Amy Raskopf - In-Site Communications, IR Scott Tarriff - President and CEO David Riggs - CFO.

David Amsellem - Piper Jaffray Tim Lugo - William Blair Irina Koffler - Cantor Fitzgerald Robert Sussman - Bentley Capital.

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 First Quarter 2015 Earnings 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] It’s now my pleasure to turn the floor over to Amy Raskopf. You may begin your conference..

Thank you, Keith. Welcome to Eagle Pharmaceuticals’ first quarter 2015’s earnings call. This is Amy Raskopf, of In-Site Communications, Investor Relations for Eagle Pharmaceuticals. With me on today’s call is Scott Tarriff, President and CEO; and David Riggs, CFO.

This morning, the Company issued a press release detailing financial results for the first three months ending March 31, 2015. This call can be access through the Investors section of the Eagle Web site at www.eagleus.com and you could 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 the beliefs, 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, May 19th.

You will find the dial-in information in today’s press release. The archive webcast will be available for one year on our Web site at eagleus.com. For the benefit of those who maybe listening to the replay our archive webcast, this call was held and recorded on May 12, 2015.

Since then Eagle may have made announcements related to the topics discussed, so please reference to Company's most recent press releases and SEC filings. And with that, I will turn the call over to Eagle’s CEO, Scott Tarriff..

Thank you, Amy, and good morning, everyone. I am very excited about the many positive developments since the beginning of the year.

We entered into a transformational partnership with Teva for the commercial about rapid infusion bendamustine product and the upfront cash milestone in this important part of the shift enabled our possibility in the first quarter of 2015. We filed the NDA for the product and now looked forward for the PDUFA date for rapid in December.

Approved, we believe the additional milestone and royalty payments from Teva as well as potential launch next year of our tentatively approved bendamustine will expedite our ability to deliver long-term sustainable growth.

Ryanodex sales were 1.6 million in the first quarter 2015 and continue to trend as expected demonstrating their commercialization strategy is working. We look forward to replicating this success and leveraging relationships that we're building with Ryanodex for future products including our bivalirudin candidate.

We remain on track to summit an NDA for this unique ready-to-use, liquid version of Angiomax in the near future. I will discuss these and other developments in greater detail later on the call, but first I will ask David to review the results of the quarter.

Dave?.

Thank you, Scott. Our revenue mix has changed significantly since March 31, 2014. Today our revenues consist of one product sales comprised of sales of Ryanodex which we launched in August 2015.

Sales of diclofenac/misoprostol, which we launched in January 2015 and sale of argatroban to two commercial partners; two, royalties we received on commercial partner net product sales of argatroban to their respected customers; and three the license another income for the three months ended March 31, 2015, total revenues were $36.3 million as compared to $5 million in the prior year quarter.

The increase was driven by the $30 million upfront cash payment from Teva under the license agreement for the rapid infusion bendamustine product, and $1.6 million in net sales of Ryanodex during the 2015 period. R&D expense was $6.3 million in the first quarter of 2015.

The $2.5 million increase reflects higher projects spending for rapid infusion bendamustine including cost associated with the new drug application we submitted to the FDA on February 13, 2015, and pemetrexed as well as higher salaries and personnel related expenses.

These costs were offset impart by lower related Ryanodex and diclofenac/misoprostol spending. SG&A expense was $4 million in the first quarter of 2015 the $2.5 million increase was primarily driven by transaction related expense, Ryanodex marketing expenses, professional fees and personnel related expenses.

Of our $10.3 million in combined R&D and SG&A expenses, $1.4 million was associated with onetime charges related to the Teva Eagle license agreement, NDA submission and launch preparation activities. We are very pleased that in the near future we will be submitting a second NDA requesting marketing approval for our bivalirudin product candidate.

Expansions in the second quarter will be somewhat higher to meet this important goal. R&D costs should normalize after this point could be lower in the Q3 and Q4 since we don’t forecast any additional NDA submissions in the second half of 2015. Net income attributable to common stockholders was $19.

7 million in the first quarter of 2015 or $1.38 per basic and $1.31 per diluted share compared to a net loss attributable to common stockholders of $3.2 million or $0.36 per basic and diluted share for the same period last year.

As Scott mentioned one of the highlights of the quarter was the Teva agreement with the rapid infusion bendamustine product.

As I previously mentioned we received an upfront cash payment of $30 million from Teva conjunction with this agreement on March 18, 2015 we raised $54.3 million in net proceeds from an underwritten public offering of Eagle Pharmaceuticals’ common stock.

As a result we closed the quarter with $115.9 million in cash, cash equivalents and short-term investments and $192.9 million in additional paid-in capital and we had a $102.9 million in stockholders’ equity as of March 31, 2015. And with that I will turn it back over to Scott..

Well thank you David. While this was a terrific quarter for Eagle, we recorded $36 million in revenue, including $30 million from our exclusive licensing agreement with Teva for our bendamustine rapid infusion product and we are very pleased that our product will be marked in by the pioneer in the bendamustine space assuming FDA approval.

Teva has an unparallel access of knowledge and we are confident that they will achieve significant conversion of the market.

In addition to the upfront $30 million cash payment that drove our profitability in the first quarter we are eligible for up to 90 million, in additional milestone payments and we'll receive a very healthy double-digit percentage royalty on future net sales of the product.

In regard to this the transformational been for Eagle and a catalyst for our future growth.

On February 13, we submitted the NDA for the FDA for the rapid infusion 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 regime.

This was the same indication with Teva's Treanda but our product is administered at a 10 at 50 ML mixture as opposed to 30 to 60 milligrams, in the 500 ML categories. The FDA accepted the FDA filing with PDUFA date of December 13, 2015.

Our bendamustine rapid product is orphan drug designation for the treatment of CLL and indolent B-cell NHL, when administered in low volume and a shorter fusion time. This may afford seven years marketing exclusivity upon approval.

Additionally a new patent pertaining to the rapid infusion bendamustine product was granted this quarter which extends its patent coverage out to March of 2033. We believe the issued patents combined with the orphan drug designation that this product can treat NHL and CLL may provide longevity for the product.

We have several additional patents pending at the backlog and look forward to additional patent insurances in the near future. We believe Teva will b very successful converting the market to rapid which is eagerly await the FDA decision on rapid infusion bendamustine.

Assuming the product is approved on or before its PDUFA date in mid December we'd receive an approval milestone from Teva. We are confident in our ability to deliver sustained drawing foreseeable future driven by both EPS and a potentially rich pipeline and remember as we look towards next year.

We have a contractual right to launch our tentatively approved liquid bendamustine 500 ML batch commencing in May 1, 2016. Sales of Ryanodex and we are optimized dantrolene product were strong in the first quarter, more than 200% higher than in Q4 2014, we sold $1.6 million worth of Ryanodex last quarter.

Ryanodex continued to trend as expected in April and now our unaudited sales of April were over $600,000, we expect ongoing sequential growth as we continue to convert the market to our product. We believe this growth directly reflects our marketing and salesforce execution as well as the benefits of Ryanodex of the legacy dantrolene formulation.

Our average selling price per vial during the quarter was $22,010 up from $2070 last quarter. During the first quarter we stocked over 130 unique outlets either hospitals or surgery centers, 92% of these were hospitals.

Ryanodex indicated for the treatment of malignant hypothermia MH a potentially fatal condition that can triggered when genetically susceptible patients come in contact during surgery with certain inhaled anesthetics or specific muscle relaxants.

One vial of Ryanodex contains the same amount of dantrolene sodium as 12.5 vials of other approved dantrolene sodium formulations. Our product can be reconstituted and administered in less than 1 minute by one anesthesia provider and far less volume of is billable 5ML versus an amount of 20ml.

This is critically important in treating malignant hypothermia where every second counts. We are now aware of two events in which Ryanodex has been used and it performs exactly as expected. As I've discussed in the past there are approximately 800 to a 1,000 cases per year at IV administered dantrolene or standard of care. All 6000 U.S.

hospitals are required to stock dantrolene, there are approximately an increasing 3,000 ambulatory care and surgeon centers that stock the product for a total of 9,000 outlets stocking dantrolene.

Hospitals and organizations that had converted to our product include Brigham and Women's, University of Pittsburgh, Mayo Clinic, the NIH, Kaiser, Children's Hospital of Philadelphia, the University of California Health Systems and the VAs under contract in many VA hospitals. Ryanodex is orphan drug exclusively for MH in the U.S. designation in EU.

We are very pleased that FDA has granted us seven years of marketing exclusivity and we view Ryanodex exclusively. Coupled with our four Orange Book listed patents we believe we will enjoy a long life cycle for Ryanodex. We look forward to ongoing market penetration in the U.S.

And we're making progress in our plans for a clinical trial to evaluate Ryanodex in a second indication, the treatment of exertional heat stroke or EHS which we believe is a subset of malignant hypothermia. EHS is a leading cause of death among student athletes and as a leading cause on non-combat related death among military personnel.

Currently there are no products on the market to treat this critical and unmet need. In March we held a productive type C meeting with FDA for Ryanodex and exertional heat stroke, the path forward appears to be a hybrid development program including human and animal efficacy and safety data.

We are working on our clinical plans for this potential new indication. Right now we are hopeful that we will able to conduct a meaningful, supportive study in Saudi Arabia in September during Hajj.

Although this will not be our pivotal study, this is a significant step forward in ultimately expanding Ryanodex's label to include exertional heat stroke. Ryanodex already has orphan drug designation in the United States for exertional heat stroke as well as a U.S.

patent for heat stroke which we believe will give substantial longevity to the product with this indication, assuming that we succeed in expanding the label to include EHS. So let's move now on to our ready to use or RTU bivalirudin candidate.

This product is our enhanced ready to use version formulation of bivalirudin, the same ingredient and in the medicine's companies anticoagulant Angiomax which had U.S. sales of over $600 million in 2014. Bivalirudin is a unique product it is purchased by the hospital pharmacy but stocked predominantly in cath lab where it is used.

Today when a patient presents in a hospital a second and sometimes third shift cath lab nurse reconstitute the lyophilized powder Angiomax based on related patients. This is done in the cath lab not in the pharmacy and this manipulation outside the pharmacy tends to make everyone nervous.

Our RTU bivalirudin is a stable liquid intravenous ready to use liquid formulation. It requires no manipulation, the nurse can simply spike it and we believe this will be a key driver of adoption for our product assuming FDA approval. We would also expect the benefit from the relationships we continue to build for Ryanodex.

We are right on-track to submit our NDA in the very near future which could mean acceptance for filing by the end of July and a PDUFA date in Q1 2016. We will work hard on a number of fronts to be able to bring this product to the market as early as next year.

With the 30 million upfront payment of Teva under bendamustine the $54.3 million in net proceeds from the underwritten public offering of the Eagle Pharmaceuticals' common stock during the first quarter. Eagle's very well capitalized to pursue multiple opportunities for future growth.

We believe our position will only strengthen if FDA approves a rapid inclusion product because this would trigger a milestone from Teva and facilitate the launch of this important product. This important product launch is in Teva’s very capable hands and the expectations of solid revenue stream with no sales cost.

We are able to focus on methodically growing Ryanodex sales while developing and commercializing our other value add and products such as the RTU bivalirudin and our 500 ML bendamustine which we can bring to the market in May of next year.

To recap, there are several important milestones in the near future that we expect will build value and we'll file the NDA for RTU of bivalirudin in the very near future and we expect the acceptance for filed by the end of July and our PDUFA date to be 10 months after filing. We expect additional patent plans for our rapid infusion bendamustine.

We plan to conduct a study of Ryanodex in exertional heat stroke planned for this year. The PDUFA date for rapid infusion bendamustine is December 13th I am assuming it's approved and we expect Teva would launch product shortly thereafter triggering another milestone payment from Teva.

A decision should be made regarding the seven years specific for rapid at approval or shortly thereafter. We look forward to ongoing market penetration of Ryanodex for MH while we advance development for exertional heat stroke. And into next year we have the potential launch of our 500ml bag of bendamustine.

So with so many near term events to drive value and strong balance sheet affording us financial flexibility, we are very excited about the year ahead and our prospects for the future and its growth. With that, I would like to open the call for questions. Operator, please go ahead with the instruction..

[Operator Instructions] And we can take our first question from David Amsellem with Piper Jaffray. Please go ahead..

Just a couple, on bendamustine, can you talk about what you're hearing regarding how Teva is handling this issue regarding the EMA inactive ingredient in their liquid form and are they now supplying customers with the lyophilized form.

And what you think all of that means for conversion to 3102, the small bag, once it gets approved? So that's number one.

Then number two is, this is related to the first question is, is it your expectation that once 3102 is available that Teva will just do a hard switch and that ultimately you won't see a need to launch the big bag, 3101, once you have the right to do so in May 2016, so maybe you could talk about how you thinking about that? Thanks..

So let me tackle all of that if I can. So bendamustine clearly Teva had to have the situation with their liquid formulation that contains the EMA. I mean I think we are all very aware of that.

It looks from the discussions we've had with customer base is that the customers are using predominantly that liquid product, reconstituting differently than they normally would, they still need to be fully gowned, laminar flow hoods. It causes difficulty for them. The customer base isn’t thrilled about the situation.

The market still seems to be as I mentioned predominantly in the liquid and not in the [indiscernible].

And so based on that, when you think about all of the significant benefits that rapid will have including the fact that it doesn’t have caustic solvents, doesn’t include EMA, we would think that the conversion to rapid should be very significant, I think it's going to be hard to ask customers to use a product with the EMA when they have the choice for rapid.

So based on that David I think conversion probably looks pretty strong for us. As far as the large bag, I think it's very important thing. We have the right to launch that drug next year and we are still looking into the plans and thoughts about that, and we don’t have anything tangible to discuss with you at this moment..

And then if I may ask a question on the bivalirudin opportunity.

So hypothetically, if Hospira were to win and generics would enter the market, how do you think that would play into Medicines' decision to initiate litigation against you or do think they would just ultimately cede the market to generics and move on? What is your view on along how that may play out?.

David it's very hard to predict what benefits company will do in these situations. Perhaps it's a better question for them but our view point as we spoke in the past, we believe being a very strong patent position to get this drug out of market quickly, hopefully next year.

And I think if the market is genericized and the Appellate Court is ruled in favor of a generic, it should be an easier path for us to get in the market. And we are doing everything we can to be prepared to bring that product to the market '16..

Okay. And then last one if I may on Ryanodex and exertional heat strokes, you mentioned that the study in Saudi Arabia will not be a pivotal study. But I guess the question then is, what would be the next steps after that study.

And may be talk about the clinical plan in terms of both the animal data and when do you think the additional human work would entail beyond the Saudi study? Thanks. .

So we had a very good productive meeting with FDA a few weeks ago and it's clear from our view and in that meeting and the agency understands the need for the product and understands the marketplace now, and it is very positive interaction where they're working with this different product to the market.

So we'll do some union work and some animal work. We have good history of animal work with exertional heatstroke particularly and it bodes well to the plan now to totally to get a clinical trial done in Saudi Arabia. It will show safety in compromised patient and eagerness which is ultimately what we need to do.

And in order to have the product label expanded for heatstroke eventually we need to I will a quote and say, a handful of patients in a more formal setting that we can track, and so after we get through this study the first item would be to take a look at the data, if you have a drug acts in patients in heat ailments and heatstroke we should have plenty of patients available to us in September.

And we'll sit back, meet with the FDA and open this, we need to find some patients that we can track for longer period of time than these transient patients out in Saudi Arabia so we're working on our plans to do that and we'll feel pretty good about the opportunity ahead of us..

And we can take our next question from Tim Lugo with William Blair. Please go ahead..

Can you discuss your ability to launch your liquids, large bag formulation and maybe what you're thinking more into maintaining those rights and maybe at a high level this, is this product really just a hedge in case the rapid infusion product isn't approved and what happens if rapid is approved, so any market for this product?.

Thanks Tim, it's a very good question. Yes, we have the ability to launch that big bag a little bit less than a year from now. As I mentioned earlier we're still working on our plans determining what direction to take into product, but ultimately it could be a very important product to us.

It will allow Eagle to commercialize some products which I think is important to us both financially and strategically. And we believe that there might be a marketplace where people would want the larger bag as opposed to proactive. We haven't determined any of our pricing strategies.

We start about a year to figure that all our but we do have the right to that big bag, and we'll determine going forward that to utilize that rate and continue to expand our profitability for the Company..

Okay I understood, and it sounds like you have some additional IP for benda pending, Teva is obviously in litigation, maybe broadly can you talk about expectations for durability of that product for the rapid infusion product and maybe how long the tailwind you believe there will for that product?.

Yes, another great question Tim, so we think that the bendamustine family will provide long-term profitability for the Company which critical is in our approach to working with Teva. As I said somebody talked their perfect partner they're just wonderful, they're doing a great job.

The interaction between the two companies has just been -- it's been correct. Hopefully we'll wind up with the seven year exclusivity. We have the orphan drug designation. We would hope that will translate into the orphan drug exclusivity provider for seven years. We have two patents issued to us now for bendamustine.

We have another five or six patents at the patent office, we believe those will come through and open an initiative. So at the end of process we could wind up with the exclusivity due to the orphan drug and multiple orange book listed patents protecting us.

And then ultimately as the market unfolds and eventually when generics do come out of the viable form, we have the big bag at our disposal, we also under certain circumstances have the ability to launch the little bag and you just at the growth for seven or eight years between exclusivity patent.

I think we should wind up with some pretty significant value for this product family for quite a variable time to excite me it should feel long-term sustainable growth that we have worked so hard to create..

That good to hear and I guess lastly in your growth I believe you had a development partner for evaluating the royalty rate and you'd be paying out, is that depended at all it's their generics on the market when you launch?.

That royalty rate would be paid off to our development partners with a flat of the value that we are putting into the Company. And it's been flat throughout out time and it is capped eventually to serve them..

And our next question comes from Irina Koffler with Cantor Fitzgerald. Please go ahead..

I was wondering maybe if you could provide a little bit more of an update on any latest that you've heard on Angiomax litigation and also what gives you such conviction that you can launch next year when Medicines’ can sue you and trigger a 30 month stay?.

Thanks Irina, so the question about Angiomax, I don't think we know any more than the problem that we have got that litigation, via concerning [indiscernible] our arguments were heard, I don't remember may be a month ago or five weeks ago and we're waiting just like everybody else is word on that outcome and as we look toward next year, we're filing it here soon.

We'll see if we're sued or not, I don't think that they would complete that that will occur and we just think we have a reasonably strong position and we're hopeful that we can get through the courts you know prior to the full 30 months.

We were successful with getting through the courts on our litigations on bendamustine, hopeful we'll be able to duplicate it.

But you're right, there's a major chance that we get stuck for the full 30 months if we're sued and we're cognizant of that, but we're going to do everything we can, I think we have a good position to get us through and onto the market as soon as we possibly can..

Thanks and I don't know if you thought there was a new FDA log blog today about deuterated compounds now getting orphan drug exclusivity in the FDA taking a softer stand on an active moiety and so forth, you think that this bodes well for your orphan drug exclusivity?.

Yes, I didn't see that blog today but we spend quite a bit of time, we have some good experience in the orphan drug group and we were able to achieve the seven years for Ryanodex and when we look at the rationale presented to the orphan drug group at FDA to receive the designation, we feel pretty good at that, we're sure that you're translating to the seven years.

Now we'll found out an approval shortly thereafter we'll be starting the dialogue with the agency shortly and we're hopeful..

And then on, just a small administrative one, can you break out the diclofenac/misoprostol revenues?.

Yes, the diclofenac alley was really small this quarter, it was somewhat insignificant, have to strike that..

[Operator Instructions] We can go next to Robert Sussman with Bentley Capital, please go ahead..

Thank you.

On the cash of $116 million and the recent equity offering you did, would that all be required to inflate the pipeline or are you also considering acquisitions?.

No, this is David Riggs. We are considering transactions which would advance the company. You know in our current pipeline and in part especially as we look forward to approval in milestone payments and so forth that our cash balance should grow and should be very helpful in us looking at product transactions and even M&A activity..

Can you give us a little more granularity on your acquisition philosophy whether you're looking to buy individual products or companies or how anything that you would buy would fit with your current pipeline?.

Hi Robert, you know very good strategic question. We're just getting started on the process of analyzing our options.

We're in business eight years now, it took us eight years to get to the point where we are, looks to be very strong profitability going forward and we'd like to take advantage of the cash that we have the clean balance sheet that we have and what appears to be very significant earnings potential going forward and I think we have a, quite a bit of opportunity to acquire either products or companies.

What we're missing here at Eagle now is the commercialization capability to bring some of these key products to the market as soon as next year.

And we’re focused first on building a sales capability to be able to take advantage of the pipeline and we'll just see where that takes us, but we’re a hospital specialty company and we're looking for products that would benefit from a promotion to either the hospital it could be the emergency room, the hospital pharmacy and to fusion centers and that's where we're focused right now..

It appears we have no further questions at this time, so I will turn the floor back over to Scott Tarriff for any additional or closing remarks..

Thank you. Thank you everyone for taking the time, thank you for joining us, I appreciate it and look forward to speaking to you again in the near future. Have a good morning..

And this does conclude today's program, thanks for your participation, you may now disconnect and have a wonderful day..