Xeris Biopharma Holdings Inc

NASDAQ:XERS

Earnings Call Analysis

Upbeat 2024 Guidance Amidst Robust Growth

Xeris expects to drive revenue between $170 million to $200 million in 2024, marking 4%-22% growth, or 10%-30% excluding nonrecurring partner revenue. Even with uncertainties like Keveyis' generic competition, double-digit growth is projected. The financial strategy, including recent debt financing and disciplined cash management, will support commercial product expansion, fund Phase III for levothyroxine, and technology investments. By year-end, an anticipated $55-$75 million cash position emphasizes the enterprise's sustainable momentum.

Promising Technology Partnerships and Financial Performance in 2023

Xeris Pharmaceuticals has had a robust year, fostering strong relationships and delivering promising results. The company's collaboration with Amgen, centering on the XeriJect program, is well-progressing towards initial clinical activities, and with Regeneron, has completed development for two molecules, looking forward to potential commercialization that could trigger additional payments. These partnerships define both the innovative drive of Xeris and its potential for financial growth.

Financial Milestones Achieved: Strong Revenue Growth and Cash Management

2023 marked a year with impressive revenue growth for Xeris, driven by a 40% increase in net product revenue and a total revenue boost of 49% compared to the previous year. With disciplined cash management, the company closed out the year with $72.5 million in cash and a generation of $6.5 million in cash for the fourth quarter, highlighting successful operation and financial prudence.

Strategic Debt Refinancing and Solid Revenue Projections for 2024

Looking ahead to 2024, Xeris expects to continue its upward trajectory, with total revenue anticipated to grow between 4% to 22%. This forecasted growth is underpinned by the debt refinance with Hayfin Capital, which not only provides Xeris with $50 million at transaction close but also offers an additional $15 million to manage convertible notes. Demonstrating trust in Xeris' strategic execution, this refinancing lowers the total capital cost and fuels further investment in technology and pipeline expansion.

Growth Drivers: Gvoke and Recorlev to Compensate for Keveyis

Xeris anticipates the absence of growth in Keveyis will be offset by its other products Gvoke and Recorlev. The company is thrilled with the expanding referrals and solid conversions to patients on drug for these therapies, indicating a strong demand and promising future for these offerings. Despite challenges with payer processes, a 50% to 60% conversion rate in such therapies is considered strong, leading the company to remain optimistic about its potential for consistent growth.

Earnings Call Transcript 2023-Q4

[Operator]

Hello, everyone, and welcome to the Xeris Fourth Quarter and Full Year 2023 Financial Results Conference Call and Webcast. My name is Emily, and I'll be coordinating your call today. [Operator Instructions]. I'll now turn the call over to Allison Wey, Senior Vice President of Investor Relations. Please go ahead.

[Allison Wey, executive]

Thank you, Emily. Good morning, and welcome to Xeris BioPharma's Fourth Quarter and Full Year 2023 Financial Results and Conference Call. This morning, we issued 2 press releases, 1 on the company's financial results and the other on refinancing our debt facility with Hayfin Capital. Both can be found on our website.

We're joined this morning by Paul Edick, Chairman and CEO; and Steve Piper, our CFO. After our prepared remarks, we will open the lines for questions. Before we begin, I would like to remind you that this call will contain certain 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 press release and risk factors included in our SEC filings, including our quarterly report on Form 10-Q. Any forward-looking statements on this call represent our views only as of the date of this call and subject to applicable laws, we disclaim any obligations to update such statements.

I'll now turn the call over to Paul.

[Paul Edick, executive]

Thanks, Allison. Good morning, everyone, and thank you for joining us today. Let me start by thanking everyone who contributed in some meaningful way to us delivering an outstanding year for the company. including the patients we serve, the health care providers we enable and the dedicated Xeris team that executes at a very high level every day. 2023 was an exceptional year of performance and growth for Xeris highlighted by our total revenue, which grew an impressive 49% from 2022 to $164 million in 2023 and ending 2023 with over $72 million in cash. This revenue growth, along with Xeris' strong cash position continues to demonstrate the sustainability of the enterprise we're building.

In 2023, we significantly advanced our once-weekly subcutaneous XeriSol levothyroxine program. We completed enrollment in our Phase II clinical study and have made considerable progress on manufacturing and device development. Even more exciting, we are starting to demonstrate the potential value of our Xeris Technology business. In 2023, we successfully advanced this business and generated over $10 million in total revenue. I'm going to focus the majority of my remarks on our full year performance, and Steve will touch base on the full year and fourth quarter performance in his prepared remarks.

Starting with our commercial business and starting with Gvoke. Gvoke had another outstanding year in 2023. We grew revenue by 28% to $67 million. We grew Gvoke prescriptions to over 215,000 and in 2023. And Gvoke continues to outpace all other products in the category and drove 10% glucagon market growth in 2023. The new ready-to-use good gun products now represent almost 80% of both new and total prescriptions. And Gvoke continues to capture market share. At the end of February, Gvoke market share of new and total prescriptions in the retail boon market, are approximately 34% and 32%, respectively. As I've said before, we see tremendous opportunity for Gvoke. We estimate that approximately 15 million people with diabetes are at increased risk of severe low blood sugar. A primary risk factor for a severe low is being on insulin in sulfonylureas and those who are should be carrying a ready-to-use rescuglucadon like Gvoke HypoPen. However, less than 10% of people at risk of a severe hyperglycemic event have already used [ rescue glucagon ] product on hand, leaving far too many people with diabetes still left without protection against a potentially life-threatening severe level of sugar event, we are just scratching the surface of this opportunity.

The universe of health care stakeholders and advocates have declared that the addition of a ready-to-use rescue glucagon, such as Gvoke should be a key element of the standards of care in diabetes. The challenge remains getting practicing health care professionals to adopt these standards of care as their standards of practice. As I mentioned previously, Gvoke is driving the majority of market growth in this category and we believe that Gvoke will continue to be the primary and dominant voice in the market.

On to Recorlev. We're very pleased with our progress with Recorlev, driving patient referrals and converting them to new patient starts. We see tremendous potential for Recorlev in increasing dynamic Cushing's market. The key difference from most other products used in the category is that Recorlev actually treats the underlying condition in Cushing's by normalizing cortisol levels in the body which is a differentiation that resonates with physicians. We grew Recorlev net revenues to $29.5 million, nearly a 300% increase compared to the prior year. and referrals and new patient starts have outpaced our expectations each quarter in 2023. Recorlev generated $9.8 million in net revenue for the fourth quarter and an increase of an increase of 158% over the same period in 2022 and an increase of 21% over the third quarter 2023. We're very pleased with the steady increase in Recorlev revenue quarter-over-quarter. Patient referrals continue to be robust, and the underlying patient demand grew 28% over the third quarter. The number of unique prescribers with new referrals also continues to grow. The average number of patients on Recorlev increased over 145% from the same period in 2022.

Our healthy pipeline of patient referrals and health care professionals using Recorlev as a first-line therapy are key indications that record is seen as an important option for Cushing's patients, especially given Recorlev multipronged approach to suppressing cortisol production as post-surgery treatment for Cushing's syndrome.

Moving to Keveyis. We grew Keveyis revenue 15% compared to 2022, despite the launch of a generic competitor in early 2023. This performance exceeded our expectations for the brand in 2023 by delivering $56.8 million, well in excess of the $40 million revenue milestone, which triggered as CVR for strongly shareholders. Steve will provide more detail on the CVR. In the fourth quarter, revenue per Keveyis was $14.1 million, which is an 11% increase from the third quarter of this year. However, it was a 2% increase compared to the same period in 2022. In the second half of the year, we started to see modest patient loss to generic competition. The fourth quarter was the first quarter we saw pressure from the generic impacting our net revenue. That said, even with a whole year of generic competition, we exited 2023 retaining over 90% of our patients on Keveyis. This is a testament to our team's ability to find new patients and the value of our Xeris Care connections team which provides support for periodic -- primary periodic paralysis patients and providers. As a result, patients and medical community are willing to fight for the Keveyis brand. That said, we expect payer pressure will persist, and we may see sequential quarterly decline in Keveyis revenue in 2024, which we've accounted for in our 2024 guidance that we'll talk about later. However, we continue to find new patients and build the top of the deferral funnel, which is key to maintaining Keveyi's contribution to our commercial portfolio.

Before I move on to our levothyroxine program, a quick comment on the Change Healthcare cybersecurity issue 2 weeks ago. We believe this has the potential to temporarily slow adjudication of pharmaceutical prescriptions in general. The degree to which that potential for delayed adjudication may impact our specialty pharmacy and retail business is yet unclear and really too early to talk.

Now on to our XeriSol levothyroxine program, a potential once-weekly subcutaneous injection. The last patient last visit was just last week, which keeps us on track for data from the Phase II study midyear. This oral liquid dose conversion data will help to inform our proposal to the FDA for a pivotal Phase III program. We anticipate requesting an end of Phase II meeting later this year. If we gain alignment with FDA on a Phase III study program, we could start that study as early as mid-2025.

Now on to our formulation technology business. We're very excited about the potential value of this business can provide for patients, care dealers, health care professionals and our Xeris partners. We made a lot of progress to validating new Xeris technology in 2023 from signing the Regeneron platform deal a year ago. to successfully formulating the preprescribed target product profile for XeriJect TEPEZZA. And as such, receiving the associated $6 million success payment from Amgen. As recently as January, Amgen executed the exclusive worldwide license agreement to develop, manufacture and commercialize a subcutaneous formulation of teprotumumab using our XeriJect technology in Thyroid Eye Disease. Under terms of the agreement, Xeris has the potential to receive up to $75 million in development, regulatory and sales-based milestones as well as an escalating single-digit royalty based on future sales of TEPEZZA using the XeriJect technology.

Next step in this program. The newly integrated Amgen team has been formed around the XeriJect program. Development work continues and planning is underway in preparation for initial clinical stage activities. As for the Regeneron collaboration, we have completed formulation development for both initial molecules. Regeneron's stability and nonclinical valuations will take place over the next 6 months. Assuming continued success, that could lead to potential -- there potentially executing a license option for further clinical development and commercialization of any of the molecules in the platform, which would trigger an additional onetime payment. Regeneron also has the option to nominate additional molecules for formulation development at any time for which we would receive an additional upfront per molecule. We're excited about the potential for our XeriJect business and believe this could be a significant contributor to the growth of Xeris over time. We continue to discuss additional XeriJect collaborations with numerous companies.

And before I went to our 2024 financial guidance, I want to touch on our debt refinance with Hayfin Capital that we announced this morning. Since we began our relationship with Hayfin 2 years ago, we have proven to them that we can execute on our strategy, growing and derisking our enterprise. This has given them the confidence in Xeris to further support us by committing an additional $50 million at close of the transaction with another $15 million of committed capital at our discretion to settle the 2025 convertible notes and by providing of uncommitted capital for potential M&A purposes, while lowering our total cost of capital overall. Hayfin has been a great partner to Xeris willing to support the growth of our enterprise with nondilutive capital. Steve will go into more details on the transaction.

Looking at 2024. As our momentum continues, we expect to grow total revenue in the range of $170 million to $200 million. Our total revenue range implies a 4% growth at the low end, 22% growth at the high end and 13% at the midpoint. However, net of nonrecurring partner revenue, our range for 2024 represents approximately a 10% growth at the low end, 30% at the high end and 20% at the midpoint. Very positive potential of continued growth of the enterprise, either way you look at it. Recall in 2023, we initially gave a wide revenue range as we are not sure of the rate of expected decline in Keveyis due to generic competition. and revenue contribution from technology partners, which is an episodic in nature altogether. Same unknowns and uncontrollables exist for 2024. That said, this double-digit revenue growth, coupled with our recent debt financing and continued disciplined cash management allows us to further invest in the growth of our commercial products, fund Phase III readiness activities for our pipeline levothyroxine program; and lastly, make incremental investments in our emerging technology business. And we still expect to end 2024 with a very healthy cash position of between $55 million and $75 million, further demonstrating the sustainability of the enterprise that we're building.

I'm now going to turn the call over to Steve for additional details on our financial performance.

[Steven Pieper, executive]

Thanks, Paul, and good morning, everyone. As Paul mentioned, 2023 was another year of exceptional performance and growth for Xeris. All 3 of our commercial products grew revenue for the full year and fourth quarter compared to last year. We ended the year with net product revenue of $153.4 million a 40% increase compared to last year. Our various partnerships contributed meaningful revenue with a record $10.5 million of other revenue for the full year 2023. Total revenue in 2023 was $163.9 million, a 49% increase compared to last year. Revenue growth coupled with our disciplined cash management resulted in Xeris ending 2023 with cash of $72.5 million and generating $6.5 million of cash in the fourth quarter. This is a significant milestone for Xeris, and it continues to demonstrate our ability to be a self-sustaining enterprise.

Moving on to our fourth quarter and full year results. For the fourth quarter, total revenue was $44.4 million, representing a 34% increase over the same quarter last year. Gvoke net revenue for the quarter was $18.6 million representing a 25% increase compared to the same period last year. Full year net revenue was $67 million, representing a 28% increase compared to last year. In the fourth quarter, Gvoke prescriptions topped 59,000, a 43% increase compared to the same period last year. Consistent with the historical trend following the typical back-to-school spike for the glucagon market in Q3, the total glucagon prescription market declined 7% in the fourth quarter. Despite the 7% market decline, Gvoke total prescriptions grew 1% in the same period, ending the quarter with total retail market share of approximately 31%. Gvoke continues to gain market share in 2024 ending February at approximately 32%.

Moving to Recorlev. Recorlev net revenue was $9.8 million for the fourth quarter and $29.5 million for the full year 2023. Compared to Q3 2023, net revenue increased by 21%, driven by a steady increase in underlying patient demand. We are encouraged by the growth in Recorlev's patient demand which has been fueled by a consistently healthy pipeline of referrals. Moving to Keveyis. Keveyis' net revenue for the quarter was $14.1 million representing a 2% increase compared to the same period last year. Full year 2023 net revenue was $56.8 million, representing a 15% increase compared to last year. While our strategy to invest in Keveyis and defend brand prescribing has been successful to date, in Q4, we saw a slight decrease in patient demand due to increased generic pressure. We will continue to deploy strategies to protect Keveyis, and we'll continue to invest in Xeris Care connections as they offer the best-in-class therapy and support for primary periodic paralysis patients.

Before I move on to our other revenue, and as I covered in my prepared remarks in November, I want to again address the Keveyis CVR milestone that was achieved in 2023. 2023 Keveyis net revenue was over $56 million, exceeding the Keveyis CVR milestone of $40 million. Consistent with my previous remarks, we will settle this obligation in Xero's common shares later this month and anticipate issuing approximately 7.5 million common shares which is a modest increase of approximately 5% of outstanding shares.

Moving on to our other revenue. In 2023, we generated $10.5 million in other revenue. This was mainly comprised of our technology partnership business, which we significantly advanced in 2023. We will be making incremental investments in our technology business in 2024 and to further advance our existing partnerships and attract new partners in 2024 and beyond. These investments include accelerating GMP manufacturing readiness and clinical scale up to enable our partner programs to move into clinical development. We believe these investments are necessary to further demonstrate the full value of our technology platform. Looking ahead to 2024, we expect to grow total revenue in our issuing full year total revenue guidance of $170 million to $200 million. 2024 revenue will be driven by the continued growth of Gvoke and Recorlev and impacted by an expected decline in Keveyis and the potential episodic contributions from our technology partnership business.

Moving down the P&L. Cost of goods sold in the fourth quarter was $7.6 million, a 20% increase compared to the same quarter last year. For the year, cost of goods sold was $28.6 million, an increase of 27% compared to last year. These increases are mainly driven by higher product sales. Research and development expenses were $6.4 million for the quarter, and $22.3 million for the full year, a modest increase of 7% compared to prior year, driven by our Levo Phase II clinical study and an increase in personnel costs. Selling, general and administrative expenses were $37.6 million for the quarter, an increase of $3.2 million relative to the same period last year. This increase was driven by rent expenses related to the facility lease that commenced in April 2023 and personnel costs, primarily driven by a modest field expansion. Compared to last quarter, SG&A was relatively flat. On a full year basis, SG&A was $146.1 million, an increase of approximately $8 million or 6% versus last year.

Moving on to cash. We ended the year with a very healthy cash position and generated positive cash for the first time in Xeris' history in the fourth quarter. As of December 31, 2023, we had total cash of $72.5 million compared to $66 million as of September 30, 2023, generating $6.5 million in cash in the quarter. Cash utilization for the full year '23 was $49.5 million, a significant improvement over 2022 cash utilization of over $100 million. Earlier today, we announced that we refinanced our senior secured term loan with Hayfin Capital. As a result, we are reducing the interest rate we pay on our loan by over 200 basis points as we move from a SOFR plus 9% rate to a SOFR plus 6.95% rate in the new agreement. Additionally, we drew down an incremental $50 million at close resulting in a total facility of $200 million with the ability to draw down an additional $15.2 million to redeem our outstanding 2025 convertible notes. The new loan is interest only with a term of 5 years, we must maintain minimum cash and achieve minimum revenue targets. These covenants are in line with our previous Hayfin agreement. This new agreement is a testament to the confidence Hayfin as in Xeris' ability to successfully execute our strategy.

From a cash guidance perspective, we expect 2024 and to end 2024 with a very healthy cash position of $55 million to $75 million, which includes the incremental $50 million from Hayfin less onetime costs, including a call premium commitment fees and other adviser and legal fees, adding a net $35 million to cash in the first quarter. We expect SG&A to be relatively flat to 2023. Furthermore, we expect R&D to increase by approximately $5 million relative to 2023 as we make strategic investments in our own pipeline and our emerging technology partnership business. The incremental capital from our refinanced Hayfin facility, coupled with the continued growth of our revenue, allows us to further invest in the growth of our commercial products, fund Phase III readiness activities for our own pipeline levo program; and lastly, make incremental investments in our emerging technology partnership business. To summarize, Zeros had a year of exceptional performance and growth in 2023, and we look forward to continuing to build on that momentum in 2024.

With that, operator, please open the line for questions.

[Operator]

[Operator Instructions]. Our first question today comes from Oren Livnat with H.C. Wainright. Please go ahead.

[Oren Livnat, analyst]

I have a couple. Just to get out of the way on the Amgen partnership, first congrats on further validation of that platform. Beyond what you had in the script, is there anything you can tell us about [indiscernible] expected time lines to the next important value-creating events and when we might start to get some more clarity on that program? And say, if you are the only iron in the fire they have now on [ sub-Q ] TEPEZZA, so to speak? Or is it within your contract, are they allowed to also be continuing to work with other tech platforms? And I have a follow-up.

[Paul Edick, executive]

I'll take the second one first, Oren. They can work on anything they want to work on. We don't have an exclusive deal. They've already announced or even [ Heldeim ] announced that they were no longer working on their program. They've got some internal programs, and I believe that Amgen may have an internal program also. So if I was in that market with a multibillion-dollar asset, I have a lot of irons in the fire. We're one of those. And with our technology, I believe, probably the best option that they have to extend that franchise and grow that franchise as a patient self-administered drug. And the second part, timing to an event. As you can imagine, the integration of the companies is just completing and the team around TEPEZZA has been reformed and they're getting up to speed. The work we were doing in terms of preclinical is still ongoing, and they're mapping out their development and clinical program. So things are going along well. With a little bit of a disruption between the Verizon and then Amgen transition.

[Oren Livnat, analyst]

All right. And on levo, you told us maybe in January that you completed enrollment in the last visit, right? Can you give us, I guess, any more granularity on timing other than midyear or I guess really not. But certainly, in the interim, have you had any informal stations with the FDA or perhaps more work with your consultants that gives you any more color and expectations around the potential Phase III in the requirements with regards to end points?

[Paul Edick, executive]

Yes. So in January, we said we had completed enrollment, and we just last 2 weeks ago or last week, we had our last patient last visit. It will take a few months to analyze all that data that's been collected. So that's why we should have data midyear. We will as fast as we can go to the FDA for an end of Phase II, Phase III discussion. That has its own calendarization. That will take us pretty much to the end of the year, we believe. And with good alignment on what a Phase III program might look like. And to the other part of your question, we don't know. And we haven't had conversations with them about a Phase III program yet. Our going in assumption is 1 study. And that if we get good alignment by the end of the year, we can start that study. We can get going on IRBs and all that kind of stuff and get that study up and running test case middle of '25. I think it covers the whole thing.

[Operator]

The next question comes from Glen Santangelo with Jefferies.

[Glen Santangelo, analyst]

Paul, just a couple of prior questions for you, and then I have a follow-up for Steve. First, your 2 growth markets here when you think of Gvoke, I mean Amphastar is now on BAQSIMI now for a couple of few quarters. And then as it relates to Cushing's, Teva has recently launched a generic version of Korlym. So I'm kind of curious to get your take how you see the competitive landscape in each of those markets kind of shifting. And are those shifts positive for you? Or are they negative?

[Paul Edick, executive]

Thanks, Glen. Those are important questions. The -- so Gvoke and Amphastar, we want them to be as active as possible in the marketplace. That's the only way -- right now, like I said in my prepared remarks, there's about 10% growth in the market. We're basically driving all that growth. we think that Amphastar kind of picking up the ball from Lilly and really getting going with their commercial business is only going to fuel market growth, and that's good for us. We've never really -- even with Lilly, we weren't ever really selling BAQSIMI against Gvoke or Gvoke against BAQSIMI, we're both selling for the benefit of the patient. So -- and the opportunity is so huge market growth is really what both companies should be focused on is what our focus is. And we're hopeful that Amphastar really gets going in a more significant way.

As for Teva and the dynamic in the Cushing's market, as we know, the Cushing's market has been generic for a long time with several new big brands over the last decade or so. there's always been that dynamic. I think this particular situation with Korlym being as big as it is, that dynamic, we believe, will play in our favor because we think we have a really good differentiation versus Korlym in terms of our ability to normalize cortisol. And having a generic in the market is going to sort of be disruptive for that franchise and to our estimation, kind of put it in play for others like us to take share. So I see both dynamics as potentially positive for us.

[Glen Santangelo, analyst]

Okay. And maybe if I could just follow up with Steve on the guidance. Steve, in your prepared remarks, you sort of gave us a little bit of color around the guidance. But when we think about the growth 4% to 22%, it's a pretty big range. And so I was wondering if you could just unpack that a little bit. Are there any sort of incremental sort of milestone payments you're expecting within those -- within that guidance range? And then secondly, when you think about your 3 products, it kind of sounds like you're suggesting Keveyis is seeing some weakness. And so maybe we should expect that to be down modestly in '24 with that offset by growth in the other 2 products? Am I thinking about all that correctly? Or is there anything more you can give us related to the guidance?

[Paul Edick, executive]

Well, I think we might need to tag team on that one a little bit. So I'll take the various products. Keveyis, I mean we had an amazing 2023 with Keveyis. We've said all along, sooner or later, we're going to start losing a few patients, sooner or later, we're going to see some price larization. The degree to which that is going to potentially happen is the potential downside is just as big this year as it was last year. And our guidance was to reflect a wide range because we weren't sure. And so what we see so far this year is a little bit of patient loss but we're not too sure of the degree to which that's going to accelerate or not.

I'll turn it over to Steve.

[Steven Pieper, executive]

Yes. Yes. And I think we were hopefully pretty clear in our prepared remarks that we do expect a decline as opposed to 2023 where we saw growth. So yes, that's driving the wide range. I think we're excited about the growth, the continued growth of both Gvoke and Recorlev on the top end of the guidance, yes, I think that, that -- we touched a little bit on the kind of episodic nature of this technology partnership business and the contributions. We saw [ 10.5 million ] from our various partnerships in 2023. And the degree to which that is sticky again in 2024 remains to be seen. We don't control that fully, as you know. That is at the -- largely at the discretion of our partners.

[Paul Edick, executive]

The pace of our partner.

[Steven Pieper, executive]

And the pace of our partners. So yes, that -- I think you're thinking about it the right way, Glenn, that that's what's driving the wide range in 2024.

[Paul Edick, executive]

And the potential lack of growth in Keveyis, we expect to be made up by Gvoke and Recorlev. And that's why we also, in my remarks, I gave little bit of the range. If you took out the nonrecurring one-timers, the range is greater growth in the all double-digit growth across the range. So...

[Operator]

Our next question comes from Chase Knickerbocker with Craig Hallum.

[Chase Knickerbocker, analyst]

Maybe just to start on a clarifying question on guidance. So ending the year, obviously, with $72.5 million in cash based on that first press release, you're adding about $35 million in the first quarter. And so it is my math right that, that means cash burn if we kind of take that $107.5 million cash number combined is somewhere around $40 million at the midpoint of your cash guide. Is that kind of the right math there?

[Steven Pieper, executive]

Yes, you're about right.

[Chase Knickerbocker, analyst]

Got it. Maybe just for starting with Keveyis, what actions are the payers taking? Just a little bit more detail there as far as what you've seen so far? Are they forcing patients to switch that are currently on therapy or when you're getting them to the top of the funnel, they're pushing them to the generic first. Just kind of clarification there on exactly what's happening. And then if we look at 2024, is it mainly going to be volume is what you're expecting? Or do you expect to give some ground on price as well?

[Paul Edick, executive]

So we don't expect any more movement on price unless there's a second generic at the end of the day. It's going to be volume. And payers are going to do what the payers do. I mean it's all the same stuff. There's a denial, there's an appeal, et cetera. And little by little, they cleave off a few patients here and there. It's in their best interest. We get that. And they're going to -- we believe that's going to persist, and that will [ loss in ] -- will result in more patient loss. Depending -- net-net, depending on how fast we fill the funnel. There's still a lot of patients out there. We're going to be still very aggressive, but we have to be forward-looking in terms of our expectations for a decline. So that's what we're signaling. I think that...

[Chase Knickerbocker, analyst]

Yes, that answers it. And then on Recorlev, kind of first, just kind of give us a little bit of a look into the background as far as how is the funnel kind of looking? Are you seeing any sort of shrinkage in kind of time from script written to script finally being filled? And then any kind of increase in your success rate of kind of appeals and all that, just success rate of going from script print into the script field?

[Paul Edick, executive]

Yes. So we're thrilled with the continued growth in the referrals to therapy. I mean it is really accelerating. We're thrilled with the amount of patients that are being referred to therapy. our conversion to patients on drug continues to be really solid and continues to grow. So we're happy with that. The time to -- the time factor is real. I mean the more you grow, the more patients you put on the more you become a target with payers and it takes more time. That being said, and I've said this before, if you look at the retail market for Gvoke and you say, what would be a good percent of covered lives between commercial and Medicare, 75% would be great. 80% is about as good as you get in pharmaceutical business. In rare disease in these expensive drugs, 50% to 60% of conversion from referral to patients on drug, we think is equivalent and really good. And it varies in that range. Sometimes it's a little slower, sometimes it's a little more, but it's in that 50% to 60% range. And we think that's solid conversion percentage for the number of referrals we're getting.

[Chase Knickerbocker, analyst]

And then taking that commentary and kind of relating it to what 2024 might look like. I mean this is kind of a hard one for us to model. Obviously, it's been a little bit lumpy as far as growth goes. I mean what should we think of -- from as far as like a sequential growth rate? Should we think of it as kind of bouncing between the low teens we saw in Q3 of '23 and kind of the low 20s that we saw in Q4 of 2023 as it relates to kind of how the funnel is looking and how those kind of conversions have been trending?

[Steven Pieper, executive]

Yes. I think good question, Chase. And we haven't -- we've been pretty deliberate not providing specific product guidance. But what I would say is, I think you can expect kind of a similar steady increase in patient demand and revenue growth over 2023. So I don't think that there's -- we're not expecting some kind of step function increase in the middle of the year that would accelerate that. At least that's not in the cards right now. But I think to expect a similar kind of steady growth year-over-year is a fair kind of starting assumption.

[Operator]

The next question comes from Roanna Ruiz with Leerink Partners.

[Roanna Clarissa Ruiz, analyst]

So a question for XP-8121. Could you remind us what your expectations are for the Phase II data coming this year? And what kind of results would you hope to see that would give you more confidence to advance into Phase III?

[Paul Edick, executive]

The -- this study is very -- is predicated on the confirmation of the conversion from the oral dose to the liquid dose at more dosage strengths across the range. So levothyroxine has -- there's like 10 or 12 different dosage strengths. And our Phase I study where we provided the FDA with a couple of those -- a couple of dosage points, they just wanted to see it across more dosages and across with patients who are actually on legal or former levo patients. So the information we will get will be a confirmation of that conversion at every dosage across the range number one. Number two, we're gathering a great deal of information on the market need relative to the screen failures we've seen. Our goal was to get patients who were stable on current medication, and they were hard to find. So that will be important data as well. But it's just a confirmatory study for the dosage conversion and then we'll have a discussion with the FDA on Phase III program.

[Roanna Clarissa Ruiz, analyst]

Got it. Super helpful. And for Recorlev too, what are you guys hearing anecdotally from the field force in terms of their interactions with physicians about its profile? And what are you thinking about is expected steady growth into 2024, just like broad strokes, could it come from the field force, physicians getting more educated or more experienced with Recorlev, something like that. .

[Paul Edick, executive]

Thanks, Roanna. The patients are coming from everywhere. The more physicians are getting exposed to Recorlev, the more it becomes a valuable tool for them. So we've seen individual physicians go from trying it to using it first line. So it's the experience that they get, which patients are being cortisol is being managed and normalized, patients are not having a lot of side effects, physicians get more and more comfortable. In terms of the physician interaction in the field, it's been very receptive. We're getting great conversations with physicians. The receptivity of Recorlev has been very high. So that's been very positive. I mean, depending on -- if you go to doctor calls, you're going to find ones that have never even heard of Recorlev because they're not accessible to us. But the vast majority of physicians that are accessible, initial trial has been good, a broad cross-section of physicians and the experience has been positive. So that's all -- I think that's all good.

[Operator]

The last question comes from David Amsellem with Piper Sandler.

[David Amsellem, analyst]

So on Recorlev, I'm sure you guys are well aware of the Corcept study called Catalyst, which looked at -- is looking at prevalence and that's going to be presented later this year at ADA. I guess I wanted to just get your general thoughts on how you're thinking about those results in terms of the prevalence of hypercortisolism, what do you think that could mean for Recorlev and the opportunity for the product going forward? And to the extent that there is indeed a fundamentally different understanding of hypercortisolism do you envision expanding your commercial organization to target a lot of audience of physicians, namely diabetologist, how are you thinking about all that?

[Paul Edick, executive]

Okay. There's a lot to unpack in there, David. Bottom line, the -- we like the direction that Corcept is going in with the Korlym franchise because we do believe that moving up in terms of patient severity is a good thing. Market expansion is really, I believe, their goal, which is good for us as well. We'll benefit from that market expansion. And if you recall, I think the last call, we talked about -- we originally were targeting 3,200 more severe patients. And now our target is expanded to about -- about a patient base of potentially 8,000. And I think the strategy of moving up in the treatment paradigm, it's even bigger than that. So that's important for us. And I mean as they drive market growth, that expansion helps us as well. So.

[David Amsellem, analyst]

Okay. That's helpful. And then in terms of expanding the commercial infrastructure.

[Paul Edick, executive]

We always look to add resources wherever we can. And however, when we can afford it. One of the things, as Steve said, the benefit of having a great partner like Hayfin is they recognize the progress we've made and the degree to which we've derisked the business. They want to see us invest further for additional market penetration in our commercial business. They want to see us advance the technology business, and they want to see us advanced Levo. So they've really stepped up at reduced cost to help us do all of the above. We are expanding tomorrow in the Recorlev organization, but we're always looking at it, and this will be an important year from that perspective.

[David Amsellem, analyst]

Okay. That's helpful. And sorry if I missed this, but are you getting frontline Cushing's patients on to Recorlev. Is that a decent chunk of the overall patient mix thus far?

[Paul Edick, executive]

Today, it's a pretty good chunk of the overall patient mix. The answer to that is, yes, we are getting them. those patients take a little bit longer to adjudicate insurance, but we're being very successful there as well. Early on, we were getting only the patients who are switching. But as physicians get comfort with a patient that has been on a couple of different things and has tried several different drugs and Recorlev answers his need, then we begin to get first-line patients from that clinician. So.

[Operator]

I'll now turn the call back to Paul Edick for closing remarks.

[Paul Edick, executive]

Thanks, everybody, for great questions and thanks for listening today. As you heard, we have delivered another year of exceptional growth, and we're very proud of our performance to date. We expect that momentum will continue in 2024, and we look forward to another year of growing an enterprise for which we can all be proud. Thank you very much.

[Operator]

Thank you, everyone, for joining us today. This concludes our call, and you may now disconnect your lines.