Good morning. Welcome back to Oppenheimer's 34th Annual Healthcare Conference. I'm Leland Gershell, one of the Analysts on the Biotech Research team, and we're delighted to have with us as our next presenting company Xeris Biopharma. Xeris is a commercial stage company, three products on the market, also has some development programs, and that's coupled with a proprietary platform for drug delivery that's also very, very interesting, is generating some partnerships with other companies. On behalf of the company, we have Paul Edick, who is the Chairman and CEO. If we have time at the end, can take a couple of questions. Please submit through the Q&A function on Zoom. With that, I'll hand it over to Paul.
Thank you, Leland. Glad to be here. Much appreciated. I was about to let you keep going with the presentation. You're doing so well. Yes, Xeris Biopharma Holdings. We're a growth-oriented biopharma company and, you know, committed to improving lives and developing commercial innovative products across a range of therapies. I'll talk about all three pillars of our business in a minute. I gotta make sure the slide will move first. Oh, please do pay attention to our forward-looking statement. They seem to get longer every day. Very informative and very important. As Leland mentioned, there are three pillars to our business. You know, we are a self-sustaining, growth-oriented company with three commercial assets that I'll talk about: Gvoke, Recorlev, and Keveyis. Products in development or a product in development.
I'll talk about our XeriSol and XeriJect formulation platforms and the technology partnerships that we're developing as a result of our proprietary and very unique technologies. We are executing on that strategy, driving growth through effective commercial execution, developing new product candidates, and collaborating with pharmaceutical and biotech companies. Excuse me. Evidence of that, if you look at our 2023 guidance compared to 2022, almost night and day, we've improved in every single category. We're growing revenue, utilizing less cash and conserving cash. Our revised guidance as of January 4th is at the high end of our $160 million-$165 million revenue range and at the low end of our cash burn, $52 million-$57 million, and year-end cash of $72 million, which is above the last guidance in November, $65 million-$70 million, and cash flow positive in the fourth quarter.
As you can see, our revenue growth remains strong, growing every quarter. We are growing every quarter, and we will continue to do so throughout 2024. We've guided to continued growth. If you look at our portfolio, our proprietary formulation technology really is fueling our portfolio. Gvoke and Ogluo are the XeriSol technology. Ogluo is Gvoke in Europe, in the U.K., by the way. And our levothyroxine product, it'll talk a little bit more about as we go through the presentation for hypothyroidism, is a product of our XeriSol technology. The two partnerships that we have so far, Amgen, that just signed the license for future development of TEPEZZA in thyroid eye disease using our XeriJect formulation, and Regeneron, that we're currently in the formulation development stage on two of their assets, hopefully leading to a license to further develop those and several others.
That is a platform deal that Amgen has the right to put several products into our technology. Looking at our product, our commercial business a little bit more in depth. Gvoke HypoPen, for those who don't follow us on a regular basis, is a ready-to-use rescue pen that anybody can use on a moment's notice to treat severe hypoglycemia. It's the first and first that product that lends itself to self-administration. Recorlev is an oral medication that normalizes cortisol, which is the root cause of Cushing's syndrome over the long term, improving just about every biomarker and indicated for a full umbrella of endogenous Cushing's syndrome. Keveyis is a product that very few people really know much about. It is for primary periodic paralysis. I'll talk a little bit more about that when I get to the Keveyis sections. It's a very unique condition, very rare.
We'll spend some time on that as well. Go a little deeper in Gvoke. Ready-to-use liquid glucagon for the treatment of severe hypoglycemia. Our main product is Gvoke HypoPen. It's a ready-to-use product, lends itself to self-administration. Very simple. You can see that in the pictures here. It's a very small device. It has a window where you can pull the red cap off. You press the yellow cap, hold down for five seconds on exposed skin, arm, abdomen, thigh. And this little window will turn red, and you know that you've administered the dose. 99% success. People, even trained and untrained, get it right the first time.
So very unique innovation relative to what used to be out there, which were just the self-administered kits where you had to actually mix the drug, measure the right dose, give yourself an injection, or have someone else give you an injection. People got it wrong over 70% of the time. Evidence of what is happening in the marketplace, I think, is critically important to the discussion of Gvoke HypoPen. There's a very, very large market that already exists. Essentially, if you're on insulin or sulfonylureas, you're at increased risk for a severe low. Right now, of the 15 million people that that represents, there's less than a million who currently get a prescription for a ready-to-use glucagon rescue product such as Gvoke HypoPen.
Even though all of the clinical organizations, patient advocacy organizations, such as ADA, AACE, Endo, and ISPAD, all have in their new updated guidance or guidelines or recommendations. They all do them slightly differently. They all have a recommendation for a ready-to-use glucagon for rescue, such as Gvoke HypoPen, in their guidance and as standard of care. Why are only less than 1 million of the 15 million actually getting a prescription for one of these products, such as Gvoke HypoPen, is because physicians have yet to make it make standard of care, standard of practice. And that's what we really need to work on, is making the prescription of a rescue device concomitant with a prescription for insulin or sulfonylurea. And that's what we're working on. But right now, there are a lot of people who go unprotected.
You know, interestingly, one of the questions we get quite frequently lately is, so what will happen with this market with GLP-1s? Will fewer people be taking insulin? And when people do doctor calls, they hear doctors saying, yes, fewer people might be taking insulin. With 15 million people in need of a rescue device, if millions stop taking insulin in favor of GLP-1s, there is still a huge and robust market opportunity and millions of people who remain unprotected. So the GLP-1s should not be a factor for Gvoke HypoPen going forward. The other thing, the other question we get pretty frequently is, well, do CGMs eliminate the need, the risk? The answer to that is they do not.
92% of the data that's been published, 92% of people on a CGM spend some of their day in hypoglycemia, which is defined as less than 70 mg per deciliter of glucose. As much as one-third continue to experience severe hypoglycemia and spend a significant amount of time each day in level 2 hypoglycemia, which is high risk of a severe low. So once again, is there still a huge and important marketplace here? Absolutely. And you can see that over the last five or six years, the glucagon market in total has continued to grow and now back up to double-digit growth in 2023. And we expect that it'll continue to grow in the years to come. You can see the first estimate is that little dot right there, which is the January.
You know, you can see continued growth on an estimated basis for the first month of 2024. It's just another representation of similar information. Retail prescription market share. Gvoke continues to grow, which is the purple. BAQSIMI continues to grow, which is the nasal dry powder version of a ready-to-use product. And the legacy kits continue to decline. They will go away for all intent and purpose. Lilly and Novo have both discontinued their kit product, so that should accelerate that decline even more. And if you look at that from a revenue basis through the third quarter of this year, continued strong growth for Gvoke, and we expect it to continue in the coming years. Moving on to Recorlev. Recorlev is a product for Cushing's syndrome.
The most important thing to know about Recorlev is it normalizes cortisol, which is the goal of therapy in endocrine disease caused by an overproduction of cortisol. Cushing's is a debilitating disease. There are a number of impacts on the CNS system that really do impair people's quality of life: heart attacks, fatigue, stroke, high blood pressure. The list goes on and on. This is a relatively rare condition, but treatable. The problem historically has been when you look at the products that are available and used regularly for Cushing's, most of them are not indicated for Cushing's syndrome, and several of them have pretty significant side effects. The biggest product of which is Korlym, which actually does not normalize cortisol. Symptomatically, patients feel better, but you're not getting normalization of cortisol. So that is an important element of messaging and change for endocrinologists.
You've got a better product than Korlym in Recorlev. Isturisa is used for a relatively new product, used pretty frequently. Some pretty significant side effects, really bad hirsutism, and in a population that is 80% female, not something you want to have a lot of. Oop, wrong direction. If you look at the way we're targeting Recorlev, it has the broadest indication and treats the root root cause of the disease. It achieves rapid and sustained reduction of cortisol, reduces signs and symptoms as a result of treatment. And the other thing is, we surround these patients with what we call Xeris Care Connections.
It's really a best in class, ongoing full service support team for patients and physicians everywhere from getting the referral to therapy right, helping with prior authorization if that's necessary through the the specialty pharmacy, helping patients to get on therapy, counseling them as to what to expect, and then helping them through their titration to the most effective dose. Really is a a service that physicians value quite significantly. And also, our target is the 8,000 prescription treated adult non-malignant patients, post-surgical. You can see that Recorlev is relatively new, most very recently launched. Launch in this category and in a lot of rare disease categories is a very stepwise fashion. As you start to get better and better at clearing insurance, getting patients through the testing process and on therapy, as that continues to improve, growth rates continue to improve.
You can see that we've grown every single quarter pretty significantly. We fully expect to continue that. We're very pleased with the launch trajectory so far, and we're very excited about the future of Recorlev. Moving on to Keveyis. Keveyis is for what is called primary periodic paralysis. What happens is patients experience symptoms of clumsiness, extreme fatigue, and actual paralysis, paralytic attacks that are very acute, can be debilitating. They happen without warning. Every single patient has different triggers for those periodic paralytic events. It's incredibly rare. We estimate between 4,000 and 5,000 potentially diagnosed PPP patients in the U.S. with events weekly or even daily. Life changes for these patients. They can't do the normal things that you would do: drive a car, you know, go to the movies, go to dinner.
They never know when they might have an event. And that's where one of the things that really does help is, once again, the Care Connections, really surrounding these patients with everything from a dedicated patient access manager throughout their journey, the clinical pharmacy, and even patient mentors that are patients who've been on Keveyis for a year or two and have gone through that reintroduction to life, being able to get back behind the wheel of a car, for example, and out to dinner, and really help them and handhold them through that. Physicians have been very, very interested in this. One of the reasons that we've been on the market with generic competition for the last year and actually grew Keveyis simply because physicians are willing to fight for brand in order to get those services for their patients. And Keveyis works.
It works across patients with sodium, calcium, and potassium channel mutations, sustained benefits over time. It's demonstrated very tolerable, and the dosing is very individualized, so you can get the right dose for the right patient for the right outcome. And once again, continuing to grow into or through 2024 or 2023. You know, we always get asked, so what's the future of Keveyis? Do we expect more generic competition? Probably. Do we potentially expect price degradation? Probably. Should we expect patient loss? Probably. But we've done a remarkable job with this product to date in the acquisition of Strongbridge, which is when we got Keveyis. We anticipated that we would have a couple of generics and that our goal was to hold the product flat to slightly down. We've done tremendous relative to that initial expectation.
Moving into our formulation technologies and development pipeline, as I mentioned, levothyroxine for hypothyroidism, Amgen deal and Regeneron deal, the XP-8121, which is for thyroid, hypothyroidism. We are it's a so this product right now is a daily oral. One of the big issues with the daily oral, one of the most prescribed medicines in the U.S., 103 million prescriptions a year on average. But a lot of patients experience some kind of difficulty with the product, that there are compliance issues, hard to control symptoms, interactions with concomitant medications, GI side effects, lack of absorption. And when you really add it all up, that's about 30% of the population that's experiencing one or more of those issues.
What we're building is a once-weekly subcutaneous injection of a liquid levothyroxine, which will bypass the GI tract and improve regimen with less frequent administration, more consistent blood levels instead of the up and down you get with orals. And, you know, relatively small volume, can be room temperature stable, subcutaneous injection using our XeriSol formulation. And then we have XeriJect. You get with XeriJect, we can do. XeriJect is an injectable paste. It's a low viscosity paste that has a high drug loading capability. Injection volumes are significantly reduced. Very good syringeability. We can deliver this through a 25-30 gauge needle, ready to use, doesn't require reconstitution, no mixing required, and potentially improved stability depending on the asset we're working with. So a unique, very different technology. It's a delivery mechanism only.
We don't change or reconstitute the molecule we're working with in any fashion. We concentrate it and suspend it in our low viscosity paste. A little bit more, if you go look at our website, you'll see some more detail on the two technologies. XeriSol is best suited for peptides and small molecules, and XeriJect is best suited for drugs and biologics, large molecules, monoclonal antibodies, and vaccines. Right now, we're dealing with predominantly monoclonal antibodies from our partner companies. And we frequently get asked, you know, how do you compare to Halozyme? Halozyme is yesterday's technology. It works. It's good. But you don't really get a subcutaneous injection. You get a subcutaneous infusion, which is still an office procedure, and it's a push infusion over anywhere from two to 10 minutes and fairly large volumes, 5 mL.
With XeriJect, you get a true subcutaneous injection, less than 30 seconds, low volume, small-gauge needle, 27- or 29-gauge needle, can potentially be self-administered, which is very different than an HCP-administered and in-office procedure, could potentially be room-temperature stable depending on the molecule and depending on the market need, can be ready to use. It's not a vial and syringe, can be used in prefilled syringes, auto injectors, pumps, and probably a pharmacy benefit versus a medical benefit, whereas Halozyme is a medical benefit. What we say is, if a company is already invested in Halozyme technology, good, is taking them from step A to step B, XeriJect will take them from step B to step C or D. It really is tomorrow's technology that we're innovating today around several molecules for big partners.
Our portfolio is supported by a strong intellectual property estate, over 166 total patents globally, of which 31 are U.S.-based. Very well, all three products or both products, Gvoke and Recorlev, very well protected. As I mentioned, protection on Keveyis—almost forgot. Protection on Keveyis went away in August of 2022, and we've continued to sell the product extremely well, actually grew it in 2023. So it's more than just the patent at the end of the day that can support a product. Our team is a very experienced team. We've been together, most of us, in several companies, in fact, all of us at one point or another with one iteration or another in two, sometimes three companies.
You know, we like to say we can finish each other's sentences, but a very experienced team that knows how to build a company and is doing it again and again. So if you look at Xeris Biopharma, what are the important things you should take away from an investment perspective? We're a diversified, rapidly growing revenue base with three commercial assets in large addressable markets. We have a strong pipeline focused on developing medicines that address unmet medical needs and leverage our proprietary XeriSol and XeriJect formulations. As I mentioned, we're developing a once-weekly subcutaneous levothyroxine. We continue to build partnerships with large pharmaceutical companies to apply our formulation science to their proprietary products.
As everyone knows, we announced in January 10th to be specific, worldwide license that was signed by Amgen for XeriJect formulation of TEPEZZA, which I think is a huge validation of the potential value of Xeris technology. We have a very attractive financial profile. As the company, we anticipate year-end 2023 liquidity to be greater than $72 million. We have a successful M&A track record with a continued focus on acquisitions to leverage our commercial footprint. We will grow both organically and inorganically. We've stated that, and that is part of our mission. We have a proven and experienced management team that we've built companies. We know how to build companies. We know how to build great companies. We're building Xeris around three growth-oriented strategic pillars, all of which could deliver significant value to shareholders. With that, I will conclude.
I think we have a few minutes left if there are any questions. Leland, what , two minutes quicker than I thought.
No, very, very, very nicely done. Thank you, Paul. Yeah, so there are a couple questions. You know, I think with respect to Recorlev, you know, we have Korlym generics entering the market. Just want to ask kind of what you see there, just, you know, in terms of what may be, you know, what increasing challenges that may present and, you know, what are the challenges that you've seen irrespective of that with respect to kind of gaining, you know, further traction in adoption of Recorlev?
Yeah, I think good question. I normally touch on that. That's probably where the two minutes went. This is not a price-driven market, first and foremost. There's a lot of products.
There's a lot of generics, and physicians are using brand, and payers are paying for brand. That said, a discount to current price Korlym to Korlym generic, I think, is going to be important for payers, and they'll probably try to force some of that switch. Korlym is such a big product in the category, that forcing of the switching from Korlym to Korlym generic in the short to mid-term shouldn't really hurt us in terms of our opportunity. We're small. We're growing, and Korlym is a good target for us, especially if physicians don't want to use a generic or don't want their patients subject to a generic. We have the Care Connections that gives them great support. In truth, a fascinating element of the marketplace right now is our branded price is actually lower than the Korlym generic price.
So if price ends up being an issue, they can get a brand for a better price anyway. So it's neither here nor there. They have a follow-on product that if you I'm assuming you would ask about. So they're going to be trying to switch Korlym to the next generation, which in essence, with generic attacking from one side and trying to switch on the other side, puts the entire franchise in play, in my opinion, which I think is an opportunity for us.
Got it. Good. That's helpful. And then, you know, as we see the company turning toward cash flow positive and, you know, it seems like, you know, you guys are pretty focused in the endocrine space, should we think about Xeris as continuing to build out maybe other products that you may see out there that you could bring on that may be late-stage or early commercial? You know, would that be the right sort of theme for us to kind of think along?
Yeah. The Strongbridge acquisition is the best example of that. It, they had a product that was already in front of the FDA. Our diligence, we were able to get very comfortable that it had a high likelihood of being approved. And they had a product on the market that was generating cash that we believed we could continue to generate a lot of cash.
We took $50 million in synergies through that company acquisition. So another Strongbridge I would do tomorrow, right? We're looking at other things like that. If we can find more products in our current neuro and endo space, great. There are two or three adjacent therapeutic areas that we'd be very comfortable and very happy going into as well. We, I, we do believe we want to have a company that's across multiple therapeutic areas with two or three drugs in each category, not five drugs in endo because you're never going to get to the third, fourth, and fifth conversation with endocrinologists. So the days of three or four drugs per category are when you could get a lot of time with docs. It just doesn't work that way anymore.
So a little bit broader with a few drugs in each category, either through our own technology development such as levothyroxine or through acquisition.
Great. Good. And then maybe just, you know, back to sort of the original product for Gvoke, do you know, there have been other products for this indication that have been available, you know, perhaps for longer? Have you seen kind of overall growth in the category in terms of the market of patients who are taking a kind of a rescue drug by its marketing through you, or are you replacing kind of what had been, you know, the other products that had been available, you know, before Gvoke?
Yeah, replacing and growing the category. So the rescue kits, the red kit that used to be, you know, from Lilly, which was the one that was predominant in the U.S., very, very hard to execute. It's a dry powder that needs reconstitution with a diluent, and then you have to draw the right dose, almost impossible for an individual to do while experiencing a severe low. And either trained or untrained, even trained healthcare professionals delivered the wrong dose over 70% of the time. So just an ineffective therapy. And one of the reasons that glucagon has not been really, you know, thought of by physicians, we've got to rebuild that mentality, is because they would prescribe it for patients who would never use it. They go to the emergency room, which is, you know, right now, there's over 200,000 emergency room visits every year for severe hypo.
Somewhere between 20,000 and 30,000 people die every year from severe hypo. So this is not a trivial situation, okay? If you think about EpiPen, you know, fewer incidents, fewer people going to the emergency room, fewer fatalities, yet everybody's got an EpiPen if they have a severe allergy. So we're trying to rebuild that mentality with a product that actually works. The other product in the category, which was the Lilly product, was the dry powder nasal spray, launched about a year before us, launched in endocrinology, in pediatric endocrinology, where Lilly is very strong, and got off to a really good start. But they were sort of plowing the field for us a little bit. So we were able to go right in behind them and really gain share fairly quickly. I think we're currently between the two.
We're 80%-82% of the total glucagon rescue market. And within the category, we're like Lilly 60%, we're 40%. Lilly just sold that BAQSIMI product to Amphastar, you know. They will be promoting soon, we hope. And one of the things that's been really good is Lilly has in when under their ownership, they focused BAQSIMI on growing the category. Everybody on insulin should have a rescue device. And now we fully expect that Amphastar will continue that grow the category. Everybody on insulin should have a rescue device. If that happens, Gvoke HypoPen will do extremely well. You know, we'll get our share. What needs to happen is eight million people need to be filling prescriptions for Gvoke HypoPen or BAQSIMI instead of less than a million. It's the right thing to do. It's the right thing for patients.
And at the end of the day, you're saving lives. That's, you can't do anything more important than save lives.
Terrific. And I think with that, we're at the time. So thank you, Paul, for taking us through all that, all that's going on at Xeris. And thanks everybody for joining.