Good morning. Welcome to Needham's 23rd annual healthcare conference. I'm Serge Belanger, one of the equity analysts at Needham. For our next session, happy to have Xeris Pharmaceuticals with us this morning. We have the company's CEO, Paul Edick. That's gonna give us a presentation, and then we'll proceed to Q&A. For those listening online, you do have the option to submit questions via the portal that you're watching the presentation in. We'll take those after Paul is done with his presentation. I'll hand it over to Paul. You can proceed with your presentation.
Serge, thank you very much. We're very happy to be here today. I'm gonna go through the presentation as efficiently as possible, and then happy to answer any questions. Xeris is a growth-oriented biopharma company. You know, we're developing and commercializing innovative products across a range of therapies. Before I go any further, I would refer everyone to our forward-looking statement, which is available on our website, and this presentation is available on our website. Let me start out with just a little bit of an overview. There are really three pillars to value creation that we're building at Xeris. We have a series of marketed products. I'll go into each one of them in some detail.
We're developing new products for our pipeline using our proprietary technologies, our formulation science, which really our formulation science is the foundation of the company, and I'll get into that in more detail. We're using that formulation science to engage and partner with other companies, mostly big pharma companies, who are needing to make their products either more soluble, get larger molecules into the body, etc. I'll talk a little bit about those later on in the presentation. Really, three pillars of value creation. How are we doing against that strategy? We're driving growth. We're developing new products, and we're collaborating with big pharma companies. If you look at 2023 versus 2022, we had an outstanding year. We reported $164 million of net revenue, $72 million of cash at the year-end. We grew double digits in all of our products.
Keveyis, which is a product we'll talk a little bit about, grew actually overall in terms of its contribution in the face of generics in 2023. Very good performance. We've advanced both our partnerships and our own portfolio. If you look at it on a revenue growth basis, that's a beautiful line. It's straight up and to the right. Continues every year. You see that the third quarter is always bigger than the other quarters. That's the Gvoke effect in the back-to-school period. Our revenue continues to grow. We anticipate growing our revenue again this year. We've guided $170 million-$200 million in terms of full-year revenue. Really nice growth. We've also guided to $70+ million on the balance sheet at the end of the year as well. Without having to raise any additional capital.
If you look at our portfolio, Gvoke is for severe hypoglycemia. We'll talk about that in detail. Ogluo is the Gvoke of Europe. I think it's launched in four or five countries now, really starting to grow. levothyroxine is our pipeline product for hypothyroidism. The two active partnerships that we have with Amgen and Regeneron. Both at the end of formulation and in the stability stage. I guess I got a little ahead of myself on this slide. Our guidance for 2024, $170 million-$200 million in total revenue, up from $164 million. Year-end cash, $55 million-$75 million, up from $72 million. Last year, I think last year we increased the bottom end of our guidance two or three times as the year went on. Let's talk a little bit about Gvoke. Gvoke is a ready-to-use liquid glucagon for the treatment of severe hypoglycemia. Very simple product to use.
It's a small cylinder. Kind of the shape of an EpiPen, but smaller. For those of you who know EpiPen, people refer to GVOKE as the EpiPen for diabetics. Severe low blood sugar happens when your glucose drops below 70 milligrams per deciliter. Very simple, you pull off the red cap. You press the yellow down on exposed skin, an arm, abdomen, thigh. Wait 5 seconds and you've treated yourself. Your glucose usually will get back up to a normal range within 10 or 15 minutes. What is the situation and what is the issue? Everybody, sooner or later, whether you're a type one or type two diabetic, if you're on insulin or if you're on a sulfonylurea, you're at increased risk for a severe blood sugar event.
AACE, the American Diabetes Association, the Endocrine Association, ISPAD, everybody who is an advocate or a professional organization in the world of diabetes has changed their recommendations and/or their guidelines to say that if you are on insulin or a sulfonylurea, you should have a rescue ready-to-use rescue medication handy. And that is in the neighborhood of 15 million people who are taking insulin and/or sulfonylureas. Less than 1 million actually have a ready-to-use rescue glucagon product such as GVOKE HypoPen in their possession and carry it around. That is a problem. That is a public safety issue, public health crisis that in the diabetes population is preventable. You don't need to be dying of severe hypo if you have these products available. Very much like you don't need to die from a severe allergy if you have an EpiPen.
So we're fighting a little bit of an uphill battle getting physicians to recognize that they should co-prescribe a ready-to-use rescue glucagon such as Gvoke with every insulin prescription. And this is evidence of that fact. People think, you know, I'm doing all the right things. I'm eating right. I'm exercising right. And I'm taking care of myself. I shouldn't have a severe low. When in actuality, 92% of people in this particular survey spent time below 70 milligrams per deciliter, which is severe low blood sugar. And a third of people continue to experience severe hypoglycemia or spend a significant amount of time in even lower, down as low as 30 milligrams per deciliter. So the question of who is at risk? Everyone who's on an insulin or sulfonylurea product. If you look at the total market for glucagon, it continues to grow.
It's grown except for the COVID years in 2019 and 2020. It's grown every single year. Continues to grow. A lot of the acceleration of the growth is being driven by Xeris and GVOKE. At some point, it's going to continue to grow even faster. The other product in the market is a nasal product. It's now an Amphastar product. As they ramp up their activity with two companies talking to the endocrine community and the physician community at large, we fully expect that the growth in the market will accelerate. It's only a matter of time. You see the spike in the third quarter just about every year except the COVID year, which is back to school. It's a phenomenon where kids going back to school, you want to make sure that they've got a device handy.
Then when you look at the overall retail prescription market, you see Baqsimi is the nasal continues to grow. We continue to grow. We continue to take share. And we continue to increase the number of prescriptions every single quarter, every single year. Very good, very nice picture. Same thing with revenue. Keep in mind one of the things that people ask, what happened in 2020? We launched the GVOKE HypoPen in the middle of a pandemic. And we grew very nicely and we've grown incredibly well since then. And we'll continue to grow this year. That's it on GVOKE. It's a pretty straightforward product. It's very important, life-saving medication. Recorlev is our drug for the treatment or the normalization of cortisol in Cushing's syndrome. These are patients that are quite ill. They have a lot of comorbidities. There are a number of products in the marketplace.
Recorlev is, I think, the newest in the market and treats the underlying condition where a lot of the products that are used in this category are treating the symptoms of Cushing's, but not necessarily treating the underlying condition, which comes in the form of normalizing cortisol. If you look at various products in the marketplace, a lot of products have no indication for that, are used pretty regularly, have no indication for Cushing's, don't normalize cortisol. There are a number of products that have some pretty severe side effects. Recorlev stands out in this group as being studied in the category, having an indication for Cushing's, actually treating the underlying condition, which is normalization of cortisol, while doing so with a modest amount of side effects.
Keeping in mind that there's a lot of churn in this category because these patients have a lot of comorbidities and don't necessarily react well to any individual drug. They have to find the drug that actually works for them the best. We think that's Recorlev and it's growing every single day. The physician feedback is outstanding on Recorlev as well. It's really giving them a tool to do what they intended to do in the first place, which is to normalize cortisol. If you look at the target audience, the real target is about 8,000 drug-treated adult non-malignant patients. Recorlev has the broadest set of indications. It achieves rapid, sustained reduction of cortisol. It's performing very well.
The other thing we do is we wrap these patients with all kinds of services to support their efforts to get reimbursement, to better understand how to titrate their drug, and really kind of a handholding process that allows patients to be oriented to the drug more effectively. I've got something in my screen. I'm trying to get rid of it. Okay. Then once again, you look at the growth rates for Recorlev. It's done really well in the first year and a half, two years. Launched in the middle of last year. Grew very nicely in 2023. We continue to see outstanding growth in referrals. Time from referral to on-drug tends to be lengthy. It's a new drug in the category and you've got to get insurance reimbursement on a patient-by-patient basis. So that takes some time, but doing incredibly well. Moving on to Keveyis.
Keveyis is an interesting drug. Keveyis is a drug for primary periodic paralysis, which is a condition that is triggered in any number of different ways that causes patients to experience paralysis, neuromuscular disorder that is paralysis in nature without warning and episodically. There's anywhere from 4,000-5,000 PPP patients in the United States. Symptoms vary on a per-patient basis. The attacks can vary in terms of duration and severity. Frequency is for a lot of people weekly. For a quarter of the people, as often as daily. What happens with these patients is they actually lose a lot of the ability to participate in a normal life. What Keveyis does is it treats the condition in a way that these patients can regain a lot of what they had lost. They can get back behind the wheel of a car.
They can be back out in society, going to the movies, going out to dinner without the fear of a sudden paralytic attack. Works across patients with both sodium and potassium channel mutations. Has a sustained benefit over time. Very good tolerability profile. The dosing is flexible and adjustable on a per-patient basis. It's titrated to whatever is the most effective dose on a per-patient basis. The other thing, too, once again, the care connections. We wrap these patients with all kinds of services, helping them to clear insurance.
In this particular situation, we actually have what we call patient mentors where we assign a current KEVEYIS patient to a new KEVEYIS patient to help them through especially the first couple of months of therapy, getting used to the drug, getting used to finding the right dose, getting insurance cleared, and just answering a lot of those reentry into life questions that a lot of people have. It's getting to be kind of a boring picture. Everything's up and to the right. KEVEYIS grew again in 2023 on a revenue basis. And in the face of a generic for the full year, which is an outstanding performance, there was a CVR that was a part of the acquisition of Strongbridge when we bought that business to acquire KEVEYIS and Recorlev that was set at $40 million. So we far exceeded the performance necessary to benefit the former Strongbridge shareholders.
So that was a nice thing to see and a hell of a performance. I talked earlier about the third leg of our stool, which is a formulation technologies or the other two legs of our stool, formulation technologies and our development pipeline. We are developing a Levothyroxine product. Levothyroxine is the second most prescribed drug in the United States. It is currently a daily oral medication. The problem with that is not everyone tolerates it incredibly well. We're building with our XeriSol technology a once-weekly subcutaneous injection.
And we also have 2 partnerships on our XeriJect technology, which is a delivery, a sub-Qtaneous injectable medium where we suspend drugs in that medium and are able to get them into the body in a sub-Q injection in a very short period of time at reasonably high drug load with Amgen and thyroid eye disease and with Regeneron with 2 products, neither one of which have been disclosed. If you look at the potential value of a levothyroxine product, why build a once-weekly sub-Qtaneous product? 1, a lot of these patients have absorption issues, so they don't absorb the oral product very well in the gut. A lot of them have severe gastrointestinal side effects. So compliance becomes an issue. And going from a once-daily to a once-weekly improves compliance, bypassing the gut, improves absorption, and reduces side effects.
Our market research, universally, patients who either are on or have been on and had to stop taking oral Levothyroxine are unanimously interested in a once-weekly subcu injection. This product will come in a dial-a-dose pen, very convenient, very easy, basically a little pin prick. So when you look at the percentage of the patients that experience either lack of absorption, widely variable blood levels on a daily basis, and/or gastrointestinal side effects, some of which would be the same patient experiencing all three, if you assume that's 25% of the population overall, at today's prices, that could be worth in the neighborhood of $2-$3 billion market segment that this drug would compete in or focus on. So really excited about the Levothyroxine product. We'll have the phase 2 dosing information in the second quarter.
Mid-year, we will go to the FDA in the back half of the year to get agreement on our phase 3 program and then hopefully get that started by middle of 2025. If you look at it a little bit more closely to the XeriJect technology and why we've attracted an Amgen with their thyroid eye disease product, why we've attracted Regeneron with a couple of different products, is we're able to get drug loading of a multiple of what other technologies have been able to do, other technologies that are commonly used to get to a subcutaneous kind of push injection or push infusion that takes 2-10 minutes. We can do a multiple of the drug load. Injection volumes are significantly reduced. Syringeability is very good in a 25-30 gauge needle. It's ready to use. There's no reconstitution necessary, no mixing.
In most cases, improved stability and in a lot of cases, room temperature stability. The graphics here just look at where we end up, and it's a long process. There's some proprietary aspects to it. But it is an emerging technology that really is taking drugs into tomorrow, getting patients out of the doctor's office, out of the hospital, and in a lot of cases, into the home for the self-administration. I think I just went through that whole slide. I'll skip that. We very frequently, people ask us, how does it compare to Halozyme? Very favorably. I think Halozyme has been the technology of yesterday and today for quite a while, served a purpose, still serves a purpose in a lot of situations.
But true subcutaneous injection is less than 30 seconds and up to a couple milliliters or below a couple milliliters, can be self-administered or can be administered by a healthcare professional, small volume injections, room temperature stable, and a multiple of the drug load that others have been able to achieve, especially Halozyme. Our portfolio is backed by an incredible patent estate on all products. Anything we use our technology with, we develop an entire patent portfolio around that product with our technology. So our patent estate continues to grow with every drug we work with. And when we work with a partner drug, they benefit from that patent development as well. The team has been together for a long time in one way or another. We've done several companies together. Some of us have worked in three companies together over the last three decades.
So very experienced team, but also very experienced together, which makes a big difference at the end of the day. So if you look at why invest in Xeris, we have a diversified and growing revenue base with three commercial assets. We have a strong pipeline focused on developing medicines that address unmet medical needs, and we leverage our XeriSol and XeriJect formulations. That pipeline is levothyroxine right now. But as we go forward, we can bring forward additional medications using either one of those technologies to build better drugs to add to our commercial portfolio. We continue to add partnerships with large pharma companies in order to apply either the XeriSol technology or XeriJect technology. Right now, we have the two big ones, but we're working on additional ones every single day.
It's a very long sales cycle, but once we get people interested, we work very diligently to try to get them across the finish line, and we anticipate that we'll add more partnerships in the future. From a financial point of view, a very attractive financial picture, we're going to continue to invest in the business this year. We're going to invest in our commercial business. We're going to continue to drive our commercial assets. We're going to invest in our ability to manufacture at scale the various products in our technologies. And we'll still end the year between $55 and $75 million of cash without the need to go to the market to raise capital and no need to dilute our investors at any point. We've been successful at M&A, and now that we continue to grow, we're getting to a point of critical mass.
Our ability to look at adding additional assets, either products or companies, to our platform only improves every single day, and that's a part of our focus this year and going on into future years. And as I said, we've got a proven and experienced management team, and we're driving value in all three pillars of the business. So I think I finished in under 25 minutes, but hopefully not too fast, Serge, and hopefully people got the points, but I'll turn it over to you if there are any questions. Thanks, Paul. Great overview. I guess first on GVOKE, as you highlighted in your slides, seen pretty impressive growth over the last few years. Curious where you think the next leg of growth comes. You highlighted that there are some treatment guidelines. How closely are these guidelines followed, and could that be a source of growth for the future?
Yeah, it's interesting. The guidelines are really important for the medical societies and the patient advocacy organizations because it is the glue around which all of their programs. So when you partner with ADA and you do a program or you partner with an endo, the things they do are oriented around those guidelines. So that's a good thing. The degree to which the individual physician pays attention or follows the guidelines varies dramatically. Over time, it gets better. But it does allow for a more full-throated conversation with healthcare professionals that say, "Look, your society says this is the right thing to do." Where the rubber has to hit the road more with endocrinology or with primary care when it comes to severe hypoglycemia is the recognition that it's going to happen to everybody sooner or later.
You may have patients that have gone 10 years without a severe hypo. It's going to happen. So just like allergies and EpiPen, why wouldn't you co-prescribe a Gvoke when you prescribe insulin? It's so easy to do. And to a large degree, offices are busy and doctors are busy. So we work with the staff and try to get standing orders, try to get the staff to make sure that when somebody's leaving with an insulin or sulfonylurea prescription, they've got a Gvoke prescription. That's a lot of our focus right now. What do you estimate is the percentage of diabetics that actually carry a glucagon product like this? Right now, less than 1 million out of the 15 million who should. So less than 10%, which is it's also there is a recognition. There's a piece of it is on the patient as well.
The patient needs to recognize, or a person with diabetes needs to recognize, that I can eat all the gummy bears and drink all the juice boxes and manage my glucose as best possible. But if it doesn't go just right, I'm going to end up in the ER. So it's easy. It's a $25-$30 copay. Get yourself a Gvoke and make sure that you've got it in your backpack, in your nightstand, wherever, because it's going to happen sooner or later. Yeah. And in terms of the competitive field, it seems like Baqsimi is kind of the main competitor now. The legacy products are slowly exiting. Well, most everybody but I think one or two of the generic companies are the only ones that still have a kit out there. Lilly discontinued theirs, Novo discontinued theirs. Amphastar is selling Baqsimi, so they're not going to be promoting a kit.
So it really is us and Baqsimi. The kits will be a they'll be down to single-digit % of the business over time, simply because a lot of them are on automatic refill and nobody uses them. So the goal, the chore, the mission, whatever you want to call it for us and hopefully for Amphastar is market growth, getting more physicians and more office staff to recognize that when people are on insulin or sulfonylurea, they should have one of them, either Baqsimi or us or Gvoke. I'd love them to have Gvoke, but they should have at least one of them. Yeah. And then on Keveyis. Keveyis, yeah. Keveyis. Now that there's some potential generic competition, how do you think the stickiness to Keveyis is in that kind of environment and whether you see it as a threat going forward?
Well, we had generic competition for the entire year of 2023, and Keveyis did incredibly well. Physicians, because of the services we offer patients and the way we really support patients, is a tremendous benefit to physicians as well as the patient. But because we do that, physicians are willing to fight for brand. Brand medically necessary, do not substitute, whatever it takes. If there's always a prior authorization, there's always an appeal. Physicians are more than willing to participate in appealing to get brand. So it's been incredibly sticky. Part of we had a really good year and really good fourth quarter and had a really good call for our quarterly results. And everybody says, "Well, why did your stock go down?" I think people are anticipating. And we even guided that we figured in 2024, we'll start losing patients on Keveyis.
I think there's a little bit of an overreaction to how much that will be. We believe we'll see some in the first quarter, and then it'll kind of be slow, taper down after that. But so far, it remains incredibly resilient, and brand remains pretty sticky. So we're encouraged by what we see so far this year as well. XP-8121, you're going to get phase 2 results later this year. You talked about the phase 3 plans for potentially getting underway next year. What do you envision right now, what those phase 3 trials could look like? Nobody really knows until you sit down with the FDA. They tend to raise the bar and ask for more and more and more and more with whatever sponsor is in there.
Suffice it to say, we anticipate good phase 2 data, which is really just confirming the dose conversion from oral to liquid at every single dose. There's like half a dozen different dosage levels of levothyroxine. So we've got to have a conversion from the oral to the liquid at every single one of them. So that's what this phase 2 study will show. Based on what we did in phase 1 with healthy volunteers, it shouldn't be a problem. We anticipate we'll get what we need. Then it's a matter of. It's a well-characterized drug that is very effective. It's been on the market a long time. So the hurdle for going from oral to liquid and daily to weekly shouldn't be a high one. It should be a relatively straightforward study, more safety than efficacy at the end of the day.
But we'll have that conversation with the FDA in the back half of 2024, and we'll see what they ask for in terms of number of patients, duration, washout period, etc. Okay. And for those who keep a close eye on Tepezza and the thyroid eye disease space, anything you can tell us about the collaboration with Amgen, where it's at, and what the next steps are? Yeah, it's very positive. With Amgen acquiring Horizon, there was a little bit of a lull in the handover. So you've got the reconstitution of a whole new team around Tepezza. But the teams are our team and their team working together very well. The work plan is coming together. Everything continues to progress. We're done with the target formulations. They're on stability. We should have that data for them, I think, in the third quarter. Don't hold me to that.
So it's going very well. The handover caused a little bit of a delay, but not huge. I mean, it was a long waiting period between the announcement of that deal and when it actually comes, right? Well, but the Horizon kept trudging forward. I mean, they were great. They actually put us in a position where Amgen could very quickly pick up the license because it was clear that we had achieved what they need to get them to a sub-Q that looks like what they want it to look like and can be delivered the way they want it delivered, needle size, time, whole nine yards. So they did a hell of a job. Once it was Amgen kind of putting the team, reconstituting a little bit of a different team with mostly Amgen people, that slowed us a little bit, but not substantially.
We're very, very happy with where we are with that. Got it. All right. Well, I guess we'll wrap it up here. So I want to thank you for telling us Xeris, and I think there's some exciting catalysts coming up for this year and obviously some strong top-line growth that accompanies that. So thank you. Thank you very much. I appreciate the opportunity. Love talking about our company. We think we're building something kind of special. Great. Well, thanks again. Thank you.