Good morning, everyone. My name is Reed, and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmaceuticals' Third Quarter 2020 Earnings Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer period.

[Operator Instructions] As a reminder, this conference call is being recorded today, November 2, 2020. It is now my pleasure to turn the floor over to Ms. Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. Please go ahead..

Thank you, Reed. Welcome to Eagle Pharmaceuticals’ third quarter earnings call. This is Lisa Wilson, In Investor Relations for Eagle Pharmaceuticals. With me on today's call are Eagle’s Chief Executive Officer, Scott Tarriff; David Pernock, President and Chief Operating Office; and our newly appointed Chief Financial Officer, Brian Cahill.

This morning, the company issued a press release detailing financial results for the three months ended September 30, 2020. 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 archived webcast will be available for one year on our website at eagleus.com. For the benefit those who may be listening to the replay or archived webcast, this call was held and recorded on November 2, 2020. 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 CEO, Scott Tarriff. .

Well, thank you, Lisa, good morning, everyone. Let me begin by saying that Eagle is quietly having a great year due to COVID constraints and the general state of the specialty segment. We have not spoken to as many of you and as often as in previous years.

Through the first nine months of the year, Eagle has had a number of critical successes that we believe positioned the company for significant growth over the next few years. This morning, we issued two press releases. The first was our quarterly earnings announcement in which we described a strong quarter and provide a roadmap to the near future.

The second release announced the appointment of Brian Cahill as our new CFO, as well as a number of key additions to the clinical formulations and commercial teams that we believe will strengthen the executive team. This is Brian's first earnings call, and he will be speaking to you shortly.

Brian has been with Eagle for four years as our VP of Finance. Collectively, these appointments provide us with the internal resources to focus on operational excellence and realize the full potential of our multiple pipeline opportunities. First, I'll review Q3 highlights and provide an overall business update.

As I mentioned up front, the third quarter was very strong, coming in at $1.17 per diluted share on a non-GAAP basis and reflects, among other things, the efficiency of our business model. For the first nine months of this year, we earned $2.58 per share compared to $2.13 in the first nine months of 2019.

Notably, this $2.58 is just $0.03 less than the $2.61 we posted for the full year of 2019. Given this strong performance to-date, 2020 is shaping up to be a growth year for Eagle. And at the same time, we've been able to continue to support our R&D efforts and build our pipeline for the future.

Let me take a moment to expand on what I mean when I discuss the efficiency of our business model. We've tried to build Eagle primarily through organic growth. In doing so, there may be periods similar to the one we just left when earnings dipped temporarily while the R&D cycle catches up. Now, we are back on growth trajectory.

And considering our expectations around launching vasopressin shortly, combined with SymBio’s recent approval bendamustine and having received final approval for PEMFEXY, we believe our prospects for earnings growth, not just in 2020 but in 2122, 2022, and beyond, are excellent and keep in mind the impact that all this growth will have, especially considering that we only have 13 million basic shares outstanding.

Beyond that, we are building out a strong pipeline. This includes fulvestrant and SM-88 in our oncology group, and on the critical care side of our business, we have a potential number of RYANODEX expansion opportunities to offset the expected decline of BENDEKA due to TREANDA competition in 2023.

All of this positions us well for a period of sustained earnings growth that is already underway. We continue to reinvest our earnings in both our product pipeline and in the company. This year, we have bought back $33 million in stock, bringing total repurchases since August of 2016 to $205 million or 22% of the company.

Clearly, this constitutes a significant return of capital to our shareholders. As an example, at the time of our February 2014 IPO, our basic share count pro forma was 14 million shares. And today, as I just stated, six years later, it's 13 million shares. Let me turn now to our product highlights beginning with vasopressin.

I am pleased to say that vasopressin was formally granted priority review by FDA last month. On our last quarter's call, I noted that FDA had asked us a few specific questions which we responded to fully back in September. We are hopeful about receiving approval shortly and would then potentially plan to bring the product to market soon thereafter.

Remember, our original trial date was scheduled back in May but was postponed due to COVID. We just learned that the new trial date is set for January 11, 2021. The proceedings will be held over Zoom, and we expect the trial to take about one week. We anticipate that we will have a decision by around mid-year.

The 30-month stage just ended this past October. And based on the strength of our legal position and if approved, we are seriously considering launching our product prior to this court decision. We continue to anticipate that when the launch does occur, we will maintain our 180 days of exclusivity.

This is an important opportunity for us as sales of VASOSTRICT are expected to reach $700 million this year. Turning now to our oncology portfolio. We have our first bendamustine product approval with our partner SymBio in Japan, 250-milliliter bag, and are awaiting approval of the 50-milliliter, 10-minute rapid infusion product.

SymBio currently sells about $85 million in bendamustine annually and will begin converting to our product in January. We anticipate that the royalties and milestones will build to $10 million to $25 million per year. Eagle recently received the $5 million approval milestone payment, bringing the total received from SymBio to $17.5 million so far.

This will become a consistent and meaningful income stream for us. Now, turning to our fulvestrant product candidate, EA-114, which targets estrogen receptor -positive HER2 negative advanced breast cancer. We just had a positive Type C meeting with FDA and have the minutes now. The next step is to submit the protocol.

We believe we have a study design that will address all of the open questions, and we are targeting year end to complete this process.

Once we reach alignment with the agency, we'll – we will provide a comprehensive update of the study protocol and other details of the program probably in the form of an Analyst Day to take place early in the New Year. You'll also hear from top breast cancer thought leaders.

We are really proud of this program and excited about the potential to improve outcomes in this patient population. We look forward to sharing more specifics around the study design, timing, costs, and anticipated benefits to patients. Now, let me touch briefly on where we are with some of our ongoing other work in oncology and critical care.

PEMFEXY or Pemetrexed for Injection, represents a significant opportunity for us as well. We have a unique J-code as announced last quarter. We also now have approval for the multiuse file, which means we can participate in a larger segment of that market.

And we are about 15 months away from the February 1, 2022 market entry and are busy preparing to capitalize on this sizable opportunity. And as you may recall in August, FDA granted orphan drug designation for SM-88, which is our strategic partner Tyme Technologies lead product for the treatment of pancreatic cancer.

A pivotal trial to evaluate oral SM-88 for third-line treatment of patients with metastatic pancreatic cancer is underway. And we understand that time will have data next year.

This is an exciting and promising therapeutic and another valuable part of our oncology product portfolio that will continue to contribute to our growth over the next several years. Turning now to RYANODEX portfolio. I'll start with RYANODEX for the treatment of brain damage secondary to nerve agent exposure.

This month, we are initiating dose ranging studies in another animal model in nonhuman primates. These studies involving administration of RYANODEX intravenously and will help to demonstrate efficacy and delineate the appropriate dosing strategy.

We are also going to include an arm using an intramuscular formulation of EA-111 in the nerve agent program. These early results will then allow us to update our special protocol assessment, or SPA, and gain alignment with FDA prior to proceeding with the remainder of the GLP efficacy study.

We are aiming to complete our low-volume, push IV for nerve agent program by the end of the second quarter of next year followed by a submission to FDA for approval.

In terms of other RYANODEXR indications under development, we have a research partnership with NorthShore University Health System to study the potential use of dantrolene sodium in treating traumatic brain injury or TBI and concussions. Our first study is concluding, and we expect to have results shortly. We look forward to sharing what we learn.

Our collaboration with the University of Pennsylvania to develop an intranasal Alzheimer's disease indication for RYANODEX continues to focus on a unique role how this regulation may play in treating this disease. A second more comprehensive preclinical model is starting this year.

In August, UPenn’s preclinical research showing that dantrolene sodium administered intranasally improve both memory and cognitive function in a mouse model of Alzheimer's disease, was published in the Journal of Alzheimer's Disease. We're also starting work on acute radiation syndrome this year.

As you can see, with this exciting portfolio of potential indications for RYANODEX, we will be growing our acute care business to complement our oncology business. So, when you step back and look at all of this, 2020 has already started what appears to be another growth, a strong growth cycle for Eagle.

If we assume a near-term vasopressin launch, the SymBio milestones and royalties and the PEMFEXY market entry in 2022, you can see that we are entering a strong growth cycle.

Looking ahead, fulvestrant, SM-88 with our strategic partner Time Technologies and the multiple RYANODEX indications could contribute to a considerable long-term growth cycle for 2020 and beyond. Before I turn the call over to Brian, I would like to also welcome Dr. Judi Ng-Cashin, John Kimmet, Dr. Valentin Curt, and Dr. Gaozhong Zhu to the Eagle team.

We hired all of these talented people to put us in the best position to advance our programs to the clinical phase and ultimately to the market. And with that, I am delighted to turn the call over to our new CFO, Brian Cahill, to discuss our third quarter financials.

Brian?.

one, the EA-114 pilot trial and CMC initiatives; two, the RYANODEX trials for the treatment of nerve agent exposure and Acute Radiation Syndrome; three, EA-111 IND-enabling toxicology studies and CMC scale of activities; four, EA-112 formulation development and additional preclinical work at the University of Pennsylvania and North Shore University Health System; five, regulatory advocacy for costs for RYANODEX EHS; and number six, launch preparedness for vasopressin and PEMFEXY.

SG&A expense in the third quarter of 2020 decreased to $17.7 million compared to $18.5 million in the third quarter of 2019 primarily due to decreases in T&E, trade show costs, and external legal expenses. Excluding stock-based compensation and other noncash and nonrecurring items third quarter 2020 SG&A expense was $11.9 million.

We are reiterating our 2020 guidance that SG&A expense on a non-GAAP basis is expected to be $61 million to $64 million as compared to $56 million in 2019. The year-over-year increase is largely attributable to higher sales and marketing payroll, partially offset by lower external legal spend and T&E expenses.

Net income for the third quarter was $7.1 million or $0.52 per basic and $0.51 per diluted share compared to a net loss of $2.4 million or $0.17 basic and diluted share in the prior-year period.

Adjusted non-GAAP net income for the third quarter of 2020 was $16.1 million or $1.19 per basic and $1.17 per diluted share compared to adjusted non-GAAP net income of $3.7 million or $0.27 per basic and $0.26 per diluted share in the prior-year quarter.

For a full reconciliation of non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of our press release. Our adjusted non-GAAP EBITDA for the third quarter of 2020 was $21 million compared to $4 million in the prior-year quarter.

Adjusted non-GAAP EBITDA for the three quarters of 2020 was $47 million compared to $38.3 million in the first three quarters of 2019. For the first three quarters of 2020, cash flows from operations excluding shifts and receivables was $38.9 million compared to $37.5 million in the first three quarters of 2019.

For the 12 months ended September 30, 2020, adjusted non-GAAP EBITDA was $57.7 million. As of September 30, 2020, the company had $89.7 million in cash and cash equivalents and $52.2 million in net accounts receivable, $34.3 million of which was due from Teva. The company had $36 million dollars of outstanding debt.

Therefore, as of September 30, 2020, the company had net cash plus receivables of $105.9 million. In the third quarter of 2020, we purchased $28 million of Eagle’s common stock as part of our $160 million share repurchase program. From August 2015 through September 30, 2020, we purchased $205 million of our common stock.

With that I'll ask the operator to open the call for questions..

And we'll go first to Randall Stanicky with RBC Capital..

Great. Thanks. Scott, I just have a couple of questions. First on vasopressin, you've called out priority review at FDA. Can you help us understand what that means from a generic drug perspective and how that plays into your thinking on timing.

And then the follow-up there is for those on the line give us a sense of where your confidence is in terms of willingness to launch at risk? So, that's number one. Number two, I just wanted to ask on the management adds. You announced the addition of a host of folks this morning.

Should we be thinking about that as bolstering the bench or positioning for offense with respect to thinking around the business and, more specifically, business development? And then, just the – a last one on R&D, it dropped down to $5 million this quarter. The implied guidance suggests a huge step-up or a big step-up in 4Q.

If you could just clarify how you're thinking about the spending trends on R&D for the rest of this year that would be great. Thanks..

Well, thank you, Randall. Good speaking to you. I took a lot of notes on your question. So, if I missed something, chime back in. So, look, the priority review, my understanding of it is that was granted to us primarily for two reasons. One, our 30-month stay is in the past, and we're first to file.

So, what does that mean? We – what we know is having responded what, we believe, is completely to all the remaining questions. What we do know is that the file is under active review.

And so, based on what we've submitted in that active review and the priority review nature of it, you know, the best we can say is that, we believe, that that approval is going to come shortly.

You know, there is no specific date that I can give everyone, but it is under active review and we expect that this – it should happen, you know, in what I would call the near-term. And it could happen at any time, but we'll just have to wait and see. That assumes that everything that we responded to, we did so in a satisfactory manner.

In terms of the confidence at launching at risk, as we've stated over the last several months, Randall, is that, we believe, we have a strong position in our litigation. And we'd like to get to the market as soon as we can. That's in the best interests of our shareholders. And so, we have not made a formal, a final decision yet as a board.

But we’re working diligently on coming to a conclusion. And, you know, I think there's a pretty good likelihood that ultimately we'll decide to get the product to the market and take advantage of all the hard work it takes to get this product approved and all the money that we've spent and just get going. And it's important to us.

As I mentioned in my earlier comments, now that we see the growth, we have pretty significant growth 2020 over 2019, launched vasopressin and launched PEMFEXY. And now that we have the SymBio royalty coming in, our growth looks wonderful going forward and have the ability to keep managing the pipeline.

In terms of the management changes, we believe that we are very close, very close to building something very special, right? We have the revenue coming in. We have the earnings coming in. And we got what appears to be a near-term pipeline. This Type C meeting we had with FDA on fulvestrant appears to have gone rather well.

We need to have a protocol finalized between us and the agency. Once we do that, we'll know exactly the timing and all the aspects of getting that product to the market. And we wanted to make sure that we have the very best people in this company to be able to close out what we've been working on in a long number of years. We have a great staff.

I’m really very happy with the team that we've assembled over the years. But we think we have just hired some really incredible talent to just wrap this all up and get it done. And, yes, on the BD side, it certainly gives us a better chance to take on more.

It gives us a better chance to appropriately define the diligence items that are required to make a decision. So we're just really excited, you know, with the growth stage that we're currently in and about the people and the products and the pipeline that we have to really go through some really great years again here.

Hopefully I handled it on and then, Brian, do you want to make a comment about the $5 million and where we are with R&D?.

Sure. Yeah. I mean, you see our guidance, Randall. You're right. We do have a lot of activity and a lot of programs that I mentioned in the fourth quarter in particular. You know, launch preparators for vaso, right, remember that's not approved yet. So, there's a good amount of expense there and the programs were EA-111 and other RYANODEX indications..

Randall, did we hit everything? Anything that we missed?.

Yeah. No. That was helpful. I guess, the only other thing, Scott, would be as you think about BD, we asked you this, you get this question every quarter, right? And you're sitting on $90 million in cash and you have been active in BD.

So, as we're sitting here today, should we be thinking that you are thinking about business development and how productive you want to be there any differently today versus prior quarters?.

Well, I believe, Randall, it's a very thoughtful question and it takes I think a thoughtful response. We do want to get the company bigger and we want to be smart about it. You know, if you look at the BD that we've done thus far, you know, the pancreatic cancer program that we have with time, you know, could wind up being very special.

There's obviously risk when you're in clinical especially in something in the nature of pancreatic cancer. But we feel good where we are so far and what we've seen so far coming out of that program. And it's that particular program and other programs like that that are of interest to us.

But at the same point, in addition to time, if you look at the company now, we really de-risked assuming vasogets to the market. You know, between vaso, PEMFEXY and the SymBio royalties coming out, you know, we have really very nice growth in earnings. We're making what we believe is really strong progress with R&D and clinical.

I think as we look, and David heads up, he’s here with me, David heads up the BD for us, I think we'd like a balance of clinical work and already marketed products. And we're working hard, but we don't feel a lot of pressure. And we've really derisked the pipeline and the earnings a lot over the last few months.

And we continue to look hard, but we're being very selective..

We have David Amsellem with Piper Sandler..

Hi. This is Zach [ph], on for David. Thank you, guys, for taking my question today. Sorry if I missed this, but one question regarding the VASOSTRICT. Congrats on priorities review.

But – so, my question is, when you submitted the additional data to the FDA in August, what was the FDA really looking for their given your competence? And what are some of the issues that you think could surface as they do review the filing now? Thank you..

Thanks, Zach. So, the question, really, was the nature of the questions that they asked. A lot of it has been we've been in the FDA for 2.5 years, and we've done quite an amount of work. A lot of it all surrounds, as I mentioned on the last call, this is a polypeptide. And the whole field of polypeptide has a lot of work being done around it right now.

And I believe that the agency has asked us to do work around a very old molecule. And being first to file, and having an active research program going on, we've been asked to update, I think, the nature of the product and do work around the polypeptide side of things. And, you know, we've done great work.

It's made us far more knowledgeable and that was the basis of the majority of the questions. And so, we believe that we've fully answered their questions. Yeah, I mean, you never know until you know. We feel confident, quite confident, you know, and we'll just have to wait for them to get back to us. But, as we said, we are under active review.

Our 30-month stay has expired. We are the first to file. They've given us a priority status. So, we know that they're looking at it diligently. And, you know, all we can say, at this point, as what we've been saying, is that we're hopeful that we'll get an approval here shortly..

Okay. Great.

And if I could slip in one follow-up on BD, do you guy – do you envision filing other ANDAs in the future along the lines of vaso [indiscernible] or do you plan on sticking more with the 505(b)(2) strategy?.

I think the way to respond to you is that, in our strategic plan, we are a 505(b)(2) and a proprietary technology company, right? So, fulvestrant, even though it's a 505(b)(2), when we're done, we probably would have now dosed, I don't know, almost 900 patients and subjects by the time that program is over, and we'll probably be $80 million or so into that.

So, not all 505(b)(2)s are created equally.

And, you see, some of our other 505(b)(2)s, where we had like PEMFEXY, where you get a biowaiver and you don't put as much science behind it, we like to consider ourselves to be more science-oriented now with work on Alzheimer's and concussions and, certainly, the novelty of SM-88 on the pancreatic side of things.

But that doesn't mean – and we don't have anything in the short term to talk to you about that we're working on.

But we do believe, with the team that we have assembled, we can handle complex ANDAs like vasopressin and if there are companies that need help in getting these difficult products through all the issues that it takes we're very willing partners and very good partners I think.

And so, we're looking at more of that and we will continue to be an opportunistic company. And that's what I think we do best and that's what we're going to continue to do. But I consider us to be a far more high-science-approach company than we were six years ago when we took the company public..

We'll go next to Tim Lugo with William Blair. Please go ahead. .

Thanks for the question. So, I guess we're all trying to poke around the vasopressin timing.

Can you maybe refine it a little bit more if you were to receive an approval soon? Would you consider a launch before year-end or is this something where you would probably address after the January trial?.

Hey, Tim. Good to hear from you. Thank you. I don't believe we're in a position to answer that fully yet. We're just going through that. We only found out about the July 11 trial data a few days ago. So, we need to regroup and talk about it. However, we're confident in our position.

We'll probably come out of the four-day trial more confident is my guess, my hope. Let's see what happens. But we are focused on monetizing the asset as soon as we can. I wish I could give you a more detailed answer but we're still looking at it. But either way, I mean, January 11 is right around the corner.

We're going to find a way to bring value to shareholders as quickly as we can..

Okay. Understood. And for the [indiscernible] products, you mentioned that kind of volumes haven't kind of normalized to pre-pandemic levels.

Do you think that could – we could see some sort of normalization in Q4 as it seems like oncology infusions are still kind of out of focus and recovering across the industry though obviously the pandemic concerns are heightening?.

Yeah. No, Tim, that's, you know, let me have David respond to some of that for you. He keeps close track of it. You know, I don't know if what you're seeing with your other companies or what you're seeing in the industry is different than we are.

But David, why don’t you give an overview?.

Yeah. Sure. Thanks, Scott. Hi, Tim. How are you? Yeah. You know, basically, we're starting to see some normalization as you know, right, as things are, in some parts of the country, improving. You know, you never know it seems like we're starting enter the second wave again, too. So, it's kind of hard to predict.

So, some of these things are kind of out of our control. But, you know, so far, we think we're seeing some stabilization and more return to more normal visits, which is good for the patients and so we're thinking that's most likely kind of continue..

Okay. Understood. And maybe just one last, David, question. You know, whenever you do launch, you're going to generate a ton of cash.

Can you just give us a kind of sense of that trajectory you expect for the launch? How durable it will be? What kind of that kind of shape and duration of that curve? And then what do you do with that cash? I mean, you mentioned BD but you’re going to, you know, have a major step up in cash if a launch goes kind of as it would be expected.

Would you look at kind of larger BD, more transformative deals, or this would it be kind of smaller time like deals and as well as some buyback?.

You know, Tim, that is, you know, very – we are going through our strategic planning process now because there's so many opportunities ahead of us, right? It's exciting to be going back into this growth curve and being so close with some of our key R&D programs. And so the durability of the asset of vasopressin is a little bit unknown.

What I can tell you is it's been a heck of a difficult product to get approved with what's been required for an ANDA. I mentioned it on the last call that the work that we've done, I mean, we have $25 million invested in this now. Half of that is in R&D. And you wouldn't expect to put that kind of money into an ANDA.

And yet, that's what the requirement was. And other than being first to file, you would never have committed to that level of spend. And so I don't believe that this is an easy ANDA for others to get approved. Now, having said that it appears that has settled with a lot of companies. So we don't know what the settlements are.

So it's a little bit hard to predict. But we do believe that this product will be very valuable for a number of years, and it will generate a lot of cash for the company. And so then what do we do with the cash? Look, we also have a clean balance sheet. We have net cash. We've been buying back our stock.

So the fact that we've been taking a slow and steady approach to our business the last six years has really put us in a fun wonderful position because we have so much opportunity to do with our stock, and the balance sheet, and the cash to really do anything that we'd like to. So, we're looking at all of the things that you're suggesting.

And, look, we bought back 22% of the company already. I don't know what's going to happen to the market. I don't know what's going to happen to our stock as we go through this, you know, what appears to be a really good earnings period, assuming that vasopressin gets to the market.

You know, who knows? If the stock doesn't react, we'll be buying back more of our stock because we believe in ourselves. If there's a transformational deal that we can do that is strategic and financial and accretive, we're not afraid to do that either. We like what we're doing in oncology. We like what we're doing in critical care.

Could we do smaller deals? Sure. But we, you know, I view us as being an opportunistic company. I view us as having the ability to do whatever we need to do to continue this growth. And between the team that we already have, with Brian and the entire team of people in the executive suite, David's been doing such a phenomenal job for the company.

Now, with the new hires that we have to really add to this, you know, the sky is the limit for us if we could execute. It starts with the vasopressin approval. Hopefully, that that'll happen. It'll build on the earnings growth that we've had, you know, that we’ve quietly snuck up on everybody and had growth in 2020.

And so, you know, I think our opportunities are limitless. Let's just put our heads down and get it done and, hopefully, good things will happen for us..

[Operator Instructions] And we'll go next to Brandon Folkes with Cantor Fitzgerald..

Hi. Thanks for taking my questions and congratulations to the new hires and, Brian, on the promotion. So, I’m just going to stay on the vasopressin subject here.

Given that you now have a [indiscernible] party, as you stated, does this trigger any sense of formalized timelines? I know it’s an [indiscernible], but is the agency under any obligation to give you formalized timelines in terms of review for your application? And then maybe secondly still in vasopressin, if I look at the R&D guidance and the inventory figure, it looks like the manufacturing of the product still needs to be done.

So, can you just give us any color in terms of the manufacturing’s lead time for vasopressin and how quickly you could turn that around to supplying the market if you got approval very, very shortly? Thank you..

Thank you, Brandon. We can't really comment more on the timelines. There's nothing more to say other than it's under active review, and we hope it's going to happen shortly. It may or may not, right? It's not that exact.

But we're hopeful with everything that we know and everything we see, and certainly having just received a priority review, we feel good about all of this. But we do have some inventory. We can launch. We're obviously preparing for launch, if we're able to. So, I think our supply chain is in good shape. Our manufacturing is in good shape.

We're taking this opportunity incredibly seriously. We recognize the value it is to our shareholders, to our company, and bringing price down for the patient population. And so, now, we're in good shape and ready to go. And hopefully, we'll get our approval and make a decision. And then, we have the court case right around the corner, four days.

And hopefully, we'll have a good showing there that we expect to..

Okay..

Did I answer everything sufficiently for you?.

You did..

If we had more color on timeline, we would tell everybody, right?.

Yes. You’re right..

All we could do is give you the most up-to-date thinking that we have in a world that’s not certain. .

No. Exactly. And look, onto the topic in terms of pricing what you can, but I appreciate that. Maybe one last one just sort of very, very high level, yeah? You talked about the shift repurchases you've done. You talked about how you sort of reaching an inflection point, you mentioned a lot of cash flow and timing.

I mean if the public markets continue to not recognize that going forward, you obviously see a lot of value in the share, would you ever looked at taking the company private or any sort of strategic alternatives if your value is not recognized in the public markets going forward?.

Yeah. That's also a very good thought process. The way we look at it, we've been buying back. We've been buying back, we've been taking the company private share-by-share over the last few years with the share buyback. We had I think $116 million Brian, authorized buyback and we've reduced that by $25 million.

So, we still have a pretty sizable amount authorized whatever that number is of a sizable amount. We could go do another ASR if the stock doesn't react. There are a number of ways we can buy back the company. Would we take it private? You know maybe. That's probably a little bit more difficult, but I don't think we would rule that out.

Look, I think we're just very, very focused as we have been on building shareholder value and growing the company. And we start to our plan, right? I know it was – we went through a little bit of a painful couple of years by sticking to our organic growth and not making a deal to plug a couple of years of declining earnings.

But we just thought slow and steady was the way to do this. We're thrilled about our balance sheet. We're thrilled about our cash. We're thrilled about the fact that we had the ability to buy back our shares at the prices that we bought it back. And, hopefully, that'll prove to have been, you know, a smart move for us.

And, you know, we're just going to do what we need to do to get the pipeline through, hopefully launch these products successfully, and, you know, see what comes our way. But the good news is we have the ability to do a lot and we have a great team and great partners and, you know, we're looking at anything and everything.

And if anybody has any thoughts, you know, don't hesitate to reach out to us. But, you know, we want to return value to our shareholders and we're focused on that..

And we’ll go next to Gregg Gilbert with Truist. .

Thanks. Good morning, Scott and team, one more vaso question and, I think, it's a different one than you've gotten.

Is a settlement off the table at this point given how far along we are and how complicated the number of filers are and other settlements or would you say that never say never and until a court case actually happens?.

Yeah. Gregg, thanks for the question. Good speaking to you this morning. You know, you never say never about anything in life these days, I think. You know, let's just see what happens all the way around. Let's get the approval.

But, look, I think our responsibility is to optimize the best we can, the value to our shareholders, and repay them for the money that we’ve spent to date and take advantage of the opportunity that we’ve worked so hard at.

And I think that's the wonderful part about our management team is we’ve just, you know, are focused on improving shareholder value and returning as much as we can.

And we will continue to do in every facet of our business what's in everybody's best interest and keep an open mind about all of these things we've spoken about, you know, taking the company private, the transformational deals, small deals, buying back your stock, settling.

Like we did with Lilly on PEMFEXY, right? That turned out to be great for us having a fixed date launch in February of 2022. So, yeah, we're open to everything that will improve the shareholder return. .

That makes sense. I’m, sorry. Go ahead..

Most importantly, I’m sorry, Gregg, just to finish. But most importantly, right, and let’s’ not lose sight of it, most importantly, in a way that maximizes the benefit to the patient population that we strive to serve.

And so, we haven't spoken about it a lot today because it was vaso focus but we're really, really excited about the potential trend and the tremendous value it could bring to this patient population, to metastatic postmenopausal breast cancer patients.

At the end of the day, that's really the reason that we're in business, is to help the patients across this great country. And that's what we're mostly focused on. I'm sorry, I cut you off.

What we’re you going to say, Gregg?.

No problem. My other question was about your use of the word transformational a couple of times. I haven't gone back to the last 50 conference calls to see how many times you've used that word yet. I'll do that later.

But I'm curious if you're more open-minded to transformational change now than in the past? And if so, why? It sounds like you're open-minded about anything that would enhance shareholder value but maybe you could drill down a little more on open-mindedness to transformational now whereas it may not have made sense before. Thanks..

Yeah. Well, let's see. I think it was Tim that brought up the word in the call first a little earlier. If it wasn’t Tim then taking away from someone else that brought up the question I apologize.

But I think, Gregg, you know, what happened here to us, right, you know, and you've been following the company and talking to us for, you know, pretty much the 15 years that we've been in business. We came out of the gates when we went public and, we had a great run from an earnings standpoint and from a stock standpoint.

And then as I said earlier, you know, we decided to do this mostly internal with internal growth, right? And we had that little dip for a couple of years. And it would be – it was harder to do something transformational when you had earnings decline and you are waiting a few years for the pipeline to deliver. It would have been more difficult.

We believed in the pipeline, and it would have been more dilutive to our loyal shareholders. And so now we just find ourselves in a different situation. We have pretty good growth 2020 over 2019, get vaso and these other products out. We have the SymBio behind us.

You know, we're going to go through a large, you know, hopefully significant growth period of time. At the same time, we've moved the rest of the pipeline. It's not just getting vaso to the finish line and SymBio to the finish line and PEMFEXY to the finish line.

Now, we feel we're closer, much closer with fulvestrant and potentially with these new indications of dantrolene, RYANODEX,. We even have a high-end version of RYANODEX now being tested in our nerve agent study. So we're making progress. We have the people in place now, the people we had in the new [indiscernible] people.

And so maybe this is a better time to think about something transformational than it was over the last 24 months. And so, yeah, I think we're – you know, I think you're correct. I think there's – we're more open to things now than we were. .

No further questions at this time. I'll turn it back to Scott Tarriff for any closing remarks. .

Thank you, everyone. This has been a lively great session, a great quarter. Thank you, everybody, for your questions. I thought they were remarkably thoughtful. Look, 2020 is shaping up to be a year of strong earnings growth for us. And we've made a great deal of progress across the board. That's what we're speaking about today.

Vaso and fulvestrant have what I call company-changing potential. Fulvestrant also has the potential to change the paradigm around the treatment of advanced breast cancer and improved patient outcomes.

And we plan to finish out the year strong as we build upon our recent accomplishments and continue to deliver value to our shareholders and lifesaving therapeutics to patients who can benefit. We're just excited. And hopefully, we have some really good strong days ahead of us. So, thank you. Have a great day.

Stay safe, and can't wait to speak to all of you again. Thank you..

And this does conclude today's program. We appreciate your participation, and you may now disconnect..