Jazz Pharmaceuticals at Wells Fargo Conference: Strategic Insights Unveiled

Published 03/09/2025, 16:52
Jazz Pharmaceuticals at Wells Fargo Conference: Strategic Insights Unveiled

On Wednesday, 03 September 2025, Jazz Pharmaceuticals (NASDAQ:JAZZ) presented at the Wells Fargo 20th Annual Healthcare Conference 2025. The company highlighted its recent FDA approval for doravaprone and discussed future challenges, such as the potential entry of generic competitors. Jazz Pharmaceuticals is focused on expanding its epilepsy franchise and leveraging its strengths in oncology.

Key Takeaways

  • Jazz Pharmaceuticals received FDA approval for doravaprone, addressing a significant unmet need.
  • Xywav’s growth in idiopathic hypersomnia remains strong despite generic competition.
  • The company is preparing for the potential impact of generic Xyrem in 2026.
  • Zanidatumab trials are progressing, with results expected in Q4 2025.
  • Jazz is prioritizing R&D investments and exploring opportunities in rare diseases.

Financial Results

  • Xywav Growth: Strong performance driven by idiopathic hypersomnia, with 400 net patient additions in Q2.
  • Generic Xyrem Impact: Planning for various scenarios due to potential generic entry in 2026.
  • Operating Expenses: Focused on disciplined spending and R&D investments.

Operational Updates

  • Doravaprone Approval: FDA approval received ahead of the PDUFA date, now available for patients.
  • Zepzelca sNDA: Filed with the FDA for combination use in lung cancer, with a PDUFA date of October 7.
  • Zanidatumab Trials: Ongoing Phase III trials in GEA, breast cancer, and BTC.

Future Outlook

  • R&D Investment: Prioritizing programs that advance patient care.
  • Business Development: Seeking opportunities in rare oncology and epilepsy.
  • CEO Transition: Renee Gala appointed as the new CEO to drive company operations.

Q&A Highlights

  • Oxybate Market Dynamics: Orexins are seen as adjunctive therapies, not substitutes for oxybate.
  • Zanidatumab Development: Optimistic about the potential of zanidatumab as a best-in-class HER2 therapy.
  • Zepzelca Growth: Positive outlook for Zepzelca as a first-line maintenance treatment in lung cancer.

For more detailed insights, please refer to the full transcript below.

Full transcript - Wells Fargo 20th Annual Healthcare Conference 2025:

Mohit Bansal, Biopharma Analyst, Wells Fargo: Thank you very much for joining us today. My name is Mohit Bansal. I’m one of the biopharma analysts here at Wells Fargo. And this is my first session, not Conchus’ first session. And I’m happy to have team from Jazz Pharmaceuticals with us.

We have Phil Johnson, the CFO of the company and Amal Gobatrand with us. She is heading the you are the VP Oncology Therapy Area Head and most importantly, Jenny, Clinical Development Head. So we’ll have a lot of questions for you. Thank you very much for joining us today.

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: Thank you for having us.

Mohit Bansal, Biopharma Analyst, Wells Fargo: So Phil, why don’t we start with the overview? And I mean, you were here last year, and how do you see the year has been for you and the investment thesis at this point, which investors should hear about?

Phil Johnson, CFO, Jazz Pharmaceuticals: Thanks, Mohit. Thanks for the invite to be here. It’s always a pleasure. And there’s quite a buzz in the hallways this year as well, so great to have a chance to meet with a number of investors. So it’s been a really fun last year.

I’ve been really pleased with the decision that I had made to come join Bruce, Renee, Amal and others on the Jazz team and the progress that we’ve been making driving the business both on the commercial side as well as on the R and D side with progression of zanitamab clinical trials. And on corporate development as well, we’ve had a couple of recent announcements. Before I get started with remarks, let me just reiterate some

Mohit Bansal, Biopharma Analyst, Wells Fargo: of the

Phil Johnson, CFO, Jazz Pharmaceuticals: disclaimers For full understanding of the risks that may impact our business, please do consult our SEC filings, some of those recent updates we provided, look at our second quarter earnings materials. If we do refer to guidance during the Q and A session today, know that that’s the guidance that was issued as of our second quarter call. These are a couple of comments Mohit on just recent developments even since we would have had our earnings call. So really pleased that we received approval for earlier than the PDUFA date. Many were concerned about would there be regular and consistent interactions with FDA that would lead to a timely action on our midazo or diradavaprone applications.

So really pleased there. We actually got approval prior to the PDUFA date, are already out now serving patients. This is a really dreadful disease, effectively this K27M mutant diffuse midline glioma often affecting pediatric and adult patients who really had no therapeutic option and really nothing new since the advent of radiotherapy fifty, sixty years ago. So really pleased with that development. It shows our ability to spot and then acquire opportunities to advance patient care in really hard to treat diseases where there’s significant unmet need.

Initial read in these first few weeks have been really strong and look forward to providing an update when we get to our third quarter call as well. Also concluded a licensing transaction to build out our epilepsy franchise, preclinical deal we did with SANEONA, where we think could be a best in class asset, so really pleased to have announced that. And then notably, announced the conclusion of the CEO search looking for Bruce Kozaz replacement and very pleased that Renee Gala has been selected and looking forward to her continued leadership. I think her and the management team board are very focused on driving the legacy that Bruce has created, but then also taking it further. And I think Renee has got insights to be able to do that and knows I think the strength she can build on here at Jazz and also the things that we can do much better at as well.

So looking forward to that new leadership that Rene will provide. I’m also pleased with the way the year has been going, really strong results with XiWave, really strong net patient adds in the second quarter, four hundred or so within idiopathic hypersomnia were the only approved treatment and have no near term competition. And then we continue to see really strong performance in narcolepsy as well where there is another branded competitor and we have authorized generic competition as well. We miss points to the value that patients and physicians see in low sodium in these patient populations, those with narcolepsy and hepatic hypersomnia. They are at an increased risk of cardiovascular events.

So certainly driving up sodium in these patients is not probably something that physicians would want to be doing. At a recent sleep meeting, we had presented data from our Xylo study, in fact showing that when patients go from a high sodium oxybate to a low sodium oxybate that produces clinically meaningful reductions in blood pressure. And this is a benefit that only Xywav can offer. So we feel we’re really well positioned with that franchise here and the strong that patient has in the first half of the year as we think about the second half of the year. Maybe I’ll turn it over to Tamal to talk about some of the developments on the clinical side of things.

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: Right. Hello, everyone. A lot of exciting catalysts in oncology. The most imminent one for us is the Zepzelca approval. We have an sNDA that’s been filed with the FDA for Zepzelca in combination with atezolizumab in patients with extensive stage lung cancer who have previously received induction and then go on to maintenance Zepzelca.

The PDUFA date is right around the corner, October 7, so really excited about this upcoming milestone. We have several other important data readouts that we are expecting this year. And obviously, the major one is the HORIZON-three zero one, which is our frontline GEA study with zanidatumab in combination with chemotherapy in patients with HER2 positive advanced or metastatic GA cancer versus the standard control, which is a combination of Herceptin and chemotherapy. And we’re anticipating those results in readout in fourth quarter twenty twenty five. So a lot of exciting upcoming catalysts.

We’ve also recently initiated a Phase II trial in the neoadjuvant setting for breast cancer and zanidetamab HER2 positive breast cancer. So we’re expanding on the promise of what zanidetamab can deliver in breast cancer. That’s the two zero eight study. And we also have three ongoing Phase III studies for zanidatumab, so the three zero one trial, the HORIZON-three zero three trial, which is zanidatumab in combination with chemotherapy versus Herceptin in chemotherapy in patients with HER2 positive metastatic breast cancer who have previously received TDXD and have progressed on it or are intolerant to it. And then we have obviously our three zero two trial, HERORIZMAN three zero two trial, which is the frontline study of zanidetamab with chemotherapy, plus or minus an anti PD-one in frontline metastatic BTC that is that will be supporting our accelerated approval for zanidetamab in BTC.

A lot going on, we also obviously have the ACTION trial that will support the accelerated approval of dorbataprone. So four, three large Phase III trials are ongoing, so quite exciting.

Mohit Bansal, Biopharma Analyst, Wells Fargo: A lot of action going on. Yes. Great. So I don’t know where to start at this point. So maybe let’s just talk to talk a little bit about oxybate.

I mean, Xywav, I mean, again, we were like last couple of years, people are worried with generics and Avadel, like all the Lumiris and all competition. It seems like Xywav has been growing through all that, not just in IH, but also in epilepsy as well. So can you talk a little bit about where is this growth coming from? And how much confidence does it give you for second half in 2026 as well

Phil Johnson, CFO, Jazz Pharmaceuticals: going forward? Yes, absolutely. No, you’re right. We’ve been really pleased with how well Xywav has done. Obviously, the big driver of growth when you look at the net patient adds also translates into revenue is coming in idiopathic hypersomnia.

We do expect for that to continue to be the case going forward. That is still, I’d say, a market that we’re building, building awareness in, physicians and patients as well on the benefits of oxybate therapy for idiopathic hypersomnia. It’s difficult to know exactly what the epidemiology is there. Anecdotally, we do hear from a number of treating physicians that in their practice they feel like they have as many idiopathic hypersomnia patients as narcolepsy patients, although

Unidentified speaker: if you look at that some of

Phil Johnson, CFO, Jazz Pharmaceuticals: the published epidemiology, it might indicate that that population might be half of the narcolepsy population. But again, we still see good opportunity for continued growth in IH. Narcolepsy, we’d indicated a while back that we could see quarters where there were not net patient adds, but net patient decreases. We’ve not seen that. So we’re very pleased with the performance of with both branded competition and with authorized generic competition.

Definitely think this speaks to the benefit that patients and physicians see to low sodium, as I mentioned earlier, which is the unique attribute that Xywav can offer. We do have upcoming the potential for generic Xyrem to come to the market beginning effectively at the 2026. Technically, the unlimited volume authorized generic player, HICMA, has the ability, and they have had for quite some time, to come in with their own generic. To date, they have elected not to do that, And we’ll monitor the situation going forward. But certainly, the introduction of generic Xyrem would affect potentially not only that authorized generic revenue that we have, the Xyrem revenue that we have.

Then I think question mark on would there be an impact or not? And if so, to what extent on Xywav? I think that will depend also on how payers are looking at the space and how payers are thinking about this dynamic of the unique benefit that Xywav offers in terms of low sodium for these patient populations.

Mohit Bansal, Biopharma Analyst, Wells Fargo: Got it. So I mean, 2026 could also be an interesting year given that there is a possibility of generics. So what is your internal expectations regarding these generics? And I mean, again, you cannot guide for next year. But again and I got like again, directionally, should we be expecting growth?

Or should we be concerned about these challenges a little bit than the smaller numbers?

Phil Johnson, CFO, Jazz Pharmaceuticals: So I’ll probably stop short of saying should you look for growth or not at this point in time. Obviously, that would come with our in 2026. Do think we’re planning for a variety of scenarios. I think it’s prudent to plan that generics would come in beginning in January 2026. Again, as I mentioned, let’s take the example where Hikma is one of those coming in.

They can only do the authorized generic with us or their own true generic. They can’t do both. So if they were coming with a generic, the impact for us would be that authorized generic income would go away. Clearly, we’d expect a significant impact on remaining, which is pretty small now, remaining Xyrem revenue. And again, very uncertain what would be the impact to Xywav from the introduction of a generic Xyrem.

Again, the only product that has low sodium, we’ve talked before about the benefits that we’ve seen and been publishing data on of low sodium in a patient population that has an increased risk for cardiovascular events. So we think we’re as well positioned as we can be. We’re prepared for a number of different outcomes, and we’ll be flexible and react as we go forward to the market condition.

Mohit Bansal, Biopharma Analyst, Wells Fargo: Got it. And at least from Hikma, you would know beforehand that there are

Phil Johnson, CFO, Jazz Pharmaceuticals: We have so we haven’t said the exact notice period that they have, but they do have a notice period to tell us that they want to stop with the authorized generic. We also have commented we’d expect that would be of high interest to analysts and investors. And should we receive such a notice, we pretty promptly make a public statement to that effect.

Mohit Bansal, Biopharma Analyst, Wells Fargo: Got it. Very helpful. And then the other question is about Oraxins and in this market. So how do you see Orexens as a challenger? And what investors should look at world sleep data to understand the profile better?

I mean, I’m sure you are

Unidentified speaker: looking at that as well.

Phil Johnson, CFO, Jazz Pharmaceuticals: Absolutely. Coming up soon. So we actually look at the orexins as to be the most potent sort of daytime waking agent that we have seen to date and actually be able to provide narcolepsy patients in particular, I think question mark is still on IH patients, with improved outcomes. But we don’t see that coming at the expense of oxybate therapy. We do see this as being like current daytime waking agents are now adjunctive combination therapy to help patients to get better outcomes to deal with their narcolepsy symptoms.

This is a condition that has both nighttime and daytime symptoms. Oxibate has been shown to deal very effectively with a number of the sleep parameters that plague these patients and also lead to improvements in a number of their daytime symptoms as well. I do think as you’re looking at data coming from the orexin, looking at things like what is the incidence of insomnia that’s being caused in these patients, this is a class where if that effect that waking effect is not wearing off in time for someone to begin getting normalized sleep in the evening, does that actually complicate some of the issues that they’re having with their condition or not? But again, we think this could be great for patients to get better relief of their symptoms in combination with oxybate, but

Unidentified speaker: not as a substitute for. Got it. Very, very helpful. So

Mohit Bansal, Biopharma Analyst, Wells Fargo: I promise that I’ll ask a lot of questions about ZYNNE. So let’s just start with that. So of course, I mean, there’s very important readout with the in GEA coming up. And in oncology trials, I mean, trials or readouts getting pushed out is not always a bad thing. So can you just help us set the expectation, how you are thinking about this trial?

There are three different arms. And then I have a lot of specific questions there.

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: Yes. So it is obviously a complex trial. There are three different arms. Of them is the control, which is the combination of Herceptin and platinum and 5FU regimen. And then there are the active arms.

And one of them is zanidatumab that would replace Herceptin with the combination of chemotherapy. And the third one is zanidatumab plus an anti PD-one, the cusulizumab in combination with chemotherapy as well. And those two arms will compare themselves to the control. So the arm of Tisli versus plus Zany versus the control, and then the arm of ZANI alone and chemotherapy versus the control. So we do have two active arms for this study.

And what we do know is the control. The control has been tested over many years across several trials, three phase three trials, large trials that are global trials, where that control has been really used over more than 1,000 patients. And what we’ve seen is even with the most recent trial, the KEYNOTE-eight 11, that control has performed consistently, which has a median PFS of around seven to eight months, six month change and eight months. But that’s pretty much the extent of it from a PFS standpoint, as well as the OS standpoint has been pretty consistent as well. So we are pretty confident with as much data possible about this control arm.

So that’s one reassurance. And then the other, you know, aspect that makes us believe that potentially our active arms could be performing better than what we had initially anticipated is the data from two zanidatumab study in the frontline setting. Those are two Phase II study run by Jazz and Beijing. And the results were pretty consistent in terms of response rates, PFS, with also a very compelling OS that was recently presented at ASCO going over thirty six months median OS for that combination of Xanip with chemotherapy. So a lot of evidence that would lead us to believe that the delay could be coming from Active At the active arm.

Remains to be seen. Yeah.

Mohit Bansal, Biopharma Analyst, Wells Fargo: This is helpful. So I mean, other question, like, the question I get is that, how should we interpret the arm C data when the data are released, right? I mean, it is not, it is comparing itself to arm A, but not to arm B. Yeah. How meaningful is arm B versus C comparison, which inevitably people will do, and does it matter more for tislelizumab versus your drug?

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: I mean, there are several things that we are looking into. So one is the subset of patients that are PD L1 negative. So how they would benefit from the arm that has XANI plus chemotherapy alone versus also the arm that has the anti PD-one. And we’re also looking at the patient subset that we will be looking at the patient subset that is PD L1 positive, because there the benchmark is a bit different in light of the readout and approval of the KEYNOTE-eight eleven regimen. So it’s going to be several things that will factor into our decision, but we’ll be looking at all those aspects.

Mohit Bansal, Biopharma Analyst, Wells Fargo: And Keynote 11 is not the right comp, right? Because they enrich the patient for PD-one hundred five.

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: That’s correct. Yeah. Yeah. Yeah.

Mohit Bansal, Biopharma Analyst, Wells Fargo: That’s good to know. So, I mean, in terms of disclosure, how would you disclose the data? Because Jazz’s history is like, you release the top line, and then you release more data at the conference. But in this case, there is some, like there are two things which people want to know, whether the OS trend was positive, and what did you do in arm C, which is not, you cannot say stat C because it’s not powered for that versus B, but how would you characterize these two points there?

Phil Johnson, CFO, Jazz Pharmaceuticals: Still to be determined. We’ve got, first, to be able to see the data and then figure out how do we characterize that data in a qualitative way that’s meaningful for investors that when they see the eventual data at the medical meeting, they feel like we’ve accurately portrayed that. So I can’t give you specifics exactly right now. I think it will be data dependent. I do think in terms of your question on what we might be saying in terms of some of the performance on various measures, whether that’s arm C or arm B or we talked earlier this morning about overall survival versus progression free survival, You know, some of those may be evident in the way we’re qualitatively describing the study.

So for example, we’ve said in the past to be able to submit, we need obviously to hit the primary endpoint for PFS. We don’t necessarily need to have statistically significant improvement in overall survival, but certainly not be showing a detriment to be able to meet what we would view as FDA’s likely expectation. So if we’re saying that primary endpoint, providing some safety commentary, management quote and then our next steps from a regulatory perspective are proceeding to submission, I think that would indicate that the OS is in line with what we think regulatory expectations would be. Conversely, if we’re saying we’re going to wait until the second OS interim to be able to submit, then that would mean that there was something happening that was not providing us that level of confidence. We still need to have, with the data in hand, I think that robust discussion internally on how do we provide a qualitative view that would accurately capture the data.

Mohit Bansal, Biopharma Analyst, Wells Fargo: Got it. Very helpful. And then regarding OS, so OS at this there will be an interim at this point for OS as well. So basically, like, it doesn’t have to be strategic. It needs to be in the right direction.

Is that your comment? Yes,

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: that’s correct. So they’re dual primary endpoint, but the final PFS obviously has to be set safe. The OS does not have to be set safe.

Unidentified speaker: Got it.

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: But if we get there, that would be great.

Mohit Bansal, Biopharma Analyst, Wells Fargo: Very helpful. Very helpful. I mean, so given that the trial has taken longer than anticipated, like probably, OS data are probably more mature than you would have gotten.

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: That’s correct. Right? We don’t know where the OS data

Phil Johnson, CFO, Jazz Pharmaceuticals: are coming

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: from. Obviously, we’re blinded to the arms, but we are getting more events the longer we wait, which does increase the chances that we can make a meaningful interpretation of the OS data when we have that first analysis.

Mohit Bansal, Biopharma Analyst, Wells Fargo: Very helpful. And then other question we get a lot is that, I mean, we’ll have GA data. I mean, like Jacob trial actually tells us that, I mean, that combination of Herceptin with Projeta did work in GA, but did not work on OS, but it did it does work really well in breast cancer. So by converse logic, if it works if your drug works in GA, does it increase your chances in breast cancer as well?

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: Yeah, I mean, believe so. There are obviously differences in the biology of breast cancer versus GA, but there are a lot of similarities. One of them is, you know, the use of anti HER2 agents, and definitely more sensitivity to anti HER2 therapy in the breast cancer setting than there is in GEA. So if we can actually make a dent in GEA, I’m even more confident about what we can do in breast cancer. We’ve also seen activity of zanidatumab across many, many tumors that overexpress HER2, many other tumors, including VTC, where we have an approval, where the activity is really compelling, and several other tumors as well that we’ve tested the monotherapy as well as the combination of zanubatumab.

So definitely this would be an extra kind of piece of evidence that ZANI is a potent anti HER2 agent and safe.

Mohit Bansal, Biopharma Analyst, Wells Fargo: Got it. I mean, at least in GA, you are the first. But I mean, and HER2 is also running a trial in first line. How do you see HER2 as a potential competition in that area?

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: Yes. I mean, so you stated it. Obviously, the most obvious is that zanidatumab readout in the frontline will come first. And we believe it has the potential to redefine the standard of care. And you know, what that will do to the benchmarks for the Enhertu trial remains to be seen.

But we do believe that

Mohit Bansal, Biopharma Analyst, Wells Fargo: we have

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: strong reasons to believe why that three zero one trial would be positive. There are also other reasons to believe why zanidatumab could be a best in class HER2 targeted therapy. Some of it is coming from our BTC monotherapy trial, where single agent activity of zanidatumab in BTC is comparable to combination therapy in BTC of anti HER2 agents, as well as the activity noticed with an HER2 in that setting with really good durability. So we are seeing good activity across several trials of banidatumab. We also believe in the uniqueness of the mode of action of benedatumab, which is to bind to the two epitopes of the HER2 receptor.

But the way it binds in that trans configuration actually adds to its effectiveness in blocking the HER2 pathway. Effective downstream blockade of the HER2 signaling, effective blockade of the HOMO and heterodimerization of the HER2 receptors, as well as something that we’ve observed that is unique to zanidetamab that we don’t see in preclinical models when you combine Herceptin and pertuzumab is an activation of the immune system as well, with complement activation, ADCC as well, that we believe will boost its activity and potentially durability.

Unidentified speaker: Got it. That’s very helpful.

Mohit Bansal, Biopharma Analyst, Wells Fargo: And then the last one is that your breast cancer program, a little bit of the thought was that Enhertu will move into first line, right? And then you will have second line. And HER2 does look like it will move into first line, but my recent checks with the doctors are like, a couple of doctors are a little bit, know, oh, maybe I’ll move sixty percent patients, or fifty percent patients, because they and the safety is also real, right? So they have so much experience with the two drug combo there. So if, let’s just say, Hercept or Enhertu is not the first line agent for the most patients, does that change your opinion about your own drug, or do you still see the drug fitting in from there?

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: Yeah, I mean, so just to go back to the comment about the HER2 study results, I mean, as an oncologist and previously a breast medical oncologist, I would feel compelled to share those results with my patients, to give them, you know, that option to have that conversation. The results of DB09 are quite compelling. You know, will it be used with birtuzumab, which is the arm that read out, or alone that remains to be seen? So I think that there is going to be broad adoption just because of the results. There’s also a lot of familiar the oncologists are quite familiar with using Enhertu because it’s been on the market for breast cancer for a while now.

So they know how to manage those toxic effects. So I don’t think there are major hindrances to the uptake in the The one thing that we are hearing is how long do I need to keep patients on? Do I need to keep them on all the way until they progress, the way the trial was designed, or can I give them a break because it does have a cytotoxic payload, it does have cumulative toxicities, and patients may want to break? So that’s a possibility. We’re still waiting to see how, you know, it’s going to be used.

Now for the three zero three trial, it is designed to address both scenarios.

Phil Johnson, CFO, Jazz Pharmaceuticals: So

Amal Gobatrand, VP Oncology Therapy Area Head, Jazz Pharmaceuticals: they must have received TDXD. Doesn’t matter if they receive it in the front line or second line, there’s no specific order. And they either must have progressed following TDXD, or if they’re intolerant to it, they can also come in. So that other scenario where they discontinue TDXD because they can’t tolerate it, they would still be eligible for the trial. So we should be able to address that.

Mohit Bansal, Biopharma Analyst, Wells Fargo: Awesome.

Unidentified speaker: Thank you very much for this.

Mohit Bansal, Biopharma Analyst, Wells Fargo: So maybe the like the rest of the oncology portfolio at this point, starting with Zepzelca. So I mean, this market has become a little bit more competitive, but again, you will have a label update as well. So there are pushes and pulls going forward. So how should we think about the portfolio or the Zepzelca growth going forward? Because you have first line coming in, but second line, you have a lot more competition.

Phil Johnson, CFO, Jazz Pharmaceuticals: Yes. I think it’s an exciting time actually for physicians treating small cell lung cancer. I think one of the physicians at one of the sessions at ASCO had said the data that was presented both first line maintenance as well as in the second line represented more advancement in those three hours than it has seen in the prior thirty years. I think both in the first line maintenance setting with Sebselka in combination with atezolizumab, really pleased with the progression free survival and overall survival benefit that was shown. Certainly very hopeful that, that would receive first cycle approval and become standard of care in that setting.

And then also, tarlatumab has very strong second line data also with an OS benefit, and we probably expect that in that setting to become standard of care and pretty widely utilized over time as well. So really pleased we’re able to contribute to this advancement that’s being seen in small cell lung cancer patients and that for us it’s in that first line maintenance setting, which should allow us the opportunity to treat more patients and for a longer duration of time.

Mohit Bansal, Biopharma Analyst, Wells Fargo: Got it. Very helpful. So last couple of questions. One is on the operating expenses, right? I mean, exciting times, but at the same time, you have a lot going on.

So you have been very disciplined this year. How should we how are you thinking about managing margins, expansions as well as expansion opportunity that exists in your portfolio right now?

Phil Johnson, CFO, Jazz Pharmaceuticals: I’d say, first and foremost, while we are cognizant of margins, we’re most focused on the investment side of it. So if we’ve got really strong investments to make in the R and D pipeline, we will make those. This happens to be a year where we’re seeing a pretty significant reduction in R and D expense as we had the three eighty five trial read out negatively last year, so no longer investing in that program. And we had just based on enrollment timing and some of the way that those enrollments were structured higher expenses versus any data map last year than this year. So we’re absolutely focused on identifying whether they’re internal to Jazz currently or coming in from the outside, additional programs that we can invest in that could lead to significant advances in patient care and spending behind those.

But I think you’ll see a disciplined approach. If we don’t have those opportunities, we’re not going to spend on low likelihood or low impact trials. And the SG and A, I’d say G and A, there’s a strong emphasis to ensure that, that is managed very tightly. And selling and marketing expenses go with the opportunities that we have in the portfolio. So really pleased we completed that Chimerix acquisition, had the doravaprone or Modesto approval before the PDUFA date.

We’re clearly investing to make sure that we’re successful in commercial uptake, payer access, etcetera. So you’ll see increases in expenses in the second half of the year due to that. So again, the approach will be to be focused on driving value with assets. The margin will sort of come out of that. We do want to look for ways that we can leverage existing infrastructure that we have.

So for example, it would be great now that we’re going to be in pediatric brain cancer. If we can find other ways to leverage some of those same resources and relationships, we’ll be building with additional assets over time. That’s a really efficient way to scale the business. So if you can find those opportunities, we’d love to prosecute those. Similarly, building out the epilepsy franchise beyond what we have with Epidiolex, the SANEONA licensing agreement that we just recently announced, other potential corp dev as a way to leverage existing infrastructure to very efficiently utilize it, drive margin expansion.

Mohit Bansal, Biopharma Analyst, Wells Fargo: Got it. And then BD side of it, right? I mean you have been active, but it seems like what you have traditionally done versus now, you are kind of focused on your areas and you are just trying to build leverage on your existing franchise. At this point, I mean, do you think you have enough or you are still out there looking for something?

Phil Johnson, CFO, Jazz Pharmaceuticals: There are certainly significant opportunities in rare oncology. There is quite a bit of really interesting science in epilepsy space. I would say objectively, beyond orexins, there’s not a lot going on in sleep currently. And we do have a strong interest in looking for other rare diseases that we could participate, apply our accumulated expertise and knowledge. You have not seen us yet transact there, but we certainly have been looking for opportunities, and that is a potential space where you can see us announce a licensing transaction or acquisition in the future.

Mohit Bansal, Biopharma Analyst, Wells Fargo: Awesome. So now to the my favorite question of the day. One year down the line, next year, Wells Fargo’s conference. You are here. I hope you are here.

I hope I am here, too. And if I ask you, like, same question that I asked, like, what would make you very happy looking back at the year and say, this has been a great year?

Phil Johnson, CFO, Jazz Pharmaceuticals: So at a high level, in our industry, there’s sort of two main things that like it’s maybe one main thing that changes stock price, which is changing expectations. And two main ways you really do that in our industry: one is by having outstanding clinical data and the other is by outperforming on launches. And we have the opportunity to do both of those upcoming with the upcoming first line GEA readout with zanidatumumab as well as with the launch of Modesto. So I’m hopeful that a year from now, we’ll be talking about how both of those have outperformed expectations and have the potential or are realizing the potential to really change standard of care for patients with these diseases. I also expect and hope we’ll be talking about some of the tweaks that Renee will have brought about as new CEO in Jazz and how we’re implementing on that strategy as well.

Much more to come, I think, in terms of what we can do with some of the internal development of our molecules. And then we have a very strong position to do additional corporate development with the cash flow we generate, the resources we’ve got in hand already on the balance sheet, 1.7 at most recent quarter end, so we’re very well positioned to continue to build our business for future growth.

Mohit Bansal, Biopharma Analyst, Wells Fargo: On that high note, thank you very

Phil Johnson, CFO, Jazz Pharmaceuticals: much for joining us today. Thank you very much for having us. Really appreciate it. Thank you.

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