Eagle Pharmaceuticals Inc (EGRX) 2015 Q2 法說會逐字稿

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  • Operator

  • Welcome, everyone, to the Eagle Pharmaceuticals' second-quarter 2015 earnings results conference call.

  • (Operator Instructions)

  • As a reminder, this conference call is being recorded today, August 11, 2015. It is now my pleasure to turn the floor over to Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. Ma'am, you may begin.

  • - IR

  • Thank you, Keith. Welcome to the Eagle Pharmaceuticals' second-quarter 2015 earnings call. This is Lisa Wilson of In-Site Communications Investor Relations for Eagle Pharmaceuticals. With me on today's call are Scott Tarriff, President and Chief Executive Officer and David Riggs, Chief Financial Officer. This morning, the Company issued a press release detailing financial results for the three-months ended June 30, 2015. This can be accessed in the Investor section of the Eagle website at EagleUS.com. You can also access the webcast of this call from there.

  • Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation or intent regarding future events and the Company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to Eagle Pharmaceuticals' management as of today and involve risks and uncertainties, including those noted in this morning's press release and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. Eagle Pharmaceuticals specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law.

  • A telephone replay of the call will be available shortly after completion through Tuesday, August 18. You'll find dial-in information in today's press release. The archived webcast will be available for one year on our website at EagleUS.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on August 11 of 2015. Since then, Eagle may have made announcements related to the topics discussed, so please reference the Company's most recent press releases and SEC filings.

  • With that, I'll turn the call over to Eagle's CEO, Scott Tarriff.

  • - President & CEO

  • Thank you, Lisa. Good morning, everyone. This was another positive quarter for Eagle, highlighted by progress in both R&D and commercial execution. We now have three NDAs on file with FDA, with PDUFA dates in the coming eight months for products that will enter very large markets, where we believe our improved formulations will enable us to win significant market share. The nearest of these is our Rapid Infusion, Ready-To-Dilute, Bendamustine product, which will be marketed by Teva. This product has a December PDUFA date and if approved, we believe that the additional milestone in royalty payments we will receive as a result of Teva's marketing efforts would expedite our ability to deliver long-term sustainable growth. I will discuss this and other developments in greater detail later on the call. But first, I'd like to ask our CFO, David Rigs, to review the results of the quarter. David?

  • - CFO

  • Thank you, Scott. Our revenue mix has changed since June 30, 2014. Today, our revenues consistent of one, product sales, comprised of sales of Ryanodex, which we launched in August 2014 and sales of Diclofenac/misoprostol, which we launched in January 2015 and sales of Argatroban to two commercial partners. Two, royalties we receive on commercial partner net product sales of Argatroban to their respective customers. Finally, three, license and other income. For the three-months ended June 30, 2015, total revenues were $6 million, as compared with $5.8 million in the prior-year quarter. The increase was driven by $1.4 million in net sales of Ryanodex, $600,000 in net sales of Diclofenac/misoprostol and a $1.3 million increase in Argatroban sales during the 2015 period, coupled with a $300,000 increase in royalty income, offset in part by the absence of license and other income. As you may recall in the second quarter of 2014, we recorded $3.5 million related to a milestone event associated with the FDA approval of Diclofenac/misoprostol. There was no license or other income in the second quarter of 2015.

  • R&D expense increased by $1.3 million to $5.9 million in the second quarter of 2015 compared to the prior-year quarter. The increase reflects an increase in spending due to the timing of the bivalirudin NDA submission, costs related to the Pemetrexed program and higher salaries and other personnel-related expenses. These costs were offset in part by a decrease in spending related to Bendamustine, for which we submitted the NDA in the first quarter 2015 and Diclofenac/misoprostol spending, which we launched in January. SG&A expense increased by $2.4 million to $5.1 million in the second quarter of 2015 compared to the prior-year quarter. Sales and marketing expenses for the second quarter of 2015 increased by $1 million from the prior-year quarter to $1.9 million, primarily driven by a $1 million in Ryanodex marketing expenses. Additionally, salary and personnel-related expenses increased by $1.2 million. Professional fees increased by $200,000 over the prior-year period. Net loss attributable to common stockholders was $8.2 million for the second quarter of 2015, or $0.53 per basic and diluted share compared to a net loss attributable to common stockholders of $2.9 million or $0.21 per basic and diluted share for the same period last year. We closed the quarter with $103.7 million in cash, cash equivalents and short-term investments and $194.6 million in additional paid-in capital. We had $96.4 million in stockholders equity as of June 30, 2015.

  • With that, I'll turn the call back over to Scott.

  • - President & CEO

  • Thank you, David. This was another very positive quarter for Eagle, highlighted by the FDA accepting two Eagle NDAs for filing. The first of these is our NDA for the Rapid Infusion, Ready-to-use Bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with Rituximab or with Rituximab containing regimen. This is the same indication as Teva's Treanda, but our product is administered in 10 minutes, in a 50 mL admixture, as opposed to 30 minutes or 60 minutes in a 500 mL admixture. The target date for action on this NDA is December 13, this year. Our Bendamustine product has orphan drug designation for the treatment of CLL and indolent B-cell NHL when administered in low volume and a short infusion time. This may afford seven years marketing exclusivity upon approval. Additionally, a new patent pertaining to the Rapid Infusion Bendamustine product was granted in the second quarter, which extends it patent coverage out all the way to March of 2033. We believe the IP surrounding our formulation combined with the orphan drug designation for this product to treat NHL and CLL may provide longevity for the product. Several additional patents are pending at the patent office. I'm pleased to note today that we recently received notice of allowance for one of these patents. We expect it to be issued shortly. We'll provide more details in due course.

  • We believe our marketing partner, Teva, will be highly successful in converting the market to Rapid. We expect a full or nearly full conversion to Rapid relatively quickly. The shorter infusion time will benefit patients and the infusion centers alike. We believe as Teva indicated on its most recent earnings call on July 30, that it is going to be a very important product. We eagerly await the FDA's decision on Rapid Infusion Bendamustine, which will trigger an approval milestone from Teva and facilitate the product launch by Teva. We continue to plan to file for an unique J-code for Rapid by the end of this year. We're hopeful that it'll be granted. I look forward to a preliminary decision most likely in April or May of 2016. We also have the contractual right to launch our tentatively approved liquid Bendamustine in a 500 mL bag. That starts May 1, 2016. I wanted to highlight that our liquid formulations are DMA free and so will not face the same issues that Teva's liquid Treanda formulation has encountered when used with closed system applicators. We believe there is an opportunity for our liquid formulation of Bendamustine in both the 50 mL Rapid Infusion and the 500 mL admixture.

  • Now, moving on to our Ready-To-Use or RTU bivalirudin candidate. We filed the NDA during the second quarter. We look forward to FDA's decision in March of 2016. This product is our enhanced Ready-To-Use version formulation of bivalirudin, the same ingredient that's in the Medicines Company's anticoagulant, Angiomax, which had US sales of over $600 million in 2014. Unlike Angiomax and potential generics, our RTU bivalirudin is a stable liquid IV ready to use liquid formulation. It requires no manipulation, the nurse can simply spike it and hang it. We believe this will be a key driver of adoption of our product assuming FDA approval. We would also expect to benefit from the relationship we continue to build for Ryanodex. Importantly, we have recently renegotiated our licensing arrangement with SciDose on RTU bivalirudin and our optimized formulation of Pemetrexed, the active ingredient in Alimta. Under the new term, payments will be 15% and 25% of net profit respectively. Each of these (inaudible) represents a substantial reduction from our previous potential payment obligation for these products and will increase our margin on sales of these products assuming regulatory approval. To quickly touch base on Pemetrexed, our product is an optimized version of Lilly's Alimta. We tagged US sales of $1.2 billion in 2014. The branded product is a branded product is a lyophilized powder, cytotoxic indicated for non-small cell lung cancer. As with RTU bivalirudin, our liquid formulation requires no reconstitution and no dilution, meaning the healthcare staff is less exposed to cytotoxic vapors. We are moving forward with this opportunity and expect we will be in a position to launch with generics in a few years.

  • Now, turning over to Ryanodex, our optimized dantrolene product for the treatment of Malignant Hypothermia. As Dave mentioned, sales were $1.4 million in the second quarter. Additionally, our average selling price during the quarter declined slightly to $2,082 per vial down from $2,210 in Q1. Our external sales force was realigned in Q2 to better fit Eagle's needs and allow for better alignment in the field. During the second quarter, 95% of our unit vial volume was sold to hospitals and medical centers, up from 92% reported at the end of Q1. Hospitals and medical centers represent a highly desirable market with a greater return per sale and we believe will play a significant role in making Ryanodex the standard of care for MH. Ryanodex is now available at leading hospitals, and universities throughout the country, including the Mayo Clinic hospitals, the University of North Carolina and Dignity Health, to name a new. We look forward to achieving further market penetration going forward. Furthermore, because the product represents such an improvement over existing treatment options, due to the significantly shorter admin time of Ryanodex versus the old 12-vial formulation and the reduction in diluent volume among other aspects, we believe that a switch to Ryanodex will continue to grow.

  • As I had mentioned, we view Ryanodex as an annuity, we expect that MH will be eclipsed however by the larger opportunity for this product, the second indication, the treatment of Exertional Heat Stroke or EHS. EHS is a sudden, unpredictable and life-threatening condition. It mostly affects adolescents and young adults and is a leading cause of death among high school, college and high-performing athletes. It is a leading cause of non-combat related death among military personnel. The main criteria for diagnosing EHS are rectal temperature above 104 degrees Fahrenheit, central nervous system dysfunction and metabolic abnormalities. Morbidity and complications such as severe liver and kidney failure, acute coagulation disorders are directly related to the time that the core body temperature remains above the critical threshold. Current standard of care is limited to cooling the patient as quickly as possible within 30 minutes of diagnosis via whole body water emersion with administrating fluids. There are no drug products on the market to treat this potentially fatal and critical unmet need. Scientific evidence indicates that EHS may be linked to Malignant Hypothermia, for which Ryanodex is currently approved. The same genetic mutation in MH patients has been found in many patients with EHS. Given that Ryanodex can be reconstituted and administered in less than one minute, by one clinician in just 5 mLs of diluent, we believe it may offer significant patient benefits in treating Exertional Heat Stroke.

  • We are actively planning to conduct a meaningful study in Saudi Arabia this September during Hajj. The proscribed rights of this pilgrimage entails strenuous physical effort at a time when daytime temperatures at Mecca typically soar above 100 degrees. In fact, yesterday, the temperature in Mecca was 111 degrees Fahrenheit. It is expected that tens of thousands of the 2.5 to 3 million participants attending from around the world will be afflicted with heat-related disease. Our study will be conducted at four hospitals in the Mecca region with the top emergency medical experts on heat stroke participating as investigators. We will select patients who are between the ages of 18 and 45 and who met the criteria of EHS: hypothermia, mental impairment and muscle involvement. Half of these patients will receive standard of care and the other half will receive standard of care plus Ryanodex. Given the potential genetic link between MH and EHS, we are conducting genotype testing on every patient entering the study to see if they're positive for the known mutations identified in MH. Our evaluation also includes using universally validated assessments for mental status, cardiovascular and metabolic abnormalities and laboratory tests to assess liver and kidney impairment and coagulation disorders, which are all key issues with the disease. Our planned study will evaluate the safety and efficacy. While it may not serve as a pivotal study for FDA approval, I want to emphasize that we are collecting clinically meaningful data. We have improved the robustness of the study over the past few months.

  • Eagle has been working with the Saudi health authorities and the Saudi medical community. We are extremely pleased with their knowledge and commitment. This EHS study is a very novel and difficult study. With the help of many leading experts, we're hopeful that we will have a positive outcome. Keep in mind, that the study starts in only about five weeks from now. Once the study is complete, we'll analyze the data and meet with the FDA to determine next steps. Given our prior discussions with FDA and how devastating this disease truly is, we're optimistic that we'll succeed in expanding Ryanodex's label to include Exertional Heat Stroke. Hopefully provide significant therapeutic options for this life-threatening condition. The orphan drug designation in the US for EHS as well as a US patent for heat stroke, we believe Ryanodex would have substantial longevity in EHS, assuming that we're successful in gaining the label expansion. Of course, the product also has orphan drug exclusivity in the US for MH as well as designation in the EU. Coupled with our four orange book listed patents, we believe we'll enjoy a long life cycle of Ryanodex.

  • With the $30 million upfront payment -- the $30 million from Teva under the Bendamustine agreement and a $54.3 million in net proceeds from the underwritten public offering of Eagle common stock during the second quarter, Eagle is well-capitalized to pursue multiple opportunities for future growth. We believe our position will only strengthen if FDA approves the Rapid Infusion product because this would trigger another milestone payment from Teva and facilitate the launch of this important product. We look forward to the FDA's decision for Rapid on or before December 13. With this important product launch in Teva's very capable hands and the expectation of a solid revenue stream with no sales costs, we are focusing on methodically growing Ryanodex sales while identifying, developing, licensing and commercializing other value-added products. We expect to launch RTU bivalirudin in March, then followed by RTD Bendamustine in the 500 mL bag early May of next year. We expect to be marketing at least four products by the end of Q2 next year, while enjoying double-digit royalties from Teva on Rapid. This, coupled with a strong balance sheet, affording us financial flexibility and additional opportunities in our pipeline, gives us great confidence in our ability to deliver value to our shareholders.

  • With that, I'd like to open the call for questions. Operator, please go ahead with the instructions.

  • Operator

  • (Operator Instructions)

  • David Amsellem, Piper Jaffray.

  • - Analyst

  • I have a couple. So first on the Bendamustine products. I was wondering if you could perhaps provide a little insight into how we should think about the role of the small bag and the role of the big bag bearing in mind that you -- if you so chose, could launch the big bag product next May. So I guess with that in mind, would you expect that with FDA action in December, do you think that Teva would just launch and just do a hard switch, obviating the need for launch on the big bag? Or is there going to be a role for the big bag come May 2016? Maybe try to help us understand that because I think that there is a number of moving parts here that make it a little bit difficult to model. So if you could help us there, that'd be great. Thanks.

  • - President & CEO

  • Thanks, David. It's good to hear from you. I think everything you said is correct. Bendamustine Rapid launches obviously this year. As I just mentioned, we believe that there will be a nearly full if not full conversion to Rapid. Now if timing goes according to plan, that conversion to Rapid is going to occur prior to May 1, when we launch the big bag. We have the right to launch the big bag. We will launch the big bag in May.

  • Now keep in mind, what we've said so many times previously, the way the financial relationship works between the two companies. They pay us a double-digit royalty on what they sell. We pay them the same double-digit royalty on what we sell. So therefore, we earn quite a bit more for every vial that we sell under the Eagle name than under the Teva name. So we'll take advantage of our May 1 opportunity. There's a large segment of the business, David, that is a little bit more price sensitive than others, that would hold value in being able to buy at a slightly lower price than having the big bag. So we see both products fitting into the marketplace perfectly. We'll take advantage of the profit opportunity we have by launching the big bag.

  • - Analyst

  • So to be clear, you don't think that there's a inherent conflict in launching a product that ostensibly will complete with Teva, who as it turns out is also your partner. Particularly considering that they could very well should succeed at a full conversion. There's no inherent conflict there that you see? In other words, maybe to paraphrase you, they are customers. That Teva, essentially will just concede to you, that particularly the price sensitivity? Is that the way to think about it?

  • - President & CEO

  • I don't know what Teva is going to do, David. But I think the point in all of this is that the relationship between the two companies, which I have to tell you is going incredibly well. They're just wonderful people there, we deal with them every day between committees and subcommittees. There's a lot of work to be done in the reimbursement, in the orphan drug designation and the launch plans and the supply chain. The companies work very, very well together. I'm enjoying the relationship between the two firms. But it's what was contemplated in the contract when we negotiated and what we all bargained for several months ago. It was known that obviously we have the May 1 date. I think there's a place in the market where big bag will be well-received and because of the profit that we earned on it, we'll do everything we can to create value for our shareholders.

  • - Analyst

  • Thanks. Then if I can ask a follow-up, so you're going to be launching in May. Then you also have the Bivalirudin product. I may have missed this earlier, but just give us your latest thoughts on when you'll start to hire additional reps? Is it safe to say that these will be your own reps? You're not going to deploy a contract sales force here? Maybe talk about the headcount as well as you're going to need to support these launches?

  • - President & CEO

  • Yes, A very, very good question, David. I think that is the one area still left unresolved for Eagle as we go forward. That is how we build that sales force. There are numerous options that we're looking at currently on how to do that and best optimize the P&L. But as you point out, we do have Ryanodex, which is with a contract sales organization. Ryanodex' sales, we believe would be benefited by having more people selling it. Right now, we don't want to put more people selling just one product, especially given its size. So we're handcuffed there a little bit. What we're expecting then, as you turn the corner into next year, we'll have three marketed products Ryanodex, big bag and the Ready To Use Bivalirudin. In addition, we'll be getting royalty from Teva on their sales of Rapid. As a Company, we're looking at all opportunity now to build a sales force. A contract sales force wouldn't necessarily be our first choice, but it's certainly a viable choice. We could -- we can build a sales force ourselves. We can co-promote. We can actually do a combination of all of the three. We're very attuned to the fact that the launch period is critical anytime you bring a new product to the market. We're also very cognizant of bringing too much sales cost into the Company's P&L too soon. We're looking to balance all those aspects. We don't have a firm answer for you at this point. But we're working diligently. We expect that we'll have a path forward on how we plan to market these three drugs next year pretty shortly.

  • - Analyst

  • All right. Thank you.

  • - President & CEO

  • Yes. Thank you very much.

  • Operator

  • Randall Stanicky, RBC Capital Markets.

  • - Analyst

  • Scott, just a follow-up, can you talk about the durability of cash flows from both the big bag but also Rapid? How does that change or not change in the face of a generic lyophilized product? Obviously, we'll have a better idea of that once we move post trial and decision. But obviously you're thinking of launching big bag has to play and I would assume to your thinking around the lift from generic at some point down the road?

  • - President & CEO

  • Yes. A very good question, Randall, all the way around. So it's really very interesting. As I outlined previously, our view of the world is, we'll have big bag and Rapid on the market at the same time. The Markman hearing that took place a few months ago gives us pretty good comfort that there shouldn't be generics on the market for quite a while -- lyophilized generics. You're right, we'll know more after the trial coming up. I would note that Teva's settled with many of these ANDA holders already. Let's see what happens by the time you get to the end of November when you have the trial. It's our belief that we won't see ANDAs for a while. Obviously, there's not complete certitude around that, so we have to be guarded.

  • Again part of our decision-making in launching the big bag is the profit that we'd make on it compared to just collecting the royalty on Rapid. But what I would remind everyone again, which goes into our thinking pretty importantly, is that the way this contract is designed that the day that there is a generic Bendamustine in any form, we have the right to terminate Teva and to bring Rapid back into Eagle and market both products. I suppose there is a possibility that could happen while there's still seven years of exclusivity due to the orphan drug exclusivity. Based on that, our ability to eventually have Rapid back, the profit from the big bag, the profit from the little bag, the way the market is shaped up, the seven years of exclusivity we hope to get, and then all these patents we have had; right? This is going to be our fourth patent protecting our product -- probably four orange book listed patents here. We think we've created a situation where we're going to have a significant amount of profit coming into this Company for a lengthy period of time. That's the way we see the market unfolding. It obviously -- it has to play out. But that's our view at this point.

  • - Analyst

  • Scott, that would be -- if you do take back Rapid, would those -- the profits from both of those products be royalty free to Teva? You wouldn't have to pay them anything?

  • - President & CEO

  • No. We still pay the double-digit royalty even after that period of time.

  • - Analyst

  • Okay. I have one follow-up. Can you talk about your expectations for Bivalirudin? Specifically, the question I have is, should we be looking at your ability to go into that market that will be genericized with the differentiated offering as an analog for how some of the other markets could play out? I'm thinking with Bendamustine itself, Alimta -- should we expect to see [repeats] of those other opportunities?

  • - President & CEO

  • Randall, also a very interesting question. I think the way to look at Eagle is every product has a different story and every product has a different set of qualities. There's a range of value. So I would say when we have a product like Rapid, which in my mind offers unusual benefit to the patient, I think, we have to look at that as a separate analog than Bivalirudin or Angiomax or a lyoto liquid cytotoxic. The Argatroban product that we launched several years ago was a good analog. Our market share, last I looked, after about 3.5 years is over 40% of the market. It's sticky share because it's not generically rated to the ANDAs when they come to the market. Typically ANDA holders do not have the ability to go back in with a sales force and speak directly to pharmacy to make that conversion back. I think on Bivalirudin, we should do very well if things go according to plan. Part of the reason why we need a sales force, we need to be speaking to hospital pharmacy, reminding them of the value of a Ready To Use product that is reconstituted primarily in the cath lab. So we believe we will gain very strong market share with this product. It should be sticky. We should keep it once we gain it. But I would look at all of these products, product by product, when you analyze the tail or the longevity of our products.

  • - Analyst

  • That's great. Thanks, Scott.

  • - President & CEO

  • You're welcome. Thank you.

  • Operator

  • (Operator Instructions)

  • Tim Lugo, William Blair.

  • - Analyst

  • Scott, do you have any rough estimates for how large that market is that's maybe more price sensitive and more amenable to the big bag bin there versus Rapid? Is it a minority? Is it 60%? Any sort of rough guidance would be helpful.

  • - President & CEO

  • Yes, Tim, the best our research indicates that we're talking about a 20% to 25% share of the market. It's primarily these disproportionate share hospitals, the dish hospitals, which best described as large charity care centers across the state. We think the number is somewhere along those lines.

  • - Analyst

  • Okay. You mentioned that you're expecting a Rapid conversion if December 13 goes well. Is that spelled out in the agreement? Or is that just based on the public commentary from Teva while your conversations in here points there?

  • - President & CEO

  • It's not spelled out in the contract, Tim. But it's based on not only their public comments but the interaction that we have had with them in the last few months. There's a lot -- I mentioned earlier, there's just a lot of dialogue between the two companies as we both prepare to make this a very important launch. There's a lot that goes into being successful here. We speak to the daily. Again wonderful people and our views of conversion is based on all of our interaction and just our view of the marketplace.

  • - Analyst

  • Understood. I guess switching to the dantrolene Saudi study, it sounds like a robust study. It sounds like you're going to have potentially large numbers enrolled. How many true EHS patients do you think you'll be capturing in the study? Maybe for David, there's a generic testing component. I assume R&D will be picking up next quarter?

  • - President & CEO

  • Do you want to take the expense --

  • - CFO

  • Sure, Tim, thank you. We expect to see R&D basically at the same levels that you've seen recently especially around the level of the first quarter. Mainly because the spending in the Bendamustine has tailed off. We filed the Bivalirudin NDA.

  • - Analyst

  • Okay, that's good to hear. Maybe Scott, do you have any estimates for how many treated EHS patients you'll be enrolling?

  • - President & CEO

  • Yes, so Tim, the study certainly has become far more robust over the last few months. I think the team here at Eagle have, with help from the Saudi team, has really done a great job turning this into not just a safety study but also collecting some very meaningful clinical work. It's just a very different-looking study than it was six months ago. We're just thrilled with the way it looks like it's turning out, hopefully. I mean it's difficult to conduct a clinical trial in Saudi Arabia during the Hajj. This is, I think, it's landmark in many respects. As I mentioned earlier, typically, in the typical year, there's 2.5 or 3 million people. There are a very significant number of heat-related illnesses during the Hajj.

  • Now, what FDA has told us, fortunately, very good news, that in terms of the safety component, heat illness is acceptable. It doesn't need to be Exertional Heat Stroke. We don't know how many patients we'll get. We'd love to get 100, 50 and 50. We'll have plenty of drug at these four hospitals to dose more patients than that. We're targeting patients in that 18 to 45-year bracket that had the symptoms that are more likely to be EHS as opposed to other heat illnesses. But it's hard to tell exactly how many we'll get, It looks like if this is a typical season, that there's more than enough potential patients to make this a meaningful study, we are just going to have to wait and see.

  • - Analyst

  • Understood. It sounds like your collecting a significant amount data. Is there, what are the expectations for when you'll be able to release top line from the study?

  • - President & CEO

  • Yes, it'll definitely be the best we can tell, Tim, it'll be this year. We're going to try as quickly as we can -- I can't promise that it's going to be October but hopefully November. Let's see what we collect and how many patients that we have. But it won't be long. The study runs from the 19th until I think it's the 27th. Somewhere in there. So the data of collection period is short. Hopefully with some luck, we'll get some patients that are not migrating back to their home countries. It would be great if we get a handful of these patients that we can actually monitor over a six-month period of time. I don't know if we'll be successful in that. As soon as we have the data, the FDA's asked us to come back with the data and sit with them one more time to decide what to do going forward. They seem to be very interested. The community is interested. We'll report back as soon as we can. Five weeks from now, we'll start dosing patients. We'll see how we do.

  • - Analyst

  • Sounds like an interesting study. Thanks for taking my questions.

  • - President & CEO

  • A very interesting study. Thank you.

  • Operator

  • It appears we have no further questions at this time. So I'll return the floor back to Scott Tarriff for any additional or closing remarks.

  • - President & CEO

  • Well, thank you. Thank you everyone for taking the time to listen. Another wonderful quarter for Eagle. I look forward to providing further updates. It's a very meaningful year, obviously for the Company. Again, thank you. I appreciate it.

  • Operator

  • This does conclude today's program. Thanks for your participation. You may now disconnect. Have a great day.