Welcome, everyone. Thank you for being here. I'm Sanchita from JPM. We have with us here today CEO of Xeris Biopharma, Paul Edick.
Thank you. Welcome, everybody. I'm gonna give you the overview on Xeris and then we'll have a Q&A. Xeris is a growth-oriented biopharma company committed to improving the lives of and developing and commercializing assets in both rare and specialty areas. I would remind everyone to pay attention to our forward-looking statements. Investing is always a risk. Let me start out with an overview of the company. Xeris has a very diversified revenue base. We have three marketed assets, all growing. Recorlev, I'll talk a little bit about. It's in the launch stage. 2022, we've guided to $105 million-$110 million. We'll finish at the top end of that range. We have a specialized commercial platform in endocrinology and in neurology.
We'll go into some of the products. Our pipeline is emerging. We're developing. We have underlying technologies that I'll talk about, XeriSol and XeriJect. We're developing products for our own commercialization, but we're also developing products with partners using our XeriJect technology that I'll spend a couple of minutes on as well. We're in a strong financial position. I won't go through all the pieces, but we're gonna end the year. We guided to $110 million-$120 million in cash by the end of the year. We're gonna end above that. Very healthy capital position and an experienced management team that's been there, done that a few times. I'll first talk about our approved products. We have three, the first one being Gvoke, the most important product that we have.
It's for severe hypoglycemia for people who are on insulin predominantly, in three forms: an auto-injector, a pre-filled syringe and a vial of liquid. We also have a drug by the name of Keveyis for primary periodic paralysis. Say that 3x fast. Recorlev for Cushing's syndrome. I'll talk about all three of them in some detail. Let's talk about Gvoke. It's a ready-to-use liquid glucagon for the treatment of severe hypoglycemia. If you're familiar with glucagon at all for hypoglycemia, historically, there's only been a mixed kit, a kit that you have lyophilized have to remix draw it out in a syringe, et cetera. If you're having a severe event as a low blood sugar you're not gonna be able to do that.
These ready-to-use products are really what are gonna be the mainstay going forward and Gvoke is the primary one on the market. Very easy to do. It's easier than an EpiPen. You know, people refer to it as the EpiPen for diabetics. You pull off the red cap, you press the yellow end on abdomen, thigh, arm, yo u hold it down for 5 seconds. You hear a click, the window goes red, you've been treated. Very easy, very convenient. It's incredibly important when you think about it. There are 8.4 million people in the United States today who are on insulin. The number one side effect of being on insulin is low blood sugar. Anyone who is on insulin that experiences a low blood sugar can go severely low at any moment.
You can go for 10 years and never have a severe low and then all of a sudden you do. It isn't a category where you can predict who's more at risk than others, because the mere fact of being on insulin puts you at severe risk. The unfortunate thing is, of those 8.4 million people historically and even now post-pandemic and I think the pandemic has had a lot to do with not really getting this market energized the way it should, but only about a 10% of that population actually has a ready-to-use glucagon for an emergency. That to a large degree is really sad at the end of the day because there are over 250,000, as much as 300,000 hospital emergency room visits every year for severe hypoglycemia.
Somewhere between 25,000 and 30,000 people die every year from severe hypoglycemia, yet physicians are not yet motivated enough that every time you prescribe an insulin product, you should prescribe a ready-to-use glucagon for rescue, in particular, the Gvoke. This is what the market has looked like historically. You can see the blue line at the top is 2022. We're really starting to see growth. We're starting to see acceleration. We're almost at double-digit growth. A lot of that has been muted. If you see the green line down there, that was 2020, I believe, which was just a terrible year because of COVID. Now that we're out of the pandemic, we think this market is gonna start to grow again. It's us and Lilly at the end of the day that are really gonna drive it.
If you look at new prescriptions, the NRX share, Lilly is the red line. They have a product called Baqsimi, which is a nasal version. We are the blue line. Together we have about 70%-75% of new prescriptions. The old legacy kits are the purple line that is declining and is gonna keep declining. What that results in is a market that is predominantly the new ready-to-use products now. The old legacy kits down below 40% and continuing to decline. Us and Lilly and you can see that on the previous slide and on this slide, the gap between their market share and our market share are starting to close.
We anticipate over time that we're gonna split this market and that 80%-90% of the market will be the new ready-to-use products that lend themselves to easy administration, but also self-administration. The ability to rescue oneself has never existed until these ready-to-use products. Moving on to Keveyis. Keveyis is approved for the treatment of hyperkalemic and hypokalemic issues related to primary periodic paralysis. This is a very interesting, rare condition that. The unique thing about Keveyis and the unique thing about PPP is doctors, clinicians don't identify these patients. They treat all of the symptoms. They treat the periodic paralysis. They treat the events of paralysis in the extremities. They treat some of the other side effects, but they don't recognize the constellation of issues.
What we do is we, through the analysis of payer data, through the analysis of CPT-4 and ICD-10 codes, we're able to go in and identify a constellation of treatment episodes and a constellation of issues that people are having. We can go to a physician and say, "Look, we've analyzed your practice and based on that analysis and this constellation of things you're treating, we think you've got a PPP patient. Can we figure out who that patient is? Get them into the office, get them identified, get them on treatment." The only way these patients are identified is through our analysis of billing and diagnosis data. Once identified, physicians are very willing to put them on therapy. You can see over the last several years, this product has grown dramatically, continues to grow.
See 9 months through 2022, $35 million that was reported in the third quarter and it continues to grow. We had a great fourth quarter. One thing to note, there was a generic that was approved for Keveyis. The important thing to understand about a generic in any rare category is most rare products are only provided through a specialty pharmacy one specialty pharmacy. Most physicians write dispenses written for these kinds of patients 'cause they wanna make sure they get the product they're intending. There are a lot of barriers to entry and the average payer only has two or three of these patients. Getting payers to really be active is going to be a challenge for anybody. We believe we can defend this business and even grow it in the future. Moving on to Recorlev.
Recorlev is a cortisol synthesis inhibitor. Basically, what we do with Recorlev is we normalize cortisol in Cushing's syndrome. Okay? For those of you who are familiar with Cushing's syndrome, you know that it's a serious rare endocrine disorder, caused by the overproduction of cortisol. Most of these patients have surgery a nd Cushing's causes all kinds of different issues from heart attack, stroke, obesity, I could go on and on. It's a debilitating condition. It's a debilitating disease. To a large degree, the products that have been on the market have not been terribly effective at normalizing cortisol. That's what Recorlev does. If you look at the population, it's a relatively small population at the diagnosis level, but by the time you get down to the therapeutically treated population, it's only about 8,000.
Those who are targeted, that we're targeting are the ones that are not well controlled, are not seeing control of and/or normalization of cortisol. That in and of itself is about 40% of the population that are uncontrolled and that represents better part of a $2 billion opportunity. If you look at the market, you see a number of products, several of which that are used, several of which are not indicated. Recorlev has been studied in Cushing's, has been approved in Cushing's, has a label in Cushing's, it's indicated in Cushing's and is highly effective with relatively low side effects. When you compare that to some of the other products, there are some that will patients feel good, but their cortisol is not being controlled or normalized.
There are other products that are doing something relative to cortisol normalization, but with a lot of side effects. Isturisa, for example, very high androgenic side effects, hirsutism, hair growth. The other thing you'll see when you look at this chart is there's a lot of products, both generic and brand. There's room for a lot of improvement in terms of patient satisfaction. Like I said, easily 30% of the patients that are on drug are not being satisfied. They're not getting to a normalized cortisol and they're not having, you know, relief of side effects. Despite the availability of new therapies, there's still a great deal of switching and churn and unmet need in this category. 27% of patients discontinue from whatever therapy they're on, which is incredibly high.
We think that Recorlev fills this unmet need very effectively. Provides the best opportunity for active long-term cortisol normalization, rapid and sustained reduction of cortisol. We surround the patient with both patient resources, partner resources like mentors, a buddy system. There's a number of things we do to make sure the patients can get on therapy and stay on therapy effectively. Recorlev, even in the label, has good monitoring protocols. We're very excited about Recorlev. It's off to a very good start. In a couple of quarters, we reported $2.5 million in the third quarter. One of the important things to keep in mind, you look at that and you say, "Oh, is it like $1 million, only a couple million?" These patients Once identified, there's a It's not a prescription.
They don't go to Walgreens. It's a referral. That referral has to have lab work, it has to have an EKG. Patient's got to go through payer authorization. We need to get authorization for payment from whatever their insurance is. They're put on therapy. That takes time, sometimes 2, 3, 4 months for a patient, depending on the difficulty of clearing insurance. The other thing that's got to happen is these patients are started on a low dose and they're titrated up slowly. It takes several months before they're ever gonna get to the maximum dose or the most effective dose. This is a one patient at a time, nice slow growth, but very, very big opportunity down the road. Oops, I'm backwards. Sorry. The other thing, I just.
Just a quick mention, we've built a relatively large commercial organization to support all three of these brands. Gvoke, between field sales, inside sales that we built during the pandemic because you couldn't call on doctors, retail trade, medical affairs, there's approximately 170 FTEs in there. Recorlev has a dedicated organization, very similar pharmacy services, patient support, medical affairs, about 30 FTEs. Keveyis has a dedicated organization of about 30 as well, with a lot of the same things, patient support, patients pharmacy services. All in all, about 230 customer-facing resources in the company and room to grow. Those are our commercial assets. We also have several development assets based on our technologies. We have two approaches to formulation chemistry, one that we call XeriSol and one that we call XeriJect.
XeriSol, we take products that are not stable in solution, maybe not terribly soluble. We can make them t-stable and soluble. Part of that is taking the water out of formulations, putting in liquids that act like water but aren't really water. That's glucagon, for example. No one has ever been able to develop a ready-to-use liquid, room temperature stable glucagon. We were the first and only ones to be able to do that. We have an approach to chemistry called XeriJect. If you've listened to the news or seen the press releases, we did a deal with Merck to take one of their large molecules that's currently an IV therapy and turn it into a prefilled subcutaneous injection.
We're working with a company called Horizon on a drug called Tepezza, which is currently about a $3 billion franchise, to once again take that from infusion, an IV, which takes an entire day, eight infusions over the course of 5 months and turn it once again into a subcutaneous injection. It'll take 15 seconds. If you compare that, for example, to other kinds of technologies, we compare very favorably to a household name. Everybody knows Tepezza. Our product can potentially be self-administered. The Tepezza product is still kind of a long 5-15 minute infusion. We can do a 15-30 second injection. We have room temperature stability. They don't really challenge stability. And it's ready to use, you know, potentially for self-administration in whatever. Depending on the drug.
This slide is for demonstration purposes because we wanted to kind of characterize the time it takes and also who's in control. At the end of the day, these are partnered programs. The partner's in control. You can see at the bottom. There are several programs for working with companies that have large molecules that really have. We've hit what we need to do, but they haven't necessarily decided whether they're gonna take the product forward into full clinical development and into regulatory, you know, commercialization. We wait. At whatever point they decide to go forward, there's preclinical phase I, phase II, etc. Pretty normal programs. Merck and Horizon are in the formulation development stage. That takes time and could be anywhere from 1 year to 2 years. We've got to formulate, we've got to optimize.
They're probably gonna do preclinical work in terms of getting IND-enabling studies done. Before they're gonna pick up the option to take it into clinical development and commercialization. All of these deals, there will be, we believe, at some point, especially with the Merck and Horizon deal, those come with development milestones, regulatory milestones, commercial milestones. This piece of the business could be quite valuable down the road. The way we're using our technology for our own portfolio currently is developing our lead asset, which is a once weekly liquid levothyroxine for subcutaneous injection. Taking what is today an oral therapy that anywhere from 15%-30% of patients either don't absorb the oral properly, can't handle the side effects of the oral gastrointestinally.
It's a very large subset of patients that our market research says would be very open to a once weekly subcu injection. We've developed that. We're moving into dose ranging in phase II. We hope to get that study started early in the second half of the year. The levothyroxine is the first or second most prescribed drug in the United States. Huge opportunity. If we just take the 30% of patients that are experiencing problems, it's easily a $2 billion-$3 billion market segment that we would have a product for. Very excited about that and it's moving through the clinical program as aggressively as we can move it. It's a large market. We've already demonstrated proof of concept. The dose conversion is perfectly linear. We've studied it at three doses in an ascending manner.
It's perfectly linear in terms of 4/1 conversion. We think in the dose finding, we'll see the same result as we get into that next study. Our portfolio, or the entire portfolio, both with XeriJect, XeriSol and any drug we work on for a partner is. The patent estate is huge. We patent our process with every individual drug. We patent how we get to that drug. With XeriSol, for example, we patent the method of administration because XeriJect is a delivery mechanism at the end of the day. We don't change the molecule. What we do is we get it into the subcutaneous tissue. Our medium goes away and the drug reconstitutes in the body. Very excited about that and really strong intellectual property estate.
The team that we've assembled has been together in various forms for 30 years. We've done several companies together. Very experienced team. Built and developed many products and many companies. In conclusion, what I would say is we have a very diversified current revenue base with multiple marketed products in multiple therapeutic areas. We'll do upwards of $110 million when we announce 2022. We have a specialized commercial platform that can cover both neurology and endocrinology and some high-value primary care. We're building a diverse pipeline, both for our own use and for partners, which gives us a very good amount of flexibility in the future. We've got a lot of cash. We're gonna report over $120 million at the end of 2022 and we've got an experienced management team.
With that, I would say thank you and open it up to questions.
Thank you, Paul. We'll open the floor for any questions. I can kick things off. Paul, you mentioned about the Keveyis product. Could you please talk more about the Strongbridge acquisition and your strategy to defend the Keveyis franchise for the foreseeable future? Also please elaborate on any IP risks.
The Strongbridge acquisition was an enabling acquisition for us in terms of enterprise development. It was the perfect addition of a company. We were able to acquire the Keveyis product, which was an intact and growing franchise, you know, commercial asset. We acquired the Recorlev product that was in front of the FDA. We had a high degree of confidence that it would be approved. We had an endocrinology commercial organization. We're able to realize $50 million of synergies through that acquisition. We were able to get the deal at a relatively inexpensive, you know, very low premium. It really did accelerate our entire enterprise development.
Thank you. Just going back to the press release, which was done last week and then also you mentioned about it earlier in the presentation, that at the end of 2022, the cash and cash equivalent would be approximately $120 million. How do you project your cash runway?
We've got more than enough cash to get to cash flow break even. We've said we're gonna get to cash flow break even by the end of 2023. We will do that. We've got cash to get to profitability. One of the things people always ask about little companies like us is, "When's the next time you're gonna raise money?" And we've been pretty emphatic. We're not going to. We can run our operations, we can run our company to profitability, with the cash that we have and the cash that we're generating.
Okay. Thank you. In terms of Recorlev, there was that chart with Q1, Q2, and Q3 sales. Could you please help us understand the sales cycle and then also what the expansion and the growth strategy would be for that product?
Recorlev, it's an interesting product. It's a rare disease. The patient journey, the process, once a patient is identified, the physician has to do a series of lab tests. They have to do an EKG. A lot of times physicians have those labs. They do labs in their office. They might have an EKG. Very frequently, they'll schedule a patient to come back for labs, or they'll send them to an outside lab, or they'll schedule them to come back for an EKG, or they'll send them to the clinic for an EKG. The patient journey takes a little bit of time. You know, there's several visits. A referral is generated. That referral goes to the specialty pharmacy. The specialty pharmacy has to clear insurance.
The specialty pharmacy and our patient partners engage with the patient to initiate the process of clearing insurance. Once insurance is cleared, all the tests are done, the referral is complete, then the patient is started on the lowest dose of the drug. They're monitored to see how they're doing and the physicians will begin to titrate up until they hit the most effective dose and it's on an individual patient basis. Some patients, they could be from diagnosis to on therapy, a few weeks to a month. There are some patients, it could be 4-6 months before they're really on therapy and beginning their titration.
Thank you. Moving on to the last commercial product in your pipeline, Gvoke. In the statement which was released earlier in the week, therefore it was mentioned that better-than-expected prescription of Gvoke. How do you think about the market opportunity for that?
Yeah. Two different things there. One, the opportunity remains huge. There's over eight million people on insulin. The number one side effect of insulin is severe low blood sugar. That's what we do, is prevent severe low blood sugar. The opportunity remains huge and you don't have to find the patients. They're there. They're everybody who's taking insulin, daily insulin. The better-than-expected growth is if you look at the market, you see that the first quarter is usually a little slow. Second quarter begins to accelerate. The third quarter is pretty good because of it's back to school and people wanna make sure that their children have Gvoke before they go to school. You usually see the fourth quarter drop, which it did, but not as much as normal. That was encouraging.
That the fourth quarter that's usually a little down, there's a lot of short weeks in there, all the holidays, we were encouraged by that. It continues to grow. I think 2022, I think on the slide is gonna end up being about 9% growth. I think it's close to double digits. Pre-pandemic, it was growing between 25% and 30%. We think eventually we'll get back to that.
Okay. Moving on to the pipeline products. For XeriJect, you mentioned about the collaboration with Horizon and then also with Merck on the slide. What can we expect from those partnerships?
Yeah. I wish I could tell you more. The fact that we could say the name and what we're working on is a step in the right direction. We've got several partners that we can't say who it is or what we're working on. The way it works is we need to hit a target product profile, which is a formulation process and optimization of that formulation. Merck, for example, has an option to pick up the license. Once they do, then it's a traditional development program and we get development, regulatory, and commercial milestones. Those are already agreed to and once they pick up the option, that goes into effect. Horizon, you know, similar process, a little bit different.
The deal is a little bit different, same kind of thing. Development, regulatory, and commercial milestones that once they sign the license and we hit target product profile, that'll all kick in. In terms of what to expect in terms of announcements and things and, you know, points of inflection, that's one of the reasons we show the one slide where it takes a good year to 18 months, sometimes longer, to really get there because of the formulation process. The XeriJect, we can formulate just about any large molecule, any monoclonal antibody, because we don't change the drug in any way. We suspend it in our system, inject it into subcutaneous tissue. Our system disintegrates and the drug reconstitutes in the body. You know, we're confident we can do our part.
It's a matter of whether the company wants to then take it forward in full clinical development that our deal would kick in with what one could argue is significant upside financial benefit.
Thank you. Moving on to my last question. It's for XP-8121. You mentioned that there was a positive phase I data and that you would be entering into phase II sometime later this year. Could you talk more about that program and then, and also the plans for the upcoming phase II trials?
That's the levothyroxine product. As I mentioned, levothyroxine is a huge product and there's a significant percentage of those patients that are not able to stay on it because of the gastrointestinal side effects or lack of absorption. Our phase I study was to PK/PD study, to be able to see what the dose conversion is. We did three doses in an ascending manner. We saw a perfectly linear relationship that we know what the, if the, what the conversion from oral to liquid will be at any dose. We were able to model any dose you could think of. We went to the FDA with a proposal to go straight to phase III and use that statistical modeling as the phase II.
Very reasonably, the FDA said, "We'd like a little bit more phase II data, a little bit more dose-ranging data, then come back and we'll discuss a phase III program." That's the study we're going to do. We anticipate the data will be just as good. Hopefully, we'll get that started. I'm pretty sure we'll get that started in the second half of this year. We'll go back to the FDA with a phase III proposal. We have the ability and the capability to develop that product ourselves, where we can commercialize it ourselves. We're really excited. It's a $2 billion opportunity.
Thank you. If no further questions, this will be the end of the session. Thank you, everyone, for your time.
Thank you.