Q4 2025 Xeris Biopharma Holdings Inc Earnings Call

March 2, 2026

Speaker #2: Thank you for joining us, and welcome to the Xeris Biopharma Q4 2025 Earnings Conference Call. After today's prepared remarks, we will host a question-and-answer session.

Speaker #2: If you would like to ask a question, please press star 1 on your telephone keypad. To withdraw your question, press star 1 again. I will now hand the call over to Allison Wey, Senior Vice President of Corporate Communications and Investor Relations.

Warren: Thank you, Warren. Good morning and welcome to the Xeris Biopharma 2025 Full Year Financial Results Conference Call. Earlier this morning, we issued a press release detailing our 2025 financial and operating results and financial guidance for 2026. This press release is available on our website. Joining me on the call today is John Shannon, our CEO, and Steve Pieper, our CFO. Following our prepared remarks, we'll open the call for questions. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements regarding Xeris's future expectations, plans, strategies, objectives, and financial performance. These forward-looking statements are based on management's current assumptions and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied.

Allison Wey: Thank you, Warren. Good morning and welcome to the Xeris Biopharma 2025 Full Year Financial Results Conference Call. Earlier this morning, we issued a press release detailing our 2025 financial and operating results and financial guidance for 2026. This press release is available on our website. Joining me on the call today is John Shannon, our CEO, and Steve Pieper, our CFO.

Speaker #2: Please go ahead.

Speaker #3: Thank you, Lauren. Good morning, and welcome to the Xeris Biopharma 2025 full-year financial results conference call. Earlier this morning, we issued a press release detailing our 2025 financial and operating results, as well as financial guidance for 2026.

Speaker #3: This press release is available on our website. Joining me on the call today is John Shannon, our CEO, and Steve Pieper, our CFO. Following our prepared remarks, we'll open the call for questions.

Allison Wey: Following our prepared remarks, we'll open the call for questions. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements regarding Xeris's future expectations, plans, strategies, objectives, and financial performance.

Speaker #3: Before we begin, I’d like to remind you that today’s discussion will include forward-looking statements regarding Xeris’s future expectations, plans, strategies, objectives, and financial performance.

Allison Wey: These forward-looking statements are based on management's current assumptions and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied.

Speaker #3: These forward-looking statements are based on management's current assumptions and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied.

Warren: For discussion of these risks and uncertainties, please refer to the risk factors described in our filings with the SEC. Any forward-looking statements made on this call speak only as of today's date, and except as required by law, the company undertakes no obligation to update or revise these statements. In addition, during today's call, we will reference certain financial measures that are presented on a non-GAAP basis. A reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is included in our earnings release. With that, I will now turn the call over to John for his opening remarks.

Allison Wey: For discussion of these risks and uncertainties, please refer to the risk factors described in our filings with the SEC. Any forward-looking statements made on this call speak only as of today's date, and except as required by law, the company undertakes no obligation to update or revise these statements.

Speaker #3: For discussion of these risks and uncertainties, please refer to the risk factors described in our filings with the SEC. Any forward-looking statements made on this call speak only as of today's date, except as required by law.

Speaker #3: The company undertakes no obligation to update or revise these statements. In addition, during today's call, we will reference certain financial measures that are presented on a non-GAAP basis.

Allison Wey: In addition, during today's call, we will reference certain financial measures that are presented on a non-GAAP basis. A reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is included in our earnings release. With that, I will now turn the call over to John for his opening remarks.

Speaker #3: A reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is included in our earnings release. With that, I will now turn the call over to John for his opening remarks.

John Shannon: Thanks, Allison. Good morning, everyone. We expected 2025 to be a transformational year for Xeris, and it was. Our performance extended well beyond our incredible Q4 and full year revenue growth. Across the organization, we executed with discipline and focus, advancing our strategic priorities and driving measurable progress throughout the business. Most importantly, we reached a defining milestone: financial self-sustainability. Our progress across the entire business has enabled us to forever put behind us the question of our ability to self-fund our strategy, our pipeline, and our future. Now, as we enter 2026, we do so with clear momentum, positioned to drive rapid revenue growth, execute on our advanced pipeline, and thoughtfully prepare for even greater opportunities ahead. I'm excited and confident that our long-term strategy is firmly on track. Before diving into the details, I want to recognize and thank the entire Xeris team.

Speaker #4: Thanks, Allison, and good morning, everyone. We expected 2025 to be a transformational year for Xeris, and it was. Our performance extended well beyond our incredible fourth quarter and full-year revenue growth.

Speaker #4: Across the organization, we executed with discipline and focus advancing our strategic priorities and driving measurable progress throughout the business. Most importantly, we reached a dividing milestone.

John Shannon: Most importantly, we reached a defining milestone: financial self-sustainability. Our progress across the entire business has enabled us to forever put behind us the question of our ability to self-fund our strategy, our pipeline, and our future.

Speaker #4: Financial self-sustainability. Our progress across the entire business has enabled us to forever put behind us the question of our ability to self-fund our strategy, our pipeline, and our future.

John Shannon: Now, as we enter 2026, we do so with clear momentum, positioned to drive rapid revenue growth, execute on our advanced pipeline, and thoughtfully prepare for even greater opportunities ahead. I'm excited and confident that our long-term strategy is firmly on track. Before diving into the details, I want to recognize and thank the entire Xeris team.

Speaker #4: Now, as we enter 2026, we do so with clear momentum, positioned to drive rapid revenue growth, execute on our advanced pipeline, and thoughtfully prepare for even greater opportunities ahead.

Speaker #4: I'm excited and confident that our long-term strategy is firmly on track. Before diving into the details, I want to recognize and thank the entire Xeris team.

John Shannon: The performance you delivered in 2025 and the strength of our outlook for 2026 is a direct result of your extraordinary commitment, focus, and disciplined execution across every part of our enterprise. Now to the results. Q4 total revenue grew 43% year-over-year to nearly $86 million. This outstanding quarterly result was driven by strong demand across all three products. For the full year, total revenue increased by an incredible 44% to $292 million. This performance was broad-based and strengthened as the year unfolded. Most importantly, it fueled our ability to deliver nearly $60 million in adjusted EBITDA and, for the first time, net income on a full year basis. The exceptional performance we delivered in the Q4 was no aberration. It reflects consistent progress throughout the year as we executed with increasing discipline and effectiveness.

Speaker #4: The performance you delivered in 2025 and the strength of our outlook for 2026 is a direct result of your extraordinary commitment, focus, and disciplined execution across every part of our enterprise.

Speaker #4: Now to the results. Fourth quarter total revenue grew 43% year over year to nearly $86 million. This outstanding quarterly result was driven by strong demand across all three products.

John Shannon: For the full year, total revenue increased by an incredible 44% to $292 million. This performance was broad-based and strengthened as the year unfolded. Most importantly, it fueled our ability to deliver nearly $60 million in adjusted EBITDA and, for the first time, net income on a full year basis.

Speaker #4: For the full year, total revenue increased by an incredible 44% to $292 million. This performance was broad-based and strengthened as the year unfolded. Most importantly, it fueled our ability to deliver nearly $60 million in adjusted EBITDA, and for the first time, net income on a full-year basis.

John Shannon: The exceptional performance we delivered in the Q4 was no aberration. It reflects consistent progress throughout the year as we executed with increasing discipline and effectiveness.

Speaker #4: The exceptional performance we delivered in the fourth quarter was no aberration. It reflects consistent progress throughout the year, as we executed with increasing discipline and effectiveness.

John Shannon: As a result, we exited 2025 with strong momentum, increased confidence in our strategy, and a significantly stronger operating platform. Let me walk you through performance across our 3 commercial products. First, Recorlev. Recorlev remained the primary growth engine for Xeris in 2025 and delivered another strong quarter in Q4. Recorlev's growth was driven by continued expansion of the patient base, ending the year at approximately 700 patients, nearly doubling the number of patients on therapy from a year-end 2024. This growth reflects expanding prescriber awareness in a very dynamic market, coupled with increasing confidence in Recorlev's differentiated clinical profile. In January, we nearly doubled our Recorlev commercial team, significantly expanding our sales and patient support organization to increase the quantity and quality of our healthcare provider and patient interactions.

Speaker #4: As a result, we exited 2025 with strong momentum, increased confidence in our strategy, and a significantly stronger operating platform. With that, let me walk you through performance across our three commercial products.

John Shannon: First, Recorlev. Recorlev remained the primary growth engine for Xeris in 2025 and delivered another strong quarter in Q4. Recorlev's growth was driven by continued expansion of the patient base, ending the year at approximately 700 patients, nearly doubling the number of patients on therapy from a year-end 2024.

Speaker #4: First, Recorela. Recorela remained the primary growth engine for Xeris in 2025 and delivered another strong quarter in Q4. Recorela's growth was driven by continued expansion of the patient base, ending the year at approximately 700 patients, nearly doubling the number of patients on therapy from year-end 2024.

John Shannon: This growth reflects expanding prescriber awareness in a very dynamic market, coupled with increasing confidence in Recorlev's differentiated clinical profile. In January, we nearly doubled our Recorlev commercial team, significantly expanding our sales and patient support organization to increase the quantity and quality of our healthcare provider and patient interactions.

Speaker #4: This growth reflects expanding prescriber awareness in a very dynamic market coupled with increasing confidence in Recorela's differentiated clinical profile. Turning to this year, in January, we nearly doubled our Recorela commercial team.

Speaker #4: We are significantly expanding our sales and patient support organizations to increase the quantity and quality of our healthcare provider and patient interactions. This expanded commercial footprint is expected to further escalate awareness and adoption, and we expect to see the impact of this expansion most notably in the second half of this year.

John Shannon: This expanded commercial footprint is expected to further escalate awareness and adoption, and we expect to see the impact of this expansion, most notably in the second half of this year and continuing well into the future. We believe Recorlev is still in the early stages of realizing its full commercial potential. Last week, we filed a patent infringement lawsuit against two ANDA filers to vigorously enforce our rights and defend Recorlev. We are very confident in the quality and strength of our intellectual property, our legal position, and our long-term outlook for Recorlev. We have built a strong IP foundation for Recorlev with four Orange Book-listed patents that run until March 2040 and orphan drug exclusivity, which runs through the end of 2028. Our Recorlev strategy is unchanged. Recorlev is and will continue to be on an exciting journey for many years to come.

Speaker #4: And continuing well into the future. We believe Recorela is still in the early stages of realizing its full commercial potential. Last week, we filed a patent infringement lawsuit against two ANDA filers to vigorously enforce our rights and defend Recorela.

John Shannon: Last week, we filed a patent infringement lawsuit against two ANDA filers to vigorously enforce our rights and defend Recorlev. We are very confident in the quality and strength of our intellectual property, our legal position, and our long-term outlook for Recorlev.

Speaker #4: We are very confident in the quality and strength of our intellectual property, our legal position, and our long-term outlook for Recorela. We have built a strong IP foundation for Recorela.

John Shannon: We have built a strong IP foundation for Recorlev with four Orange Book-listed patents that run until March 2040 and orphan drug exclusivity, which runs through the end of 2028. Our Recorlev strategy is unchanged. Recorlev is and will continue to be on an exciting journey for many years to come.

Speaker #4: With four Orange Book-listed patents that run until March 2040, and Orphan Drug Exclusivity, which runs through the end of 2028, our Recorlev strategy is unchanged.

Speaker #4: Recorela is and will continue to be on an exciting journey for many years to come. And our expectation shared during our investor day last June of $1 billion in peak sales by 2035 remains securely intact.

John Shannon: Our expectations shared during our Investor Day last June of $1 billion in peak sales by 2035 remains securely intact. Moving to Gvoke. Gvoke delivered steady, reliable growth in 2025, reinforcing its role as a durable and predictable contributor to our portfolio. On a full year basis, revenue grew 14%, supported by broad access, strong prescriber awareness, and continued alignment with treatment guidelines. Gvoke remains a potentially life-saving rescue product that should be in the hands of every person with diabetes at risk of having their blood sugar go too low. Keveyis. Keveyis continues to outperform expectations, and 2025 was no exception. The brand's strength and durability have only become more evident given that we were able to end the year with an increase in the number of patients on therapy versus 2024.

Speaker #4: Moving to Geevo. Geevo delivered steady, reliable growth in 2025, reinforcing its role as a durable and predictable contributor to our portfolio. On a full-year basis, revenue grew 14%.

Speaker #4: Supported by broad access, strong prescriber awareness, and continued alignment with treatment guidelines, Geevo remains a potentially life-saving rescue product that should be in the hands of every person with diabetes at risk of having their blood sugar go too low.

John Shannon: Gvoke remains a potentially life-saving rescue product that should be in the hands of every person with diabetes at risk of having their blood sugar go too low. Keveyis. Keveyis continues to outperform expectations, and 2025 was no exception. The brand's strength and durability have only become more evident given that we were able to end the year with an increase in the number of patients on therapy versus 2024.

Speaker #4: Caveas. Caveas continues to outperform expectations. And 2025 was no exception. The brand's strength and durability have only become more evident given that we were able to end the year with an increase in the number of patients on therapy versus 2024.

John Shannon: As we highlighted throughout 2025, success with Keveyis reflects not only the product itself, but the comprehensive support we provide to patients living with primary periodic paralysis. Importantly, Keveyis represents our long-standing commitment to serving a small, highly underserved patient community, and it remains deeply aligned with our mission to make a meaningful difference in the lives of patients with rare diseases. Turning to our pipeline. XP-8121 continues to advance according to plan. The anticipated initiation of Phase III in the second half of 2026 marks a significant value creation inflection point for the program and underscores our conviction in its blockbuster commercial potential. XP-8121 addresses a significant unmet medical need. There are over 20 million patients with hypothyroidism on daily oral replacement therapy today.

Speaker #4: As we highlighted throughout 2025, success with Caveas reflects not only the product itself, but the comprehensive support we provide to patients living with primary periodic paralysis.

Speaker #4: Importantly, Caveas represents our long-standing commitment to serving a small, highly underserved patient community, and it remains deeply aligned with our mission to make a meaningful difference in the lives of patients with rare diseases.

John Shannon: Turning to our pipeline. XP-8121 continues to advance according to plan. The anticipated initiation of Phase III in the second half of 2026 marks a significant value creation inflection point for the program and underscores our conviction in its blockbuster commercial potential. XP-8121 addresses a significant unmet medical need. There are over 20 million patients with hypothyroidism on daily oral replacement therapy today.

Speaker #4: Turning to our pipeline, XP8121 continues to advance according to plan. The anticipated initiation of Phase 3 in the second half of 2026 marks a significant value creation inflection point for the program and underscores our conviction in its blockbuster commercial potential.

Speaker #4: XP8121 addresses a significant unmet medical need. There are over 20 million patients with oral replacement therapy today. Of those 20 million patients, we believe there are 3 to 5 million patients who are unable to achieve and sustain normal range due to GI absorption issues.

John Shannon: Of those 20 million patients, we believe there are 3 to 5 million patients who are unable to achieve and sustain normal range due to GI absorption issues. XP-8121 is a once-weekly subcutaneous levothyroxine injection that potentially solves this problem for many patients. As we look ahead to Phase III, the program is entering a pivotal stage, one where execution, milestones, and value creation become increasingly tangible and visible. We believe XP-8121 has the attributes to become a differentiated high-impact therapy for patients and a meaningful growth driver for Xeris. Building on our strong commercial momentum, we are entering 2026 with three clear priorities. First, we remain focused on driving rapid revenue growth and are making targeted investments across our sales, patient support, and commercial infrastructure. Second, we will continue to advance XP-8121, our once-weekly subcutaneous levothyroxine for hypothyroidism.

Speaker #4: XP8121 is a once-weekly subcutaneous levothyroxine injection that potentially solves this problem for many patients. As we look ahead to phase three, the program is entering a pivotal stage.

Speaker #4: One where execution milestones and value creation become increasingly tangible and visible. We believe XP8121 has the attributes to become a differentiated, high-impact therapy for patients, and a meaningful growth driver for Xeris.

John Shannon: We believe XP-8121 has the attributes to become a differentiated high-impact therapy for patients and a meaningful growth driver for Xeris. Building on our strong commercial momentum, we are entering 2026 with three clear priorities.

Speaker #4: Building on our strong commercial momentum, we are entering 2026 with three clear priorities. First, we remain focused on driving rapid revenue growth and are making targeted investments across our sales, patient support, and commercial infrastructure.

John Shannon: First, we remain focused on driving rapid revenue growth and are making targeted investments across our sales, patient support, and commercial infrastructure. Second, we will continue to advance XP-8121, our once-weekly subcutaneous levothyroxine for hypothyroidism.

Speaker #4: Second, we will continue to advance XP8121, our once-weekly subcutaneous levothyroxine for hypothyroidism. We believe XP8121 has the opportunity to become our next blockbuster, potentially generating $1 to $3 billion in peak revenue.

John Shannon: We believe XP-8121 has the opportunity to become our next blockbuster, potentially generating $1 to 3 billion in peak revenue. As we prepare to initiate our Phase III program in the second half of 2026, we intend to significantly step up our R&D investments, marking a critical milestone for both the asset and the company. Third, we remain committed to maintaining a strong balance sheet with disciplined operating execution. This approach preserves our flexibility to make ongoing prioritized investments in our business. Together, these priorities position Xeris perfectly to drive sustained performance over the near, medium, and long term.

Speaker #4: As we prepare to initiate our phase three program in the second half of 2026, we intend to significantly step up our R&D investments marking a critical milestone for both the asset and the company.

John Shannon: Third, we remain committed to maintaining a strong balance sheet with disciplined operating execution. This approach preserves our flexibility to make ongoing prioritized investments in our business. Together, these priorities position Xeris perfectly to drive sustained performance over the near, medium, and long term.

Speaker #4: Third, we remain committed to maintaining a strong balance sheet with disciplined operating execution. This approach preserves our flexibility to make ongoing prioritized investments in our business.

Speaker #4: Together, these priorities position Xeris perfectly to drive sustained performance over the near medium and long term. With that momentum as context, before turning the call over to Steve, I'd like to briefly share our outlook for 2026.

John Shannon: With that momentum as context, before turning the call over to Steve, I'd like to briefly share our outlook for 2026. For the full year, we are expecting total revenue between $375 million and $390 million, representing more than 30% growth at the midpoint compared to 2025. We will continue to be adjusted EBITDA positive even as we significantly step up our R&D and commercial investments. With that, I'll turn the call over to Steve, who will take you through our financial results in greater detail and review our guidance for 2026.

Speaker #4: For the full year, we are expecting total revenue between $375 million and $390 million, representing more than 30% growth at the midpoint compared to 2025.

John Shannon: We will continue to be adjusted EBITDA positive even as we significantly step up our R&D and commercial investments. With that, I'll turn the call over to Steve, who will take you through our financial results in greater detail and review our guidance for 2026.

Speaker #4: We will continue to be adjusted EBITDA positive even as we significantly step up our R&D and commercial investments. Now, with that, I'll turn the call over to Steve, who will take you through our financial results in greater detail and review our guidance for 2026.

Steve Pieper: Thanks, John. The results we are reviewing today are the product of a year defined by discipline, focus, and strong execution across the organization. I too want to thank our employees for your dedication, accountability, and relentless focus on delivering against our priorities. Your efforts continue to strengthen our operational foundation and position us for sustained success. Turning now to the Q4 and full year results. Total revenue for the Q4 was $85.8 million, representing 43% growth year-over-year. The strong performance reflects continued underlying demand across our portfolio. Importantly, this performance reinforces the momentum we carried through the end of the year as we enter 2026 with a solid foundation for continued growth. For the full year, total revenue was $291.8 million, an increase of 44% compared to 2024.

Speaker #5: Thanks, John. The results we are reviewing today are the product of a year defined by discipline, focus, and strong execution across the organization. I, too, want to thank our employees for your dedication accountability and relentless focus on delivering against our priorities.

Speaker #5: Your efforts continue to strengthen our operational foundation and position us for sustained success. Turning now to the fourth quarter and full-year results: Total revenue for the fourth quarter was $85.8 million, representing 43% growth year over year.

Steve Pieper: Turning now to the Q4 and full year results. Total revenue for the Q4 was $85.8 million, representing 43% growth year-over-year. The strong performance reflects continued underlying demand across our portfolio. Importantly, this performance reinforces the momentum we carried through the end of the year as we enter 2026 with a solid foundation for continued growth. For the full year, total revenue was $291.8 million, an increase of 44% compared to 2024.

Speaker #5: The strong performance reflects continued underlying demand across our portfolio. Importantly, this performance reinforces the momentum we carried through the end of the year as we enter 2026 with a solid foundation for continued growth.

Speaker #5: For the full year, total revenue was $291.8 million, an increase of 44% compared to 2024. This growth was driven by robust demand across all three commercial products: LeCorLev, Gvoke, and Keveyis.

Steve Pieper: This growth was driven by robust demand across all three commercial products, Recorlev, Gvoke, and Keveyis. Looking at our performance from a product level. Recorlev revenue was $45.3 million in Q4 and $139.3 million for the full year. This reflects growth of more than 100% both for Q4 and the full year, and was driven almost entirely by a continued expansion of the patient base, reflecting strong underlying demand and increasing prescriber confidence. Gvoke delivered revenue of $24.6 million in Q4 and $94.1 million for the full year. Performance reflected steady prescription growth, broad access, and favorable gross-to-net dynamics. Gvoke continues to serve as a stable and predictable contributor to our revenue base.

Speaker #5: Looking at our performance from a product level, LeCorLev revenue was $45.3 million in the fourth quarter and $139.3 million for the full year. This reflects growth of more than 100% for both the fourth quarter and the full year, and was driven almost entirely by a continued expansion of the patient base, reflecting strong underlying demand and increasing prescriber confidence.

Steve Pieper: This reflects growth of more than 100% both for Q4 and the full year, and was driven almost entirely by a continued expansion of the patient base, reflecting strong underlying demand and increasing prescriber confidence.

Steve Pieper: Gvoke delivered revenue of $24.6 million in Q4 and $94.1 million for the full year. Performance reflected steady prescription growth, broad access, and favorable gross-to-net dynamics. Gvoke continues to serve as a stable and predictable contributor to our revenue base.

Speaker #5: Gvoke delivered revenue of $24.6 million in the fourth quarter and $94.1 million for the full year. Performance reflected steady prescription growth, broad access, and favorable gross-to-net dynamics.

Speaker #5: Gvoke continues to serve as a stable and predictable contributor to our revenue base. Keveyis generated revenue of $12.8 million in the fourth quarter, and $47.6 million for the year.

Steve Pieper: Keveyis generated revenue of $12.8 million in Q4 and $47.6 million for the year, supported by an increase in the average number of patients on therapy. Our performance continues to benefit from our focused approach to ongoing healthcare provider and patient support. Overall, the breadth of contribution across our portfolio reinforces the durability of our revenue base and the focus of our team to meet and exceed goals. Gross margin for Q4 was 87% and for the full year was 85%, reflecting steady improvement relative to prior year, driven by favorability from product mix. R&D expenses were $7.9 million for the quarter and $31.2 million for the year.

Speaker #5: Supported by an increase in the average number of patients on therapy, our performance continues to benefit from our focused approach to ongoing healthcare provider and patient support.

Steve Pieper: Overall, the breadth of contribution across our portfolio reinforces the durability of our revenue base and the focus of our team to meet and exceed goals. Gross margin for Q4 was 87% and for the full year was 85%, reflecting steady improvement relative to prior year, driven by favorability from product mix. R&D expenses were $7.9 million for the quarter and $31.2 million for the year.

Speaker #5: Overall, the breadth of contribution across our portfolio reinforces the durability of our revenue base and the focus of our team to meet and exceed goals.

Speaker #5: Gross margin for the fourth quarter was $87%, and for the full year was $85%, reflecting steady improvement relative to prior year driven by favorability from product mix.

Speaker #5: R&D expenses were $7.9 million for the quarter, and $31.2 million for the year. The 22% increase year over year primarily reflects our continued discipline investment in advancing our pipeline, including increased spend to support our preparation for the upcoming phase three clinical trial XP8121.

Steve Pieper: The 22% increase year-over-year primarily reflects our continued disciplined investment in advancing our pipeline, including increased spend to support our preparation for the upcoming Phase III clinical trial, XP-8121. SG&A expenses were $47.5 million for the Q4, representing an increase of approximately 18% compared to prior year. For the full year, SG&A expenses were $182.4 million, an increase of approximately 12%, driven by incremental personnel-related investments to support the rising demand for our commercial products. Adjusted EBITDA for the Q4 was $25.1 million, an improvement of $16.8 million compared to last year. For the full year, adjusted EBITDA was $59.4 million. The improved results reflect continued operating leverage and underscores our ability to scale revenue while maintaining a disciplined approach to expense management.

Speaker #5: SG&A expenses were $47.5 million for the quarter, representing an increase of approximately 18% compared to the prior year. For the full year, SG&A expenses were $182.4 million, an increase of approximately 12%, driven by incremental personnel-related investments to support the rising demand for our commercial products.

Steve Pieper: For the full year, SG&A expenses were $182.4 million, an increase of approximately 12%, driven by incremental personnel-related investments to support the rising demand for our commercial products. Adjusted EBITDA for the Q4 was $25.1 million, an improvement of $16.8 million compared to last year.

Speaker #5: Adjusted EBITDA for the fourth quarter was $25.1 million, an improvement of 16.8 million compared to last year. For the full year, adjusted EBITDA was $59.4 million, the improved results reflect continued operating leverage and underscores our ability to scale revenue while maintaining a disciplined approach to expense management.

Steve Pieper: For the full year, adjusted EBITDA was $59.4 million. The improved results reflect continued operating leverage and underscores our ability to scale revenue while maintaining a disciplined approach to expense management.

Steve Pieper: We also delivered another period of net income in Q4. As a result, we reported net income on a full year basis for 2025. Importantly, our 2025 performance resulted in an improved balance sheet, which provides us with the flexibility to fund continued revenue growth, advance XP-8121, and operate the business from a position of financial strength. As John outlined, we have entered 2026 guided by a clear set of priorities that underpin our decision making. These priorities include: 1, driving continued rapid revenue growth. 2, initiating the Phase III study for XP-8121, a significant milestone for the company. Lastly, maintaining disciplined investment prioritization as we continue to enhance operating leverage. We believe this balanced approach positions us well for 2026 and beyond. Turning to our outlook for 2026.

Speaker #5: We also delivered another period of net income in the fourth quarter, and, as a result, we reported net income on a full-year basis for 2025.

Speaker #5: Importantly, our 2025 performance resulted in an improved balance sheet which provides us with the flexibility to fund continued revenue growth, advance XP8121, and operate the business from a position of financial strength.

Steve Pieper: As John outlined, we have entered 2026 guided by a clear set of priorities that underpin our decision making. These priorities include: 1, driving continued rapid revenue growth. 2, initiating the Phase III study for XP-8121, a significant milestone for the company.

Speaker #5: As John outlined, we have entered 2026 guided by a clear set of priorities that underpin our decision-making. These priorities include: 1. Driving continued rapid revenue growth.

Speaker #5: 2. Initiating the phase 3 study for XP8121, a significant milestone for the company. And lastly, maintaining disciplined investment prioritization as we continue to enhance operating leverage.

Steve Pieper: Lastly, maintaining disciplined investment prioritization as we continue to enhance operating leverage. We believe this balanced approach positions us well for 2026 and beyond. Turning to our outlook for 2026.

Speaker #5: We believe this balanced approach positions us well for 2026 and beyond. Turning to our outlook for 2026, we expect total revenue to be between $375 and $390 million for the full year.

Steve Pieper: We expect total revenue to be between $375 and $390 million for the full year, representing over 30% growth at the midpoint. This outlook reflects expanding patient demand across our products. Our revenue growth is also expected to drive a modest improvement in gross margin as we continue to benefit from a favorable product mix. Moving to R&D. As we plan to initiate our Phase III study for XP-8121 in the second half of the year, we expect R&D to increase by approximately $25 million. This step up reflects a deliberate and disciplined allocation of capital to advance XP-8121 and is critical to unlocking its significant long-term value and future potential, which we believe is $1 to 3 billion in peak sales.

Speaker #5: Representing over 30% growth at the midpoint. This outlook reflects expanding patient demand across our products. Our revenue growth is also expected to drive a modest improvement in gross margin, as we continue to benefit from a favorable product mix.

Steve Pieper: Moving to R&D. As we plan to initiate our Phase III study for XP-8121 in the second half of the year, we expect R&D to increase by approximately $25 million. This step up reflects a deliberate and disciplined allocation of capital to advance XP-8121 and is critical to unlocking its significant long-term value and future potential, which we believe is $1 to 3 billion in peak sales.

Speaker #5: Moving to R&D, as we plan to initiate our phase three study for XP8121 in the second half of the year, we expect R&D to increase by approximately 25 million.

Speaker #5: This step-up reflects a deliberate and disciplined allocation of capital to advance XP8121 and is critical to unlocking significant long-term value and future potential.

Speaker #5: Which we believe is $1 to $3 billion in peak sales. Looking at SG&A, we continue to invest and scale our commercial enterprise to support LeCorLev on its own journey to $1 billion in peak sales by 2035.

Steve Pieper: Looking at SG&A, we continue to invest and scale our commercial enterprise to support Recorlev on its own journey to $1 billion in peak sales by 2035. As such, we plan to increase SG&A by approximately $45 million in 2026, primarily due to the expansion we recently completed. This deliberate material step up in investment will drive significant revenue growth, resulting in improved operating leverage across the business. As we committed to in 2025, we expect to remain adjusted EBITDA positive moving forward and specific to 2026, we expect adjusted EBITDA will grow on an absolute dollars basis compared to 2025. Our business has never been on more solid financial ground. The sales growth momentum is enabling our reinvestment strategy, and every dollar we deploy is aimed at expanding our capabilities and positioning Xeris for sustained long-term growth.

Speaker #5: As such, we plan to increase SG&A by approximately $45 million in 2026, primarily due to the expansion we recently completed. This deliberate, material step-up in investment will drive significant revenue growth, resulting in improved operating leverage across the business.

Steve Pieper: This deliberate material step up in investment will drive significant revenue growth, resulting in improved operating leverage across the business. As we committed to in 2025, we expect to remain adjusted EBITDA positive moving forward and specific to 2026, we expect adjusted EBITDA will grow on an absolute dollars basis compared to 2025.

Speaker #5: As we committed to in 2025, we expect to remain adjusted EBITDA positive moving forward, and, specific to 2026, we expect adjusted EBITDA will grow on an absolute dollars basis compared to 2025.

Steve Pieper: Our business has never been on more solid financial ground. The sales growth momentum is enabling our reinvestment strategy, and every dollar we deploy is aimed at expanding our capabilities and positioning Xeris for sustained long-term growth. With that, I'll turn the call over to the operator for Q&A.

Speaker #5: Our business has never been on more solid financial ground. The sales growth momentum is enabling our reinvestment strategy and every dollar we deploy is aimed at expanding our capabilities and positioning Xeris for sustained long-term growth.

Steve Pieper: With that, I'll turn the call over to the operator for Q&A.

Speaker #5: With that, I'll turn the call over to the operator for Q&A.

Allison Wey: We will now begin the question-and-answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star one on your telephone keypad. To withdraw your question, press star one again. Please pick up your handset when asking a question. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of David Amsellem with Piper Sandler. Your line is open. Please go ahead.

Operator: We will now begin the question-and-answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star one on your telephone keypad. To withdraw your question, press star one again.

Speaker #1: We will now begin the question and answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star 1 on your telephone keypad.

Speaker #1: To withdraw your question, press star 1 again. Please pick up your handset when asking a question. If you are muted locally, please remember to unmute your device.

Operator: Please pick up your handset when asking a question. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of David Amsellem with Piper Sandler. Your line is open. Please go ahead.

Speaker #1: Please stand by while we compile the Q&A roster. Your first question comes from the line of David Anselem, with Piper Sandler. Your line is open.

Speaker #1: Please go ahead.

David Amsellem: Hey, thanks. Just a couple for me. Helpful color on the spend this year. Was wondering, though, as you think about the expansion of Recorlev, and the widening of the addressable market that you've seen and certainly your competitors have seen, can you talk about the extent of additional operating leverage that you think you're going to be able to realize longer term and specifically interested in further sales force expansion? I guess we've seen, for instance, your competitor expand the sales force a few times. Is that a good way to think about what you're going to need to do to adequately support Recorlev? That's number 1.

Speaker #3: Hey, thanks. So just a couple for me. Helpful color on the spend this year. I was wondering, though, as you think about the expansion of LeCorLev and the widening of the addressable market that you've seen, and certainly your competitors have seen, can you talk about the extent of additional operating leverage that you think you're going to be able to realize longer term? Specifically, I'm interested in further Salesforce expansion, or I guess we've seen, for instance, your competitor expand the Salesforce a few times.

David Amsellem: I guess we've seen, for instance, your competitor expand the sales force a few times. Is that a good way to think about what you're going to need to do to adequately support Recorlev? That's number 1.

Speaker #3: Is that a good way to think about what you're going to need to do to adequately support LeCorLev? So that's number one. And then, number two is, as you think about the IP litigation—and I realize this is going to play out over the long term—but just help us understand how that's playing into your sense of urgency regarding the potential acquisition of an asset where you can leverage your now expanded commercial organization.

David Amsellem: Number two is, as you think about the IP litigation, and I realize this is gonna play out over the long term, but just help us understand how that's playing into your sense of urgency regarding the potential acquisition of an asset where you can leverage your now expanded commercial organization. That would be helpful color as well. Thank you.

Speaker #3: That would be helpful color as well. Thank you.

Steve Pieper: Thanks, David. It's John. Let's start with the expansion. We just doubled our commercial footprint as of the first of January. When I say that, it's not only our salespeople but all the patient support, medical affairs, pharmacy services, all of those things that it takes to manage this very complex patient as you bring them onto therapy. We see that, you know, as, you know, a significant move that we need to do in order to continue to drive the growth we're driving and get those patients on therapy and keep them on therapy. As we continue to expand in the outer years, we'll need to add more resources in that capacity. It just takes more to again manage the patient loads.

John Shannon: Thanks, David. It's John. Let's start with the expansion. We just doubled our commercial footprint as of the first of January. When I say that, it's not only our salespeople but all the patient support, medical affairs, pharmacy services, all of those things that it takes to manage this very complex patient as you bring them onto therapy.

Speaker #4: Thanks, David. It's John. Let's start with the expansion. We just doubled our commercial footprint as of the 1st of January. When I say that, it's not only our salespeople, but all the patient support, medical affairs, pharmacy services—all of those things that it takes to manage this very complex patient.

John Shannon: We see that, you know, as, you know, a significant move that we need to do in order to continue to drive the growth we're driving and get those patients on therapy and keep them on therapy. As we continue to expand in the outer years, we'll need to add more resources in that capacity. It just takes more to again manage the patient loads.

Speaker #4: As you bring them on to therapy, we see that as a significant move that we need to make in order to continue to drive the growth we're seeing.

Speaker #4: And get those patients on therapy and keep them on therapy. As we continue to expand into outer years, we'll need to add more resources in that capacity.

Speaker #4: It just takes more to, again, manage the patient loads. So we see that as continuing and continuing based on scale and how we grow there.

Steve Pieper: We see that as continuing and continuing based on scale and how we grow there. We're also making, you know, additional investments in data studies, things like that. We'll see that over time as well. We see a, you know, a constant and consistent increase in expense and investment on Recorlev for the next several years. As it relates to your question, I think around IP litigation and how does that change anything? Well, as I said in my opening comments-

John Shannon: We see that as continuing and continuing based on scale and how we grow there. We're also making, you know, additional investments in data studies, things like that. We'll see that over time as well. We see a, you know, a constant and consistent increase in expense and investment on Recorlev for the next several years. As it relates to your question, I think around IP litigation and how does that change anything? Well, as I said in my opening comments-

Speaker #4: We're also making additional investments in data, studies, things like that. So we'll see that over time as well. And so we see a constant and consistent increase in expense and investment on LeCorLev for the next several years.

Speaker #4: As it relates to your question, I think around IP litigation and how does that change anything? Well, as I said in my opening comments, our strategy is unchanged on LeCorLev.

John Shannon: Our strategy is unchanged on Recorlev. We will continue to do exactly what we said we were gonna do. We think we know we can get this thing to $1 billion by 2035. Those investments will again, continue to come on a scaled approach so that we can, you know, again, manage the growth that we're driving. We see that as longer term, and we feel strongly that we'll continue to do that, and we'll be able to get this to a $1 billion product by 2035.

Speaker #4: We will continue to do exactly what we said we were going to do. We think we know we can get this thing to a billion dollars by 2035.

Speaker #4: Those investments will, again, continue to come on a scaled approach so that we can, again, manage the growth that we're driving. So we see that as longer term, and we feel strongly that we'll continue to do that.

Speaker #4: And we'll be able to get this to a $1 billion product by 2035.

Allison Wey: Your next question comes from the line of Brandon Folkes with H.C. Wainwright. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Brandon Folkes with H.C. Wainwright. Your line is open. Please go ahead.

Speaker #1: Your next question comes from the line of Brandon Folks, with HC Wainwright. Your line is open. Please go ahead.

Brandon Folkes: Hi, thanks for taking my questions, and congratulations on another very good quarter. So maybe just following on from the earlier line of questioning, can you just help us think about the evolution of capital deployment beyond 2026? You know, as you realize this operating leverage in the business, what's your updated thinking about sort of internal allocations that you've laid out today on the call, versus perhaps external business development? Does the emergence of this IP litigation change your appetite to perhaps sort of bring in something between sort of now and when XP-8121 comes to market to just sort of hedge the product concentration risk? Then secondly, maybe I'll just ask this 'cause maybe it goes in. Can you just talk about the evolution of gross margin here longer term?

Speaker #5: Hi, thanks for taking my questions, and congratulations on another very good quarter. Maybe just following on from the earlier line of questioning, can you help us think about the evolution of capital deployment beyond 2026?

Speaker #5: As you realize this operating leverage in the business, what's your updated thinking about sort of internal allocations that you've laid out today on the call?

Speaker #5: Versus, perhaps, external business development, does the emergence of this IP litigation change your appetite to perhaps sort of bring in something between now and when '81, '21 comes to market, to just sort of hedge the product concentration risk?

Brandon Folkes: Does the emergence of this IP litigation change your appetite to perhaps sort of bring in something between sort of now and when XP-8121 comes to market to just sort of hedge the product concentration risk? Then secondly, maybe I'll just ask this 'cause maybe it goes in. Can you just talk about the evolution of gross margin here longer term?

Speaker #5: And then secondly, maybe I'll just ask this because maybe it goes in. Can you just talk about the evolution of gross margin here longer term?

Brandon Folkes: How should we think about gross to net in 2026 across your portfolio, as we think about the evolution just with regards to product mix? Thank you.

Speaker #5: How should we think about gross to net in 2026 across your portfolio, as we think about the evolution just with regards to product mix?

Speaker #5: Thank you.

John Shannon: Let me try to start this, Brandon Folkes, and I don't know that we got all those questions in there, so, we'll try to answer them all. You know, so, as you heard in our comments, we're in a position where we're self-sustainable in terms of the amount of leverage we're getting from the business and our ability to support, you know, whatever is in front of us, specifically XP-8121 and Recorlev growth. You know, as it relates to the IP, again, nothing's changed. It's unchanged. We weren't surprised by these lawsuits.

Speaker #4: Let me try to start this, Brandon, and I don't know that we got all those questions in there. So, we'll try to answer them all.

Speaker #4: So, as you heard in our comments, we're in a position where we're self-sustainable in terms of the amount of leverage we're getting from the business and our ability to support whatever is in front of us.

Speaker #4: Specifically, '81, '21. And LeCorLev growth. And as it relates to the IP, again, nothing's changed. It's unchanged. We weren't surprised by these lawsuits. So we knew this was coming.

John Shannon: We knew this was coming, we saw this coming, we're prepared for it. We still see a future where we have lots of opportunities in front of us with respect to our own existing technology and capabilities to drive growth for a long time, as well as external. We see all of that in front of us. Now that we're at this point where we're, you know, forever, you know, have situations where as long as we continue to grow, we'll be able to continue to leverage that into future growth. I'll let Keith cover any of the kinda...

Speaker #4: We saw this coming. We're prepared for it. And we still see a future where we have lots of opportunities in front of us with respect to our own existing technology and capabilities to drive growth for a long time, as well as external.

John Shannon: We see all of that in front of us. Now that we're at this point where we're, you know, forever, you know, have situations where as long as we continue to grow, we'll be able to continue to leverage that into future growth. I'll let Keith cover any of the kinda...

Speaker #4: So we see all of that in front of us. And now that we're at this point where we'll forever have situations where, as long as we continue to grow, we'll be able to continue to leverage that in the future growth.

Speaker #4: So and then I'll let Steve cover any of the kind of.

Steve Pieper: Yeah. I'll just add on to John's comments around operating leverage and some of the questions that have come up. I mean, yeah, I think when you start to do the math on our growth trajectory and look at even with the step-up in investment, it's becoming clear that, you know, the balance sheet is as strong as ever, and it will continue to improve, and our operating leverage will continue to improve. That opens up capacity to do other things. The good news is we don't have to do other things. We've got great assets, both commercial assets and an asset in the pipeline, a blockbuster in the wings. Certainly opens up capacity to do other things.

Speaker #3: Yeah, I'll just add on to John's comments around operating leverage and some of the questions that have come up. I mean, yeah, I think when you start to do the math on our growth trajectory and look at—even with the step up in investment—it's becoming clear that the balance sheet is as strong as ever, and it will continue to improve.

Speaker #3: And our operating leverage will continue to improve, and so that opens up capacity to do other things. The good news is, we don't have to do other things.

Steve Pieper: That opens up capacity to do other things. The good news is we don't have to do other things. We've got great assets, both commercial assets and an asset in the pipeline, a blockbuster in the wings. Certainly opens up capacity to do other things.

Speaker #3: We've got great assets—both commercial assets and assets in the pipeline—a blockbuster in the wings. But certainly, it opens up capacity to do other things.

Steve Pieper: We'll continue to be disciplined about business development and evaluating those things. Touching on your question around gross margin and gross-to-net. Our gross-to-net, you know, we benefited on Gvoke specifically this year. I would say gross-to-nets on balance have kind of steadied out, so we're not expecting any material movement either way in 2026 on the gross-to-net front. From a gross margin perspective, as we've noted over the last, you know, year and a half, we've seen a nice steady increase in our gross margin, really benefiting from product mix. We see that continuing for the foreseeable future and, you know, approaching kind of best-in-class gross margin profiles for a company that looks like us.

Speaker #3: We'll continue to be disciplined about business development and evaluating those things. Touching on your question around gross margin and gross to net, Sarah—gross to net, we benefited on Gvoke specifically this year.

Steve Pieper: I would say gross-to-nets on balance have kind of steadied out, so we're not expecting any material movement either way in 2026 on the gross-to-net front. From a gross margin perspective, as we've noted over the last, you know, year and a half, we've seen a nice steady increase in our gross margin, really benefiting from product mix.

Speaker #3: I would say gross to net, on balance, have kind of steadied out. So we're not expecting any material movement either way in '26 on the gross to net front.

Speaker #3: From a gross margin perspective, as we've noted over the last year and a half, we've seen a nice steady increase in our gross margin, really benefiting from product mix.

Steve Pieper: We see that continuing for the foreseeable future and, you know, approaching kind of best-in-class gross margin profiles for a company that looks like us. Hopefully, that addresses your questions, Brandon.

Speaker #3: We see that continuing. For the foreseeable future, and approaching kind of best-in-class gross margin profiles for a company that looks like us. So hopefully that addresses your questions, Brandon.

Steve Pieper: Hopefully, that addresses your questions, Brandon.

Brandon Folkes: It does. You got all of them, so I appreciate that, and I appreciate the color. Congrats again.

Speaker #5: It does. You got all of them, so I appreciate that. And I appreciate the color. Congrats again.

Allison Wey: Your next question comes from the line of Chase Knickerbocker with Craig-Hallum. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Chase Knickerbocker with Craig-Hallum. Your line is open. Please go ahead.

Speaker #1: Your next question comes from the line of Chase Knickerbocker with Craig Hallum. Your line is open. Please go ahead.

Chase Knickerbocker: Good morning. Congrats on all the progress here, and thanks for taking the questions. Maybe just first to start out, a little bit more color on guidance would be helpful. Can you just kinda walk us through, maybe with kind of some rough outlines, how you're kinda thinking about the top line by product in 2026, obviously, largely being, you know, being driven by Recorlev, but any sort of thoughts, you know, kinda down the product portfolio would be helpful?

Speaker #5: Good morning. Congrats on all the progress here, and thanks for taking the questions. Maybe just first to start out, a little bit more color on guidance would be helpful.

Speaker #5: Can you just kind of walk us through, maybe with some rough outlines, how you're kind of thinking about the top line by product in 2026?

Speaker #5: Obviously, largely being driven by LeCorLev. But any sort of thoughts kind of down the product portfolio would be helpful.

Steve Pieper: Good morning, Chase. Yeah, I'll take this one. On the revenue, I think, you know, maybe we'll start with the easiest one is Keveyis. You know, we see that Keveyis is kind of, you know, been a steady contributor over the last, you know, 5, 6 quarters in terms of its revenue contribution. It's kind of, you know, flattening out, so to speak. I think that's a fair assumption moving forward. On Gvoke, I think what we've talked about, you know, over the last year is that we see that again being a steady contributor in that high single-digit, low double-digit growth. I would anticipate that we're gonna see that play out in 2026 that way. Then for Recorlev, that is, you know, the growth driver.

Speaker #3: Good morning, Chase. Yeah, I'll take this one. So, on the revenue, I think maybe we'll start with the easiest one, which is Caveas. We see that Caveas has kind of been a steady contributor over the last five or six quarters in terms of its revenue contribution.

Speaker #3: And it's kind of flattening out, so to speak. So I think that's a fair assumption moving forward. On Gbook, I think what we've talked about over the last year is that we see that, again, being a steady contributor.

Steve Pieper: I think that's a fair assumption moving forward. On Gvoke, I think what we've talked about, you know, over the last year is that we see that again being a steady contributor in that high single-digit, low double-digit growth. I would anticipate that we're gonna see that play out in 2026 that way. Then for Recorlev, that is, you know, the growth driver.

Speaker #3: And that high single-digit, low double-digit growth—and I would anticipate that we're going to see that play out in 2026 that way. And then for LeCorLev, that is the growth driver.

Steve Pieper: You can kind of back into the math there in terms of the contribution there. That's, that's on balance what we're expecting. You know, we do expect some contribution from, you know, our partnerships, other revenue. Historically, it's been in that 5 to 10 range. I think that's a fair assumption for 2026.

Speaker #3: So you can kind of back into the math there in terms of the contribution there. But that's, on balance, what we're expecting. And we do expect some contribution from our partnerships—other revenue. Historically, it's been in that $5 to $10 million range.

Speaker #3: I think that's a fair assumption for 2026.

Chase Knickerbocker: Helpful. Maybe just specifically on Recorlev, you know, obviously, you know, very strong implied guide. Can you maybe talk to us about kind of what you've seen so far in Q1, even kind of before that sales force expansion, you know, benefit that you will get here? You know, there was a competitive product that was kind of expected in the market in 2026. I mean, any kind of anticipation that you sensed in the market from that is kind of now unwound and kinda come to your benefit? Just some thoughts there would be helpful.

Speaker #5: Helpful. And maybe just specifically on LeCorLev, obviously, very strong implied guide. Can you maybe talk to us about kind of what you've seen so far on Q1, even kind of before that Salesforce expansion benefit that you will get here?

Chase Knickerbocker: You know, there was a competitive product that was kind of expected in the market in 2026. I mean, any kind of anticipation that you sensed in the market from that is kind of now unwound and kinda come to your benefit? Just some thoughts there would be helpful.

Speaker #5: And there was a competitive product that was kind of expected in the market in 2026. I mean, any kind of anticipation that you sensed in the market from that, that has kind of now unwound and kind of come to your benefit?

Speaker #5: Just some thoughts that would be helpful.

John Shannon: Yeah. Chase, it's John. I, you know, I think Q1 is as we expected. It's pretty typical. You know, we get a lot of, you know, payer resets and co-pay resets and things like that that slow down the quarter early on in January. We see that it's another typical year. You know, that's all kind of starting to rebound pretty aggressively in February and going into it usually does so in March. We're seeing that standard. In terms of, you know, a lack of a new competitor, I don't think that's really changed much. The market dynamic is still very strong towards finding and diagnosing people with hypercortisolemia and getting them treated. That momentum continues in the marketplace.

Speaker #4: Yeah, Chase, it's John. I think the first quarter is as we expected. It's pretty typical. We get a lot of payer resets and copay resets and things like that that slow down the quarter early on in January.

Speaker #4: We see that it's another typical year. But that's all kind of starting to rebound pretty aggressively in February. And going into usually does so in March.

John Shannon: We're seeing that standard. In terms of, you know, a lack of a new competitor, I don't think that's really changed much. The market dynamic is still very strong towards finding and diagnosing people with hypercortisolemia and getting them treated. That momentum continues in the marketplace.

Speaker #4: So we're seeing that standard. In terms of a lack of a new competitor, I don't think that's really changed much. The market dynamic is still very strong towards finding and diagnosing people with hypercortisolemia.

Speaker #4: And getting them treated. So that momentum continues in the marketplace. And now with our expanded team in there, we're in a great position to capture more of it.

John Shannon: You know, and now with our expanded team in there, we're in a great position to capture more of it. We don't see any of that slowing down, you know, in our, in our organization or as well as with any of our competitors.

Speaker #4: And we don't see any of that slowing down in our organization, or with any of our competitors, as well.

Chase Knickerbocker: Helpful, guys. Thank you.

Speaker #5: Helpful, guys. Thank you.

Allison Wey: Your next question comes from the line of Dennis Ding with Jefferies. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Dennis Ding with Jefferies. Your line is open. Please go ahead.

Speaker #1: Your next question comes from the line of Dennis Ding with Jefferies. Your line is open. Please go ahead.

Dennis Ding: Hi, good morning. Thanks for taking our questions. We have two on Recorlev. Number one, it's been a few years since the launch, so I guess, what is holding you back from issuing Recorlev guidance? I guess, what additional data do you need to make an informed approach to guidance? Number two, do you have any updated thoughts on how you're thinking about the market if Teva indeed is able to secure specialty pharmacy to distribute generic Korlym, and if you think that's a risk at all? I mean, thanks.

Speaker #6: Hi, good morning. Thanks for taking our questions. We have two on LeCorLev. So, number one, it's been a few years since the launch, so I guess what is holding you back from issuing LeCorLev guidance?

Speaker #6: And I guess what additional data do you need to make an informed approach to guidance? And then number two, do you have any updated thoughts on how you're thinking about the market?

Dennis Ding: Number two, do you have any updated thoughts on how you're thinking about the market if Teva indeed is able to secure specialty pharmacy to distribute generic Korlym, and if you think that's a risk at all? I mean, thanks.

Speaker #6: If Teva indeed is able to secure specialty pharmacy to distribute generic Corlim, and if you think that's a risk at all? Many thanks.

John Shannon: Yeah. Dennis, the first one is, you know, we don't give specific product guidance, and we haven't. You know, we just, you know, give a total revenue guidance and try to give it, you know, the color Steve just gave. That there's no hesitation there. It's just that's what we do. I don't know I understood or could even hear your last question, so maybe you could repeat that.

Speaker #4: Yeah, Dennis, the first one is we don't give specific product guidance, and we haven't. And so we just give a total revenue guidance. And try to give it the color Steve just gave.

Speaker #4: So there's no hesitation there. It's just that's what we do. And then, I don't know if I understood or could even hear your last question.

Dennis Ding: Yeah. Yeah. Maybe I'll just repeat that. Yeah. I was just wondering if you have any updated thoughts on how you're thinking about the Cushing's market and for Recorlev specifically, if Teva is indeed able to secure a specialty pharmacy to distribute generic Korlym, if you, if you think that is a risk at all, for your business moving forward?

Speaker #4: So maybe you could repeat that.

Speaker #6: Yeah, maybe I'll just repeat that. Yeah, I was just wondering if you have any updated thoughts on how you're thinking about the cushions market, and for LeCorLev specifically?

Speaker #6: If Teva is indeed able to secure a specialty pharmacy to distribute generic Corlim, do you think that is a risk at all for your business moving forward?

John Shannon: Yeah. We don't see that as a risk at all for our business. With respect to generic Korlym, we haven't seen that for the last couple years. We don't see that going forward. This is a scenario where a clinician will have to write a referral for someone to normalize cortisol in order to get to Recorlev, and that's a very different approach than what Korlym does.

Speaker #4: Yeah, we don't see that as a risk at all for our business. With respect to generic Corlim, we haven't seen that for the last couple of years.

Speaker #4: We don't see that going forward. This is a scenario where a clinician will have to write a referral for someone to normalize cortisol in order to get to LeCorLev.

Speaker #4: And that's a very different approach than what Corlim does.

Dennis Ding: Okay. Thank you.

Speaker #6: Okay, thank you.

Allison Wey: Your next question comes from the line of Roanna Ruiz with Leerink Partners. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Roanna Ruiz with Leerink Partners. Your line is open. Please go ahead.

Speaker #1: Your next question comes from the line of Rowan Ruiz, with Liebrink Partners. Your line is open. Please go ahead.

Steve Pieper: Hi, this is Michael on for Roanna Ruiz at Leerink Partners. Congrats on your great quarter. We have some question about XP-8121. Could you provide more color on your interactions with the FDA regarding the upcoming initiation of the Phase III program? Are there any remaining gating items or regulatory dependencies that needs to be handled before the initiation?

[Analyst] (Leerink Partners): Hi, this is Michael on for Roanna Ruiz at Leerink Partners. Congrats on your great quarter. We have some question about XP-8121. Could you provide more color on your interactions with the FDA regarding the upcoming initiation of the Phase III program? Are there any remaining gating items or regulatory dependencies that needs to be handled before the initiation?

Speaker #5: Hi, this is Michael on for Rowan Ruiz at Liebrink Partners. And congrats on your great quarter. We have some questions about XP8121. Could you provide more color on your interactions with the FDA regarding the upcoming initiation of the phase three program?

Speaker #5: And are there any gating remaining gating items or regulatory dependencies that needs to be handled before the initiation?

John Shannon: We've had all the interactions with the agency. We're very much aligned on everything we need to do. No regulatory gating. The gating that we're going through right now is we wanna enter that phase III trial with the actual go-to-market device. Formulation scale up for commercial scale up. We're going through all the steps before we start that phase III to get all that work done and enter that phase III with the actual go-to-market device scaled up at commercial scale, which is really important when you're going into, you know, kind of a narrow therapeutic window area with a lot of range of doses. We want to make sure we take the time now so that we don't create delays later in the approval process. That's what's really the gating item, and that's what we're working on.

Speaker #4: So, we've had all the interactions with the— We're very much aligned on everything we need to do, so no regulatory gating that we're going through right now as we want to enter that Phase 3 trial.

Speaker #4: With the actual go-to-market device, and formulation scale-up for commercial scale-up. So we're going through all the steps before we start that Phase 3 to get all that work done.

John Shannon: Formulation scale up for commercial scale up. We're going through all the steps before we start that phase III to get all that work done and enter that phase III with the actual go-to-market device scaled up at commercial scale, which is really important when you're going into, you know, kind of a narrow therapeutic window area with a lot of range of doses.

Speaker #4: And enter that phase three with the actual go-to-market device scaled up at commercial scale, which is really important when you're going into kind of a narrow therapeutic window area.

John Shannon: We want to make sure we take the time now so that we don't create delays later in the approval process. That's what's really the gating item, and that's what we're working on.

Speaker #4: With a lot of range of doses, we wanted to make sure we take the time now so that we don't create delays later in the approval process.

Speaker #4: So that's what's really the gating item, and that's what we're working on.

[Analyst] (Leerink Partners): Got it. Great. Are you thinking about any partnership optionality for AD-121 at all?

Speaker #5: Got it. Great. And are you thinking about any partnership optionality for 8121 at all?

John Shannon: You know, that's a great question. We don't need to do a partnership. We have what we need to get this to market. We think it's an outstanding opportunity for ourselves. You know, from that perspective, we don't need to, but it doesn't mean that the right situation came along that we wouldn't consider that.

Speaker #4: That's a great question. We don't need to do a partnership. We have what we need to get this to market. We think it's a kind of standing opportunity for ourselves.

Speaker #4: And from that perspective, we don't need to. But it doesn't mean that the right situation came along that we wouldn't consider that.

Steve Pieper: That would drive incremental value.

John Shannon: Yeah.

Speaker #3: That would drive incremental value.

Speaker #4: Yeah.

[Analyst] (Leerink Partners): Great. Thank you.

Speaker #5: Got it. Great. Thank you.

Allison Wey: Your next question comes from the line of Jason Butler with Opco. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Jason Butler with Opco. Your line is open. Please go ahead.

Speaker #1: Your next question comes from the line of Jason Doer with OpCo. Your line is open. Please go ahead.

Jason Butler: Hey, good morning, Jason on for Lee and Rochelle, congrats on the strong quarter.

Jason Dorr: Hey, good morning, Jason on for Lee and Rochelle, congrats on the strong quarter.

Speaker #3: Hey, good morning. Jason on for Lieblinger Shell and congrats on the strong quarter. Understanding your early in the process, could the team provide any guidance on the patent infringement lawsuit for LeCorLev against the Andofilers?

John Shannon: Thank you.

Jason Butler: Understanding you're early in the process, could the team provide any guidance on the patent infringement lawsuit for Recorlev against the ANDA filers? You know, maybe what might the timelines be, and what does a favorable outcome look like for the Xeris team? Thank you.

Jason Dorr: Understanding you're early in the process, could the team provide any guidance on the patent infringement lawsuit for Recorlev against the ANDA filers? You know, maybe what might the timelines be, and what does a favorable outcome look like for the Xeris team? Thank you.

Speaker #3: Maybe what might the timelines be and what does a favorable outcome look like for the Xeris team? Thank you.

John Shannon: Well, as you can tell, we're early in. You know, we just filed on Thursday, the lawsuit. Timing-wise, I don't know, years, months, you know. You know, more to come on that. We feel really strongly in, you know, our four Orange Book patents that run till 2040. That's really important that we, you know, kinda make sure we defend and stay behind those.

Speaker #4: Well, as you can tell, we're early in. We just filed the lawsuit on Thursday. Timing-wise, I don't know—years? Months? So, more to come on that.

Speaker #4: We feel really strongly in our four Orange Book patents that run till 2040. So that's really important that we make sure we defend and stay behind those.

Jason Butler: Appreciate the color there. Looking forward to following. Thank you.

Jason Dorr: Appreciate the color there. Looking forward to following. Thank you.

Speaker #3: Appreciate the color there. Looking forward to following. Thank you.

Allison Wey: Your next question comes from the line of Balaji Prasad with Barclays. Your line is open. Please go ahead.

Operator: Your next question comes from the line of Balaji Prasad with Barclays. Your line is open. Please go ahead.

Speaker #1: Your next question comes from the line of Jenna Davidner, with Barclays. Your line is open. Please go ahead.

Balaji Prasad: Hi. Thank you for taking my question. I was just curious on the Recorlev litigation, what your openness or appetite for a settlement could be appreciating your confidence in the 2040 patent timeframe, but also maybe the balance between removing any potential overhang that could, in theory, last several years versus settling for a couple of years prior to 2040. I'm just curious what your thought process there is. Thank you.

Jenna Davidner: Hi. Thank you for taking my question. I was just curious on the Recorlev litigation, what your openness or appetite for a settlement could be appreciating your confidence in the 2040 patent timeframe, but also maybe the balance between removing any potential overhang that could, in theory, last several years versus settling for a couple of years prior to 2040. I'm just curious what your thought process there is. Thank you.

Speaker #7: Hi. Thank you for taking my question. I was just curious on the LeCorLev litigation, what your openness or appetite for a settlement could be appreciating your confidence in the 2040 patent timeframe, but also maybe the balance between removing any potential overhang that could, in theory, last several years versus settling for a couple of years prior to 2040.

Speaker #7: I'm just curious what your thought process there is. Thank you.

John Shannon: Thanks for the question, Jenna. I clearly can't comment on, you know, legal strategy, and litigation strategy. I do appreciate the question.

Speaker #4: Yeah. Thanks for the question, Jenna. I clearly can't comment on legal strategy and litigation strategy. So I do appreciate the question.

Allison Wey: There are no further questions at this time. I will now turn the call back to John Shannon, CEO, for closing remarks.

Operator: There are no further questions at this time. I will now turn the call back to John Shannon, CEO, for closing remarks.

Speaker #1: There are no further questions at this time. I will now turn the call back to John Shannon, CEO, for closing remarks.

John Shannon: Thanks. Thanks, everyone, for your questions. In closing, 2025 was a defining year for Xeris. We exited the year with strong momentum, a more durable operating foundation, and tremendous confidence in our strategy. We believe our commercial portfolio is well positioned to drive continued rapid revenue growth, and our pipeline, specifically XP-8121, has extended meaningful longer-term value as we look ahead. As we enter 2026, our priorities are clear. We believe the immediate and long-term opportunities for Xeris are increasingly exciting, and we remain committed to translating our continued success and momentum into long-lasting value for the patients we serve and our shareholders. We appreciate your time and your continued support. Thank you.

Speaker #4: Thanks. And thanks, everyone, for your questions. In closing, 2025 was a defining year for Xeris. We exited the year with strong momentum, a more durable operating foundation, and tremendous confidence in our strategy.

John Shannon: We believe our commercial portfolio is well positioned to drive continued rapid revenue growth, and our pipeline, specifically XP-8121, has extended meaningful longer-term value as we look ahead. As we enter 2026, our priorities are clear.

Speaker #4: We believe our commercial portfolio is well positioned to drive continued rapid revenue growth, and our pipeline, specifically XP8121, adds extended meaningful longer-term value as we look ahead.

Speaker #4: As we enter 2026, our priorities are clear. We believe the immediate and long-term opportunities for Xeris are increasingly exciting, and we remain committed to translating our continued success and momentum into long-lasting value for the patients we serve and our shareholders.

John Shannon: We believe the immediate and long-term opportunities for Xeris are increasingly exciting, and we remain committed to translating our continued success and momentum into long-lasting value for the patients we serve and our shareholders. We appreciate your time and your continued support. Thank you.

Speaker #4: We appreciate your time and your continued support. And thank you.

Allison Wey: This concludes today's call. Thank you for attending. You may now disconnect.

Operator: This concludes today's call. Thank you for attending. You may now disconnect.

Q4 2025 Xeris Biopharma Holdings Inc Earnings Call

Request a DemoDemo

XERS

Xeris Biopharma Holdings

Earnings