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Hello, and welcome to the Xeris Biopharma Third Quarter 2024 Financial Results Conference Call. My name is Harry, and I'll be your operator today. [Operator Instructions]
I would now like to hand the conference over to Allison Wey, Senior Vice President of Investor Relations and Corporate Communications. Thank you. Please go ahead.
Thank you, Harry, and good morning. We appreciate you joining our third quarter results call today. I'm joined by John Shannon, our CEO; and Steve Pieper, CFO. This morning, we issued a press release with our detailed results, which can be found on our website. After our prepared remarks, we will open the line for questions.
Before we begin, I would like to remind you that this call will contain forward-looking statements concerning the company's future expectations, plans, prospects and financial performance. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those forward-looking statements. For more information on such risks, please refer to our earnings release and risk factors included in our SEC filings. Any forward-looking statements in this call represent our views only as of the date of this call and subject to applicable law. We disclaim any obligations to update such statements.
Let me now pass the call over to John.
Thanks, Allison, and good morning, everyone. I'm excited and proud to report another record-breaking quarter with total revenue of over $54 million and product revenue of nearly $53 million led by strong demand of Recorlev and Gvoke. Our product revenue growth of 27% marks the 12th consecutive quarter of over 20% growth. That's right, 12 quarters in a row of over 20% growth with the last 2 quarters accelerating to 26% and now 27%, respectively.
The entire Xeris team is focused on driving growth, and I'm so proud to see them executing on all fronts. In addition to our outstanding commercial success, we also significantly advanced our lead pipeline product, XP-8121, our once-weekly subcu levothyroxine, and executed as planned on all of our technology partner programs.
Over the last several months, our primary focus has been executing the three strategic priorities I outlined back in August, when I became CEO. As a reminder, these priorities are: first, the rapid and sustained growth of our commercial franchises; second, enhancing our financial discipline while ensuring we maintain a strong balance sheet to fund our strategic growth investments; and third, enhancing our communications and transparency with you, our stakeholders.
So let's get in how we're doing, starting with priority one. I'm pleased to report another record quarter of product sales, hallmarked by the accelerating growth of Recorlev, the ongoing rapid growth of Gvoke and the continuing durability of our Keveyis brand. Across all three products, the commercial team continued to execute our plans, resulting in a 27% product revenue growth this quarter compared to Q3 last year.
Looking specifically at each of our products. In line with Recorlev's best-in-class profile, we saw a record number of new referrals in the third quarter. In addition, the team has been focused on ensuring the smoothest and most efficient process to support patients getting started on Recorlev, which has driven a 126% increase in new patient starts compared to last year.
Our targeted commercial investments on Recorlev are accelerating the growth of Recorlev revenue to nearly $18 million, up 119% over Q3 '23 and up 33% over last quarter. Recorlev continues to have, in our view, a best-in-class profile for endogenous hypercortisolemia and patients with Cushing's syndrome for whom surgery is not an option or has not been curative. Endogenous hypocortisolemia Cushing's syndrome is caused by chronic elevated cortisol exposure, often the result of a benign tumor of the pituitary orogerenal gland.
This is where Recorlev comes in, an oral twice-daily tablet that has been shown to normalize cortisol levels safely and effectively across multiple etiologies. As I mentioned in August, the Cushing's syndrome marketplace is expanding rapidly and creating strong tailwinds for Recorlev. Every day, more and more people are being screened, tested and ultimately diagnosed with hypercortisolemia. And recall, as part of our disciplined and focused investment priority, we just increased the size of our Recorlev sales and patient support teams by 50% in July to build on this momentum. And we expect that expansion to fuel continuing strong growth in the future.
Turning now to Gvoke. This product continues to have enormous market potential, given the overall population of people with diabetes who are at risk for severe hypoglycemia. We are very pleased to see our efforts continuing to pay off. In the third quarter, Gvoke achieved almost $23 million in revenue, a 29% increase. We saw a 20% increase in total prescriptions coming from an increase in new prescribers as well as an increasing number of repeat prescribers.
Excitingly, we continue to steadily gain market share with our new prescription share now standing at 37%. Severe hypoglycemia can be a life-threatening and requires prompt treatment with emergency glucagon and/or medical intervention. The best way to ensure prime treatment is to have a filled prescription for a ready-to-use glucagon product and to carry that at all times. Gvoke is an easy-to-use, reliable glucagon auto-injector that patients can use swiftly at the onset of symptoms. We are just scratching the surface of the total addressable patient population of over 14 million people still unprotected. And with patent protection to 2036, Gvoke has a very long runway.
Wrapping up the commercial execution is the durability of Keveyis as a branded product. We are thrilled to have generated such strong support for Keveyis in the medical and patient community and to see that translating to continued dedication to the brand. Despite the availability of generic competition, we believe Keveyis is best-in-class, surrounded by a tremendous support system that is valued by both the patient and the health care provider. In fact, while we're still early in the fourth quarter, we continue to find and support new PPP patients every week. Given our exceptional year-to-date performance and expectations for the remainder of the year, I'm excited to announce we are raising our revenue guidance to $198 million to $202 million.
Moving to our second strategic priority, our renewed commitment to financial discipline and execution of strategic growth investments, which enables the creation of short- and long-term value. Steve will go through our detailed financial results in just a bit. So I'll just cover a few key highlights.
We've made great strides with our financial profile. Our greater than 25% product revenue growth, our strong margin profile and our disciplined expense management all are contributing to our very healthy cash position of over $69 million in cash. This allows us to invest in the growth of our business with no need to conduct any dilutive financing. We anticipate that our fast-growing commercial franchises will remain the core value driver, along with the advancements in our development stage pipeline, led by XP-8121.
I can't stress this enough, the more we evaluate clinical data and perform market research, the more excited we get owing to the overall size of the hypothyroidism market, and in particular, the number of patients who are unable to control their hypothyroidism with oral therapy. Last week, at the American Thyroid Association meeting, we presented data from our Phase II study, showing that 40% of the patients referred to the study as being in control were screened out of the study because they were out of normal range. With positive Phase II clinical data in hand, we initiated discussions with the FDA in preparation for a Phase III registrational program with XP-8121.
We have had favorable engagement and look forward to further interactions with the agency as we work through finalizing plans and timelines. While we assess and determine the optimal path to registration, we expect to be able to provide a fulsome update in the first half of 2025.
Just a brief mention of our technology partner programs. They are all progressing per each partnership agreement, and we're actively working on potential new partnerships. Our current and potential partners recognize the unique features of our XeriSol and XeriJect technologies and the benefits our platforms may provide to their respective businesses. As our partnership programs advance and become more meaningful contributors to our business results, we will be sure to provide updates.
Moving to our third strategic priority. We've been busy hearing from investors and getting your feedback. I can personally share that I very much enjoy digging into this role as the CEO and connecting with our investor community, all with the intention of increasing transparency and improving the quality of our communications. I was happy to hear that many of you recognize we have been executing and delivering meaningful growth with our current assets. We also understand you would like us to share more metrics that would provide a clear picture of the long-term health of our company, and we're committed to providing even greater clarity as part of our 2025 guidance.
Finally, the most exciting and consistent thing we heard was that almost all of you see Xeris as a unique execution company with multiple fast-growing products and a promising pipeline positioned well to create significant shareholder value in the short and long term.
With that, I'm going to hand it over to Steve to review our financial results for the quarter and year-to-date.
Thanks, John, and good morning, everyone. As John highlighted earlier, we are very pleased with our third quarter results and the positive momentum we are seeing with our business.
We ended Q3 with net product revenue of $52.9 million and total revenue of $54.3 million, increasing by approximately 27% and 12%, respectively compared to prior year. This marks the 12th consecutive quarter with greater than 20% product revenue growth. On a year-to-date basis, net product revenue was $139.6 million and total revenue was $143 million, increasing by approximately 26% and 20%, respectively, compared to prior year. Remember that last year, in the third quarter, we recognized $6 million for achieving the prespecified target product profile milestone from Horizon. Excluding that nonrecurring item, total revenue increased by 28% and 26% for the quarter and year-to-date versus prior year.
Moving to our products. We are excited by the acceleration we are seeing from Recorlev. For the quarter, Recorlev net revenue was $17.7 million and for the year was $41.7 million, both more than doubling compared to prior year periods. On a sequential basis, Recorlev net revenue increased by over $4 million compared to Q2. For reference, last quarter, Recorlev net revenue increased by $2.7 million compared to the first quarter. This acceleration quarter-over-quarter is a result of our growing pipeline of referrals and our ability to convert them into more patients on Recorlev. We continue to see an increase in new patients growing 25% versus Q2. And we expect with the recently completed Recorlev commercial expansion that this momentum will continue.
Gvoke net revenue was $22.9 million for the quarter and $59.6 million on a year-to-date basis, representing a 29% and 23% increase compared to the same periods last year. This growth was primarily driven by an increase in total Gvoke prescriptions. Consistent with prior years, Gvoke maintained healthy growth in the back-to-school period. We are confident in Gvoke's continued growth as new prescription market share has increased to over 37% as of the most recent weekly data.
Keveyis net revenue for the quarter and year-to-date was $12.2 million and $38.4 million, respectively. In Q3, we saw a modest increase in the number of patients on Keveyis for the second quarter in a row as we continue to generate a strong pipeline of referrals. As a result of generic competitive pressure, pharmacy reimbursement has decreased, resulting in a modest negative impact to Keveyis net pricing. Sitting here today, we continue to remain extremely confident in our ability to defend Keveyis against generic competition.
Given the strong performance of all three of our products and the momentum we are generating, we are raising our total revenue guidance to $198 million to $202 million from the previous guidance of $190 million to $200 million.
Moving on to cost of goods sold. Cost of goods sold as a percent of total product revenue increased to 25.7% and 19.6% in Q3 and on a year-to-date basis. Like many fast-growing biopharmaceutical companies, we are strategically implementing process changes with our CMOs to ensure we are able to increase capacity and maintain an adequate supply to meet the growing demand for our products. This quarter, we wrote off $3.6 million of Gvoke components as a result of manufacturing process changes required to support ongoing capacity expansion efforts. It is worth noting that this charge had no impact to cash in the quarter. We are focused on ensuring we have adequate supply to support our fast-growing products, and we'll continue to invest accordingly.
Research and development expenses were $5.9 million for the third quarter, relatively flat compared to the third quarter of 2023 and were primarily comprised of costs for our pipeline, notably XP-8121, and continued investment in our technology platforms and partnerships. On a year-to-date basis, research and development expenses were $19.5 million, a $3.5 million increase compared to prior year, which was primarily to support our pipeline increased personnel costs for the continued investment in our technology platforms and partnerships.
Selling, general and administrative expenses were $45 million and $123.3 million for the quarter and year-to-date, respectively, an increase of 21% and 14% compared to prior year. These increases were primarily driven by costs related to the previously announced CEO succession plan and related corporate restructuring, resulting in a one-time charge of $6.1 million in the third quarter. Excluding this nonrecurring charge, SG&A only increased by 4% compared to Q3 of last year. This increase was driven by the expansion of our Recorlev commercial organization.
From a total operating expense perspective, we ended the quarter relatively flat to last quarter, when you exclude the non-routine charges of $9.7 million, which includes the CEO succession plan and related restructuring charges as well as the Gvoke component write-off. We were able to keep these operating expenses relatively flat while generating approximately 14% in product revenue growth versus prior quarter.
Moving to cash. We ended the quarter in a strong cash position with over $69 million. Cash utilization has improved every quarter this year, and we expect that trend to continue into Q4. Given our confidence in the health of the business, which considers our increased revenue guidance as well as the expenses associated with our Q3 Recorlev commercial expansion, we are tightening our ending 2024 cash guidance to $68 million to $72 million from $60 million to $75 million. We will continue to drive robust revenue growth, maintain our strong margin profile and diligently manage expenses, which gives us confidence that the business is financially sound and does not require any dilutive financing to fund our growth.
Looking ahead to 2025, we will provide detailed financial guidance when we release our year-end results in March. With that, operator, please open the lines for questions.
[Operator Instructions] Our first question today will be from the line of Chase Knickerbocker with Craig-Hallum.
Congrats on a really great quarter here. John, maybe just, first, help us think about kind of the specific drivers for Recorlev and specifically, obviously, within your business, kind of peel back the curtain a little bit for us on kind of what you see as market growth here and what you see as kind of specific your team's execution and kind of talk a little bit about the pipeline kind of entering Q4. Because seemingly, this market has a really attractive growth profile from here. And I think investors can think that this inflection sort of continues. Just kind of speak to your confidence level there.
Yes. I think I really kind of think about this as tailwinds in terms of the market growth. And we're riding on that with a product that is Recorlev is a great product if you really want to normalize cortisol and inhibit cortisol production, right, and maintain that. So we're riding on that market expansion in that respect. And our success is really driven by our team of people out there identifying these people with hypercortisolemia who have Cushing's as well as our patient access people who are really helping them get them started.
So as you hear in my script and as we've talked a lot about, we're filling the top of the pipeline with referrals, and we're getting better and better at pulling those referrals into new patient starts. So those 2 aspects are 100% driven by our team and our support services out in the field.
Great. And then maybe...
Talk about the pipeline in the -- yes, yes, I should. So with respect to the pipeline we're accelerating on both. So we've been -- like at the top of that pipeline or what we like to call it the top of the funnel is driving those referrals. And we continue to accelerate that level. We're accelerating at both ends. So it's looking great.
Great. And then Steve, maybe help us think a little bit about kind of the path to breakeven. You essentially guided to cash flow breakeven positive in Q4 kind of within that implied cash guidance. And then as we kind of go into '25, as we kind of balance potential levo Phase III program and kind of the continued inflection you guys are showing in margins, kind of walk us through how investors should think about your business getting to a cash flow breakeven position on a go-forward basis sustainably.
Yes. Chase, thanks for the question, and I appreciate you asking me to guide on '25. As I mentioned in my prepared remarks, we're not prepared to provide that '25 guidance yet. Specifically with levo, there's still work to be done there, FDA discussions underway. So we expect to provide a more fulsome update in the first half of '25 and how that factors into our thinking for '25.
But I think you hit on something that, yes, we're really confident in the trajectory of the business, particularly on the top line, coupled with a strong margin profile. And in my prepared remarks, I mentioned that our operating expenses were relatively flat when you back out a couple of one-time charges in the quarter. So I think we see that path and we'll provide more detailed guidance in March of next year. But we're sitting here feeling very confident about the financial profile of Xeris and where we're heading.
The next question will be from the line of Leland Gershell with Oppenheimer.
Great execution on another quarter here. Just a question on the P&L, the cost of goods, Steve, after you back out the $3.6 million from the Gvoke write-off, looks like the gross margin may have been a little bit lesser than it had been earlier this year. Just wondering if you can comment how we should think about that maybe through the fourth quarter and going forward?
Yes. I would say the write-off in the third quarter was -- just the size of it was probably a little bit higher, but I think as a biopharmaceutical company that has -- particularly with Gvoke, with the supply chain, you have write-offs from time to time. We don't anticipate the same degree of write-off in the fourth quarter. And I think, look, we don't comment typically specifically on product-level gross margin. But look, I think it's fair to assume that as we continue to sell more Recorlev, that should improve our overall gross margin.
So on balance, we look at it as healthy gross margins north of 80%, and we should continue to remain in that spot.
Got it. And John, I know that this would be clarity we'll be coming into on 8121 as you continue with FDA discussions and we get into early next year. But just wondering if at this point, you could share just broad strokes of what you may see for pivotal clinical trial for 8121.
Yes, I'm not prepared to get into that because, like I said, we're in discussions and it's an iterative process in terms of kind of what we want to accomplish with this product in terms of things you want in a label, things like that. So I don't want to give an opinion on any of that stuff right now.
The next question today will be from the line of Oren Livnat with H.C. Wainright..
On Recorlev, really impressive growth there year-over-year. Can you just talk more about the moving parts within that year-over-year and sequential growth? Are you -- maybe some of the pushes and pulls with regards to average dose versus gross to net. I know there was a price increase in the July, yet net sales were just slightly lower than the total patient growth year-over-year. I'm just curious if that's just lumpiness in terms of timing of pull-through or payer dynamics. And I have a follow-up.
It's not payer dynamics. And the other parameters you were asking about is things like dose, things like persistence and things like that are all still similar and same. What's really driving Recorlev growth right now is adding new patients at the top of the funnel and pulling them through to new patient starts. I can't emphasize that enough. That's the game right now. And we're -- and that's where we're really having great success.
Over time, some of those other things are going to move. But when you're adding new patients so quickly, Oren, and physicians start low and go slow in terms of raising things up, dosing and things like that are going to take time to come up. And that's fine. Our goal right now is to get the patients on and get them started -- get them referred and get them started.
Talk about the makeup between -- go ahead, sorry.
No, we're just not having a payer pressure stuff. So it must be just timing of where patients...
Okay. And I think in the past, you've talked about being pretty excited about seeing first-line patients already. Can you just give us an update on the overall makeup of the patient base now between first-line and switchers? And for the latter, what do you think is the main reason patients would switch, and I guess that is for both uncontrolled patients more likely, but even in maybe a controlled patients, which is a larger portion of the overall Cushing's market, is it possible some of that may even switch over, just given this approved therapy versus off-label keto?
So I don't have the exact mix, but it's -- we get a lot of naive to draw new patients and we're getting a lot of switches. So it's significant amongst both of them. I don't know the percentages exactly, but -- so the reason we're getting them is if -- and especially on the new patients, if physicians really want to normalize cortisol and inhibit cortisol production, Recorlev's the best choice. If -- on these switches, it's usually they're not in control and they're switching to something else, and they want to again normalize cortisol. And again, Recorlev is the great choice there.
All right. And on Gvoke, you've talked ad nauseum about -- well, not ad nauseum, but point out the underpenetration of the overall glucagon market, right, why doesn't it look more like EpiPen with this huge at-risk population, but it's not standard of care, clearly, yet for these applications to get rescue. The overall market is probably, including old generics, it's probably in the low single digits now. And I'm just wondering, given that in the guidelines now, what will it take? And how long do you think it will take for this market to accelerate, so we start seeing more new insulin or new at-risk patients to an existing ones starting to get prescribed rescue therapy?
Yes. So let me start with where you started. It should be the standard of care just based on the guidelines. It should be the standard of care. What we're trying to do is make it the standard of practice for clinicians, and we're trying to drive that. We're the only ones doing it, to be honest. And so it's -- any growth in this marketplace is being driven by the Xeris team by going into physicians' offices, alerting them of the standard of care and getting them to change practice and make it part of their standard of practice. That's the game we're out there for.
And how long is it going to take? When is it going to pop? I don't have an answer for you. But what I can tell you is we have a long runway and a lot of time to get it done. And we're going to work on this until we run out of runway. And the Gvoke team gets out there every day and really fights for the patients to make sure the ones that aren't protected are protected, and we'll continue to do that. So I don't know exactly how long, but we're in for the fight.
All right. Just one last quick one. It sounds like you're planning to give some more detail in guidance for next year in March. Is that most likely just going to be a product breakout, hopefully, given a little more visibility on your Recorlev in particular? Or can we also hope for maybe OpEx and margin guidance as well? Or that's TBD?
It's a great question, and let me answer. We've got a lot of -- we -- as I said in my remarks, we've talked to a lot of investors in the last 90 days. And we got a lot of advice on what we need to report on. And we're taking all that into account, and we will look at what are the key metrics of our business going forward that we really should communicate, so people can truly understand the value that we're creating for shareholders, not only short term but also long term. So I'm not going to give you exact measures, but I will tell you there will be more indifferent.
Our next question will be from the line of Roanna Ruiz with Leerink Partners.
This is Mick ask on for Roanna. Maybe first on Recorlev. Curious what the outlook is on sales force expansion going forward and whether you continue to add new reps from here? And then could you also comment on how long it's taking physicians to titrate patients to stable doses in the real world? And I guess, any sense around where the dose is landing relative to the patent dose you look at in clinical trials?
Let me start with the last one. We're not at the doses, and we've been really clear on that because clinicians are starting low and going slow. So we're definitely at lower dosing. We're getting -- physicians are finding really, really strong results in treating their patients. I don't know how long it will take to ever get up to that level. But again, the reason it's going to stay low for some period of time is because of the new patients we're bringing on. And again, they're coming in at low doses and being titrated up. So as long as our rates of -- and what do we say, 126% increase in new starts, that's going to drive that number -- keep that number where it's at for some period of time. What was the other part of the -- expansion. You know what, we had a great foresight as we're looking at what's going on in the market and made 2 expansions over the last 9 months in order to meet that demand. And I think we got it. I think we're in a good spot right now. So -- but I can tell you that if things continue to accelerate at levels that even exceed our expectations, we -- it's a good place for us to invest in terms of driving the growth of this product and getting more and more people on Recorlev, which is really what that expansion would drive.
Got it. That's helpful. And then for Gvoke, any differences you saw this year in terms of the back-to-school dynamics relative to prior years? I think you mentioned 37% of the market as of October. So I'm curious what your outlook is on gross to net for Gvoke in the coming quarters and whether you could continue to grow share from here into 2025?
I think there's -- I think Q3 was almost identical to every other Q3, the way things work, the way share moved, and we're back to gaining share again. Because as I said before, we're the ones out there driving the market growth. And with that growth, it's becoming share. The other -- the kits and the vaccine is not growing share, not growing. So that's just us at this point right now. So I see that as, again, how do we continue to do that? And of course, we're capturing all of that growth. So we'll continue to pick up share every quarter, like we have been in the past.
Yes. And then gross to net, I think, was your other question, Nick. We continue to maintain our gross to nets kind of where they've been over the last 12 to 18 months. It's always a trade-off of access versus discounting. And so we're pretty strategic about those decisions that we make to protect price but also try to ensure patients have access to our products. So I would say just a long-winded way of saying that we don't anticipate significant changes to our gross and that's looking ahead.
[Operator Instructions] And our next question will be from the line of David Amsellem with Piper Sandler.
And I joined late, so sorry if you had addressed these two questions. One, can you just talk about how you're thinking about the trajectory of Keveyis longer term, just given the competitive landscape. So that's number one, just high level, your thoughts about the sustainability of that product.
And then number two, just a big-picture question on the Cushing space. We've seen a lot of acceleration in sales and there are, of course, other products that are in development such as relacorilant. You have Kinetics with an asset in development, that's further downstream. But I guess, the question here is how concerned are you about other modalities potentially creating more in the way of noise for Recorlev longer term?
Yes. Let me answer Keveyis first. And I think we've said this the last 2 quarters, we have a lot of confidence in the durability of Keveyis. And the way you look at this and measure when you've got generic competition is can you continue to keep patients, do patients come back, to go generic and come back? And can you continue to find new patients and get them started on brand? So it's about patients and then it's about what's being reimbursed at the pharmacy level and how that impacts. And what we've been saying for at least the last 2 quarters now is that we can keep the patients and we're -- in some cases, we're slightly growing the patients. So we're maintaining our patient base by again bringing on news and some people coming back. So we're maintaining at that level, getting some pressure on the price, which we saw in the numbers this quarter.
And that's just a result of pricing pressures down to the pharmacy level that -- on reimbursement by the payers. So we're seeing a little bit of pressure. We think that -- we think, again, it's durable. There are people -- the value of Keveyis is all the support services around it, and that's deeply valued by not only the patients, but the health care providers. And that's why we are -- why this brand is being so durable. And we think it can be and continue to be durable. If more and more generics come out and come after it, I don't know. But I can tell you right now that, right now, we're winning that fight on behalf of the patients.
Recorlev, I think all this activity in the space is good. I mean you heard me refer to it as tailwinds. What's going on with respect to recognizing cortisol as a culprit in things like resistant diabetes, in resistant obesity, in Cushing's, all of these areas are good for our Recorlev brand. Recorlev is, in our opinion, one of the best at inhibiting the synthesis of cortisol, and that's really the endgame here is can you inhibit that cortisol level and really help the patients. And that really will drive kind of managing the comorbidities of hypercortisolemia and Cushing's. So I think it's all good. Happy to have it. We're -- we benefit from it because it brings a lot more awareness to testing, and that's a good spot for us.
With no further questions on the line, I will now hand the call back to John Shannon for closing remarks.
Thank you. In closing, the entire Xeris team is executing on all fronts, resulting in another record quarter of revenue, setting us up well for a very strong finish in 2024. In addition to our outstanding commercial success, we are also significantly advancing our lead pipeline product, XP-8121, and executing as planned on all our technology partner programs. We are excited to be increasingly recognized as a unique biopharmaceutical company with multiple fast-growing products and a promising pipeline. I'm confident we are well positioned to create significant shareholder value in both the near and long term. Thanks for being with us this morning.
This will conclude the Xeris Biopharma Third Quarter 2024 Financial Results Conference Call. Thank you to everyone who is able to join us today. You may now disconnect your lines.