Hello all and warm welcome to the Xeris Biopharma Holding First Quarter 2023 Financial Results Call. My name is Elisa, and I'll be the operator for today. [Operator Instructions] And now have the pleasure of handing over to your host today, Allison Wey, Senior Vice President of Investor Relations and Corporate Communications to begin. Allison, please go ahead when you are ready.

Thank you, Elisa. Good morning and welcome to Xeris Biopharma first quarter 2023 financial results conference call and webcast. A press release with the company’s financial results was issued earlier this morning and can be found on our website. We are joined this morning by Paul Edick, Chairman and CEO; and Steve Pieper, CFO. Paul will provide opening remarks, Steve will provide details on our financial results, and after a few closing remarks by Paul we will open the call for Q&A. Before we begin, I would like to remind you that this call will contain forward-looking statements which may include but are not limited to statements concerning our business practices, future expectations, plans, prospects, clinical approvals, commercialization, corporate strategy, and performance which constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements made during this call, as a result of various important factors, including our financial position and need for financing including to fund our product development programs or commercialization efforts. Whether our products will achieve and maintain market acceptance, our reliance on third party suppliers, including single source suppliers, our reliance on third parties to conduct clinical trials, the ability of our product candidates to complete successfully with existing and new drugs, adverse effects of macroeconomic conditions on our business operations and clinical activities and our end collaborate -- collaborate ability to protect our intellectual property and proprietary technology as well as other risk factors set forth in our filings with the Securities and Exchange commission. Any forward looking statements in this call represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. Subject to obligations under applicable law, we disclaim any obligations to update such statements. I'll now turn the call over to Paul.

Thank you, Allison. You can take a breath. Good morning, everyone, and thank you for joining us today. Before I highlight our achievements for the first quarter, I think it's important that I reiterate what we're trying to build at Xeris. Every day, everyone at Xeris is intensely focused on building a substantial, patient-centric, commercially-focused, self-sustaining biopharma enterprise with multiple products -- commercial products in multiple therapeutic areas, a highly targeted development pipeline that has significant long-term promise and increasingly a significant value added technology partnership business, literally a three-dimensional enterprise. What you'll hear today is that we are continuing to progress very successfully on that journey. We are executing on our vision, as I said, just a few short weeks ago when we reported outstanding 2022 results. Our momentum from 2022 has set us up for a great 2023. First quarter 2023, delivered another Recorlevd of quarterly revenue, strong underlying demand for Gvoke Keveyis and Recorlevlev. Another potentially very valuable XeriJect partnership and a continued healthy cash position. Here are the headlines. We have achieved first quarter total revenue of $33.2 million, representing 50% growth compared to first quarter of '22. We ended first quarter 2023 with $95.1 million in cash, cash equivalence and short term investments. We announced a research collaboration and option agreement with Regeneron for XeriJect formulations and we are reaffirming our 2023 guidance of total revenues of $135 million to $165 million cash utilization from operating activities of between $57 million and $77 million and year-end cash, cash-equivalent and short-term investments of between $45 million and $65 million. Steve will go into those in greater detail as we progress. Let's start with the commercial portion of our business, which generated $32 million in the quarter, representing a 47% increase over last year in the first…

Thanks Paul. Good morning everyone. I will focus my remarks on key financial results for the first quarter 2023, the details of which are in the press release issued this morning. Total revenue was a record $33.2 million, representing a 50% increase over the same quarter last year. Strong underlying patient demand across all three products coupled with revenue from our collaboration partnerships drove this growth in total revenue. Gvoke net revenue for the quarter was a record $15 million representing a 21% increase compared compared to the same period last year. Continued growth in Gvoke prescriptions and market share drove this increase. Gvoke prescriptions topped 45,000 for the first time, a 50% increase compared to the same period in 2022. Gvoke ended the quarter with total retail market share of approximately 28% compared to approximately 21% in March of 2022. The total glucagon prescription market grew 3% compared to the fourth quarter of 22. Notably Gvoke total prescriptions grew 10% in the same period once again significantly outpacing the market more promising. We are seeing this momentum continue into the second quarter, as Paul mentioned with Gvoke, weekly prescriptions exceeding 4,000 prescriptions in consecutive weeks. Moving to Keveyis. Keveyis net revenue for the quarter was $12.8 million, representing a 37% increase compared to the same period last year. This revenue growth was driven by an increase in the number of patients on Keveyis. To date, we have not experienced any material negative impact to Keveyis from the launch of a generic. We continue to proactively monitor and defend Keveyis against generic competition while seeking patents to restore our exclusive rights. Moving to Recorlev, net revenue for the quarter was $4.5 million, which represents an 18% increase over the fourth quarter. This growth was primarily driven by increases in the…

[Operator Instructions] Our first question for today comes from Oren Livnat of H.C. Wainwright.

Congrats on a good quarter. I have a few. On guidance, you reiterated a solid growth year-over-year. And I'm just trying to get some help on the range of that. It's still quite wide and you haven't narrowed it one third of the way through the year. So could you just remind us the major pushes and pulls there? And also, I can't remember who'd mentioned this in the past, but at the top end, does that include revenue recognition potentially for the Horizon formulation? And I have a follow-up.

Oren, this is Paul. The answer to the second part of your question is. Yes, it does include that revenue. In terms of the breadth of the range, we said back in March when we established the range, that as the year progresses and we see how Keveyis plays out and how the generic plays out and we'll know if we can tighten the range. But there's a lot of unknowns right now.

Okay. On Gvoke, you highlighted the share gains that you've been impressive, maybe even accelerating recently. And I'm just wondering, firstly, with the sale of vaccine, do you think that's going to have any impact on the competitive dynamics in the space, whether they'll get better, worse or stay the same? And like you highlighted, there was a pretty strong quarter-over-quarter into your seasonally toughest one. So can you comment, first of all, were gross to net better than expected in the first quarter? And actually, should we expect that to improve through the year as we've normally seen.

Steve?

Yes, I can answer the second question, Oren. The gross to net, as we said kind of midway through last year, they've kind of moderated, and it kind of leveled off. So no, that's not driving it. We don't expect that to improve over the course of 2023.

Okay. And lastly on...

To the first part of your question on Gvoke, we need, and we have said all along that we want our voices in this marketplace in order to get more market growth. I think the value that really extracted for their product speaks to the potential for the category and having somebody who is dedicated to endocrinology and to the category, I think, can only help. So we're anticipating another voice in the marketplace will increase the market growth, and that will benefit us in the long run.

Great. And on OpEx, they were both actually quite light. I was surprised to see SG&A down despite, I think it was the fourth quarter sales force expansion. Can you just talk about, I guess, how lumpy that is going forward? I know you gave sort of full year characterization. But did you actually trim some core costs across the board?

No, not at all. We're expecting SG&A for the full year to be relatively flat. I mean, there could be some lumpiness in terms of marketing promotional spend quarter-to-quarter. But by and large, we look at it from a full year perspective, Oren, it's going to be relatively flat compared to 2022.

And R&D, it sounds like you said you're focusing on levothyroxine. Is the current run rate until that Phase 2 really kicks in here pretty good to go on R&D?

Yes. On R&D, I would expect to see a slight uptick in Q2 and for the balance of the year when you're looking at it from a quarter-over-quarter perspective, primarily in the second half of that Phase II levo program really kicks in.

Our next question from today comes from Glen Santangelo of Jefferies.

Paul, I also want to follow-up on these reimbursement dynamics for Gvoke here in 1Q, right? Because if I look at your scripts, right, they were up 10%, and I think there was a price increase, so we can maybe flesh out the reimbursement dynamics a little bit more. But I would have thought with the scripts being as strong as they were, the revenues would have been a little bit better than flat versus -- sequentially versus 4Q. So if you could flesh that out a little bit, that would be great.

Glen, this is Steve. I'll take that question. So yes, what we saw in the first quarter, we're working pretty proactively with our wholesalers. And I think there was a little bit of shift in channel inventory in the first quarter, and that happens from time-to-time. The -- our wholesalers will tighten up their inventory a bit. If they swing that one or two weeks within the quarter, it makes a difference, and that's what we saw really. But nothing unusual and nothing concerning about that. That just happens from time-to-time.

Okay. And then with respect to Keveyis, this is kind of four quarters in a row with revs roughly about $13 million. And I think you said, Paul, in your prepared remarks, right, you're not really seeing any evidence of any generic competition. So absent that generic competition, is this kind of roughly the right run rate for this product that we should be thinking about? Or based on sort of your marketing plans, do you see a bigger opportunity here? How should we think about the growth of that product going forward, sort of absent any incremental generic competition?

Yes, that's a good question. The -- we're -- we need -- we're taking kind of a wait and see on that. The potential for Keveyis, we think, is significantly higher. And without a generic or without the threat of a generic, we would add resources and drive Keveyis even harder. Right now, we're driving Keveyis as hard as we can with the current resources that we have and generating good solid quarter-over-quarter every single quarter, like you said, $13 million-ish. And we need to see how the whole generic thing plays out and what they do relative to payers and discounting and rebating, and whether or not a second generic enters the market. If -- and then we also have to see if we are successful in our patent application and the appeal that we have going on in the middle of this year. So as things play out, we could substantially upsize our effort and drive a lot more Keveyis over time. But that's just not in the cards right now.

Our next question today comes from Roanna Ruiz of SVB Securities.

So a quick question on Recorlev. I was curious if you could update us on, if you're seeing anything around how long the titration process has been for patients as physicians get more comfortable, could that titration period possibly get shorter and you can get patients on drug more quickly?

Yes. Good question, Roanna. We are starting to see more titration, we're seeing the average dose start to creep up, and that's a very good sign. The other thing that we're seeing is the maximum dose, we're not getting to the higher doses that we thought, which I think is also a good sign the drug is working and physicians are starting to use it even for drug-naive patients. So all good signs, and we are starting to see the titration. Whether or not it's going to happen faster versus slower over time, we don't have enough to understand that yet.

Got it. Okay. And then I wanted to ask a bit more about your new collaboration with Regeneron. Basically, could you give us a rundown of what makes you really excited about this program and the opportunity for possibly multiple products? And when might we get more clarity on future steps or milestones around these programs?

So there's a lot -- we would love to talk about that we just can't talk about. But what excites us about the Regeneron deal is, it's a platform deal. I mean, Regeneron is starting out with identification of two products or molecules that they want to put into our system. The status of which -- we're just getting started. I mean, I think they just -- we're just having kickoff meetings and things like that to start the formulation of the first molecule and then the second molecule to follow on soon. The real interesting part is they can nominate additional molecules down the road for formulation and continued development. So the degree to which it could become a platform of products in our formulation is very exciting. And when you think about it, each one of those molecules, depending on if they take them forward into clinical development and eventual approval and commercialization, each one comes with its own set of milestones and both development, regulatory and commercial milestones, as well as royalties. So the eventual value could be very significant.

Our next question today comes from David Amsellem of Piper Sandler. David, please go ahead.

This is Skylar on for David. First, I was wondering, can you talk about the kind of patients who were getting Recorlev? Are they mainly those with prior exposure that received ketoconazole? Can you just speak to the overall patient mix? And then also what your view is on the potential commercial impact on Recorlev of Corcept's next-generation cortisol modulator relacorilant, and if you see that as posing a challenge to Recorlev at all?

Good morning, Skylar, I will take the second half first. We don't expect the next-generation anytime soon. Corcept product and one would expect that it would probably just cannibalize the product that they have. We're not seeing that as an additional big competitor in the marketplace. To your first question, in terms of patient mix, we tried to hit that in our prepared remarks. We're very excited about the patient mix, because it's not just patients coming from keto. If patients coming from predominantly two areas. One, other products in very specifically Korlym, because we have a product that is very effective at normalizing cortisol, Korlym doesn't do that. And we've got -- we're getting patients from Isturisa and others. The really exciting piece is about 30% of the patients we're getting have not been on any drug, that we're the first drug therapy post surgery. That sets physicians are more and more and very quickly, we're only a year into this, that one year into experience with Recorlev, physicians are using Recorlev first-line therapy. That's very exciting. So we think the patient mix is surprisingly positive. We did anticipate getting more of the uncontrolled or patients who have been through several products. But the mix we're getting is really good, bodes very well for the future of the drug.

We have no further questions, so I would like to hand back to the management team for any closing remarks.

Thank you very much. Thanks all for joining us. What you heard today confirms once again that we have a durable business on its way to being self-sustaining, through continued revenue growth, careful allocation of resources and prudent expense management, we expect to cash flow breakeven in the fourth quarter. And by achieving that milestone prove we can be self-sustaining biopharmaceutical company. I'd also like to take this time to thank all of our patients and caregivers for their support and also the Xeris team for the tireless work that they've done over the last several years through just about every headwind you could imagine. We're very excited about our business and very excited about our future prospects. So thank you very much, and have a great day.

Thank you all for joining. That concludes today's Xeris Biopharma Holdings' first quarter 2023 financial results call. Have a great rest of your day, and you may now disconnect.