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Citi 18th Annual BioPharma Conference

Sep 7, 2023

Michael Brock
Managing Director, Citigroup

Thanks, everybody, for joining us today. My name is Michael Brock. I'm a managing director in Citigroup's Healthcare Investment Banking Group. I'm focused on biopharma, and I've been doing this for a couple of decades, all focused on biopharma. So it's great to have you here with us today, and I'm delighted to introduce the management team of Eagle Pharmaceuticals. So Scott Tarriff and Brian Cahill is with us today, the chief financial officer. So, what I'd like to do is maybe turn it over to the CEO and the CFO. So Scott, maybe lead us off with a little bit of a introduction of Eagle Pharma, how the company has evolved over time, and how you sit currently today.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Well, I'd love to. And thank you, Michael. And I thank you personally and Citi for inviting us. It's been just a fantastic conference so far, and just honored to be here. I really do appreciate it. So Eagle, you know, what a great time to be associated with the company now. We've been in business, it's hard to imagine, 15 years. We've had seven products approved over the years, and we've done rather well. We're sitting here 15 years later, and we just had a step up in our earnings last year. We tripled the historical run rate. It's carried into 2023, and we're in a situation now where we, you know, we haven't raised any money in about 8 years. We've been funding everything internally. As I mentioned, we have this step up.

Right now, what's so exciting about the business is we've been investing pretty heavily in R&D as we are transitioning from what was a more 505(b)(2) spec pharma company now to what we would define ourselves as—it's just a small pharmaceutical, diversified pharmaceutical business. We just had great success in the clinic on a breast cancer drug, EA114, which puts us back into what's probably gonna be a very significant growth period now going forward. So we have an oncology business, and we have a acute care hospital business. The R&D's working out great. Our market share has been great. It's really just exciting and thrilled to be able to speak to everybody about the company.

Michael Brock
Managing Director, Citigroup

That's terrific. I think, you ended with a little bit of dialogue around your recent Type C meeting.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yes.

Michael Brock
Managing Director, Citigroup

That was last week we saw the press release. So I'd love for you to tell this audience a little bit more about how that meeting took place and how you feel about the outcomes.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah. You know, it is so exciting and so interesting. And you think about a company our size, and you think about drug discovery and the process that it takes. But we've now spent over five years and, close to $70 million.

Michael Brock
Managing Director, Citigroup

Indeed.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Developing this drug.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

And so what we've done, it's, it's fascinating when you start to hear the story, but we've now treated 800 women with either the brand drug Faslodex or various Eagle internally developed formulations. It's probably the largest study done in the drug. What we found, how would I describe it? Shocking, surprising, unusual.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We found more information about how the drug works. We took that information that we had and went back and developed a new formulation of the drug. We found that there are certain subpopulations that do not behave when provided the drug the way you would think they would.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We set out to develop a new formulation that would change the way the true drug is provided, the way it's dosed, and to take these subpopulations, which, by the way, makes up 54%.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Of the patients. We believe that we have a drug now that will be far more effective and efficient for the majority of the women with these breast cancers taking the drug. And it's a big it's a big category, right? [inaudible].

Michael Brock
Managing Director, Citigroup

Can you, Scott, not to interrupt, but can you describe a little bit about how it's novel and how it's differentiated from previous formulations?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah. It's so it's hard to do today, Michael.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

As you can probably appreciate, we're still, you know, one area that our company is really very strong at is in intellectual property.

Michael Brock
Managing Director, Citigroup

Sure.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Patenting. So, we still are collecting data to go back into our patents. And quite frankly, for competitive reasons, right, we're trying to keep some of this information as a trade secret. I think what you'll do, fortunately, from a shareholder standpoint, is we'll be rolling out more information about exactly what we've done. I think probably end of the year or in January, we'll have a little coming out party, if you will, going through all of this. But I think everybody will be, as I said, surprised and probably thrilled that we've been able to correct a problem. So it's almost as if we discovered a problem and cured it all in the same.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

In the same time. But it's really it's fascinating. And that's part of our industry, right? That's what happens when you have the perseverance to take 5 or 6 years in a company our size, $60-$70 million, and treat 800 women to come to a conclusion like this. We're really very excited that and, you know, we're proud of the fact that we persevered and hung in here.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? And then we come to the conclusion that we are on track to file next year already. And so once we get the drug onto market, you know, we'll go through. We had this step up, Michael, in earnings. And now you're gonna have another step up again when you get the product to the market.

Michael Brock
Managing Director, Citigroup

Terrific.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We're doing it with a really pretty clean balance sheet. We funded it this way out of our own profits over the years. And so, as I say, we're going through really a wonderful time with the company.

Michael Brock
Managing Director, Citigroup

Right. Can you just, and maybe last question on this topic, can you describe a little bit about sort of the regulatory steps and the timeline between now and filing an NDA?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah. So what happens is, the Type C Meeting, you know, what the question that you asked is, a path forward with the agency on how to proceed to get the product to the market. And so we have to do a couple of more what I would define as confirmatory studies. And so, we've been pretty aggressive. We've had confidence. You know, when we were speaking to investors over the last year, we've been a little subdued. You know, you always like to actually have your meeting with the FDA and make sure that, you know, you're in sync with them. So it was a wonderful meeting. They're doing a great job, dialoging and helping us and providing advice. And so we're actually starting to treat subjects on our next study that we hope will be a pivotal study, in October already.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

So you'll see us talk about, you know, the recruitment rates and how we get through that. Then what I'll add too, the great thing about this is because we have this oncology vision, right? We have Bendeka and Belrapzo and we have PEMFEXY on the market. We don't need any additional infrastructure.

Michael Brock
Managing Director, Citigroup

Great.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Market to drug. So value will fall to the bottom line pretty quickly, which is also very positive for our investor base.

Michael Brock
Managing Director, Citigroup

Terrific. Well, thank you for that. Switching gears just a little bit to the bendamustine franchise, can you describe for this audience some of your expectations around the franchise, particularly in light of competitive entrants?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah. So that's also a very interesting topic, all of this, right? It's a great industry. You just have to love, this segment of the industry. So we developed a very novel form of bendamustine. We've been on the market, I think, Brian, about eight years now.

Michael Brock
Managing Director, Citigroup

8 years, yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? It's been a great success. We licensed the drug to Teva.

Michael Brock
Managing Director, Citigroup

Right.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

And they've just been. They're great partners, and they've been doing just a marvelous job for us. So Bendeka, what you just give a little history of the company. This is a chemotherapy drug. It needs to be infused in 30 or 60 minutes. And we were able to reformulate it in a way that we can infuse our drug in just 10 minutes.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

You can just think about, you know, our friends and family. It's typically an elderly cancer sitting in the infusion chair and watching your chemotherapy drip into your arm for an hour.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

30 minutes, getting it down to 10 minutes. It's been just a great success. It became the drug of choice pretty quickly in CLL and NHL. We're very proud of it. We've had patent protection, as you can imagine, from the novelty of the invention. Bendeka is still patent protected until the end of 2027.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? So we still have what's about 4 years in it. The old, legacy product, Treanda, which is historically kept only 10% of the market. That product went generic, back in December of 2022. So there's no generic competition for Bendeka. There's therapeutic substitution within the marketplace in the Bendamustine market. And so I think there were a number of people who had the fear that the market would shift from the 10-minute infusion back to the 60-minute. But the way oncology works, the way reimbursement works, and quite frankly, we just have a far superior product on the market.

We've lost very little share to Treanda generics. We've outperformed now since December when we had competition. We have another form of Bendamustine called Belrapzo. Which has had maybe around 8% of the market as well 6 to 8%.

Michael Brock
Managing Director, Citigroup

Historically.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We have some competition there as well. We've been able to keep a large majority of that share. So as we're sitting here, we've far outperformed a number of people's expectations about how much share we would keep in the Bendamustine market. That's reflected in the last 18 months, the last 6 quarters where we've, you know, we've exceeded expectations.

Michael Brock
Managing Director, Citigroup

Right.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We're doing well. It continues to drive a lot of cash for the company.

Michael Brock
Managing Director, Citigroup

Sure.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

So we can develop drugs like EA114 for breast cancer. And then, you know, we'll talk about it, but we have this huge clinical trial, worldwide clinical trial for severe bacterial pneumonia.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

That we're in the middle of. So we're taking the cash from these products, putting it into R&D. Thank goodness, right, our first big hit in EA114 worked out. So we're thrilled about that. And then in nine months, we'll get the answer on our pneumonia study, and we can hope for the best. And you can just see the transformation from a company that was, you know, what you would call spec pharma, 505(b)(2) business 15 years ago when we started, taking the cash that we've created and putting it into what I would call pretty novel pharmaceutical products, in the case of new product for breast cancer and then for pneumonia. So we're just thrilled. And thank goodness it's working out for us.

Michael Brock
Managing Director, Citigroup

It's great. And I'll, I'll you know, Brian will spend some time talking a little bit about the financials and the financial expectations and the forecast. But can, can we just hit the highlights on the maybe the next product franchise or the PEMFEXY program?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yes.

Michael Brock
Managing Director, Citigroup

Can you describe a little bit about those market dynamics, similarly to what you did for?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah. So we launched PEMFEXY February of 2022.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? It's a new form of what was Lilly's Alimta product.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

It was filed as an NDA through the 505(b)(2) pathway. And, to the credit of our oncology salesforce, which I think we have one of the best small, nimble oncology teams out there, we'll fall probably, give or take, close to, $100 million this year. If you just look at our earnings the first half of the year, I think it was, a little over $40 million or around 40. So without giving specific product guidance, if you just double that in the second half, you can see where we are. And so to wind up launching a product like that, we now have almost 23%-24% share of the market.

Michael Brock
Managing Director, Citigroup

Right.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? Up from 6% when we left.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

December. So it's just another one of these nice products. So we think, right, from our vantage point, we believe that we've created a very nice niche oncology portfolio, right? And you add PEMFEXY to it last year, and now you add fulvestrant to it.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

If we were able to achieve, you know, mid-20s for PEMFEXY, our expectation is we should at least be able to do that ultimately with EA114 when it comes to the market.

Michael Brock
Managing Director, Citigroup

Makes sense.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

You know, so now what we need to do is add more oncology products to the portfolio.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

which would be great because we have all the infrastructure that we need. We have the commercial team. I think we can build on the success once we get our hands on additional products.

Michael Brock
Managing Director, Citigroup

Yeah. Terrific. One question on Barhemsys and Byfavo. What are you doing to support those, and how do you expect those two programs to ramp?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah. So that is when you take a look at Eagle, and if you just go back, Michael, I don't know, let's just go back in time 2 or 3 years ago.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Here we are. We have an oncology team, and we have an acute care hospital.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

And we used to market both these drugs with one salesforce. It's just hard to do, but we did well. And so as we were launching PEMFEXY and had a vision of what would happen there, we decided to invest in our commercial infrastructure. So we separated the two salesforces. And, you know, at the beginning of last year, we have a dedicated oncology team, and we have a dedicated hospital team. So we have about 80 people in sales and.

Michael Brock
Managing Director, Citigroup

Nearly.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

The commercial group now, right?

Michael Brock
Managing Director, Citigroup

Nearly.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Which is about 80 people?

Michael Brock
Managing Director, Citigroup

Nearly 80 people.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah. So that's why, you know, our expenses are higher this year.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

What we went out to do is we purchased this company last year for cash, mostly, this Acacia company that had Barhemsys and Byfavo, postoperative nausea and vomiting and a short-acting sedation product that will replace propofol.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

In a number of areas. We happen to love the hospital business, right? It's a hard business to ramp, right, creating brands within the hospital. It's slow.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

And steady, but it's very sticky once you get it. And we happen to have purchased two incredibly wonderful products, and we're investing behind it. So if you go back to the Q1 of just this year, the beginning of 2023, we put a stake in the ground, and we're saying that's the relaunch.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

That was the Q1 that we had our full trained and all our territories in place in the hospital side. So we have about 40 territories in the hospital. After two quarters, we now had last quarter what we reported was 19,000 patients well used one of the two drugs.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

If we talk about adoption and, you know, the desire for people to use these drugs and the benefit of the drug and the feedback we're getting, it's wonderful. The difficult part of the hospital business is they're inexpensive drugs.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

You need a lot of people to be on these drugs to get to the numbers that you wanna get to. Having 19,000 people in your first or Q2 of launch it's just exciting 'cause the feedback's good.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

I think we mentioned that we only had last quarter 275 hospitals or centers using the drug out of about 5,000 or 5,500. So you can just start to think.

Michael Brock
Managing Director, Citigroup

Right.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

That over time, you know, if you go from 275 to 2,750, and then your market share per location doubles or triples, you can see where this thing is gonna get to, right? And so we happen to believe that over time, we're gonna get to the numbers that we expect. The products are patent protected until 2031 and 2032, right? So it's really a great ramp. We're just in the beginning of the ramp, and I recognize that it's slow, but we have 50, 50 great individuals out commercializing the product for us. We're investing behind it.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

It's a good time for us to invest. Then we'll just have to decide what to do as our R&D pans out. What do you do with an oncology company and an acute care hospital company? We need to address that, right? We're gonna need to do that soon. We'll see where it takes us because at face value, the two divisions don't really fit together that well.

Michael Brock
Managing Director, Citigroup

Right.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? Who's the natural buyer for hospital and oncology company? So we just need to think through those strategic issues now over the next really few months.

Michael Brock
Managing Director, Citigroup

Yeah. That makes sense. Just regarding that Acute Care side again, and the sales force, do you feel as though it's right-sized, or is that something that you'll just have to determine over time depending on additional programs that you may find strategically or different pipeline assets come to the market?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah. It's a hard question. Thank you.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

You know, there's a balance between what you can afford and how much you can invest into products like these. You know, I think 50 people is probably a good size for now. You know, intellectually, you would say, "Well, we're gonna have a far better ramp if we had 75 people than 50 people." But that business right now is losing money. So how much do you wanna put into it? And our view is, "Well, let's just see how we do with the size that we have now.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

And then we'll figure it out. I mean, in fairness to the team, who I think's doing a fantastic job, we've only been two quarters into the launch.

Michael Brock
Managing Director, Citigroup

Sure.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

My view is, why don't we just give it until, you know, the Q4 of next year, see where we are, see what we learn, see if we can keep the growth up. The growth over the last three quarters has been about 25% or 30% a quarter.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

If you just map that out, you know, you get to be a pretty sizable number relative, Q4 of next year. If we can get to that rate, if we can see that continued ramp up, then we probably would invest behind it. But a lot of it has to do with the success or failure that we have in our pneumonia drug because if that passes.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

If we get that drug to the market, then we're gonna have one of the biggest hospital companies.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

out in the marketplace in the last couple of decades.

Michael Brock
Managing Director, Citigroup

Yeah. Appreciate that it's that complicated, but, you know, probably prudent to see how this plays out for a little bit.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

I think so.

Michael Brock
Managing Director, Citigroup

Yeah. Switching gears a little bit to the pipeline, can you talk to us a little bit about where ENA-001 and CAL02 are in the pipeline and some of your expectations around that?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah. Why don't we talk about CAL02 first.

Michael Brock
Managing Director, Citigroup

Sure.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

If you don't mind. Because, Michael, it's for a company our size, taking on a product like this is probably unusual.

Michael Brock
Managing Director, Citigroup

Right.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? But CAL02 is a lot of ways to describe it. I like to describe it as an antitoxin.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

But when it's agnostic to the antibiotic. So when you have a patient with community-acquired severe bacterial pneumonia, and that patient is in the hospital and is provided an antibiotic, right, that process that occurs as these pore-forming toxins that invade the cell and help with the replication of the bacteria, the strength of the bacteria, and which progresses the disease state. And CAL02 was designed by some really very clever scientists at the University of Bern.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

That just removes these toxins from the body, right? It's a liposome that removes toxins. So when we speak to infectious disease physicians, and if you would ask them if the toxins were removed, are the patients going to perform better and have better outcomes? And the answer is very clearly yes.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

So we are very convinced from the preclinical work that we've done and a small phase I study in 19 patients that CAL02 does exactly what it was invented to do. It removes these toxins, these virulence factors from the body.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

which theoretically should have a tremendous positive impact on the disease progression. I think that's a basic belief that everybody would agree with. So the question then becomes, with all the comorbidity and the disease state of severe pneumonia, did we design a study, and did we power a study effectively that could discern the difference statistically of the progression of a patient with or without CAL02?

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? That's really what it comes down to. And so for a phase II study, which may or may not be a pivotal study, we receive this Qualified Infectious Disease Product designation by the FDA, which is very prestigious. With that comes an extra five years of exclusivity.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

So assuming that CAL02 is an NCE, we'll get 10 years of exclusivity. We have patents that will probably run into the 40s. And so the opportunity here is tremendous. We've received fast track.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Designation. We're hoping at the appropriate time to receive breakthrough.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Considering that the opportunity is so significant for the product, not just in the U.S. but worldwide, severe bacterial pneumonia's still the second or third cause of death worldwide. It's a really incredibly large market. We decided to go and power up, and we're trying to recruit 275 patients worldwide.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Which is a big study for a phase II.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

And so hopefully, we it was overkill, and we've really significantly powered up. But we think that's the best way to be able to prove statistically that the drug is going to to work. We'll hope to file it in the EU and the United States simultaneously if we're so fortunate enough to pass. And by the time we leave this year, we should have, I don't know, 80-100 sites up and running. We have about 10 or 11 sites now. We have, you know, approaching a dozen patients. You know, it's the middle of summer here.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Let's see how we progress as we get through the season and get through Q4 and Q1. But we should have an interim result of 50% of the patients somewhere, let's call it early Q2.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Then we're gonna know if we passed or failed. That has so much strategic implications as to how we run the company and what we do with these two divisions. We're just, Michael, we're excited and anxious. You know, every day we check to see how many patients we have recruited 'cause it sure would be nice to get that data.

Michael Brock
Managing Director, Citigroup

Right. And what is triggering that interim result? Is it number of patients, recruited or treated? And what is that number?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right. It's at the 50% mark.

Michael Brock
Managing Director, Citigroup

50% mark.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We'll have of 275. We'll know. And if we powered right, it should give us some pretty good understanding about the success or failure of the product.

Michael Brock
Managing Director, Citigroup

Good. Well, that's, that's terrific. I had some questions around IP, but I think you covered that, potentially into the 40s is pretty remarkable.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

It's, yeah. If you know, it's how do you look at these things, Michael, from, you know, we're at an investor conference. From an investor standpoint, you know, it would be a remarkable leap forward for the company.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

If it passes. Same thing with EA114 on breast cancer. But we can't lose sight of the fact that both of those drugs will have a dramatic improvement in the patient population, both drugs with the opportunity, say, of a tremendous number of lives over the next decade or two. And, if that doesn't excite you as being part of this industry, nothing will.

Michael Brock
Managing Director, Citigroup

Yeah. Terrific. Switching one more time, maybe back to some of the financials. You I think you recently raised guidance. Can you describe a little bit about some of the factors that went into that? I'm not sure if this is for Brian or for you, but or either.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Well, let me start, and then Brian could take it. But what I would say about the financials, why we're on this topic, Michael, before I turn it over to Brian is that over the next nine months and correct me where I'm off a little bit, Brian.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We're gonna spend about $40 million still on this clinical trial.

Michael Brock
Managing Director, Citigroup

Right.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

For, CalO2.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

And obviously, right, the obvious statement's either gonna pass or it's gonna fail. If it fails, then that $40 million is not going to replicate, right? We're gonna be done. If you look at our businesses, we earn quite a bit of money in our oncology business. We lose money in our hospital business. And the bulk of the loss on the hospital business comes from the expense of the clinical trial of CAL02. And when we get to, you know, worst case, I hope, middle of next year, so, you know, 9 months from now already, we're either gonna have a success, and nobody's gonna care how much we spend to finish the study, or you're gonna have a failure, and you're gonna add $40 million or $35 million back into EPS.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? So getting through that study financially, one way or another, is a really big deal for the company.

Michael Brock
Managing Director, Citigroup

Terrific.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right?

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

The success that we've had in raising guidance has mainly been from our ability to overachieve the forecast for our products, PEMFEXY.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Bendamustine. Anything to add?

Michael Brock
Managing Director, Citigroup

Yeah. You're right. And the sustainability as we as is proven out for in the best in the Bendamustine franchise, as we're looking forward to that.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Great.

Michael Brock
Managing Director, Citigroup

which is really exciting for our company, right? We have these really the best pipeline, the best clinical trials that we've ever had in our history, and we are funding them internally. That's.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Terrific.

Michael Brock
Managing Director, Citigroup

How I sum it up.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah.

Michael Brock
Managing Director, Citigroup

So this, which is special as a company and, you know, great in my position and is interesting.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Quite unique, actually.

Michael Brock
Managing Director, Citigroup

Can you just remind the audience a little bit about current cash position, maybe guidance for the end of the year, and, and also, touch on the share repurchase?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Sure. So we had, as you know, we raised our guidance, as you mentioned, not too long ago, for $4.00-$4.70 per share, raised our expected EBITDA for this year. At, you know, at the end of the last quarter, we had around $100 million in working capital. Which is pretty significant, as compared to our market cap. A great story as well. And, you know, we're gonna get through the, you know, continue this through the end of the year. And we'll still be strong, even with the spend on our balance sheet through the end of the year, right?

Michael Brock
Managing Director, Citigroup

Great. Let's talk a little bit about longer-term strategy for the business. Scott, in fairness, I know you referenced the two, you know, distinct separate business lines that you have, and you'll have to make some strategic decisions around that. But you have the opportunity to build one or the other or both or pivot completely. And so.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

It.

Michael Brock
Managing Director, Citigroup

I'd love to hear your current thinking around.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah. So we're just, you know, we had to wait. As hard as it is, we needed to see where the R&D is gonna pan out, right? So thank goodness we have this big victory with the EA114. It helps us with our strategic planning.

Michael Brock
Managing Director, Citigroup

Sure.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

So what I would tell you, what we're looking at now that we're starting to speak to some of our investors about and internally, when is the right time to split the company in two and to separate the oncology business from the hospital business, right? And so what we're thinking about is it probably will make sense, and we could not have made these decisions until we had EA-114 behind our belt. Because think about it this way, Michael. Had we been successful with CAL02 and failed with EA-114, we'd be looking to divest our oncology business and stick with a longer-term.

Michael Brock
Managing Director, Citigroup

Of course.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Care hospital play.

Michael Brock
Managing Director, Citigroup

That makes sense.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Now that you have 114 behind you, it looks like we're gonna have a rather profitable, high-growth oncology business. And so if you take out the loss from the hospital business, you know, so for instance, if you just take the top end of our guidance of $470, you know, the oncology business so this is not meant to be; let's just treat this directional and not meant to be a formal guidance or indicative of numbers. But generally speaking, that $470 is really $770, give or take, for the oncology business. And so if you take a look at that oncology business and you now put Fulvestrant EA114 on top of that, we have a very diversified, high-growth oncology business. And what you would say, "Well, what do you do with that?" You probably wanna acquire.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We've spoken about this on our earnings calls previously, but we can probably bring a $100 million oncology product into our commercial team and into our infrastructure with a de minimis amount of additional infrastructure cost, right? So t he leverage that we have by bringing in another product is pretty significant.

Michael Brock
Managing Director, Citigroup

Quite powerful.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yeah. So that's what we need help with is finding some products to acquire.

Michael Brock
Managing Director, Citigroup

Okay.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Bring into the company. It makes more sense about that when you take a look at the stark difference between the profitability right now of the two divisions.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

And so what in our oncology side, what we would love to do is add products, build. We have about 21 months or so, give or take, until EA114 comes to the market.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

And then look at that oncology company and who's your, you know, who's your peer group there, a rolled-up, diversified oncology.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Business. I think that would be pretty meaningful and powerful. And so it would be great to strive to build that. On the hospital side, we have the Barhemsys and the Byfavo, which is gonna be this nice, slow, steady ramp that is probably gonna be break-even, you know, call it 24 months from now. But that business looks very different with or without CAL02. And so I think we're probably coming to the conclusion that it makes sense now to split the company in two somehow. And we don't know how to do that. We don't know the timing behind it. But it really seems that we have two distinct businesses right now that we wanna build and have a lot of faith in both of. And we just have to figure out the best way to make that happen.

Michael Brock
Managing Director, Citigroup

Yeah. Terrific. Well, I happen to know some people who could probably help you with that, so.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Okay.

Michael Brock
Managing Director, Citigroup

I just going back to the oncology business.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Yes.

Michael Brock
Managing Director, Citigroup

How would you describe the profile of what might be like an ideal candidate or target for us?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right now, I mean, it's pretty clear to us. We've taken on some for our size, unusual clinical risk over the last two or three years.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We've spent a lot of money in R&D.

Michael Brock
Managing Director, Citigroup

Right.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We haven't received any credit for. And now you have the really two victories, right? The success of PEMFEXY that launched only last year, the fact that we can get up to almost a quarter of the market in market share is great. And now with EA114 coming to the market in under two years. And so I think the best thing for us is not to take on any more clinical risk in the short term and take advantage of the infrastructure and take advantage of this great sales team that we've built.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

So what we'd like to do is bring an already marketed drug to the market. And so for instance, what we've looked at, there are, you know, a number of one-product oncology companies. We can probably acquire a company like that and remove, I don't know, 70%-80% of the expense.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? So the financial synergy that you would get at the same time you would diversify our portfolio would be pretty powerful. And so I think we can do that one time now until our own infrastructure costs become saturated. But I believe the best thing that we can do for shareholders is potentially just add another product.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Do it with a minimal amount of additional expense, diversify the company, and wait for EA114 to come to the market. That's our view today of the best way to build shareholder value.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Grow the company in the short term.

Michael Brock
Managing Director, Citigroup

Have you spent some time thinking about how you might finance such an acquisition?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We have. You know, it's in this today's environment. It's a little bit more difficult, obviously. That's gonna dictate size of the acquisition. You know, obviously, interest rates are higher now than they've been in the last couple of years. We think our stock price is just unusually low right now. It's hard to imagine that we can trade at these levels. If you go back to what Brian was saying about working capital, if you just take our guidance and you look at the end of the year, our working capital is significant relative to our market size. It's as if we're getting no credit for the future cash flow or very minimal credit for the future cash flow products.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

You know, I don't think we're getting any credit yet for EA114. But in fairness, we only, you know, had this FDA meeting, you know, the last week of the summer.

Michael Brock
Managing Director, Citigroup

Terrific.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Going into Labor Day. So today's really our kickoff of being able to speak to investors about the details of it and the remarkable size of the opportunity. So we'll see how that goes. But in theory, you know, you'd wanna take on as much debt as you could right now because we think we pay that debt back pretty quickly once EA114 gets to the market.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We may have to use some of our equity, which we have no desire to do at these share prices. And so we're just gonna have to work our way through, that conflict between equity and debt.

Michael Brock
Managing Director, Citigroup

Sure.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

And then the size of an acquisition, either a product acquisition or a company acquisition, will probably be dictated by, you know, how we can fund the acquisition.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

But we feel so much more comfortable about it today with a high level of confidence that EA114 gets to the market, and we'd be able to pay down any debt that we would take on pretty darn quickly.

Michael Brock
Managing Director, Citigroup

Right.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

And so now, I think this really comes down to being a smart leadership team. We have a phenomenal board. We have, you know, great advisors. You know, how do we work our way through this incredible opportunity that we have, the most, efficiently and effectively over the next 6 and 12 months?

Michael Brock
Managing Director, Citigroup

Great. Great. Then, notwithstanding your earlier comments that we'll need to wait and see how some pipeline opportunities pan out before we make decisions on what we do with the two business lines, just maybe a final question, kind of a recap question for the audience. How do you view sort of Eagle Pharmaceuticals, you know, five years in the future? Where, what do you envision for this organization?

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Well, you know, I can clearly say that, the growth rate of this company over the next five years should be rather significant, right?

Michael Brock
Managing Director, Citigroup

Right.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

EA114, our lives changed pretty dramatically two weeks ago.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? Internally, we just feel it. We have a clear path on how to bring a EA114 to the market. We feel very confident in our ability to bring the product to the market. And so I think it's probably safe to say that our size of our company will double in that five-year period that you're referring to, right?

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Which is a great feeling because we just tripled the earnings of the company in 2022. Now we think we can grow pretty significantly off of that base. You know, we just have to figure out what to do between now and the time that EA114 comes to the market. So, you know, we plan to become a diversified pharmaceutical company. I think we'll have a mainstay in oncology. There's a lot that we can do with that. Maybe after EA114 gets to the market, we're taking a little bit more clinical risk. There are a lot of great small companies with some great technology that need cash.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

You know, that's something that we have. We've always been able to build cash at operations. I think that's gonna continue for the next five years. So I can envision us growing ourselves into a diversified oncology business. And then the hospital business, which we love, is going to be dictated by CAL02 if, you know, the outcome of that. But, you know, we'll have a nice hospital business. There's also a lot of very, you know, very important hospital products that are available for acquisition as well.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

The biggest value driver for us in the short term is on the oncology space. But I can see us ultimately splitting this business into two. However, we do it either formally or informally.

Mm-hmm.

I don't see any reason why we're not building and growing a hospital business. It's actually a pretty darn good business to have if you're successful in it. I mean, there's a tremendous amount of pharmaceutical products purchased every year in hospital.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Right? It's a big market. It's lower-priced products 'cause they're acute care than we're used to in oncology these days. But it's a really nice business to have. So what I would envision, right, what, what we talk about on the leadership team is we have two really great businesses.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

I think we're gonna grow both of them.

Michael Brock
Managing Director, Citigroup

Great. That makes sense. There is scarcity value associated with the acute care hospital, standalone hospital business. There aren't many standalone businesses like that left.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Oh, and there's. I mean, it's ripe to roll up.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

As well. You know, we have, I don't know, 40 Eagle employees in and out of hospitals around the country every day. We're building a great relationship with the people who purchase and use pharmaceuticals in the hospitals. I think we have a great reputation. It started out when we brought Ryanodex to the market 8 years ago, which is a fantastic lifesaving product as well. And we may as well build on that reputation. And we may as well take advantage of it. And you're right. There is a scarcity. And there's, you know, we get calls every day. People are in still developing really wonderful hospital products.

Michael Brock
Managing Director, Citigroup

Yeah.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Somebody needs to go and consolidate them and really build a great hospital business. I think the key, which you brought up today, Michael, is, well, how do we do it because we have two pretty different businesses.

Michael Brock
Managing Director, Citigroup

Mm-hmm.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

How do we deploy those two businesses within Eagle?

Mm-hmm.

Or outside of Eagle, to give both of those businesses the best chance they have of being successful?

Michael Brock
Managing Director, Citigroup

Yeah. It makes sense. Well, I've come to the end of my prepared questions, but I would like to open it up to the audience. If anybody in the audience has a particular question for either Scott or Brian? No? Well, on behalf of Citi, I would very much like to thank you for being here today and sharing your story and your vision for the company, which I think is really exciting. We look forward to spending more time with you and trying to, you know, help you sort through some of these challenges that are coming your way as well.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

We would enjoy that immensely, Michael.

Michael Brock
Managing Director, Citigroup

Very good.

Scott Tarriff
President and CEO, Eagle Pharmaceuticals

Thank you again for inviting us. It's very kind of you.

Michael Brock
Managing Director, Citigroup

My pleasure. Thank you.

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