Q4 2024 Jazz Pharmaceuticals plc Earnings Call
Thank you for watching. Bye.
Jeannie: Thank you for standing by. My name is Jeannie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals fourth quarter 2024 webcast. All lines have been placed on mute to prevent any background noise.
Jeannie: We encourage you to review the statements contained in today's press release, and our slide deck and the risks and uncertainties described under the caption risk factors in our annual report on Form 10-K for the fiscal year ended December 31, 2023 or.
Jeannie: Our quarter report on Form 10-Q for the quarter ended September 32024, and our subsequent filings with the SEC, including our annual report on Form 10-K for the fiscal year ended December 31, 2024, which identify certain risk factors that may cause the company's actual events performance and resolve.
Jeannie: <unk> to differ materially from those contained in the forward looking statements made on today's webcast.
Jeannie: We undertake no duty or obligation to update these forward looking statements.
Jeannie: As noted on slide three we will discuss non-GAAP financial measures on this webcast descriptions of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP financial measures are included in today's press release and a slide presentation available on the investors section of our website I will now turn the call over to Bruce.
Bruce: Thanks, Jeff Good afternoon, everyone. Thank you for joining us today to discuss <unk> fourth quarter and full year 2024 results I'll start on slide five.
Bruce: I'm very pleased to report that 2024 was another record year for jazz our strong commercial execution resulted in more than $4 billion in total annual revenue in fourth quarter revenue of nearly $1 1 billion our highest ever.
Bruce: Importantly, we helped more patients who benefit from our highly differentiated therapies in areas with limited or no therapeutic options. These achievements reflect the tenacity and dedication of our talented employees around the world.
Bruce: On the R&D front, we achieved several important development and regulatory milestones in 2024 headlined by the accelerated approval of <unk> ore in the U S for the treatment of second line her two positive biliary tract cancer or BTC in November.
Bruce: In addition, we believe the positive results from the Phase III <unk> clinical trial in first line maintenance for small cell lung cancer will support expansion into an earlier line of treatment potentially benefiting a broader patient population.
Bruce: We plan to further diversify our commercial and pipeline portfolios through strategic corporate development, which remains a key focus for jobs.
Bruce: As part of our ongoing search, we're evaluating neuroscience and oncology assets, while also contemplating other rare and orphan diseases.
Bruce: In addition, durability of revenue efficiency of commercial call points and alignment with our expanded R&D capabilities are part of our considerations as we assess opportunities to maximize long term shareholder value through corporate development.
Bruce: Turning to slide six I'm pleased to confirm we achieved our 2024 guidance delivering topline growth at the upper end of our range at 1.3 dollars 7 billion and adjusted net income on a non-GAAP basis Bill.
Bruce: Bill will discuss our 2024 financial results and 2025 guidance in more detail later in the call.
Bruce: On the commercial front, our sleep epilepsy, and oncology portfolios are each annualizing at over $1 billion base.
Bruce: Based on fourth quarter net product sales.
Bruce: <unk> remains the number one branded treatment for narcolepsy based on revenue and the only FDA approved therapy to treat idiopathic hypersomnia or IH.
Bruce: We've been pleased with our execution across narcolepsy NIH as our team has navigated the entry of high sodium fixed dose branded ox abate and authorized generic or AG competition since their introduction in 2023.
Bruce: <unk> net product revenues grew 15% in 2024 compared to 2023 and it is poised to reach blockbuster status. This year.
Bruce: Oncology revenues grew 9% in 2024 to a record of more than $1 $1 billion, even with changes to pediatric protocols, which temporarily impacted <unk> revenue in the second half of 2024.
Bruce: We're unable to discuss our commercial performance in greater detail.
Bruce: Overall, our 2024 total revenue grew 6% compared to 2023, reflecting our strong execution of the commercial strategies we are implementing.
Bruce: We continue to advance promising opportunities in our pipeline, we look forward to the data readout from the horizon <unk>, one phase III trial evaluating <unk> in first line gastroesophageal adenocarcinoma or gea while.
Bruce: While we had previously provided an estimate of the second quarter of this year for top line progression free survival readout based on our more mature projections of events accrued to date, we now expect data readout in the second half of this year.
Bruce: Rob will share additional color on this trial a bit later in the call.
Rob: The first slide BTC confirmatory trial.
Rob: <unk> III breast cancer trial, and phase II Pan tumor trial are all progressing well.
Rob: In addition, we plan to submit a supplemental new drug application or asset in D. A preserved zilkha as maintenance therapy in first line extensive stage small cell lung cancer in the first half of 2025.
Rob: We remain focused on driving growth, while maintaining a disciplined and strategic approach to capital allocation our financial.
Rob: Full strength and cash flow enable us to invest in our commercial portfolio pipeline and future corporate development opportunities.
Speaker Change: Before we move on as previously shared I'll be retiring from my role as CEO This year.
Speaker Change: It's been a privilege to lead <unk> through the growth and significant diversification that has transformed the business into the fully integrated Biopharma company. It is today.
Speaker Change: Importantly, we remain committed to reaching more patients by making strategic investments through corporate development focus that will continue during the CEO transition period.
Speaker Change: After a successor is appointed I'll continue serving as chairman of the board of directors, providing ongoing leadership and strategic guidance.
Speaker Change: I'm confident Jazzes next leader, we'll continue delivering for patients employees partners and shareholders.
Speaker Change: I'll now turn the call over to Renee to discuss our commercial performance after which Rob will cover our R&D pipeline.
Speaker Change: Phil will then provide a financial overview and review our 2025 guidance and then we'll open the call for Q&A Rene.
Renee: Thanks, Chris before I cover individual commercial products I'd like to thank the jazz team for their tremendous efforts across the year, which resulted in each of our promoted commercial products achieving their highest ever annual revenues in 2024.
Renee: Beginning on slide eight and our sleep portfolio, our focused efforts to educate physicians and patients on the benefits of <unk>, including the importance of meaningfully reducing sodium intake continue to resonate in the market.
Renee: View every high sodium oxidate patient as one who could benefit from low sodium sideways as people living with narcolepsy are at a two to three times higher risk of cardiovascular comorbidities, such as stroke and heart failure than the general population.
Renee: In addition results from their rhythm study demonstrated patients with IH experienced a higher likelihood of comorbid conditions across multiple clinical categories, including cardiovascular conditions.
Renee: There were approximately 14150 patients taking sideways exiting 2024, representing approximately 1850 net patient adds compared to the end of 2023.
Renee: In the fourth quarter, there was a meaningful increase of approximately 525 net patient adds comprised of 175 narcolepsy patients and 350 IH patients.
Renee: Total fleet revenue, which includes <unk> xyrem net product sales plus royalties from high sodium oxidate AEG was $506 million in the fourth quarter and exceeded $1 $9 billion for the full year.
Renee: <unk> net product sales grew 16% year over year to approximately one $5 billion in 2024 and were $401 million in the fourth quarter of 2024.
Renee: The initiatives, we implemented at the end of 2023 and throughout 2024, including field force expansion digital and media campaigns and the field nurse educator program, coupled with our jazz care services contributed to both patient demand and persistency across narcolepsy NIH.
Renee: <unk>.
Renee: We believe the IH market, we are building, but the first and only FDA approved therapy to treat IH represents the most opportunities for patient growth and is a durable segment of our sleep portfolio.
Renee: Our field team continues to expand the breadth and depth of Hcp's prescribing sideways for IH by highlighting the significant unmet patient needs and the benefits of treating multiple symptoms of IH with XI ways.
Renee: On slide nine we turn to <unk> with net product sales of $275 million in the fourth quarter, representing a 14% increase compared to the same quarter in 2023.
Renee: For the full year 2024 at the dialects revenue was approximately $972 million up 15% year over year, primarily driven by underlying demand.
Renee: Key drivers of demand growth in the U S. Included continued positive response to data on the benefits of that the dialects.
Renee: Seizure control, reaching adult patients in long term care facilities, along with broad quality access.
Renee: In December we presented nurse reported responses to the become survey in long term care facilities that showed at the dialects treatment was associated with an overall reduction in seizure frequency and improvements in patients' abilities, such as communication cognition and emotional functioning we.
Renee: This continued data generation and increased penetration in the adult patient setting and long term care facilities will drive demand.
Renee: Growth in the adult patient setting is supported in part by data showing many lgs patients reach adulthood without a specific lgs diagnosis and by providing health care professionals with clear diagnostic tools to identify adult lgs patients.
Renee: Whether we believe that the dialects as a durable long lived asset and I'm pleased to share. We recently settled with all 10 current and to filers.
Renee: Under the settlement agreement, we granted each of those anti <unk>, a license to manufacture market and sell its own generic version of that the dialects beginning in the very late twenties thirties or earlier under certain circumstances, we're pleased with the momentum and growth about the dialects and expect it to reach.
Renee: Blockbuster status in 2025.
Renee: Moving to oncology on slide 10, Riley snap product sales were approximately $101 million for the fourth quarter 2024, and approximately $411 million for the full year, representing a 4% year over year increase compared to full year 2023.
Renee: In our third quarter earnings we reported a temporary negative impact to <unk> revenue due to an update to children's oncology group pediatric treatment protocols for acute lymphoblastic leukemia or a L. L. This update impacts the timing of Asparaginase administration pushing back to you separately.
Renee: At least by 10 weeks.
Renee: It's important to note the protocol changes do not change the recommended total number of asparaginase doses and we don't anticipate an impact to underlying demand for riley's revenues are still expected to normalize early this year.
Renee: We see the most opportunity for growth in the adolescent and young adult or a Y a market and we are continuing to educate oncologists, who treat these patients on the benefits of asparaginase therapy.
On slide 11, I'll discuss steps Alka.
Renee: Net product sales for the full year 2024 were approximately $320 million up 11% year over year in the fourth quarter is that Falcon that product sales increased 6% year over year to approximately $78 million.
Renee: <unk> remains the treatment of choice for second line small cell lung cancer, and we continue to hear positive feedback from physicians on its clinical benefits and ease of use and administration for patients in their health care practices.
Renee: Expansion into first line maintenance therapy for extensive stage small cell lung cancer represents an opportunity to extend the duration of treatment, while reaching patients earlier in their disease progression. We plan to submit an S. NDA for <unk> in this indication in the first half of this year.
Renee: Moving to slide 12 to covers that HERA, we had an exciting fourth quarter with the FDA approval of <unk>. The first and only dual her two targeted by specific antibody approved for her two positive second line BTC and the U S.
Renee: Our experienced oncology team swiftly initiated the commercial launch of <unk> following approval and I'm pleased to share that the first BTC patient was treated with Cy HERA in December.
Renee: We recognized approximately $1 million of net product sales and <unk> 24.
Renee: The initial reception from Hcp's has been positive and we have the right capabilities and infrastructure to deliver a successful launch of <unk> in second line her two positive BTC <unk>.
Renee: Physicians currently diagnosing and treating BTC patients significantly overlap with our existing SAP Selco call universe positioning us to leverage our current footprint to help accelerate the launch and uptake of <unk> for second line her two positive BTC.
Renee: <unk> has the potential to deliver greater efficacy outcomes compared to the current standard of care for BTC, while providing better tolerability and safety to maximize patient outcomes and benefit.
Renee: Although BTC represents a small patient population. This initial launch will help establish the HERA with health care professionals and allow them to get meaningful experience with it.
Renee: With that I'll turn it over to Rob for an update of our pipeline and upcoming milestones Rob.
Rob: Thanks Renee.
Rob: I'll begin on slide 14.
Rob: We achieved an important milestone for patients and our company in 2024 with the FDA approval of <unk> in second line BTC.
Rob: Along with the initiation of our first line BTC confirmatory trial.
Rob: Beyond BTC, we significantly advanced standard data Mab development, including our ongoing first line <unk> trial.
Rob: And the initiation of the phase III empower breast cancer trial, and phase II Pan tumor trial.
Bruce: As Bruce mentioned earlier.
We are now expecting the top line PFS readout from our phase III frontline.
Trial evaluating zone data mab with standard of care chemotherapy with or without the addition of a PD one agent.
Bruce: In the second half of 2025.
Recruitment for this trial is on track and we expect to complete enrollment within the next few weeks.
Bruce: As a reminder, this is an events driven trial.
Bruce: Our updated estimate is based on a more mature projection of progression events relative to the initial protocol assumptions.
Bruce: Well, we as the sponsor remain blinded to the results of the trial. We are encouraged by the positive results from two independent phase II trials presented data Mam and first lines that have demonstrated increased median PFS.
Bruce: Duration of response.
Bruce: And confirmed objective response rates.
Bruce: If positive we expect the PFS data from this trial will support registration.
Bruce: Moving to other programs in October 2024, we reported highly encouraging results from the phase III <unk> trial of <unk>.
Bruce: In combination with <unk> compared to <unk> alone when administered as maintenance therapy in first line extensive stage small cell lung cancer.
Bruce: The combination demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of overall survival and progression free survival.
Bruce: The results have the potential to be practice, changing and we look forward to presenting the data at a medical meeting this year.
Bruce: Which is an important step toward potential inclusion NCC and guidelines and compendium listings.
Speaker Change: As Rene mentioned, we plan to submit an NDA to FDA in the first half of 2025 to expand <unk> label to include first line maintenance.
The epic dialects trial in Japan remains ongoing as we collect long term safety data, which was included in the trial design for 26% and 52 week analysis.
Speaker Change: Numeric improvements were observed in the primary and several secondary endpoints.
Speaker Change: And we expect to have substantive discussions with <unk> by mid 2025.
Speaker Change: Turning to slide 15, I'll review the unique clinical profiles of HERA presented data man and why we believe has the potential to become the her two targeted agent of choice.
Speaker Change: <unk> has demonstrated activity in multiple her two expressing cancers.
Speaker Change: It's by powered topic binding results in multiple mechanisms of action, all resulting in tumor cell death.
Speaker Change: Danny has been shown to interfere with her two signaling.
Speaker Change: Which also disrupts hetero dimerization of her two and her three further inhibiting tumor cell signaling and growth.
Speaker Change: <unk> also causes receptor clustering and internalization inducing immune destruction through ADC ADC P and CDC.
Speaker Change: We think that <unk> induces complement dependent cytotoxicity and a level that is highly differentiated in the category.
Speaker Change: <unk> profile includes established safety and Tolerability.
Speaker Change: Ease of administration.
Speaker Change: Single agent activity without chemotherapy.
Speaker Change: Combines well with other therapies, including chemotherapy.
Speaker Change: We believe that a data mab has the potential to be a best in class <unk> targeted therapy for multiple her two positive solid tumors.
Speaker Change: Importantly, <unk> was added to the end CCN and ESMO guidelines for biliary tract cancer after approval as part of an off cycle review.
Speaker Change: Highlighting the meaningful advance of HERA represents for her two positive BTC patients.
Speaker Change: Slide 16 highlights the potential presented data math and BTC and beyond.
Speaker Change: In addition to FDA approval for BTC, the European Medicines agency validated the marketing authorization application presented data map in second line BTC in 2024.
Speaker Change: And we await potential approval as early as <unk> 2025.
Speaker Change: We've already discussed the opportunity we are pursuing in ziyang. Additionally, we initiated the phase III empower trial.
Speaker Change: Which is designed to evaluate <unk> in combination with chemotherapy in breast cancer patients.
Speaker Change: Progressed on or are intolerant to in her too.
Speaker Change: With this ongoing phase III trial, we have the opportunity to be the first her to targeted therapy to demonstrate efficacy and safety in breast cancer patients posted her too.
Speaker Change: We also have multiple ongoing trials in early stage breast cancer.
Speaker Change: Including through our collaboration with MD Anderson Cancer Center, and the <unk> program.
Speaker Change: <unk> monotherapy as shown promising activity across a range of tumor types.
Speaker Change: And we initiated a phase II pan tumor trial to generate additional data across a variety of her two expressing solid tumors.
Speaker Change: Overall, we are incredibly excited about the opportunity that's out of the data amount represents for patients with her two expressing tumors.
Speaker Change: Now I will turn the call over to Phil for a financial update Bill.
Phil: Thanks, Rob I'll start with our topline results on slide 18, as a reminder, our full financial results are available in today's press release and in our 10-K, which will be filed tomorrow morning.
Phil: In the fourth quarter of 2024, we achieved nearly $1 $1 billion in total revenues. We were pleased to deliver this top line growth, which was driven by increases highway of epic dialects and oncology revenues.
Phil: And for full year 2024, we reported approximately $4 $1 billion in total revenues, representing 6% growth over 2023.
Phil: This marks our 28th consecutive year of topline growth and as you've seen in our guidance. We expect 2025 to be our 20 <unk> consecutive year.
Phil: Turning to slide 19, our full year 2024, non-GAAP adjusted net income was approximately $1 37 billion.
Phil: And we reported non-GAAP adjusted EPS of $20 90.
We continue to generate significant cash from our business demonstrating the strength and diversity of our portfolio.
Phil: We recorded approximately $1 $4 billion of cash from operations for the full year 2024 and ended the year with $3 billion in cash on hand.
Phil: Consistent with our prior communications in January we made a voluntary repayment of $750 million.
Phil: To reduce the principal amount of our term loan b.
Phil: During 2024, we continue to utilize our share repurchase authorization and spent approximately $311 million repurchasing shares.
Phil: Going forward, if not used for corporate development investments to enhance our future growth prospects. We expect a significant portion of free cash flow to go towards debt paydown share repurchases or some combination thereof.
Phil: Finally, our overall financial position and robust operating cash flows provide significant flexibility to invest in value driving commercial and R&D programs as well as in promising corporate development opportunities.
Phil: We're pleased to share our full year financial guidance for 2025, beginning on slide 20.
Phil: Our 2025 total revenue guidance range of $4, one 5 million to $4 4 billion.
Phil: Represents 5% year over year top line growth at the midpoint driven by our diversified commercial portfolio spanning sleep epilepsy and oncology topline.
Phil: Topline growth in 2025 was underpinned by our expectation of continued growth of XI wave.
Phil: At the dialogue, reaching blockbuster status and the assumption of the HIFU remarks about AG royalty revenue will continue for the full year.
Phil: As a reminder, if hikma and others enter the market with true generics our AG royalty revenue will go away and we could have rapid erosion of remaining xyrem revenue.
Phil: While we believe we'll be well positioned with the XI wave given it's not 80 rated to all other HIFU remarks debates, including generics the impact of true generic Xyrem on XI wave revenue is uncertain and will depend on a number of factors such as the continued recognition by hcp's patients and payers of the value of low sodium.
Phil: Other dynamics, we anticipate throughout the year include a continued decline of Xyrem revenue and normalization of related revenue early this year.
Phil: We anticipate modest revenues from like Europe, given the small BTC patient population, although our successful DTC launch is key to providing HCP with valuable experience with Sahara ahead of a potential launch in gea.
Phil: Finally, while we don't provide quarterly guidance I do want to note. Our first quarter revenues have historically been affected by several factors, including re authorizations in inventory build in the latter part of the prior year, which can contribute to lower revenues in the first quarter compared to other quarters.
Phil: Now I'd like to draw your attention to several items on slide 21.
Phil: With regard to operating expenses, our non-GAAP adjusted SG&A guidance range is one to five to 131 billion.
Phil: Increase in non-GAAP adjusted SG&A reflects continued investment in our lead commercial products.
Phil: We remain focused on operational excellence and continued execution of our commercial initiatives from last year to further drive growth of our diversified portfolio.
Phil: Our non-GAAP adjusted R&D guidance range of $720 to $770 million represents an 8% decrease from 2024.
Phil: We're continuing to focus investments on priority programs, including the broad Fannie data Mab development program that has the potential to positively impact many patients and deliver significant shareholder value.
Phil: The decrease from 2024 is primarily driven by a reduction in clinical studies and outside service costs relating to <unk> hundred eight five and continued portfolio prioritization.
Phil: On the bottom line, we expect adjusted net income in 2025 to be one four to $1 5 billion. This reflects our expectation of continued strong commercial performance and disciplined expense management, while continuing to invest in our highly differentiated commercial portfolio and pipeline.
Bruce: I'll now turn the call back to Bruce for closing remarks.
Bruce: I'll conclude our prepared remarks on slide 23.
Bruce: 2024 was a record year for our promoted commercial products and we expect to deliver continued strong execution in 2025, <unk> remains poised to reach blockbuster status in 2025, and we expect <unk> to remain the number one branded narcolepsy treatment with continued growth and IH.
Bruce: <unk> represents a significant growth opportunity with an estimated $2 billion plus in peak sales potential.
Bruce: We look forward to submitting the SNB <unk> with the potential to help more patients for a longer duration and extend survival.
Bruce: Our proven strength in commercial and pipeline execution and corporate development are supported by our continued focus on operational excellence and strategic capital allocation.
Bruce: I'm confident <unk> is well positioned to deliver our 20 <unk> consecutive year of topline growth in 2025 drive meaningful shareholder value with data readouts, such as the phase III <unk> trial, and pursue strategic corporate development opportunities to deliver long term sustainable growth.
That concludes our prepared remarks, I'd now like to turn the call over to the operator to open the line for Q&A.
Bruce: Thank you we will now begin the Q&A question and answer session.
Bruce: If you have dialed in I would like to ask a question. Please press star one on your telephone keypad to raise your hand and joined the queue if.
Bruce: If you would like to withdraw your question simply press Star one again.
Bruce: If you are called upon to ask your question and our listening via loud speaker on your device. Please pickup your handset and ensure that your phone is not on mute when asking your question. We do ask to please limit yourself to one question.
Bruce: Again press star one to join the queue.
Speaker Change: And your first question comes from the line of Marc Goodman with Leerink. Please go ahead.
Speaker Change: Yeah, Rob can you talk about the Orexin 441.
Speaker Change: Type of comment you can make have you figured out the safety margin is your low dose kind of doing what you wanted to do.
Speaker Change: Any comments there would be helpful. And then just on the settlement with that <unk> is there any recent European so cagy can you actually give us the date.
Speaker Change: So mark this is Bruce maybe I'll jump in on your second question first.
Speaker Change: We actually think saying our epidiorite settlements with all 10 Endo filers go out to the very late 2000, thirteen's is being pretty specific I'll remind you those agreements have confidentiality provisions, which limit what else we can say so.
Speaker Change: All we're going to have to say at the moment is very late 2000, <unk>, Rob I'll kick it over to you for one update.
Speaker Change: Thanks, Bruce So Mark we don't have an update on the trial that we said we are initiating.
Speaker Change: This is a trial with 441 in <unk>, one patients small number rethought about 10 or so.
Speaker Change: But so far no updates on that but we do think that.
Speaker Change: But even in a small number of patients that will help us define a better therapeutic index.
Speaker Change: No updates at this time.
Speaker Change: Your next question comes from the line of Jessica Fye with J P. Morgan. Please go ahead.
Jessica Fye: Hey, guys. Good afternoon. Thanks for taking my question for the Horizon Gea trial, I think you said, you'll complete enrollment in the next few weeks. So just to confirm is that for the Upsized 919 patient target enrollment can you remind us when you completed enrollment of the originally planned 714 patients.
Jessica Fye: And then I guess, while I'm at it on this trial, Rob when you see the event rate maturing differently than initially projected as it seems to be here do you take that as positive neutral or negative before probability of success. Thank you.
Speaker Change: Go ahead Rob.
Speaker Change: Okay, Hi, Jess.
Speaker Change: So we are referring to the $9 18, when we say we will be completing enrollment.
Speaker Change: In the coming weeks.
Speaker Change: Have you said when the 714.
Speaker Change: Was enrolled.
Speaker Change: As you know we are blinded to.
Speaker Change: The results of the trial and so we can't say what's driving.
Speaker Change: The slower accrual of events, whether that's coming from control arm or the experimental arms.
Speaker Change: Generally speaking.
Speaker Change: Certainly it could be a good thing.
Speaker Change: The experimental arms are having a significant effect and pushing that out, but we don't see the data.
Speaker Change: So we don't know for sure.
Speaker Change: I would say that.
Speaker Change: The control arm, certainly could be behaving differently than prior trials. However.
Speaker Change: We've seen three phase III trials in this setting and the control arm has been pretty consistent across those.
Speaker Change: So I don't expect a big surprise on the control arm, but again, we are we are blinded to that information.
Speaker Change: We have an external vendor who is tracking events and gives us periodic updates.
Speaker Change: But as we've said we're confident in the second half of this year.
Speaker Change: Depending on how the events continue to roll in that certainly could come in and <unk>.
Jason: Your next question comes from the line of Jason <unk> with Bank of America. Please go ahead.
Jason: Oh, Hey, guys. Thanks for taking my question just on M&A, you know you guys seem to be flagging.
Jason: Flagging that again this year and I guess, it's been a dominant part of the jazz investor discussion for a while now but you really havent like swung the bat in a big way six GW and so I'm just kind of curious maybe why that is ultimately if you can reflect on that and then with this epidemic epidiorite patent settlement in place and now having.
Jason: The runway on our $1 billion franchise plus.
Jason: Well into next decade, just how does that alter how you guys think about M&A.
Jason: Having that longevity of assets now.
Jason: So Jason this is Bruce I'll jump in with a little historical perspective, and then maybe I can have Phil.
Jason: Give you a more forward looking view.
Jason: Just as a reminder, we completed the GW acquisition in May of 2021.
Jason: And levered up to some degree to do that and spent some time after that bringing leverage back down quickly and considerably and during that period, we were needless to say not pursuing larger transactions as we had forecast.
Jason: To say, we haven't done anything I think would would forget that we did the zany data mab transaction.
Jason: Rich wallet had a smaller upfront certainly has been a major focus for us in terms of value creation potential of the company. We remain excited about it.
Phil: Phil maybe you could take the part of the question that refers to what we're expecting going forward.
Phil: Bill.
Bill: Sorry, I have a bad connection here. So I was trying to get onto a handheld not use the speaker phone took me a second.
Speaker Change: So Jason as Bruce mentioned, we Deleveraged substantially from the time of the GW deal I think we close effectively at about four nine times net leverage at that point in time as of the end of.
Speaker Change: 2024 that was down to one eight times. So we certainly have significant financial resources.
Speaker Change: Bolstered by the strong cash flow that we generate as well to engage in M&A and licensing activities.
Speaker Change: Various sizes, we do have active efforts looking at each of our verticals to continue to build our growth prospects and those that would include epilepsies, where very long runway with that the dialogue has been and continues to be a strong coin I think could be overall SaaS story.
As well as making it even more attractive area for us to be investing yet so certainly do look at opportunities to build out that franchise further.
Speaker Change: As Bruce mentioned in his prepared remarks, we do look at areas that would be either adjacencies to and in some cases.
Speaker Change: Areas that share characteristics with where we've been successful in the past often we use are more orphan indications more focused call points the ability to add significant value with services. In addition to just product.
Speaker Change: And leverage those capabilities that we've built and honed over the years. So continue to be very active looking I certainly would not take the lack of announcing a large deal as lack of activity or interest in doing things and certainly had commented in the past.
Speaker Change: <unk> expectation of those activities slowing down as we move into the coming quarters.
Speaker Change: Stay tuned we're active in looking do feel there is opportunities that are value to jazz and of patients don't see valuations at this point in time being a significant impediment to transacting in the areas where we're looking.
Speaker Change: So hope that gives you some color.
Speaker Change: Your next question comes from the line of Annabel <unk> with Stifel. Please go ahead.
Annabel: Hi, Thanks for taking my question.
Speaker Change: Just quickly answer the soccer just curious if there was any strange trend.
Annabel: We ended the airway side compressing a little bit.
Annabel: And then what can we expect from <unk>. This year I know you're filing an S. N D. A the approval is not expected to expect until 2026, but.
Annabel: Could we be seeing some Memphis and guideline list.
Annabel: Pendulous thing for this specific indication.
Annabel: Yeah.
Annabel: Yes. Thanks for the question. This is Renee so in terms of what we've seen with <unk>. We have continued to see strong performance I would say typically from Q3 to Q4, we do have a dynamic where there are less buying days for our distributor in Q4.
Annabel: Compared to Q3, we had a similar dynamic in 2023, so that did have some impact I will note, though that as we mentioned on the call. Our sales increased 11% to $320 million in 2024 that was the highest year ever for us that silica and that is what they compare.
Annabel: <unk> entrant in the market with <unk>.
Annabel: As we look at 2025, we mentioned we plan to file in the first half of this year for our first line extensive stage.
Annabel: Our first line extensive stage data.
Annabel: We will not be promoting of course in the first line until we have that approval, we would hope to get on treatment guidelines as soon as we have the data out and available and in a peer reviewed journal, which we're working diligently on and then I would also say that the benefit of course in the first line is to be able.
Annabel: To reach patients earlier in their overall treatment journey. We do believe there is a larger group of patients to access 27000 in first line versus 17000, and the second line and about 70% of those first line patients are extensive stage excuse me.
Also longer duration of treatment in the first line. So we do expect to see growth ends up silica, but again, we won't be promoting in the first line until we have an actual approval and then if I just step back and think about <unk> positioning in the second line.
Annabel: We would expect to see in Delta as a new competitive entrant too.
Annabel: To see some gain in the second line I'd also say, we continue to receive a lot of positive feedback from physicians on <unk> in terms of its clinical benefit the ease of use it does not require extended monitoring or an inpatient stay which is of course different from Intel trusts. So.
Annabel: We do expect to continue to see some strength in <unk> and we look forward to having the ability to promote in the first one.
Annabel: Okay.
Andrea <unk>: Your next question comes from the line of Andrea <unk> with Goldman Sachs. Please go ahead.
Annabel: Thanks for taking our questions.
Speaker Change: Bruce I was just wondering if you might be willing to provide an update on the CEO search and the background or fit that the board is looking for and then in the context of that this ongoing transition.
Speaker Change: As a follow up to the M&A or BD question earlier, how should we think about that that strategy and the timing.
Speaker Change: For a potential transaction to occur this year.
Speaker Change: Yes, thanks for the question.
Speaker Change: I'm not going to give a detailed.
David: David on the CEO selection process other than to say as was true when this was.
Speaker Change: Announced back in December.
Speaker Change: Take our time and get it right we're not in a hurry, we want to make the right choice and the right choices dictated by where the company is today and where we want to take it.
Speaker Change: I will say, we're just starting to.
Speaker Change: Reach out in the marketplace and we're getting positive feedback that the position is an attractive one in terms of where the company is positioned.
Speaker Change: Positioned today, we're obviously coming off a very strong 2020 for NR.
Speaker Change: Excited about our prospects for 2025.
Speaker Change: On the M&A BD side, we're really well positioned right now we've got strong operating results our commercial teams. Our R&D teams are executing well across the board.
Speaker Change: So from an operational perspective, we feel ready to take on.
Speaker Change: Additional programs and more products and as Phil mentioned from a financial perspective, whether it's our balance sheet, our cash on hand or cash flow again, we feel very well positioned to really take advantage of our infrastructure leverage it.
Speaker Change: And continue to add growth opportunities to our business.
Speaker Change: Your next question comes from the line of Troy Langford with TD Cowen. Please go ahead.
Troy Langford: Hi, Congrats on all the progress this quarter and thanks for taking our question.
Troy Langford: Just a really quick one on the opportunity for <unk> in breast cancer.
Troy Langford: About how many breast cancer patients total do you think would fall into that and her to progression or intolerance bucket that.
Erika: Erika potentially address should extra seat in the phase III trial.
Renee: So Renee I don't know if you want to make an overarching comment about the opportunity we see for <unk>.
Speaker Change: Or is there any data, including in breast cancer and then.
Speaker Change: Rob maybe you could talk a little bit more about how we see this fitting into the breast cancer treatment landscape.
Rob: Sure. Thanks, Bruce so as we step back and look at the broader market opportunity.
Rob: Do you see this as a two plus billion dollar opportunity overall, when we look at the indications. We're focused on right now that includes PTC gea breast cancer as well as Pan tumor now BTC, we said.
Rob: <unk> that we expect their revenues to be quite.
Rob: Quite modest there given the very small patient population, but as we get into larger indications such as gea, we'd look at 63000 patients across the U S Europe, and Japan as compared to 12000 for BTC and that as we progress into breast <unk>.
Rob: Can't say, we're looking at more than 150000 patients across those same geographies. So while we haven't broken that up into the different elements. We do feel quite confident that there is a much broader opportunity to go after there Rob.
Rob: Yes, I would just add that hurt.
Speaker Change: Her two positive breast cancer patients in the metastatic setting tend to get multiple.
Rob: Lines of therapy.
Currently that's the Cleopatra regimen, followed by in her too.
Rob: There is an ongoing frontline in her two trial and theirs.
Rob: There is optimism that will ultimately become the standard of care in frontline so whether it be third line plus are second line plus.
Rob: We think with positive results from the trial that we have ongoing.
Rob: <unk> would become the treatment of choice.
Rob: After patients have progressed on inherent too.
Rob: And we think that captures.
Rob: High proportion of patients given that these patients tend to.
Rob: And to be able to go on subsequent lines of therapy.
Speaker Change: Your next question comes from the line of of course Tomorrow with Jefferies. Please go ahead.
Rob: Hi, This is Amy answer Carlos Thanks, so much for taking our question.
Speaker Change: How should we think about the pricing strategy for Danny depending on whether the doublet or triplet arm hidden horizon Gea, if pricing remains consistent how would the outcome of these arms impact your peak sales estimates.
Rob: Renee.
Renee: Yes, I'm happy to jump in there so we have priced at.
Speaker Change: <unk> Hara for BTC with a 28 day cycle WAC cost of approximately $35550 now when we priced it for BTC. There was also a view of <unk>.
Speaker Change: Thinking about gea coming shortly thereafter, we haven't given specificity around gea I'll say the cycle. There is 21 days versus the 28 day cycle for BTC and then the weight based dosing is slightly different for BTC.
Speaker Change: We're looking at more of a average median weight of a patient when we get the 28 day cycle price, but with respect to GE a what we're looking at is a threshold above and below a certain weight you would be going with a certain dose.
Speaker Change: <unk>.
Speaker Change: We're not looking specifically at the doublet and triplet arm.
Speaker Change: And giving.
Speaker Change: Specific guidance with respect to the pricing or the peak what we're really focused on is ensuring that we're able to capture a meaningful opportunity with gea and Thats. Rob had mentioned also a much larger opportunity with breast cancer.
Speaker Change: Your next question comes from the line of Mohit Bansal with Wells Fargo. Please go ahead.
Mohit Bansal: Great. Thank you very much for taking my question and congrats on the progress.
Rob: Rob if you could help me understand.
Rob: The arm C of GE trial, a little bit of detail.
Rob: It seems like in the context of commercial aspect. It is a pretty important given that majority of the patients are PD lone high patients.
Rob: But again this is not powered to show benefit.
Rob: B.
Rob: So it seems like you are looking at does that benefit or herceptin.
Rob: That may be enough. So in that context could you help us understand like how would you look at on sea and how should investors like us look at RMC when the when the data come out.
Rob: The context of a market almost you can thank you.
Rob: So for starters.
Rob: I would say that the proportion of patients for whom the standard of care remains herceptin chemo.
Rob: We think is quite high.
Rob: <unk> hundred 11 trial, we don't think represents the true epidemiology, it's likely that that trial was enriched.
Rob: PD lone positive PD lone positive patients given the ubiquitous PDL one testing when that trial was conducted.
Rob: We also think there's a question around.
Rob: How to define PD lone positive.
Rob: Our pet are all patients with one Cps score of one or higher truly benefiting or would that optimal cutoff be higher and if it's higher.
Rob: It really does drive that proportion of patients who truly benefit from from a PD one down quite a bit having said that we think <unk> has the opportunity to be.
Her two agent of choice, regardless of PD lone status.
Rob: RMB will demonstrate that.
Rob: <unk>.
Rob: <unk> combined with chemotherapy and RMC has the opportunity to.
Rob: To demonstrate that in <unk>.
Rob: In combination Additionally, with because it wasn't that we.
Rob: We haven't spoken to the specific power of a comparison.
Rob: Arm C.
Rob: Fee versus B, and we don't necessarily think of that as being required I mean, certainly for <unk>.
Rob: For the RMC regimen of both <unk> in combo with chemo to be approved it has to be better than the RMA and it also has to be from a broad benefit risk perspective, better than giving XI here, along with chemotherapy and so we'll have an opportunity.
Rob: To look at all of those data as part of this trial and again, we think Sahara will be regardless of PD lone status of the herd.
Rob: Two of choice.
Rob: Okay.
Rob: Yeah.
Speaker Change: Your next question comes from the line of David <unk> with Piper Sandler. Please go ahead.
David: So how are you thinking about <unk> exclusivity runway.
David: Particularly with the label expansion opportunity.
Speaker Change: Personal lines. So that's number one and then secondly to the extent that your own Orexin program doesn't Pan out I guess my question here is how badly do you need to be in the Orexin game. So to speak in other words would you continue to pursue other actions.
David: Or do you feel like there is other areas in terms of M&A and Biz Dev.
Speaker Change: That.
Speaker Change: That you would then turn your focus on just trying to get a better sense of how youre thinking about your sleep franchise to the extent there isn't.
Speaker Change: Orexin that moves forward.
Speaker Change: On your pipeline thanks.
Speaker Change: Where do you want to start on the ZIP So quick question.
Speaker Change: Sure happy to do that so with respect to exclusivity we have a composition of matter patent that extends to December 2029, and then we have additional patent applications that could extend that IAP protection further I don't think we had any.
Speaker Change: Comments beyond that to offer today, but stay tuned.
Speaker Change: And then on your specific question on the erection space. We continue to watch as we all do data emerging from different agents in terms of what we're seeing is the benefits of Orexin therapy, certainly an exciting new mechanism of action.
Speaker Change: Across these serious sleep disorders, particularly with the daytime benefit a little less clear right now whether the benefits at night are positive or whether there are in fact.
Speaker Change: Potential concerns.
Speaker Change: Concerns with.
Speaker Change: What it would do to night time sleep. We certainly believe there is a role for ongoing use of oxalate is a nighttime agent that.
Speaker Change: That helps consolidate sleep and produce additional daytime benefits as we've seen with other daytime agents that are currently available or has been studied.
Speaker Change: In terms of do we need to be in that space were of course interested.
Speaker Change: In the sleep space, where we are a leader.
Speaker Change: We're also interested in other potential areas all across neuroscience oncology and as we've talked about.
Speaker Change: Their disease, where we've got a relevant capabilities. So I don't want to narrow it down to only one area, but we're looking broadly across each of these areas for opportunities that we think would be a good fit.
Speaker Change: Meeting an unmet need.
Speaker Change: Good fit with our capabilities on the commercial side efficient call point.
Speaker Change: Good durability, and an opportunity to diversify and produce sustainable growth over the longer term.
Speaker Change: Your next question comes from the line of Amy <unk> with Needham. Please go ahead.
Amy: Good evening, Thanks for taking my question, perhaps to switch gears to the ultimate franchise could.
Speaker Change: Could you talk about some of the dynamics in the narcolepsy market and how you're seeing them rise impact either your business or the overall market.
Speaker Change: I'm seeing switches from Xyrem or xylene and don't rise or any such facts and then also you know as the <unk> have the ability to launch their own generics at the end of the yeah.
Speaker Change: How should we think about sort of shoring up the xyrem revenues switching them to <unk>.
Speaker Change: And then maybe just sort of what type of payer dynamics, you expect once additional generics come to market and how that might impact <unk>.
Speaker Change: Thank you.
Speaker Change: Yes, I mean that was a multi part question for sure, but Rene maybe you could talk about just what we're seeing in the <unk> space.
Speaker Change: In particular, how we think XI wave has continued to be positioned.
Rene: Yeah, absolutely happy to step through that so I'd say just looking at our full year results in the fourth quarter results that we had were really pleased with what we're seeing with sideways. We had record revenues in the fourth quarter, 19% year over year with 525 pace.
<unk> adds that includes of course, narcolepsy and IH and when we look at where our ads are coming from and narcolepsy, that's coming from both new to Oxidate patients as well as patient switching from high sodium ox abates and that's across all of the high sodium oxalates.
Rene: In terms of how we think about AG. So when we look at 2026.
Speaker Change: Heard Phil earlier say that our assumptions with respect to our 2025 guidance.
Speaker Change: Include the fact that we will be receiving royalty revenues from <unk> throughout 2025. So if we're thinking about the market in that way and of course, we don't know if any authorized generics will decide to launch early that would be if hikma where it is.
Speaker Change: To decide specifically to launch early that would invite other author alright, other generics into the market before early 2026 and in that case for full generics they would need to have their own brands because right now the authorized.
Speaker Change: Generics are distributed through our rounds.
Speaker Change: We look at 2026, what that that looks like is a situation where our ability to continue to drive revenues with XI wave is dependent on the continued appreciation of the differentiation of low sodium and.
Speaker Change: The importance of that to long term health in 2026, if we see full generics on the market since royalty revenues would cease to exist and then we would also expect further erosion of XI Ram, which we do not actively promote and have not app.
Speaker Change: <unk> promoted since we launched XI way.
Speaker Change: We continue to educate on the benefits of reducing sodium including generating important data in this area.
Speaker Change: With <unk> being the only low sodium oxidate and therefore, the only one that doesn't carry a warning related to high sodium oxidate.
Speaker Change: Sorry high sodium intake.
Speaker Change: We can see clearly that physicians and patients are choosing that long term health benefits as well as the flexible dosing that comes with <unk>.
Speaker Change: Maintaining strong payer coverage of course is important throughout this we have the vast majority of our patients that are commercial today, and we had great coverage with more than 90% of commercial lives covered.
Speaker Change: And so we will continue to educate on the benefits of reducing sodium and continue to generate data.
Speaker Change: And we have already shared data that makes it clear that with both narcolepsy and idiopathic hypersomnia Theres, an increased prevalence of cardiovascular comorbidities, including heart failure and stroke compared to the general population. Those findings came from both CB bond.
Speaker Change: And CV rhythms studies.
Speaker Change: So stepping back we will be continuing to focus on strengthening the differentiation of XI ways with physicians customers and payers. We believe we're well positioned for 2026 highway there's not a b rated relative to generics and as we look at the Mark.
Speaker Change: With narcolepsy in idiopathic hypersomnia, we see the most opportunity for growth with idiopathic hypersomnia, we're continuing to build that market, but we're still early very low penetration currently and definitely additional room for growth.
Speaker Change: And I'll just jump in to remind people of that.
Speaker Change: Percentage of our revenues coming from the.
Speaker Change: The high sodium business the old Xyrem branded sales in AG are royalties has continued to decline over time now probably in the latest quarter, maybe dipping below 10% for the first time.
Speaker Change: Yeah.
Speaker Change: Your next question comes from the line of Gary Nachman with Raymond James. Please go ahead.
Gary Nachman: Thanks, Good afternoon.
Gary Nachman: 2025 guidance you didn't break down the revenue components. Specifically this time. So can you give us more of a sense of how you expect the neuro and oncology franchises to trend relative to the overall revenue growth of 5% that you said this year.
Gary Nachman: And then just the R&D as you're scaling back it expenses relative to last year down 8% just talk more about the re prioritization of the pipeline and whats the right level of spend going forward for R&D as a percentage of revenue. Thank you.
Gary Nachman: Yes.
Gary Nachman: Phil.
Gary Nachman: Yeah.
Gary Nachman: Yes, I'm happy to.
Gary Nachman: So on revenue it might be helpful. As you think about the pushes and pulls for the year sort of step through.
The various products may start with the larger ones first and work my way down.
Gary Nachman: So XI wave as Renee had mentioned really strong momentum growing 18% in the full year last year and 19% in the fourth quarter.
Gary Nachman: Really strong net patient adds 525 in the fourth quarter, so well positioned for continued growth. There. Similarly up the dialogue really strong momentum against 15% growth for the full year of 14% in the fourth quarter and well positioned to reach blockbuster status.
Speaker Change: 2025, I'm very pleased with.
Speaker Change: Longevity of that franchise moving forward.
Speaker Change: <unk> a.
Speaker Change: About 4% growth for the full year relatively flat in the fourth quarter, reflecting the negative impact that we mentioned in the second half of 2024 coming from the Cogs Protocol change, where we continue to expect revenue to normalize early this year.
Speaker Change: <unk> again, 11% growth for the full year that did dip down to 6% in the fourth quarter in part for the number of days that we had for shipping as Rene mentioned, we feel really good about prospects for <unk>.
Speaker Change: When we get the first line maintenance indication include new treatment guidelines get it into the label when approved by FDA.
Speaker Change: And in the interim we may see some weakness in <unk> sales as adulterer gained share in that second line plus setting.
Speaker Change: Does it tell you really strong growth, particularly in the second half of the year in the U S.
Mentioned in the past, we're monitoring that situation to understand how much of that uptick you saw in the second half is sustainable.
Speaker Change: Providing a new base for the product.
Speaker Change: How much of that may be.
Speaker Change: Transitory and it's really relates to use of tusa mab.
Speaker Change: Prepare patients.
Speaker Change: For their procedures that can lead to an increased incidence of Vod. So again, we'll see in coming quarters, if that's durable.
Speaker Change: And then on the.
Speaker Change: So remarks abate front as Rene mentioned, if you think about the AG royalty revenue that nearly tripled in 2024 compared to 2023 that was largely due to the significant increase in the royalty rate in late 2023, as well as additional volume coming through that channel in 2024.
Speaker Change: With that royalty rate increase now fully annualized growth about royalty revenue should moderate accordingly in 2025, and then finally XI around.
Speaker Change: Revenue was less than half in 2024, when it was in 2023 with revenue coming down 59%. So mathematically the drag from lower Xyrem revenue has to moderate in 2025 would be a bit of a.
Speaker Change: <unk>, if you will less of a drag on growth this year than it was last year. So that gives you some color across the portfolio in terms of R&D spend.
Speaker Change: Mentioned at the very end of your question, Gary the sort of percent of revenue, we're not necessarily thinking of it in that way, we do think.
Speaker Change: We have some very good opportunities, particularly with Fannie data mab that make a lot of sense to invest behind and we've got those great investment opportunities, we will fund those and that will cause the.
Speaker Change: Funding level as a percent of revenue to moderate up or down depending on how many of the opportunities that we have.
And.
Speaker Change: Mentioning of cortex, and prior answer to questions on some of the prioritization on R&D really reflects some of the Readouts. We had last year 305 to certain extent 150 as well.
Speaker Change: Those are programs from no longer investing behind given those outcomes.
Speaker Change: We do expect to be active in corporate development activities that certainly would add to our portfolio and could bring in a promising additional assets to invest behind so that can lead to additional uptick and then we will see as we go forward with the data readouts with any data Mab and we more fully talk about the full program of how to invest behind that asset to drive the most value.
Speaker Change: For jazz and impact the most patients sort of additional investments that will come there, but those would be some of the pushes and pulls that site.
Speaker Change: Hum.
Speaker Change: No.
Speaker Change: Your next question comes from the line of Gregory <unk> with RBC capital markets. Please go ahead.
Gregory: Hi, guys. Its an issue on for Gregg. Thanks for the updates this quarter and for taking our questions. As you look at <unk> phase III topline now guided for the second half how should we be thinking about timelines for subsequent analyses, including the second and third in term overall survival analyses and quickly on <unk>, what levers can be pulled or hangups removed.
Gregory: To enhance uptake across the treatment segments. Thanks, so much.
Speaker Change: Rob why don't you start on.
Gregory: On the zany data mab.
Speaker Change: Readout timing and then Renee you can comment on at the dialogues.
Gregory: Yes.
Speaker Change: The projected readout that we just provided is based on progression events and at the time of that PFS analysis, we would have the first interim analysis for overall survival.
Speaker Change: So as you've seen as you see that timeline gets pushed out of course that also allows for greater maturity and overall survival. So we'd expect more maturity of that first interim than we might have had.
Speaker Change: If the readout we're sooner.
Speaker Change: Again, we're not referring specifically to the pace of overall survival events.
Speaker Change: So this.
Speaker Change: This new projection.
Speaker Change: Has no implications for the second survival analysis or the final.
Speaker Change: Three in total.
Speaker Change: And then I'll jump in on the <unk> question. So I would say, we're really pleased with the growth that we're seeing we do have a.
Speaker Change: Quite a bit of runway now that we're really excited about and clothing that GW transaction, we were quite confident and.
Speaker Change: Durability and long live nature of this asset and we're pleased to be at a point now where we can have greater clarity on what that looks like so as we look at what's driving the increased growth right now and what we'll continue to lean into it.
<unk> is highly differentiated and that's supported by the data that we've generated for both seizure of non seizure benefits and that data really resonates with physicians as well as the caregivers we have great momentum in the adult in long term care setting and that's an area, we're making investments in the breadth and quality of our acts.
Speaker Change: <unk> continues to improve and that's having a positive impact as we see pull through.
Speaker Change: Uh huh.
Speaker Change: Excuse me persistency has always been a hallmark of this brand and we're seeing great impact even additional benefit to persistent see-through nurse navigator programs and we're also piloting new programs within this this area, where we're seeing some early success.
Speaker Change: Highly targeted consumer ads and also things like we've added virtual account manager position. So this is an area, where we continue to learn and we're really thrilled with the results that we're seeing.
Speaker Change: Your next.
John Lee: <unk> comes from the line of John Lee with Truth Securities. Please go ahead.
John Lee: Congrats on the quarter and thanks for taking the questions. This is awesome one for June just a couple from us.
I know you haven't updated us completely on the four for one program, but what are you thinking in terms of the amount of dose reduction.
John Lee: And just going off of David's question earlier around how much longer could depending patents for subs alka extend exclusivity beyond December 'twenty 'twenty nine thank you.
John Lee: So I hate to do this to you on the last question, but I don't think we're going to provide additional information.
John Lee: On either of those you know obviously, we've talked about the ability to go to.
John Lee: A lower dose in in patient study in healthy normals on four one so that's one of the things we're exploring even in a small number of patients and then on <unk>. We don't have specific additional information on.
John Lee: And what that could mean in terms of.
John Lee: Longer exclusivity for that agent at this point.
Bruce <unk>: That concludes our Q&A session I will now turn the conference back over to Bruce <unk>, Chairman and Chief Executive Officer for closing remarks.
Bruce <unk>: Yes, Thank you operator, and I apologize to the couple sell siders, we didn't get to we were giving our best shot to get through everything.
Bruce <unk>: Hopefully we'll talk to you later this evening I'd like to just close today's call by recognizing our jazz colleagues for their efforts and thank our partners and shareholders for their continued confidence and support and thank you all for joining us today.
Bruce <unk>: This concludes today's conference call you may now disconnect.
Bruce <unk>: [music].