Lisa Wilson - Investor Relations Scott Tarriff - President and CEO David Riggs - Chief Financial Officer Ken Degen - Senior Vice President, Hospital Sales and Marketing.

David Amsellem - Piper Jaffray Irina Koffler - Cantor Fitzgerald Tim Lugo - William Blair & Company.

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 Fourth Quarter and Year End 2014 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. It’s now my pleasure to turn the floor over to Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. You may begin your conference..

Thank you. Good morning. And welcome to Eagle Pharmaceuticals’ fourth quarter and year end 2014 financial results call. This is Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. With me on today’s call is Scott Tarriff, President and Chief Executive Officer; and David Riggs, Chief Financial Officer.

We will be joined for the Q&A session by Ken Degen, Eagle’s Senior Vice President of Hospital Sales and Marketing. This morning the company issued a press release detailing financial results for the three months and fiscal year ended September 30, 2014.

This call can be access -- press release, excuse me, can be access through the Investor Relations section of the Eagle website at eagleus.com and you could also access the webcast of this call from there.

Before we just 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 Eagle’s 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 Wednesday, December 25th.

You will find dial-in information in today’s press release. The archive webcast will be available for 30 days online at eagleus.com. For the benefit of those who maybe listening to the replay, our archive webcast of this call will come recorded on December 17, 2014.

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

Thank you, Lisa. Good morning, everyone. 2014 was a very strong year for Eagle Pharmaceuticals. Beyond our successful IPO, we achieved many milestones, which we recapped in our press release this morning. These included two approvals and one tentative approval from the FDA and the launch of our first internally marketed product Ryanodex.

We successfully completed the clinical trial of our bendamustine rapid infusion product and recorded positive outcomes last month. We also received two orphan drug designations and two patent issuances and saw the dismissal with our prejudice of Teva’s first patent infringement suit.

I will discuss these positive developments in greater detail later on the call, but first, I would like to ask David to review the financial results.

Dave?.

Thank you, Scott. Good morning, everyone. Our revenues consist of product sales of argatroban to our two commercial partners, royalties we received on their net product sales of argatroban to their respective customers and since September sales of Ryanodex.

For the three months ended September 30, 2014, total revenues were $2.8 million, as compared to $4.6 million in the prior year quarter. Decrease was due to lower sales of argatroban to our partners and lower royalties, partly offset by $249,000 in net product sales of Ryanodex, which we launched late -- in late August of 2014.

R&D expense was $5.9 million for the quarter of 2014. The $2,500,000 increase over the prior year quarter reflects higher development costs on our product portfolio overall, but particularly on the clinical trial of our bendamustine rapid infusion product and on our RTU bivalirudin candidate.

SG&A expense increased $3.9 million in the third -- three months ended September 30, 2014, compared to $820,000 during the same period of 2013. This increase primarily related to increases in headcount, professional and legal fees, associated costs with operating as a public company and the Ryanodex product launch expenses.

Net loss for the fourth quarter 2014 attributable to common stockholders was $9.1 million or loss of $0.65 per basic and diluted share, compared to a net loss of $649,000 or $0.21 per basic and diluted share for the quarter -- fourth quarter of 2013.

I want to clarify that our higher loss in the fourth quarter was driven largely by Ryanodex launch costs and bendamustine development expenses. We do not expect continue to occur this level of net loss. Turning to the full year results.

For the 12 months ended September 30, 2014, total revenues were $19.1 million as compared to $13.7 million in the prior year quarter.

The increase reflects the $3.8 million we received from Hikma on the FDA approval of diclofenac/misoprostol and a $2.3 million increase in royalty income in 2014, primarily offset by $689,000 and decreased product sales. R&D expense was $16.8 million in the 12 months ended September 30, 2014.

The $7 million increase over the same period last year reflects higher development cost on our product portfolio overall. But particularly the clinical trials are rapidly infused bendamustine product, RTU bivalirudin, and legal and development cost to support approval of diclofenac/misoprostol.

SG&A expense increased by $4.3 million in the 12 months ended September 30, 2014 to $9.3 million. This increase was primarily related to Ryanodex product launch expenses, professional and legal fees associated with operating as a public company and higher insurance and professional fees in fiscal 2014.

Net loss attributable to common stockholders was $19.6 million or a loss of $1.97 per basic and diluted share compared with a net loss of $9.9 million or a loss of $3.25 per basic and diluted share in 2013.

We had cash and cash equivalents of $22.7 million plus $20 million in short-term investments, $137.3 million in additional paid in capital and $33.1 million in stockholders’ equity as of September 30, 2014. And with that, I’d like to turn it back over to Scott..

Thank you, David. Since our last call in August, we have focused on Ryanodex launch, completing the clinical trial of our bendamustine rapid infusion product and advancing our other clinical programs. And I’m very pleased with our success in each of these areas. Starting with bendamustine, there were multiple positive developments in recent months.

First, the FDA granted Tentative approval for our bendamustine product in July. This product is a Ready-to-Dilute concentrate solution of bendamustine. It will be dispensed in a 500 mL bag same as those the in-market formulations of Treanda lyophilized powder and liquid formulation which have been launched last month.

Because our bendamustine RTD product is a Ready-to-Dilute liquid which avoids many of the health risks inherent in reconstituting the cytotoxic drug from powder form. We believe the market will be re-stepped into it once it is commercially available.

Also in July, the FDA granted this product orphan drug designation for the treatment of CLL and indolent B-cell NHL and administered in low volume in a shorter infusion time. Last month, we received positive data from our bendamustine rapid infusion clinical trial, in which our formulation was administered in 50mL admixture in just 10 minutes.

This is a significant reduction in dose volume and time. In this study, our rapidly infused product was found to be bioequivalent to Treanda and the incidence and profile of adverse events were comparable. This is important because our rapidly infused product delivers the same amount of active ingredient as Treanda but with a lower admixture volume.

We believe that our rapidly infused bendamustine product will provide meaningful clinical and safety benefits to patients and healthcare providers alike in the treatment of both NHL and CLL.

We fully expect that Teva has recently launched Treanda liquid formulation will successfully convert a large portion of the existing lyophilized market to liquid Ready-to-Dose market. This is to our advantage as the market will already be trying for our liquid formulation by the time we come to the market.

At such time, we believe our RTD bendamustine product will offer significant advantages over the Treanda liquid formulation, including increased stability resulting in longer shelf life, faster infusion time reducing required nursing time with each patient and reduced waste because our product will be available in multi-use vial.

So now I’m going to quickly touch on the patent litigation, the first lawsuit in which Teva alleged that our bendamustine product infringes on its 524 patent has now been dismissed with prejudice. This removed the 30-month stay that would have prevented us from entering the market until March of ‘16. We are obviously very pleased with this outcome.

Cephalon filed a second lawsuit in September alleging that our bendamustine product infringes its newly issued 270 patent and that case remains pending. We now have two patents covering Eagle’s bendamustine including the newly issued patent covering administration of our rapidly infused bendamustine product.

We believe these patents combined with the orphan drug designation for rapidly infused bendamustine to treat NHL and CLL, may provide longevity for the product. We are progressing with our plans to bring the product to market as early as next year.

Moving now to our optimized dantrolene product, we launched Ryanodex at the end of August, just over a month after it was approved by FDA for the treatment of malignant hyperthermia or MH.

This potentially fatal condition can be triggered when genetically susceptible patients come in contact during surgery with certain inhaled anesthetics or specific muscle relaxant. There are approximately 800 to a 1,000 cases per year of MH, an IV administered dantrolene or standard of care. All 6,000 U.S.

hospitals are required to stock dantrolene and they are approximately about an additional 3,000 ambulatory care and surgery centers that also stock the product, for a total of 9,000 outlets stocking dantrolene. MH can be fatal untreated and there could be significant patient complications associated with an MH event.

Treating MH is difficult and highly stressful for the anesthesiologists, surgeons and their patients. If an MH crisis occurs during the surgery, the patient must be stabilized and removed from the triggering anesthesia. Dantrolene must be administered and time is the efforts.

By example, one study, every 20-minute delay in administering dantrolene was associated with a 30% increase in patient complication. The old dantrolene product is difficult to administer and a large number of 60 mL vials must be reconstituted by multiple staff during the acute phase of the crisis.

Ryanodex is a re-formulated version of dantrolene sodium that uses a nanosuspension technology for improved performance in treating MH. One vial of Ryanodex contains the same amount of dantrolene sodium as 12.5 vials of other approved dantrolene sodium formulations.

Our product could be reconstituted and administered in less than one minute by one anesthesia provider and with far less vials of 5 mL versus 720 mL. This is critically important in treating MH in every second count.

We launched Ryanodex at the end of August using a small cells force of about 20 and they are targeting the approximately 9,000 outlets that I mentioned earlier.

Now, I’m very pleased to report and in a recent case of malignant hyperthermia in a two-year old boy, his MH was reversed quickly after dosing with Ryanodex and the drug worked exactly as intended. We are all very proud and excited to have been part of his rapid recovery.

To date, we have sold 386 vials of Ryanodex across approximately 65 different customers, translating into approximately $800,000 sales. Hospitals represent 90% of our sales to date. The average hospital purchased six vials and the average surgical center and local medical center order was three vials of Ryanodex.

Early conversions include multiple top-tier hospitals, including Brigham and Women's and Children's Hospital of Philadelphia, CHOP. In addition, the National Institutes of Health, the NIH, has agreed to convert and Pfizer recently signed a contract. So we look forward to the coming conversions across these networks.

We are finding that the process and length of time from initial call to purchase varies greatly between facilities.

Factors that they seem to include the size of the hospital and the level of authority held by the leader of the pharmacy department, a well trenched leader at a larger hospital is more likely to make the decisions to purchase Ryanodex without a P&T committee and indeed not all hospitals are requiring them.

However, a pharmacy leader who is new to a facility working in smaller facility may be a little more comfortable, if the roughly $7,000 to $10,000 cost to stock the product is authorized by P&T.

With our two-year shelf life, this equates to $3,000 to $5,000 per year, so while Ryanodex is priced at a premium to the current cost, we believe this premium pricing is warranted by the significant advantages of Ryanodex over the legacy products and that we have priced the drug responsibly.

Based upon these figures, the stocking opportunity ahead of us, if we were to convert a 100% of this facility is about $80 million, thereafter reorders would be about half of this yearly.

Given the obvious significant advantages of Ryanodex, we believe that a facility is highly unlikely to refer to the old 720 mL formulations and that Ryanodex will become the standard of care.

Ryanodex’s orphan designation for this indication in United States and we are still awaiting FDA’s decision on granting us the seven-year marketing exclusivity protection. Coupled with our four Orange Book listed patents, we believe we will enjoy a long lifecycle for Ryanodex and we look forward to ongoing market penetration.

We are planning to seek approval for Ryanodex outside of the United States and we are pleased that the EMA recently granted Ryanodex orphan drug designation or malignant hyperthermia in the EU. And we look forward to a 2015 regulatory submission to enable hospitals and patients in the EU to access this important product.

We have made progress on our plans for a clinical study to evaluate Ryanodex in the second indication, the treatment of exertional heatstroke or EHS, which we believe is a subset of malignant hyperthermia. EHS is a leading cause of death among student athletes and is a leading cause of non-combat related death among military personnel.

Currently, there are no products on the market to treat this critical and unmet need. We have modified our plans for this project since the last call. Instead of a pilot study in Saudi Arabia, we now intend to conduct a pivotal trial during the Hajj in September of 2015 in Saudi Arabia.

This would be a short study lasting about a month and would evaluate Ryanodex in treating patients suffering in exertional heatstroke. Ryanodex already has orphan drug designation in the U.S. for exertional heatstroke, as well as the U.S.

patent for heatstroke, which we believe would give substantial longevity to the product in this indication, assuming that our pivotal trial successful and the label is expanded to improve EHS. In a nutshell, dantrolene has been on the market for around 35 years and its safety is widely accepted.

Ryanodex is now approved and we believe that our product is safe. EHS is a major problem and there are no drugs on the market to treat this disease. Student athletes are dying, soldiers are dying, pilgrims to the Hajj are dying and those who suffer -- and those who survive, suffer morbidities, including organ damage and neurological damage.

It is very difficult to find a control setting to conduct the trail EHS and we believe Saudi Arabia presents an excellent opportunity. We recently requested a Type C meeting with FDA and we hope that meeting will take place late February or early March.

We will be asking the FDA to accept data generated exclusively in Saudi Arabia based on the rationale, I just described. If the agency agrees, we expect to complete our study early in Q4 of our fiscal 2015 and assuming positive data we could be filing for new indication for Ryanodex in the first half of our fiscal 2015.

If the FDA believes more patients are needed from non-Saudi sites, we can conduct a study in April or May of 2016 with the U.S. military. We will provide an update on our strategy and timeline after we meet with the FDA later this winter.

Another near-term event is that we plan to file an NDA in the first half of 2015 for our RTU bivalirudin, our enhanced ready-to-use version of the anticoagulant Angiomax. U.S. sale for Angiomax was $580 million for the 12 months ended September 30, 2014. I mentioned several patent allowances and issuances.

We will continue to execute our strategy to further strengthen our intellectual properties surrounding our products and product candidates. Today, Eagle is a well-capitalized public company with two products in the market, plans to launch a third product in the near future and tentative approval for fourth bendamustine.

In 2015, we continue to be -- we will continue to be aggressive with bendamustine. We will file an NDA for RTU bivalirudin and we expect to conduct a pivotal trail of Ryanodex in exertional heatstroke, a potential label expansion for the product. We’re excited about the year ahead and look forward to your ongoing support.

With that, I’d like to open the call for questions. Keith, please go ahead with the instructions..

Okay. Certainly. [Operator Instructions] And we can take our first question from David Amsellem. Please go ahead. Your line is open..

Thanks. Just a couple, so first on bendamustine, one thing that Teva commented on it, it’s a recent investor update was that it suggested that their orphan status on bendamustine -- on Treanda was a potential gadding factor you being able to launch.

So I wanted to get your commentary on that and how we should think about that? Then secondly, also on bendamustine, can you give us some color on the potential that this get settle? Do you think that Teva is open to potential settlement? And then lastly on Ryanodex for exertional heatstroke, maybe give us some color on the endpoint, you think you’re going to be evaluating in the setting? More importantly, what you think the FDA wants to see in that pivotal study? Thanks..

Thank you, David. So let start with the first question, the best way to approach bendamustine is, as we mentioned, we progressed extremely well this year with the product. We have our upcoming pre-NDA meeting with FDA and we’ll learn a lot more.

And as we state our goal is to bring the product to the market as soon as possible and we’re preparing accordingly and that takes into account the orphan drug issues that you mentioned and so forth. So as we have further updates, we’ll provide them. And from our standpoint, it’s our obligation to optimize the asset, bring into market and so forth.

And as we have further updates on how we are going to do that, we’ll continue to update everyone. As it relates to EHS endpoints, we have a draft protocol that we presented to the agency in advance of our Type C meeting. And we believe that there are markers that we will be able to use as our endpoint.

And after we have our discussion with them later in the winter to see if they agree with us and how they feel about it, we’ll report back that as well..

Scott, let’s say, if I may elaborate on the question on the EHS, I mean, are you -- are there going to be clinical endpoints as well when you say markers, I mean, are you talking about evidence of organ damage, are you looking at say fever reduction, I mean, any additional color you could provide there?.

Yes. So probably, David, the best way to explain it is all of the above. And so when we met with the agency the first time on exertional heat stroke. Essentially what they told us was, there are -- there is not a lot of knowledge about exertional heat strokes since there are no drugs on the market and nobody has really studied it before.

But they challenged us with and what they told us was, let’s not pick any specific primary endpoints. Your job is to provide dantrolene in addition to standard of care. So standard of care is cooling an IV fluid. And what they told us was, show us that there is a benefit to dosing and adding dantrolene to standard of care.

And what we’ve done since that first meeting is propose several items and several markers and different opportunities to prove that when you add Ryanodex to standard of care, we’ll see an improvement in these patients either a meeting our improvement or an indication of future improvement.

Because if you realize, you know, some of these patients, the problems with the morbidity that they have progress over time. So now it’s an acute study, the study is only going to take about a month. But really what we are going to is dose, take a look, see what we have and go back to them..

Okay. Thank you..

You are welcome..

And we will take our next question from Irina Koffler. Please go ahead your line is open..

Thanks. You mentioned that your rapid infusion Treanda is bioequivalent to Teva’s Treanda. So I was just wondering how you are thinking about regulatory submission strategy.

Is this going to be an ANDA and sNDA to the larger bag? Can you help us sort of understand that a little bit better?.

Yes. It’s good to hear from you, Irina. So our 50 mL product will be filed as in NDA and as I mentioned, we have our upcoming FDA meeting. So we will be discussing some of the options with them.

But what we should probably point out is that the intention of the clinical trial that we just passed is to update the how to administer section of the already tentatively approved vials.

And so the intent is to take the clinical trial data and change the label instead of saying take our liquid in place of 500 mL bag and infuse over a long period of time. The label will now say take the liquid, place it in a 50 mL bag and infuse it in 10 minutes. And we’ll update everybody post FDA meeting..

So just to understand, it sounds like you will have two NDA filings, one for the larger bag, one for the smaller bag.

But the smaller bag data that you recently collected is just to update the label of the larger bag?.

Well, I think the answer to that is likely at the end of the process, Irina. There will only be one product. And that will be the formulation which we have so the 500 mL and 50 mL bag is the same formulation and what we expect would occur is that our label will only say take the 50 mL and infuse in 10 minutes..

Okay. Got it. And then the orphan drug exclusivity or the designation, right now you just have designation.

If you were to get exclusivity, does that mean that you can then go around Teva’s exclusivity or is it -- do you still have to wait? And do you -- and are you planning on launching anyway?.

Yeah. So the first question about orphan drug exclusivity. Our understanding of the regs is that if our rapid product is approved prior to the expiration of the current orphan drug exclusivity. We would be allowed into the market during the exclusivity period.

That’s our understanding of what the orphan drug designation does, assuming that the designation transfers to exclusivity. So the answer to your question is yes. And in terms of launch, we are planning to get the product to the market as soon as we can regardless of which label is in the product initially..

Okay.

And then just one last one if I may, on the Angiomax development, so there is 2029 formulation patent, sort of remaining that these are the ones that you would certify against and what’s your -- I don’t know, what’s your estimate of whether or not you can get around them?.

Yes. So what we’ve said before is that we are very confident in our patent position relative to those patents. Our situation in our patent position is different than that of the ANDAs. We think, we have a strong position and believe we can get the drug to the market as early as 2016..

Okay. Thank you..

Thank you..

[Operator Instructions] We’ll take our next question from Tim Lugo. Please go ahead. Your line is open..

Hey. Thanks for taking my question. Scott, I might have missed this earlier, but did you say when the upcoming FDA meeting is scheduled? And also at the meeting, how are you going to discuss maybe the possibility of a label carve-out of CLL versus NHL indication? It sounds like what you just said is that you might not need that label carve-out.

Can you just kind of flush this out a little bit more?.

Yes. Sure. And thanks for being on the call, Tim. So our meeting will be this month. So it’s soon obviously, since we are going into the holidays. And in these pre-NDA meetings, they will cover all aspects of the filing. And essentially, it’s to share the date with them from the study that we just completed.

And find out specifically how they would like us to file and what the timelines looks like. I wish I had more information to provide to you but why don’t we all regroup after that meeting..

That’s why it sounds like we updated M&A. I guess regarding, Ryanodex, it seems like the launch is going well.

The six vials per hospital, is that something you think is a run-rate and when should we hear about the seven-year of exclusivity?.

Yeah. On the seven-years, Tim, quite frankly, we thought we were ahead already. We are surprised it’s taking as long. We keep hearing that the decision is going to be made shortly but it hasn’t happened yet. So we are waiting as impatiently as everybody else is.

And in terms of the size of the orders going forward, maybe I will ask Ken Degen, who is here with me to comment..

Yeah. Thanks, Scott. And good morning everyone, good morning, Tim. Yeah, we do anticipate that that run-rate is going to continue based upon the data that we’ve seen so far. We are also pleased as Scott said earlier, that some of the largest and most influential institutions have recognized the benefits associated with Ryanodex.

But specific to your question, yes, we do anticipate that run-rate to continue on a per institution basis..

Okay.

And if you receive exclusivity, will the old formulations still be available?.

Of the old dantrolene formulation, Tim?.

Yeah..

Yes. We don’t believe, again, from our reading of the regs in the situation like this, where there is a follow-on product that the agency removes the old product from the market, so we believe that we’ll continue the way it is..

Understand.

And maybe one last question, can you just talk about maybe the capital needs, if you are able to launch spend benda during calendar 2015?.

Hey Tim. It’s Dave. Yes, we’ve said publicly on a number of occasions that we have sufficient cash to get up to the point of launch. However, in order to launch the product, we certainly are going to need additional cash to fund working capital requirements and to scale up the sales force.

So in terms of the amounts, we haven’t really said how much I think we’d be comfortable with it, maybe $20 million range..

Understood. Thank you..

[Operator Instructions] As it appears we have no further questions, I will turn the program back over to Scott Tarriff for any closing remarks or additional commenting..

Well. Thank you everybody for joining us this morning. Obviously, it’s been an exciting year for the company. We look forward to another positive year in ‘15 and thank you very much..

This does conclude today’s program. Thank you for your participation. You may now disconnect your lines..