Q2 2025 Xeris Biopharma Holdings Inc Earnings Call

Speaker #1: Hello everyone , and thank you for joining the various Biopharma second Quarter 2020 earnings conference call . My name is Sammy , and I'll be coordinating your call today .

Speaker #1: During the presentation , you can register a question by pressing star followed by one on your telephone keypad . If you change your mind , please press star , followed by two on your telephone keypad to remove yourself from the question queue .

Speaker #1: I'll now hand over to your host , Allison Wey , Senior Vice President of Investor Relations and Corporate Communications , to begin . Please go ahead .

Speaker #1: Allison .

Speaker #2: Thank you Sammy . Good morning , everyone , and thank you for joining our call today . I'm joined with John Shannon , our CEO , and Steve Piper , our CFO .

Speaker #2: Earlier 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 lines for questions .

Speaker #2: 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 .

Speaker #2: 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 our risks , please refer to our earnings release and the risk factors included in our SEC filings .

Speaker #2: Any forward looking statements in this call represent our views only as the date of this call , and subject to applicable law . We disclaim any obligation to update such statements .

Speaker #2: Please note , some metrics we will discuss today are represented in a non-GAAP basis . We reconciled the comparable GAAP and non-GAAP figures in our press release .

Speaker #2: Please let me pass the call over to John for his opening remarks .

Speaker #3: Thanks , Alison , and good morning , everyone . I'm excited to report that the strong momentum we established in the first quarter continued into the second quarter , driving another period of incredible performance and positioning us to outperform our original expectations for 2025 .

Speaker #3: Our total revenue grew 49% to a quarterly record of almost 72 million . This success is being fueled by the strength of our commercial product portfolio , which grew 46% to approximately 68 million in Q2 .

Speaker #3: Our exceptional performance was driven by an increased patient demand across all three products . Ricola continues to lead our growth with very strong demand , driven by its differentiation as a much needed treatment for patients with hypercortisolemia and endogenous Cushing's syndrome .

Speaker #3: Gvoke once again delivered consistent , steady growth , supported by our efforts to increase awareness and reinforce adherence to medical guidelines . And at the same time , remains strong as we continue to add new patients , which led to an increase in the average number of patients on therapy in Q2 .

Speaker #3: Building on this strong foundation and the exceptional results from both Q1 and Q2 , we are raising our full year revenue guidance to reflect the very positive trajectory we see ahead .

Speaker #3: Our revised outlook anticipates total revenue in the range of 280 to 290 million , surpassing the high end of our previous guidance and representing year over year growth of 40% at the midpoint .

Speaker #3: This significant upward revision reflects our confidence in the growing demand for our commercial products and our operational discipline as we execute against our strategic priorities .

Speaker #3: Now , let's turn to a more detailed review of performance by product , beginning with Ricola . In the second quarter , Ricola grew an impressive 136% year over year , reaching over 31 million of revenue in the quarter .

Speaker #3: The average number of patients on therapy grew by more than 122% year over year , reinforcing our confidence that Ricola is solidifying its position as an important treatment option for patients with Cushing's syndrome .

Speaker #3: As we outlined during our June Analyst Day , Ricola is the right product at the right time . It's uniquely positioned to capitalize on the fast growing Hypercortisolemia and Cushing's Syndrome market .

Speaker #3: We are making deliberate and strategic investments to drive sustained growth through over the near and long term . These efforts are focused on a deepening engagement with healthcare professionals to accelerate patient identification , while simultaneously strengthening our support model for patients as they navigate their therapeutic journey .

Speaker #3: Turning to Jibo , Zhibo posted another great quarter with revenue of 23 million , a 17% increase compared to the second quarter of last year .

Speaker #3: Prescription volume continued its steady upward trend , driven both driven by both growth in prescribers and increased adoption among existing ones . We expect Gvoke to remain a strong and dependable driver of our overall performance throughout the remainder of the year .

Speaker #3: Given the extensive number of people with diabetes that don't yet carry ready to use glucagon , gvoke is well positioned for steady long term growth for many years to come .

Speaker #3: Now let's turn to CVS . CVS continues to demonstrate its importance in the treatment of patients with primary periodic paralysis , with revenue of more than 11 million in the second quarter .

Speaker #3: We saw a modest increase in the average number of patients on therapy , along with growth in new patient starts , underscoring the strength of the brand and our team's focus on execution .

Speaker #3: In fact , today is the ten year anniversary of FDA approval and remains an important part of our portfolio , consistently serving patients with p.p.p .

Speaker #3: And reinforcing our commitment to addressing the needs of this ultra rare community with a dependable and proven therapy . In addition to strong commercial execution , as I mentioned earlier , the second quarter was also defined by an important strategic milestone .

Speaker #3: Our first ever Analyst and Investor Day . This event was a pivotal moment for us as we outlined our long term vision and key growth drivers , most notably Korolev and our lead pipeline asset , XRP 81 .

Speaker #3: 21 the engagement we received from the investment community underscores the excitement we feel about the opportunities ahead . As many of you heard on Investor Day , we believe that XRP 8121 are novel .

Speaker #3: Once weekly subcutaneous therapy in development for the treatment of hypothyroidism is a very special product in the making of all the patients with primary hypothyroidism in the US .

Speaker #3: We estimate that 3 to 5 million of them are ideal candidates for this therapy because of their inability to achieve control with daily oral levothyroxine due to gastrointestinal absorption issues .

Speaker #3: We believe XRP 8121 represents a transformative opportunity in a space that has seen little to no meaningful innovation for decades , despite there being a significant unmet medical need .

Speaker #3: This is not for lack of trying , but because of the technical challenges our substantial . We've invested the time and resources to solve for those challenges , leveraging our proprietary technology to develop a novel formulation and a high precision delivery system capable of reliably administering a wide array of doses .

Speaker #3: Our clinical program will also generate a wealth of meaningful data , including regular thyroid hormone monitoring and quality of life assessments , which we believe can improve patient care , enhance our regulatory and potentially support differentiated claims .

Speaker #3: submission , Before I turn the call to Steve , I want to reiterate that our strong performance in the first half of the year further reinforces our confidence in the strength of our business and growth opportunities ahead of us .

Speaker #3: The increase in our 2020 revenue guidance reflects the momentum we've built by remaining focused on our strategic priorities , executing with discipline and delivering value for patients , providers and shareholders .

On a sequential basis sgna expenses were flat.

Turning to adjusted Eva, I'm pleased to report that adjusted evaa in the quarter was a positive 12.5 million.

Compared to Prior year this reflects an improvement of nearly 13 million.

This further demonstrates our ability to translate strong Topline performance into meaningful. Bottom line results.

That operational efficiency. Empowers us to reinvest strategically in high impact organic growth opportunities.

Before moving to our near-term Outlook and guidance, I want to reiterate that our strong financial position. Gives us the flexibility to execute on our strategic priorities with confidence. We are taking deliberate value-driven actions to Advanced arrows, to its next phase of growth.

By leveraging our operational and financial strengths, we are well positioned to realize the full potential of our portfolio and pipeline.

Our Focus remains clear to drive, meaningful durable growth and deliver lasting value for our shareholders.

Turning to our near-term outlook and guidance.

We are revising our full year 2025 Outlook to account for the strong year-to-date performance.

We are raising our total revenue guidance to 280 to 290 million from the previous range of 260 to 275 million.

This new Range represents year-over-year growth of 40% at the midpoint and reflects our confidence in the growing demand for our products, particularly the continued acceleration and Adoption of record us.

From a gross margin perspective, we continue to expect a modest Improvement in gross margin compared to 2024.

As we highlighted during investor day, we will continue to make incremental value-driven Investments.

Given the outperformance of our commercial products. This year, we are accelerating investments in both recorlev and XP 8121. This will result in a modest year-over-year increase in total sgna and R&D expenses.

We now anticipate a low to mid teens percentage, increase year-over-year compared to our prior expectations of a mid to high single-digit. Increase.

This reflects continued investment in further expanding our recora commercial footprint. It ensures we've remained on track to initiate patient dosing in our pivotal phase 3 trial for XP 8121 in 2026.

Investments. We remain committed to delivering continued positive, adjusted ibaa going forward.

With that, I'll now hand the call over to the operator for Q&A.

Operator.

Thank you very much.

To ask a question. Please press star. Followed by 1 on your telephone keypad. Now, if you change your mind, please press star followed by 2.

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Our first question comes from, Chase Knickerbocker and Craig and Hallen. Your line is open. Please go ahead.

Thanks for the question. Uh, good morning Congressman, nice quarter here. Maybe just first on. Um, go can you talk about that growth to net benefit? Is that going to be something that's kind of 1 time or something? You can hold on to

Yeah, Chase, this is Steve. I'll just take that question. Uh, yeah, we anticipate that favorability to continue for the balance of the year.

Got it. Um, and so if I think about kind of the script growth that was seen in the quarter,

Um, is that kind of the way that we should think about the gvoke franchise in the back half?

Um, or just some general thoughts on Gvoke, and then I've got a follow-up on our CAR left. Thanks.

Chase, you know, on gvoke, the third quarter is always uh, a bigger growth quarter with the back to school movement. So there definitely. You see a script growth that will increase in, um,

In Q3 and then usually is consistent in the Q4 like um so so I I I think you're going to see a you know increase coming up and then and then and then you know getting back to more kind of that. You know I think it's in that high single digit, you know, growth rate um on a quarter to quarter basis

Opal and um you know, good to see the continued, you know, pretty impressive momentum. Obviously in Rico

Um, can you just kind of give us an update on kind of where your prescriptions are coming from? From a physician perspective? Is this still, you know, very much majority endo

And then any sort of update you'd be willing to give us just on kind of the average dosage per patient or kind of average. You know, call it wac price per patient at this point.

Yeah, it's, it's, it's, it's pretty much Endo. Um, and you know,

At least half of our patients are are new to therapy so again and and and all of our growth is coming from new starts.

So there's really no movement that leads to virtually no movement and kind of

The increase in dose. Um, I I think that's you know, with the amount of people we're adding on new um and the way they go low and titrate up. Um again we don't we don't think we're going to see real

Material movement in the dose range, at least for, you know, sometime ahead. I don't know, maybe it's next year or sometime or but, but, but it's definitely out, uh, it'll be out for a while.

And then last thing for me, John um you know, there's a potential for a, you know, existing competitor to launch a new drug obviously around the end of the year. Can you just um kind of refresh us on your thoughts on kind of how or if um you think that changes the competitive environment in the hyper cordal ISM Market? Um towards the end of the year here?

Yeah, I think, you know, look more voice in this market because it's growing so quickly, um, and there's so much attention on on.

testing for cortisol in situations, where

You know, things you're on today that should be working aren't working specifically thinking about you know, if you're on insulin and it's not working, what's going on? Let's look for you know, things like you know, cortisol levels and if when you find elevated cortisol, um, that that is really generating the, the market movement and the Dynamics in this Marketplace. So another, another player in this space, um, is, you know, brings more noise to that to that situation. And I think that's good for all of us.

Great. It's interesting. Any questions.

Hi, thanks so much. This is Alex on for David uh just 1 for us from us with the hypercortisolism market. Expanding how are you envisioning long-term? Spend to supportive and do you foresee any headcount or promotional expansion in the near term? And then in that vein, do you have plans to call on General Practitioners in the future?

Um, Alex, you know, we outlined in our investor day back in June, that we would continue to invest in this space, um, given that the Dynamics of the marketplace. And, um, and so yeah, so yes, we anticipate and we said we will be increasing our our commercial footprint. We, you know, we are, we are, we begun that process. We're we're working through that and making sure that we continue to expand to support the dynamic growth in this Marketplace. So, uh, and we'll be making tremendous Investments over the next, you know, several years. Um, as we continue to build the recoil of brand because as I said in in our comments on at investor day, and again, today we think we think Rico is the right product at the right time coming into this Marketplace.

and um, so it it it's, it's right for the investment and and we will be making those

Our next question comes from Christian Clark from layering Partners. Your line is open. Christian, please, go ahead.

Good morning. This is Chris Clark on for Rana Ruiz. Just have 1 question. Do you have any plans to generate further clinical data to further solidify Rico's body proposition Beyond borders on normalization, particularly in patients with secondary core businesses. Like stubborn diabetes?

Um, long term, yes, I mean, but you know it even in our own existing data. Um, things like diabetes, those comorbidities are resolved. Um, and that's, you know, we we, you know, that exists in our current data sets, um, when you, when you treat the elevations in cortisol. So, um, so yeah, and we'll continue to it to, you know, generate more and more data around that.

Thank you very much.

As a reminder to ask a question. Please press star. Followed by 1 on your telephone keypad.

Our next question comes from Jason door from Oppenheimer. Your line is open, Jason, please go ahead.

Hey, good morning, it's Jason here on for Wheeling your shell and thank you for taking the question.

Uh, couple questions on gvoke. How do you see the treatment landscape, evolving over the next 2 to 3 years especially in regards to competitors? And could you provide any additional color on how the revenue might look in the next 2 to 3 years with the gvoke, wild DX collaboration with American region.

Thank you.

Um,

I'm I'm going to try to break that down. The first question was with respect to gvoke and the opportunity in patients with diabetes.

Um, is is the way I heard it. So, as you know, and as we've talked a lot about there are 15 million patients out there today.

That should have a ready-to-use rescue glucagon on hand. Um, just based on the medical guidelines.

and,

From our estimates, probably only about a million of them, actually have something on hand, so our job along with our competitors. Um, is to is to find those patients who are not, um, currently protected with a rescue Med.

And get them protected and that's a lot of work getting to the clinicians. Um to to basically help them understand the guidelines in some cases and then also you know, assure that they're adhering to them in a way that their patients get protected. That's, that's the process. That's what we're doing. That's what the competitors should be doing. Um, and that's that, you know, that's the long-term landscape. So there's a lot of Runway there to, to continue to do that.

Um, as for the Vial DX, um, opportunity out there, you know?

and, you know, as they get out there in the marketplace, we'll be able to give further guidance that, you know, for this year there's not much impact

Um, much more impact to our revenues than we've already seen. Um, but you know, in our years we'll we'll probably be in a better position in next year. And, and Beyond to really give some guidance on, you know, where that's going. And how that's performing.

Really appreciate it. Thank you.

We currently have no further questions. So now to hand back to John Shannon, with some closing remarks.

Thanks.

As I look back on my first year, leading zeros. I'm incredibly proud of what we've accomplished together.

Stepping into this role, my priority was to build on the company's strong Foundation. While positioning us to deliver, robust growth across the commercial franchise and advancing our pipeline.

Q2 was another great quarter for zeros.

Underscoring, the continued momentum of our of our business.

Our performance reflects not only strong execution across our commercial portfolio, but also our unwavering commitment to delivering, meaningful value to patients, Healthcare Providers, and shareholders alike.

Will you remain committed to driving meaningful growth? And operational excellence. Our team is energized and aligned around executing our strategic priorities ensuring that our differentiated products continue to improve, patient outcomes.

Thank you again for your time this morning.

This concludes today's call. We thank everyone for joining. You may now disconnect your lines.