treat from other TPOs to DOPTELET? When would you do that or is that kind of a patient-driven decision and how that happens?

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

I'm very big on individualizing care. Most patients, if they've been on something and it's working well may not very much want to switch. But for example somebody let's say started on eltrombopag, this is just a random example. Somebody started on eltrombopag when they were 15 and they were coming home every night to dinner so they could eat dinner at six and not eat after dinner and then take eltrombopag at bedtime. That would work well in terms of the dietary restrictions. Now, maybe they've grown up. They're 17. They're doing a lot of "teenager" things. They're not eating at home at 6:00 every night. They have trouble managing finding an eating-free time. Maybe they go out for drinks, all those things. Those are patients I might switch.

If somebody says, it's annoying but I can handle it and I'm doing fine, that's OK. And some people might like getting shots once a week. Maybe their sister is a nurse or a friend of theirs is an EMT who lives down the block and therefore, those people might say, I know what's going on here, it's working, I'm comfortable, I don't want to take a risk by changing and having something new happen that I'm not aware of even though it sounds good. So, I think it's going to be a very individual thing but I think we already know that a reasonable number of patients will gradually change over time.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

And in terms of the Nova patients. How do you think about in terms of the percentage of patients that say, coming off of steroids that you would pull DOPTELET first versus the other?

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

Again, the way I would handle that, I give the patient a choice and because there are very many therapies now available, it's not reasonable to list every single one and go through every single immunosuppressive agent and etcetera. So, I kind of talk about the pros and cons of Splenectomy, Rituximab, and TPO agent. Depending on the patient's preference, they could choose one or the other of those and I would usually go with their preference although I would guide it if there were special factors that would make things not favorable, let's say for one of the options. For example, if somebody has low immunoglobulin levels, taking their spleen out is more risky and they'd have a greater chance, we believe, of developing a serious life-threatening or life taking infection. So, I would probably not want them to do a Splenectomy. Again, that's just one of many examples.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Thank you. And then just switching gears a little bit. In terms of coverage and access reimbursement now. Where are you in terms of for ITP and CLD across the board for DOPTELET?

Jason Hoitt -- Chief Commercial Officer

Yes, that's a great question, Matt. And obviously, our discussions with payers are ongoing. I think as Dave mentioned in his prepared remarks, we've shared information on the approval and the price change with 75% of the PBMs and plans that represent over 90% of covered lives in the US. Our market access team's strategic focus is on the top 30 plans that represent greater than 70% of covered lives in the US. But as you know, some anecdotes coming in. We've seen some large plans, the Medicaid plans and others that had previously implemented step edits such that a patient that was prescribed DOPTELET would have to fail before getting DOPTELET. We've seen those steps removed in these early days of launch as a result of the adjusted WAC price and our conversations with payers.

We've seen one large PBM that had plans to implement a step, ultimately remove that before implementation as a result of these discussions. And largely, each decision is plan specific but we've seen a number of plans add DOPTELET in one fashion or another while they're working through their P&P review. We've seen other plans put it in a non-formulary position, which doesn't mean that we wouldn't have access, it just means that a physician needs to state medical necessity in order to gain access. So, it's a spectrum but largely what we're seeing in these early days, we're incredibly pleased with how plans are reviewing this. The response to the clinical profile and overall the reaction to the adjustment that we took in WAC price to ensure that price and market access wasn't a barrier to patients receiving the drug that they need.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Okay, that's very helpful. And then, in terms of just gross to net right now. How should we think about that given the price change?

Mark Hahn -- Chief Financial Officer

Hi, Matt. This is Mark. Great, great question. So, I think, let me take a step back and walk back in time. I think as we were talking in previous quarters, people were gravitating around 40%, maybe a little higher than 40% range for the CLD indication at the old price. I think you should expect for CLD that to come down a bit but for ITP I think it could be even lower. Part of the reason for that is, if you think about the profile of the patients. When you have a CLD patient, each individual patient, if they're on Medicare could hit them the donut hole or if they're on commercial insurance could have a substantial copay. When you look at ITP, because of the chronicity and the repeat of dosing, if they're a Medicare patient they'll go through the donut hole early on in therapy so the later ones will be subject to that rebate. And likewise, with commercial patients, maybe the early prescriptions, there'll be some copay associated with it but later on, they'll hit their out-of-pocket maximums and those will flow through without any copay assistance from us. So, you should expect the ITP gross net to be lower than the CLDs.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Okay, that's very helpful. And then in terms of competition in CLD, the market has lusotrombopag responded to your price cut?

Mark Hahn -- Chief Financial Officer

No, not to our knowledge. So, we will monitor that very closely. But at the moment, we have a substantially lower flat price than they.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Right. Well, congrats on the progress and thanks for taking my questions.

Mark Hahn -- Chief Financial Officer

Thanks, Matt.

Operator

Your next question comes from the line of Joe Pantginis with HC Wainwright. Your line is now open.

Joe Pantginis -- HC Wainwright -- Analyst

Hi guys, good morning. And I think my questions might be for Dr. Bussel. Dr. Bussel, could I just speak with you again. I'm curious. I guess my first question is going into a little more of the weeds for the test potential ITP addressable population and then going a little more macro after that. How many ITP patients might have compromised liver metrics to start and then could be patients for initial DOPTELET treatment based on sort of hepatic toxicity components in competitive labels?

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

That's a little bit of a Catch-22 answer because if they have abnormal liver tests, typically they may not have ITP but may have thrombocytopenia in the context of liver disease or let's call it secondary ITP. The percentage of patients who would fit that I think would depend a lot on geography and local epidemiology. There is an article from USC back in 2006 that suggested they saw a relatively high percentage of those patients because they reported on hundreds of them. I have never seen very many of those. I would say less than 5% in my practice. So, it may depend a lot on where you are and who you see.

Joe Pantginis -- HC Wainwright -- Analyst

Now that's helpful. Thank you. And then my more macro question is, and you did talk to these a little bit during your answers earlier, and that's regarding the ASH Guidelines that are being finalized for this year. How do you see these guidelines really driving prescribing habits especially to the point that this is such a heterogeneous disease?

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

My impression is that and again, that's just my impression because I don't think there's great data though people have tried to publish on this. My impression is that the people who really know ITP probably won't pay too much attention. And I heard Jason give you some statistics on who's doing the treatment, etcetera. I would say the majority of treaters by far are not that ITP savvy. So those people, I think if there's a question will go to the ASH Guidelines and follow them because that will give them a level of confidence and safety if you will for them in what they do. So, I think it'll have a substantial effect but not an amazing universal effect.

Joe Pantginis -- HC Wainwright -- Analyst

Got it. Thank you, guys.

David Zaccardelli -- President and Chief Executive Officer

Thanks so much.

Operator

We have no further questions at this time. I will now turn the call back to the presenters.

David Zaccardelli -- President and Chief Executive Officer

Thank you, operator. And I just want to close by thanking Dr. Bussel for joining us today and providing his insights as a world expert in ITP. And thank everybody else for joining the call and we look forward to updating you on future calls. Thanks.

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation and have a wonderful day. You may disconnect.

Duration: 60 minutes

Call participants:

David Zaccardelli -- President and Chief Executive Officer

Dr. James Bussel -- Professor and Merited at Weill Cornell Medicine

Mark Hahn -- Chief Financial Officer

Jason Hoitt -- Chief Commercial Officer

Eun Yang -- Jefferies -- Analyst

Tessa Romero -- JP Morgan—Analyst

Laura Chico -- Wedbush Securities—Analyst

Jonathan Miller -- Evercore -- Analyst

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Joe Pantginis -- HC Wainwright -- Analyst

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