image
Healthcare - Drug Manufacturers - Specialty & Generic - NASDAQ - US
$ 0.9
12.7 %
$ 11.7 M
Market Cap
1.06
P/E
EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2015 - Q2
image
Executives

Lisa Wilson - Investor Relations, In-Site Communications, Inc. Scott Tarriff - President and Chief Executive Officer David Riggs - Chief Financial Officer.

Analysts

David Amsellem - Piper Jaffray Randall Stanicky - RBC Capital Markets Tim Lugo - William Blair & Company.

Operator

Good morning. My name is Keith, and I will be your conference operator today. At this time, I would like to welcome everyone to the Eagle Pharmaceuticals Second Quarter 2015 Earnings Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer period.

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

Lisa Wilson

Thank you, Keith. Welcome to 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 through the Investors section of the Eagle website at eagleus.com, and 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 will find dial-in information in today’s press release. The archive 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 our archive webcast, this call was held and recorded on August 11, 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. And with that, I’ll turn the call over to Eagle’s CEO, Scott Tarriff..

Scott Tarriff

Thank you, Lisa, and 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 the 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, if approved, we believe that the additional milestone and 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 Riggs to review the results of the quarter.

David?.

David Riggs

Thank you, Scott. Our revenue mix has changed since June 30, 2014.

Today, our revenues consist 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 of 2015, and sales of argatroban to two commercial partners; and two, royalties we receive on commercial partner net product sales of argatroban to their respected customers; and finally three, license and other incomes.

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 $300,000 increase in royalty income, offset in part by the absence of license and other income.

As you may recall in the second 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 of 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 $1 million in RYANODEX marketing expenses. Additionally, salary and personnel related expenses increased by $1.2 million and 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, and we had $96.4 million in stockholders’ equity as of June 30, 2015. And with that, I’ll turn the call back over to Scott..

Scott Tarriff

Well, 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 a rituximab-containing regimen.

This is the same indication as Teva’s Treanda, but our product is administered in 10 minutes at a 50 ML admixture, as opposed to 30 minutes or 60 minutes in a 50 ML admixture. The target date for action on this NDA is December 13, this year.

Our bendamustine product is 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 its 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. And I’m pleased to note today that we recently received notice of allowance for one of these patents. We expected to be issued shortly and we’ll provide more details in due course.

We believe our marketing partner Teva, will be highly successful in converting the market to rapid, and we expect a full or nearly full conversion to rapid relatively quickly. The shorter infusion time will benefit patients and the infusion centers alike.

And 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 unique J-code for rapid by the end of this year, and we’re hopeful that it will be granted and look forward to preliminary decision most likely in April or May of 2016. We also have a contractual right to launch our tentatively approved liquid bendamustine in a 500 ML bag and that starts May 1, 2016.

I want to highlight that our liquid formulations are DMA-free, and so we’ll not face the same issues that Teva’s liquid TREANDA formulation has encountered, when used with closest dima-applicators [ph]. 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 onto our ready-to-use or RTU bivalirudin candidate, we filed the NDA during the second quarter, and 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 is in the medicine’s companies anticoagulant Angiomax, which had U.S.

sales of over $600 million in 2014. Unlike, Angiomax and potential generics, our RTU bivalirudin is a stable liquid ID ready-to-use liquid formulation, it requires no manipulation. The nurse can simply spike it and hang it, and 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 Sidos [ph] on RTU bivalirudin and our optimized formulation of pemetrexed, the active ingredient of Alimta. Under the new terms, payments will be 15% and 25% of net profit respectively.

Each of these developments represents a substantial reduction from our previous potential payment obligation for these products, it will increase our margin on sales of these products assuming regulatory approvals. To quickly touch base on pemetrexed, our product is an optimized version of Alimta, which had U.S. sales of $1.2 billion in 2014.

The 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’re 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 $22,010 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 for sale, and we believe we’ll play a significant role in making RYANODEX the standard of care for MH.

RYANODEX is now available in leading hospitals and universities throughout the country, including the Mayo Clinic Hospitals, University of North Carolina, and Dignity Health to name a few. We look forward to achieving further market penetration going forward.

Furthermore, because the product represent 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 biluvin [ph] vial volume, among other aspects, we believe that a switch to RYANODEX will continue to grow.

As I mentioned, we view RYANODEX as an annuity. We expect that MH will be eclipsed however, at 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, and is a leading cause of non-combat related death among military personnel. The main criteria for diagnosing EHS are rectal temperature above 104 degree 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 immersion with administrating fluids. There are no drug products in the market to treat this potentially fatal and critical unmet need.

Scientific evidence indicates that EHS may be linked to malignant hyperthermia 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 five MLs of biluvin, 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 pro-scribe [ph] rites of this pilgrimage entails strenuous physical effort at a time when daytime temperatures at negative – 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 million to 3 million participates 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.

You 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 are 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 test to assess liver and kidney impairment and coagulation disorders, which are all key issues with the disease.

Our planned study will evaluate both safety and efficacy, and while it may not serve as a pivotal study for FDA approval, I want to emphasize that we are collecting clinically meaningful data. We haven’t proved the robustness of this 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, and with the help of many leading experts, we are hopeful that we will have a positive outcome.

Keep in mind that the study started 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 are optimistic that we will succeed in expanding RYANODEX label to include exertional heat stroke and hopefully provide significant therapeutic option for this life-threatening condition. With orphan drug designation in the U.S. for EHS, as well as a U.S.

patent for heatstroke, we believe RYANODEX would have substantial longevity in EHS assuming that we’re successful in gaining the label expansion. And, of course, the product also has orphan drug exclusivity in the U.S.

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 with RYANODEX.

With the $30 million upfront payment to $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 cost, 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 and 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] We can take our first question from David Amsellem with Piper Jaffray. Please go ahead..

David Amsellem

Thanks and 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 products next May.

So, I guess, with that in mind, is it, would you expect that, with FDA action in December, do you think that Teva will 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, 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 would be great. Thanks..

Scott Tarriff

Thanks, David. It’s good to hear from you. So, I think everything you said is correct. Bendamustine rapid launches, obviously, this year. And as I just mentioned, we believe that there will be nearly full, not full conversion to rapid.

Now, 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 and we will launch the big bag in May.

Now, keep in mind, what we said so many times previously the way the financial relationship works between the two companies, they pay us double-digit royalty on what they sell, and we pay them the same double-digit royalty on what we sell.

So, therefore, we earn quite a bit more for every file that we sell under the Eagle name than under the Teva name. So we’ll take advantage of our May 1 opportunity.

And there are a – there’s a large segment of the business, David, that is a little bit more price-sensitive than others that would hold value and is being able to buy at a slightly lower price, and having the big bag.

And so we see both products fitting into the marketplace perfectly, and we’ll take advantage of the profit opportunity we have by launching the big bag..

David Amsellem

So to be clear you don’t think that there is an inherent conflict in launching a product that are sensibly would compete with Teva who at the time there is also your partner and if they – and particularly considering that they very well should succeed at a full conversion if you don’t, there is no inherent conflict there that you see.

In other words, there is maybe – to paraphrase you this, their customers at Teva essentially will just concede to you that piece of the price sensitivity, and is it that the way to think about it?.

Scott Tarriff

Well, I don’t know what Teva is going to do, David. But I think the point this is that, the relationship between the two companies, which I have to tell you is going incredibly well. I mean, 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, in the launch plans, and he supply chain. The companies worked 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, and it was known that, obviously, we have the May 1 date.

And I think there’s a place in the market, where big bag will be well received and because of the profit that we earn on it, we’ll do everything we can to create value for our shareholders..

David Amsellem

Okay. And, let me ask a follow-up, so you are going to be launching in May and then you also have bivalirudin products, so and then we missed this year.

But just give us your latest thoughts on when you start to hire additional reps, and is it safe to say that these would be your own reps you are not going to deploy the contract sales force here and maybe talk about the head count, as well as given any to support these losses?.

Scott Tarriff

Yes, very, very good question, David. I think that is the one area still left unresolved for Eagle, as we go forward, and 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.

In RYANODEX sales, we believe would be benefited by having more people selling in. Right now, we don’t want to put more people selling just one product, especially given its size, and we’re handcuffed there a little bit.

And 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 by bivalirudin. In addition, we’re getting royalty from Teva on their sales of rapid. And as a company, we’re looking at all opportunities now to build the sales force.

The contract sales force would necessarily be our first choice, but it certainly a viable choice we could – we can build the sales force ourselves. We can co-promote and we can actually do a combination of all the three.

We’re very attuned to the fact that the launch period is critical anytime you bring a new product to the market, and we’re also very cognizant of bringing too much sales costs into the company’s P&L too soon. And we’re looking to balance all those aspects.

We don’t have a firm answer for you at this point, but we are working diligently and we expect that we’ll have a path forward on how we plan to market these three drugs next year, pretty shortly..

David Amsellem

All right. Thank you..

Scott Tarriff

Yes. Thank you very much..

Operator

We’ll take our next question from Randall Stanicky with RBC Capital Markets. Please go ahead..

Randall Stanicky

Great. Thanks, Scott.

Just a follow-up, can you talk about the durability of cash flows from both the big bag but also rapid? And, 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 a big bag as it is planned, I would assume to, you’re thinking around the risk on generics at some point down the road?.

Scott Tarriff

Yes. 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 is 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 ANDA’s for a while. Obviously, there is 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 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.

And I suppose, there is a possibility that 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 in all these patents we’ve had. Right, this is going to be our fourth patent protecting our product, probably four Orange Book listed patents here.

We think we 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..

Randall Stanicky

Scott, that would be – if you did take back rapid, would those – the profits from both those products be royalty free to tell that you wouldn’t have to pay them anything?.

Scott Tarriff

No, we still pay the double-digit royalty even after that at the time..

Randall Stanicky

Okay. And I have one follow-up, can you talk about your expectations for bivalirudin.

And 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 read through to those other opportunities?.

Scott Tarriff

Randall, also a very interesting question and I think the way to look at Eagle is every product has a different story. And every product has a different set of qualities, and there is a range of value. And 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 vial to liquid cytotoxic. Our argatroban product that we launched several years ago is a good analog. Our market share, last I looked after 3.5 years is over 40% of the market.

It’s taking [ph] share, because it’s not generically rated to – the end is when they come to the market. And typically, ANDA holders do not have the ability to go back into the sales-force and speak directly to the pharmacy to make that conversion back. I think on bivalirudin, we should do very well.

If things go according to plan and 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..

Randall Stanicky

I know. That’s great. Thanks, Scott..

Scott Tarriff

You’re welcome. Thank you..

Operator

[Operator Instructions] We can take our next question from Tim Lugo with William Blair. Please go ahead..

Tim Lugo

Thanks for taking the question.

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

Scott Tarriff

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 DSH hospitals, which best described as large charity care centers across the state. And we think that number is somewhere along those lines..

Tim Lugo

Okay. And 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 with your counterparts there?.

Scott Tarriff

It’s not spelled out in the contract, Tim. But it’s based on not only their public comments, but the interaction that we’ve had them in the last few months. There’s a lot, as 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 them daily. Again, wonderful people and our views of conversion is based on all our interaction and just our view of the marketplace..

Tim Lugo

Understood. And, 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 you think you’ll be capturing in the study? And maybe for David, the genetic testing on comments, I assume R&D will be picking up next quarter..

Scott Tarriff

So, you want to take the expense or…?.

David Riggs

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 we’re spending on bendamustine is tailed off and we filed bivalirudin NDA..

Tim Lugo

Okay.

That’s good to hear and maybe, Scott, do you have any estimates for how many true EHS patients would be enrolled?.

Scott Tarriff

So, Tim, the study certainly has become far more robust over the last few months. I think the team here at Eagle with help from the Saudi team, it’s 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 is landmark in many respects.

As I mentioned earlier, typically in a typical year, there’s 2.5 million 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 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 drugs at these four hospitals to dose more patients than that. We’re targeting patients in that 18 to 45 year bracket that have the symptoms that are more likely to be EHS as opposed to other heat illnesses, but it’s hard to tell exactly how many will get.

It looks like, if this is a typical season, there’s more than enough potential patients to make this a meaningful study, which is going to have to wait and see..

Tim Lugo

Understood. And it sounds like you’re collecting significant out data.

Is there – what are the expectations for when you’d be able read top line from the study?.

Scott Tarriff

Yes. It will definitely be the best we can tell, Tim, it will 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 19 until, I think it’s the 27, somewhere in there.

So the data collection period is short. Hopefully, with some lock, 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 six-month period of time, I don’t know, we’ll be successful in that.

As soon as we have the data the FDA has 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, and we’ll report back as soon as we can. Five weeks from now, we’ll start dosing patients and we’ll see how we do..

Tim Lugo

It sounds like an interesting study. Thanks for taking my questions..

Scott Tarriff

Very interesting study. Thank you..

Operator

And it appears we have no further questions at this time. So I’ll turn the floor back to Scott here for any additional or closing remarks..

Scott Tarriff

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

And this does conclude today’s program. Thanks for your participation. You may now disconnect. Have a great day..

ALL TRANSCRIPTS
2023 Q-2 Q-1
2022 Q-4 Q-3 Q-2 Q-1
2021 Q-4 Q-3 Q-2 Q-1
2020 Q-4 Q-3 Q-2 Q-1
2019 Q-4 Q-3 Q-2 Q-1
2018 Q-4 Q-3 Q-2 Q-1
2017 Q-4 Q-3 Q-2 Q-1
2016 Q-4 Q-3 Q-2 Q-1
2015 Q-4 Q-3 Q-2 Q-1
2014 Q-4 Q-3