This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
3/2/2026
Hello, everyone. Thank you for joining us and welcome to the Xeris Biopharma fourth quarter 2025 earnings conference call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. To withdraw your question, press star 1 again. I will now hand the call over to Allison Way, Senior Vice President of Corporate Communications and Investor Relations. Please go ahead.
Thank you, Warren. Good morning, and welcome to the Xerox 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 Piper, 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' 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. 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 obligations 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.
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. 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. 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. 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. 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 fourth quarter was no aberration. It reflects consistent progress throughout the year as we executed with increasing discipline and effectiveness. 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. First, Recorilev. Recorilev remained the primary growth engine for Xeris in 2025 and delivered another strong quarter in Q4. Recorilev'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. This growth reflects expanding prescriber awareness in a very dynamic market coupled with increasing confidence in Recorla's differentiated clinical profile. Turning to this year, in January, we nearly doubled our Recorla commercial team, 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 and continuing well into the future. We believe RecorLive 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 RecoraLift. We are very confident in the quality and strength of our intellectual property, our legal position, and our long-term outlook for RecoraLift. We have built a strong IP foundation for RecoraLift 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. And our expectation shared during our investor day last June of 1 billion in peak sales by 2035 remains securely intact. Moving to GVOTE. GVOTE 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. GVOTE 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. 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. 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. Importantly, CAVEAS represents our longstanding 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, XP8121 continues to advance according to plan. The anticipated initiation of phase three 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. XP8121 addresses a significant unmet medical need. There are over 20 million patients with hypothyroidism on daily 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. 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, 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. 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 XP8121, our once-weekly subcutaneous levothyroxine for hypothyroidism. We believe XP8121 has the opportunity to become our next blockbuster, potentially generating one to three billion in peak revenue. 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. 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 Xerox 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. 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. 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.
You're reading a preview of the XERS Q4 2025 earnings call.
Free account.
