NASDAQ:XERS Xeris Biopharma Q2 2025 Earnings Report $7.28 -0.03 (-0.34%) Closing price 08/13/2025 03:59 PM EasternExtended Trading$7.28 0.00 (0.00%) As of 08/13/2025 07:56 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Xeris Biopharma EPS ResultsActual EPS-$0.01Consensus EPS -$0.03Beat/MissBeat by +$0.02One Year Ago EPSN/AXeris Biopharma Revenue ResultsActual Revenue$67.71 millionExpected Revenue$64.58 millionBeat/MissBeat by +$3.13 millionYoY Revenue GrowthN/AXeris Biopharma Announcement DetailsQuarterQ2 2025Date8/7/2025TimeBefore Market OpensConference Call DateThursday, August 7, 2025Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)SEC FilingEarnings HistoryCompany ProfilePowered by Xeris Biopharma Q2 2025 Earnings Call TranscriptProvided by QuartrAugust 7, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: In Q2, Zerus Biopharma delivered record revenue of $71.5 million, representing 49% year-over-year growth, and raised its full-year guidance to $280–290 million (+40% at midpoint). Positive Sentiment: RECORLEV net revenue surged 136% year-over-year to $31.4 million, driven by a 122% increase in patients on therapy, prompting expanded commercial investments to deepen HCP engagement and patient support. Positive Sentiment: The Gvoke franchise grew 17% to $23.5 million in Q2, benefitting from a 5% uptick in prescription volume, favorable gross-to-net dynamics, and a large long-term market opportunity among under-protected diabetic patients. Positive Sentiment: Zerus continues to advance its pipeline, notably XP-8121, a novel once-weekly subcutaneous hypothyroidism therapy targeting 3–5 million patients, with pivotal Phase 3 dosing slated for 2026. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallXeris Biopharma Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xThere are 7 speakers on the call. Operator00:00:00Hello, everyone, and thank you for joining the Zerus Biopharma Second Quarter twenty twenty five Earnings Conference Call. My name is Sami, and I'll be coordinating your call today. I'll now hand over to your host, Alison Way, Senior Vice President of Investor Relations and Corporate Communications to begin. Please go ahead, Alison. Speaker 100:00:29Thank you, Sami. Good morning, everyone, and thank you for joining our call today. I'm joined with John Shannon, our CEO and Steve Piper, our CFO. Earlier this morning, we issued a press release with our detailed results, which can be found on our Web site. After our prepared remarks, we will open the lines for questions. Speaker 100:00:46Before we would 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 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. 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 obligation to update such statements. Please note some metrics we will discuss today are represented in a non GAAP basis. Speaker 100:01:27We've reconciled the comparable GAAP and non GAAP figures in our press release. Please let me pass the call over to John for his opening remarks. Speaker 200:01:37Thanks, 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. Our total revenue grew 49 percent to a quarterly record of almost $72,000,000 This success is being fueled by the strength of our commercial product portfolio, which grew 46% to approximately $68,000,000 in Q2. Our exceptional performance was driven by an increased patient demand across all three products. RECORLEV continues to lead our growth with very strong demand driven by its differentiation as a much needed treatment for patients with hyperchordicillemia and endogenous Cushing syndrome. Speaker 200:02:31Gvoke once again delivered consistent steady growth, supported by our efforts to increase awareness and reinforce adherence to medical guidelines. And at the same time, KEVEYIS remains strong as we continue to add new patients, which led to an increase in the average number of patients on therapy in Q2. 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. Our revised outlook anticipates total revenue in the range of $280,000,000 to $290,000,000 surpassing the high end of our previous guidance and representing year over year growth of 40% at the midpoint. 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 200:03:33Now let's turn to a more detailed review of performance by product, beginning with RECORLEV. In the second quarter, RECORLEV grew an impressive 136 year over year, reaching over $31,000,000 of revenue in the quarter. The average number of patients on therapy grew by more than 122% year over year, reinforcing our confidence that RECORLEV is solidifying its position as an important treatment option for patients with Cushing's syndrome. As we outlined during our June Analyst Day, RECORLEV is the right product at the right time. It's uniquely positioned to capitalize on fast growing hyperchordicillemia and Cushing syndrome market. Speaker 200:04:19We are making deliberate and strategic investments to drive sustained growth for Recorlev over the near and long term. These efforts are focused on a deepening engagement with health care professionals to accelerate patient identification while simultaneously strengthening our support model for patients as they navigate their therapeutic journey. Turning to Gvoke. Gvoke posted another great quarter with revenue of $23,000,000 a 17% increase compared to the second quarter of last year. Prescription volume continued its steady upward trend driven by both growth in prescribers and increased adoption among existing ones. Speaker 200:05:04We expect Gvoke to remain a strong and dependable driver of our overall performance throughout the remainder of the year. 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. Now let's turn to KEVEYIS. KEVEYIS continues to demonstrate its importance in the treatment of patients with primary periodic paralysis. With revenue of more than $11,000,000 in the second quarter, 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 KEVEYIS brand and our team's focus on execution. Speaker 200:05:46In fact, today is the ten year anniversary of KEVEYIS' FDA approval, And KEVEYIS remains an important part of our portfolio, consistently serving patients with PPP 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, 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 Recorlev and our lead pipeline asset, XP 8121. 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 XP-eight thousand one hundred twenty one, our novel once weekly subcutaneous therapy in development for the treatment of hypothyroidism, is a very special product in the making. Speaker 200:06:54Of all the patients with primary hypothyroidism in The US, we estimate that three to five 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. We believe XP-eight thousand one hundred twenty one 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. This is not for lack of trying, but because of the technical challenges are substantial. We've invested the time and resources to solve for those challenges, leveraging our proprietary XEROSOL technology to develop a novel formulation and a high precision delivery system capable of reliably administering a wide array of doses. 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 submission and potentially support differentiated claims. Speaker 200:08:04Before 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. The increase in our 2025 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. With that, I will now turn the call over to Steve, who will provide a comprehensive review of our financial performance for the quarter and provide detail around our updated guidance and outlook. Speaker 300:08:41Thanks, John, and good morning, everyone. We had another record breaking quarter. On a year over year basis, total revenue grew 49% to $71,500,000 while net product revenue increased 46% to $67,700,000 RECORLEV net revenue was $31,400,000 representing a 136% increase year over year. Sequentially, revenue grew by record $5,900,000 This performance was primarily driven by higher average number of patients on RECORLEV, which increased 122% compared to the prior year and 24% compared to the prior quarter. RECORLEV has continued its strong momentum into August with no signs of slowing down. Speaker 300:09:35Gvoke net revenue was $23,500,000 increasing 17% versus last year. This increase was attributable to total Gvoke prescriptions growing 5% coupled with some favorability in our gross to net. KEVEYIS net revenue was $11,500,000 a slight uptick compared to the first quarter twenty twenty five. The average number of patients on therapy modestly increased and we continue to capture a healthy number of new patient starts. Royalty contract and other revenue generated in the quarter was $3,800,000 As we announced in March, Xeris received FDA approval for Gvoke VialDx, which triggered a one time milestone payment from our commercial partner American Region that accounted for the majority of other revenue in the quarter. Speaker 300:10:30Turning to gross margin. Gross margin in the quarter was 82%, slightly below the first quarter due to expenses associated with Gevo capacity expansion efforts that were non routine. On a year to date basis, gross margin was 84%. Research and development expenses were $8,100,000 for the quarter, a $2,200,000 increase versus last year. This increase primarily reflects our continued investment in our pipeline namely XP-eight 121 in our products. Speaker 300:11:07Selling, general and administrative expenses were $44,400,000 in the quarter, an increase of 11% compared to prior year. The increase in SG and A expenses primarily reflects the impact from the Q3 twenty twenty four RECORLEV commercial expansion as well as other personnel related costs. On a sequential basis, SG and A expenses were flat. Turning to adjusted EBITDA. I'm pleased to report that adjusted EBITDA in the quarter was a positive $12,500,000 compared to prior year. Speaker 300:11:44This reflects an improvement of nearly $13,000,000 This further demonstrates our ability to translate strong top line 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 advance Cerus 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. Speaker 300:12:37Our 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 $280,000,000 to $290,000,000 from the previous range of $260,000,000 to $275,000,000 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 RECORLEV. From a gross margin perspective, we continue to expect a modest improvement in gross margin compared to 2024. Speaker 300:13:33As 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-eight thousand one hundred twenty one. This will result in a modest year over year increase in total SG and A and R and 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 RECORLEV commercial footprint and ensures we remain on track to initiate patient dosing in our pivotal Phase three trial for XP-eight thousand one hundred twenty one in 2026. Speaker 300:14:24It is important to note that with our raised revenue guidance and deliberate incremental value driven investments, we remain committed to delivering continued positive adjusted EBITDA going forward. With that, I'll now hand the call over to the operator for Q and A. Operator? Operator00:14:46Thank you very much. Our first question comes from Chase Knickerbocker from Craig Hallum. Your line is open. Please go ahead. Speaker 400:15:10Thanks for the question. Good morning. Congrats on the nice quarter here. Maybe just first on Gevo. Can you talk about that gross to net benefit? Speaker 400:15:19Is that going to be something that's kind of onetime or something you can hold on to? Speaker 300:15:24Yes, Chase. This is Steve. I'll just take that question. Yes, we anticipate that favorability to continue for the balance of the year. Speaker 400:15:43Got it. And so if I think about kind of the script growth that was seen in the quarter, Is that kind of the way that we should think about the Gvoke franchise in the back half? Or just some general thoughts on Gvoke? And then I've Operator00:15:58got a follow-up on Recorlev. Speaker 200:16:02Chase, on Gvoke, the third quarter is always a bigger growth quarter with the back to school movement. So definitely, you see a script growth that will increase in Q3 and then usually is consistent into Q4. So I think you're going to see an increase coming up and then getting back to more kind of that I think it's in that high single digit growth rate on a quarter to quarter basis. Speaker 400:16:40Helpful. And good to see the continued pretty impressive momentum obviously in RECORLEV. 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 very much majority endo? And then any sort of update you'd willing to give us just on kind of the average dosage per patient or kind of average, call it, WAC price per patient at this point? Speaker 200:17:08Yes. It's pretty much endo. And at least half of our patients are new to therapy. So again, and all of our growth is coming from new starts. So there's really no movement. Speaker 200:17:26That leads to virtually no movement in kind of the increase in dose. Think that's you know, with with the amount of people we're adding on new and the way they go slow and titrate up, again, we don't we don't think we're gonna see real material movement in the dose range, at least for some time ahead. I don't know. Maybe it's next year or sometime, but it's definitely out. It'll be out for a while. Speaker 400:18:01And then last thing for me, John. There's a potential for existing competitor to launch a new drug, obviously, around the end of the year. Can you just, kind of refresh us on your thoughts on kind of how or if you think that changes the competitive environment in the hypercortisim market towards the end of the year? Speaker 200:18:23Yes. I think, look, more voice in this market because it's growing so quickly 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 it when you find elevated cortisol, that that is really generating the the market movement and the dynamics in this marketplace. So another another player in this space, know, brings more noise to that to that situation, and I think that's good for all of us. Speaker 400:19:13Great. Thanks for taking the questions. Operator00:19:19Our next question comes from David Amsellem from Piper Sandler. Your line is open, David. Please go ahead. Speaker 500:19:27Hi, thanks so much. This is Alex on for David. Just one for us from us. With the hypercortisolism market expanding, how are you envisioning long term spend to support Recortisiv? And do you foresee any headcount or promotional expansion in the near term? Speaker 500:19:46And then in that vein, do you have plan to call on general practitioners in the future? Thank you. Speaker 200:19:55Alex, we outlined in our Investor Day back in June that we would continue to invest into this space given the dynamics of the marketplace. And so yes, we anticipate and we said we will be increasing our commercial footprint. We've begun that process. We're working through that and making sure that we continue to expand to support the dynamic growth in this marketplace. And we'll be making tremendous investments over the next several years as we continue to build the RECORLEV brand. Speaker 200:20:34Because as I said in our comments on at Investor Day and again today, we think RECORLEV is the right product at the right time coming into this marketplace. And so it's right for the investment, and we will be making those. Operator00:21:00Our next question comes from Christian Clarke from Leerink Partners. Your line is open, Christian. Please go ahead. Speaker 600:21:09Good morning. This is Chris Clark on for Rwanda Ruiz. Just have one question. Do you have any plans to generate further clinical data to further solidify RECORLEV's value proposition beyond cortisol normalization, particularly in patients with secondary comorbidities like stubborn diabetes? Speaker 200:21:31Long term, yes. I mean but, you know, even in our own existing data, things like diabetes, those comorbidities are resolved. That's we we you know, that exists in our current dataset. When you treat the elevations in cortisol. So yes, and we'll continue to generate more and more data around that. Speaker 600:22:02Thank you very much. Operator00:22:12Our next question comes from Jason Doerr from Oppenheimer. Speaker 600:22:15It's Jason here on for Leland Gershell. A couple of questions on Gvoke. How do you see the treatment landscape evolving over the next two to three years, especially in regards to competitors? And could you provide any additional color on how the revenue might look in the next two to three years with the Gvoke WildDx collaboration with American Region? Thank you. Speaker 200:22:48I'm going to try to break that down. The first question was with respect to Gvoke and the opportunity in patients with diabetes, the way I heard it. So as you know, and as we've talked a lot about, there are 15,000,000 patients out there today that should have a ready to use rescue glucagon on hand 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, is to find those patients who are not currently protected with a rescue med and get them protected. Speaker 200:23:38And that's a lot of work getting to the clinicians, 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 the process. That's what we're doing. That's what the competitors should be doing, and that's the long term landscape. So there's a lot of runway there to continue to do that. Speaker 200:24:05As for the Vile DX opportunity out there, more to come on that as we go. Our partner is going to launch by the end of the year. And as they get out there in the marketplace, we'll be able to give further guidance. For this year, there's not much impact, much more impact to our revenues than we've already seen. But in out years, we'll probably be in a better position in next year and beyond to really give some guidance on where that's going and how that's performing. Speaker 200:24:47We Operator00:24:53currently have no further questions. So I'd now like to hand back to John Shannon for some closing remarks. Speaker 100:25:00Thanks. Speaker 200:25:02As I look back on my first year leading Ziros, 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 Zerus. Underscoring the continued momentum 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, health care providers and shareholders alike. We remain committed to driving meaningful growth and operational excellence. Speaker 200:25:45Our 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. Operator00:26:02This concludes today's call. We thank everyone for joining. You may now disconnect your lines.Read morePowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Xeris Biopharma Earnings HeadlinesXeris Biopharma (NASDAQ:XERS) Rating Increased to Buy at HC Wainwright3 minutes ago | americanbankingnews.comXeris Biopharma assumed with a Buy at H.C. WainwrightAugust 12 at 5:49 PM | msn.comThe $7 company helping Nvidia build the world’s first trillion-dollar robot …Michael Robinson has been at the forefront of the technology market for over 40 years. Spotting some profitable trends in tech … well ahead of Wall Street. Like when he called Nvidia at a mere 80 cents a share. Or Bitcoin when it was trading for just $300. Throughout his illustrious career … Michael has given his followers almost 150 different chances to register triple-digit gains. | Weiss Ratings (Ad)Xeris Biopharma (NASDAQ:XERS) Raised to Strong-Buy at Wall Street ZenAugust 11 at 2:59 AM | americanbankingnews.comCritical Survey: Xeris Biopharma (NASDAQ:XERS) versus CASI Pharmaceuticals (NASDAQ:CASI)August 10, 2025 | americanbankingnews.comXeris Biopharma (NASDAQ:XERS) Sees Strong Trading Volume After Better-Than-Expected EarningsAugust 10, 2025 | americanbankingnews.comSee More Xeris Biopharma Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Xeris Biopharma? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Xeris Biopharma and other key companies, straight to your email. Email Address About Xeris BiopharmaXeris Biopharma (NASDAQ:XERS), a biopharmaceutical company, engages in developing and commercializing therapies in Illinois. The company offers Gvoke, a ready-to-use liquid-stable glucagon for the treatment of severe hypoglycemia pediatric and adult patients; Keveyis, a therapy for the treatment of hyperkalemic, hypokalemic, and related variants of primary periodic paralysis; and Recorlev, a cortisol synthesis inhibitor proved for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome. It is also developing XP-8121, a once-weekly subcutaneous injection of levothyroxine that is in phase I clinical trial for the treatment of hypothyroidism; and non-aqueous XeriSol and XeriJect technologies for various therapies. The company was incorporated in 2005 and is headquartered in Chicago, Illinois.View Xeris Biopharma ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Why BigBear.ai Stock's Dip on Earnings Can Be an Opportunity CrowdStrike Faces Valuation Test Before Key Earnings ReportPost-Earnings, How Does D-Wave Stack Up Against Quantum Rivals?Why SoundHound AI's Earnings Show the Stock Can Move HigherAirbnb Beats Earnings, But the Growth Story Is Losing AltitudeDutch Bros Just Flipped the Script With a Massive Earnings BeatIs Eli Lilly’s 14% Post-Earnings Slide a Buy-the-Dip Opportunity? Upcoming Earnings Palo Alto Networks (8/18/2025)Medtronic (8/19/2025)Home Depot (8/19/2025)Analog Devices (8/20/2025)Synopsys (8/20/2025)TJX Companies (8/20/2025)Lowe's Companies (8/20/2025)Workday (8/21/2025)Intuit (8/21/2025)Walmart (8/21/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
There are 7 speakers on the call. Operator00:00:00Hello, everyone, and thank you for joining the Zerus Biopharma Second Quarter twenty twenty five Earnings Conference Call. My name is Sami, and I'll be coordinating your call today. I'll now hand over to your host, Alison Way, Senior Vice President of Investor Relations and Corporate Communications to begin. Please go ahead, Alison. Speaker 100:00:29Thank you, Sami. Good morning, everyone, and thank you for joining our call today. I'm joined with John Shannon, our CEO and Steve Piper, our CFO. Earlier this morning, we issued a press release with our detailed results, which can be found on our Web site. After our prepared remarks, we will open the lines for questions. Speaker 100:00:46Before we would 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 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. 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 obligation to update such statements. Please note some metrics we will discuss today are represented in a non GAAP basis. Speaker 100:01:27We've reconciled the comparable GAAP and non GAAP figures in our press release. Please let me pass the call over to John for his opening remarks. Speaker 200:01:37Thanks, 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. Our total revenue grew 49 percent to a quarterly record of almost $72,000,000 This success is being fueled by the strength of our commercial product portfolio, which grew 46% to approximately $68,000,000 in Q2. Our exceptional performance was driven by an increased patient demand across all three products. RECORLEV continues to lead our growth with very strong demand driven by its differentiation as a much needed treatment for patients with hyperchordicillemia and endogenous Cushing syndrome. Speaker 200:02:31Gvoke once again delivered consistent steady growth, supported by our efforts to increase awareness and reinforce adherence to medical guidelines. And at the same time, KEVEYIS remains strong as we continue to add new patients, which led to an increase in the average number of patients on therapy in Q2. 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. Our revised outlook anticipates total revenue in the range of $280,000,000 to $290,000,000 surpassing the high end of our previous guidance and representing year over year growth of 40% at the midpoint. 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 200:03:33Now let's turn to a more detailed review of performance by product, beginning with RECORLEV. In the second quarter, RECORLEV grew an impressive 136 year over year, reaching over $31,000,000 of revenue in the quarter. The average number of patients on therapy grew by more than 122% year over year, reinforcing our confidence that RECORLEV is solidifying its position as an important treatment option for patients with Cushing's syndrome. As we outlined during our June Analyst Day, RECORLEV is the right product at the right time. It's uniquely positioned to capitalize on fast growing hyperchordicillemia and Cushing syndrome market. Speaker 200:04:19We are making deliberate and strategic investments to drive sustained growth for Recorlev over the near and long term. These efforts are focused on a deepening engagement with health care professionals to accelerate patient identification while simultaneously strengthening our support model for patients as they navigate their therapeutic journey. Turning to Gvoke. Gvoke posted another great quarter with revenue of $23,000,000 a 17% increase compared to the second quarter of last year. Prescription volume continued its steady upward trend driven by both growth in prescribers and increased adoption among existing ones. Speaker 200:05:04We expect Gvoke to remain a strong and dependable driver of our overall performance throughout the remainder of the year. 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. Now let's turn to KEVEYIS. KEVEYIS continues to demonstrate its importance in the treatment of patients with primary periodic paralysis. With revenue of more than $11,000,000 in the second quarter, 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 KEVEYIS brand and our team's focus on execution. Speaker 200:05:46In fact, today is the ten year anniversary of KEVEYIS' FDA approval, And KEVEYIS remains an important part of our portfolio, consistently serving patients with PPP 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, 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 Recorlev and our lead pipeline asset, XP 8121. 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 XP-eight thousand one hundred twenty one, our novel once weekly subcutaneous therapy in development for the treatment of hypothyroidism, is a very special product in the making. Speaker 200:06:54Of all the patients with primary hypothyroidism in The US, we estimate that three to five 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. We believe XP-eight thousand one hundred twenty one 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. This is not for lack of trying, but because of the technical challenges are substantial. We've invested the time and resources to solve for those challenges, leveraging our proprietary XEROSOL technology to develop a novel formulation and a high precision delivery system capable of reliably administering a wide array of doses. 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 submission and potentially support differentiated claims. Speaker 200:08:04Before 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. The increase in our 2025 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. With that, I will now turn the call over to Steve, who will provide a comprehensive review of our financial performance for the quarter and provide detail around our updated guidance and outlook. Speaker 300:08:41Thanks, John, and good morning, everyone. We had another record breaking quarter. On a year over year basis, total revenue grew 49% to $71,500,000 while net product revenue increased 46% to $67,700,000 RECORLEV net revenue was $31,400,000 representing a 136% increase year over year. Sequentially, revenue grew by record $5,900,000 This performance was primarily driven by higher average number of patients on RECORLEV, which increased 122% compared to the prior year and 24% compared to the prior quarter. RECORLEV has continued its strong momentum into August with no signs of slowing down. Speaker 300:09:35Gvoke net revenue was $23,500,000 increasing 17% versus last year. This increase was attributable to total Gvoke prescriptions growing 5% coupled with some favorability in our gross to net. KEVEYIS net revenue was $11,500,000 a slight uptick compared to the first quarter twenty twenty five. The average number of patients on therapy modestly increased and we continue to capture a healthy number of new patient starts. Royalty contract and other revenue generated in the quarter was $3,800,000 As we announced in March, Xeris received FDA approval for Gvoke VialDx, which triggered a one time milestone payment from our commercial partner American Region that accounted for the majority of other revenue in the quarter. Speaker 300:10:30Turning to gross margin. Gross margin in the quarter was 82%, slightly below the first quarter due to expenses associated with Gevo capacity expansion efforts that were non routine. On a year to date basis, gross margin was 84%. Research and development expenses were $8,100,000 for the quarter, a $2,200,000 increase versus last year. This increase primarily reflects our continued investment in our pipeline namely XP-eight 121 in our products. Speaker 300:11:07Selling, general and administrative expenses were $44,400,000 in the quarter, an increase of 11% compared to prior year. The increase in SG and A expenses primarily reflects the impact from the Q3 twenty twenty four RECORLEV commercial expansion as well as other personnel related costs. On a sequential basis, SG and A expenses were flat. Turning to adjusted EBITDA. I'm pleased to report that adjusted EBITDA in the quarter was a positive $12,500,000 compared to prior year. Speaker 300:11:44This reflects an improvement of nearly $13,000,000 This further demonstrates our ability to translate strong top line 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 advance Cerus 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. Speaker 300:12:37Our 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 $280,000,000 to $290,000,000 from the previous range of $260,000,000 to $275,000,000 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 RECORLEV. From a gross margin perspective, we continue to expect a modest improvement in gross margin compared to 2024. Speaker 300:13:33As 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-eight thousand one hundred twenty one. This will result in a modest year over year increase in total SG and A and R and 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 RECORLEV commercial footprint and ensures we remain on track to initiate patient dosing in our pivotal Phase three trial for XP-eight thousand one hundred twenty one in 2026. Speaker 300:14:24It is important to note that with our raised revenue guidance and deliberate incremental value driven investments, we remain committed to delivering continued positive adjusted EBITDA going forward. With that, I'll now hand the call over to the operator for Q and A. Operator? Operator00:14:46Thank you very much. Our first question comes from Chase Knickerbocker from Craig Hallum. Your line is open. Please go ahead. Speaker 400:15:10Thanks for the question. Good morning. Congrats on the nice quarter here. Maybe just first on Gevo. Can you talk about that gross to net benefit? Speaker 400:15:19Is that going to be something that's kind of onetime or something you can hold on to? Speaker 300:15:24Yes, Chase. This is Steve. I'll just take that question. Yes, we anticipate that favorability to continue for the balance of the year. Speaker 400:15:43Got it. And so if I think about kind of the script growth that was seen in the quarter, Is that kind of the way that we should think about the Gvoke franchise in the back half? Or just some general thoughts on Gvoke? And then I've Operator00:15:58got a follow-up on Recorlev. Speaker 200:16:02Chase, on Gvoke, the third quarter is always a bigger growth quarter with the back to school movement. So definitely, you see a script growth that will increase in Q3 and then usually is consistent into Q4. So I think you're going to see an increase coming up and then getting back to more kind of that I think it's in that high single digit growth rate on a quarter to quarter basis. Speaker 400:16:40Helpful. And good to see the continued pretty impressive momentum obviously in RECORLEV. 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 very much majority endo? And then any sort of update you'd willing to give us just on kind of the average dosage per patient or kind of average, call it, WAC price per patient at this point? Speaker 200:17:08Yes. It's pretty much endo. And at least half of our patients are new to therapy. So again, and all of our growth is coming from new starts. So there's really no movement. Speaker 200:17:26That leads to virtually no movement in kind of the increase in dose. Think that's you know, with with the amount of people we're adding on new and the way they go slow and titrate up, again, we don't we don't think we're gonna see real material movement in the dose range, at least for some time ahead. I don't know. Maybe it's next year or sometime, but it's definitely out. It'll be out for a while. Speaker 400:18:01And then last thing for me, John. There's a potential for existing competitor to launch a new drug, obviously, around the end of the year. Can you just, kind of refresh us on your thoughts on kind of how or if you think that changes the competitive environment in the hypercortisim market towards the end of the year? Speaker 200:18:23Yes. I think, look, more voice in this market because it's growing so quickly 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 it when you find elevated cortisol, that that is really generating the the market movement and the dynamics in this marketplace. So another another player in this space, know, brings more noise to that to that situation, and I think that's good for all of us. Speaker 400:19:13Great. Thanks for taking the questions. Operator00:19:19Our next question comes from David Amsellem from Piper Sandler. Your line is open, David. Please go ahead. Speaker 500:19:27Hi, thanks so much. This is Alex on for David. Just one for us from us. With the hypercortisolism market expanding, how are you envisioning long term spend to support Recortisiv? And do you foresee any headcount or promotional expansion in the near term? Speaker 500:19:46And then in that vein, do you have plan to call on general practitioners in the future? Thank you. Speaker 200:19:55Alex, we outlined in our Investor Day back in June that we would continue to invest into this space given the dynamics of the marketplace. And so yes, we anticipate and we said we will be increasing our commercial footprint. We've begun that process. We're working through that and making sure that we continue to expand to support the dynamic growth in this marketplace. And we'll be making tremendous investments over the next several years as we continue to build the RECORLEV brand. Speaker 200:20:34Because as I said in our comments on at Investor Day and again today, we think RECORLEV is the right product at the right time coming into this marketplace. And so it's right for the investment, and we will be making those. Operator00:21:00Our next question comes from Christian Clarke from Leerink Partners. Your line is open, Christian. Please go ahead. Speaker 600:21:09Good morning. This is Chris Clark on for Rwanda Ruiz. Just have one question. Do you have any plans to generate further clinical data to further solidify RECORLEV's value proposition beyond cortisol normalization, particularly in patients with secondary comorbidities like stubborn diabetes? Speaker 200:21:31Long term, yes. I mean but, you know, even in our own existing data, things like diabetes, those comorbidities are resolved. That's we we you know, that exists in our current dataset. When you treat the elevations in cortisol. So yes, and we'll continue to generate more and more data around that. Speaker 600:22:02Thank you very much. Operator00:22:12Our next question comes from Jason Doerr from Oppenheimer. Speaker 600:22:15It's Jason here on for Leland Gershell. A couple of questions on Gvoke. How do you see the treatment landscape evolving over the next two to three years, especially in regards to competitors? And could you provide any additional color on how the revenue might look in the next two to three years with the Gvoke WildDx collaboration with American Region? Thank you. Speaker 200:22:48I'm going to try to break that down. The first question was with respect to Gvoke and the opportunity in patients with diabetes, the way I heard it. So as you know, and as we've talked a lot about, there are 15,000,000 patients out there today that should have a ready to use rescue glucagon on hand 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, is to find those patients who are not currently protected with a rescue med and get them protected. Speaker 200:23:38And that's a lot of work getting to the clinicians, 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 the process. That's what we're doing. That's what the competitors should be doing, and that's the long term landscape. So there's a lot of runway there to continue to do that. Speaker 200:24:05As for the Vile DX opportunity out there, more to come on that as we go. Our partner is going to launch by the end of the year. And as they get out there in the marketplace, we'll be able to give further guidance. For this year, there's not much impact, much more impact to our revenues than we've already seen. But in out years, we'll probably be in a better position in next year and beyond to really give some guidance on where that's going and how that's performing. Speaker 200:24:47We Operator00:24:53currently have no further questions. So I'd now like to hand back to John Shannon for some closing remarks. Speaker 100:25:00Thanks. Speaker 200:25:02As I look back on my first year leading Ziros, 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 Zerus. Underscoring the continued momentum 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, health care providers and shareholders alike. We remain committed to driving meaningful growth and operational excellence. Speaker 200:25:45Our 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. Operator00:26:02This concludes today's call. We thank everyone for joining. You may now disconnect your lines.Read morePowered by