Hello, everyone, and welcome to the Xeris Biopharma's First Quarter 2024 Financial Results Conference Call and Webcast. My name is Seb, and I'll be the operator for your call today. I will now hand the floor over to Allison Wey to begin the call. Please go ahead when you're ready.

Thank you, Seb. Good morning, and welcome to Xeris' 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'll 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 included in our SEC filings and our annual report on Form 10-K that will be filed following this call. Any forward-looking statements in this call represent our views only as of the date of this call and are subject to applicable law. We disclaim any obligations to update such statements. I'll now turn the call over to Paul.

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 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 was 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. On Monday, we announced another technology partnership by 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 growth 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 going to start with Recorlev today. We grew Recorlev net sales to $10.6 million in the quarter, a 137% increase compared to last year. 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 the first quarter of 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. 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 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. This didn't happen as rapidly as we expected. Unpredictably, underlying patient demand for Keveyis remains 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. Importantly, we're also seeing this momentum carry well into the second quarter. We are committed to the primary periodic paralysis community and finding new patients continues to be key to maintaining Keveyis' contribution to our commercial portfolio. Moving to Gvoke. Gvoke's net sales increased approximately 10% in the quarter compared to the 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. 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 the prior year. However, the glucagon market, our script growth, and importantly, the utilization of our co-pay 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. clearing house 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. This meant that many of our retail pharmacies struggled to dispense Gvoke prescriptions and Gvoke patients were unable to utilize our co-pay 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 utilization of our co-pay 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. 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, if it were not for the Change Healthcare situation, we believe we would have exceeded expectations for Gvoke in total product revenue in the quarter. Moving to our technology platforms. Our XeriSol and XeriJect platform science is growing and becoming an 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. 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 bi-hormonal 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 Xeris 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. Regeneron's stability and nonclinical evaluations will take place over the next six months. Assuming continued success, that could lead to them potentially executing a license option for further clinical development and 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, this 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 the FDA on a Phase III study design, we can start that study as early as mid-2025. 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. 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.

Thanks, Paul, and good morning, everyone. As Paul mentioned, we are 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 the prior year, and an 8% increase from the fourth quarter of 2023. This growth was primarily driven by the average number of patients on Recorlev increasing 139% from last year and 18% compared to the fourth quarter. 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 on 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 the brand continues to be successful. 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 the prior year and 35% compared to the fourth quarter. This performance continues to reinforce the strength of the Keveyis brand, including Xeris CareConnection, 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. As Paul mentioned, we believe that Gvoke's growth and net revenue were 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, and 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. 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. This increase was driven by rent expense related to our headquarter lease, which commenced in April 2023, and higher personnel costs, 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 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. 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.

Operator, please open the lines for questions.

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

Actually, Oren, it's Paul. The raising the bottom is being less conservative on Keveyis. 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 hit in the first quarter and see 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 anticipated. Still, there is some softening there, but we're very pleased and a little bit surprised by how resilient Keveyis is.

Yes, I would just add to that, Oren, that we're seeing that momentum really continue into Q2 as well across all of our brands, and that gives us confidence to raise the bottom end.

Great. Regarding levo, you mentioned that you completed Phase II successfully, and I understand you're waiting a couple more months for additional data. Could you clarify what specific outcomes you need to see for it to be considered successful? Are there any delays in receiving this data, or is it simply a matter of analyzing the data?

It's just a matter of data crunch. We've 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.

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

We have not gotten the top-line data yet.

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

It's all in, yes. 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. The timing of it was pretty directly correlated with the timing of the cyber attack.

Going forward, will we see a rebound and possibly stock in the second quarter? Is there any lingering effect from a net unit economics perspective? Will we need to provide more or different patient assistance than usual in the second quarter to retain patients we may have lost or otherwise failed to ship to?

Yes. 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 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 back, but there may be a period of a little bit of increased abandonment. If there was a prescription written for a patient, even if they don't pick up that one, they're probably going to get another one written. So we'll still get those patients.

Yes. And what I would say, Oren, to your first question around wholesaler inventory levels, I would say that in total, our wholesalers are running at historically low inventory levels. Whether or not they build inventory up remains to be seen. We don't anticipate it going any lower, is what I would say. So no downside there, but if anything, potential for upside, but that really remains to be seen.

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

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 bi-hormonal pump that would provide 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 something that has been a pursuit in 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. So we have the glucagon that is liquid-stable glucagon that can be put in the pump to facilitate further clinical development, Phase II, and Phase III of the pump with both hormones. At some point, 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 significant sales of our different formulation of glucagon in the future.

Got it. That helps. And 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 the second quarter, and what you expect for the rest of the year?

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

This is Schuyler 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? And just overall, how you're thinking about the addressable patient population in light of the Catalyst study data showing the prevalence of Cushing's might be much higher than previously understood?

Yes. Great questions. We believe that the addressable patient population is much larger than it's been viewed historically without question. So 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. 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 essentially, we're getting patients from across the board. Interestingly, physicians who've tried Recorlev are starting to use it first line. 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.

Great. That is helpful. And 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 tailwinds that will increase the penetration of the overall market?

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

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

Yes. 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 5% or 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. There are 15 million people out there who need a rescue device, and only 1 million actually have one. So there's tremendous opportunity.

This is Conor on for Chase. It seems like Keveyis continues to hold in there. Can you give us an update on the treatment from payors this year? Are we going to start seeing any forced switching to the generic?

We are experiencing some patient loss, but payors are not pushing for that conversion as aggressively as we expected. We thought that with the insurance resets in the first quarter, payors would aggressively encourage switching, but it is not happening as quickly as we anticipated. Additionally, a significant number of patients who are moved to a generic are returning to the brand. One major reason for this is the lack of support services they used to receive, such as patient mentorship. There’s a lot of support available when they're on the brand that generics do not offer. So while we are losing some patients, we are also bringing quite a few back. This contributes to the overall resilience we are observing, and Keveyis is performing better than our cautious guidance for 2024, which we provided without knowing what to expect. We have been pleasantly surprised by this outcome.

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

Our role is straightforward. We are beginning to develop a new version of glucagon that will be quite distinct from Gvoke. This is a glucagon specifically designed for pumps, compatible with all their components. We anticipate completing this formulation within the year. Beta Bionics will then need to conduct their own testing to validate our work, and from there, they will progress to a Phase II program for the dual-hormone system and potentially a Phase III program, contingent on success. All of this will be managed by Beta Bionics. We will provide support through consultation and assistance with drug studies, as they primarily focus on devices rather than drugs. Our role includes manufacturing supply for both Phase II and Phase III stages. In return, we will receive a low double-digit royalty and a markup on the supplied materials, and we will continue to assist them during the commercialization phase.

This is Rohan on for Leland Gereshell. Just a couple from me. When you think about the subcutaneous levo opportunity, how are you viewing possible paths forward with respect to either developing the drug in-house or maybe engaging in some performance collaboration?

We're open to both. We have the capabilities to develop it in-house, and we believe that we have the financial resources in the future, especially 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 rule out the potential for a partner to help 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 routes in the gastrointestinal tract. 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. We're always active in business development. It took some time to finalize the Beta Bionics deal. We're constantly discussing our technologies with others, and more companies are approaching us as we expand in that area. Regarding Regeneron, they are conducting stability work over the next six months, and I don't anticipate any announcements this year.

I just want to follow up on Recorlev. It outperformed a bit our expectations on patients and sales. But I'm curious what you're seeing regarding ongoing up titration of dose trends over time for longer-term patients now and new patients.

We are seeing up titration 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 up titration, but that's a ways off.

In terms of adding resources, are those mostly on the hub and market access services? Or are you actually putting more reps in the field to broaden or deepen the field presence?

So let me start with the adding of resources. We're adding to the patient support services, and we continue to add a little bit at a time to the field force. We don't want to disrupt the field force, but we will continue to add 10, 15 reps to the field force. We would like to, over time, get up to the 50, 60 range because the opportunity is just so big.

28 as of today.

28 as of today. We will add another 10 to 15 over the next couple of quarters.

New CDC data released earlier this year indicates that the number of severe hypoglycemic events resulting in hospitalizations has decreased to 200,000 from approximately 240,000 based on the last report. Thank you for your contribution to this improvement, which has likely also impacted automated insulin delivery. I am curious about the 25% of patients who continue to be hospitalized.

Kelly, thanks a lot. We really appreciate the question. I do believe we're having an impact. More people with ready-to-use rescue devices, such as Gvoke and HypoPen, are likely having an effect. The most important thing that we're trying to focus on right now and have been for a while is getting 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. 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 and still getting admitted to the hospital. There are still mortality associated with this, as you know. It is really the job of the healthcare professional to automatically prescribe Gvoke and HypoPen whenever they prescribe insulin. That's number one. And I think the community needs to continue to be motivated to say that this could be me. Even if you've been perfectly managing your condition for decades, it can happen to anybody. Those are the two things we need to do. Thank you. We appreciate it.

We have no further questions on the call. So I hand the floor back to Paul Edick for closing remarks.

Thank you. As you heard, we've delivered another 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 in enterprise, which we can all be very proud of.

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