Earnings Labs

Jazz Pharmaceuticals plc (JAZZ)

Q1 2020 Earnings Call· Tue, May 5, 2020

$202.85

+0.81%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+2.62%

1 Week

+3.16%

1 Month

+9.27%

vs S&P

-2.31%

Transcript

Operator

Operator

Welcome to the Jazz Pharmaceuticals plc First Quarter 2020 Earnings Conference Call. Following an introduction from the company, we will open the call for questions. I will now turn the call over to Kathy Littrell, Head of Investor Relations at Jazz Pharmaceuticals.

Kathy Littrell

Management

Thank you, Valerie, and thanks to those of you joining our investor call. Today, we reported our first quarter 2020 financial results and updated our financial guidance for 2020. The press release and the slide presentation accompanying this call are available in the Investors section of our Web site. On the call today are Bruce Cozadd, CEO; Dan Swisher, President; Renee Gala, CFO; Rob Iannone, Executive Vice President, R&D. And then joining for our Q&A session will include Mike Miller, Executive Vice President, U.S. Commercial; Phil Jockelson, Sweep and Neuroscience Therapeutic Head; Ann Borgman, Hematology and Oncology Therapeutic Head; Jed Black, Sleep and Neuroscience; and Sean Mendes, Senior Vice President, Strategy and Finance. I'd like to remind you that today's call include forward-looking statement, such as those related to our future financial and operating results and which involve risks and uncertainties that could cause actual events, performance and results to differ materially. We encourage you to review the statements contained in today's press release and our latest SEC disclosure docs, which identify certain factors that may cause the company's actual results to differ materially from those projected. In particular, there is significant uncertainty about the duration and severity of the COVID-19 pandemic and its impact on Jazz's business and operations. The updated guidance reflects management's current expectations of the impact of these factors on our business. We undertake no duty or obligation to update our forward-looking statements. On this call, we discuss non-GAAP financial measures. Reconciliations of GAAP to non-GAAP financial measures discussed on the call are included in today's press release and slide presentation available on our Web site. I'll now turn the call over to Bruce

Bruce Cozadd

Management

Thank you, Kathy. And I am not sure whether you mentioned audio-visual risk factors in your precursor, but we apologize in advance if you hear dogs barking or children playing in the background. Good afternoon, everyone and thank you for joining us. I'll begin by sharing how proud I am of Jazz employees and their commitment to support continued delivery of our essential medicines to patients around the world during this unprecedented time. And we'd like to thank them for their dedication and ingenuity. In the first quarter, we generated total net revenues of $535 million and made significant progress toward our key 2020 objectives. We are actively preparing for the U.S. launches of lurbinectedin and JZP-258, and are excited by the opportunity to bring these two important treatment options to patients later this year. Although, we experienced limited financial impact of COVID-19 in the first quarter, given the global economic slowdown, the increasing unemployment rate and the overall disruption to global health care systems, we have updated our financial guidance, including proactively reducing operating expenses to reflect the potential impact on our business for the remainder of 2020. We are excited about the opportunities ahead for Jazz and remain focused on diversifying our portfolio of essential medicines to provide innovative and life changing options for patients, through both our internal efforts and corporate development transactions. Building off before transactions we entered into last year, we will continue to pursue opportunities that align with our strategy. Our strong balance sheet with cash, investments and undrawn revolver totaling $2.6 billion, position us well to manage through the impact of the pandemic. With the ongoing global impact of COVID-19, we are focused on ensuring the continuity of patient care and our business operations. Our key priorities are; maintaining sufficient supply of our…

Dan Swisher

Management

Thanks, Chris. Hope all of you can hear me. All right. So we saw strong growth in global Defitelio and Vyxeos sales in the first quarter versus the same period in 2019. However, Erwinaze sales in the first quarter were negatively impacted due to an extended and ongoing supply disruption. So starting with Vyxeos, in the first quarter, sales performance was driven by strong performance in Europe. In the U.S., our focus has been on reinforcing our efficacy profile in front line secondary AML, while reaching to new physicians and broadening adoption among community accounts. While we made some progress in this quarter, in the first quarter, this has been challenging due to the impact of COVID-19. Recent recommendations for managing cancer patients are focused on avoiding hospitalization to limit exposure risk, including the use of oral oncolatics and less intensive treatment. This has had a negative impact on Vyxeos demand primarily in the U.S. And until this disruption resolves, we expect challenges to remain. But as we do look to support future growth opportunities for Vyxeos this quarter, we did make progress in launching an expanded distribution footprint by putting in place contracts with group purchasing organizations or GPOs, which will help improve access and community accounts. Additionally, we look forward to the presentation of five year overall survival data from our pivotal 301 study later this month at the virtual ASCO meeting, which will add to the strength of evidence for Vyxeos for the treatment of newly diagnosed secondary AML patients. Now on to Defitelio, we are pleased with the strong global performance in the first quarter compared to same period in 2019. However, the COVID-19 pandemic is having an impact on recent Defitelio use. At present, hospitals have reduced deferred or applied temporary stricter eligibility criteria for…

Rob Iannone

Management

Thank you, Dan. During the first quarter, our R&D priorities were directed toward advancing our key development programs, and making progress and key regulatory submissions. We implemented our continuity plans to mitigate the impact of COVID-19 on our R&D programs. However, we are starting to see some impact to patient enrollment and delays in initiation of new clinical trials. Our priorities remain focused on ensuring the safety of patients enrolled in our clinical trials, while maintaining the integrity of our studies, so that we can advance important treatment options for patients. We are working closely with our investigators and study sites to mitigate delays in initiating and progressing clinical trials. I'll begin with our development activities in Sleep and Neuroscience. Our studying of JZP-258 in idiopathic hypersomnia completed enrollment ahead of schedule in the first quarter. We implemented the use of remote monitoring and are working with our contract research organization to enable enrolled patients to remain in the study. Our goals are to ensure that study investigators continue to monitor patient safety, provide access to study drug and maintain patient continuity. We have implemented mitigation plans to enable us to maintain the integrity of this important Phase III study. Moving to Sunosi. We continue to believe that EDS in major depressive disorder or MDD, is an important unmet medical need and an important market opportunity, given the data generated in patients who had a history of depression in the Phase III narcolepsy and OSA studies. We had an objective to initiate a Phase III study evaluating Sunosi for EDS related to MDD later this year. However, given the challenge to initiating and enrolling studies in the current COVID-19 environment and our privatization activities, we are no longer planning to initiate an indication enabling study. We will continue to investigate…

Renee Gala

Management

Thanks, Rob. First, I'd like to take a moment to share how excited I am to join Jazz during such a catalyst rich time for the company, and be able to contribute to our important mission of providing essential medicines to patients around the world. Turning to the financial update. In the first quarter, our net revenues were $535 million, an increase of 5% from the first quarter last year. This was primarily driven by the double-digit growth of Xyrem, Defitelio, and Vyxeos, which grew 11%, 14% and 13%, respectively. Total Net product sales increased 11% excluding Erwinaze, which was significantly impacted by reduced product availability. Now I'll turn to operating expenses. During the first quarter, our adjusted SG&A expenses increased 27% to $188 million and adjusted R&D expenses increased 46% to $80 million over the same period last year. This was in line with our expectations and reflects our intentional and disciplined investment in key value drivers, including preparing for multiple product launches, diversifying our commercial portfolio and growing our R&D pipeline. On first quarter adjusted net income and EPS included acquired IP R&D expense for the $200 million upfront payment we made to PharmaMar for the exclusive U.S. rights to lurbinectedin. Our adjusted net income for the quarter was $26 million or $0.45 per share compared to $164 million or $2.83 per share for the same period last year. Turning to guidance, we recognize the uncertainty associated with the impact of COVID-19. And we assume that the majority of the negative financial impact on our business related to the pandemic will be in the second quarter with a return to normalized operations later in the year. Our guidance takes into account the impact of multiple factors, including declines in medical visits with fewer patients accessing treatment, reduced sales…

Kathy Littrell

Management

Thanks Renee. To everyone in the very long queue today, we kindly request that you limit yourself to one question during this call so that everyone has an opportunity to ask their question. We will gladly address any additional questions after the call or you can reenter the queue. With that said, operator, please open the line for questions.

Operator

Operator

Thank you [Operator Instructions]. Our first question comes from Brandon Folkes with Cantor Fitzgerald.

Brandon Folkes

Analyst

With regards to JZP-258, I know we’ve asked this a few times but as we get closer. Can you just elaborate on how we should think about the switch playing out? Should be think of 258 initially targeting new patient start and maybe some of the higher risk Xyrem patients? Or should we expect to see a strong push to switch well controlled with Xyrem patients out of the gate? Thank you.

Bruce Cozadd

Management

We've given some indication of where we're going with the 258 launch, but we'll obviously provide more detail as we come up to approval implementation on or REMs and the final launch. But Dan, why don't I hand it over to you to give some color on how we're thinking about the appropriate patients for 268 and how we might go about that?

Dan Swisher

Management

Well, as you guys know, we've been at this for quite some time in terms of looking for new formulation, because we had heard from our existing patients and physicians that this was a real concern of having this level of sodium, albeit at the risk benefit was positive for Xyrem given the severe nature of narcoleptic disease. So we actually see this as the preferred product for all patients. Clearly, there's going to be new patients who may have had concern about the sodium load and were not getting access, but also new patients coming in with good access should be put on to 258, given the efficacy profile was shown to be very comparable in the switch for any conversion study we did in our Phase III. But we also think existing patients, both patients themselves as they become aware of another treatment option that retains efficacy but really gives a long-term safety benefit, as well as physicians. And as we've started to do the research there for lifelong therapy with patients that have significant comorbidities, we see this as the preferred long-term treatment option.

Operator

Operator

Our next question comes from Gary Nachman of BMO Capital Markets. Your line is open.

Gary Nachman

Analyst

Just regarding the impact from COVID-19, patients are already well maintained on Xyrem. Is it easy enough for them to get products from SDS and continue with their treatments? So no major hiccups there. So really more new patients to treatment that are being impacted. I just want to confirm that that's the dynamic that's been playing out so far in the second quarter, and how you see that for the rest of the year?

Bruce Cozadd

Management

Yes, Mike, maybe I can send that one over to you.

Mike Miller

Analyst

The overall pharmacy operations are very good in Q1. Remember that Q1 tends to be the tougher quarter from a payer perspective for all specialty drugs, not just Xyrem. And I think we navigated extremely well. I think earlier, we had stated that we saw PEs in the second half of March slowing down. We do in more recent data have seen an improvement in that trend, and we feel good about our full year guidance for Xyrem.

Bruce Cozadd

Management

Yes, and PEs as patient enrollments, we just saw a break as people were sheltering in place where people were not going into visit their doctors. And so we anticipate some slowdown in new diagnosis and people initiating therapy for the first time.

Operator

Operator

Thank you. Our next question comes from David Amsellem of Piper Sandler. Your line is open.

David Amsellem

Analyst

So on Sunosi, just putting aside COVID-19 for a moment. Are you at all troubled at how the product is gaining traction given that you have fairly good payer access? Looks like the footprint of the product is fairly limited given the payer access. So I was wondering if you could help us understand how you're thinking about the launch, the trajectory, what you are doing right and what you need to do differently? Thanks.

Bruce Cozadd

Management

Well, I'll start and then maybe ask Mike to join in. I would say we're very happy with our patient access. Although, I’ll also remind you that's only a couple months ago now that we got there. Our key strategic emphasis for 2020 has been to broaden the set of prescribers, particularly into the OSA audience and our sales force, I think was out accomplishing exactly that objective when COVID-19 hit and access became limited to physician audiences. We sent our field force home for their own safety and to protect the communities in which they live, and that's obviously made it harder for us to achieve that objective. As I mentioned, we saw some really good things during the first quarter and maybe I'll ask Mike to elaborate on that a bit.

Mike Miller

Analyst

And as Bruce touched on, three out of the four major payers that we have secured for Sunosi only began in this quarter. So we began with very much a pull through focus this quarter for our sales force. OSA has now, accounts for about 60% of our scripts and was moving in a very good trend. And COVID-19 has not only hurt our access but has really preoccupied the pulmonology community. And they are the major drivers of OSA . So we continue being encouraged with the refill rates, we hear good things from physicians and clearly from them from patients. And we feel very good and excited to get back to it after COVID-19 subsides.

Operator

Operator

Thank you. Our next question comes from Greg Gilbert with SunTrust. Your line is open.

Greg Gilbert

Analyst · SunTrust. Your line is open.

I was wondering if you'd weigh in on the comments that Avadel made about its regulatory legal strategy, as well as their data itself, the top line? And also Rob on lurbi, do you think it could come early in light of the blistering pace that we've seen for some other recent oncology approval of the FDA? Thanks.

Bruce Cozadd

Management

Thanks, Greg, for that sophisticated one question. On Avadel's comments, I'm not sure we're going to respond specifically to everything they've said. What we've said is that we've got meaningful intellectual property protection around Xyrem with our orange book listed patents that go to drug-drug interaction with valproate and the method of safe distribution embodied in our REMs, that we think is truly important to patients and the public in terms of the way this safely distribute and oxidate product. Our belief is that Avadel should certify to both families of our patents, those patents as a reminder go out to 2033 and 2023. And we have a long history of obtaining and defending intellectual property as necessary. Part of this does come down to what regulators do, and we think regulators share a commitment to safe use of the product with respect to the drug-drug interaction and how its distributed. Rob, maybe I could turn it over to you for lurbinectedin piece.

Rob Iannone

Management

Yes, I mean, one that I wouldn't speculate on. Obviously, this is a priority review program. It's a fairly discreet package and has a fairly straightforward review. Things are going as expected but it's hard to speculate on whether it comes in early or not.

Operator

Operator

Our next question comes from Jacob Hughes with Wells Fargo Securities. Your line is open.

Jacob Hughes

Analyst · Wells Fargo Securities. Your line is open.

With respect to COVID-19, does that potentially slow down your appetite or ability to do deals? And any color on the pipeline now versus pre-COVID?

Bruce Cozadd

Management

Maybe I can ask Renee to weigh in a little bit about how we're thinking about corporate development.

Renee Gala

Management

So as I stated, corporate development continues to be an important strategic objective for us. Clearly, there are complications to undertaking certain due diligence activities and whatnot during a COVID-19 environment. But I don't think that's going to have an impact on deals getting done this year. And as we think about what's most important to Jazz, we'll continue to look at both late stage opportunities, as well as early stage opportunities to be able to fill in the pipeline.

Operator

Operator

Our next question comes from Akash Tewari of Wolfe Research.Your line is open.

Akash Tewari

Analyst

So I just wanted to clear something up, your labeling language for Xyrem and valproic sodium recommended initial Xyrem dose reduction of at least 20% for patients who could take both drugs incumbently, which sounds to me like your first dose on Xyrem reduced, the second dose is kind of the same. So given the Avadel product is physically kind of like a single product. How were the patient who was on the Avadel product be able to incorporate the concombinant dosing language that you put on the current Xyrem label? Thanks.

Bruce Cozadd

Management

I would say our language in our label was designed to ensure that patients and physicians understand the concomitant use of oxidate in valproate results in higher levels of oxidate than would be predicted otherwise. And that dose modification of a significant magnitude as warranted and we've got specific instructions for that in our label and dosing in administration. And that's whether you're stable on oxidate and then you're adding valproate or whether you're stable on valproate and then adding oxidate. In either case, you need to be careful. Again, we don't know what Avadel is proposing put in their label and that will be between them and the regulators. But it is important that again treaters and patients understand that interaction to make sure you don't get an inadvertent overdose of oxidate.

Operator

Operator

Thank you. Our next question comes from Jason Gerberry of Bank of America. Your line is open.

Jason Gerberry

Analyst

Good evening, and thanks for taking my question. Maybe just on the Erwinaze update. From the outside looking in, it looks like the assumption is Jazz must have been better off going it alone with 458 as a wholly owned asset versus competing perhaps lesser economics and trying to negotiate or extend with PDL. So can you address this. And you know, whether you feel you can be in an equal or better place in terms of gross profit derived from JZP-458 in a couple of years post launch from where you are with Erwinaze in the past one or two years? Thanks.

Bruce Cozadd

Management

I’ll sort of flip that around and answer the narrow part of your question first, which is around gross margin. Obviously, from a gross margin perspective Erwinaze was not one of our higher gross margin products. We think with a more modern manufacturing process with a recombinant product we’ll actually have an improvement in terms of lower cost of goods. There are also some advantages from a tax rate perspective to having developed this product with that in mind. But I think much more important than the gross margin aspect is coming back to why we developed this product in the first place, which is to ensure that ALL patients have access to a reliable high quality product where we're not limited by supply in meeting current demand and thinking about growing demand to meet the needs of all patients, including patients in the adolescent young adult group who would benefit from a pediatric inspired regimen that contains an asparaginase where we see better survival and to allow for broadening use of our product into more geographic markets as well. As a reminder, the existing product is approved in Japan and still not launched there. So the most important driver for development was really bringing that high quality reliable agent to market with the ability to meet current demand and grow demand beyond that. So it's also true we think it would be a higher gross margin product for us, but that was not the driving force.

Operator

Operator

Our next question comes from Ami Fadia with SVB Leerink. Your line is open.

Ami Fadia

Analyst · SVB Leerink. Your line is open.

Maybe in light of the Avadel data and the successful trial. Could you talk to us about your program for the once nightly low sodium product? And when do we think that it could reach a phase through your pivotal trial stage, and what are your development plans there? Thank you.

Bruce Cozadd

Management

Ami, we haven't really said much about our plans for that, we've been pretty quiet. The most important thing for people to remember about our once nightly program is it's once nightly low sodium development. We clearly feel that reducing that sodium load is critically important to the long-term health of patients, existing and new patients. And so we've incorporated that into our development plan, but we haven't given any more specifics yet on that. I will remind you we've got a good track record of moving quickly through development. With our agents, I think certainly we did a nice job of getting 258 through pivotal trial and into the regulators, and certainly happy with how we're doing that with 458 as we speak. So more to come but that's all we said today.

Operator

Operator

Our next question comes from Jessica Fye with JPMorgan. Your line is open.

Jessica Fye

Analyst · JPMorgan. Your line is open.

Within the updated hemonc guidance, can you elaborate a little bit on which products are harder hit within that overall range coming down by 14% at the midpoint? Was that largely Vyxeos? In particular I'm also curious it's worse than expected interruption for Erwinaze factors into that at all, which would obviously not be COVID related?

Bruce Cozadd

Management

Yes, maybe I'll ask Dan to address that question.

Dan Swisher

Management

Yes, I think near-term they've all been somewhat effective but I would say Vyxeos little more so in the U.S. where there's kind of a push for outpatient and finding the oral oncolytics or other approaches. I think as the capacity comes back with the in patient and people can manage, obviously non-COVID cases as well as COVID, the five year survival data that's coming through at ASCO reinforces the efficacy profile for Vyxeos. So we continue to show nice growth in Europe. I think that's going to be relatively uninterrupted. But in the U.S. getting the data and getting back into physicians and enabling more intensive therapy options for patients will be something we anticipate in the second half. Erwinaze is non-COVID related and unfortunately some of the shortfall in guidance is related to worse than forecast disruption and supply.

Bruce Cozadd

Management

And Jess, I'll just add that in addition to being significantly supply constrained in the first quarter of 2020. Of course, we're happened to be comparing back to a first quarter and 2019 where we had unusually positive supply. And that's I think why Renee highlighted that if you back out that swing in Erwinaze first quarter to first quarter, I think you get a better sense for how the rest of our business is doing.

Operator

Operator

Our next question comes from Ken Cacciatore of Cowen and Company. Your line is open.

Ken Cacciatore

Analyst

Follow-up on the Avadel question and a question of my own. On Avadel, Bruce, is there any FTC impediments to you buying Avadel if you could comment on that? And then in the after hours if we look at your shares, they’re trading at less than five times 2021 EBITDA, practically begging for you all to maybe take this company private. Can you give any thoughts as to where would be compelling reason for you all to maybe think about taking a more aggressive strategy to share buyback or actually going all the way and trying to take the company private? Thank you.

Bruce Cozadd

Management

So, Ken, no comment on your first question, for obvious reasons. On your second question, I don't think you need to look at after hours trading today. You can just look at in general where we're trading to say that the company has excellent cash flow relative to its current value. We continue to pursue a strategy that we think adds significant diversification to our revenue growth drivers. We think this is, as Renee said, a catalyst rich year in terms of making that much more visible, whether that's progress on a Sunosi launch, launch of lurbinectedin, launch of 258, moving Sunosi into Europe, continued growth of Vyxeosin Europe, moving 458 closer to a market and the potential for additional corporate development transactions. So we've got work to do but we're excited about making progress on that and making it clear to investors what that longer term more diversified revenue stream looks like. You raised a good question, which is the use of cash to buy back shares. And in fact, we've been an aggressive purchaser of our own shares over the last few years. We continued that in the first quarter. I will admit we hit pause a little bit as we came into COVID-19 just to make sure we understood a little bit about how initial efforts to contain viral spread to flatten the curve to eventually get people back toward normalcy in terms of resuming customer interactions, delay of advanced clinical trials and the like. So we did hit pause a little bit but we remain convinced that our shares are a good investment for us, so long as we don't constrain our ability to be aggressive on the corporate development side, which continues to be a significant priority for us.

Operator

Operator

Our next question comes from Randall Stanicky of RBC Capital Markets. Your line is open.

Randall Stanicky

Analyst

Bruce, can you talk about 258 and specifically, how should we think about the promo and ad spend there and you need to expand the rep base? I'm trying to understand how much incremental spend we could see from the launch of 258. And then specifically, does that fall into 2020 or 2021? Thanks.

Bruce Cozadd

Management

So Randall, some of that spend will absolutely fall into this year. Our goal is to gain approval in July, implement our REMs and be ready to launch in the fourth quarter. So some of that spend will happen this year. In terms of promotion you know, we are going to do what we can to make this a very successful launch. We want patients to have access to what we believe is a better lifelong therapy, and you can expect that our focus will be on 258 and less on Xyrem once we make that switch. In terms of field force, I think that's a broader question. We want to make sure we're doing right by Xyrem this year, certainly preparing for a successful launch of 258 but continuing our progress on Sunosi. Aand so as we think about having the right field force for that, we're really thinking holistically about Sleep and Neuroscience now and into the future. Dan, anything you want to add to that?

Dan Swisher

Management

No, I think you covered it well. Thanks, Bruce.

Operator

Operator

Our next question comes from Annabel Samimy of Stifel.

Annabel Samimy

Analyst

Just question on 458, is everything continues with enrollment in the trial, you're able to file by fourth quarter. Can you confirm whether you're going to be having to refer to the PDL BLA filing and whether you have to refer to anything that might block you from an IP perspective to launch immediately on approval if it’s available to you? Thanks.

Bruce Cozadd

Management

So Annabel, we're really excited about the progress we're making with 458, and want to make sure we continue to do everything we can in combination with COG and FDA to make sure we make this therapy available, particularly as we continue to have periods where we're out of stock with Erwinaze I think this is essential. We're confident we have everything we need to move through the regulatory process. Just as a reminder, we have a relatively straight forward end point in our trial. So we think we're in good shape to move quickly to the market.

Operator

Operator

Our next question comes from Ronny Gal of Bernstein.

Ronny Gal

Analyst

Just redoing Annabel’s questions, is there a legal barriers to the market? I hear we have a pool, but is there IP that you have to contend with. And then my question to think about the U.S. going from an unemployment from somewhat under five to something like 11%, which is CBO prediction for next year. Have you begin to think about what that would mean in terms of headwinds to Xyrem, the expectation is most of the growth in employed will shift Medicaid towards the end of the year as opposed to now. And kind of wonder, if you kind of think year-over-year have you begin to think about the impact down?

Bruce Cozadd

Management

So Ronny, I'll give you the one and half questions, because I wasn't trying to duck the end of the prior question. We think what we have -- we have what we need to move forward, we developed a new drug product and don't see a barrier to bringing that to market. So maybe, Mike, I could turn it over you to reflect a little bit on what any change in employment status, for example, would mean to payer mix and to how we think about Xyrem revenues in 2020 and beyond.

Mike Miller

Analyst

As you know, Ronny, the primary payer for Xyrem is commercial overwhelmingly, and we have not seen a significant shift in the payer mix on Xyrem so far. We continue to provide patient support programs that enable patients to get drug if they financially qualify. We will continue to do that. Again, we feel very good about where we are in our guidance and our gross to net and where we're heading.

Bruce Cozadd

Management

But to be clear, our guidance for the rest of the year does contemplate that we would see a shift in payer mix that would actually result in higher gross to net overall for Xyrem.

Operator

Operator

Our next question comes from Balaji Prasad of Barclays.

Balaji Prasad

Analyst

So my question is on lurbinectedin. So we last spoke about your thoughts in exploring this for front line therapy. Has there been any progress in the front in identifying the form lurbinectedin could play a role in front line lung cancer? Thank you.

Bruce Cozadd

Management

So Rob, maybe I can ask you or Ann to weigh in on that.

Rob Iannone

Management

So we know based on the data that are publicly available that lurbinectedin is highly active and even more often in patients who are sensitive to platinum, which is the greatest majority of small cell lung cancer patients. And so, we do see an opportunity to move into first line small cell lung cancer. As you know, despite recent advances there with the addition of immuno oncology, PDL1 inhibitors, the prognosis is still extremely poor. The median survival is about 12, 13 months depending on whether you look at the data. And so given the tolerability profile of lurbinectedin, we do think that there's an opportunity ultimately to move into the front line setting.

Operator

Operator

Our next question comes from David Risinger of Morgan Stanley.

David Risinger

Analyst

I just wanted ask a quick question, most of my questions have been answered. With respect to Erwinaze in 2021. Could you just talk about how we should think about that curve over the course of 2021?

Bruce Cozadd

Management

So David, as we publicly said, our contract will conclude at the end of 2020 but with a contractual right to sell through inventory in production. As we hit the end of the year, we think that will take us partway through 2021, depending on the level of that inventory. And of course we're doing everything we can to make sure that patients will have access to therapy, even beyond current supply by bringing 458 to market as rapidly as we can. We've got a goal of getting that BLA in as early as the end of this year. We think FDA is motivated to, if the data is what we hope the data will be, move quickly through the regulatory process as well. And our focus for this year is keeping that timeline as short as possible. We're starting to explore path for ex-U.S. approval in EU in other markets as well.

Operator

Operator

Our next question comes from Esther Rajavelu of Oppenheimer.

Esther Rajavelu

Analyst

I'm just curious if you are seeing any impact of telemedicine, especially obviously franchise or do you anticipate that maybe contributing to uptake, especially for the new launches over the course of the year?

Bruce Cozadd

Management

It's a good question and maybe I'll broaden my answer a little bit to say, we're not far into this. We are coming up on two months into a pretty radical change in how patients and physicians interact. And I think we're still at the early end of figuring out the art of the possible in terms of diagnosing, treating, monitoring patients with a variety of disorders remotely or requiring less in-person visits. I think that willingness to find new ways to get things done has long lasting implications on how companies like ours and healthcare professionals may interact in a way that could be more efficient and more impactful than the focus we've had historically, which has been largely on in-person, not entirely but largely on in-person promotions. So I will say we're seeing things now. But I just also want to stress I think we're still early on in figuring out the art of the possible. And that may require changes in how people go about doing diagnostics, what diagnostics can be done in a less intensive setting, as well as regular visits. Dan or Mike, anything you guys want to add to that?

Dan Swisher

Management

I’d just sort of add that, I think Jazz is in a particularly strong position, both because of the medicines we're currently providing for significant whether life threatening or life changing therapy, say in narcolepsy or in cancer, and we are a pretty flexible, innovative company. So we are trying a number of things to continue that engagement, both within the company but obviously with our customers and healthcare practitioners. Good example is COVID hit and we have hired the entire neuroscience field force in Germany remotely train them, and they're ready for virtual launch in mid May. And there's a number of, there's a high degree of customer interest engagement. And so they’ll look forward to getting face to face. I don't think you can ever negate the importance of that, but there's ways to really leverage those relationships more broadly with digital means. And so we're experimenting and with a number of different brands and regions, and look forward to continuing to get that leverage post-COVID. And then as I say with new product launches, there's obviously a lot of customer interest regardless of the situation. So we're looking forward to the second half of 2020.

Mike Miller

Analyst

And I will just piggyback on what Dan said specifically with respect to the upcoming launch of lurbinectedin. We've reached out to treaters of small cell lung cancer to see how their treatment of their patients has changed. And there is certainly an awareness of mitigating risks of COVID-19. But clearly for these patients the most important treatment objective is to in fact continue their treatment first line and then with progression the second line. And we're not during the from their perspective, that will be a significant impact.

Kathy Littrell

Management

And operator, this will be -- the upcoming question will be our last question.

Operator

Operator

Thank you. Our final question comes from our Umer Raffat of Evercore ISI.

Umer Raffat

Analyst

Bruce, I wanted to touch up on Avadel and specifically, two parts. Number one, I'm curious how you thought about their cataplexy attack reduction relative to the trial experience we’ve seen with Xyrem? And also as it relates to the carve out point, I recall one of the ANDA was par sort of carve out and FDA obviously didn't allow that but what if Avadel attempt a contraindication. How do you think about that in the context of what your patent claims?

Bruce Cozadd

Management

So Umer on that latter point, again, I think we said what we're going to say about their carve out strategy in terms of what we think is important for patients and physicians to understand about safe and effective use of oxybate. They may have a different point of view, but I think we're clear as to what our point of view is. On the cataplexy data, I'll say with Xyrem and with 258, we've put our data out. Many of you may remember 258 data in the spring last year led to a much fuller discussion of that data at Worlds Sleep in Vancouver in September. And we’ll look forward to seeing more data from Avadel over time in an appropriate setting. I think it's too early with the amount of data they've provided, which by the way is perfectly understandable as you're just releasing top line data. I wouldn't have expected a lot of detail at this point. But given the trial designs were different, I think it'll take a while to understand what the data do and don't mean on safety and efficacy. We do know in the case of Xyrem, the product has a long use of as a mainstay of narcolepsy therapy. And then more recent, we've got 258 data, which we think addresses the most important liability of Xyrem from a patient and physician standpoint, which is of a high sodium content that leads to the type of sodium warnings we see in the Xyrem label. So more to come as we see more data from Avadel, but probably too early to make any significant conclusions on that front. And maybe since Kathy said that was the last question. I'll just end by, again, thanking you all for joining us and reiterating our enthusiasm about the business. I have to say our team on Xyrem is doing an excellent job under the circumstances and making sure patients continue to have access to their therapy through this time. We look forward to resuming our growth of Xyrem and then quickly bringing lurbinectedin and JZP-258 to market, and continuing our clinical development plans with heavy emphasis on 458 this year and then continuing our efforts to broaden our portfolio through internal development and corporate development. So with that, thank you all for joining us.

Operator

Operator

Thank you. I'd like to turn the call back over to Kathy Littrell for any closing remarks.

Kathy Littrell

Management

Thank you again for joining us today. I'll echo what Bruce said. But we will be participating in the upcoming virtual Bank of America, RBC and Goldman Sachs Healthcare Conferences, and hope to speak with many of you during those events. This now ends our call.

Operator

Operator

Ladies and gentlemen, you may all disconnect. Have a great day.