Good morning, everyone. My name is Keith and I will be your conference Operator today. At this time, I would like to welcome everyone to Eagle Pharmaceuticals ' Second Quarter 2021 Financial results call. All lines have been placed on mute to prevent any background noise. After the speakers remarks, there will be a question and answers period.

At that time, if you have a question, please [Operator Instructions]. As a reminder, this conference call is being recorded today, August 9th, 2021. It is now my pleasure to turn the floor over to Ms. Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. Please go ahead..

Thank you, Keith. Welcome to Eagle Pharmaceuticals Second Quarter Earnings call. This is Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. With me on today's call are Eagle's Chief Executive Officer Scott Tariff, Chief Medical Officer Dr. Judith Ng-Cashin, and Chief Financial Officer Brian Cahill.

This morning, the Company issued a press release detailing financial results for the three months [Indiscernible] 6/30/2021. This press release and a webcast of this call can be accessed through the Investor's section of the Eagle website and 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 [Indiscernible] 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 guaranteed as future performance.

Actual results may differ materially from those projected in the forward-looking statements. Eagle Pharmaceuticals specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. A telephone replay will be available shortly after completion of this call.

You will find the dial-in information in today's press release. The archived webcast will be available for one year on our website at eagleus.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on August 9th 2021.

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

Thank you, Lisa. Good morning everyone, and thank you for joining our call today. We had a strong and productive quarter. Before I get into those details, I wanted to share some overarching thoughts.

We're proud of the strategy deployed here at Eagle over the past few years, If we assume for a moment that we bring days of present to the market relatively soon, then we are entering a new phase where Vasopressin, PEMFEXY, [Indiscernible] in Japan, and now Landiolol, are shaping our growth.

Some may argue that this progress has been slow, but we have managed Eagle with a low-risk, effective and efficient approach. Importantly, every day we add to our footprint in hospitals and oncology, and every day our Eagle employees interact with physicians, pharmacists, and nurses in these settings.

Combine this with our clinical regulatory quality and manufacturing experience, and we believe that we will continue to drive growth. What we have quietly done is build a very robust hospital and oncology Company with broad multi-functional capabilities.

We have accomplished this while still buying back $211 million or 22% of our Company, maintaining a clean, strong balance sheet, and continued to post strong earnings as evidenced by today's announced $0.93, which represents a 63% increase from $0.57 a year ago. We also have net cash and working capital of around $100 million on hand.

Obviously, our goal is to accelerate the growth of the Company. Bendamustine in both U.S. and Japan, and RYANODEX Vasopressin, and PEMFEXY have all been largely organic. We now add in Landiolol.

Let me point out that by being disciplined, meaning not using significant amounts of our cash to pay off for assets, or diluting our shareholders, we have done this in a way that in essence we get paid for our commercial and functional infrastructure.

With Landiolol, we will use our much-needed and clearly much-desired commercial and functional capability that we have been building. Landiolol will enter the organization with very little additional infrastructure requirements or cash requirements. We're also hopeful that other companies see the value and need for the Eagle platform.

and that we announce a further expansion of the pipeline. At the same time, we are targeting products like Landiolol which are more mainstream pharma products with longer exclusivity and transitioning away from reformulations and Spec Pharma.

We remain very proactive about building out a strong foundation for sustained future growth and believe additional pipeline products will be announced soon. Between our internal research and development and our ongoing business development efforts, we will -- we believe we'll be able to generate consistent growth for the Company.

Turning now to our second quarter, we outperformed consensus earnings forecast and we had what we believe was an excellent few days in court on Vasopressin. We expanded the Bendamustine franchise in Japan, and we are getting very close to our PEMFEXY launch and a period of exclusivity beginning February 1st already.

Taken together, these factors will contribute to a potentially doubling of revenues and impressive revenue growth next year in 2022. In terms of our products, let me start with Vasopressin. The trial, which had been delayed more than a year due to COVID, began on July 7th. We believe the trial went well.

In some respects, the delay turned into a positive as it allowed us to gather significantly more proof and assurance that our product is manufactured and maintained within the appropriate non-infringing ph range. We expect to have the court's ruling around mid-September.

In mid-June, we responded to the CRL with full study results and were assigned a GDUFA date of 12/15. Our belief is that we had a very robust response and believe we satisfied all questions raised by FDA. We were pleased that FDA maintained priority review of our ANDA for Vasopressin, which is very important program for us.

And remember, Eagle is first to file with an ANDA referencing VASOSTRICT, which had total U.S. sales of $786 million in 2020. In light of the priority review, as well as being flagged as a COVID priority, we continue to believe that we can bring Vasopressin to the market this year.

We look forward to updating you about the trial outcome and the decision from FDA in the weeks and months to come. In addition to the Vasopressin opportunity, we are excited now to be getting close to our four-month exclusivity period for PEMFEXY, which begins on February 1st. This is another significant market for us. A U.S.

sales of ALIMTA in 2020 totaled nearly $1.3 billion. As you recall, we also have approval for a multi-dose file and we have a unique J-Code which provides coding clarity to outpatient facilities and physicians and also facilitate access for patients and reimbursement from Medicare, Medicaid, and commercial insurance.

We've been looking forward to this launch since we first received FDA approval in February of last year, and believe it will be an important revenue stream in 2022 and beyond. Now, moving to our Bendamustine products in Japan, which are progressing nicely.

In the second quarter, we announced that SymBio, our partner in Japan, received approval from the Pharmaceuticals and Medical Devices Agency or PMDA for TREAKISYM, ready-to-dilute liquid formulation. That approval meaningfully increases the market opportunity for TREAKISYM in Japan.

Also in the second quarter, and notably ahead of schedule, SymBio filed an application with the PMDA for the TREAKISYM rapid infusion, 50 ml liquid formulation. That application was based on the results of clinical studies investigating the safety and pharmacokinetics of TREAKISYM [Indiscernible] administered by 10-minute intravenous infusion.

With these important extensions of the bendamustine franchise, Eagle's Japan royalty and milestone income next year is expected to be in the $20-25 million range, representing another solid source of revenue.

Taken together, the launch of Vasopressin late this year and exclusive launch of PEMFEXY, and the royalty income from Japan, we have a solid foundation for revenue growth next year. In 2022, we will have ample cash and we will be very well-positioned for another strong year.

So now let's turn to '23, '24 and beyond, and how we plan to ensure long-term sustainable growth for Eagle, and in the face of declining revenues due to trended generics in late '22. Our licensing agreement with AOP Orphan Pharmaceuticals for the U.S. commercial rights for Landiolol is a very exciting near-term opportunity.

Judi will discuss the scientific merits of the product, as well as the regulatory path for it in a few moments. But first I'd like to share how it helps in our transformation to a Company that is less reliant on Spec Pharma and reformulations.

First for the initial indication, upon approval as I mentioned earlier, Eagle will need very little additional infrastructure to support the launch as we already call on most of these providers. And second, Landiolol is a new chemical entity or NCE and will therefore received five years of exclusivity.

The sees the Eagle's first NCE and is a true catalyst in reshaping our Company as we evolve into a mainstream pharmaceutical Company with a vibrant pipeline of products less reliant on reformulations.

And third, it allows for very efficient flows through to the P&L, because we have the infrastructure largely in place in our existing footprint to handle marketing and commercial efforts. We're excited to bring this important therapeutic to the U.S. and believe that we have a clear regulatory path forward.

In addition to the upfront $5 million milestone payment, and we will split profits equally, which we believe benefits our shareholders, we can look forward to a significant revenue stream in 2023.

We are very proud that we were able to find a way to bring such an important product to the Company and in light of all of these factors, Vasopressin, PEMFEXY, SymBio and now Landiolol, we anticipate significant growth going forward even in the face of diminishing revenue eventually for bendamustine in 2023.

With that, I'll now call -- I'll turn the call over to Judi, our Medical Officer -- our Chief Medical Officer, to discuss Landiolol in more detail. Judi..

Thank you, Scott. While Landiolol is a novel therapeutic in the U.S., it has been used in the care of critically ill patients in Japan and Europe for years. Landiolol was first approved in Japan in 2002 as [Indiscernible] and in several European markets as Rapid Lock in 2016.

Landiolol is indicated as an anti-arrhythmic agent in Europe for Supra Ventricular Tachycardia and for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, post-operative, or other circumstances or short-term control of the ventricular rate with the short-acting agent is desirable.

As well as non-compensatory sinus tachycardia, wherein the physician's judgment, the rapid heart rate requires specific intervention. In Japan, Landiolol has also been approved for the treatment of ventricular fibrillation or ventricular tachycardia.

The management of rapid heart rate or tachycardia in critically ill patients can be quite complicated, regardless of the underlying cause which may include shock, arrhythmia, heart failure, and the postoperative setting.

Beta blockers, also known as Beta adrenergic blocking, are agents are class of drugs that works by blocking the neurotransmitters, norepinephrine and epinephrine from binding to their receptors. These neurotransmitters contribute to the development of tachycardia.

The Beta 1 receptor Beta blockers are used frequently in critical care settings to manage tachycardia. However, the available Beta 1 Beta blockers in the U.S. can also have the unwanted effects of decreasing the contractility or muscle strength of the heart and of lowering blood pressure.

Landiolol has the potential to become a cornerstone therapy in the management of these patients. It is ultra-short acting with a rapid on-and-off effect that allows clinicians to balance heart rate control and blood pressure more precisely.

In Addition, it predominantly affects heart rate without much effect on cardiac contractility and blood pressure. We believe that clinicians in the U.S. will welcome Landiolol as a key therapeutic tool for the more precise management of tachycardia in the critical care setting.

There could be additional clinical settings for which Landiolol has the potential to improve patient management. The FDA has tentatively agreed that a pediatric study being conducted in Europe could form the basis for an initial pediatric study plan for future submission to the agency.

In terms of the regulatory timeline to approval in the U.S., in June of -- pardon me, in July of 2020, AOP held a Type C meeting with the FDA, at which time AOP proposed a submission strategy in which it would provide summaries of pre-existing safety and efficacy data and a meta-analysis of published randomized controlled trials.

The FDA tentatively agreed with this approach and deemed these datasets adequate to support up proposed ANDA without additional U.S. based clinical trials.

ALP intends to submit the ANDA in the first quarter of 2022, seeking approval of Landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.

The expected review time is 10 months based on feedback from the agency that was provided during the previously held Type C meeting. With that, I will turn the call over to Brian Cahill to discuss our second-quarter financials. Brian..

Thank you, Judi. And good morning. In the second quarter of 2021, total revenue was $48.1 million compared to $41.9 million in Q2 of 2020.

Product sales during the second quarter increased by $5.2 million year-over-year, totaling $19.6 million compared to $14.4 million in Q2 of 2020, primarily driven by a $3.2 million and $3.5 million increase in RYANODEX and BELRAPZO sales respectively.

The BELRAPZO product sales were $7.6 million in the second quarter compared to $4.1 million in Q2 of 2020. Eagle recognizes the BELRAPZO sales and shipments by Eagle to wholesalers. Based on IMS data, Eagle's market share of vendor [Indiscernible] and wholesalers shipments to end-users was 8% of the U.S.

market for the Second Quarter compared to 5% for the prior-year quarter. Second-quarter RYANODEX product sales was $7.9 million compared to $4.7 million in Q2 of 2020, driven by strong reorders in the quarter. Orders from RYANODEX are cyclical, driven primarily by product [Indiscernible].

With few customers acquiring dantrolene unless their stock is expiring, Q2, 2021 royalty revenue was $28.5 million compared to $27.6 million in the prior-year quarter. This is almost entirely from BENDEKA for each period. Eagle's royalty rate on BENDEKA was 30% during the second quarter of 2020, and 31% during the second quarter of 2021.

Royalty revenue also includes royalties earned from sales on TREAKISYM by SymBio. On the expense fronts, R&D expenses were $9.9 million for the second quarter, compared to $7.1 million in the prior-year quarter. excluding stock-based compensation and other non-cash and non-recurring items. R&D expense during the second quarter was $9,200,000.

The year-over-year increase is largely attributable to higher spend on Vasopressin and RYANODEX programs. We expect R&D spend in 2021 on a non-GAAP basis will be between $34 million and $38 million up from our prior guidance of $26 million to $30 million.

The change is the result of our launch preparative strategy on Vasopressin, reflecting our confidence in the outcome of the trial, as Scott has discussed.

The anticipated 2021 R&D spend includes; loss preparedness and CMC initiatives for Vasopressin, the round of X trials for the treatment of nerve agent exposure, and EA-114 clinical, and CMC initiatives. SG&A expenses in the second quarter of 2021 totaled $16.6 million compared to $18 million in the second quarter of 2020.

The decrease is primarily related to stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, the second quarter of 2021 has seen a expense was $12.4 million.

Net Income for the second quarter was $3.6 million or $0.28 per basic and $0.27 per diluted share compared to a net loss of $0.3 million or $0.02 per basic and diluted share in the prior-year period.

Adjusted non-GAAP net income for the second quarter was $12.4 million or $0.95 per basic and $0.93 per diluted share, compared to adjusted non-GAAP net income of $8 million or $0.59 per basic and $0.57 per diluted share in the prior-year quarter For a full reconciliation of non-GAAP Net Income to the most comparable GAAP financial measures, please see the tables at the end of our press release.

As of 6/30/2021, the Company had $108.7 million in cash and cash equivalents and $30 million in outstanding debt. So we had $78.7 million in net cash. We ended the quarter with $52.7 million in net accounts receivable.

In the second quarter of 2021, we purchased an additional $2.9 million of Eagle's common stock as part of our $160 million share repurchase program. Since 8/2016 through 6/30/2021, we have repurchased $211 million of our common stock. With that, I'll ask the Operator to open the call for questions. Operator, please go ahead..

And at this time, if you would like to ask a question, [Operator Instructions]. We'll take today's first question from Brandon Folkes with Cantor Fitzgerald. Please go ahead..

Hi, thanks for taking my question and congratulations on the acquisition in the quarter. So maybe firstly, can you just elaborate on the [Indiscernible] factors between now and filing Landiolol in 1Q 2021? And then maybe on Vaso, a question I get but I'd love to just get your input here.

Just given the discussions around the CRL and what we've seen in the case. Do you think that the judge need to have an approved product yet to rule on the case? And then along -- staying on Vaso, just then -- if this case that go in your favor, does Endo have any additional avenues to stop you launching straightaway? Thank you..

Well, thanks, Brandon. Why don't we take the Vaso questions first. And the first answer is no. The judge does not need to weigh nor will he. We had some good conversations about the plan going forward in the courtroom. And as we stated, our expectation is that we'll hear from him.

The court will rule by around mid September, and so I don't think there's an issue there.

As far as what Endo may or may not do, let's see what the opinion is, but based on our knowledge of the situation and the work that we've been doing, our expectation is that we should be able to go to the market later in the year, assuming we have both an approval and a decision.

And we're expecting both of those to wrap up here in the next 3 to 6 weeks. And I think it's just right around the corner, and we're gearing up to get to the market, as Brian indicated in his section. So we feel rather positive about our position now, and let's get through these next few weeks, but we're feeling pretty good.

In the case of Landiolol, we're just going through the normal process that takes place, and so a little bit of work that AOP needs to get done to move the product into U.S., but we also think, from all the diligence that we've done in wrapping up the agreement that we are in pretty good shape to get the product filed in the first quarter as we just announced.

It's also obviously a very exciting growth driver for the Company going forward.

Did I answer all of that, Brandon?.

You did, thanks very much. Maybe just -- so then on Vaso, any reason we should think or anything we should consider that you wouldn't be able to ship product basically on December 15 or December this year, so have the trucks.

loaded, ready-to-go?.

The only thing I can say about that, Brandon, is that we are -- I think we are consistent with our thought process. What -- we believe that we're in good position to get it launched before the year's over.

I mean, obviously we need to see the court's decision, we need to get an approval, but that's our expectation that we're in a position to get the product to the market..

Okay. No, I appreciate that. Thanks very much and congrats on the progress..

Thank you very much. Appreciate it..

Our next question is from Tim Lugo with William Blair. Excuse me. Please go ahead..

[Indiscernible] Thanks for taking the questions. So I was just wondering, you mentioned, I guess first of all, congrats on the Landiolol deal.

Can you provide more color on the potential size of that opportunity, and how big you think that could be for you? And then second of all, with restrictions starting to creep back in in certain regions, how should we think about the second half of the year for the current franchise and how are your inventory levels from the bendamustine franchise looking?.

Thank you. Very good. So the size of Landiolol, as you can imagine after going through quite a bit of diligence to bring the agreement into the Company and bring the product into the Company, we have a range of forecasts, as you can imagine, from high to low.

I would say that give or take, generally speaking, I think about a $100 million of peak sales is a good starting point and then we're just going to have to refine that as we get into some more and get the product launched. I think that a $100 million peak sales is probably the right number to work on for now and we'll refine it as we go on.

And then the second half of the year as it relates to anything that may go on in the economy, let me turn that over to Brian..

What I think about the potential COVID creep, I would just reverse the tape back 6 months on [Indiscernible]. That's the way that we think about it. And potentially wheel it back..

But our Inventory levels are just fine..

And the inventory levels are fine. Our supply chain has not and we have no expectation that it will be interrupted..

Okay. Awesome. Thanks..

Thank you..

And frankly, if it was today, we would have sufficient safety stock to pull us through, so no interruption and sufficient supply..

Good..

And our next question is from Daniel Busby with RBC Capital Markets. Please go ahead..

Hey, good morning guys. This is Steve [Indiscernible] Dan. Thanks for taking our questions here. I've got two, and I'll ask them both upfront here.

First is on just the PEMFEXY launch, you guys had in February come [Indiscernible] about six months away, so I was curious if you guys can provide a little more color on how you guys are preparing for that launch and any color on how that's going to go.

And then on the second one for Vaso, just based on -- it sounds like based on your confidence from the trial that happened a few weeks ago here, I'm just kind of curious if a settlement with Endo is still on the table, and if you guys are still in -- are in any type of discussions with them on that. Thanks for taking the questions..

Steve, thank you. PEMFEXY, it's just an exciting opportunity. The length is about a billion 3 product, we should have four months of exclusivity. We're gearing that up in that particular case with the J-Code that we have, and now the multi-dose vial approval.

I think the conversion that we'll see from our convexity is similar to the conversion that you will normally see in the ANDA world, which we think is pretty considerable. We're expecting to have, really, a very, very strong 4 months.

Then other competitors will come into the market obviously, and then we'll see the value of the J-Code and what that gets us by having that differentiation. But the ramp-up should be pretty good because of the reimbursement that we have.

And look, if we maintain 5% of the market at a price that hospitals are willing to pay for the advantages that we have in our product in a billion-dollar market, that's a pretty considerable tail going forward, and so we think it's a great opportunity and you combine that with Vasopressin and the royalties were getting out of Japan, you can see why we're so excited about next year.

It could just be a remarkable year of the Company's history, and then through Landiolol and in another deals we hope to do going forward, I think we've turned a corner and we're in great shape. And as far as the Vaso settlement, I just don't know what to comment about that. We think we're in a very strong position right now.

Our expectation, you know, our hope after sitting in the courtroom for three days, is that we'll wind up in a good position and we'll get that out of the way after the COVID related delays and we'll get through that portion of it.

And we think we did a really strong job in responding to the CRL, we've put a remarkable amount of effort into that, spent a lot of money, did a lot of work and we're very hopeful and our expectation in turn really is that we'll get approved before the year's over. And so based on those two elements, I believe that puts us in a good strong position.

If there's a settlement to be had that makes sense, then we'll listen. We'll do what's in the best interest of our shareholders. That's our obligation. But right now we're very focused on monetizing the asset, bringing in meaningful value to the Company, combining it with the rest of the pipeline and now Landiolol.

And we'll do what we need to do to grow this Company as aggressively and safely as we can. And I think we're looking forward. I know we're looking forward to next year and let's see what happens with all these different leverage that we have.

But again, our expectation is that we're creating significant value for our shareholders and we're really a short period of time away from that..

Great. Thanks for your time, guys..

Yeah. Thank you..

[Operator Instructions] for questions today. Next will be David Amsellem with Piper Sandler.

Please go ahead?.

Hi, this is Jack on for David. Thanks for taking my questions and congrats on the Landiolol agreement. Just a question for me on the bendamustine franchise. I was just hoping to get your latest thoughts on how you see the market evolving, particularly with BENDEKA once generics for legacy trend enter in the market at the end of the year.

And then if you could also just provide a quick update on where things stand with Fulvestrant, and potential thoughts on timing for filing there, that'd be great too. Thanks..

Fantastic, Jack. I appreciate it. So the bendamustine franchise, we're very consistent in what we've been saying. I think give or take, Brian, we get about a $100 million a year coming in on the asset.

And once generics come into the market [Indiscernible], what we've been saying is this 30-40% decline from the franchise is what we can see over the near term after generics come to the market, which leaves us with about 35 or $40 million hole that we need to make up.

And so when you take a look at that relative to everything else we have in the Company, we think we've done more than enough to be able to give us back the $40 million that we may lose from the franchise over a couple of years after generic launch.

Between PEMFEXY and Vasopressin and now Landiolol and the rest of the pipeline and other things that we expect to hopefully announce, I think we get through that hurdle and we continue to grow the Company out in the future, even with the trended generics coming to the market.

In case of Fulvestrant, we're collecting some more data, and we expect to have some news before the year's over. Hopefully that's on track and going well, you know, that could be another very significant product for the Company. Add that into the mix.

And we think our future is rather bright, we're very excited, and I would add that it appears that a number of companies around the globe, domestically and internationally see the footprint that we have here at Eagle.

And if you're trying to launch a hospital product or an oncology product and you don't have the infrastructure that we have or the commercial capability that we have, I think there are a number of companies that are seeing us as a fantastic partner to bring their products through the FDA and commercialize successfully.

And hopefully, we will have other agreements similar to Landiolol coming to fruition here before too long, further increasing the pipeline and the growth of the Company. Let's see how that all works out for us..

Great. Thank you..

Thank you very much..

It would appear as we have no further questions. I will return the floor to Scott Tariff for closing remarks..

Thank you. Thank you again, for joining us today. We had a strong and productive quarter adding meaningfully to our product pipeline and revenue base for the years to come, we have a lot to look forward to in the second half of this year with Vasopressin.

'22 stands to be a pivotal year of robust growth for Eagle with the launch of PEMFEXY and expanding our track with some product portfolio in Japan. And now in early '23, we have potential launch Landiolol.

We are solidifying our hospital and critical care product portfolio and continue to pursue near and, long-term opportunities for growth, both organically and licensed, all of which will enable us to deliver value to our shareholders and important medicines to the patients in need.

We look forward to updating you as we continue to evolve our base of business and grow our earnings in the short-term, long-term. Stay safe. Thank you for spending the time with us. And we look forward to updating in the near future. Thanks for joining us today. Appreciate it..

This will conclude today's program. Thanks for your participation, you may now disconnect..