Good morning, everyone. My name is Ashley, and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmaceuticals' Fourth Quarter and Full Year 2021 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.

[Operator instructions] As a reminder, this conference call is being recorded today, March 7th, 2022. It is now my pleasure to turn the floor over to Ms. Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. Please go ahead..

Thank you, Ashley. Welcome to Eagle Pharmaceuticals fourth quarter 2021 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.

This morning, the company issued a press release detailing financial results for the three months ended December 31st, 2021. 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 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 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 March 7th, 2022.

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

Well, thank you, Lisa. Good morning, everyone, and thank you for joining our call today. 2022 certainly got off to an exciting start for us with two very significant product launches, Vasopressin and PEMFEXY. A lot of great work went into getting these two drugs to the market, and we're delighted that providers and patients now have access.

In fact, for Vasopressin, the market is exceptionally strong, largely due to the rise in COVID cases, and we shipped significantly more Vasopressin than we anticipated. For PEMFEXY, we're finding significant desire for the benefits that the product can bring customers as well.

And from a revenue perspective, it's useful to look at these two assets together. Leading up to these launches, we have been guiding that we expect to double our revenue and more than double our earnings in '22. And we believe that we are comfortably well ahead of that run rate.

We finished '21 with cash and cash equivalents of $98 million, which would have been even higher, but we elected to buy back $21 million of our own shares over the course of the year because we're bullish on our company and our prospects.

Our confidence is even greater now based on the fact that we launched Vasopressin and PEMFEXY into extremely strong markets, and we've been able to commercialize both products using our existing infrastructure.

Today, we are providing some early guidance for Q1 of '22, adjusted non-GAAP earnings per share of around $4, a range of 380 to 410, and a number that is significantly higher than what we have earned in most years.

This includes revenue of around $120 million to $130 million giving us every reason to believe that we should exceed the doubling of our revenue in '22. In terms of Q2, we have no contractual limit on PEMFEXY volume. But right now, we're expecting a little less COVID cases, so Vasopressin volume would come down a bit.

Based on current trends, we believe Q2 revenue and earnings should be around the same as Q1, although it's too soon to have complete certitude as pricing in these markets can be variable. We will provide an update as we have more visibility.

If Q1 and the rest of the year play out as we anticipate, we expect to generate operating cash flows that could be as much as $170 million in 2022. I want to reiterate the significance of what it means to Eagle to be generating this amount of cash and have such a strong balance sheet. Our top priority is put this cash to good use.

Considering that we have very little debt on our balance sheet currently, if we take even a modest amount of debt, it's easy to see that we could have a significant amount of cash to make acquisitions, which, depending on how we raise the money, would be minimally dilutive.

And remember, too, that over the past several years, we have bought back around $230 million of our own shares. We are seeing a lot of good business development options. And as we have stated before, we expect to make an acquisition in the first half of this year and another acquisition in the second half of this year.

Importantly, as we go through this process of assessing appropriate targets, we are mindful of avoiding clinical and regulatory risk. We are looking for financial synergy, knowing that our talented sales infrastructure can handle additional products in a segment where they have great access and great relationships.

This is a very good period in time historically to be a buyer. With the Biotech Index down as much as it is, we are finding very good acquisition opportunities and take advantage of our past prudent handling of our cost - of our cash and balance sheet. So now on to Vasopressin. Let's talk about each of these programs starting with Vasopressin.

In the fourth quarter of '21, events played out as we thought they would. The market for Vasopressin is actually much bigger than we thought. '21 saw record product usage likely due to increased COVID hospitalizations and '22 in the first quarter, the market was up significantly for Vasopressin.

As we go forward, we will continue to watch for the trends for COVID hospitalizations to determine where the Vasopressin numbers will be going forward. But from a share standpoint, we are very pleased with our performance. Already in '22, the market is up again.

So we feel very good about our ability to sell quite a bit of product during the first six months here of our exclusivity. And it's worth noting, we are hitting these revenue numbers for Vasopressin even with two additional competitors in the market with us right now.

We have strong relationships with our hospital-based customers and a highly skilled sales force. And remember, we're not a generics company. We have forged long-standing relationships in this space, and our salespeople meet directly with the key decision-makers on a regular basis.

We believe that gives us a strategic advantage when selling our products. Our uptake has been very positive. And in fact, we received a lot of inbound calls. Our customers were ready for this product and are happy to be receiving it.

And now as far as PEMFEXY goes, as I mentioned earlier, just two weeks after our Vasopressin launch, we brought PEMFEXY to the market.

Our ready-to-use PEMFEXY may actually prove to be a larger opportunity than Vasopressin, given that PEMFEXY has been provided reimbursement that should allow customers to benefit from the improvements that we have made to the molecule.

And now in terms of bendamustine, add this to our growing bendamustine franchise in Japan, which is expected to contribute about another $20 million in royalty and milestone revenue this year. Last year, our partner in Japan launched the TREAKISYM ready-to-dilute formulation, and approval for the rapid infusion 50 ml liquid formulation is pending.

So now we have Vasopressin and PEMFEXY on the market. And as I mentioned earlier, we've accomplished that with our existing commercial team. We have a lot of confidence in our sales force. They know the hospital and critical care space well, and I believe we will hit our target numbers.

With the strength of these launches, we are continuing the evolution of Eagle in establishing ourselves as a significant factor in the oncology and hospital sectors.

And now if we turn to the pipeline and our plans for the balance of the year, we are currently preparing to begin clinical trials for CAL02a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe pneumonia in combination with traditional antibacterial drugs.

Those trials should begin in the third quarter, and we feel very positive about this asset. CAL02 has the potential to change the standard of care for patients and to have a broad therapeutic impact, especially in critical situations.

Despite the widespread availability of antibiotic drugs today, pneumonia is still the leading cause of infectious mortality in the world. CAL02's ability to neutralize virulence effectors to fill significant medical need by offering physicians a new treatment that could dramatically improve patient outcomes.

Also, as we announced in January, we are on track to support the submission of a new drug application for Landiolol in the second quarter of this year. Landiolol is a beta-1 adrenergic blocker and fits nicely into our expanding hospital-based footprint.

As you recall, we entered into a licensing agreement in August of '21 with AOP Health to engage with the FDA to obtain alignment on the content and format of the preclinical and clinical data required to support an NDA, seeking approval of Landiolol in the US.

Keep in mind that Landiolol is already commercially available in Japan and in several European markets where it has been very successful. We are very much looking forward to advancing this asset.

We believe the product could achieve $100 million to $150 million of new brand peak sales and making it accessible in the United States is of extreme importance to us.

To sum up, we are taking an extremely intentional approach as we identify potential acquisition targets, mindful of avoiding near term clinical and regulatory risk, and looking for assets that we can easily integrate into our robust sales structure.

Our sales organization, which is easily expandable is our greatest strategic asset outside of our products. We're really excited about '22 and what it will bring for Eagle. We are in the unique position of having the wherewithal to accelerate the growth of the company this year and then again through the acquisitions we will be making.

We are well funded. We will generate significant cash flow from operations this year and with minimum - with minimal dilution, we will be in a strong position to acquire a number of assets that will fit well into our hospital oncology segments where we have established a strong position.

And in fact, we could spend a significant amount of our current market cap during a period of time where we have an unusually high growth in EPS and still have minimal dilution to our shareholders. As you can see, we have a lot to look forward to. With that, I'll turn the call over to Brian Cahill to discuss our fourth quarter financials.

Brian?.

Thank you, Scott. Good morning. In the fourth quarter of 2021, total revenue was $42.3 million, compared to $49.9 million in Q4 of 2020. Full year 2021 revenue was $171.5 million, compared to $187.8 million in 2020. Product sales during the fourth quarter were $16.2 million, compared to $22.9 million in Q4 2020.

The decrease was driven by lower product sales of BELRAPZO and RYANODEX. For the full year 2021, product sales decreased by $7.3 million from 2020, driven by decreases in sales of BENDEKA, BELRAPZO, and RYANODEX, partially offset by product sales on the launch of TREAKISYM.

BELRAPZO product sales were $5.5 million in the fourth quarter of 2021, compared to $10.2 million in Q4 of 2020. For the full year, BELRAPZO sales totaled $23.7 million, compared to $27.5 million in 2020. Fourth quarter RYANODEX product sales were $6.1 million, compared to $7.9 million in Q4 of 2020.

Orders for RYANODEX are cyclical, driven primarily by product expiry [ph] For the full year, RYANODEX sales totaled $25.3 million, as compared to $28.3 million in 2020. Q4 2021 royalty revenue was $26.2 million, compared to $27 million in the prior year quarter.

For the full year 2021, royalty revenue totaled $106.5 million, compared to $110.5 million in 2020. Eagle's royalty rate on BENDEKA was 32% during the fourth quarter of 2021 and 31% for the fourth quarter of 2020. On October 1st, 2021, the rate increased for the final time to 32%. This is the royalty rate on BENDEKA.

Beginning in the first quarter of 2021, royalty revenue also includes royalties earned on sales of TREAKISYM by SymBio. On the expense front, R&D expenses were $3.8 million in the fourth quarter compared to $9.4 million in the prior year quarter. The decrease is largely attributable to the non-recurrence of development costs on Vasopressin.

Excluding the expense of acquired in-process research and development, stock-based compensation, and other non-cash and non-recurring items, R&D expense during the fourth quarter was $2.6 million and was $32.5 million for the full year of 2021. We expect R&D spend in 2021 on a non-GAAP basis to be in the range of $46 million to $50 million.

This reflects expected clinical and CMC work on CAL02 and fulvestrant and costs of other ongoing programs. SG&A expenses in the fourth quarter of 2021 totaled $20.3 million, compared to $18.2 million in the fourth quarter of 2020.

The increase is related to higher employee related expenses and consulting costs, partially offset by a decrease in stock compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, fourth quarter of 2021 SG&A expense was $14.6 million.

Full year SG&A expense decreased by $3.3 million to $75.3 million in 2021, compared to $78.6 million in 2020.

This decrease was principally due to the non-recurrence of costs related to the collaboration with Tyme Technologies in the prior year and lower stock-based compensation expense, partially offset by higher employee related expenses and external legal costs on Vasopressin litigation.

Excluding stock-based comp and other non-cash and non-recurring items, SG&A expense in '21 was $54.9 million. We expect our SG&A spend in 2022 on a non-GAAP basis will be in the range of $54 million to $58 million.

Net loss for the fourth quarter was $6.2 million or $0.48 per basic and diluted share, compared to net income of $8.1 million or $0.62 per basic and $0.60 per diluted share in the prior year period.

Net loss for the full year was $8.6 million or $0.66 per basic and diluted share compared to net income of $12 million or $0.89 per basic and $0.87 per diluted share in 2020.

Adjusted non-GAAP net income for the fourth quarter of 2021 was $11.2 million or $0.87 per basic and $0.85 per diluted share compared to adjusted non-GAAP net income of $12.8 million or $0.98 per basic and $0.96 per diluted share in the prior year quarter.

Adjusted non-GAAP net income for the full year of 2021 was $34.1 million or $2.64 per basic and $2.59 per diluted share, compared to adjusted non-GAAP net income of $48.7 million or $3.62 per basic and $3.54 per diluted share in 2020.

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 Scott mentioned earlier, we are setting guidance for Q1 2020 in the range of $120 million to $130 million for revenue and adjusted non-GAAP earnings in the range of $3.80 to $4.10 per share.

As of December 31st, the company had $97.7 million in cash and cash equivalents, and we had $26 million in outstanding debt. So we had $71.7 million of net cash. We had $41.1 million in net accounts receivable.

In the fourth quarter of 2021, we purchased an additional $8.6 million of Eagle's common stock as part of our $160 million share repurchase program. Importantly, from August 2016 through December 31st, 2021, we've repurchased $228 million of our common stock. With that, I'll open - I'll ask the operator to open the call for questions, please.

Operator?.

[Operator Instructions] And we will take our first question from Tim Lugo with William Blair. Please go ahead..

Thank you for the questions and congratulations on a strong launch of both products, and thank you for the guidance as well. But most of us on the call, we have to also do the back end of the year.

Could you maybe directionally give us some ideas on the durability of Vaso in the back end of the year and how PEMFEXY should be growing in the second half of the year?.

Yeah. Thanks, Tim. Yeah, look, good question. And I will tell is - we don't have complete visibility to that. There is a lot of factors that go into these markets. Obviously, the first half is going to be very strong for the company because we have the exclusivity period.

The second half of the year is actually going to be pretty strong as well relative to our historical earnings. I mean I think PEMFEXY, as you look out over a number of years is probably going to be the stronger of the two products because of the way the drugs reimbursed.

And so we're pretty confident that PEMFEXY will be a significant part of the company. Vasopressin probably will as well, but it's hard to tell at what levels. Much of this has to do with the strength of COVID over the years or certainly over the course of the next 12 months.

We don't know where another variant may pop up and how long COVID will be around. We are getting very good share on Vasopressin and having great relationships with customers, even with a couple of people in the market with us. So our expectation is by the time we're done, the back half of this year will be strong.

And then as you go to '23, '24, '25, we have a lot of confidence that we'll be able to use all this cash we're generating to make sure that we're building growth in this company.

And so we're looking at the first half as a way to build cash to accelerate the earnings going forward, and we're pretty excited about the long-term prospects of the company..

Understood. And I know it's not - you're not in a perfect position to give us 2023 guidance and beyond. But maybe if you - as you're looking at business development, can you just talk to us about how you're assessing targets. You mentioned in your commentary that you're looking to avoid clinical risk.

Does that mean marketed products or does that mean maybe development-stage assets, which you think have minimal clinical risk? And historically, you've been focused on 505(b)(2), is that changing with Landiolol and kind of the acquisitions to come? And also lastly, given the kind of macro issues, is RYANODEX for radiation sickness program, is that maybe have a potential for any progress there?.

Thanks, Tim. All good questions. Let me try to take it as best as we can. But what we're finding is, as I mentioned in the script, that this is probably a wonderful time historically to be in an acquisition mode. We have cash. We have an unused balance sheet. We have plenty of opportunity to acquire.

At the same time, what we're finding are quality assets that have been you know, are cheaper today historically than they've ever been. And for a lot of reasons, we're finding people that are probably far better off selling their assets than trying to raise money and build commercial for it.

What you'll see us do this year is to take the sales organization that we have, that we've spent a number of years building. We have a tremendous reputation, I think, in the call point of hospitals and in the community oncology setting.

And so what we'd like to do is take advantage of the infrastructure that we spent these years building because we believe we can add products into this infrastructure and have a minimal increase in the amount of cost in people or infrastructure needed.

In the beginning, what we'd like to do is make a couple of acquisitions of already marketed products that are early in their growth stage that have patent life to them that we could just add like a Landiolol and other products that we're looking at and build a company that would be known as a strong hospital oncology franchise.

We probably won't abandon the 505(b)(2) process. It's worked out well for us. But in the course of the year, we'd like to buy more NCEs, more branded products. We have the capability of commercializing those products and that's the way we'll handle it.

And I think we should be thought of not as the regulatory pathway we take to bring our products to the market, but more as where we sell, where our call point is and that's acute care hospital and oncology. Then later in time, you'll probably see us bringing in some clinical programs like a CAL02 again and building our pipeline.

But let's go into our strength, take advantage of the cash and the balance sheet and let's go add growth products into the company and make sure we keep this great growth that we have in '22 going. We do still have a few indications on RYANODEX we're working on.

It's starting to take a back burner to the company's development as we bring in Landiolol and CAL02 and other projects. We probably won't pursue radiation going forward. We just don't think that's a big enough market relative to what we've just achieved, but there are a few things we're working on with RYANODEX.

We'll see how they pan out in the upcoming years..

Understood. Thanks for all the question..

Thanks, Tim..

We will take our next question from Brandon Folkes with Cantor Fitzgerald. Please go ahead..

All right. Thanks for taking my questions and congratulations on the progress, strong guidance and I appreciate all the color. Maybe just two for me, Scott, your comment on sort of much having to do with COVID, right.

Can you just elaborate there? And just in terms of it, are you thinking about you know, given the increased usage we saw in Vaso with COVID, net-net are COVID outbreaks a positive for Eagle this year, just on the back of Vaso or sort of given PEMFEXY and the rest of the business negative? And then maybe secondly, just with TREANDA generics coming at the end of the year, how do we think about reigniting BELRAPZO growth, right.

Is that a level we should think about that you could pull? Or is it sort of settled into the market and its current market share? Thank you..

Thanks, Brandon. Boy, I'll tell you what I don't know the answer to the COVID question, right. It's been a drag in our earnings for the last two years, as chemotherapy visits have been down and the BELRAPZO and BENDEKA numbers have probably been suppressed over the last two years because of that.

Now we launched Vaso, which is benefited by COVID hospitalizations, and we can see the strong quarter that we're having and probably the strong first half. I think we're just going to have to see what happens to COVID. From our standpoint, it's still not predictable.

If hospitalization start to spike again, if you go into the colder weather again next year and they start coming up, Vasopressin is still going to be a big part of our business. And so we'll just have to see. But for living in the moment anyway, right now, it's - the Vasopressin numbers are larger than they would otherwise have been, I think.

So for today, it's a positive. In terms of TREANDA generics, we're in the same place we've been. We think we are going to give up that 30%, 35% of the income we have from it, offset by the launch in Japan.

And so if we've been bringing in about $100 million a year on the bendamustine franchise, if that goes down by $30 million or $35 million, and we pick up $20 million in Japan, it's just - it's manageable. It's very manageable, especially with this growth that we're going through now. So we're prepared for it. We'll optimize the position as best we can.

It's important to note that BENDEKA is just a better product considerably better with the shorter infusion time is very well accepted by patients, nurses, and physicians. So we think we'll do well. Let's see what happens. But all in all, you bring it all together and the company has never been in a stronger position than it is today..

Thanks. Maybe on that point, one more if I may. You obviously have tremendous financial flexibility at this stage. But it sounded like you're looking at, I guess, tuck-in acquisitions initially.

Is that a correct characterization or should we just think about that you're going to be opportunistic in the valuation environment and it could go either way - on business development?.

Yeah. Thanks, Brandon. I would say that right now, we are being opportunistic in finding many opportunities. It's just - we're running a company. Everyone on the call is investors. It's an unusual situation right now.

The fact that we were so prudent over the years and how we managed our cash and our balance sheet, it just put us in a situation where we're building such significant cash, still have ability to obviously use our balance sheet that we haven't used before. And we're finding assets that are devalued compared to where they've been historically.

And so our goal is to grow the company and to grow it in a way that gives us the best certitude going forward and gives us the best patent life and the ability to grow in oncology and acute care. And so I won't rule anything out, but we're going to bring products into the company. The size of those acquisitions, we'll see what goes on.

But as the company gets bigger and our earnings grow, we probably have the ability to do bigger deals later. And so from a company that went from wanting to do everything organically, having now brought three products to the market in TREAKISYM in Japan and then PEMFEXY and Vasopressin the ups and downs of the R&D for us.

Right now, we're seeing the fruit of all that hard work, and we're going to go put it to use and bring products in. And now we'll probably be a company that's more acquisitive than we have been in the past. And just as long as we're finding good strong value out there, nothing is off the table.

We're just going to get this company bigger with taking, again, prudent risk, manageable debt and just continuing to grow. It's an exciting time for us, and we're looking forward to it..

I agree. Congratulations and thanks. Good luck for the rest of the year..

[Operator Instructions] We will take our next question from David Amsellem with Piper Sandler. Please go ahead..

Thanks. So I have just a few. So on Vasopressin, I wanted to drill down on your thought process regarding sales for the exclusivity period.

I guess the question here is, can you elaborate on where you think your share of the market is going to trend? Or are you - and then secondly, are you thinking about strong sales in the context of the COVID environment and hospitalizations? And is that what is more of a paramount driver? I just wanted to get a sense of, is it share growing, is it just the market growing? And how do you think about that? That's number one.

And then number two is, as you talk about Vasopressin beyond the exclusivity period, do you have any sort of market intel [ph] on how crowded you think the market is going to get, not just in the back half of the year, but looking into 2023? And then lastly, just on BENDEKA and the bendamustine business, knowing that it is - it has a unique J-code, but that notwithstanding.

I guess, with a flow of entrance for TREANDA, what keeps the product from BENDEKA, I should say, from declining precipitously, I guess, in the context of a flood of generics on the predecessor product, how do you think about that? Thank you..

Yeah. You're welcome. David let's take this one at a time. But let's go to the last one. Let's go to BENDEKA. First and foremost, this is a therapeutic alternative. We are not getting generic competition for BENDEKA. We have done extremely well in the courts with BENDEKA. We have numerous patents that go out to 30. We've won in the courts. We've settled.

It's a therapeutic conversion, not a generic conversion. And based on the reimbursement, there is a unique J-code for TREANDA. There's a unique J-code for BENDEKA. There's a unique J-code for BELRAPZO. We just happen to have the better product on the market.

It would be a shame to change patients after this time from the benefits of one drug to the inferior benefits of another drug. It doesn't typically happen. It probably won't happen. We again, have great relationships with our customers. The patients love our product. The nurses love our product, the physicians love our product.

Chances are we're probably correct with our assessment of the amount that we're going to lose. We can handle it easily. We're prepared for it, and we don't expect it to be a major issue for the company. Thrilled about the launches we've just had. If you want to go back to Vasopressin, let's wait and see what our share is at the end of the quarter.

It's hard to give guidance before the quarter is over because we don't have the market size numbers you have to see what it is. If you use the Q4 numbers for Vaso to predict what Q1 looks like, our share is very good.

And the reason our EPS guidance is so significant for the quarter is largely due to a very significant amount of Vasopressin that we've sold both in share and specific volume. We expect our share to continue, we expect our share to grow. The unknown is what happens to price. We don't know how many other people are coming into the market.

We're not privy to those settlements that Endo has. But we're very confident that we will maintain a very significant market share of Vasopressin due to our relationships with our customers and the strength of our sales force. And we expect that that share to continue for many years to come..

Okay. Thank you..

Welcome..

And there are no further questions at this time. I will turn the call back over to Mr. Scott Tarriff for any closing remarks..

Well, thank you again for joining us today with so many exciting initiatives ongoing and into works. We're looking forward to a year of just outstanding growth at Eagle.

The near and intermediate drivers of this growth, and our ability to bring in large enough hospital oncology products that we can leverage and grow our enormously talented commercial sales team and footprint within the space.

With Vasopressin and PEMFEXY product successfully launched together with our highly promising pipeline, including Landiolol and CAL02, we intend to build upon the strong foundation and bring value to our shareholders. We very much look forward to updating you as we deploy our cash and grow the company going forward.

Stay safe, and thank you for spending the time with us today. Appreciate it..

Thank you. And this does conclude today's program. Thank you for your participation. You may disconnect at any time. And have a wonderful day..