Welcome to our dedicated page for Xeris Biopharma Holdings news (Ticker: XERS), a resource for investors and traders seeking the latest updates and insights on Xeris Biopharma Holdings stock.
Overview
Xeris Biopharma Holdings Inc (XERS) is a biopharmaceutical company that specializes in developing and commercializing innovative, ready-to-use biotherapeutics. The company is distinguished by its deep expertise in formulation science and biotherapeutic development, with a unique focus on addressing challenging conditions in the fields of endocrinology, neurology, and gastroenterology. By leveraging proprietary technologies such as XeriSol and XeriJect, Xeris aims to simplify treatment administration and improve patient outcomes through ultra-low volume injectable devices and patient-friendly formulations.
Core Technologies and Product Portfolio
Central to Xeris Biopharma’s mission is the use of breakthrough formulation science. The company’s proprietary technologies have been instrumental in creating products that stand out for their ease of use and direct applicability to clinical needs. XeriSol focuses on innovative formulation strategies while XeriJect has paved the way for ultra-low volume injectable devices that potentially mitigate the discomfort of traditional injection methods. This technological edge supports a portfolio that is uniquely positioned to serve patient populations requiring precise, efficient, and less invasive therapeutic solutions.
Commercial Products
Xeris has successfully brought several therapies to market that address critical conditions with new methods of administration. The product Gvoke offers ready-to-use liquid glucagon, designed for the rapid treatment of severe hypoglycemia, thereby ensuring swift and reliable relief during emergencies. Keveyis, another milestone, is recognized as the first FDA-approved therapy intended for primary periodic paralysis, marking a significant advancement in neuromuscular treatment options. Additionally, Recorlev provides an FDA-approved treatment for endogenous hypercortisolemia in adults with Cushing's Syndrome. Each of these commercial products not only meets specific therapeutic needs but also exemplifies the company’s commitment to refining drug delivery through advanced biotherapeutic formulations.
Innovative Pipeline and Formulation Science
Beyond its existing market offerings, Xeris Biopharma has a robust pipeline of development programs aimed at expanding its footprint in the biotherapeutic landscape. The company’s ongoing research utilizes its own formulation platforms to address unmet clinical needs. By continuously focusing on innovation in drug formulation and injectable delivery, Xeris demonstrates an unwavering commitment to pushing the boundaries of conventional treatment methodologies. Its efforts in refining ultra-low volume, ready-to-use biotherapeutics provide a strategic advantage, potentially alleviating the challenges associated with traditional injection therapies for hundreds of millions of patients.
Market Position and Competitive Landscape
Operating within the competitive arena of biopharmaceuticals, Xeris Biopharma holds a distinct niche due to its focus on patient-friendly, ready-to-use biotherapeutics. Its targeted approach in addressing conditions related to endocrinology, neurology, and gastroenterology distinguishes it from more traditional pharmaceutical companies. Positioned in a sector that demands constant innovation and a careful balance of safety and efficacy, Xeris has integrated rigorous formulation science with practical clinical applications, thus reinforcing its reputation as a company grounded in deep technical expertise and clinical insight.
Patient-Centric Approach and Value Proposition
The company’s innovative approach is underscored by its commitment to enhancing the treatment experience for patients. By developing therapies that are not only clinically effective but also easier to administer, Xeris focuses on lowering the barriers to treatment adherence. The incorporation of patient-friendly injectable devices, designed to ease the discomfort commonly associated with injections, speaks to a broader vision of improved quality of life. This patient-centric perspective is woven into every facet of the company’s operations, ensuring that every product is developed with the end-user’s comfort and convenience in mind.
Operational Excellence and Regulatory Rigor
Xeris Biopharma operates in an environment where compliance and clinical precision are paramount. The company’s products have undergone and continue to meet stringent regulatory standards, assuring stakeholders of both safety and efficacy. Through a disciplined regulatory strategy and a commitment to high-quality manufacturing practices, Xeris reinforces its position as a trusted entity in the formulation and delivery of biotherapeutics. This adherence to strict quality control further enhances the reliability of its products, establishing a strong foundation for long-term credibility in an increasingly competitive field.
Conclusion
In summary, Xeris Biopharma Holdings Inc presents a compelling case study in the integration of advanced formulation science with practical biotherapeutic applications. Its commercial products, such as Gvoke, Keveyis, and Recorlev, exemplify its ability to address diverse patient needs effectively. Supported by proprietary technologies like XeriSol and XeriJect, the company’s approach highlights a strategic blend of innovation, patient focus, and operational rigor. Through its commitment to developing ultra-low volume, ready-to-use therapies, Xeris continues to enhance treatment options within endocrinology, neurology, and gastroenterology, providing a clear reflection of expertise and a steadfast commitment to improved patient outcomes.
Xeris Biopharma Holdings (Nasdaq: XERS) announced changes to its Board of Directors. Ricki Fairley has resigned effective immediately, while John Schmid will not seek re-election at the 2025 Annual Stockholders Meeting, which will reduce the board size to eight members.
The company has appointed James Brady as a new director to fill the immediate vacancy. Brady brings over thirty years of experience from AstraZeneca, where he held various leadership positions, most recently serving as Chief Financial Officer of MedImmune, AstraZeneca's biologics discovery and development division. He currently serves on the Board of Directors and Audit Committee of Verona Pharma plc (Nasdaq: VRNA).
Xeris Biopharma Holdings (Nasdaq: XERS) has received FDA approval for its supplemental new drug application (sNDA) of Gvoke VialDx™, the first concentrated, ready-to-dilute liquid glucagon for use as a diagnostic aid during radiologic examinations in adult patients.
The company has partnered with American Regent for commercialization in the U.S., with Xeris handling product supply while American Regent manages commercialization efforts. The product will be available in 1-count or 10-count packages of 1 mg per 0.2 mL single-dose vials, with market availability expected in Q3 2025.
This development targets the growing procedural gastroenterology market, with an estimated 20 million gastrointestinal endoscopic procedures performed annually. The product is designed to temporarily inhibit movement of the gastrointestinal tract in adult patients during radiologic examinations.
Xeris Biopharma (XERS) reported strong financial results for Q4 and full-year 2024, with record quarterly revenue of $60M (35% growth) and annual revenue of $203M (24% growth). Key product performance includes:
- Gvoke® Q4 revenue: $23.3M (+25% YoY), with 35% market share
- Recorlev® Q4 revenue: $22.6M (+131% YoY)
- Keveyis® Q4 revenue: $11.1M (-21% YoY)
The company ended Q4 with $71.6M in cash, generating $2M in cash flow and $8.3M in Adjusted EBITDA for the quarter. For 2025, Xeris projects total revenue guidance of $255M-$275M, representing over 30% growth at the mid-point.
Xeris Biopharma Holdings (Nasdaq: XERS) has announced it will release its fourth quarter and full-year 2024 financial results before U.S. markets open on March 6, 2025. The company will also provide 2025 financial guidance during this release.
Management will host a conference call and webcast at 8:30 a.m. Eastern Time on the same day. The company currently has three commercially available products: Recorlev® for endogenous Cushing's syndrome, Gvoke® for severe hypoglycemia treatment, and Keveyis® for primary periodic paralysis. Their pipeline includes XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, along with early-stage programs utilizing their XeriSol® and XeriJect® technology platforms.
Xeris Biopharma Holdings (Nasdaq: XERS) has appointed Dr. Anh Nguyen as Chief Medical Officer (CMO), succeeding Ken Johnson, who will retire on April 1, 2025. Dr. Nguyen, who previously worked at Xeris, will oversee the company's Medical, Regulatory, Preclinical and Clinical Development, and Pharmacovigilance functions.
Dr. Nguyen brings significant experience in developing first-in-class therapies and has previously served as Vice President at Asklepios Biopharmaceutical. His past achievements include contributing to the '21st Century Cures Act' and leading Gvoke®'s NDA and MAA approvals during his previous tenure at Xeris. The transition comes as Xeris prepares for Phase 3 development of XP-8121 and continues to grow its commercial portfolio, particularly Recorlev®.
Xeris Biopharma Holdings (Nasdaq: XERS) has announced its participation in three major upcoming healthcare investor conferences in early 2025. The company will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, featuring a fireside chat at 1:20 pm ET. Subsequently, Xeris will attend the Leerink Global Healthcare Conference in Miami on March 10, with a fireside chat scheduled for 8:40 am ET, followed by the Barclays 27th Annual Global Healthcare Conference in Miami on March 11 for 1x1 meetings only.
The growth-oriented biopharmaceutical company, focused on developing and commercializing innovative therapeutic products, will have its senior management team available for one-on-one meetings at all three events. Interested parties can access webcast information for the fireside chats through Xeris' investor relations website.
The American Diabetes Association (ADA) and Xeris Pharmaceuticals have announced a multi-year strategic partnership to promote awareness about glucagon prescriptions for diabetes patients. The collaboration focuses on emphasizing that all individuals with diabetes on blood glucose-lowering medications should have glucagon, preferably in ready-to-use form.
Key statistics highlight that up to 46% of type 1 diabetes patients and 21% of type 2 diabetes patients using insulin experience at least one severe hypoglycemia event annually. These events result in over 202,000 emergency department visits yearly, with 25% requiring hospitalization.
The partnership aims to develop educational materials and training resources for healthcare professionals and diabetes patients, alongside launching a national awareness campaign. The initiative aligns with ADA's updated Standards of Care in Diabetes—2025, addressing the critical need for proper glucagon prescription rates and emergency preparedness for those at risk of severe hypoglycemia.
Xeris Biopharma Holdings (XERS) has announced it expects to exceed its 2024 financial guidance with projected total revenue of $203 million, surpassing previous guidance of $198-$202 million. The company anticipates ending 2024 with over $71 million in cash, cash equivalents, and short-term investments, achieving positive cash flow in Q4.
Q4 2024 highlights include $60 million in total revenue, representing 35% growth, with Recorlev® net revenue increasing approximately $5 million (28%) sequentially. Gvoke® achieved approximately 35% market share, while Keveyis® maintained stable patient numbers. The company received a $3 million milestone payment from Beta Bionics for developing a XeriSol® glucagon formulation. However, Amgen terminated its exclusive worldwide license agreement following a portfolio assessment.
Xeris Biopharma Holdings (XERS) has announced the granting of restricted stock units (RSUs) to 19 new employees as part of its Inducement Equity Plan. The Compensation Committee of Xeris' Board of Directors approved the grants on January 2, 2025, consisting of an aggregate of 181,500 shares of common stock.
The RSUs will vest over a three-year period in equal annual installments, contingent upon the employees' continued employment with Xeris or its subsidiaries. These equity awards were granted exclusively to new hires as an employment inducement under NASDAQ Listing Rule 5635(c)(4).
Xeris Biopharma Holdings (Nasdaq: XERS) has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's senior management will engage in a fireside chat scheduled for December 3, 2024, at 8:00am Eastern Time. The event will be accessible through a live webcast on the 'Events & Presentations' section of Xeris' Investor Relations website, with a replay available for 30 days following the presentation.
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