Xeris Biopharma Holdings, Inc.

and corporate communication to begin. Please go ahead.

Thank you, Drew. Good morning and welcome to Zara's Biopharma second quarter and first half 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 John Shannon, our new CEO and Steve Piper, our CFO. After our prepared remarks, we will open the lines for questions. Before we begin, I would like to remind you that this call will contain forward looking statements concerning the company's future expectations, plans, prospects and financial performance. Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those forward looking statements. For more information on such risks, please refer to our earnings release and risk factors included in our SEC filing. 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 will now turn the call over to John Shannon.

Thank you, Allison and good morning everyone. I'm honored to speak with you for the first time as the CEO of Zara's. It's an exciting time for our company as we start this new era and I'm thrilled to serve in this role. As you all saw from this morning's earnings release, we had an outstanding second quarter. But before we get into the results, I wanna take a moment to outline my near term priorities as the new CEO. I'm focused on three key priorities to guide our strategic initiatives and decision making processes in the near term. These represent important opportunities for creating value for our stakeholders. The first priority is maintaining rapid commercial growth and expanding the reach of our treatments to the patient communities they serve. We have three great commercial products making meaningful impact on patients' lives. We aim to pursue growth strategies that are both ambitious and sustainable. We're confident that our existing products can continue to deliver meaningful growth in the near and long term. And we intend to consistently optimize how we deploy the resources necessary to drive them. The second priority is a renewed commitment to financial discipline, ensuring investments are made wisely and remain focused on value accretion. We've built a diverse and resilient business model that can weather market fluctuations and deliver consistent performance. We can achieve our business objectives by employing prudent financial planning, appropriate risk management, and by maintaining a strong cash reserve. We ended the second quarter with a very healthy 77 million in cash and investment. And we intend to deploy those financial resources judiciously as business needs or opportunity warrants. Given our strong cash position and rapid growth of our business, I do not plan to raise any cash by adding any incremental debt or equity that would result in shareholder dilution. Given our differentiated and enviable portfolio of assets, any M&A activity will be measured and opportunistic. In the near to intermediate term, we expect business development activity will be focused on the addition of new technology partnerships or commercial partnerships that can leverage our existing products, formulations, or commercial capabilities, which add to our growth. The third priority is to improve the quality of our external communications and guidance. Our external stakeholders are critical to our success, and it is extremely important that we listen closely to feedback and communicate in the best manner possible, setting the right expectations around the ability of our products to deliver growth and value. To that end, we understand that our initial 2024 revenue guidance suggested that we were not confident in the growth prospects of this business. As I explained with my first priority, we are committed to driving rapid and sustained growth of our commercial products. Given our first half performance and our momentum going into the second half of the year, we are confident in the performance and growth of our business. Therefore, we are raising the low end of our total revenue outlook for the full year from 175 million to 190 million. Our updated total revenue range is now 190 to 200 million. By executing on these three priorities, I expect to build upon the strong foundation we've created, which will drive our overall business performance to new heights. Now, let's move on to the highlights of the second quarter. I'm very pleased to report that we post in an outstanding quarter of total revenue, 48 million, a 26% increase over Q2 last year. Driven by continued strong demand of all three products, as well as contributions from our partnerships. Our portfolio of commercially available products, Recorolev, GVogue, and Caveus, each of which is a transformative therapeutic in their own respective market, collectively generated more than 46 million in revenue, a 26% increase over the same quarter in 2023. This marks the 11th quarter in a row of greater than 20% growth. For the first half of 2024, these products are up 25% over the same period last year. Our commercial engine is clearly working. We're enjoying continuing rapid growth in both GVogue and Recorolev, and a very sturdy commitment to Caveus from both patients and healthcare professionals. Let's get into a little more of the details, starting with Recorolev. As a reminder, Recorolev is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisillemia in patients with Cushing syndrome for whom surgery is not an option or hasn't worked. Importantly, Recorolev is the only treatment approved for all etiologies of Cushing syndrome, and has been proven in long-term studies to normally be effective. Recorolev is a very strong treatment that can normalize cortisol levels. Cushing syndrome is an extremely challenging disorder with a two to four times higher mortality rate than the general population and comorbidities that drastically impact a person's quality of life. While there are multiple approved medical treatments available, patients often struggle to gain control over the disease given its complexities. Clinicians increasingly recognize the burden of hypercortisillemia and are expanding their testing efforts. Not surprisingly, more patients with the disease are being discovered every day. In Q2, Recorolev generated a record number of referrals and a record number of new patients starts. With such favorable dynamics, we're confident Recorolev is entering into a period of accelerating growth. Moving on to GVOC. I'm sure you'll recall that GVOC Hypopen is our liquid -to-use glucagon in an autoinjector used for the treatment of severe hypoglycemia in people with diabetes. Owing to the prevalence and preventable hospitalizations and mortality associated with severe low blood sugar, the health advocacy organizations, including the American Diabetes Association and the Endo Society have reached consensus opinion that any person with diabetes taking either insulin or sulfonylurea should always be carrying a -to-use glucagon product like GVOC. We estimate that of the approximately 15 million people in the US that should be protected, fewer than 1 million currently are. Thankfully, our ongoing efforts to increase awareness of this discrepancy and the need to protect patients at risk is gaining traction and driving market growth. Total prescriptions for GVOC in Q2 grew 13% sequentially over Q1 and 27% over the same quarter last year. Importantly, GVOC's market share increased to 34%. In the quarters and years ahead, we expect to steadily add more prescribers and protect more and more of the 14 million plus patients who remain unprotected. Last but by no means least, we turn to Cavaeus. What an amazing story Cavaeus continues to be for the patients that need it and for our Xeris business. Just to remind you, Cavaeus is used to treat primary periodic paralysis or PPP, which is an ultra rare genetic neuromuscular condition that interferes with the normal functioning of muscle movements. Cavaeus lost orphan exclusivity in August of 2022, yet has proven extremely resistant to generic substitution given the uniqueness of the disorder and the PPP community's critical reliance on Xeris support for both healthcare professionals and our patients. During Q2, the number of patients being treated with Cavaeus was nearly equivalent to Q1 and that trend has continued into Q3, a remarkable achievement. We're increasingly optimistic about the longer term strength and resilience of Cavaeus and will continue to provide services that matter most for the wellbeing of patients suffering from PPP. Quickly shifting to our pipeline. In late May, we announced positive top line results of our phase two study of XP8121, our once weekly subcutaneous injectable formulation of levothyroxine. The team is busy preparing for an end of phase two meeting with the FDA this fall, during which time we will seek clarification about the phase three requirements necessary to earn approval for this novel product. The more we evaluate the data and market potential of XP8121, the more excited we get, owing to the size of the hypothyroidism marketplace and the desperate need for innovation to serve patients struggling for control. Enumerable reports have been published documenting the various compliance and absorption challenges that can interfere with bioavailability of oral levothyroxine. Of note, in our phase two study, 40% of the patients considered stable at the time of screening were found to have their TSH or T4 outside of normal range. Finally, in Q2, we welcomed the beta-bionics to our stable of partners seeking to leverage our formulation technology to create novel medicines. As announced in May, we're aiding beta-bionics in the development of a novel, ready to use glucagon formulation that could work optimally in their dual hormone pump program. So once again, I couldn't be more excited for Xerus as we end the phase two study. We're a new era, and I'm confident that we are well on our way to building an innovative, self-sustaining, fast-growing biopharmaceutical company committed to making a difference in patients' lives. And with that, I'm going to pass over to Steve to walk you through the details of our second quarter financial results.

Thanks, John. Good morning, everyone. We ended the quarter with net product revenue of 46.5 million and total revenue of 48.1 million, both increasing by approximately 26% compared to prior year. -to-date net product revenue was 86.8 million and total revenue was 88.7 million, both increasing by approximately 25% compared to prior year. This growth in revenue was driven by strong performance from both RecorLev and Givo. RecorLev net revenue was 13.3 million for the quarter, increasing 86% compared to prior year. On a sequential basis, RecorLev net revenue increased by an impressive 2.7 million, representing growth of 26%. These increases were driven by the average number of patients on RecorLev, increasing 124% from last year and 25% compared to Q1. We expect this rapid growth to continue based on our robust pipeline of referrals, growing 31% compared to Q1, our ability to convert these referrals into patients on RecorLev, as well as our field expansion, which we completed in early July. Givo net revenue was 20 million for the quarter, representing a 28% increase compared to the same period last year. This growth was driven by a 27% increase in Givo prescriptions. As we mentioned during our prior quarter remarks, the change healthcare cybersecurity breach temporarily impacted Givo net revenue in the first quarter. Although we do not believe we recovered the loss revenue from the first quarter, growth in patient demand, which consistently exceeded 5,000 weekly prescriptions since May, as well as increased orders from our wholesalers have signaled to us the impact has been resolved. Caveus net revenue for the quarter and year to date was 13.1 million and 26.2 million. Despite generic competition, revenue only decreased slightly by 2% on a year to date basis. As we have repeatedly stated, Caveus is resilient and we will continue to invest and defend the brand. Our commitment to this strategy has proven to be successful as we continue to generate a healthy pipeline of patient referrals. Given the strong performance of all three of our products in the first half of the year, and the momentum we are currently generating, we are confident in tightening our total revenue guidance by substantially raising the low end of the range with revised guidance of 190 to 200 million from the previous guidance of 175 to 200 million. Moving down the P&L, cost of goods sold is a percentage of total product revenue decreased by 4% for the quarter compared to the prior year. This decrease was primarily the result of an increase in RecurLev revenue, resulting in a product mix with lower costs. Research and development expenses were 5.8 million for the second quarter. These expenses were relatively flat compared to the second quarter of 2023, and were primarily comprised of costs for our pipeline, notably XP8121 and further development of our technology platform, XeroSol and Xerogect. On a -to-day basis, research and development expenses were 13.6 million, a $2.4 million increase compared to prior year, which was primarily a result of investments in our pipeline and increased employee costs to support XeroSol and Xerogect. Consistent with my previous remarks, we are focused on advancing our pipeline and supporting our XeroSol and Xerogect technology platform, which will result in an increase in R&D costs this year compared to 2023. We expect a modest increase in R&D spend relative to the first half. Selling general and administrative expenses were 40 million for the quarter and 78.4 million for the year, an increase of 6% and 10% compared to prior year. These increases were driven by higher personnel costs, primarily due to our field expansion in the fourth quarter of last year. Looking ahead for the full year, we expect a modest increase in second half expenses relative to the first half, as we have made investments that are focused on supporting our revenue growth. Moving to cash, we ended the quarter in a healthy cash position of 77.6 million. Looking ahead to our year end, we are tightening our cash guidance to 60 to 75 million from the original 55 to 75 million, which considers our revised revenue guidance, as well as the additional investments we have made in the RECORLA business. We are able to make these investments as a result of continued strong revenue growth. We are seeing great momentum across our business, which is translating to consistent and meaningful revenue growth and driving the financial health of our enterprise. With that, operator, please open the line for questions.

Thank you. We will now start today's Q&A session. If you would like to ask a question, please press star followed by one on your telephone keypad. If you wish to withdraw your question, it's star followed by two. Our first question today comes from Rowan Aruiz from LeeRink Partners. Your line is now open. Please go ahead.

Great, good morning, everyone. So I have a question for RECORLA first. Seems like the new patient starts are growing well in the quarter. How do you think that will trend into the second half this year? And I'm also curious with the newly expanded field force, could that continue to be a tailwind later this year and possibly into 2025?

John, please. Hey, Rowan, it's John. Yes, I mean, as I said, it's accelerating. We're growing the new starts and new referrals. We see that continuing to accelerate in Q3 and we see that through the end of the year. And we just put the new sales force on out in the additional sales reps out into the field in the last couple of weeks and they'll start contributing early later this year and early next year.

Got it, helpful. And for GVOC, I also was curious, would you consider focusing the field force a bit more on driving back to school, prescribing for GVOC to sort of maximize that going into later this year? And could you just remind us, what are the GVOC reps doing today in terms of tackling some of these prescribers versus other prescribers for adults, et cetera?

Yeah, so as you pointed out, the third quarter back to school starts kicking in and like this week and next week. And as always, we will focus in that area for that time period, which is primarily pediatric endo. And as we've shown and you guys understand is Baxemi has a pretty strong hold on that space only because they launched right into it several years ago. So from our perspective, we hold on and continue to grow during this timeframe. It's our biggest growth quarter every year and it'll be that way this year. But we also then focus on how do we bring every day, how do we bring more of the 14 million people that are not protected today on GVOC?

Got it, thanks.

Our next question comes from David Amsnellen from Hyposanla. Your line is now open, please go ahead.

Hi, thank you, this is Skylar on for David. First, on Rekorolev, can you talk about your long-term expectations in the context of the recent catalyst data from Corecept, which showed that 24% of patients with difficult to treat type 2 diabetes are not protected from Rekorolev. In this study actually had Cushing syndrome, which might indicate that the true prevalence is higher than previously understood. And then separately, how are you thinking about GVOC growth over the remainder of the second half of the year? And touching on last question, just the degree of seasonality we should expect with the back to school season, just so we can better think about the phasing of revenue. Thank you.

Okay, let me start with Rekorolev. And I think you're pointing out part of what I had in my prepared remarks is that more and more patients are being tested and screened for high cortisol levels, which is ideal for the marketplace and ideal for our product, because Rekorolev normalizes cortisol. So it fits right in for why some of the accelerate, we're seeing some of the acceleration in our growth and how our product fits into what's going on in that space. For GVOC, we expect to continue to grow and drive kind of more and more people who aren't protected to prescribe and or get GVOC just in case. That will continue strongly through the third quarter, which is always our strongest quarter, and then into the fourth quarter as well. So we look to see this steady continuous growth that we've been pounding out the last several quarters to continue on GVOC.

Yeah, maybe just to, this is Steve Schuyler, just to get a little more specific on GVOC. I think historically we've seen, in the back half of the year, 20% growth, and we've enjoyed that through the first half of the year. So I would expect that trend to continue with probably a little bit more dramatic growth in the third quarter. But I think that's kind of where I would peg things for the second half of the year.

So, yeah. Thank you guys.

Our next question comes from Chase Nickerbocker from Craig Hallen. Your line is now open, please go ahead.

Good morning. Thanks for taking the questions. And first of all, John, congrats on the new role. Looking forward to watching you execute here. First, just on housekeeping on GVOC, revenue, net sales grew a little bit more than prescriptions in the year, year over year. Is that some stocking dynamics, or is there a little bit of pricing benefit year over year? Just click there.

Yeah, Chase, this is Steve. I would say it's probably just a little bit of stocking, maybe a little bit of price, but nothing material. Got it, thanks.

And maybe so far through the first half of the year, at least in our data, we've seen some pretty nice share gains relative to competitors. Can you just speak to kind of what you've seen in your data kind of in the first half of the year on new RX trends here with your -to-use competitors with GVOC?

Yeah, I think we see the same thing you do is, yes, we're gaining share, but we're gaining that share primarily by market growth and capturing in an ordinate amount of the market growth directly to GVOC. So we're not out there directly getting it from existing Viximi patients, we're getting it from the market growth that's out there and the market growth that we're driving. So, and we think that trend will continue.

Yeah, and so kind of thinking about that through the remainder of the year and into next with kind of you guys taking a majority of new patient starts from here, maybe that is a little bit different in Q3, but you would expect that to kind of remain the case outside of maybe that -to-school seasonality?

Yeah, if you went back and just mapped this out over the last couple of years, you see that we have share gains pretty consistent every quarter, and then we get to the third quarter and it kind of flattens out in terms of increases, and then it picks up again in Q4. That trend will probably continue this quarter.

Got it, and then just on Recurl Up, I mean, just kind of taking a step back and looking at the market as a whole, can you help me kind of parse through what is maybe just some increased diagnosis of cushions here versus you guys making competitive gains from some that have failed other therapies, maybe just doing better there? And then I might have missed this, sorry, I'm jumping around, but just speak to the pipeline as far as kind of sequential growth there and how that kind of informs you guys' confidence in the back-end of the year, thanks.

Let me try to answer your Recurl Up question because there's a couple dynamics there. There's more and more people being tested and more and more people being diagnosed with elevated cortisol, and again, we normalize cortisol. There's also a level of complexity in terms of treating this, and there's no perfect product for anybody. So there's some bouncing around between therapies, and we benefit from that. So we're picking up patients from new starts to people that have switched, to people that have tried other things and now are moving over. So there's all kinds, people are coming from all places in terms of new starts. And I don't know that I understood your last question about the pipeline, are you referring to the Recurl Up? Just on the pipeline of patients for

Recurl Up, yeah, for the Recurl Up pipeline, yeah.

Yeah, it's stronger than ever. And it continues to build for us. And like I said, it's coming from all places.

Then just lastly on Cabeas, would you expect kind of a consistent kind of treatment from payers kind of through the remainder of the year? And that kind of informs some of the confidence here. And then when was, you know, you typically think kind of Q1 for potential payer changes, that would kind of be the next time where there would, you know, be something that we should think about from an investor perspective.

Yeah, I would think about Q1, as you pointed out. That's when, you know, kind of, there's all kinds of resets going on there. What we saw in Q2 and what we're seeing in Q3 is we're adding new patients at a very, very strong pace. And as I said in my prepared remarks, we were basically even Q2 to Q1 in terms of patients. And we see that trend continuing for the rest of the year.

Thanks for the questions, guys. Congrats on a really nice quarter.

Thanks, Jason.

We will now take our final question from Rowan Matha from Oppenheimer. Your line is now open. Please go ahead.

Hi, this is Rowan. I'm from the Ingershow. Congratulations on another strong quarter. Just a couple from me. I'm from CoreLift. Can you give some detail on how the payer reception and coverage has been in the last quarter and how it's changed over time? And this is a question that I've been asking is on Cavaeus, any granularity you could provide on the sturdiness of the business? And how do you think about how resilient the franchise might be in the coming years? Thank you.

Okay, so let me talk about payer coverage with CoreLift. And it's really not changed. What happens is you get, spend more and more time in these spaces with these rare brands is you get better and better at moving patients from a referral through the payer process and you do it faster and you do it more efficiently. So, and I think that's what's also leading to when you have a really strong referral pipeline that you can turn that into new starts. And we saw both of those accelerate in the second quarter and continue to see that going into the third quarter. And for Cavaeus, we've said, I think we've done an amazing job of kind of managing this space for the benefit of the patients with PPP. And that is being, we see that in the resilience that patients and physicians are willing to, fight for brand. So we see that continuing. Now, could it get, maybe another player coming in or something would maybe potentially disrupt that. But until that happens, we're really confident that it's gonna hold its resiliency.

Great, thank you.

We have no further questions in the queue at this time. So I'll hand back over to the team for closing remarks.

Well, thank you everyone for listening today. As you've just heard, Xeris is stronger than ever. I'm confident that by executing on the three priorities I talked about earlier, we will deliver a robust business result that will ultimately translate into meaningful shareholder value. Thank you again for your time this morning.

That concludes today's call. Thank you for joining. You may now disconnect your line.