Earnings call transcript: Xeris Pharmaceuticals Q4 2024 beats EPS forecast, stock surges

Xeris Pharmaceuticals Inc. (XERS), with a market capitalization of $562 million, reported its fourth-quarter 2024 earnings, surpassing expectations with an earnings per share (EPS) of -0.03, compared to the forecasted -0.06. The company also exceeded revenue forecasts, reporting $60.1 million against the anticipated $55.99 million. Following the earnings announcement, Xeris Pharmaceuticals’ stock rose 8.49% in premarket trading, reaching $4.09. According to InvestingPro data, analysts maintain a strong buy consensus on the stock, with price targets ranging from $3 to $6.60.

Key Takeaways

• Xeris Pharmaceuticals reported a smaller-than-expected loss per share for Q4 2024.
• Revenue for the quarter exceeded forecasts by approximately $4.11 million.
• The company’s stock price surged by 8.49% in premarket trading.
• Recorlev and Gevo products drove significant revenue growth.
• The company projects strong revenue growth for 2025, between $255 million and $275 million.

Company Performance

Xeris Pharmaceuticals experienced a robust Q4, with significant year-over-year growth in net product revenue, particularly from its Recorlev and Gevo products. The company achieved a 34-35% increase in Q4 net product revenue, contributing to a total revenue of $203.1 million for 2024, marking a 24% growth compared to the previous year. InvestingPro analysis reveals an impressive gross margin of 81.36%, demonstrating strong operational efficiency. For deeper insights into Xeris’s financial metrics and growth potential, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers. The company’s strategic focus on expanding its prescriber base and disciplined expense management has bolstered its competitive position in the endocrinology market.

Financial Highlights

• Total revenue: $203.1 million in 2024 (24% growth YoY)
• Q4 net product revenue: $57 million (34-35% increase YoY)
• Gross margin: 84% in Q4, 82% for the full year
• Adjusted EBITDA: Over $8 million in Q4

Earnings vs. Forecast

Xeris Pharmaceuticals exceeded expectations with an EPS of -0.03, compared to the forecasted -0.06, representing a positive earnings surprise. The company’s revenue of $60.1 million also surpassed the forecast of $55.99 million, reflecting strong performance in key product lines.

Market Reaction

Following the earnings release, Xeris Pharmaceuticals’ stock experienced a notable increase, rising 8.49% in premarket trading to $4.09. This upward movement positions the stock near its 52-week high of $4.10, indicating strong investor confidence in the company’s financial performance and future prospects. The stock has shown remarkable momentum, delivering a 50.2% return over the past six months. InvestingPro subscribers can access additional technical indicators and momentum metrics to better understand the stock’s trajectory.

Outlook & Guidance

Looking ahead, Xeris Pharmaceuticals projects total revenue for 2025 to be between $255 million and $275 million, indicating a potential growth of approximately 30%. Supporting this optimistic outlook, InvestingPro reports that two analysts have recently revised their earnings estimates upward for the upcoming period. The company maintains a "GOOD" Financial Health Score of 2.94, suggesting solid fundamentals despite current non-profitability. The company anticipates continued growth in its Recorlev and Gevo products, with steady performance expected from KEVEYIS. Preparations for the Phase 3 development of XP8121, a hypothyroidism treatment, are also underway, with potential clinical trials starting in 2026.

Executive Commentary

John Shannon, CEO of Xeris Pharmaceuticals, highlighted the company’s exceptional commercial execution in 2024, stating, "2024 was an unprecedented year of exceptional commercial execution." He also expressed confidence in the company’s financial strength, with CFO Steve Piper noting, "Zaris has never been financially stronger."

Risks and Challenges

• Potential supply chain disruptions could impact product availability.
• Market saturation in the endocrinology sector may limit growth.
• Macroeconomic pressures could affect consumer spending and healthcare budgets.
• Regulatory changes could pose challenges to product approvals.
• Competition from other pharmaceutical companies may intensify.

Q&A

During the earnings call, analysts inquired about the drivers behind Recorlev’s growth, to which the company attributed both new and existing prescriber engagement. Questions also focused on potential market access changes, which the company confirmed as stable, and the possibility of expanding its sales force and investments to support future growth.

Full transcript - Xeris Pharmaceuticals Inc (XERS) Q4 2024:

Operator: Good morning and welcome to the Xerus Biopharma Fourth Quarter and Full Year twenty twenty four Financial Results. My name is Harry and I’ll be your operator today. All lines are currently in listen only mode, and there will be an opportunity for Q and A after management’s prepared remarks. I would now like to hand the call over to Alison Wei, Senior Vice President of Investor Relations and Corporate Communications. Thank you.

You may proceed.

Alison Wei, Senior Vice President of Investor Relations and Corporate Communications, Xeris Biopharma: Thank you, Harry. Good morning, everyone. We appreciate you joining our call today. I’m joined by John Shannon, our CEO and Steve Piper, our 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’d 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 our 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 a personal loss, we disclaim any obligation to update such statements.

Please note some metrics we will discuss today are represented in a non GAAP basis. We reconcile the comparable GAAP and non GAAP figures in our earnings release. Let me pass the call over to John for opening remarks.

John Shannon, CEO, Xeris Biopharma: Thanks, Allison, and good morning, everyone. 2024 was an unprecedented year of exceptional commercial execution, focused pipeline development and disciplined capital management. I want to thank our employees, the healthcare community and the patients we serve for helping us to meet or exceed all of our goals consistent with our journey to become a fast growing, self sustaining biopharmaceutical company. Our focus execution and performance in 2024 has positioned XERUS perfectly for what I will call a transformational year in 2025. Let me start with the highlights for 2024.

I will cover the full year results at a high level and Steve will provide more detail on Q4 and full year in his remarks. I’m proud to report that we exceeded our full year guidance with total revenue of over $2.00 $3,000,000 growing 24% versus last year led by strong demand for Recorlev and Gevo and continuing durability of the KEVEYIS brand. Across all three products, the commercial team continued to execute our plans, resulting in 28% product revenue growth for the full year 2024 versus 2023. Looking specifically at each of our products, let’s start with Recorlev, which is rapidly becoming our flagship brand. We saw a record number of referrals and new patient starts, especially in the back half of the year, representing more than $64,000,000 in total revenue in 2024, an impressive 118% growth versus 2023.

Our focused and targeted investments in Recorlev are paying off and we see this momentum continuing as we enter 2025. Turning now to Gevoque. What a great year. This product continues to deliver steady predictable growth. On a full year basis, Gevoque achieved nearly $83,000,000 in revenue, an increase of 24% versus 2023.

We saw the same increase in prescriptions totaling 265,000 coming from an increase in new prescribers as well as an increasing number of repeat prescribers. Next is KEVEYIS. The durability of this brand continues to impress. It maintains strong support in the medical and patient community resulting in continued dedication to the brand. KEVEYIS ended the year with approximately $50,000,000 in revenue for the full year.

Although revenues declined 13% on a full year basis, we ended the year with approximately the same number of patients on therapy as we started with. We achieved this principally by continuing to find new PPP patients and support their journey to brand. In 2024, our partnership revenue held steady with approximately $6,000,000 in other revenue as we continue to successfully deliver for our technology partners. Moving on to our pipeline, specifically XP8121, our Phase three once weekly subcu product for hypothyroidism. In 2024, we successfully completed our Phase two study for XP8121 and generated the data we needed to progress into Phase three.

In preparation for Phase three, we advanced the development of our final drug formulation and device design and had ongoing discussions with the agency to ensure alignment on critical aspects of the clinical study and a path to an eventual regulatory approval. As I move on to 2025, I want to reiterate that we remain focused on the three strategic priorities I outlined back in August when I became CEO. As a reminder, those are: one, we will drive rapid and sustained growth of our commercial products two, we will remain financially disciplined maintaining a healthy balance sheet and funding our growth opportunities, while importantly not diluting shareholders. And finally, we will enhance our communications and transparency with you, our stakeholders. So with that as a backdrop, let’s talk about 2025.

Clearly, our Ziris business has reached a whole new level of growth and momentum. As such, I’m excited to share that we are guiding total company revenue between $255,000,000 and $275,000,000 in 2025, representing more than 30% year over year growth at the midpoint. Let me repeat that. That’s more than 30% year over year growth at the midpoint. Also in our press release for the first time, we reported adjusted EBITDA, which turned positive in the fourth quarter and will continue to be positive going forward.

With our exceptional top line revenue growth, attractive and improving margin profile and planned investments to both drive our revenue growth and develop XP8121, we believe adjusted EBITDA is the right metric to demonstrate we are a thriving commercial biopharmaceutical company capable of fueling its own growth. The focus and efforts that will enable such a transformative 2025 are fundamentally the same things that contributed to our exceptional growth in the second half of twenty twenty four. Starting with Recorlev. Recorlev is emerging as the right product at the right time with what we believe is a best in class profile to safely and effectively normalize cortisol levels in the treatment of endogenous hypercortisolemia in adult patients with Cushing syndrome. The hypercortisolemia marketplace is expanding rapidly in light of new evidence that sustained high levels of cortisol could be a factor in stubborn forms of many chronic medical conditions, including diabetes and cardiovascular disease.

As such, more and more people are being screened, tested and diagnosed with hypercortisolemia and ultimately treated. As a reminder, we shared our view of this emerging opportunity last year and rapidly increased our investments in our sales and patient support organizations by 50%. We’ve already begun to see the impact of these investments and expect that they should fuel continuing growth for the foreseeable future. Moving to Gevo. Of the fifteen million people on insulin or sulfonylureas, we estimate that only about one million have a prescription for a life saving therapy such as Gevo Kytopen.

We continue to chip away at the total addressable patient population of fourteen million people still unprotected. Our Gevo sales team is working every day on behalf of these patients who based on the medical guidelines should be protected, but are not. Specifically, our team, the Gevo team is focused on helping physicians to understand and become more compliant with the new medical guidelines. In January, we announced a multi year strategic partnership with ADA to reinforce the importance of prescribing a ready to use glucagon such as GevoK Hypopen for those at high risk for hypoglycemia. With such a large untapped market in GevoK’s patent protection to 02/1936, we expect Gevoque to steadily grow for many years to come.

On to KEVEYIS. The durability of this brand remains impressive and we expect that durability to continue into 2025. We plan to continue our efforts to find new PPP patients every week and get them on KEVEYIS so they can enjoy the benefits of therapy. Just a brief mention of our technology partner programs. We remain committed to our technology platform and are actively working on current programs and seeking new partnerships.

We continue to deliver for our partners meeting their technical and target product profile requirements. We are confident that we will continue to deliver in this manner for our current and future partners. However, because this area of our business is largely dependent on each partner’s business objectives, we’ll only provide updates as they advance and become more meaningful contributors to our business results. In 2025, we see our partner revenue continuing to deliver results similar to the past couple of years. Moving on to XP8121.

As we stated before, we are really excited about this product and the unmet medical need it can address in the hypothyroidism market. What is interesting about hypothyroidism treatment is that there has been no real innovation of research for decades in this metabolic condition affecting approximately twenty million people in The U. S. We estimate that approximately twenty percent of these patients do not consistently meet their clinical goal of normalizing thyroid hormone levels And they cannot reach their goals with oral forms of therapy for a multitude of factors, including certain GI conditions like celiac disease to taking common medications such as proton pump inhibitors, all of which affect oral bioavailability. If approved, XP8121 will be the first and perhaps only self administered therapy that isn’t affected by these challenges.

We are taking a very planned full development approach for XP8121. We continue to have favorable engagement with the FDA and expect to provide a fulsome update mid year. This update will further highlight the unmet medical need, the market opportunity, the Phase three study design as well as projected timing of our development program. Keeping in mind that our development of XT8121 is enabled by our very own proven Xerasol technology. Additionally, our commercial capability is highly leverageable, including our extensive endocrinology sales footprint and our proven patient, payer and channel support capabilities.

With that, I’m going to hand it over to Steve to review our financial results for the quarter and year and provide more details on our 2025 guidance.

Steve Piper, CFO, Xeris Biopharma: Thanks, John, and good morning, everyone. Our fourth quarter twenty twenty four performance marked the end of a very successful year, and I can say that Zaris has never been financially stronger. This quarter, we ended with net product revenue of $57,000,000 and total revenue of $60,100,000 dollars increasing by approximately 3435% compared to prior year. This is the thirteenth consecutive quarter with greater than 20% product revenue growth. On a full year basis, net product revenue was $196,600,000 and total revenue was 203,100,000 increasing by approximately 2824% compared to prior year.

Recorilav net revenue in the fourth quarter was $22,600,000 a 131% increase compared to the same period in 2023. This growth was driven by the average number of patients on RECORALAV increasing 123% from the same period in 2023. For the year ending 2024, RECORALAV net revenue was $64,300,000 a 118 increase compared to 2023. On a sequential basis, Recorlev net revenue increased by a record $5,000,000 in the fourth quarter. The strategic investments we made in the Recorlev commercial organization in mid-twenty twenty four coupled with favorable and evolving market dynamics helped drive the accelerated revenue gains we saw in the back half of twenty twenty four.

GVOC net revenue was $23,300,000 for the quarter and $82,800,000 for the year, representing a 2524% increase compared to the same periods last year. This growth was primarily driven by an increase in total Gevo prescriptions growing 1823% compared to prior year. KEVEYIS net revenue for the quarter and year to date was $11,100,000 and $49,500,000 In the fourth quarter, we saw average patients on KEVEYIS hold relatively steady compared to the third quarter. We also generated $3,100,000 in other revenue in the fourth quarter and for the year $6,400,000 In the fourth quarter, we successfully formulated a unique XERESOL formulation of glucagon for Beta Bionics, resulting in the recognition of $1,000,000 in revenue. Moving on to gross margin.

Gross margin was 84% in the fourth quarter, a 1% improvement compared to the same period in 2023. This improvement was driven by a favorable product mix. For the year, gross margin was 82%, relatively flat to prior year. Improvements to our gross margin in the year from a favorable product mix were offset by previously reported Gevo capacity expansion costs in the third quarter twenty twenty four. Research and development expenses were $6,100,000 for the fourth quarter, relatively flat compared to the same quarter twenty twenty three.

For the year, research and development expenses were $25,600,000 a $3,200,000 increase compared to prior year. This increase was to support XP8121 and increased personnel costs for the continued investment in our technology platforms and partnerships. Selling, general and administrative expenses were $40,100,000 and $163,500,000 for the quarter and year, respectively, an increase of seven percent and twelve percent compared to the same periods last year. These increases were driven by personnel costs, primarily due to the Recorlev commercial expansion. In addition, for the year, we incurred a one time charge of $6,100,000 in the third quarter related to the CEO succession plan and related corporate restructuring.

Rounding out our 2024 results, in the fourth quarter, we continued to maintain a very healthy cash position, generating over $2,000,000 in cash and ending the year with $71,600,000 Looking ahead to 2025 and as we announced earlier today, we expect total revenue to be between $255,000,000 to $275,000,000 Using the midpoint of this guidance, total revenue would grow over 30% annually, exceeding our growth rate in 2024. Primary drivers of this growth in 2025 will be Recorlev and Chivo, and we expect KEVEYIS will continue to hold its own. We do anticipate contribution from our partnerships, which we believe will be consistent with the revenue generated over the past few years. For RECORLEV, we continue to see a growing pipeline of referrals and expect another record number of patients on therapy in the first quarter. Over the course of 2025, we expect patient demand to grow at or above what we drove in the second half of twenty twenty four.

For Gevo, we expect steady prescription growth as we endeavor to serve the 14,000,000 patients that are unprotected today. Rounding out the products for KEVEYIS, we may see continued pressure on reimbursement and net pricing similar to what we experienced in 2024. However, we expect patient demand to remain steady as we work to keep existing patients on therapy and add new patients to KEVEYIS. Moving down the P and L, we expect a modest improvement in 2025 to our already attractive gross margin. This improvement we expect will be driven by favorable product mix.

We anticipate SG and A and R and D expenses, which in total were approximately $189,000,000 in 2024, to only increase modestly with a growth rate in the mid to high single digits compared to 2024. Our second half twenty twenty four commercial Recorlev commercial expansion and continued investment in this brand, combined with the incremental investments supporting XP8121, will primarily drive the increases in SG and A and R and D, respectively. Given our strong top line growth expectations, our healthy and improving gross margin profile, our disciplined expense management and strong cash position, it is clear that Zaris will turn an important financial corner in 2025 that will position the company to execute on its priorities without the need to dilute shareholders. Furthermore, in keeping with our commitment to greater transparency, we are now reporting on adjusted EBITDA. This is not only an appropriate financial measure for this stage of the company’s evolution, but more importantly, we believe this is an appropriate measure to assess the strength of the company’s true operating performance.

It is our belief that as we report on this metric moving forward, it should provide confidence that the company is financially healthy with sufficient capital to fund our priorities. As mentioned in this morning’s press release, we reported adjusted EBITDA of over $8,000,000 in the fourth quarter, and we anticipate that Zaris will be adjusted EBITDA positive on a go forward basis. In closing, Zaris has never been financially stronger. Our accelerating revenue growth coupled with our attractive and improving margin profile and disciplined capital allocation will result in a financially transformative 2025 for XERIS. With that, operator, please open the line for questions.

: Thank

Operator: you. Our first question today will be from the line of Chase Knickerbocker with Craig Hallum. Please go ahead. Your line is open.

Chase Knickerbocker, Analyst, Craig Hallum: Good morning. Thanks for taking the questions and congrats on a record quarter here. First, kind of just on the Recorlev strength, just help us better characterize, I guess, specifically kind of the strength there of prescribers who are already writing, what kind of growth are you seeing from them? And then what kind of growth in overall writers are you seeing? Basically, how much of this growth is going deeper with existing writers and kind of benefiting from their growth and prescriptions as people have kind of just a better appreciation of this disease state versus you guys successfully expanding your writer base?

John Shannon, CEO, Xeris Biopharma: Hey, Chase, it’s John. It’s both. Like we continue to expand our writer base, but you also are getting more and more riders writing more patients. So as they get comfortable in utilizing Recorlev, they begin to add more patients. So we have both happening.

And with the expansion of the sales force, that’s also allowing us to get to new patients. So, it’s coming from all places.

Chase Knickerbocker, Analyst, Craig Hallum: Do you get a sense of kind of what the increase in year over year kind of prescriptions in kind of hypercortisolism is in the market? Do you have any kind of sense?

John Shannon, CEO, Xeris Biopharma: We don’t. I mean, as you know that these there’s no data out there that supports exactly where all these patients are. And so it’s hard to kind of figure that out. But obviously that’s why you have people in the field so that you can find these patients.

Chase Knickerbocker, Analyst, Craig Hallum: Yes. Got it. And obviously what you’re seeing so far in Q1 kind of gives you the confidence for what’s a really strong guide here. Anything else you can give us just from deeper than the kind of record kind of pipeline and kind of incrementally what you’re seeing even better than Q4, that sort of thing? And then just lastly from me on KEVEYIS, how should we think about it on a year over year basis in 2025?

Should we be thinking about kind of the same decline as what we saw in 2024? Or should we be kind of analyzing what we saw in Q4? Thanks.

John Shannon, CEO, Xeris Biopharma: I think to your first question, we’re trying to really point what we saw in the back half of 2024, we anticipate we’re going to see for all of 2025. We’re seeing this acceleration and growth of our business that we’re confident we’re going to be able to do in 2025 and even better than we did on a full year basis for 2024. So, it’s a lot of the same stuff that we’ve been executing on. And then for KEVEYIS, I think KEVEYIS may have found maybe its bottom, but we so we don’t know exactly what’s going to happen, but it looks like we’re really holding our own, especially as we hold on to patients.

Mazzi, Analyst, Leerink Partners: Great. Thanks, Hess.

Operator: Our next question will be from the line of Oren Livnatz with H. C. Wainwright. Please go ahead. Your line is open.

Oren Livnatz, Analyst, H.C. Wainwright: Thanks for taking the questions. Just first, I want to just clarify that last commentary on Recorlev growth. Just so we understand, when you talk about growth rates consistent or better than what we saw in the latter part of 2024, are you talking about year over year patient add rates? I mean, that was in the mid-one 25% range. Is that what we’re talking about?

Or are we just talking about sort of sequential average quarterly revenue growth?

Steve Piper, CFO, Xeris Biopharma: Yes, probably not on a growth rate percentage rate because it’s off of a higher end now, right? So but I think on that like an absolute from an absolute perspective, I think what we saw in the back half should we expect will continue throughout 2025. We’ve reached kind of a new trajectory and this thing isn’t slowing down, Orin. So I would think about it more from the underlying number of patient adds rather than a growth percentage.

Oren Livnatz, Analyst, H.C. Wainwright: Okay. Makes sense. And in general, have there been any changes to access in that market? Obviously, the market itself is growing, but is there anything changing within it with regards you know, off label prescribing or lack thereof, changes in managed care positioning within that space? And, also, how are you doing on the sort of post initiation, interaction with patients and offices as we think about patients’ type trading up over time?

Is that something you guys are proactively interacting with offices and patients to sort of push them to continue to check levels and optimize therapy? And I have one follow-up.

John Shannon, CEO, Xeris Biopharma: So on the first part of your question, no changes in reimbursement. Everything’s pretty much the same. Obviously, there’s a great opportunity and once a patient is on is to help them and keep them on. And we continue to invest in that and work on that as an important aspect of helping to drive our growth.

Oren Livnatz, Analyst, H.C. Wainwright: Okay. And just lastly, obviously, you guys are really excited about 08/2021 and we’ve all been sort of waiting for a while to get that clarity. So it sounds like you’re still planning to give us more midyear. Pardon me. Are you able to talk about now, like maybe if there’s anything still TBD on that front between now and midyear updates?

Or is it just about preparing how you want to roll out the reveal there, so to speak?

John Shannon, CEO, Xeris Biopharma: We’re still having a dialogue with the agency and as we planned. This is all part of our plan here was, how we go to the agency, how do we work out the clinical, the device and the path of regulatory approval, was a process that we’ve been running and we’ll be prepared to talk more about exactly where that all lands by midyear.

Oren Livnatz, Analyst, H.C. Wainwright: All right. Appreciate it. Great quarter end guidance. Thanks.

: Thanks, Oren. Thanks, Oren.

Operator: The next question today will be from the line of Glenn Santangelo with Jefferies. Please go ahead. Your line is open.

Glenn Santangelo, Analyst, Jefferies: Yes. Thanks for taking my questions. Just a couple of quick financial ones. Steve, I think you said that gross margin was 84% in the fourth quarter and that was up 100 basis points. Recognizing sort of what happened in the third quarter when we look at that margin that gross margin expansion in 4Q, is that the right way to think about 2025 based on the mix assumptions that you sort of making for 2025?

Steve Piper, CFO, Xeris Biopharma: Yes. I think that’s a good starting assumption right there, Glenn, moving forward, plus or minus.

Glenn Santangelo, Analyst, Jefferies: All right. But then moving on to your expenses. I mean, it seems like I think you used the word that you expect your operating expenses to be up only modestly when looking at R and D was flat in 4Q and SG and A was up about 7%. So how should we think about that term sort of up modestly because it starts to seem like a lot of leverage in the model obviously which you know. But just sort of help us put those operating expenses into context?

Thanks.

Steve Piper, CFO, Xeris Biopharma: Yes. I think you hit the nail on the head, Glenn, that we are creating some leverage in the P and L with our operating expenses. We continue to invest in Recorlev and we had some adds to SG and A in the second half as a result of the Recorlev expansion. So you’ll get the full year effect of that in 2025. And then I think, we’ll invest incrementally in $81.21 The real spend though, it’s worth pointing out the real bolus of spend when you start talking about clinical spend will be more of a 2026 phenomenon.

Glenn Santangelo, Analyst, Jefferies: Okay. Thanks a lot.

: Sure.

Operator: The next question will be from the line of David Amsellem with Piper Sandler. Please go ahead. Your line is open.

: Thanks. So just a couple for me. Number one is looking at one of your competitors with Corland, there’s significant growth in sales and marketing spend for that company. And a lot of it, of course, is supporting this expanded market and expanded understanding of the prevalence of hypercortisolism. So I guess that sort of begs the question, how are you thinking about the long term spend to support Recorlev?

And do you expect significant headcount expansion in terms of the sales force? Do you expect significant overall promotional growth in promotional spend to support the product? Just help us understand that as our understanding of the market evolves and we have greater clarity on the extent to which this is a much bigger market compared to our understanding of it historically. So that’s number one. And then number two, can you just remind us how we should think about the durability and exclusivity runway for Recorlev that would be helpful.

Thank you.

John Shannon, CEO, Xeris Biopharma: Wow, a lot to unpack there. We see the expansions both Corcept and Recordati in this space as is really adding to the opportunity. Raising awareness, raising testing, will get more and more people identified and treated. We see that all as positive and adding to the tailwinds that we’re all enjoying in this space. I think that’s important that that continues and it’s helping all of us really find these patients and get them on therapy.

So that’s all the positive and adding to the positive momentum in the space. And then what was the second part, somebody? Exclusivity on Recorlev. Exclusivity on Recorlev. I think our patents are on the Recorlev goes to 02/1940.

And we have orphan exclusivity through ’29 in 2028.

Steve Piper, CFO, Xeris Biopharma: ’20 ’8. End of ’20 ’20 ’8.

John Shannon, CEO, Xeris Biopharma: So again, a lot of runway here, a lot of opportunity to continue to advance this market. And the other piece of this is we have Recorlev. We think Recorlev is, as I said in my remarks, the right product at the right time. So I think we have the best in class in terms of normalizing the synthesis of cortisol, which is a very important aspect to treating these patients. So, I think we’re it’s just perfect timing for us.

: And headcount expansion, what’s your expectation longer term?

John Shannon, CEO, Xeris Biopharma: Longer term investments in Recorlev will continue as we see the opportunity and we will continue to advance our investments in here. Because like we said, we have plenty of runway and a really accelerating market that says, yes, invest. How we invest, I’m not going to talk about exactly how that works out over the next several months, but we definitely are, see that as one of our key priorities of investment. All right. Thanks.

Operator: The next question will be from the line of Leland Gershell with Oppenheimer. Please go ahead. Your line is open.

: Great. Good morning. Great to see the positive investment EBITDA and thanks for taking our questions. Just two from us. Just first, John, just wanted to ask with respect to Gevo, given the updated guidelines, if you just maybe go into some detail maybe how you’re leveraging that update with respect to growing the product?

And then also want to ask on 08/2021 as we look forward to the unveiling of the broader plan in the year, would you be able to say that you at least intend to enter the candidate into Phase three potentially by the end of the year? Thank you.

John Shannon, CEO, Xeris Biopharma: Yes. Let me start with Gevoque, and the guidelines. The guidelines are pretty clear and our job and our team is really focused on not only raising awareness of the guidelines, but also helping clinicians, offices become more compliant with the guidelines, so that we can get the 14,000,000 people today that are not protected, they’re unprotected, and should be protected based on the guidelines. So, our focus in those offices every day is to help those offices advance their practice in a way that can get these people protected. And our Gevo team is doing that on a day everyday basis.

We see that as a long term opportunity. It’s going to take effort and we continue to invest in that effort. 8,121, I think, Steve, as Steve pointed out, yes, we’re making investments this year. They’re not super large investments. They’re more Phase three readiness, so that we can get started in the clinic.

Probably our thinking is sometime in 2026. But, yes, it’s more Phase three readiness this year.

: Got it. Thanks very much.

Operator: The next question will be from the line of Masihir Ali Mohamad with Leerink Partners. Please go ahead. Your line is open.

Mazzi, Analyst, Leerink Partners: Hi. This is Mazzi on for Roan Ruiz. Just a couple from us. I guess, firstly, as we think about the expansion with Recorlev, how and the recent sales expansion, is there any thoughts in terms of 2025 of increasing the sales force or any changes to the commercial strategy?

Steve Piper, CFO, Xeris Biopharma: So, I think sitting here today, we feel pretty confident with what we have, in terms of our commercial footprint for Recorlev. That being said, we’ve had two expansions over the last fifteen months. So we’ll be opportunistic as the market dynamics unfold. And if we see an opportunity to invest incrementally in Recorlev this year, we’ll do that. But right now, sitting here today, no, we don’t have any firm plans for an expansion.

Mazzi, Analyst, Leerink Partners: Great. And then last one for me. On 08/2021, as we think about kind of moving through the trials and into a potential commercialization phase for that, how would the synergies of your current existing products play a role in that? And is that something that you guys could build upon as you think about commercial, are you kind of taking advantage of your already strong footprint within the endocrine space?

John Shannon, CEO, Xeris Biopharma: That’s exactly it. That’s why we’re another reason why we’re so excited about 08/2021 is it fits perfectly with our endocrinology footprint across Gevo and Recorla for that matter. And we have all the capabilities from patient support to channel and pharmacy. So it’s a perfect fit for us and we’ll be able to slide it right into our existing footprint. So another exciting reason.

The other thing that’s exciting about it, it’s our own organic development program. It’s zero cell technology, which we know how to use, we know how to work with and proven in our Gevo product. So again, it’s those are two things that really are get us excited about our ability to get this to market and be successful once we get there.

Mazzi, Analyst, Leerink Partners: Great. That makes a lot of sense. Thanks for the time.

Operator: And our next question will be from the line of Oren Livnat with H. C. Wainwright. Please go ahead. Your line is open.

Oren Livnatz, Analyst, H.C. Wainwright: Hey, thanks for the follow ups. I just wanted to clarify on the guidance. You talked about sort of sustained positive EBITDA. Are you able to put a stake in the ground right now and say that for the full year or before year end that you’ll be cash flow breakeven this year? And on Recorlev, just wanted to check on seasonality.

Obviously, Orphan Drugs are subject to a pretty material growth to net changes in Q1 typically. Obviously, you’re talking about really strong patient growth and overall revenue growth there. Can you just talk about the cadence and whether we should expect sequential growth quarter over quarter in net revenue you think in Q1 or like most competitors, should we see maybe a dividend before we accelerating through the year? Thanks.

John Shannon, CEO, Xeris Biopharma: All right. Let me take the recoral of one and then I’ll throw Steve the first question you asked. Like every company that’s in especially in the rare disease space, there are resets and things that go on in the first quarter. So you see a little bit of slowdown in the first January, February timeframe and that starts to rebound towards the end of the quarter. So Q1 is always a little bit slower and then it picks back up.

So and it’s I don’t really call it a seasonality. It’s just it’s all about the payer resets. And we see that across all of our products. But specifically more importantly Recorlev and Keveyis probably feel at the most.

Steve Piper, CFO, Xeris Biopharma: So, Oren, on your cash question, I think you probably picked up on the fact that we’re not really guiding on cash going forward.

Oren Livnatz, Analyst, H.C. Wainwright: So

Steve Piper, CFO, Xeris Biopharma: let me just start with one. We have plenty of cash to operate the business moving forward. And hopefully clear from the guidance we provided this morning that the company is on really solid financial ground with a really promising outlook for ’25, right? 30% revenue growth at the midpoint of our guidance, healthy already healthy and improving gross margins and modest operating expense growth, and obviously adjusted EBITDA moving forward, positive moving forward. So I think what we’re doing what we’re saying here is we’re transitioning from a kind of a cash burn story that we have been historically.

And we want to focus investors on the growing strength of our P and L and the operations of the business. So that’s kind of answering your question without answering it. But I think what’s important is that feel really good about where this business is heading, particularly in 2025.

Oren Livnatz, Analyst, H.C. Wainwright: All right. Thank you so much.

Operator: Thank you. This concludes Q and A. I will now hand the call back to John Shannon for closing remarks.

John Shannon, CEO, Xeris Biopharma: Thank you. And thank you everyone for your questions. As you just heard, the continued momentum of our commercial business, our exciting pipeline along with our unrelenting focus on execution will create even more value for our patients and our shareholders and set Xerus up for a transformational 2025. Thank

Operator: you. Thank you. This concludes the Xeris Biopharma fourth quarter and full year twenty twenty four financial results. You may now disconnect your lines.

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