Q1 2025 Xeris Biopharma Holdings Inc Earnings Call
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2025 results conference, Paul. My name is Makiah, and I'll be the moderator for today's call.
Speaker Change: All right, we'll be muted in the presentation portion of the call with an opportunity for your questions and answers at the end. At this time, I'd like to pass the call over to our Senior Vice President of Investor Relations and Corporate Communications, Alice Nueh. Allison, you may proceed.
Allison Wey: Thank you, Matthias. Good morning, everyone. We appreciate you joining our call this morning. Today I'm joined by John Shannon, our CEO and Steve Pieper, our CFO . Early this morning we issued a press release with our detailed results, which can be found on our website. After our prepared remarks, we will open the line for questions. Before we begin, I'd like to remind you that this call will contain forward-looking statements concerning the company's future expectations, plans, projects, and financial performance. Forward-looking. [inaudible]
Allison Wey: Statements are subject to risks and uncertainties that could cause actual results to different materially from those forward-looking statements. For more information on our risks, please refer to our earnings release and risk factors, including in our FCC filing. Any forward-looking statements on this call represent our views only as of the data that's called, and subject to what but a lot, we just claim any obligations to update such statements. But please note, some metrics we will discuss today are presented on a non-capacity.
Allison Wey: We've reconciled the comparable gap and non-GAAP figures in our earnings release. Let me pass this all over now to John for opening remarks. Thanks Allison and good morning everyone.
John Shannon: I'm excited to announce that we're off to an exceptional start this year. In the first quarter, we delivered another record-breaking performance, growing total revenue by 48%, a testament to the strength of our strategy and execution.
John Shannon: As such, we are raising the bottom end of our revenue guidance from 255 to 260 million, increasing our implied full year total revenue growth to nearly 32 percent at the midpoint of our guidance range.
John Shannon: Our momentum is being fueled by the foundation we established in the back half of 2024. Our Q1 success was driven by continued commercial strength across our entire portfolio.
with Regicorla of Leading the Charge
John Shannon: Recoral Love continues to distinguish itself as our fastest growing and now our largest product.
John Shannon: Gaining traction as a uniquely differentiated therapy for patients with hypercordosolemia and endogenous cushing syndrome. At the same time, GVO delivered steady growth, supported by our ongoing efforts to enhance both awareness and compliance with the medical guidelines.
John Shannon: Let's take a closer look at each of the products starting with RecoryLens.
John Shannon: In the first quarter, revenue for record level was up 141% exceeding 25 million 251% exceeding 251% exceeding 251%
John Shannon: The average number of patients on therapy grew 124% compared to the same period in 2024. This significant achievement is the direct result of the targeted investments we made last year.
John Shannon: which were designed to support patient access, enhanced healthcare provider engagement, and accelerate overall brand performance. These investments have proven highly effective in driving sustained growth and establishing a strong foundation for the future.
John Shannon: As we progress through the first half of the year, we are excited by our growth trajectory and remain confident that this momentum will continue to build. We believe Recurlev is the right product at the right time and expect that it will continue to deliver value for patients and stakeholders alike well into the future.
John Shannon: Turning to G-Vogue, G-Vogue continues to deliver steady, reliable growth, reinforcing its position as a key contributor to our commercial portfolio.
John Shannon: Q1 Revenue of nearly 21 million reflected strong, consistent increases in prescriptions which were up 8% compared to Q1 last year.
John Shannon: Our efforts to attract new prescribers, while also increasing prescriptions among existing prescribers, remains on pace.
John Shannon: This growth trajectory reflects the strengths of our strategic efforts to expand G-vokes reach and highlights the value it consistently delivers to both patients and prescribers.
John Shannon: As we look ahead, we remain top in an G-vox ability to sustain its current momentum as G-vox remains an important contributor to our growth.
John Shannon: Finally, let's talk about the durability of today's revenues were over 11 million for the quarter growing slightly over Q4 2024.
John Shannon: Today, this remains a key product within our portfolio, continuing to serve patients with unwavering support from the medical and patient communities.
John Shannon: The average number of patients on caveats improved slightly in Q1.
John Shannon: Underscoring our ongoing success in identifying and engaging new PPP patients.
John Shannon: New patient starts group compared to the prior year period, further reinforcing this progress. Caveasis Resilience highlights the broader value our products bring to patients and healthcare providers. Strengthening our commitment to delivering impactful, reliable treatment options.
John Shannon: In addition to our strong Q1 commercial performance, I want to take a moment to highlight a key achievement from this past quarter that reflects the strength of our strategy, discipline and commitment to delivering sustained growth.
John Shannon: In March, we proudly announced that the FDA approved our Supplemental New Drug Application for GVOC VILVX. This approval expands GVOC's use as an IV administration, enabling its utilization as a diagnostic aid during radiologic examination.
John Shannon: In tandem with the regulatory approval, we also announced a strategic partnership with American Region to commercialize G-Vote Biodex in the US.
John Shannon: Under the terms of this collaboration, Xeris will be responsible for product supply while American region will oversee commercialization efforts. The partnership is positioned to maximize the market reach and success and success of the X, particularly within the hospital and acute care settings.
John Shannon: I want to express my sincere gratitude to the Xeris team, our partners in American Region and the broader medical community for their dedication to making this achievement possible. Together, we're continuing to deliver solutions that improve lives and advance medical practices.
Thank you for watching!
John Shannon: Building on this momentum, I'd like to highlight the progress we've made within our pipeline, particularly with XP-8121
John Shannon: As we stated before, we are really excited about this product and the unmet medical media can address in the hypothyroidism market. This metabolic condition affects approximately 20 million people in the U.S.
John Shannon: We estimate that at least 20% of these patients do not consistently meet their clinical goal of normalizing thyroid hormone levels.
John Shannon: and they cannot reach their goals with oral forms of therapy for a multitude of factors, all of which affect oral biobyalability. If approved, XP-81-21 will be the first and potentially the only self-administered therapy designed to overcome these obstacles.
John Shannon: As a reminder, the development of XP-8121 is made possible by our proven zero-salt technology, a cornerstone of our innovation.
John Shannon: Furthermore, XP-8121 leverages our clinical development, regulatory and commercial infrastructure while expanding our commitment to the endocrinology community.
John Shannon: In keeping with our commitment to transparency and open communication, we are pleased to share that we will provide a more comprehensive update of XP-8121 at our first analyst and investor date, schedule on June 3rd.
Wey, Schuyler Broek,
Speaker Change: As a company, we remain focused on the three strategic priorities I outlined back in August of last year when I became CEO . As a reminder, those are.
Speaker Change: One, drive rapid and sustained growth of our commercial products to improve adoption and utilization.
Speaker Change: 2. Manage our business with financial discipline, maintaining a healthy balance sheet, and funding our growth opportunities, one most importantly, not diluting shareholderism. And finally, enhance our communication and transparency with you, our stakeholders.
Speaker Change: We have delivered exceptional performance in Q1, further strengthening our outlook for the year ahead. By staying true to our priorities, we are well positioned and even more confident we will achieve our full year financial objectives.
Speaker Change: Before I hand the call over to Steve for a detailed financial update, I want to emphasize the importance of our first-ever analyst and investor day, scheduled for June 3rd in New York City.
Speaker Change: This event will offer an excellent opportunity to share deeper insights into our strategic vision and the promising initiatives we have planned for the future.
Speaker Change: I will be joined by several members of the Xeris Management team, as well as key opinion leaders, and together we will discuss evolving market dynamics,
Speaker Change: We hope you'll join us for what promises to be an informative and impactful session. We will issue a follow-up press release with further details on the agenda and participation logistics in the coming weeks.
Speaker Change: And with that I will now turn the call over to Steve who will provide a comprehensive review of our financial performance for the quarter.
Steve Pieper: Thanks, John , and good morning everyone. We had another record-breaking quarter. On a year-over-year basis, total revenue grew 48 percent to 60.1 million, while that product revenue increased 44 percent to 57.8 million.
Speaker Change: This strong performance marks the 14th consecutive quarter of greater than 20% product revenue growth, underscoring our unwavering commitment to our top priority, driving rapid and sustained
Speaker Change: Recallive Net Revenue was 25.5 million, up 141% compared to last year.
Speaker Change: Sequentially, Recurla of Nat Revenue grew 3 million. The average number of patients on Recurla have increased 124% and 15% respectively.
Speaker Change: This growth reaffirms our expectation that patient demand in 2025 will need to fore exceed the levels we drove in the second half of 2024
Speaker Change: Jivo Knatt Revenue was 20.8 million, increasing 26% versus last year.
Speaker Change: This increase was attributable to total G-vogue prescriptions growing 8% coupled with lower hull sailor purchases in Q-1, 2020-4.
Speaker Change: Keveyes Net Revenue was $11.4 million, up slightly compared to the fourth quarter 2024. These results reflect the continued resilience of the Keveyes brand.
Speaker Change: Other revenue generated in the quarter was 2.3 million. As we announced in March, Xeris received FDA approval for GVO-File DX, which triggered a milestone payment that made up a maturity of the other revenue in the quarter.
Speaker Change: As John highlighted, American region will lead commercialization efforts for this product while Xeris will maintain responsibility for product supply.
Speaker Change: Turning to Gross Margin, Gross Margin in the quarter was 85%, Sequentially Gross Margin improved by 200 basis points, driven by favorable product mix.
Speaker Change: Research and development expenses were $7.8 million for the quarter relatively flat compared to last year. These expenses were comprised of costs associated with XB8121 and continued investment in our technology platforms and partnerships.
Speaker Change: Selling general and administrative expenses were $44 million, an increase of 15% compared to prior year
Speaker Change: The increase in SGNA expenses primarily reflects the impact from the Q3 2024 Recallive Commercial Expansion as well as other personnel related costs.
Speaker Change: Rounding out our first quarter results, I am excited to report adjusted EBITDA on the quarter was a positive 4.4 million in line with our commentary last quarter and further supporting our commitment to delivering positive adjusted EBITDA going forward.
Speaker Change: Our solid financial position provides us with the flexibility to advance our strategic priorities without the need for dilutive financing. These efforts underscore a disciplined approach to financial management and our commitment to delivering long-term value.
Turning to our near-term Outlook in Guidance
Speaker Change: First, it's important to highlight the meaningful strides we have taken in enhancing the financial health of the enterprise.
Speaker Change: With a recent appreciation in our stock price, we accelerated the redemption of our 2025 convertible notes, reducing our total debt by 15 million and in turn generating interest expense savings
Speaker Change: It is worth noting that there was only a partial impact of the convertible node redemption in the first quarter and the remaining portion will be reflected in our second quarter results
Speaker Change: Based on the information available to us today, we do not anticipate any material impact to our operations or financial performance, given the vast majority of our operations are US-based.
with that context.
Speaker Change: And as John mentioned earlier, we are tightening our full-year revenue outlook
Speaker Change: We are raising the bottom end of our total revenue guidance from $255 to $260 million, increasing our implied full year total revenue growth to nearly 32% at the midpoint of our guidance
Speaker Change: Further, we continue to expect a modest improvement in gross margin compared to 2024. Asked DNA and R&D expenses are still projected to increase modestly with a mid to high single digit growth rate relative to 2024.
Speaker Change: Lastly, I want to affirm our expectation that we will continue to be adjusted even to our positive going forward.
Speaker Change: With that, I'll now hand the call over to the operator for Q&A. Operator?
Speaker Change: Thank you. We were not against today's Q&A session. If you would like to ask a question, please press star, followed by one on your Q&A session. If for any reason you would like to remove that question, please press star, followed by two.
Speaker Change: Again, to ask the questionist, star 1. Will Paul feel briefly why your questions are registered?
Speaker Change: The first question is from the law of David Amsellem with Pieper's similar. You might proceed.
David Amsalom: Thanks, so I wanted to drill down on the growth you're seeing in Recurles and clearly the overall market is expanding, so I'm wondering out loud.
Speaker Change: Settling out here, just given the market expansion and this evolving understanding of the prevalence of hypercortisolism at some of one. And with this
Speaker Change: Market Expansion, how should we think about your commercial infrastructure and the extent to which you're going to be calling on a wider audience of endocrinologists and potentially general practitioners. Thank you.
Thank you for watching!
Thanks, David. This is John Shannon.
Let's start with your...
Speaker Change: Second question first. So, as you know, we expanded our sales organization in the back half of last year in anticipation and as we saw this market expansion happening with Ricorla [inaudible]
Speaker Change: So, we saw an opportunity for us to expand in that and we made that happen and that's really what's driving a lot of our current growth is our expansion in the back half of last year.
in terms of peakier sales.
Speaker Change: We haven't updated our guidance on that, we haven't given any guidance on that but that's something that we will probably give a lot more color to at our Analysts and Investor Day in June .
Speaker Change: Not probably, we will give more color to that. And we think that's a good opportunity for us to lay that out. But we, as you can imagine, like you pointed out here, there's a significant expansion going on there. And we think there's a great opportunity for us and record love in that.
Thank you for watching!
If I may, we can follow up.
Speaker Change: Thank you. Your competitor has had multiple sales force expansions, we're alluding to a course up with expansion of their commercial organization last year, and then also this year. So I guess my question is do you anticipate further infrastructure, commercial infrastructure expansion?
the more recent one, notwithstanding.
Speaker Change: So we, like you pointed out, we've had two expansions as well and the last one was
was a 50% expansion of our existing sales organization.
Speaker Change: So right now we're good where we're at in terms of our infrastructure but as this market grows and the opportunity grows we see an opportunity for further expansion and when that comes you know we'll see but it'll really follow the market expansion.
Wey, Schuyler Broek,
Okay, thank you.
Thank you.
Thank you. Thank you.
Speaker Change: Thank you. The next question is from the line of Mazahir Alimohamed with Lee Rink Partners. You may proceed.
Speaker Change: Hi all, this is Mazahir Alimohamed, Roanna. Just two from us, so the first one is, what are the primary drivers behind them?
Speaker Change: The operational efficiency and the level of profitability improvement that you have, do you feel that's sustainable as you continue to invest in the commercial organization?
Speaker Change: And then a second one would be, can you just highlight for us if you have some additional color maybe on the key development milestones and strategies for XP 81-21 that we should be focusing on and monitoring throughout the remainder of the year?
Thank you.
Thank you for watching!
Speaker Change: Yeah, so I'll take, this is Steve, I'll take the first question around the operational efficiency. Yeah, I think, you know, as John laid out, one of our priorities, key priorities is to remain financially disciplined and...
Speaker Change: I think we've done just that, just given the guidance that I reiterated and it really starts with driving the growth at the top line.
We're seeing significant growth [inaudible]
Primarily from Recoral Ed.
Speaker Change: You can see it in the gross margin improvement over the last couple of quarters.
Speaker Change: And then from an expense management perspective, we're keeping...
Speaker Change: SGNA, expenses, R&D expenses, relatively in-checked. So I think that's creating a lot of the operational efficiency that you're seeing in our financial results. And you know, as we've...
Speaker Change: We tied it to in March, and we reiterated this morning. You know, we expect to be adjusted you with that positive moving forward, so you can assume that that's going to carry on into the future.
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Speaker Change: And I'll answer your question on the XPA-D121. The next key milestone is June 3rd at our Analysts and Investor meeting. We've been talking about this. We're going to lay out
Speaker Change: What the opportunity is, we'll be bringing in key opinion leaders as well so people can understand the opportunity that we can hit with the XP-8121
Speaker Change: and in there we'll lay out the development pathway, the regulatory pathway, and that'll also be able to lay out timing of various things throughout the next several years. So more to come on that and just in a few weeks, maybe it is a three weeks away, we'll be ready to talk about all of that.
Wey, Schuyler Broek,
That was great, thank you [inaudible]
Thank you for watching!
Speaker Change: Thank you. The next question is from Alam, of Jason Doerr with Oppenheimer. You may proceed.
David Amsellem, Paul Edick
Jason Doerr: Hey, this is Chase and representing Oppenheimer today, and thank you for taking the question. Could you be backing off the last question? As we wait for more details on the upcoming XB program at the upcoming investor analyst day, are there any details you can preview on the physical study design?
Thank you, everyone. Thank you.
Thank you.
Speaker Change: No, I don't think we should do that. Let's wait for the, let's wait three more weeks.
Chase and we plan this.
Speaker Change: We've been talking about this. We want to do this all at once. We want to lay out what the opportunity is. How we're going to go about that opportunity is a real one medical need here. [inaudible]
Speaker Change: We really think we can solve it, and we want to be able to communicate and articulate that all in once [inaudible]
Speaker Change: and then help spend people can understand how we're going to develop this going forward. And that's why we plan to do this in an analyst investor day on June 3rd.
Speaker Change: Yeah, that sounds great. I'm really looking forward to it. Thank you.
Speaker Change: Thank you. The next question is from the lot of Chase Knickerbocker with Craig Hollum. You may proceed.
Thank you for watching!
Chase Knickerbocker: Good morning. Thanks for taking the questions. I actually wanted to ask on the glue-cogon market here.
Chase Knickerbocker: Any impact that you've seen from any formulary strategy there and then just kind of on their sales strategy are they driving market growth as well or kind of what have you seen from them competitively from a commercial perspective?
Yeah.
Chase Knickerbocker: Competitively, I haven't seen much. I think this first quarter we saw, there's occasionally every other year or every year or so, there's things that change in the formulary aspects. We saw a little bit of that.
MQ1, I think all of that's behind us.
Chase Knickerbocker: From a market growth, we're the ones driving the market growth. The market grew about 5%, we grew 8 when I look at prescriptions, and that's really what we're trying to do is focus on driving market growth.
Chase Knickerbocker: Getting more and more clinicians compliant with the medical guidelines and getting more and more patients protected. That's what we're doing and by doing that we focus on the market growth and getting these new patients protected.
Chase Knickerbocker: and we're beating that market growth right now. So that's how we attribute to what our performance is and I'm really excited about the performance we had in Q1.
I've got it, Nunca Ves, [inaudible]
Chase Knickerbocker: You know, a bit better than we had modeled to use to hold in there [inaudible]
Anything from a formulary perspective there as things kind of...
Chase Knickerbocker: You know, reset here in Q1 and anything else from a competitive perspective there that we should be watching through the year.
Nothing from a formulary, nothing from a competitive standpoint.
Chase Knickerbocker: Steve talked about this in Q4 that we seem to find the spot where we can really manage us and we continue to find new patients.
Chase Knickerbocker: Every quarter, every week, and by doing that we continue to maintain this brand pretty flat right now. So we feel really good about where we're at with it and that we see an opportunity to continue to maintain this pace.
David Amsellem,
Speaker Change: So just to put a finer point to it, I mean you would expect that that brand is pretty consistent through the year, typically it's Q1, where we see any potential changes on formulae.
Thanks for watching!
Speaker Change: Yeah, typically, although we didn't see it maybe as pronounced this quarter for Kivea specifically, so yeah, I think we're expecting that it would kind of live in where we saw Q1's performance for the balance of the year.
Speaker Change: Thanks. And then just launch from me on just kind of the tariff side of things. Can you just kind of walk us through where any of your drug germany manufactured any additional kind of context you're willing to give there as the industry kind of prepares for potential sector-specific tariff?
Thank you.
Speaker Change: Yeah, thanks, Chase for the question. So yeah, most of our operations, manufacturing operations are US, we are a US-centric company. So we do source some materials, ingredients, OUS.
But, again, as I mention in my prepared remarks…
Speaker Change: Those have been factored into our guidance. We don't expect any material impact from the terrorists. And to maybe draw a more specific point, we don't source anything from China.
David Amsellem,
and finished goods and final manufacturing is in the U.S.
Moe, yes, yes, yes
Allison Wey, Steven Pieper, John Shannon
Speaker Change: Thank you. There are no further questions waiting at this time. I'll have to pass the call, back over to Jillian Shen for any closing remarks.
Thank you.
Speaker Change: Q1 has been another impressive quarter for Xeris, highlighting our sustained momentum in robust performance. We remain dedicated in our commitment to accelerating sustainable revenue growth across our commercial portfolio, while ensuring our products continue to improve patient's lives in meaningful ways.
Speaker Change: We are more dedicated than ever to fostering a transparent communication and strengthening our relationships with all stakeholders. And we look forward to seeing you on June 3rd at our Analysts and Investor Day and appreciate your continued confidence in Xeris Pharmaceuticals. Thank you.
Thank you for watching!
Thanks for watching!
Speaker Change: Thank you all. This is Nothing Today's Call. We appreciate your participation. Hope you all have a wonderful day, and you may now disconnect your line.