Good morning, and welcome to today's program. My name is Keith, and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmaceuticals' Second Quarter 2020 Earnings Results Conference Call. 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, August 10, 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, Keith. Welcome to Eagle Pharmaceuticals second 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; and Chief Financial Officer, Pete Meyers.

This morning, the company issued a press release detailing financial results for the three months ended June 30, 2020. This press release and a webcast of this call can be accessed through the Investors section of the Eagle Web site 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 Web site at eagleus.com. For the benefit of those who maybe listening to the replay or archived webcast, this call was held and recorded on August 10, 2020.

Since then, Eagle may have made announcements related to the topics discussed. So, please reference to 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, and good morning everyone. We had an excellent first-half when it comes to our earnings with a strong first quarter, and we have followed up now with a strong second quarter, generating EBITDA of $10.8 and $0.50 in diluted non-GAAP earnings per share.

Our sales force has done a tremendous job, and we are proud of the fact that while chemotherapy visits are down double digits and we still don't have full access to our customers due to COVID, which we expect to return in the second-half, we have maintained strong earnings.

Keep in mind we don't have products in our portfolio that have been benefited by COVID. In fact, we have also had destocking headwinds for BELRAPZO in the first-half that we expect will reverse going forward.

We have a healthy balance sheet to enable continued investment in our pipeline programs, and have added to our clinical team to further support our goals in the quarter. A panel of the DC circuit affirmed the lower court's ruling in our orphan drug exclusivity case, and we prevailed in our district patent litigation against four BENDEKA ANDA filings.

We have got great news on PEMFEXY, which includes the final approval from FDA since our settlement last year, and the recent approval for a multi-dose vial.

We also received the unique J-code, and given our initial period of exclusivity in 2022, this represents a significant opportunity for Eagle with a longer lifecycle than originally anticipated, and last week, our strategic collaboration partner Tyme Technologies announced that FDA granted orphan drug designation for its lead product candidate, SM-88, the treatment for patients with pancreatic cancer.

Now, looking ahead, we have a lot of important work to do in the second-half of the year along with several important opportunities. We are expecting to get another approval bendamustine with our licensing partner SymBio late this year, and we see long-term value from that income stream.

In a few minutes, I will share our plans to get vasopressin to the market as soon as we can. We are also making progress with FDA around the nerve agent indication for RYANODEX, and we still remain very excited about fulvestrant. Now, let me share the specifics on these programs and walk you through our plans for the balance of the year and into 2021.

I'll start with our oncology opportunities. Regarding our fulvestrant product candidate EA-114, which targets estrogen receptor positive advanced breast cancer, our work here could represent the cornerstone of our oncology franchise, and potentially our most significant pipeline opportunity.

More importantly, our product could substantially improve the clinical outcomes for these postmenopausal metastatic breast cancer patients. In our pilot study in healthy postmenopausal women, we previously met our initial internal objectives, and in fact just recently, received additional data from this study, that is also very encouraging.

Our next steps are to meet with the agency to finalize our clinical plans and get the product to the market as efficiently as we can. After the FDA meeting, we will finally provide more details about Eagle's concept in treating these women, and why we believe that represents a significant benefit in the market.

Let me also briefly talk about SymBio and Tyme.

SymBio, our Japanese licensing partner expects to receive approval of its ready-to-dilute liquid bendamustine product, which triggers a $5 million milestone payment, followed by the potential of $10 million to $25 million in annual royalties from SymBio for first launching the 500 ml pack and then the 50 ml pack.

This represents a meaningful income source for us going forward. We are also encouraged by what we are seeing in Tyme study of SM-88, a late-stage novel investigational agent for pancreatic cancer, and look forward to updating you as we learn more.

Ultimately, our oncology franchise did not only include fulvestrant, but BENDEKA, and BELRAPZO, and PEMFEXY that we will launch in '22 under license from Eli Lilly, and SM-88 for pancreatic cancer under the license from Tyme Technology.

Now, let me turn to our critical care franchise, starting with vasopressin, which we feel very positive about, and anticipate approval in a reasonable timeframe. As we have stated over the past two years, the development of vasopressin is complex. Vasopressin is a complex API, and being first to file required us to perform significant work.

In fact, by the end of this year, we would have invested $25 million in legal and R&D expense on the development of this product. Vasopressin is an older polypeptide product originally approved based on published clinical experience and chemistry data.

The field of polypeptides is rapidly evolving, and FDA is incorporating new scientific standards, which will also apply to other vasopressin ANDA filers, not just the Eagle. Much of the work that we've been doing is new to the molecule.

Obviously, this is not a first cycle review approval, and FDA has recently asked us a few specific questions, all of which we anticipated, but one. Fortunately, our science as it relates to this project is deep, and we hope to respond in totality to the questions raised by FDA next month.

We are working with the agency on the new polypeptide standards, and while those conversations do not allow us to accurately forecast the timing of the approval at this time, all outstanding questions may very well be cleared up by the end of next month, as our testing is completed.

Additionally, based on the nature of these comments from FDA, and historical precedent, we do not believe that we are in danger of losing our exclusivity. This is obviously not certain, but we do have a good level of confidence here. Next, I'd like to address our launch time. COVID is unfortunate on so many levels.

Our trial date, which was originally scheduled for May of 2020 was postponed, and we do not have a new date yet. Nevertheless, it is important to point out that our 30 months day ends in October of this year. By law and assuming we have our approval in hand, we could launch our product without a court decision. We are evaluating this opportunity now.

The decision will be made based on our view of both non-infringement and invalidity of the patents, both of which, we believe we are in strong position. Based on all of this, we have confidence in the approval, and confidence in the ultimate trial.

That said, we believe our launch time has potentially shifted from this year, and may move into early '21. The timing should be updated next month. We continue to anticipate when the launch does occur we will maintain our 180 days of exclusivity. Also, I'll remind you that the sales of VASOSTRICT are expected to reach about $700 million this year.

Now, let me turn to our RYANODEX franchise. As noted in our press release this morning, on Friday evening, we were notified by FDA the complete response letter for RYANODEX for exertional heat stroke. We have determined that we will no longer pursue this indication.

On our last earnings call, we indicated that for the last nine months of this year we would have aggregate revenue of RYANODEX greater than all of 2019 even with the absence of the exertional heat stroke indication. This remains our expectation. Importantly, we have a number of other potential exciting indications for RYANODEX.

Regarding RYANODEX for the treatment of brain damage secondary to nerve agent exposure [technical difficulty] finalize a Special Protocol Assessment, or SPA, which will be submitted this month. The review period is 45 days, in which, time we hope to have a mutually-agreed upon protocol.

If we do, we will then start the study and plan to file a new drug application in the first-half.

We also continue to make progress on developing new indications and new formulations for RYANODEX, including acute grant radiation syndrome, and we share the results of our study with NorthShore University HealthSystem before year-end for traumatic brain injury.

In collaboration with the University of Pennsylvania for the treatment of Alzheimer's disease, which we refer to as EA-112, and we're developing an intranasal formulation, and we're also working on EA-111, an intramuscular formulation by RYANODEX. As you can see, there is a lot of good work going on.

All of these can contribute to the accelerating diversification and earnings power of the company in the next several years. We are making steady progress across the board, and all are supported by Eagle's strong fundamentals.

We are focused on the Vasopressin launch, followed by the PEMFEXY launch, all while moving fulvestrant and RYANODEX indications of lung, which will provide significant growth for the company even without the exertional heat stroke approval. Let me pause here for a moment to thank Dr. Adrian Hepner, who is on the call with us today.

As you know, Adrian is leaving the company and he has done the just a great job for Eagle his last year was about a week ago, but he will continue to consult with us for an extended period of time. And with that, I'll turn the call over to Pete to discuss our second quarter financials.

Pete?.

Thank you, Scott. In the second quarter of 2020, total revenue was $41.9 million, compared to $56.7 million in Q2 2019.

Product sales during the second quarter decreased to $14.4 million, compared to $29.4 million in Q2 2019, primarily due to a decrease of $11.3 million in product sales of BELRAPZO, the decrease of $6.2 million in product sales of BENDEKA. These decreased sales were partially offset by an increase in RYANODEX's sales of $1.8 million to $4.7 million.

BELRAPZO product sales were $4.1 million in the second quarter, compared to $15.4 million in Q2 2019. As a reminder, second quarter 2019 BELRAPZO revenue reflected wholesaler stocking occasion by the June 2019 cutover to the branded name. Based on IMS data, Eagle's market share of bendamustine wholesaler shipments to end users was 5% of the U.S.

bendamustine market for the second quarter. As we discussed in our Q1 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 utilization of physician-administered oncology products.

According to IMS data poll through, bendamustine products is down approximately 10% compared to the period prior to mid-March. Additionally, several wholesalers have reduced inventory levels during this period. As we've discussed in the past, Eagle books revenue and ex-factory sales to wholesales.

We have yet to see a reversal in these trends, but continue to anticipate a normalization of both usage and wholesale inventory levels as outbreaks abate.

We are encouraged by positive trends in the healthcare delivery broadly, and we believe that the American healthcare system is well-positioned today to provide patients with safe access to these life-saving treatments. Second quarter RYANODEX product sales were $4.7 million, compared to $2.9 million in Q2 2019.

Orders for RYANODEX are cyclical driven primarily by product expert. Despite the challenges to our commercial efforts and accessing our current and potential customers precipitated by the COVID-19 pandemic, particularly in the second quarter, we continue to expect record sales for the product for the full-year.

In the second quarter, RYANODEX had a 30% market share of normalized dantrolene injection units. Q2 2020 royalty revenue was $27.6 million compared to $27.3 million in the prior year quarter. BENDEKA royalty were [technical difficulty] compared to $26.5 million in the second quarter of [technical difficulty].

Eagle continues to receive royalties from Teva at a 30% royalty rate following our amended license agreement. On October 1, 2020, the rate will increase to 31% for 12 months, and then, rise again to 32% on October 1, 2021 where it will remain for the life of the product.

Gross margin was 69% during the second quarter of 2020 as compared to 62% in the second quarter of 2019. Expansion in gross margin of second quarter 2020 was by driven by an increase in RYANODEX sales, lower BENDEKA product sales in the period to a marketing partner on which Eagle earns no profit, and the increase in BENDEKA royalty revenue.

On the expense run, R&D expenses were $7.1 million for the second quarter, compared to $9 million in the prior quarter. The decrease primarily resulted from lower spending on vasopressin partly offset by an increase in fulvestrant expense.

Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the second quarter was $6 million. As a result of COVID-related delays, we are lowering our 2020 R&D non-GAAP expense guidance to $40 million to $44 million, as compared to $31 million in 2019.

The anticipated 2020 R&D spend includes, number one, EA-114 pilot trial and CMC initiatives; two, the RYANODEX trials for the treatment of nerve agent exposure and acute radiation syndrome; number three, EA-111 IND-enabling toxicology studies and CMC scale up activities; number four, EA-112 formulation development and additional pre-clinical work at the University of Pennsylvania and NorthShore University HealthSystem; number five, regulatory advocacy for RYANODEX EHS; number six, launch preparedness for vasopressin and PEMFEXY.

SG&A expense for the second quarter of 2020 increased to $18 million compared to $17.2 million in the second quarter of 2019. Increases in stock compensation expense were partially offset by decreases in T&E tradeshow cost and external legal expenses.

Excluding stock-based compensations, another non-cash, and non-recurring items, second quarter 2020 SG&A expense was $12.2 million. We are reiterating our 2020 guidance that SG&A expense on a non-GAAP basis will 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 spent. Net loss for the second quarter was $256 million or $0.02 per basic and diluted share compared to net income of $6.7 million or $0.49 per basic and $0.48 per diluted share in the prior year period.

Adjusted non-GAAP net income for the second quarter of 2020 was $8 million or $0.59 per basic and $0.57 per diluted share compared to adjusted non-GAAP net income of $11.8 million or $0.86 per basic and a $0.84 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 EBITDA for the second quarter of 2020 was $10.8 million compared to $15.5 million in the prior year quarter.

First-half 2020 EBITDA was $25 million compared to $34.3 million in the first-half of 2019. First-half 2020 cash flow from operations including shift to receivables was $22.9 million compared to $42.4 million in the first-half of 2019. For the 12 months ended June 30 2020, EBITDA was $40.7 million.

As of June 30 2020, the company had $108.2 million in cash and cash equivalents and $46.8 million in net accounts receivable, $35.7 million of which was due from Teva. The company had $37 million in outstanding debt. Therefore, as of June 30 2020, the company had net cash plus receivables of $118 million.

In the second quarter of 2020, we purchased $4 million of Eagle's common stock as part of our $160 million share repurchase program. From August 2016 through June 30 2020, we have repurchased $176.9 million of our common stock. With that, I'll ask the Operator to open up the call for questions..

[Operator Instructions] We will go to Randall Stanicky with RBC Capital Markets. Please go ahead..

Great. Thanks, Scott.

Can you go into more detail on the complete response letter, what it was based on with respect to RYANODEX for exertional heat stroke? I'm just trying to understand if there's any read-through or not to any other indications, and then, does that add at all to your urgency in thinking about business development? That's the first question.

And then, the second question, can you just talk about what you're planning to propose to FDA for fulvestrant in terms of study design, or at least, if you're not able to do that, what would the anticipated timeline around clinical work look like based on what you think would make the most sense? Thanks..

Thank you, Randall. So look, on EHS, for the remaining indications that we have, I don't believe that there's a read-through as it impacts these other indications that are in other divisions, and used for different indications.

The EHS, if I can sum up [technical difficulty] the best I can, there's just not enough evidence to approve the indication probably due to the fact that we've still not been able to test in enough patients, right? I think a lot of it comes down to sample size, and if we had been able to run a well-controlled, double-blinded study with large numbers of patients, it may have worked out differently.

I think that's what it comes down to unfortunately. As far as fulvestrant goes, so look, what can I say -- look, to be clear, we do believe we have a product which may improve outcomes. We've now dosed over 350 women at this point, and we just received some more data over this past weekend.

So, now we're going to go to FDA, plan to finalize the clinical programs that you're asking about the timing.

So, once we have better understanding about what we need to do, and we have full agreement with the agency, we'll come back to everybody with the details, the real details of the opportunity, and the next steps and the timing, but our intention is that our next study, which may or may not be the registration study, we're working through that now should start this year, and so, we're moving very aggressively to get that going.

I don't think we can give you the exact timing yet, Randall. We'd like to wait till we get back from this meeting with the FDA. We really know what's going on and have the details before we speculate. We have had some dialog with them on the topic.

So, we feel that we have a reasonable sense of how we need to progress, but let's go have that meeting, come back, and really dig into the opportunity..

That sounds good. On EHS, what changed though? Presumably you had meetings with FDA, you showed them the study work to the number of patients, they said, "Go ahead, submit," and then we got the CRO.

So, I mean can you give us any more detail on what happened, and then just on the part of business development, does that increased business development relative to share repurchases?.

Yes. So look, I don't really know if I have more insight on the complete response, Randall. It's been going on for four years, I think, and I don't think there's a heck a lot more than I can say is that unfortunately we just weren't able to get the patients and the type of study that was required.

I think that's really what it comes down to, even going back to the [indiscernible] this last time, we're excited, but with still 10 patients, and as it relates to business development, our view of it, as you can see today we're very bullish on our vasopressin situation.

So, if we launch vasopressin and then go into PEMFEXY, that's a significant increase in the earnings power and will probably last for several years, and so, we're excited about rolling into those two approvals reasonably soon, and then the SymBio, we overlooked that sometimes, but that's all royalty income coming in.

So, that's a quite a lot of profit coming into the company, and that starts in a few months.

And then, as you look at those which seems to have a little bit more certitude behind them, vasopressin, SymBio, and PEMFEXY, and all that time we're now working aggressively on fulvestrant and nerve agents, and have data reads coming down on traumatic brain injury, starting our study this year now on nerve agents, and let's see what happens with the pancreatic cancer product from SM-88, that deal that we did recently, that data comes out next year.

That's what we think is a really wonderful pipeline that drives really very nice earnings for many years to come, but look, that's the great thing about having the balance sheet and the cash that we have in earning the money that we have, we still have the capability of doing more by bringing more products and so we're looking pretty aggressively.

I know we keep saying that, but I guess absence of the Tyme deal, we haven't done a lot of, not for lack of trying but we just haven't found the perfect opportunity. Maybe it doesn't have to be perfect. Maybe it needs to be very good, but we just don't feel pressure.

Even with the EHS situation, we just think the pipeline is so strong that we're very selective, and so, we keep looking, and hopefully we'll make the company bigger, we want to get it bigger and more profitable quickly, and we think we're doing that, we think we're well on the way..

Great. Thanks, Scott..

Thank you..

We'll take our next question from Tim Lugo with William Blair. Please go ahead..

Hey, guys, this is [indiscernible] on for Tim. Thanks for taking the questions. I was just wondering if you could share a little more detail, give us a little more color on the vasopressin questions and testing going on.

It sounds like you were mentioning more testing, but do you still expect to see possible that they would approve it within sort of a month of getting that data.

So what kind of data are they often having? And second related to that, you said the launch maybe push back to 2021 at this point, so is that sort of turned by the approval timing or the legal situation?.

Yes, really very good question.

Let me make sure I cover everything if I don't remind me at the end of the statements, I'll make, but to be to be clear, we expect to respond to the questions in totality by the end of next month, and then there's a review time, and we're not sure what that review time is going to be and how long it's going to take them to respond, and that's why we indicated that it's potentially moved from this year or two early next year, but as I said in my comments, in my prepared comments, we're very confident in getting this product approved.

The question of timing is a little bit up in the air and the testing that they've asked us to do, as I tried to stay in my prepared comments is that there's a lot of work being done on these polypeptides and they've asked us to do a lot of work around again, what's in old molecule and this first to file, I guess that's our obligation, and everybody else behind this is going to have to do this work as well, which for us is actually encouraging because we were willing to spend $25 million to get this product to market, and I think that spend and all the time that we've taken is going to pay-off, and so, though I can't speak exactly to the testing that we've needed to do, but we've done quite a bit of testing on the molecule, quite a bit of testing on our product for the last two years that we've been at the FDA, we're wrapping that up now.

I think we've had our final conversations with the FDA about what we need to do for the most part, we're doing it, it's almost complete, we'll send it back to them, and we'll wait to get the approval and figure out how to get to market..

Okay, great. Thanks to clarify like, I guess one other quick question.

Just the fulvestrant meeting with the FDA, has that been scheduled?.

It has not been scheduled yet. We're doing that now. We just received some additional data in fact over the weekend.

Yesterday, we were reviewing the data quite a bit and add to our encouragement and now I think we have a really very nice package, a very detailed nice opportunity to send to FDA meet with them and plan accordingly, and hopefully this next study will start soon, very soon and we can get going, and then, it will be exciting for us to be able to have a call, or communicate with everyone, more strategically and more detailed about what the plans are and why our project seems to be so compelling to these women and that'll be an exciting day for all of us I think to sit talk about how we may be able to treat these women, hopefully better than they're being treated today..

Thank you. It makes sense. Thanks..

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

Thanks. So just a couple of quick ones, so I know on Vasostrict you talked about it being approvable and as yourselves you are really good or bad you know, your chances, I guess my question here is what has changed here and can you speak more granularity than the challenges associated with getting that approved, that's number one.

And then, number two, can you provide more specifics on your BD priorities? I know you talked about it earlier on the call, but maybe give us a sense of how you're thinking about it and also with that in mind also looking you are looking at [indiscernible]. Thanks..

Hi, David. Thank you very much. Okay, I took notes from your questions. Hopefully, I'll address all of them, and if I don't, just chime back in. So, first on to vasopressin, I don't think anything's changed, right? As I tried to point out, it's just a very complex product to get approved. There's a lot of work that needs to be done.

You know, from our perspective the type of company we are, the approval of vasopressin looks and feels a lot more like an NDA 505(b)(2), than it does in ANDA, and clearly as I mentioned, we're not in a first cycle, we've been in the, you know, we've been at FDA over two years now, and we continue to feel questions and do additional testing and all of that is worked out great for us.

We have a lot of confidence in our product in our formulation, we have a lot of confidence in getting it approved, we were just asked a handful of additional questions, some of which required us to do some additional testing that testing will be completed here very shortly, and we will respond to this last handful of questions next month, and then, we wait for that other approval coming out of the FDA, but we do feel confident that after a couple of years and all the money that we've spent and all the testing that we've done that we have a really good handle on it.

There is nothing in there that we weren't able to do or our product as far as we know, couldn't hold up to, and we're just wrapping it up and we'll get the approval here. So that's where we are, we're confident and I don't think anything's really changed, other than the normal know the normal work that goes on.

In terms of ED, we're open minded, David, as I said, and I keep stressing we want to get the product the company to be bigger and more profitable and more diversified. I will say when we talk about it inside the company, we look at it.

The company has clinical risk at this stage of our lives as opposed to commercial risk, right, because we're working through the FDA on vasopressin, on nerve agents to unfold the strength. SM-88, you know, Tyme is doing that. We do have a clear path on PEMFEXY because we have final approval, just had final approval another product presentation.

We're under license, so we know that's going to launch. Vasopressin, as I said, we feel rather confident in SymBio getting their approval, the best that we can tell in Japan that seems to be moving along rather well. I think at the end of the day, rather than take on more clinical risk.

I think we moved to commercial risk and take on products that are about to get approved or products that are already on the market. I think that would serve us well to mix up the type of risk we have in the company as we're moving forward and growing the company and getting bigger. I believe that's the best way to look at it..

Okay. Thanks..

Thanks, David..

[Operator Instructions] We'll go next to Brandon Folkes with Cantor Fitzgerald. Please go ahead..

Hi, thanks for taking my question. Apologies if some of these have been on answered, I am jumping between a few calls. Firstly, I just want to follow on this vasopressin theme here. Once you resubmit the data to the FDA, is it actually going to be a formalized review period again, it will work with that review period be.

Secondly, maybe just any color you can provide into what you're seeing in BELRAPZO usage in the clinic in July, and then last, any update on the RYANODEX COVID program? Thank you..

Yes, so that was, you know, let me take these in orders you had, last you had COVID, you had BELRAPZO and the first question related to the timing of Vaso, and so, the date for Vaso and how long it will take the FDA to approve is unclear at this point, and so, we think it's going to happen sooner than later.

I don't think I can give you a lot more information about it. So we may be able to update that for you next month.

So, the plan is to get this data in half conversations with FDA, and I think we'll be able to pinpoint a little bit better when that product will be ultimately approved, and as I said, maybe we can give some thought to it, our articulation of it is, potentially we won't launch this year, and it looks like it's going likely into early next year, and hopefully we're right about that, and we'll be able to update you again in September.

As far as COVID, we have stopped working on that project. I think we mentioned that before.

We just feel that there is just too much going on in the company right now as we move through everything else, and to pick up more work that we need to do to ready ourselves to go into the clinic, I think we'd rather push that off to the side and concentrate on all the things we've been speaking about today, and as it relates to BELRAPZO, so what we're seeing maybe I can turn that over to you, Pete and then, maybe David as well, who can bring more color to the BELRAPZO situation..

Hi, Brandon, thanks for the question. This is Pete, as far as BELRAPZO there were three issues really. One was a tough year over year comparison as you know, the second quarter 2019 was the high watermark of the score for BELRAPZO revenue due in large part to some inventory stocking associated with the switchover to the brand name in that quarter.

Number two, we had in the second quarter of 2020, one of our wholesalers appears to have brought down their ending June inventory terms of weeks on hand to a level that was unusually low; and number three, pull through in the market.

As you can see from the IMS data I'm sure you track, if one were to look at the period from middle of March, which is the same general matter the timing of the commencement of lockdown.

From middle of March till now, if one were to look at that period relative to the equivalent number of weeks prior to Middle-March, the bendamustine pulled through is down about 10% maybe 11%, and so all of those three factors conspired to impact or second quarter 2020 BELRAPZO revenue, and we're hopeful that the latter two will normalize here is as we move through the third quarter..

Yes, yes, and Pete just this is David just add on to that. Basically as you know, chemotherapy visits dropped quite a bit, right. So basically across in many oncology products such as for bendamustine that's for sure, and we're starting to see returns to that, right, we start to see people coming back in on a more regular basis.

There were cases were in the hot areas where basically major institutions like Memorial Sun Catering were essentially closed for chemotherapy business. So, it was not that unusual.

So we kind of expected that is in this quarter, we expect that to rebound as well, and then, there was some downstream impact on as Pete said, some of the wholesalers basically just stocking a few weeks less supply, right, which impact inventory levels, and we hope that that starts to stabilize to that was all due basically not to anything specific to the brand, but just to basically COVID-related issues.

Wholesalers needed to stock other things in their warehouses related to COVID that took up physical space and also just the fact that there was some cash pressure put on the middleman due to COVID, basically they carry less, but those should normalize. So, we are very optimistic about the last six year to year for BELRAPZO..

Right, thank you very much. One follow-up if I may. Sorry, just circling back to vasopressin. How should we think about your manufacturing scale up and ability to scale up pretty quickly after approval to launch the product? Should you launch it at risk or whether you are successful in court? Thank you..

Yes. Thanks, Brand. So, we are very confident in our ability to manufacture and supply. We don't think that's going to be a problem at all. We have a lot of experience with manufacturing product we have been working on for a quite a while. Again, so we have high confidence in our ability to manufacture, meet demand, and get that product to the market..

All right, thank you..

Thank you..

And it does appears we have no further questions, I'll return the floor to Scott Tarriff for any additional or closing remarks..

Thank you. We are really very excited about where we are right now. Balance of 2020 will continue to be very active for Eagle as we build on the momentum of the past several months. We look forward to the near term launches of vasopressin, PEMFEXY, and a royalty coming out of SymBio.

We will continue as brought up in the call recently to seek out synergistic business development opportunities that's important to us. The therapeutics under development have the potential to save and improve patient lives and serve to complement our existing foundation of established products.

While the pandemic has certainly changed landscape in many ways, we at Eagle will continue to focus on serving our shareholders as well as the patients who can benefit from our products. Have a great day everyone. Thanks for taking the time. Really appreciate it, and look forward to speaking everybody again pretty soon. Thanks again. Bye now..

This will conclude today's program. Thanks for your appreciate your participation. You may now disconnect. Have a great day..