Categories Earnings Call Transcripts, Health Care

Eagle Pharmaceuticals Inc. (EGRX) Q3 2020 Earnings Call Transcript

EGRX Earnings Call - Final Transcript

Eagle Pharmaceuticals Inc.  (NASDAQ: EGRX) Q3 2020 Earnings Call dated Nov. 02, 2020

Corporate Participants:

Lisa M. Wilson — Investor Relations – In-Site Communications, Inc.

Scott Tarriff — Founder, Chief Executive Officer and Director

Brian Cahill — Chief Financial Officer

David Pernock — President and Chief Operating Officer

Analysts:

Randall Stanicky — RBC Capital Markets — Analyst

Zachary Sachar — Piper Sandler — Analyst

Tim Lugo — William Blair — Analyst

Brandon Folkes — Cantor Fitzgerald — Analyst

Gregg Gilbert — Truist — Analyst

Presentation:

Operator

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. [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.

Lisa M. Wilson — Investor Relations – In-Site Communications, Inc.

Thank you, Reed. Welcome to Eagle Pharmaceuticals’ third quarter earnings call. This is Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. With me on today’s call, are Eagle’s Chief Executive Officer, Scott Tarriff; David Pernock, President and Chief Operating Officer; 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 and the company’s future performance, may be considered forward-looking statements, as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to Eagle Pharmaceuticals’ management as of today, and involve risks and uncertainties, including those noted in this morning’s press release, and our filings with the SEC. Such forward-looking statements are not 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 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.

Scott Tarriff — Founder, Chief Executive Officer and Director

Well, thank you, Lisa, and 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 position 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, 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 upfront, the third quarter was very strong, coming in at a $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 the 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. Doing so, there may be a period 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 for bendamustine, and having received final approval for PEMFEXY, we believe our prospects for earnings growth, not just in 2020, but in ’21, ’22 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 SQUARE METER-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 [Indecipherable] 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 formerly granted priority review by the 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 we 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 stay 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-ml bag and are awaiting approval of the 50-ml, 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 designed 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 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 will also hear from top breast cancer thought leaders. We are really proud of this program and excited about the potential outcomes in this patient population. We look forward to sharing more specifics around the study design, timing, cost and anticipate 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 multi-use vial, 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 of oral SM-88 for third line treatment of patients with metastatic pancreatic cancer is underway, and we understand that Tyme 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 our 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 on non-human 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 RYANODEX indications under development, we have a research partnership with NorthShore University HealthSystem, 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 the unique role of calcium dysregulation 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, improved both memory and cognitive function in a mouse model of Alzheimer’s disease, was published in the Journal of Alzheimer’s disease. We are also starting work in 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 stepback 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 Tyme Technologies and 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, Dr. 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, 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?

Brian Cahill — Chief Financial Officer

Thank you, Scott, and I’m pleased to be with you all today. In the third quarter of 2020, total revenue was $49.9 million compared to $41.1 million in 3Q of 2019. Product sales during the third quarter increased to $17.3 million, compared to $14.7 million in the third quarter of 2019. Increases in sales of BELRAPZO and RYANODEX were partially offset by a decrease in BENDEKA product sales.

BELRAPZO product sales were $8.7 million in the third quarter of 2020 compared to $3.4 million in the third quarter of 2019. Based on IMS data, Eagle’s market share of bendamustine, wholesaler shipments to end users was 8% of the U.S. bendamustine market for the third quarter. As we discussed on our second quarter results call, the COVID-19 pandemic and associated lockdowns have resulted in a decrease in healthcare utilization broadly, and specifically led to a reduction in the utilization of physician administered oncology products. According to IMS data, pull-through of bendamustine products is down approximately 30%, compared to the period prior to the mid-March shutdown. We’ve yet to see a reversal in these trends, but continue to anticipate a normalization, as outbreaks abate. We are encouraged by the American Healthcare system’s innovation, to deliver lifesaving treatments to patients, in the face of the challenges that have stemmed from the COVID-19 pandemic.

Third quarter RYANODEX product sales were $4.2 million compared to $2.6 million in the third quarter of 2019. Orders for RYANODEX are cyclical, driven primarily by product expertise, despite the challenges to our commercial efforts in accessing our current and potential customers, precipitated by the COVID-19 pandemic, 2020 year-to-date RYANODEX sales have already exceeded full year sales of any prior-year period.

For the third quarter of 2020, royalty revenue was $27.6 million compared to $26.5 million in the prior year quarter. Of this, BENDEKA royalties were $27.6 million in the third quarter of 2020 and $26.2 million in the third quarter of 2019. In the third quarter, Eagle earned royalties from Teva at a 30% royalty rate, following our amended license agreement. On October 1, 2020, the rate increased to 31% for 12 months, it will rise again to 32% on October 1, 2021, where it will remain for the life of the product. In the third quarter of 2020, we also earned a $5 million milestone payment from SymBio, based on the approval of TREAKISYM RTD in Japan.

Gross margin was 76% during the third quarter of 2020, as compared to 64% in the third quarter of 2019. The expansion in gross margin in the third quarter of 2020 was driven by number one, an increase in RYANODEX sales; two, lower BENDEKA product sales in the period to our marketing partner, on which Eagle earns no profits. Three, the increase in BENDEKA royalty, and number four, the $5 million milestone payment from SymBio.

On the expense front, R&D expenses were $4.8 million for the third quarter, compared to $10.2 million in the prior year quarter. The decrease primarily resulted from low spending on our vasopressin and RYANODEX EHS programs, as well as lower stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense, during the third quarter was $5.3 million.

We are reiterating our 2020 non-GAAP R&D expense guidance of $40 million to $44 million as compared to $31 million in 2019. The anticipated R&D spend includes the one, the 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 up activities. Four, EA-112 formulation development and additional preclinical work at the University of Pennsylvania and NorthShore University HealthSystem. Five, regulatory advocacy costs for RYANODEX CHS 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 non-cash and non-recurring 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 $24 million or $0.17 per 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 an 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 $14 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 in 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 of outstanding debt. Therefore, as of September 30, 2020, the company had net cash plus receivables of $105 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 2016 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.

Questions and Answers:

Operator

[Operator Instructions]. We’ll go first to Randall Stanicky with RBC Capital great.

Randall Stanicky — RBC Capital Markets — Analyst

Great, thanks. Scott. I have a couple of questions, first on vasopressin, you called out priority review with 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 in 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 2, I just want 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 a last one on R&D, 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.

Scott Tarriff — Founder, Chief Executive Officer and Director

Well, thank you. Randall. Good speaking to you. I took a lot of notes on your question. So if I miss something, chime back in. So 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. And so, what does that mean? 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, the best we can say is that, we believe that that approval is going to come shortly. There is no specific date that I can give everyone. But it is under active review, and we expect that this should happen, what I would call the near term. 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 of launching at risk, as we 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 interest of our shareholders. And so, we have not made a formal final decision yet as a Board, but we are working diligently on coming to a conclusion, and I think there is a pretty good likelihood, that ultimately we will 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 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 ’20 over ’19, launch vasopressin, launch PEMFEXY, and now that we have the SymBio royalty coming in our growth looks wonderful going forward and we have the ability to keep managing the pipeline.

In terms of the management changes, we believe that we are very close to building something very special, right. We have the revenue coming in, we have the earnings coming in, and 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 a long number of years.

We have a great staff. 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 with the growth stage that we’re currently in, and about the people and the products in the pipeline that we have, to really go through some really great years again here.

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

Brian Cahill — Chief Financial Officer

Sure. Yeah, I mean you our guidance Randall, and you’re right, we do have a lot of activity and a lot of programs that I mentioned in the fourth quarter. In particular, launch preparedness for vaso, right? Remember, that’s not approved yet. So there’s a good amount of expense there and the programs for E-111 and other RYANODEX indications.

Scott Tarriff — Founder, Chief Executive Officer and Director

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

Randall Stanicky — RBC Capital Markets — Analyst

Yeah, no, that was helpful. I guess the only other thing Scott would be, as you think about BD, we ask 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’re thinking about business development and how productive you want to be there any differently today versus prior quarters?

Scott Tarriff — Founder, Chief Executive Officer and Director

Well, I believe, Randall. It’s a very thoughtful question, and then it takes, I think thoughtful response. We do want to get the company bigger and we want to be smart about it. If you look at the DD that we’ve done thus far, the pancreatic cancer program that we have with Tyme, could wind up being very special. There is 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 Tyme, if you look at the company now, we’ve really derisked, assuming vaso gets to the market, between vaso, PEMFEXY and the SymBio royalties coming out, with 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 to balance of clinical work and already marketed products, and we’re working hard. But we don’t feel a lot of pressure, 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.

Randall Stanicky — RBC Capital Markets — Analyst

Got it. Thanks Scott. Thank you.

Operator

We have David Amsellem with Piper Sandler.

Zachary Sachar — Piper Sandler — Analyst

Hi, this is Zach on for David. Thank you guys for taking my question today. Sorry if I missed this, but one question regarding VASOSTRICT. Congrats on priority review, but — so my question is, when you submitted the additional data to the FDA in August, what was the FDA really looking for there, given your confidence? And where are some of the issues that you think could surface as they do review the filing now? Thank you.

Scott Tarriff — Founder, Chief Executive Officer and Director

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. 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 the very old molecule, and first to file on having active research program going on, we’ve been asked update, I think the nature of the product and do work around the polypeptide side of things.

And we’ve done great work, it has made us far more knowledgeable, and that was the basis of the majority of the of the questions. And so we believe that we fully answered their questions. I mean, you never know until you know. We feel confident — quite confident and I would 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 first to file. They’ve given us a priority status. So we know that they are looking at it diligently, and all we can say at this point is what we’ve been saying, is that we’re hopeful that we’ll get an approval here shortly.

Zachary Sachar — Piper Sandler — Analyst

Okay, great. And if I could slip in one follow-up on BD. Do you envision filing other ANDAs in the future, along the lines of VASOSTRICT your DE plans sticking more with the 505(b)(2) strategy?

Scott Tarriff — Founder, Chief Executive Officer and Director

I think the way to respond to you is that, in our strategic plan, we are — a 505(b)(2) 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 will 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 vial waiver, 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 — 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 are 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 all 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.

Zachary Sachar — Piper Sandler — Analyst

Okay, great. Thank you.

Scott Tarriff — Founder, Chief Executive Officer and Director

Thank you.

Operator

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

Tim Lugo — William Blair — Analyst

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?

Scott Tarriff — Founder, Chief Executive Officer and Director

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 11th trial date a few days ago. So we need to regroup and talk about it. However, we are 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, January 11 is right around the corner. We’re going to find a way to bring value to shareholders, as quickly as we can.

Tim Lugo — William Blair — Analyst

Okay, understood. And for the bendamustine products, you mentioned that kind of volumes haven’t kind of normalized to pre-pandemic levels. Do you think that we could see some sort of normalization in Q4, as it seems like oncology infusions are still kind of a focus and recovering across the industry, though? Obviously the pandemic concerns are heightening?

Scott Tarriff — Founder, Chief Executive Officer and Director

Yeah. Oh Tim. That’s, you know — let me have David respond to some of that for you. He keeps close track of it. 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?

David Pernock — President and Chief Operating Officer

Yeah sure. Thanks Scott. Hi Tim, how are you? Basically, we’re starting to see some normalization, as you know, right as things in some parts of country are improving. You never know. It seems like we’re starting to enter into the second wave again too, so it’s kind of hard to protect. So some of these things are out of our control. But so far we think we are seeing some stabilization and more return to more normal business, which is good for the patients and so we think that’s what most likely will kind of continue.

Tim Lugo — William Blair — Analyst

Okay, understood. And maybe just one last vaso question, 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 shapens duration of that curve? And then what do you do with that cash? I mean you mentioned BD, but you’re going to have a major step-up in cash, if the launch goes kind of as a — as it would be expected. Would you look at kind of larger BD and more transformative deals, or this — would it be kind of smaller time like deals as well as some buyback?

Scott Tarriff — Founder, Chief Executive Officer and Director

Well Tim, that is very — we are going through our strategic planning process now, because there are so many opportunities ahead of us, right. It’s exciting to be going back into this growth curve, and being so close with our — 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 has been a heck of a difficult product to get approved, with what has been required for an ANDA. As 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 wise. 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 Endo 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 or 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? Well 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 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 — what appears to be, a really good earnings period, assuming that vasopressin gets to the market.

Who knows, if the stock doesn’t react, we will be buying back more of our stock, because we believe in ourselves. If there is 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 — I view us as being an opportunistic company.

I view us as having the ability to do what 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 has been doing such a phenomenal job. And now with the new hires that we have to really add to this, the sky is the limit for us if we could execute it. It starts with the vasopressin approval, hopefully that will happen. It will build on the earnings growth that we’ve had, that we quietly snuck up on everybody and had growth in 2020. And so I think our opportunities are limitless. Let’s just put our heads down and get it done and hopefully good things will happen to us.

Tim Lugo — William Blair — Analyst

Understood. Thank you.

Scott Tarriff — Founder, Chief Executive Officer and Director

Thank you, Tim.

Operator

[Operator Instructions]. We’ll go next to Brandon Folkes with Cantor Fitzgerald.

Brandon Folkes — Cantor Fitzgerald — Analyst

Hi, thanks for taking my questions. Congratulations to the new hires, and Brian, on the promotion. So I am just concerned of the vasopressin subject here. Given that you now have a [Indecipherable] party review status, does this trigger any sense of formalized timelines on it’s ANDA. But just how far — yeah does the agency and any obligation give you formalized timelines in terms of review for your application? And then maybe secondly, still on 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 lead time for vasopressin, how quickly you could turn that around to supplying market, if you got approval very-very shortly. Thank you.

Scott Tarriff — Founder, Chief Executive Officer and Director

Thank you, Brandon. We can’t really comment more to 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. We are hopeful to everything that we know and everything we see, and certainly having just received the priority review, we feel good about all of this. We do have some inventory we can launch. We are 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, we are in good shape and ready to go and hopefully we’ll get an approval make a decision. And then we have the court case right around the corner, four days and hopefully we’ll have a — the good showing there that we expect to, Did I answer everything sufficiently for you?

Brandon Folkes — Cantor Fitzgerald — Analyst

You did. Probably just want more color on timeline, but you can’t give more, I know that.

David Pernock — President and Chief Operating Officer

If we had more on time, we would tell everybody, right. All we could do, is we had the most up to date thinking that we have in a world, that’s not certain.

Brandon Folkes — Cantor Fitzgerald — Analyst

Yeah, exactly. And look, you answered it specifically in terms of I think what you can propose. I appreciate that. Maybe one last one, just sort of a very, very high level. You talk about the share repurchases you’ve done. You talk about how you sort of reached an inflection point and you mentioned a lot of cash flow coming. I mean, if the public markets continue to not recognize that going forward, you obviously see a lot of value initially. Would you ever look at taking the company private or any sort of strategic alternatives, if your value is not recognized in the public markets going forward?

Scott Tarriff — Founder, Chief Executive Officer and Director

Yeah. That’s also a very good thought process. The way we look at it, 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 $160 million, Brian, authorized buyback and we’ve reduced that by $25 million now, so we still have a pretty sizable amount authorized, whatever that number is, a sizable amount. We could go to 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? 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 stuck to our plan, right. I know it was — we went through a little bit of a painful couple of years by sticking to 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 will prove to have been, you know, a smart move for us and we’re just going to do what we need to do, to get the pipeline through, hopefully launch these products successfully and 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 we’re looking at anything, and everything, and if anybody has any thoughts don’t hesitate to reach out to us. But we want to return value to our shareholders and we’re focused on that.

Brandon Folkes — Cantor Fitzgerald — Analyst

All right. Thank you very much.

Scott Tarriff — Founder, Chief Executive Officer and Director

Thank you.

Operator

We will go next to Gregg Gilbert with Truist.

Gregg Gilbert — Truist — Analyst

Thanks. Good morning Scott and team. One more vaso question, 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 until a court case actually happens?

Scott Tarriff — Founder, Chief Executive Officer and Director

Yeah, you know, Greg, thanks for the question. Good speaking to you this morning. You never say never about anything in in life these days, I think. 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 spent to-date and take advantage of the opportunity that we worked so hard at.

And I think that’s the wonderful part about our management team is we just 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 these things we’ve spoken about. Taking the company private, 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 ’22. So yeah, we are open to everything, that will improve the shareholder return.

Most importantly — I am 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 focused, but we’re really, really excited about the potential fulvestrant 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 patients across this great country. And that’s what we’re mostly focused on. I’m sorry, I cut you off, what where you going to say?

Gregg Gilbert — Truist — Analyst

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 have 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 are 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.

Scott Tarriff — Founder, Chief Executive Officer and Director

Yeah. Well, let’s see. I think it was. Tim that brought up the word in the call first earlier [Speech Overlap]. If it wasn’t Tim, and I’m taking away from someone else who brought up the question, I apologize. But yeah, I think Gregg, you know what happened here to us, right and you’ve been following the company and talking to us, we’re pretty much — the 15 years that we’ve been in business.

We came out of the gates when we went public and you know we had a great run from an earnings standpoint and from a stock standpoint. And then as I said earlier, we decided to do this, mostly 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 were 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 different situation. We have pretty good growth ’20 over ’19, get vaso and these other products out. We have the SymBio behind us. We’re going to go through a large, 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 an IM 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 and the new people. And so maybe this is a better time to think about something transformational, that it was over the last 24 months. And so, yeah, I think we are — I think you’re correct. I think there is — we’re more open to things now than we were.

Gregg Gilbert — Truist — Analyst

Thanks a lot.

Scott Tarriff — Founder, Chief Executive Officer and Director

Thank you, Gregg.

Operator

With no further questions at this time, I will turn it back to Scott Tarriff for any closing remarks.

Scott Tarriff — Founder, Chief Executive Officer and Director

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.

Operator

[Operator Closing Remarks].

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