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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2017 - Q4
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Executives

Lisa Wilson - Investor Relations Scott Tarriff - Chief Executive Officer Pete Meyers - Chief Financial Officer.

Analysts

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

Operator

Good day and welcome to today’s program. My name is Keith and I will be your conference operator today. At this time, I would like to welcome everyone to Eagle Pharmaceuticals’ Fourth Quarter and Full Year 2017 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, February 26, 2018. It is now my pleasure to turn the floor over to Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. Please go ahead..

Lisa Wilson

Thank you, Keith. Welcome to Eagle Pharmaceuticals’ fourth quarter and full year 2017 earnings call. This is Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. With me on today’s call are Eagle’s Chief Executive Officer, Scott Tarriff and Chief Financial Officer, Pete Meyers.

This morning, the company issued a press release detailing financial results for the 3 and 12 months ended December 31, 2017. This press release and a webcast of this call can be accessed through the Investors section of the Eagle website at eagleus.com.

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 maybe 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 will be available shortly after completion of this call.

You will find the dial-in information in today’s press release. The archived webcast will be available for 1 year on our website, eagleus.com. For the benefit of those who maybe listening to the replay or archived webcast, this call was held and recorded on February 26, 2018.

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 will turn the call over to Eagle’s CEO, Scott Tarriff..

Scott Tarriff

Thank you, Lisa and good morning everyone. In 2017, Eagle continued to develop best-in-class injectibles for patients and caregivers and drive value for shareholders. Since going public in 2014, we have delivered significant year-over-year growth in both revenue and EBITDA.

We were profitable in ‘15 generating EBITDA and non-GAAP EPS of $7 million and $0.41 respectively. EBITDA then grew to $64 million in 2016 and now to $96 million in 2017 reflecting an additional 50% growth. And during the same timeframe, our non-GAAP EPS rose from $0.41 in ‘15 to $2.79 in 2016 and now up to $4.34 in 2017.

I would also like to point out that we have experienced profit margins, expanded profit margins over the same period due to our significant revenue growth coupled with our operating leverage. The company’s EBITDA margin for ‘17 was 40%, up from 34% in 2016 and 10% in 2015. I think you will agree that our historical performance has been extraordinary.

Based on our ability to provide growth from our current assets in our portfolio and the opportunities to leverage our balance sheet, 2018 could be another year of continued growth for Eagle. Combined with the strength of our pipeline and some key upcoming catalysts, we expect the business will continue to deliver strong results.

I would like to recap a few highlights of the year before we turn to a discussion of what’s ahead in ‘18. First, we delivered record revenue of $237 million primarily on the strength of our bendamustine formulation, Bendeka for which we received milestone and royalty payments from Teva and have licensed rights to SymBio in the Japanese market.

We also advanced multiple pipeline programs including the fulvestrant clinical study which we began enrolling during the fourth quarter of last year and we are very pleased to report that last week we completed enrollment and randomization of subjects ahead of the schedule at our 12 sites.

And are on track and successful to file an NDA early in the fourth quarter of this year. We received tentative FDA approval for PEMFEXY, our pemetrexed injection. The first company to do so using the 505(b)(2) pathway.

We announced positive results with an initial study of Ryanodex for the treatment of nerve agent induced seizures and seizure related brain damage. And we expanded the patent portfolios for our bendamustine and dantrolene formulations to strengthen our protection of these product families for existing and potentially new indications.

Our strong cash position during the year enabled us to strategically buyback more than $44 million of Eagle stock in addition to the $37 million of buyback in 2016 for a total of $81 million reflecting our continued belief and the potential of our business to deliver value over the long-term.

I am also excited to report that we have agreed on a path forward with the FDA for an additional clinical trial for Ryanodex for exertional heat stroke. The trial will be conducted in August of this year during the Hajj pilgrimage, similar to the study we conducted during the Hajj in 2015.

We are confident in our ability to run the study and are excited that we can now proceed with our work on EHS. We anticipate similar positive results and hope that this time conditions on the ground will allow us to recruit more subjects.

We believe we have collected a very strong data set over the years with a slight threatening condition and that the new Hajj study will support earlier data. If all goes as plan the study will be started and completed within a week. The Hajj this year will be held starting in August 19.

A successful and depending on the FDA’s review time, we can potentially go into market with an EHS product for most of the 2019 season. And as we begin 2018, I am pleased with the overall momentum in other areas of the business as well. Our priorities for the year are as follows. We intend to file our most advanced programs.

I am pleased to announce that we filed an ANDA this quarter for the first of two assets in 2018 and are awaiting FDA acceptance of the filing. If accepted for the filing, we will provide you with more details about the product. An additional asset is being developed and we anticipate a submission during the second half of the year.

The combined branded sales of these two products are $500 million and growing. With our fulvestrant trial now fully enrolled and randomized with 600 subjects, we are on track to file an NDA early in the fourth quarter of the year pending the outcome of the study. This product has worldwide branded sales in excess of $1 billion.

Our work with Ryanodex continues on multiple trends. In addition to exertional heat stroke which I just discussed, our efforts to develop an IM injection and other potential indications are moving. We expect to be able to update you on these efforts in the coming months.

And lastly as we evaluate our opportunities we will focus on optimizing our financial position and utilizing our cash strategically. To that end we solidified Eagle’s biologics business.

We have been very pleased with the acquisition of Arsia and took the opportunity to settle the $48 million of potential milestone obligations in exchange for $15 million in cash. Our total investment in Eagle Biologics is $45 million.

Doctors Langer and Klibanov had signed long-term consulting agreements with us and will continue to advance their work which holds tremendous promise for Eagle to develop biobetters in the fastest growing sector of the industry. And they will continue working with us across the full range of Eagle products.

We also intend to continue purchasing Eagle’s shares as part of the Board approved share repurchase plan. Since August 2016, we have completed the repurchase of approximately $81 million of Eagle stock, an additional $94 million remains authorized and we plan to continue to opportunistically purchase shares.

We believe 2018 could very well be yet another transformative year for the company. With that I will turn the call over to Pete Meyers to further update our fourth quarter and full year financial results.

Pete?.

Pete Meyers

Thank you, Scott. As Scott mentioned we posted a record 2017 on multiple fronts; revenue, EBITDA and EPS. Let me begin with a review of the quarter. In the fourth quarter of 2017, total revenue was $46.8 million compared to $81.1 million in Q4 2016, which included a $40 million milestone payment from Teva.

Product sales were $10.4 million compared to $9.1 million in the prior quarter driven by increases in Bendeka and Ryanodex partially offset by a decrease in Argatroban. Fourth quarter Ryanodex product sales were $4.6 million, up 20% on a year-over-year basis.

Ryanodex dollar market share rose from 53% in 3Q to 70% in 4Q and Ryanodex unit market share rose from 29% in 3Q to 48% in 4Q. Royalty income increased as well to $36.4 million as a result of the increased market share on Teva sales of Bendeka, as well as an increase in the royalty rate from 20% to 25%.

On the expense front, R&D expenses decreased $6.8 million to $9.4 million for the quarter compared to $16.2 million in the prior year quarter largely due to lower levels of API purchases. SG&A expenses decreased $4.2 million to $13.4 million in the fourth quarter of 2017 compared to $17.5 million in the fourth quarter of 2016.

The decrease was due to the expiration of the Spectrum promotion contract at the end of June 2017 as well as a reduction in marketing expenses. These reductions were partially offset by the increase in personnel-related expenses associated with the expansion of our sales force during the second quarter of 2017.

Net income for the fourth quarter was $9.1 million, or $0.61 per basic share and $0.58 per diluted share compared to net income of $57.3 million or $3.75 per basic and $3.52 per diluted share in the three months ended December 31, 2016 due to the factors discussed above.

Adjusted non-GAAP net income for the fourth quarter of 2017 was $15.6 million or $1.05 per basic and $1 per diluted share compared to adjusted non-GAAP net income of $17.2 million or $1.12 per basic and $1.05 per diluted share in the prior year quarter. Turning now to our full year results.

In 2017, we grew revenue of 25% to $236.7 million compared with $189.5 million in 2016. Total product sales reflecting all legal products increased $4.7 million to $45.3 million during the year compared to $40.6 million in 2016 driven primarily by a 50% increase in Ryanodex sales to $17.5 million.

Royalty income increased to $153.9 million compared to $99 million in 2016 due to increased of sales of Bendeka and an increase in our royalty rate from 20% to 25% effective in the fourth quarter of 2016. License and other income was $37.5 million in 2017 compared with $50 million in 2016.

License and other income reflects payments received for achieving certain contractual milestones in connection with Eagle’s Bendeka licensing agreement with Teva as well as an upfront payment in 2017 associated with the SymBio collaboration covering Japanese rights for bendamustine products.

Gross margin expanded to 76% in 2017 as compared to 71% in 2016 despite a significant decrease in the continuing contribution of milestone to overall revenue.

On the expense front, R&D expense increased to $32.6 million in 2017 compared to $28.3 million in 2016 as a result of our development efforts to advanced multiple product candidates, including fulvestrant, for which we commenced a clinical trial in the fourth quarter of 2017.

Excluding stock-based compensation and other non-cash and non-recurring items, 2017 R&D expense was $27.6 million. 2018 R&D expense is expected to be in the range of $46 million to $50 million.

This reflects ongoing expenses for the enrollment of fulvestrant and Ryanodex EHS clinical trials as well as API outlays in anticipation of the 2019 launch of fulvestrant if approved.

Since we were able to complete enrollment in the fulvestrant study ahead of schedule, a larger portion of our full year 2018 R&D spend will be expensed during the first quarter of 2018. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense from 2018 would be in the range of $39 million to $43 million.

SG&A expenses increased in 2017 by $18.1 million to $71.4 million in 2017 compared to $53.3 million in 2016.

The increase in SG&A expense is related primarily to number one increases in personnel related expenses due to the expansion of our sales force throughout 2017; number two, marketing expenses associated with pre-launch EHS disease state awareness initiatives; number three, increased external legal expenses; and lastly, staff additions incurred to support expansion of the company.

These increases were partially offset by the expiration of the Spectrum promotion contract at the end of June 2017. Excluding stock-based compensation and other non-cash and non-recurring items, 2017 SG&A expense was $56.9 million. 2018 SG&A expense is expected to be in the range of $61 million to $64 million.

Excluding stock-based compensation and other non-cash and non-recurring items, SG&A expense for 2018 would be in the range of $45 million to $48 million. For the full year, the company recorded a net tax expense of $21 million compared to a benefit of $28 million in 2016.

The tax expense in 2017 was favorably impacted by the recognition of federal R&D tax credits and the impact of employee stock option exercises. These favorable impacts were partially offset by an adjustment to Eagle’s net deferred tax asset to reflect the impact of recently enacted federal tax reform legislation.

The tax provision in 2016 was impacted by reversal of evaluation allowance which had been carried against the company’s net deferred tax assets. We anticipate that tax reform will positively impact Eagle’s tax expense beginning in 2018. For 2018, we estimate a combined effective tax rate of 24%.

Net income for the year ended December 31, 2017 was $51.9 million or $3.44 per basic and $3.27 per diluted share as compared to net income of $81.5 million or $5.24 per basic and $4.96 per diluted share for year ended December 31, 2016 as a result of the factors discussed above.

Adjusted non-GAAP net income for 2017 was $69 million or $4.57 per basic and $4.34 per diluted share compared to adjusted non-GAAP net income of $45.9 million or $2.96 per basic and $2.79 per diluted share in 2016.

For a full reconciliation of non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of today’s press release.

Our adjusted EBITDA for 2017 was $96.2 million compared to $63.9 million in 2016 reflecting an increase of over 50% and is particularly noteworthy considering that the company earned only $38 million in milestones during 2017 and $50 million in milestones during 2016. Our EBITDA converts efficiently into cash flow.

For example in 2017, our cash flow from operating activities, excluding the increase in net accounts receivable was $71 million. In 2017, we completed the $75 million in share repurchases authorized by our Board in 2016 and expanded a program by $100 million during the third quarter of 2017.

Through December 31, 2017, we had purchased $5.8 million as part of the expanded program. As of December 31, 2017, the company had a $114.7 million in cash and cash equivalents and $53.8 million in net accounts receivable, $40 million of which was due from Teva. The company had $48.8 million in outstanding debt.

With that, I will turn the call back over to Scott..

Scott Tarriff

Thanks, Pete. To recap, 2018 could very well be another significant year for Eagle with multiple potential filings and additional revenue opportunities. We filed an ANDA for our first of two assets in 2018 with the second filing planned for the back half of the year.

With our fulvestrant trial now fully randomized, we are on track to filing an NDA in early Q4 of this year and importantly, we continue to work with our Ryanodex portfolio which we believe has the potential to treat multiple hypothermic conditions.

There remains a high clinical need in the market to treat these conditions have not been adequately addressed.

We are encouraged by our agreement with the FDA and a likely plan for exertion of heat stroke and remained hopefully that our ongoing discussions with FDA and our clinical work will allow us to continue to advance Ryanodex for these important occasions. With that, I would like to thank you for your continued support and open the call for questions.

Operator, please go ahead..

Operator

[Operator Instructions] We will take our first question from David Amsellem with Piper Jaffray. Please go ahead..

David Amsellem

Thanks. So, just a couple.

First on Ryanodex on the path forward in EHS, can you just walk through the design of the study, particularly the primary outcome measures? And my understanding is it’s going to be the same as the prior Hajj study, so just confirm that? And then were you surprised that, that’s what the FDA had agreed to and is this just a question of the agency wanting more human exposures or is there something else that we should be thinking about regarding that study? So that’s number one.

And number two, on the ANDA you talked about, I know that you are not providing much in the way of details, but do you expect it needs to be litigated ANDA’s? Are these products that have multiple other filers, just help us understand what kind of opportunity realistically we could be talking out here and if we have to be thinking about 30 month stays? Thanks..

Scott Tarriff

Hey, thanks David. Thanks for asking the question. Okay, that’s a lot. Let’s start at the beginning, so the Ryanodex design is very similar to what we did in ‘15. So in essence what we will have is two groups randomized, half will receive standard of care, which is cooling and fluids and the other half will receive standard of care plus Ryanodex.

The primary endpoint is identical as to last time, the Glasgow Coma Scale, so no difference. It’s basically once again standard of care versus Ryanodex.

Are we surprised with our conversations since July? I would say, no, look at the end of the day, I think when you get right down to it, there is a desire for more data compared to what we had in the past. So, we are going to go back and essentially conduct similarly designed study as we had before.

Does that answer the question well?.

David Amsellem

Yes.

I guess, I am generally not going to get a better window into the agency’s thinking, was this just a question of human – just more human exposures and wanted to get a sense of their comfort level with Glasgow Coma Scale as the primary outcome measure?.

Scott Tarriff

Well, look I don’t know the answer to that fully, David, but what I will say is I think we can all take quite a bit of sense of accomplishment that the outcome of the study – the design of the study is pretty similar to what we did before. So, there weren’t any major significant changes.

We are still randomizing patients, standard of care versus Ryanodex and using the same primary endpoints. So, as I said, I think it just comes down to warming more than what we had. I think it’s really nothing more complicated than that after the 8 or 9 months that we have been discussing this with them since the CRL.

And then on ANDA’s, yes, go ahead..

David Amsellem

Yes, sorry go ahead on the ANDA’s?.

Scott Tarriff

Yes. So on the ANDA’s there are two products as we have mentioned in the past. Combined, their sales are $500 million and growing, right. So, it’s a growing collective market.

These are two markets where there is only one competitor in each of the markets and so there is only one player, so call it whatever you want a branded generic or a branded product, these are two markets combined $0.5 billion. Each of the two, there is only competitor today, one will be litigated likely and one will not.

As for our other filers, we don’t know, it’s hard to tell. We maybe the only filers in both, but there is no way to know until the product is accepted and we get a little deeper into it, but there are no other current players in these two markets..

David Amsellem

Okay, thank you..

Scott Tarriff

You are very welcome..

Operator

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

Randall Stanicky

Great. Thanks, Scott. So, just a couple.

Number one is the follow-up on EHS, this current Hajj study, there is – just to be clear there is no 72-hour monitoring requirement with respect to this trial that was discussed in the context of the first shell, is that right?.

Scott Tarriff

That’s correct..

Randall Stanicky

Okay, good.

And then can you just walk through the path forward for DIH, I think the strategy has evolved a little, but you and I have talked about that, but how do we think about next data points or milestones and how do we get comfortable that we could see that opportunity emerge in 2019 or 2020, what’s your current thinking on time to market there?.

Scott Tarriff

Yes. I think, Randall, we are still thinking through all of the possibilities for Ryanodex going forward. What we do know is that there is a real need for Ryanodex in both disease states, right.

As we look at it, what exactly is what we define as DIH, it’s very interesting, what we believe that all of these disease states and others that we have not discussed yet with the investors, there are number of diseases that the medical community believes is caused by this calcium overload.

And essentially to us as we look at all the research that’s being done around the world and specifically in the patients that we are looking at in EHS and DIH, that’s really hard to discern the differences between – difference between the diseases.

So, for instance, if you have someone that you suspect of having exertional heat stroke, which is 104 degrees and some confusion, we will call that exertional heat stroke, but we also don’t know if they have traces of amphetamines in their system.

And so as we continue to look and we continue to research, we feel very confident now in the path forward for exertional heat stroke, go back to the Hajj now in August and hopefully getting that product filed this year and on to market early next year depending on their review time.

We will continue to monitor our thoughts about the amphetamine process. We are clear that eventually the product – our product, Ryanodex, will be used in both and we will just see now how we decide to go forward with them and we will report back here over the next weeks..

Randall Stanicky

Okay.

And let me just follow-up, so just to be clear, as you think about path forward, the idea is to get on market for EHS and with a broad label that could reach a broader patient pool with some blurring of indication, is that right?.

Scott Tarriff

Not necessarily. Let’s – I think we need some time to be able to respond better. We do have our clinical trial open. We have some of these music festivals coming up as soon as late March, where we think we have a lot of subjects to collect in the hot weather and we are going to continue to look at that and see how we are going to handle the label.

Clearly, we need a product on the market that treats both the symptoms of calcium release in malignant hyperthermia, which we have exertional heat stroke and then to these people who predispose to the same disease state once they take amphetamines and again we will report back in more detail as the weeks progress..

Randall Stanicky

Okay. Can I just sneak one more and Eagle Biologics you have now invested $45 million and clearly the biologic opportunity down the road is a big one. How can we monitor pipeline progress or get comfortable that things are progressing.

Obviously, there is a big opportunity, but it’s hard from the outside to get a sense in terms of what you have going on in the pipeline?.

Scott Tarriff

Yes. So, we will report Randall on how we are dealing with the biologics business regularly. You will see news flow coming out of Eagle over the course of this year about what we are doing. This technology – there is two very important aspects to this acquisition.

First, the technology in viscosity reduction of biologics can be used in so many ways that will benefit patients and our shareholders. We have the ability with this technology to help branded companies with first time biologics lower their viscosity.

What does that do for them? We are seeing situations where we are having discussions about reducing the number of injections. We are having discussions about how to take subcu IV drugs turning them into subcu drugs.

And we also have the opportunities we discussed in the past at great length is going to the biosimilar market and taking some biosimilars in giving those individuals a chance to have a leg up on their competition and take these IV biosimilars to a subcu route.

We can also go to biosimilars that have multiple injections and reduced a number of injections as a way to improve the products in the biosimilar space. We continue to work on molecules in-house on our own for a proof-of-concept and to have animal data and tox data and then take it forward to biosimilar companies and branded companies.

So far, we are very pleased with the progress we are making and the reason that we decided to bide down those milestone obligations now and we believe that this technology and this capability will be a significant leg of Eagle’s growth as we start to get to the later stages of the current products that we spoke about today in the pipeline.

And so these are products that will come to the market 4 or 5 years from now, but hopefully starting this year and going forward, we will start to sign deals we see milestone payments and so forth as a way to bring value into the company in the near-term. Very, very excited about this acquisition, couldn’t be more pleased since we made it.

And then second to that, what we now have is what I will refer is taking the ground in Cambridge, which is just for our industry, just a remarkable place to do business. We have some very talented PhDs and we have access to some very talented people at MIT. And quite frankly, they are helping us with our entire pipeline and our portfolio.

They have helped us with fulvestrant, they are helping us with the IM version of Ryanodex, Drs. Langer and Klibanov are about the most brilliant minds in our industry and having them helping us and consulting with us regularly has been just wonderful. And so we are thrilled with this acquisition.

And as we sit here today, I am very confident that we will see significant value coming out of this acquisition in the years to come. And you will start to hear more about it as the year progresses as well..

Randall Stanicky

Okay. Thanks, Scott..

Scott Tarriff

Thank you, Randall..

Operator

[Operator Instructions] We will go next to Tim Lugo with William Blair. Please go ahead..

Tim Lugo

Thanks for taking the question. You mentioned earlier in your commentary and you may elaborate your balance sheet in 2018, you already have some debt of course on the balance sheet.

What are your current thoughts on business development? What type of assets you are looking at, you already have a pretty decent sized pipeline? Are you looking at commercial assets?.

Pete Meyers

This is Pete. Thanks for the question, Tim. What Scott was referring to is that our position at the moment is we are somewhat obvious asset gatherer given the environment and given our balance sheet and given our presence in hospital infrastructure. And so we do have a lot of opportunities.

As we mentioned when we last spoke, the hurdle rate is quite high. And it’s high because candidly it needs to compete with buying better on stock which at these levels as you know is quite compelling. So we continue to look at assets that would fit our infrastructure in a late stage are commercialized.

But candidly if our pipeline develops the way we hope and expected to in 2018, we have our hands from an operating perspective..

Tim Lugo

Fair enough.

And Bendeka royalties in 2017 were pretty tied within $36 million to $37 million range quarterly, are there any reasons that you are going to vary from this range in 2018 that you are either contractually or that you are hearing from your partner regarding the underlying market?.

Scott Tarriff

Yes. So Tim I think the bendamustine market did rather well in ‘17. I think the Teva team from a marketing standpoint did a truly excellent job positioning bendamustine against the other competitors that we have been speaking about coming into the market. Bendamustine just happens to be a great trust.

Its safety profile over the years has been really very important, very significant. Its price point is really very positive. And at the end of the day patients performed very well on Bendamustine.

And so the volume, I think if I recall the range that Teva provided at the early part of ‘17 that we are all a little bit surprised that by the time they came into the very upper end of that range in volume on Bendamustine for the year was down just very slightly, far succeeding our earlier projections.

And so I don’t see any reason to believe that Bendamustine is not going to be a main stay in the CLL and NHL and do very well till the end of the time that we have the product on the contract. And so we are very pleased with what they have done, I think we all should be. And so yes now they are doing a great job..

Tim Lugo

Okay.

And for the next Hajj study, is there a patient number that you will be targeting to or do you hope this study will provide for the next round will be up there?.

Scott Tarriff

It’s hard to say Tim, because it’s an odd study to run from the standpoint that we can’t hang around Hajj and keep doing patients until we get to the certain number of patients, it’s four days. We got 34 patients last year and about a day in a quarter until the stampede happened.

I remember speaking to our team in that first date and we thought that the pace of recruiting would have run over about 120 and we will not have the stampede. So I would say this time around if we would get 70 – 60 or 70 patients we would be very pleased. But it’s out of our control.

We will just have to run the study the same way we did last time, hopefully to work out the same way, take out a unusual event that it did not occur again in ‘16 or ‘17, if ‘18 is a clean year we should meet more than enough subjects to do what we hope to do..

Tim Lugo

Understood. Thanks for the question..

Scott Tarriff

You’re welcome..

Operator

It does appear we have no further questions at this time. I will return the floor to Scott Tarriff for any additional or closing remarks..

Scott Tarriff

Thank you, everyone. The one last item that I will just remind everybody to focus on before we break on this particular call is the fact that we have completed the randomization of our 600 subjects for fulvestrant, that’s a product that is going to be or already is over $1 billion worldwide.

And the fact that we have gone from two injections to one that would reduce the drug from 10 ml to 5 ml that we have all been eliminated the pain in what is one of the most painful drugs to be delivered I think in oncology, that we maybe taking the warning off the label and that we may have the unique J-code just what we did with Bendeka is potentially if not the largest opportunity in the history of the company just about the largest opportunity.

Now, we have to wait for results of the study. And we will have that in the summer time. But we do have all 600 patients enrolled and as soon as we get those results. Obviously, if we pass that clinical trial, the opportunity for the company that we think we can then get the product to market by around mid-next year is very significant.

And I think you will hear from us and as we speak with investors over the next few weeks and months, we will be focused in – on fulvestrant and the value that they could bring again not only to Eagle but to patients. We are just thrilled about having the safer product potentially if we do what we hope we do. And let’s see how we go.

But we have made a major accomplishment in dosing and randomizing those 600 subjects as quickly as we did. Now we are just very excited to see the results and hopefully move the asset forward. And with that, I would just like to say thank you for everyone attending. I appreciate and look forward to speaking to all of you over the next number of weeks.

Thank you..

Operator

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

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