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Dova Pharmaceuticals, Inc. (NASDAQ:DOVA)
Q1 2019 Earnings Call
May 7, 2019, 9:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning and welcome to the Dova Pharmaceuticals first 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 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 in the risk factors section of the company's annual report on form 10-K filed with the SEC on March the 5th, 2019 and quarterly report on form 10-Q for the quarter ended March 31st, 2019, which can be assessed 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 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 claims any obligation to do so even if the company 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 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 call.

David Zaccardelli -- President and Chief Executive Officer

Thank you, Operator and good morning, everyone. Joining me on the call this morning is 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.

The agenda for today's call is as follows -- I'll begin by providing an overview on our ongoing commercial efforts to support the launch of Doptelet in our first approved indication for thrombocytopenia in patients with chronic liver disease or CLV who are scheduled to undergo a procedure. I'll also highlight key launch metrics for the quarter.

In addition, we will update you on our progress in Europe with the MAA for the CLV indication. Then I'll provide an update on our chronic immune thrombocytopenia or ITP program that has a supplemental NDA currently under review by the FDA with a target action date of June 30th, 2019. I will then move on to a brief update of our ongoing Phase 3 clinical program for chemotherapy-induced thrombocytopenia or CIT and provide an overview of the potential market opportunity.

Finally, I'll provide an update on our global partnering strategy before turning the call over to Mark to review the company's financial performance for the first quarter of 2019. After that, we will open the call up for questions.

Let's begin with our Doptelet launch update. As I mentioned on our last call, since December, we have focused on reevaluating our commercial strategy and operations, including marketing, sales, market access, and reimbursement support services. As we previously announced in early January, we restructured our US sales team primarily to minimize redundancy on 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. This team is responsible for driving Doptelet education and adoption in the key market segments of hepatology, hematology, interventional radiology, and some GIs that primarily treat liver disease. Initial results from this realignment have been encouraging due to enhanced clarity of goals and accountabilities down to the physician level.

In addition to our revised sales deployment model and critical commercial hires we highlighted on our last earnings call, we have added additional depth to our commercial leadership team, with Doug Kylander joining Dova as Vice President, Market Access and Patient Services. Doug joins us with a deep background in the oncology space, having most recently led market access function at Pharmacyclics, a division of AbbVie Oncology and insight for that. His expertise in this space will add immediate value as we finalize our ITP launch plans begin our work in the CIT market.

Salix, our co-promotion partner is responsible for growing Doptelet in the GI, colorectal surgery, and proctology practices, has continued to demonstrate strong sales support and is an integrated part of our sales strategy in the GI market. As a quick reminder, Salix is deploying approximately 100 sales representatives who are promoting Doptelet as one of two products in their call plan.

In return, we play Salix a quarterly fee based on net sales related to prescriptions written by their target physicians. Based on key observations and feedback from our initial launch efforts as well as focused insights derived from target customers, we launched a new marketing campaign during the first week of April.

In addition to a newly launched campaign, we have a revised action-oriented message that speaks to risks associated with bleeding. The revised positioning, messaging, and marketing campaign have tested well in market research with our target customers. We are increasingly optimistic that these modifications will successful support Doptelet's use as a first-in-class differentiated treatment for thrombocytopenia in patients with CLV scheduled to undergo a procedure.

As noted in our press release, Q1 revenue increased to $4 million, a 43% increase over Q4 2018, while inventories remained relatively stable as we continued to pull through prescriptions to patients.

I'll now move to our key metrics for Doptelet for the first quarter, which includes total prescribers, sales engagement of healthcare providers, payer metrics, and channel inventory. Through March 31st, Doptelet has been on the market for nearly ten months. From launch to March 31st, 2019, a total of 1,060 healthcare professionals have prescribed Doptelet with an increasing number of repeat writers. These include physicians using Doptelet for multiple patients within their practice and in some cases repeat courses for the same patient undergoing procedures.

In the first quarter, Dova sales representatives conducted more than 13,000 calls with greater than 6,500 unique healthcare providers. In addition, Salix representatives reached an additional 9,000 unique HCPs in the quarter.

For prescriptions in the first quarter that have gone through adjudication process with payers, 82% of those prescriptions have been approved with an average time to payer decision of 6.3 days. Both of these metrics are consistent with what we observe and previously disclosed for the fourth quarter of 2018. And lastly for metrics, inventory held in the channel by specialty pharmacies in our contracted network remained relatively constant compared to the fourth quarter.

Beyond our metrics, I would also like to highlight we have noted some improvement in our gross to net adjustments and we are gaining more experience with Doptelet in the market. We are pleased that discounts, rebates, and other gross to net adjustments have been better than our previous expectations.

To summarize, we have made specific, clear, and measurable changes to our commercial strategy, including sales, marketing, and market access as we work to expand the use of Doptelet to more patients in need during the remainder of 2019 and beyond.

With that launch update, I'll now move on to provide an update on the ITP indication for which an sNDA is under review by the FDA. With a PDUFA date on June 30th, roughly seven weeks away, we are in the process of hiring our incremental commercial infrastructure to enable a successful launch of Doptelet in the second indication, if approved. We are enhancing our salesforce by recruiting experienced hematology, oncology sales professionals to the team. Our goal is to have a full complement of sales staff hired and trained by the PDUFA data, positioning us well to launch successfully into the ITP market.

As a quick reminder, ITP is an autoimmune bleeding disorder characterized by thrombocytopenia, abnormally low platelet counts. Chronic ITP affects approximately 60,000 adults in the United States and despite currently available therapy, which include two other TPO receptor agonist, there remains an important unmet medical need for patients with ITP.

Our sNDA is supported by data in ITP patients from a Phase 3 randomized double-blind placebo-controlled study where primary and secondary efficacy endpoints were met with high statistical significance as well as two Phase 2 clinical trials. Based on clinical trial results, we believe that Doptelet has a differentiated profile and potential represents a significant improvement over other approved therapies for ITP, including an increased level of convenience for patients.

Our commercial has been working tirelessly to finalize a coordinated cross-functional companywide launch strategy in ITP. We are currently in the process of finalizing our brand positioning, messaging, and marketing campaigns to promote Doptelet to targeted physicians who treat ITP in the hematology and oncology segments of the market.

Lastly, we have defined our market access strategy and are finalizing our specific tactics necessary to ensure that Doptelet will not be disadvantaged at launch. We will share more details of our marketing, market access strategy, and other commercial activities on a future call.

Now, moving on to CIT, we continue to make significant progress in our Phase 3 randomized double-blind placebo-controlled trial that is evaluating the efficacy and safety of Doptelet in patients with non-hematologic tumors receiving chemotherapy who develop CIT. We continue to enroll patients at over 50 active international trial sites and we expect to announce results for primary and select secondary endpoints in the first half of 2020.

Again, as a quick reminder, CIT is a common complication in cancer patients undergoing cytotoxic chemotherapy for the treatment of various tumors. As I mentioned on our last call, a recent publication from the peer-reviewed BMC Cancer Journal assessed the risk and consequences of CIT in clinical practice using healthcare claims databases. The publication indicated that patients experience CIT during multiple cycles of chemotherapy with a high incidence of CIT associated with cytarbine and carboplatin-based regimens.

We continue our market research efforts to characterize the market opportunity for Doptelet in the treatment of CIT. With no approved drug therapies for CIT, current treatments include chemotherapy dose reduction or chemotherapy cycle delay, either of which may affect clinical outcome of the patient's cancer treatment. In some cases of CIT, administration of platelet transfusion also 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 the addressable CIT market to include approximately 71,000 patients annually in the US. 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.

Now, with regard to Europe, as you may have seen last week, we announced that we received a positive opinion from the committee for medicinal products for human use, the CHMT, of the European Medicines Agency and we expect the EU Commission's decision on approval of the CLD MAA in the third quarter of this year.

As a reminder, outside of the US, we plan to partner with companies that are experts at commercialization in their respective territories. We are in ongoing discussions with potential partners and will provide updates as these discussions as these discussions progress.

In addition, we will continue to evaluate opportunities for in-licensing products and programs that may be complementary to our pipeline. With that commercial, clinical, and business development overview, I will now turn the call over to Mark to present a financial overview for the quarter. Mark?

Mark Hahn -- Chief Financial Officer

Thanks, Dave. Good morning, everyone. Let me begin today by highlighting that we recently entered into an amended and restated loan agreement with Silicon Valley Bank to extend the interest only period on our $20 million debt facility by 12 months to May of 2020. The amendment also provides us possible access to additional capital.

First, if the ITP indication is approved before July 31st, 2019, we will have the ability to withdraw $10 million. And second, upon achievement of certain regulatory and commercial milestones before specified dates, we will have the ability to draw up to an additional $20 million in the aggregate in two trenches. The interest-only period will extend automatically up to an additional 12 months as these additional draws are made.

March 31st, 2019, we had $92.7 million in cash and equivalents, and we believe this cash will support our operating activities for at least the next 12 months allowing us sufficient resources to launch Doptelet in the ITP indication if approved and complete the CIT study, including a readout of topline data. The potential additional borrowings under the loan amendment will provide additional runway if and when drawn.

Now on to the operating results -- for the first quarter of 2019, Dova reported net product sales of $4 million. As a reminder, we recognize revenue using the selling methodology when products are delivered to our specialty pharmacy partners. Cost of sales for the first quarter were $0.5 million, which consisted of the cost of inventory, royalty payments to Astellas, and certain distribution and overhead costs.

R&D expenses were $4.1 million in the first quarter of 2019 compared with $3.4 million for the first quarter of 2018 with the increase primarily due to the cost of the ongoing CIT Phase 3 clinical trial.

SG&A expenses were $15.8 million in the first quarter of 2019 compared to $10.3 million for the same period in 2018. The increase was primarily driven by the increased level in 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 $16.4 million for the first quarter of 2019 compared with a net loss of $13.8 million for the first quarter of 2018.

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. Moving forward, we are focused on continuing to improve the sales trajectory of Doptelet in the CLD indication, gaining approval for Doptelet in the ITP indication and executing a successful launch, progressing enrollment in the CIT trial to allow for topline data in the first half of 2020, obtaining approval in Europe for Doptelet for the CLE indication, and of course, maintaining a strong balance sheet.

With the changes in progress we have made over the past quarter, I believe Dova has the people, products, and resources necessary to deliver novel therapies to patients in need and create significant value for shareholders.

With that, I'd now like to open up the line for questions. Operator, could you open the line, please?

Questions and Answers:

Operator

Sure. Ladies and gentlemen, if you'd like to ask a question, please press * then the 1 key on your touch-tone telephone. That's *1 to ask a question. Our first question comes from the line of Joe Pantginis with H.C. Wainwright. Your line is open.

Joe Pantginis -- H.C. Wainwright & Co. -- Managing Director

Hi, guys. Good morning. I'm just curious, starting with CLD, are you looking to still put in place any further efficiencies with regard to your agreement with Salix, especially since it looks like your efforts thus far are seeing some nice positive initial traction?

David Zaccardelli -- President and Chief Executive Officer

Yes. Thanks, Joe for the question. As you know, our partnership with Salix is just coming up on a couple of quarters. As we are continuing to traction with that relationship, we're wanting to make sure that plays out fully. Currently, we continue to have a very positive, collaborative co-promotion agreement. As we see it, we will keep that in place for the foreseeable future while we progress CLD.

Joe Pantginis -- H.C. Wainwright & Co. -- Managing Director

That's helpful. The follow-up with regard to the recent CHMP opinion -- obviously, you're not going to discuss the specifics of your ongoing discussions with potential partners, but can you disclose whether you saw maybe a change in the tenor of interest following the positive opinion from CHMP?

David Zaccardelli -- President and Chief Executive Officer

I think we've had previously and currently significant interest from partners in Europe and in other areas of the world that are interested in having market access to Deptelet. We are progressing those and have collaborated and had people look at it from a due diligence perspective. So, we continue to advance that. At the same time, we want to make sure we select the right partner and are making sure we're very careful and thoughtful about that.

Joe Pantginis -- H.C. Wainwright & Co. -- Managing Director

Thank you very much.

Operator

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

Tessa -- JP Morgan -- Analyst

Hi, guys. This is Tessa on for Anupam this morning. Thank you very much for the updates here and for taking our questions in the quarter. Two from us -- you have noted the salesforce is being recruited in anticipation for the potential launch in chronic ITP. Can you provide further detail on how you are thinking about five in scope here and what the key elements would be as you guide physicians on the medical education side and maybe what that target physician patient population looks like in your view?

My second question is on CLD. I notice there looks to be a bit of a downtick in call volume and reach to healthcare prescribers in 1Q. I'm wondering what that could be attributed to and how you expect it to evolve in the next few quarters. Thanks so much, guys.

David Zaccardelli -- President and Chief Executive Officer

Thanks, Tessa. I'm going to have Jason provide you the color on both those questions.

Jason Hoitt -- Chief Commercial Officer

Thanks, Tessa. This is Jason. I'll address your second question first with regard to call volume of Q4 versus Q1. I think what you see in terms of the total number of calls and reach of physicians is purely a function of having fewer reps on board than we did in Q4 or Q1. So, if you look at the numbers of calls being made per rep over the course of the quarter, we see essentially similar results from Q4 to Q1 based on the revised size. As you recall, we reduced our infrastructure to 44 sales reps and five RDs in January. So, with fewer people, clearly, they were able to make fewer calls than the more expanded team in Q4.

With regard to our buildout in ITP. Firstly speaking, when you think about those physicians that are treating ITP, it's primarily hematologists, hema-oncs, and medical oncologists are the three main call points that cover the ITP market. With that said, as we think about hiring additional personnel into the salesforce, we're targeting folks that have deep experience in working within those specific call points. We want people that have existing relationships and understanding of the workings of practices that are caring for these patients with ITP.

From a sizing perspective, for competitive reasons, I don't want to get into the specific size of the ITP salesforce. What I will say is that it's consistent with where we've guided previously in terms of the total number of people that will be required to cover the ITP market and those physicians that are caring for patients with ITP.

Tessa -- JP Morgan -- Analyst

Thanks so much for taking our questions.

Operator

Our next question comes from the line of Geoff Porges with SVB Leerink. Your line is open.

Andrew -- SVB Leerink -- Analyst

Hi, this is Andrew calling for Geoff. A question about your short plan for ITP more specifically -- will you consider reallocating or shut down CLD?

David Zaccardelli -- President and Chief Executive Officer

Thanks for the question. I think that we are proceeding at the moment with a clear focus on CLD that is in front of us and the team is laser-focused on increasing the sales trajectory and utilization of Doptelet in CLD. We believe there is a continued unmet medical need in that space. At the same time, as you pointed out, we are preparing for ITP and building out the team to make sure we have a successful launch in ITP.

We see that both indications will be well-served as we carry on and if approved, we think we'll strike the right balance in relationship, keeping in mind our co-promotion partner, Salix, has approximately 100 sales representatives focused on CLD exclusively. I think both indications are being addressed and we continue to want to push them forward to their maximum market penetration in 2019 and beyond.

Andrew -- SVB Leerink -- Analyst

Great. Thank you. Another question -- can you comment on what advantage you have in ITP versus other products and how do you provide compatibility in that indication?

David Zaccardelli -- President and Chief Executive Officer

Yeah. Good question. I think we believe that Doptelet is going to be well-differentiated in a couple of areas, one on the safety side with regard to liver toxicity. We think that we will have a favorable profile for patients and physicians and also, on a convenience end of it with regard to taking the product with food, making it easier for patients to utilize.

Of course, I think the clinical trial results in the overall safety and efficacy of the product will speak for itself. I think that we're well-positioned to make a successful launch in the space. It is an area where TPO agonists are understood and utilized and we think Doptelet has a role in helping those patients.

As I mentioned, we will make sure we are not disadvantaged from a market access perspective in the TPO agonist space in ITP. We'll have additional information on how we're approaching that on a future call.

Andrew -- SVB Leerink -- Analyst

Thank you.

Operator

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

Jonathan Miller -- Evercore ISI -- Analyst

Hi, guys. Thanks for taking my questions. Two here on the ongoing CLD launch -- one, could you give us an updated breakdown on the different doses, what percentage of patients on a high versus the low dose and how you expect that to continue to evolve? Secondly, you mentioned that gross to net including all of the rebates and free product has been better than your early expectations. Previously, you said that gross to net number overall would be significantly higher than 25%. When you say that it's better, do you mean better than 25%? Can you give us a ballpark on overall gross to net?

Jason Hoitt -- Chief Commercial Officer

Yes. This is Jason. I'll take the first part of that question and then Mark will take the second piece around gross to net. With regard to the split between the 10 count and the 15 count, it still remains relatively consistent at about a 50/50 split between the two doses.

Mark Hahn -- Chief Financial Officer

On the second question on the gross to net, I think the way to look at that is when we are giving guidance back at launch and you put all the numbers together, I think most of the sell side and even the buy side can up with estimates of gross to net being in the high-30s to low 40s on an ongoing long-term basis.

And on our early calls, I said they were actually running significantly higher than that because of some of the programs that we had in place, making sure the patients got their medicine, even though maybe some of the payers were taking a little bit longer than we had hoped.

As we went through the course of the year and we had taken some fairly conservative views on where things like copay assistance would shake out and where Medicare obligation would shake out. As we come through and we get into the first quarter and we get through the first quarter, we're seeing the actual copay assistance coming in and the actual donut hole coverage coming in or rebates coming in.

We can see that we're running better than we had predicted when we set up our original estimates -- I guess to more directly answer your question, they are better. They're not down to the level that you indicated in your question, but I don't think we ever expected them to be that low to begin with. We always expect them to be in the high-30s to low 40s.

Jonathan Miller -- Evercore ISI -- Analyst

That makes sense. Thanks so much.

Operator

As a reminder, ladies and gentlemen, that's' *1 if you would like to ask a question, * then the 1 key on your touch-tone telephone. Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Your line is open.

Matt Kaplan -- Ladenburg Thalmann -- Managing Director

Good morning, guys. I wanted to dig in a little bit more to the CLD indication and specifically how is the product performing in the second quarter since the launch of the new marketing strategy being implemented?

Jason Hoitt -- Chief Commercial Officer

This is Jason, Matt. As you recall, the new marketing campaign, our new positioning, method, and the campaign associated with it launched in -- so, we trained our sales team in the first week of April and then it hit the field the second week of April. We're still only a few weeks into this new campaign associated with the risk of bleeding and the real call to action for physicians to treat these patients and take a more proactive stance.

What I can tell you is the feedback we're hearing from our field team is incredibly positive in terms of the new campaign and the new messaging leading to an increased productivity in the nature of the conversations they're having with physicians around the risks associated with bleeding and thrombocytopenic patients with chronic liver disease. It's a great start, I would say, based on the feedback we're hearing from the field and we're hearing from customers. However, we're going to continue to monitor that progress over the course of the rest of the quarter and into the third quarter.

Matt Kaplan -- Ladenburg Thalmann -- Managing Director

Okay. That's helpful. Staying in CLD, how has the Salix partnership been performing in the first quarter and what you're seeing now?

Jason Hoitt -- Chief Commercial Officer

This is Jason again. So, I would say that given that the first quarter was the first full quarter that the Salix team has been deployed, focused on those GI targets where they have their core area of expertise, we continue to see nice growth in the base of new prescribers across the board. I would say that we're hitting our stride in terms of our relationship with Salix all the way from a leadership level down to a territory level on a rep to rep coordination of key offices.

The relationship is evolving in a really nice way. We're seeing results of the relationship. As we've said previously, it will take a couple of quarters in the field to see the results of the impact of the relationship, but as you can see, Salix was able to reach an additional 9,000 HCPs beyond what the Dova sales team was able to do in the quarter. So, we are seeing results from the team and we're happy with how the relationship with Salix is progressing.

Matt Kaplan -- Ladenburg Thalmann -- Managing Director

And then in that vein, how has the product been prescribed across the different specialists? Can you give us some detail there?

Jason Hoitt -- Chief Commercial Officer

So, what I can say is that when we look at the breakdown of our referrals, 92% of the referrals that have come in have come from offices of hepatologists, hematologists, gastroenterologists, and interventional radiologists. About 70% of those come from the hep and GI world, which isn't surprising given that we're focused on chronic liver disease patients. Then if you look at an further breakdown, 79% of the referrals are coming from the offices in HCPs decile seven through ten.

We're seeing the bulk of the business coming from what likely isn't surprising to you guys, but we're seeing the bulk of the business coming from the highest likelihood offices. When we talk about the office, we're talking about the office as a whole. So, it could be the nurse practitioner or the PA that works underneath or works with a hepatologist or gastroenterologist.

Matt Kaplan -- Ladenburg Thalmann -- Managing Director

That's very helpful. Then last on CLD -- are you seeing any competition from lusutrombopag and what has that been like?

Jason Hoitt -- Chief Commercial Officer

So, again, what we're hearing is to a degree anecdotal, as we've said previously. We don't see sales data specifically for lusutrombopag, but we're hearing that they have their contract sales team out there in offices. Anecdotally, I'm not hearing anything that's concerning from a competitive perspective in terms of traction that they'd be gaining with any of the key opinion leaders. We know that contract organization is out there, but anything beyond that would be anecdotal at this point.

Matt Kaplan -- Ladenburg Thalmann -- Managing Director

Shifting to ITP as you're preparing for the launch there, what are your thoughts on how to handle pricing in that indication?

Jason Hoitt -- Chief Commercial Officer

So, I think we've done the research necessary to come up with our approach and strategy at the time of a potential ITP approval. What I would say is consistent with what we've said previously, we will not allow market access to be a barrier to Doptelet getting to the patients that need it. I think at this point, that's probably as far as we're going to go with regard to the market access strategy. As you know, there are a number of levers that can be pulled in the market access realm and we're strategically ready to go and come PDUFA, we'll provide more clarity around the overall commercialization strategy inclusive of our market access approach.

Matt Kaplan -- Ladenburg Thalmann -- Managing Director

Thanks, Jason. Congrats on the progress, guys.

Operator

I'm showing no further questions at this time. I'd now like to turn the call back over to David for closing remarks.

David Zaccardelli -- President and Chief Executive Officer

Thanks, again, everyone for joining today and we look forward to updating you on our future calls. Have a great day.

Duration: 36 minutes

Call participants:

David Zaccardelli -- President and Chief Executive Officer

Mark Hahn -- Chief Financial Officer

Jason Hoitt -- Chief Commercial Officer

Joe Pantginis -- H.C. Wainwright & Co. -- Managing Director

Tessa -- JP Morgan -- Analyst

Andrew -- SVB Leerink -- Analyst

Jonathan Miller -- Evercore ISI -- Analyst

Matt Kaplan -- Ladenburg Thalmann -- Managing Director

More DOVA analysis

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