All right. Welcome to the 41st annual JP Morgan Healthcare Conference. My name is Matt Bannon. I'm a banker here at JPM. I'm really excited to be setting the stage for our next presenting company, Aurinia Pharmaceuticals. On behalf of Aurinia, we have CEO Peter Greenleaf. Peter, the stage is yours.
Well, thanks, Matt. Thanks to JP Morgan for having us here at the conference this year. Looking forward to the next 40 minutes or so between the presentation and the Q&A to update you all on our progress as a company as we enter the new year. We've had some good news entering it, so I look forward to updating you on all fronts for the company. Before I do, of course, I wanna just point you to our forward-looking statements, and as well for our most recent filings with the FDA to just point you to our site at auriniapharma.com in our investor section there. If you don't know who the organization is, a good place to start is we're a fully integrated biopharmaceutical company at this stage.
When I joined four years ago, we were a development- stage company, our progress has taken us to a point where we're cutting across all the paths that I think pharmaceutical companies try to get to. I think we've built at this stage a very strong foundation for future growth. Our mission, as many companies are, is to transform the lives of the patients that we serve. Today, for us, that's in lupus nephritis. I'll talk a lot more about that. More broadly, as we think about pipeline, it's autoimmune disease. Our first commercial asset, a product called LUPKYNIS, voclosporin is the generic name, was approved and launched almost to the end of this month, two years ago.
This year, we just produced our unaudited financials for the end of the year and produced about $103.5 million for year-end 2022. I'll get into how that translates to 2023 as well. The company's been built with an executive team that has broad-based leadership experience, whether it be at small pharmaceutical companies and biotech, large pharmaceutical companies, building companies inorganically or organically, research and development, and commercialization. Feel very comfortable that we have a leadership team that's been doing this for some time. Our product, LUPKYNIS, is partnered outside the U.S. with our partner at Otsuka, who has the EU responsibility for the product. I'll talk about how their progress has been as I go through the deck.
It's a basic upfront, and then royalty-based structure. We do the manufacturing for them, and it's a cost-plus arrangement on manufacturing. Talk more about that as I go through. We have an emerging pipeline that we've been building over time. About four years ago, we were only a single asset company, but we've brought in a couple of early-stage programs that have been progressing nicely. I'll talk about those. In a tough financial market, which we've all been talking a lot about here and hearing about, we stand today with end-of-year cash balance of just around $390 million in cash and cash equivalents, and we have no debt on the books. Our projections for 2023 are about $120 million-$140 million in revenue, net revenue to the company.
The star of the show here today really is our product that's been approved. It's called LUPKYNIS. It's a calcineurin inhibitor. Our first approach with the product was to go after a offshoot of the disease of lupus. I think the place you have to start to understand lupus nephritis is first with what SLE or lupus actually is. It's a multisystem, multi-organ disease, so patients unfortunately suffer with a lot of different symptoms. Approximately 300,000 patients suffer from lupus in the U.S., we believe, for lupus nephritis, which is the most complicated and the most serious impact of lupus.
When patients progress on to kidney involvement, this is when they are much more apt to move to chronic kidney disease, move on to dialysis, potentially for even transplantation, and have a much higher risk of death. The outcomes, if you treat the disease aggressively, patients can do just fine. There has been a gap in terms of new therapies here. This is classically the disease of lupus nephritis has been treated with a mix of generic products, steroids and other autoimmune, other inflammatory inhibitors, such as MMF. SLE, as a surrogate, it disproportionately affects people of color and women of middle age. If you look at LN in terms of its burden, it. Basically, lupus nephritis accelerates nephron loss in patients.
If, in fact, this happens and it's not treated aggressively and found early, these patients end up with bad outcomes. You can see here up to a 45 times higher increase of kidney failure in these patients. They end up on dialysis if they're not treated aggressively. There are other common associated diseases, higher risk of heart conditions, and, of course, of premature death. The obvious offshoot of these things, if they progress on to these complications, is that there's a huge economic burden to the disease. In our world, we often get the question of, you know, "How does your coverage look with payers?
Do payers resist your product coming into the market?" I think our payer group out there and the physicians we deal with every day understand there's a huge both economic and clinical burden from lupus nephritis. Important to understand what the goals of therapy are. What the slide you see up in front of you is just taking an aggregate of the three largest bodies of guidelines that are out there today. That's the KDIGO guidelines, the American College of Rheumatology guidelines, and then the European EULAR equivalent of guidelines. The oversimplified goals of therapy are with an SLE patient, you should be taking a urine screen, a urine dipstick test on every visit.
When they have elevated proteinuria, to aggressively treat to reduce that below 1 g and to do it at at levels and as quick or at time periods as quick as three, six, and one month. Why is this important? It's important because when you look at the data that's out there's limited data on the host of generic products that are out there. On the newly launched products, if you're trying to achieve this goal, it's hard to do it with the data that's out there for certain compounds. With our product, obviously, we've been able to not just reduce these levels and do it more significantly, which I'll get into, but to do it quickly, which is an important goal of therapy.
There's a huge need, not only driven from what we know about the clinical burden, but what you're seeing up in front of you is in Optum Healthcare, which is one of our, one of our payers out there in the market space today that did a patient record study between a five-year period of 2015 to 2019 of 150,000 unique patients diagnosed with SLE and over 100 million individual discrete records, right? This is a significant patient sample. This gets to, as we've talked about in some of our quarterly calls, why the market actually needs to be developed. If you look at those patients with SLE, 50% of them are not even screened today through these patient records for lupus nephritis. They come in, their patients...
The patients are observed on their symptoms. 50% of them are not even getting urine screens, right? Huge element or percentage of the patients that aren't could be undiagnosed out there. Those patients coming in are only 1%-2% are monitored regularly, meaning they come in when they have symptoms. There's not active protocols in place to monitor them outside of the office. Shockingly, over 70% of these diagnosed patients go untreated. Even the ones that have elevated proteinuria end up not getting drug therapy. This is prior to even having drugs like our drug or other newly approved therapies in this space.
50% of those patients end up progressing on, even those that are on the therapies available in this time period end up progressing on to end-stage renal disease at one year. When we think about the call to action here, what we need to do, it's not just about our product, but we have to change the way this disease is viewed, and more importantly, how aggressively physicians and patients both seek treatment and treat to the guidelines that are set out there in the marketplace by the academicians and thought leaders that build the guidelines and really look hard at the data that's out there. If you don't know much about LUPKYNIS, this is sort of the payoff of the message, how we fulfill these needs very closely.
The product is a new molecular entity, it was built off the backbone of previous calcineurin inhibitors. More specifically, it's a one- amino acid chain difference to the chemical structure. Basically, by this amino acid modification, it's given the product a dual mechanism, one that does a very highly effective job at immunosuppression, and the other that we believe helps to stabilize podocytes, hopefully helping to provide a healing effect into the kidney. In the data that we've produced today, we see a triple the chance of complete response with LUPKYNIS. In our studies, both in our phase two studies and our phase three studies, the control arm that we utilized was a standard of care. For the active treatment, we actually combined LUPKYNIS with the standard of care.
By doing that, we saw nearly a 51% improvement in terms of the lowering of proteinuria in these patients. More importantly, that it does this very quickly. Does it at six months, we see significant improvement. At one year, we see a significant improvement. Our initial approval and label was based on one-year data. As I'll get into, we've actually produced three-year data through the extension of this trial that was preplanned in our phase three study.
Not only does the product work in a very diverse group of patients as just evidenced through the primary outcome, if you break apart the patients that we see, as I said earlier, the majority of patients that suffer from this disease are African American patients, Asian patients, and Hispanic patients of middle age, females. If you break apart how we actually work in whether it be Black patients, Asian patients, or Hispanic patients, you can see that we have even greater response numbers in patients of color. Regardless of the segment of patients, regardless of the stage of disease or the patient demographics, this disease or this drug performs exceptionally well.
If you look at the speed, which, going back to the guidelines, remember, we're trying to hit goals as early as three to six months, and optimally by one year, hitting your maximized effect of proteinuria reduction. You can see a 50% reduction in UPCR, as early as one month over the standard of care, and as high as, you know, two and doing it, sustained through the end of our study. At three and six months, seeing significant reductions, 2 times faster than that, than the standard of care. If you look at the extension study we did, we took this large study, and then we had, a two-year extension on top of the baseline one-year data that we had, and we looked at two major things.
One being, how did the product continue to perform on holding and sustaining the right levels of proteinuria in the urine? Then second, how's the kidney functioning? First generation CNIs, there's always been a belief, and that belief I think, has been substantiated through the transplant area, that at very, very high doses over long periods of time in transplant patients, the calcineurin inhibition can cause nephrotoxicity. It's clearly a question of, well, if I treat patients with this drug, will I see a degradation of effect on the patient's kidneys? At least as measured out to three years with the doses we're using by eGFR, you don't see effect in terms of degradation of kidney function by eGFR. You see stable eGFR over a three-year period.
Of course, when you're looking at that alongside of the efficacy, how actually we're doing in terms of controlling proteinuria, you can see whether it be eGFR or UPCR, we're sustaining the effects of the drug all the way out to three years. I will tell you that at least at this stage of the game, we're the only drug that has produced data out to this period of time. In this study as well, you asked the question, well, now you're taking low-dose steroids, you're taking MMF, and you're adding to the equation yet another immunosuppressive agent. The major question should be, well, can you do that, get efficacy, and do it in a world where you're not in any way compromising the patient in terms of safety?
Whether you look at our phase II study or our phase III data, at least within our in both studies, we saw a comparable profile for voclosporin to the current standard of care. Infection rates, minor complications to patients across the board. You're getting greater improved efficacy, a doubling of efficacy, with no discount in terms of the impact to patient on the risk side of the equation. Our goal in launching the product was pretty simple, but a lot of complexity to get there. Our goal has been to establish LUPKYNIS as the new standard of care in the treatment of lupus nephritis. I think the entry card to that, it's a, it's a big ambition, but it's how we studied the drug.
We studied the drug in a diverse population, and we set it up right as a current standard of care. By doing that, we know we have to create sense of urgency on diagnosis. I showed you data where there's not this great sense of urgency with rheumatologists today to aggressively diagnose patients with this disease. The first thing you have to do is create the demand for understanding impact of the disease and doing a much more aggressive approach to diagnosis. In line with that, you know, making sure that as we see the evolution of guidelines, that we become a major part of that. Patients are a big part of this equation.
If you think about lupus, and it's the fact that it hits multi-organs and the symptoms that result from that, patients can experience joint pain, they can experience skin interactions, fatigue. These are symptoms that impact the daily functions of patients' lives and how they live. Well, when they have elevated proteinuria, there's no outward symptom or effect on patient's quality of life until it's too late. We have to educate more physicians on the burden. I think they know it, but I think they need to treat more aggressively towards the guideline targets and towards what the impact actually is from a data-driven standpoint to patients if they're not treated aggressively.
The other side of that is we've got a patient population that has to understand that outside of these life-changing symptoms that they have, they could have underlying disease that's progressing to a point that could put them at a much higher risk for kidney loss. If they're at a much higher risk for kidney loss, they're at a much higher risk for even mortality. We have to start to, in the appropriate way, educate patients on the importance of early diagnosis, more routine management, and getting in to see your physician more frequently. We have to differentiate the product, and that's across the total, right? We have really strong data with this product, but it has to be positioned against the guidelines.
It has to be clearly differentiated at the molecule level and from a data standpoint against first generation calcineurin inhibitors and as well, emerging therapies. Today, that might be BENLYSTA, in the future, obviously, and we hope this for patients, there'll be competition. We have to ensure that the rapidity and the magnitude of our response are clearly seen by physicians and differentiated. Trial needs to turn to adoption. Obviously, we've had real good trial with the product up to this point, we need to move that to more standard of care type adoption. We're concentrating that on high decile physicians. This is clearly an area, like many others in our industry, where the 80/20 rule applies, 80% of these patients do see a concentrated group of nephrologists and rheumatologists.
That's where we need to set up our beachhead. lastly, we need to support the patient stay on drug and adhere to drug therapy over time because really their kidneys, they count on it, and it will drive and improve longer- term outcomes for patients if we can continue to work on persistency. This is a task that, yes, it'll be driven through the physician, but it also needs to be driven at home To the patient. if you look at creating a sense of urgency in driving this earlier diagnosis and treatment, we're doing it across a host of different tactics.
That's everything from, you know, 150 customer-facing on full-time equivalent employees in the field covering medical affairs, direct sales, corporate accounts, reimbursement support specialists, but also tactics that cross other channels, whether it be online to web-based education, major medical meetings, data production, continuous data production. It's always critical for us to go into ACR and ASN with new data to talk about, whether it be about burden of disease or our drug's impact on it. Guidelines in the future across the full complement of communication channels, we're trying to drive greater sense of urgency for treatment. That's not just with the physician, it's also with the patient. We have currently in place a host of different patient education programs, both online and through fulfillment.
If they attend some of our programs, we support them with education materials, but also with new education campaigns that we're looking at, whether that be through celebrity-type endorsement or like our currently launched disease state activation campaign, where we're trying to drive patients to understand the urgency to even ask physicians for urine screens when they go in to visit their rheumatologist or the nephrologist. Doing that in a way that, as our ad says up here, "Peeing in a cup sucks," but listen, hey, if you don't like it, like, the outcome of not doing it can be a lot worse, like losing your kidney. There's a subtlety to the cuteness of the message that gets across a very important message.
Patients with lupus need to take very seriously that when the kidney becomes involved, that their disease has progressed to a point where it can have much worse outcomes, and they need to take that seriously, get on aggressive therapies, also adhere to those therapies over time. We've not only initiated patient education programs from the outset, but we're taking up a notch the programs that we have in place over 2023 and beyond. In support of the patient and the physician in our healthcare environment today, we knew it was important to put together sort of a bespoke program to support this rare disease population as it pertains to not only education, but support through the reimbursement process. We have a closed system to how we distribute the drug, and to patients, that's a specialty distribution.
When a physician wants to prescribe the product, it's just not a normal prescription. They fill out what we call a Patient Start Form, which for all intents and purposes is a prescription. That activates a whole chain of support network for the patient and the physician. The physician can opt into the program, the patient opts in, we distribute the drug directly to the patient, we provide education support materials to the patient, and we support the patient and the physician office practice in the entire reimbursement process and fulfillment process.
Why?
What's that?
Why?
Pardon me.
There are remarkable amounts of. Why?
Well, I think, you know, with novel therapies in the marketplace today, our payer system has not made it an easy process for patients.
Side effects and holding it, but, you know, that's one of the. Immediately, you say you've got all this support for patients.
Yeah, no, it has nothing to do with side effects 'cause Yeah, no. For those who are online, we had a question in the room that asked, "Well, why all this patient support? Is it due to the fact that you're, you know, there are side effects to the drug?" Not from our clinical studies. We've not seen that there's a, you know, an adverse side effect profile to the drug. One is patients need to be supported to be educated on their disease and the need for treatment. Number two, we have a system out there today that in supporting patients to stay on their therapies with their insurance plans and with drug distribution, to be able to get their meds, to have the support that they need to stay on them.
That's a, you know, whether it be educational resources, financial assistance with getting on the drug, or just treatment support and education around why it's important to stay on the drug. We think it's good for the patient. We know it's good for the office environment to help and support them. In the end, we put a significant amount of behind this program that we call Aurinia Alliance, which is really personalized one-on-one support for both patients and physician office practices throughout their treatment journey. Thank you for the question. How haVe we done? Is the obvious next question.
Well, if you look at our Start Forms through the fourth quarter of this year, in the quarter itself, we had 406 new prescription Start Forms, year to date, just below 1,700, which equates to patients on therapy by the end of the year of just over 1,500, which is growth quarter-on-quarter of almost 200 patients from 1,354 at the end of Q3 2022. More than 84% of the prescription Start Forms that we have have been converted on patients onto treatment, which is quite an accomplishment. After 12 months of therapy, because we have a large enough N of patients that have crossed 12 months of therapy, we can tell you that approximately 50% remain on drug.
I can also tell you that that 50% is when we look at patients' records that are actually within samples that we pull, is very consistent with how we see MMF used if MMF and steroids are utilized alone. That persistency number is pretty close to what we see with the current standard of care. It's greatly in need of improvement, it's actually not bad progress out of the gates in the launch. Outside the U.S., as I mentioned, a big goal for us is expanding this drug geographically. We do that with our partner at Otsuka. This was a collaboration that we wrote about three years ago. It's a royalty-based agreement, we support them in all their progress in terms of clinically and all the progress on the regulatory front.
This has produced for us, in terms of non-dilutive capital into the company, approximately $80 million to the company. In 2023, we have a target once three of the major markets in Europe get pricing and reimbursement for the drug of another $10 million milestone. The partnership includes the two largest economic contributors to drugs of our size and where the real patient impact are, and that's the European Union, the U.K., and Japan. We got EU approval in September of this past year, U.K. in November, and we're currently working on country reimbursements. Japan is a target for us for filing by the back half of this current year. Shifting gears, then we can move to what's left of the time for Q&A, to our pipeline.
Just a short three years ago, we were a single asset company, but we've done some work to start the process towards diversification of the company and enriching our pipeline with new innovation through two early-stage asset in licensing opportunities in the inflammatory space. If you look at our pipeline across total, obviously, LUPKYNIS was the major investment and sort of a thesis of investment for the company, which is an approved product right now. We have ongoing support for this product, both regulatory commitments and commercial support that we do medically for the product. In addition to that, we have two compounds that we've coined AUR200 and AUR300, and then we are doing some work to look at different formulations and put up product put-ups for LUPKYNIS in the future.
AUR200, as I mentioned earlier, is clearly focused on autoimmune and inflammatory diseases, as is AUR300. AUR200 is an Fc fusion protein. It's a B-cell inhibitor targeting both B-cell activating factor, or BAFF, and a proliferation-inducing ligand, or APRIL. We see this asset as a potential best-in-class asset. It's got a proven mechanism of action. There are other B-cell inhibitors targeting these pathways that are ahead of us in development. As I said, through the work we're doing in the IND-enabling phase here, our goal is to show how we believe this compound is actually differentiated from a mechanism. Think affinity, think potential for potency, think potential for more concentrated dosing. These are things that we will have to prove out on the progression from into first human clinical studies.
We're excited about this B-cell blocking agent. It is targeted for an IND submission in 2023. AUR300, now this is a novel peptide. This is much more of a first-in-class approach. It's basically looking at targeting macrophages via the CD206 receptor. There has been data produced to show that this early macrophage modulation can actually lead to addressing inflammation in patients with autoimmune disease and fibrotic disorders by decreasing fibrogenic and inflammatory cytokines. We have to prove that out in the early studies we're doing to get us into human clinical trials. We think this has a high potential for differentiation and has a unique target towards autoimmune diseases and fibrotic diseases.
CD206 and macrophage approaches have been probably more popular in cancer, but I can tell you from our scientific advisory board perspective, this is quite novel and, we're sort of on the leading edge of looking at this type of work in autoimmune disease outside of cancer. Year-end financials, guidance on where we're going in 2023. Through the quarter, $28.3 million in Q4. Again, this is unaudited, but, you know, obviously we feel comfortable reporting at least where we've projected to. $103.5 million in net product revenues for the year. Remember, we got a milestone from Otsuka in the year, so that adds up to $134 million in net revenue outside of just LUPKYNIS revenue.
Lastly, our guidance for 2023, which we confirmed here at JP Morgan of $120 million-$140 million. In close, before we go to a more broad Q&A, as I started out, you know, we've progressed the company greatly over the last four years from a development stage organization to a fully integrated biopharmaceutical company that really has charged from asset development to one of really trying to charge towards a mission of changing the lives of patients suffering from autoimmune diseases. Our first commercial asset in just under the two years of launch has progressed nicely. $40 million in revenue the first year, $103.5 million in the second, and continued growth into 2023.
I think our team, we've done a nice job of building expertise across. Progress with Otsuka has been exceptional in terms of getting approvals in their geographies. We're working on a emerging diversified pipeline and wanna continue to do that. Lastly, unlike many companies in our space, we continue with a strong balance sheet of almost $400 million in cash, no debt, and a projected business growth of $120 million-$140 million in 2023. We're excited about the future. We're excited about the progress we made, and we look forward to telling you more about our story as we progress. With that, I will end.
Hey, Peter.
Yeah. Hi.
I was wondering if you could provide maybe some more color around the recent settlement with Sun and, kind of the defensibility of the dosing protocol and patent? Thanks.
The reference is to a press release that went out, and by the way, this information is publicly available because, you know, there's a motion, a filing with the USPTO and the PTAB to potentially pull the IPR filing that was made by Sun. While there are parameters of the settlement agreement that, you know, we have confidentiality around, what I can tell you is we have settled the challenge with Sun that relates to the IPR and the litigation, the ongoing litigation that we had with Sun, centered on their product CEQUA, where we were suing them for patent infringement.
All I can tell you is, you know, there's a couple contingencies to it that we have to see through the PTAB process and then, of course, the most simplified way to look at it is that both companies, you know, sort of drop their active progress towards each product. And that on an ongoing basis, you know, neither company will have an ability to further litigate or illegally challenge either product. Being a little cagey 'cause I wanna make sure that we keep confidentiality to the things that we promised to Sun in that process, but feel comfortable that we have, we've settled up those two challenges. In terms of our go-forward patents, we have one Track One patent on file with the USPTO.
The number of the patent filing is 140. You can look at that, and you can look at the correspondence we've had with the USPTO on that. That's public. The issue date, well, because it's a Track One, at least the time period we're to hear back from them, and they reserve the right to change this, but is approximately April of this year. We should be hearing back on that patent. Why is it important? Well, it's important because it takes the new data that we have through the phase III trial we ran. Remember, the patent, the '036 patent, the dosing patent that we have, was issued after phase II data, but not at completion of the phase III data. This narrows the frame of the patent, the '036 patent.
It adds new data to the equation, and I think addresses almost all of the challenge areas that came as part of the IPR. We think it strengthens the '036 patent. There's not additional time that comes alongside of it. It would be, again, complementary to '036 and believe it would be significant to strengthening the story around our dosing patent. We continue to look at other ring-fencing opportunities around that dosing patent. When they become real and fileable, we'll report them.
Thanks. We do have an online Q&A portal if you wanna submit a question anonymously. I can ask it for you. Peter, the guidance of 120-140, I guess, just narrow it down, what gives you confidence in that, looking forward?
Well, I mean, I'll start with the front end of the funnel, and that's our prescription Start forms or patient Start forms that we see. If you look at the progress from the third quarter, we reported PSFs through October. In October, I mean, a large percentage of our PSFs come from southern states, we had a major hurricane in the southern states in October. We reported 113 PSFs. By year-end, we reported well above 400. We saw a pretty massive turn in terms of November and December performance on the PSFs that lead me to believe that we're starting to see the right momentum on our equivalent of new prescriptions. In combination with that, we saw significant progression on getting patients onto therapy and getting them on therapy faster.
You would hope that a patient can get on a drug as quickly as a prescription is started. The reality is, through the reimbursement process, through the approval process, it takes time. We have moved, whether it be 90-day action, 60-day action, or 30-day action, I think we're at around or above 60% of patients getting on drug as early as 20 days, right? Our progress there has been incredible. Our patients on therapy have grown... We're at that point where they're growing almost at a faster rate than where our, where our Patient Start Forms are. All the activity metrics in terms of what our sales force is producing and the, you know, patients getting on therapy give me confidence that we can achieve those numbers.
Revenue this year for the product was about $100. I'm just trying to square those numbers. How many patients go off the therapy?
Well, as I said, at 1 year, there's about 50% persistency with the group of patients that we had. The way you have to think about patient growth is you're at least as we get to a year, you've got to replenish the 50% of patients that go off the drug and then grow above that.
Why do they leave? Is it that they don't feel they need it, or is it the side effects, or is it the-
Well, as I said, there's a host of different reasons. They very much align in terms of persistency to the current standard of care. If you look at where the market was before we were ever in it, MMF and steroid persistency at a year, at least from our data, looks very similar.
Yeah, steroids suck.
Oh, clearly, that's why in our study, we actually used a low-dose steroid and a reduction regimen. Many of our physicians who are active treaters today have used the combination as an ability to almost remove steroids from the equation. To answer your question, the oversimplified answer is it's either patient or physician, or physician-driven. Then there's a host of reasons under. You know, many physicians treat this disease to a control point and then remove drug, and then if they take a urine screen again and they have elevated proteinuria, come back to the drug. The guidelines don't speak to it that way, so that's something we have to treat, have to change over time.
Insurance non-reimbursement after a certain time has not been an issue. We don't hear a lot of AE-like reasons for discontinuing drug. Thank you.
How much of that, if you can disclose it, should we expect from ex-US sales and how should we think about the contribution in 2024 and beyond?
As we said, I think if you look at Benlysta maybe as a comparator. Benlysta is GSK's product that's been out there for 13 years in SLE. I believe, at least from the data that I've seen, somewhere around 15% of their global sales come from ex-U.S. territories. Point being, you know, 85% comes from the U.S. market. We see this as, you know, an ability to contribute. For us, we're getting a, you know, high single- digit or high single digit progressing to low double-digit royalty over time and a cost plus arrangement on the manufacturing side. It can be a contributor, but not something that's gonna significantly move the needle relative to the U.S. business. We try to keep investors' eyes keenly focused on the U.S. business.
Got it. Got time for one more question. Got one more. How should we think about business development going forward?
Well, I think, as I mentioned in the presentation, we're inquisitive, and we know that, building sustainable companies, you have to continually be searching for new innovation. We're hunting, looking, and we're inquisitive. I think the market is very ripe for good deals to happen, both on the research and the development side and potentially even as things emerge on the commercial side. We are very clear about our priority order. What we're trying to drive here is the value of our business based upon the launch of this drug. Yes, we have to diversify, but at the same time, we're not in a hurry, and we wanna do smart deals, and we wanna keep our focus right. Our eye is mostly pointed towards autoimmune disease broadly and to development stage assets.
you know, like most others out there in the marketplace today, we're looking. If we find something that's right and we can get the economics right, we would strike. I wanna make sure everybody hears that we got our priority order right. It's continue to focus on the launch, put our resources here. That's what's gonna drive the most immediate value, and we have time to create sustainable value through pipeline.
Awesome. Thanks so much, Peter, and thanks everyone for coming.
Thank you.