Eagle Pharmaceuticals - Q1 2022

Transcript

Moderator (participant)

Good morning, everyone. My name is Gretchen, and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmaceuticals first quarter 2022 financial results. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer period. At that time, if you have a question, please press star and one on your telephone keypad. As a reminder, this conference call is being recorded today, May 9, 2022. It is now my pleasure to turn the floor over to Ms. Lisa Wilson, investor relations for Eagle Pharmaceuticals. Please go ahead.

Lisa Wilson (Investor Relations)

Thank you, Gretchen. Welcome to Eagle Pharmaceuticals first quarter 2022 earnings call. This is Lisa Wilson, investor relations for Eagle Pharmaceuticals. With me on today's call are Eagle's President and Chief Executive Officer, Scott Tarriff, and Chief Financial Officer, Brian Cahill. Dr. Mike Greenberg, VP, Medical Affairs, will be available during the Q&A session. This morning, the company issued a press release detailing financial results for the three months ended March 31, 2022. This press release and a webcast of this call can be accessed through the investors section of the Eagle website at eagleus.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events in the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act.

These forward-looking statements are based on information available to Eagle Pharmaceuticals management as of today and involve risks and uncertainties, including those noted in this morning's press release and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. Eagle Pharmaceuticals specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. A telephone replay will be available shortly after completion of this call. You'll find the dial-in information in today's press release. The archive 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 archive webcast, this call was held and recorded on May ninth, twenty-twenty-two.

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. With that, I'll turn the call over to Eagle's President and CEO, Scott Tarriff.

Scott Tarriff (President and CEO)

Well, thank you, Lisa. Good morning, everyone, and thank you for joining our call today. We're delighted to share that the early momentum we saw at the beginning of 2022 continues to build, reflecting strong initial sales of $34 million for vasopressin and $37 million for PEMFEXY during the quarter. We had a great quarter we anticipated with non-GAAP earnings of $4.04 per share and over $50 million of net income after tax on a non-GAAP basis. Well on our way to the best year in our company's history. Our cash position is about $70 million with $130 million in receivables for a total cash plus receivable of $200 million and only $24 million of debt. Keep in mind, we built inventory and bought back $8 million in stock in the quarter as well.

If the rest of the year plays out as we anticipate, 2022 will be a very strong year. We still have exclusivity for both vasopressin and PEMFEXY. Our market share for vasopressin was 24% for the trailing four weeks, and we are seeing significant acceptance of PEMFEXY in the marketplace. We are extremely pleased with these numbers. Our company has evolved, and the Eagle story has been simplified. We are in the enviable situation of having significant cash for a company of our size and almost no debt, and rather profitable, which gives us many options. We have a lot to look forward to in the second half of the year, starting with our pending acquisition of Acacia Pharma, which is expected to close in June.

As part of that acquisition, we expect to gain two products, Barhemsys, the first and only antiemetic approved by the FDA for rescue treatment of postoperative nausea and vomiting despite prophylaxis, and Byfavo, indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Both are new chemical entities or NCEs with strong patent protection. We are on track to support AOP Health's NDA filing for Landiolol later this month. Assuming approval, we will have three branded novel NCEs, Barhemsys, Byfavo, and Landiolol on the market going into the growth phases. We expect we will continue to generate considerable cash from the rest of the product line, Bendeka, Belrapzo, Ryanodex, Bendamustine in Japan, and now vasopressin and Pemfexy, to be followed by Landiolol if approved.

In a relatively short amount of time, we have developed a far more diversified revenue stream, anticipated to go from three commercial products to eight, and soon it could be nine with Landiolol. Our highly skilled and experienced sales force is one of our greatest assets, and we are leveraging this strength as we broaden our footprint in the acute care and oncology spaces. Looking ahead, we have our very exciting and potentially blockbuster asset, CAL02, a novel first-in-class antitoxin agent for the treatment of severe pneumonia in combination with traditional antibacterial drugs. We plan to start our Phase 2b/3 study clinical trial later this year. In terms of Fulvestrant, we are in the middle of dosing our next study and expect results in the fall. We will keep you updated on what happens here. What does this all mean for Eagle?

We continue to build significant cash relative to our size, and we will be spending some of that cash on the Acacia purchase. We're likely to take on some debt later this year and combined with the debt existing cash and our building cash, we will now turn our attention to pursuing additional opportunities to strengthen both the portfolio and the pipeline. This is now where we are focused. One of our key objectives is to pursue additional opportunities for currently marketed products and pipeline assets. We have already accomplished quite a lot thus far in 2022, and have made enormous progress to expand our presence in oncology and hospital critical care. Our disciplined approach to our balance sheet and our prudent use of cash have led to the success we have had with organic growth.

With the intent to further diversify the company and build out our pipeline, we plan to strategically take advantage of the acquisition opportunities as they arise without taking on undue clinical or regulatory risk and with minimal dilution and debt. This is a great start to what will clearly be a pivotal year for Eagle as we expect to finish 2022 in a very strong position. We aspire that by the time we leave this year, we are a further diversified pharmaceutical company continuing to build both cash and shareholder value. With that, I'll turn the call over to Brian Cahill to further discuss our first quarter results. Brian?

Brian Cahill (CFO)

Well, thank you, Scott, and good morning. In the first quarter of 2022, total revenue was $115.9 million compared to $41.2 million in Q1 of 2021, primarily reflecting the strong launches of vasopressin and PEMFEXY. Product sales during the first quarter were $90.1 million compared to $17.1 million in the Q1 of 2021. Vasopressin sales totaled $34.3 million in the first quarter of 2022. PEMFEXY sales were $37.2 million in the first quarter of 2022. BELRAPZO product sales were $5.9 million in the first quarter of 2022 compared to $5.7 million in Q1 of 2021.

First quarter RYANODEX product sales were $6.6 million compared to $6.8 million in Q1 of 2021. Orders for RYANODEX are cyclical, driven primarily by product expiry. Q1 2022 royalty revenue was $25.8 million compared to $24.1 million in the prior year quarter. Eagle's royalty rate on BENDEKA was 32% during the first quarter of 2022 and 31% for the first quarter of 2021. The rate will remain at 32% going forward. Royalty revenue also includes royalties earned on sales of TREAKISYM by SymBio. On the expense front, R&D expenses were $6.1 million for the first quarter of 2022 compared to $14.3 million in the prior year quarter.

This decrease is largely attributable to non-recurring development costs on vasopressin and lower spend on Fulvestrant and RYANODEX related projects. Excluding stock-based compensation and other non-cash and non-recurring items, first quarter 2022 R&D expense was $5.4 million. We expect R&D spend in 2022 on a non-GAAP basis to be between $46 million and $50 million. This reflects expected clinical and CMC work on CAL02 and Fulvestrant and cost on other ongoing programs. This does not include potential R&D expenses for Acacia or its products should that transaction close. SG&A expenses in the first quarter of 2022 totaled $22.2 million compared to $19.9 million in the first quarter of 2021. This increase was primarily related to external legal spend for the anticipated acquisition of Acacia and sales and marketing costs for the launch of PEMFEXY.

This is partially offset by a decrease in stock compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, first quarter 2022 SG&A expense was $16.6 million. We expect our SG&A spend in 2022 on a non-GAAP basis to be between $54 million and $58 million. As mentioned with the R&D expense guidance, these figures do not contemplate the potential acquisition of Acacia. Net income for the first quarter of 2022 was $44.1 million, or $3.47 per basic and $3.41 per diluted share, compared to a net loss of $0.4 million or 3 cents per basic and diluted share in the prior year period. Adjusted non-GAAP net income for the first quarter of 2022 was $52.2 million, or $4.10 per basic and $4.04 per diluted share.

Compared to adjusted non-GAAP net income of $3.2 million or $0.24 per basic and diluted share in the prior year period. For a full reconciliation of non-GAAP measures to the most comparable GAAP measures, please see the table at the end of our press release. As of March 31, 2022, the company had $69.5 million in cash and cash equivalents. We had $130.9 million in net accounts receivable and $24 million in outstanding debt, resulting in $176.4 million in net cash plus receivables. In the first quarter of 2022, we repurchased an additional $8.1 million of Eagle's common stock as part of our $160 million share repurchase program. From August 2016 through March 31, 2022, we have repurchased $236.1 million of our common stock. With that, I'll ask the operator to open the call for questions. Operator, please go ahead.

Moderator (participant)

At this time, if you'd like to ask a question, please press the star and one on your touch tone phone. You can remove yourself from the queue at any time by pressing the pound key. Once again, that is star and one to ask a question. We'll take our first question from Brandon Folkes from Cantor Fitzgerald.

Brandon Folkes (Managing Director and Biotech Equity Research)

Hi, thanks for taking my questions, and congratulations on a strong quarter. No surprise, maybe my first question on the vaso market. Can you just talk about how you've seen the vaso market shape up versus your expectations? Obviously, you did give guidance for Q1-Q2. Was the entrance of American Regent expected? How does that play into the exclusivity? And then what are you seeing in the pricing market compared to expectations, I guess maybe at the end of the quarter, just given in those guidance?

Scott Tarriff (President and CEO)

Hey, Brandon, thank you for the question. Vaso is shaping out, I would say, pretty much as we expected. We have about a quarter of the market, 24% share. I think we're being smart about how we're approaching it. The pricing is, you know, fine as we expected as well. We're very pleased with the share and the numbers. We still have exclusivity into the middle of July and expect to have a really good uptake in share and continue to do well over the next several weeks.

Brandon Folkes (Managing Director and Biotech Equity Research)

Okay. Just any comments on the exclusivity?

Scott Tarriff (President and CEO)

Oh, well, no, I don't think it's pretty much what we expected and anticipated when we looked at the landscape going into it. No, I think it's, you know, pretty much what we thought. You know, we spoke in the past, we had a number of scenarios, a number of models. This fit pretty accurately into one of them and, you know, it's. We're just thrilled about where we are right now.

Brandon Folkes (Managing Director and Biotech Equity Research)

Okay. Maybe just one more from me, then I'll hop back in the queue. You did mention about taking on debt later in the year. Should we think about that as being for larger, more maybe transformative acquisitions? Just any color around that comment. Thank you.

Scott Tarriff (President and CEO)

Yeah, very insightful, Brandon. Yes, exactly. You know, it's if you take a look at where we are today as we've stated, we just went from, you know, assuming Landiolol gets approved, it'll get filed later this month. You know, we just went from historically three products on the market to nine products on the market. We'd like to transact accretive large deals if we can, you know, and take advantage of where we are now with all this cash that we have. At the market where it is, we'd much rather, since we've never used debt before, really, we have, what, this $24 million of debt.

You look at our new EBITDA levels, there's no reason that we shouldn't build shareholder value by taking the cash we have, the cash we're building, and take on some reasonable debt. If you look at that, we can make a pretty significant accretive transaction shortly, and that's really what our intent is. At the same time, I think you'll see us doing some smaller transactions where we also build the pipeline, but the focus in the short term is really continue to build upon this new EBITDA level that we have.

If the Acacia transaction yields the revenue and profitability that we forecast, this is, you know, that was also a great transaction for us and hopefully this company is getting a lot bigger quickly and consistently and, you know, that's what we plan to do with the cash and use a little bit of debt. Yes. You're exactly right. Thank you.

Brandon Folkes (Managing Director and Biotech Equity Research)

Great. Thank you very much and congratulations on the quarter.

Scott Tarriff (President and CEO)

Thank you.

Moderator (participant)

The next question comes from Tim Lugo from William Blair.

Lachlan Hanbury-Brown (Senior Equity Research Associate)

Hey, guys, Lachlan on for Tim. Thanks for taking the questions and I'll add my congratulations on the strong quarter. I guess a couple as well on the recent launches. So just on vasopressin, you mentioned the share leading the quarter. Has the kind of market dynamics been relatively stable since the end of the quarter or are you seeing, you know, continued increase in share and how it changes there? Then on PEMFEXY, sort of a similar question. You obviously have the volume limits for Q1. Is there any commentary you can give on what you're seeing so far in Q2? Have you know, seen increasing demand relative to what you saw in February and March or anything along those lines?

Scott Tarriff (President and CEO)

Yeah. Thank you for the question. Let's start with vaso. I would say vaso is, you know, pretty flat, in good shape right now. You know, our share has been 24%. The number that we quoted was the last four weekly numbers, so the last month. You know, we expect that we'll continue to do well in that market, and it's, you know, fortunately, it's pretty stable. I think that's fantastic. In terms of PEMFEXY, we spent the, you know, Q1, with those limited vials that we had and putting those into distribution, and we're going through the process of pulling that all through, and we're getting great feedback. It's a great product, right? I think we invented a product in PEMFEXY that has significant advantages in the marketplace, and it's being accepted well.

We think that PEMFEXY will probably have, you know, a good life cycle over a couple of years here. We're very excited about both as the PEMFEXY market builds and, you know, we're in a good place, and hopefully, we'll deploy our resources effectively and just continue to grow the company and diversify.

Lachlan Hanbury-Brown (Senior Equity Research Associate)

Great. Thanks. I guess on PEMFEXY, if I could follow up a bit. Just thinking about sort of the second quarter, how much of the demand in the first quarter was the sort of stocking versus actual patient demand that you're seeing?

Scott Tarriff (President and CEO)

As typical, you know, you spend the first period of time in a launch in stocking. You know, we've had some, you know, pretty good pull-through, and that pull-through will continue to build and sales will continue to build. The important part of it is that that's happening now, it's happening at a good pace and, you know, the customer contact we're having has been very positive. Again, the fact that it is a ready-to-dilute product that doesn't need to be mixed and some of the other advantages we have are being received very, very well. You know, we're just pleased and we're probably on track from where we expect to be.

Lachlan Hanbury-Brown (Senior Equity Research Associate)

Awesome. Thank you.

Scott Tarriff (President and CEO)

Thank you.

Moderator (participant)

Once again, that is star one to ask a question. We'll take our next question from David Amsellem from Piper Sandler.

David Amsellem (Managing Director and Senior Research Analyst)

Thanks. Just a couple. First, can you just give us a refresher on how you're thinking about how the bendamustine market is going to evolve once generics of the legacy form of the product, enter the market? What's your expectation for, you know, your share, or I should say BENDEKA's share, and how you think about, pricing dynamics? That's number one. Secondly, I wanted to get your thoughts on the assets that you're acquiring in the Acacia Pharma transaction. And specifically, I wanted to pick your brain on how you're thinking about sales potential of Byfavo and BARHEMSYS and in the context of, you know, other agents, that are available cheaply in these categories. Any helpful commentary there would be great. Thanks.

Scott Tarriff (President and CEO)

Thank you, David. Let's start with your BENDEKA question. The best way to think about this is, you know, BENDEKA was, in our mind, a tremendous leap of value in the marketplace from Treanda and quite frankly, BELRAPZO. BENDEKA takes the infusion of bendamustine from 30 and 60 minutes down to 10 minutes, which the feedback that we've had over the years that we've been on the market has been received, you know, just significantly well by patients, nurses, and physicians. It's just a better product in the market, and you can see that from the market share. When Treanda generics come to the market eventually, that is clearly a therapeutic substitution to BENDEKA. It's not a generic substitution. BENDEKA is gonna be protected now. I think it goes out to 28 with the recent settlement that we have.

We have many years of enjoying Bendeka. The question really is, how many people are gonna go back to 30- and 60-minute that they have to reconstitute again? Certainly, I would say it's gonna be really hard to switch patients in the middle of a cycle. We've been saying consistently that we believe we'll keep 65%-70% of the market. From everything that we've seen thus far and the users that we speak to, we believe that that's consistent and it's probably what's gonna wind up happening. It's just hard to see major institutions that are worried about their patients switching away from Bendeka to a generic Treanda. We feel pretty good about the long-term value that Bendeka will supply.

Quite frankly, if that wasn't the case, we'd be selling a heck of a lot more BELRAPZO than we are, right? Because BELRAPZO has the same label as Treanda, and we have our sales force selling BELRAPZO, and people just prefer BENDEKA. I don't think that's gonna change. Second to that, the assets of Acacia, you know, with our sales team and the foundation that the Acacia team has laid thus far, I think we're gonna do well and why we made the acquisition. We haven't projected yet where we think those products are. I think it's a little bit too early. I will say that we think we purchased the assets at a pretty steep discount to what we perceive to be the DCF of that product line.

You know, just we have a little bit of heavy lifting to get to those numbers, but we're, you know, pretty confident. If I recall, the combined market value of those two products are about $3 billion. If you think at peak sales, we get about 10% of those markets, then, you know, this is pretty significant peak sales for the two products. You know, they're acute care products, they're low price, but the pricing that we have in mind for the two products Byfavo, BARHEMSYS are, you know, on the lower end of the spectrum. We believe that we'll make our money through a lot of volume. The margins are still very good on the products.

We're not too concerned that both products just have label improvements, they're beneficial, and we think with our sales force and the right messaging, along with the really tremendous groundwork that Acacia has laid, excuse me, thus far, we're gonna do rather well with those two products.

David Amsellem (Managing Director and Senior Research Analyst)

Okay. Thank you.

Scott Tarriff (President and CEO)

Thank you, David.

Moderator (participant)

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

Scott Tarriff (President and CEO)

Well, thank you again for joining our call today. We have a lot to look forward to in the months ahead as we continue to deploy our cash wisely to build a strong and diverse foundation for sustained growth. We look forward to sharing our progress with you as we always do. We continue to work hard to provide patients and providers with the medicines they need and deliver value to our shareholders. We're looking forward to, you know, another really strong year for the company. Thank you again for being with us this morning.

Moderator (participant)

This does conclude today's program. Thank you for your participation. You may disconnect at this time. Have a great day.