Eagle Pharmaceuticals (EGRX) Q4 2017 Earnings Conference Call Transcript

Eagle Pharmaceuticals (EGRX 2.05%)
Q4 2017 Earnings Conference Call
Feb. 26, 2018 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, and welcome to today's program. My name is Keith and I'll be your conference operator today. At this time I'd 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. And at that time if you have questions, you need to press * and 1 on your touchtone phone. 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 -- Investor Relations

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 three 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 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 will be available shortly after completion of this call.

You'll find the dial-in information in today's press release. The archived webcast will be available for one year on our website, eagleus.com. For the benefit of those who may be 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'll turn the call over to Eagle's CEO, Scott Tarriff.

Scott Tarriff -- Chief Executive Officer and Director

Thank you, Lisa, and good morning, everyone. In 2017, Eagle continued to develop best in class injectables 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 2015, 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 time frame, non-GAAP EPS rose from $0.41 in 2015 to $2.79 in 2016 and now up to $4.34 in 2017. I'd also like to point out that we've experienced expanded profit margins over the same period due to our significant revenue growth coupled with our operating leverage. The company's EBITDA margin for 2017 was 40%, up from 34% in 2016 and 10% in 2015.

I think you'll agree that our historical performance has been extraordinary. Based on our ability to provide growth from our current assets and 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 pipelines and 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 2018.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 in our 12 sites and are on track, if 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 of the initial study of Ryanodex for the treatment of nerve-agent-induced seizures and seizure-related brain damage, and we expanded patent portfolios for bendamustine and dantrolene formulations to strengthen our protection of these product families for existing and potential new indications. Our strong cash position during the year enabled us to strategically buy back more than $44 million in Eagle's stock in addition to the $37 million of buyback in 2016, for a total of $81 million, reflecting our continued belief in the potential for our business to deliver value over the long term.

I'm 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 for this life-threatening condition and that the new hajj study will support earlier data. If all goes as planned, the study will be started and completed within a week. The hajj this year will be held starting on August 19, 2018. If successful and depending on the FDA's review time, we could potentially be on the 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 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're 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 fronts. In addition to exertional heat stroke, which I just discussed, our efforts to develop an IM injection and other potential indications are moving forward. 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 have signed long-term consulting agreements with us and we 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 shares as part of the board-approved share-repurchase plan. Since August 2016, we have completed the repurchase of approximately $81 million in single 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'll turn the call over to Pete Meyers to further update our fourth-quarter and full-year financial results. Pete?

Pete Meyers -- Chief Financial Officer

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 2017, total revenue was $86.8 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, partly offset by a decrease in Argatroban. Fourth-quarter [Inaudible] 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 increase in [Inaudible] Teva sales of Bendeka as well as an increase in the royalty income 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 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 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 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 2017 was $15.6 million, or $1.05 per basic and $1.00 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 25%, to $236.7 million, compared with $189.5 million in 2016. Total product sales, reflecting all Eagle 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 the increased sales of Bendeka and an increase in our royalty rate from 20% to 25% effective in the fourth quarter 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 76% in 2017, as compared to 71% in 2016, despite a significant decrease in the continuing contribution of milestones 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 advance multiple-products candidates, including fulvestrant, for which we commenced the clinical trials in the fourth quarter 2017. Excluding stock-based compensation and other non-cash and non-recurring items, 2017 R&D expense is $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 Ryandodex EHS clinical trials as well as API [Inaudible] in anticipation of 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 will be expensed during the first quarter of 2018. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense in 2018 will be in the range of $39 million to $43 million. SG&A expenses increased in 2017 by $18.1 million $71.4 million in 2017, compared to $53.3 million in 2016. The increase in SG&A expenses related primarily to No. 1, increases in personnel-related expenses during the expansion of our sales force throughout 2017; No. 2, marketing expenses associated with prelaunch EHS, disease data awareness initiatives; No. 3, increase in 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 adjusted Eagle's net deferred-tax assets to reflect the impact of recently enacted federal tax reform legislation. The tax provision in 2016 was impacted by the reversal of evaluation allowance which has been carried against the company's net-deferred tax assets. We thus feel that the 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 the 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 $75 million in share repurchases authorized by our board in 2016 and expanded the 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 $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'll turn the call back over to Scott.

Scott Tarriff -- Chief Executive Officer and Director

Thanks, Pete. To recap, 2018 could very well be another significant year for Eagle with multiple potential filings and additional revenue opportunities. We've filed an ANDA for our first of two assets in 2018 with the second filing plan for the back half of the year. With our fulvestrant trial now fully randomized, we are on track to file 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 hyperthermic conditions.

There remains a high clinical need in the market to treat these conditions that have not been adequately addressed. We are encouraged by our agreement with the FDA and our likely plan for exertional heat stroke and remain hopeful that our ongoing discussions with FDA and our clinical work will allow us to continue to advance Ryanodex for these important indications. With that, I'd like to thank you for your continued support and open the call for questions. Operator, please go ahead.

Questions and Answers:

Operator

And at this time, if you'd like to ask a question, please press * and 1 on your touchtone telephone. You can remove yourself from the queue by pressing the # key. We'll take our first question from David Amsellem with Piper Jaffray. Please go ahead.

David Amsellem -- Piper Jaffray -- Managing Director

Thanks. 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 No. 1. And No. 2, on the ANDAs, you talked about another -- I know you're not providing much in the way details, but do you expect these to be litigated ANDAs and are these products that have multiple other filers, just help us understand what kind of opportunity realistically we could be talking about here, and if we have to be thinking about 30-month stays.

Thanks.

Scott Tarriff -- Chief Executive Officer and Director

Thanks, David. Thanks for asking the question. OK, that's a lot. Let's start at the beginning.

So the Ryanodex design is very similar to what we did in 2015. 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 the 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 was a desire for more data compared what we had in the past. So we're going to go back and essentially conduct a similarly designed study as we had before.

Did that answer your question well?

David Amsellem -- Piper Jaffray -- Managing Director

Yeah. I guess I'm trying to get a better window into the agency's thinking. Is this just a question of just more human exposures and wanted to get a sense of their comfort level with the Glasgow Coma Scale as the primary outcome.

Scott Tarriff -- Chief Executive Officer and Director

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 endpoint. So, as I said, I think it just comes down to wanting more than what we had.

I think it's really nothing more complicated than that. After the eight or nine months that we've been discussing this with them since the CRL. And on the ANDAs-[Crosstalk]

David Amsellem -- Piper Jaffray -- Managing Director

Yeah, this -- sorry, go ahead. And on the ANDAs --

Scott Tarriff -- Chief Executive Officer and Director

So on the ANDAs, there are two products, as we've 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's 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's only one competitor today. One will be litigated likely and one will not. As far as other filers, we don't know.

It's hard to tell. We may be the only filers in both but there's 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 -- Piper Jaffray -- Managing Director

OK, thank you.

Scott Tarriff -- Chief Executive Officer and Director

You're very welcome.

Operator

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

Randall Stanicky -- RBC Capital Markets -- Managing Director

Great. Hey, Scott, just a couple. No. 1 is the follow up on EHS.

This current hajj study, just to be clear, there's no 72-hour monitoring requirement with respect to this trial that was discussed in the context of the first trial. Is that right?

Scott Tarriff -- Chief Executive Officer and Director

That's correct.

Randall Stanicky -- RBC Capital Markets -- Managing Director

OK, good. And then can you just walk through the path forward for DIH? I think the strategies evolved a little bit, you and I have talked about, 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 -- Chief Executive Officer and Director

I think, Randall, we're 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. 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 a 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're looking at in EHS and DIH, it's really hard to discern a difference between the diseases. So, for instance, if you have someone that you suspect is having exertional heat stroke which is 104 degrees and some confusion, we'll call that exertional heat stroke, but we also don't know if they had 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 going back to the hajj now on August and hopefully getting that product filed this year and on the market early next year depending on the review time. We'll continue to monitor our thoughts about the amphetamine process.

We're clear that eventually the product -- our product Ryanodex will be used in both and we'll just see now how we decide to go forward with them and we'll report back here over the next weeks.

Randall Stanicky -- RBC Capital Markets -- Managing Director

OK. 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 with a broad label that could reach a broader patient pool with some blurring of indication. Is that the right --

Scott Tarriff -- Chief Executive Officer and Director

Not necessarily. I think we need some time to be able to respond better. We do have our clinical trial opened. 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're going to continue to look at that and see how we're going to handle the label.

Clearly, we need a product on the market that treats both the symptoms of calcium release and 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'll report back more detail as the weeks progress.

Randall Stanicky -- RBC Capital Markets -- Managing Director

OK. Can I just sneak one more in? In Eagle Biologics, you've 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's 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 -- Chief Executive Officer and Director

Yeah. We'll report, Randall, on how we're doing in the Biologics business regularly. You'll see news flow coming out of Eagle over the course of this year about what we're doing. This technology -- there's 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 doe for them? We're seeing situations where we're having discussions about reducing the number of injections. We're having discussions about how to take subq -- IV drugs and turning them into subq drugs.

And we also have the opportunity, as we discussed in the past at great length, going to the biosimilar market and taking some biosimilars and giving those individuals a chance to have a leg up on their competition and take these ID biosimilars to a subq route. We could also go to biosimilars that have multiple injections and reduce the 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 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're very pleased with the progress we're making and the reason that we decided to [Inaudible] 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.

So, these are products that will come to the market four or five years from now but, hopefully, starting this year and going forward we will start to sign deals, receive milestone payments, and so forth as a way to bring value to the company in the near term. I'm very, very excited about this acquisition, couldn't be more pleased since we made it. And second to that, what we now have is what I will refer to as a stake in the ground in Cambridge, which is just for our industry just a remarkable place to do business. We have some very talented Ph.D.s 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 helped us with fulvestrant. They're helping us with the IM version of Ryanodex. Doctors Langer and Klibanov are about the most brilliant minds in our industry, and having them helping us and consulting with us regularly is just wonderful. And so we're thrilled with this acquisition.

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

Randall Stanicky -- RBC Capital Markets -- Managing Director

Thanks, Scott.

Scott Tarriff -- Chief Executive Officer and Director

Thank you, Randall.

Operator

As a reminder, if you'd like to ask a question, that's * and 1 on your touchtone phone. We'll go next to Tim Lugo with William Blair. Please go ahead.

Tim Lugo -- William Blair and Company -- Analyst

Thanks for taking the question. You mentioned in the earlier commentary that you may leverage your balance sheet in 2018. You already have some debt, of course, on the balance sheet. What are your current thoughts on business developments, what type of assets are you looking at? You already have a pretty decent sized pipeline.

Are you looking at commercial assets?

Pete Meyers -- Chief Financial Officer

This is Pete. Thanks for the question, Tim. What Scott was referring to is that our position at the moment is we're a somewhat obvious asset-gatherer given the environment and given our balance sheet and given our presence in hospital infrastructure. So, we do [Inaudible] 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 back our own stock, which, at these levels, in our view, is quite compelling. So we continue to look at assets that would fit our infrastructure, either late-stage or commercialized, but, candidly, if our pipeline develops the way we hope and expect it to in 2018, we have our hands full from an operating perspective.

Tim Lugo -- William Blair and Company -- Analyst

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

Scott Tarriff -- Chief Executive Officer and Director

Tim, I think the bendamustine market did rather well in 2017. I think the Teva team from a marketing standpoint did a truly excellent job positioning bendamustine against the other competitors that we've been speaking about coming into the market. Bendamustine just happens to be a great drug. Its safety profile over the years has been really very important and very significant.

Its price point is really very positive. And, at the end of the day, patients perform 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 were all little bit surprised by at the time, they came in at the very upper end of that range, and volume on bendamustine for the year was down just very slightly, far exceeding our earlier projections. And so I don't see any reason to believe that bendamustine is not going to be a mainstay in CLL and NHL and do very well till the end of the time that we have the product on the contract.

And so, we're very pleased with what they've done. I think we all should be. And so, yeah, they're doing a great job.

Tim Lugo -- William Blair and Company -- Analyst

OK. And for the next hajj study, is there a patient number that you'll be targeting to provide -- that you hope the study will provide for the next round with the FDA?

Scott Tarriff -- Chief Executive Officer and Director

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 dosing patients until we get to a certain number of patients. It's four days. We got 34 patients last year in about a day and a quarter until the stampede happened. I remember speaking to our team in that first day and we thought that the pace of recruiting would have gone over about 120 had we not had the stampede.

I would say this time around, if we would get 70 -- 60 or 70 patients, we'd be very pleased, but it's out of our control. We'll just have to run the study the same way we did last time. Hopefully, it'll work out the same way, take out an unusual event that did not occur again in '16 and '17. If '18 is a clean year, we should meet more than enough subjects to do what we hope to do.

Tim Lugo -- William Blair and Company -- Analyst

Understood. Thanks for the question.

Scott Tarriff -- Chief Executive Officer and Director

You're welcome.

Operator

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

Scott Tarriff -- Chief Executive Officer and Director

Thank you, everyone. The one last item that I would 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've gone from two injections to one, that we've reduced the drug from 10 ml to 5 ml, that we've all but eliminated the pain in what is one of the most painful drugs to be delivered, I think, in oncology, that we may be taking the warning off the label, and that we may have a unique J-code just like we did with Bendeka, is potentially, if not the largest opportunity in the history the company, just about the largest opportunity.

Now, we have to await the results of the study and we'll have that in the summertime 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 the market by around mid-next year, is very significant. And I think you'll hear from us, and as we speak with the investors over the next few weeks and months, we'll be focused in on fulvestrant and the value that they can bring again not only to Eagle but to patients. We're just thrilled about having this safer product potentially, if we do what we hope we do. Let's see how we go, but we've made a major accomplishment in dosing and randomizing those 600 subjects as quickly as we did and we're just very excited to see the results and, hopefully move the asset forward.

And with that, I'd just like to say thank you for everyone attending. I appreciate it 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.

Duration: 39 minutes

Call Participants:

Lisa Wilson -- Investor Relations

Scott Tarriff -- Chief Executive Officer and Director

Pete Meyers -- Chief Financial Officer

David Amsellem -- Piper Jaffray -- Managing Director

Randall Stanicky -- RBC Capital Markets -- Managing Director

Tim Lugo -- William Blair and Company -- Analyst

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