Xeris Biopharma Q1 2024 Earnings Report

Xeris Biopharma EPS Results

• Actual EPS: -$0.14
• Consensus EPS: -$0.12
• Beat/Miss: Missed by -$0.02
• One Year Ago EPS: N/A

Xeris Biopharma Revenue Results

• Actual Revenue: $40.64 million
• Expected Revenue: $41.56 million
• Beat/Miss: Missed by -$920.00 thousand
• YoY Revenue Growth: N/A

Xeris Biopharma Announcement Details

• Quarter: Q1 2024
• Date: 5/9/2024
• Time: N/A
• Conference Call Date: Thursday, May 9, 2024
• Conference Call Time: 8:30AM ET

Xeris Biopharma (NASDAQ:XERS) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for endocrine and orphan diseases. The company’s proprietary formulation platform is designed to enable liquid stability of drugs that traditionally require reconstitution before injection. By eliminating the need for on-site mixing and simplifying administration, Xeris aims to improve patient safety, adherence, and convenience in high-need therapeutic areas.

The company’s flagship product, Gvoke, is a ready-to-use liquid glucagon autoinjector and prefilled syringe that has been approved by the U.S. Food and Drug Administration for the treatment of severe hypoglycemia in adults and pediatric patients with diabetes. Gvoke is the first and only ready-to-use glucagon rescue product, offering rapid emergency treatment without the time-consuming reconstitution steps required by traditional glucagon kits. In addition to Gvoke, Xeris is advancing a pipeline of liquid-stable therapies, including investigational rescue treatments for seizures and other acute conditions.

Founded in 2008 and headquartered in Chicago, Illinois, Xeris Biopharma operates primarily in the United States while exploring international partnerships to expand the reach of its novel drug-delivery technologies. The company is led by President and Chief Executive Officer Paul Edick, whose leadership has guided Xeris from its early research stages through the commercialization of its first product. As Xeris continues to grow its portfolio, it aims to address unmet needs across a spectrum of endocrine and neurology indications.

Xeris Biopharma Q1 2024 Earnings Call Transcript

Key Takeaways

• Revenue growth and guidance raise: Q1 2024 total revenue rose 22% YoY to $40.6 M and net product revenue grew 25% to $40.3 M, prompting management to tighten full-year guidance to $175 M–$200 M.
• RECORLEV momentum: Net sales jumped 137% YoY to $10.6 M driven by a 139% increase in patients on therapy and record patient referrals, fueling confidence in its long-term Cushing’s market potential.
• KEVEYIS resilience: Despite generic competition, Q1 sales reached $13.1 M (up 3% YoY) as stronger-than-expected patient demand and retention extended into Q2.
• GVOKE recovery: Net revenue climbed 10% YoY to $16.6 M with prescriptions up 27% and market share at 33%, overcoming an estimated $3 M temporary Q1 sales impact from the Change Healthcare cybersecurity breach.
• Technology partnerships advancing: Xeris entered a collaboration with Beta Bionics for pump-stable glucagon, secured an Amgen license for subcutaneous TEPEZZA, and expects Levothyroxine Phase 2 data by end of Q2.

Presentation

[Operator]

I will now hand the floor over to Allison Wey to begin the call. Please go ahead when you're ready.

[Allison Wey, Head of Investor Relations at Xeris Biopharma Holdings Inc.]

Thank you, John. Good morning, and welcome to Xeris's first quarter 2024 financial results conference call and webcast. This morning, we issued our press release, which can be found on our website. We're joined this morning by Paul Edick, Chairman and CEO, and Steve Pieper, our CFO. 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 press release and risk factors, including in our SEC filings in our annual report on Form 10-K that will be filed following this call.

[Allison Wey, Head of Investor Relations at Xeris Biopharma Holdings Inc.]

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. I'll now turn the call over to Paul.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Thanks, Allison. Good morning, everyone, and thank you for joining us today. Let me start again by thanking everyone who's contributed in some meaningful way to us delivering an outstanding quarter for the company, including the patients we serve, the healthcare providers we enable, and the dedicated Xeris team that executes at a high level every day. The headline for today's call is 22% growth in total revenue versus last year, with momentum already building in the second quarter, giving us confidence to tighten our total revenue guidance, raising the bottom from $170 million to $175 million, making for a great start to 2024. At a high level, we have continued our strong commercial performance across all three of our products. Recorlev, Gvoke, and Keveyis together grew net sales by a combined 25% in the first quarter compared to last year.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

On Monday, we announced another technology partnership, entering into a new collaboration and license agreement with Beta Bionics. You'll recall that in January, we announced Amgen had executed the exclusive worldwide license agreement to develop, manufacture, and commercialize a subcutaneous formulation of Tepezza using our XeriJect technology in thyroid eye disease. I'm excited by the momentum we've already generated, the continued momentum into April, and I believe we're well-positioned to deliver on all fronts in 2024. Let's start with the performance of our commercial products in the first quarter. We're gonna start with Recorlev today. We grew Recorlev net sales to $10.6 million in the quarter, a 137% increase compared to last year.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

We're very excited with Recorlev's progress, driving a quarterly record of patient referrals and converting those referrals into new patients on drug at a record pace. As patient referrals continue to grow, the underlying patient demand has shown increasing growth, with average patients on drug growing 18% versus the previous quarter and 139% versus first quarter 2023. The number of unique prescribers with referrals also continues to grow. Growth in the first quarter was fueled not only by the significant increase in our patient referral pipeline and new patient starts, but importantly, by a significant increase in the number of unique prescribers who recognize the value in treating patients with Recorlev. It bears repeating that we see tremendous potential for Recorlev in an increasingly dynamic Cushing's market.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

The key advantage prescribers recognize with Recorlev versus most other products used in the category is that Recorlev actually treats the underlying conditions in Cushing's by normalizing cortisol levels in the body. Increasingly, prescribers recognize this and that Recorlev is an ideal therapy for treatment of patients with Cushing's. Capitalizing on this momentum, we continue to add to our commercial team and patient assistance resources in support of continued Recorlev growth. Moving to Keveyis. The Keveyis brand remains incredibly resilient in the face of generic competition. We're off to a much stronger start in 2024 than we anticipated, with Keveyis growing 3% compared to the first quarter last year. I stated last quarter that we expected to see a decline in Keveyis sales in the first quarter and for the year, driven by generic competition and payer resets.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

This didn't happen as rapidly as we expected. Underlying, excuse me, underlying patient demand for Keveyis remained stronger in the first quarter than we anticipated, which we believe was driven by our continued ability to find and start new patients, as well as retain existing Keveyis patients. This resulted in sales that significantly exceeded our expectations for the quarter, and importantly, we're also seeing this momentum carry well into the second quarter. We're committed to the primary periodic paralysis community, and finding new patients continues to be the key to maintaining Keveyis's contribution to our commercial portfolio. Moving to Gvoke. Gvoke's net sales increased approximately 10% in the quarter compared to prior year, while Gvoke prescriptions grew 27%. This net sales increase was largely driven by Gvoke's gain in market share and the continued growth of the glucagon market in January and February.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

As of the last published weekly figures in April, Gvoke's share of total prescriptions was over 36%. The total glucagon market started off the year with growth consistent with historical trends as well. For reference, in February, the glucagon market grew a healthy 15% compared to prior year. However, the glucagon market, our script growth, and importantly, the utilization of our copay assistance program were all negatively impacted in late February and March, when Change Healthcare announced their cybersecurity breach and shut down their claims processing systems. For those who are less familiar with the situation, Change Healthcare is the largest U.S. clearinghouse that adjudicates prescription claims between pharmacies and payers. This shutdown essentially prevented the adjudication of many prescriptions by many pharmacies, especially certain chains through normal means, starting in February through early April.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

This meant that many of our retail pharmacies struggled to dispense Gvoke prescriptions, and Gvoke patients were unable to utilize our copay assistance program for several weeks. Not only did this impact prescription processing, but it also resulted in tightening of inventory by wholesalers. We calculate, based on the change in the prior utilization of our copay card, that the Change Healthcare cybersecurity breach had as much as a $3 million temporary impact on Gvoke net sales in the first quarter. To be clear, this unprecedented situation did not have a similar impact on Recorlev or Keveyis, as they are dispensed through a single specialty pharmacy that was able to quickly switch to alternate means of prescription adjudication. Importantly, in late April and early May, we have seen recovery in prescription fulfillment and wholesaler purchases commensurate with script demand.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Based on the most recent week of Gvoke new prescription data, new prescription market share for Gvoke has increased to 37%, and we believe the total glucagon market will return to historical growth trends by the end of the second quarter. To be very clear, were it not for the Change Healthcare situation, we believe we would have exceeded expectations for Gvoke and total product revenue in the quarter. Moving to our technology platforms. Our XeriSol and XeriJect platform science is a growing and increasingly important part of our overall enterprise development. Not only is our formulation science what has enabled the development of Gvoke and our levothyroxine pipeline product, but it's also enabling a growing number of partnerships that could deliver considerable revenue well into the future.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

On our latest partnership, on Monday, we announced that we entered into an exclusive worldwide collaboration and license agreement with Beta Bionics for the development and commercialization of a new and unique XeriSol-based formulation of a liquid stable glucagon for use in bihormonal pumps or pump systems. Just to be clear, this is not Gvoke. We are formulating a new glucagon specifically for use in a pump. Through this partnership, we have the potential to receive payments through clinical development and low double-digit royalties on future sales of XeriSol glucagon for pumps and pump systems. Some other notable developments in the quarter: as we announced in January, Amgen executed the exclusive license agreement to develop, manufacture, and commercialize a subcutaneous formulation of teprotumumab using our XeriJect technology in thyroid eye disease. With Regeneron, we have completed formulation development for both initial molecules.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Regeneron's stability and non-clinical evaluations will take place over the next six months. Assuming continued success, that could lead to their potentially executing a license option for further clinical development, commercialization of any of the molecules in the platform, which would trigger additional one-time milestones. Now on to an update of our XeriSol levothyroxine program, a potential once-weekly subcutaneous injection. We successfully completed the Phase II clinical study, and data will be available by the end of the second quarter. As a reminder, the oral dose conversion data will help 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 design, we could start that study as early as mid-2025.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Here is my overriding message today: Our commercial product portfolio is generating significant growth, and we are adding new meaningful technology partnerships. We continue to meet or exceed expectations across the board, despite the temporary impact of external, uncontrollable events, such as Change Healthcare. That continued performance and our future outlook is what gives us confidence in tightening our revenue guidance for 2024. We are raising the low end of our total revenue range from $170 million to $175 million. Our revised total revenue guidance is now $175 million to $200 million. Our overall strong business performance is also enabling us to make incremental investments in our commercial business, our technology business, and our internal pipeline, while maintaining our cash guidance of $55 million to $75 million at year-end 2024.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

We continue to build a healthy, self-sustaining enterprise. I'll now turn the call over to Steve for additional details on our financial performance.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

Thanks, Paul, and good morning, everyone. As Paul mentioned, we're off to a great start. All three of our commercial products grew revenue in the first quarter compared to last year. We ended the quarter with net product revenue of $40.3 million, a roughly 25% increase compared to last year, and total revenue of $40.6 million, a 22% increase compared to last year. Starting with Recorlev revenue, Recorlev net revenue was $10.6 million for the first quarter, a 137% increase compared to prior year, and an 8% increase from the fourth quarter 2023. This growth was primarily driven by the average number of patients on Recorlev, increasing a 139% from last year and 18% compared to the fourth quarter.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

We continue to be encouraged by the patient demand growth for Recorlev, which has been fueled by a consistently increasing pipeline of referrals, growing 93% compared to last year and 10% compared to the fourth quarter. Based off the early success of our fourth quarter Recorlev field expansion and a strong start to the second quarter, we will continue to add field and patient support resources this year to drive revenue growth in 2024 and beyond. Moving to Keveyis. Keveyis net revenue for the quarter was $13.1 million, representing a 3% increase compared to the same period last year. Keveyis continues to be resilient and actually beat our internal estimate in the first quarter. Our strategy to invest in Keveyis and defend brand continues to be successful.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

Starting in the fourth quarter and continuing into the first quarter, we saw a slight decrease in patient demand due to generic pressure. However, this decrease was lower than we anticipated and was offset by an increase in pricing. Our patient referrals increased 27% compared to prior year and 35% compared to the fourth quarter. This performance continues to reinforce the strength of the Keveyis brand, including Xeris Care Connections, which offers the best-in-class therapy and support for primary periodic paralysis patients. Moving to Gvoke. Gvoke net revenue was $16.6 million for the first quarter, representing a 10% increase compared to the same period last year. Importantly, in the first quarter, Gvoke prescriptions grew 27% compared to the same period last year, and Gvoke ended the quarter with market share of 33%, a 5% share increase from the same period last year.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

As Paul mentioned, we believe that Gvoke's growth and net revenue was negatively impacted by the Change Healthcare cybersecurity breach, which we estimate had as much as a $3 million temporary impact on Gvoke net sales in the first quarter. Looking ahead to the second quarter, we are seeing strong demand for Gvoke in underlying patient prescriptions, which exceeded 5,000 in the most recent weekly data, as well as increased orders from our wholesalers. We believe that the temporary effects of the Change Healthcare cybersecurity breach impacts will be largely resolved by the end of the second quarter. Looking ahead to the full year, we are tightening our total revenue guidance by raising the low end of the range, with revised guidance going to $175 million to $200 million from the original guidance of $170 million to $200 million.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

We are tightening our guidance to reflect the strong performance of Recorlev, the continued resilience of Keveyis, and the expected contributions from our technology partnerships. Moving down the P&L. Cost of goods sold in the fourth quarter was $6 million, a 12% increase compared to the same quarter last year. This increase was driven by higher product sales. Research and development expenses were $7.8 million for the quarter, an increase of $3 million compared to the same period last year. Consistent with my remarks in March, we continue to make strategic investments in our pipeline, notably levothyroxine and our emerging technology partnership business, which has and will result in an increase in our R&D costs this year. Selling general and administrative expenses were $38.4 million for the quarter, an increase of $4.8 million compared to the same period last year.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

This increase was driven by rent expense related to our headquarters lease, which commenced in April 2023, and a higher personnel cost, primarily driven by a modest field expansion in the fourth quarter. Looking ahead for the full year, we are projecting a modest increase to SG&A this year, which includes the impact of the incremental investment we are making in the Recorlev, Recorlev business to drive growth in 2024 and beyond. Moving to cash. We ended the quarter with $87.4 million in cash, which included net proceeds from the Hayfin term loan refinancing of approximately $35 million. From a cash guidance perspective, we continue to maintain our previous guidance of $55 million to $75 million, which considers our revised revenue guidance, as well as the additional investments we are making in the Recorlev business.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

We are able to make these investments as a result of strong revenue growth, combined with continued disciplined expense management of our enterprise. Xeris is off to a great start in 2024, and we look forward to continuing to build on this momentum. With that, operator, please open the lines for questions.

[Operator]

Thank you. If you would like to ask a question, please press star one on your telephone keypad, or press star two if you would like to withdraw your question. The first question comes from Oren Livnat from H.C. Wainwright. Please go ahead.

[Oren Livnat, Analyst at H.C. Wainwright]

Thanks. I got a couple. First, on the guidance, can you just clarify, tightening up the bottom end, you know, is that essentially maintaining your conservative assumptions on Keveyis? You know, tightening up the bottom as it outperforming Q1, but essentially continuing to assume a significant decline going forward from generic impact? And I have follow-ups.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

... Actually, Oren, it's Paul. The raising the bottom is being less conservative on Keveyis. We're, we're pretty excited about what happened in the first quarter. It exceeded what we anticipated, and contrary to what we guided previously, we had said that we thought we'd get a get hit in the first quarter and some decline thereafter. The first quarter hit wasn't even close to what we thought, therefore, the decline will be a little bit less than what we thought. Still, there's some softening there, but we're, we're very pleased with, and we're a little bit surprised by how resilient Keveyis is.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

Yeah, I would just add to that, Oren, that, you know, we're seeing that momentum really continue into Q2 as well, across all of our brands.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Yeah.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

That gives us confidence to raise the bottom end.

[Oren Livnat, Analyst at H.C. Wainwright]

Great. And on Levo, I think you said that you successfully completed Phase II, and I guess you're still waiting for a couple of months to see more data. Can you just remind us, you know, what you need to see? What is-- what, what did success entail, and is there any delay in, I guess, us seeing this data? Is there anything to work through still at this point, or is it just a matter of a data crunch?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

It's just a matter of data crunch. We've last patient, last visit, successful completion is we hit the number of patients we needed. We've gotten everybody through the study. We've got all the patient records. Now, it's a matter of just crunching through all the data. If you recall, the purpose of the study was to confirm the conversion ratio from oral to liquid. In our Phase I healthy volunteer study, that was a 4X conversion. This study is designed to confirm whether that is still the case when we do it at multiple doses or multiple different dosage levels in actual hypothyroid patients.

[Oren Livnat, Analyst at H.C. Wainwright]

Can you say if there was any difference between healthies and thyroid patients at this point?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

We have not gotten the top-line data yet.

[Oren Livnat, Analyst at H.C. Wainwright]

All right, great. And just lastly, on Gvoke, thanks for quantifying that impact. I know you had already expected a little destocking this quarter, and it sounds like this cyberattack caused additional headwinds. Can you just say, was that $3 million impact inclusive of normal seasonal destocking? Is that all in the sort of net impact of everything versus what-

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Yeah

[Oren Livnat, Analyst at H.C. Wainwright]

- sort of the underlying demand sales would have been, that $3 million?

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

It's all in. Yeah, so it's the underlying demand, which you would see in scripts as well as, wholesaler destocking, which, was significantly more pronounced, than we've historically seen. And the timing of it was pretty directly correlated with the timing of the, the cyberattack.

[Oren Livnat, Analyst at H.C. Wainwright]

So going forward, should... I mean, obviously, the scripts look great. On top of that, should we expect some rebound and maybe stock in in Q2? And is there any hangover from a, you know, net unit economics perspective in general? Like, you know, do you have to do additional or different patient assistance than you would normally be doing in the Q2 to salvage patients that you might have, you know, lost or otherwise right to ship?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Yeah. We don't have to do anything extra, we don't believe. The co-pay card is a pretty good barometer of what's going on with patients, and, you know, we're already starting to see it rebound. Whether or not we get back those prescriptions that may have been stacking up at the pharmacies, we'll see. We believe we'll get some of them, but there may be a period of a little bit of increased abandonment. But if there was a prescription written for a patient, even if they don't pick up that one, they're probably gonna get another one written, so we'll still get those patients.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

Yeah, and what I would say, Oren, to your first question around wholesaler inventory levels, I would say that on, in total, our wholesalers are running at historically low inventory levels. Whether or not they build, you know, inventory up, remains to be seen.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Mm-hmm.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

We don't anticipate it going any lower, is what I would say. No downside there, but if anything, potential for upside. That really remains to be seen.

[Oren Livnat, Analyst at H.C. Wainwright]

All right, thanks. I will get back in queue and not hog the time. Thanks.

[Steven Pieper, CFO at Xeris Biopharma Holdings Inc.]

Thanks, Oren.

[Operator]

Our next question comes from Roanna Ruiz, from Leerink Partners. Please go ahead.

[Roanna Ruiz, Analyst at Leerink Partners]

Great morning, everyone. So I wanted to ask about the collaboration with Beta Bionics. So what is the approximate timeline to possible commercialization of this glucagon pump? And how big do you think that market opportunity could be?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Well, I think that is a little bit more of a question for Beta Bionics at the end of the day. What we've done is Beta Bionics, obviously, they've been in the process of developing a bihormonal pump that would provide it with an algorithm that detects your insulin and detects your glucose and can give you a little bit of each as necessary. It really has been, you know, something that has been a pursuit in the control of glycemic control for decades. They have perfected the pump, and they have it on the market with one hormone, being the insulin component. Our deal will facilitate the second hormone.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

So we have the glucagon that is liquid stable glucagon that can be put in the pump to facilitate further clinical development, Phase II, Phase III of the pump with both hormones. At some point, you know, hopefully in the next few years with approval, it could be an important part of glycemic control for a lot of patients. Anybody that's on a pump today, could very well want to have a closed loop system with two hormones included. So for us, it's an important partnership because it could mean for significant sales of our new different formulation of glucagon in the future.

[Roanna Ruiz, Analyst at Leerink Partners]

Got it. That helps. Second question on Recorlev. It seems to be showing some really great traction. Could you talk about the weekly growth trends that you saw in patient referrals in the recent quarter, and if you're seeing anything going into second quarter and what you expect for the rest of the year?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Yeah. So I don't have the weekly data right here in front of me. We track it like a hawk, as you can imagine. But the growth in referrals has been outstanding, and April has been even more encouraging. We're not going to preview what April did, but if sitting here today, April for both Recorlev and Keveyis and Gvoke, for that matter, are all looking great.

[Roanna Ruiz, Analyst at Leerink Partners]

Great. Thanks.

[Operator]

Our next question comes from David Amsellem from Piper Sandler. Please go ahead.

[Analyst at Piper Sandler]

Hi, this is Skyler on for David. First, on Recorlev, can you talk more about the patient footprint, just what you're seeing from treatment naive versus experienced, and thoughts on the trajectory? Just overall, how you're thinking about the addressable patient population, in light of the Catalyst study data that shows the prevalence of Cushing's might be much higher than previously understood?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Yeah, great questions. We believe that the patient, the addressable patient population is much larger than it's been, than the way this category has been viewed historically, without question. So that we see that as a tremendous opportunity. To the first part of your question, we're getting patients who have been on other products. There's quite a bit of churn in this category, as you would expect, and these are ill people. They have a lot going on. We are getting quite a few patients from Korlym, simply because our product normalizes cortisol. We don't just treat symptomatically, so that, we believe, gives us an advantage. But in essence, we're getting patients from across the board. And interestingly, physicians who've tried Recorlev are starting to use it first line.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

So we're getting drug-naive patients, which is early in the lifespan of a product in this kind of category, in this kind of rare disease, to already be getting first-line patients. So we're very encouraged by that, and I think that's what's driving the referral pipeline to a large degree.

[Analyst at Piper Sandler]

Great. That is helpful. Then just one more. How are you thinking about the overall growth of the glucagon rescue category, the underlying opportunity there, and what do you think would be some tailwind that increase the penetration of the overall market?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

The rescue category in glucagon? I didn't hear the first part of your question.

[Analyst at Piper Sandler]

Yes, just the overall opportunity there and what you think will increase penetration of that market.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Yeah. I mean, if you look at what's going on, we've seen some fluctuation in the growth rate of the total market over time, but we fully expect it to get back to double-digit growth. Pre-pandemic, it was growing 25% to 30%, so there's good momentum there. What's even more important is, regardless of the potential growth or the rate of growth of the overall market, which we're driving the majority of that growth, our share of new prescriptions is increasing dramatically. If you look at it, it's grown, you know, 5%-6% in the last few months. So as the market growth increases, our share is increasing, so that all bodes really well for the future, for Gvoke. And there's, you know, there's 15 million people out there-

[Analyst at Piper Sandler]

Great

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

... who need a rescue device, and only 1 million actually have one. So there's tremendous opportunity.

[Analyst at Piper Sandler]

Helpful. Thank you.

[Operator]

Our next question comes from Chase Knickerbocker from Craig-Hallum. Please go ahead.

[Analyst at Craig-Hallum]

Hey, good morning, everyone. This is Connor on for Chase. Thanks for taking my questions. It seems like Keveyis continues to hold in there. Can you give us an update on the treatment from payers this year? Are we gonna start seeing any forced switching to the generic?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

So we are seeing. I mean, we're not saying we've had no patient loss. We're seeing some patient loss, but payers are not forcing that conversion as aggressively as we had anticipated. We figured the opportunity with payer, you know, insurance resets in the first quarter, payers would take the opportunity to be pretty aggressive about forcing a switch. It's just not happening as rapidly as we would have thought. The other thing we're seeing is a reasonably high percentage of patients who are forced to go to a generic are actually coming back. A big part of that is they don't get the support services that they're used to. They don't have a patient mentor anymore.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

There's a lot that they're surrounded with when they're on the brand that help support their sort of re-entry into life that the generics don't provide. Yeah, we're losing some, but we're getting quite a few of them back. And that is a part of the overall resilience that we're seeing, and Keveyis is performing a lot better than we had. We've been pretty conservative in our 2024 guidance, not knowing what was really gonna happen. And, you know, we've been a little surprised, but in a good way.

[Analyst at Craig-Hallum]

Great. And then maybe, can you dive into what else is required for the Beta Bionics partnership on your end? What do you need to get ready?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Our role is pretty simple. You know, we are already starting to formulate the new version of glucagon, which will be very different than what is in Gvoke. It's a pump-specific glucagon that will be compatible with all of the components of a pump. We'll formulate that. We expect we can get that done this year, and then Beta Bionics will have to do some testing of their own to confirm whatever we give them. And then Beta Bionics will move into a Phase II program for the dual hormone system, and then onto a Phase III program, assuming success. That's all 100% Beta Bionics.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

We will support those programs through advice and consulting, and helping them with drug studies and things like that, because they're a device company more than they are a drug company. So we'll provide that support and advice in terms of the components of a drug trial. We will manufacture supply for both Phase II and Phase III. But beyond that, you know, we get a low double-digit royalty and we get a markup on supply, and we'll continue to support them well into commercialization.

[Analyst at Craig-Hallum]

Great. Thanks for taking my questions.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

You're welcome.

[Operator]

Our next question comes from Rohan Mathur from Oppenheimer. Please go ahead.

[Rohan Mathur, Analyst at Oppenheimer]

Hi, thanks for taking my question. This is Rohan on for Leland Gershell. Just a couple from me. When you think about the subcu levo opportunity, how are you viewing possible paths forward with respect to either developing the drug in-house or maybe engaging in some form of collaboration?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

We're open to both. We, you know, we have the capabilities to develop it in-house, and we, you know, we believe that we have the financial resources in the future, especially as our, as our commercial assets grow and start to deliver more cash to the balance sheet. We can develop it. By the time it's ready for commercialization, our organization will be more than capable of launching it commercially. That doesn't obviate the potential for a partner not to get it done, but to make it a bigger drug than we would ourselves. We see the segment of patients for whom this would be a perfect option, those who are not getting good absorption, people who have dramatically variable blood levels, people who can't tolerate the oral in the gastrointestinal tract.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

We think that's about a 25% segment of the overall population, which even at today's prices, regardless of future prices, could be a $2 billion segment. So we think it's a huge opportunity, and if we choose to partner, it would be for the purposes of making it even bigger.

[Rohan Mathur, Analyst at Oppenheimer]

Got it. With respect to the Regeneron partnership, should we expect to see any updates this year and maybe anything else on the business development front?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

We're always active on the business development front. You know, it took us a while to get the Beta Bionics deal done. We're always talking to people about our technologies and we're having more and more companies approach us as we do more with that end of the business. Regeneron, I think I already said in my comments, that they're over the next six months, they're doing their stability work. I don't expect any announcements this year from that.

[Rohan Mathur, Analyst at Oppenheimer]

Thank you.

[Operator]

Our next question is a follow-up from Oren Livnat at H.C. Wainwright. Please go ahead.

[Oren Livnat, Analyst at H.C. Wainwright]

Thanks. I just want to follow up on the Recorlev. It outperformed a bit our expectations on patients and sales, but I'm curious what you're seeing regarding the ongoing uptitration of dose, you know, those trends over time for, you know, longer-term patients now and new patients. Obviously, that's an important part of the long-term potential of the product. And also, can you expand a bit on, I think you mentioned the incremental investments you're making this year behind that? You know, are those mostly on the hub and market access services, or are you actually putting more reps in the field to broaden or, I guess, deepen the field presence? Thanks.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

So thanks, Oren. There's, like, about three or four in there.

[Oren Livnat, Analyst at H.C. Wainwright]

Yeah.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

So let me start with dose, dose, dose titration. So we are seeing uptitration on an individual patient basis. However, we're adding new patients so quickly at the low end, at the starting dose, that the average dose per patient is not moving that fast, because we're adding so many patients so quickly at the point of entry, at the starting dose. Over time, with a larger subset of patients, we'll start to see more impact on the revenue base based on uptitration, but that's a ways off. In terms of adding resources, we're adding to the patient support services, and we continue to add a little bit at a time to the field force.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

We don't want to disrupt the field force, but we will continue to add, you know, 10, 15 reps to the field force. We would like to, over time, get up to the 50, 60 range, to be able, because the opportunity is just so big.

[Oren Livnat, Analyst at H.C. Wainwright]

So, how many reps are you at now? I'm sorry.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

I'm looking at John Shannon to see if I can get this answer. 28, I believe.

[Rohan Mathur, Analyst at Oppenheimer]

Yeah, we have 28 now.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

28 as of today. We'll add, you know, another-

[Rohan Mathur, Analyst at Oppenheimer]

10-15.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

10 to... Yeah.

[Oren Livnat, Analyst at H.C. Wainwright]

Over time?

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Yep.

[Oren Livnat, Analyst at H.C. Wainwright]

Okay.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Over the next couple of quarters.

[Oren Livnat, Analyst at H.C. Wainwright]

Oh, okay. Thanks. Appreciate it.

[Operator]

Our next company comes from Kelly Close. Sorry, next question is from Kelly Close. Kelly, please go ahead.

[Kelly Close, Analyst at Close Concerns]

Good morning. Thank you for all of this. New CDC data came out earlier this year, showing from the National Diabetes Statistics Report, showing that severe hypo events landing people in the hospital have dropped to 200,000 from closer to 240,000 the last time the data was given. So thank you so much for this. You've had a big impact in this as probably AID as well. I was just wondering if you could talk about, you know, 25% of those people were still admitted to the hospital. It does seem like this number should be 0, going to the hospital. The DKA numbers have gone up, you know, but what else can be done?

[Kelly Close, Analyst at Close Concerns]

You know, what else would you like to see in terms of partnerships, maybe philanthropic, you know, maybe other corporate partnerships? This obviously, people, this number going into the hospital could still change dramatically.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Hey, Kelly. Thanks a lot. We really appreciate the question. And I do believe we're having an impact. I do believe more people with ready-to-use rescue devices such as Gvoke HypoPen. It's gonna have an impact. You're absolutely correct. The most important thing that we're trying to focus on right now, and have been for a while, is to getting the healthcare professionals to really reengage. Whenever they write a prescription for insulin or sulfonylurea, they should absolutely co-prescribe a Gvoke or a ready-to-use rescue product. That is, it should be mandatory. When you look at the allergy category, if you've got a severe allergy and you don't get a HypoPen, that would be a rare situation. This is an equally life-threatening situation. People are still going to the ER, still getting admitted to the hospital.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

You know, there are still mortality associated with this, as you know. It is really the job of the healthcare professional to automatically or make sure it's standing orders in their office, prescribe a Gvoke HypoPen whenever they prescribe insulin. That's number one. And number two, I think the community needs to continue to be motivated to say, "Yep, you know, that could be me." You know, even if you've been perfectly managing your condition for decades, it can happen to anybody. So those are the two things we need to do.

[Kelly Close, Analyst at Close Concerns]

Yeah. Thank you so much. I know we're all just really grateful to all of the clinicians who are really overworked also. So, you know, also questions coming from the patient community and so forth, I think would also be really helpful, and that also seems doable. So thank you very, very much-

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Yeah

[Kelly Close, Analyst at Close Concerns]

for all of your incredible impact.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Thank you. We appreciate it.

[Operator]

We have no further questions on the call, so I'll hand the floor back to Paul Edick for closing remarks.

[Paul R. Edick, Chairman and CEO at Xeris Biopharma Holdings Inc.]

Thank you. As you heard, we've delivered another growth, quarter of growth and are very proud of our performance to date. We expect the momentum to continue in the balance of 2024. We've seen a tremendous acceleration in April, and we look forward to another year of growing an enterprise which we can all be very proud of.

[Operator]

This concludes the conference call. Thank you all very much for joining.

Participants

Executives

• Allison Wey, Head of Investor Relations
• Paul R. Edick, Chairman and CEO
• Steven Pieper, CFO

Analysts

• Kelly Close, Analyst at Close Concerns
• Oren Livnat, Analyst at H.C. Wainwright
• Roanna Ruiz, Analyst at Leerink Partners
• Rohan Mathur, Analyst at Oppenheimer
• Analyst at Craig-Hallum
• Analyst at Piper Sandler